Shape memory alloy low profile port

Abstract

The embodiments disclosed herein relate to a port system that includes a body defining a reservoir and a port system. The body or port system is formed of a shape memory material and is transitionable between an expanded and a collapsed configuration. The port body or reservoir in the collapsed configuration can provide a reduced overall port size or outer profile for subcutaneous placement and / or between access events. The port requires a smaller incision site, thus requiring fewer or no sutures, improving patient recovery time, patient comfort, reducing scarring, and improving aesthetics. The port stem in the collapsed configuration can be smaller than the catheter lumen and transition to an expanded configuration that is larger than the catheter lumen and facilitates a fluid-tight seal between the port stem and the catheter.

Description

[Technical field]

[0001] The present invention relates to a low profile port made of a shape memory alloy. [Background technology]

[0002] Briefly summarized, embodiments disclosed herein relate to a port system with a collapsible reservoir and associated methods. The port can include a body defining a reservoir, the body being formed of a shape memory material, such as a metal, alloy, or Nitinol. The port body can transition between an expanded configuration and a collapsed configuration. Advantageously, the port can transition to the collapsed configuration to provide a reduced overall size or outer profile for insertion and / or between access events. The port can require smaller incisions, thereby reducing or eliminating the need for any sutures to close the incision, improving patient recovery time, patient comfort, reducing scarring, and improving aesthetics. Summary of the Invention

[0003] Disclosed herein is a subcutaneous access system comprising a catheter defining a lumen, a port, the port comprising a port stem configured to engage the catheter to provide fluid communication therewith, a body including a shape memory material and defining a reservoir in fluid communication with the port stem, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller overall profile, and a needle-penetrable septum disposed over the reservoir and configured to provide percutaneous access to the reservoir.

[0004] In some embodiments, the port stem comprises a shape memory material and is configured to transition between an expanded configuration and a collapsed configuration. In some embodiments, the port stem in the collapsed configuration defines a first outer stem diameter and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter. In some embodiments, the first outer stem diameter is smaller than an inner lumen diameter of the catheter in a relaxed state and the second outer stem diameter is larger than an inner lumen diameter of the catheter in a relaxed state. In some embodiments, the shape memory material comprises a metal, composite, or alloy and includes one of nickel, titanium, zinc, copper, gold, iron, aluminum, a copper aluminum nickel alloy, a nickel titanium alloy, or Nitinol.

[0005] In some embodiments, the body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the 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. In some embodiments, the body in the expanded configuration defines a first port volume, and the body in the collapsed configuration defines a second port volume, the second port volume being less than the first port volume.

[0006] 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 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 reservoir volume being less than the first reservoir volume.

[0007] In some embodiments, the body at a first temperature can transition from a collapsed to an expanded configuration and the body at a second temperature can transition from an expanded to a collapsed configuration. In some embodiments, the first temperature is equal to or greater than 98.6°F (37°C) and the second temperature is less than 98.6°F (37°C). In some embodiments, the first temperature is greater than 98.6°F (37°C) and the second temperature is equal to or less than 98.6°F (37°C). In some embodiments, the body at the second temperature is configured to be plastically deformable. In some embodiments, the body at the first temperature is in the austenitic phase and the body at the second temperature is in the martensite phase.

[0008] In some embodiments, the body in the collapsed configuration comprises a folded portion disposed on an outer surface of the body. In some embodiments, the folded portion comprises a plurality of corrugations disposed on an outer surface of the body, the corrugations configured to enable a transition between the expanded and collapsed configurations of the body. In some embodiments, the body comprises one of a frame structure, a shell structure, a honeycomb structure, or an exoskeleton structure formed of a shape memory material. In some embodiments, the subcutaneous access system further comprises a second material, distinct from the shape memory material, disposed over the shape memory material to form a continuous outer profile.

[0009] Also disclosed is a method of manufacturing a port, the method comprising forming a body defining a reservoir and a reservoir opening, the body including a shape memory material and transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller overall profile, forming a stem defining a stem lumen in fluid communication with the reservoir, and coupling a needle-penetrable septum to the reservoir opening, the needle-penetrable septum providing percutaneous access to the reservoir.

[0010] In some embodiments, the port stem comprises a shape memory material and is configured to transition between an expanded configuration and a collapsed configuration. In some embodiments, the port stem in the collapsed configuration defines a first outer stem diameter and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter. In some embodiments, the first outer stem diameter is smaller than an inner lumen diameter of the catheter in a relaxed state and the second outer stem diameter is larger than an inner lumen diameter of the catheter in a relaxed state. In some embodiments, the shape memory material comprises a metal, composite, or alloy and includes one of nickel, titanium, zinc, copper, gold, iron, aluminum, a copper aluminum nickel alloy, a nickel titanium alloy, or Nitinol.

[0011] In some embodiments, the body in the expanded configuration defines one of a first port height, a first port width, or a first port length, and the 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. In some embodiments, the body in the expanded configuration defines a first port volume, and the body in the collapsed configuration defines a second port volume, the second port volume being less than the first port volume.

[0012] 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 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 reservoir volume being less than the first reservoir volume.

[0013] In some embodiments, the body at a first temperature can transition from a collapsed to an expanded configuration and the body at a second temperature can transition from an expanded to a collapsed configuration. In some embodiments, the first temperature is equal to or greater than 98.6°F (37°C) and the second temperature is less than 98.6°F (37°C). In some embodiments, the first temperature is greater than 98.6°F (37°C) and the second temperature is equal to or less than 98.6°F (37°C). In some embodiments, the body at the second temperature is configured to be plastically deformable. In some embodiments, the body at the first temperature is in the austenitic phase and the body at the second temperature is in the martensite phase.

[0014] In some embodiments, the body in the collapsed configuration comprises a folded portion disposed on an exterior surface of the body. In some embodiments, the folded portion comprises a plurality of corrugations disposed on an exterior surface of the body, the corrugations configured to enable a transition between the expanded and collapsed configurations of the body. In some embodiments, the body comprises one of a frame structure, a shell structure, a honeycomb structure, or an exoskeleton structure formed of a shape memory material. In some embodiments, the method further comprises a second material, distinct from the shape memory material, disposed over the shape memory material to form a continuous exterior profile.

[0015] A more particular description of the present disclosure will be made with reference to specific embodiments thereof as illustrated in the accompanying drawings, it being recognized that these drawings depict only exemplary embodiments of the invention and therefore should not be considered as limiting its scope, exemplary embodiments of the invention will be described and explained with additional features and details through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0016] [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 in an expanded configuration according to an embodiment disclosed herein. [Figure 2B] 1 is a top cross-sectional view of a port in an expanded configuration according to an embodiment disclosed herein. [Figure 2C] 1 is a longitudinal cross-sectional view of a port in a collapsed configuration according to an embodiment disclosed herein. [Figure 2D] 1 is a top cross-sectional view of a port in a collapsed configuration according to an embodiment disclosed herein. [Figure 2E] 1 is a top cross-sectional view of a port in an expanded configuration according to an embodiment disclosed herein. [Figure 2F] 1 is a top cross-sectional view of a port with a folded portion in a collapsed configuration according to an embodiment disclosed herein. FIG. [Figure 3A] 1 is a transverse cross-sectional view of a port in an expanded configuration according to an embodiment disclosed herein. [Figure 3B] 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. [Figure 4A] 1 is a longitudinal cross-sectional view of a port stem in a collapsed configuration according to an embodiment disclosed herein. [Figure 4B] 1 is a longitudinal cross-sectional view of a port stem in an expanded configuration according to an embodiment disclosed herein. [Figure 4C] 1 is a transverse cross-sectional view of a port stem in a collapsed configuration according to an embodiment disclosed herein. [Figure 4D] 1 is a transverse cross-sectional view of a port stem in a collapsed configuration and with a folded portion according to an embodiment disclosed herein. [Figure 4E] 1 is a transverse cross-sectional view of a port stem in an expanded configuration according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] 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 easily separated from the specific embodiment and can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0018] With regard to the terms used herein, it should also be understood that each term is intended to describe certain 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 among a group of features or steps, and do not impose any order or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in this order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply any particular fixed position, orientation, or direction, for example. Rather, such designations are used to indicate relative positions, orientations, or directions, for example. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include the plural.

[0019] 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 otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0020] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0021] To aid in illustrating 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, a horizontal plane extends along the transverse and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.

[0022] 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. 1 illustrates a vascular access device or "port" 100 with a body that includes a shape memory material and is transitionable between expanded and collapsed configurations to facilitate subcutaneous placement. Port 100 may generally include a port body 150 that defines a 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 use, reservoir 110 may be percutaneously accessed by penetrating septum 120 with a needle to fluidly access the reservoir.

[0023] The port 100 may further comprise 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 may extend generally parallel to the longitudinal axis. The stem 130 may be configured to be coupled to a catheter 90 or similar device configured to access the vasculature of a patient. The catheter 90 may comprise an elongate body defining a lumen 92 extending therethrough.

[0024] In one embodiment, either the body 150 or the stem 130 may include a first material 152. In one embodiment, the first material 152 may be a shape memory material, such as a metal, alloy, alloy containing zinc, copper, gold or iron, a composite, a copper aluminum nickel alloy, a nickel titanium (NiTi) alloy ("Nitinol"), etc. In one embodiment, either the body 150 or the stem 130 may include a second material 154, such as a non-shape memory material, a plastic, a polymer, a metal, an alloy, a composite, etc.

[0025] In one embodiment, the body 150 may be formed entirely of a first material 152. In one embodiment, the body 150 may comprise a frame, shell, "honeycomb" or "exoskeleton" structure formed of the first material 152 and may include a coating or "filler" material formed of one or more second materials 154 disposed thereon to form a continuous outer profile. These and other forms of material are considered to be within the scope of the present invention.

[0026] In one embodiment, the first material 152 can transition between a first and a second configuration. In one embodiment, a first temperature (e.g., a temperature at or above body temperature) can cause the first material 152 to transition from the second configuration (e.g., the collapsed configuration) to the first configuration (e.g., the expanded configuration), and a second temperature (e.g., a temperature below body temperature) can cause the first material 152 to transition from the first configuration (e.g., the expanded configuration) to the second configuration (e.g., the collapsed configuration).

[0027] In one embodiment, the first material 152 at a second temperature (e.g., a temperature below body temperature) can be plastically deformed from a first configuration (e.g., an expanded configuration) to a second configuration (e.g., a collapsed configuration). The first material 152 at a first temperature (e.g., a temperature above body temperature) can transition the first material 152 from the second configuration (e.g., a collapsed configuration) to the first configuration (e.g., an expanded configuration).

[0028] In one embodiment, the first material 152 in the first (expanded) configuration can be in the austenite phase and the first material 152 in the second (collapsed) configuration can be in the martensite phase. In one embodiment, the first material 152 at the first temperature can be in the austenite phase and the first material 152 at the second temperature can be in the martensite phase.

[0029] In one embodiment, as shown in Figures 2A-2D, the port body 150 can be configured to transition between an expanded configuration (Figures 2A-2B) and a collapsed configuration (Figures 2C-2D). In one embodiment, the material of the port body 150 in the expanded configuration can be in the austenitic phase and the material of the port body 150 in the collapsed configuration can be in the martensite phase.

[0030] Figure 2A shows a longitudinal cross-sectional view of the port 100 in an expanded configuration. Figure 2B shows a top cross-sectional view of the port 100 in an expanded configuration. Figure 2C shows a longitudinal cross-sectional view of the port 100 in a collapsed configuration. Figure 2D shows a top cross-sectional view of the port 100 in a collapsed configuration.

[0031] In one embodiment, in the expanded configuration (FIGS. 2A-2B), 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 may each extend along a different axis. In one embodiment, the port body 150 in the expanded configuration can define a first port volume (V1) that provides a first outer profile or dimension.

[0032] In one embodiment, in the collapsed configuration (FIGS. 2C-2D), 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) that provides a second outer profile or dimension. 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).

[0033] In one embodiment, the second collapsed configuration of the port body 150 can include a folded configuration disposed in an outer profile, as shown in Figures 2E-2F. Figure 2E shows a top cross-sectional view of the port 100 in an expanded configuration. Figure 2F shows a top cross-sectional view of the port 100 in a collapsed configuration including a folded portion. In one embodiment, the folded portion of the port body can allow the outer surface of the port body 150 to be collapsed to a smaller profile, volume, or size. In one embodiment, as shown in Figure 2F, the folded portion can include a plurality of pleats that extend approximately vertically to allow the outer surface of the port body 150 to be disposed within a smaller horizontal circumference. For reference, the horizontal circumference of the port body 150 in the expanded configuration is shown in dashed lines. In one embodiment, the folded portion can be formed from a first material 152, one or more second materials 154, or a combination thereof.

[0034] Figures 3A-3D show an embodiment of a port 100 with a collapsible reservoir 110. Figure 3A shows a transverse cross-sectional view of the port in an expanded configuration. Figure 3B shows a transverse cross-sectional view of the port in a collapsed configuration. Figure 3C shows a longitudinal cross-sectional view of the port in an expanded configuration. Figure 3D shows a longitudinal cross-sectional view of the port in a collapsed configuration.

[0035] 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) that extend 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 a different axis. In one embodiment, the reservoir 110 can define a first reservoir volume (RV1).

[0036] 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 a zero volume or a negligible volume.

[0037] In one embodiment, the port body 150 can be exposed to a first temperature (e.g., body temperature or above 98.6° F. (37° C.)) to provide a first configuration, e.g., an expanded configuration. The port body 150 can be exposed to a second temperature (e.g., below body temperature or below 98.6° F. (37° C.)) to provide a second configuration, e.g., a collapsed configuration. In use, the port 100 can define a collapsed configuration when the port 100 is positioned external to the patient. Advantageously, the collapsed configuration can provide a smaller overall profile, size, or volume and can be positioned subcutaneously through a relatively smaller insertion site. Advantageously, a smaller insertion site can require fewer or no sutures to close the insertion site, resulting in less scarring, improved recovery time, improved patient comfort, and improved aesthetics. In one embodiment, when port 100 is placed subcutaneously, it can be exposed to a first temperature, such as body temperature or above 98.6° F. (37° C.), to transition from a collapsed (second) configuration to an expanded (first) configuration. Advantageously, when port 100 is placed subcutaneously, the change in temperature can transition port 100 to the expanded configuration ready for use.

[0038] In one embodiment, the port 100 in the expanded configuration can be plastically deformed, i.e., malleable, to the second collapsed configuration while the port 100 is at a second temperature (e.g., below 98.6°F (37°C)). The port 100 can remain in the collapsed configuration until the port 100 is placed subcutaneously. When placed subcutaneously, a temperature change from the second temperature to a first temperature (e.g., above 98.6°F (37°C)) can cause the port 100 to transition from the second collapsed configuration back to the first expanded configuration. Advantageously, the port 100 can be plastically deformed to a smaller overall profile to enable subcutaneous placement through a relatively small incision site. Once placed subcutaneously, the port 100 can be triggered by a temperature change to transition from the collapsed configuration to the expanded configuration ready for use.

[0039] In one embodiment, the first temperature can be above body temperature or above 98.6° F. (37° C.). Thus, the port 100 can be transitioned from the expanded to the collapsed configuration outside of the patient as described herein. Once subcutaneously placed, the port 100 can remain in the collapsed configuration. In use, the clinician can apply a heating pad, or similar device, to the skin surface adjacent the location of the subcutaneously placed port 100. The heating pad can warm the port to a temperature above body temperature or above 98.6° F. (37° C.) and transition the port 100 from the collapsed to the expanded configuration ready for use. Once the procedure is complete, the port 100 can be allowed to cool to body temperature and the port 100 can transition to the collapsed configuration. In one embodiment, the port 100 can be allowed to cool to body temperature and the port 100 can be plastically deformed to the collapsed configuration by contact through the skin to provide a lower profile. Advantageously, the port 100 can maintain a collapsed configuration after subcutaneous placement and between uses, providing a lower profile, reducing skin stretching, reducing scarring, and improving patient comfort and aesthetics. When access to the port 100 is required, the port 100 can be selectively transitioned to an expanded configuration by heating.

[0040] In one embodiment, the port 100 can be plastically deformed to reduce in size along a first axis and expand in size along a second axis extending at an angle to the first axis. Thus, the port body 150 can plastically deform to reduce in cross-sectional area in a first plane and fit through a relatively smaller incision site than would otherwise be required in the expanded configuration. For example, the port body 150 can be configured to plastically deform and reduce in size along one of the transverse or lateral axes and expand along the longitudinal axis to reduce the cross-sectional area of ​​the port body 150 along a lateral perpendicular plane. Thus, the port 100 can fit through a relatively smaller insertion site than would otherwise be required in the expanded configuration.

[0041] In one embodiment, as shown in Figures 4A-4E, the port stem 130 can include a first material, such as a shape memory material, and can be configured to transition between a collapsed configuration (Figures 4A, 4C, 4D) and an expanded configuration (Figures 4B, 4E). Figures 4A-4B show longitudinal cross-sectional views. Figures 4C-4E show transverse cross-sectional views through the port stem 130 in the distal direction, i.e., facing toward the catheter 90. In one embodiment, the material of the port stem 130 in the expanded configuration can be in the austenitic phase and the material of the port stem 130 in the collapsed configuration can be in the martensite phase.

[0042] As shown in FIGS. 4A, 4C-4D, in the collapsed configuration, the port stem 130 can define a first outer stem diameter (SD1). The first stem diameter (SD1) can be smaller than the first inner lumen diameter (CD1) of the catheter 90 in the relaxed state. As shown in FIGS. 4B and 4E, in the expanded configuration, the port stem 130 can define a second outer stem diameter (SD2). The second stem diameter (SD2) can be the same as or larger than the first inner lumen diameter (CD1) of the catheter 90 in the relaxed state. In one embodiment, the port stem 130 in the collapsed configuration can include a folded portion (FIG. 4D) configured to allow the port stem 130 to transition between the first outer stem diameter (SD1) in the collapsed configuration and the second outer stem diameter (SD2) in the expanded configuration.

[0043] In use, the catheter 90 can be coupled to the port stem 130 by slidably engaging the port stem 130 with the catheter lumen 92 while the port stem 130 is in the collapsed configuration. The port stem 130 can then be transitioned from the collapsed configuration (FIGS. 4A, 4C-4D) to the expanded configuration (FIGS. 4B, 4E). In one embodiment, the port stem 130 can be transitioned from the expanded configuration to the collapsed configuration by a temperature change and / or by plastic deformation, as described herein. In one embodiment, the port stem 130 can be transitioned from the collapsed configuration to the expanded configuration from a subcutaneously disposed state by a temperature change, as described herein. In the expanded configuration, the port stem 130 can define a second outer diameter (SD2) that is greater than the inner lumen diameter (CD1) of the catheter in a relaxed state. Thus, the port stem 130 can expand a portion of the catheter to a second inner lumen diameter (CD2) and provide a fluid-tight seal between the port stem 130 and the catheter.

[0044] Advantageously, the port stem 130 can provide a secure interference fit between the port stem and the catheter lumen. Additionally, the catheter can be slidably engaged with the port stem 130 prior to transitioning to the expanded configuration, requiring a relatively small columnar force and reducing slippage within the confined moist environment of the tissue pocket. Once engaged, the port stem can be transitioned to the expanded configuration to provide a tight interference fit between the port stem and the catheter lumen.

[0045] In one embodiment, a first temperature can transition the port 130 from a first expanded configuration to a second collapsed configuration, and a second temperature can transition the port 130 from the second collapsed configuration to the first expanded configuration. In one embodiment, the port 130 can be plastically deformed from the first expanded configuration to the second collapsed configuration while at the first temperature. Then, a second temperature can transition the port stem 130 from the second collapsed configuration to the first expanded configuration.

[0046] In one embodiment, the first temperature can be less than body temperature or less than 98.6° F. (37° C.). The second temperature can be body temperature or greater than 98.6° F. (37° C.). Thus, the port stem 130, disposed externally to the patient, can be exposed to the first temperature and transitioned to a second collapsed configuration or plastically deformed. The port 100 can then be subcutaneously positioned and the port stem 130 can be slidably engaged with the catheter lumen 92. The port stem 130 can then be exposed to a second temperature, i.e., greater than body temperature or 98.6° F. (37° C.), transitioning the port stem 130 from the collapsed configuration to an expanded configuration to provide a fluid-tight seal between the port stem 130 and the catheter lumen 92.

[0047] 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 understood by those skilled in the art. In the broader aspects, these adaptations and / or modifications are also encompassed. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A subcutaneous access system comprising: a catheter defining a lumen; a port; The port is a port stem configured to engage the catheter to provide fluid communication with the catheter; a body including a shape memory material and defining a reservoir in fluid communication with the port stem, the body being transitionable between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller overall profile; a needle-pierceable septum disposed over the reservoir and configured to provide percutaneous access to the reservoir; Equipped with A subcutaneous access system, wherein the port stem comprises a shape memory material and is configured to transition between an expanded configuration and a collapsed configuration.

2. 10. The subcutaneous access system of claim 1, A subcutaneous access system, wherein the port stem in the collapsed configuration defines a first outer stem diameter and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter.

3. 3. The subcutaneous access system of claim 2, A subcutaneous access system, wherein the first outer stem diameter is smaller than an inner lumen diameter of the catheter in a relaxed state and the second outer stem diameter is larger than the inner lumen diameter of the catheter in a relaxed state.

4. The subcutaneous access system according to any one of claims 1 to 3, The shape memory material includes a metal, composite, or alloy and contains one of nickel, titanium, zinc, copper, gold, iron, aluminum, copper aluminum nickel alloy, nickel titanium alloy, or nitinol.

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

6. 6. The subcutaneous access system of claim 5, A subcutaneous access system, 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.

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

8. The subcutaneous access system according to any one of claims 1 to 7, A subcutaneous access system, 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.

9. 9. The subcutaneous access system of claim 8, A subcutaneous access system, 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.

10. The subcutaneous access system according to any one of claims 1 to 9, A subcutaneous access system, 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 reservoir volume being smaller than the first reservoir volume.

11. The subcutaneous access system according to any one of claims 1 to 10, A subcutaneous access system, wherein the body at a first temperature is capable of transitioning from a collapsed configuration to an expanded configuration, and the body at a second temperature is capable of transitioning from the expanded configuration to the collapsed configuration.

12. 12. The subcutaneous access system of claim 11, A subcutaneous access system, wherein the first temperature is greater than or equal to 37°C and the second temperature is less than 37°C.

13. 12. The subcutaneous access system of claim 11, A subcutaneous access system, wherein the first temperature is greater than 37°C and the second temperature is less than or equal to 37°C.

14. The subcutaneous access system according to any one of claims 11 to 13, The subcutaneous access system, wherein the body at the second temperature is configured to be plastically deformable.

15. The subcutaneous access system according to any one of claims 11 to 14, The subcutaneous access system, wherein the body at the first temperature is in an austenitic phase and the body at the second temperature is in a martensite phase.

16. The subcutaneous access system according to any one of claims 1 to 15, A subcutaneous access system, wherein the body in the collapsed configuration comprises a folded portion disposed on an exterior surface of the body.

17. 17. The subcutaneous access system of claim 16, A subcutaneous access system, wherein the folding portion comprises a plurality of folds disposed on an outer surface of the body, the folds being configured to enable a transition between the expanded and collapsed configurations of the body.

18. The subcutaneous access system according to any one of claims 1 to 17, A subcutaneous access system, wherein the body includes one of a frame structure, a shell structure, a honeycomb structure, or an exoskeleton structure formed of a shape memory material.

19. 20. The subcutaneous access system of claim 18, The subcutaneous access system further comprising a second material, different from the shape memory material, disposed over the shape memory material to form a continuous outer profile.

20. 1. A method of manufacturing a port, comprising the steps of: forming a body defining a reservoir and a reservoir opening, the body comprising a shape memory material and capable of transitioning between an expanded configuration and a collapsed configuration, the collapsed configuration defining a smaller overall profile; forming a port stem defining a stem lumen in fluid communication with the reservoir; coupling a needle-pierceable septum to the reservoir opening, the needle-pierceable septum configured to provide percutaneous access to the reservoir; Equipped with The method, wherein the port stem comprises a shape memory material and is configured to transition between an expanded configuration and a collapsed configuration.

21. 21. The method of claim 20, The method, wherein the port stem in the collapsed configuration defines a first outer stem diameter and the port stem in the expanded configuration defines a second outer stem diameter, the second outer stem diameter being larger than the first outer stem diameter.

22. 22. The method of claim 21 , The method, wherein the first outer stem diameter is smaller than an inner lumen diameter of the catheter in a relaxed state and the second outer stem diameter is larger than the inner lumen diameter of the catheter in a relaxed state.

23. The method according to any one of claims 20 to 22, The method, wherein the shape memory material comprises a metal, composite, or alloy and contains one of nickel, titanium, zinc, copper, gold, iron, aluminum, copper aluminum nickel alloy, nickel titanium alloy, or nitinol.

24. The method according to any one of claims 20 to 23, The method, wherein the 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.

25. 25. The method of claim 24, 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.

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

27. The method according to any one of claims 20 to 26, 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.

28. 28. The method of claim 27, 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.

29. The method according to any one of claims 20 to 28, The method, 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 reservoir volume being smaller than the first reservoir volume.

30. The method according to any one of claims 20 to 29, A method, wherein the body at a first temperature is capable of transitioning from a collapsed configuration to an expanded configuration, and the body at a second temperature is capable of transitioning from the expanded configuration to the collapsed configuration.

31. 31. The method of claim 30, The method, wherein the first temperature is equal to or greater than 37°C and the second temperature is less than 37°C.

32. 31. The method of claim 30, The method, wherein the first temperature is greater than 37°C and the second temperature is less than or equal to 37°C.

33. The method according to any one of claims 30 to 32, The method, wherein the body at the second temperature is configured to be plastically deformable.

34. The method according to any one of claims 30 to 33, The method, wherein the body at the first temperature is in the austenitic phase and the body at the second temperature is in the martensite phase.

35. The method according to any one of claims 20 to 34, The method, wherein the body in the collapsed configuration comprises a folded portion disposed on an exterior surface of the body.

36. 36. The method of claim 35, The folding portion comprises a plurality of pleats disposed on an exterior surface of the body, the pleats being configured to enable a transition between the expanded and collapsed configurations of the body.

37. The method according to any one of claims 20 to 36, The method, wherein the body includes one of a frame structure, a shell structure, a honeycomb structure, or an exoskeleton structure formed of a shape memory material.

38. 38. The method of claim 37, The method, wherein the subcutaneous access system further includes a second material, distinct from the shape memory material, disposed over the shape memory material to form a continuous outer profile.

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