Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-09-06
2004-04-06
Bui, Vy Q. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S185000
Reexamination Certificate
active
06716228
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a surgical device. More particularly, the invention relates to a vascular access device including a needle and sliding surgical blade which facilitates vascular access and associated skin incision without the need for retrieval of multiple surgical tools. The present invention further relates to methods for utilizing the present vascular access device.
2. Description of the Prior Art
Vascular access via guidewires and catheters has become a common method for performing a variety of minimally invasive procedures. The use of catheters as a means of accessing the human body helps to minimize trauma that might otherwise take place, and those skilled in the art are continually attempting to develop new procedures and instruments which improve upon and expand treatments.
Most vascular access procedures begin with the insertion of a guidewire to a treatment site. Once the guidewire is properly inserted, the physician may utilize the guidewire to insert and maneuver a catheter to a predetermined treatment site. Insertion of a guidewire and catheter is generally accomplished using a multiple step process involving a separate and distinct needle and surgical blade.
Specifically, the physician first makes an incision at a predetermined treatment site and returns the scalpel to a tray table adjacent the operating table (this may also be done after needle insertion). The access opening created by the initial incision is required to permit entry of the catheter after creation of the skin incision, because the catheter is substantially larger than a common guidewire and needle. The physician then retrieves a traditional needle from the tray adjacent the operating table and inserts the needle into the patient's vascular system at a selected location. Once the needle is properly positioned, the physician maneuvers a guidewire through the needle, into the vascular system and to a predetermined location within the vascular system. When the guidewire is properly positioned, the physician may remove the needle, insert the catheter and move forward with the specific procedure.
The many steps and instruments required during the initial stages of guidewire and catheter insertion make the possibility for mishaps more likely. For example, the physician, or nurse, must take the exposed scalpel from a tray to the patient and back to the tray, thus increasing the risk of injury to the operators and exposure to blood born pathogens such as HIV and Hepatitis B and C viruses. In addition, when one performs skin incisions after the insertion of a needle, there is a possibility that the skin incision is not directly adjacent to the needle. Inaccuracies such as this result in tissue being left between the incision and the needle, prevent insertion of the catheter and require revision of the incision. Current techniques further require that the incision be performed prior to the insertion of the needle into the skin of a patient. This may necessitate additional skin incisions in the event vascular access is not successful and another access site is required.
In view of the many shortcomings associated with the current and prior techniques utilized during the initial insertion of a catheter and/or guidewire, a need currently exists for an efficient and accurate surgical tool for performing these procedures. The present invention provides such a tool.
SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to provide a surgical access device. The device includes a hub supporting a needle shaped and dimensioned for penetrating tissue in a desired manner and a surgical blade coupled to the needle for movement along the length of the needle such that the surgical blade may be selectively moved along the needle to incise tissue adjacent the needle.
It is also an object of the present invention to provide a surgical access device including a housing positioned adjacent the hub, wherein the housing is shaped and dimensioned for storing the surgical blade when not in use.
It is another object of the present invention to provide a surgical access device wherein the housing includes a slot into which the blade is retracted in its nonuse position.
It is a further object of the present invention to provide a surgical access device wherein the housing is substantially cylindrical and surrounds a proximal end of the needle.
It is yet another object of the present invention to provide a surgical access device wherein the surgical blade slides relative to the needle.
It is still a further object of the present invention to provide a surgical access device wherein the surgical blade forms part of a surgical blade assembly.
It is also an object of the present invention to provide a surgical access device wherein the surgical blade assembly includes a through hole through which the needle passes for coupling the needle to the surgical blade.
It is a further object of the present invention to provide a surgical access device wherein the surgical blade assembly includes a handle.
It is also an object of the present invention to provide a method for surgical access. The method is achieved by percutaneously accessing a subject with a needle of a surgical access device to create an access opening, retrieving a surgical blade coupled to the needle from a storage position, and moving the surgical blade relative the needle such that the surgical blade incises tissue adjacent the access opening created by the needle.
Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
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Bui Vy Q.
Welsh & Flaxman
Yale University
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