Access port including a septum with three protrusions and a communication device for identification of the septum

ES 2 554 783 T3

DESCRIPTION

Septa that includes at least one identifiable feature, access ports that include the same, and related procedures

The inlets or access ports provide a convenient procedure for repeatedly delivering medications to remote areas of the body without using surgical procedures. The port can be fully implanted in the body and allows the infusion of medications, parenteral solutions, blood products, and other fluids. The port can also be used for blood sampling.

Known ports typically include a chamber accessible through a self-sealing septum. Prior art septa vary in shape from a wafer-like cylindrical block of silicone to a precast septum of US Patent No. 4,802,885 issued to Weeks et al. The precast septum of US Patent No. 4,802,885 includes opposing convex surfaces and a peripheral shoulder.

In common practice, a caregiver locates the port septum by palpation. Access to the port is accomplished by percutaneously inserting a needle, usually a non-shaped needle, perpendicularly through the septum of the port and into the chamber. The drug or fluid is then administered by bolus injection or continuous infusion. Ordinarily, the fluid flows through the chamber, into a catheter, and finally to the site where the fluid is desired. Except for the septum, traditional ports are constructed entirely of metal or entirely of plastic. Each type of construction has unique advantages and disadvantages.

All metal constructions have the advantages of maintaining a septum in a self-sealing manner after repeated percutaneous injections. Additionally, all metal constructions, such as titanium or stainless steel, provide a port that is both biocompatible and compatible with the injected fluid.

However, all metal constructions have the disadvantages that they are relatively heavy, difficult to manufacture and relatively expensive. Additionally, the all-metal ports produce large artifacts in magnetic resonance imaging (MRI). On the other hand, all-plastic ports have the advantages that they are inexpensive to construct, light in weight, and do not create an artifact in MRI. However, ports constructed of plastic have the disadvantage that infused fluids can react with the plastic body of the port. The all-plastic ports have the disadvantage that they cannot maintain a sealing engagement with the septum after repeated percutaneous injections. Additionally, the all-plastic ports are prone to nicks and scratches on the interior surface by the access needle. These nicks and scratches could lead to foci of infection, blood clots, or precipitation formations.

Efforts have been made to combine the advantages of all-metal ports with all-plastic ports. For example, in US Patent No. 4,802,885 issued to Weeks et al., A metal reservoir having a chamber sealed by a preformed silicone septum is lined in a single piece of silicone elastomer. However, all-metal ports lined by a single piece of elastomer have significant deficiencies. These deficiencies include quality control problems during manufacturing, and expensive molding procedures.

Other efforts have focused on providing a multi-piece, all-plastic housing that cooperates with an open metal cup to seal in a septum. For example, see US Patent No. 5,213,574 issued to Tucker. This design has deficiencies associated with it, including defects in the plastic housing that can produce an improperly sealed septum. Once the septum is improperly sealed, the entire port must be discarded.

Therefore, a need has arisen for an access port device that addresses the problems of prior art port devices.

A variety of implantable devices, known as subcutaneous access ports, are used to deliver fluids to or remove fluids from a patient's bloodstream. Such access ports typically include a non-needle penetrable housing that encloses one or more fluid cavities and defines for each such fluid well an access opening communicating through the housing on a side thereof that is adjacent to the patient's skin when the access port is implanted in the body. A needle-penetrable septum is housed in and seals each access opening. Outlet conduits located on an outlet stem communicate with each of the fluid cavities to dispense medication therefrom to a predetermined location in the patient's body through an implanted catheter attached to the access port.

Once the access port and catheter have been implanted under the skin of a patient, amounts of medication or blood can be dispensed from one such fluid well through a needle.

ES 2 554 783 T3 non-profiled that traverses the skin of the patient and penetrates the septum in one of the respective fluid cavities. This medication is directed through the distal end of the catheter to an entry point into the venous system of the patient's body.

Blood can also be drawn to take samples from a patient's body through an access port. This is accomplished by piercing the skin of the patient and one of the respective septa with a non-shaped needle and applying negative pressure thereto. This causes blood to be drawn through the catheter into the fluid cavity corresponding to the perforated septum and then out of the patient's body through the needle.

To prevent further clotting, the extraction line is flushed with saline or heparin, again using a non-shaped needle that pierces the patient's skin and septum in the same way as if a drug was being infused.

Both intermittent and continuous injections of medication can be dispensed through the access port. Continuous access involves the use of a non-shaped needle attached to an ambulatory-type pump or gravity feeding IV bag suspended above the patient. The ambulatory type pump or IV bag continuously feeds the drug or fluid through the needle into the fluid cavity in the access port and from there through the catheter to the point of entry into the venous system.

To facilitate the location of each respective septum once the access port has been implanted, some access ports incorporate a raised circular ring located around the outer perimeter of the septum. In this context, see US-A1-2004 / 0006316, although this earlier publication is of a skin mounted port rather than a subcutaneously implanted port. In an implanted port, such a raised ring enhances the tactile sensation provided by the subcutaneous septum to the fingertip with which a physician palpates. Alternatively, other access ports have used palpation ribs in place of a raised circular ring for substantially the same purpose. Palpation ridges allow the location of the septum to be accurately determined when the access port is implanted subcutaneously.

To exclude reaction with tissues in the patient's body, the access ports are constructed of non-reactive materials, such as titanium or stainless steel. Although these materials are non-reactive, access ports constructed using titanium or stainless steel materials produce an interfering or blurry image of the patient's body in the vicinity of the implanted access port when diagnostic imaging techniques such as obtaining magnetic resonance imaging (“MRI”), CT scans, or computed tomography. The blurred region produced by the presence of a metal access port in a patient's body extends beyond the access port itself. Thus, the use of metallic access ports limits the diagnostic imaging techniques that can be used in relation to those areas of the body where an access port is implanted. Instead of metallic materials, some access ports have been made at least in part from biocompatible plastics.

A further problem related to materials for and fabrication of access ports is the detrimental effect of some fabrication processes on the fluids that flow through the fluid cavities and related structures located between the fluid cavities and the catheter. During the fabrication of an access port, whether the port is made up of metallic or plastic materials, it becomes necessary to form the fluid cavities and outlet conduits through which the fluid will be directed to the attached catheter. This manufacturing process often leaves sharp edges, joints, and corners where the fluid cavity serves to direct fluid flow through an outlet conduit. When blood or other fluids are injected through the septum into the fluid cavity, the pressure developed within the fluid cavity tends to cause fluid to flow through the outlet conduit. When the fluid in the fluid cavity flows past the sharp edges and corners produced in the manufacture of the access port, turbulence occurs, assuming the shape of a vortex, adjacent to the sharp edges and corners. Some fluids, such as blood, are sensitive to this turbulence and lysis of the erythrocyte component of injected blood may occur in these turbulent areas.

Furthermore, the production of the circular fluid cavities often results in the creation of zones within the housing in which fluid flow is retarded. These areas are called dead spaces and usually occur in transitional areas, such as when the bottom of the septum is interconnected with the walls of the fluid cavity and when the floor of the fluid cavity meets the outlet duct through from which the fluid should flow. When the flow of fluids through dead spaces is retarded, stagnation occurs, resulting in some amount of fluid being trapped within these dead spaces. If the access port is used to draw or transfuse blood, the blood trapped in these dead spaces can form clots and block fluid flow through the fluid cavity.

Also, in some anterior vascular access ports, the internal reservoirs are made up of two pieces of plastic that are bonded together. This results in an undesirable joint being formed when adjacent pieces abut each other. The inside of the reservoir should be as smooth as possible to help prevent damage to blood cells or the initiation of blood clotting during the infusion or drawing of blood through the port.

ES 2 554 783 T3

A further problem encountered in the design and construction of the access port concerns the placement of the septa within the access port housing. The placement of the septa within the housing is a balance between two conflicting goals. These are the need to separate the septa at such a distance that the septa can be easily differentiated for the purpose of injection and the need to limit the overall dimensions of the access port for aesthetic reasons and patient comfort. However, the separation of the septa to facilitate their differentiation results in a corresponding separation of the fluid cavities. This result is contrary to another structural need for multi-cavity access ports, namely that the outlet conduits from each fluid cavity are very close at the point where the implanted catheter is to engage the access port.

To guide the flow of a fluid from each of the spatially spaced fluid cavities to give the side-by-side configuration of fluid outflow required by the dimensions of a multi-lumen catheter, intermediate structural elements have been required. Naturally, this complicates the manufacturing process and increases its cost, as well as structural failure changes.

There are several examples of such intermediate elements used to overcome the manufacturing limitations imposed on the construction of a conduit that flows from spatially separated fluid cavities to give a side-by-side configuration acceptable for a catheter. One is to produce conduits in the form of curved metal tubes which are then insert molded or welded to give the larger body of the access port. The use of such a metal component will interfere with the production of an access port that has no limits in terms of diagnostic imaging techniques that can be used in relation to those areas of the body where an implant is implanted. access port. Furthermore, the integrated nature of such metal outlet conduits increases the possibility of drug leakage through the interstices between the metal tubes and the body of the access port.

Alternatively, to produce fluid flow from spatially spaced fluid cavities to give the very close lumens of a catheter, each fluid well has been designed with its own spatially spaced outlet stem. These outlet stems are then coupled by a core structure for permanent attachment to the very close lumens of a catheter. This type of arrangement increases the size of the overall access port and its cost of manufacture by adding thereto the need to manufacture and assemble the core element. Catheter port connections made in this manner are permanent. Therefore, if the catheter is to be shortened by trimming it, that trimming must occur at the distal end of the catheter, and this precludes the use of any type of specially designed tip or valve.

A further set of problems encountered in the use of access ports relates to the actual connection of the catheter to the access port. This is most commonly accomplished by attaching the catheter to an exit stem that protrudes from the access port housing. In an attempt to lock the catheter to the access port exit stem, screw-type systems have been developed in which the catheter is attached to an exit stem, and the exit stem is then screwed into the access port. However, when using this system it is difficult to determine the amount of catheter engagement on the exit stem. Some catheter connection systems do not allow visual verification of the junction. As a result, leakage and failure may occur.

To overcome this problem, access ports are produced where the catheter is pre-attached at the factory. Although this practice mitigates many of the problems with leakage and failure due to catheter slippage, this system dramatically limits the type of catheter that can be used with the access port. This precludes the use of catheters that have specialized distal tips, as the distal end of the catheter is the only end that can then be trimmed for final sizing. For example, catheters that use a Groshong® slit valve at their distal end cannot remove anything from the distal tip of the catheter without compromising the catheter.

Thus, there is a need for an improved vascular access port that overcomes the problems noted above, and that can be inexpensively manufactured. The present invention meets these needs and provides other related advantages.

Summary

The present invention is defined in claim 1 below. The dependent claims refer to optional features and preferred embodiments. One aspect of the present disclosure relates to an access port for providing subcutaneous access to a patient. More particularly, an access port may comprise a body configured to capture a septum to repeatedly insert a needle through it into a defined cavity within the body. In addition, the septum includes at least one topographic feature configured for identification of the septum. Furthermore, the present disclosure encompasses a septum for an access port to provide subcutaneous access to a patient, wherein the septum comprises a body exhibiting a plurality of topographic features configured for identification of the septum.

ES 2 554 783 T3

A further aspect of the present disclosure relates to an access port for providing subcutaneous access to a patient, which includes a body configured to capture a septum to repeatedly insert a needle through it into a defined cavity within the body, and means for the identification of the septum. The means for identification comprise a plurality of topographic features of a septum surface. The means for identification may comprise a visually perceptible characteristic selected from the group consisting of: a color, a symbol, a letter, a pattern, and markings. In a further embodiment, the means for identification may comprise an X-ray detectable feature or an ultrasound detectable feature. In still a further embodiment, the means for identification may comprise an RFID tag.

A procedure for identifying a subcutaneously implanted access port is disclosed below. More particularly, an access port may be provided that includes a septum. In addition, a plurality of topographical features of the access port septum can be perceived. In addition, the subcutaneously implanted access port can be identified in response to perception of the at least one septum feature of the access port.

Features of any of the aforementioned embodiments may be used in combination with each other in accordance with the present disclosure. Furthermore, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art upon consideration of the description that follows, the accompanying drawings, and the appended claims.

Brief description of the drawings

The advantages of the present disclosure will become apparent upon review of the following detailed description and drawings, which illustrate representations (not necessarily drawn to scale) of various aspects of the present disclosure, in which:

FIGS. 1A-1D depict various views of a two-port implantable access device;

FIGS. 2A-2E depict various views of a single port implantable access device;

FIGS. 3A-3D depict various views of an implantable access device;

FIG. 4 represents an alternative embodiment of the cup element of FIGS. 1-3;

FIGS. 5A and 5B depict views of another alternative embodiment of the cup element of FIGS. 1-3;

FIG. 6 shows a schematic side cross-sectional view of a subcutaneously implanted access port;

FIGS. 7 and 8 show a perspective view and a schematic side view, respectively, of a septum including a shoulder;

FIGS. 9 and 10 show a perspective view and a schematic side view, respectively, of a septum including a plurality of projections;

FIGS. 11 and 12 show a perspective view and a schematic side view, respectively, of another embodiment of a septum including a plurality of projections;

FIGS. 13 and 14 show a perspective view and a schematic side view, respectively, of a further embodiment of a septum including a plurality of projections;

FIGS. 15 and 16 show a perspective view and a schematic side view, respectively, of yet a further embodiment of a septum including a plurality of projections;

FIGS. 17 and 18 show a perspective view and a schematic side view, respectively, of a septum including a plurality of elongated projections;

FIGS. 19 and 20 show a perspective view and a schematic side view, respectively, of another embodiment of a septum including a plurality of elongated projections;

FIGS. 21 and 22 show a perspective view and a schematic side view, respectively, of a septum including a recess;

FIGS. 23 and 24 show a perspective view and a schematic side cross-sectional view, respectively, of a septum including a plurality of recesses;

ES 2 554 783 T3 FIGS. 25 and 26 show a perspective view and a cross-sectional view, respectively, of a septum including a plurality of elongated recesses;

FIGS. 27 and 28 show a perspective view and a cross-sectional view, respectively, of a septum including a recess and a projection;

schematic lateral, schematic lateral, FIGS. 29 and 30 show a perspective view and a schematic side cross-sectional view, respectively, of a septum including a recess and a protrusion, in which the protrusion is positioned generally within the recess;

FIG. 31 shows a perspective view of a septum including a plurality of projections and a plurality of recesses positioned around a center of revolution;

FIG. 32 shows a perspective view of a septum including a plurality of elongated projections and a plurality of elongated recesses;

FIG. 33 shows an exploded assembly view of an embodiment of an access port according to the present disclosure;

FIG. 34 shows a perspective view of the assembled access port shown in FIG. 33;

FIG. 35 shows a top elevational view of the assembled access port shown in FIG. 3. 4; and FIG. 36 shows a simplified representation of a cross-sectional section of the access port shown in FIGS. 33-35.

Detailed description

FIGS. 1A-1D depict various views of a two-port implantable access device 10. Port 10 generally comprises a housing element 12 defining fluid chambers 22A and 22B. The chambers are sealed by housing 12, bottom cup elements 14A and 14B, and self-sealing septum elements 16A and 16B. In this embodiment, housing 12 is preferably formed of titanium, stainless steel, ceramic, and / or other biocompatible material. The septum 16A and 16B is preferably formed of silicon or other semipermeable materials that allow the entry and exit of needles to supply fluid to the chambers 22A and / or 22B. An outlet port 18 is provided in communication with chambers 22A and 22B, which supply fluid out of chambers 22A and / or 22B to a predetermined location, through stem 20 and attached catheter (not shown), as shown. understands in technique.

The septa 16 are formed in a generally circular shape and, as shown in the drawings, may include a mouth 26 or a concave portion 28 on the outer surface thereof. The embouchure is advantageous for visual and / or tactile location of port device 10, and as a locator for needle insertion. Also, the concave portion 28 provides similar characteristics, but can be used in areas where a protruding mouth is not desirable. Septa 16A and 16B and housing 12 are preferably formed with matching tongue and groove portions, as shown in the side view drawings of FIGS. 1A and 1C. The housing may further include molded top member 24 that presses against the septum for added stability.

In contrast to the plastic materials used in the prior art, the cup portion 14 is preferably formed from titanium or stainless steel to resist scratches and / or debris from being introduced into the chambers as a result of needle impacts therein. Preferably, cup 14A and 14B is attached to housing 12 through insert molding, press fit, ultrasonic welding, biocompatible glue, and / or other attachment means. FIGS. 2A-2E depict a single port version of the port device of the present invention, and is constructed in a manner similar to that shown in FIGS. 1A-1D.

FIG. 3A-3D represent another embodiment of the port device. In this embodiment, cup member 14 'includes side wall portions 28 that are dimensioned to fit within chamber 22', defined by housing 12 '. Cup member 14 'is attached to housing 12' by insert molding, press fit, ultrasonic welding, biocompatible glue, or other attachment means known in the art. The septum 16 'is similar to the septum 16A and / or 16B and may also include a mouth or concave portion, described above. In this embodiment, a metal ring 30 is provided which circumscribes the top of housing 12 'and is positioned above septum 16'. Ring 30 preferably includes flange elements 32, which have a top surface dimensioned to drive a needle downwardly toward the septum, thereby preventing erroneous entry of needles into the septum. In this embodiment, the ring structure is made of titanium, stainless steel or ceramic material to increase the mechanical resistance to perforation and / or tearing. Therefore, since the ring element 30 will protect the other

ES 2 554 783 T3 components, the housing may be formed of less expensive material, eg plastic, etc. Ring element 30 and housing 12 'preferably include mating tongue and groove portions to hold the ring element securely against the housing, as shown. Additionally, the bottom surface of flange elements 32 is dimensioned to bias against the septum, thereby holding the septum in place.

FIGS. 4 and 5A-5B depict alternative embodiments for the cup element described above in FIGS. 1-3. In the embodiment of FIG. 4, the cup element 14 "defines an outlet port 18 'therein, and preferably located at the bottom of the cup 14", as shown. A stem 20 'is connected to port 18' at one end, and a catheter 36 is connected to the other end of stem 20 '. To provide a low profile shape, it is preferred that stem 20 'includes an elbow, or part at an angle, to direct fluid laterally away from the port, as shown. In FIGS. 5A and 5B, the cup 14 "'is formed with a flange 40 to define an opening 38 that is dimensioned to accept a stem 20" therein. Cup 14 "and / or 14 'is provided to better fit anatomically in the subcutaneous areas around muscle tissue, and each connects to the housing (not shown) in a manner similar to the embodiments of FIGS. 1,2 or 3.

As discussed above, access ports can provide percutaneous access to a patient. In more detail, referring to FIG. 6 a schematic side cross-sectional view of another embodiment of an access port 50 is shown, which is implanted within a patient. In greater detail, the access port 50 includes a housing or body 60 defined by a cover 54 and a base 56. Cap 54 and base 56, as known in the art, can be configured to capture a septum 118 between them. As shown in FIG. 6, the cap 54 and the base 56 can be coincidentally coupled to each other along a registration line 55. Cap 54 and base 56 may be fastened or secured to each other via mechanical fasteners such as screws or other fasteners, may be adhesively fastened to each other, or may be fastened to each other as is known in the art. In addition, cap 54, base 56, and septum 118 may collectively define a cavity 66 in fluid communication with an outlet stem lumen 71. As shown in FIG. 6, the body 60 of the access port 50 may be implanted in a patient 67 to position the cavity 66 subcutaneously within the patient 67. As is known in the art, sutures may be used to secure the access port 50 within the patient. 67, if desired. After the body 60 has been implanted in a patient 67, the upper surface of the septum 118 can be positioned flush or generally aligned with the surface of the skin surface 76 of the patient 67 and can be repeatedly punctured to create a percutaneous canal from the outside of the patient's skin into cavity 66. Exit stem 71 may create a fluid communication conduit from cavity 66 through exit stem 71 and into patient 67. As mentioned above, a catheter can be coupled to outlet stem 71 for fluid communication with cavity 66 and to transfer fluid to a desired remote location from cavity 66 and into a patient 67. Port body 60 Port 50 may comprise a biocompatible material such as polysulfone, titanium, or any other suitably biocompatible material as is known in the art. Thus, generally, the body 60 can be formed of a biocompatible plastic material. Body 60 may include a concave bottom or, in another embodiment, may include a flat bottom, without limitation. Furthermore, as mentioned above, the access port 50 may comprise a so-called single-port or multiple-port configuration (eg, two-port, three-port, etc.), without limitation.

One aspect of the present disclosure contemplates that an access port septum may include at least one perceptible or identifiable feature to identify the septum and, optionally, the access port. Naturally, the identifiable feature can be perceived after the access port has been implanted within a patient. For example, at least one or perhaps multiple identifiable feature (s) of an access port septum may correspond to information (eg, a manufacturer's model or design) related to the access port. Thus, an identifiable characteristic of one access port of a particular model may be unique relative to most if not all other identifiable characteristics of another access port of a different model or design. Naturally, the at least one identifiable characteristic of an access port can be correlated in addition to any information of interest, such as the type of port, the type of catheter, the date of manufacture, the material batches, the part numbers, etc. In this way, once at least one identifiable characteristic of an access port is observed or otherwise determined, correlation of at least one such characteristic of an access port can be carried out, and information can be obtained. related to the access port. Accordingly, "identification," as used herein and in relation to a septum, means providing the ability to correlate selected information of interest to a perceptible characteristic of a septum.

In one embodiment, at least one feature may be perceived by palpation (ie, by examining by touch), by other physical interaction, or by visual observation. Accordingly, a person can touch or feel the septum of the access port to perceive at least one identifying feature of the septum. In another embodiment, at least one identifiable feature may be perceived through ultrasound or X-ray imaging. In still a further embodiment, at least one identifiable characteristic may be perceived through communication or interaction of magnetic, light or radioelectric energy with the septum.

Returning to the embodiment in which at least one characteristic can be perceived through palpation, another

ES 2 554 783 T3 physical interaction or visual observation, an exterior surface feature or topography of a septum of an access port can be configured for perception. For example, the present disclosure contemplates that a septum may include at least one topographical feature configured to identify the access port after it has been implanted. More particularly, FIGS. 7 and 8 show a perspective view and a schematic side view, respectively, of a septum 118 that includes at least one topographic feature. Generally, septum 118 may include a base region 122 and a raised region 120 that extends from base region 122 and includes a septum surface 121. As seen in the art, septum 118 may be structured for mounting within the housing, wherein the housing causes at least a portion of septum 118 to compress. Such compression can facilitate sealing of a perforation or opening that is formed between septum surface 121 and septum surface 109. FIGS. 7 and 8 show an embodiment of septum 118, including an annular recess 124 that extends circumferentially around raised region 120 as well as a recess 126 that is formed in base region 122. In addition, as shown in FIGS. FIGS. 7 and 8, septum 118 may be substantially symmetrical around central port 111. Such a configuration can facilitate substantially uniform compression within at least a portion of base region 122 when a periphery of base region 122 is compressed. Additionally, a protrusion 130 may extend from septum surface 121 and may be configured to identify septum 118 (and, optionally, an access port with which septum 118 is mounted). Accordingly, the protrusion 130 may be of a selected size and shape, allowing perception through palpation. As shown in FIGS. 7 and 8, protrusion 130 may optionally include a generally rounded end 131. Such a configuration can provide a structured protrusion for identification of septum 118, which is relatively robust and resists damage in response to repeated physical interactions, such as palpation. Of course, the protrusion 130 may have a number of selected features, such as, for example, fillets, chamfers, concave surfaces, convex surfaces, through holes, cavities, grooves, or other geometric features as may be desired.

The present disclosure further contemplates that a septum may include a plurality of projections that are collectively structured for the perception and identification of the septum. For example, FIGS. 9 and 10 show a perspective view and a schematic side view, respectively, of a septum 118 including three projections 130. The septum 118, as shown in FIGS. 9 and 10, can be configured generally as described above with respect to FIGS. 6 and 7. However, as shown in FIGS. 9 and 10, septum 118 may include projections 130, which are substantially identical. Additionally, optionally, protrusions 130 may be positioned substantially equidistant from central port 111, as shown in FIGS. 9 and 10. Such a configuration may allow the perception of the projection 130, the identification of the septum 118 in response to the perception of the projections 130, and can also allow an indication of the position of the central access 111 (i.e., the center of the surface septum 121). As shown in FIGS. 9 and 10, each of the projections 130 may include a generally rounded end 131. In other embodiments, each of the projections 130 may have an end that is configured as desired (eg, similarly, substantially identical, or different), without limitation. Furthermore, it can be appreciated that projections 130 may incorporate various selected positions, sizes, or configurations in a septum for the perception and identification of such a septum. For example, FIGS. eleven and 12 show a perspective view and a schematic side view, respectively, of another embodiment of a septum 118 that includes three projections 130 that are larger than the projections 130 shown in FIGS. 9 and 10. As shown in FIGS. eleven and 12, the projections 130 may be positioned substantially equidistant around the central port 111 and each of the projections 130 may include a generally rounded (eg, at least partially spherical, generally convex, or generally oval) end 131.

As mentioned above, the present disclosure contemplates that a septum may include at least one protrusion and that the protrusion may be configured, as desired, for perception and identification of the septum. For example, a projection extending from a surface of a septum can include at least one substantially flat surface. FIGS. 13 and 14 show a perspective view and a schematic side view, respectively, of a septum 118 including projections 130, each including a substantially flat surface or a substantially flat end 133. Otherwise, septum 118, shown in FIGS. 13 and 14, can be configured generally as described above with respect to FIGS. 9 and 10. As shown in FIGS. 13 and 14, the projections 130 may be generally cylindrical when extending from the septum surface 121. Of course, in other embodiments, the projections 130 may be tapered when extending from the septum surface 121. Furthermore, the cross-sectional shape of the projections 130 (taken transverse to the direction of extension from the septum surface 121) may be generally circular, generally rectangular, generally triangular, generally oval, or generally polygonal, without limitation. Of course, the size of each of the projections 130 can be selected to provide an identifiable topography for the septum 118. For example, in another embodiment, FIGS. fifteen and 16 show a perspective view and a schematic side view, respectively, of a septum 118, which is configured generally as described above with reference to FIGS. 13 and 14, but including projections 130 that are larger than projections 130 shown in FIGS. 13 and 14. Such a configuration may be perceptibly different (eg, by palpation) from the embodiment of septum 118 shown in FIGS. 13 and 14.

As mentioned above, at least the overhang of a septum can be dimensioned, shaped, and

ES 2 554 783 T3 be structured as desired. For example, in another embodiment, a septum can include at least one protrusion that is elongated. For example, FIGS. 17 and 18 show a perspective view and a schematic side view, respectively, of a septum 118 that includes elongated projections 140. As shown in FIGS. 17 and 18, elongated projections 140 may each extend between a lateral end 142 and a lateral end 144, generally along a linear (ie, straight) path. Of course, in other embodiments, elongated projections 140 may extend along respective arcuate paths between each of side ends 142 and 144, respectively. In addition, at least one elongated projection may form a pattern (eg, spiral, substantially concentric rings, substantially parallel lines, intersecting lines, etc.). As shown in FIGS. 17 and 18, elongated projections 140 may extend up onto septum surface 121 along substantially parallel paths. In addition, elongated projections 140 may be positioned substantially equidistant from central port 111. As shown in FIGS. 17 and 18, each of the elongated projections 140 may have a generally rounded boundary surface 141, as shown in FIG. 18. Of course, the present disclosure contemplates that at least one elongated protrusion can incorporate various sizes, shapes, and configurations. For example, FIGs. 19 and 20 show a perspective view and a schematic side view of a septum 118 that includes elongated projections 140, each including a substantially flat surface or a substantially flat end 143. Thus, it can be appreciated that such a septum 118 can be perceptibly distinguished from septum 118, shown in FIGS. 17 and 18.

In a further aspect of the present disclosure, a septum may include at least one recess that is structured for perception and identification of the septum. For example, FIGS. 21 and 22 show a perspective view and a schematic side cross-sectional view (taken through recess 150), respectively, of a septum 118 that includes a recess 150. As shown in FIGS. twenty-one and 22, the recess 150 is defined by an arcuate surface 151, which is formed on the septum surface 121. In addition, the recess 150 may be generally aligned with the central access 111, if desired. Such a configuration can provide a discernible feature to identify septum 118. Naturally, surface 151 may comprise a plurality of substantially flat surfaces or at least one arcuate surface (eg, partially spherical, partially cylindrical, generally oval, or any other arcuate surface known in the art). In addition, a periphery of recess 150 may be generally circular, as shown in FIGS. 21 and 22, or it may have another selected shape. For example, without limitation, a periphery of a recess formed in a septum may be substantially oval, substantially rectangular, generally polygonal, star-shaped, or otherwise as may be desired.

In another embodiment, a septum may include a plurality of recesses configured for perception (eg, visual or by palpation) and identification of the septum. For example, FIGS. 23 and 24 show a perspective view and a schematic side cross-sectional view (taken through each of the recesses 150) of a septum 118 including recesses 150. As shown in FIGS. 2. 3 and 24, each of the recesses 150 may be defined by an arcuate side surface 153 and a substantially flat inner surface 155. In addition, each of the recesses 150 may be positioned substantially equidistant from the central port 111 and may also be substantially equally circumferentially spaced from each other. Each of the recesses 150 may have a selected depth in the septum surface 121. For example, as shown in FIGS. 23 and 24, each of the recesses 150 may have a substantially equal depth. In other embodiments, at least one of the recesses 150 may have a depth that is different from at least one other of the recesses 150. In a further embodiment, each of the recesses 150 may have a different depth. Similarly, as shown in FIGS. 2. 3 and 24, each of the recesses 150 may be substantially identical. In other embodiments, one or more of the recesses 150 may be configured differently from at least one other of the recesses 150.

The present disclosure also contemplates that at least one recess formed in a septum may comprise at least one elongated recess. Thus, the present disclosure contemplates that a septum may include at least one elongated recess configured to identify the septum, an access piece to which the septum is mounted, or both. For example, FIGS. 25 and 26 show a perspective view and a schematic side cross-sectional view (taken through elongated recesses 160), respectively, of a septum 118 that includes elongated recesses 160. Generally, each of the elongated recesses 160 may extend to along septum surface 121 along a selected path. For example, as shown in FIGS. 25 and 26, each of the elongated recesses 160 may extend along a substantially linear or straight path. Optionally, as shown in FIGS. 25 and 26, the paths that each of the elongated recesses 160 follow may be substantially parallel to each other. Of course, in other embodiments, the elongated recesses may be arcuate, not parallel, or may at least partially cut from each other. As shown in FIGS. 25 and 26, elongated recesses 160 may be positioned substantially equidistant from central port 111. As discussed above in relation to elongated projections, at least one elongated recess may form a selected pattern. Such a pattern may be desirable to identify a particular septum.

In another embodiment contemplated by the present disclosure, a septum may include at least one projection and at least one recess configured for perception and identification of the septum. For example, FIGS. 27 and 28

ES 2 554 783 T3 show a perspective view and a schematic side cross-sectional view (taken through recess 150 and protrusion 130), respectively, of a septum 118 including a recess 140 and a protrusion 130. Recess 140 and protrusion 130 may be structured relative to one another for perception (eg, visually or by palpation) and identification of septum 118. As mentioned above, a recess, a boss, or both (if present) can be tapered. As shown in FIGS. 27 and 28, each of recess 140 and projection 130 are generally tapered with increasing distance from septum surface 121. More particularly, as shown in FIG. 28, the recess 140 is defined by a tapered side surface 145 and a substantially flat surface 147. As shown in FIG. 28, the tapered side surface 145 is frusto-conical and increases in size with increasing distance from the septum surface 121. Furthermore, as shown in FIG. 28, the projection 130 is defined by a tapered side surface 135 and a substantially flat surface 137. As shown in FIG. 28, tapered side wall 135 is frusto-conical and decreases in size with increasing distance from septum surface 121. Of course, either recess 140 or projection 130 can increase in size with increasing distance from septum surface 121, if desired. In addition, as mentioned above, a cross-sectional shape of either recess 140 or projection 130 can be selected from any of a number of geometries known in the art. Accordingly, a tapered side surface that forms a tapered projection or recess can define a truncated cone exhibiting selected geometry. In summary, the combination of at least one recess and at least one protrusion may comprise at least one identifiable feature of a septum and may be beneficial in the perception and identification of such a septum.

The present disclosure contemplates various configurations of a septum that includes at least one projection and at least one recess. For example, FIGS. 29 and 30 show a perspective view and a schematic side cross-sectional view, respectively, of a septum 118 including a recess 150 and a projection 130. Furthermore, as shown in FIGS. 29 and 30, protrusion 130 is positioned generally within recess 150. Also as shown in FIGS. 29 and 30, both the recess 150 and the projection 130 may be generally centered with respect to the central access 111. Of course, in other embodiments, neither the recess 150 nor the projection 130 can be centered with respect to the central access 111. Furthermore, protrusion 130 may be positioned over and extend from any portion of substantially flat surface 157 or side wall surface 155, without limitation.

Accordingly, the present disclosure contemplates that at least one protrusion, protrusion region, recess, recessed region, waviness, or adjacent features of different elevation may comprise a feature for identifying a septum of an access port. In a claimed embodiment of the invention, a plurality of projections 80 are spaced about a selected center or other point on a septum surface of a septum. FIG. 31 shows a perspective view of an exemplary embodiment of a septum 118 that includes projections 130 positioned substantially symmetrically about a center of revolution 115. Center of revolution 115, as shown in FIG. 31, is a point on the surface of septum 121 with which axis 113 intersects. Axis 113 is not aligned with a central axis of septum 118, and is otherwise positioned or oriented. Thus, protrusions 130 are substantially equidistant from center of revolution 115 and are circumferentially spaced substantially equally from each other and about center of revolution 115. Similarly, a plurality of recesses 150 may be spaced substantially symmetrically about the center of revolution 115. In another embodiment, one or more of the projections 130, one or more of the recesses 150, or both may be placed on one or more selected closed plane figures (eg, a circle, an ellipse, a rectangle, a triangle, etc.) to identify a septum.

Furthermore, in another embodiment, a topography of a septum may comprise elongated projections and elongated recesses. FIG. 32 shows a perspective view of one embodiment of such a septum, including alternating elongated circumferentially extending projections 140 and circumferentially extending elongated recesses 160. Optionally, the elongated circumferentially extending projections 140 may be circumferentially of substantially equal size relative to the elongated circumferentially extending recesses 160. In another embodiment, a septum may have an upper topography comprising elongated circumferentially extending projections and alternating elongated circumferentially extending recesses that are of different circumferential size. Optionally, it can be appreciated that transition regions may optionally extend circumferentially between elongated circumferentially extending projections 140 and elongated circumferentially extending recesses 160. Such transition regions may be generally smooth tapered or transitional regions between an elongated circumferentially extending protrusion 140 (or any other protruding protrusion or region) and an adjacent circumferentially extending elongated recess 160 (or any other recess or recessed region ). Thus, such transition regions can form a wavy topography that is generally smooth transitions between circumferentially adjacent recessed regions and overhangs.

It should be understood that the present disclosure contemplates access ports having a septum with an exposed surface defined, at least in part, by a periphery that is not circular in nature. Instead, the present

The disclosure contemplates that an access port may have a periphery that is generally quadrilateral, generally rectangular, generally triangular, generally elliptical, generally oval, generally polygonal, or otherwise configured. It should also be understood from the description of the various above-described embodiments of an access port septum that the present disclosure encompasses different variations, additions, combinations, or features. Therefore, the present disclosure is not limited to the exemplary embodiments described above.

Generally, the present disclosure contemplates that means may be provided to identify a septum. In one embodiment, as described above, at least one topographic feature may comprise means for identifying a septum. In another embodiment, at least one visual feature can be perceived and used to identify a septum. For example, a color, a pattern, one or more letters, one or more numbers, symbols, any markings, or combinations thereof, may be formed on or as part of a septum. Such a configuration can allow visual perception and identification of a septum. Furthermore, the present disclosure also contemplates that at least one feature of an access port of the present disclosure may not be observed visually or by palpation but rather may be observed otherwise. For example, the means for identifying a septum may comprise at least one feature that can be observed through interaction with an imaging technology such as X-ray or ultrasound. For example, a metal feature (eg, a plate or other metal geometry) may be included within a septum of an access port. As can be appreciated, such a metal feature can be represented on an x-ray generated by exposing the access port to X-ray energy while simultaneously exposing an X-ray sensitive film to passing X-ray energy. through the access port. In addition, the present disclosure contemplates that the size, shape, or both the size and shape of a metal feature of an access port can be configured to enhance identification of an access port. For example, assuming that a metal feature comprises a metal plate, the size, shape, or both can be selectively tailored for identification of a septum. Similarly, a feature of an access port can be adapted for detection through ultrasonic interaction. Such a feature may comprise an exterior topographic feature. In another embodiment, such a feature may comprise a composite structure that includes two or more materials that form a contact surface (ie, an interior feature or surface) that can be identified by ultrasound imaging. In a further aspect of the present disclosure, it is contemplated that a communication technology in which the information is embedded in an access port of the present disclosure may be used. Generally, a communication device (eg, a beacon, a light emitting element, an ultrasound emitting transducer, etc.) can be inserted or otherwise attached to a septum of the present disclosure. Such a communication device can be configured to transmit information in response to a given impulse. More specifically, a septum can be exposed to a request signal (eg, sound, impact or acceleration, light, radio waves, etc.). Such a request signal can cause the communication device to transmit information therefrom via sound, light, radio waves, or as otherwise known in the art. Such information may be used to identify an access port of the present disclosure. Thus, a wide variety of means of identifying a septum can be used to identify a septum.

In an exemplary example, radio frequency identification technology may be employed to identify a septum of an access port. In particular, so-called active RFID tags are powered by an internal battery and are typically read / write devices. Currently, a suitable battery coupled with suitable low-power circuitry can guarantee functionality for up to ten years or more, depending on usage and operating temperatures and read / write cycles. So-called passive RFID tags work without a separate external power supply and without obtaining operating power generated from the reader. Passive RFID tags are typically programmed with a single data set (typically 32 to 128 bits) that cannot be modified. Read-only labels can function as an identifier comparable to barcodes, which can contain selected product-specific information. Therefore, passive RFID tags can be much lighter than active RFID tags, less expensive, and can offer a substantially unlimited operational lifespan. In one embodiment, an RFID tag can be affixed to an outer surface of a septum. In another embodiment, an RFID tag can be inserted into a septum. An advantage of the RFID approach is the non-contact, line-of-sight nature of the technology. RFID tags can be read through a variety of visually and environmentally challenging conditions, where other optically related technologies may be less effective.

As will be appreciated by those skilled in the art, any septum configured in accordance with the above-described aspects of the present disclosure can be incorporated within a housing or body to form an access port. For example, FIG. 33 shows an exploded mounting view of an embodiment of an access port 50 that includes a septum 118 comprising a plurality of projections 130. More particularly, septum 118 may be positioned between a lid 54 and a base 56 (collectively forming a housing) to form an access port 50. As shown in FIG. 33, the base 56 may include a raised retaining wall 79 that forms a recess in which the septum 118 can be placed. In addition, the cap 54 can fit generally around the raised retaining wall 79 and can capture the septum 118 between

ES 2 554 783 T3 base 56 and septum 54 to form a cavity within access port 50. Additionally, an opening 59 may be formed by cover 54 and may allow access to septum 118 when septum 118 is captured between the lid 54 and base 56. In addition, as shown in FIG. 33, the outlet stem 71 may include a stem base 73 which can be positioned within and sealed to an outlet recess 93 formed within the base 56. Of course, outlet stem 71 may be in fluid communication with a cavity formed within access port 50. Optionally, suture plugs 89 may be placed within suture cavities 91 formed in base 56. Suture plugs 89 they may comprise a flexible material (eg, silicone, rubber, etc.) that can provide some elasticity between the sutures that engage the access port (ie, base 56) to a patient.

In greater detail, FIG. 34 shows a perspective view of an assembled access port 50. As shown in FIG. 34, a side periphery 95 (eg, one or more side walls) of access port 50 may be generally triangular. Thus, cap 54 and base 56 may collectively form a generally triangular housing or body of access port 50. Furthermore, the present disclosure contemplates that the lateral periphery 95 may be tapered or extend arcuately between the upper surface 61 of the lid 54 and the lower surface 51 of the base 56. As shown in FIG. 34, a cross-sectional section (taken in a selected plane substantially parallel to the lower surface 51, if flat, of the base 56) of the access port 50 may be larger near the lower surface 51 of the base 56 and it may be relatively smaller near the top surface 61 of cap 54. FIG. 35 shows a top elevational view of access port 50 shown in FIG. 35 and illustrates a generally triangular shape defined by lateral periphery 95. Additionally, FIG. 36 shows a simplified representation of a cross-sectional section of access port 50. As shown in FIG. 36, the lateral periphery 95 of the access port 50 may define three lateral regions 103 which extend between the associated vertex regions 101. Furthermore, in one embodiment and as shown in FIG. 36, the lateral periphery 95 may define a substantially equilateral generally triangular shape. As can be appreciated, the lateral regions 103 may extend arcuately between the associated vertex regions 101; thus, the side regions 103 may form the "sides" in a generally triangular shape. Furthermore, although the vertex regions 101 are rounded, it can be appreciated that such vertex regions 101 form an intersection between the adjacent side regions 103. Accordingly, it can be appreciated that the term "generally triangular," as used herein, encompasses any generally three-sided geometry in which adjacent sides intersect, without limitation. For example, "generally triangular" includes three-sided polygons, circular triangles, equilateral triangles, etc., without limitation.

Although certain representative embodiments and details have been shown for the purpose of illustrating aspects of the present invention, it will be apparent to those skilled in the art that various changes can be made to the methods and apparatus disclosed herein without departing from the scope of the invention. of the claims that follow. For example, other sizes and shapes of the access port may be used; and various embodiments and structures other than those shown in the drawings may be employed to form at least one identifiable feature of an access port of the present disclosure.

A further disclosure of the invention is provided below in the numbered paragraphs:

1. An access port to provide subcutaneous access to a patient, comprising:

a body configured to capture a septum to repeatedly insert a needle through it into a defined cavity within the body; and at least one topographic feature of the septum configured for identification of the septum.

two. The access port of paragraph 1, in which the at least one topographic feature is selected from the group comprising:

at least one projection and at least one recess.

3. The access port of paragraph 1, wherein the at least one topographic feature comprises a plurality of projections.

Four. The access port of paragraph 3, wherein each of the plurality of projections has a generally rounded end or a substantially flat end.

5. The access port of paragraph 4, wherein each of the plurality of projections is substantially identical.

6. The access port of paragraph 3, wherein the plurality of projections comprises three substantially identical projections, wherein the three projections are positioned substantially equidistant from a central axis of the septum.

ES 2 554 783 T3

7. The access port of paragraph 3, wherein at least one of the plurality of protrusions is elongated, wherein the at least one elongated protrusion extends in a linear or arcuate manner.

8. The access port of paragraph 7, wherein the at least one elongated projection comprises at least two linearly extending elongated projections, wherein the at least two linearly extending elongated projections are substantially parallel to each other .

9. The access port of paragraph 1, wherein the at least one topographic feature comprises a single protrusion, wherein the single protrusion is substantially aligned with a central axis of the septum.

10. The access port of paragraph 1, wherein a lateral periphery of the access port is generally triangular.

eleven. A septum for an access port to provide subcutaneous access to a patient, comprising:

a body presenting at least one topographic feature configured for the identification of the septum.

12. The septum of paragraph 11, wherein the at least one topographic feature comprises a plurality of projections.

13. The septum of paragraph 12, wherein each of the plurality of projections has a generally rounded end or a substantially flat end.

14. The septum of paragraph 13, wherein each of the plurality of projections is substantially identical.

fifteen. The septum of paragraph 12, wherein the plurality of projections comprises three substantially identical projections, wherein the three projections are positioned substantially equidistant from a central axis of the septum.

16. A procedure for identifying a subcutaneously implanted access port, comprising:

providing an access port that includes a septum;

perceive at least one topographic feature of the septum of the access port; and identifying the subcutaneously implanted access port in response to perception of the at least one septum feature of the access port.

17. The method of paragraph 16, wherein sensing the at least one topographic feature comprises palpating the at least one topographic feature or visually perceiving the at least one topographic feature.