BR112020004908B1 - DOOR TUNNELING SYSTEMS - Google Patents

Abstract

Provided herein is a system including, in some embodiments, an aerodynamic door and a door tunneler. The port includes a septum and a stabilizing element. The septum is disposed over a cavity in a port body, and the septum is configured to accept a needle therethrough. The stabilization element is configured to stabilize the port in vivo and maintain needle access to the septum. The port tunneler includes an adapter and a release mechanism. The adapter is on a distal end portion of the port tunneler and the adapter is configured to securely hold the port while subcutaneously tunneling the port from an incision site to an implantation site for the port. The release mechanism is configured to release the port from the adapter at the deployment site to the port.

Description

FUNDAMENTALS

[001] The standard procedure for positioning a vascular access device, such as a port, requires two incisions: a first incision near the clavicle, used to introduce a catheter into the superior vena cava for vascular access, and a second incision further in. low in the chest, where the port is finally implanted into a port bag and connected to the catheter. The creation and closure of the port pocket represents a large percentage (about 42%) of the procedure and increases tissue trauma and the risk of infection at the second incision site. Additionally, the requirement for the second incision increases the healing potential. Provided here are port tunneling systems and methods that address the above.

SUMMARY

[002] Provided herein is a system that includes, in some embodiments, an aerodynamic door and a door tunneler. The port includes a septum and a stabilizing element. The septum is disposed over a cavity in a port body, and the septum is configured to accept a needle therethrough. The stabilization element is configured to stabilize the port in vivo and maintain needle access to the septum. The port tunneler includes an adapter and a release mechanism. The adapter is on a distal end portion of the port tunneler. The adapter is configured to securely hold the port while subcutaneously tunneling the port from an incision site to an implantation site for the port. The release mechanism is configured to release the port from the adapter at the deployment site to the port.

[003] In such embodiments, the stabilization element is an inflatable section of the door. The inflatable section includes an uninflated state providing a port profile configured to subcutaneously tunnel the port from an incision site to a port deployment site. The inflatable section further includes an inflated state configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[004] In such embodiments, the inflatable section imparts a triangular prismatic-like shape to at least a portion of the door when in the inflated state. A cross section of this triangular prismatic-like shape is a triangle.

[005] In such embodiments, the inflatable section is configured to inflate with one or more fluids; one or more polymers; or a combination thereof. The one or more fluids are selected from pure fluids and mixtures including solutions.

[006] In such embodiments, the inflatable section is configured to inflate by introducing a solution including at least one polymer precursor that forms a polymer with at least one other polymer precursor after polymerization and cross-linking within the inflatable section.

[007] In such embodiments, an intumescent polymer is disposed in the inflatable section. The inflatable section is configured to inflate by a combination of introducing water or saline to expand the inflatable section and swelling the intumescent polymer with the water or saline to further expand the inflatable section.

[008] In such embodiments, the port tunneler further includes an inflation lumen fluidically connected to the inflatable section for inflating the inflatable section with the one or more fluids.

[009] In such embodiments, the port tunneler further includes a hub at a proximal end of the port tunneler. The hub is configured to fluidly connect with a syringe to deliver one or more fluids through the inflation lumen in the inflatable section.

[0010] In such embodiments, the port further includes a one-way valve configured to close the inflation section when releasing the port from the port tunneler with the release mechanism.

[0011] In such embodiments, the stabilizing element is at least one pair of legs. The pair of legs is configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[0012] In such embodiments, the pair of legs is configured to assume a deployed state when releasing the port from the port tunneler with the release mechanism. The adapter is configured to retain a proximal end portion of the port including the pair of legs in a collapsed state of the pair of legs before releasing the port from the port tunneler with the release mechanism.

[0013] In such embodiments, the stabilization element is a bullet-like shape with door wings. The winged bullet shape is configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[0014] In such embodiments, the stabilizing element is an inflatable section of the door, a pair of legs, a bullet-like shape with wings of the door, or a combination thereof. The inflatable section includes an uninflated state providing a port profile configured to subcutaneously tunnel the port from an incision site to a port deployment site. The inflatable section further includes an inflated state configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum. Each of the pairs of legs and the winged bullet-like shape are also configured to stabilize the port from rolling around a central axis of the port in vivo, thus maintaining needle access to the septum.

[0015] In such embodiments, the system also includes an installation tool. The installation tool is configured to hold at least a distal end portion of the port for connecting a catheter to a proximal end portion of the port. The installation tool is further configured to facilitate installation of the port into the adapter at the distal end portion of the port tunneler.

[0016] Also provided herein is a port tunneler, including, in some embodiments, an adapter and a release mechanism. The adapter is on a distal end portion of the port tunneler. The adapter is configured to securely maintain a streamlined port while subcutaneously tunneling the port from an incision site to an implantation site for the port. The release mechanism is configured to release a streamlined port from the adapter at a location of deployment to the port.

[0017] In such embodiments, the port tunneler further includes an inflation lumen. The inflation lumen is configured to fluidically connect to an inflatable section of an aerodynamic port to inflate the inflatable section with one or more fluids.

[0018] In such embodiments, the port tunneler further includes a hub at a proximal end of the port tunneler. The hub is configured to fluidly connect to a syringe to deliver one or more fluids to the inflation lumen.

[0019] In such embodiments, the adapter is further configured to retain at least one pair of legs of an aerodynamic door in a collapsed state of the pair of legs.

[0020] In such embodiments, the adapter is further configured to maintain an aerodynamic port having a bullet-like shape with wings.

[0021] In such embodiments, the port tunneler further includes a handle on a proximal end portion of the port tunneler. The handle includes a release mechanism release button configured to release an aerodynamic port from the adapter when the release button is pressed.

[0022] In such embodiments, the port tunneler is configured for arrangement in a sheath alongside a catheter connected to an aerodynamic port when the port is disposed in the adapter.

[0023] Also provided herein is an aerodynamic port including, in some embodiments, a septum and a stabilization element. The septum is disposed over a cavity in a port body, and the septum is configured to accept a needle therethrough. The stabilization element is configured to stabilize the port in vivo and maintain needle access to the septum. The port further includes a profile configured to subcutaneously tunnel the port in a port tunneler from an incision site to an implantation site for the port.

[0024] In such embodiments, the stabilization element is an inflatable section of the door. The inflatable section includes an uninflated state, contributing to the profile configured to subcutaneously tunnel the port from an incision site to an implantation site for the port. The inflatable section further includes an inflated state configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[0025] In such embodiments, the inflatable section imparts a triangular prismatic-like shape to at least a portion of the door when in the inflated state. A cross section of this triangular prismatic-like shape is a triangle.

[0026] In such embodiments, the port further includes a one-way valve configured to close the inflation section when releasing the port from a port tunneler.

[0027] In such embodiments, the stabilizing element is at least one pair of legs. The pair of legs is configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[0028] In such embodiments, the stabilization element is a bullet-like shape with door wings. The winged bullet shape is configured to stabilize the port from rolling around a central axis of the port in vivo, thereby maintaining needle access to the septum.

[0029] Also provided herein is a method that includes, in some embodiments, loading a streamlined port into an adapter in a distal end portion of a port tunneler, inserting the port into an incision at a first body location, tunneling subcutaneously the port to a deployment location in a second body location using a port tip, and releasing the port from the adapter with a port tunneler release mechanism. The port tunneler adapter is configured to retain a port stabilizing element in a collapsed state. Releasing the port from the adapter allows the port stabilization element to assume an expanded state to stabilize the port and maintain needle access to a port septum in vivo.

[0030] In such embodiments, the method further includes making the incision at the first body location, wherein the incision is sized to require no more than one or two sutures to close the incision.

[0031] In such embodiments, the method further includes implanting a cardiac end of a catheter into the superior vena cava.

[0032] In such embodiments, the method further includes connecting a port end of the catheter to the port and locking the catheter in the port with a catheter lock before loading the port into the port tunneler adapter. Connection and locking of the port end of the catheter into the port is either prior to or subsequent to implantation of the cardiac end of the catheter into the superior vena cava.

[0033] In such embodiments, the method further includes removing the port from the second body location with a port retriever. The door retriever includes a hook for pulling the door out of the second body location through a hole in the tip of the door.

[0034] In such embodiments, the method further includes removing the port from the second body location with one or more standard surgical tools.

[0035] Also provided herein is a method including, in some embodiments, loading a streamlined port at a proximal end of a sheath, tunneling the port to an implantation site at a second body location at a distal end of the sheath, and releasing the port from the distal end of the sheath. The sheath is configured to retain a door stabilizing member in a collapsed state along a length of the sheath. Releasing the port from the sheath allows the port stabilization element to assume an expanded state to stabilize the port and maintain needle access to a port septum in vivo.

[0036] In such embodiments, the method further includes making an incision at a first body location, establishing a tract to the second body location, and sequentially dilating the tract with a set of sequential dilators. The incision is sized to require no more than one or two sutures to close the incision. After dilating with the dilator set, the sheath is left in place for aerodynamic port loading.

[0037] In such embodiments, the method further includes implanting a cardiac end of a catheter into the superior vena cava.

[0038] In such embodiments, the method further includes connecting a port end of the catheter to the port and locking the catheter in the port with a catheter lock before loading the streamlined port into the sheath. Connection and locking of the port end of the catheter into the port is either prior to or subsequent to implantation of the cardiac end of the catheter into the superior vena cava.

[0039] In such embodiments, the method further includes removing the port from the second body location with a port retriever. The door retriever includes a hook for pulling the door out of the second body location through a hole in the tip of the door.

[0040] In such embodiments, the method further includes removing the port from the second body location with one or more standard surgical tools.

[0041] In such embodiments, the method further includes removing the port from the second body location with another sheath along the tract from the first body location to the second body location.

[0042] These and other features of the concepts provided herein can be better understood with reference to the drawings, description and attached claims.

DESIGNS

[0043] Figure 1 provides a schematic illustrating a system including an aerodynamic door and a door tunneler in accordance with some embodiments.

[0044] Figure 2 provides a schematic illustrating a number of aerodynamic ports according to various embodiments.

[0045] Figure 3A provides a schematic illustrating an end view of an aerodynamic door including a first pair of legs in accordance with some embodiments.

[0046] Figure 3B provides a schematic illustrating a side view of the aerodynamic door including the first pair of legs according to some embodiments.

[0047] Figure 3C provides a schematic illustrating a top view of the aerodynamic door including the first pair of legs according to some embodiments.

[0048] Figure 3D provides a schematic illustrating a bottom view of the aerodynamic door including the first pair of legs according to some embodiments.

[0049] Figure 4 provides a schematic illustrating deployment of the aerodynamic door with the first pair of legs of a door tunneler according to some embodiments.

[0050] Figure 5A provides a schematic illustrating an end view of an aerodynamic door including a second pair of legs, in accordance with some embodiments.

[0051] Figure 5B provides a schematic illustrating a side view of the aerodynamic door including the second pair of legs, according to some embodiments.

[0052] Figure 5C provides a schematic illustrating a top view of the aerodynamic door including the second pair of legs, according to some embodiments.

[0053] Figure 6A provides a schematic illustrating an end view of an aerodynamic door including a third pair of legs, in accordance with some embodiments.

[0054] Figure 6B provides a schematic illustrating a side view of the aerodynamic door including the third pair of legs, according to some embodiments.

[0055] Figure 6C provides a schematic illustrating a top view of the aerodynamic door including the third pair of legs according to some embodiments.

[0056] Figure 7 provides a schematic illustrating deployment of the aerodynamic door with the second pair of legs of a door tunneler according to some embodiments.

[0057] Figure 8A provides a schematic illustrating an end view of an aerodynamic door including a bullet-like shape with wings, in accordance with some embodiments.

[0058] Figure 8B provides a schematic illustrating a side view of the aerodynamic door including the bullet-like shape with wings, according to some embodiments.

[0059] Figure 8C provides a schematic illustrating a top view of the aerodynamic door including the bullet-like shape with wings, in accordance with some embodiments.

[0060] Figure 9A provides a schematic illustrating an end view of an aerodynamic door including an inflatable section in accordance with some embodiments.

[0061] Figure 9B provides a schematic illustrating a side view of the aerodynamic door including the inflatable section according to some embodiments.

[0062] Figure 10 provides a schematic illustrating a system including the aerodynamic gate of Figures 9A and 9B and a gate tunneler in accordance with some embodiments.

[0063] Figure 11 provides a schematic illustrating a port tunneler including a handle in accordance with some embodiments.

[0064] Figure 12 provides a schematic illustrating a set of sequential dilators for a tunneling implant procedure according to some embodiments.

[0065] Figure 13 provides a schematic illustrating a traction explant procedure with a port retriever in accordance with some embodiments.

[0066] Figure 14 provides a schematic illustrating a port retriever including a gripper in accordance with some embodiments.

[0067] Figure 15A provides a schematic illustrating a port recoverer in a recovery state according to some embodiments.

[0068] Figure 15B provides a schematic illustrating a port retriever in a withdrawn state according to some embodiments.

[0069] Figure 16 provides a schematic illustrating an installation tool according to some embodiments.

DESCRIPTION

[0070] Before some particular embodiments are provided in more detail, it should be understood that the particular embodiments provided here do not limit the scope of the concepts provided here. It should also be understood that a particular embodiment provided herein may have features that can be readily separated from the particular embodiment and optionally combined or replaced with features of any of a number of other embodiments provided herein.

[0071] Regarding the terminology used here, it should also be understood that the terminology is intended to describe some particular embodiments, and the terminology does not limit the scope of the concepts provided herein. Unless otherwise noted, ordinal numbers (e.g., first, second, third, etc.) are used to distinguish or identify different features or steps within a group of features or steps and do not provide a serial or numerical limitation. For example, "first", "second", and "third" features or steps need not necessarily appear in that order, and the particular embodiments including those features or steps need not necessarily be limited to the three features or steps. It should also be understood that, unless otherwise stated, any label such as "left", "right", "front", "back", "top", "bottom", "front", "reverse", " clockwise", "counterclockwise", "up", "down" or other similar terms such as "top", "bottom", "backward", "forward", "vertical", "horizontal" , "proximal", "distal" and the like are used for convenience and are not intended to imply, for example, any specific location, orientation or fixed direction. Instead, these labels are used to reflect, for example, location, orientation, or relative direction. It should also be understood that the singular forms of "a", "an" and "the" include plural references unless the context clearly indicates otherwise.

[0072] With respect to "proximal", a "proximal portion" or a "proximal end portion" of, for example, a catheter includes a portion of the catheter intended to be proximate to a clinician when the catheter is used on a patient . Likewise, a "proximal length" of, for example, the catheter includes a length of the catheter intended to be proximal to the clinician when the catheter is used in the patient. A "proximal end" of, for example, the catheter includes an end of the catheter intended to be proximate to the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion or the proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of the catheter is not a terminal portion or terminal length of the catheter.

[0073] With respect to "distal", a "distal portion" or a "distal end portion" of, for example, a catheter includes a portion of the catheter intended to be near or on a patient when the catheter is used on the patient . Likewise, a "distal length" of, for example, the catheter includes a length of the catheter intended to be near or on the patient when the catheter is used on the patient. A "distal end" of, for example, the catheter includes an end of the catheter intended to be near or on the patient when the catheter is used on the patient. The distal portion, the distal end portion or the distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of the catheter is not a terminal portion or terminal length of the catheter.

[0074] As used herein, a "streamline port" includes a contour or profile configured to minimize resistance when the port is moved within a patient's body from one location to another, for example, when the port is subcutaneously tunneled under a patient's skin from an access site to a separate final destination from the access site. An outline or profile of the aerodynamic port described herein includes, but is not limited to, the shape of a bullet, pill or wedge, and is generally longer than it is wide. In some embodiments, a tip of the streamlined port described herein is tapered toward the distal end in order to facilitate direct tunneling of the port from one location to another location through loose connective tissue or subcutaneous tissue. In some embodiments, the tip of the streamlined port is rounded to encapsulate the port from one location to another location via a sheath.

[0075] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as is commonly understood by those skilled in the art.

[0076] The standard procedure for positioning a vascular access device, such as a port, requires two incisions: a first incision near the clavicle, used to introduce a catheter into the superior vena cava for vascular access, and a second incision lower in the chest, where the port is finally implanted into the port bag and connected to the catheter. The creation and closure of the port pocket represents a large percentage (about 42%) of the procedure and increases tissue trauma and the risk of infection at the second incision site. Additionally, the requirement for the second incision increases the healing potential.

[0077] Provided herein are port tunneling systems and methods that address the foregoing. Port tunneling systems include, in some embodiments, streamlined ports configured for introduction into a first incision site; port delivery systems or "port tunnelers" configured to subcutaneously tunnel ports to a second implantation site; and port retrieval systems or "port retrievals" configured to retrieve ports from the second deployment site to the first incision site. Such port tunneling systems and methods for positioning their ports remove a need for a second incision to create a port pocket and implant a port therein. This decreases procedure time for port positioning, mitigates tissue trauma, and reduces the risk of infection at the second site. Additionally, removing the second incision has a cosmetic benefit for the patient in terms of less scarring.

[0078] Referring now to Figure 1, a schematic is provided illustrating a port tunneling system 1000, including an aerodynamic port 1100 and a port tunneler 1200, in accordance with some embodiments. Before covering specific features of any door tunneling system or its components (e.g., aerodynamic doors, door tunnelers, door retrievers, installation tools, etc.), some general features of door tunneling systems are covered using the port tunneling system 1000 of Figure 1, thereby providing a general explanation of the concepts provided herein. As such, it is possible that some of the port tunneling systems do not include one or more of the general features. Port retrievers and installation tools, which are also part of port tunneling systems, are covered later.

[0079] An aerodynamic port, such as the aerodynamic port 1100, is a percutaneous port including a septum and a stabilization element to stabilize the port in vivo. (See, for example, septa 3110, 5110, 6110 and 8110 and stabilizing elements 3120, 5120, 6120 and 8120 of Figures 3A-3D, 5A-5C, 6A-6C, 8A-8C.) The septum is disposed on a cavity with chambers in a port body, and the septum is configured to accept a needle through the septum, thereby providing needle access to one or more chambers of the cavity. The stabilization element is expandable or static, and the stabilization element is configured to stabilize the port in vivo and maintain needle access to the septum and one or more chambers of the port. Additionally, the port includes a sufficiently small profile to subcutaneously tunnel the port into a port tunneler from an incision site to an implantation site (e.g., upper chest) to the port. The small profile resembles a bullet, pill, or wedge shape depending on the particular embodiment, but the port is generally longer than it is wide.

[0080] A port tunneler, such as port tunneler 1200, includes an adapter such as adapter 1210 and a release mechanism for releasing the aerodynamic port from the adapter. (See, for example, adapter 7210 of Figure 7.) The adapter is on a distal end portion of the port tunneler or on a distal end thereof. The adapter is configured to securely hold the port while subcutaneously tunneling the port from an incision site to an implantation site for the port. The release mechanism is configured to release the port from the adapter at the deployment site to the port.

[0081] A port tunneler, such as port tunneler 1200, may be configured for arrangement in a sheath along with a catheter such as catheter 1130 connected to an aerodynamic port, such as aerodynamic port 1100, as shown in Figure 1. Release The port from the adapter through the port tunneler release mechanism releases the catheter to slide out of the sheath as the port tunneler is withdrawn from a patient, ultimately through the patient's incision site. The sheath may be a separation sheath configured to extract the catheter through the sheath when the sheath is separated. This is useful when one end of the catheter opposite the port is positioned, for example, in the superior vena cava, before subcutaneously tunneling the port to the implantation site. However, the catheter can be placed before or after subcutaneous tunneling from the port to the implantation site. Furthermore, a sheath does not need to be used, as a guidewire in place can be directly followed by the port tunneler 1200 with the streamline port 1100 and catheter 1130 loaded therein.

[0082] A port tunneler, such as port tunneler 1200, may also include a handle, such as handle 1230, on a proximal end portion of the port tunneler or a proximal end thereof. (See also Figures 11A and 11B.) The handle includes a release (e.g., release button 1232, trigger, switch, etc.) of the release mechanism configured to release an aerodynamic port, such as aerodynamic port 1100, from the adapter when release is activated. As shown in Figure 1, for example, the handle 1230 includes the release button 1232, which is configured to push a deployment rod of the release mechanism to disengage the door from the adapter when the release button is pressed.

[0083] Having covered some general features of door tunneling systems, we now cover some specific features of door tunneling systems, such as specific features of aerodynamic doors, door tunnelers, door recoverers and installation tools. However, it should be understood that a particular embodiment, such as, without limitation, any of the aerodynamic doors of Figure 2 may have features that can be readily separated from the particular embodiment and optionally combined with or replaced by features of any of the various embodiments.

[0084] Referring now to Figure 2, a schematic is provided illustrating a number of aerodynamic ports in accordance with various embodiments. As shown, the number of ports includes ports 2102, 2104, 2106, 2108, 3100, 5100, and 8100.

[0085] Each streamlined port is configured for insertion through a puncture at a location such as the internal jugular access site and implantation at an implantation site by subcutaneous tunneling of the port through, for example, the upper chest. Thus, each port includes a profile configured to use the port as the leading edge of a port tunneler, deliver the port through an introducer sheath, or both. A tunneling tip of a port body can be configured as aggressive for direct tunneling into a port tunneler or over a wire, or the encapsulation tip can be configured as soft for delivery through an introducer sheath.

[0086] Each aerodynamic port also includes at least one expandable or static stabilization element configured to provide stability to the port in vivo (e.g., in a port pocket at the implantation site). Such stabilization elements include, but are not limited to, one or more stabilization elements selected from legs (or wires), wings, inflatable elements, and shapes of the doors themselves, at least the legs and inflatable elements being deployable after the establishment of the port pocket for deployment. Additionally, the legs can have an open cell design, which allows a port to be removed from the connective tissue during an explant procedure without tearing the tissue. Such stabilization elements are configured to stabilize their respective ports, preventing the ports from rolling around their central axes in vivo. For example, a door may include deployable legs, such as doors 2102, 2104, 2106, 3100, or 5100, or the door may include wings such as door 8100.

[0087] These stabilization elements are configured for different implant and explant procedures with different tools, some of which are standard surgical tools (e.g., clamps, pliers, etc.), and some of which are included in surgical tunneling systems. door, such as door retrievers configured to engage with hooks, holes, or recesses in streamlined doors. For example, a port with deployable legs that open toward an end proximal to or away from the tunneling tip of the port (e.g., ports 2102, 2104, and 2106) is configured for deployment using a port tunneler or assembly of sequential dilators through an incision at the internal jugular access site. The port 2108, which also has deployable legs opening toward a proximal end of the port, is configured for delivery over a wire, as shown by the wire entering the tip of the port 2108 and exiting through one side of the tip. Explanation of such ports is accomplished using a port retriever (e.g., port retriever 1500 of Figures 15A and 15B for port 2104) or a sheath through a second incision in the upper chest. In another example, a port with implantable legs opening outwardly from a proximal end or toward the tunneling tip of the port (e.g., port 5100) is configured for implantation and explantation using at least the array of sequential dilators through a single incision at the internal jugular access site.

[0088] In view of the foregoing, the aerodynamic port 2102 is configured for a tunneling implant procedure through a first incision, e.g., at the internal jugular access site, and a traction explant procedure through a second incision, for example, in the upper chest, whose explant procedure does not require retraction of the stabilizing pair of legs. The streamlined port 2104 is also configured for a tunneling implant procedure through the first incision, but the port 2104 is further configured for a sheath-assisted explant procedure in which the pair of stabilizing legs is retracted with a one-piece hook. door retriever (e.g., door retriever 1500 of Figures 15A and 15B) to pull the door through the sheath. Each door of the aerodynamic doors 2106 and 3100 includes a retractable stabilizing element (see, e.g., Figure 3D), the stabilizing element being a pair of legs when extended. Port 3100 is configured with a softer tip for a sheath-assisted implant procedure and port 2106 is configured with a more aggressive tip for a tunneling implant procedure. The 5100 Streamline Port is configured with a softer tip for a sheath-assisted implant procedure through an incision, for example, at the internal jugular access site and an explant procedure at the same internal jugular access site. The 8100 streamline port is configured for a tunneling implant procedure and an explant procedure with standard surgical clamps or pliers, like the 2102 port; that is, ports 2102 and 8100 do not require the port salvagers provided here for explant. As such, ports can be configured with any combination of multiple features selected from a soft tip for a sheath-assisted deployment procedure or an aggressive tip for a tunneling (including over a wire) deployment procedure; one or more stabilizing elements, such as legs (or wires), wings and shapes of the doors themselves; directionality of the one or more stabilization elements for implantation and explantation through a single incision or two different incisions; and additional features such as hooks, holes or recesses for retrieval with one or more door retrievers (e.g., the port retriever 1500 of Figures 15A and 15B). The ports in Figure 2 are examples that illustrate these different combinations.

[0089] Each aerodynamic port includes a septum with a shape and configuration comparable to existing non-aerodynamic ports. For example, the septum has a surface area proportional to existing non-aerodynamic ports. In contrast to existing non-aerodynamic ports, any port identification protrusions (e.g., power port identification protrusions for aerodynamic power ports) or septum indication protrusions are on the port body, which maximizes the port area. septum surface for needle access. However, these port identification protrusions and septum indication protrusions are not limited to positioning on the port body. Port identification protrusions and septum indication protrusions may be included on the septa in some embodiments.

[0090] Each aerodynamic port may be radiopaque, MRI conditional, or secure, or a combination thereof.

[0091] Each aerodynamic port may further include a radio frequency identification ("RFID") tag. A door's RFID tag may include readable information recorded on the RFID tag at the time of the door's manufacture. Readable information can identify the type of door by model number, batch number, date of manufacture, etc. Furthermore, a door's RFID tag can be writable so that patient information can be written to the RFID tag.

[0092] Each streamlined port can be pressure-fitted, welded, joined or threaded, or printed using metal 3D printing to form the port body. The septum is symmetrical, and the septum can be mounted by various press-fit fittings, optionally with adhesive or additional thermal bonding. Stabilization elements, such as the pair of stabilization legs (or wires), may be attached to the port body for an implant or explant procedure, or movable to provide or retract stability for an implant or explant procedure.

[0093] Referring now to Figures 3A-3D, schematics are provided illustrating views of an aerodynamic door 3100, including a first pair of legs 3120, in accordance with some embodiments. As shown, the port 3100 includes a septum 3110 and the first pair of legs 3120. The first pair of legs 3120 includes a first leg 3120a and a second leg 3120b. A catheter 3130 connected to port 3100 with a catheter lock 3132 is also shown in at least Figures 3B and 3C. The door 3100 includes a retractable stabilizing member, the stabilizing member being the first pair of legs 3120 when extended. Port 3100 is configured for at least one sheath-assisted implant procedure.

[0094] The septum 3110 of the aerodynamic port 3100 is opposite the first pair of legs 3120; however, the septum 3110 can only be positioned at a distal end of the port 3100, as exemplified by the port 1200 of Figures 9A and 9B. Such unique positioning of the septum 3110 at the distal end of the port 3100 is a consequence of the port 3100, requiring only a single incision for introduction, tunneling, and positioning of the port 3100 at an implantation site. Eliminating the second incision commonly used to place a port reduces trauma, the risk of infection, and scarring at the site of the possible second incision, thereby freeing up the area for injections through the uniquely positioned septum 3110 at the distal end of the port 3100.

[0095] The first pair of legs 3120 of the aerodynamic door 3100 is an example of a stabilizing element of the aerodynamic doors provided herein, the first pair of legs 3120 configured to stabilize the door 3100 from rolling about a central axis of the port 3100 in vivo, thereby maintaining needle access to septum 3110. The first pair of legs 3120 of port 3100 is configured to assume a collapsed state while in an adapter of a port tunneler (or introducer sheath) and a state expanded or implanted while outside the port tunneler adapter (or introducer sheath). The expanded state of the first pair of legs 3120 stabilizes the port 3100 from rolling around a central axis of the port 3100 in vivo, thereby maintaining needle access to the septum 3110.

[0096] In the collapsed state of the first pair of legs 3120, each leg of the legs 3120a and 3120b lies along its own side of the aerodynamic port body 3100 and is held in place by the port tunneler adapter (or introducer sheath). . The collapsed state of the first pair of legs 3120 allows the port 3100 to assume an initially small profile to subcutaneously tunnel the port 3100 in the port tunneler from an incision site to an implantation site. That is, the first pair of legs 3120 includes a collapsed state that confers or otherwise contributes to a sufficiently small profile of the port 3100 to subcutaneously tunnel the port 3100 from an incision site to an implantation site for the port 3100 .

[0097] In the expanded state of the first pair of legs 3120, each leg of the legs 3120a and 3120b is configured via shape memory to protrude from a proximal end of the aerodynamic door body 3100. The expanded state of the first pair of legs 3120 allows the port 3100 to assume a subsequently large profile to secure the port 3100 at the implantation site and maintain needle access to the septum 3110. That is, the first pair of legs 3120 includes an expanded state configured to stabilize the port 3100 from of rolling around a central axis of the port 3100 in vivo, thereby maintaining needle access to the septum 3110.

[0098] Leg 3120a and leg 3120b may be joined to form a 'U' shape at a distal end of the aerodynamic port 3100, as best shown in Figure 3D. Each leg of legs 3120a and 3120b is held in place by its own leg retainer (e.g., a hole through a door body extension 3100), which allows, in some embodiments, the pair of U-shaped legs 3120 slide longitudinally along the body of the port 3100. Due to the shape memory of the pair of legs 3120, sliding the pair of U-shaped legs 3120 toward the distal end of the port 3100 shortens the pair of legs proximally to the leg retainers and narrows its width end to end. Sliding the pair of U-shaped legs 3120 toward a proximal end of the port 3100 lengthens the pair of legs proximally to the leg retainers and widens its width from end to end. This is useful for adjusting the end-to-end width of the pair of legs 3120 of the door 3100 for different sized deployment locations.

[0099] Referring now to Figure 4, a schematic is provided illustrating the deployment of the aerodynamic gate 3100 having the first pair of legs 3120 from a gate tunneler 4200 in accordance with some embodiments. During a tunneling implant procedure, port 3100 and pair of legs 3120 are contained in port tunneler 4200 or in an adapter at the distal end of port tunneler 4200. (See, for example, adapter 7210 of Figure 7. ) As such, port tunneler 4200 restricts the pair of deployment legs 3120 until port 3100 exits port tunneler 4200 at the deployment location (e.g., port bag) to port 3100. By releasing port 3100 from port tunneler 4200 with the release mechanism, the first pair of legs 3120 is configured to assume a deployed state.

[00100] Referring now to Figures 5A-5C, schematics are provided illustrating views of an aerodynamic door 5100, including a second pair of legs 5120, in accordance with some embodiments. As shown, port 5100 includes a septum 5110 and second pair of legs 5120. Second pair of legs 5120 includes a first leg 5120a and a second leg 5120b. A catheter 5130 connected to port 5100 with a catheter lock 5132 is also shown in Figures 5B and 5C. Port 5100 is configured with the second pair of distally opening legs 5120 for at least one sheath-assisted implant procedure at the internal jugular access site and one explant procedure through the access site.

[00101] The septum 5110 of the aerodynamic port 5100 is opposite the second pair of legs 5120; however, the septum 5110 may only be positioned at a distal end of the port 5100, as exemplified by the port 1100 of Figures 9A and 9B. Again, such unique positioning of a septum at a distal end of a streamlined port is a consequence of the port requiring only a single incision for introduction, tunneling, and positioning of the port at an implantation site.

[00102] The second pair of legs 5120 of the aerodynamic door 5100 is another example of a stabilizing element of the aerodynamic doors provided herein, the second pair of legs 5120 configured to stabilize the door 5100 from rolling about a central axis of the door 5100 in vivo, thereby maintaining needle access to the septum 5110. The second pair of legs 5120 of the port 5100 is configured to assume a collapsed state while in an adapter of a port tunneler (or an introducer sheath) and an expanded state or implanted while outside the port tunneler adapter (or introducer sheath). The expanded state of the second pair of legs 5120 stabilizes the port 5100 from rolling around a central axis of the port 5100 in vivo, thereby maintaining needle access to the septum 5110.

[00103] In the collapsed state of the second pair of legs 5120, each leg of the legs 5120a and 5120b lies along its own side of the aerodynamic port body 5100 and is held in place by the port tunneler adapter (or introducer sheath). . The collapsed state of the second pair of legs 5120 allows the port 5100 to assume an initially small profile to subcutaneously tunnel the port 5100 in the port tunneler from an incision site to an implantation site. That is, the second pair of legs 5120 includes a collapsed state that imparts or otherwise contributes to a sufficiently small profile of the port 5100 to subcutaneously tunnel the port 5100 from an incision site to an implantation site for the port 5100. .

[00104] In the expanded state of the second pair of legs 5120, each leg of the legs 5120a and 5120b is configured via shape memory to protrude from a distal end of the aerodynamic door body 5100. The expanded state of the second pair of legs 5120 allows the port 5100 to assume a subsequently large profile to secure the port 5100 at the implantation site and maintain needle access to the septum 5110. That is, the second pair of legs 5120 includes an expanded state configured to stabilize the port 5100 at from rolling around a central axis of the port 5100 in vivo, thereby maintaining needle access to the septum 5110.

[00105] Each leg of legs 5120a and 5120b is held in place by its own leg retainer (e.g., a hole through a door body extension 5100), which allows, in some embodiments, each leg of legs 5120a and 5120b slide individually and longitudinally along the body of the streamlined port 5100. Due to the shape memory of each leg of the legs 5120a and 5120b, sliding a first leg such as the leg 5120a toward the proximal end of the port 5100 shortens the distal leg to its retainer leg and narrows an end-to-end width with a second leg, such as leg 5120b. Sliding the first leg toward a distal end of the port 5100 extends the distal leg to the leg retainer and extends the end-to-end width with the second leg. This is not only useful for adjusting the end-to-end width of the pair of legs 5120 in the expanded state of the port 5100 for different sized deployment locations, but individually adjusting each leg of the legs 5120a and 5120b allows fine tuning of the expanded state.

[00106] The aerodynamic doors 3120 and 5120, respectively, of Figures 3A-3D and 5A-5C differ at least in the positioning of their leg retainers and the union of their pairs of legs. Again, port 5100 is configured with the second pair of legs 5120 opening distally for at least one sheath-assisted implantation procedure at the internal jugular access site and one explant procedure through the access site. However, the leg retainers on the streamlined port body 3120 may be located at the proximal end of the port body 3120 (such as the port 5120) rather than the distal end of the body. Furthermore, the leg 5120a and the leg 5120b may be joined to form a 'U' shape (like the first pair of legs 3120 of the door 3120) at the proximal end of the aerodynamic door 5100, instead of being unjoined or separate. Again, the particular embodiments provided herein are examples and do not limit the scope of the concepts provided herein.

[00107] Referring now to Figures 6A-6C, schematics are provided illustrating views of an aerodynamic door 6100, including a third pair of legs 6120, in accordance with some embodiments. As shown, port 6100 includes a septum 6110 and third pair of legs 6120. Third pair of legs 6120 includes a first leg 6120a and a second leg 6120b. A catheter 6130 connected to port 6100 with a catheter lock 6132 is also shown in Figures 6B and 6C.

[00108] The septum 6110 of the aerodynamic port 6100 is opposite the third pair of legs 6120; however, the septum 6110 may only be positioned at a distal end of the port 6100, as exemplified by the port 1100 of Figures 9A and 9B. Again, such unique positioning of a septum at the distal end of a streamlined port is a consequence of the port, requiring only a single incision for introduction, tunneling, and positioning of the port at an implantation site.

[00109] The third pair of legs 6120 of the aerodynamic door 6100 is another example of a stabilizing element of the aerodynamic doors provided herein, the third pair of legs 6120 configured to stabilize the door 6100 from rolling about a central axis of the door 6100 in vivo, thereby maintaining needle access to the septum 6110. The third pair of legs 6120 of the port 6100 is configured to assume a collapsed state while in the adapter of a port tunneler (or an introducer sheath) and an expanded state or implanted while outside the port tunneler adapter (or introducer sheath). The expanded state of the third pair of legs 6120 stabilizes the port 6100 from rolling around a central axis of the port 6100 in vivo, thereby maintaining needle access to the septum 6110.

[00110] In the collapsed state of the third pair of legs 6120, each leg of the legs 6120a and 6120b lies along its own side of the aerodynamic port body 6100 and is held in place by the port tunneler adapter (or introducer sheath). . The collapsed state of the third pair of legs 6120 allows the port 6100 to assume an initially small profile to subcutaneously tunnel the port 6100 in the port tunneler from an incision site to an implantation site. That is, the third pair of legs 6120 includes a collapsed state that confers or otherwise contributes to a sufficiently small profile of the port 6100 to subcutaneously tunnel the port 6100 from an incision site to an implantation site for the port 6100. .

[00111] In the expanded state of the third pair of legs 6120, each leg of the legs 6120a and 6120b is configured via shape memory to curve inwardly a medial section of the leg and outwardly a proximal end portion or proximal end portion of the door body. aerodynamics 6100. The expanded state of the third pair of legs 6120 allows the port 6100 to assume a subsequently large profile to secure the port 6100 at the implantation site and maintain needle access to the septum 6110. That is, the third pair of legs 6120 includes an expanded state configured to stabilize the port 6100 from rolling about a central axis of the port 6100 in vivo, thereby maintaining needle access to the septum 6110.

[00112] Each leg of legs 6120a and 6120b is held in place by its own leg retainer (e.g., a hole through a door body extension 6100) and secured to the aerodynamic door body 6100. Due to the shape memory of each leg of legs 6120a and 6120b, immediately upon releasing the streamline port from the port tunneler adapter, each leg curves inwardly the medial section of the leg and outwardly the proximal end or proximal end portion of the port body 6100. That said, the port 6100 may alternatively be configured so that the third pair of legs 6120 curves outward from a distal end or distal end portion of the port body 6100 similar to the streamlined port 5100 of Figures 5A-5C. The curved medial sections of the pair of legs 6120 form a compressible spring with a spring constant for expanding the port 6100 to adjust implantation sites of different sizes in the expanded state. Furthermore, the spring constant is sufficient to secure the 6100 port at the implantation site without causing trauma.

[00113] Referring now to Figure 7, a schematic is provided illustrating the deployment of the aerodynamic door 6100 having the third pair of legs 6120 from a door tunneler in accordance with some embodiments. During a tunneling implant procedure, the port 6100 and pair of legs 6120 are contained within an adapter 7210 at a distal end of the port tunneler. As such, adapter 7210 prevents leg pair 6120 from deployment until port 6100 exits adapter 7210 from the port tunneler at the deployment location (e.g., port bag) to port 6100. When releasing port 6100 From the port tunneler adapter 7210 with the release mechanism, the first pair of legs 6120 is configured to assume a deployed state.

[00114] Referring now to Figures 8A-8C, schematics are provided illustrating views of an aerodynamic door 8100 including a pair of wings 8120 in accordance with some embodiments. As shown, port 8100 includes a septum 8110 opposite the pair of wings 8120. The pair of wings 8120 includes a first wing 8120a and a second wing 8120b providing a winged bullet shape to the port 8100. A catheter 8130 connected to the port 8100 with an 8132 catheter lock is also shown in Figures 8B and 8C. Port 8100 is configured for at least one tunneling implant procedure and one explant procedure with standard surgical forceps or pliers; that is, the 8100 does not need the port retrievers provided here for explant.

[00115] The septum 8110 of the aerodynamic port 8100 is opposite the pair of wings 8120; however, the septum 8110 may only be positioned at a distal end of the port 8100, as exemplified by the port 1100 of Figures 9A and 9B. Again, such unique positioning of a septum at a distal end of a streamlined port is a consequence of the port, requiring only a single incision for introduction, tunneling, and positioning of the port at an implantation site. However, because port 8100 has a more pronounced or steeper distal end than some of the other aerodynamic ports provided herein, such modification to the distal end of port 8100 results in a less pronounced bullet shape of port 8100.

[00116] The pair of wings 8120 of the aerodynamic door 8100 is another example of a stabilizing element of the aerodynamic doors provided herein, the pair of wings 8120 configured to stabilize the door 8100 from rolling about a central axis of the door 8100 in vivo, thereby maintaining needle access to the septum 8110. Due to the already small profile of the port 8100, as well as the ability of the pair of wings 8120 to stabilize the port 8100 in vivo, the port 8100 does not need to include expanded and collapsed states. That said, each wing of the pair of wings 8120 may be, in some embodiments, disposed on a spring member in a wing cavity in the door body 8100. Like the pair of legs 6120 of the aerodynamic door 6100, immediately after releasing the door aerodynamics 8100 from a port tunneler adapter, each wing exits its cavity transitioning the port 8100 from a collapsed state to an expanded state. This is useful for expanding the coverage area of port 8100 if desired.

[00117] Referring now to Figures 9A, 9B and 10, schematics 9A, 9B and 10 are provided illustrating views of an aerodynamic door 9100 including an inflatable section 9120 as a stabilizing element and a door tunneler 10200 for the door 9100 of according to some modalities.

[00118] As shown in Figure 10, the port tunneling system 10000, including the aerodynamic port 9100 and the port tunneler 10200, is configured with an inflation mechanism distributed between the port 9100 and the port tunneler 10200. The mechanism of inflation allows the port 9100 to assume an initially small profile to subcutaneously tunnel the port 9100 in the port tunneler 10200 from an incision site to an implantation site. The inflation mechanism further allows the port 9100 to assume a subsequently large profile to secure the port 9100 at the implantation site and maintain needle access to the septum of the port 9100.

[00119] Referring to the port tunneler 10200 of Figure 10, the port tunneler 10200 includes an inflation lumen 10222 disposed in an inflation tube, a first fitting or hub 10224 at a proximal end of the inflation tube, and a second accessory at a distal end of the inflation tube, each of which is considered part of the inflation mechanism. The inflation tube or inflation lumen 10224 thereof is configured to fluidly connect to both a source of one or more fluids (e.g., a syringe including the one or more fluids) and the inflatable section of the aerodynamic port 9100 to inflate the inflatable section with one or more fluids. The first fitting or hub 10224 at the proximal end of the inflation tube may be configured as a female Luer taper fitting to accept a corresponding male Luer taper fitting of a syringe 1001 for delivering the one or more fluids to the inflation lumen 10222. Such tapered fittings Luer can be slide-type or lock-type Luer conical fittings. The second fitting at the distal end of the inflation tube may be configured as a male or female fitting in any of a number of ways to connect the inflation tube or the inflation lumen 10222 thereof to the inflatable section of the port 9100 through an opening. on port 9100, the opening of which includes a fitting corresponding to the second inflation tube fitting.

[00120] Regarding port 9100 of Figures 9A and 9B, port 9100 includes a septum 9110 and inflatable section 9120. A catheter 9130 connected to port 9100 with a catheter lock 9132 is also shown in Figures 9A and 9B. The septum 9110 of the aerodynamic port 9100 may be uniquely positioned at a distal end of the port 9100, as shown in Figures 9A and 9B. A unique positioning of the septum 9110 at the distal end of the port 9100 is a consequence of the port 9100, requiring only a single incision for introduction, tunneling and positioning of the port 9100 at an implantation site. Elimination of the second incision commonly used to place a port in an implantation site reduces trauma, risk of infection, and scarring at the second incision site, thereby freeing up the area for injections through the 9110 septum uniquely positioned at the distal end of the port. 9100. That said, port 9100 may alternatively include septum 9110 in a position opposite the inflatable section 9120 of port 9100.

[00121] The distributed inflation mechanism between the aerodynamic port 9100 and the port tunneler 10200 allows the port 9100 to assume the initially small profile to subcutaneously tunnel the port 9100 in the port tunneler 10200 from an incision site to a of implantation and a subsequent large profile for securing the port 9100 at the implantation site and maintaining needle access to the septum 9110. The inflatable section 9120 of the aerodynamic port 9100 is another example of a stabilizing element of the aerodynamic ports provided herein, the section inflatable 9120 configured to stabilize the port 9100 from rolling about a central axis of the port 9100 in vivo, thereby maintaining needle access to the septum 9110.

[00122] The inflation mechanism distributed between the aerodynamic port 9100 and the port tunneler 10200 allows the port 9100 to assume the initially small profile to subcutaneously tunnel the port 9100 in the port tunneler 10200 from an incision site to a of implementation. The inflatable section 9120 of the door 9100, which is included as part of the inflation mechanism of the door tunneling system 10000, makes the small profile of the door 9100 possible with an uninflated state of the inflatable section 9120. That is, the inflatable section 9120 includes an uninflated state imparting or otherwise contributing to a sufficiently small profile of the port 9100 to subcutaneously tunnel the port 9100 from an incision site to an implantation site for the port 9100.

[00123] The inflation mechanism distributed between the aerodynamic port 9100 and the port tunneler 10200 further allows the port 9100 to assume the subsequently large profile to secure the port 9100 at the implantation site and maintain needle access to the septum 9110. inflatable section 9120 of the door 9100 makes possible the large profile of the door 9100 with an inflated state of the inflatable section 9120. That is, the inflatable section 9120 further includes an inflated state configured to stabilize the door 9100 from rolling about a central axis of the door 9100. port 9100 in vivo, thereby maintaining needle access to the septum 9110. In the inflated state of the inflatable section 9120, the inflatable section 9120 imparts a triangular prismatic-like shape to at least a portion of the port 9100. For example, a medial portion of the port 9100 may resemble a triangular prism when the inflatable section 9120 is in the inflated state. A cross section of this triangular prism is a triangle.

[00124] The inflatable section 9120 of the port 9100 may be configured to inflate with one or more fluids. The one or more fluids may be delivered to the inflatable section 9120 by a syringe (e.g., syringe S of Figure 10) through the inflation lumen 10222 of the port tunneler 10200, the one or more fluids selected from pure fluids and mixtures including solutions. Pure fluids may include gases such as nitrogen or argon; liquids such as water; or a combination thereof. Mixtures can include gases such as air; liquids such as mineral oil, saline or one or more solutions of polymer(s) or polymer precursor(s); or a combination thereof.

[00125] With respect to one or more solutions of polymer(s) or polymer precursor(s), the inflatable section 9120 may be configured to inflate by introducing a solution into the inflatable section 9120 by syringe, the solution including at least a polymer precursor (e.g., polymer precursor A) that forms a polymer with at least one other polymer precursor (e.g., polymer precursor B) after polymerization and cross-linking in the inflatable section 9120. The at least one other polymer precursor polymer (e.g., polymer precursor B) may be disposed in the inflatable section 9120 at the time of manufacture or introduced into the inflatable section 9120 before or after solution, including the at least one polymer precursor (e.g., polymer precursor A) . Inflation of the inflatable section 9120 may include a combination of introducing one or more of the polymer precursor solutions into the inflatable section 9120 for a first expansion of the inflatable section 9120 and subsequently allowing the at least one polymer precursor (e.g., polymer precursor A) and at least one other polymer precursor (e.g., polymer precursor B) to polymerize and cross-link in a second expansion of the inflatable section 9120. That said, the first and second expansions of the inflatable section 9120 may occur simultaneously and the first and second expansions of the inflatable section 9120 may be coextensive. Inflation of the inflatable section 9120 may further include applying a low-grade biocompatible amount of heat for polymerization, cross-linking, or both polymerization and cross-linking. Cross-linking hardens the polymer in inflatable section 9120.

[00126] The inflatable section 9120 of the port 9100 may be configured to inflate with one or more polymers, optionally in combination with one or more of the foregoing fluids. The one or more polymers may be one or more swellable polymers disposed in the inflatable section 9120 at the time of manufacture. The inflatable section 9120 may be configured to inflate by a combination of introducing one or more of the foregoing fluids (e.g., water, saline, etc.) to the inflatable section 9120 for a first expansion of the inflatable section 9120 and subsequently allowing the one or more swellable polymers to swell in the presence of the one or more fluids in a second expansion of the inflatable section 9120. That said, the swelling kinetics of the one or more swellable polymers may be such that the first and second expansions of the inflatable section 9120 occur simultaneously. Furthermore, the first and second expansions of the inflatable section 9120 may be coextensive.

[00127] The aerodynamic port 9100 may include a one-way valve configured to close an opening in the inflation section 9120 of the port 9100 when releasing the port 9100 from the port tunneler 10200. The one-way valve may include a diaphragm or sphere configured to rest against an interior of the opening for inflation section 9120. Pressure from an inlet inflation fluid or a male fitting on the distal end of the inflation tube of the port tunneler 10200 can hold open the one-way valve by displacing the diaphragm or ball . Once the pressure from the inlet inflation fluid or male fitting is removed, the internal pressure in the inflation section 9120 of the port 9100 presses the diaphragm or ball against the opening of the inflation section 9120, keeping the one-way valve closed. Alternatively, the one-way valve may be a float valve that closes the opening to the inflation section 9120 of the port 9100 when releasing the port 9100 of the port tunneler 10200.

[00128] With regard to the implementation of the aerodynamic port 9100 of Figures 9A and 9B, vascular access is established at a first incision site, and the catheter tip is advanced to a location such as the superior vena cava. The catheter is then trimmed and attached to port 9100. Port 9100 is then positioned in port tunneler 10200 and encapsulated subcutaneously to an implant site, such as the upper chest. An inflation solution is then injected into the inflation lumen of the port tunneler 10200, and the inflatable section 9120 of the port 9100 is inflated to its full dimensions. The port tunneler 10200 is then removed, thereby disconnecting the port 9100 from the inflation lumen, which closes the one-way valve of the port 9100. The access site is then closed. Port 9100 is then accessed with a needle function to verify proper operation.

[00129] Referring now to Figure 11, a schematic is provided illustrating a port tunneler 11200 including a full-size handle 11230 in accordance with some embodiments. The 11230 handle is configured to provide the operator with a grip suitable for tunneling and positioning aerodynamic doors. Regarding port encapsulation, an initial tunneling path can be started with a typical tunneler. The port tunneler 11200 can be configured flexibly enough to follow the initial tunneling path. Furthermore, as set forth herein, a tunneling tip of a port body may be configured to be aggressive for tunneling directly into a port tunneler, such as the port tunneler 11200. As shown, the port tunneler 11200 further includes a push button. release button 11232 to release a tunneling port from adapter 11210. Release button 11232 is configured to push a deployment rod of a release mechanism on port tunneler 11200 to disengage the port from adapter 11210 when the release button release 11232 is pressed. The port tunneler 11200 is configured to be subsequently removed from the tunneling path without disturbing the position of an already placed catheter, for example, in the superior vena cava.

[00130] Referring now to Figure 12, a schematic is provided illustrating a set of sequential dilators 12000 for a tunneling implant procedure according to some embodiments. As shown, streamlined ports, such as adjustable port 1100, may be configured for deployment through an introducer sheath 12030 of a sequential dilator assembly 12000. The sequential dilator assembly 12000 includes, but is not limited to, a tool typical tunneling, tunnelizer, initial dilator, or first dilator 12010 to, for example, 1/8” in diameter; a second dilator 12020; and an end introducer sheath 12030 of sufficient diameter to accommodate an aerodynamic port with a stabilization element. In order to establish a thin-walled support sheath for deploying an aerodynamic port (e.g., aerodynamic port 1100), a tunneling path is initiated at an incision site with the initial dilator 12010, which includes a flexible length extending the from its proximal end to screw the remainder of the dilator set 12000 onto it. In a first stage of dilation, the second dilator 12020 is screwed onto the initial dilator 12010, which is finally removed. Then, in a second stage of dilation, the final introducer sheath is threaded over the second dilator 12020 and the initial dilator 12010. Subsequently, the initial dilator 12010 and the second dilator 12020 are removed leaving the introducer sheath 12030 in place. The port is implanted through the 12030 introducer sheath into a port pocket at a final implant site. The 12030 introducer sheath is subsequently withdrawn and any stabilizing elements, such as a pair of collapsed legs, are immediately expanded to secure the port to the port pocket in the final location. The advantage of sequential dilation with the 12000 Sequential Dilator Set is the less aggressive development of dissection along the implant path, as well as better control over the final location of the implant. Additionally, only one or two stitches are needed to close the incision site, if any stitches are necessary.

[00131] The previous tunneling path initiated with the initial dilator 12010 can be used to place a guidewire, which can be used to tunnel the aerodynamic port over the wire 2108 to the final implant site.

[00132] This set of sequential dilators facilitates tunneling of the ports during implantation to the final location of the implant, regardless of the explant procedure. Furthermore, this set of sequential dilators assists the jugular explant procedure, running the first and second dilators over the tunneler.

[00133] Referring now to Figures 13 and 14, schematics are provided illustrating a port retriever 14000 including a clamp 14210 and a traction explant procedure 13000 with the port retriever 14000 in accordance with some embodiments. As shown, the 14000 door retriever includes a full-size handle configured to provide the operator with adequate grip for retrieving streamlined doors. Additionally, the handle includes a slider 14232 configured to push an end support sheath over the forceps 14210 so that the clamp fingers of the forceps 14210 can properly clamp the port for the traction explant procedure. The port retriever 1400 is configured for port retrieval through the same tunneling path as the tunneling implant procedure in order to eliminate scarring typically associated with port explants.

[00134] In connection with the traction explant procedure 13000 for a port, a set of dilators, such as the sequential dilator set 12000, is used to pass a catheter to a distal end of the port, proximate to a catheter lock. With port 5100 of Figure 13, for example, the first dilator 12010 of the set of sequential dilators 12000 is passed over the catheter 5130 descending into the catheter lock 5132. The second dilator 12020 is passed over the first dilator 12010 also descending into the catheter lock. catheter 5132. After sufficient dilation is established, a final support sheath (e.g., sheath 12030 of sequential dilator assembly 12000) is placed and port retriever 14000 is advanced to port 5100 below the support sheath for engagement. the port 5100. Collet fingers of the collet 14210 are configured to deflect over an angled recess in the distal end of the port 5100. The slider 14232 is configured to push the support sheath over the collet 14210. Once engaged, the port 5100 can be retracted through the support sheath as the second pair of legs 5120 collapses into the support sheath.

[00135] Referring now to Figures 15A and 15B, schematics are provided illustrating a port retriever 15000 in different states of use, according to some embodiments. As shown, the door retriever includes a handle 15330, a door shell 15310 and a door hook 15312, wherein Figure 15A shows the door retriever 15000 in a retrieval state, and Figure 15B shows the door retriever 1500 in a withdrawal status. The recovery state of the door retriever 1500 is configured to hook a door such as the door 2104 of Figure 2 with the door hook 15312 of the door retriever 15000. After the door is hooked, the handle 15330 can be closed to form the withdrawn state of the door reclaimer 15000. In doing so, the door is pulled into the door shell 15310, thereby retracting any deployed stabilizing elements, such as any pairs of legs. Additionally, once the handle is closed, snap tabs or detents prevent the handle from opening again, preventing accidental redeployment of the door when removing the 15000 door retriever. This door retrieval is configured to facilitate door retrieval. , for example, from the upper chest in a two-step port retriever procedure.

[00136] Referring now to Figure 16, a schematic is provided illustrating an installation tool 16300 in accordance with some embodiments. As shown, installation tool 16300 includes a port scoop 16310 configured to hold at least a distal end portion of a port such as port 3100 for connecting and locking a catheter (e.g., catheter 3130) to an end portion. proximal to the port. Installation tool 16300 is further configured to facilitate installation of the port into an adapter on a distal end portion of a port tunneler.

[00137] With regard to implantation of an aerodynamic port provided herein, a desired vessel is located and accessed with an introducer needle at an access site. The access needle is removed and replaced with a guidewire. An introducer is advanced over the guidewire. The correct position of the guidewire is confirmed by fluoroscopy, the depth measurement at the guidewire is noted, and the guidewire is removed. Alternatively, the above can be performed by ECG guidance. A port catheter is then trimmed to the correct length, taking into account the distance from the access site to, for example, the superior vena cava plus the desired distance from the access site to a desired port pocket location, e.g. For example, in the upper part of the chest. The catheter is attached to the port, which can be pre-installed on the port tunneler. The port tunneler is then inserted into the access location and tunneled to the desired port pocket location. The introducer is then removed and the catheter is folded into the access site. The catheter tip is confirmed by fluoroscopy, and the port is released from the port tunneler. The port tunneler is removed, and the port is then accessed and verified for correct flow.

[00138] Furthermore, with respect to the deployment of an aerodynamic port provided herein, the port may be deployed in the following manner: An aerodynamic port is carried in an adapter in a distal end portion of a port tunneler. The port is inserted into an incision at a first body location, which incision is sized to require no more than one or two sutures to close the incision. The port is subcutaneously tunneled to an implantation site in a second body location using a tip of the port. The port is released from the adapter with a port tunneler release mechanism. The port tunneler adapter is configured to retain a port stabilizing element in a collapsed state. Releasing the port from the adapter allows the port stabilization element to assume an expanded state to stabilize the port and maintain needle access to a port septum in vivo.

[00139] When implanting the aerodynamic port, a cardiac end of a catheter is also implanted into the superior vena cava. One port end of the catheter is connected to the port and locked into the port with a catheter lock before loading the port into the port tunneler adapter. Connection and locking of the port end of the catheter into the port is either prior to or subsequent to implantation of the cardiac end of the catheter into the superior vena cava.

[00140] The aerodynamic door is removed from the second body location with a door retriever. The door retriever includes a hook for pulling the door out of the second body location through a hole in the tip of the door. Alternatively, the port is removed from the second body location with one or more standard surgical tools.

[00141] Furthermore, with respect to the deployment of an aerodynamic port provided herein, the port may be deployed in the following manner: An incision is made at a first body location, which incision is sized to require no more than one or two sutures to close the incision. A tract is established for a second body location. The tract is sequentially dilated with a set of sequential dilators. After dilation with the dilator set, the sheath is left in place to load a streamlined port. The port is loaded at a proximal end of the sheath. The port is encapsulated in an implantation site at the second body location, at a distal end of the sheath. The port is released from the distal end of the sheath. The sheath is configured to retain a door stabilizing member in a collapsed state along a length of the sheath. Releasing the port from the sheath allows the port stabilization element to assume an expanded state to stabilize the port and maintain needle access to a port septum in vivo.

[00142] When implanting the aerodynamic port, a cardiac end of a catheter is also implanted into the superior vena cava. One port end of the catheter is connected to the port and locked into the port with a catheter lock before loading the port into the sheath. Connection and locking of the port end of the catheter into the port is either prior to or subsequent to implantation of the cardiac end of the catheter into the superior vena cava.

[00143] The aerodynamic door is removed from the second body location with a door retriever. The door retriever includes a hook for pulling the door out of the second body location through a hole in the tip of the door. Alternatively, the port is removed from the second body location with one or more standard surgical tools. Alternatively, the port is removed from the second body location with another sheath along the tract from the first body location to the second body location.

[00144] Although some particular embodiments have been provided here, and although the particular embodiments have been provided in some detail, it is not the intention of the particular embodiments to limit the scope of the concepts presented here. Additional adaptations and/or modifications may appear to those skilled in the art and, in broader aspects, such adaptations and/or modifications are also covered. Therefore, departures may be made from the particular embodiments provided herein without departing from the scope of the concepts provided herein.

Claims (12)

1. System (1000, 10000), CHARACTERIZED by the fact that it comprises: a) an aerodynamic port (1100, 2102, 2104, 2106, 2108, 3100, 5100, 8100, 9100) including: a septum (3110, 5110, 6110 , 8110) disposed over a cavity in a port body configured to accept a needle therethrough; and a stabilizing member (3120, 5120, 6120, 8120, 9120) configured to stabilize the IN VIVO port and maintain needle access to the septum (3110, 3110, 6110, 8110); and b) a port tunneler (1200, 10200) including: an adapter (1210, 11210) on a distal end portion of the port tunneler (1200, 10200) configured to securely hold the port while subcutaneously tunneling the port from an incision site for an implantation site for the port; and a release mechanism configured to release the port from the adapter (1210, 11210) at the deployment location. 2. System (1000, 10000), according to claim 1, CHARACTERIZED by the fact that the stabilization element (3120, 5120, 6120, 8120, 9120) is an inflatable section (9120) of the door, the inflatable section ( 9120) including: an uninflated state imparting a profile for the port configured to subcutaneously tunnel the port from an incision site to an implantation site for the port; and an inflated state configured to stabilize the port from rolling around a central axis of the IN VIVO port, thereby maintaining needle access to the septum (3110, 3110, 6110, 8110). 3. System (1000, 10000), according to claim 2, CHARACTERIZED by the fact that the inflatable section (9120) is configured to inflate with one or more fluids; one or more polymers; or a combination thereof, and the port tunneler (1200, 10200) further includes an inflation lumen (10222) fluidically connected to the inflatable section (9120) for inflating the inflatable section (9120) with the one or more fluids. 4. System (1000, 10000), according to claim 3, CHARACTERIZED by the fact that the port further includes a one-way valve configured to close the inflation section (9120) when releasing the port from the port tunneler (1200 , 10200) with the release mechanism. 5. System (1000, 10000), according to any one of claims 2 to 4, CHARACTERIZED by the fact that the inflatable section (9120) is configured to inflate by introducing a solution including at least one polymer precursor that forms a polymer with at least one other polymer precursor after polymerization and cross-linking within the inflatable section (9120). 6. System (1000, 10000), according to any one of claims 1 to 5, CHARACTERIZED by the fact that the stabilizing element (3120, 5120, 6120, 8120, 9120) is at least one pair of legs (3120 , 5120, 6120) configured to stabilize the port from rolling around a central axis of the IN VIVO port, thereby maintaining needle access to the septum (3110, 5110, 6110, 8110). 7. System (1000, 10000), according to claim 6, CHARACTERIZED by the fact that the pair of legs (3120, 5120, 6120) is configured to assume a deployed state when releasing the port from the port tunneler ( 1200, 10200) with the release mechanism, and the adapter (1210, 11210) is configured to retain a proximal end portion of the port including the pair of legs (3120, 5120, 6120) in a collapsed state of the pair of legs ( 3120, 5120, 6120). 8. System (1000, 10000), according to any one of claims 1 to 5, CHARACTERIZED by the fact that the stabilizing element (3120, 5120, 6120, 8120, 9120) is a bullet-like shape with wings (8120 ) port configured to stabilize the port from rolling around a central axis of the IN VIVO port, thereby maintaining needle access to the septum (3110, 5110, 6110, 8110). 9. System (1000, 10000), according to any one of claims 1 to 8, CHARACTERIZED by the fact that it further comprises: c) an installation tool (16300) configured to maintain at least a distal end portion of the port to connect a catheter to a proximal end portion of the port and facilitate installation of the port into the adapter (1210, 11210) on the distal end portion of the port tunneler (1200, 10200). 10. System (1000, 10000), according to claim 1, CHARACTERIZED by the fact that the adapter (1210, 11210) is further configured to retain at least one pair of legs (3120, 5120, 6120) of the aerodynamic port ( 1100, 2102, 2104, 2106, 2108, 3100, 5100, 6100, 8100, 9100) in a collapsed state of the leg pair (3120, 5120, 6120), or in which the adapter (1210, 11210) is further configured to keep the door aerodynamic by having a bullet-like shape with wings (8120). 11. System (1000, 10000), according to any one of claims 1 to 10, CHARACTERIZED by the fact that it further comprises a handle on a proximal end portion of the port tunneler (1200, 10200), the handle including a release mechanism release button configured to release the aerodynamic port (1100, 2102, 2104, 2106, 2108, 3100, 5100, 6100, 8100, 9100) from the adapter (1210, 11210) when the release button is pressed . 12. System (1000, 10000), according to any one of claims 1, 7 or 8, CHARACTERIZED by the fact that the port tunneler (1200, 10200) is configured for arrangement in a sheath next to a catheter connected to an aerodynamic port (1100, 2102, 2104, 2106, 2108, 3100, 5100, 6100, 8100, 9100) when the port is disposed on the adapter (1210, 11210).