Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2002-07-05
2004-08-24
O'Connor, Cary E. (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
C606S093000, C606S08600R, C606S094000
Reexamination Certificate
active
06780191
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the surgical field of cannulas and to the apparatus and process for injecting and/or aspirating biological material or apparatus into/out of the body for treatment and support.
BACKGROUND OF THE INVENTION
The use of cannulas to gain access to the interior regions of a patient's body is very old. In recent history, the use of the cannula in all types of surgery has gained wide acceptance. Heart catheterization and delivery of stints contributed to the increased popularity, as well as laproscopic surgery of all kinds. These techniques have reduced patient trauma, incidence of infection and hospital stays. These procedures have in common gaining access to the interior of the body by a small stab wound through which is inserted a cannula for maintaining a passageway. All sorts of other surgical implements may then traverse this passageway depending on the specific procedure to be performed on the patient.
Vertebroplasty was introduced to the medical arts as a percutaneous technique for repairing spinal compression fractures by injecting bone cement into the vertebral body. However, the technique quickly expanded to osteoporotic individuals that had been treated with narcotics and immobilization. The bone cement is used to shore up the collapsing vertebrae for support which relieves the pain associated with undue pressure on the nerves.
Radiologists and surgeons are involved in the procedure since the process is monitored by fluoroscopy and has the potential for leakage of the cement into the local blood stream. Some of the critical parameters of the procedure involve the mixing of the cement to an appropriate viscosity, ensuring that the cement is radio-dense for viewing, properly placing the injector inside the cancellous portion of a vertebra, and rigorously controlling injection pressure and quantity. See “Vertebroplasty: Dangerous Learning Curve,”
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DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 6,273,916 to Murphy describes vertebroplasty, generally, as performed on a prepped and draped prone patient who has been injected with a local anaesthetic. A skin incision is made over the selected vertebrae and a needle is inserted in a posterior approach to engage the vertebral body. A suitable cement is prepared using a contrast medium, such as barium powder, mixed with methylmethacrylate powder, and a monomer liquid. The cement (PMMA) becomes unworkable within 4 to 11 minutes from mixing.
Cement is injected into the vertebrae, while visualized by lateral and anterior-posterior X-ray projection fluoroscopy imaging. The injection is halted if the cement starts to extend into unwanted locations, such as the disc space or towards the posterior quarter of the vertebral body where the risk of epidural venous filling and spinal cord compression is greatest. If no unwanted migration is detected, the injection continues until the vertebrae is adequately filled. The amount of cement injected may vary considerably, e.g. from 4 to 36 cc.
Reiley et al, U.S. Pat. No. 6,048,346, teach a posterior-lateral approach for accessing the interior of the vertebrae for injecting bone cement or treatment substances or a combination of both. The bone cement is injected using a caulking gun-like device with a ram rod in the barrel.
Goldenberg et al, U.S. Pat. No. 5,634,473, and Goldenberg, U.S. Pat. No. 5,843,001, both teach a removable handle for biopsy needles used for bone biopsy.
What is needed in the art is a simple apparatus having several components operated by the same handle to perform cannulazation and treatment of the body.
SUMMARY OF THE INVENTION
Accordingly, it is an objective of the instant invention to teach a kit having a guide needle, cannulas, several different cannula tips, a plunger, a clearing tool, a connector and a universal handle.
It is a further objective of the instant invention to teach a kit for biopsy and injection of biological materials which is sized to deliver a precise amount of biological material.
It is another objective to teach a kit with several interchangeable tips to be fitted on the leading end of the cannula for different penetrations of the body.
It is a still further objective of the invention to teach a kit for orthopedic use to perform bone biopsy and to deliver a biological material to the cancellous portion of bone.
It is yet another objective to teach a kit in which the universal tool has plural elements spring biased together and forms a temporary connection with the other components of the kit by operation of the spring bias.
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U.S. application Ser. No. 09/828,539, Filed: Apr. 4, 2001; Preissman, Howard, “Enhanced Visibility Materials for Implantation in Hard Tissue”.
DePuy Catalogue, 1995, “Mixing Assembly”, Cat. No. 5401-33-00; “Cement Injector Gun”, Cat. No. 5401-34-000.
US application No. 2001/0012968; Filed: Aug. 9, 2001; Howard Preissman.
McHale & Slavin PA
Melson Candice C.
O'Connor Cary E.
Yacmur LLC
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