Patent Description:
The placement process also leaves behind scars that can be several centimeters long. Scar formation is exacerbated by tension on the skin during port placement and during wound healing. This is of particular significance for ports defining larger vertical profiles such as power injection ports, that place increased tension on the incision and surrounding tissue, exacerbating scar tissue formation. The vertical heights of existing power injection ports are influenced by two factors, the thickness of the septum, and the depth of the reservoir for accommodating the bevel of the access needle.

For power injection ports, septum thickness needs to be sufficient to prevent rupturing when contrast fluid is introduced under pressure. Further, the configuration of Huber-type, non-coring access needles with sufficient lumen diameter to provide the necessary flow rate, e.g., at least about <NUM> milliliter per second, results in an extended needle bevel to accommodate the lumen opening. Accordingly, the reservoir depth is also required to be sufficient to fit the entire needle bevel into the reservoir. If the needle bevel is not entirely within the reservoir, the contrast fluid can escape to the surrounding tissues, and is detrimental to the patients' health. The combined effect of these two factors demand power injection ports to have a relatively large transverse profiles. Accordingly, implanting such ports requires substantial stretching of incision site and the surrounding tissues, inducing scarring.

What is needed therefore, is a system and a method for streamlining the port placement process. The placement system, including a placement tool and a port, simultaneously forms an incision, dissect tissue, create a tissue pocket of the correct size for the port being placed, and place the port subcutaneously. This results in reduced procedure times, reduced scarring, and minimized wound management. Further, the port includes features that allow for a low overall profile, while still capable of withstanding power injection. Thus reducing tension on the tissue pocket and incision site, reducing potential scarring.

<CIT> relates to a port catheter for introducing a fluid into a hollow organ of a human or animal body including a port unit implantable into the human or animal body, which port unit includes an interior chamber, to which the fluid to be introduced into the hollow organ of the human or animal body can be supplied.

<CIT> relates to an attachment mechanism for a surgically implantable medical device including one or more fasteners which may be simultaneously moved from an undeployed position to a deployed position by operation of an integral actuator.

<CIT> relates to a system for attaching a fluid access port to a patient.

<CIT> relates to an instrument for subcutaneously inserting an injection reservoir attached to an inflatable prosthesis by means of an elongated fluid conduit.

<CIT> relates to a surgical fastening system for implantable devices.

Embodiments of the present invention are generally directed to an implantable access port configured to provide needle access to a vasculature of a patient for the delivery of medicaments or the like. In accordance with one embodiment, the access port is shaped and configured to minimize scarring to a patient after the port has been subcutaneously implanted.

Disclosed herein is a subcutaneous access port system, comprising of a placement tool including a proximal handle and a distal port holder, and an implantable access port releasably secured to the port holder, the port comprising of a housing including a base and a reservoir, a needle-penetrable septum covering the reservoir, and a body coupled to the housing over the needle-penetrable septum, the body comprising of a stem cover configured to engage the distal port holder, and a tunneling edge opposite of the stem cover sharpened to facilitate dissection of the tissue as the implantable access port is urged subcutaneously.

In some embodiments, the subcutaneous access port system further comprises an indicia marker, the indicia marker disposed between the base and the body. The indicia marker is radiopaque and includes one of an alphanumeric symbol and shape denoting one of a feature and an orientation of the port. The placement tool engages an outer surface of the stem cover. The placement tool engages one of an inner surface of the stem cover, an end surface of the stem cover, and a stem aperture of the housing, the stem aperture also configured for receiving a stem portion, the stem portion providing fluid communication between the reservoir and a catheter attached thereto. The stem cover includes one of a protrusion, a detent, and a socket, configured to engage the placement tool. The body further includes a skive on a side surface thereof, the skive defining a tapered footprint of the distal portion of the body. The septum defines a convex upper surface to allow a needle to access the reservoir at an acute angle relative to a skin surface of the patient. A vertical depth of the reservoir is less than a maximum length of a bevel of an access needle, accessing the port. A footprint shape of the port includes one of a circular, crescent, reniform, elongate balloon and arrow shape.

In some embodiments, the septum includes a reinforcement. The reinforcement includes one of a wire reinforcement and a matrix reinforcement. The reinforcement includes a wire mesh. The reinforcement includes a plurality of individual wire strands, and one of the individual wire strands extends through a center-point of the septum. The reinforcement includes a matrix of silicone rubber with one of a plurality of particles and a plurality of fibers disposed therein. The plurality of particles are formed of one or more of a metal, a ceramic, and a polymer, and the particles range in size from <NUM> to <NUM> in diameter. The plurality of fibers are formed of one or more of a metal, a ceramic, and a polymer, and the fibers range in length from <NUM> and <NUM> in diameter.

Also disclosed herein is a system for placing an implantable port, comprising of a port; and a placement tool, comprising of an elongate body including a handle, a port holder disposed at a distal end of the elongate body and configured to releasably secure the port thereto, the port holder including a base, a curved panel, and a tunneling edge, and an actuator configured for selectively releasing the port.

In some embodiments, the base defines a perimeter, the shape of the perimeter matching the shape of a footprint of the port. The base and the curved panel define a recess, the recess configured to receive a distal portion of the port. The tunneling edge is sharpened and configured to dissect tissue when the placement tool is urged subcutaneously. The curved panel is formed of a first panel arm and a second panel arm, each of the first and second panel arms being hingedly coupled to the port holder. The actuator operably connects to the first and second panel arms, the actuator selectively moving the first and second panel arms between a closed position that retains the port, and an open position that releases the port.

Also disclosed herein is a port placement tool for placing an access port subcutaneously, comprising of a first elongate arm extending from a proximal end to a distal end, including a first gripping feature disposed at a proximal end and a first port holder disposed a distal end, a second elongate arm extending from a proximal end to a distal end, including a second gripping feature disposed at a proximal end and a second port holder disposed a distal end, and the first arm and the second arm hingedly connected at a mid-portion, one of the first port holder and the second port holder including a blade extending from a distal portion thereof.

In some embodiments, the first and second port holders include curved loops, shaped to receive a portion of an implantable access port. The first port holder includes a first blade and the second port holder includes a second blade, each of the first and second blades engage at a lateral mid-point of the tool.

Also disclosed herein is a method of subcutaneously placing an implantable access port, comprising of providing a port implantation system including a port and a placement tool, the port including a tunneling portion and a stem cover, the tunneling portion terminating in a tunneling edge, the stem cover extending over a stem portion of the port, and the placement tool engaging the stem cover to releasably secure the port to a distal end of the placement tool, inserting the tunneling edge through an incision on a skin surface of a patient, creating a tissue pocket using the tunneling portion of the port by urging the port subcutaneously to dissect subcutaneous tissue, releasing the port from the placement tool, and withdrawing the placement tool from the body of the patient. In some embodiments, the tunneling edge is sharpened. The incision is formed by one of a scalpel and a sharpened tunneling edge.

Also disclosed herein is a method of placing an access port subcutaneously, comprising of providing a port implantation system, the system including a placement tool and a port, the placement tool including a port holder configured for receiving the port, the port holder including a curved panel defining a recess and a tunneling edge, releasably securing the port to the port holder, creating an incision using the tunneling edge of the placement tool by inserting the port holder through a skin surface of a patient, creating a tissue pocket using the curved panel of the placement tool by urging the port holder subcutaneously to dissect subcutaneous tissue, releasing the port from the placement tool, and withdrawing the placement tool from the body of the patient. In some embodiments, the tunneling edge is sharpened.

Features from a given embodiment can be incorporated into other embodiments. Example embodiments of the invention will be desc's ribed and explained with additional specificity and detail through the use of the accompanying drawings in which:.

Labels such as "left," "right," "front," "back," "top," "bottom," "forward," "reverse," "clockwise," "counter clockwise," "up," "down," or other similar terms such as "upper," "lower," "aft," "fore," "vertical," "horizontal," "proximal," "distal," and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction.

With respect to "proximal," a "proximal portion" or a "proximal end portion" of, for example, a medical device disclosed herein includes a portion of the medical device intended to be near a clinician when the medical device is used on a patient. Likewise, a "proximal length" of, for example, the device includes a length of the device intended to be near the clinician when the device is used on the patient. A "proximal end" of, for example, the device includes an end of the device intended to be near the clinician when the device is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the device can include the proximal end of the device; however, the proximal portion, the proximal end portion, or the proximal length of the device need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the device is not a terminal portion or terminal length of the device.

With respect to "distal," a "distal portion" or a "distal end portion" of, for example, a medical device disclosed herein includes a portion of the medical device intended to be near or in a patient when the device is used on the patient. Likewise, a "distal length" of, for example, the device includes a length of the device intended to be near or in the patient when the device is used on the patient. A "distal end" of, for example, the device includes an end of the device intended to be near or in the patient when the device is used on the patient. The distal portion, the distal end portion, or the distal length of the device can include the distal end of the device; however, the distal portion, the distal end portion, or the distal length of the device need not include the distal end of the device. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the device is not a terminal portion or terminal length of the device.

As used herein, a "footprint" is a two-dimensional area substantially defined by a perimeter of an object when viewed from a plan view perspective. As used herein, the term "sharpened" is defined as a reduction in a radius of curvature between two facets, from that of a substantially rounded edge to that of a relatively more angular edge.

Embodiments of the present invention are generally directed to implantable access ports and placement tools. The ports are configured to provide needle access to a vasculature of a patient for the delivery of medicaments or the like. In accordance with embodiments disclosed herein, the access port is shaped and configured to define a low profile and minimize scarring to a patient after the port has been subcutaneously implanted. Further implantation tools facilitate the incision, dissection, sizing and placing of the port, simplifying the process for inserting the access device within the patient.

<FIG> show various details of an implantable access port ("port") <NUM> according to an exemplary embodiment. The port <NUM> includes a port housing ("housing") <NUM>, a port body ("body") <NUM>, and a needle penetrable septum ("septum") <NUM>. The port <NUM> includes a stem side, from which a stem portion <NUM> extends, and a tunneling side, opposite the stem side and used to define a tissue pocket, as described in more detail herein. The housing <NUM> includes a housing base <NUM> extending substantially horizontally from a stem side, to a tunneling side. A reservoir <NUM> is disposed on an upper surface of the base <NUM>, and a stem portion ("stem") <NUM> extends horizontally from a stem side of the housing <NUM>. The housing base <NUM> further includes an extended tunneling portion <NUM> for supporting indicia <NUM> and a tunneling portion <NUM> of the body <NUM>.

The stem <NUM> can be coupled with a catheter, catheter locking device <NUM>, or combinations thereof, or similar endovascular device. As used herein, the "catheter <NUM>" includes a portion of a catheter that engages the stem and any associated locking mechanisms, collars, barb features, combinations thereof, or the like for securing the catheter to the stem <NUM>. The stem <NUM> defines a lumen <NUM> extending from the reservoir <NUM> and provides fluid communication between the reservoir <NUM> and the catheter <NUM>.

As shown in <FIG>, the septum <NUM> is disposed over the reservoir <NUM> and secured in place by the port body <NUM>. In an embodiment, the septum <NUM> includes palpation features <NUM>, such as bumps. Examples of palpation features can be found in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>, each of which are incorporated by reference in their entirety into this application. Once the port <NUM> is subcutaneously implanted, the palpation features <NUM> allow a clinician to locate the port <NUM> and more specifically the septum <NUM> in order to access the port <NUM>. The palpation features <NUM> can vary in number and position and can indicate to a clinician the location and orientation of the port <NUM>.

<FIG> shows a plan view perspective of the port <NUM>. The port <NUM>, including the tunneling portions <NUM>, <NUM> provide a substantially triangular, arrow-like, shaped footprint. The reservoir <NUM> as shown defines a substantially circular footprint, although it will be appreciated that other shaped footprints are contemplated. The housing <NUM> can be formed of a substantially rigid material, such as polymers, plastics, titanium, stainless steel, or similar suitable materials.

In an embodiment, a tunneling edge <NUM> of the port body <NUM>, substantially opposite the stem side defines a sharp edge to facilitate placement of the port <NUM> within the patient. In an embodiment, the tunneling edge <NUM> facilitates separation of the tissue and forms a tissue pocket when the port <NUM> is urged subcutaneously into the patient. As shown in <FIG>, a side view of the tunneling edge <NUM> provides an angle φ. The angle of the tunneling edge φ can be between <NUM>° and <NUM>°. In an embodiment, the tunneling edge <NUM> defines a rounded edge for blunt dissection of the tissues.

In an embodiment, the port body <NUM> is formed of a relatively pliable material, such as silicone rubber or similar suitable material, and can be overmolded onto the housing <NUM>. In another embodiment, the body <NUM> is formed of a more rigid material, such as plastic, polymer, stainless steel, titanium, or similar material to that of the housing <NUM>, and can be snap-fitted or press-fitted onto the port housing <NUM>. In another embodiment, the body <NUM> is formed of a combination of pliable and rigid materials. For example, some portions of the body <NUM> can be formed of a pliable material while other portions, such as tunneling portion <NUM>, tunneling edge <NUM>, or combinations thereof include a rigid material. The pliable material can reduced stress points along a port body, and therefore reduce scarring, while the rigid material can provide a tunneling edge to separate the tissue as the port <NUM> is urged into the patient. In an embodiment, the tunneling edge can be sharpened sufficiently so that it is capable of nicking the skin to form an incision. In an embodiment the tunneling edge <NUM> includes a blade for nicking the skin to form an incision. In an embodiment, the blade can be selectively retractable.

In an embodiment, the outer profile of the port body <NUM> defines a smooth, unobtrusive shape that reduces tissue stress points on an exterior of the port <NUM>. The port body profile minimizes tension on the subcutaneous tissue during placement, this in turn minimizes the formation of scar tissue. As shown in <FIG>, in an embodiment, a tunneling portion <NUM> of the body <NUM> extends from a tunneling side of the reservoir <NUM>, away from the stem side to define an extended-sigmoid, sloped profile, when viewed from a side view perspective. The angle θ of the tunneling portion <NUM> can be between <NUM>° and <NUM>°. In an embodiment, the angle θ can be less than the angle φ of the tunneling edge <NUM>. In an embodiment, the angle θ can be greater than the angle φ of the tunneling edge <NUM>. In an embodiment, the angle θ can be substantially the same as the angle φ of the tunneling edge <NUM>. The sigmoid profile of the tunneling portion <NUM>, provides a hollow <NUM> between a tunneling edge <NUM> and the reservoir <NUM>. The hollow <NUM> provides a frictionless air gap between the surface of the tunneling portion <NUM> and the tissues that are being separated, which facilitates dissection of tissue and formation of a tissue pocket as the port is urged subcutaneously. In an embodiment, the side elevation profile of the tunneling portion <NUM> can include other shapes such as straight, convex, concave, or combinations thereof.

As shown in <FIG>, the port <NUM> further includes indicia <NUM>. The indicia <NUM> can include a radiopaque marker, formed of titanium or similar suitable radiopaque material, so as to be visible under fluoroscope, ultrasound, or similar imaging medium, once the port <NUM> is subcutaneously implanted. The indicia <NUM> can include symbols engraved therein to indicate an orientation, feature, or combinations thereof about the port. For example, the indicia <NUM> can have the letters "CT" engraved therein, together with being formed as a half-moon shape to indicate to a clinician the orientation of the port <NUM> and the suitability of the port for power injection.

The port <NUM> can further include one or more suture holes <NUM> extending through the port <NUM> to allow the port <NUM> to be secured to surrounding tissue once subcutaneously implanted. The suture holes <NUM> can further include suture plugs <NUM> disposed therein to prevent tissue ingrowth. The suture plugs <NUM> can be formed of silicone rubber or similar suitable needle penetrable material. As shown the suture holes are disposed at a stem side of the port <NUM> and oriented vertically. However, it will be appreciated that other numbers, combinations, positions, and orientations of suture holes <NUM> are contemplated.

In an embodiment, the port body <NUM> includes a stem cover <NUM>, extending from the port body <NUM> and surrounds a top and side portions of the stem <NUM>. The cover <NUM> can define a cylindrical shape with a substantially circular cross-section. The cover <NUM> further includes an opening <NUM> on a lower side. The opening <NUM> facilitates assembly of the port <NUM>, allowing the body <NUM> to be urged downwards over the housing <NUM> and the stem <NUM>. The cover <NUM> can further include one or more protrusions <NUM>, detents <NUM>, or combinations thereof that are configured to engage a distal end of a placement tool, for example insertion tool <NUM> shown in <FIG>. In an embodiment the cover <NUM> is configured to substantially surround both the stem <NUM> and a portion of the catheter <NUM> that engages the stem <NUM>. A distal portion of the placement tool <NUM> can then engage an outer surface of the cover <NUM> to manipulate both the port <NUM> and the catheter <NUM> attached thereto.

<FIG>, show various features of an embodiment of a port <NUM>. Similar to embodiments described herein, the port <NUM> includes a port housing <NUM>, a port body <NUM> including an extended tunneling portion <NUM> and a tunneling edge <NUM> that can be sharpened to facilitate implantation, and a needle penetrable septum <NUM>, including palpation features <NUM>. The housing <NUM> defines a reservoir <NUM> that is bounded by the needle-penetrable septum <NUM>, and includes a stem aperture <NUM>. The stem aperture <NUM> is configured for receiving a port stem <NUM>. The port stem <NUM> is formed as a separate structure from the housing <NUM> and is configured to engage the stem aperture <NUM> to provide fluid communication between the reservoir <NUM> and a catheter <NUM>.

In an embodiment, the port body <NUM> includes a stem cover <NUM>, extending from a stem side of the port body <NUM>. The stem cover <NUM> can define a cylindrical shaped recess with a substantially circular cross-section. The stem cover <NUM> further includes an opening <NUM> on a lower side. The stem cover <NUM> can further include one or more protrusions <NUM>, detents <NUM>, sockets <NUM>, or combinations thereof that are configured to engage a distal end of a placement tool, for example placement tool <NUM>.

In an embodiment, the distal end of the placement tool <NUM> engages an inner surface of the stem cover <NUM>, an end surface of the stem cover <NUM>, the stem aperture <NUM>, or combinations thereof to secure the port <NUM> to a distal end of the placement tool <NUM>. The placement tool can then be used to manipulate the port <NUM> into position within the body of the patient. Once the port <NUM> is in position, the tool disengages the port <NUM> and the clinician can optionally use the placement tool to attach the stem <NUM> and catheter <NUM>. The stem <NUM> can be urged distally to engage the stem aperture <NUM>. The catheter <NUM> can then engage the stem <NUM> to provide fluid communication between the reservoir <NUM> and the vasculature of the patient. In an embodiment, the stem <NUM> and catheter <NUM> can be attached simultaneously.

<FIG> show various views of the port <NUM>. As shown in <FIG>, in an embodiment, a tunneling portion <NUM> of the body <NUM> extends away from the stem cover <NUM> to define an extended sigmoid slope shape, when viewed from a side profile. The tunneling portion <NUM> facilitates dissection of tissue by the port <NUM> to form a tissue pocket, as the port is urged subcutaneously. As shown in <FIG>, port body <NUM> further includes one or more skives 262A, 262B extending along a side portion of the body <NUM> and angled to define a tapered, substantially triangular-shaped footprint to the port <NUM> when viewed from a plan view. The skives <NUM> further define a streamlined overall profile to the port <NUM> and, together with the tunneling edge <NUM> and profile of the tunneling portion <NUM>, further allows the port <NUM> to be urged through the tissue to define a tissue pocket while minimizing potential scarring.

<FIG> shows an embodiment of a port <NUM>. Similar to port <NUM>, port <NUM> includes a port housing <NUM>, a port body <NUM> including an extended tunneling portion <NUM> and a sharpened tunneling edge <NUM> to facilitate implantation, and a needle penetrable septum <NUM>, including palpation features <NUM>. The port <NUM> further includes a stem cover <NUM> extending from a stem side of the port body <NUM>. The stem cover <NUM> can define a cylindrical shaped recess with a substantially circular cross-section. The stem cover <NUM> further includes an opening <NUM> on a lower side as well as one or more protrusions <NUM>, detents <NUM>, sockets <NUM>, or combinations thereof that are configured to engage a distal end of a placement tool, for example placement tool <NUM>. In an embodiment, socket <NUM> includes an opening on an inner surface, communicating with the cylindrical recess defined by the stem cover <NUM>. The stem portion <NUM> can be formed as a separate structure from the port housing <NUM> and engages a stem aperture <NUM>.

In an embodiment, an ingrowth guard <NUM> can be disposed within the recess defined by the stem cover <NUM>, sockets <NUM>, or combinations thereof. The ingrowth guard <NUM> further includes a recess <NUM> for receiving a stem <NUM> and a portion of a catheter and/or catheter lock <NUM> connected to the stem <NUM>. As shown in <FIG>, the ingrowth guard substantially fills the void created between an inner surface of the stem cover and an outer surface of the catheter <NUM> when coupled to the port.

Implanted subcutaneous access ports are expected to have a certain amount of ingrowth around, for example, the port, stem, etc. The amount of tissue ingrowth can increase with geometry such as holes, and indentations that provide recesses for the tissue to grow into. Advantageously, once the port is placed subcutaneously, the ingrowth guard prevents any tissue from growing into the recesses between the catheter and/or catheter lock <NUM> and the port body stem cover <NUM>. Accordingly, when the port is removed, the catheter <NUM>, ingrowth guard <NUM>, and optionally the stem <NUM> can be removed to provide a clean surface with which the placement tool <NUM> can engage. Without the ingrowth guard <NUM> in place, tissue growth can obstruct the protrusions <NUM>, detents <NUM>, sockets <NUM>, or combinations thereof and prevent the placement tool <NUM> from engaging the port <NUM>, <NUM>.

<FIG> show embodiments of an implantable access port <NUM>. Similar to embodiments described herein, the port <NUM> includes a port housing <NUM>, a port body <NUM> including a tunneling edge <NUM> to facilitate implantation, and a needle penetrable septum <NUM>, including palpation features <NUM>. The housing <NUM> defines a reservoir <NUM> bounded by the needle-penetrable septum <NUM> and includes a stem <NUM>. The stem <NUM> configured for engaging a catheter <NUM> and providing fluid communication between the reservoir <NUM> and the catheter <NUM>.

As shown in <FIG> embodiments of the port <NUM> define a low-profile so that a minimum horizontal length or width of the port <NUM> is greater than the maximum vertical height of the port <NUM>. Typical power injection ports define a substantially higher profile in order to provide a sufficiently strong septum and tall enough reservoir. By contrast, embodiments described herein define a substantially lower profile for a similar overall footprint.

As shown in <FIG>, <FIG>, <FIG>, the footprint of the port <NUM> can vary in shape including circular e.g. port 310A, crescent shape or a reniform 'kidney bean' shape, e.g. 310B, 310C. It will be appreciated that other shapes of port footprint are also contemplated including triangular, trapezoid, hexagon, polygon, and the like. Embodiments of port <NUM> also define a substantially flat underside and a continuous, smooth, rounded upper side. These profile shapes allow the port <NUM> to define a relatively smooth, unobtrusive shape and reduces tissue stress points on an exterior of embodiments of the port <NUM>. Further, the profile of the body <NUM> minimizes tension on the subcutaneous tissue pocket and sutures that close the post-insertion incision, this in turn minimizes the formation of scar tissue.

<FIG> shows an incision line <NUM> through which port 310A is inserted subcutaneously. When the incision <NUM> is closed behind the port 310A, the circular footprint and rounded upper surface minimizes the area of stress points <NUM> on the incision <NUM>, thereby minimizing the formation of scar tissue. Further, the circular footprint allows the port 310A to be eased through an incision that is less than the maximum width of the port 310A itself, thereby allowing for a smaller incision site <NUM>.

<FIG> shows port 310B with a crescent shape, or reniform "kidney bean" shape footprint including a convex tunneling portion <NUM>, first and second lobes <NUM>, <NUM>, and a concave stem-side portion <NUM>. A stem <NUM> extending from the stem-side portion <NUM>, along a longitudinal axis. In an embodiment, a tunneling edge <NUM> can be sharpened and extends from a first side, proximate a first lobe <NUM>, through to a second side, proximate a second lobe <NUM>. The incision <NUM> required to insert the port 310B subcutaneously can be shorter than the lateral width of the port 310B and the same length as a longitudinal length (y) of the port <NUM> that extends along a longitudinal axis between the stem-side portion <NUM> at the base of the stem <NUM>, and the tunneling portion <NUM>.

As shown in <FIG>, positioning the port 310B subcutaneously includes inserting the port 310B sideways with the first lobe <NUM> passing through the incision <NUM> first. The port 310B is then inserted by rotating through substantially <NUM>° about a transverse axis until a second lobe <NUM> passes through the incision <NUM>. As the port <NUM> is rotated about the transverse axis, the sharpened tunneling edge <NUM> facilitates separation of the tissue thereby forming a tissue pocket. Once placed subcutaneously, the stress points <NUM>, adjacent the first and second lobes <NUM>, <NUM> are positioned away from a mid-point of the incision <NUM> and closer to the end points of the incision <NUM>, diverting any stress on the incision sutures away from the relatively weaker mid-point of the incision <NUM>. In an embodiment, the incision <NUM> is formed by a scalpel. In an embodiment, the tunneling edge <NUM> can include a blade to nick the skin and form the incision <NUM>. In an embodiment the blade is retractable.

<FIG> shows port 310C with an extended crescent shape, or 'kidney bean' shape footprint including a convex tunneling portion <NUM>, first and second lobes <NUM>, <NUM>, and a concave stem-side portion <NUM>. The stem <NUM> extending along a longitudinal axis from the stem-side portion <NUM>. In an embodiment, a tunneling edge <NUM> can extend from a first side through to a second side. The incision <NUM> required to insert the port 310C subcutaneously can be shorter than the lateral width of the port 310C and the same length as a longitudinal length (y) of the port extending along a longitudinal axis from the stem-side portion <NUM>, at the base of the stem <NUM>, through to the tunneling portion <NUM>.

As shown in <FIG>, positioning the port 310C subcutaneously includes inserting the port 310C sideways with the first lobe <NUM> passing through the incision <NUM> first. The port 310C is then inserted by rotating through substantially <NUM>° about a transverse axis until a second lobe <NUM> passes through the incision <NUM>. As the port 310C is rotated about the transverse axis, the sharpened tunneling edge <NUM> facilitates separation of the tissue forming a tissue pocket. Further, the stress points <NUM>, adjacent the first and second lobes <NUM>, <NUM> are positioned away from the incision <NUM>, reducing any stress on the incision sutures and reducing the formation of scar tissue.

<FIG> shows an embodiment of port 310D including an elongate balloon shaped footprint. Similar to port 310A, port 310D includes rounded edges to facilitate passing through an incision <NUM>, the incision <NUM> extending laterally the same or slightly less than the lateral width of the port. Advantageously, the shape of port 310D provides a larger target area with which to access the port and yet does not require any larger of an incision <NUM>. Further the larger target area allows an access needle to be inserted at an acute angle to the skin surface, as discussed in more detail herein.

As shown in <FIG>, <FIG>, <FIG>, the septum <NUM> defines a convex profile when viewed from a side view. As shown in <FIG>, the convex septum <NUM> allows an access needle <NUM>, such as a Huber-type, non-coring needle, to pass through the septum <NUM> at an acute angle relative to a skin surface <NUM> of the patient and access the reservoir <NUM> therebelow. In an embodiment, the access needle can pass through the septum at an angle of <NUM>° or less relative to a horizontal plane of the port <NUM>. Further, the angled entry position allows the entire opening of the needle lumen to remain within the reservoir <NUM> even if the transverse depth of the reservoir <NUM> is shorter than a maximum width (x) of the needle bevel <NUM>. Advantageously, this allows the port <NUM> to define a lower profile than typical ports while still enabling the entire needle bevel <NUM> to fit within the reservoir <NUM>.

As shown in <FIG>, in an embodiment a septum <NUM> can include reinforcements such as wires, particles, or combinations thereof. It will be appreciated that any of septa <NUM>, <NUM>, <NUM> can also include reinforcements described herein. In an embodiment, the reinforcements can include one or more wires <NUM> extending through the septum <NUM>. The wires can be formed of metal such as titanium or stainless steel, polymers such as nylon, ceramics, or any suitable material. The wires <NUM> can extend from a first side to a second side, and at least one of the wires <NUM> can pass through a center-point <NUM> of the septum <NUM>. In an embodiment, as shown in <FIG>, the wires <NUM> form a mesh structure extending through the septum <NUM>. The openings between the individual strands of wires <NUM> are sufficient to allow an access needle <NUM> to pass therebetween. In an embodiment, the septum <NUM> can be formed by overmolding needle penetrable silicone rubber over the wires <NUM>.

In an embodiment, the septum <NUM> includes particles <NUM> to create a reinforced composite material. The particles <NUM> can include metal, ceramics, polymers, or combinations thereof. The particles <NUM> can range in size from <NUM> to <NUM> in diameter, and are disposed within a matrix of silicone rubber to form the septum <NUM>. In an embodiment, the septum <NUM> includes filaments <NUM> to create a reinforced composite material. The septum <NUM> can include a matrix of silicone rubber and woven or non-woven filaments <NUM> disposed therein. The filaments can be between <NUM> and <NUM> in length and formed of metal, ceramics, polymers, or combinations thereof.

Advantageously, the reinforcements of the septum <NUM> allow the septum <NUM> to define a thinner transverse height while maintaining the ability to withstand typical power injection pressures. Further, the reinforcements can also define a septum with a convex profile, as described herein. Accordingly, a port including the reinforced septum <NUM> can define a lower profile, reducing stress placed on the surrounding tissue.

<FIG> depicts various details of an implantable access port placement tool ("placement tool" or "tool"), generally designated at <NUM>, according to an embodiment. As shown, the tool <NUM> includes an elongate body <NUM> extending between a distal end <NUM> and proximal end <NUM>. A proximal portion of the body defines a handle <NUM> for grasping of the tool. The handle can further include a grip surface <NUM> to assist the grasping of the tool <NUM>.

The tool <NUM> further includes a port holder <NUM> disposed at a distal end <NUM> of the tool <NUM>. The port holder <NUM> is configured to releasably hold an access port <NUM> prior to its placement in a subcutaneous tissue pocket defined in the placement tool <NUM>. It will be appreciated that port <NUM> can include any of the port embodiments <NUM>, <NUM>, <NUM> disclosed herein as well as other generic access ports.

The port holder includes a base <NUM> defining a flat underside and an elliptical perimeter <NUM> extending from a first side, to a distal end <NUM>, to a second side. The footprint of the elliptical perimeter <NUM> substantially matches the footprint of a port <NUM>. Extending from the elliptical perimeter <NUM> is a panel <NUM> that defines a cavity <NUM>. The cavity <NUM> is configured to receive a portion of the access port <NUM>. The panel <NUM> is angled in a proximal direction and curved to match the elliptical perimeter <NUM>. As shown in <FIG>, a side profile of the panel <NUM> extends proximally from the elliptical perimeter <NUM> to provide a sloping tunneling portion that facilitates dissection of tissue as the placement tool is urged subcutaneously.

In an embodiment, the port holder <NUM> is sized to match the approximate size of the access port <NUM>, enabling the clinician using the placement tool <NUM> to insert the port holder into a subcutaneous pocket and determine whether the pocket is sufficiently sized to receive the access port <NUM> prior to insertion. This simplifies the placement of the port <NUM> for the clinician. It will be appreciated that size, shape and configuration of the port holder <NUM>, the base <NUM>, the curved panel <NUM>, or combinations thereof, can vary in order to receive different sizes, shapes and configurations of port <NUM>. In an embodiment, a portion of the elliptical perimeter <NUM> can be sharpened to provide a sharpened tunneling edge <NUM>. The tunneling edge <NUM> can be used to separate the tissue of the patient and define the subcutaneous tissue pocket into which the access port <NUM> will be placed. In an embodiment, a portion of the elliptical perimeter <NUM> includes a blade for nicking the skin and forming an incision. In an embodiment, the blade is formed of separate material from the tool <NUM>, or port holder <NUM> and is selectively retractable.

Advantageously, the tool <NUM> provides a single instrument within which to create an incision, separate the subcutaneous tissues to create a tissue pocket, size the tissue pocket to match the size of the port, and place the port within the tissue pocket, or combinations thereof. A procedure that previously required a scalpel to create an incision, a Kelly clamp to separate the tissues, and repeated insertion of the port until the tissue pocket is of the correct size. Further, the tool <NUM> provides an instrument that performs the incision, separation, sizing and placing of the port <NUM>, or combinations thereof, in a single action.

As shown in <FIG>, in an embodiment, the port holder includes a first and second curved panel arms 524A, 524B. Each of panel arms 524A, 524B engage along a longitudinal axis to define a profile substantially the same as panel <NUM>. Each of first and second curved panel arms 524A, 524B are hingedly connected to the port holder <NUM> at a side portion and rotate thereabout along a horizontal plane. The first and second curved panel arms 524A, 524B can also be operably connected to an actuator <NUM> located on the handle <NUM>. In use, with a port <NUM> placed within a tissue pocket, a clinician can selectively release the port <NUM> from the port holder <NUM> by actuating the actuator <NUM> which causes the first and second curved panel arms 524A, 524B to open and release the port <NUM>. The tool <NUM>, along with port holder <NUM> can then be removed proximally while leaving the port <NUM> in place.

In an exemplary method of inserting an access port subcutaneously, a port is provided such as is discussed in embodiments herein. The port can be coupled to a distal end of a placement tool, for example tool <NUM>. In an embodiment, the placement tool <NUM> includes a port holder <NUM> that includes a recess <NUM>. The port engages the recess of the port holder and is secured thereto. The placement tool further includes a sharpened tunneling edge <NUM> and a sloped profile to facilitate formation of a tissue pocket as the tool is urged subcutaneously.

In an embodiment, an incision is formed either by using a scalpel, or by using the tunneling edge <NUM> of the placement tool <NUM> that includes a blade, the tool is then urged subcutaneously. The sharpened tunneling edge and sloped profile of the panel simultaneously dissects the tissue to form a tissue pocket and sizes the pocket to fit the port. In an embodiment the placement tool is then withdrawn and the port is then placed within the tissue pocket. In an embodiment, the port is coupled with the port holder <NUM> prior to subcutaneous placement of the tool <NUM>. With the port placed subcutaneously, the user actuates an actuator mechanism <NUM> which causes the panel arms 524A, 524B to rotate outwards and release the port from the distal end of the placement tool <NUM>. The placement tool <NUM> can then be withdrawn.

In an embodiment, as shown in <FIG>, the placement tool <NUM> includes an elongate body <NUM> extending between a distal end <NUM> and a proximal end <NUM>. A proximal portion of the body <NUM> defines a handle <NUM> for grasping of the tool. The handle can further include a grip surface <NUM> to assist the grasping of the tool <NUM>. The tool <NUM> further includes a flattened base portion <NUM> disposed at a distal end <NUM>. The base portion <NUM> defines an elliptically-shaped tunneling edge <NUM> that can be sharpened to facilitate tissue dissection and formation of a tissue pocket. Optionally, the tunneling edge <NUM> can include a blade for nicking the skin and forming an incision. As shown in <FIG>, a plan view of the base portion <NUM> shows the base <NUM> defining a footprint that substantially matches the footprint of a port <NUM>. It will be appreciated that the shape of the base portion <NUM> can vary to match the shape of the port footprint it is configured to insert.

In use, the placement tool <NUM> is grasped by the clinician and urged subcutaneously. In an embodiment, the tool <NUM> includes a blade to nick the skin and form an incision, through which the tool <NUM> is then urged. In an embodiment, the incision is formed by a scalpel. The tool <NUM> is then urged subcutaneously to dissect the tissue until the entire base portion <NUM> is disposed within the patient. Since the shape of the base portion <NUM> is the same, or slightly larger than a footprint of the port <NUM> to be inserted, the tool <NUM> defines a tissue pocket of a suitable size and depth. The placement tool <NUM> can be withdrawn and the port <NUM> can be disposed within the tissue pocket. It will be appreciated that port placement can be performed with or without a catheter <NUM> coupled to the port <NUM>. In an embodiment the placement tools <NUM>, <NUM> are formed of metal, polymer, plastic, or any suitable rigid material, or combinations thereof. For example, the tool body <NUM> can be formed of a polymer and include a metallic tunneling edge <NUM>. These and similar combinations are contemplated to fall within the scope of the present invention.

As shown in <FIG>, an embodiment of a placement tool <NUM> is disclosed. The placement tool <NUM> includes a first arm <NUM> extending from a proximal end to a distal end, and a second arm <NUM> also extending from a proximal end to a distal end. The first and second arms <NUM>, <NUM> are hingedly connected at a mid-portion <NUM>. A proximal end of each of the first and second arms <NUM>, <NUM> include a finger loop <NUM>, or similar structure to allow the clinician to grip each of the first and second arms <NUM>, <NUM> with a finger or thumb. The tool <NUM> further includes a latch <NUM> disposed between the first and second arms <NUM>, <NUM> and designed to lock the first and second arms <NUM>, <NUM> in one or more closed positions. As shown, the latch <NUM> is disposed towards a proximal end, although other configurations are contemplated.

A distal end of the first and second arms <NUM>, <NUM> each include a port holder <NUM>, e.g. first and second port holder 610A, 610B. The port holder <NUM> is configured to receive a side portion of a port <NUM>. In an embodiment, the port holder includes a curved loop shaped to receive a lobe of the port body although it will be appreciated that the shape of the port holder <NUM> can vary to fit different shaped ports.

A distal end of the first arm <NUM>, the second arm <NUM>, or combinations thereof also include a blade <NUM>. The blade <NUM> extends distally from a distal end of the port holder <NUM>. The blade <NUM> can define a crescent shape that extends around and in front of a port <NUM> disposed within the port holder. The blade, <NUM> can include a sharpened distal edge for forming an incision and dissecting tissue. In an embodiment, both the first and second arms <NUM>, <NUM> each include a blade <NUM>, e.g. first and second blades 640A, 640B, which engage at a lateral mid-point when the placement tool <NUM> is in one or more closed positions. In an embodiment each of the blades 640A, 640B can slide over each other in a scissor-like action as the finger loops are moved toward and apart from each other by the clinician.

In an exemplary method of use, the placement tool <NUM> can secure a port <NUM> between each of the port holders 610A, 610B. A user can close the port holder <NUM> about the port <NUM> by moving the finger loops <NUM> toward each other until the latch <NUM> engages and locks the placement tool <NUM> in a closed position. The clinician can then urge the placement tool subcutaneously, by using the blade <NUM> to form an incision. The clinician continues to urge the placement tool <NUM> subcutaneously to dissect the tissue and form a tissue pocket. When the port <NUM> is placed, the clinician can unlock the latch <NUM> and move the finger loops <NUM> apart to release the port <NUM>. The placement tool <NUM> can then be withdrawn. It will be appreciated that port placement can be performed with or without a catheter <NUM> coupled to the port <NUM>. In an embodiment the placement tool <NUM> is formed of metal, polymer, plastic, or any suitable rigid material, or combinations thereof. For example, the first and second arms <NUM>, <NUM> can be formed of a polymer and include a metallic sharpened blade <NUM> disposed therein. These and similar combinations are contemplated to fall within the scope of the present invention.

<FIG> shows an embodiment of a placement tool <NUM>. The placement tool <NUM> includes an elongate body <NUM> extending between a distal end <NUM> and proximal end <NUM>. A proximal portion of the body defines a handle <NUM> for grasping the tool. A distal portion of the tool <NUM> further includes a port holder <NUM>. The port holder <NUM> is configured to releasably secure an access port <NUM>, for example ports <NUM>, <NUM>, prior to placement in a subcutaneous pocket defined in the body of a patient.

The port holder <NUM> includes mechanisms for securing the port holder <NUM> to the port, for example to the stem cover <NUM>. The mechanisms include various latches, protrusions, abutments, detents, connectors, and the like, for releasably securing the port holder <NUM> to the port stem cover <NUM>. The handle <NUM> includes an actuator <NUM> that is operably connected to mechanisms within the port holder <NUM>. In use, a clinician can actuate the actuator <NUM> to selectively release the stem cover <NUM> from a distal connecting portion <NUM> of the port holder <NUM>. The placement tool <NUM> further includes a safety clip <NUM> to prevent premature release of the port <NUM> from the tool <NUM>.

In an exemplary method of inserting an access port subcutaneously, a port is provided such as is discussed in embodiments herein. The port can be coupled to a distal end of a placement tool, e.g. tool <NUM> in an embodiment, the placement tool engages a stem cover. In an embodiment the placement tool engages an outer surface of the stem cover and the port is coupled to the catheter prior to insertion. In an embodiment, the placement tool engages an inner surface of the stem cover, an end surface of the stem cover, a stem aperture <NUM>, or combinations thereof. The catheter <NUM> and stem portion <NUM> are engaged with the port after subcutaneous insertion. The port further includes a tunneling edge and a sloped profile to facilitate formation of a tissue pocket by the port. In an embodiment, an incision is formed by either using a scalpel, or by using a sharpened edge of the port. The port is then urged subcutaneously using the placement tool. The tunneling edge and sloped profile of the tunneling portion of the port simultaneously dissects the tissue to form a tissue pocket as well as sizes the pocket to fit the port. With the port placed subcutaneously, the user actuates an actuator mechanism which releases the port from a distal end of the placement tool.

Claim 1:
A subcutaneous access port system, comprising:
a placement tool (<NUM>, <NUM>, <NUM>) including a proximal handle (<NUM>, <NUM>, <NUM>) and a distal port holder (<NUM>, 610A, 610B, <NUM>); and
an implantable access port (<NUM>, <NUM>) releasably secured to the port holder (<NUM>, 610A, 610B, <NUM>), the implantable access port (<NUM>, <NUM>) comprising:
a housing (<NUM>, <NUM>) including a base (<NUM>) and a reservoir (<NUM>, <NUM>);
a needle-penetrable septum (<NUM>, <NUM>) covering the reservoir (<NUM>, <NUM>); and
a body (<NUM>, <NUM>) coupled to the housing (<NUM>, <NUM>) over the needle-penetrable septum (<NUM>, <NUM>), the body (<NUM>, <NUM>) comprising:
a stem cover (<NUM>, <NUM>) configured to engage the distal port holder (<NUM>, 610A, 610B, <NUM>); and
a tunneling edge (<NUM>, <NUM>) opposite of the stem cover (<NUM>, <NUM>),
wherein the tunneling edge (<NUM>, <NUM>) is sharpened to facilitate dissection of the tissue as the implantable access port (<NUM>, <NUM>) is urged subcutaneously.