Surgery – Instruments – Means for removal of skin or material therefrom
Reexamination Certificate
2001-03-13
2003-01-07
Lindsey, Rodney M. (Department: 3765)
Surgery
Instruments
Means for removal of skin or material therefrom
C451S087000, C451S090000, C451S099000, C604S290000
Reexamination Certificate
active
06503256
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the removal of surface portions of dead or living tissue, sometimes termed microdermal abrasion or micro-dermabrasion. More particularly, the invention relates to an improved apparatus and process for the abrasion of surface portions of human tissue by the controlled flow of abrasive particles.
BACKGROUND OF THE INVENTION
Conventional microdermal abrasion apparatuses employ a stream of abrasive particles such as sand applied to the surface of the tissue or skin by means of a vacuum pump through an opening in a hand held tool (termed a handpiece) which is sealed against the skin. The handpiece is passed over the area of skin to be abraded so the particle stream can impinge on the skin through an opening in the handpiece. The spent particles and the removed tissue are then collected by vacuum pressure in the handpiece and are delivered to a collection container for later disposal. Suitable filtration is provided to prevent the escape of the abraded tissue and particles into the vacuum pump and the atmosphere.
Conventional handpieces usually provide a first channel for conducting abrasive particles from a supply container to the area to be treated and a second channel for conducting the spent particles and abraded skin away from the area treated to the collection container.
A typical prior art microdermal abrasion device is shown in U.S. Pat. No. 5,037,432. The hand-held head disclosed in this patent is a long tubular structure including an inlet passage for the abrasive particles and an outlet passage for removal of the spent particles and abraded skin. A treatment orifice in the form of an off-center hole at a 45° angle to the longitudinal axis of the handpiece is aligned with the abrasive particle inlet passage to permit the abrasive particle to reach the area of skin to be treated.
The above described handpiece has several drawbacks. Because the treatment orifice is off-axis, the handpiece must be carefully positioned to assure proper contact with the area under treatment, and because it must be held at an angle, is difficult to manipulate over a curved surface such as a human face. As a consequence, the patented handpiece is both uncomfortable and tiring to use.
Moreover, the patented handpiece has been found to be subject to frequent clogging. This requires the operator to repeatedly stop the treatment to clear the blockage.
In addition, the handpiece described above includes a disposable tip or bell section which contains the treatment orifice. The tip is press-fitted onto the body of the handpiece and is tightly sealed thereto to prevent accidental escape of abraded skin and loss of vacuum. This makes it hard to remove for replacement. Further, with the treatment orifice positioned off the longitudinal axis, the tip must be carefully aligned with the particle inlet passage. Although an alignment key on the tip and a cooperating keyway on the handpiece body are provided, the need for proper alignment adds to the difficulty of removal and replacement.
As previously noted, prior art devices typically employ vacuum pumps as the source of operating power. However, the prior art (including the patented device described above) do not provide a convenient way for the suction to be changed by the operator when a weaker or more forceful stream of abrasive particles is desired at particular locations. Similarly, continuously variable control of particle flow rate, i.e., particle volume, has not been provided. Instead, only a single or a few predetermined flow rates are permitted. For example, U.S. Pat. No. 5,954,730, issued to Bernabei, provides a two-position switch operated valve allowing two levels of suction pressure.
In addition, in some conventional handpieces, the tubes leading from the particle supply container and to the collection container are formed integrally with or press-fitted onto the handpiece. This means that the handpiece must also be discarded when the tubes, which are subject to wear due to the effects of the abrasive particles flowing therein, are replaced. This construction also makes sterilization of the handpiece impractical, and sterility of only the replaceable tip can be assured.
In other known devices, threaded fittings are provided for connecting the handpiece to the tubes, such as disclosed in U.S. Pat. No. 5,037,432, issued to Molinari. In this device, however, the diameter of the handpiece is small for ease of handling. Therefore, a tool is required to manipulate the threaded connections, which is both inconvenient and time consuming. Also, the small size of the fittings dictates use of fine threads which have proved to be subject to cross-threading.
Yet a further problem with known prior art relates to the particle supply and waste containers. Typically, the containers are permanent parts of the apparatus so the supply container must be refilled when empty and the waste container must be emptied when full. When either of these operations are performed, clouds of fine abrasive dust are released.
In the case the supply container, this is an inconvenience in that the dust settles on surrounding surfaces and must be removed. Moreover, care must be taken to avoid abrasion when the surfaces are cleaned.
In the case of the waste container, however, the problem is more severe as the abraded skin particles are a source of potential biological contamination to which the operator is directly exposed when emptying the waste container. In addition, the dust cloud released when the container is emptied is a source of environmental contamination.
In one known device disclosed in U.S. Pat. 5,971,999 to Naldoni, a refilled supply container is employed which is then used as the waste container when it is empty. However, these containers are open while they are attached to and removed from the Naldoni machine, so the operator and the environment are still exposed to the clouds of abrasive particles.
In another known device shown in French Patent 2,712,172 to Rabier, a filter bag inside a non disposable outer container is used for waste collection. The full bag is open when it is removed from the outer container, thus again exposing the operator and the environment to the contaminated waste. Also, during disposal, the operator and the environment will be exposed to any contaminated dust which escapes through the filter bag into the outer container.
Moreover, with all of the known devices, various non-disposable parts are permanently mounted on the machine. This makes it difficult, if not impossible, to clean these parts thoroughly.
Yet another problem in the prior art is non-uniform flow and clogging of the abrasive particles in the supply line and the passages of the handpiece. These problems are apparently related in a complex manner to the geometry of the flow passages, and are serious drawbacks in conventional equipment.
SUMMARY OF THE INVENTION
According to the present invention, a novel apparatus and process is provided which alleviates the problems with prior art devices as stated above, and which provides other operational improvements as well.
A first aspect of the invention is the provision of a novel handpiece having several important features.
As a first feature, the novel handpiece is comprised of an elongated body portion, a particle supply channel and a waste removal channel extending lengthwise through the body portion, and a removable tip which may be attached to one end of the body portion, A treatment orifice is provided at one end of the tip and is aligned with the longitudinal axis of the handpiece. The particle stream exits the particle supply channel at a point which is radially displaced from the longitudinal axis of the handpiece, but the particle supply channel is so oriented that the stream of abrasive particles is directed substantially toward the center of the treatment orifice. In a preferred embodiment, this is achieved by angularly offsetting the particle supply channel relative to the longitudinal axis of the handpiece.
A further feature of the novel handpiece is the employment of a cou
Cho Young
Maguire George
Parkin Roger
Dermamed, Inc.
Ostrolenk Faber Gerb & Soffen, LLP
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