Percutaneous access

Details Percutaneous access Percutaneous access

2003-06-16

2004-07-06

Mandez, Manuel (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S093010, C604S124000, C604S500000

Reexamination Certificate

active

06758841

ABSTRACT:

TECHNICAL FIELD
The invention relates generally to percutaneous access, and more specifically to methods and devices associated with percutaneous access.
BACKGROUND INFORMATION
Long term access to a patient's bloodstream (longer than one month, for example) is required for many medical treatments including antibiotic therapy, hemodialysis access, chemotherapy regimens, and other treatments that require repeated infusion or blood processing. In some cases, internal access to the patient is required for years. Current devices and methods generally negatively impact the quality of the patient's life, and the patient sometimes develops complications as a result of the long term access. Vascular access devices used for longer term treatments include tunneled central catheters (including dialysis catheters), implanted infusion ports (including dialysis ports), dialysis grafts, and fistulas. A cuffed catheter can be used for non-vascular access, such as to the abdominal cavity for peritoneal dialysis to prevent infection.
Tunneled catheters can cause infection of the bloodstream or peritoneum and the skin entry site. The external portion of the catheter can fracture or otherwise fail due to its movement after placement. Also, the placed catheter can be accidentally or intentionally removed from the body, causing the patient pain and other complications. There is also the possibility of increased wear, damage, or disassembly caused by the patient “playing with” the placed device. The skin entry site requires constant maintenance and clamps are required to prevent bleeding through the catheter and to prevent air embolus. The portion of the catheter external to the patient's body frequently is uncomfortable for the patient. The external catheter and the skin entry site can prevent the patient from bathing normally or engaging in normal physical activities.
Subcutaneously implanted access ports require the use of needles to access the port through the patient's skin. Using needles, such as the large needles used for dialysis ports, creates the potential for infection and causes the patient pain. The access port reservoir has the potential of accumulating debris and harboring infection. In the event an internally-connected catheter connecting to this type of port needs to be replaced, a surgical procedure is required.
Grafts and fistulas on the patient's arm are disfiguring, and they require frequent access with large bore needles which causes pain and eventually destroys the access route. Grafts and fistulas also require invasive vascular surgery to be created and revised. Additionally, interluminal declotting is often necessary.
With respect to medical devices that are permanently implanted into a patient, such as a pacemaker for example, access is limited to surgical means in order to reach the device to replace batteries or repair components. Electrical leads that pass through the skin to supply power and control for the internally-implanted device can cause infection.
SUMMARY OF THE INVENTION
The invention relates generally to percutaneous access, and more specifically to methods and devices associated with percutaneous access. In one embodiment, an access device allows physicians and other medical personnel to obtain long term percutaneous access to a patient's body. The access device reduces the opportunity for infection by completely shielding fluid connections (that extend into the interior of the patient's body) from the patient's skin and from the external environment. The access device has no protruding external elements, and can be protected by a low-profile cover that is substantially flush with the patient's skin. The access device thus is cosmetically appealing and allows substantially normal physical activity. The cover is difficult to remove accidentally or intentional from the access device. The access device allows access to the interior of the patient without requiring a needle to pierce the skin. Further, internal components, such as a catheter or a valve, can be replaced without a surgical procedure.
In one aspect, the invention involves a medical device. The medical device includes a housing defining a cavity, a first opening into the cavity, and a second opening into the cavity. The housing is implantable in a patient to dispose the cavity subcutaneously within the patient. The first opening is substantially flush with the surface of the skin of the patient and creates a percutaneous passageway from the exterior of the skin of the patient into the cavity. The second opening creates a passageway from the cavity into the interior of the patient. The medical device further includes a connector coupled to the second opening and disposed substantially within the cavity and allows for a connection between a first device and a second device disposed within the interior of the patient. In one embodiment, the housing defines a flange for extending subcutaneously into the patient to anchor the housing in the patient.
In another embodiment, the medical device further includes a cover that is removably couplable to the housing. The cover selectively seals and exposes the first opening and is cover substantially coplanar with the surface of the skin of the patient when sealing the first opening. The cover is removable to allow the first and second devices to be connected via the connector. The cover includes a locking mechanism to prevent the cover from being inadvertently removed. In other embodiments, the cover is canoe or elliptically shaped. In one embodiment, the cover further includes an electrical connector. In another embodiment, the cover further includes a display.
In yet another embodiment, the connector includes a luer connector. In other embodiments, the medical device further includes a valve. In still other embodiments, the medical device further includes a cap removably coupled to the luer connector to selectively seal and expose the luer connector. The cap removably couples to the luer connector with a threaded connection. In some embodiments, the luer connector is telescopic and capable of being extended out of the cavity when the cover is removed from the first opening. In other embodiments, the luer connector includes a pivoting luer connector which opens a fluid path through the second opening when pivoted to a first position and seals the fluid path through the second opening when pivoted to a second position. In yet another embodiment, the connector includes an electrical connector. In another embodiment, the connector is releasably couplable to the second opening.
In still another embodiment, the first device includes a connection tube and the second device includes a catheter. The catheter includes a single lumen catheter a multilumen catheter.
In one embodiment, the first device includes an infusion device for infusing medication into the patient. In another embodiment, the first device includes a device for removing bodily fluids of the patient. In still another embodiment, the first device includes a device for removing, purifying, and reintroducing blood into the patient.
In another embodiment, the connector includes an electrical connector. In one embodiment, the electrical connector is releasably couplable to a battery disposable entirely within the cavity for supplying power to the second device. In another embodiment, the electrical connector is releasably couplable to a control device disposable entirely within the cavity for supplying control signals to the second device.
In another aspect, the invention relates to a method of obtaining percutaneous access to the interior of a patient. The method includes making a straight incision in the patient and implanting in the patient through the straight incision a medical device. The medical device includes a housing defining a cavity, a first opening into the cavity, and a second opening into the cavity. The housing is implantable in a patient to dispose the cavity subcutaneously within the patient. The first opening is substantially flush with the surf

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