Implantable vascular access port with dual and needle lock for high flow

Abstract

An implantable vascular access port having a main port body having one or more hollow interior chambers formed therein, each having a floor at the base of the interior chamber. The port body has an exit orifice formed in a side wall of the interior chamber. One or more parallel, lateral or angled access orifices are located in the side wall of the main port body opposite to the exit orifice relative to the port floor and associated septum (parallel or lateral or angled access orifices or septum), wherein at least one vertical access orifice and septum are positioned opposite to the floor of the interior chamber). The port chamber in the region of the exit orifice has an at least partially conical shape that is directional aligned with the parallel or lateral or angled access orifices and septum, wherein the exit orifice is continuous with a reversible exit tube or port body needle locking mechanism.

Description

Background Art

[0001] The present invention relates to a medical device that is implantable subcutaneously in a patient to facilitate medical personnel's access to the patient's vascular system.

[0002] Subcutaneous vascular access port is an implantable medical device that allows long-term repeated access to the patient's central venous system to inject various drugs and draw blood for various laboratory tests. The vascular port is particularly useful for cancer patients to administer chemotherapy for a long time under conditions of poor venous access. The vascular access port can also be used to inject iodinated contrast agents for diagnostic computed axial tomography (CAT) scans that are usually performed in cancer patients. The subcutaneous vascular access port is designed to facilitate medical professionals to reliably and quickly access the central venous system for a long time. The subcutaneous position is advantageous because when not in use (i.e., when not accessed with a dedicated needle), the covering soft tissue acts as a barrier to infection. Single lumen and double lumen ports are respectively suitable for the administration of a single drug and the simultaneous administration of two drugs.

[0003] A typical subcutaneous access port consists of a main port body consisting of a hollow, generally cylindrical access chamber with a solid, impenetrable floor (which is farthest from the skin) and a more shallow, penetrable, flexible diaphragm or partition (which is closer to the skin surface), thereby allowing repeated needle access to the hollow chamber at different time points. The impenetrable port body, including the sides and floor, is typically composed of a metal alloy or plastic material with varying degrees of radiopacity. The penetrable diaphragm is typically formed of an elastically deformable material (such as a silicone elastomer) and is radiolucent. This allows fluoroscopically guided access when the port cannot be easily accessed by palpation. The standard port access needle is a hollow beveled needle (called a Huber needle), which is manufactured in various lengths and specifications and is designed not to coring or removing portions of the silicone diaphragm. The bevel or cutting edge of the Huber needle is nearly perpendicular to the needle axis, resulting in separation of the silicone without creating a hole. The length of the Huber needle is usually in the range of 0.5 inches to 1.5 inches, and the diameter is in the range of 22 gauge to 19 gauge. The standard cylindrical access chamber usually has a rigid tubular exit orifice or conduit on one side wall, which can then be connected to a more flexible catheter, which is then usually inserted into the patient's central vein, such as the internal jugular vein or subclavian vein. The flexible catheter material can be cut to the appropriate length for the individual patient and is usually made of silicone rubber or polyurethane. The catheter can then be inserted into the desired vein through a removable larger plastic sheath system (usually a peelable sheath made by various manufacturers, which includes perforations and can be split so that the sheath is removed in two halves after successful catheter introduction). The port and attached catheter (continuous with the central venous system) allow long-term reliable central venous access. Venous access is established by palpating the port body and inserting the needle through the skin and then through the septum into the chamber (until the needle tip touches the back wall), and then blood can be attempted to be aspirated. The ability to freely aspirate blood from the port and the ability to easily inject saline or other similar solutions into the port with minimal resistance is considered satisfactory clinical demonstration of establishment of satisfactory vascular access.

[0004] A general example of an access port is shown in sagittal section. Figure 1 and in coronal section in Figure 2. This generally known port device 20 includes a main port body 22, which is approximately frustoconical in shape and thus has a hollow chamber 24, which is substantially cylindrical in shape. The chamber 24 has a flat, impenetrable floor or bottom surface 26 and a flexible, penetrable and deformable septum 28 (exemplarily a silicone elastomer), which is designed to receive a coreless hollow access needle or Huber needle to establish vascular access. The septum 28 includes a thick central portion 21 and a thinner edge portion or flange 23 for placement in a circumferential channel or groove 25 to anchor the septum in place in the main port body 22. FIGS. 1 and 2 Figure 2 The access port 20 shown has an outlet orifice 30 inside the port chamber that leads to an attached hollow outlet tube 32 that is subsequently attached to the proximal end 34 of an attached intravascular catheter 36, thereby allowing flow continuity between the port chamber 24, the outlet orifice 30, the outlet tube 32, and the proximal end 34 of the ultimately attached intravascular catheter 36. The outlet orifice 30 is formed in the side wall of the main port chamber 24 within the port body 22 at a distance above the base plate 26. A typical port is implanted in the subcutaneous tissue of the upper chest wall, and then the proximal end 34 of the catheter 36 is inserted into the distal end of the catheter 36 into one of the central veins (such as the internal jugular vein or the subclavian vein, as shown in FIG. Fig. 22 Attached to the outlet pipe 32 before.

[0005] Despite Fig. 22 The implanted vascular ports shown are effective devices, but they can fail over time, sometimes requiring surgical modification or replacement. Problems that can occur include catheter thrombosis, fibrin sheath formation around the intravascular portion of the catheter, and delayed catheter tip migration to an undesirable location. A fibrin sheath is a biological film or coating that can form around the intravascular portion of the catheter (including the tip), thereby restricting or completely blocking flow ( Fig.23 ). Clot dissolving drugs (such as tissue prothrombin activator (TPA)) are initially used to dissolve the intravascular clot and / or the surrounding fibrin sheath. When intra-catheter coagulation occurs, if the clot dissolving drugs are ineffective in reestablishing patency, then a surgical revision is required. If clot dissolving drugs (such as TPA) do not dissolve or eliminate the surrounding fibrin sheath, then mechanical removal of the sheath via endovascular stripping with an annular snare ( Fig.24 ), or alternatively a surgical modification of the port may be performed. Endovascular dissection typically requires puncturing the femoral vein in the groin area: placement of an endovascular sheath, a diagnostic catheter, followed by placement of an annular cuff under fluoroscopic conditions through the diagnostic catheter and then around the end of a fibrin sheath covering the port catheter ( Fig.24After sheathing the port catheter, traction is applied to peel off the overlying attached fibrin sheath or biofilm. This procedure is generally effective in removing the fibrin sheath, but can result in catheter breakage with the resulting intravascular foreign material, which can then migrate to the right heart and / or pulmonary circulation ( Fig.25 Similarly, if the catheter tip migrates or flips over to an undesirable location (such as the internal jugular vein), the tip can be cannulated from below after venous access is obtained via the femoral vein and can be repositioned or pulled down to the superior vena cava or right atrium ( Fig.26 ). It would be clinically desirable to have simpler, safer, more streamlined, and more effective methods to maintain secondary patency and functionality of vascular access ports.

[0006] If the catheter (tunnel-shaped or non-tunnel-shaped) leaves the skin, unlike the port that is integrally included under the skin, additional establishment methods can be used to remedy the aforementioned problems. These methods focus largely on the ability to place the wire through the proximal hub of the catheter. The wire advancement and manipulation through the catheter lumen can be used to remove blood clots in the blood vessel or destroy the covering fibrin sheath, thereby usually re-establishing the patency of the catheter. Small wire brushes, which are usually used to obtain cytological samples from the mucosal surface of the bile duct or ureter, have also been used for the purpose of reconstructing the patency of the catheter, instead of simple wire manipulation. If the wire or brush manipulation is unsuccessful, the catheter can be exchanged for a new catheter via the wire. In addition, the balloon destruction of the intravascular fibrin sheath, after the malfunctioning catheter is removed via the wire (usually achieved by a vascular sheath with a valve), can also be performed before the placement of a new catheter to ensure that there is no residual fibrin sheath attached to the vessel wall.

[0007] During port placement, difficulties may arise in the formation of redundant catheter loops in soft tissue, which are difficult to straighten or reduce. This usually occurs in the subcutaneous tissue near the vascular access site after initial intravascular catheter placement, via lubricated plastic tubing or peeling off the sheath (which is advanced into the vein and then removed). Redundant catheter loops lead to kinking of the catheter and resulting device failure. Redundant loops are sometimes difficult to remedy, requiring a large amount of soft tissue manipulation or surgical modification. It is clinically desirable to have a more reliable and effective method for initial catheter placement, and to have a way to solve such catheter placement complications.

[0008] Port removal can sometimes result in inadvertent cutting or separation of the catheter from the port body with the resulting intravascular foreign body, and the catheter is often difficult to identify and palpate during surgical removal, making removal of the port and attached catheter difficult, particularly in the presence of a large amount of surrounding scar tissue or when the catheter is old, degraded, and fragile. During this process, the catheter may be inadvertently cut or disconnected, resulting in loose intravascular foreign bodies. Surgical port modification or replacement can also be a lengthy process, first the obsolete port and catheter must be removed, and then the new port must be placed in a step-by-step manner similar to the initial placement. Port designs for better addressing the aforementioned problems may be desirable.

[0009] Standard port designs do not allow high flow applications, such as apheresis or dialysis, and most available devices are unable to achieve the required flow rates. It is desirable to have a vascular access port that maintains simple or conventional needle access for low flow applications (such as medical administration and blood extraction) while allowing high flow applications (such as apheresis or dialysis). The CRBARD PowerFIow port (U.S. Patent Application Publication No. 2014 / 0207086) allows high flow applications (such as apheresis), but is difficult to access (requiring specialized nursing training), thereby particularly limiting its clinical practicality for conventional low flow intravenous access. This design requires some unique steps to access the port, which is different from the method of accessing traditional ports, which makes it impossible for undertrained nursing staff to use it routinely. In addition, the plastic deformable vascular catheter is advanced at an angle through the rigid access channel in the device; the rigid access channel is likely to be kinked or curled, thereby reducing the flow rate and preventing reliable vascular access. These design features significantly limit its effectiveness in solving the aforementioned clinical problems.

[0010] U.S. Patent Application Publication No. 2005 / 0085778 describes a port device 38 (hereinafter referred to as Figure 3 and Figure 4 ), the port device 38 provides a suboptimal solution to some of the aforementioned problems by theoretically allowing the placement of a guidewire 40 through a directional curved port chamber 42, which is shaped like a bubble pipe bowl or an old-fashioned hearing aid (using a specially curved needle (WYR-GYD needle) 44, which has a pencil point end and a side hole 46, which is located near its distal end at an approximately right angle). After penetrating the port septum 48 in a specific orientation, in combination with the cup-shaped port chamber 42, the curved WYR-GYD needle 44 guides the wire 40 toward the exit catheter 50 ( Figure 4). The design requires the use of a specialized curved WYR-GYD non-standard needle 44 to access the port 38 in a specific orientation, thereby increasing the difficulty of access via existing devices, particularly without fluoroscopy or special training. Compared to current devices, these requirements can significantly limit the usefulness of the device for routine clinical work for medical professionals. Stocking of specialized curved WYR-GYD needles 44 for routine clinical access of a single specific device is also impractical. The cup-shaped or angled port chamber 42 also makes it difficult to access the port 38 using a standard straight or 90 degree Huber needle because the depth varies from one side of the port to the other, making it difficult to advance the needle in a consistent manner to the required depth for reliable vascular access. For routine clinical work, there is no other means of accessing the port. Even if the port is successfully accessed with a specific non-standard curved WYR-GYD needle 44, the wire 40 is advanced at a 90 degree angle (with different mechanical disadvantages of associated increased resistance), thereby limiting wire advancement, manipulation, and steerability. In addition to limiting wire manipulation, the 90-degree orientation of the wire also limits the ability to perform other interventions, such as the exchange of devices via the wire to facilitate surgical modifications. In addition, the design does not allow high-flow applications, such as apheresis or dialysis. These design features significantly limit its effectiveness in solving the aforementioned clinical problems.

[0011] Purpose of the Invention

[0012] It is an object of the present invention to provide an improved vascular access device and / or related surgical method which solves the aforementioned problems.

[0013] A more specific object of the present invention is to provide improved vascular access ports and / or related surgical methods, both for low-flow vascular access in general and for high-flow vascular access in particular.

[0014] These and other objects of the present invention will be apparent from the drawings and description thereof.While each object of the present invention is considered to be achieved by at least one embodiment of the present invention, there is not necessarily any single embodiment that achieves all of the objects of the present invention. Summary of the invention

[0015] The present invention provides an improved single lumen vascular access port and / or associated surgical methods, wherein the port includes at least two distinct needle access points or ports, at least one of which is a standard superficial penetrable flexible septum or partition positioned proximal to the skin surface for conventional clinical access (vertical or vertical or top access port) for entry at 90 degrees or nearly 90 degrees relative to the surface of the interior chamber floor; and at least a second independent parallel access or lateral access port having a penetrable septum (parallel to the port chamber floor or at an acute angle preferably less than about 40° relative to the port chamber floor) to facilitate economical advancement of various intravascular wires, brushes, devices or tools through the port chamber (and then into the outlet tube and attached intravascular catheter) for maintaining secondary port patency by removing or dislodging intravascular blood clots and / or an attached fibrin sheath attached to the intravascular catheter. The lateral access orifice may have a steeper angle (up to about 70°) relative to the port floor to improve orifice palpation and identification and ergonomic needle advancement to the lateral access orifice, particularly important for reliable execution of high-flow applications of apheresis and dialysis as contemplated herein. The outlet tube is similarly angled to maintain a colinear relationship with the lateral access orifice so that an access needle advanced through the lateral access orifice can easily traverse the port chamber to enter the outlet orifice and outlet tube (lateral or linear access orifice) in a straight path. In addition, the angled, more downwardly positioned outlet rod lowers the overall center of gravity of the port body and limits tipping or tilting of the implant device, which is accentuated by the drag created by the catheter attached to the outlet rod.

[0016] The present invention provides an improved single lumen vascular access port and / or associated surgical methods, wherein the port includes two different needle access points or orifices; one of which is a standard superficial vertical or top access port with a penetrable flexible septum, which is positioned close to the skin surface for routine clinical access for low flow applications (needle placement is at least generally perpendicular to the upper and lower walls of the port device and the adjacent overlying skin); and a second independent lateral access port or linear access port for high flow applications and other interventions (needle placement or insertion straight across the internal chamber of the port device to the exit orifice in the internal chamber, parallel to the port chamber floor and the lower wall of the port or at an acute angle, preferably a small angle or a shallow angle relative thereto), which has a penetrable septum to allow the previously placed undesirably migrated intravascular port catheter end position to be repositioned by fluoroscopic repositioning of the needle advancement, and subsequently allowing a steerable wire to pass through the lateral side wall or linear access port and subsequently through the catheter under fluoroscopic conditions.

[0017] The present invention provides an improved single lumen vascular access port and / or associated surgical methods wherein the port comprises two distinct needle access points or ports, one of which is a standard superficial penetrable septum or septum positioned close to the skin surface for routine clinical access (vertical or top access port for low flow applications), and a second independent lateral access port or linear access port having a penetrable septum to enhance the safety of port removal via the wire, thereby preventing inadvertent severing or dislodging of the port catheter, thereby creating an intravascular foreign body.

[0018] The present invention contemplates an improved single lumen vascular access port and / or associated surgical methods wherein the port comprises two distinct needle access points or ports, one of which is a standard superficial penetrable flexible septum or septum positioned close to the skin surface for routine clinical access (vertical or top access port for low flow rate applications), and a second independent lateral access port or linear access port having a penetrable septum to allow initial wire-guided catheter placement, thereby aiding in steering the catheter to a given vascular location and improving catheter pushability during deployment or aiding in immediate remediation or delayed port catheter placement complications, such as commonly redundant and / or kinked extravascular subcutaneous catheter rings.

[0019] The present invention provides an improved single lumen vascular access port body design and / or associated surgical methods, wherein the port body includes two different needle access points or ports, one of which is a standard superficial penetrable flexible septum or septum positioned close to the skin surface for conventional clinical access for low flow applications (top or vertical access port), and a second independent lateral access port or linear access port having a penetrable septum to allow port exchange of a failed port via a wire or to replace it with a different tunneled intravascular access device, such as a Hickman catheter or a plasma dialysis catheter.

[0020] The present invention provides improved vascular access ports and / or associated surgical methods to accommodate a variety of wires or intravascular devices so that they can be used at their optimal mechanical advantage or working angle to help maintain secondary port patency or facilitate port exchange via a linear access orifice (at or near 180 degrees).

[0021] According to features of the invention, when traversing linear access, the needle traverses the internal chamber of the port device along a linear path or direction to traverse the output orifice on the opposite side of the chamber. The straight line can be at an acute angle relative to the vertical or normal (and necessarily at an acute angle to the skin surface and the horizontal or upper and lower walls or floor of the port device) so that the linear path of needle insertion slopes downward from the lateral access orifice to the outlet orifice and the continuous outlet tube. The co-linear orientation of the lateral access orifice and the outlet tube facilitates the needle traversing the chamber to enter the outlet orifice and the outlet tube or optionally enter the port body channel, which is continuous with the outlet orifice and the outlet tube. The lateral access orifice may have an angle of up to about 70 degrees relative to the port floor or lower wall to improve the ergonomics of reliable lateral access orifice identification and access needle placement. The outlet orifice and the continuous outlet tube located at the lower end of the port body facilitate preventing the port device from tipping over or rotating in response to the catheter drag on the outlet tube. The outlet tube parallel to the angled straight access needle path may be similarly angled relative to vertical and at an acute angle relative to the floor of the port chamber, either the single lumen or double lumen version of the devices described herein.

[0022] Preferably, the outlet orifice is in communication with an outlet tube or rod; the outlet tube or rod is continuous with the outlet orifice and the internal chamber at least on the upstream side, co-linear with the access linear path or direction of the needle from the lateral sidewall or straight access orifice to the chamber outlet orifice. On the upstream side, the outlet tube (or in a continuous adjacent channel in the port body communicating with the internal chamber) is provided internally (within its lumen) with a convex element (such as a rib, a bump, an ear, a tooth, etc.) or a concave element (usually a groove or a depression) that matches a corresponding concave or convex element on the access needle to temporarily lock or fix the needle to the port body. The coupling or locking element may be located in the outlet tube itself, or upstream in the port chamber channel, opposite the lateral access orifice, in contiguity with the outlet tube or rod. Once locked in place, the straight access needle eliminates turbulence and therefore, and thereby eliminates the limitations to large flow applications inherent in utilizing a top or vertical access orifice for this purpose. Straight tubes or pipes have lower friction losses or turbulence relative to large volume chambers or angled pipes. For this reason, the use of rigid needles reduces the inherent risk of kinking when deformable thin-walled plastics (vascular catheters) are used for access, especially when advanced at an angle. Interlocking needles or locking mechanisms facilitate needle stability and create a tight seal, allowing high-flow procedures (such as apheresis or dialysis) to prevent backflow. At least one of the two convex and concave parts of the locking mechanism may include an elastomeric material, such as plastic. When attempting to use a port for a high-flow access procedure (such as apheresis or dialysis), multiple options are available: placement of two independent single-lumen ports, one of which is used as venous access and the other for venous return; placement of a single-lumen port, which is used as venous access and a peripheral intravenous cannula is used for venous return; or placement of a double-lumen port, which has both venous access and return capabilities. The interlocking needle mechanism also provides stability to other contemplated methods and procedures described herein, such as wire advancement through an attached intravascular catheter, thereby facilitating port placement, port catheter repositioning, maintenance of secondary patency, port removal, and port exchange over the wire.

[0023] The present invention provides an improved vascular access port body shape, port chamber shape and exit orifice configuration to optimally guide various wires, devices or tools through the port chamber via the aforementioned lateral sidewalls or one or more linear access orifices to the port chamber exit orifice and subsequently to placement into an attached exiting intravascular catheter.

[0024] The present invention provides improved vascular access ports and / or related surgical methods to facilitate stripping of the fibrin sheath via a needle and subsequent wire (in an intravascular annular cuff) that is placed through a linear access port orifice to reduce the likelihood of intravascular catheter fragmentation and intravascular foreign body generation, thereby restoring or maintaining port catheter patency in a more effective and safe manner.

[0025] The present invention provides improved vascular access ports and / or related surgical methods in which a second port orifice or penetrable septum allows an optional skin penetration site for drug administration in situations where one of the orifices is less desirable for routine clinical use (e.g., hematoma or local skin site trauma or irritation) or for simultaneous administration of a second mixed or compatible drug.

[0026] The present invention provides an improved dual lumen vascular access port and / or related surgical methods, wherein the port includes a total of four different needle access points or orifices, specifically, two parallel vertical access adjacent orifices for routine clinical use and two adjacent linear access orifices for maintaining secondary patency, thereby achieving all of the aforementioned properties, functions and methods of a single lumen device. The linear access paths can be angled toward each other to provide space outside for manipulating two needles simultaneously, if necessary. In addition, the linear access paths can be angled downward to place the access orifices closer to the skin surface, thereby facilitating orifice positioning and needle deployment. Such dual lumen vascular access ports can be used to perform high flow applications, such as dialysis using both an inlet needle and an outlet needle outside of apheresis.

[0027] The single lumen access port according to the present invention comprises at least two different needle access points or ports, at least one of which is a standard shallow penetrable flexible septum or septum positioned close to the skin surface for routine clinical access (vertical or vertical or top access port), and a second independent linear access port or lateral access port having a penetrable septum (entering parallel to the port chamber floor or at an acute angle relative to the port chamber floor) to facilitate the placement of various intravascular wires, devices or tools to help maintain secondary port patency, facilitate initial port placement, improve the safety of port removal, allow port exchange and high flow access (pheresis or dialysis) via wire. Physicians will primarily use the secondary linear access or working port for the aforementioned purposes under fluoroscopic guidance, while nurses may primarily use the vertical access port for routine clinical use (generally speaking, applications with low flow rates) without fluoroscopy; the latter in a manner equivalent to ports on the market. Professional nurses (such as apheresis or dialysis nurses) can also be trained to access lateral or linear access ports for high flow applications, such as apheresis or dialysis. Lateral or linear access ports (which are usually located on the sidewall of the port body, which is opposite to the exit outlet tube and catheter) allow various devices (including but not limited to wires) to advance at the best working angle (180 degrees or nearly 180 degrees) to enter the exit intravascular catheter. Although the lateral access port is usually arranged in the sidewall of the port body, the term "lateral" represents that the port is in the "side" of the conventional maintenance port in the top wall or upper wall of the vascular access port body. Shallow angle lateral or linear access ports provide an ideal approach angle for advancing needles and subsequently advancing wires or other devices to engage or enter the exit outlet tube and the subsequent intravascular catheter, which is located on the opposite end or side of the port body to perform various intravascular procedures with the goal of restoring or improving the patency and function of the vascular port. The lateral or linear access orifice (which may be disposed in a parallel or angled plane relative to the lower wall or floor of the port device) provides an ideal approach angle for wire advancement, manipulation, and steerability both before and after entry into the exit catheter and ultimately into the vascular system. The design goal is to not significantly change the skills or equipment required by nurses or other medical personnel for routine clinical port access relative to current devices. Therefore, there is no need for new training or new equipment for routine access purposes.

[0028] The port body shape can be configured to best accommodate lateral or linear access apertures and guide the initial needle and subsequent various wires, devices or tools through the port body to the exit outlet tube and the final intravascular catheter via one or more aforementioned linear access apertures. For example, the port body can be wider (relative to the exit catheter) to accommodate the placement of one or more linear access apertures. Therefore, a type of port can present a horseshoe shape with a more tapered or tapered end located on the exit catheter side, and a relatively wide end that incorporates one or more linear access apertures. The overall circular port chamber can passively help guide the needle toward the tapered end. The rounding of the edge of the port body along the wider horseshoe-shaped end can reduce friction for easier port placement, removal or exchange. Optionally, the port body can present a smoother, elongated, rectangular or teardrop shape on the outside to reduce friction during port removal or exchange after scar tissue has been formed, while applying traction to the port with a clamp. The more tapered or tapered inner profile of the port chamber relative to one or more linear access working orifices is conducive to or helps guide the needle into the exit outlet tube and ultimately guide the wire into the intravascular catheter and subsequently into the vascular system. Optionally, the port body and / or chamber can be configured in a more traditional cylindrical shape, a truncated conical shape, or preferably an elliptical or spherical shape (a true sphere or an oblate spheroid), because the latter design promotes the circulation and mixing of the injection fluid, thereby minimizing the dead angle in the chamber. Sharp edges and corners cause sudden changes in direction of the fluid flow through the port chamber, thereby generating dead zones, cell shearing, platelet activation, and coagulation. Perspective guidance can assist in the placement of the access needle into the circular or semicircular linear access port orifice or septum, and then guide the needle into the outlet tube while maintaining the most ergonomic shape for minimizing the activation of the dead angle and coagulation chain reaction in the port chamber. Tactile features (depressions or ridges incorporated into the linear access or lateral access orifices) are conducive to needle access without perspective guidance. For example, a skin-covered frustoconical feature (a palpable depression, indentation, or inwardly tapering recess) helps guide the needle toward a smaller, deeper inner septum (at its junction with the port chamber wall) that aligns with an exit orifice on the opposing port chamber wall.

[0029] Different outer port body shapes and inner chamber sizes and shapes can confer different advantages. For example, the outer port body can be frustoconical, elliptical frustoconical, ellipsoidal ovoid, torpedo-shaped or teardrop-shaped, but include a smaller inner cylindrical, frustoconical, elliptical frustoconical, spherical or ellipsoidal port chamber (constituting similar or different shapes of the corresponding port body and chamber) that provides space for a frustoconical, elliptical frustoconical, frustoconical or other shaped skin-covered palpable recess or inwardly tapered recess, resulting in a smaller inner septum for guiding or aligning the access needle with the exit orifice and exit tube. The wider outer part is easier to palpate and enter, while the smaller inner portion more effectively guides or aligns the access needle to the exit orifice on the opposite side of the chamber. For example, an external frustoconical port body shape with a flat dome optimizes palpation of low flow vertical access, while a spherical (true sphere or oblate spheroid) or ellipsoidal internal chamber optimizes flow dynamics within the chamber, limiting eddy currents and thereby minimizing thrombus formation within the chamber. Different geometries and sizes of the respective port bodies and chambers may also enhance palpable lateral access orifice features, such as providing space for incorporation of an inwardly tapered recess or palpable recess, resulting in a smaller internal septum for guiding or aligning an access needle with the exit orifice and exit tube.

[0030] The straight access needle can be a coreless straight Huber needle. However, in this case, the nearly vertical orientation of the cutting edge (while allowing the needle to split or separate the silicone) also results in some deflection of the wire placed through the needle. This potential mechanical disadvantage can be eliminated using a Seldinger needle, which is a straight beveled needle that includes a beveled solid stylet that protrudes from the end of the needle while preventing coring of the silicone septum.

[0031] In one embodiment of the invention, the port body or portion thereof according to the invention is at least partially radiopaque, while the corresponding vertical access and linear access orifices and the exit orifice are radiopaque, thereby facilitating fluoroscopically guided needle placement through the orifices, but can be particularly used with one or more linear access orifices for preparation of various vascular interventions, the primary goal of which is to maintain secondary port patency or to perform high flow procedures, such as plasmapheresis or dialysis. For example, only the side walls of the port body may be radiopaque or partially radiopaque, while both the vertical access orifice and the linear access orifice together with the exit orifice may be radiopaque. The linear access and / or vertical access orifices may have enhanced radiopaque edges to facilitate fluoroscopic needle placement. Alternatively, the port body may be largely radiopaque, with a fully or partially radiopaque edge or rim added to the other radiolucent linear access orifices, vertical access orifices and exit orifices to also facilitate fluoroscopic needle placement. This is an important port body design feature because a linear access port may be more difficult to access by palpation alone than a standard vertical access port, and once accessed, any procedures to remedy a malfunction of the vascular access port must always be guided by fluoroscopy, typically performed by a physician such as a radiologist.

[0032] Whether in current clinical vascular access devices or the devices described herein, vertical access ports are optimized for needle access by palpation only and are typically performed by nurses; however, fluoroscopy can also be used in laborious clinical scenarios for confirmation of correct needle position or fluoroscopically guided direct needle access. For the primary purpose of high-flow applications (such as apheresis or dialysis), linear access ports require only occasional access, thereby solving vascular port failures, catheter repositioning, port removal, or port exchange. However, if the vertical access port or septum is difficult to access due to covering skin or subcutaneous lesions, or if simultaneous administration of mixed or compatible drugs is desirable, the linear access port can also be used for routine clinical use. If, for example, a dedicated apheresis nurse encounters difficulties, or if a physician performs one of the multiple fluoroscopically guided interventions described herein, the linear access port can be accessed as needed by palpation of the various features described herein or by fluoroscopy.

[0033] These devices for maintaining port patency and optimal function include, but are not limited to, steerable wires, microbrushes, and microballoons, and are typically placed by a physician (such as a radiologist) under lens-guided conditions. Devices for remedying catheter failures have previously been described for accessible vascular access devices, such as tunnel-shaped Hickman catheters, but the novel linear access orifices and related methods described herein allow them to be effectively used for the setting of otherwise inaccessible subcutaneous vascular access ports. One or more of the aforementioned unique second linear access orifices and port bodies and port outlet designs are conducive to the placement and use of such devices. These devices can be placed through a larger 18-gauge coreless Huber needle or a Seldinger needle including a stylet, and are then typically used to access a second vertical access port for conventional clinical purposes (22 to 19 gauge), such as the administration of drugs. The use of linear access orifices and larger and possibly longer coreless Hubers or Seldinger needles including stylets may only be occasionally needed to resolve vascular port failures or perform high-flow procedures, such as apheresis or dialysis. The slidable wire material of the straight access orifice via No. 18 Huber or Seldinger needle can be used for re-clearing the occupied port catheter lumen and / or destroying the fibrin sheath around the end of the port catheter, to replace TPA or in combination therewith. Steerable wire material can also be used for repositioning the misplaced catheter end, which can migrate to an undesirable position, for example, such as the internal jugular vein. The ideal position of the catheter end is generally considered as the superior vena cava or the right atrium. After the placement of the straight access orifice and catheter, the wire material advancement to the inferior vena cava allows the safer fibrin sheath stripping relative to the current method. Femoral vein puncture allows the placement of angiographic catheters under perspective conditions, and the placement (from below) of the collar positioning wire material and continuous port catheters around the top. The collar can then be tightened around the port catheter, and then traction can be applied to make the fibrin sheath or biofilm removable. By fixing a longer wire material in the inferior vena cava away from the right atrium, the wire material allows the safer and easier capture of the port catheter. More importantly, the support of wire material reduces the possibility and consequence of the inadvertent fracture of the port catheter. If the catheter is accidentally fractured from the fibrin sheath stripping procedure, the loose piece can still be located on the wire material and can be removed from the femoral access via the collar. In the case of not utilizing the accompanying wire material, the fibrin sheath stripping can cause loose intravascular foreign bodies, which can then migrate to the heart or pulmonary circulation. Silicon or latex microballoons can also be advanced through No. 18 Huber or Seldinger needles, and then expand distally at the end of the port catheter to destroy surrounding fibrin sheaths or biofilms.

[0034] The ability to advance a needle and subsequently a wire through a linear access port and internal lumen of a port may allow for more reliable initial wire-guided catheter placement, or to help remedy immediate or delayed subcutaneous port catheter placement complications, such as redundant and / or kinked catheter loops in extravascular soft tissue.

[0035] The independent second lateral or linear access port with a penetrable septum enhances the safety of port removal via the wire, thereby preventing the inadvertent cutting or removal of the port catheter and the resulting generation of redundant intravascular foreign bodies. The identification and safe removal of the catheter may sometimes be secondary difficulties due to the large amount of adhesions around the scar tissue. The placement of the needle and subsequent wire through the linear access port and catheter enhances the operator's ability to feel and safely dissect around the catheter to remove it, while reducing the possibility of accidentally transecting the catheter and causing intravascular foreign bodies. If transecting of the catheter occurs, although it is unlikely due to traversing the wire, the fragment can be retrievable with an intravascular ring because the wire can fix it.

[0036] Independent lateral or linear access orifices (parallel to the port chamber floor or entering at an acute angle relative to the port chamber floor) with a penetrable septum allow port exchange via wires for failed ports, thereby increasing the speed and efficiency of replacing failed ports. Typically, port modification requires the gradual removal of failed ports and then the gradual replacement of new ports. After the existing port is freed from the surrounding scar tissue by blunt dissection through one or more incisions, the placement of needles and subsequent wires through the linear access orifices (opposite to the working end of the port catheter) allows the failed port to be exchanged via wires. The peelable sheath can be initially placed via the wire, thereby facilitating the placement of the new port and the attached catheter by reducing friction. The initial peelable sheath placement also often allows time to set the length of the new port catheter (before it is placed in the venous system) via the wire and through the peelable sheath relative to the length of the old port catheter.

[0037] The double lumen vascular access port according to the present invention comprises a total of four different needle access points or orifices, specifically, two parallel vertical access orifices for conventional clinical use and two adjacent or adjacent linear access orifices for remedying port catheter failure. A midline vertical or vertical septum is provided to divide the internal chamber of the port body into corresponding port body chambers. A palpable ridge or optional recess may be located between two parallel port septa or partitions to facilitate placement of the needle into the corresponding port body chamber by palpation. Two adjacent linear access orifices located on the side of the double lumen port body (opposite to the exit catheter) allow various devices (including but not limited to two wires) to be advanced into the corresponding half of the exit intravascular catheter at a preferred shallow angle (acute angle) or an optimal working angle (i.e., a right angle (180 degrees)) that exits the intravascular catheter, which includes the midline septum feature of the double lumen Portacath design. The linear access orifice provides an ideal approach angle for advancing a needle into a corresponding semicircular or semicylindrical exit orifice, and subsequently advancing a wire or other device to engage or enter a corresponding exit half of an intravascular catheter, the corresponding half being located on a port body opposite the linear access orifice, to perform various intravascular procedures or to perform high-flow vascular procedures (such as plasma separation or dialysis) with the goal of restoring or improving patency of a vascular port. A more conical or tapered shape of the interior surface of the corresponding port body chamber (separated by a midline septum, which is opposite to the corresponding linear access working orifice) facilitates or helps guide two corresponding linear access needles or, optionally, wires into the corresponding exit orifices, then obtaining access to the two halves of the exit catheter and vascular system under perspective conditions, for performing various methods described herein. The linear access orifice (aligned with the corresponding exit orifice) provides an ideal approach angle for advancement of a needle and / or wire before and after entering the exit catheter and the final vascular system, as well as wire manipulation and steerability.

[0038] The specific needle design including a semicircular (or semi-cylindrical) cannula and a semicircular (or semi-cylindrical) pointed stylet can provide for directly engaging the semicircular outlet orifice, allowing the cannula to be temporarily locked to the port body and the outlet tube (particularly for high flow procedures). High flow applications (such as apheresis and dialysis) require direct needle engagement (connected with a reversible locking mechanism (no backflow)) in the corresponding half of the semicircular outlet tube, thereby requiring the use of a corresponding semicircular cannula and a semicircular pointed internal stylet. The traditional cylindrical cannula with a pointed stylet (Seldinger needle) can be used to guide the wire into the semicircular outlet orifice in any low flow application (such as the maintenance of the patency of the secondary port) without the need to fix or lock the needle directly to the outlet orifice. Optionally, to allow use of a conventional cylindrical needle assembly with a dual lumen vascular access port according to the present invention, the vascular access port can be provided with (1) a dual outlet tube with a cylindrical lumen, (2) a dual flow outlet tube with a proximal end portion and a distal end portion, the proximal end portion having two cylindrical lumens and the distal end portion having a semi-cylindrical lumen, and (3) a thickened port body wall having two cylindrical lumens that communicate with the semi-cylindrical lumen in the outlet tube.

[0039] The port body shape can be configured to best accommodate the linear access apertures, and initially guide the needle and subsequently guide various wires, devices or tools through the port body to the exit outlet tube and the final intravascular catheter via one or more of the aforementioned linear access apertures. For example, the port body can be wider relative to the exit catheter to accommodate the placement of one or more linear access apertures. Therefore, a type of port can present a horseshoe shape with a more tapered or tapered end located on the exit catheter side, and a relatively wide end that incorporates one or more linear access apertures. The overall circular port chamber can passively help guide the needle toward the tapered end. The rounding of the edge of the port body along the wider horseshoe-shaped end can reduce friction for easier port placement, removal or exchange. Optionally, the port body can present an elongated, elliptical or teardrop shape on the outside to reduce friction during port removal or exchange after scar tissue is formed, wherein traction is applied to the port by a clamp. The tapered or tapered interior profile of the port chamber wall (as opposed to one or more straight access working orifices) facilitates or assists in guiding the needle or wire into the exit exit tube and ultimately into the intravascular catheter and subsequently into the vascular system.

[0040] Alternatively, the body of the dual chamber vascular access point can be configured in a more conventional manner with two cylindrical or preferably elliptical or round spherical chambers (true spheres or oblate spheroids) separated by a palpable ridge, because this design promotes circular motion and mixing of the injected fluid, thereby minimizing dead angles in the chamber. Sharp edges and corners cause sudden changes in direction of the fluid flow through the port chamber, thereby generating dead zones, cell shearing, platelet activation, and coagulation. After traversing the port chamber, fluoroscopic guidance only allows the access needle to the circular or semicircular linear access port orifice or septum and then to the placement in the outlet port and outlet tube, and then the wire is screwed into the exit catheter, while maintaining the most ergonomic shape for minimizing the activation of the dead angle and coagulation chain reaction in the port chamber. Relative to current devices, this design does not substantially change the techniques or equipment required for conventional clinical dual lumen port access by nurses or other medical professionals. Therefore, for conventional vertical access purposes, no new training or new equipment is required.

[0041] In another embodiment of the invention, the double lumen port body or portion thereof according to the invention is at least partially radiopaque, while the corresponding vertical access orifice and linear access orifice and exit orifice are radiolucent, thereby facilitating fluoroscopically guided needle placement through the orifice (but particularly one or more linear access orifices) for preparation of various vascular interventions, the primary goal of which is to maintain secondary port patency or for performing high flow procedures such as apheresis or dialysis. For example, only the sidewalls of the port body may be radiopaque or partially radiopaque, while the vertical access orifice and the linear access orifice and the corresponding exit orifice may all be radiolucent. Alternatively, the linear access orifice, the vertical access orifice or the exit orifice may have an enhanced radiopaque edge to facilitate fluoroscopic needle placement. Alternatively, the double lumen port body may be largely radiopaque, wherein a fully or partially radiopaque edge or margin is provided for the otherwise radiolucent linear access orifice, the vertical access orifice or the exit orifice to facilitate fluoroscopic needle placement. This is an important port body design feature because accessing a linear access port can be more difficult in some circumstances than a standard vertical access port when only palpation is utilized; and once accessed, any procedures used to remedy a malfunction of the vascular access port can always be guided by fluoroscopy, typically performed by a physician (such as a radiologist).

[0042] Thus, an implantable vascular access port may be provided with different degrees of radiopacity or radiotranslucency to facilitate access under fluoroscopic guidance. If (i) a main portion of the port body has a first predetermined degree of radiopacity, (ii) the lateral access aperture and the exit aperture exhibit a second predetermined degree of radiopacity, and (iii) the port body has an edge region extending around and defining the lateral access aperture and the exit aperture, the edge region having a third predetermined degree of radiopacity, then at least one of the second and third predetermined degrees of radiopacity is substantially different from the first predetermined degree of radiopacity. Optionally, the vertical access aperture may also be distinguished by the second predetermined degree of radiopacity or by an edge region of the third predetermined degree of radiopacity. The radiopacity may vary between substantially 0 (radiotranslucent) and substantially 100% (completely radiopaque). The degree of radiopacity is understood to be qualitative, and each degree of radiopacity may be within a numerical or percentage range, but in cases where the degree differs for enhanced visualization, the respective ranges of radiopacity do not overlap. Thus, the various physical features are distinguished in a fluoroscopic manner. It is understood that the radiopacity of a lateral access port or a top (vertical) access port is the same as and determined by the radiopacity of the associated septum.

[0043] In summary, the dual lumen access port according to the present invention includes a total of four different needle access points or ports, specifically, two parallel vertical access ports for conventional clinical use and two adjacent linear access ports for high flow applications (such as apheresis or dialysis) and maintaining secondary patency, thereby achieving all of the aforementioned properties, functions and methods of a single lumen device.

[0044] In a high-flow vascular access method according to the present invention, ideally for apheresis or dialysis, a catheter is attached to the hollow outlet tube of a vascular access port, and the catheter is extended or deployed in the patient's central venous system. The distal end portion of the coreless needle assembly is inserted through the lateral access septum and the orifice along a linear path, inserted into the internal chamber across the access port, and inserted into the hollow outlet tube through the outlet orifice. The coreless needle assembly is releasably locked to the hollow outlet tube at least indirectly, and the stylet is removed from the coreless needle assembly after the distal end portion of the coreless needle assembly is inserted through the lateral access septum. Thereafter, blood is guided from the patient's central venous system through the catheter, hollow outlet tube, and cannula at a high flow rate. An apheresis or dialysis procedure is performed on the blood, which flows from the patient's central venous system through the catheter, hollow outlet tube, and cannula, and then the blood is returned to the patient's vascular system.

[0045] Blood can be returned to the patient's vascular system by directing the blood through a peripheral or central needle cannula or a separately implanted vascular access port. Optionally, the vascular access port through which blood is withdrawn from the patient can be a double lumen port with both precision access and return capabilities. In the latter case, the port body of the dual lumen port preferably has (i) at least two internal chambers, (ii) at least two outlet orifices, each communicating with a respective one of the at least two internal chambers, (iii) at least two lateral access orifices, each defining a respective linear access path or direction to a respective one of the at least two outlet orifices, (iv) at least two top access orifices, each formed in the upper wall and defining a respective vertical or vertical access path or direction substantially perpendicular to the upper wall and the lower wall or the bottom wall, (v) at least two first diaphragm covers, which close a respective one of the at least two lateral access orifices, (vi) at least two second diaphragm covers, which close a respective one of the at least two top access orifices, and (vii) at least a hollow outlet tube passage, which is fluidically connected to a respective one of the at least two internal chambers and a respective one of the at least two outlet orifices.

[0046] A specific needle design including a semicircular (or semi-cylindrical) cannula and a semicircular (or semi-cylindrical) pointed stylet may be provided. To directly engage the semicircular outlet orifice to allow temporary locking of the cannula to the port body and outlet tube (particularly for high flow procedures). Similarly, high flow applications (such as apheresis and dialysis) require direct needle engagement (connected with a reversible locking mechanism (no backflow)) to the corresponding half of a conventional semicircular outlet tube. To allow the use of a conventional cylindrical needle assembly with a double lumen vascular access port, the vascular access port may be provided with (1) a double outlet tube with a cylindrical lumen, (2) a double flow outlet tube with a proximal end portion and a distal end portion, the proximal end portion having two cylindrical lumens, the distal end portion having a semi-cylindrical lumen, and (3) a thickened port body wall with two cylindrical lumens, the cylindrical lumen communicating with the semi-cylindrical lumen in the outlet tube. Alternatively, a semi-cylindrical stylet needle may be used for releasably lockable engagement of the needle cannula with the semi-circular outlet tube lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 A sagittal cross-sectional view of an access port device designed according to the prior art.

[0048] Figure 2 is along the vertical plane (orthogonal to Figure 1 plane), along the line II-II Figure 1 Coronal cross-sectional view of an access port of an access port device.

[0049] Figure 3is a sagittal cross-sectional view of a cup-shaped or tapered access port lumen device according to a prior art design that includes a specialized curved pencil-point access needle that in turn includes a distal side hole along the apex of the curved needle.

[0050] Figure 4 For similar Figure 3 A sagittal cross-sectional view of a prior art design of FIG. 1 , also showing a guidewire that is slidably inserted through the needle device and into the catheter.

[0051] Figure 5 is a top plan view of an access port device according to selected exemplary embodiments of the present invention wherein one vertical access septum and one linear access septum have an overall oval shape relative to the port body.

[0052] Figure 6 is taken along the line VI-VI Figure 5 Midline sagittal view of the access port device.

[0053] Figure 7 for Figure 5 Midline sagittal section view of the access port device with a standard curved Huber needle inserted through the perpendicular access port septum and associated orifice.

[0054] Figure 8 for Figure 5 A midline sagittal cross-sectional view of an access port device with a straight Huber needle or Seldinger needle inserted through the linear access septum and associated orifice, also showing a guidewire slidably inserted through the needle toward an opening of a tubular catheter attachment site that protrudes from the port body.

[0055] Fig. 9 is along the vertical plane (which is perpendicular to Figure 6 plane), along the line IX-IX Figure 5 Coronal cross-sectional view of the access device in , showing the tapered shape of the port chamber pointing toward the opening of the tubular catheter attachment site.

[0056] Fig.10 is along the horizontal plane (which is perpendicular to Figure 6 plane), along the line XX intercepted Figure 6 Horizontal cross-sectional view of the access device.

[0057] Fig.11 For similar Fig.10 , also showing a straight Huber or Seldinger needle inserted through the horizontal port septum or orifice with a guidewire slidably inserted through the needle to the exit rod or tube and the attached single lumen catheter.

[0058] Fig.12 is a top view of a dual lumen access port device according to selected exemplary embodiments of the present invention, wherein two vertical access septa and two linear access septa or orifices have an overall oval or elliptical frusto-conical shape relative to the port body.

[0059] Fig.13 For along Fig.15 The line XIII-XIII intercepts Fig.12 Sagittal cross-sectional view of the access port device.

[0060] Fig.14 is along the vertical plane (which is perpendicular to Fig.13 drawing plane), along Fig.12 The line XIV-XIV intercepts Fig.12 and Fig.13 is a coronal cross-sectional view of an access device and showing the tapered shape of the port chamber with two semicircular openings pointing toward the double lumen tubular catheter attachment site.

[0061] Fig.15 is along the horizontal plane (which is perpendicular to Fig.13 drawing plane), along Fig.13 The line XV-XV intercepts Fig.12 to Fig.14 A horizontal cross-sectional view of an access device also showing the attached double lumen catheter.

[0062] Fig.16 For similar Fig.15 , also showing two straight Huber or Seldinger needles inserted through two separate straight access port septa or orifices, wherein a guidewire is slidably inserted through the respective needles into the two halves of the double lumen catheter.

[0063] Fig.17 is a top view of an access port device according to selected exemplary embodiments of the present invention, wherein one vertical access septum and one linear access septum have an overall frusto-conical shape relative to the port body.

[0064] Fig.18 is taken along the line ⅩⅧ-ⅩⅧ Fig.17 Midline sagittal view of the access port device.

[0065] Fig.19 is along the vertical plane (which is perpendicular to Fig.18 plane), along the line XIX-XIX Fig.17 Coronal cross-sectional view of an access device showing the tapered shape of the port chamber pointing toward the opening of the tubular catheter attachment site.

[0066] Fig. 20 is along the horizontal plane (which is perpendicular to Fig.18 plane), along which the intersection of XX-XX is taken Fig.18 Horizontal cross-sectional view of the access device.

[0067] Fig.21 For similar Fig. 20 , also showing a straight Huber or Seldinger needle inserted through a linear access port septum or orifice, wherein a guidewire is slidably inserted through the needle into a single lumen catheter.

[0068] Fig. 22 A schematic diagram of a central venous access system for a general patient designed according to the prior art.

[0069] Fig.23 Schematic diagram of a central venous access system for a typical patient according to the prior art design, in which a biofilm or fibrin sheath is coated on the intravascular portion of the catheter tip.

[0070] Fig.24 For similar Fig.23 Schematic diagram of a typical patient's central venous access system designed according to the prior art, showing the positioning of the annular cuff via the catheter and the fibrin sheath.

[0071] Fig.25 For similar Fig.24 Schematic diagram of a typical patient's central venous access system according to prior art design, illustrating a procedure-related complication of a free intravascular catheter segment, which may occur in the absence of the inventive device described herein.

[0072] Fig.26 Schematic diagram of a central venous access system for a typical patient according to prior art design, showing an inverted or misplaced catheter.

[0073] Fig. 27 is a schematic diagram of a central venous access system according to the present invention, illustrating advancement of an annular cuff over a wire placed through a port level septum in preparation for fibrin sheath stripping, commensurate with the methods described herein.

[0074] Fig.28 For similar Fig. 27 Schematic diagram of a central venous access system according to the present invention showing further advancement of an annular cuff via a wire placed through a port to linearly access the septum and subsequently via a catheter coated with a fibrin sheath that is ideally positioned to perform a fibrin sheath stripping, commensurate with the methods described herein.

[0075] Fig.29 For similar Fig.28 Schematic diagram of a central venous access system according to the present invention, showing removal of a fibrin sheath via an annular cuff of a wire placed through a linear access port septum, consistent with the methods described herein.

[0076] Fig.30 For similar Fig.28 Schematic diagram of a central venous access system according to the present invention showing how the location of a broken catheter segment can be removed in a controlled manner via a wire placed through the linear access port septum, thereby preventing Fig.25 The complications of free intravascular segments shown are commensurate with the approach described in this article.

[0077] Fig.31 is a schematic diagram of a central venous access system according to the present invention showing the catheter tip being inverted and the wire advanced into the linear access port septum in preparation for catheter repositioning, commensurate with the methods described herein.

[0078] Fig.32 For similar Fig.31 A schematic diagram of a central venous access system according to the present invention showing repositioning of a catheter tip performed using a wire placed through a linear access port septum, wherein the wire is shown exiting from the end of the catheter, consistent with the methods described herein.

[0079] Fig.33 For similar Fig.32 Schematic diagram of a central venous access system according to the present invention showing repositioning of a catheter tip performed using a wire placed through a linear access port septum, wherein the wire has now been withdrawn into the catheter, commensurate with the methods described herein.

[0080] Fig.34 is a schematic side elevation view of a coreless needle and cannula assembly, and a cross-sectional view of an outlet tube formed with cooperating snap-lock mating formations that may be used in any of the vascular access ports disclosed herein.

[0081] Fig.35 is a schematic side elevation view of another implantable vascular access port according to the present invention having a frustoconical body and a frustoconical (shown) or cylindrical chamber.

[0082] Fig.36 For similar Fig.35 Schematic side elevation view of an implantable vascular access port showing optional superior or higher positioning of the inlet or lateral orifice and the outlet stem.

[0083] Fig.37 A schematic side elevation view, in part, of another implantable vascular access port according to the present invention showing a frustoconical port body and an oval or ellipsoidal chamber.

[0084] Fig.38 For similar Fig.37 Schematic side elevation view of an implantable vascular access port showing a tangential outlet tube relative to an oval or ellipsoidal port chamber, and a tapered skin-covered exterior inwardly tapering depression or palpable indentation forming a lateral access orifice with an internal septum.

[0085] Fig.39 For similar Fig.38 Schematic side elevation view of an implantable vascular access port showing a curved or dual-angled outlet tube.

[0086] Fig.40 A schematic side elevation view, in part, of yet another implantable vascular access port according to the present invention showing a frustoconical port body and a frustoconical (shown) or cylindrical chamber and internal angled exit stem.

[0087] Fig.41 For similar Fig.40 Schematic side elevation view of an implantable vascular access port showing a modified frustoconical port body shape with an internal angled exit stem and a lateral access orifice.

[0088] Fig.42 For similar Fig.41 Schematic side elevation view of an implantable vascular access port showing an ellipsoidal interior chamber with an internal angled exit rod.

[0089] Fig.43 For similar Fig.42 Schematic side elevation view of an implantable vascular access port body showing a tangential exit rod and access orifice relative to an ellipsoidal port chamber having an internal angled exit rod.

[0090] Fig.44 FIG. 4 is a schematic horizontal cross-sectional view of another implantable dual-chamber vascular access port according to the present invention.

[0091] Fig.45 For a larger proportion Fig.44 Detail of a port body, showing an annular bead inside a corresponding passageway in the port body wall for reversibly locking the stylet cannula to the port body to allow fluid communication between the passageway and a corresponding channel in the dual flow outlet tube.

[0092] Fig.46is a schematic perspective view of a universal vascular access port according to the present invention, showing areas of varying degrees of radiopacity or translucency to facilitate use under fluoroscopic guidance.

[0093] Fig.47 is a schematic partial cross-sectional view of a dual-chamber vascular access port with dual outlet tubes according to the present invention.

[0094] Fig.48 Schematic diagram of an outlet tube for a dual chamber vascular access port showing two lumens, each lumen having a distal end having a D-shaped cross section and a proximal end having a circular cross section. DETAILED DESCRIPTION

[0095] As used herein, the terms "vertical access" and "straight access" refer to the respective angles of placement or insertion of a needle through the skin surface into a vascular access port implanted below the skin surface. The term "vertical access" refers to a direction of needle placement or insertion that is generally or at least mostly perpendicular to the floor surface of the interior chamber of the access port and the skin covering the vertical access septum of the port (as opposed to the skin covering the side walls of the port, which may be inclined or angled). As described herein, the vertical access orifice in the port body is covered by a penetrable flexible septum that is positioned close to the skin surface for routine clinical access. At the same time, the vertical access orifice is located in the upper surface of the implantable vascular port (immediately adjacent to the skin surface) and may be referred to as the "top access orifice".

[0096] Ideally, the vertical access needle insertion line or direction is oriented 90° relative to the floor surface of the end body internal chamber or the lower wall of the port body. However, in practice, the needle insertion direction may deviate from the exact vertical 90° by an angle of 10° to 20°.

[0097] Meanwhile, the term "straight access" refers to a direction of needle placement or insertion that is at least partially parallel to the bottom or lower wall of the implanted vascular access port, or is preferably tilted at an angle of less than about 40° but possibly up to about 70° relative to the bottom or lower wall. The port sidewalls and the skin covering the port sidewalls may be tilted or angled relative to the bottom plate of the port body. The straight access orifice is configured for placement or penetration of a needle, which is preferably parallel to or nearly parallel to the (preferably flat) bottom plate of the port. However, a straight access path (exemplarily for high flow rate access applications, such as apheresis and dialysis) may be tilted at an angle of up to about 70° relative to the lower wall of the port body. The straight access path is colinear with the outlet tube on the opposite side of the port body to facilitate engagement of the transverse chamber needle in the outlet tube. The outlet tube or port body is provided with a reversible needle locking mechanism for performing high flow procedures (such as apheresis and dialysis), as well as stable needle positioning for performing other methods described herein.

[0098] The vascular access "port body" is contemplated herein to mean a housing or shell made of a material that resists penetration by a medical needle. The body of the vascular access port is provided with an opening or orifice through which a needle may be inserted. A "lateral access orifice" or "linear access orifice" is used herein to mean an opening located in the port body to allow linear access to an outlet tube on the opposite side of the port chamber. Although lateral access ports are typically provided in the side walls of the port body, the term "lateral" as used herein refers to an access port or orifice that is "to the side" of a conventional maintenance access port in the top or upper wall of the vascular access port body. Thus, the lateral access port may be located in the upper wall of the vascular access port body (lateral to the main or conventional access orifice). However, it is contemplated that a lateral access port (to efficiently facilitate certain applications such as high flow venous access for dialysis and apheresis) defines a linear access path oriented between 0 and approximately 70 degrees from the horizontal lower wall of the port body and the floor surface of the associated internal chamber (in line with the outlet tube on the opposite side of the port chamber).

[0099] As described herein, a "lateral access port" or "linear access port" in a port body is covered by a penetrable flexible membrane positioned proximal to the skin surface for allowing fluoroscopic repositioning of a previously placed, undesirably migrated intravascular port and / or associated catheter tip (by advancing a needle through the lateral sidewall or linear access port, then through the port body, into the exit rod, and subsequently advancing a steerable wire through the needle into the attached catheter under fluoroscopic conditions).

[0100] The term "outwardly tapered chamber extension" is used herein to refer to a recess or auxiliary cavity within the port body that communicates with the main internal port cavity on the inside and forms an outlet orifice that communicates with an outlet tube that is configured to extend into a vein of the patient upon implantation or deployment of the associated vascular access port into the patient. The outlet orifice may be defined as the entirety of the recess or auxiliary cavity between the internal cavity itself and the outlet tube, or may alternatively be limited to one plane, such as the upstream or downstream end of the recess or cavity. In the present disclosure, this is the last option that is generally contemplated.

[0101] The term "inwardly tapered recess" is used herein to refer to a recess, depression or recessed portion that extends from its outer surface through the port body to the internal cavity of the port body. The recess, depression or recessed portion has a transverse dimension (width, diameter) that is smaller on the inside than on the outside. The recess, depression or recessed portion may be hemispherical, oval, elliptical, hyperbolic, etc., and have an accompanying circular cross-section or may be conical with a polygonal cross-section. Other tapered geometries may also be utilized. The inwardly tapered recessed portion in the port body typically includes a lateral access orifice that is provided with a self-sealing septum or membrane at the inner end for needle penetration at its junction with the inner chamber wall.

[0102] As used herein with reference to high flow vascular access applications such as apheresis and dialysis, the word "needle" and the term "needle assembly" refer to a coreless access needle assembly that includes an outer cannula and a sharp inner stylet (which traverses the longitudinal lumen of the cannula). The cannula and corresponding arrow inner stylet can be cylindrical or semi-cylindrical (with a D-shaped cross-section), depending on the shape of the lumen of the corresponding outlet tube. The semi-cylindrical cannula and stylet shape is desirable for a dual lumen port described herein (see, e.g., Fig.15 ), while cylindrical needles can be used in various single lumen versions and another dual lumen embodiment with outwardly angled lateral access ports (see Fig.44 ). The stylet and cannula are preferably made of metal or alloy material. The cannula is formed near the distal end with an annular groove or one or more beads (optionally annular) for cooperating with an elastic bead or groove in a reversible locking configuration, which protrudes from the inner surface of the outlet tube or tubular passage inside the wall of the port body of the existing implantable vascular access port as described herein. The stylet is used to penetrate the self-sealing membrane or septum and is removed from the cannula once the cannula is releasably locked to the outlet tube or port body passage.

[0103] As described herein, the port body of a vascular access port is preferably made of a majority of at least partially radiopaque material. Ideally, the material is not completely radiopaque to allow visualization of the internal lumen and the needle's progress through the lumen toward the exit orifice during a vascular access procedure. The port body may have a small portion, such as along an edge region, surrounding the lateral access, top access, and exit orifices, which have a radiopaqueness that is significantly different from the main portion of the port body to facilitate visual detection of the orifices and septum during the access procedure. Typically, but not necessarily, the septum is made of a radiopaque material; in another version, the port body of a vascular access port as described herein is preferably made of a majority of radiopaque material to allow visualization of the needle's progress through the lumen toward the exit orifice during a vascular access procedure. The edges surrounding the lateral access, top access, and exit orifices of the radiopaque port body are at least partially radiopaque. Likewise, typically, but not necessarily, the septum is made of a radiopaque material.

[0104] like Figures 5 to 11 The implantable vascular port device or apparatus 52 shown includes a main port body 56 having an internal chamber 54 formed therein. The main port body 56 can have a variety of shapes, including but not limited to frustoconical, elliptical frustoconical, teardrop, torpedo, horseshoe, and oval. The port body 56 and the port chamber 54 can each have similar or different shapes. Possible chamber shapes include but are not limited to cylindrical, frustoconical, elliptical frustoconical, ellipsoidal, and spherical. Figures 5 to 11 The port body 56 and port chamber 54 are shown in an elliptical frustoconical shape. The main port body 56 has two penetrable septa 58 and 60 that extend across and close the respective orifices 158 and 160: a vertical or top access orifice septum 58 in the orifice 158 similar to a conventional port, and a novel linear or lateral sidewall access septum 60 in the orifice 160 (which is primarily used to perform various interventions to facilitate initial port placement, port catheter repositioning, maintenance of secondary port patency, port removal, high flow applications, and port exchange). The radiolucent septa 58 and 60 are formed of an elastically deformable material, such as a silicone elastomer. The vertical or top access septum 58 and the linear or lateral sidewall access septum 60 each include a Figures 6 to 9 The respective thickened center portions 41a and 41b and the thinner edge portions or flanges 43a and 43b are shown for placement in the respective circumferential channels or grooves 45a and 45b to anchor the diaphragm in place in the main port body 56. The main port body 56 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 56, a titanium liner can be used along the floor or bottom surface 62 of the port chamber 54.

[0105] In one version of the implantable vascular access port, the port body 56 and port chamber 54 are wider on the side including the linear access septum 60 to accommodate and facilitate needle placement from various approach angles, as opposed to the opposite side of the port body 56 including the hollow outlet tube 64, which may be narrower or tapered. A sufficiently wide linear access port orifice may also be formed in a standard frustoconical port body without widening the side of the port including the linear access orifice.

[0106] The linear or lateral sidewall access orifice 160 may have a variety of shapes and sizes, such as being in a circular, oval, or rectangular configuration; if the port body and chamber are in a frustoconical configuration, the linear access orifice is angled or curved. A wider linear access orifice may allow for easier needle placement from different needle skin penetration locations and approach angles. In another version, the linear access orifice 160 may be narrower and therefore less dependent on the port body shape, thereby allowing for precise alignment of the linear access septum 60 with the port chamber exit orifice 66. A narrower linear access orifice 160 may be more difficult to aim or access, but may be precisely aligned with the exit port chamber exit orifice 66, thereby facilitating placement of the linear access needle 72 and subsequent slidable wire 74 therethrough into the exit orifice 66 and attached catheter 70.

[0107] In one version, the port body is relatively radiopaque, while the corresponding silicone covered top access and lateral sidewall apertures are radiopaque. The rim of at least a portion of the radiopaque port body 56 surrounding the narrower precisely aligned radiopaque linear or lateral sidewall access aperture 160 may be made more radiopaque than the port body to better guide placement of an access needle through the linear access septum 60 under direct fluoroscopic guidance; such a modification may be valuable regardless of the size of the aperture. Thus, the disadvantages of accessing a small linear access aperture 160 may be overcome by utilizing a protruding radiopaque port body marker along its edge, thereby allowing fluoroscopic needle placement while taking advantage of the more precise alignment of the linear access aperture 160 with the port chamber exit aperture 66. The exit aperture 66 is configured to be radiopaque (similar to the corresponding access aperture) to facilitate fluoroscopic intubation with a needle or wire; similarly, the exit aperture 66 may have a protruding at least partially radiopaque rim or edge for needle guidance. In another version, the access openings are provided along similarly radiolucent top and lateral sidewalls and the exit opening is radiolucent, thereby similarly directing needle placement into or through any of the aforementioned openings under fluoroscopic conditions. The port chamber exit opening 66 may be surrounded by the inner surface of the interior chamber 54 having a straight tapered or funnel-like shape and defining an outwardly tapered chamber extension (as opposed to a curved funnel) to facilitate placement of a slidable wire 74 through a straight access needle 72, which is placed through the straight access septum 60 to facilitate entry of the wire 74 into the hollow exit tube 64 and subsequently into the proximal catheter 70 ( Figures 8 to 11 ). Alternatively, the needle may engage directly with a channel in the port body 56 adjacent to the exit orifice 66 or exit stem 64 prior to wire advancement.

[0108] Figures 6 to 9 The straight tapered outlet orifice or outwardly tapered chamber extension 66 is shown positioned flush with the floor or bottom surface 62 of the interior chamber 54 of the port body 56. Alternatively, the straight tapered chamber outlet orifice 66 may be centered at a midpoint between the top or upper surface 68 of the port chamber 54 and the floor or bottom surface 62 or anywhere therebetween, with the precise location preferably being aligned with the location of the linear or lateral sidewall access orifice 160. Figure 7A vertical access orifice 158 is shown for conventional clinical use, with a curved Huber access needle in place for injecting medication into the internal port chamber 54, which then passes through the port chamber outlet orifice 66, the hollow outlet tube 64, and ultimately into the proximal catheter 70. The main port body 56 may have one or more circular or elliptical eyelets 78 formed along its periphery, particularly along the peripheral or circumferentially extending foot 79, to allow suturing of the port device 52 to the underlying soft tissue within a surgically created subcutaneous pocket. These eyelets 78 may be filled or unfilled with a silicone elastomer material.

[0109] In the double lumen implantable vascular access port 252 ( Figures 12 to 16 ), two internal port chambers 254 are separated by a midline divider or partition 282 and exhibit respective vertical or top access orifices 258 and respective linear access or lateral sidewall orifices 260. Port 252 includes a main port body 256, which in one form is of an elliptical frustoconical configuration and has four penetrable septa, namely two vertical access septa 258' on respective orifices 285 (similar to conventional dual ports) and two linear access or lateral sidewall septa 260' on respective orifices 260 (primarily used to perform various interventions to facilitate port placement, port repositioning, maintenance of secondary port patency, port removal and port exchange). The septa (258' and 260') are formed of an elastically deformable material, such as a silicone elastomer. The construction of the respective vertical and linear access septa (258' and 260') may include a thickened central portion 241 (such as Fig.13 and Fig.14 The diaphragm is provided with a circumferential channel or groove 245 (shown) and a thinner edge portion 243 for placement in the circumferential channel or groove 245 to anchor the diaphragm in place in the main port body 256. The main port body 256 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 256, a titanium liner (not separately shown) can be used along the floor or bottom surface 262 of the port chamber 254.

[0110] The linear access orifice 260 may have a variety of shapes and sizes, such as presenting a circular, elliptical, or rectangular configuration; if the port body 256 and chamber 254 present an elliptical frustoconical configuration, then the exterior and interior body surfaces, not individually labeled, have surface curvatures along multiple dimensions. Where the linear access orifice 260 and associated septum 260' are provided with a larger width (parallel to the floor or bottom surface 262), it may be easier to place a needle from different approach angles. In another version of the dual lumen implantable vascular access port 252, the linear access orifice 260 may be narrower and, therefore, more independent of the port body shape, thereby allowing for more precise alignment of the linear access orifice 260 with the corresponding port chamber outlet orifice 266. The narrower parallel access orifice 260 may be more difficult to aim or enter, but can be precisely aligned with the semicircular exit orifice 266 of the exit port chamber in the horizontal and / or vertical plane, thereby facilitating the placement of the linear access needle 272 and the subsequent sliding wire 274 to the semicircular exit orifice 266 and to the corresponding side of the attached double lumen catheter 284 (with a midline separator or separator 253). Optionally, the needle 272 can be directly engaged with the exit orifice 266 before the wire is advanced. A specific needle design including a semicircular or D-shaped cannula and a semicircular pointed stylet may be required to directly engage the semicircular exit orifice 266. A traditional round cannula with a pointed stylet (Seldinger needle) can also be sufficient to guide the wire into the exit orifice without inserting the needle directly into the semicircular exit orifice. High flow applications such as apheresis and dialysis require direct needle engagement into the respective halves of the semicircular outlet tubes coupled with a reversible locking mechanism (no backflow), necessitating the use of corresponding semicircular cannulas and semicircular tip internal stylets.

[0111] The edges of the radiopaque port body 256 (not separately designated) surrounding the narrower precisely aligned radiolucent linear access orifices 260 may be made more radiopaque than the port body 256 to better allow placement of the access needle 272 through the linear access septum 260' under direct fluoroscopic guidance; such a modification may be valuable regardless of the size of the orifice. Thus, the disadvantages of accessing a small linear access orifice 260 may be overcome by utilizing prominent radiopaque port body markers along the edges of the otherwise radiolucent orifice, thereby allowing fluoroscopic needle placement while taking advantage of the precise alignment of the linear access orifice 260 with the port chamber exit orifice 266. The radiopaque midline divider or divider 282 of the dual lumen port device 252 facilitates guidance of the access needle 272 during placement through the two respective linear access orifices 260 by fluoroscopy as well as by a palpable subcutaneous ridge 283 formed by the upper edge of the midline divider / divider 282 ( Fig.12 , Fig.15 and Fig.16 ).

[0112] Insertion or deployment of the linear access needle 272 adjacent to the corresponding side of the midline divider 282 simultaneously aligns the linear access needle with the corresponding semicircular exit orifice 266 ( Fig.15 and Fig.16 ). A specific needle design (not shown) including a semi-cylindrical cannula and a semi-cylindrical pointed stylet can be used to directly engage the semi-circular outlet orifice to allow temporary locking of the cannula to the port body and outlet tube, particularly for high-flow procedures. High-flow applications such as apheresis and dialysis require direct needle engagement (coupled with a reversible locking mechanism (no backflow)) into the respective halves of the semi-circular outlet tube, thereby requiring the use of a corresponding semi-circular cannula and semi-circular pointed internal stylet.

[0113] Optionally, to allow the use of a conventional cylindrical needle assembly with a double lumen vascular access port according to the present invention, the vascular access port may be provided with (1) a double outlet tube with a cylindrical lumen, as described below with reference to Fig.47 As discussed, (2) a dual flow outlet tube having a proximal end portion having two cylindrical lumens and a distal end portion having a semi-cylindrical lumen, as described below with reference to Fig.48 and (3) a thickened port body wall 277 having two cylindrical lumens 281 and 283 ( Fig.15 ), the cylindrical lumens 281 and 283 communicate with the semi-cylindrical lumen 263 in the outlet tube 264. The cylindrical lumens 281 and 283 are provided with annular locking beads (as discussed herein) for releasably retaining the stylet cannula, particularly for use in high-flow procedures. The cylindrical lumens 281 and 283 may have a proximal portion that extends parallel to the partition 282 to facilitate the receipt of the needle assembly. Optionally, the linear or lateral access orifice 260 may be provided at a greater distance from the partition 282, such as Fig.44 As shown, to allow proper co-linear insertion of the needle into lumens 281 and 283.

[0114] The port chamber exit aperture 266 may be radiolucent in an otherwise at least partially radiopaque port, facilitating cannulation with a needle or wire. Alternatively, the exit aperture 266 may be provided with a radiopaque edge in an otherwise radiolucent port body, facilitating cannulation with a needle or wire. The port chamber outlet orifice 266 may be provided with a corresponding straight tapered or funnel-shaped guide surface (defining an outwardly tapered chamber extension) on the corresponding downstream side of the internal chamber 254 (a half or partial funnel on either side of the midline divider 282 in the double lumen version) to facilitate placement of the slidable wire 274 through a flat direct access needle (cylindrical or semi-cylindrical) 272, which is placed through the straight access septum 260' to facilitate entry of the semi-circular cross-section wire 274 or needle 272 into the corresponding lumen 263 of the double lumen hollow outlet tube 264 and subsequently into the corresponding half 285 of the proximal double lumen catheter 284 (partitioned by the midline catheter divider 253) (see Fig.16 ). Fig.13 and Fig.14 The straight tapered exit orifice or outwardly tapered chamber extension 266 (a half or partial funnel on either side of the midline divider / divider 282 of the double lumen version) is shown positioned flush with the floor 262 of the port chamber 254. Optionally, the straight tapered chamber exit orifice 266 may be centered at the midpoint between the top or upper surface 268 and the floor or bottom surface 262 of the port chamber 254 or anywhere therebetween, the precise location preferably being aligned with the location of the straight access orifice 260. The corresponding vertical access orifice 258 for conventional clinical use is used to bend a Huber needle (e.g., Figure 7 The double lumen outlet tube 264 includes a midline groove 251 that receives the midline divider 253 (partition 253) of the double lumen catheter 284. Fig.12 , Fig.15 and Fig.16 ). The main port body 256 may have one or more circular or oval eyelets 278 formed at spaced locations in the outwardly and circumferentially extending foot 279 to allow suturing of the double lumen implantable vascular access port 252 to the underlying soft tissue within the surgically created subcutaneous port. These eyelets 278 may be filled or unfilled with a silicone elastomer material.

[0115] Another single lumen implantable vascular access port device 352 (eg Figures 17 to 21352) includes a main port body 356 having a hollow chamber 354 formed therein. The main port body 356 has two penetrable orifices (358 and 360), which include a vertical or top access orifice 358 and a linear or lateral access orifice 360 ​​covered or bridged by corresponding septa 353' and 360'. The vertical access orifice 358 allows conventional port access, while the novel linear access orifice 360 ​​allows or facilitates the performance of various interventions to facilitate initial port placement, port catheter repositioning, maintenance of secondary port patency, port removal, and port exchange. In this implantable vascular access port device 352, the main port body 356 is truncated conical, and the main port chamber 354 is cylindrical, truncated conical or preferably ellipsoidal, and the design of the ellipsoidal or spherical port chamber promotes circular movement and mixing of the injected fluid, thereby minimizing dead space within the chamber. Sharp edges and corners cause abrupt changes in direction of fluid flow through the port chamber, resulting in dead zones, cell shear, platelet activation, and coagulation. The frustoconical body 356 may surround a cylindrical, frustoconical, or preferably ellipsoidal port chamber 354 (e.g., Fig.17 ). However, the port body 356 may take on different shapes, including but not limited to frustoconical, elliptical frustoconical, horseshoe, teardrop, torpedo, or oval, to reduce friction during port exchange, one of the contemplated methods or procedures being made possible by the present invention, but maintaining the desired non-turbulent characteristics of the ellipsoidal or spherical (true sphere or oblate spheroid) port chamber 354 (not shown). In another version, the radiolucent lateral access orifice 360' is formed by an inwardly tapered recess or palpable depression in the port body, thereby allowing access needle placement into a linear access septum, which may no longer be located along the periphery of the port body 356, but more centrally adjacent to the port chamber (not shown). Therefore, the port chamber 354 and the port body 356 may have similar or different shapes, respectively. The septa (358' and 360') are formed of an elastically deformable material, such as a silicone elastomer. The vertical and linear access diaphragms 358' and 360' include thickened central portions 341 and 342 (eg, Fig.18 and Fig.19340 and 341. The main port body 356 includes a plurality of linear access openings 340 and 342, each of which is provided with a plurality of linear access openings 340 and 343. The linear access openings 340 and 341 are provided with a plurality of linear access openings 340 and 344 for placement in axial channels or grooves 345 and 346 to anchor the septa 358' and 360' in place in the main port body 356. The main port body 356 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 356, a titanium liner (not shown) may be used along the floor or bottom 362 of the port chamber 354. The linear access orifice 360 ​​may have a variety of shapes and sizes, presenting, for example, a circular, oval, or rectangular configuration; in a frustoconical implantable vascular access device 352, the linear access septum 360' is partially curved, such as Fig.17 and Fig. 20 As shown. A wider linear access aperture may allow for easier needle placement from different skin penetration site locations and approach angles. In another version, the linear access port aperture 360 ​​may be narrower and therefore less dependent on the port body shape, thereby allowing precise alignment of the linear access port septum 360' with the port chamber exit aperture 366. The narrower linear access aperture 160 may be more difficult to aim or access, but may be precisely aligned in the horizontal and / or vertical plane with the exit port chamber exit aperture 366, thereby facilitating placement of the linear access needle 372 and the subsequent slidable wire 374 therethrough into the exit aperture 366, the exit rod 364, and the attached catheter 70 ( Fig.21 ). The edges of the radiopaque port body 356 surrounding the narrower precisely aligned linear access orifice 360 ​​may be made even more radiopaque than the port body 354 to better allow access needle entry and placement through the linear access septum 360' under direct fluoroscopic guidance; such a modification may be beneficial regardless of the size of the orifice. Thus, the disadvantages of accessing a small linear access orifice 360 ​​may be overcome by utilizing prominent radiopaque port body markers along the edges of the orifice, thereby allowing fluoroscopic needle placement while taking advantage of the more precise alignment of the linear access orifice 360 ​​with the port chamber exit orifice 366. The port chamber outlet orifice 366 may be positioned in a straight tapered or funnel-like shape or outwardly tapered chamber extension of the interior chamber 354 (e.g., as opposed to a curved funnel) to facilitate placement of a slidable wire 374 through a straight access needle 372, which is placed through the straight access septum 360' to facilitate entry of the needle 372 or wire 374 into the hollow outlet tube 364 and subsequently into the proximal catheter 370 ( Figures 19 to 21 ). Optionally, the needle may directly engage a channel in the port body 356 adjacent to the exit orifice 366 or exit stem prior to wire advancement. Figures 19 to 21The straight tapered outlet orifice (outwardly tapered chamber extension) 366 is shown positioned flush with the floor or bottom surface 362 of the port chamber 354. Alternatively, the straight tapered chamber outlet orifice 366 may be centered at the midpoint between the top surface 368 and the floor surface 362 of the port chamber 354 or anywhere therebetween, with its precise location preferably being aligned with the horizontal access orifice 360. The vertical access orifice 358 for conventional clinical use is preferably located at a substantially horizontal position. Figure 7 370, wherein the curved Huber access needle is in position for injecting medication, which may then enter the port chamber 354, then the port chamber outlet orifice 366, then the hollow outlet tube 364, and finally the proximal catheter 370. The main port body 356 may have one or more circular or oval eyelets 378 formed along its periphery, particularly along the outwardly and circumferentially extending foot 379, to allow suturing of the port or vascular access device 362 to the underlying soft tissue within the surgically created subcutaneous port. These eyelets 378 may be filled or unfilled with a silicone elastomer material.

[0116] Such as Figure 1 and Figure 2 The general port device 20 shown is Fig. 22 , the port device 20 is surgically implanted in the subcutaneous soft tissue of the upper chest wall, with the proximal catheter attached to the port body 22, and the catheter 36 is shown entering the internal jugular vein 88 to the right, with the distal end of the catheter 36 located in the central venous system, the superior vena cava (SVC) or the right atrium (RA). Similar to Fig. 22 , Fig.23 A typical port device 20 is shown in which a fibrin sheath 90 or biofilm surrounds the distal intravascular portion of the catheter 36, thereby causing catheter malfunction, complete catheter occlusion or at least the inability to aspirate blood from the catheter, hampering the ability to confirm proper needle position within the port chamber, and thus hampering safe conditions for infusion of fluids or medications. Fig.23 , Fig.24 A typical port device 20 is shown with a fibrin sheath 90 or biofilm surrounding the distal intravascular portion of the catheter 36, leading to catheter failure. An intravascular annular cuff 92 exiting a catheter 94 placed from a femoral vein puncture is shown surrounding the port catheter 36 and the fibrin sheath 90, just prior to tightening the cuff in preparation for stripping the fibrin sheath from the catheter (an established procedure in the medical field). Similar to Fig.24 , Fig.25 A typical port device 20 is shown, following stripping of the fibrin sheath with an annular cuff 92, demonstrating a known complication of such a procedure, which is catheter fragmentation, resulting in a loose body 96 within the vessel. Fig. 22 , Fig.26A typical port device 20 is shown in which a catheter 36 has an abnormally turned or migrated catheter tip in the internal jugular vein, resulting in catheter malfunction and an undesirable location for injected medications, and also prone to venous thrombosis (a known complication of central venous ports). This abnormal catheter location can be achieved by using a catheter similar to Fig.24 In the manner of fibrin sheath formation, the distal end of the catheter is sheathed to remediate, thereby repositioning the catheter tip into the superior vena cava or right atrium; alternatively, the port can be modified surgically.

[0117] Fig. 27 An improved fibrin sheath stripping procedure according to the present invention is shown, which utilizes the above reference Figure 3 11 . The main port body 56 has two penetrable septa 58 and 60 covering respective orifices 158 and 160, wherein the vertical access septum or orifice 58 is similar to the septum or orifice of a conventional port, and wherein the linear access septum 60 is primarily used to perform various interventions to facilitate initial port placement, maintenance of secondary port patency, port removal, and port exchange. A slidable wire (such as a polytetrafluoroethylene coated guidewire sold by Terumo Medical under the trademark "GLIDEWIRE", or other suitable wire) is inserted through a straight Huber needle or Seldinger needle via the linear access port orifice 160, inserted through the catheter 36 to secure the fibrin sheath 90 and help prevent fragmentation of the catheter from stripping of the fibrin sheath. An intravascular annular cuff 92 exiting the catheter 94 placed from the femoral vein puncture is shown surrounding the wire 74 in preparation for stripping the fibrin sheath from the catheter. Similar to Fig. 27 , Fig.28 A port device 52 according to the present invention is shown with a fibrin sheath 90 or biofilm surrounding the distal intravascular portion of the catheter 36, leading to catheter failure. An intravascular annular cuff 92 leaving a catheter 94 placed from a femoral vein puncture is shown surrounding the port catheter 36 and the fibrin sheath 90, just prior to tightening the cuff in preparation for stripping the fibrin sheath from the catheter 36. Similar to Fig.28 , Fig.29 The subsequent safe removal of the fibrin sheath 90 from the port catheter 36 having the annular cuff 92 is shown with a reduced risk of catheter fragmentation via the wire 74 placed via the linear access port 60. Fig.29 , Fig.30 Safe removal of a catheter segment 96 according to the present invention via annular cuff 92 is shown, as the segment is secured to a wire 74 placed through a linear access port 160, a known complication of fibrin sheath stripping. After the catheter segment 96 is sheathed over the wire via a femoral vein access site via a vascular sheath, it can then be safely removed.

[0118] Fig.31 A port device 52 according to the present invention is shown having a catheter tip that has flipped or migrated abnormally in an internal jugular vein 88, resulting in catheter malfunction and an undesirable location for injecting medications, and also being susceptible to venous thrombosis (a known complication of central venous ports). Wire 74 is shown placed in the linear access port orifice 60 before exiting the distal end of the catheter into the port catheter 36. According to the invention described herein, the abnormal catheter position can be remedied by pushing the slidable wire 74 through the catheter, thereby repositioning it in the superior vena cava or right atrium, such as Fig.32 shown.

[0119] Placement of a wire through a linear access port and subsequently through a catheter (eg Fig.32 ) can be used to remove blockages or thrombi within the blood vessels to restore catheter patency. Fig.32 , Fig.33 Partial wire withdrawal is shown after catheter recanalization or removal of an intravascular thrombus from the catheter. Fig.32 It is also demonstrated how various tools (such as microbrushes or microballoons) can be advanced through the port device to disrupt and dislodge attached fibrin sheaths or thrombi as a means of controlling the flow of blood. Figures 27 to 30 Alternative procedures and approaches to the described problem.

[0120] Placement through the linear access port 60 and subsequently through the catheter 36 (eg Fig.32 Wire 74 (shown) can facilitate initial catheter 36 placement into the central venous system, particularly in situations where friction or kinking is encountered during advancement of the catheter 36 through the peel-back sheath, which is commonly used to advance the catheter into the central venous system. Wire advancement may also be beneficial in situations where redundant loops of the catheter are formed in the subcutaneous tissue after initial catheter 36 placement and peel-back sheath removal (only a small portion of the catheter in the venous system), thereby securing the catheter 36 in the venous system and increasing the pushability of the catheter 36 so that the loop can be eliminated.

[0121] Fig.32 It is also demonstrated how the advancement of the wire 74 can help prevent inadvertent transection of the catheter during port removal, thereby increasing the ability to palpate the catheter to avoid severing the catheter, and also preventing complete transection due to its presence within the catheter lumen; in the unlikely event of complete transection, the loose segment can be secured to the wire, thereby allowing segment 96 to be retrieved, as shown. Fig.30 Demonstrated.

[0122] Fig.32It is also demonstrated how placement of a sufficiently long wire through a linear access port, via a catheter into the central venous system, can allow a failed port device 52 (after the skin incision has been made and it has been freed from any surrounding scar assembly) to be exchanged via the wire for a newly assembled vascular port device 52 of similar length. Exchange of a failed port device 52 via the wire may require a linear access port (which incorporates an access needle 72) to be inserted into the vascular port. Fig.21 ) and can be facilitated by peel back sheath placement via a wire to a subcutaneous port seat and catheter tunnel (after removal of the original failed port device 52), thereby reducing friction for placement of a new port device 52. The port device can be exchanged, for example, a Portacath device 52 or a new tunneled vascular device, such as a Hickman catheter or plasma dialysis catheter.

[0123] Fig.34A large bore (19-gauge to 14-gauge) coreless needle assembly 466 (circular or semicircular cross section) for high flow access applications (e.g., for apheresis or dialysis) is shown, along with a hollow outlet tube 464 (circular or semicircular cross section) that can be used as a hollow outlet tube in any of a variety of single (circular outlet tube) or dual access (semicircular or circular outlet tube lumen) implantable vascular ports described herein, such as outlet tubes 64, 264, 364, 522, 534, 538, 550, 582, 600. The coreless access needle assembly (circular or semicircular) 466 can include a sharp inner stylet 466a (with an outer cannula 466b), the stylet 466a spanning the longitudinal lumen 466c of the cannula. The outlet port or outlet rod 464 is provided with at least one annular bead or ridge 468 along the inner surface, which is inserted into an annular groove or indentation 470 in the outer surface 472 of the cannula 466b to lock the cannula to the outlet port in high flow applications. The bead 468 and the groove 470 form a snap-fit ​​that anchors the cannula 466b in place and additionally provides tactile resistance or vibration feedback to the operator during the deployment or coupling procedure; the operator can sense that the bead 468 is in the groove 470 in part by sound and in part by resistance to further forward movement or retraction. Thus, a reversible snap-fit ​​mechanism such as the bead 468 and the groove 470 can minimize or eliminate the need for fluoroscopic guidance during horizontal or lateral access or linear access needle placement (0 to 70 degrees relative to the port floor). The fixation of the cannula 466b in the desired position within the length of the outlet tube 464 is facilitated by the tactile, vibration and auditory feedback generated by the snap mechanism. Different sized annular beads or ridges (e.g., different heights) may be staggered along the length of the outlet tube 464 from small (proximal) to large (distal) to accommodate and form a tight fit around more than one size needle diameter, thereby anchoring or engaging larger needles more proximally in the outlet tube and anchoring or engaging smaller diameter needles more distally in an outlet tube that is best suited for uniform or nearly uniform diameters throughout its length. Alternatively, the annular beads or ridges may be the same size or height; but may accommodate different needle diameters due to the overall gradual taper of the inner diameter or inner surface of the outlet tube 464 from large (proximal) to small (distal), thereby forming a tight fit around more than one size needle diameter, thereby anchoring or engaging larger needles more proximally in the outlet tube and anchoring or engaging smaller diameter needles more distally in the outlet tube. Of course, the positions of the bead 468 and the groove 470 may be reversed: the bead 468 may be formed on the cannula 466 b and the groove 470 along the inner surface 474 of the tubular outlet port 464 .A plurality of annular beads 468, 468', 468" may be formed along the inner surface 474, spaced apart from one another, to accommodate stylet assemblies 466, 466', 466" having cannulas 468b, 468b', 468" having different diameters or specifications. In this case, the inner surface 474 of the outlet tube 464 may exhibit longitudinally staggered sections 474, 474' and 474" of corresponding diameters, thereby increasing in diameter in the proximal direction (i.e., from the free end 464a of the port 464 toward the corresponding port chamber). Typically, the stylet 466a is made of stainless steel, while the cannula 466b and / or the outlet tube 466 are made of at least a partially elastic polymer material, thereby facilitating the formation of a snap-fit ​​cooperation and seal.

[0124] Alternatively, a plurality of mutually spaced annular grooves 470 may be provided along the outer surface 470 of the cannula 466b. In another variation, the inner surface 474 of the outlet port 464 and the needle assembly 466 may be formed with a plurality of pairs of cooperating beads and grooves, which are of equal diameter and radial dimensions, but axially spaced from one another along the length of the needle assembly and the outlet port. The snap-lock coupling of the beads 468 and grooves 470 not only serves to maintain the high flow cannula 466b secured to the corresponding vascular port 52, 252, 352, but also facilitates the coupling operation and tightly fits the cannula to the inner surface 474 of the corresponding outlet tube 64, 264, 364 to prevent backflow. As disclosed herein, horizontal or lateral sidewall access ports allow linear large bore needle assembly cannula access to outlet tubes 464, 64, 264, 364 and the outlet tubes of all vascular port devices disclosed herein for allowing maximum flow rates relative to vertical or top access ports which have greater friction losses and turbulence associated with flow through a large volume chamber (having 90 degree needle access).

[0125] When the port device described herein is used for high flow access procedures such as apheresis or dialysis, multiple options are available: two independent single lumen ports, one of which is used for venous access and the second for venous return; single lumen port placement, where the port is used for venous access and a peripheral intravenous cannula is used for venous return; or placement of a dual lumen port, with both venous access and return capabilities. The locking needle mechanism also facilitates and supports the stable advancement of wires or other intracavitary devices through horizontal or lateral or linear access needles for performing the various methods and procedures described herein, which facilitates port placement, maintenance of secondary patency (including fibrin sheath stripping and microbrush / microballoon utilization), port catheter repositioning, port removal, and port exchange, all of which are achieved through the horizontal access orifice.

[0126] A latching needle mechanism as contemplated herein may generally include a male element and a female element, such as Fig.34As shown. The outlet tube can be made of an elastic polymer material that enhances the operability of the latch mechanism. The outlet tube can be further tapered distally to the latch mechanism to accommodate smaller intravascular catheters (which fit on the distal outlet tube end with a locking collar) as needed.

[0127] Fig.35 An implantable vascular port device or apparatus 502 is shown including a frustoconical main port body 506 having a frustoconical interior chamber 504 formed therein. The main port body 506 has a sidewall 508 and a tapered outer surface 510. The port body 506 and the port chamber 504 may each have similar or different shapes and / or sizes. Fig.35 A frustoconical port chamber 504 and a frustoconical outer port body 506 are shown. The main port body 506 has two penetrable septa 512 and 514 that extend across and close respective orifices 516 and 518. Orifice 516 is a vertical access orifice similar to a conventional port, while orifice 518 constitutes a straight access orifice that is primarily used for high flow applications and for performing various interventions to facilitate initial port placement, port catheter repositioning, maintenance of secondary port patency, port removal, and port exchange. The septa 512 and 514 are formed of an elastically deformable material, such as a silicone elastomer. The mounting of the septa 512 and 514 to the port body 506 can be as described above. The port body 506 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 506, a titanium liner may be used along the floor or bottom surface 520 of the port chamber 504. The access port 518 and outlet tube 522 (with an inner end defining an outlet port 524) are located midway between the lower wall or floor 526 and upper wall 528 of the port body 504.

[0128] Fig.36 The vascular access port 502' is shown with Fig.35 The port 502 is the same as that of the embodiment of the present invention, and the reference numerals naming the various component parts are the same. Fig.35 In the port, the access orifice 518, the outlet orifice 524 and the outlet tube 522 are positioned closer to the upper wall 528 than to the lower wall or floor 526.

[0129] Fig.37 The vascular access port 530 is shown similar to Fig.35 and Fig.36Access ports 502 and 502'. Port 530 exhibits the same structural features as ports 402 and 502', except for the different reference numerals as shown. Instead of a frustoconical interior chamber 504, port 530 has an elliptical or ellipsoidal interior chamber 532. An outlet tube 534 is generally perpendicular to the interior surface of the chamber and joins the chamber 532. In contrast, Fig.38 The modified vascular access port device 536 shown has an outlet tube 538 that is tangentially connected to the elliptical or ellipsoidal internal port chamber 532, thereby minimizing turbulence within the chamber. The port device 536 exhibits another feature that can be incorporated into any of the port devices disclosed herein, namely a frustoconical, conical or hemispherical recess (inwardly tapered recess) 537, which includes a lateral access orifice in the port body, which is provided with a self-sealing septum or membrane 539 at the inner end for needle penetration at its confluence with the inner chamber wall. The recess 537 has an edge 537' at the outer end, which facilitates tactile detection via the touch of the patient's epidermis and underlying tissue (tactile recess). The recess 537 generally has a frustoconical surface (not separately specified), but other shapes can be used.

[0130] like Fig.39 As shown, the implantable vascular port device or apparatus 540 includes a main port body 541 having a frustoconical outer surface 543 and an elliptical or ellipsoidal internal chamber 548. The internal chamber 548 is formed with an outlet orifice 546, which is connected to a curved, double-angled or serpentine outlet tube 542 through the outlet orifice 546 so that it eventually leaves the port, which is flush or nearly flush with the port floor. The outlet tube 546 has an upstream portion 544 and a downstream portion 550, the upstream portion 544 is continuous or continuous with the outlet orifice 546, and the downstream portion 550 is preferably disposed at or near the lower wall 547 of the port body 541.

[0131] Port body 541 ( Fig.39 ) has two penetrable septa, an upper or top septum 553 (for vertical low flow access) and a lateral septum 554 (for transverse linear access that can be used for high flow applications). The septa 553 and 554 extend across and cover the respective orifices 551 and 552. The septa 554 and 554 are formed of an elastically deformable material, such as a silicone elastomer. The mounting of the septa 553 and 554 to the port body 541 can be as described above. The port body 541 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 541, a titanium liner can be used along the floor surface or bottom surface 548' of the internal chamber 548.

[0132] Port device or apparatus 540 ( Fig.39 ) facilitates straight needle deployment, with both the access orifice 552 and the outlet orifice 546 located near the upper end of the port device. The upstream portion 544 of the outlet tube 542 is in line with the access orifice 552 and its associated septum 554. The placement of the downstream portion 550 of the outlet tube 542 at the bottom or lower wall 547 of the port device minimizes or eliminates tilting of the device through the conduit connected to the outlet tube 542.

[0133] Fig.40 An implantable vascular port device or apparatus 560 is shown, which includes a frustoconical main port body 562 having a frustoconical interior chamber 564 formed therein. The main port body 562 has a sidewall 566 and a tapered outer surface 568. The main port body 562 has two penetrable septa 570 and 572 extending across and closing respective orifices 574 and 576. Orifice 574 is a vertical access orifice similar to a conventional port, while orifice 576 constitutes a linear access orifice for use primarily in high flow applications and for performing various interventions to facilitate initial port placement, port catheter repositioning, maintenance of secondary port patency, port removal, and port exchange. The septa 570 and 572 are formed of an elastically deformable material, such as a silicone elastomer. The mounting of the septa 570 and 572 to the port body 562 can be as described above. The port body 562 is formed of a biocompatible material, such as a titanium alloy or other biocompatible corrosion-resistant metal, or of a biocompatible plastic. When plastic is used for the port body 562, a titanium liner may be used along the floor or bottom surface 578 of the port chamber 564. The access orifice 576 is located at the upper end of the side wall 566, while the outlet orifice 580 is disposed lower down along the side wall 566. An outlet tube 582 communicating with the interior chamber 564 via the outlet orifice 580 is angled downwardly, in line with the linear insertion path 583, for the needle to extend from the access orifice 576 to the outlet orifice 580. This design facilitates access to the linear access orifice 576 relative to the skin surface while minimizing the tilting of the port by the weight of the exit catheter.

[0134] Fig.41An implantable modified truncated cylindrical vascular access port 584 is shown having a downwardly angled needle insertion path 585 similar to the truncated conical port 560. Port 584 has a different external geometry, wherein an angled tapered side 586 has a linear access orifice 588 and an associated septum 590 that are directed at an angle to facilitate access. The angled tapered sidewall 586 can also facilitate access to the linear access orifice 588 relative to the skin surface while minimizing the tilting of the port by the weight of the exit catheter. In addition, port 584 exhibits the same structural features as port 560, including the geometry of the internal chamber 564.

[0135] Fig.42 Shows something like Fig.41 The port 584 is a modified frustoconical vascular access port 584', but has an elliptical or ellipsoidal interior chamber 592. Although Fig.43 Shows something like Fig.42 A modified frustoconical vessel port 594 of the port 584' of FIG. 584', but with the upper sidewall portion having two mutually inclined facets 596 and 597 at the upper end and having an access orifice 598 at a steep angle relative to the port floor, the access orifice 598 being located in the curved sidewall portion. The port 594 also has an outlet tube 600 that is inclined and tangentially oriented relative to the elliptical or ellipsoidal inner chamber 592, thereby optimizing the flow dynamics within the chamber.

[0136] Fig.44 A dual lumen implantable vascular access port 602 is shown having two internal port chambers 604, 605 separated by a midline divider or partition 606 having two vertical access orifices (not shown) and two linear access orifices 616 and 618. The port 602 includes a main port body 610 having an elliptical frustoconical or oblate spheroidal configuration and having four penetrable septa, namely two vertical access septa (not shown) covering corresponding orifices (not shown) (similar to conventional dual orifices described herein and another dual lumen port according to the present invention ( Fig.12 )), and two linear access septa 612 and 614 on orifices 616 and 618, are primarily used for high flow applications and for performing various interventions to facilitate port placement, port repositioning, maintenance of secondary port patency, port removal, and port exchange. The septa 612, 614 are formed of an elastically deformable material, such as a silicone elastomer, and may include a thickened central portion (not shown) that is anchored or mounted as described above.

[0137] The needle insertion paths 620 and 622 from the orifices 616, 618 and septa 612, 614 to the circular outlet orifices 624 and 626 on the upstream side of the semi-cylindrical outlet tubes 628 and 630 are straight lines, preferably angled toward each other to provide space outside the septa 612, 614 for manipulating two needles simultaneously, if desired. Alternatively, the straight insertion paths 620 and 622 may be angled downward (e.g., Figure 40 to Figure 43 ) to place the access ports 616, 618 closer to the skin surface, thereby facilitating port positioning and needle deployment. Such dual lumen vascular access ports can be used to perform apheresis or dialysis procedures. Each circular outlet port can transition to a corresponding semicircular outlet tube lumen (see Fig.48 In another embodiment, each circular outlet opening may transition into two separate circular parallel or nearly parallel outlet tubes and outlet tube lumens (see Fig.47 ), which may require a smaller inward angle of the needle insertion approach. In this optional device version, a separate exit rod can be attached to a separate intravascular catheter.

[0138] like Fig.45 As shown in more detail, Fig.44 The port body 610 of the dual lumen implantable vascular access port 602 has passages or channels 632 and 634 extending in the sidewall 636 of the port body from the respective outlet orifices 624 and 626 to the respective lumens 638 and 640 of the outlet tubes 628 and 630. The passages 632 and 634 are provided with inwardly projecting annular beads 642 and 644 that cooperate with annular grooves on the circular stylet cannula (see Fig.34 and related description) to reversibly lock the needle cannula to the port body 610 for high flow applications. The dual lumen composite outlet tubes 628, 630 include a centerline groove or slot 645 ( Fig.44 ), the midline groove or slot 645 receives a double lumen catheter (28, Fig.15 and Fig.16 ) of the centerline separator (253, see Fig.15 and Fig.16 ).

[0139] like Fig.46As shown, an implantable vascular access port 646, representative of any of the ports described herein, may be provided with varying degrees of radiopacity or radiotranslucency to facilitate access under fluoroscopic guidance. A main portion 648 of a port body 650 has a first predetermined degree of radiopacity. A lateral access aperture 652 and its associated septum 654 and an exit aperture 656 and an optional top access aperture 658 and its associated septum 660 exhibit a second predetermined degree of radiopacity. The port body may be provided with edge regions 662, 664, and optionally 666 extending and defined around the lateral access aperture 652, the exit aperture 656, and the top access aperture 658, respectively, the edge regions 662, 664, 666 having a third predetermined degree of radiopacity. At least one of the second and third predetermined degrees of radiopacity is substantially different than the first predetermined degree of radiopacity. In other words, the radiopacity (and also radiotranslucency) of the different orifices 652, 656, and 658 differ to allow fluoroscopic visualization. Thus, the lateral access orifice 652 and the exit orifice 656 can be easily located visually during a needle insertion procedure, particularly for high flow applications such as apheresis and dialysis. The radiopacity can vary between substantially 0 (radiotranslucency) and substantially 100% (completely radiopaque). The degree of radiopacity is understood to be qualitative, and each degree of radiopacity can be within a numerical or percentage range, but in cases where the degree differs for enhanced visualization, the corresponding ranges of radiopacity do not overlap. Thus, the various physical features are distinguished in a fluoroscopic manner. It should be understood that the radiopacity of the lateral access orifice 652 or the top (vertical) access orifice 658 is the same as and determined by the radiopacity of the associated septum 654 and 660.

[0140] like Fig.47 As shown, the dual lumen vascular access port 670 has two internal chambers 672, 674 separated by a divider or partition 676, as described above with reference to Fig.44 The port body wall 678 has two cylindrical passages 680, 682 defining respective outlet orifices (not individually designated) and provided with respective annular elastomeric beads 684, 686 for snap-fit ​​insertion into grooves on the outer surface of the stylet assembly cannula (not shown). Two separate outlet tubes 688 and 690 are attached to or integral with the port body wall 678, with lumens 692 and 694 being coaxial with and communicating with the respective passages 680, 682. Fig.47 In a modification of the embodiment, the locking beads 684, 686 may be disposed in the outlet tube lumens 692 and 694 instead of in the channels 680, 682.

[0141] like Fig.48 As shown, it is used to replace the double-lumen hollow outlet tube 264 ( Figures 12 to 16) includes two lumens 702, 704 each having a distal end 706, 708 having a D-shaped cross section and a proximal end portion 710, 712 having a circular cross section. The proximal end portions 710, 712 are internally formed with inwardly protruding annular beads 714, 716 for removable insertion into an annular groove of a cannula (not shown) of a corresponding stylet assembly (not shown). Between each distal end 706, 708 and the corresponding proximal end portion 710, 712, the corresponding lumen 702, 704 is formed with a transition section (not separately designated) including a half surface 718, 720, which gradually transitions from a linear configuration at the distal end 706, 708 to a semicircular profile at the proximal end portion 710, 712. Thus, the outlet tube 700 accommodates a cylindrical needle cannula at the inner or proximal end and a conventional bifurcated catheter at the outer or distal end (see Fig.15 284). The outlet tube 700 can taper from a wider proximal end at the port body to a smaller diameter at the distal end, wherein the intravascular catheter is coupled to the outlet tube.

Claims

1. An implantable vascular access port, comprising: a port body having a lower or bottom wall, an upper wall parallel thereto and at least one side wall extending between said upper wall and said lower or bottom wall, said port body having at least one internal chamber, said port body having at least one outlet opening formed in said at least one side wall thereof, said at least one outlet opening being in communication with said at least one internal chamber, said port body having at least one lateral access opening formed opposite said at least one outlet opening, said at least one lateral access opening defining a linear access path or direction through said at least one internal chamber to said at least one outlet opening, said outlet opening being positioned lower than said lateral access opening to form a downwardly inclined path, said port body having at least one top access opening formed in said upper wall, said at least one top access opening defining a vertical or upright access path or direction perpendicular to said upper wall and said lower or bottom wall; at least one first penetrable lateral access septum region and at least one second penetrable vertical access septum region, the at least one first penetrable lateral access septum region and the at least one second penetrable vertical access septum region attached to the port body, the first penetrable lateral access septum region covering or closing the at least one lateral access aperture, and the second penetrable vertical access septum region covering or closing the at least one top access aperture, the at least one first penetrable lateral access septum region and the at least one second penetrable vertical access septum region being made of a self-sealing penetrable material designed for repeated penetration by an access needle; and At least one hollow outlet tube is attached to the port body and is in fluid communication with the at least one interior chamber and the at least one outlet orifice.

2. An implantable vascular access port according to claim 1, wherein the port body and one of the at least one hollow outlet tube are provided with at least one convex or concave locking element for cooperating with at least one concave or convex locking element on the needle cannula, respectively, to removably lock the cannula to the at least one outlet tube or the port body, so that the cannula is connected to the lumen of the outlet tube.

3. An implantable vascular access port according to claim 1, wherein the at least one internal chamber is provided with at least one outwardly tapered chamber extension in the at least one side wall, the at least one outwardly tapered chamber extension having a first transverse dimension at the at least one internal chamber and a second transverse dimension at the at least one outlet orifice, the first transverse dimension being greater than the second transverse dimension, and the at least one outlet orifice being separated from the at least one internal chamber by a length or height dimension of the at least one outwardly tapered chamber extension.

4. The implantable vascular access port of claim 3, wherein the at least one outwardly tapered chamber extension is aligned with the at least one lateral access orifice such that during a medical procedure when a distal end portion of a hollow needle is inserted through the at least one first penetrable lateral access septum region and traverses the at least one internal chamber, a surface of the at least one outwardly tapered chamber extension is configured to passively guide the needle or wire toward the at least one exit orifice into the at least one hollow exit tube, thereby allowing the wire to be advanced into a catheter attached to the exit tube.

5. The implantable vascular access port of claim 1 , wherein the at least one lateral access orifice comprises a palpable inwardly tapered recess, the at least one first penetrable lateral access membranous region being disposed at an inner end of the inwardly tapered recess at its junction with the at least one internal chamber.

6. An implantable vascular access port according to claim 1, wherein the at least one side wall has an external surface on the side opposite to the at least one exit orifice, the external surface having a lower portion and an upper portion, the external surface presenting different angles relative to the upper wall and the lower wall or bottom wall, and the upper portion is inclined from the lower portion toward the upper wall.

7. The implantable vascular access port of claim 6, wherein the at least one hollow outlet tube has an axis at an inlet end proximate to the at least one internal chamber that is co-linear with the linear access path or direction.

8. The implantable vascular access port of claim 1, wherein the at least one sidewall has an exterior surface having at least a portion with a contour selected from the group consisting of straight, sloped, and curved.

9. The implantable vascular access port of claim 1, wherein: A major portion of the port body has a first predetermined degree of radiopacity; the at least one lateral access aperture and the at least one exit aperture exhibit a second predetermined degree of radiopacity; the port body having an edge region defining and extending along the at least one lateral access aperture and the at least one exit aperture, the edge region having a third predetermined degree of radiopacity; and At least one of the second predetermined level of radiopacity and the third predetermined level of radiopacity is different than the first predetermined level of radiopacity.

10. The implantable vascular access port of claim 1 further comprising a catheter attached to the at least one hollow outlet tube; and at least one medical device or tool selected from the group consisting of a guidewire, a needle, a microbrush, or a microballoon device, the at least one medical device or tool extending through the at least one first penetrable lateral access septum region, the at least one internal chamber, the at least one outlet orifice, and the at least one hollow outlet tube and the catheter for use in performing an intravascular procedure.

11. The implantable vascular access port of claim 1 , wherein the at least one first penetrable lateral access septum region is disposed in a plane oriented at least partially transverse to the superior wall and the inferior or bottom wall.

12. A dual-lumen implantable vascular access port, comprising: A port body, the port body having a first internal chamber and a second internal chamber separated from each other by a partition having a covering on a subcutaneous palpable ridge, each of the first internal chamber and the second internal chamber having a corresponding bottom surface or base surface, the port body having a first outlet port and a second outlet port in at least one side wall thereof, the first outlet port and the second outlet port being respectively connected to the first internal chamber and the second internal chamber, the first outlet port and the second outlet port being arranged on opposite sides of the partition, the port body being respectively formed with a first access port and a second access port opposite to the first outlet port and the second outlet port, the first access port and the second access port being respectively on corresponding sides of the partition and each defining a respective linear access path or direction through a respective one of the first interior chamber and the second interior chamber toward a respective one of the first outlet orifice and the second outlet orifice, the first outlet orifice being located lower than the first access orifice to form a downwardly inclined path, the port body having a third access orifice and a fourth access orifice formed in an upper wall, the third access orifice and the fourth access orifice each being disposed on opposite sides of the partition and each defining a respective vertical or perpendicular access path or direction perpendicular to the bottom or base surface of the respective one of the first interior chamber and the second interior chamber; at least one first penetrable lateral access septum region and at least one second penetrable vertical access septum region attached to the port body, the first penetrable lateral access septum region covering or closing the first access aperture and the second access aperture, and the second penetrable vertical access septum region covers or closes the third access aperture and the fourth access aperture, the at least one first penetrable lateral access septum region and the at least one second penetrable vertical access septum region being formed of a self-sealing penetrable material designed for repeated penetration by an access needle; a first hollow outlet tube attached to the port body and in fluid communication with the first interior chamber and the first outlet orifice; and A second hollow outlet tube is attached to the port body and is in fluid communication with the second interior chamber and the second outlet orifice.

13. A double-lumen implantable vascular access port according to claim 12, wherein at least one of the port body, the first hollow outlet tube and the second hollow outlet tube is provided with a locking formation for cooperating with a corresponding locking member on a tubular needle assembly member to removably lock the tubular needle assembly member to the port body.

14. The dual lumen implantable vascular access port of claim 13, wherein the locking formation and the locking member are each taken from the group consisting of a male latch element and a female latch element.

15. The dual lumen implantable vascular access port of claim 13, wherein the first hollow outlet tube is attachable to an intravascular catheter to withdraw blood from the venous system, and wherein the second hollow outlet tube is attachable to an intravascular catheter to return filtered blood to the venous system, thereby allowing apheresis or dialysis.

16. A double-lumen implantable vascular access port according to claim 12, wherein the needle insertion paths from the first access port and the second access port to the first outlet port and the second outlet port respectively located at the upstream side of the first hollow outlet tube and the second hollow outlet tube are straight lines at an angle to each other to provide space outside the port body for manipulating two needles simultaneously.

17. The dual lumen implantable vascular access port of claim 16, wherein the two needle insertion pathways are angled downward, and the first access port and the second access port are disposed proximal to the patient's skin surface to thereby facilitate port positioning and needle deployment.

Images