Silicone low-profile port with rigid base plate and stem

Abstract

The embodiments disclosed herein relate to a port system with a collapsible reservoir and associated methods. The port has a body defining a reservoir and formed of a compliant material. The port body is capable of transitioning between an expanded and collapsed configuration. The port may further include a port stem or base plate formed of a rigid or needle impenetrable material. The base plate may be aligned with the floor of the reservoir to prevent an access needle from passing through the bottom of the reservoir. The port, i.e., reservoir, may transition to a collapsed configuration to provide a reduced overall size or outer profile for insertion and / or between access events. The port requires a smaller incision, thereby requiring fewer or no sutures, improving patient recovery time, patient comfort, reducing scarring, and improving aesthetics.

Description

[Technical Field]

[0001] The present invention relates to a silicone low profile port with a rigid base plate and stem. [Background technology]

[0002] Briefly summarized, embodiments disclosed herein relate to a port system with a collapsible reservoir and related methods. When a port or similar rigid medical device is placed subcutaneously, the size of the device, e.g., overall volume, transverse height, etc., can cause stretching and erosion of surrounding tissue. For example, if the port is placed in the chest wall, it may protrude relative to the skin surface. Stretched skin tissue over the port can erode, causing a wound or even exposing the port. This is further exacerbated by chafing from clothing or a seat belt. Summary of the Invention

[0003] Embodiments disclosed herein relate to a port system including a port having a body defining a reservoir and formed of a compliant material. The port body can transition between an expanded configuration and a collapsed configuration. The port can further include a port stem or base plate formed of a rigid or needle-impenetrable material. The base plate can be aligned with the floor of the reservoir to prevent an access needle from passing through the bottom of the reservoir. Advantageously, the port can transition to a collapsed configuration to provide a reduced overall size or outer profile for insertion and / or between access events. The port requires a smaller incision, which can result in fewer or no sutures required to close the incision, improving patient recovery time and comfort, reducing scarring and erosion, and improving aesthetics.

[0004] Disclosed herein is a subcutaneous access port comprising: a port stem formed of a first material, the first material being rigid and having a first durometer; and a body defining a reservoir in fluid communication with the port stem, the body being formed of a second material, the second material being flexible and having a second durometer, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller outer profile of the port.

[0005] In some embodiments, the first material comprises one of a plastic, a polymer, a metal, an alloy, or a composite. In some embodiments, the second material comprises one of a plastic, a polymer, an elastomer, a synthetic rubber, an organic rubber, a silicone rubber, or a composite. In some embodiments, the port body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the port body in the collapsed configuration defines one of a second port height, a second port width, or a second port length. In some embodiments, the second port height is either less than the first port height, the second port width is less than the first port width, or the second port length is less than the first port length.

[0006] In some embodiments, the port body in the expanded configuration defines a first port volume and the port body in the collapsed configuration defines a second port volume, the second port volume being smaller than the first port volume. In some embodiments, the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length and the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length. In some embodiments, the second reservoir height is either less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is shorter than the first reservoir length. In some embodiments, the reservoir in the expanded configuration defines a first reservoir volume and the reservoir in the collapsed configuration defines a second reservoir volume, the second volume being smaller than the first volume.

[0007] In some embodiments, the subcutaneous access port further comprises a needle-pierceable septum disposed over the reservoir and configured to provide percutaneous access to the septum via a needle. In some embodiments, the needle-pierceable septum is formed of either a second material or silicone rubber. In some embodiments, the first durometer hardness of the first material is greater than the second durometer hardness of the second material. In some embodiments, the first material is a rigid material that is substantially resistant to deflection, and the second material is an elastically deformable material. In some embodiments, the body is elastically deformable from an expanded configuration to a collapsed configuration.

[0008] In some embodiments, the body is elastically deformable from the collapsed configuration to the expanded configuration. In some embodiments, the subcutaneous access port further includes a third material, the third material being elastically deformable and having a third durometer hardness greater than the second durometer hardness and less than the first durometer hardness. In some embodiments, the third material is disposed on an outer surface of the body. In some embodiments, the third material is disposed on a wall of the reservoir. In some embodiments, the subcutaneous access port further includes a base plate formed of one of the first material or a flexible, needle-impenetrable material. In some embodiments, the base plate and the stem are integrally formed as a single, unitary piece.

[0009] Also disclosed is a method of subcutaneously deploying a port, the method including: providing a port including a port stem configured to engage a catheter and provide fluid communication therewith; a body defining a reservoir and transitional between expanded and collapsed configurations, the body in the collapsed configuration defining a smaller overall volume than the body in the expanded configuration; and a septum disposed over the reservoir and penetrable by a needle; transitioning the port from the expanded configuration to the collapsed configuration; inserting the port body through an insertion site to subcutaneously deploy the port; and transitioning the port from the collapsed configuration to the expanded configuration.

[0010] In some embodiments, the method further includes percutaneously accessing the port with a needle before transitioning the port from the collapsed configuration to the expanded configuration. In some embodiments, the method further includes percutaneously accessing the port with a needle after transitioning the port from the collapsed configuration to the expanded configuration. In some embodiments, the port stem is formed of a first material that is a rigid material including one of a plastic, a polymer, a metal, an alloy, or a composite, and the body is formed of a second material that is a flexible material including one of a plastic, a polymer, an elastomer, a synthetic rubber, an organic rubber, a silicone rubber, or a composite. In some embodiments, the first material has a first durometer hardness and the second material has a second durometer hardness, the second durometer hardness being lower than the first durometer hardness.

[0011] In some embodiments, the port in the collapsed configuration defines a width that is narrower than the width of the port in the expanded configuration, a height that is less than the height of the port in the expanded configuration, or a length that is less than the length of the port in the expanded configuration. In some embodiments, the reservoir of the port in the collapsed configuration defines a width that is narrower than the width of the reservoir in the expanded configuration, a height that is less than the height of the reservoir in the expanded configuration, or a length that is less than the length of the reservoir in the expanded configuration. In some embodiments, the reservoir in the collapsed configuration defines a volume that is less than the volume of the reservoir in the expanded configuration.

[0012] In some embodiments, the needle-penetrable septum is formed of the same material as the body. In some embodiments, the body further comprises a third material, the third material exhibiting elastically deformable mechanical properties and having a third durometer hardness lower than the first durometer hardness and higher than the second durometer hardness. In some embodiments, the third material is disposed on an outer surface of the body. In some embodiments, the third material is disposed on a wall of the reservoir. In some embodiments, the method further comprises a base plate formed of the first material or a flexible, needle-impenetrable material. In some embodiments, the base plate and the port are integrally formed as a single, unitary piece.

[0013] Also disclosed is a method of manufacturing an access port, the method including forming a port stem comprising a first material, the first material being a rigid material and having a first durometer, and forming a body defining a reservoir in fluid communication with the port stem, the body comprising a second material, the second material being a flexible material and having a second durometer, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller outer profile of the port.

[0014] In some embodiments, the first material comprises one of a plastic, a polymer, a metal, an alloy, or a composite. In some embodiments, the second material comprises one of a plastic, a polymer, an elastomer, a synthetic rubber, an organic rubber, a silicone rubber, or a composite. In some embodiments, the port body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the port body in the collapsed configuration defines one of a second port height, a second port width, or a second port length.

[0015] In some embodiments, the second port height is less than the first port height, the second port width is less than the first port width, or the second port length is less than the first port length. In some embodiments, the port body in the expanded configuration defines a first port volume and the port body in the collapsed configuration defines a second port volume, the second port volume being less than the first port volume. In some embodiments, the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length.

[0016] In some embodiments, the second reservoir height is less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length. In some embodiments, the reservoir in the expanded configuration defines a first reservoir volume and the reservoir in the collapsed configuration defines a second reservoir volume, the second volume being less than the first volume.

[0017] A more particular description of the present disclosure will be made with reference to specific embodiments thereof which are illustrated in the accompanying drawings. It is recognized that these drawings depict only typical embodiments of the invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional features and details through the use of the accompanying drawings. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a perspective view of a port coupled to a catheter according to an embodiment disclosed herein. [Figure 2A] 1 is a longitudinal cross-sectional view of a port according to an embodiment disclosed herein. [Figure 2B] 1 is a longitudinal cross-sectional view of a port according to an embodiment disclosed herein. [Figure 2C]1 is a longitudinal cross-sectional view of a port according to an embodiment disclosed herein. [Figure 2D] FIG. 2 is a top cross-sectional view of a port according to an embodiment disclosed herein. [Figure 3A] 1 is a transverse cross-sectional view of a port in an expanded configuration according to an embodiment disclosed herein. [Figure 3B] FIG. 1 is a transverse cross-sectional view of a port in a collapsed configuration according to an embodiment disclosed herein. [Figure 3C] 1 is a longitudinal cross-sectional view of a port in an expanded configuration according to an embodiment disclosed herein. [Figure 3D] 1 is a longitudinal cross-sectional view of a port in a collapsed configuration according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0019] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be readily separated from the specific embodiment and optionally combined with or substituted for features of any of the other embodiments disclosed herein.

[0020] With regard to the terms used herein, it should also be understood that each term is intended to describe certain specific embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not impose any order or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps need not necessarily be limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such designations are used to indicate, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural.

[0021] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0022] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a needle includes the end of the catheter intended to be near or within a patient when the catheter is used with the patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0023] To aid in explaining the embodiments described herein, as illustrated in Figure 1, a longitudinal axis extends substantially parallel to the axial length of the catheter. A transverse axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and transverse axes. As used herein, horizontal planes extend along the transverse and longitudinal axes. Vertical planes extend perpendicular to the horizontal plane.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. FIG. 1 illustrates a vascular access device or "port" 100 including a collapsible reservoir 110 configured to facilitate subcutaneous placement. Port 100 may generally include a port body 150 defining reservoir 110 and a needle-penetrable septum 120 disposed over reservoir 110. In one embodiment, septum 120 may be formed of silicone rubber or a similar suitable material. In one embodiment, the septum material may define a durometer hardness of substantially 50 Shore D, although higher or lower Shore D durometer hardnesses are also contemplated. In use, the reservoir may be percutaneously accessed by penetrating septum 120 with a needle to fluidly access the reservoir.

[0025] The port 100 can further include a port stem 130 extending along a stem axis 80, the port stem 130 defining a stem lumen 132 in fluid communication with the reservoir 110. In one embodiment, the stem axis 80 can extend substantially parallel to the longitudinal axis. The stem 130 can be configured to couple to a catheter 90 or similar device configured to access a patient's vasculature. The catheter 90 can include an elongate body defining a lumen extending therethrough. In one embodiment, the port stem 130 can be formed of a first material. In one embodiment, the first material can be a substantially rigid material defining a first durometer hardness, such as a plastic, polymer, polyoxymethylene (POM or "Delrin®"), polyetheretherketone (PEEK), metal, alloy, stainless steel, titanium, composite, or the like. In one embodiment, the first material is formed of a resilient material. In one embodiment, the first material can withstand any elastic or plastic deformation. In one embodiment, the first durometer can be greater than or equal to 70 Shore D. However, other durometers are contemplated.

[0026] In one embodiment, as shown in FIG. 2A , the port body 150 can be formed of a second material. The second material can be different from the first material. In one embodiment, the second material can include a compliant material capable of elastic deformation. In one embodiment, the second material can include a plastic, polymer, elastomer, organic or synthetic rubber, silicone, or the like. In one embodiment, the second material can have a second durometer hardness that is lower than the first durometer hardness of the first material. In one embodiment, the second durometer hardness can be less than 70 Shore D. In one embodiment, the septum 120 can be formed of the same material as the second material. In one embodiment, the septum 120 can be formed of a material that is different from the first material.

[0027] In one embodiment, as shown in FIGS. 2A-2D , the port 100 can further include a needle-impenetrable base plate 140 disposed below the reservoir 110 and extending over at least a portion of the lower surface of the reservoir 110. FIG. 2D shows a top view of the port 100 with the base plate 140 extending under at least a portion of the reservoir 110. In one embodiment, the base plate 140 can define the lower surface of the reservoir 110. In one embodiment, the base plate 140 can define a horizontal diameter or horizontal surface area. These horizontal diameters or horizontal surface areas can be the same as or greater than the horizontal diameters or horizontal surface areas of the reservoirs 110.

[0028] In one embodiment, the base plate 140 can be formed of a material capable of withstanding penetration by a needle striking it. In one embodiment, the base plate 140 can be formed of a substantially rigid material, such as a plastic, polymer, metal, alloy, or composite, such as the same material from which the first material, i.e., the port stem 130, is formed. In one embodiment, the base plate 130 can be formed of an elastically or plastically deformable (i.e., malleable) material, i.e., a flexible, needle-impenetrable material, configured to withstand penetration by a needle striking it. Exemplary materials include plastics, polymers, metals, alloys, composites, KEVLAR®, and the like. Advantageously, a base plate 130 formed of a flexible, needle-impenetrable material not only allows the port 100 to collapse along a horizontal axis, e.g., a longitudinal axis or a lateral axis, but also prevents a needle from penetrating the floor of the reservoir 110.

[0029] In one embodiment, as shown in FIG. 2B, the stem 130 and base plate 140 may be formed from the same material and integrally formed as a single, unitary piece. In one embodiment, as shown in FIG. 2A, the stem 130 and base plate 140 may be formed as separate structures. In one embodiment, as shown in FIGS. 1 and 2D, the port 100 may define a substantially radially symmetric shape extending about a central transverse axis. In one embodiment, the port 100 may define a substantially circular, oval, triangular, square, or rectangular footprint or plan view. However, it will be understood that other shapes are contemplated.

[0030] In one embodiment, as shown in FIG. 2B , the port 100 can comprise a third material. The third material can include elastically or plastically deformable materials, including plastics, polymers, elastomers, composites, organic or synthetic rubbers, silicone materials, and the like. In one embodiment, the third material can define a third durometer hardness that is higher than the second durometer hardness of the second material. In one embodiment, the third durometer hardness can be the same as or lower than the first durometer hardness of the first material.

[0031] In one embodiment, the port body 150 can be formed of a third material and define the reservoir 110. In one embodiment, as shown in FIG. 2B , the port body 150 can include a second material 152, forming the reservoir 110, and a third material 154 disposed on an outer surface of the second material 152 and forming a portion of the outer surface of the port body 150. In one embodiment, the third material 154 can extend across the entire outer surface of the port body 150 to form a “shell” surrounding the portion of the port body 150 formed of the second material 152. In one embodiment, as shown in FIG. 2C , the walls of the reservoir 110 can include the third material 154 disposed thereon.

[0032] In one embodiment, as shown in FIGS. 3A-3D, the port 100 can be configured to transition between an expanded configuration (FIGS. 3A, 3C) and a collapsed configuration (FIGS. 3B, 3D). In one embodiment, in the expanded configuration, the port body 150 can define a first port height (H1), a first port width (W1), or a first port length (L1) extending along a transverse axis, a lateral axis, and a longitudinal axis, respectively. However, it will be understood that these heights, widths, or lengths can each extend along different axes. In one embodiment, the port body 150 can define a first port volume (V1).

[0033] In one embodiment, in the collapsed configuration, the port body 150 can define a second port height (H2), a second port width (W2), a second port length (L2), or a second port volume (V2). In one embodiment, the second port height (H2) can be less than the first port height (H1). In one embodiment, the second port width (W2) can be less than the first port width (W1). In one embodiment, the second port length (L2) can be less than the first port length (L1). In one embodiment, the second port volume (V2) can be less than the first port volume (V1).

[0034] In one embodiment, in the expanded configuration, the reservoir can define a first reservoir height (RH1), a first reservoir width (RW1), or a first reservoir length (RL1) extending along a transverse axis, a lateral axis, and a longitudinal axis, respectively. However, it will be understood that these heights, widths, or lengths may each extend along different axes. In one embodiment, the reservoir 110 can define a first reservoir volume (RV1).

[0035] In one embodiment, in the collapsed configuration, the reservoir 110 can define a second reservoir height (RH2), a second reservoir width (RW2), a second reservoir length (RL2), or a second reservoir volume (RV2). In one embodiment, the second reservoir height (RH2) can be less than the first reservoir height (RH1). In one embodiment, the second reservoir width (RW2) can be less than the first reservoir width (RW1). In one embodiment, the second reservoir length (RL2) can be less than the first reservoir length (RL1). In one embodiment, the second reservoir volume (RV2) can be less than the first reservoir volume (RV1). In one embodiment, the second reservoir volume (RV2) of the reservoir 110 can define zero volume or a negligible volume.

[0036] In one embodiment, the port 100 can be biased toward an expanded configuration (FIGS. 3A, 3C). In the expanded configuration, the port 100 can be configured to receive a needle extending percutaneously through the septum 120 to access and place fluid within the reservoir 110. The fluid can then pass through the stem lumen 132 into the catheter lumen 92 and into the patient's vasculature.

[0037] In one embodiment, port 100 can be elastically deformed from an expanded configuration to a collapsed configuration. In the collapsed configuration, port 100 can define smaller dimensions (e.g., height, width, length) or a smaller overall volume to facilitate subcutaneous placement of the port. Advantageously, this collapsed configuration can require a smaller incision site to place the port subcutaneously, thereby requiring fewer or no sutures to close the incision site, reducing scarring, improving patient recovery time, and / or improving aesthetics. Once placed subcutaneously, port 100 can return to its expanded configuration ready for use.

[0038] In one embodiment, the reservoir 110 can elastically deform between an expanded and a collapsed configuration, allowing the port 100 to elastically deform between the expanded and collapsed configurations. In one embodiment, the port 100 can elastically deform along a first axis and elastically expand along a second axis extending at an angle relative to the first axis. The port body 150 can thus elastically deform to reduce its cross-sectional area in a first plane and fit through a smaller incision site than would otherwise be required in the expanded configuration. For example, the port body 150 can be configured to elastically deform along one of a transverse or lateral axis and elastically expand along a longitudinal axis to reduce the cross-sectional area of ​​the port body 150 extending along a lateral, perpendicular plane. The port 100 can thus fit through a smaller insertion site than would otherwise be required in the expanded configuration.

[0039] In one embodiment, the port 100 may be biased to the expanded configuration and may be configured to include a vacuum disposed within the reservoir 110 to maintain the port 100 in the collapsed configuration. The port 100 may then be inserted through an insertion site and placed subcutaneously. Once placed subcutaneously, the vacuum may be released from the reservoir 110, and the port 100 may transition from the collapsed configuration to the expanded configuration. In one embodiment, the vacuum may be maintained within the reservoir 110 by sealing the stem lumen 132. Once the port 100 is placed subcutaneously, the seal on the stem lumen 132 may be broken to release the vacuum. In one embodiment, the vacuum in the reservoir 110 may be released by percutaneously accessing the port with a needle through the needle-pierceable septum 120. Advantageously, as the port transitions from the collapsed configuration to the expanded configuration, the vacuum within the reservoir 110 may draw fluid through the access needle and into the reservoir 110.

[0040] In one embodiment, port 100 may be biased toward the collapsed configuration. In one embodiment, port 100 may maintain the collapsed configuration during subcutaneous placement and does not require any restrictions or constraints to maintain the collapsed configuration during placement. Port 100 may then be transitioned from the collapsed configuration to the expanded configuration once placed subcutaneously.

[0041] In one embodiment, the port 100 biased toward the collapsed configuration can be accessed by a needle placed subcutaneously and extending percutaneously. The needle can provide pressurized fluid to the reservoir 110 of the port 100. The reservoir 110 can be configured to transition to an expanded configuration as fluid is introduced into the port 100. The port 100 can transition from the expanded configuration to the collapsed configuration when fluid flow stops and the fluid passes through the stem 130 to the catheter 90. Advantageously, a port 100 biased toward the collapsed configuration can require a smaller insertion site compared to a port 100 in the expanded configuration. Furthermore, the port 100 can remain in the collapsed configuration until accessed by the needle. This can provide a lower profile, reducing scarring between access events, reducing skin stretching, and improving aesthetics. In one embodiment, the port 100 can be bi-stable in both the expanded and collapsed configurations.

[0042] Advantageously, a port body 150 formed from compliant material(s), i.e., a second and / or third material, that is elastically deformable between expanded and collapsed configurations, can improve patient comfort when placed subcutaneously. Advantageously, embodiments of port 100 can have a lower risk of erosion.

[0043] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art. In broader aspects, these adaptations and / or modifications are also encompassed. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A subcutaneous access port, comprising: a port stem formed of a first material, the first material being a rigid material and having a first durometer; a body defining a reservoir in fluid communication with the port stem, the body being formed of a second material, the second material being flexible and having a second durometer, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller outer profile of the port; Equipped with The subcutaneous access port further includes a third material, the third material being elastically deformable and having a third durometer hardness greater than the second durometer hardness and less than the first durometer hardness.

2. 10. The subcutaneous access port of claim 1, The subcutaneous access port, wherein the first material comprises one of a plastic, a polymer, a metal, an alloy, or a composite.

3. 3. The subcutaneous access port according to claim 1, The subcutaneous access port, wherein the second material comprises one of a plastic, a polymer, an elastomer, a synthetic rubber, an organic rubber, a silicone rubber, or a composite.

4. The subcutaneous access port according to any one of claims 1 to 3, A subcutaneous access port, wherein the port body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the port body in the collapsed configuration defines one of a second port height, a second port width, or a second port length.

5. 5. The subcutaneous access port of claim 4, A subcutaneous access port, wherein the second port height is either less than the first port height, the second port width is less than the first port width, or the second port length is less than the first port length.

6. The subcutaneous access port according to any one of claims 1 to 5, A subcutaneous access port, wherein the port body in the expanded configuration defines a first port volume and the port body in the collapsed configuration defines a second port volume, the second port volume being smaller than the first port volume.

7. The subcutaneous access port according to any one of claims 1 to 6, A subcutaneous access port, wherein the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length.

8. 8. The subcutaneous access port of claim 7, A subcutaneous access port, wherein the second reservoir height is either less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length.

9. The subcutaneous access port according to any one of claims 1 to 8, A subcutaneous access port, wherein the reservoir in the expanded configuration defines a first reservoir volume and the reservoir in the collapsed configuration defines a second reservoir volume, the second volume being smaller than the first volume.

10. The subcutaneous access port according to any one of claims 1 to 9, The subcutaneous access port further comprises a needle-pierceable septum positioned over the reservoir and configured to provide percutaneous access to the septum by a needle.

11. 11. The subcutaneous access port of claim 10, A subcutaneous access port, wherein the needle-pierceable septum is formed from either a second material or silicone rubber.

12. The subcutaneous access port according to any one of claims 1 to 11, A subcutaneous access port, wherein the first durometer of the first material is greater than the second durometer of the second material.

13. The subcutaneous access port according to any one of claims 1 to 12, A subcutaneous access port, wherein the first material is a rigid material and is substantially resistant to bending deformation, and the second material is a resiliently deformable material.

14. The subcutaneous access port according to any one of claims 1 to 13, A subcutaneous access port, wherein the body is elastically deformable from an expanded configuration to a collapsed configuration.

15. The subcutaneous access port according to any one of claims 1 to 13, A subcutaneous access port, wherein the body is elastically deformable from a collapsed configuration to an expanded configuration.

16. 10. The subcutaneous access port of claim 1, The third material is disposed on the exterior surface of the body, a subcutaneous access port.

17. 17. The subcutaneous access port of claim 1 or 16, A third material is placed in the wall of the reservoir, a subcutaneous access port.

18. The subcutaneous access port according to any one of claims 1 to 17, The subcutaneous access port further comprises a base plate formed from one of the first material or a flexible material impenetrable by a needle.

19. 20. The subcutaneous access port of claim 18, A subcutaneous access port, wherein the base plate and port stem are integrally formed as a single, unitary piece.

20. 1. A method of manufacturing an access port, comprising: forming a port stem including a first material, the first material being a rigid material and having a first durometer; forming a body defining a reservoir in fluid communication with the port stem, the body including a second material, the second material being flexible and having a second durometer, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller outer profile of the port; Including, The method, wherein the access port further includes a third material, the third material being elastically deformable and having a third durometer hardness greater than the second durometer hardness and less than the first durometer hardness.

21. 21. The method of claim 20, The method, wherein the first material comprises one of a plastic, a polymer, a metal, an alloy, or a composite.

22. 22. The method of claim 20 or 21, The method, wherein the second material comprises one of a plastic, a polymer, an elastomer, a synthetic rubber, an organic rubber, a silicone rubber, or a composite.

23. The method according to any one of claims 20 to 22, The method, wherein the port body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the port body in the collapsed configuration defines one of a second port height, a second port width, or a second port length.

24. 24. The method of claim 23, The method, wherein the second port height is either less than the first port height, the second port width is less than the first port width, or the second port length is less than the first port length.

25. The method according to any one of claims 20 to 24, The method, wherein the port body in the expanded configuration defines a first port volume and the port body in the collapsed configuration defines a second port volume, the second port volume being smaller than the first port volume.

26. The method according to any one of claims 20 to 25, The method, wherein the reservoir in the expanded configuration defines one of a first reservoir height, a first reservoir width, or a first reservoir length, and the reservoir in the collapsed configuration defines one of a second reservoir height, a second reservoir width, or a second reservoir length.

27. 27. The method of claim 26, The method wherein the second reservoir height is either less than the first reservoir height, the second reservoir width is less than the first reservoir width, or the second reservoir length is less than the first reservoir length.

28. The method according to any one of claims 20 to 27, The reservoir in the expanded configuration defines a first reservoir volume, and in the collapsed configuration A method wherein a reservoir defines a second reservoir volume, the second volume being smaller than the first volume.

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