Subcutaneous ports for minimally invasive implantation

Abstract

A port and kit for minimally invasive implantation in a subject's body are disclosed. The rear of the port includes a port gripper configured for clamping by the clamping head of a medical clamp. The port is pushed through a subcutaneous opening and a subcutaneous void and / or passage to a target implantation site using the medical clamp, and the medical clamp can be released from the port gripper and removed from the subcutaneous void and / or passage. The port body can be configured to create, dilate, and / or be inserted into a subcutaneous void and / or passage through a surgical opening in or near the axillary region of a subject.

Description

[Technical field]

[0001] Related Applications This application claims priority to PCT Application No. PCT / US20 / 41140, filed July 8, 2020, U.S. Provisional 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 by reference herein. As a result, the entire disclosures of all related applications identified in this section are incorporated by reference in their entirety. [Background technology]

[0002] The present disclosure relates to devices and methods for facilitating and / or improving repeated delivery of fluids (e.g., fluids carrying medicinal agents such as nutrients, drugs, and / or chemotherapeutic agents) to the vascular system of a subject, and particularly, but not exclusively, to vascular access ports and methods of minimally invasive delivery and methods of deployment thereof in the body of a subject.

[0003] Repeated needle sticks to facilitate the delivery or withdrawal of fluids (e.g., drugs or medications) into a patient's vascular system can result in local tissue damage and reduced vascular function and needle placement accuracy in subjects, a phenomenon that is particularly evident in, for example, chronic diabetes, dialysis, or chemotherapy patients who require continuous and repeated intravenous fluid administration over long periods of time.

[0004] A vascular access port is a device that allows for such repeated needlesticks and fluid administration while minimizing the cumulative damage caused by needlesticks and dynamic injection of fluids. The access port is implanted subcutaneously in a surgically created pocket near a large blood vessel, usually in the chest. It basically consists of a port body containing a cavity covered with a septum member configured to support the upper skin layer and to accept repeated needlesticks, through which sealed intravascular fluid delivery to the surrounding body tissues occurs. 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 that injected fluids are diluted in the bloodstream.

[0005] Implantation of a port is considered a minor procedure performed under local or general anesthesia by an interventional radiologist or surgeon. First, the surgeon achieves access to the desired vein, and a skin incision is made at the access point after the fact. Second, a larger incision is made above the desired location of the port, through which a pocket-like subcutaneous space is created using a blunt device. A catheter is stretched subcutaneously between the two incisions using a blunt tunneler. Then, one end of the catheter is inserted into the vein, and the other end is coupled to the port. Optionally, during deployment, the catheter is cut to the desired length.

[0006] Although recent advances have been made in access port design, there remains a need to develop ports and methods for implanting and deploying them that are less traumatic and invasive, and hopefully easier to perform by non-surgical medical personnel.

[0007] Please note that this background description is not intended to aid in determining the scope of the claimed subject matter, and is not intended to construe the claimed subject matter as limited to implementations that solve any or all of the shortcomings or problems presented above. Discussion of any technology, document, or reference in this Background section should not be construed as an admission that the described subject matter is prior art to any of the inventive subject matter claimed in the present invention. Summary of the Invention

[0008] The present disclosure relates to devices and methods for facilitating and / or improving repeated delivery of fluids (e.g., fluids carrying medicinal agents such as nutrients, drugs, and / or chemotherapeutic agents) to the vascular system of a subject, and particularly, but not exclusively, to vascular access ports and methods of minimally invasive delivery and methods of deployment thereof in the body of a subject.

[0009] In some embodiments, a subcutaneous port is provided. The subcutaneous port may include a port body containing a cavity, where the cavity includes a first opening covered by a septum configured for repeated needle penetrations 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 gripper configured to releasably engage a medical clamp, where the port body is configured to be pushed into a subcutaneous target implantation site using the medical clamp when the medical clamp is engaged with the port gripper. In some embodiments, the port gripper is configured to receive manual force and / or torque from the medical clamp in at least one axial direction, where the manual force and / or torque received by the port gripper is sufficient to releasably attach the medical clamp to the port gripper.

[0010] In some embodiments, the port body includes a rigid port body member surrounding the cavity and / or defining a first cavity opening, the rigid port body member including a front portion, a rear portion, and sides extending from opposing sides thereof between the front and rear portions, where the rear portion includes a port gripper.

[0011] In some embodiments, the manual force and / or torque received by the port gripper is sufficient to use the subcutaneous port to create or enlarge a subcutaneous gap and / or passageway in the subject's body and / or to move the subcutaneous port along the subcutaneous gap and / or passageway without slipping off the port gripper or releasing the port gripper.

[0012] In some embodiments, the second cavity opening is adjacent to the port gripper and / or is located below the port gripper and distal from the first cavity opening.

[0013] In some embodiments, the port gripping portion includes a wall, where the wall includes opposing first and second outer wall surfaces dimensioned to match a clamping surface of a medical clamp.

[0014] In some embodiments, the port grippers are configured to exert a force of less than 10 kgf and / or a hand torque of about 0.25 N when the gripping surfaces of the medical clamp are oriented and spaced apart to substantially conform to the shape and thickness of the wall. * m or less.

[0015] In some embodiments, the port gripping portion is configured to allow the manual arms of the medical clamp to interlock when the clamping surfaces of the medical clamp are oriented and spaced apart to conform to the shape and thickness of the wall.

[0016] In some embodiments, the first and second wall exterior surfaces are parallel.

[0017] In some embodiments, the port gripper includes a clamp engagement feature.

[0018] In some embodiments, the clamp engagement features include one or more of a tapered surface, a roughened surface, a knurled surface, teeth, depressions, and through holes.

[0019] In some embodiments, the clamp engagement feature is formed in a wall including the first and second outer surfaces.

[0020] In some embodiments, each of the wall exterior surfaces extends vertically between the sides of the port body.

[0021] In some embodiments, each of the wall exterior surfaces extends horizontally between the lower and upper portions of the port body.

[0022] In some embodiments, the average or maximum thickness of the wall is between about 1 mm and 4 mm, and / or the angle between the first and second wall outer surfaces is less than or equal to about 20°.

[0023] In some embodiments, the second cavity opening is adjacent to and / or located below the port gripper.

[0024] In some embodiments, the port body includes multiple components coupled together, where the port gripper is associated with a first of the multiple coupled components.

[0025] In some embodiments, the septum is associated with a second of the coupled plurality of components that is different from a first of the coupled plurality of components.

[0026] In some embodiments, the second cavity opening is associated with a third one of the plurality of coupled components that is different from either the first or second one of the plurality of coupled components.

[0027] In some embodiments, the port gripper includes a locking structure or mechanism configured to prevent lateral movement of the medical clamp on the port gripper and / or rotational movement relative to the port gripper when the medical clamp is engaged and attached to the port gripper.

[0028] In some embodiments, the securing structure or mechanism includes laterally opposed boundary walls extending from at least one of the first and second wall outer surfaces, where the opposed boundary walls are laterally spaced relative to one another to snugly mate with one of the clamping surfaces of the medical clamp.

[0029] In some embodiments, the locking structure or mechanism is configured to generate lateral compression and / or locking of the medical clamp to the portion when the medical clamp is engaged and attached to the port gripper.

[0030] In some embodiments, the port body is configured to create, expand, and / or be inserted into a subcutaneous space and / or passageway via a surgical opening in or near the axillary region where the subject's arm joins the respective shoulder.

[0031] In some embodiments, the subcutaneous space and / or passageway is extendable anteriorly across the subject's pectoralis major muscle.

[0032] In some embodiments, the port body is configured to be implanted through a subcutaneous space and / or passageway at a target implantation site located inferiorly relative to the subject's clavicle and / or anteriorly relative to the pectoralis major muscle.

[0033] In certain embodiments, a surgical kit is provided that may include a subcutaneous port and a catheter, where a first end of the catheter is configured to be inserted into a 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 the lumen of the catheter and a cavity of the subcutaneous port.

[0034] In some embodiments, the first end of the catheter is configured to be inserted into the vascular system via the lower portion of the subject's axillary vein, inferiorly and / or laterally toward the subject's pectoralis minor muscle.

[0035] In some embodiments, the surgical kit further includes a peel-apart sheath configured to be inserted over the wire into the axillary vein and configured for inserting a first end of the catheter through the peel-apart sheath and into the axillary vein after removing the wire from the axillary vein.

[0036] In some embodiments, the surgical kit further includes a dilator configured to be inserted into the axillary vein while in the peel-apart sheath, and wherein the first end of the catheter is configured to be inserted through the peel-apart sheath after removing the dilator from the peel-apart sheath.

[0037] In some embodiments, the surgical kit further includes a medical clamp configured to be releasably engageable with the port gripper.

[0038] In some embodiments, the medical clamp is configured as a medical forceps and / or is selected from a Kelly artery clamp, a surgical needle holder, and a locking forceps.

[0039] In certain embodiments, a method is provided that may include forming a surgical opening across a skin layer of a subject, creating a subcutaneous space and / or passageway below the skin layer through the surgical opening, clamping a port gripper of a subcutaneous port with a medical clamp, pushing the subcutaneous port through the subcutaneous opening and the subcutaneous space and / or passageway to a target implantation site with the medical clamp, releasing the medical clamp from the port gripper, and removing the medical clamp from the subcutaneous space and / or passageway.

[0040] In some embodiments, the method includes the step of creating or enlarging a subcutaneous space and / or passageway with said medical clamp prior to said clamping step.

[0041] In some embodiments, the port gripper includes a wall including opposing first and second wall outer surfaces, and wherein the clamping step includes interlocking a manually operable arm of a medical clamp to apply a continuous gripping force against the first and second wall surfaces of the port gripper.

[0042] In some embodiments, the method includes forming a subcutaneous opening in the subject's armpit.

[0043] In some embodiments, the method includes inserting a first end of a catheter into the vasculature of a subject through a surgical opening and coupling a second end of the catheter to a subcutaneous port to form fluid communication between a lumen of the catheter and a cavity of the subcutaneous port.

[0044] In some embodiments, the first end of the catheter is inserted into the vascular system via the subject's axillary or jugular vein.

[0045] In some embodiments, any access to the vasculature and / or across the subject's skin layer is achieved directly through the subcutaneous opening after the shaping step.

[0046] In some embodiments, the method includes at least one of the steps of accessing a vein of a subject with an access needle, inserting a wire into the vein through the access needle, removing the access needle from the vein, inserting a peel-apart sheath and / or a dilator over the wire into the vein, removing the wire and / or dilator from the vein, inserting a first end of a catheter through the peel-apart sheath and into the vein, and removing the peel-apart sheath from the vein.

[0047] In some embodiments, the vein is an axillary vein or a jugular vein.

[0048] In some embodiments, the medical clamp is configured as a medical forceps and / or is selected from a Kelly artery forceps, a surgical needle holder, and a locking forceps.

[0049] In certain embodiments, a kit for creating repeatable therapeutic access to a subject is provided. The kit may include a subcutaneous port, the subcutaneous port including a port body containing a cavity, the cavity including a first opening covered by a septum configured to pass repeated needle penetrations, 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 rigid port gripper configured to releasably engage with the medical clamp, the port body being configured to be pushed into a subcutaneous target implantation site using the medical clamp when the medical clamp is engaged with the port gripper.

[0050] In some embodiments, the medical clamp includes opposed pivotally connected clamping arms.

[0051] In some embodiments, the port gripper includes a wall, where the wall includes first and second outer surfaces dimensioned to accommodate distal portions of opposing pivotally connected clamping arms.

[0052] All technical or / and scientific words, terms, and phrases used herein have the same or similar meaning as commonly understood by those of ordinary skill in the art to which the invention pertains, unless otherwise defined or described herein. The exemplary embodiments of methods (steps, procedures), apparatus (devices, systems, components thereof), equipment, and materials illustratively described herein are exemplary and illustrative only and are not intended to be necessarily limiting. Although methods, apparatus, and materials equivalent or similar to those described herein can be used in practical or / and experimental embodiments of the invention, exemplary methods, apparatus, devices, and materials are illustratively described below. In case of conflict, the present patent specification, including definitions, will control. [Brief description of the drawings]

[0053] Various embodiments will now be discussed in detail in conjunction with the figures described below, with an emphasis on highlighting advantageous features. These embodiments are for illustrative purposes, and no proportions illustrated herein are intended to limit the scope of the disclosed technology. These drawings include the following figures, in which like numerals refer to like parts:

[0054] [Figure 1] 1A-1C show a plan view, a side cross-sectional view, and a plan cross-sectional view, respectively, of an exemplary deployed vascular access port, according to some embodiments. [Diagram 2] 2A-2C diagrammatically illustrate another exemplary variation of the port gripper of the exemplary subcutaneous port shown in FIG. 1A, according to some embodiments. [Diagram 3] 3A-3H illustrate schematic diagrams of exemplary scenarios depicting steps in an exemplary procedure for implanting the exemplary subcutaneous port shown in FIG. 1A, according to some embodiments. [Figure 4]4A-4K diagrammatically illustrate an exemplary scenario depicting steps of an exemplary procedure for implanting the exemplary subcutaneous port shown in FIG. 1A through a single opening formed in a subject's armpit, in accordance with some embodiments. [Figure 5A] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 5B] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 5C] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 5D] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 5E] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 5F] 5A-5F show various views of an exemplary subcutaneous port including a port gripper, according to some embodiments. [Figure 6] 6A and 6B are schematic illustrations of front cross-sectional views of a first exemplary port grasper before and after clamping with an exemplary medical forceps, according to some embodiments. [Figure 7] 7A and 7B are schematic illustrations of front cross-sectional views of a second exemplary port grasper before and after clamping with an exemplary medical forceps, according to some embodiments. [Figure 8] 8A and 8B are schematic illustrations of front cross-sectional views of a third exemplary port grasper before and after clamping with an exemplary medical forceps, according to some embodiments. [Figure 9A] 9A and 9B show axial views of another exemplary subcutaneous port comprising a port gripper, according to some embodiments. [Figure 9B] 9A and 9B show axial views of another exemplary subcutaneous port comprising a port gripper, according to some embodiments. [Figure 10A] 10A and 10B show plan and axial views, respectively, of the subcutaneous port of FIG. 9A being grasped with medical forceps, according to some embodiments. [Figure 10B] 10A and 10B show plan and axial views, respectively, of the subcutaneous port of FIG. 9A being grasped with medical forceps, according to some embodiments. [Figure 11] 1A-1C show axial views of an exemplary subcutaneous port including another exemplary configuration of the port gripper, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] The following description and examples will explain in detail some exemplary aspects, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that there are numerous variations and modifications of the invention that are encompassed by its scope. Therefore, the description of an embodiment should not be deemed to limit the scope of the invention.

[0056] 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 agents such as nutrients, drugs, and / or chemotherapeutic agents) to the vascular system of a subject, particularly, but not exclusively, to vascular access ports and methods of delivery and deployment thereof in a subject's body. In some embodiments, the vascular access ports of the present disclosure can improve the safety and / or efficacy of surgical implantation procedures of access ports and catheters by reducing the size or number of surgical procedures (such as cutting, dissection, and tunneling), their duration and / or complexity, and thereby resulting in a less traumatic experience and easier recovery for the patient.

[0057] As used herein, the term "vascular access port" refers to an implant intended for repeated delivery of fluids administered to and / or withdrawn from a subject. In this context, "repeated" may refer to more than 10 consecutive needle sticks, optionally more than 100 consecutive needle sticks, optionally more than 1,000 consecutive needle sticks, optionally more than 10,000 consecutive needle sticks, or more or less. In this context, "needle" may refer to a needle approved for delivery of fluids through a vascular access port, such as for intravenous administration.

[0058] The disclosures described herein are also advantageous when used with vascular access ports having a septum member configured for repeated puncture by a needle, although this particular feature is not required and other forms of needle access openings or platforms may be applied. Some vascular access ports described herein collectively include one or more components configured for long-term implantation in a living subject (e.g., a human) and for repeated fluid transfer access through a septum member or the like when properly assembled and deployed. The vascular access port includes at least a structure referred to herein as a "port body" that functions as a facilitating structure for fluid transfer access and / or as a support structure configured to hold a component applicable for fluid transfer access (e.g., a septum).

[0059] The port body may be structurally and / or functionally configured to facilitate at least the basic function of a vascular access port, the repeated, cumulative delivery of fluids to or withdrawal of fluids from a subject's vasculature. In some embodiments, the port body may be initially configured to optionally lack or not include one or more other features, optional or essential, to facilitate additional functions associated with delivery, deployment, and / or extended use of the vascular access port. The port body may be connected to at least one other component to provide additional features or capabilities to the vascular access port, such as, for example, improved or simplified deliverability, selective fixation to body tissue surrounding the port body, and / or enhanced stability at a selected implantation site, such as a preformed subcutaneous space.

[0060] In some embodiments, the port body forms a cavity below (e.g., below) the needle access opening and / or septum, said cavity being sized, shaped, and configured to repeatedly receive a needle tip, to accumulate a volume of a selected or predetermined fluid (e.g., a liquid such as a solution, suspension, or colloid), and / or for administration of a fluid to and / or withdrawal of a fluid from the vasculature of a living subject. In some embodiments, a vascular access port may include a single or several separate cavities, optionally covered by one or several separate septum members, provided as a single element, or several interconnectable members, some or all of which may be provided in the port body, or in several portions or members of a vascular access port, each configured as a separate port body.

[0061] A catheter having a distal end that physically enters the patient's vascular system may be attached to the vascular access port before or after implantation. Once connected, the lumen of the catheter is in direct fluid communication with the cavity of the port body. The vascular access port described herein, or a kit including the same, may or may not include such a catheter, and may or may not include a connector for connecting to such a catheter. The vascular access port may have additional components and functionality not related to the delivery or withdrawal of fluids. The vascular access port may be referred to herein simply as a "port" or an "implant." A "subcutaneous port" refers to a vascular access port, and optionally more generally, any other medical implantable port, specifically configured for implantation under the skin tissue, and accessible by means of a needle puncturing or penetrating therein, percutaneously, through the overlying skin tissue.

[0062] The vascular access port optionally includes a port gripper configured to facilitate effective continuous, optionally locked, clamping or grasping of the port using a medical clamp. The medical clamp includes a distal clamping head selectively operable with an elongate arm extending distally therefrom, and the clamping head selectively changeable between an open (non-clamping) configuration and a closed (clamping) configuration. In the closed configuration, two clamping surfaces of two opposing pivotally connected clamping head members forming the clamping head are pressed against each other from opposite sides of the port gripper. The medical clamp may optionally be provided to the user with the port as a kit, or may be a common clamping or grasping device typically used by physicians implanting subcutaneous ports, and may optionally be configured as a Kelly artery clamp, a surgical suture needle holder, a surgical grasper, a locking forceps, a hemostat, or the like, or other medical forceps.

[0063] Deployment of a vascular access port involves inserting at least the port body into a target implantation site in a subject's body so that an upper portion of the port body is available for repeated fluid transfer access. Insertion of the port (or port body) can be performed by using a medical clamp to first apply a port gripper to a continuous clamping position (and optionally lock in this clamping position) and then manually pushing and / or moving the port using the arms of the medical clamp.

[0064] The deployment of the vascular access port may include compressing the tissue mass surrounding the port body, thereby increasing the volume of the void formed between the periphery of the port body and the compressed tissue mass at the target implantation site. In some embodiments, the void and / or surgical passage from the incision on the subject's skin to the site is performed prior to clamping the port using the same medical clamp (e.g., Kelly forceps or needle holder). The void may be a subcutaneous void located between or below the skin tissue layers at the target implantation site. Concurrently with or immediately after increasing the void volume, the increased void volume is occupied by the vascular access port, such as by increasing the volume of the port body or by coupling one or more solid formed components (e.g., port body extensions). This also includes situations where the compression of the tissue mass may be a direct result of such an increase in the port body volume. The compressed tissue mass provides continuous pressure normal to the deployed vascular access port, thereby enhancing fixation and / or stability at the subcutaneous void. The port body may include a lower portion defining a cavity and an upper portion coupled to a septum member covering the cavity, and the vascular access port may be deployed such that the compressed tissue mass surrounds only the lower portion of the port body and not the upper portion.

[0065] 1A-1C diagrammatically illustrate an exemplary vascular access port (10) configured as a subcutaneous port before and after implantation in a subject (SUB) (e.g., a living human patient). Vascular access port (10), shown in plan view in FIG. 1A and in side cross-sectional view in FIG. 1B, includes a port body (11) defining a cavity (12) coupled with a septum member (13) that covers and seals cavity (12) from the environment. Septum member (13) is configured for repeated needle punctures, such as needle (14) shown in FIG. 1B, without compromising the seal of cavity (12) both during placement therethrough and after the needle has been withdrawn. The cavity (12) is optionally open to a first cavity opening covered by a septum member (13) and a second cavity opening configured to couple with a lumen of a catheter to facilitate fluid communication therebetween. In some embodiments, the second cavity opening is located at the rear of the port (10) adjacent to and / or below a port gripping portion (21) configured for gripping or clamping by a medical clamp.

[0066] The port (10) is subcutaneously implantable beneath a skin layer (SKL) (optionally including adipose tissue therein or below) through a single opening or incision (INS) in the subject (SUB) at a target implantation site (IMS). When fully deployed, the vascular access port (10) has a cavity (12) that is in fluid communication with the vascular system (VSC) of the subject (SUB), typically the subclavian vein or one of the vena cavae, such that fluid administered into the cavity (12) via a needle (14) immediately flows into the subject's vascular system. A catheter (15) with a catheter lumen (16) has a first catheter end (17) that is positioned in and opens to the vascular system (VSC) and a second catheter end (18) that is connected to the port body (11) and opens to the cavity (12), with the catheter ends (17) and (18) opening to the catheter lumen (16) to allow fluid communication between the cavity (12) and the vascular system (VSC). In some embodiments, both the port (10) and the catheter (15) are introduced and implanted in the subject (SUB) through a single opening or incision (INS). FIG. 1B shows an optional deployment scheme in which the port (10) is positioned in the upper chest portion of the subject adjacent to an access opening made to the jugular vein and the first catheter end (17) is positioned in the superior vena cava adjacent to the right atrium of the subject. The vascular access port (10) may optionally be provided separately from the catheter (15) with a connector configured for selective connection therebetween within the body, or the vascular access port (10) and catheter (15) may be provided together, as an assembly kit or as an integrated device.

[0067] In some embodiments, the port (10) may be substantially rigid such that most or all of the portions surrounding the cavity (12) are non-deformable or formable under normal stresses occurring during or after subcutaneous implantation in the subject's body, and in some other embodiments, at least one portion thereof is configured to flex or move relative to other portions of the port (10) (e.g., relative to the port body (11) or a rigid portion thereof) before, during, or after implantation, depending on the design. In some embodiments, the port (10) is configured as a squeezable subcutaneous port, capable of penetrating through small openings that would not allow the port (10) to pass through at its maximum cross-sectional circumference when in an elastically relaxed state, such as those formed by a puncture or incision made in the patient's skin. Penetration through such openings may be achieved by elastically forcing one or more portions of the port (10) locally by the opening neck as the port (10) is pushed distally through the opening.

[0068] In some embodiments, the port (10), and in particular the port body (11), includes a rigid inner member (19) that defines the cavity (12), and a flexible outer member (20) that is connected to the inner member (19) along at least one lateral circumference of the inner member, thereby forming a selected predetermined spatial shape for the port (10) when in an elastically relaxed state (e.g., as shown in FIG. 1A). The outer member (20) may be configured to have sufficient elastic resistance to compression when subjected to naturally occurring subcutaneous stresses to maintain the selected spatial shape within a surgically formable subcutaneous space. Additionally, the outer member (20) is configured to be locally compressible relative to the inner member (19) and to substantially maintain its overall volume by expanding remotely from the compressed region, thereby facilitating the port (10) being forced into the subcutaneous space when the port (10) is forced through a skin opening that is larger than the maximum cross-sectional circumference of the inner member and smaller than the maximum cross-sectional circumference of the selected spatial shape.

[0069] The port (10) includes a port gripper (21) having a relatively thin wall bounded by two opposing surfaces configured for effective and continuous clamping or grasping by a medical clamp (e.g., the surgical needle holder (119) shown in FIG. 7 and / or the Kelly artery clamp (230) shown in FIG. 9A). The port gripper (21) is located at or extends from the rear of the port body (10) or a rigid structural member thereof, and optionally includes a thin wall bounded by two opposing surfaces sized and shaped for effective 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 between the opposing surfaces of the thin wall is about 20° or less, optionally about 10° or less, or optionally about 5° or less.

[0070] The port body (11) may include an upper portion or member surrounding at least an upper portion of the cavity (12) and / or connecting to the septum member (13), which may narrow at its rear to form the port gripping portion (21). The port gripping portion (21) is constructed with sufficient rigidity and / or strength to prevent mechanical breakage when clamped under the skin layer of the subject (SUB) and manually moved, and is optionally made of a metal alloy such as stainless steel or titanium alloy, or a hard polymer such as polyetheretherketone (PEEK). In some embodiments, the port gripping portion (21) is formed such that opposing surfaces conform to the desired clamping orientation of the medical clamp.

[0071] The port gripper (21) is configured to transmit manual force and / or torque in at least one axis, e.g., a first axis of gripping normal to a thin-walled surface and optionally in other directions, through the medical clamp to the port (10). The manual force and / or torque is optionally sufficient to lock the medical clamp to the port gripper (21). In some embodiments, the manual force and / or torque is sufficient to use the gripped port (10) to create or enlarge a subcutaneous space and / or passageway in the subject's body and / or to move the port (10) along a subcutaneous space and / or passageway without slipping off the port gripper (21) or releasing the port gripper (21). The port gripper (21) is optionally configured such that when the distal portions of the clamping head members forming the medical clamp are oriented and spaced apart to conform to the shape and thickness of the thin wall, a hand force of about 20 kgf or less, optionally about 10 kgf or less, about 5 kgf or less is required. The port gripper (21) is optionally configured such that when the distal portions of the clamping head members forming the medical clamp are oriented and spaced apart to conform to the shape and thickness of the thin wall, a hand torque of about 0.25 N is required. * m or less, 0.20N * m or less, or approximately 0.15N * m or less.

[0072] 2A-2C diagrammatically illustrate another exemplary variation of the port gripper (21) of the port (10). Fig. 2A shows a first exemplary variation of the port gripper (21) having a thin wall (22a) with two substantially flat and parallel opposing surfaces (23a), where the port gripper (21) is configured to effectively mate with a clamping head member (25a) of a first exemplary medical clamping head (24a) configured to apply sufficient clamping force when the clamping head members (25a) are oriented substantially parallel to each other, at least at their distal portions, and when the clamping head members (25a) are spaced apart by a distance equal to or slightly less than the thickness of the thin wall. FIG 2B shows a second exemplary variation of a port gripper (21) having a thin wall (22b) with two opposing surfaces (23b) that are substantially flat and tapered toward each other, where the port gripper (21) is configured to effectively mate with a clamping head member (25b) of a second exemplary medical clamp head (24a) configured to apply sufficient clamping force when the clamping head members (25b) are oriented substantially tapered toward each other, at least at their distal portions, and when the clamping head members (25b) are spaced apart a distance equal to or slightly less than the thickness of the thin wall. FIG 2C shows a third exemplary variation of a port gripper (21) having a thin wall (22c) with two opposing surfaces (23c) each having a non-planar (e.g., toothed) pattern. In this manner, when the clamping head member (25c) is spaced apart a distance equal to or slightly less than the thickness of the thin wall (22c) and engages the surface (23c) of the thin wall (22c) having a mating non-planar pattern, the port gripping portion (21) can effectively fit over a third exemplary medical clamp head (24c) configured for locking in at least one axis.

[0073] 3A-3H diagrammatically illustrate a typical scenario representing possible steps in a typical procedure for implanting a vascular access port (10) together with a catheter (15) into a subject (SUB) through a single opening surgically made across the patient's skin. Although a typical sequence of implantation shows steps related to first forming an access into the vasculature VSC, followed by steps related to implanting the port (10) into a subcutaneous space in the body of the subject (SUB), and other steps related to catheterization by positioning a first end of the catheter (15) into the vasculature, the procedure according to some embodiments can be performed in other sequences, such as first implanting the port (10), then forming the access, and then implanting the first end of the catheter (17), or catheterization followed by implanting the port (10), or both at least partially in parallel. As shown in FIG. 3A, a subcutaneous opening (optionally an incision (INS) style) is made across the skin layer of the subject (SUB), optionally in the neck region or above (or above) the clavicle, and an access needle (30) is introduced therethrough into the nearby vascular system (VSC) (e.g., the jugular vein, or the subclavian vein, as shown). In some embodiments, the access needle (30) is tipped to puncture and / or penetrate through the skin, thereby optionally forming a surgical opening or a portion thereof, before an incision is made with a scalpel across or adjacent the skin. As shown in FIG. 3B, a guidewire (31) may then be inserted through the lumen of the access needle (30) and into the vascular system (VSC).

[0074] As shown in FIG. 3C, the port (10) may be clamped with a medical clamp (32) to aid in its implantation. If the incision (INS) is not already created, the physician may make an incision immediately prior to port implantation or may increase the size of the incision (INS) using, for example, a scalpel or the port (10) itself. Prior to clamping the port (10), a subcutaneous space and / or passage (SCV) may be created through the incision (INS) using the medical clamp (32) or another instrument. The subcutaneous space and / or passage (SCV) extends from the incision (INS) to a target implantation site (IMS), which is optionally located in the upper chest region and / or below (below) the clavicle.

[0075] The port (10) may then be pushed through the incision (INS) into the subcutaneous space and / or passageway (SCV) using the medical clamp (32) clamped thereto (FIG. 3D). In some embodiments, the presented order is reversed and the port (10) is implanted at the implantation site (IMS) before the access needle (30) and / or guidewire (31) are introduced into the subject's (SUB) body. In some embodiments, as shown, the second end (18) of the catheter (15) is already connected (fixedly or removably) to the port (10), but may be provided in a separate state and may be connected during delivery through the incision (INS) or before or after clamping the port (10) with the medical clamp (32). Following implantation of the port (10) at the target implantation site (IMS), the first end (17) of the catheter (15) is optionally positioned outside the body of the subject (SUB), however, in some other embodiments, the first end (17) of the catheter (15) may be located inside the vascular system (VSC) before the port (10) is implanted. Once the proper port (10) location has been confirmed, the medical clamp (32) may be released (loosened) from the port (10) and withdrawn from the subcutaneous space and / or passageway (SCV).

[0076] Before or after implantation of the port (10), the access needle (30) may be removed from the subject's (SUB) body while leaving the guidewire (31) in the selected pathway within the vasculature (VSC) (FIG. 3E). Subsequently, a peel-apart sheath (33) (which may be split along a prefabricated weakened line, for example) may be inserted over the guidewire (31) and into the vasculature (VSC). The guidewire (31) may then be removed from the vasculature (VSC), leaving the peel-apart sheath (33) in place. If the peel-apart sheath (33) is introduced with a dilator (34) extending along its lumen, the dilator (34) may also be withdrawn from within the peel-apart sheath (33), as shown in FIG. 3F. Once the lumen of the peel-apart sheath (33) is secured, the first end (17) of the catheter (15) is introduced therethrough into the vascular system (VSC) and optionally positioned in the superior vena cava or right atrium, as shown successively in Figures 3G and 3H. After verifying that the port (10) and / or catheter (15) are in the proper position and functioning, the peel-apart sheath (33) is broken and removed from the subject's (SUB) body, optionally while imaging, and the incision (INS) is closed (e.g., by suturing).

[0077] 4A-4K diagrammatically illustrate a typical scenario depicting steps in a typical procedure for implanting a vascular access port (10) together with a catheter (15) into a subject (SUB) through a single opening surgically made across the patient's skin in the subject's (SUB) armpit (axilla). Although a typical sequence of implantation shows steps related to first forming an access into the subject's vasculature, followed by steps related to implanting the port (10) in a subcutaneous space in the subject's (SUB) body, and other steps related to catheterization by positioning a first end of the catheter (15) into the vasculature, the procedure according to some embodiments can be performed in other sequences, such as implanting the port (10) first, then forming the access, and then implanting the first end of the catheter (17), or implanting the port (10) after catheterization, or implanting both at least partially in parallel.

[0078] 4A and 4B respectively illustrate partial internal side and front views of the upper torso of the subject (SUB). A subcutaneous opening (optionally by an incision (INS)) is made across the skin layer of the subject (SUB) in or near the axillary region at the junction of the subject's (SUB) right or left arm and the respective shoulder, optionally adjacent to the anterior axillary line. Access to the subject's (SUB) axillary vein (AXV) is made by penetrating the subject's (SUB) body through the incision (INS), optionally inferiorly (lower) and / or laterally and / or posteriorly to the pectoralis minor muscle. Next, as shown in FIG. 4C, an access needle (40) can be introduced through the incision (INS) into the axillary vein (AXV), optionally in its inferior (peripheral) portion as shown. In some embodiments, the access needle (40) is first tipped to puncture and / or penetrate through the skin, and thereby optionally form a surgical opening or portion thereof, before an incision (INS) is made (e.g., using a scalpel) across or adjacent to the skin. A guidewire (41) can then be inserted through the axillary vein (AXV) and through the lumen of the access needle (40) into the subject's vasculature (FIG. 4D), after which the access needle (40) can be removed, leaving the guidewire (41) extending into the axillary vein (AXV) (FIG. 4E).

[0079] As shown in Figure 4F, a subcutaneous space and / or passage (SCV) may be created using sharp and / or blunt surgical instruments, optionally with medical clamps (42) (which may be similar or identical to medical clamps (32), through incision (INS), optionally anterior to the pectoralis major muscle of the subject (SUB). The subcutaneous space and / or passage (SCV) extends from incision (INS) to a target implantation site (IMS) optionally located in the upper chest region and / or inferior to the clavicle, optionally anterior to the pectoralis minor and major muscles (e.g., as shown in Figure 4A) and / or optionally between the third rib and the clavicle, optionally adjacent the top of the second rib. In some embodiments, the void and / or passageway (SCV) is formed across or across the pectoralis major muscle, and may be performed subcutaneously (through or just below the overlying skin layer) above or anterior to the pectoralis major muscle, but may also be performed at least partially through or below (posterior to) the pectoralis major muscle. The port (10) may be clamped with a medical clamp (42) to aid in its implantation. If the incision (INS) is not already formed, the physician may make the incision immediately prior to port implantation or may increase the size of the incision (INS), for example, with a scalpel or the port (10) itself.

[0080] As shown in FIG. 4G, the port (10) may be pushed through the incision (INS) into the subcutaneous space and / or passageway (SCV) using a medical clamp (42) clamped thereto, and implanted at the target implantation site (IMS). In some embodiments, the presented order may be reversed and the port (10) may be implanted at the implantation site (IMS) before the access needle (40) and / or guidewire (41) are introduced into the subject's (SUB) body. In some embodiments, as shown, the second end (18) of the catheter (15) is already connected (fixedly or removably) to the port (10), but may be provided in a separate state and may be connected during delivery through the incision (INS) or before or after clamping the port (10) with the medical clamp (42). Following implantation of the port (10) at the target implantation site (IMS), the first end (17) of the catheter (15) is optionally positioned outside the body of the subject (SUB), however, in some other embodiments, the first end (17) of the catheter (15) can be placed inside the axillary vein (AXV) before the port (10) is implanted.

[0081] Once the proper port (10) location has been confirmed, the medical clamp (42) may be released (loosened) from the port (10) and withdrawn from the subcutaneous space and / or passageway (SCV), as shown in FIG. 4H. Before or after implantation of the port (10), a peel-apart sheath (43) may be inserted over the guidewire (41) into the axillary vein (AXV). The guidewire (41) may then be removed from the subject's vasculature leaving the peel-apart sheath (43) in place (FIG. 4I). If the peel-apart sheath (43) is introduced with a dilator extending along its lumen, the dilator may also be withdrawn from within the peel-apart sheath (43). Once the lumen of the peel-apart sheath (43) is secured, the first end (17) of the catheter (15) is introduced therethrough into the axillary vein (AXV) and optionally positioned into the superior vena cava (SVC) or into the right atrium (RA), as shown successively in Figures 4J and 4K. Prior to insertion, the catheter (15) may optionally be cut to a selected length based on the dimensions of the path length from the implantation 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 port (10) may be accommodated by pushing or pulling the port (10) within the subcutaneous space and / or passageway (SCV). After verifying that the port (10) and / or catheter (15) are in the proper position and functioning, optionally while imaging, the peel-apart sheath (43) is broken and removed from the subject's (SUB) body, and the incision (INS) is closed (e.g., by suturing or gluing).

[0082] 5A-5D illustrate various views, an assembled perspective view (FIG. 5A), an exploded perspective view (FIG. 5B), a side cross-sectional view (FIG. 5C), and a front cross-sectional view (FIG. 5D) of an exemplary squeezable subcutaneous port (100). Port (100) is optionally an exemplary configuration of port (10), and may include some or all of the structural and / or functional features described with respect to port (10). Port (100) (optionally, particularly in at least a portion of its elastically relaxed state) may have a maximum width of 50 mm or less, optionally a maximum width of 25 mm or less, a maximum height of 30 mm or less, optionally a maximum height of 15 mm or less, and a maximum length (with or without a catheter connection means) of 50 mm or less, optionally a maximum length of 30 mm or less. In some embodiments, the port (100) is configured to reform and / or change into a narrower cross-section (without becoming wider or tearing when passing therethrough) to compress and pass through a surgical opening, where the surgical opening has a maximum opening circumference of about 80 mm or less, optionally about 60 mm or less, optionally about 40 mm or less, and / or is formed by a surgical incision that is about 20 mm or less in length, optionally about 15 mm or less in length, or optionally about 10 mm or less in length.

[0083] The port (100) includes a rigid inner member (101) including a cavity (102) open to a first cavity opening (103) and a second cavity opening (105). The first cavity opening (103) is surrounded by a septum member (104) and configured for repeated needle penetration therethrough into the cavity (102). The second cavity opening (105) is configured to facilitate fluid communication between the cavity (102) and the lumen of the catheter. The inner member (101) is configured with sufficient rigidity to accommodate (safely and efficiently) a selected length of needle and prevent the needle tip from penetrating therethrough. The septum member (104) is optionally oval-shaped, but as shown, other shapes are possible.

[0084] The cap member (106) is bonded over the septum member (104) and over an upper portion of the inner member (101) to form a unitary rigid encapsulated core body of the port (100). The septum member (104) is restrained in place, and optionally compressed, at least in part, between the cap member (106) and the inner member (101). The inner member (101) and / or the cap member (106) are optionally formed from a hard plastic, such as PEEK, or from a metal, such as a titanium or stainless steel alloy. The cap member (106) is optionally fixedly connected to the inner member (101) by methods such as adhesive, compression fit, and / or welding (e.g., ultrasonic welding if the parts are made of plastic, or laser welding if the parts are made of metal). The encapsulation core body, once fully assembled, is configured to have sufficient rigidity and strength to maintain a typical internal pressure during injection into the cavity (102) (optionally at or about 300 psi, approximately 5 ml / sec injection). A lumen extension (107) is coupled to the inner member (101) and configured to extend at its distal portion through the second cavity opening (105) towards the cavity (102) and provide a fluid-tight passageway through its proximal portion to the lumen of the catheter. A connector member (108) is coupled over the lumen extension (107) and configured to facilitate selective connection between the catheter distal end and the port (100), such as with a luer fitting based connection mechanism.

[0085] As shown in Figures 5E and 5F, the port (100) includes a port gripper (117) (optionally the same or similar in structure, function, and / or dimensions as the port gripper (21)), where the port gripper (117) is provided at a proximal end of the port (100) and is configured to facilitate effective and safe gripping of the port (100) with a gripping means such as a medical clamp. The port gripper (117) may be provided as a proximal extension of the cap member (106) as shown, and may be positioned above the lumen extension (107) and the connector member (108) (e.g., closer to the first cavity opening (103)). Figure 5E illustrates the port (100) being gripped at the port gripper (117) with a typical medical clamp (119) (e.g., configured as a surgical needle holder). The port gripping portion (117) includes a horizontally extending wall (120) having opposing flat outer wall surfaces such that the medical clamp (119) may be positioned with its arms vertical (one above the other) and held by a medical practitioner. Alternatively, the wall (120) may be positioned with its flat surfaces in other orientations, optionally including vertical. The wall (120) is optionally configured with a size, flat surface area, thickness and / or durability and / or strength to facilitate a secure grip of the port (100) by the medical clamp (119) and to push, squeeze, and move through a surgical opening smaller than its maximum relaxed dimension without releasing the grip or mechanically breaking. The medical clamp (119) may be used to form or increase the size of a subcutaneous space or passageway prior to gripping and delivering the port (100) to the subcutaneous space.

[0086] Port gripper (117) optionally includes a locking structure configured to prevent lateral and / or rotational movement on and relative to wall (120) of the medical clamp when the medical clamp is engaged and attached. As shown in FIG. 5F, port gripper (117) includes a recessed section (121) configured to accommodate a lower head member (122) of medical clamp (119), where a top surface of recessed section (121) is also the lower (lower) wall surface of wall (120). Port gripper (117) also includes laterally opposed boundary walls extending (123) from an upper (upper) outer wall surface of wall (120) and configured to accommodate an upper head member (124) of medical clamp (119). The opposing boundary walls (123) may be laterally spaced from one another to provide a snug fit with the upper head member (124) and / or its clamping surface.

[0087] 6A-6B diagrammatically illustrate front cross-sectional views of an exemplary alternative configuration of the securing structure of the port gripper (117) before and after clamping with an exemplary medical clamp having opposing head members (127) each including a projection 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 bounding walls (123). The recesses (128) are sized and shaped to snugly fit and accommodate the projections (126). In this manner, lateral movement of the medical clamp (125) may be reduced or prevented. The recesses (128) may be non-circular (e.g., star-shaped, cross-shaped) to prevent rotational movement of the medical clamp (125) relative to and on the wall (120).

[0088] In some embodiments, the port gripper (117) includes a locking structure or mechanism configured to cause lateral compression and / or locking of a medical clamp when the medical clamp is engaged and attached to the port gripper (117). Figures 7A-7B diagrammatically illustrate front cross-sectional views of another exemplary configuration of the locking structure of the port gripper (117) before and after clamping with a medical clamp (119). In this configuration, the walls (120) are covered on each of their outer surfaces as shown with a cushion member (129) that is flexible and configured to compress into a volumetric shape that mates with the clamping surfaces of the head members (122 and 124) and therebetween to increase (and optionally maintain or decrease) stiffness and / or form a boundary wall portion (130) to surround the head members (122 and 124). Port gripper (117) is configured such that when a medical clamp is engaged and attached, and optionally its arms locked together, cushion member (129) forms a shape and stiffness sufficient to prevent lateral movement of medical clamp (119) on wall (120) and / or rotational movement relative to wall (120).

[0089] 8A-8B diagrammatically illustrate front cross-sectional views of an exemplary configuration of the locking mechanism of port gripper (117) before and after clamping with medical clamp (119). In this configuration, the lower section (131) of port gripper (117) (below the lower / lower surface of wall (120)) is shaped and / or constructed differently than the upper section (132) of port gripper (117) (above the upper / upper surface of wall (120)) such that when head members (122 and 124) of medical clamp (119) are pressed towards wall (120), the locking mechanism is activated laterally, locking at least one of the lower section (131) and upper section (132). As shown in this example, when the lower head member (122) engages and is received in the lower section (131), it moves laterally outwardly a lower boundary wall (133) that extends downwardly from the wall (120). The lower boundary wall (133) then acts as an arm that rotates about its interface with the wall (120) and moves laterally inwardly relative to the upper head member (124) an upper boundary wall (134) that extends upwardly from the wall (120) and acts as an arm extension of the lower boundary wall (133). When activated to function as described under a normal clamping force or pressure applied by the medical clamp (119), the upper boundary wall (134) is configured to press laterally and / or downwardly against the upper head member (124) sufficiently to substantially prevent lateral movement of the medical clamp (119) on the wall (120) and / or rotational movement relative to the wall (120) when the medical clamp is engaged and attached, optionally locking the arms together. In some embodiments, a cushion member (135) is also provided in the lower section (131) and / or upper section (132) to affect a more uniform fit and pressure transfer between the head members (122 and 124) and the lower section (131) and / or upper section (132).

[0090] In some embodiments, the inner member (101) may be functionally configured or adaptable to serve as a vascular access port, but may be incapable, insufficient, or less compatible with providing one or more, optionally essential, features to improve, facilitate, or mitigate implantation and / or long-term use of the port (100). The port (100) includes a flexible outer member (110) that, when in at least a resiliently relaxed state, provides a final spatial shape and dimensions to provide one or more additional features, including, but not limited to, stability and / or fixation at the implantation site, percutaneous accessibility, identification and / or positioning of the septum member (104) for repeated percutaneous fluid administration, protection to the port body and / or overlying skin layers, and the like.

[0091] The outer member (110) is connected to the inner member (101) along at least one lateral circumference thereof, thereby forming a selected, predetermined spatial shape of the subcutaneous port when in a resiliently relaxed state. Optionally, the outer member is configured, at least in its circumferential section, as a skirt or ring-like element surrounding most or all of the circumference of the inner member (101) and, optionally, also the circumference of the cap member (106). In order to maintain a sufficient rigid pushability for the insertion and implantation of the port (100), the rigid inner member (101) extends longitudinally along most or all of the length of the port (100) and, optionally in combination with the cap member (106), serves as a rigid spine-like structure of the port (100). The inner member (101) includes a distal (front) portion (113) that extends distally relative to the cavity (102) and has a rounded or sharply protruding leading edge (116) configured to facilitate or ease the penetration of the port (100) through the subcutaneous opening. The port (100) may be configured such that the distal portion (113) is not covered by the outer member (20) that may extend laterally distally therefrom, but is covered with a thin layer of the outer member (110) (as shown) such that sufficient rigidity and pushability are not substantially compromised. Outer member (110) is optionally made of silicone or other flexible and resilient polymer or rubber and is optionally extruded, cast, or molded over the periphery of inner member (101) or over the periphery of the sealed core body (i.e., the structure formed by the interconnected inner member (101), septum member (104), and cap member (106)) within the confines of a mold of an optionally selected shape when forming subcutaneous port (100).

[0092] 9A-9B illustrate axial views of another exemplary vascular access port (200), including a port body (201) and at least one port body extension (204) that is restrictively movable along at least one pathway (205) defined in the port body (201). The at least one port body extension (204) includes a first arm (208) positioned to the right of the median plane of the port body (201) and a second arm (209) positioned to the left of the median plane. The port body extension (204), specifically the first and second arms (208, 209), are each rotatably and slidably coupled to the port body (201) and configured to rotate about an axis of rotation and slide along the pathway (205) on at least one of two opposing sides of the port body (201) when changing from a delivery configuration to a deployed configuration. The port body (201) has a lower portion (210) and a rear portion (211), the rear portion (211) being coupled to the septum member (202), and the lower portion (210) surrounding a cavity (203) defined by the port body (201) and located below and covered by the septum member (202). The lower portion also includes a first exterior surface extending over most or all of the right side of the lower portion (210) and a second exterior surface extending over most or all of the left side of the lower portion (210). The rear end (214) of the port body (201) is connected to a catheter connector (215) configured to connect to a proximal end of a catheter (e.g., catheter (15)) to facilitate fluid communication between the cavity (203) and the lumen of the catheter.

[0093] The vascular access port (200) is selectively changeable from a delivery configuration (shown in FIG. 9A ) to a deployed configuration (shown in FIG. 9B ) by moving the first and second arms (208 and 209) along the first and second pathways (205), respectively. When in the delivery configuration, a forward portion (207) of each port body extension (204) is positioned axially distal to the port body (201). When changed to the deployed configuration, the port body extensions (204) and port body (201) are approximated along the median plane of the port body (201) while the laterally facing portions (206) of the port body extensions (204) are moved laterally away from the median plane, thereby reducing the length-to-width ratio of the switched vascular access port (200). When in the deployed configuration, the port body extension (204) is securely and removably connected to the port body (201), thereby allowing for selective return from the deployed configuration to the delivery configuration. Additionally, the rear end (214) of the port body (201) also remains uncovered by the port body extension (204) after being transformed into the deployed configuration, for example, to avoid collision with the catheter connector (215) and / or a catheter connected thereto.

[0094] A port gripper (216) (optionally similar or identical in structure, function, and / or dimensions to port gripper (21)) is positioned on the rear end (214) of the port body (201) above the catheter connector (215) to, for example, allow a user to selectively move and / or move the port (200) subcutaneously and to the target implantation site while avoiding collision with the catheter connector (215) and / or the catheter connected thereto. A user can use a medical forceps to pinch the port gripper (216) and push the switchable vascular access port (200) when in a delivery configuration to the target implantation site using the medical forceps. Once within the target implantation site, the port (200) can be changed to the deployed configuration by using forceps to push the port body (201) distally relative to the port body extension (204) and / or by pulling the port body extension (204), such as with a retraction member (219) connected to the first and second arms (208 and 209), when the port body (201) resists movement.

[0095] Port gripping portion (216) includes a thin wall portion (217) including opposing outer surfaces extending parallel to the medial plane from either side thereof, and as shown in Figures 10A and 10B, wall portion (217) is configured for grasping and / or clamping by a medical forceps, including but not limited to a needle holder or Kelly artery 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 to allow for sufficient clamping contact area from either side of wall portion (217) and accumulation of sufficient clamping, gripping, and locking force using a medical forceps.

[0096] Wall portion 217 may be configured as a septum split cavity 218 formed from opposite sides at rear end 214. Cavity 218 is shaped and dimensioned to accommodate a pair of tips of a medical forceps and to allow the pair of tips to open and close inwardly into the wall portion and to grasp wall portion 217 from both sides. Figure 11 illustrates an exemplary configuration of an alternative port gripper 216 having a thin wall portion 217' similar to wall portion 217, but which does not join the cavity but rather provides more space for maneuverability of the forceps tips.

[0097] As used herein, the terms "a," "an," and "the" below, written in singular grammar, mean "at least one," or "one or more." The use of "one or more" herein does not change this intended meaning of "a," "an," or "the." Thus, the terms "a," "an," and "the" as used herein may refer to and include a plurality of the described entities or objects, unless otherwise defined or described herein or unless otherwise clearly indicated by the context. For example, the terms "unit," "device," "assembly," "mechanism," "component," "element," "step or procedure" as used herein may refer to and imply a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and a plurality of steps or procedures, respectively.

[0098] As used herein, each of the following terms "comprise", "include", "have", "comprise", "comprises", and their linguistic / grammatical variations, derivatives, and / or conjugates shall mean "including but not limited to" and shall be taken as specifying the stated component(s) and not excluding the addition of one or more additional components, features, properties, parameters, integers, steps, or groups thereof. Each of these terms shall be considered equivalent to the expression "consisting essentially of".

[0099] The term "method" as used herein refers to, but is not limited to, steps, procedures, practices, means, or / and techniques for accomplishing a given task, and refers to either known steps, procedures, practices, means, or / and techniques or those that can be readily developed from known steps, procedures, practices, or / and techniques by those of ordinary skill in the art relevant to the disclosed invention.

[0100] Throughout this disclosure, numerical values ​​of parameters, features, characteristics, objects, or dimensions may be described or explained in terms of a numerical range format. Such numerical range formats as used herein are intended to illustrate the implementation of some exemplary embodiments of the present invention, and are not intended to rigidly limit the scope of the exemplary embodiments of the present invention. Thus, any numerical range described or stated also refers to and encompasses all possible subranges and individual numerical values ​​(wherein the numerical values ​​may be expressed as integers, integrals, or fractions) within the described or stated numerical range. For example, a numerical range of "1-6" refers to all possible ranges such as "1-3", "1-4", "1-5", "2-4", "2-6", "3-6", etc., and within the described or stated numerical range of "1 to 6", individual numerical values ​​such as "1", "1.3", "2", "2.8", "3", "3.5", "4", "4.6", "5", "5.2", "6", etc. This applies regardless of the breadth, scope, or magnitude of the numerical range described.

[0101] Furthermore, for purposes of describing or explaining a numerical range, the phrase "ranging between about a first numerical value and about a second numerical value" is considered equivalent and has the same meaning as the phrase "ranging from about a first numerical value to about a second numerical value," and thus, these two equivalently-meaningful phrases can be used interchangeably. For example, when describing or explaining a numerical range of room temperature, the phrase "room temperature refers to a temperature in the range of about 20° C. to about 25° C." is considered equivalent and has the same meaning as the phrase "room temperature refers to a temperature in the range of about 20° C. to about 25° C.."

[0102] As used herein, the term "about" may mean ±10% of the stated numerical value.

[0103] It is to be appreciated that, for clarity, certain aspects, characteristics, and properties of the invention that are illustratively described and presented in the context or form of multiple separate embodiments may also be illustratively described and presented in any suitable combination or subcombination in the context or form of a single embodiment. Conversely, various aspects, characteristics, and properties of the invention that are illustratively described and presented in a combination or subcombination in the context or form of a single embodiment may also be illustratively described and presented in the context or form of multiple separate embodiments.

[0104] While the present invention has been illustratively described in conjunction with specific embodiments thereof and presented as specific exemplary embodiments, it is evident that many alternatives, modifications, and / or variations thereof will be apparent to those skilled in the art, and accordingly, it is intended to embrace all such alternatives, modifications, and / or variations that fall within the spirit and broad scope of the appended claims.

[0105] All publications, patents, and / or patent applications mentioned herein are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and / or patent application was indicated to be incorporated herein by reference or citation. Furthermore, citation or identification of a reference herein shall not be construed or understood as an admission that the reference represents or corresponds to prior art to the present invention. Although section headings are used, they should not necessarily be construed as limiting.

[0106] The methods disclosed herein include one or more steps or acts for achieving the described method. The steps and / or acts of the method may be interchanged without departing from the scope of the claims. In other words, unless a specific order of steps or acts is specified, the order and / or use of specific steps and / or acts may be changed without departing from the scope of the claims.

Claims

1. 1. A subcutaneous port, comprising: The subcutaneous port includes a port body containing a cavity, the cavity including a first opening covered by a septum configured to pass repeated needle penetrations therethrough, and a second opening configured to facilitate fluid communication between the cavity and a catheter; the port body includes a rigid port body member surrounding the cavity and / or defining a first opening, the rigid port body member including a front portion, a rear portion, and sides extending from opposing sides thereof between the front portion and the rear portion; the port body includes a rigid port grip including a wall located at a rear portion of the port body; the wall includes closely spaced, opposing wall outer surfaces configured to be sandwiched between linearly extending distal ends of a medical forceps; a front portion of the port body is configured to be pushed from a rear portion of the port body into a subcutaneous target implantation site using a medical forceps when a distal end of the medical forceps is engaged with the port gripper; A subcutaneous port, wherein the port gripper is configured to receive manual force and / or torque from the medical forceps in at least one axial direction, and wherein the manual force and / or torque received at the port gripper is sufficient to removably attach a distal end of the medical forceps to the port gripper.

2. The subcutaneous port of claim 1, wherein the port body includes a flexible outer member that is locally compressible against the rigid port body member when forced through an epidermal opening.

3. 2. The subcutaneous port of claim 1, wherein the manual force and / or torque experienced by the port gripper is sufficient to use the subcutaneous port to create or enlarge a subcutaneous gap and / or passageway in a subject's body and / or to move the subcutaneous port along the subcutaneous gap and / or passageway without slipping off the port gripper or releasing the port gripper.

4. 4. The subcutaneous port of claim 1, wherein the second opening is adjacent to the port gripper and / or is located below the port gripper and distal from the first opening to the port gripper.

5. 5. A subcutaneous port as described in any one of claims 1 to 4, wherein the port grippers are configured such that when distal ends of the medical forceps are oriented and spaced relative to one another to substantially conform to the shape and thickness of the wall, the hand force is 98.1 N or less and / or the hand torque is 0.25 Nm or less.

6. 6. A subcutaneous port as described in any one of claims 1 to 5, wherein the port gripper is configured to allow manual arms of the medical forceps to interlock when distal ends of the medical forceps are oriented and spaced relative to one another to conform to the shape and thickness of the wall.

7. 7. The subcutaneous port of claim 1, wherein each of the wall exterior surfaces extends perpendicularly between sides of the port body.

8. 7. The subcutaneous port of claim 1, wherein each of the wall exterior surfaces extends horizontally between a lower portion and an upper portion of the port body.

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

10. 10. The subcutaneous port of any one of claims 1 to 9, wherein the port gripper includes a locking structure or mechanism configured to prevent lateral movement of the medical forceps on the port gripper and / or rotational movement relative to the port gripper when a distal end of the medical forceps is engaged and attached to the port gripper.

11. 11. The subcutaneous port of claim 10, wherein the securing structure or mechanism includes laterally opposed boundary walls extending from at least one of the first and second wall outer surfaces, wherein the opposed boundary walls are laterally spaced from one another to snugly mate with one of the distal ends of the medical forceps.

12. The subcutaneous port of claim 10 or 11, wherein the fixing structure or mechanism is configured to generate lateral compression and / or locking of the medical forceps when the medical forceps is engaged and attached to the port gripper.

13. 13. The subcutaneous port of any one of claims 1 to 12, wherein the port body is configured to create, expand, and / or be inserted into a subcutaneous space and / or passageway via a surgical opening in or near the axillary region where a subject's arm joins their respective shoulder.

14. 14. The subcutaneous port of claim 13, wherein the subcutaneous void and / or passageway is extendable anteriorly across the subject's pectoralis major muscle.

15. 15. The subcutaneous port of claim 13 or 14, wherein the port body is configured to be implanted through the subcutaneous void and / or passageway at a target implantation site located inferiorly relative to the subject's clavicle and / or anteriorly relative to the pectoralis major muscle.

16. 1. A surgical kit comprising: A subcutaneous port according to any one of claims 1 to 15; a catheter; 1. A surgical kit, wherein a first end of the catheter is configured to be inserted into a subject's vascular system via a surgical opening, and a second end of the catheter is connected or connectable to a subcutaneous port to form fluid communication between a lumen of the catheter and the cavity of the subcutaneous port.

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

18. 18. The surgical kit of claim 16 or 17, further comprising a peel-apart sheath configured to be inserted over a wire into an axillary vein, and the peel-apart sheath configured for inserting a first end of the catheter through the peel-apart sheath and into the axillary vein after removing the wire from the axillary vein.

19. 20. The surgical kit of claim 18, further comprising a dilator configured to be inserted into the axillary vein while in the peel-apart sheath, and wherein a first end of the catheter is configured to be inserted through the peel-apart sheath after removing the dilator from the peel-apart sheath.

20. 20. The surgical kit of any one of claims 16 to 19, further comprising a medical forceps configured to be releasably engageable with the port gripper.

21. 1. A kit for creating reusable therapeutic access to a subject, the kit comprising: a subcutaneous port, the subcutaneous port including a port body containing a cavity, the cavity including a first opening covered by a septum configured to pass repeated needle penetrations therethrough, and a second opening configured to facilitate fluid communication between the cavity and a catheter; and The kit includes a medical forceps having a linear distal end and manually operable, pivotally connected, interlockable arms; wherein the port body includes a port gripper configured to releasably engage a distal end of the medical forceps, and wherein the port body is configured to be pushed into a subcutaneous target implantation site using the medical forceps when the medical forceps is engaged with the port gripper; the port gripper includes a wall having first and second exterior surfaces dimensioned to (1) receive a distal end of the pivotally connected arm and (2) enable the pivotally connected arm to interlock when a distal end of the medical forceps engages the wall.

22. A subcutaneous port comprising: The subcutaneous port includes a port body containing a cavity, the cavity including a first opening covered by a septum configured to pass repeated needle penetrations therethrough, and a second opening configured to facilitate fluid communication between the cavity and a catheter; the port body includes a rigid port body member surrounding the cavity and / or defining a first opening; the port body includes a flexible outer member locally compressible against the rigid port body member when forced through a skin opening; the rigid port body member includes a rigid port gripper configured to releasably engage a medical clamp, the port body being configured to be forced through the epidermal opening into a subcutaneous target implantation site using the medical clamp when the medical clamp is engaged with the port gripper; A subcutaneous port, wherein the port gripper is configured to receive manual force and / or torque from the medical clamp in at least one axial direction, and wherein the manual force and / or torque received at the port gripper is sufficient to releasably attach the medical clamp to the port gripper.

23. The subcutaneous port of claim 22, wherein the second opening is disposed adjacent to the port gripping portion and / or below the port gripping portion and farther from the first opening than the port gripping portion.

24. A subcutaneous port as described in claim 22 or claim 23, wherein the port gripping portion has a wall including opposing first and second outer wall surfaces dimensioned to accommodate a clamping surface of the medical clamp.

25. A subcutaneous port as described in any one of claims 22 to 24, wherein the port gripping portion has a wall and is configured such that when the clamping surfaces of the medical clamp are oriented and spaced relative to one another to substantially conform to the shape and thickness of the wall, the hand force is 98.1 N or less and / or the hand torque is 0.25 Nm or less.

26. A subcutaneous port as described in any one of claims 22 to 25, wherein the port gripping portion has a wall and is configured to enable manual arms of the medical clamps to interlock when the clamping surfaces of the medical clamps are oriented and spaced relative to each other to conform to the shape and thickness of the wall.

27. A subcutaneous port as described in any one of claims 24 to 26, wherein each of the port gripping portions on an outer wall surface extends vertically between the sides of the port body.

28. A subcutaneous port as described in any one of claims 24 to 26, wherein each of the outer wall surfaces extends horizontally between the lower and upper parts of the port body.

29. A subcutaneous port described in any one of claims 24 to 28, wherein the average or maximum thickness of the wall is greater than or equal to 1 mm and less than or equal to 4 mm, and / or the angle between the first and second outer wall surfaces is less than or equal to 20°.

30. A subcutaneous port as described in any one of claims 22 to 29, wherein the port gripper includes a locking structure or mechanism configured to prevent lateral movement of the medical clamp on the port gripper and / or rotational movement relative to the port gripper when the medical clamp is engaged and attached to the port gripper.

31. A subcutaneous port as described in claim 30, wherein the fixing structure or mechanism includes laterally opposed boundary walls extending from at least one of the first and second wall outer surfaces, wherein the opposed boundary walls are laterally spaced from one another to snugly mate with one of the clamping surfaces of the medical clamp.

32. A subcutaneous port as described in claim 30 or 31, wherein the fixing structure or mechanism is configured to generate lateral compression and / or locking of the medical clamp when the medical clamp is engaged and attached to the port gripping portion.

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