Surgery – Instruments – Light application
Reexamination Certificate
2001-12-31
2004-03-02
Peffley, Michael (Department: 3739)
Surgery
Instruments
Light application
C606S009000, C606S013000
Reexamination Certificate
active
06699237
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to face-lifting devices, and more specifically, it relates to a surgical device that can quickly and safely separate tissue planes. In addition, the invention relates to a face-lifting device that can apply energy to tissue to induce tightening.
2. Description of Related Art
Definitions, Critical Anatomy and Nomenclature:
Cutting (in surgery) is herein defined as relatively cleanly breaking through similar or dissimilar tissues with minimal adjacent tissue trauma and thus little tissue stretching, tearing or ripping. Lysis (in surgery) is herein defined as breaking through similar or dissimilar tissues with or without adjacent tissue trauma and may involve stretching, tearing or ripping. Depending upon the tissues lysed, the degree of stretching or tearing of lysed tissue edges may be inconsequential or may even result in a desirable benefit such as post surgical contraction. Planes of tissue are not often flat and represent the curviform intersection of dissimilar tissues and are made at least partly of fibrous tissues, either loose and spongy or firm and tough. Planes between the soft internal organs are usually loose and spongy. Planes of tissues in the face and on bones are firm and tough. Undermining is herein defined as tissue separation either within or between defined tissue planes. Undermining may be sharp (instrument) or dull (instrument) depending upon the amount of fibrous tissue binding or existing between the tissue planes to be separated. Undermining is usually performed, as is most surgery, with the intention of minimizing trauma. Sharp instrument undermining is usually performed to separate highly fibrous or collagenous tissues; however, sharp undermining suffers from the risk of penetrating adjacent tissues inadvertently because of loss of ability to follow the desired plane. Inability to follow or maintain the plane in sharp undermining is frequently due to limited visibility, difficulty “feeling” the fibrous plane, or scarring (collagen fibrosis) resulting from previous trauma or surgery. Even experienced surgeons may from time to time lose the correct plane of sharp undermining; great skill is required. Blunt undermining allows a rounded, non-sharp tipped, instrument or even human finger to find the path of least resistance between tissues; once the desired plane is found by the surgeon, it is easy to maintain the plane of blunt undermining until the task is complete. Unfortunately, blunt undermining between highly fibrous tissues such as the human face usually causes tunneling with thick fibrous walls. Dissection usually implies sorting out and identification of tissues and usually implies that some sort of undermining has been performed to isolate the desired structure(s). In face-lifting surgery, plastic surgeons have so commonly used the terms undermining and dissection interchangeably that they have become synonymous in this specific situation. Tracking means to maintain a direction of movement upon forcing a tissue-separating instrument without unpredictable horizontal movement or leaving the desired tissue plane(s). Planar tracking means to stay in the same tissue planes. Linear tracking means to move uniformly in a straight or uniformly curved path without unpredictable movement. Groups of linear tracks may form a network that creates an undermined tissue plane.
Disadvantages of the current face-lifting and brow-lifting techniques are numerous and have resulted in undesirable outcomes and litigation. Face-lifting and tissue-tightening devices described in the prior art resemble undermining devices that were constructed with cutting edges that rely entirely on the skill of the surgeon to maintain control. Inadvertent lateral cutting or tissue trauma may be difficult to control. Thus, tissue positioning of a cutting edge is the paramount problem with current face-lifting/undermining technology. In addition, speed of separation is important to reduce the time that the patient is exposed to anesthetic drugs; time duration of anesthesia may be directly related to the risk of anesthetic complications. Use of prior art undermining devices (including scissors, sharp rhytisectors, etc.) in these planes during cosmetic surgery has, at times, resulted in unwanted cutting, trauma or perforation of adjacent structures. Scissors and rhytisectors are planar cutting instruments; thus, the position of the cutting edges with respect to the surface of the face is controllable only by the surgeon who must estimate cutting edge's location, as no intrinsic third dimensional limitation to movement exists in the instrument. Unfortunately, scissors with 3 dimensional or “bulbous”, spheroidal tips cannot close completely to cut or define a plane in target tissues. Scissors with 2 dimensionally rounded tips can close all the way to cut target tissue however the shape and tips are prone to inadvertently wander undesirably between tissue planes because of a lack of a third dimensional limitation.
Current electro surgical devices for use in general surgery must be delivered through large open pockets or through the limited access, slow moving and tedious endoscopes if they are to see use in the aforementioned settings. U.S. Pat. No. 5,776,092 by Farin describes a single tube device that can deliver laser, ultrasound or radio frequency devices to treat tissue. However, Farin's device is not intended for separating tissue planes and is susceptible to catching, tearing or puncturing the tissue when manipulated. It would be advantageous to provide a device for the precise application of energy to proper face-lift tissues to be separated and energized while excluding vital structures such as nerves and delicate vessels and maintaining an exact distance from the very delicate surface of the skin. It would be additionally advantageous for the same provisions to allow for a uniform forward tracking and feel of motion of the device that provides a surgeon with instantaneous knowledge. Properly sized and placed bulbs and lysing segments address all of these problems in a manner not previously possible.
Just as sharp undermining or dissection has its disadvantages, as previously mentioned, blunt dissection suffers from its own difficulties as well. Forcing a blunt object through tissue avoids indiscriminate sharp cutting of important structures (nerves, vessels). Blunt undermining compacts the stronger, firmer, strands of collagen even contained within tissues as soft fat into thicker “bands” (some overly thick for uniform cutting). However, disadvantageously for the aforementioned intentions, traditional purely-blunt-object undermining often results in random motion or uncontrollable-slippage of the underminer tip on forward motion and thusly loss of precise tracking of the underminer through target tissue. Additionally, thickened devices often “hang-up” or get caught in various tissue structures for example collagenous bands.
Currently it takes many surgeons varying amounts of time often exceeding 10-20 minutes and even an hour to dissect the scalp brow-lifting plane and coagulate blood vessels, especially if coagulation is needed for unsealed emissary vessel trauma. It is desirable to provide a tissue-lifting device that would reduce time for a surgeon to do both tissue plane separation and coagulation as well as aids in maintaining proper tissue positioning and tracking through the appropriate layers. The operative time reduction should exceed 90%. Reduced operating time means less time a wound is open to potential sources of infection, lowered surgical costs less operating room time, less risk under anesthesia, and thus a general improvement in the procedure.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a method and a device that can be used by surgeons to quickly and safely separate tissue planes.
It is another object of the invention to provide a facial tissue lifting and facial tissue-tightening device that easily maintains the proper dissection plane by constrain
Da Silva Luiz B.
Weber Michael Robert
Weber Paul J.
Pearl Technology Holdings, LLC
Peffley Michael
Vrettakos Peter
Wooldridge John P.
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