Patent Document

PRIORITY APPLICATIONS 
       [0001]    This Utility Application claims priority from the Provisional Patent Application Ser. No. 61/608,830 filed on Mar. 9, 2012. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to the injection of drugs and other fluids, that are highly viscous, into a patient, where it is desirable to evenly distribute the fluid over a relatively small area in proximity to the point of injection. 
         [0003]    Specifically, dermal fillers are used in a relatively small target area to smooth the wrinkles of the face and/or to augment other facial areas such as lips to create a more attractive appearance, by adding volume and fullness to the skin to correct moderate to severe facial wrinkles and folds such as lines from the nose to the corners of the mouth as well as lip enhancement. Typical dosages of these dermal fillers are 0.6 mL in wrinkles and folds, and 1.5 mL per lip. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    The present invention is an improved hypodermic needle constructed and arranged such that the needle has multiple openings to evenly distribute a viscous drug or other material over a relatively small area in proximity to the point of injection. 
         [0005]    Procedures during and after plastic surgery recommend use of soft tissue dermal filler fluids to add volume. These fillers are highly viscous and are injected at a specific location in or under a layer of the skin. These fluids may for example include Restylane (a trademark of Medics Aesthetics, Inc., Scottsdale Ariz.), Juvaderm (a trademark owned by Allergan Industrie SAS and Allergan, Inc. Irvine, Calif.), Radiesse (a trademark of Merz Aesthetics, Inc. San Mateo, Calif.) and other fillers, which are injected with a hypodermic needle. It is often difficult to discharge these fluids, because of their high viscosity, through the openings in the hypodermic needle and distribute the fluid in an even manner over the area of the skin where the dermal filler is to be injected and deposited. 
         [0006]    There are several difficulties in discharging the dermal filler during the procedure. These include at least the following: a constant high force or pressure is required to be applied against the plunger of the hypodermic needle by the operator to force the fluid out of the needle; and the difficulty of distributing the viscous fluid through a single outlet at the terminal end of the needle. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1A  is a plan view of a hypodermic needle. 
           [0008]      FIG. 1B  is a sectional view of a hypodermic needle taken from lines C-C from  FIG. 1A . 
           [0009]      FIG. 1C  is a perspective view of a hypodermic needle of the present invention shown as it is inserted into the facial area of a patient during the process of injection a fluid. 
           [0010]      FIG. 2A  is a plan view of a needle of the present invention. 
           [0011]      FIG. 2B  is a sectional view of the needle shown in  FIG. 2A  taken along lines D-D. 
           [0012]      FIG. 2C  is a sectional view of the needle shown in  FIG. 2A  along lines E-E. 
           [0013]      FIG. 3A  is a plan view of an alternate needle of the present invention. 
           [0014]      FIG. 3B  is a sectional view of the needle shown in  FIG. 3A  taken along lines F-F. 
           [0015]      FIG. 3C  is a sectional view of the needle shown in  FIG. 3A  taken along lines H-H. 
           [0016]      FIG. 3D  is a sectional view of the needle shown in  FIG. 3A  taken along lines G-G. 
           [0017]      FIG. 4  is a plan view of a portion of facial skin showing an area having a wrinkle or wrinkle line or other area to receive treatment. 
           [0018]      FIG. 5  is section view along lines B-B of  FIG. 6 . 
           [0019]      FIG. 6  is a plan view of a wrinkle line section of skin similar to  FIG. 4  with a needle shown injected into the skin area. 
           [0020]      FIG. 7A  is a cross section view along lines I-I of  FIG. 7B  of an alternative needle shown in  FIG. 7B  having several openings and the distal end closed with different sized and shaped openings. 
           [0021]      FIG. 7B  is a plan view of the needle shown in  FIG. 7A . 
           [0022]      FIG. 7C  is a cross section view along lines J-J of the needle in  FIG. 7B  showing a cross section of the hole and barrel of the needle. 
           [0023]      FIG. 8A  is a plan view of another alternative needle having square openings along its length with the distal end closed. 
           [0024]      FIG. 8B  is an enlarged view of detail A from  FIG. 8A . 
           [0025]      FIG. 9A  is a plan view of yet another alternative needle having rectangular openings along its length with the distal end closed. 
           [0026]      FIG. 9B  is an enlarged view of detail B from  FIG. 9A . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0027]    The present invention is an improved needle which would be a part of and typically used with a hypodermic needle. As seen in  FIG. 1A , hypodermic needle  10  has a barrel  11  which typically would be of glass or other clear material in order to see the contents within barrel  11 . The contents would typically be a fluid  12 . A plunger  13  slides within barrel  11  which has at the distal end a plunger head  14  which as known in the art keeps the fluid  12  at the distal side of head  14  within barrel  11 . A thumb rest  15  is at the proximal end of plunger  13  and a finger flange  16  is located at the proximal end of barrel  11 . A needle  20  with a beveled tip  24  is attached to the distal end of barrel  13  at needle hub  17 . Needle  20  is a hollow tube having an inner wall  23  within needle  20 . Typically needle  20  is made of steel and fluidly communicates with barrel  11  such that when the plunger  13  is urged in the direction of needle  20  any fluid  12  within barrel  11  will be forced out the distal end of barrel  11 , through hub  17  and through hollow needle  20  and disbursed out the distal end  24  of needle  20  at an orifice or opening  22 . 
         [0028]    As seen in  FIG. 1A , a typical hypodermic needle  10  as known in the art, has a needle  20 . The needle  20  is hollow having a needle barrel  21 , with a single opening  22  at the distal end  24  of needle  20 . 
         [0029]    The needle  20  of the present invention as seen in  FIG. 2A , provides for multiple openings or holes  25  in the needle barrel  21  of needle  20 . Thus the fluid  12  within hypodermic needle  10  is discharged through multiple openings  25  to evenly distribute the fluid  12  in the desired deposit area. As seen in  FIG. 2A , the openings  25  are arranged in a single row and are spaced apart along the length of needle  20  and there is the distal opening  22  at the distal end  24 .  FIG. 2B  shows a sectional view of needle  20  taken along lines D-D from  FIG. 2A  and further shows the openings  25  in the needle barrel  21  portion of needle  20 .  FIG. 2C  is a cross sectional view of an opening  25  taken along lines E-E from  FIG. 2A . 
         [0030]    In an alternate embodiment shown in  FIG. 3A , needle  20  has three rows of openings  25  where each row is spaced 120 degrees apart from the other adjacent row, and spaced equally around the needle barrel  21  of needle  20 . As in the prior embodiment, there is a terminal end  24  and opening  22 . The needles  20  in  FIGS. 2A and 3A  may or may not have an opening  22  at terminal end  24 , since there are other openings  25  in the needle  20 . Further, the openings  25  may have different diameters with the openings  25  closest to hub  17  having smaller diameters than those closer to the distal end  24  in view of the internal pressures to cause the fluid  12  to flow evenly out of the several openings at the same time. 
         [0031]    In use, it would be desired to inject a filler fluid  12  into a location or area of a wrinkle line  40  in the facial skin of a patient. As seen in  FIGS. 4 and 1C , plan views of an area of a wrinkle line  40  extends from a first end  42  to a second end  43 , with a portion of skin  41  that includes the wrinkle  40 . Though the  FIGS. 4 and 6  show wrinkle line  40  to be relatively straight, the wrinkle line  40  could also be curved or have a generally jagged length. Cosmetically it is desirable to fill the area below the wrinkle line  40  with a filler to at least have it appear that the wrinkle line  40  is no longer visible. The filler is a viscous fluid  12  and would be injected under the skin generally by use of hypodermic needle  10 . Typically, as known in the art, it is desirable to evenly distribute the viscous fluid  12  along wrinkle line  40 . 
         [0032]    In the prior art, a hypodermic needle  10  would be filled with a viscous fluid, and the needle  20  would be inserted into an injection opening site  30  at a first end  42  of the wrinkle line  40 . Wrinkle line  40  may extend from a point  42  to point  43 , a distance marked as A. The needle  20  would be inserted into point  42  at one end of the wrinkle line  40  under the skin  41  and the needle would extend along the wrinkle line  40  to the end of the wrinkle line  43 . Then, the person applying the filler would push the plunger  13  to force the viscous fluid  12  out of the single opening  22  of needle  20  and simultaneously begin withdrawing the needle  20  from its injection point  30 , so that the fluid  12  is evenly disbursed and distributed along the wrinkle line  40  below the skin  41  in an even manner. In other words, the desired result would be to have the needle  20  withdrawn from the opening  30  at the injection site, such that the filler fluid  12  has been evenly distributed along the wrinkle line  40 . However, this is extremely difficult in practice, since the operation of the plunger  13  by pushing the thumb rest  15  is very tiring and difficult since the viscous fluid  12  is so difficult to push out of the opening  22  of needle  20 . 
         [0033]    The advantage of the present invention, by having multiple openings  25  in needle  20 , the needle  20  is inserted at the injection site  30  extending the entire length of the wrinkle line  40  or a desired portion of the wrinkle line  40 . The needle  20  with multiple openings  25  can effectively be used to discharge the entire desired amount of fluid  12  easily through the multiple openings  25  without having to move the needle  20  during the discharge of the fluid  12 . Because the openings  25  are evenly spaced, the fluid  12  is disbursed in the desired locations evenly through the multiple openings.  FIG. 5  shows in cross section the needle  20  extending below the skin from the injection site  30  a length A from the first opening  42  to the second opening  43 . As seen in  FIG. 6  with the needle in the position shown in  FIG. 5 , the fluid  12  can be disbursed from the needle without withdrawing the needle and the fluid  12  will be disbursed evenly about the wrinkle line  40  as shown in  FIG. 6 . 
         [0034]    In alternate embodiments, it is possible the wrinkle line  40  will be sufficiently longer than needle  20  and therefore, the above steps may be repeated. In this manner, the wrinkle line  40  may be twice or three times the length of the needle  20 . In this situation, there would be additional injection locations along the wrinkle line  40 . 
         [0035]    In addition, it is known that the injection of fluids through a needle into the body often causes pain. It is believed the pain is caused likely not only by the insertion of the needle tip  24  into and puncturing the skin, but also as a result of the infusion of the fluid into the body e.g. the muscle where the tip of the needle  22  is located and where the fluid  12  leaves the needle  20  and enters the body. It is now believed that the improved needle tip  22  of the present invention provides a better method of infusing fluids through a needle and into the body by dispersing the fluid not through a single opening of the needle but through several openings of the needle as described herein. The dispersion through a plurality of openings is believed to likely reduce the pain that occurs to the patient when the fluids are injected through a single opening needle. 
         [0036]    As shown in  FIG. 7A  is a needle  20 ′ with alternate embodiments, including a plug  26 ′ or other sealing means to close the terminal end  24 ′ of needle  20 ′. In addition openings  25 ′ are shown in different sizes and shapes to facilitate tuning of the needle  20 ′, so that fluid  12 ′ will disperse from the multiple openings  25 ′ in an even and equal manner. Alternatively, the openings  25 ′ may be such that fluid  12 ′ will disperse in an unequal manner depending on the requirements of the plastic surgery. 
         [0037]      FIG. 7B  is a plan view of the needle  20 ′ showing the plurality of openings  25 ′ with various geometrical configurations. These configurations include, but are not limited to, a circle or an ellipse with an increasing eccentricity. The greater the eccentricity the longer the semi-major axis is, thus producing an ellipse which is longer and thinner. 
         [0038]      FIG. 7C  is a cross section of the needle  20 ′ in  FIG. 7B  taken at line J-J showing a cross section of the hole  25 ′ and barrel of the needle  20 ′. 
         [0039]      FIG. 8A  is a plan view of still another embodiment of the needle  100 . Needle  100  includes a plug  110  or other sealing means to close the terminal end  120  of needle  100 . Along the barrel of the needle  100  are a plurality of square apertures  130 . 
         [0040]    In this particular embodiment the square apertures  130  are separated from each other by 0.25 of an inch. The square apertures of this embodiment further measure 0.004 of an inch square, each side of the square is 0.004 inch. A spotlight blowup  140  of one of the square apertures  130  is shown. The dimensions of the square apertures  130  may vary, and although not shown, one square aperture  130  may have a different side length making the square aperture  130  either larger or smaller. In the embodiment shown in  FIG. 8A , there are four identical square apertures  130 . It can easily be seen that each of the square apertures  130  may be of a different size, or two having one size and the other two having a second size. Also, although four square apertures  130  are shown, the number and size of each of them may vary due to specific application. 
         [0041]      FIG. 9A  is a plan view of still another embodiment of the needle  200 . Needle  200  includes a plug  210  or other sealing means to close the terminal end  220  of needle  200 . Along the barrel of the needle  200  are a plurality of rectangular apertures  230 . 
         [0042]    In this particular embodiment the rectangular apertures  230  are separated from each other by 0.375 of an inch. The rectangular apertures of this embodiment further measure 0.004 of an inch on one side of the rectangle, and 0.030 of an inch on the other side of the rectangle. A spotlight blowup  240  of one of the rectangular apertures  230  is shown. The dimensions of the rectangular apertures  230  may vary, and although not shown, one rectangular aperture  230  may have a different side length on one side or the second side making the rectangular aperture  230  either larger or smaller. In the embodiment shown in  FIG. 9A , there are three identical rectangular apertures  230 . It can easily be seen that each of the rectangular apertures  230  may be of a different size, or two having one size and the other one having a second size or visa versa. Also, although three rectangular apertures  230  are shown, the number and size of each of them may vary due to specific application. 
         [0043]    The distance from one aperture to another in all embodiments may be in the range of 0.001 inch to 1.0 inch. The diameter of the circular apertures may be in the range of 0.001 to 0.5 inch. The semi-major axis of the elliptical aperture may be in the range of 0.001 to 0.5 inch. The semi-minor axis of the elliptical aperture may be in the range of 0.001 inch to 0.5 inch. The square aperture may have a side distance of 0.0001 to 0.5 inch. The rectangular aperture long side distance may be of 0.0001 inch to 0.5 inch. The rectangular aperture short side distance may be in the range of 0.0001 inch to 0.5 inch. In the case where other geometrical apertures are employed, the range of size would be equivalent to the range of the square aperture, which size would permit an equivalent amount of viscous material through. 
         [0044]    While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination and arrangement of parts, may be made without departing from the spirit and scope of the invention.

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