Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2000-02-01
2002-07-16
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C600S101000, C600S104000, C604S164010
Reexamination Certificate
active
06419654
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to systems to perform arthroscopies of joints such as the knee and more particularly relates to a diagnostic needle arthroscopy and lavage, (DNAL) system for performing arthroscopies through a single port.
2. Background Information
Arthroscopy is a surgical procedure in which an endoscope (arthroscope) is inserted into a joint. Fluid is then injected into the joint to slightly distend the joint and allow visualization of structures within the joint. Surgery is usually viewed on a monitor so that the whole operating team can visualize the surgical procedure that is being performed. The arthroscopy procedure falls into two types; operative and diagnostic. Operative arthroscopy is more interventional, utilizing larger devices and multiple ports to accomplish a variety of procedures. Diagnostic arthroscopy is less invasive, requiring smaller devices and a single port of entry into the joint. Operative arthroscopes are typically four (4) mm in diameter. The operative arthroscopic procedure is often conducted under general anesthesia and is used to examine and treat the inside of the joint for damaged tissue. Most common types of surgery using operative arthroscopic procedures includes the removal or repair of torn meniscus (cartilage), ligament reconstruction, removal of loose debris and trimming or shaving damaged cartilage. Diagnostic arthroscopy is done under local anesthetic only and is most often accompanied by a thorough rinsing out of the joint (lavage).
The value of arthroscopy as a diagnostic and therapeutic tool is well recognized by physicians. Recent advances have made it technically feasible to perform diagnostic needle arthroscopy procedures in a physician's office using a small, 1.9 mm flexible fiberoptic arthroscope. Generally the diagnostic needle arthroscopy and lavage procedure is used to diagnose and evaluate joint pathology and relieve pain and limited range of motion symptoms from ostheoarthritis that is not relieved by traditional, conservative medical treatment and management. It is also utilized in treating refractory synovitis and determining uncertain etiology. The DNAL procedure has also been found to be an excellent alternative for those patients unable to tolerate the risks of general anesthesia or are unwilling/unable to undergo joint replacement.
Osteoarthritis is a common problem for many middle-aged people. Osteoarthritis is sometimes referred to as degenerative, or wear-and-tear arthritis, produced by aging. It can also result from a direct injury to the joint. Instability from ligament damage to the cartilage and meniscal injuries cause abnormal wear and tear of the knee joint. Not all cases of ostheoarthritis are related to prior injury however. Research has shown that many are prone to develop osteoarthritis and the tendency may be genetic. Obesity is also a contributory factor. The main problem of osteoarthritis is degeneration of the cartilage that covers articulating surfaces of the joint, resulting in areas of the joint where bone rubs against bone creating bone spurs. Generally osteoarthritis develops slowly over several years. The symptoms are mainly pain, swelling, and stiffening of the joint. As the condition worsens or progresses, pain can interfere with simple, daily activities. Traditional conservative methods of medical treatment include taking anti-inflammatory medication and cortisone injections to reduce the swelling and inflammation of the joint and a variety of pain medications to suppress the bodies pain response.
Recently arthroscopic surgeries have been performed in the doctor's office to diagnose and treat a variety of symptoms including osteoarthritis, rheumatoid arthritis, crystalassociated arthritis, and mono-articulate arthritis of unknown etiology. DNAL performed in the physician's office is done under local anesthetic, with the patient awake throughout the procedure. A video monitor is typically used and the patient may observe the procedure if desired. The surgical site is prepared and draped in the appropriate manner and the procedure is performed under sterile conditions. Local anesthesia is injected into the tissue surrounding the surgical site and also into the joint.
The correct placement of an entry port or portal is performed in the usual fashion using the cannula with a sharp trocar inserted to pierce the surface tissue and then a blunt trocar (obturator) to pop through the joint capsule. The blunt obturator is removed from the cannula and the 1.9 mm arthroscope is inserted in its place. Irrigation is performed through the cannula which is connected by tubing to a hanging bag of irrigation solution (sterile saline) under pressure. Infusion of saline is performed until a clear visual field is obtained and is intermittently maintained throughout the procedure.
With the arthroscope inserted in the cannula and a clear field, the compartments of the knee may be visualized and inspected. If biopsy of interarticular tissue is desired or cartilage thickness and quality needs to be evaluated, a biopsy cannula is used to replace the diagnostic cannula and the appropriate instrument used. This is accomplished through the same single port into the joint and under visualization.
The irrigation or lavage of the joint and subsequent aspiration or removal of fluid, removes particulate matter floating in the joint and has been shown to have beneficial affects with regard to pain relief. The flushing or removal of loose bodies in the knee is also therapeutic. By comparison, operative arthroscopy requires a minimum of two larger ports into the joint for biopsy; one for the arthroscope and one for instrumentation. A disadvantage of the present system of operative arthroscopy is the requirement for a second portal for insertion of surgical instruments.
It is therefore one object of the present invention to provide a diagnostic needle arthroscopy and lavage system using a single port entry system allowing the physician to use minimally invasive, direct visualization approach for diagnosis and also provide therapeutic benefit of completely flushing of the joint with sterile saline (lavage).
Another object of the present invention is to provide a unique proprietary suction/irrigation handpiece that doubles as diagnostic entry cannula into the joint and also as a housing for a 1.9 mm fiberoptic arthroscope during the procedure. The handpiece also provides suction and irrigation capabilities on demand through finger controlled trumpet valves.
Another object of the present invention is to provide a diagnostic needle arthroscopy and lavage system that permits diagnostic evaluation of a joint along with therapeutic lavage which provides long-term pain reduction/relief by flushing loose bodies and chemical irritants commonly found in chronic osteoarthritis (OA) and rheumatoid arthritis (RA).
Yet another object of the present invention is to provide a diagnostic needle arthroscopy and lavage system that uses devices of very small size and a single entry port that is an advantage over multiple punctures and ports used in standard operative arthroscopy making the procedure ideal for use in a physician's office. With the system disclosed and described, arthroscopic diagnosis and lavage may be performed under local anesthetic only and in conjunction with a mild oral sedative. Patients experience minimum discomfort and return to normal activities, sometimes in a few hours, or the next day.
Still another object of the present invention is to provide a diagnostic needle; arthroscopy and lavage system that competes with magnetic resonance imaging (MRI) for diagnosing joint disease. The diagnostic needle arthroscopy and lavage procedure is both diagnostic and therapeutic while the MRI is only diagnostic and does not permit the opportunity to visualize joint pathology, sample tissue, or allow certain interventional treatment modalities.
Direct visualization of joint surfaces and pathology is a superior form of diagnosis when compared to MRI and is also
O'Reilly David
Patel Vinod D.
Walberg Teresa
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