Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
1999-02-26
2002-12-31
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C030S329000
Reexamination Certificate
active
06500187
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a scalpel with a double grind blade edge and detachable handle. During performance of surgery, the surgeon typically employs a scalpel to cut tissue. In this environment, the scalpel blade becomes dull within one to two minutes as evidenced by the tearing of tissues with the scalpel blade in jagged, uneven cuts. Eventually, after a total of three to five minutes, the blade will no longer cut tissues and must be replaced.
During a typical total hip or total knee surgery case, the surgeon can use as many as ten to fifteen blades. Having to change the scalpel blade that many times during the course of a single surgery eliminates any notion of continuity and greatly increases surgery time while also increasing the risk that the surgeon or nurse technician will be cut while changing the blade, thereby being exposed to communicable diseases such as AIDS and the various types of hepatitis.
Applicant has found that the necessity to change blades as often as ten to fifteen times per surgery can increase the length of time of the surgery by as much as 15% or more. A typical operating room costs about $1,200.00 per hour to staff and operate. If it were possible to save time during the performance of surgery by devising a scalpel blade that would not have to be changed as often as is currently done, great savings of time and money would result.
Applicant has found that angulation of the blade is helpful when doing certain surgical tasks. For example, it is easier to cut the skin with the blade tilted upward and for certain precise dissection, it is easier when the blade is tilted downward.
Additionally, when human tissue is torn rather than cut, ugly, painful scars result. A blade that would stay sharp for 10-20 minutes would definitely alleviate scarring and subsequent pain to the patient.
Additionally, typical scalpel blades as currently used are extremely thin, typically having a thickness of 0.015 to 0.018 inches with a large oval fixation hole in the tang of the blade. As a result, it is quite common for the scalpel blade tip to break off in the depths of the wound at the surgical site. When this occurs, it is often difficult to find and retrieve the blade tip. When a surgery is completed without retrieval of the blade tip, a malpractice law suit will often result because the unretrieved blade is easily visible in an X-ray image. Thus, also, a need has developed for a scalpel blade that has reduced brittleness and is less likely to break off in use.
It is with these needs in mind that the present invention was developed.
SUMMARY OF THE INVENTION
The present invention relates to a scalpel with double grind blade edge and detachable handle. The present invention includes the following interrelated objects, aspects and features:
(1) In a first embodiment, the present invention contemplates a scalpel having a blade with a fitting molded about the proximal end thereof. The fitting has a proximally facing opening that is sized and configured to receive an end of a distal portion of a detachable handle.
(2) In the first and second embodiments, the handle includes a proximal portion that is designed to be gripped by the surgeon and a distal portion that comprises a male coupling half designed to be received within the proximal opening of the fitting, which proximal opening comprises a female coupling half.
(3) In the first and second embodiments, the proximal and distal portions of the handle are preferably angled with respect to one another with the proximal portion of the handle being angled from about 0°-10° with respect to the axis of the distal portion of the handle. Additionally, the proximal portion of the handle is tapered from a thinner portion adjacent a distal end thereof to a thicker portion adjacent a proximal end thereof. The taper in the distal to proximal direction may be in the range of approximately 1°-2°. The male coupling half at the distal portion of the handle may be inserted within the female coupling half at the proximal end of the blade fitting in either one of two diametrically opposed orientations. Thus, due to the angulation between the proximal portion of the handle and the distal portion of the handle, the proximal portion of the handle is either angled downwardly or upwardly with respect to the axis of the blade itself. Thus, the handle may be attached to the blade in either one of these two positions depending upon the particular surgical step that is being carried out by the surgeon.
(4) In the first and second embodiments, the blade itself is provided with a double grind which enhances the sharpness and longetivity of the blade. In the preferred embodiment, the blade includes a primary grind defining an angle of 6°-10° per side and a secondary and final grind of 14°-18° per side. Thus, as should be understood, the absolute edge of the blade is defined by two angled surfaces defining the final grind of the blade which creates an angle from the edge of the blade backward of 28°-36°.
(5) In a further aspect, in the embodiments of the present invention, the blade itself is made of a thickness of from 0.020-0.029 inches as compared to commonly used scalpel blades which, as explained above, have a thickness of about 0.015-0.018 inches. Additionally, if desired, the cutting surface of the scalpel blade may be coated with a very thin layer of, for example, zirconium nitride by any suitable process such as, for example, vapor deposition. This coating increases the longetivity of the sharpness of the scalpel blade by up to ten times. Other alternative coatings and methods of coating are disclosed herein.
(6) In the second embodiment, instead of molding the fitting about the blade, the fitting is mechanically connected to the blade and may be removed therefrom for sterilization. In the second embodiment, a spring clip is interposed between the proximal end of the blade and the fitting and the blade may be attached to the fitting via the spring clip in either one of two opposed orientations.
(7) Applicant has found that applying a thin coating of body compatible intermetallic nitrides, oxides or carbides to the blade's surface markedly adds to the sharpness and longevity of the blade. Examples of such metal elements are: Titanium, Zirconium, Niobium, Hafnium and Tantalum. Additionally, adding the coatings of body compatible intermetallic phosphides to the blade surface creates a lubricious condition allowing the blade to cut more smoothly through tissues. Examples of such metal elements are: phosphides of Titanium, Zirconium, Niobium, Hafnium, Tantalum and Magnesium (Mg).
Accordingly, it is a first object of the present invention to provide a scalpel with double grind blade edge and detachable handle.
It is a further object of the present invention to provide such a device wherein a handle is receivable in a proximal fitting attached to the scalpel blade in either one of two opposed orientations.
It is a still further object of the present invention to provide such a scalpel with a blade edge defined by a double grind to enhance longetivity of sharpness.
It is a yet further object of the present invention to provide such a scalpel blade of a thickness in the range of 0.020-0.029 inches to enhance strength and significantly reduce the incidence of blade breakage.
It is a still further object of the present invention to provide such a scalpel with a proximal fitting molded about the proximal end of the blade, in one embodiment thereof.
It is a still further object of the present invention to provide such a scalpel with a proximal fitting mechanically connectable to the proximal end of the blade, in a second embodiment thereof.
These and other objects, aspects and features of the present invention will be better understood from the following detailed description of the preferred embodiment when read in conjunction with the appended drawing figures.
REFERENCES:
patent: 2382304 (1945-08-01), Foltz et al.
patent: 3311976 (1967-04-01), Matwijcow
patent: 4014343 (1977-03-01), Esty
patent: 4147443 (1979-04-01),
Spiegel H. Jay
Thaler Michael H.
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