Submucosal tonsillectomy apparatus and method

Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue

Reexamination Certificate

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C606S041000

Reexamination Certificate

active

06682501

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an apparatus to treat tonsils, and more particularly, to an apparatus that creates cell necrosis within the intratonsil lymphoid stroma while substantially preserving the underlying tonsil capsule and overlying mucosa.
2. Description of Related Art
Tonsillectomy is a procedure indicated for recurrent infection of the tonsils and surrounding tissues and/or airway obstruction caused by the tonsils. It is one of the most frequently performed operations in the western world. Post-operatively, it is also one of the most painful due to the resultant exposure of unprotected oropharyngeal nerve and surrounding muscle tissue. The healing process is a slow taking between two to three weeks for the injured tissue to become overgrown with new epithelial/mucous membrane tissue. This period is typically characterized by considerable pain, dehydration and weight loss due to difficulty in swallowing as well as occasional hemorrhaging.
Tonsillectomies and adenotonsillectomies are some of the most commonly performed surgical procedures in the United States and elsewhere, with an estimated 340,000 procedures performed in the United States each year. The major complication of tonsillectomy is post-operative hemorrhage. With refinements tonsils techniques are removed over time have been refined, electrocoagulation has been used more frequently to achieve hemostasis.
While suction electrocoagulation for removal of tonsils is an effective method with minimal blood loss (e.g. blood vessels are electrocoagulated as they are encountered), the procedure has several important limitations. First is the fact that coagulation causes trauma to surrounding and subjacent tissues 1 to 2 mm beyond the point of contact. This causes unwanted tissue necrosis and may lead to late post-operative bleeding. Also, suction electrocoagulation devices heretofore presented are not good dissecting instruments. Nonetheless, there is a tendency to use such electrocoagulation devices to cut through adherent tissue which leads to even greater tissue trauma. The other option is to switch back and forth between using a suction electrocoagulation device and a dissecting instrument such as a Fischer “hockey-stick” style dissector. Such switching between instruments prolongs the surgery and the time the patient must remain under anesthetic, permits additional hemorrhaging during instrument changes, and decreases efficiency.
Another method for the removal of tonsils involves the use of bipolar electrocoagulating forceps. With bipolar electrocoagulation, tissue damage is limited to the tissue between the tines of the bipolar coagulator. A recent study by Dr. Mario Andrea in the October, 1993 edition of Laryngoscope used this technique in 265 patients. The study demonstrated its effectiveness and also negligible delayed post-operative bleeding. The bipolar electrocoagulating forceps is designed principally for coagulation. If suction is needed, which is not uncommon, another instrument must be introduced into the operating field. To some degree, a bipolar coagulator may be used as a dissecting instrument; there are many instances where conventional dissection is more advantageous as dissection is not inherent in the bipolar coagulator's design.
There is a need for an apparatus to treat the tonsil and perform a tonsillectomy with minimal bleeding. There is a further need for an apparatus to treat the tonsils and perform a tonsillectomy without total removal of the tonsils. Yet a further need exists for an apparatus to perform a tonsillectomy by ablating the intratonsil lymphoid stroma. Still a further need exists for an apparatus to treat tonsillectomy by ablating the intratonsil lymphoid stroma while preserving the tonsil's underlying fibrous capsule and overlying mucosa.
SUMMARY OF THE INVENTION
Accordingly, an object of the invention is to provide an apparatus to treat tonsils.
Another object of the invention is to provide an apparatus to create controlled necrosis within a tonsil, particularly the intratonsil lymphoid stroma.
A further object of the invention is to provide an apparatus to create controlled necrosis of the intratonsil lymphoid stroma while substantially preserving the tonsil's underlying fibrous capsule and overlying mucosa.
Yet another object of the invention is to provide a method to create controlled cell necrosis of a tonsil's intratonsil lymphoid stroma.
Still another object of the invention is to provide a method to create controlled cell necrosis of the tonsil's intratonsil lymphoid stroma while substantially preserving the underlying fibrous capsule and overlying mucosa.
These and other objects of the invention are achieved in a cell necrosis apparatus. The apparatus includes an elongated member with a longitudinal axis. The elongated member being is configured to be position able and maneuverable in an oral cavity. First and second energy delivery devices are positioned at a distal portion of the elongated member. Each of the first and second energy delivery devices is laterally offset from the longitudinal axis.
In another embodiment, the tonsil treatment apparatus includes a template including a first tissue penetrating introducer with a first lumen. A first energy delivery device is at least partially position able in the first lumen. The first energy delivery device is advancable from the first lumen into a tonsil intratonsil lymphoid stroma.
In yet another embodiment, a method of reducing the size of the tonsil provides an elongated member coupled to a first energy delivery device with an energy delivery surface. At least a portion of the energy delivery surface is delivered into an interior of the tonsil. Cell necrosis is created in the tonsil intratonsil lymphoid stroma while preserving a tonsil fibrous capsule.


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