Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-11-25
2003-11-11
Weiss, John G. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06645178
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical devices and more particularly to an improved apparatus and method for inserting a medical device into a patient.
2. Background of the Invention
The prior art has known of various apparatuses and methods for introducing a medical device into a patient. These medical devices include cardiovascular catheters, catheter tubes, pacemaker electrodes or other medical devices that are inserted into a vein or artery of the patient.
One popular method was the Seldinger technique which utilized an apparatus comprising a dilator and a sheath. The dilator was formed from a rigid plastic tubular material terminating in a tapered tip. The sheath was formed from a flexible plastic material with a scored line extending along the length of the sheath. The sheath was carried on the dilator in a sliding relationship.
A puncture was made in the patient with a needle attached to a syringe. A flexible guide wire was passed through the needle into the patient and the needle and syringe were removed from the patient. The dilator and carried sheath was moved along the flexible guide wire into the original incision for opening or dilating the original incision and for positioning the dilator and the carried sheath within the vein or artery of the patient.
After the dilator and carried sheath was positioned in the desired region of the patient, the guide wire and the dilator were removed leaving the sheath positioned within the tissue. An internal bore of the sheath provided a conduit for introducing the medical device into the tissue and for positioning the device thereby. After the medical device was properly positioned within the tissue, the sheath was withdrawn from the tissue.
In many cases, the sheath was removed by peeling away the sheath from the medical device along the scored line extending along the length of the sheath. The device was positioned within the tissue in a simple and efficient manner.
Various forms of the dilator and the sheath apparatuses are available to the prior art. The following U.S. Patents are representative of some of the dilator and the sheath apparatuses for introducing a medical device into a patient.
U.S. Pat. No. 1,064,307 to Fleming discloses a sheath comprising a longitudinally divided body portion, a central fluid passage in the body portion, having a plurality of discharge openings communicating with the central passage and means for interlocking the longitudinally divided body portions. The means comprises dovetailed interlocking portions in the discharge end of the divided body portions, and segmental portions at the receiving end adapted to be inserted into a locking coupling.
U.S. Pat. No. 2,566,499 to Richter discloses an expansible needle assembly comprising an elongated tubular needle having one end substantially pointed and having at its opposite end an enlargement of rectangular cross-sectional shape provided with a counterbore. The needle is longitudinally divided into two substantially identical parts. A U-shaped bracket receives the enlarged portion of the needle means attaching one part of the needle to one leg of the bracket. The other leg of the bracket has a screw threaded aperture therein, a thumbscrew threaded through the aperture, and means rotatably connecting the thumbscrew to the other part of the needle at the end of the thumbscrew adjacent the other needle part.
U.S. Pat. No. 4,772,266 to Groshong discloses a dilator/sheath assembly for unstressed placement of catheter tubes into a body cavity of medical patients, which insure a stable axial relationship between concentrically superimposed sheath and dilator so that use is very facile for the medical attendant and insures a predetermined two-step gentle enlargement of a puncture site to accommodate unstressed placement of a catheter tube into a vein or artery through the puncture site and with minimal trauma to the patient.
U.S. Pat. No. 4,747,833 to Kousai et al. discloses a medical instrument-guiding tube for guiding a catheter or other rod-like medical instrument into a blood vessel. This guiding tube comprises a hollow tube body and at least one linear body integrally joined to the tube body along the longitudinal direction of the tube body. The plastic resin forming the tube body has a poor compatibility with that of linear body. The tube body and the linear body are engaged together through a complementary concave-convex engagement which can be disengaged with a reasonable force.
U.S. Pat. No. 4,840,613 to Balbierz discloses an improvement in a catheter assembly including a cannula, an inserter having a guide channel therethrough in which the cannula slidably fits and a hub structure with the cannula proximal end portion attached to the hub structure. The improvement includes a sheath having a longitudinal slit or weakened portion and being about the cannula between the inserter and the hub structure. A sheath stripping construction carried by the inserter strips the sheath from about the cannula as the cannula slides distally through the guide channel. A first lock member is carried by the inserter and an interlocking second lock member is located about the cannula between the inserter and the hub structure. The cannula is protected from contamination and from kinking and a positive lock serves to prevent its accidental withdrawal. A method of inserting a cannula using such an assembly is likewise set forth.
U.S. Pat. No. 5,098,392 to Fleischhacker et al. discloses a locking dilator and peel away introducer sheath assembly for preventing undesired rearward migration of a dilator within an introducer sheath to insure a proper longitudinal relationship. The dilator has secured to its proximal end a gripping clamp for holding securely the handle of the introducer sheath to accommodate placement of the dilator and introducer sheath into an appropriate location within a patient resulting in minimal tissue damage and trauma.
U.S. Pat. No. 5,154,703 to Bonaldo discloses a medical device which prevents the backflow of fluid therethrough and is particularly useful as a bloodless catheter assembly, that is, prevents the backflow of blood through the catheter by utilization of a self-closing valve carried in a hollow catheter housing to one end of which a catheter is fixed so as to provide a fluid passage through the catheter and catheter housing. The fluid passage in the catheter housing is sealed by a self-sealing valve element extending transversely across the passage upstream from the catheter. A hollow needle is held in the catheter housing downstream of and pointed at the valve element. Attachment of a fluid dispensing medical device to the other catheter housing end forces the valve element downstream onto the needle so as to pierce the valve element and open a fluid passage from the catheter housing upstream of the valve element through the hollow needle to the catheter. Removal of the medical device permits the resiliently biased valve element to move upstream away from the needle, thereby resealing and thus reclosing the fluid passage which extends through the hollow needle.
U.S. Pat. No. 5,125,904 and U.S. Pat. No. 5,312,355 to Lee discloses a splittable hemostatic valve and introducer sheath provided for introductions of leads or catheters through the valve and sheath combination into a vein or artery. Because of the hemostatic valve, this sheath can remain in the vein throughout the operation with the advantage of free lead exchange possibility and easier lead manipulation, especially in dual lead insertions, without bleeding, risk of air embolism or repeated sheath insertion related trauma for lead exchange. A side arm to the hemostatic valve cage provides continuous fluid drip in order to prevent clot formation in the lumen of the sheath. At the point in the operation where the introducer sheath and hemostatic valve must be removed from the lead or catheter, which must remain implanted, means are employed to split or separate the introducer sheath and valve apart so that the sheath and valve
Junker Larry G.
Thorniley John D.
Frijouf, Rust & Pyle, P.A
Lam Ann Y
Weiss John G.
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