Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2002-12-31
2004-09-14
Jones, Mary Beth (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06790185
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the Invention
This invention relates, generally, to methods for sealing biopsy tracts. More particularly, it relates to apparatus and methods that enable precise positioning of a bioabsorbable sealant plug in a predetermined optimal location.
2. Description of the Prior Art
Air leaks commonly occur at pulmonary tissue sites that have been dissected during surgical resection and manipulation or surgical resection or manipulation. Air leaks also occur after fine needle aspiration biopsy of the lung. Pneumothorax (air leakage) occurs in about thirty per cent (30%) of lung biopsies. An opening in a lung is undesirable because air leaks therefrom and causes the lung to collapse. Openings in other organs, such as the heart, liver, kidney and the lime are also undesirable due to excess bleeding and other related problems.
Pending patent application Ser. No. 10/063,620, filed May 6, 2002 by the present inventors discloses a novel hydrogel polymeric base material formed into the shape of a plug to seal a biopsy tract to prevent pneumothorax in the lungs and bleeding in other internal organs. That pending patent application is incorporated by reference into this disclosure.
There remains a need, however, for apparatus and methods for accurately delivering the sealant plug under CT imaging and other imaging modalities and deploying it with a high degree of precision to achieve optimal efficacy.
The sealant plug must be placed beyond the pleura of the lung to prevent pneumothorax. Accurate placement is required for any depth and position of the biopsy or tissue tract. Such accurate placement must also be made for other internal organs such as the liver, kidney, the heart, i.e., the sealant plug must be positioned at or beyond the surface of such organs to prevent or eliminate bleeding.
There is also a need for a sealant plug having a faster rate of hydration than the plugs heretofore known. One of the most important parameters of a sealant plug is the expansion rate and its ability to seal a tract in a short period of time.
A sealant plug is needed that provides a faster expansion rate than the sealant plugs heretofore known so that it will seal a tract faster, thereby reducing pneumothorax in a lung and bleeding in other internal organs.
However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how such apparatus and methods and improved sealant plugs could be provided.
SUMMARY OF INVENTION
The long-standing but heretofore unfulfilled need for a delivery system for accurately placing a bioabsorbable sealant plug in an optimal location in a biopsy tract is now met by a new, useful, and nonobvious invention. The novel method includes the steps of performing a biopsy procedure with a biopsy needle and a coaxial needle having a movably mounted marker thereon. When the biopsy procedure is finished, the biopsy needle is removed from a biopsy tract formed by the procedure. The coaxial needle is left in the biopsy tract in the same position it was in during the biopsy procedure.
A distance “a” is measured by an imaging means from a point of entry by the biopsy needle at a skin surface to the surface of the internal organ upon which the biopsy procedure was performed.
A distance “b” is measured by the imaging means from the surface of the internal organ at the point of entry to a lesion within the internal organ.
Where a sealant plug of cylindrical configuration having a preferred length of about two and one-half centimeters (2.5 cm) is used, a distance “d” is calculated by adding two centimeters (2.0 cm) to distance “a.” If a plug having a length of 1.5 cm is used, distance “d” is calculated by adding 1.0 cm to distance “a.” If a plug having a length of 3.0 cm is used, distance “d” is calculated by adding 2.5 cm to distance “a.” The distance added to distance “a” must position the leading end of the plug at a depth in the biopsy tract such that about one-half centimeter (0.5 cm) of the trailing end of the plug protrudes out of the biopsy tract, beyond the surface of the lung or other internal organ, for a plug of any length. Thus, half a centimeter is subtracted from the length of the sealant plug, and that length is added to distance “a” to arrive at distance “d.” After the biopsy procedure has been completed and the biopsy needle has been removed from the lumen of the coaxial needle and distance “d” has been calculated, the coaxial needle is advanced or retracted as needed so that its distal end is distance “d” from the surface of the patient's skin. Centimeter markings or graduations are imprinted, notched, or otherwise marked on the coaxial needle, beginning from its distal end.
More particularly, suppose a plug of length 2.0 cm is used and distance “d” is therefore calculated by adding 1.5 cm to distance “a” so that the trailing end of the plug will protrude from the biopsy tract by 0.5 cm when the plug is properly positioned. If distance “a” is 3.0 cm, then distance “d” is equal to 4.5 cm. If the distal end of the coaxial needle is less than 4.5 cm from the surface of the patient's skin at the conclusion of the biopsy procedure, the marker on the coaxial needle is moved to the 4.5 cm position and the coaxial needle is advanced until the marker abuts the patient's skin. If the coaxial needle is more than 4.5 cm beneath the patient's skin at the conclusion of the biopsy procedure, the marker is moved back if needed and the coaxial needle is withdrawn until the 4.5 cm marker thereon is flush with the patient's skin and the movable marker is then brought into contact with the patient's skin.
A supporting leg and a plunger are then connected to one another and their respective positions relative to one another are adjusted in accordance with a chart containing predetermined settings including a plunger-to-supporting leg ratio with respect to measurement of said distance “a.” Graduation markers on the plunger are provided to facilitate the interconnection. The plunger is then locked into position relative to the supporting leg, thereby forming a plunger/supporting leg assembly.
The sealant plug is then introduced into the coaxial needle at the trailing end thereof. The assembly is then brought into ensleeving relation with the coaxial needle. Specifically, the leading end of the supporting leg is positioned in abutting relation to the patient's skin. The leading end of the plunger enters into the trailing end of the lumen of the coaxial needle, pushing the sealant plug ahead of it in a trailing-to-leading direction. When the leading end of the supporting leg abuts the patient's skin, the sealant plug is still housed within the lumen of the coaxial needle, but it is positioned at the desired position. Specifically, the leading end of the sealant plug is flush with the leading end of the coaxial needle.
The coaxial needle is then removed from the biopsy tract while maintaining the supporting leg and the plunger in their respective positions, thereby deploying the sealant plug into the biopsy tract. The trailing 0.5 cm of the sealant plug protrudes from the biopsy tract, above the surface of the internal organ having the lesion that was the subject of the biopsy. The supporting leg and the plunger are then withdrawn, leaving the sealant plug in said internal organ at said preselected optimal position.
In a second embodiment, the method for delivering a sealant plug to an optimal position within an internal organ with a high degree of accuracy includes the steps of providing a supporting leg in the form of a pistol grip body that includes a pivotally-mounted trigger. A plunger is mounted to the supporting leg such that the plunger may be advanced or withdrawn when the trigger is pulled. A marker is slideably mounted on the plunger and graduation marks are provided along the extent of said plunger. Graduation marks are also are imprinted or otherwise provided along the extent of the supporting leg.
As in the first emb
Ahari Frederick
Fisher John S.
Biopsy Sciences, LLC
Jones Mary Beth
Smith Ronald E.
Smith & Hopen , P.A.
Szmal Brian
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