Subcutaneous port for minimally invasive implantation

Abstract

A port and kit for minimally invasive implantation within a subject's body are disclosed. A posterior portion of the port includes a port grip portion configured for gripping by a clamping head of a medical clamp. The port can be advanced to a target implantation site with the medical clamp through a surgical opening and a subcutaneous void and / or passageway, and the medical clamp can be released from the port grip portion and removed from the subcutaneous void and / or passageway. The port body can be configured to create, enlarge, and / or insert the subcutaneous void and / or passageway via a surgical opening at or near an axillary region of the subject.

Description

[0001] Related Applications

[0002] This application claims priority to PCT Application No. PCT / US20 / 41140, filed July 8, 2020, U.S. Provisional Patent Application No. 63 / 123,028, filed December 9, 2020, and U.S. Patent Application No. 17 / 146,253, filed January 11, 2021; the entire contents of each of which are incorporated herein by reference. The entire disclosure of all related applications listed in this paragraph are incorporated herein by reference in their entirety. TECHNICAL FIELD

[0003] The present disclosure relates to devices and methods for facilitating and / or improving repeated delivery of fluids (e.g., fluids carrying nutrients, medications, and / or agents such as chemotherapy) into the vasculature of a subject, and more particularly, but not exclusively, to vascular access ports and methods of their minimally invasive delivery and deployment within the body of a subject. BACKGROUND

[0004] Repeated needle puncture for the purpose of delivering or withdrawing fluids (e.g., medications or agents) into the vasculature of a patient causes injury to the local tissue and reduces the functionality of the target blood vessel and accuracy of needle placement. This phenomenon is typically evident in chronic diabetes, dialysis, or chemotherapy patients, for example, who require long-term continuous and repeated intravenous fluid infusion.

[0005] Vascular access ports are devices that enable such repeated puncture and fluid infusion while minimizing the cumulative injury caused by needle puncture and dynamic injection of fluids. The access port is implanted subcutaneously in a surgically created pocket near a large blood vessel, typically in the chest. It is formed essentially of a port body enclosing a cavity capped with a septum member configured to support the upper skin layer and accept repeated needle puncture therethrough for the purpose of delivering intravascular fluids sealed from the surrounding body tissue. The port is attached to a catheter (a thin, flexible tube) that provides fluid communication with a large blood vessel (such as the superior vena cava) so as to allow the infused fluid to be diluted in the blood stream.

[0006] Implantation of the port is considered a minor surgery performed under local or general anesthesia by an interventional radiologist or surgeon. First, the surgeon enables access to the desired vein, then creates a skin incision in the access point. A larger second incision is created above the desired location of the port, through which a pocket-like subcutaneous void is formed using a blunt device. The catheter is extended subcutaneously between the two incisions using a blunt tunneler. One end of the catheter is then inserted into the vein and its other end is coupled to the port. Optionally, the catheter is cut to the desired length during deployment.

[0007] In addition to the advances in access port design over the past few years, there remains a need to develop ports and methods of their implantation and deployment that are less traumatic and invasive, and also possibly simpler to perform by non-surgical medical personnel.

[0008] It should be noted that the background description is not intended to limit the scope of the claimed subject matter and should not be construed as limiting the claimed subject matter to solutions addressed in the background description. The background description is merely intended to help describe the subject matter of the present patent application and should not be considered as limiting the claimed subject matter to any one or more implementations described in the background. SUMMARY

[0009] The present disclosure relates to devices and methods for facilitating and / or improving the repeated delivery of fluids (e.g., fluids carrying nutrients, pharmaceuticals, and / or agents such as chemotherapy agents) into the vasculature of a subject, and more particularly, but not exclusively, to vascular access ports and methods of their minimally invasive delivery and deployment within the body of a subject.

[0010] In certain embodiments, a subcutaneous port is provided. The subcutaneous port can include a port body enclosing a cavity, wherein the cavity includes a first opening configured for repeated needle penetration therethrough and a second opening configured to facilitate fluid communication between the cavity and a catheter. In some embodiments, the port body includes a rigid port grip portion configured to releasably engage with a medical clip, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical clip when the medical clip is engaged with the port grip portion. In some embodiments, the port grip portion is configured to receive a manual force and / or torque from the medical clip in at least one axis, wherein the manual force and / or torque received at the port grip portion is sufficient to releasably secure the medical clip to the port grip portion.

[0011] In some embodiments, the port body includes a rigid port body component surrounding the cavity and / or defining the first cavity opening, the rigid port body component including an anterior portion, a posterior portion, and lateral portions extending from opposite sides thereof between the anterior portion and the posterior portion, wherein the posterior portion includes the port grip portion.

[0012] In some embodiments, the manual force and / or torque received at the port grip portion is sufficient to use the subcutaneous port to create or enlarge a subcutaneous void and / or passageway within the body of a subject and / or to manipulate the subcutaneous port along the subcutaneous void and / or passageway without slipping or releasing the grip of the port grip portion.

[0013] In some embodiments, the second lumen opening is juxtaposed with and / or is located below the port gripping portion, further from the first lumen opening than the port gripping portion.

[0014] In some embodiments, the port gripping portion comprises a wall, wherein the wall comprises opposing first and second outer wall surfaces sized to accommodate a clamping surface of a medical clamp.

[0015] In some embodiments, the port gripping portion is configured such that when the clamping surfaces of the medical clamp are oriented and spaced apart relative to one another to substantially match a shape and thickness of the wall, a manual force is equal to or less than 10 kgf and / or a manual torque is equal to or less than about 0.25 N*m.

[0016] In some embodiments, the port gripping portion is configured such that when the clamping surfaces of the medical clamp are oriented and spaced apart relative to one another to match a shape and thickness of the wall, the manually operable arms of the medical clamp are permitted to interlock.

[0017] In some embodiments, the first and second outer surfaces are parallel.

[0018] In some embodiments, the port gripping portion comprises a clamp engagement feature.

[0019] In some embodiments, the clamp engagement feature comprises one or more of a tapered surface, a roughened surface, a scored surface, a tooth, a recess, and a through-hole.

[0020] In some embodiments, the clamp engagement feature is formed in the wall comprising the first and second outer surfaces.

[0021] In some embodiments, each of the outer wall surfaces extends vertically between lateral portions of the port body.

[0022] In some embodiments, each of the outer wall surfaces extends horizontally between a bottom portion and a top portion of the port body.

[0023] In some embodiments, an average or maximum thickness of the wall is between about 1 mm and about 4 mm and / or an angle formed between the first and second outer wall surfaces is equal to or less than about 20°.

[0024] In some embodiments, the second lumen opening is juxtaposed with and / or is located below the port gripping portion.

[0025] In some embodiments, the port body comprises a plurality of members coupled to one another, and wherein the port gripping portion is associated with a first member of the plurality of coupled members.

[0026] In some embodiments, the septum is associated with a second member of the plurality of coupled members, which is different from the first member of the plurality of coupled members.

[0027] In some embodiments, the second lumen opening is associated with a third member of the plurality of coupled members, which is different from the first member and the second member of the plurality of coupled members.

[0028] In some embodiments, the port gripping portion includes a securing structure or mechanism configured to prevent lateral and / or rotational movement of the medical clamp on and relative to the port gripping portion when the medical clamp is engaged with and secured to the port gripping portion.

[0029] In some embodiments, the securing structure or mechanism includes laterally opposing boundary walls extending from at least one of the first outer wall surface and the second outer wall surface, wherein the opposing boundary walls are laterally spaced apart from each other so as to snugly fit against one of the clamping surfaces of the medical clamp.

[0030] In some embodiments, the securing structure or mechanism is configured to initiate lateral compression and / or locking of the medical clamp therewith when the medical clamp is engaged with and secured to the port gripping portion.

[0031] In some embodiments, the port body is configured to create, enlarge, and / or insert a subcutaneous void and / or passageway via a surgical opening at or near the axillary region of the subject’s arm that is coupled to the respective shoulder.

[0032] In some embodiments, the subcutaneous void and / or passageway can extend superiorly and anteriorly over the subject’s pectoralis major muscle.

[0033] In some embodiments, the port body is configured to be implanted at a target implantation site located inferior to the subject’s clavicle and / or anterior to the subject’s pectoralis major muscle through the subcutaneous void and / or passageway.

[0034] In certain embodiments, a surgical kit is provided, which can include a subcutaneous port and a catheter, wherein a first end of the catheter is configured to be inserted into the subject’s vasculature via a surgical opening, and a second end of the catheter is connected or connectable to the subcutaneous port to form fluid communication between a lumen of the catheter and a cavity of the subcutaneous port.

[0035] In some embodiments, the first end of the catheter is configured to be inserted into the vasculature via a lower portion of the subject’s axillary vein inferiorly and / or laterally to the subject’s pectoralis minor muscle.

[0036] In some embodiments, the surgical kit further includes a peel-away sheath configured to be inserted into the axillary vein through the wire and for inserting the first end of the catheter into the axillary vein through the peel-away sheath after the wire is removed from the axillary vein.

[0037] In some embodiments, the surgical kit further includes a dilator configured to be inserted into the axillary vein while in the peel-away sheath, wherein the first end of the catheter is configured for insertion through the peel-away sheath after removal of the dilator from the peel-away sheath.

[0038] In some embodiments, the surgical kit further includes a medical clamp configured to releasably engage the port gripping portion.

[0039] In some embodiments, the medical clamp is configured as a medical forceps and / or is selected from the group consisting of Kelly forceps, surgical needle holder, and locking forceps.

[0040] In certain embodiments, a method is provided that can include forming a surgical opening across a skin layer in a subject; creating a subcutaneous void and / or passageway beneath the skin layer via the surgical opening; gripping a port gripping portion of a subcutaneous port with a medical clamp; advancing the subcutaneous port with the medical clamp through the surgical opening and the subcutaneous void and / or passageway to a target implantation site; releasing the medical clamp from the port gripping portion; and removing the medical clamp from the subcutaneous void and / or passageway.

[0041] In some embodiments, the method includes creating or enlarging the subcutaneous void and / or passageway with the medical clamp prior to the gripping.

[0042] In some embodiments, the port gripping portion includes a wall comprising opposing first and second outer wall surfaces, wherein the gripping includes interlocking manually operable arms of the medical clamp so as to apply a continuous grip against the first and second wall surfaces of the port gripping portion.

[0043] In some embodiments, the method includes forming the surgical opening at an axillary region of the subject.

[0044] In some embodiments, the method includes inserting the first end of the catheter into the vasculature of the subject via the surgical opening, and coupling the second end of the catheter to the subcutaneous port to form fluid communication between a lumen of the catheter and a cavity of the subcutaneous port.

[0045] In some embodiments, the first end of the catheter is inserted into the vasculature via an axillary vein or a jugular vein of the subject.

[0046] In some embodiments, any access to the vasculature and / or across a skin layer of the subject is created directly through the surgical opening after the forming.

[0047] In some embodiments, the method further comprises at least one of accessing the vein of the subject with an access needle, inserting a wire into the vein through the access needle, removing the access needle from the vein, inserting the peel-away sheath and / or dilator into the vein through the wire, removing the wire and / or dilator from the vein, inserting the first end of the catheter into the vein through the peel-away sheath, and then removing the peel-away sheath from the vein.

[0048] In some embodiments, the vein is an axillary vein or a jugular vein.

[0049] In some embodiments, the medical clamp is configured as a medical forceps and / or is selected from the group consisting of Kelly forceps, surgical needle holder, and locking forceps.

[0050] In certain embodiments, a kit for creating a repeatable treatment access to a subject is provided. The kit can include a subcutaneous port including a port body enclosing a cavity, wherein the cavity includes a first opening configured for repeated needle penetration therethrough and a second opening configured to facilitate fluid communication between the cavity and a catheter, and a medical clamp. In some embodiments, the port body includes a port gripping portion configured to releasably engage with the medical clamp, and wherein the port body is configured to be pushed into a subcutaneous target implant site using the medical clamp when the medical clamp is engaged with the port gripping portion.

[0051] In some embodiments, the medical clamp includes oppositely pivoted connected clamping arms.

[0052] In some embodiments, the port gripping portion includes a wall, wherein the wall includes a first outer surface and a second outer surface sized to accommodate distal portions of the oppositely pivoted connected clamping arms.

[0053] Unless otherwise defined or specified herein, all technical or / and scientific words, terms or / and phrases, as used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. The exemplary embodiments of methods (steps, procedures), devices (apparatuses, systems, components thereof), equipment and materials described herein are exemplary and illustrative only and not intended to be limiting in any way. Although methods, devices, equipment and materials equivalent or similar to those described herein can be used in the practice or / and testing of the present disclosure, exemplary methods, devices, equipment and materials are described herein as examples only. In case of conflict, the patent specification, including definitions, will control. BRIEF DESCRIPTION OF DRAWINGS

[0054] Various embodiments are discussed in detail below in connection with the following drawings, in which like numbers indicate like parts. The embodiments are merely illustrative and are not intended to limit the scope of the disclosed technology. Any proportion shown in any of the figures is not limiting of the scope of the disclosed technology. The drawings include the following figures:

[0055] Figures 1A-1C Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0056] Figures 2A-2C Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments; Figure 1A Different exemplary variations of a port gripping portion of an exemplary subcutaneous port shown in

[0057] Figures 3A-3H Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments; Figure 1A Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0058] Figures 4A-4K Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments; Figure 1A Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0059] Figures 5A-5F Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0060] Figures 6A-6B Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0061] Figures 7A-7B Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0062] Figures 8A-8B Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0063] Figures 9A-9B Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments;

[0064] Figures 10A-10B Respectively shown are lateral cross-sectional and top cross-sectional views of an exemplary deployed vascular access port according to some embodiments; Figure 9Atop and isometric views of a subcutaneous port; and

[0065] Figure 11 An isometric view of an exemplary subcutaneous port including another exemplary configuration of a port grip portion is shown, according to some embodiments. DETAILED DESCRIPTION

[0066] The following description and examples detail some exemplary implementations, embodiments, and arrangements of the disclosed invention. Those skilled in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be taken as limiting the scope of the invention.

[0067] The present disclosure, in some embodiments thereof, relates to devices and methods for facilitating and / or improving repeated delivery of fluids (e.g., fluids carrying nutrients, drugs, and / or agents such as chemotherapy agents) into the vasculature of a subject, and more particularly, but not exclusively, to vascular access ports and methods of their delivery and deployment within the body of a subject. In some embodiments, the vascular access ports of the present disclosure can improve the safety and / or effectiveness of surgical implantation procedures of access ports and catheters by reducing the size or number of surgical procedures (such as incisions, cuts, and tunneling), their duration, and / or complexity, thereby also providing a less traumatic experience for the patient and easier recovery.

[0068] As used herein, the term "vascular access port" refers to an implant intended for repeated transfer of fluids that are infused into and / or withdrawn from a subject. "Repeated" in this context can refer to more than 10 consecutive needle punctures, optionally more than 100 consecutive needle punctures, optionally more than 1000 consecutive needle punctures, optionally more than 10,000 consecutive needle punctures, or more or less. "Needle" in this context can refer to a needle approved for fluid delivery through a vascular access port, such as for intravenous infusion.

[0069] The disclosure described herein is also advantageous when used in conjunction with vascular access ports having a septum member configured for repeated puncture by a needle, although this particular feature is not a requirement and other forms of needle access openings or platforms can be applicable. Some of the vascular access ports described herein include one or more components that collectively are configured for long-term implantation in a living (e.g., human) subject and for repeated fluid transfer access, such as through a septum member, when properly assembled and deployed. The vascular access port includes at least a structural object referred to herein as a "port body" that serves as a convenient structure for fluid transfer access and / or as a support structure configured for holding components (e.g., septums) that can be applicable for fluid transfer access.

[0070] The port body can be structurally and / or functionally configured to at least facilitate the basic function of a vascular access port, namely the repeated accumulation and delivery of fluid to and / or withdrawal of fluid from the vasculature of a subject. In some embodiments, the port body can optionally lack or be initially configured without one or more other features (optional or essential features) for facilitating additional functions associated with the delivery, deployment, and / or long-term use of the vascular access port. The port body can be connectable to at least one other component for providing additional features or capabilities to the vascular access port, such as improved or easier delivery capabilities, selective fixation to body tissue surrounding the port body, and / or increased stability in a selected implantation site such as a pre-formed subcutaneous void.

[0071] In some embodiments, the port body forms a cavity beneath (e.g., below) the needle access opening and / or the septum, the cavity being sized, shaped, and configured for repeated receipt of a needle tip for the accumulation of a selected or predetermined volume of fluid (e.g., a liquid such as a solution, suspension, or colloid), and / or for the infusion of fluid to and / or withdrawal of fluid from the vasculature of a living subject. In some embodiments, the vascular access port can include a single cavity or several different cavities (provided as a single element or as several interconnectable components), some or all of which can be disposed in the port body or in several portions or components of the vascular access port that are each configured as a separate port body, optionally covered with one or several different septum components.

[0072] Prior to implantation or after it, a catheter can be attached to the vascular access port, having a distal end that physically enters the vasculature of the patient. Once connected, the lumen of the catheter is in direct fluid communication with the port body cavity. The vascular access port or kit including it as described herein can or can not include such a catheter, and can or can not include fittings for connection to such a catheter. The vascular access port can have additional components and functions not associated with fluid delivery or withdrawal. The vascular access port can be referred to herein simply as a “port” or “implant.” A “subcutaneous port” refers to a vascular access port, and optionally, more generally, to any other medical implantable port that is specifically configured for implantation beneath skin tissue, and that can be accessed transcutaneously through the skin tissue covering it by way of needle puncture or penetration of its interior.

[0073] Optionally, the vascular access port includes a port grasping portion configured to facilitate effective continuous (optionally, locking) clamping or grasping of the port using a medical clamp. The medical clamp includes a distal clamping head that is selectively operable using an elongated arm extending distally therefrom, and the clamping head is selectively changeable between an open (non-clamping) configuration and a closed (clamping) configuration. When in the closed configuration, two clamping surfaces of two opposing pivotally connected clamping head components forming the clamping head are pressed against each other from both sides of the port grasping portion. The medical clamp can be provided to the user together with the port (optionally as a kit), or it can be a general clamping or grasping device commonly used by the practitioner performing the subcutaneous port implantation (optionally configured as a medical forceps, such as Kelly forceps, a surgical needle holder, a surgical grasper, a locking forceps, a hemostat, or other).

[0074] Deploying the vascular access port includes at least inserting the port body into a target implantation site in the subject's body such that the upper portion of the port body is accessible to the repeated fluid transfer access. The insertion of the port (or port body) can be performed using a medical clamp by first applying it to continuously clamp (and optionally lock it in that clamped position) the port grasping portion, and then manually pushing and / or manipulating the port using the medical clamp arm.

[0075] The vascular access port deployment can include compacting a tissue mass surrounding the perimeter of the port body, thereby increasing the volume of a void formed in the target implantation site between the perimeter of the port body and the compacted tissue mass. In some embodiments, the void and / or a surgical access from an incision on the subject's skin to the void can be performed using the same medical clamp (e.g., Kelly forceps or needle holder) before clamping it to the port. The void can be a subcutaneous void between or under layers of skin tissue at the target implantation site. The increased void volume is occupied by the vascular access port, either simultaneously with or shortly after increasing the volume of the void, such as by increasing the volume of the port body or by connecting one or more solidly shaped members (e.g., port body extensions) thereto. This also includes cases where the compacting of the tissue mass can be a direct result of such a port body volume increase. The compacted tissue mass generally affects the sustained pressure on the deployed vascular access port, and thereby increases its fixation and / or stability in the subcutaneous void. The port body can include a lower portion defining a cavity and an upper portion coupled with a septum member covering the cavity, and the vascular access port can be deployed such that the compacted tissue mass surrounds only the lower portion of the port body and not the upper portion.

[0076] Figures 1A-1C An exemplary vascular access port 10 configured as a subcutaneous port is schematically shown prior to implantation in a subject SUB (e.g., a living human patient) and after implantation in the subject. As shown in the top view in Figure 1A and the bottom view in Figure 1BThe vessel access port 10 includes a port body 11 defining a lumen 12 and coupled with a septum member 13 covering the lumen 12 and sealing it from the ambient environment. The septum member 13 is configured for repeated puncture by a needle, such as the needle 14 shown in Figure 1B The lumen 12 optionally opens to a first lumen opening closed by the septum member 13 and to a second lumen opening configured to facilitate fluid communication between the lumen and a lumen of a catheter when connected thereto. In some embodiments, the second lumen opening is located at a rear portion of the port 10, alongside and / or below a port grip portion 21 configured for gripping or clamping by a medical clamp.

[0077] The port 10 can be implanted subcutaneously in a target implant site IMS beneath a skin layer SKL (optionally including within or beneath adipose tissue) via a single opening or incision INS in a subject SUB. When fully deployed, the vessel access port 10 has the lumen 12 in fluid communication with a vasculature VSC (typically a larger vessel, such as a subclavian vein, or one of the vena cavae) of the subject SUB, such that infusion of fluid in the lumen 12 via the needle 14 will flow directly to the subject's vasculature. A catheter 15 having a catheter lumen 16 has a first catheter end 17 positioned in and open to the vasculature VSC, and a second catheter end 18 connected to the port body 11 and open to the lumen 12; the catheter ends 17 and 18 are open to the catheter lumen 16 and facilitate fluid communication between the lumen 12 and the vasculature VSC. In some embodiments, both the port 10 and the catheter 15 are introduced and implanted in the subject SUB via a single opening or incision INS. Figure 1B An optional deployment scenario is shown in which the port 10 is positioned on an upper portion of the subject's chest, proximate an access opening to the jugular vein, with the first catheter end 17 positioned in the superior vena cava proximate the subject's right atrium. The vessel access port 10 can be provided separately from the catheter 15 with a connector configured for selective connection between the vessel access port and the catheter, optionally within the body, or alternatively, the vessel access port 10 and the catheter 15 are provided together as an assembled kit or as a unitary device.

[0078] In some embodiments, the port 10 can be substantially rigid such that it is not deformable or shapeable about a majority or all of the cavity 12 under normal stresses incurred during or after subcutaneous implantation into a subject's body, and in some other embodiments, at least a portion thereof is designed and configured for bending or moving relative to other portions of the port 10 (e.g., relative to the port body 11 or rigid portions thereof) prior to, during, or after implantation. In some embodiments, the port 10 is configured as an extrudable subcutaneous port capable of penetration through a smaller opening (such as an opening formed by a puncture or incision made to a patient's skin) that cannot accommodate passage of the port 10 therethrough in its maximum cross-sectional circumference when in an elastically relaxed state. Penetration through such an opening can be achieved by forcing one or more portions of the port 10 to be locally elastically compressed by the opening neck portion as the port is pushed distally through the opening.

[0079] In some such embodiments, the port 10 and particularly the port body 11 includes a rigid inner component 19 forming the cavity 12, and a flexible outer component 20 connected to the inner component 19 along at least one lateral peripheral portion of the inner component, thereby forming a selected predetermined spatial shape for the port 10 when in an elastically relaxed state (e.g., as shown in FIGS. 1-3). Figure 1A The outer component 20 can be configured with an elastic resistance sufficient to maintain the predetermined spatial shape within a surgically formable subcutaneous void when under naturally occurring subcutaneous stresses. In addition, the outer component 20 can be locally compressed against the inner component 19, and configured to substantially maintain the overall volume by distally expanding to its compressed region, thereby facilitating extrusion of the port 10 into the subcutaneous void when pushed through a skin opening that is larger than the maximum cross-sectional circumference of the inner component and smaller than the maximum cross-sectional circumference of the predetermined spatial shape.

[0080] The port 10 includes a port grasping portion 21 having a relatively thin wall bounded by two opposing surfaces, configured for efficient continuous clamping or grasping by a medical clamp (e.g., a surgical needle holder 119 as shown in FIG. 7 and / or Kelly forceps 230 as shown in FIG. 6). Figure 9A The port grasping portion 21 is located at or extends from a rear portion of the body of the port 10 or rigid structural component thereof, and optionally includes a thin wall bounded by two opposing surfaces sized and shaped for efficient clamping by a medical clamp. In some embodiments, the average or maximum thickness of the thin wall is between about 1 mm and about 4 mm, or between about 1.5 mm and about 3 mm. In some embodiments, the angle formed between the opposing surfaces of the thin wall is equal to or less than about 20°, optionally equal to or less than about 10°, or optionally equal to or less than about 5°.

[0081] The port body 11 can include an upper portion or component that at least encloses an upper portion of the cavity 12 and / or contacts the septum component 13, and which can narrow at its rear portion to form a port grip portion 21. The port grip portion 21 is configured with sufficient rigidity and / or strength to prevent mechanical failure when clamped and manually manipulated under the skin layer of the subject SUB, and can optionally be made of a metal alloy such as stainless steel or titanium alloy, or a hard polymer such as polyether ether ketone (PEEK). In some embodiments, the port grip portion 21 is shaped with its opposing surfaces so as to accommodate a desired clamping orientation of the medical clamp thereto.

[0082] The port grip portion 21 is configured for the transmission of manual force and / or torque by the medical clamp to the port 10 in at least one axis, such as a first clamping axis normal to the thin-walled surface and optionally other axes in other directions. The manual force and / or torque is optionally sufficient to lock the medical clamp to the port grip portion 21. In some embodiments, the manual force and / or torque is also sufficient to form or enlarge a subcutaneous void and / or passageway within the subject’s body using the clamped port 10, and / or to manipulate the port 10 along the subcutaneous void and / or passageway without slipping or releasing the grip of the port grip portion 21. The port grip portion 21 is optionally configured such that the manual force is equal to or less than about 20 kgf, optionally equal to or less than about 10 kgf, equal to or less than about 5 kgf, when the distal portions of the clamping head components forming the medical clamp are oriented and spaced apart relative to each other to match the shape and thickness of the thin wall. The port grip portion 21 is optionally configured such that the manual torque is equal to or less than about 0.25 N*m, equal to or less than about 0.20 N*m, or equal to or less than about 0.15 N*m, when the distal portions of the clamping head components forming the medical clamp are oriented and spaced apart relative to each other to match the shape and thickness of the thin wall.

[0083] Figures 2A-2C Different exemplary variations of the port grip portion 21 of the port 10 are schematically shown. Figure 2A A first exemplary variation of the port grip portion 21 with a thin wall 22a is shown, in which the two opposing surfaces 23a are substantially flat and parallel to each other so as to effectively accommodate a first exemplary medical clamping head 24a configured for exerting sufficient clamping force when its clamping head components 25a are spaced apart by a distance equal to or slightly less than the thickness of the thin wall 22a, with its clamping head components 25a oriented substantially parallel to each other (at least with their distal portions). Figure 2BA second exemplary variation of the port gripping portion 21 with thin wall 22b is shown, in which the two opposing surfaces 23b are substantially flat and tapered to one another so as to effectively accommodate the second exemplary medical clamp head 24b configured for exerting sufficient clamping force when its clamp head parts 25b are oriented substantially tapered to one another (at least with their distal portions). Figure 2C A third exemplary variation of the port gripping portion 21 with thin wall 22c is shown, in which the two opposing surfaces 23c each have a non-flat (e.g., toothed) pattern. Thus, it can effectively accommodate the third exemplary medical clamp head 24c configured for locking to a surface 23c in at least one axis when its clamp head parts 25c engage a surface 23c having its matching non-flat pattern.

[0084] Figures 3A-3H Exemplary scenarios are schematically shown, representing possible steps in an exemplary procedure for implanting a vascular access port 10 and catheter 15 implantation in a subject SUB via a single surgical opening formed across the subject's skin. An exemplary sequence of implantation is shown first steps related to forming an access into the vasculature VSC, and then steps related to implanting the port 10 in a subcutaneous void within the subject SUB's body, and then other steps related to catheter cannulation by positioning the first end of the catheter 15 in the vasculature, however a procedure according to some embodiments can perform any different sequence, such as implanting the port 10 first and then forming the access and implanting the catheter first end 17, implanting the port 10 after cannulation, or implanting both of them at least partially in parallel. As Figure 3A As shown in FIG. 1 1, a surgical opening (optionally by way of an incision INS) is optionally formed across the subject SUB's skin layer at the neck region or over (on) the proximal side of the clavicle, and an access needle 30 is introduced therethrough into a nearby vasculature VSC (e.g., the jugular vein, or the subclavian vein as shown). In some embodiments, the access needle 30 is optionally applied with its tip to puncture and / or penetrate the skin, and thereby optionally form the surgical opening or a portion thereof, prior to making an incision across it or adjacent thereto with a scalpel. As Figure 3B As shown in FIG. 1 1, a surgical opening (optionally by way of an incision INS) is optionally formed across the subject SUB's skin layer at the neck region or over (on) the proximal side of the clavicle, and an access needle 30 is introduced therethrough into a nearby vasculature VSC (e.g., the jugular vein, or the subclavian vein as shown). In some embodiments, the access needle 30 is optionally applied with its tip to puncture and / or penetrate the skin, and thereby optionally form the surgical opening or a portion thereof, prior to making an incision across it or adjacent thereto with a scalpel. As

[0085] As Figure 3CAs shown in FIG. 1, port 10 can be clamped with medical clamp 32 for assisting in its implantation. In cases where incision INS has not yet been made, a practitioner can make the incision shortly before implanting the port, or increase the size of incision INS, e.g., with a scalpel or with port 10 itself. Subcutaneous void and / or passageway SCV can be formed via incision INS, using medical clamp 32 or with other instruments, prior to clamping to port 10. Subcutaneous void and / or passageway SCV extends from incision INS to target implant site IMS, which can optionally be located in the upper chest region and / or below (inferior to) the clavicle.

[0086] Port 10 can then be advanced into subcutaneous void and / or passageway SCV via incision INS using medical clamp 32 clamped to it Figure 3D ). In some embodiments, the order of presentation is reversed, and port 10 is implanted at implant site IMS prior to introduction of access needle 30 and / or guidewire 31 into the body of subject SUB. In some embodiments, as shown, second end 18 of catheter 15 is already (fixedly or releasably) connected to port 10, however it can be provided disconnected, and can be connected prior to or after clamping port 10 with medical clamp 32, prior to or during delivery through incision INS. After implanting port 10 at target implant site IMS, first end 17 of catheter 15 is optionally located outside the body of subject SUB, however in some other embodiments, first end 17 of catheter 15 can be disposed within vasculature VSC prior to implanting port 10. Once the correct position of port 10 is verified, medical clamp 32 can be released (loosened) from port 10 and withdrawn from subcutaneous void and / or passageway SCV.

[0087] Prior to or after implanting port 10, access needle 30 can be removed from the body of subject SUB, while leaving guidewire 31 in the selected path within vasculature VSC Figure 3E . Thereafter, peel-away sheath 33 (which can be torn along a pre-weakened line, for example) can be inserted into vasculature VSC over guidewire 31. Guidewire 31 can then be removed from vasculature VSC, leaving peel-away sheath 33 in place. As shown in Figure 3F , in cases where peel-away sheath 33 is introduced with dilator 34 extending along its lumen, dilator 34 can also be withdrawn from within peel-away sheath 33. As shown in Figure 3G and Figure 3H , once the lumen of peel-away sheath 33 is clear, first end 17 of catheter 15 is introduced into vasculature VSC through it, and is optionally positioned in the superior vena cava or in the right atrium. After verifying that port 10 and / or catheter 15 are in proper position and function (optionally under imaging), peel-away sheath 33 is broken open, and is removed from the body of subject SUB and incision INS is closed (e.g., by suturing).

[0088] Figures 4A-4K An exemplary scenario is schematically illustrated, representing the steps in an exemplary procedure for implanting a vascular access port 10 and a catheter 15 into a subject's SUB via a single surgical opening across the patient's skin in the subject's armpit (axillary region). The exemplary sequence of implantation first shows the steps associated with forming the access portion to the subject's vascular system, followed by steps associated with implanting the port 10 into a subcutaneous space within the subject's SUB, and then further steps associated with cannulating the catheter by positioning the first end of the catheter 15 into the vascular system. However, any different sequence may be performed according to the procedure of some embodiments, such as implanting the port 10 first and then forming the access portion and implanting the first end 17 of the catheter, implanting the port 10 after cannulation, or implanting both at least partially in parallel.

[0089] Figure 4A and Figure 4B Partial medial and anterior views of the upper torso of the subject SUB are shown, respectively. A surgical incision (optionally via an incision INS) is formed across the skin layer of the subject SUB in or near the axillary region (optionally adjacent to the anterior axillary line) where the right or left arm connects to the corresponding shoulder of the subject SUB. The access point to the axillary vein AXV of the subject SUB, which is formed by penetrating the body through the incision INS, is optionally below (below) and / or laterally and / or posteriorly to the pectoralis minor muscle. Figure 4C As shown, the access needle 40 can then be introduced into the axillary vein AXV through an incision INS, optionally in its lower (peripheral) portion, as shown. In some embodiments, the access needle 40 is optionally applied with its tip to puncture and / or penetrate the skin before (e.g., using a scalpel) making an incision INS through or adjacent to it, thereby optionally forming a surgical opening or a portion thereof. The guide wire 41 can then be inserted through the lumen of the access needle 40 into the subject's vascular system via the axillary vein AXV. Figure 4D And then the access pin 40 can be removed. Figure 4E ), leaving a guidewire 41 extending into the axillary vein AXV.

[0090] like Figure 4F As shown, optionally in front of the pectoralis major muscle of the subject's SUB, a subcutaneous space and / or pathway SCV can be formed via an incision INS using a sharp and / or blunt surgical instrument, optionally with a medical clamp 42 (e.g., which may be similar to or the same as medical clamp 32). The subcutaneous space and / or pathway SCV extends from the incision INS to the target implantation site IMS, which is optionally located in the upper chest region and / or below the clavicle, optionally in front of the pectoralis minor and pectoralis major muscles (e.g., as shown in the image). Figure 4Aand / or optionally to a third rib and the clavicle, optionally adjacent to the top portion of the second rib. In some embodiments, the void and / or passageway SCV is formed across or over the pectoralis major muscle, and it can be performed subcutaneously over or in front of the pectoralis major muscle (through or immediately under the overlying skin layer), but it can be performed at least partially through or under (behind) the pectoralis major muscle. The port 10 can then be clamped with the medical clamp 42 for aiding in its implantation. In cases where the incision INS has not been made, the practitioner can make the incision shortly before implanting the port, or increase the size of the incision INS, for example, with a scalpel or with the port 10 itself.

[0091] As Figure 4G As shown in FIG. 1 1, the port 10 can be pushed via the incision INS to the subcutaneous void and / or passageway SCV using the medical clamp 42 clamped to it, and implanted in the target implant site IMS. In some embodiments, the order of presentation can be reversed, and the port 10 is implanted at the implant site IMS before the access needle 40 and / or the guidewire 41 are introduced into the body of the subject SUB. In some embodiments, as shown, the second end 18 of the catheter 15 is already (fixedly or releasably) connected to the port 10, however it can be provided disconnected, and can be connected before or after clamping the port 10 with the medical clamp 42, before or during delivery through the incision INS. After implanting the port 10 at the target implant site IMS, the first end 17 of the catheter 15 is optionally located outside the body of the subject SUB, however in some other embodiments, the first end 17 of the catheter 15 can be disposed within the axillary vein AXV prior to implanting the port 10.

[0092] As Figure 4H As shown in FIG. 12, once the correct position of the port 10 is verified, the medical clamp 42 can be released (unclamped) from the port 10, and withdrawn from the subcutaneous void and / or passageway SCV. Prior to or after implanting the port 10, the peel-away sheath 43 can be inserted into the axillary vein AXV over the guidewire 41. The guidewire 41 can then be removed from the vasculature of the subject, leaving the peel-away sheath 43 in place Figure 4I ). In cases where the peel-away sheath 43 is introduced with a dilator extending along its lumen, the dilator can also be withdrawn from within the peel-away sheath 43. As Figure 4J and Figure 4KThe sheath 43 is peeled back in sequence, once the lumen of the sheath 43 is unobstructed, the first end 17 of the catheter 15 is passed through its introduction into the axillary vein AXV and optionally positioned in the superior vena cava SVC or the right atrium RA. Prior to insertion, the catheter 15 can optionally be cut to a selected length based on a measurement of the path length from the implant site IMS to the selected positioning of the first catheter end 17 in the patient's vasculature. The final positioning of the catheter first tip 17 and / or the port 10 can be applied by pushing or pulling the port 10 in the subcutaneous void and / or passageway SCV. After verifying that the port 10 and / or catheter 15 are in proper position and function, optionally under imaging, the peel-away sheath 43 is broken open and removed from the subject SUB's body and the incision INS is closed (e.g., by suturing or bonding means).

[0093] Figures 5A-5D Different views of an exemplary squeezable subcutaneous port 100 are shown in an assembled isometric view Figure 5A , in an exploded isometric view Figure 5B , in a lateral cross-sectional view Figure 5C , and in an anterior cross-sectional view Figure 5D . The port 100 is optionally an exemplary configuration of the port 10, and can include some or all of the structural and / or functional features described with respect to the port 10. The port 100 (optionally, particularly when at least partially in an elastically relaxed state) can have a maximum width of 50 mm or less, optionally 25 mm or less; a maximum height of 30 mm or less, optionally 15 mm or less; and a maximum length of 50 mm or less, optionally 30 mm or less (with or without a catheter connection means). In some embodiments, the port 100 is configured to reshape and / or deform to a narrower cross-section for squeezing through a surgical opening (without further widening or tearing upon passage therethrough) having a maximum opening circumference of about 80 mm or less, optionally about 60 mm or less, optionally about 40 mm or less, and / or formed by a surgical incision of about 20 mm or less, optionally about 15 mm or less, or optionally about 10 mm or less.

[0094] The port 100 includes a rigid inner component 101 including a lumen 102 opening to a first lumen opening 103 and a second lumen opening 105. The first lumen opening 103 is closed by a septum component 104 and configured for repeated needle penetration therethrough into the lumen 102. The second lumen opening 105 is configured to facilitate fluid communication between the lumen 102 and a lumen of a catheter. The inner component 101 is configured with sufficient rigidity to accommodate (safely and effectively) a selected length of a needle, and prevent penetration of a needle tip therethrough. As shown, the septum component 104 is optionally oval, but it can have any other shape.

[0095] The cap component 106 is coupled above the diaphragm component 104 and the upper portion of the inner component 101 to form a core of integral rigid encapsulation of port 100. The diaphragm component 104 is restrained in place and optionally compressed, at least partially, by and between the cap component 106 and the inner component 101. The inner component 101 and / or the cap component 106 are optionally formed of a hard plastic such as PEEK or a metal such as a titanium or stainless steel alloy. The cap component 106 is optionally fixedly attached to the inner component 101, such as by adhesives, compression fitting, and / or welding (e.g., ultrasonic welding if the part is made of plastic, or laser welding if the part is made of metal). Once fully assembled, the encapsulated core has sufficient rigidity and yield strength and is configured to retain the internal pressures typical during injection into cavity 102 (optionally at an injection rate of about 5 ml / sec at 300 psi, or higher or lower). The lumen extension 107 is coupled to the inner component 101, wherein its distal portion extends toward the lumen 102 through the second lumen opening 105 and is configured to provide a liquid-tight passage through its proximal portion to the catheter lumen. A connector component 108 is coupled above the lumen extension 107 and is configured to facilitate selective connection of the distal end of the catheter to the port 100, such as using a Luer-fit-based connection mechanism.

[0096] like Figure 5E and Figure 5F As shown, port 100 includes a port gripping portion 117 (optionally similar to or identical to port gripping portion 21 in structure, function, and / or size) located at its proximal end and configured to facilitate efficient and safe gripping of port 100 using a gripping device such as a medical clamp. As shown, port gripping portion 117 may be configured as a proximal extension of cap member 106 and located above (above) lumen extension 107 and connector member 108 (e.g., closer to first lumen opening 103). Figure 5E A port 100 is shown gripped at a port gripping portion 117 using an exemplary medical clamp 119 (e.g., configured as a surgical needle holder). The port gripping portion 117 includes a wall 120 having a relatively flat outer wall surface extending horizontally, such that the medical clamp 119 can be gripped by a physician with the arms of the clamp arranged vertically (overlapping). Alternatively, the wall 120 may be arranged with a flat surface in any other direction (including optionally vertically). The wall 120 may be configured in terms of size, surface area of ​​its flat surface, thickness, and / or durability and / or strength to facilitate a firm grip by the medical clamp 119 sufficient to push, squeeze, and manipulate the port 100 through a surgical opening smaller than its maximum slack size without releasing the grip or causing mechanical failure. The medical clamp 119 may be used to form or increase the size of the subcutaneous cavity or passage before gripping the port 100 and delivering it into the subcutaneous space.

[0097] The port gripping portion 117 optionally includes a securing structure configured to prevent lateral and / or rotational movement of the medical clamp 119 on and relative to the wall when the medical clamp is engaged with and secured to the wall 120. As shown in FIG. 12, the port gripping portion 117 includes a recessed compartment 121 configured to accommodate the lower head component 122 of the medical clamp 119, wherein the upper surface of the recessed compartment 121 is also the lower (inferior) wall surface of the wall 120. The port gripping portion 117 also includes laterally opposing boundary walls 123 extending from the upper (superior) outer wall surface of the wall 120 and configured to accommodate the superior head component 124 of the medical clamp 119. The opposing boundary walls 123 can be laterally spaced apart from one another so as to snugly fit against the superior head component 124 and / or its clamping surface. Figure 5F

[0098] Figures 6A-6B Exemplary alternative configurations of the securing structure of the port gripping portion 117 are schematically shown in front cross-sectional views before and after clamping with an exemplary medical clamp having opposing head components 127, each including a protrusion or tooth 126. As shown, each of the upper and lower surfaces of the wall 120 includes a plurality of recesses 128 between the two boundary walls 123. The recesses 128 are sized and shaped to snugly fit and accommodate the protrusions 126. This can reduce or prevent lateral movement of the medical clamp 125. The recesses 128 can be non-circular (e.g., star-shaped or cross-shaped) to prevent rotational movement of the medical clamp 125 relative to and on the wall 120.

[0099] In some embodiments, the port gripping portion 117 includes a securing structure or mechanism configured to initiate lateral compression and / or locking of the medical clamp by it when the medical clamp is engaged with and secured to the port gripping portion 117. Figures 7A-7B Further exemplary configurations of the securing structure of the port gripping portion 117 are schematically shown in front cross-sectional views before and after clamping with the medical clamp 119. In this configuration, as shown, the wall 120 is covered on each of its outer surfaces with a pad component 129 that is flexible and configured to compress into a volumetric shape that matches the clamping surfaces of the head components 122 and 124, while increasing in rigidity (optionally by remaining or decreasing in volume) and / or forming boundary wall portions 130 around the head components 122 and 124. The port gripping portion 117 is configured such that the pad component 129 forms a shape and rigidity sufficient to prevent lateral and / or rotational movement of the medical clamp 119 on and relative to the wall 120 when the medical clamp is engaged with and secured to the wall and optionally with its arms locked to one another. ​

[0100] Figures 8A-8B An example configuration of a securing mechanism of the port gripping portion 117 is schematically illustrated in front cross-sectional view, both prior to and after clamping with the medical clamp 119. In this configuration, a lower compartment 131 of the port gripping portion 117 (under the lower / under surface of the wall 120) is shaped and / or configured differently than an upper compartment 132 of the port gripping portion 117 (over the upper / over surface of the wall 120) such that when the head components 122 and 124 of the medical clamp 119 are pressed against the wall 120, the securing mechanism is activated to laterally compress and / or lock at least one of the lower compartment 131 and the upper compartment 132. As shown in this example, when the lower head component 122 engages and is received in the lower compartment 131, it forces a lower boundary wall 133 extending downwardly from the wall 120 to shift laterally outward. The lower boundary wall 133 then pivots as an arm about a portion coincident with the wall 120 and forces an upper boundary wall 134 extending upwardly from the wall 120 and acting as an arm extension of the lower boundary wall 133 to shift laterally inward against the upper head component 124. When activated to act as described, the upper boundary wall 134 is configured to compress laterally and / or downwardly against the upper head component 124 under normal clamping force or pressure applied by the medical clamp 119 sufficient to prevent lateral and / or rotational movement of the medical clamp 119 on and relative to the wall 120 when the medical clamp is engaged with and secured to the wall 120 and optionally with its arms locked to one another. In some embodiments, a pad component 135 is also provided in the lower compartment 131 and / or the upper compartment 132 for affecting more uniform engagement and pressure transfer between the head components 122 and 124 and the lower compartment 131 and / or the upper compartment 132.

[0101] In some embodiments, the inner component 101 can be functionally configured or can be adapted for use as a vascular access port, although it can not be capable, sufficient, or well compatible to provide one or more (optionally essential) features to improve, facilitate, or ease implantation and / or long-term use of the port 100. The port 100 includes a flexible outer component 110 that provides a final spatial shape and size, at least when it is in an elastically relaxed state, for providing one or more additional features including, but not limited to, stability and / or fixation in an implantation site, percutaneous accessability, identification and / or positioning of the septum component 104 for repeated percutaneous fluid infusion, protection of the port body and / or overlying skin layers, or others.

[0102] The outer component 110 is connected to the inner component 101 along at least one lateral peripheral portion thereof, thereby forming a selected predetermined spatial shape of the subcutaneous port when in an elastically relaxed state. Optionally, the outer component is configured as a skirt or ring-like element that encompasses at least a substantial portion or the entire periphery of the inner component 101, and optionally also the periphery of the cover component 106, at least in its circumferential segment. In order to maintain sufficient rigid pushability of the port 100 for its insertion and implantation, the rigid inner component 101 extends longitudinally along a substantial portion or the entire length of the port 100, to also act as a rigid spine-like structure of the port 100, optionally in combination with the cover component 106. The inner component 101 includes a distal (front) portion 113 extending distally relative to the cavity 102, having a rounded or sharp front edge 116 configured to facilitate or ease penetration of the port 100 via a surgical opening. The port 100 can be configured such that the distal portion 113 is not covered by the outer component 20, which can extend distally and laterally therefrom, but (as shown) it can be covered with a thin layer of the outer component 110, such that sufficient rigid pushability is not substantially impaired. The outer component 110 is optionally made of silicone or other flexible and elastic polymer or rubber, and when forming the subcutaneous port 100, it is optionally extruded, cast or molded over the periphery of the inner component 101 or over the periphery of the encapsulated core (i.e. the structure formed by the interconnected inner component 101, septum component 104 and cover component 106), optionally within the boundaries of a selected forming mold.

[0103] Figures 9A-9BA perspective view of another exemplary vascular access port 200 is shown, which includes a port body 201 and at least one port body extension 204 that is movably constrained along at least one defined route 205 on the port body 201. The at least one port body extension 204 includes a first arm 208 positioned to the right of a central plane of the port body 201 and a second arm 209 positioned to the left of the central plane. When changing from a delivery configuration to a deployed configuration, the port body extension 204, and in particular the first arm 208 and the second arm 209, are each rotatably and slidably connected to the port body 201 and configured to rotate about an axis of rotation and slide along the route 205 on at least one of two opposite sides of the port body 201. The port body 201 has a lower portion 210 and a rear portion 211, the rear portion 211 being connected to the septum member 202, and the lower portion 210 surrounding a lumen 203 defined by the port body 201 and positioned underneath and covered by the septum member 202. The lower portion further includes a first side surface spanning a majority or all of the right side of the lower portion 210 and a second side surface spanning a majority or all of the left side of the lower portion 210. A rear end 214 of the port body 201 is coupled to a catheter connector 215 configured for connection to a proximal end of a catheter (e.g., catheter 15) for facilitating fluid communication between the lumen 203 and a lumen of the catheter.

[0104] By moving the first arm 208 and the second arm 209 along the first route and the second route, respectively, of the routes 205, the vascular access port 200 is selectively changeable from a delivery configuration (as shown in Figure 9A to a deployed configuration (as shown in Figure 9B When in the delivery configuration, the front portion 207 of each port body extension 204 is positioned axially distal of the port body 201. When changed to the deployed configuration, the port body extension 204 and the port body 201 approach along a central plane of the port body 201, while the laterally opposing portions 206 of the port body extension 204 are laterally separated from the central plane, thereby reducing an aspect ratio of the switching vascular access port 200. When in the deployed configuration, the port body extension 204 is fixedly and releasably connected to the port body 201, thus allowing selective return from the deployed configuration to the delivery configuration. Further, the rear end 214 of the port body 201 remains uncovered by the port body extension 204 after changing to the deployed configuration, for example, to avoid engagement with the catheter connector 215 and / or a catheter connected thereto.

[0105] Port grasping portion 216 (which can optionally be similar or identical to port grasping portion 21 in structure, function, and / or size) is located on the rear end 214 of port body 201 above catheter connector 215 for allowing a user to selectively subcutaneously and in a target implantation site move and / or manipulate port 200 while avoiding engagement with, for example, catheter connector 215 and / or a catheter connected thereto. A user can utilize medical forceps to grip port grasping portion 216 and, while in a delivery configuration, utilize the forceps to push switching vascular access port 200 to a target implantation site. Once in the target implantation site, port 200 can be changed to a deployed configuration by pushing port body 201 distally relative to port body extension 204 and / or pulling port body extension 204, such as using pulling member 219 connected to first arm 208 and second arm 209, while using the forceps to resist movement of port body 201.

[0106] As shown in FIGS. 1-3, port grasping portion 216 includes a thin wall portion 217 comprising opposing side surfaces extending parallel to a central plane from two sides thereof, wall portion 217 configured for gripping and / or clamping by medical forceps including, but not limited to, a needle holder or Kelly forceps 230. In some embodiments, wall portion 217 is about 0.5 mm to 3 mm (optionally particularly about 1 mm to 2 mm) thick and / or about 2 mm to 5 mm (optionally particularly about 3 mm to 4 mm) wide for allowing sufficient clamping contact area and sufficient clamping, gripping, or locking force from both sides of wall portion 217 using medical forceps. Figure 10A Figure 10B Wall portion 217 can be configured to form a septum-separate cavity 218 in rear end 214 from both sides thereof. Cavity 218 is shaped and sized to accommodate a pair of tips of medical forceps and allow the pair of tips to perform a closing motion therein toward wall portion and utilize the pair of tips to grip wall portion 217 from both sides thereof.

[0107] Wall portion 217 can be configured to form a septum-separate cavity 218 in rear end 214 from both sides thereof. Cavity 218 is shaped and sized to accommodate a pair of tips of medical forceps and allow the pair of tips to perform a closing motion therein toward wall portion and utilize the pair of tips to grip wall portion 217 from both sides thereof. Figure 11 An alternative exemplary configuration of port grasping portion 216 is shown having a thin wall portion 217' similar to wall portion 217 but not defined by a cavity, but rather allowing greater space for forceps tip operability.

[0108] ​Each of the following terms as used herein is written in singular grammatical form: As used herein, "a," "an," and "the" mean "at least one" or "one or more." The use of the phrase "one or more" herein does not alter the intended meaning of "a," "an," or "the." Thus, as used herein, the terms "a," "an," and "the" can also refer to and encompass a plurality of the referenced entity or object, unless the context explicitly dictates otherwise or unless the context implicitly dictates otherwise. For example, the phrases: "a unit," "a device," "a component," "a mechanism," "a means," "an element," and "steps or procedures" can also refer to and encompass a plurality of units, a plurality of devices, a plurality of components, a plurality of mechanisms, a plurality of means, a plurality of elements, and a plurality of steps or procedures, respectively.

[0109] Each of the following terms: "comprise," "have," and variants of the verb "to comprise," "to have," and / or their tenses and conjugations, mean "including but not limited to," and are taken in their broadest possible way to mean that a stated

[0110] The term "method" as used herein refers to a step, procedure, way, means, and / or technique for accomplishing a given task, including but not limited to those steps, procedures, ways, means, and / or techniques known or readily developed from known steps, procedures, ways, means, and / or techniques by those of ordinary skill in the relevant art(s) of the disclosed invention.

[0111] In the present disclosure, numerical values of parameters, characteristics, features, objects, or dimensions can be stated or described in numerical range format. Such numerical range format as used herein illustrates implementation of some example embodiments of the present invention and does not rigidly limit the scope of example embodiments of the present invention. Thus, a stated or described numerical range also refers to and encompasses all possible sub-ranges and individual numerical values within the stated or described numerical range, where numerical values can be expressed as whole, integer, or fractional numbers. For example, a stated or described numerical range of "from 1 to 6" also refers to and encompasses all possible sub-ranges within the stated or described numerical range of "from 1 to 6," such as "from 1 to 3," "from 1 to 4," "from 1 to 5," "from 2 to 4," "from 2 to 6," "from 3 to 6," and the like, as well as individual numerical values, such as "1," "1.3," "2," "2.8," "3," "3.5," "4," "4.6," "5," "5.2," and "6." This applies regardless of the numerical breadth, extent, or size of the stated or described numerical range.

[0112] Further, to designate or describe a numerical range, the phrase "in a range between about a first number and about a second number" is considered to be equivalent to the phrase "in a range from about a first number to about a second number," and means the same, and thus the two equivalent phrases can be used interchangeably. For example, to designate or describe a numerical range for room temperature, the phrase "room temperature refers to a temperature in a range between about 20 °C and about 25 °C" is considered to be equivalent to the phrase "room temperature refers to a temperature in a range from about 20 °C to about 25 °C," and means the same.

[0113] As used herein, the term "about" refers to ± 10% of the recited value.

[0114] It will be fully appreciated that certain aspects, features and techniques of the present application, which are exemplary described and presented in the context of a single embodiment, also are exemplary described and presented in the context or format of any suitable combination or sub-combination of the single embodiments. Conversely, various aspects, features and techniques of the present application, which are exemplary described and presented in the context or format of a combination or sub-combination of the single embodiments, also can be exemplary described and presented in the context or format of multiple separate embodiments.

[0115] While the present application has been exemplary described and presented by means of specific exemplary embodiments and examples thereof, it is apparent that many alternatives, modifications and / or variations of the same will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and / or variations that fall within the spirit and scope of the appended claims and are included therein.

[0116] All publications, patents and / or patent applications mentioned in this disclosure are herein incorporated by reference in their entirety as if each individual publication, patent and / or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, any citation or identification of any reference in this specification should not be construed as an admission that such reference represents or corresponds to prior art of the present application. To the extent that section headings are used, they should not be construed as necessarily limiting.

[0117] The methods disclosed herein comprise one or more steps or actions for accomplishing the methods. The method steps and / or actions can be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions can be modified without departing from the scope of the claims.

Claims

1. A subcutaneous port comprising: a port body enclosing a cavity, wherein the cavity includes a first opening configured for repeated needle penetration therethrough and a second opening configured to facilitate fluid communication between the cavity and a catheter; wherein the port body includes a rigid port body component surrounding the cavity and defining the first opening, the rigid port body component including an anterior portion, a posterior portion, and a lateral portion extending from opposite sides thereof between the anterior and posterior portions, wherein the port body includes a rigid port grip portion including a wall located on the posterior portion of the port body, wherein the wall includes closely spaced apart, opposing first and second outer wall surfaces configured to be gripped between linearly extending distal tips of medical forceps, and wherein the anterior portion of the port body is configured to be pushed from the posterior portion of the port body into a subcutaneous target implantation site using the medical forceps when the distal tips of the medical forceps are engaged with the port grip portion; wherein the port grip portion is configured to receive manual force from the medical forceps in at least one axis to releasably secure the distal tips of the medical forceps to the port grip portion.

2. The subcutaneous port of claim 1, wherein, the port body includes a flexible outer component that is capable of being locally compressed against the rigid port body component when pushed through a skin opening.

3. The subcutaneous port of claim 1, wherein, the manual force received at the port grip portion is sufficient to form or enlarge a subcutaneous access within a body of a subject using the subcutaneous port and / or to manipulate the subcutaneous port along the subcutaneous access without slipping or releasing the grip of the port grip portion from the port grip portion.

4. The subcutaneous port of any of the preceding claims, wherein, the second opening is juxtaposed with and / or located below the port grip portion further from the first opening than the port grip portion.

5. The subcutaneous port of any of the preceding claims, wherein, the port grip portion is configured such that the manual force is equal to or less than 98.1 N when clamping surfaces of the medical forceps are oriented and spaced apart from each other to match a shape and thickness of the wall.

6. The subcutaneous port of any of the preceding claims, wherein, the port grip portion is configured such that manually operable arms of the medical forceps are allowed to interlock when the distal tips of the medical forceps are oriented and spaced apart relative to each other to match the shape and thickness of the wall.

7. The subcutaneous port of any one of claims 1 to 6, wherein, each of the outer wall surfaces extends vertically between the lateral portions of the port body.

8. The subcutaneous port of any one of claims 1-7, wherein, each of the outer wall surfaces extends horizontally between a bottom portion and a top portion of the port body.

9. The subcutaneous port of any of the preceding claims, wherein, an average or maximum thickness of the wall is 1 mm to 4 mm and / or an angle formed between the first and second outer wall surfaces is equal to or less than 20°.

10. The subcutaneous port of any of the preceding claims, wherein, the port grip portion includes a securing structure configured to prevent movement of the medical forceps on and relative to the port grip portion when the distal tips of the medical forceps are engaged with and secured to the port grip portion.

11. The subcutaneous port of claim 10, wherein, The securing structure includes laterally opposing boundary walls extending from at least one of the first outer wall surface and the second outer wall surface, wherein the opposing boundary walls are laterally spaced apart from one another so as to snugly fit one of the distal tips of the medical forceps.

12. The subcutaneous port of claim 10 or 11, wherein, The securing structure is configured to initiate lateral compression and locking of the medical forceps thereto when the medical forceps are engaged with and secured to the port grip portion.

13. The subcutaneous port of any of the preceding claims, wherein, The port body is configured to be inserted via a surgical opening in the subject's arm near the axillary region of the respective shoulder.

14. The subcutaneous port of claim 13, wherein, The subcutaneous access is extendable superiorly and anteriorly over the subject's pectoralis major muscle.

15. The subcutaneous port of claim 13 or 14, wherein, The port body is configured to be implanted at a target implantation site located inferior to the subject's clavicle or anterior to the pectoralis major muscle via the subcutaneous access.

16. A surgical kit comprising: a subcutaneous port according to any one of the preceding claims; and a catheter; wherein a first end of the catheter is configured to be inserted into the subject's vasculature via a surgical opening and a second end of the catheter is connected or connectable to the subcutaneous port to form fluid communication between a lumen of the catheter and a cavity of the subcutaneous port.

17. The surgical kit of claim 16, wherein, The first end of the catheter is configured to be inserted into the vasculature via a lower portion of the subject's axillary vein inferiorly and / or laterally thereto.

18. The surgical kit of claim 16 or 17, further comprising a peel-away sheath configured to be inserted into the axillary vein over a wire and for insertion of the first end of the catheter into the axillary vein through the peel-away sheath after removal of the wire therefrom.

19. The surgical kit of claim 18, further comprising a dilator configured to be inserted into the axillary vein while in a peel-away sheath, wherein, The first end of the catheter is configured for insertion through the peel-away sheath after removal of the dilator therefrom.

20. The surgical kit of any one of claims 16 to 19, further comprising a medical forceps configured to releasably engage with the port grip portion.

21. A kit for creating a repeatable therapeutically accessible access to a subject, comprising: a subcutaneous port according to any one of claims 1 to 15; a medical forceps comprising manually operable, pivotally connected and interlockable arms having linearly extending distal tips; wherein the port body comprises a port grip portion configured to releasably engage with the distal tips of the medical forceps, and wherein the port body is configured to use the medical forceps to push into a subcutaneous target implantation site when the medical forceps are engaged with the port grip portion, and wherein the port grip portion comprises a wall, wherein the wall comprises first and second outer surfaces sized to (1) accommodate the distal tips of the pivotally connected arms and (2) allow interlocking of the pivotally connected arms when the distal tips of the medical forceps are engaged with the wall.

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