WO2021118967A1

WO2021118967A1 - Side compression port

Info

Publication number: WO2021118967A1
Application number: PCT/US2020/063731
Authority: WO
Inventors: Bryon Ray DENSLEY
Original assignee: Bard Peripheral Vascular, Inc.
Priority date: 2019-12-10
Filing date: 2020-12-08
Publication date: 2021-06-17

Abstract

An access port including a septum that in one embodiment can be compressed along a horizontal plane. The access port can include a first housing portion and a second housing portion that engage each other along a vertical plane. The first housing portion and the second housing portion can compress the septum upon engagement to retain the septum in the access port. A needle accessing the reservoir transects the horizontal plane along which the septum can be compressed. The compressed septum can sustain a greater number of needle penetrations, higher fluid flow rates, higher fluid flow pressures, and provide a lower profile of septum.

Description

SIDE COMPRESSION PORT

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application

No. 62/946,319, filed December 10, 2019, which is incorporated by reference in its entirety into this application.

SUMMARY

[0002] Briefly summarized, embodiments disclosed herein are directed to side compression port. The port includes a first housing portion and a second housing portion that engage along a vertical plane, when assembled both the first housing portion and the second housing portion define a port housing. A septum is compressed between the first and second housing portions, which together define a reservoir. A port stem extends longitudinal from the housing and is in fluid communication with the reservoir. The housing portions compress the septum along a horizontal plane. A needle accessing the reservoir transects the horizontal plane. The septum compressed as such can sustain a greater number of needle penetrations, higher fluid flow rates, higher fluid flow pressures, and be manufactured to define a lower profile port housing.

[0003] Disclosed herein is an implantable access port including, a housing having a first housing portion including a first engagement surface, and a second housing portion including a second engagement surface, the first engagement surface engaging the second engagement surface along a vertical plane, a port stem extending from the housing, and a septum that, together with the housing, defines a reservoir, the first housing portion and the second housing portion configured to retain the septum therebetween.

[0004] In some embodiments, the first housing portion includes a first chamber recess, the second housing portion includes a second chamber recess, the first chamber recess and the second chamber recess co-operate to form a septum opening configured to receive the septum therein upon engagement of first engagement surface with the second engagement surface. The septum opening defines a first diameter, and a perimeter of the septum defines a second diameter, the second diameter being larger than the first diameter. The vertical plane extends through a diametric mid-point of the septum. The port stem is formed as a single monolithic structure with the first housing portion, the port stem including a lumen in fluid communication with the reservoir.

[0005] In some embodiments, the first housing portion includes a first stem recess and the second housing portion includes a second stem recess, the first stem recess and the second stem recess together defining a stem aperture configured to receive the port stem upon engagement of the first engagement surface with the second engagement surface. The septum includes a rib portion, the first housing portion includes a first channel, and the second housing portion includes a second channel, the first channel and the second channel cooperating to form an annular septum channel configured to receive the rib portion upon engagement of the first engagement surface with the second engagement surface. The annular septum channel defines a first diameter, and the rib portion defines a second diameter, the first diameter being smaller than the second diameter.

[0006] In some embodiments, the septum is compressed along an axis that extends perpendicular to the vertical plane upon engagement of the first engagement surface with the second engagement surface. The septum expands along an axis that is parallel to the vertical plane upon engagement of the first engagement surface with the second engagement surface. The first engagement surface and the second engagement surface each include an engagement structure configured to align the first housing portion with the second housing portion upon engagement of the first engagement surface with the second engagement surface. The engagement structure includes one of a protrusion, a detent, a rib, a channel, a rail, a recess, a clip, or a latch.

[0007] Also disclosed is a method of manufacturing an implantable access port including, forming a housing having a first port housing including a first engagement surface, a second port housing including a second engagement surface, the first engagement surface engaging the second engagement surface along a vertical plane, and a septum disposed between the first housing portion and the second housing portion, compressing the septum along a horizontal plane between the first port housing and the second port housing, and securing the first port housing to the second port housing to maintain the septum in the horizontally compressed state.

[0008] In some embodiments, securing the first port housing to the second port housing includes one of a mechanical fit engagement, an interference fit engagement, a snap-fit engagement, a press-fit engagement, an adhesive, bonding, or welding. In some embodiments, the first engagement surface extends from a first outer edge to a second outer edge, opposite the first outer edge, of the first port housing, and the second engagement surface extends from a first outer edge to a second outer edge, opposite the first outer edge, of the second port housing. The first engagement surface extends from a top surface to a bottom surface of the first port housing, and the second engagement surface extends from a top surface to a bottom surface of the second port housing. The vertical axis extends through a diametric mid-point of the septum.

[0009] In some embodiments, the first housing portion includes a stem portion formed integrally therewith and extending longitudinally therefrom. The first port housing includes a first stem recess and the second port housing includes a second stem recess, the first stem recess and the second stem recess co-operate to form a stem aperture upon engagement of the first engagement surface with the second engagement surface. In some embodiments, the method further includes a stem portion that engages the stem aperture and defines a lumen in fluid communication with a reservoir defined by the first port housing, the second port housing, and the septum.

[0010] Also disclosed is an implantable access port including, a housing including a body formed as a single monolithic piece, and defining a septum opening configured to receive a septum therein, the body and the septum coordinating to define a reservoir, an outmost diameter of the septum opening being less than an outermost diameter of the septum to exert a radially inward force on the septum along a first axis extending perpendicular to a transverse axis.

[0011] In some embodiments, the housing includes a septum channel extending annularly about the septum opening and configured to receive a septum rib therein. The septum rib defines the outermost diameter of the septum. The septum opening defines a beveled rim configured to facilitate urging the septum into the septum opening. In some embodiments, a cross-sectional profile of the septum defines a tapered outer edge configured to facilitate urging the septum into the septum opening. The housing includes a port stem formed as a single monolithic structure with the housing, the port stem including a lumen in fluid communication with the reservoir. The housing includes a stem aperture configured to receive a port stem therein. The port stem is secured in the stem aperture by one of a mechanical fit engagement, an interference fit engagement, a snap-fit engagement, a press-fit engagement, an adhesive, bonding, or welding. The septum, disposed within the septum opening, is configured to expand along an axis that is parallel to the transverse axis.

[0012] Also disclosed is a method of forming an access port including, forming a port housing as a single monolithic piece, the housing defining a septum opening and a reservoir, urging a septum into the septum opening along a first axis to enclose the reservoir, and compressing the septum along a second axis extending perpendicular to the first axis.

[0013] In some embodiments, the housing includes a septum channel extending annularly about the septum opening configured to receive a septum rib therein. The septum rib defines an outermost diameter of a perimeter of the septum. The septum opening defines a bevel configured to facilitate urging the septum into the septum opening. In some embodiments, a cross-sectional profile of the septum defines a tapered outer edge configured to facilitate urging the septum into the septum opening. In some embodiments, the method further includes forming a port stem as a single monolithic structure with the housing, the port stem defining a lumen in fluid communication with the reservoir. In some embodiments, the method further includes forming a stem aperture in the housing configured to receive a port stem therein. In some embodiments, the method further includes securing the stem within the stem aperture by one of a mechanical fit engagement, an interference fit engagement, a snap- fit engagement, a press-fit engagement, an adhesive, bonding, or welding. In some embodiments, the method further includes expanding the septum along the first axis as the septum is compressed along the second axis.

DRAWINGS

[0014] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0015] FIG. 1A shows a perspective view of a side compression port, in accordance with embodiments disclosed herein. [0016] FIG. IB shows an exploded view of a side compression port, in accordance with embodiments disclosed herein.

[0017] FIG. 1C shows a cross-sectional view of a side compression port, in accordance with embodiments disclosed herein.

[0018] FIG. 2A shows a perspective view of a side compression port, in accordance with embodiments disclosed herein.

[0019] FIGS. 2B-2C show cross-sectional views of a side compression port, in accordance with embodiments disclosed herein.

[0020] FIG. 3A shows a side view of a septum, in accordance with embodiments disclosed herein.

[0021] FIG. 3B shows an underside view of the septum of FIG. 3 A, in accordance with embodiments disclosed herein.

DESCRIPTION

[0022] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0023] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” “stem-side,” “closed-side” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0024] 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 medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of, for example, the medical device includes an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the medical device can include the proximal end of the medical device; however, the proximal portion, the proximal end portion, or the proximal length of the medical device need not include the proximal end of the medical device. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the medical device is not a terminal portion or terminal length of the medical device.

[0025] 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 medical device is used on the patient. Likewise, a “distal length” of, for example, the medical device includes a length of the medical device intended to be near or in the patient when the medical device is used on the patient. A “distal end” of, for example, the medical device includes an end of the medical device intended to be near or in the patient when the medical device is used on the patient. The distal portion, the distal end portion, or the distal length of the medical device can include the distal end of the medical device; however, the distal portion, the distal end portion, or the distal length of the medical device need not include the distal end of the medical device. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the medical device is not a terminal portion or terminal length of the medical device.

[0026] 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. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. [0027] FIGS. 1A-1C show various details of a side compression access port (“port”)

100 according to an exemplary embodiment. The port 100 includes a port housing (“housing”) 110 having a stem portion (“stem”) 130 extending therefrom, and a needle penetrable septum (“septum”) 116, retained by the housing 110. The septum 116 is formed of a re-sealable silicone material, or the like. The housing 110 and septum 116 together define a reservoir 122. The stem 130 defines a lumen 132 that is in fluid communication with the reservoir 122. In an embodiment, the stem 130 is formed integrally with the housing 110, as a single monolithic structure. In an embodiment, the stem is formed as a separate structure and coupled with the housing, as described in more detail herein. The stem 130 can be coupled with a catheter, catheter locking device, or combinations thereof, or similar endovascular device. Optionally, but not necessary, the port 100 can further include a stem cover 131 configured to engage a placement tool, in order to facilitate subcutaneous placement of the port 100. The reservoir 122 as shown defines a substantially circular footprint, although it will be appreciated that other shaped footprints are also contemplated. The housing 110 can be formed of a substantially rigid material, such as polymers, plastics, titanium, stainless steel, or similar suitable materials.

[0028] To assist in the description of embodiments described herein, as shown in FIG.

1A, a longitudinal axis extends substantially parallel to an axial length of the port stem 130, and is substantially parallel to a skin surface of the patient, when the port is subcutaneously implanted. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes. A horizontal plane is defined by the longitudinal and lateral axes, and a vertical plane extends normal to the horizontal plane. Further, the port 100 includes a stem side, from which a stem portion 130 extends, and a closed side, opposite the stem side, as described in more detail herein.

[0029] As shown in FIGS. 1A-1C, the septum 116 is disposed over the reservoir 122 and secured in place by the port housing 110. In an embodiment, the septum 116 includes palpation features 136, such as bumps. Examples of palpation features can be found in U.S. 8,177,762; U.S. 8,608,713; U.S. 2014/0100534; U.S. 9,579,496; U.S. 10,086,186; U.S. 2019/0060628; U.S. 8,932,271; U.S. 10,052,471; and U.S. 2018/0353743, each of which are incorporated by reference in their entirety into this application. Once the port 100 is subcutaneously implanted, the palpation features 136 allow a clinician to locate the port 100 and more specifically the septum 116 in order to access the port 100. The palpation features 136 can vary in number and position and can indicate to a clinician the location and orientation of the port 100.

[0030] The port 100 can further include one or more suture holes 140 extending through the port 100 to allow the port 100 to be secured to surrounding tissue once subcutaneously implanted. The suture holes 140 can further include suture plugs 142 disposed therein to prevent tissue ingrowth. The suture plugs 142 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 100 and oriented vertically. However, it will be appreciated that other numbers, combinations, positions, and orientations of suture holes 140 are contemplated.

[0031] In an embodiment, the port housing 110 comprises of two or more housing portions that engage along a substantially vertical plane. For example, as shown in FIGS. 1 A- 1C, the housing 110 comprises a first, stem-side, portion 112 that includes a first engagement surface 118A, and a second, closed-side portion 114 that includes a second engagement surface 118B. The first and second engagement surfaces engage along a vertical, transverse plane 102 that transects a diametric midpoint 172 of the septum 116. It will be appreciated that the housing 110 can be formed of more than two portions, and engage along a longitudinal vertical plane, or other planes angled relative to the longitudinal, lateral, or transverse axes, as will be described in more detail herein.

[0032] As shown in FIG. IB, in an embodiment, the first engagement surface 118A and the second engagement surface 118B each extend from a top surface to a bottom surface of the port 100. In an embodiment, the first engagement surface 118 A and the second engagement surface 118B each extend from a first side surface to a second side surface of the port 100, opposite the first side surface, e.g. from a left side to a right side. In an embodiment, the first housing portion 112 defines a first chamber recess 122A, and the second housing portion 114 defines a second chamber recess 122B. When each of the housing portions 112, 114 engage to form the housing 110, the chamber recesses 122A, 122B co-operate to form a septum opening 120. The septum opening 120 is configured to receive the septum 116 therein that, together with the recesses 122 A, 122B of the housing 110, define the reservoir 122.

[0033] In an embodiment, the septum 116 defines a substantially circular footprint and defines a transverse thickness. It will be appreciated that the septum can also define a triangular, square, or other closed curve, polygonal shaped footprint without departing from the spirit of the invention. The septum 116 defines a diameter that is larger than the diameter of the septum opening 120. Accordingly, as indicated by the arrows in FIG. 1C, as the housing portion 112, 114 engage to form housing 110, the septum 116, disposed therebetween, is compressed along a horizontal plane. In an embodiment, the horizontal compression of the septum 116 causes a transverse expansion of the septum 116.

[0034] As shown in FIG. IB, the first chamber recess 122A and the second chamber recess 122B each further include a channel, e.g. channels 124A, 124B, respectively. When each of the housing portions 112, 114 engage to form the housing 110, the channels 124A, 124B co-operate to form a septum channel 124. The septum channel 124 is disposed annularly along an inner surface of the septum opening 120 and is configured to receive a portion of the septum 116, for example, a rib portion 138 disposed circumferentially about the septum 116. The septum channel 124 can receive the rib portion 138 therein to secure the septum 116 in place above the reservoir 122, and inhibit transverse movement of the septum 116 relative to the housing 110.

[0035] In an embodiment, the septum rib portion 138 defines a diameter that is larger than the diameter of the septum channel 124. Accordingly, as indicated by the arrows in FIG. 1C, as the housing portion 112, 114 engage to form housing 110, the septum 116, disposed therebetween, is compressed along a horizontal plane. In an embodiment, the horizontal compression causes a transverse expansion of the septum 116.

[0036] It is important to note that the septum 116 is compressed, by the co-operation of the housings portionsl 12, 114, in a direction that is substantially perpendicular to the angle of insertion of a needle penetrating the septum 116, and as such is termed a “side-compression” port. As used herein, the angle of insertion of the needle is substantially parallel to the transverse axis, although it will be appreciated that the angle of insertion can also vary within a +/- 44° angle of the transverse axis and still fall within the scope of the present invention. Worded differently, a needle accessing the reservoir by penetrating septum 116 transects the direction of septum compression through the horizontal plane. This contrasts with existing methods, whereby a septum is compressed along an axis that is substantially parallel to the angle of insertion of the needle.

[0037] Advantageously, a septum can be provided that defines a relatively smaller transverse thickness, which can then be compressed up to a desired thickness during manufacture and assembly of the port. This provides a greater level of control over the desired thickness by modifying the amount of horizontal compression applied to the septum before joining the housing portions. This contrasts with existing methods where septa are vertically compressed, down to a desired thickness, which may fall short of the minimum transverse height to avoid hyperextension, leading to the septum rupturing. Accordingly, embodiments disclosed herein achieve a lower overall profile, improving patient comfort, and reducing scarring. Further, horizontal compression of the septum 116 improves the “self-sealing” properties of the septum, compared with that of a septum at rest. This allows for the septum 116 to sustain greater number of needle penetrations, higher burst values, higher fluid flow rates, higher fluid flow pressures, or combinations thereof.

[0038] In an embodiment, the housing portions 112, 114 can include various protrusions, detents, ribs, channels, rails, clips, latches, or similar engagement structures that co-operate to align and/or secure the housings portions 112, 114 relative to each other to form housing 110. For example, as shown in FIG. IB, the closed-side housing portion 114 includes a U-shaped engagement rail (“rail”) 126. The rail 126 protrudes from an engagement surface 118B of the housing portion 114. As shown, the rail 126 extends laterally through a base portion 146 of the housing 110 and vertically through one or more walls 144 of the housing 110

[0039] The stem-side housing portion 112 includes an engagement channel (“channel”)

128 that is configured to receive the rail 126. The channel 128 creates a recess within the engagement surface 118A of the stem-side housing portion 112, and extends laterally through a base portion 146 of the housing 110 and vertically through one or more walls 144 of the housing 110. Accordingly, when the housing portions 112, 114 are assembled, the channel 128 receives the rail 126 until the engagement surface 118A contacts engagement surface 118B. The rail 126 and channel 128 are configured to align the housing portions 112, 114 to form the housing 110. Further the rail 126 and channel 128 can co-operate to improve mechanical strength between housing portions 112, 114, for example by providing improved sheer strength along the vertical engagement plane 102. In an embodiment, the rail 126 and channel 128 can be ultrasonically welded together to secure housing portions 112, 114 to each other, forming housing 110, as described in more detail herein.

[0040] While the rail 126 is shown as disposed on the closed side housing portion 114, and the channel 128 is shown as disposed on the stem-side housing portion 112, it will be appreciated that other configurations, orientations, and numbers of engagement structures are also contemplated, for example the rail 126 can be disposed on the stem-side housing portion 112, with a corresponding channel 128 disposed on the closed-side housing portion 114. Further it will be appreciated that the housing portions 112, 114, can include any number and configuration of rails, channels, protrusions, detents, ribs, clips, posts, standoffs, latches, or similar engagement structures that co-operate to align and secure the housings portions 112, 114 relative to each other to form housing 110.

[0041] In an embodiment, the housing portions 112, 114 can be secured relative to each other to using various mechanical fit, interference fit, snap-fit, press-fit engagements, adhesives, bonding, welding, ultrasonic welding, combinations thereof, or the like. For example, a width of the channel 128 can be sized so as to be slightly smaller than the width of the rail so as to engage the rail in a press-fit engagement. Further an adhesive can be applied to the engagement surfaces 118A, 118B, rail 126, channel 128, combinations thereof, or the like to further secure the housing portions 112, 114 together to form housing 110. As described in more detail herein, in an embodiment, the port 110 can further include a port body 108 overmolded onto the housing 110 to further secure the housing portions 112, 114 together.

[0042] In an embodiment, as shown in FIGS. 2A-2C, a port 200 includes a port housing

210 including two or more housing portions that engage along a longitudinally vertical plane 202. For example, as shown in FIG. 2A, the housing 210 comprises a first, left-side, housing portion 112 and a second, right-side, housing portion 114 that engage along respective engagement surfaces 218 A, 218B, along a vertical plane 202, which transects a midpoint 172 of the septum 116.

[0043] FIGS. 2B-2C show cross-sectional views of the first, left-side, housing portion

112, and the second, right-side housing portion 114, respectively. As shown in FIG. 2B, the first, left-side housing portion 212 defines a chamber recess 222 A, a channel 224 A, and a stem recess 234A. Similarly, as shown in FIG. 2C, the second, right-side housing portion 214 defines a chamber recess 222B, a channel 224B, and a stem recess 234B. When each of the housing portions 212, 214 engage to form the housing 210, the chamber recesses 222 A, 222B co-operate to form septum opening 210 configured to retain the septum 116. The septum 116 and housing portions 212, 214 together define the reservoir 222. The channels 224A, 224B, co-operate to for an annular recess, or septum channel 224, disposed along an upper edge of the septum opening 120 and configured to receive a rib portion 138 of the septum 116, to secure the septum 116 above the reservoir 222, as described herein.

[0044] Further, stem recesses 234A, 234B also co-operate to form a stem aperture 234.

The stem aperture 234 is configured for receiving a port stem 230. The port stem 230 is formed as a separate structure from the housing 210 and is configured to engage the stem aperture 234 in, for example, a press-fit engagement to provide fluid communication between the reservoir 222 and a catheter coupled thereto. It will be appreciated that other forms of attaching the stem 230 to the housing 210, such as snap-fit, welding, bonding, etc. are also contemplated, as described herein.

[0045] In an embodiment, the housing portions 212, 214 can include an engagement structure configured to align the housing portions 212, 214 relative to each other and/or provide mechanical strength between the housing portions 212, 214. The engagement structure can include various protrusions, detents, ribs, channels, rails, recesses clips, latches, or similar engagement structures that co-operate to align and secure the housings portions 212, 214 relative to each other to form housing 210.

[0046] For example, as shown in FIG. 2B, the first housing portion 212 includes one or more protrusions 226, that extend laterally from an engagement surface 218A of the first housing portion 212. The second housing portion 214 includes one or more detents 228 disposed in the engagement surface 218B, and are each configured to receive one of the one or more protrusions 226. Accordingly, when the housing portions 212, 214 are assembled, protrusions 226 of the first housing portion 212 are received by the detents 228 of the second housing portion 214 until the engagement surface 218 A contacts engagement surface 218B. The protrusions and detents 226, 228, are configured to align the housing portions 212, 214 to form the housing 210. Further the protrusions and detents 226, 228 can co-operate to provide mechanical strength attachment between housing portions 212, 214, for example by providing sheer strength along the longitudinally vertical engagement plane, as described herein.

[0047] It will be appreciated that other configurations, numbers, orientations of the protrusions and detents 226, 228 are contemplated and can include various ribs, channels, rails, clips, latches, or similar engagement structures, combinations thereof, or the like, as described herein. Further, the housing portions 212, 214 can be secured to each other using various adhesive, welding, bonding, mechanical fit engagements, snap-fit engagements, combinations thereof, or the like, as described herein.

[0048] In an embodiment, the outer profile of the ports 100, 200 defines a smooth, unobtrusive shape that reduces tissue stress points on an exterior of the port. The port body profile minimizes tension on the subcutaneous tissue during placement, this in turn minimizes the formation of scar tissue. In an embodiment, the ports 100, 200 further include a port body 108 that is overmolded onto the housing and can secure the two or more housing portions together. In an embodiment, the port body 108 is formed of a relatively pliable material, such as silicone rubber or similar suitable material. Advantageously, the pliable material can reduce stress points along a port body, and therefore reduce scarring. In another embodiment, the port body 108 is formed of a more rigid material, such as plastic, polymer, stainless steel, titanium, or similar material to that of the housing, and can be snap-fitted or press-fitted onto the port housing. In another embodiment, the body 108 is formed of a combination of pliable and rigid materials.

[0049] Optionally, the port further includes indicia 168. The indicia 168 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 is subcutaneously implanted. The indicia 168 can include symbols engraved therein to indicate an orientation, feature, or combinations thereof about the port. For example, the indicia 168 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 and the suitability of the port for power injection.

[0050] In an embodiment, the port housing 110 can be formed as a single monolithic piece, defining a reservoir 122, as described herein. The port housing 110 can define a septum opening 120 configured to receive a septum 116 therein. The opening can include a septum channel 124 extending annularly about the opening and configured to receive a portion of the septum 116, for example, a rib portion 138 disposed circumferentially about the septum 116. The septum channel 124 can receive the rib portion 138 therein to secure the septum 116 in place above the reservoir 122, and inhibit transverse movement of the septum 116 relative to the housing 110. [0051] In an embodiment, the diameter of the septum opening 120 at its widest part, e.g. at the septum channel 124, can be less than an outermost diameter of the septum 116, e.g. the diameter of the rib 138. As such, the septum 116 can be urged into the septum opening 120 and the port housing 110 can compress the septum 116 radially inward, as discussed herein (FIG. 1C). In an embodiment, a rim of the septum opening 120 can be beveled to facilitate urging the septum into the septum opening 120 until the rib 138 is situated into the septum channel 124. In an embodiment, a perimeter of the septum 116 defines a beveled edge configured to facilitate urging the septum 116 into the septum opening. In an embodiment, as shown in FIGS. 3A-3B, a cross-sectional profile of the septum can include a tapered edge portion 150 configured to facilitate urging the septum 116 into the septum opening. For example a bottom edge of the tapered portion 150 can define a first diameter that is less than a diameter of the septum opening. In an embodiment, a bottom surface of the septum 116 can define a flat surface. In an embodiment, a bottom surface of the septum 116 can define a concave recess 152 configured to allow the tapered portion 150 to flex radially inwards and facilitate the septum 116 being urged into the septum opening 120.

[0052] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. An implantable access port, comprising: a housing including: a first housing portion including a first engagement surface; and a second housing portion including a second engagement surface; the first engagement surface engaging the second engagement surface along a vertical plane; a port stem extending from the housing; and a septum that, together with the housing, defines a reservoir, the first housing portion and the second housing portion configured to retain the septum therebetween.

2. The implantable access port according to claim 1, wherein the first housing portion includes a first chamber recess, the second housing portion includes a second chamber recess, the first chamber recess and the second chamber recess co-operate to form a septum opening configured to receive the septum therein upon engagement of first engagement surface with the second engagement surface.

3. The implantable access port according to claim 2, wherein the septum opening defines a first diameter, and a perimeter of the septum defines a second diameter, the second diameter being larger than the first diameter.

4. The implantable access port according to any one of claims 1-3, wherein the vertical plane extends through a diametric mid-point of the septum.

5. The implantable access port according to any one of claims 1-4, wherein the port stem is formed as a single monolithic structure with the first housing portion, the port stem including a lumen in fluid communication with the reservoir.

6. The implantable access port according to any one of claims 1-4, wherein the first housing portion includes a first stem recess and the second housing portion includes a second stem recess, the first stem recess and the second stem recess together defining a stem aperture configured to receive the port stem upon engagement of the first engagement surface with the second engagement surface.

7. The implantable access port according to any one of claims 1-6, wherein the septum includes a rib portion, the first housing portion includes a first channel, and the second housing portion includes a second channel, the first channel and the second channel cooperating to form an annular septum channel configured to receive the rib portion upon engagement of the first engagement surface with the second engagement surface.

8. The implantable access port according to claim 7, wherein the annular septum channel defines a first diameter, and the rib portion defines a second diameter, the first diameter being smaller than the second diameter.

9. The implantable access port according to any one of claims 1-8, wherein the septum is compressed along an axis that extends perpendicular to the vertical plane upon engagement of the first engagement surface with the second engagement surface.

10. The implantable access port according to any one of claims 1-9, wherein the septum expands along an axis that is parallel to the vertical plane upon engagement of the first engagement surface with the second engagement surface.

11. The implantable access port according to any one of claims 1-10, wherein the first engagement surface and the second engagement surface each include an engagement structure configured to align the first housing portion with the second housing portion upon engagement of the first engagement surface with the second engagement surface.

12. The implantable access port according to claim 11, wherein the engagement structure includes one of a protrusion, a detent, a rib, a channel, a rail, a recess, a clip, or a latch.

13. A method of manufacturing an implantable access port, comprising: forming a housing, comprising: a first port housing including a first engagement surface; a second port housing including a second engagement surface, the first engagement surface engaging the second engagement surface along a vertical plane; and a septum disposed between the first housing portion and the second housing portion; compressing the septum along a horizontal plane between the first port housing and the second port housing; and securing the first port housing to the second port housing to maintain the septum in the horizontally compressed state.

14. The method according to claim 13, wherein securing the first port housing to the second port housing includes one of a mechanical fit engagement, an interference fit engagement, a snap-fit engagement, a press-fit engagement, an adhesive, bonding, or welding.

15. The method according to either of claims 13-14, wherein the first engagement surface extends from a first outer edge to a second outer edge, opposite the first outer edge, of the first port housing, and the second engagement surface extends from a first outer edge to a second outer edge, opposite the first outer edge, of the second port housing.

16. The method according to any one of claims 13-15, wherein the first engagement surface extends from a top surface to a bottom surface of the first port housing, and the second engagement surface extends from a top surface to a bottom surface of the second port housing.

17. The method according to any one of claims 13-16, wherein the vertical axis extends through a diametric mid-point of the septum.

18. The method according to any one of claims 13-17, wherein the first housing portion includes a stem portion formed integrally therewith and extending longitudinally therefrom.

19. The method according to any one of claims 13-17, wherein the first port housing includes a first stem recess and the second port housing includes a second stem recess, the first stem recess and the second stem recess co-operate to form a stem aperture upon engagement of the first engagement surface with the second engagement surface.

20. The method according to claim 19, further including a stem portion that engages the stem aperture and defines a lumen in fluid communication with a reservoir defined by the first port housing, the second port housing, and the septum.

21. An implantable access port, comprising: a housing including a body formed as a single monolithic piece, and defining a septum opening configured to receive a septum therein, the body and the septum coordinating to define a reservoir, an outmost diameter of the septum opening being less than an outermost diameter of the septum to exert a radially inward force on the septum along a first axis extending perpendicular to a transverse axis.

22. The implantable access port according to claim 21, wherein the housing includes a septum channel extending annularly about the septum opening and configured to receive a septum rib therein.

23. The implantable access port according to claim 22, wherein the septum rib defines the outermost diameter of the septum.

24. The implantable access port according to any one of claims 21-23, wherein the septum opening defines a beveled rim configured to facilitate urging the septum into the septum opening.

25. The implantable access port according to any one of claims 21-24, wherein a cross-sectional profile of the septum defines a tapered outer edge configured to facilitate urging the septum into the septum opening.

26. The implantable access port according to any one of claims 21-25, wherein the housing includes a port stem formed as a single monolithic structure with the housing, the port stem including a lumen in fluid communication with the reservoir.

27. The implantable access port according to any one of claims 21-25, wherein the housing includes a stem aperture configured to receive a port stem therein.

28. The implantable access port according to claim 27, wherein the port stem is secured in the stem aperture by one of a mechanical fit engagement, an interference fit engagement, a snap-fit engagement, a press-fit engagement, an adhesive, bonding, or welding.

29. The implantable access port according to any one of claims 21-28, wherein the septum, disposed within the septum opening, is configured to expand along an axis that is parallel to the transverse axis.

30. A method of forming an access port, comprising: forming a port housing as a single monolithic piece, the housing defining a septum opening and a reservoir; urging a septum into the septum opening along a first axis to enclose the reservoir; and compressing the septum along a second axis extending perpendicular to the first axis.

31. The method according to claim 30, wherein the housing includes a septum channel extending annularly about the septum opening configured to receive a septum rib therein.

32. The method according to claim 31, wherein the septum rib defines an outermost diameter of a perimeter of the septum.

33. The method according to any one of claims 30-32, wherein the septum opening defines a bevel configured to facilitate urging the septum into the septum opening.

34. The method according to any one of claims 30-33, wherein a cross-sectional profile of the septum defines a tapered outer edge configured to facilitate urging the septum into the septum opening.

35. The method according to any one of claims 30-34, further including forming a port stem as a single monolithic structure with the housing, the port stem defining a lumen in fluid communication with the reservoir.

36. The method according to any one of claims 30-34, further including forming a stem aperture in the housing configured to receive a port stem therein.

37. The method according to claim 36, further including securing the stem within the stem aperture by one of a mechanical fit engagement, an interference fit engagement, a snap-fit engagement, a press-fit engagement, an adhesive, bonding, or welding.

38. The implantable access port according to any one of claims 30-37, further including expanding the septum along the first axis as the septum is compressed along the second axis.