Abstract:
A medical laser vertical alignment system that has a precise locating strip affixed perpendicularly to a static pressure scale and that vertically and horizontally aligns the center of rotation of a reusable detachable laser aligning device with the zero reference point of the scale. The laser beam light is adjustable to coincide with the indicated horizontal position of a set of two bubble leveling vials. It has a quick release and alignment clamping arrangement that affixes the laser aligning device to the locating strip. The leveling device can be rotated 180 degrees and the leveling vials are located at opposing sides and ends of the device for clear visibility and redundancy. There is a timer circuit in the device that shuts the laser off after a predetermined time.

Description:
BACKGROUND OF THE INVENTION 
   The present invention relates to a laser alignment system for the precise vertical positioning of the static pressure scale of a medical personal drip or drain device. More particularly, to a reusable detachable laser aligning device that releaseably, and rotatably attaches to a locating strip mounted to the back of a static pressure scale and provides a laser beam that may be horizontally leveled and indicated onto the insertion point of a patient&#39;s catheter. 
   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 the pressure monitoring, 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. 
   Prior art laser alignment systems exist but have many downfalls. Their leveling systems are not designed to be used on either side of the patient; their laser axis is not perfectly aligned with the zero reference point of their vertical static pressure scale; they have a single leveling indicator; they do not have adjustment means to level the laser light beam with the leveling indicator; visibility of the leveling indicator is poor; and they do not have a system for rapid alignment of the laser&#39;s axis with the zero reference point. 
   The present invention includes a precise locating strip affixed perpendicularly to a static pressure scale that vertically and horizontally aligns the center of rotation of a reusable detachable laser aligning device with the zero reference point of the scale. The laser is adjustable to coincide with the indicated horizontal position of both vials in a set of bubble leveling vials. The leveling device has a quick release and alignment clamping arrangement. The leveling device can be rotated 180 degrees for use on either side of the patient and the leveling vials are located at opposing sides and ends of the device for clear visibility and redundancy. There is a timer circuit in the device that shuts the laser off after a predetermined time to ensure maximum battery life and to allow a hands off setup. 
   Henceforth, such a medical laser alignment system with the described advantages 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 system for the precise alignment of a static pressure scale for a medical drip/drain system to the patient&#39;s point of body injection. 
   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 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 vertical static pressure scale. 
   It is still a further object of this invention to provide for a rotatable medical laser alignment system that orientates its pivot point to the zero reference point of a vertical static pressure scale. 
   It is yet a further object of this invention to provide a medical laser alignment system that has a pair of bidirectional leveling means for horizontal leveling of the axis of illumination. 
   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 view of the laser vertical alignment system attached to a medical pressure scale; 
       FIG. 2  is a rear view of the laser vertical alignment system attached to a medical pressure scale; 
       FIG. 3  is a perspective view of the vertical alignment laser; 
       FIG. 4  is an exploded view of vertical alignment laser showing the general arrangement of all components; 
       FIG. 5  is a perspective view of the vertical alignment tab on a vertical graduated scale; 
       FIG. 6  is a top view of the vertical alignment laser; 
       FIG. 7  is a bottom view of the vertical alignment laser; 
       FIG. 8  is a front view of the vertical alignment laser; 
       FIG. 9  is a back view of the of the vertical alignment laser; 
       FIG. 10  is a laser end view of the vertical alignment laser; and 
       FIG. 11  is an end view of the vertical alignment laser. 
   

   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. 
   The medical industry commonly utilizes a rigid substrate with a vertical graduated scale and a catheter vessel (a tube, bag, bladder, or tubing) residing adjacent the scale. Referencing of the fluid level in the vessel to the indicated scale gives the viewer the precise indication of what the static pressure is at the catheter. Since this pressure is used to determine the amount of push or drainage at the catheter insertion point, it is desirable to have the zero point of the graduated scale set to the same vertical elevation as the catheter. In this way a positive pressure indicates fluid is being pushed into the patient and a negative pressure indicates the fluid is being drained from the patient. For the scale to show the precise relative magnitude of static pressure the zero point must be correctly set. This device provides for a simple method of aligning the zero point of the scale with the catheter insertion point through the use of a horizontal laser beam directed from the zero point of the graduated scale to the catheter. 
   Looking at  FIG. 1  it can be seen that the laser vertical alignment system  2  is made up of a vertical alignment laser device  4  and a vertical alignment tab  6 . The tab  6  is rigidly affixed to the surface of a rigid substrate  7  with a vertical graduated scale  22  affixed thereon. The vertical scale  22  has a zero point  20  indicated thereon. The substrate  7  may be hung from a pole stand by rope passing through a hanging orifice  5  formed through the substrate  7  or it may be rigidly attached to a pole stand by a side clamp (not illustrated.) The tab  6  is affixed such that its linear axis resides perpendicular to the axis of the vertical scale, and is aligned with the zero reference point  20  of the scale  22 . Looking at  FIG. 5  the configuration of the tab  6  can best be seen. Tab  6  is made of an alignment strip  10  that extends normally from the centerline of mounting plate  8  such that their respective linear axes are parallel. Both components of the tab  6  are made from a rigid planar substrate. The alignment strip  10  has a linear depression or channel  14  formed thereon with an alignment orifice  12  formed there through. The linear depression  14  and alignment orifice  12  are matingly conformed to receive a stabilizing bar  24  and locating tab  18  ( FIG. 4 ) on the laser device  4  which will be discussed in detail herein. The mounting plate  8  is designed for mechanical or chemical attachment to the surface of the rigid substrate  7 . 
     FIG. 2  illustrates the back view of the device  2  affixed to substrate  7  wherein the bubble level vial  46  can readily be viewed. The drain tube  9  and feed tube  11  connect to their respective vessels that are located at an elevation to achieve the desired flows. 
   Looking at  FIG. 4  the components of the laser device  4  can be seen in an exploded view. The laser device  4  is made of two pivotally connected bodies, each having separate but integral functions for the overall operation of the laser device  4 . The scale alignment body and the laser body are pivotally connected by a pivot screw  21  that passes sequentially through aligned orifices formed through the scale alignment body back casing  26 , polymer pivot disk  36 , the laser body back casing  28 , the printed circuit board (CB)  30  and threadingly engages into a screw insert  62  that is pressed into post  32  heat staked onto the laser body front casing  34 . The linear axis of this pivot screw  21  coincides with the midpoint of the scale alignment body and the laser body. The friction between the faces of the pivot disk  36 , the scale alignment back casing  26 , and the laser body back casing  28  is strong enough to prevent the relative movement of either body without an external force. The polymer pivot disk  36  is of a resilient, smooth friction reducing material such as HDPE. Optionally locking style washers may also be included in this arrangement. 
   The scale alignment body has a depressable stabilizing bar  24  that is encased between the scale alignment back casing  26  and the scale alignment front casing  38 . A set of two compressed springs  25  reside beneath the stabilizing bar  24  and within the scale alignment body  24  exerting an upward pressure so as to force the stabilizing bar&#39;s button  40  to sit an operable amount above the assembled casing halves. A series of movement guides  42  ensure that the stabilizing bar  24  can only experience motion along the axis of compression. The scale alignment front casing  38  has a longitudinal slot  44  extending from one edge across much of its length. The stabilizing bar  24  resides directly behind and adjacent the slot  44  such that their linear axes are aligned and the stabilizing bar  24  blocks the slot  44 . 
   In operation, the stabilizing bar&#39;s button  40  is depressed, thereby compressing the springs  25  and allowing the stabilizing bar  24  with its locating tab  18  to move below longitudinal slot  44 . With the slot  44  exposed, the alignment strip  10  may be slid into and along the slot  44  until an abutment occurs with the end of the slot  44 . The button  40  is released causing the springs  25  to force the stabilizing bar  24  upward and into contact with the alignment strip  10 . Here, since the linear depression  14  and alignment orifice  12  on one side of the alignment strip  10  are matingly conformed to receive the stabilizing bar  24  and locating tab  18 , the scale alignment body of the laser device  4  is now locked onto the substrate  7  so as to reside perpendicular to the vertical axis of the graduated scale  22  and with the slot  44 , the stabilizing bar  24  and the pivot screw  21  in vertical alignment with the zero point  20 . With the stabilizing bar  24  locked into one side of the alignment strip  10 , the opposite side of the alignment strip  10  is also frictionally engaged against the longitudinal slot  44  by the force exerted on the stabilizing bar  24  by springs  25 . When the stabilizing bar  24  and locking tab  18  is engaged onto the alignment strip  10  the laser device  4  cannot move in the X, Y or Z axis with respect to the substrate  7 . 
   The laser body is made of the following components: two bubble level vials  46 ; a DC battery power source  48 ; a PCB  30  with a timer circuit, timer light  52 , laser activation button  54 , laser circuit and laser  56 ; an AC input jack  58  ( FIG. 3 ); a laser adjustment plate  60 ; a screw insert  62 , and a laser alignment screw  63  ( FIG. 7 ) that are encased between a back casing  28  and a front casing  34  with various posts  32  formed thereon. The two casing halves each have top and bottom bubble level cutouts  50  and a battery compartment  64  and battery compartment door  66  as well. 
   Looking at  FIGS. 6 ,  7  and  8  it can be seen that back casing  28  and front casing  34  each have identical bubble level cutouts  50  between which the bubble level vials  46  can be seen. This feature allows for horizontal leveling and level checking of the device from any side of the device. It also allows light to shine through the back of the level vials  46  which greatly enhances the distinction between the tinted liquid and the air bubble in the level vials  46 . The cutouts  50  are located at diagonally opposite corners of the laser body, thus a level vial  46  is always located along the top horizontal surface of the laser body after any 180 degree rotation. Additionally the offset in the bubble vials allows for edge visibility. 
   The timing circuit allows the laser  56  and laser circuit to remain energized for a specified period of time after the laser activation button  54  is depressed. This accomplished two functions. First, it allows the user to adjust the vertical height of the substrate  7  (and thus the vertical laser light indication) on the pole with both hands and second, it prevents the batteries  48  from draining in the event the laser is inadvertently left on. In the preferred embodiment this time interval is 20 seconds. 
   Looking at  FIG. 9  it can be seen that on scale alignment front casing  38  there is a screwdriver receiving widening  68  of the longitudinal slot  44  to allow access for the tightening of the pivot screw. 
     FIG. 10  illustrates that the laser  56  is centrally located within the laser body thus when the laser body is horizontally aligned, the laser  54  is in direct alignment with the pivot screw  21  and the slot  44 . Therefore when the vertical alignment laser device  4  is engaged with the vertical alignment tab on the surface of the rigid substrate  7 , the source of the laser light is aligned vertically with the zero point  20  of the vertical scale  22 . By virtue of the symmetrical design of the laser body, there would be no need to establish the alignment of the laser  56  to the zero point  20  when the laser body is rotated 180 degrees (as would be done in the situation where the pole and substrate  7  were to be moved to the opposite side of the patient.) 
   The laser device  4  is calibrated by placement of it onto a bench mounted horizontally positioned tab  6 . The spring loaded stabilizing bar  24  is depressed, fit into the linear depression  14  and released such that the tab  6  is frictionally engaged between the stabilizing bar  24  and slot  44 . The laser device  4  is then slid along the linear axis of the tab  6  until the locating tab  18  engages the alignment orifice  12 . At this time the laser device  4  is wiggled to ensure that it is locked against any horizontal and vertical movement in all three axes, X, Y and Z. The bubbles in the level vials  46  are checked for alignment between the center lines. Since the device casings are precision cast the level vials  46  should indicate true horizontal unless the level vials  46  are flawed. If flawed, they are replaced. The laser activation button  54  is depressed and a laser light is momentarily projected toward a marked spot some distance away that corresponds to a laser that is parallel to the two level vials  46  and the axis of the tab  6 . The laser is adjusted by twisting a laser alignment screw  63  so as to raise or lower laser adjustment plate  60  until the laser light resides within an acceptable distance of the marked spot. The laser device  4  is now aligned with the level vials  46  and ready for operation. 
   In operation, once aligned, the laser device  4  is attached to the alignment strip as detailed above. The laser body is pivoted slightly until the top level vial  46  has its bubble in the central, marked horizontal alignment region. The laser activation button  54  is depressed and a laser light is momentarily projected toward the catheter insertion point. The substrate  7  is raised or lowered until the laser light directly shines on the catheter insertion point. The zero reference point  20  of the vertical scale  22  is now calibrated to the static fluid pressure at the patient&#39;s catheter insertion point. Additional fluid vessels may be adjusted vertically on the pole or substrate  7  with respect to the zero reference point  20  to push fluid in or drain fluid from the patient at a known rate or with a known pressure. The positive engagement system between the vertical alignment laser device  4  and a vertical alignment tab  6  quickly and accurately positions the laser device&#39;s pivot point at the zero reference point  20  mid scale at a horizontal level position normal to the vertical scale  22 . 
   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.