Abstract:
A method for treating simple wrinkles caused by age or sun exposure comprises treating blood vessels in the wrinkles with laser light. The laser light may have a wavelength between 577 and 585 nm. The laser light may also be a laser light pulse having a pulse duration that is greater than 0.2 msec, or alternatively, greater than 0.5 msec. The output pulse may be generated with a dye laser, for instance, by exciting dye solution in a resonant cavity with one or more flashlamps. A further treatment method comprises irradiating wrinkle-bearing skin with a laser pulse where the pulse duration is selectively matched to the thermal relaxation time of blood vessels in the targeted skin.

Description:
RELATED APPLICATIONS  
       [0001]    This application is a continuation of application Ser. No. 08/822,448, filed Mar. 21, 1997, which is a division of application Ser. No. 08/461,952, filed Jun. 5, 1995, and now U.S. Pat. No. 5,624,435. The entire teachings of the above applications are incorporated herein by reference.  
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    Vascular lesions, comprising enlarged or ectatic blood vessels, pigmented lesions, and tattoos have been successfully treated with lasers for many years. In the process called selective photothermolysis, the targeted structure, the lesion tissue or tattoo pigment particles, and the surrounding tissue are collectively irradiated with laser light. The wavelength or color of this laser light, however, is chosen so that its energy is preferentially absorbed by the target. Localized heating of the target resulting from the preferential absorption leads to its destruction.  
           [0003]    Most commonly in the context of vascular lesions, such as portwine stains for example, hemoglobin of red blood cells within the ectatic blood vessels serves as the laser light absorber, i.e., the chromophore. These cells absorb the energy of the laser light and transfer this energy to the surrounding vessel as heat. If this occurs quickly and with enough energy, the vessel reaches a temperature to denature the constituents within the boundary of the vessel. The fluence, Joules per square centimeter, to reach the denaturation of a vessel and the contents is calculated to be that necessary to raise the temperature of the targeted volume within the vessel to about 70° C. before a significant portion of the absorbed laser energy can diffuse out of the vessel. The fluence must, however, be limited so that the tissue surrounding the vessel is not also denatured.  
           [0004]    As suggested, simply selecting the necessary fluence is not enough. The intensity and pulse duration of the laser light must also be optimized for selectivity by both minimizing diffusion into the surrounding tissue during the pulse while avoiding localized vaporization. Boiling and vaporization lead to mechanical, rather than chemical, damage, which can increase injury and hemorrhage in the tissues that surround the lesion. This constraint suggests that for the fluence necessary to denature the contents of the vessel, the pulse duration should be long and at a low intensity to avoid vaporization. It must also not be too long because of thermal diffusivity. Energy from the laser light pulse must be deposited before heat dissipates into the tissue surrounding the vessel. The situation becomes more complex if the chromophore is the blood cell hemoglobin within the lesion blood vessels, since the vessels are an order of magnitude larger than the blood cells. Radiation must be added at low intensities so as to not vaporize the small cells, yet long enough to heat the blood vessels by thermal diffusion to the point of denaturation and then terminated before tissue surrounding the blood vessels is damaged.  
           [0005]    Conventionally, flashlamp-excited dye lasers have been used as the laser light source. These lasers have the high spectral brightness required for selective photothermolysis and can be tuned to colors for which preferential absorption occur. For example, colors in the range of 577 to 585 nm match the alpha absorption band of hemoglobin and thus are absorbed well by the red blood cells in the blood vessels. The absorption of melanin, the principal pigment in the skin, is poor in this range, yielding the necessary selectivity.  
           [0006]    The implementation of flashlamp-excited dye lasers presents problems in the pulse length obtainable by this type of laser. Theory dictates that the length of the light pulse should be on the order of the thermal relaxation time of the ectatic vessels. Ectatic vessels of greater than 30 microns in diameter are characteristic of cutaneous vascular lesions. These large vessel have relaxation times of 0.5 msec and require pulse durations of this length. Commercially available flashlamp-excited dye lasers generally have maximum pulse lengths that are shorter than 0.5 msec. As a result, selective photothermolysis treatment of ectatic vessels larger than 30 microns currently relies on higher than optimum irradiance to compensate for the pulse duration limitations. This leads to temporary hyperpigmentation, viz., purpura.  
           [0007]    Attempts have been made to increase the pulse durations of flashlamp-excited dye lasers. The Light Amplifier disclosed in U.S. Pat. Nos. 4,829,262 and 5,066,293 was conceived by the present inventor to mitigate laser quenching from thermal effects. The design centered on developing a spatially non-coherent laser. Basically, the optics at each end of the dye cell are designed to return substantially all of the light emanating from the end aperture back through the dye cell and reflect off the dye cell walls. Specific resonating and coherent modes are not favored. The optics mix the rays and thoroughly homogenize the beam. Thus, the effects from thermal distortions induced by the flashlamp are mitigated since resonator modes are not required for lasing action to occur. The invention of this patent does not generate a light that can be concentrated to the degree obtainable by classic laser configurations. But, the large depth of field and tightly focused beams that coherent radiation provides are not necessary for many medical applications. In treating vascular lesions, focused spots a few millimeters in diameter are adequate. It is often convenient to use fiber optic delivery systems and all that is necessary is to be able to focus the energy from the long pulse dye laser into a fiber approximately one millimeter in diameter.  
           [0008]    Newer devices to treat vascular lesions are once again built according to the typical laser paradigm, i.e. lasers that generate spatially coherent light. It turns out that with optimization, these lasers generate pulse lengths that can equal or exceed those achievable by the design producing spatially incoherent radiation described above. Interestingly, dye choice has a large impact on pulse duration. Reduction in dye degradation by improving longevity through dye chemistry has enabled pulse durations approaching 1.0 msec in commercially available devices.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention relates generally to method for treating simple wrinkles caused by age or sun exposure by treating blood vessels in the wrinkles with laser light. In specific embodiments, the laser light has a wavelength in a range between 577 and 585 nanometers. The laser light may also comprise a laser light pulse with a pulse duration that is greater than 0.2 milliseconds, or in certain embodiments, a pulse duration that is greater than 0.5 milliseconds. A dye laser may be employed to generate the laser light.  
           [0010]    According to one aspect, a method for treating simple wrinkles caused by age or sun exposure comprises generating a laser light output pulse having a wavelength between 577 and 585 nanometers and delivering the output pulse to the wrinkle-bearing skin of a patient. The output pulse may be generated with a dye laser, and may also have a pulse duration that is greater than 0.2 milliseconds, or, in certain embodiments, greater than 0.5 milliseconds.  
           [0011]    According to another aspect, a method for treating simple wrinkles caused by age or sun exposure comprises generating a dye laser output pulse and delivering the pulse to the wrinkle-bearing skin of a patient. The dye laser output pulse may be generated by exciting dye solution in a resonant cavity with, for instance, one or more flashlamps. Also, the dye may be circulated through the resonant cavity while the pulse is generated. The output pulse may have a pulse duration that is greater than 0.2 milliseconds, or, in certain embodiments, greater than 0.5 milliseconds.  
           [0012]    According to yet another aspect, a laser treatment method for simple wrinkles caused by age or sun exposure comprises irradiating wrinkle-bearing skin with a laser light output pulse. In this embodiment, the pulse duration of the output pulse is selectively matched to the thermal relaxation time of blood vessels in the targeted skin. In certain embodiments, the pulse duration is greater than 0.2 milliseconds. According to some embodiments, the pulse duration exceeds 0.5 milliseconds.  
           [0013]    The above and other features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention is shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without the departing from the scope of the invention.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    [0014]FIG. 1 schematically shows a selective photothermolysis treatment system of the invention;  
         [0015]    [0015]FIG. 2 is a schematic perspective view of a first embodiment of the flashlamp-excited pulse dye laser  1  of the present invention;  
         [0016]    [0016]FIG. 3 is a timing diagram showing the relationship between the trigger signal from the controller  160 , the flashlamp driving current, and the laser pulse amplitude for one pulse of the dye laser  1 ;  
         [0017]    [0017]FIG. 4 is a circuit diagram of the flashlamp driver  162  of the present invention;  
         [0018]    [0018]FIGS. 5A and 5B show the differences between longitudinal and transverse dye flow, respectively, through the resonant cavity of a laser;  
         [0019]    [0019]FIG. 6 schematically shows a dye cell  105  configured for longitudinal dye flow through the dye cell; and  
         [0020]    [0020]FIG. 7 schematically shows a dye cell  105  configured for longitudinal dye flow and having multiple input  610 - 614  and output ports  620 - 624  to reduce the residence time of dye solution in the dye cell  105 .  
     
    
       [0021]    The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.  
       DETAILED DESCRIPTION OF THE INVENTION  
       [0022]    A description of preferred embodiments of the invention follows.  
         [0023]    Turning now to the drawings, FIG. 1 shows a selective photothermolysis treatment system  10 , which has been constructed according to the principles of the present invention. A flashlamp-excited pulse dye laser  1  for the system  10  generates an output laser light pulse  120 . The output laser light pulse  120  is coupled into a medical delivery system  20 , such as a single optical fiber, and transported to the skin  50  or other tissue of a patient. The output laser light pulse  120  achieves substantial penetration to treat a vascular lesion  60 . This lesion  60  could be of one of many different types such as portwine stain birthmarks, hemangiomas, telangiectasia, idiopathic vulvoddynia, and leg veins. Further, it could also be vessels in simple wrinkles, caused by age or sun exposure, blood vessels in scar tissue, or hair follicles.  
         [0024]    The pulse durations of the output laser light pulse  120  are matched to the thermal relaxation time of the targeted ectatic vessels. Generally, this requires durations greater than 0.2 msec. For vessels of 30 microns in diameter and larger, as are present in portwine stains of adult patients, the duration should ideally exceed 0.5 msec, whereas pulse durations of 1 msec to 10 msec should be selected when the vessels are larger than 100 microns.  
         [0025]    [0025]FIG. 2 is a schematic diagram illustrating the flashlamp-excited pulse dye laser  1  in more detail. As is generally common among most such lasers, a dye cell  105  for containing a liquid laser gain media, specifically a dye solution, extends longitudinally along a center axis  108  of the laser  1 . A front window  130  and a rear window  132  define the longitudinal extents of the dye cell  105 . Both windows  130  and  132  are transparent. The dye cell  105  is located in a resonant cavity  110 , the ends of which are defined by a first mirror  112  and a second mirror  114 .  
         [0026]    Usually, the cavity does not support only single longitudinal mode or single frequency. While the second mirror  114  is fully reflective, the first mirror  112  is partially reflective and partially transmissive, defining an output aperture  116 . As a result, a portion of the light generated in the resonant cavity  110  passes through this first mirror  112  as the output beam  120  of the laser  1 .  
         [0027]    The dye solution in the dye cell  105  is optically pumped by flashlamps  124   a  and  124   b.  Exterior to a light-transmissive left side wall  122   a  of the dye cell  105  is a left flashlamp  124   b . A right flashlamp  124   a  is on an exterior side of a right side wall  122   b , which is also transmissive to light. These flashlamps  124   a ,  124   b  generate broadband light that excites the dye solution contained in the dye cell  105 . This results in the stimulated emission of light from the excited dye solution. Right and left reflectors  126   a  and  126   b  surround the respective flashlamps  124   a  and  124   b  to maximize the light injected into the dye cell  105 . These reflectors can be elliptical or diffuse. According to the invention, the flashlamps  124   a  and  124   b  used in the present invention preferably have higher pulse energies than typically found in short pulse dye lasers. During the generation of an output laser light pulse of 5 msecs, the total pumping energy injected into the dye solution by the flashlamps is approximately 2000 Joules.  
         [0028]    A dye circulator functions to circulate dye solution through the dye cell  105  while that dye solution is being excited by the flashlamps  124   a ,  124   b . This operation enables a flashlamp-excited pulse dye laser  1  to extend the duration of the output laser light pulse  120  beyond that would be obtainable in a dye laser in which the degraded dye was not replaced during the laser pulse. For example, in a conventional laser, the degradation of the dye during the output laser light pulse would quench the lasing action within usually about 0.5 msec. In the present invention, the duration of the output laser light pulse  120  is increased beyond this quench time of the conventional laser by essentially injecting new dye into the resonant cavity to replace degraded dye that absorbs laser light and quench laser action and thus increase the pulses duration. In the embodiment shown, this circulator includes a dye pump  150  which receives new dye solution from a supply reservoir  152 . The dye is pumped into a supply manifold  154  (shown here in phantom), which distributes the dye solution flow along the longitudinal axis  108  of the dye laser  1 . The dye solution flows through the dye cell  105 , and thus the resonant cavity  110 , in a direction transverse to the axis  108  of the laser  1 . A collection manifold  156  (in phantom) collects the dye solution after it has passed through the dye cell  105  and directs it to a depleted dye reservoir  158 .  
         [0029]    A separate supply reservoir  152  and depleted dye reservoir  158  are not strictly necessary. Recirculation and filtration systems are possible. U.S. patent application Ser. No. 08/165,331, filed on Dec. 10, 1993, entitled Method and Apparatus for Replenishing Dye Solution in a Dye Laser, now U.S. Pat. No. 5,668,824, which is incorporated herein by this reference, is directed a system in which by-products from the lasing process are filtered out and the dye solution reused.  
         [0030]    A controller  160  coordinates the operation of the dye pump  150  and the triggering of the flashlamps  124   a  and  124   b  to achieve extended pulse durations of the output laser light  120  by replacing exhausted dye solution in the dye cell  105  during the laser pulses. Specifically, the controller  160  first establishes a steady state flow of dye solution through the dye cell  105  by activating the dye pump  150 . When the dye solution is flowing through the dye cell  105 , the controller  160  then sends a trigger signal to a flashlamp driver  162 . The trigger signal defines the pulse durations and causes the flashlamp driver  162  to supply a driving current to the flashlamps  124   a  and  124   b . Light from the flashlamps excites the dye solution to lase and produce the output laser light  120 .  
         [0031]    Constant amplitude output laser light pulse are produced with an intensity detector  164  that senses the intensity of the output laser light  120  and provides feedback to the flashlamp driver  162 . Typically, the detector can be a diode or other photodetector that generates an intensity signal indicative of the amplitude of the output laser light. This signal is received by the flashlamp driver  162 . There, the feedback signal is combined with the trigger signal. This allows the flashlamp driver to adaptively modify the level of the driving current to the flashlamps  124   a ,  124   b  in response to the instantaneous intensity of the output laser light. If the gain medium contains depleted dye, an increase in excitation is required to maintain constant output. If depleted dye can be removed quickly, the excitation pulse will remain nearly constant. Usually, some exhausted dye solution tends to accumulate in the dye cell  105  over the course of the pulse. In fact, even with fast circulation, the percentage of new, unexhausted, dye is never as large as the moment before the flashlamps are first driven. At least some of the light generated in the dye cell  105  is absorbed by this exhausted dye solution and this effect tends to increase the threshold level of excitation needed for lasing. The intensity detector  164  detects any reduction in output light amplitude and causes the flashlamp to be driven harder to maintain constant output levels. Thus, the driving current is varied to maintain a constant amplitude in the output light amplitude. Alternatively, ramp trigger pulse can be used to generate an increasing or decreasing intensity in the output laser light, which is optimal for some applications.  
         [0032]    Longer pulse durations are possible by circulating dye solution through the dye cell during the generation of the output laser light pulse while providing very intense exciting energies from the flashlamps  124   a  and  124   b . The maximum obtainable pulse durations without replenishing depleted dye are approximately 2.5 msec. This is achieved by using special long-lived dyes. Using the same dyes in the present invention pulse durations of 5.0 msecs are achieved by replacing the dye solution in the dye cell  105  at least twice during the pulse. As a result, as the dye solution becomes partially or completely exhausted, new solution is added to the cell  105  to replace the old solution, which is pumped out by the circulator. In the present invention, the speed at which the dye is replaced in the dye cell  105  is dependent upon the how quickly the dye degrades. If the dye is exhausted after 2.5 msec, it must be replaced within that time. The total number of times that the dye is replaced in the dye cell  105  depends upon the required pulse duration. For example, a pulse duration of 10 msec, requires the equivalent of at least four dye replacements with dye lifetimes of 2.5 msec.  
         [0033]    Photothermolysis treatment of larger ectatic vessels, for example, require the longer pulse durations obtainable by the present invention. Vessels of 100 and 200 micrometers in diameter have thermal relaxation times of 4.8 and 19.0 msec, respectively, and require similar pulse durations for optimally effective therapy. Energies are usually from 1 to 20 Joules, but fifty Joules can be required in hair removal applications.  
         [0034]    [0034]FIG. 3 shows trigger signal voltage, the flashlamp excitation in Amperes, and the laser pulse amplitude  120  as a function of time during the pulse generation. Specifically, the controller  160  first engages the dye pump  150  to establish steady state dye flow through the dye cell  105  prior to the beginning of the laser pulse. The controller  160  then sends the trigger signal to the flashlamp driver  162 . The length of this trigger signal defines the desired duration of the output laser light pulse  120 . In the example shown, the duration is 5 milliseconds plus the latency time T that is required to excite the dye solution to lase.  
         [0035]    Prior to the trigger signal, the flashlamp driver  162  maintains a slightly sub-operational current in the flashlamps  124   a  and  124   b  with a simmer current  205  as is conventional. Then, in response to the leading edge  206  of the trigger signal, the flashlamp driver  162  produces a driving current for the flashlamps  124   a  and  124   b . The flashlamps, functioning as the laser-pumping devices, pump the dye solution in the dye cell  105  into an excited state causing it to lase when the fresh dye lasing threshold  208  is reached. This causes the output laser light pulse  120  having an amplitude indicated by reference numeral  212 . Generally, the flashlamp driver  162  increases the current to the flashlamps  124   a  and  124   b  over the duration of the output laser pulse in response the feedback signal from the intensity detector  164 . Progressively more driving current is required due to the accumulation of degraded dye solution in the cell  105  which yields an increasing lasing threshold  209 . As some point, an equilibrium in the ratio of degraded dye to fresh dye is reached and the lasing threshold plateaues  211 . Now, the excitation current is also steady state  210 .  
         [0036]    The resulting laser output  212  begins as the flashlamp power rises above the threshold level  208 , time T after the rising edge of the trigger signal  206 . The pulse terminates after five millisecond when the falling edge  215  of the trigger signal is generated by the controller  160 .  
         [0037]    [0037]FIG. 4 is a circuit diagram of the flashlamp driver  162  shown in FIG. 2 that actively controls the level of driving of the flashlamps in response to the intensity of the generated laser light. Specifically, the flashlamp driver  162  receives the trigger signal from the controller  160  via conductor  305 . This trigger signal defines the time for which the flashlamps will be driven and thus the duration of the laser light pulse. The length of the laser light pulse is tunable by changing the length of the trigger signal. This signal is received at a summing node  310  through a resistor R 1 . The feedback signal, which is indicative of the intensity of the output laser light  120 , is received from the intensity detector  164  through a resistor R 2  also at the summing node  310 . The voltage of the summing node is biased by third resistor R 3  that is connected between the summing node  310  and the supply voltage Vcc. In the particular embodiment shown, the trigger signal is a low level active signal which pulls the voltage of the summing node  310  below ground. A comparator  315  compares the voltage of the summing node to the ground potential. Thus, in response to a receipt of the trigger signal the comparator  315  turns a power transistor such as an insulated gate breakdown transistor (IGBT) or power Darlington  320  on, rendering the transistor conductive. This event places the voltage of a high voltage power supply  325  across the flashlamp, which generates a driving current to the flashlamps  124   a  and  124   b . A capacitor C 1  stores charge to assist in driving the flashlamps  124   a ,  124   b . A simmer supply  340  is also connected across the flashlamps  124   a  and  124   b  to provide a simmer current to maintain a stable voltage across the lamp prior to the main excitation pulse. Without the simmer, operation is erratic. This simmer current is evident from portion  205  of the flashlamp excitation plot in FIG. 3.  
         [0038]    The applicability of the flashlamp driver  162  is not limited to flashlamp-excited dye lasers with dye circulators but can be implemented as the driver for pumping devices that excite the gain media in many other types of lasers. Many types of lasers suffer from an increased excitation threshold across the length of a light pulse. Characteristically, conventional flashlamp-excited dye lasers, without dye flow suffer from this problem. This inventive pumping device driver  162  also find applicability to these lasers and also laser-excited dye lasers. In those cases, the flashlamp or other type of laser-pumping device will supply an ever increasing excitation current in response to any loss of intensity at the laser output.  
         [0039]    [0039]FIGS. 5A and 5B illustrate the key differences between a longitudinal flow dye laser and the transverse flow configuration. The first embodiment of FIG. 1 corresponds to the transverse flow type of FIG. 5B. These configurations generally provide shorter residence time of the dye solution in the dye cell  105 . The dye solution must merely move across the width of the resonant cavity  110 . The longitudinal flow configuration of FIG. 5A offers an alternative. But, since the dye solution moves along the length of the dye cell, resident time is longer for the same flow velocity.  
         [0040]    [0040]FIG. 6 illustrates a second embodiment of the dye cell  505  in which the dye solution travels longitudinally along the length of the dye cell  505 , parallel to the laser axis  530 . The dye solution is circulated through an input port  510  by a pump  150 . The dye travels the length  1  of the dye cell  505  and exits an output port  515 . First and second mirrors  112 ,  114  define the resonant cavity  520  in which the dye cell  505  is located as described in connection with FIG. 1.  
         [0041]    The second embodiment configuration places certain limits on the dye cell  505  construction. A given cross-section of fluid  550  should traverse the length of the dye cell  505  in approximately 2.5 msec. This is a good estimate for the useable lifetime of dye solutions during lasing. But, velocity is limited by the pressure the dye cell  505  can withstand. A rule of thumb is that a flow of 10 meters per second is the maximum speed for pumps operating below 100 pound per square inch (psi). These factors limit the length of the dye cell  505  to approximately one inch in length.  
         [0042]    [0042]FIG. 7 shows a third embodiment based upon a modification of the second embodiment of FIG. 6. Here, a plurality of dye input ports  610 ,  612 ,  614  are placed longitudinally along the length of dye cell  605 . An input manifold  625  of the circulator supplies dye to each of these ports from a pump  650 . Output ports  620 ,  622 ,  624  are placed between the input ports  610 - 614  on the opposite side of the dye cell  105 . An output manifold  632  collects dye solution exiting the dye cell  605  through these ports. In this configuration, dye flowing through any one of the input ports  610 - 614  is divided and passes out both of the nearest output ports  620 - 624 , again flowing parallel to the laser axis  630 . If the longitudinal distance between an input port and the closest output port is approximately 25 mm, 50 mm between adjacent input ports, a flow velocity of 10 m/sec is sufficient to limit the residence time of the dye solution to 2.5 msec. This allows the dye solution to be interchanged twice in a 5 msec laser pulse duration or four times in a 10 msec pulse.  
         [0043]    Dye Lasers having a transverse flow of dye gain media through the resonant cavity have been developed in the past in a number of different contexts for different applications. Continuous wave (cw) dye lasers have even been developed. The dye in these lasers is pumped by another laser. This laser is focused on a small spot on a curtain of the flowing dye solution. Thus, volume of dye excited in this device is very small. Only the small portion of the dye curtain in the path of the beam from the focused pumping laser is excited, and therefore generates light by stimulated emission. Even though this type of laser-excited dye laser generates a continuous wave output, it can not produce the kilowatts of peak power with the energy content required by medical applications.  
         [0044]    Very high pulse rate transverse flow dye lasers have been developed for isotope separation applications. The intent of these designs is to produce output energies of approximately one Joule in a few microseconds. Thermal distortion, which limited firing rates were avoided by replacing the excited dye in the resonant cavity from a previous pulse with new dye and then triggering the flashlamp. Such devices have been shown to generate pulse frequencies of almost one kilohertz. In these industrial applications, the peak and average output powers and pulse frequencies far exceed those required for medical procedures where longer pulse durations, moderate peak and average powers at lower frequencies are preferred. Average power close to a kilowatt have been generated using transverse flow dye lasers. For medical application, average power of only a few Watts is required.  
         [0045]    While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.