Abstract:
A microprocessor controlled medical laser device that has a precise laser beam alignment system indicated by a series of sequentially color changing LEDS. The power management system adjusts the LED&#39;S power input so as maximize battery life, increasing it by up to six times. It&#39;s alignment is enabled by a triaxial accelerometer that may be accurately calibrated horizontally or to a plethora of angles relative to the horizontal axis. It is shock resistant and times out to turn the laser off after a predetermined time.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to a laser device that will enable the precise vertical positioning of a plethora of medical sensors, drainage systems, intubation systems, intravenous devices, catheters and the like with respect to a specific point on the patient&#39;s anatomy. This specific point may be the heart, the brain, a PIC line insertion point, or a drainage line insertion point. 
     Precise measurement of a patients vital statistics is critical with very small changes in pressure due to elevation, often having dramatic effects of drainage or supply rates, monitored pressures, static pressure scales, etc. The accurate positioning of the related sensors, scales, fluid lines and the such with respect to elevation the patient&#39;s body has heretofore been done with laser beams coupled to crude leveling devices. The battery life of these devices is generally short as the laser light&#39;s power output far exceeds what is actually needed for short range leveling. Further these early devices are susceptible to loss of accuracy by the initial calibration process, the eye of the user, the illumination of the room and from sharp impacts. Additionally, the connection of these devices to the vast array of different medical suppliers equipment and supports is problematic. Lastly, many of the prior art leveling systems are not designed to be used on either side of the patient and cannot be recalibrated. 
     None of the existing prior art systems allow for angular use such as would be helpful for the specific angular alignment of patient&#39;s anatomy while they go through an X-ray machine, and MRI scanner or a CAT scanner. 
     Henceforth, a medical laser device that could overcome the described downfalls of the prior art would fulfill a long felt need in the medical industry. This new invention utilizes and combines known and new technologies in a unique and novel configuration to overcome the aforementioned problems and accomplish this. 
     SUMMARY OF THE INVENTION 
     The general purpose of the present invention, which will be described subsequently in greater detail, is to provide a laser device for the accurate and precise alignment of medical devices to a specific point on the patient&#39;s body. 
     It has many of the advantages mentioned heretofore and many novel features that result in a new medical laser alignment system which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art, either alone or in any combination thereof. 
     In accordance with the invention, an object of the present invention is to provide an improved medical laser alignment system capable of detachment and reuse on disposable medical drain/drip systems. 
     It is another object of this invention to provide an improved medical laser alignment system capable of bidirectional horizontal indication by rotation of the laser about a pivot point. 
     It is an object of this invention to provide a medical laser alignment system that uses a multiple zero reference for the setting of the triaxial accelerometer&#39;s reference accuracy. 
     It is a further object of this invention to provide a medical laser alignment system that orientates its horizontal axis of illumination to the zero reference point of a triaxial accelerometer. 
     It is still a further object of this invention to provide for a rotatable medical laser alignment system that allows leveling for a horizontal laser light beam projection by a set of easy to see indicator lights rather than by a crude bubble level. 
     It is yet a further object of this invention to provide a compact, reliable medical laser alignment system that has programable accuracy, power saving features, a low battery alarm and which can be programmed such that the zero reference point of its triaxial accelerometer may be set to calibrate the laser light beam for a plethora of angles with respect to the horizontal. 
     The subject matter of the present invention is particularly pointed out and distinctly claimed in the concluding portion of this specification. However, both the organization and method of operation, together with further advantages and objects thereof, may best be understood by reference to the following description taken in connection with accompanying drawings wherein like reference characters refer to like elements. Other objects, features and aspects of the present invention are discussed in greater detail below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front perspective view of the medical laser device; 
         FIG. 2  is a front perspective view of the medical laser device with a first bracket rotated; 
         FIG. 3  is a front view of the medical laser device; 
         FIG. 4  is an end view of the medical laser device with the first bracket installed; 
         FIG. 5  is a side view of the medical laser device with the first bracket installed; 
         FIG. 6  is a front perspective assembly view of the medical laser device showing the location of all the key elements; 
         FIG. 7  is a rear perspective assembly view of the medical laser device showing the location of all the key elements; 
         FIG. 8  is a perspective view of the generic rotatable quick change attachment mechanism as formed on the front of the second alternate embodiment bracket; 
         FIG. 9  is a perspective view of the back of the second alternate embodiment bracket; and 
         FIG. 10  is a cross sectional view of the mounting orifice in the case bottom. 
     
    
    
     DETAILED DESCRIPTION 
     There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. 
     In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting. 
     When discussing three dimensional coordinates herein, Cartesian coordinates are used. Thus for any particular point, there is an x, y, and z coordinate, which typically correspond to how far the object is left and right, forward and back, and up and down respectively. 
     The medical laser device described herein enables the precise positioning of a plethora of medical sensors, drainage systems, intubation systems, intravenous devices, catheters and the like with respect to a specific point on the patient&#39;s anatomy. For example, in many medical procedures a catheter connected to either a drainage bag or a drip bag is inserted into an opening in the human body for pressure monitoring, or the addition or removal of fluids. This is commonly done in the patient&#39;s intracranial, intravascular, intracardiac, intrapulmonary or intrafascial compartments. The pressure at the point of the opening is often critical, as the differential pressure between this and the fluid level in the bag is the motive force for the movement of the fluids. For this fluid movement to be accomplished at a controlled rate, the differential pressure between the insertion point and the bag&#39;s fluid level must be accurately known. This requires that a precise vertical alignment of the “zero point” on the static pressure scale of the bag be made. This is accomplished through the vertical alignment of a horizontal laser beam with the insertion point of the catheter. In another medical procedure it is typical to have the patient&#39;s head angled at approximately 30° with respect to the horizontal axis when the patient passes through a horizontal CAT scanner. This is accomplished by alignment of the patient&#39;s head with an angular laser beam calibrated to 30° and positioned on the bedway of the CAT scanner. 
     Looking at  FIGS. 1 and 2  the front face and operational side of the case top  3  of the microprocessor controlled medical laser device  2  can best be seen. The case is a two part assembly made of a case top  3  and a case bottom  5 . The “ON” tab  4  is simply a U shaped cutout on the front face of the case top  3  of the laser device  2  that is able to elastically deform and flex inwards to contact the “ON” switch on the internal printed circuit board (PCB) that activates the laser diode. There is no “OFF” control of this switch as this is accomplished by a timed operation (generally set for the  30  to  40  second range) of the microprocessor. The laser diode  8  resides on the side of the PCB in alignment with the laser orifice  6  so as to allow the laser light beam  10  to project from the side of the case  3 . The top ends of three light tubes  12  extend into three orifices cut into the case top  3 . The bottom ends of these light tubes reside adjacent to three multicolor LEDs on the PCB. A first mounting bracket  14  is pivotally affixed to the case back  5 . 
     In operation, the user need only affix the proper mounting bracket to the case back  5 , attach the mounting bracket onto the piece of associated equipment or support pole, depress the “ON” tab  4 , point the laser light beam  10  to the desired spot on the patient while tilting the device  2  in the z axis until all three of the LEDS have sequentially changed from red to solid green, and then affixing the laser device  2  and associated equipment at this elevation. 
     Looking at  FIGS. 3 ,  4  and  5  it can be seen that the laser device  2  is generally rectangular with a thin profile where the laser light beam  10  projects centrally from one side. The bracket  14  is shorter than the device  2  and attaches centrally to the laser device  2 . 
     The body of the laser device  2  generally resides such that during normal operation, its longitudinal axis lies in the YZ or XZ (vertical) planes (its longitudinal axis is parallel to the Z axis) so that its laser light beam  10  projects normally (parallel to the XY plane) therefrom in the XY (horizontal) plane. It is free to rotate about the X or Y axis in this configuration. 
       FIGS. 6 and 7  show disassembled laser devices  2 . The components are organized left to right in their order of disassembly from the case top  3  to the case bottom  5  ( FIG. 6 ) and in their order of disassembly from the case bottom  5  to the case top  3  ( FIG. 7 ). The PCB  16  houses all of the functional components and is held in a spaced configuration within the case top  3  and case bottom  5  by a set of screws threadingly affixed in the aligned corner sockets  18  of the case&#39;s halves, passing through positioning orifices  19  in the corners of the PCB  16 . When assembled, the PCB aligns within the case such that the laser diode  8  resides adjacent the laser orifice  6 , the “ON” switch resided directly beneath the “ON” tab  4  and the light tubes  30  have their bottom ends directly over the top surface of the LEDS  22  and their top ends  12  extending through three orifices cut into the case top  3 . These three externally polished light tubes direct the LEDS&#39; light to the surface of the laser device  2  through a torturous bending path. These light tubes  30  are rigidly affixed to the inside surface of the case top  3 . 
     The PCB  16  houses in electrical connectivity the following: an “ON” switch  20 ; (30 sec delay automatic off) a trio of dual color (red/green) led level indicating lights  22  (red green); a triaxial accelerometer  26 ; a microprocessor  24 ; a laser diode  8 ; a power supply  28  (3 volt Cr 2450 Lithium coin battery) accessible through door  38 ; and a connection socket  32 . 
     A triaxial accelerometer was selected for its three orthogonal internal sensing elements to enable simultaneous multi-axis measurements in the x, y, and z-axes. 
     The microprocessor  24  has a flash memory, a real time clock, a timer, a power output adjustment (the laser diode is rated to operate at a maximum of a 1 milliwatt but the microprocessor limits the power input to the laser diode at 0.5-0.9 milliwatt to reduce power consumption since the laser beam generally only extends a max of 10 feet) a multiple zero reference, (for laser accuracy) a voltage reference turn off, (for battery low power operation) and a low power visual alert (when battery voltage drops below a preset lower limit the accuracy of the accelerometer begins to decline so the microprocessor makes all three red LEDS blink signaling the need for a battery change.) A connector socket  32  allows for signal connectivity between the microprocessor  24  and the programming and calibration equipment as well as for the connection of a monitor for the visual display of the microprocessor outputs. Using this connector socket  32  a two digit lcd screen may be attached that will provide a visual user interface to indicate the angle of the laser light beam with respect to the horizontal XY plane. The triaxial accelerometer  26  is rigidly mounted to the PCB  16  as is the laser diode  8  such that hard knocks will not disturb the accuracy of the laser device  2 . Recalibration is not necessary after the initial set up has been accomplished. 
     In the assembly of the laser device&#39;s PCB  16  the laser diode  8  is generally aligned to emit the laser light beam  10  perpendicular to the longitudinal axis of the PCB  16  (which has its longitudinal axis in line with the longitudinal axis of the device&#39;s case. (This is done by physical alignment with precise mechanical jigs.) To accomplish this the PCB  16  is put into a jig that holds its longitudinal axis parallel to the Z axis. The jig has a set of spring loaded programming connections (terminals) that matingly contact the programming terminals of the connector socket  32  for the microprocessor  24  on the PCB  16 . The laser diode  8  is energized so as to shoot the laser light beam  10  approximately horizontal (in the XY plane) and project it onto a first reference point some distance away. (approximately  1  meter) If the laser light beam  10  does not shine on this reference point then the laser diode is mechanically adjusted (by altering the hard soldered power connectors that affix the laser diode  8  to the PCB  16 ) until it does. Then the programming unit applies the correct algorithms to determine a first zero point reading. The laser device  2  is then rotated 180 degrees such that its longitudinal axis still resides parallel to the Z axis. This procedure is repeated with respect to a second reference point at the same vertical elevation. The programing unit applies algorithms that uses these first and second readings to establish a true zero point reading for the triaxial accelerometer&#39;s reference grid and inputs this value to the microprocessor. (Thus when the triaxial accelerometer  26  sends a signal to the microprocessor  24  that the laser device  2  is positioned at this zero point, the laser light beam  10  is projecting horizontally or it is “level”.) Since the triaxial accelerometer  26  and the laser diode  8  are both mechanically fixed on the PCB  16  this calibration is good for the life of the laser device  2 . The microprocessor  24  selectively changes the color of the LEDS  22  from red to green as the signal from the triaxial accelerometer  26  indicates that it is approaching the zero point. The LEDS  22  are arranged in a row of three. The LED  22  nearest the laser diode  8  goes from red to green when the longitudinal axis of the laser device  2  is within ½th of a degree plus or minus of the zero point. The middle LED goes from red to green when the longitudinal axis of the laser device  2  is within ¼ of a degree plus or minus of the zero point. The light furthest the laser diode  8  goes from red to green when the longitudinal axis of the laser device  2  is within ⅛th of a degree plus or minus of the zero point. Accordingly, when all three LEDS  22  have changed from red to green and remain solid green the laser light beam  10  will also be projecting at ⅛th of a degree plus or minus of the horizontal axis. In an alternate, lower costing embodiment, one of the end three lights will always be green if the beam is not level, and the remaining two lights will both turn from red to green when the device  2  is less than ½ of a degree horizontal. It should be noted that other timing/indication configurations are well know in the art and could be utilized without departing from the scope of this invention. 
     Simply stated, the triaxial accelerometer generates and sends an electronic signal to the microprocessor  24  that represents the axial position of the laser device  2  relative to the horizontal X or Y axis. Then the microprocessor  24  applies an algorithm based on this position and generates and sends an electronic instruction that determines what color each LED  22  emits. 
     It is to be noted that the laser device  2  in a similar fashion to that explained above, may be calibrated so as to adjust the zero reference scale of the triaxial accelerometer  26  to any desired horizontal angle so that the laser unit may be used to align any device to a set angle without the use of a visual display connected to the device  2  through the connection socket  32  as discussed above. This is a handy feature that finds a plethora of applications outside of the medical industry. 
     Looking at  FIGS. 6 ,  8 ,  9  and  10  the design and configuration of the attachment mechanism can best be seen on two different mounting brackets and its operation explained. The attachment mechanism may be fabricated onto any style of removable bracket to accommodate different medical device&#39;s mounting plates. For example, the round bracket  60  has a reinforced central section  75  that accommodates a threaded insert  76  that allows the bolted attachment of any bracket or device. The first mounting bracket  14  has a specific configuration for sliding engagement with a certain manufacturer&#39;s device. The attachment mechanism allows each bracket to be self tightening and additionally, interchangability of brackets is of a quick change, self adjusting style. Looking at  FIG. 8 , the attachment mechanism has a total of  8  projections arranged in a circular fashion that extend normally from the face of the round bracket  60 . There are 4 preloaded tabs  62  and 4 snap hooks  64  that are equally interspersed. Where there is a need to hold the laser device  2  in very tight locations there is a recess on the back side of the bracket that holds a double sided adhesive patch. 
     Looking at  FIG. 10  it can be seen that the circular mounting orifice  66  has an outer beveled peripherial ring  70  residing centrally about the orifice  66 . When the bracket  60  is being pressed into the orifice  66 , the beveled ring  70  acts to guide the snap hooks  64  such that they flex slightly inward (elastically deform) as they pass through the orifice  66  and then flex back to their original position such that the angled lock tooth  72  on each of the four snap hooks  70  engages behind the orifice  68  once the lock tooth  72  passes beyond the trailing edge  68 , thereby constraining the bracket  60  to the laser device&#39;s bottom case  5 . The four preload tabs  62  bear against the central raised flange  70  to provide frictional resistance for the rotation of the bracket  60  in the orifice  66  and to stabilize the bracket  60  with respect to the bottom case  5 . Each of the preload tabs  62  have stiffening or strengthening supports  74  to allow for repeated flexing without breaking or loss of tensioning ability. Only one of the snap hooks  64  has such a strengthening support  74 . ( FIG. 8 ) Testing has shown that one of the tabs historically has failed and requires the tab. Engagement of any bracket bearing the attachment mechanism to the bottom case  5  is accomplished by simply pressing, centrally, the two parts together. Removal is accomplished by pulling the bracket off from a single, off centered point on the bracket. Once engaged the bracket can be freely rotated with respect to the laser device  2  yet there is enough friction exerted between the 8 projections of the attachment mechanism and the orifice  66  to hold the device  2  in any orientation. 
     The obvious advantages of the microprocessor controlled medical laser device is that it is fast and easy to use with a high level of accuracy and reliability that is shock resistant and can be used by people with poor vision. It is capable of calibration for any desired angle, quick attachment to a plethora of mounting brackets, and has an extended battery life that lasts up to 6 times longer because of the lowered LED power output as managed by the microprocessor. 
     The above description will enable any person skilled in the art to make and use this invention. It also sets forth the best modes for carrying out this invention. There are numerous variations and modifications thereof that will also remain readily apparent to others skilled in the art, now that the general principles of the present invention have been disclosed. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.