Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-04-23
2003-09-30
Worrell, Danny (Department: 3765)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S131000
Reexamination Certificate
active
06626865
ABSTRACT:
This invention can be used in a method mediating a safe and an optimal cosmetic and functional end result for removing; excise, skin, e.g. skin pathologies, e.g. skin tumors, cosmetically improper skin defects/findings or excessive skin. This invention is related to a method for indicating a periphery line, forming at least a part of a loop on a part of a surface area, in the following denoted “patch”, especially a patch of an optionally resilient surface layer of a substrate object, which patch is intended to be removed in a step, which may cause a change of the appearance of the surface. This method is especially suited for indicating a periphery line on the skin of an animal, such as a mammal, e.g. a human.
It is previously known how to remove parts of a resilient surface layer, e.g. a patch of the skin of a human, with a cutting tool like a surgical scalpel or with a cutting edged tool, such as a punch provided with a number of V-shaped cutting blades, or a punch of circular shape. Such instruments and methods are disclosed e.g. in U.S. Pat. Nos. 5,123,907, 4,192,312 4,576,163, 4,832,045 and 4,542,742. Such cutting instruments are applied substantially on free hand until the desired depth of the cut is reached. When treating malignant skin tumors there is an obvious lack of safety when using a punch without a guiding means since the area of interest is covered by the punch itself during the actual cutting maneuver and thereby it is virtually impossible to verify that there are free macroscopic cutting margins to the tumor. The use of larger circular punches is furthermore restricted, since it is difficult or impossible to close the resulting skin defect in a cosmetically and functionally acceptable way, by a stitching operation.
The method according to this invention comprises the application on the surface of the object of a device, in the following denoted a “mask”, preferably sterile, which may comprise a “negative” mask comprising a hole with a borderline having essentially the shape of the desired periphery line, and/or a “positive” mask, in the following also denoted a “slab”, which comprises a piece of material with an outer borderline having essentially the shape of the desired periphery line. In a combined “negative” and “positive” mask the positive mask or slab essentially fills the hole in the negative mask, e.g. leaving a narrow uncovered area of preferably uniform width between said two masks. The negative and positive masks are in the following exemplified with a piece of sheet-shaped material, e.g. comprising one or more layers of sheet materials, preferably with adhesive characteristics, provided e.g. by an adhesive coating, which makes the mask adhere to the surface of the object. A negative mask according to this invention, when applied on the surface of the object, comprises a main opening with a borderline, also called inner borderline of the mask, which has essentially the shape of the periphery line of the patch, which should be indicated on the surface and optionally removed. Optionally a sterile non-sticky mask, used in combination with a sterile marking pen, can function as a “secondary template”, thereby marking the patch/area of interest and removed prior to the cutting/punching procedure. In the text, the expression “mask” thereby also includes the secondary template.
In order to choose a safe and optimal size and form of planned skin excision a preferably non-sterile template (in the following also denoted mould or model) for simulating the periphery line of the patch on the substrate is included in the invention.
The templates and masks are preferably of a non-hemostatic type, i.e. not intended to be pressed into the skin for restricting the flow of blood in the skin area and neither for the forming of a temporary pressure mark in the skin.
The invention also includes a cutting tool/punch having the corresponding size and form to each chosen variant of mask and template.
The invention comprises a kit of two or three of the following components 1, 2 and 3; 1) one or more masks, 2) one or more cutting or punching tools that can be guided by the corresponding mask, and 3) a template device for simulating a periphery line on a substrate indicating what size and shape of mask and corresponding cutting tool should be chosen.
The invention thus includes a safe novel method where the area intended to be removed before surgery could clearly be inspected and controlled for e.g. satisfying free margins, alignment with skin wrinkles etc. and that the following surgical procedure is mechanically guided by a device; the mask (or marking).
The invention is in following mainly illustrated with reference to negative masks, but that which is said about negative masks essentially applies also to positive masks or combinations of negative/positive masks, e.g. as regards shape, materials, etc.
REFERENCES:
patent: 3522800 (1970-08-01), Lesser
patent: 4192312 (1980-03-01), Wilson
patent: 4279259 (1981-07-01), Lee et al.
patent: 4542742 (1985-09-01), Winkelman et al.
patent: 4576163 (1986-03-01), Bliss
patent: 4944737 (1990-07-01), Bloom
patent: 5123907 (1992-06-01), Romaine
patent: 331392 (1989-09-01), None
Browdy and Neimark , P.L.L.C.
P Prisell AB
Worrell Danny
LandOfFree
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