FIELD

The present disclosure relates generally to medical devices, systems and methods, and more particularly to indwelling access devices, systems and methods which may comprise an implantable (subcutaneous) indwelling access port, which may be coupled with at least one implantable (subcutaneous) indwelling catheter within a body, particularly a human body.

BACKGROUND

Medical patients, such as oncology patients, hemodialysis patients and hematology patients, may be subject to frequent fluid infusion treatments and/or fluid extraction treatments. Fluid infusion treatments may deliver medication (e.g. pharmaceutical products; therapeutic drugs), bodily fluid (e.g. blood), nutrients, contrasting agents, dialysis fluid and other liquid compositions to the body, while fluid extraction treatments may remove fluids such as dialysis fluid, bodily fluid (e.g. blood as part of phlebotomy) and other liquid compositions from the body. A fluid infusion treatment and fluid extraction treatment may be part of a fluid exchange treatment, such as dialysis.

Many fluid treatments involve the use of an indwelling catheter with transgresses out of the body. However, where the catheter passes through the body, there may be an increased risk of infection inception which can spread both internally and externally.

In order to reduce the likelihood of infection associated with the foregoing transcutaneous catheter, certain medical applications may be able to utilize an access port implanted beneath the cutaneous tissue (skin) of the patient/body.

An implanted access port may include an access point, such as a septum, into which an external hypodermic needle may be inserted. The access port is coupled to an indwelling catheter, which is inserted into a vein, such as a jugular vein, subclavian vein or superior vena cava. The septum may be formed of a self-healing silicone material, which may be punctured multiple times with a small gauge needle (e.g. 20-21 gauge) with a relatively low loss in its integrity.

External access to the implanted vascular access port may be accomplished by inserting the hypodermic needle through the patient's skin and through the septum of the implanted port. However, a clinician needs to properly target the access port and, as a result, multiple needle sticks may be required to properly locate and access the access port, which may add discomfort to the patient.

Additionally, for certain medical applications, a large gauge needle (e.g. 14-17 gauge) may be required to facilitate suitable flow rates for fluids. However, large gauge hypodermic needles may damage the septum of the implanted port, which may result in the septum leaking, as well as also add discomfort to the patient. Moreover, the external hypodermic needle may introduce bacteria into the entrance site, which may increase the risk of infection.

SUMMARY

By way of general overview, the present disclosure provides medical devices, systems and methods, and more particularly provides indwelling access devices, systems and methods which may comprise an implantable, subcutaneous, indwelling access port, which may be coupled with one or more implantable, subcutaneous, indwelling catheters within a body, particularly a human body, as well as a transfer device.

The access port may include an access port body containing at least one exposable/concealable (e.g. extendable/retractable) internal needle that may extend/retract relative to the access port body to expose/conceal the internal needle. The access port may also include an access port body containing at least one exposable/concealable internal needle and having an access port body that is configured to compress (collapse) to expose the internal needle and configured to decompress (expand) to expose the internal needle.

The internal needle includes a lumen which provides a segment of a fluid passage which extends through the needle, the access port body and an adjoining catheter which is completely implanted in the host. The fluid passage may be used to delivery fluid to the host, particularly with a fluid infusion treatment, and/or extract fluid from the host, particularly with a fluid extraction treatment.

The internal needle may be concealable in, and exposable from, the access port body by a variety of mechanisms, which may include mechanical, magnetic, electrical and electro-mechanical mechanisms as disclosed herein.

The access ports herein may be used to provide peritoneal dialysis and/or hemodialysis as part of treatment for kidney disease/failure; to remove fluid from the peritoneal cavity to treat ascites; to provide nutrition to s host as part of total parenteral nutrition to treat eating and digestion disorders; to deliver cells to the host to treat cancer; to remove blood from the host to treat hemochromatosis; to deliver blood to the host to treat sickle cell disease and beta thalassemia as a few particular medical applications.

In at least one embodiment, a medical system may be provided, comprising an implantable access port configured to be implanted into a subject, the access port including an implantable access port body and at least one implantable access port needle; wherein the at least one needle is concealable inside the access port body in a concealed position and is exposable outside the access port body in an exposed position; wherein the at least one needle is arranged within the access port body to penetrate outwardly through skin of the subject from within the subject when the access port is implanted in the subject; a transfer device coupled to the at least one needle of the access port, the transfer device configured to transfer a fluid to and/or from the access port; and wherein the transfer device is configured to form a closed treatment system with the access port, wherein the transfer device includes a fluid flow passage configured to transfer the fluid to and/or from the access port.

In at least one embodiment, the transfer device may be configured to inhibit transfer of environmental contaminants into the treatment system and escape of hazardous material outside the treatment system.

In at least one embodiment, the at least one needle may include a removable needle tip, and the transfer device may include a needle tip holder configured to hold the needle tip.

In at least one embodiment, the needle tip holder may be configured to form an interference fit with the needle tip and/or configured to form a positive mechanical engagement with the needle tip.

In at least one embodiment, the at least one needle may include a needle shaft and a needle tip which is removable from the needle shaft, and the transfer device may be configured to remove the needle tip from the needle shaft, particularly by rotating the needle tip or applying a pulling force to the needle tip.

In at least one embodiment, the at least one needle may include a needle shaft and a needle tip which is installable on the needle shaft, and the transfer device may be configured to install the needle tip on the needle shaft, particularly by rotating the needle tip or applying a pushing force to the needle tip.

In at least one embodiment, the at least one needle may include a needle shaft and a first needle tip which is removable from the needle shaft, the transfer device may be configured to remove the first needle tip from the needle shaft, and the transfer device may be configured to install a second needle tip on the needle shaft.

In at least one embodiment, the transfer device may be configured to form a fluid-tight seal against the needle.

In at least one embodiment, the fluid flow passage may comprise a fluid infusion passage and/or a fluid extraction passage.

In at least one embodiment, the fluid flow passage may be configured to receive the needle therein. Furthermore, the at least one needle may include a removable needle tip, the transfer device may comprise a needle tip holder configured to hold the needle tip, and the fluid flow passage may be configured to receive the needle tip holder therein.

In at least one embodiment, the transfer device includes a fluid infusion port and/or a fluid extraction port, a needle tip removal port and/or a needle tip installation port, and a needle receiving port. Furthermore, the fluid flow passage may be in fluid communication with the fluid infusion port and/or the fluid extraction port, the needle tip removal port and/or a needle tip installation port, and the needle holding port.

In at least one embodiment, a method of treating a subject may be provided, with the method comprising extending a needle through skin of the subject from an access port implanted beneath the skin of the subject such that the needle penetrates the skin outward from within the subject to provide an exposed needle portion outside the subject; and coupling a transfer device to the exposed needle portion, wherein the transfer device forms a closed treatment system with the access port which inhibits transfer of environmental contaminants into the treatment system and escape of hazardous material outside the treatment system.

In at least one embodiment, a method of medically treating a body may be provided, with the method comprising piercing a needle through skin of the body from a medical device implanted beneath the skin of the body, wherein the medical device comprises an access port and a catheter coupled to the access port, wherein the access port houses the needle and the catheter is located in a body cavity of the body; and at least one of introducing a fluid into the body cavity with a fluid passage of the medical device and removing a fluid from the body cavity with a fluid passage of the medical device.

In at least one embodiment, the method may further comprise returning the needle beneath the skin of the body such that the needle is concealed within the body.

In at least one embodiment, the fluid passage may extend through the needle, the access port and the catheter.

In at least one embodiment, the method may further comprise removing a removable tip on the needle to open access to the fluid passage after the step of piercing the needle through skin of the body from the medical device implanted beneath the skin of the body.

In at least one embodiment, the method may further comprise performing at least one of the steps of introducing a fluid into the body cavity with the fluid passage of the medical device and removing a fluid from the body cavity with the fluid passage of the medical device after removing the removable tip on the needle to open access to the fluid passage.

In at least one embodiment, the method may further comprise replacing the removable tip on the needle to close access to the fluid passage after performing at least one of the steps of introducing a fluid into the body cavity with the fluid passage of the medical device and removing a fluid from the body cavity with the fluid passage of the medical device.

In at least one embodiment, the method may further comprise introducing a fluid into the body cavity with a fluid passage of the medical device and removing a fluid from the body cavity with a fluid passage of the medical device

In at least one embodiment, the steps of removing a fluid from the body cavity with a fluid passage of the medical device and introducing a fluid into the body cavity with the fluid passage of the medical device may be performed during a dialysis procedure. Further, the body cavity may be the peritoneal cavity, and the dialysis procedure may be a peritoneal dialysis procedure.

In at least one embodiment, the step of removing a fluid from the body cavity with a fluid passage of the medical device may be performed before the step of introducing a fluid into the body cavity with the fluid passage of the medical device.

In at least one embodiment, the step of removing a fluid from the body cavity with a fluid passage of the medical device may further comprise removing a spent dialysis fluid from the body cavity with a fluid passage of the medical device, and the step of introducing a fluid into the body cavity with the fluid passage of the medical device may further comprise introducing a fresh dialysis fluid into the body cavity with the fluid passage of the medical device.

In at least one embodiment, the access port may include an access port body; and the step of piercing a needle through skin of the body from a medical device implanted beneath the skin of the body may be performed while extending the needle from the access port body. In at least one embodiment, the step of extending the needle from the access port body may be performed by moving the needle relative to the access port body.

In at least one embodiment, the step of moving the needle relative to the access port body may be performed by at least one of a magnetic actuation, mechanical actuation and electro-mechanical actuation.

In at least one embodiment, the step of extending the needle from the access port body may be performed by moving the access port body relative to the needle.

In at least one embodiment, the step of moving the access port body relative to the needle may be performed by compressing the access port body.

In at least one embodiment, the access port body may comprise an access port body first member and an access port body second member, and the step of compressing the access port body may be performed by moving at least one of the access port body first member and the access port body second member relative to the other access port body member.

In at least one embodiment, the step of compressing the access port body may be performed by deforming the access port body.

In at least one embodiment, the access port may include an access port body, and the step of returning the needle beneath the skin of the body such that the needle is concealed within the body may be performed while retracting the needle into the access port body.

In at least one embodiment, the step of retracting the needle into the access port body may be performed by moving the needle relative to the access port body.

In at least one embodiment, the step of moving the needle relative to the access port body is performed by at least one of a magnetic actuation, mechanical actuation and electro-mechanical actuation.

In at least one embodiment, the step of retracting the needle into the access port body may be performed by moving the access port body relative to the needle.

In at least one embodiment, the step of moving the access port body relative to the needle may be performed by decompressing the access port body.

In at least one embodiment, the access port body may comprise an access port body first member and an access port body second member, and the step of decompressing the access port body may be performed by moving at least one of the access port body first member and the access port body second member relative to the other access port body member.

In at least one embodiment, the step of decompressing the access port body may be performed by deforming the access port body.

