Abstract:
A device and method of delivery of dispensing materials, such as liquids, solutions, gels of drugs, vitamins, herbal products, electrolytes or sugar solutions, or other health related items, to mammals, such as humans or other non-human animals is described. The delivery device provides a mechanism to deliver material to the mammal without injecting the material into the mammal. In one embodiment, a device, system or method for administering a material to an individual comprises a dispensing device having an elongated body sized and shaped to hold a vial containing a material to be distributed and stored within a vial. A dispensing tip cap is secured to one end of the dispensing device. The device, system or method may further contain a container comprising a dispensable material and may be configured contain a dose setting mechanism configured to dispense a predetermined amount of material to be dispensed.

Description:
PRIORITY CLAIM 
       [0001]    In accordance with 37 C.F.R. 1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority to U.S. Provisional Patent Application No. 61/892,694, entitled “METHOD OF DISPENSING MATERIAL USING A NEEDLE-LESS TIP DEVICE AND NEEDLE-LESS TIP DEVICE”, filed Oct. 18, 2013. The contents of the above referenced application are incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to the medical field, to a medical device, and method of use, adapted for delivery of a medical solution to a human or other non-human animal using a needleless delivery component; more particularly to a medical device, and method of use, adapted for delivery of predetermined doses of a material to an individual human or animal using a needleless delivery component. 
       BACKGROUND OF THE INVENTION 
       [0003]    Insulin pens provide an easy means to carry and inject insulin. Such devices, however, require a needle as insulin is an injectable deliverable. U.S. Pat. No. 5,104,380 describes a typical insulin pen. The reference is described as a generally pen-like syringe which incorporates a dose metering device provided by a cap. The cap is described as being rotatable with respect to a pen body to a position related to the dose of medicament, i.e. insulin, to be injected. The rotation compresses a coil spring which is prevented from unwinding by cooperating ratchet teeth. When the dose is to be injected, a trigger slide is moved to the left causing the ratchet teeth to come out of engagement. The spring is permitted to unwind, thereby rotating a drive sleeve, drive gear and a drive plunger. The drive plunger is formed with a quick pitch screw thread so that its rotational movement is accompanied by axial movement to cause medicament to be discharged from a cartridge and injected through a needle. A problem associated with this, along with other insulin pens, is the device requires the use of a needle. However, some situations require a delivery system which do not require injection of a medicament. As such, devices that use a needle when a needle is not required are cumbersome and can be dangerous. 
         [0004]    Therefore, what is needed in the art is an improved device that provides a safer and more effective manner of administrating controlled, pre-determined doses of drugs, vitamins, solutions, and other materials using a needless system. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention relates to a device and method of delivery of dispensing materials, such as liquids, solutions, gels of drugs, vitamins, herbal products, electrolytes or sugar solutions, or other health related items, to mammals, such as humans or other non-human animals. The device improves upon existing delivery devices known in the art and allows automatic or controlled delivery of predetermined units of a particular material to the human or animal without the use of a needle. The delivery device provides a mechanism to deliver material to the mammal without injecting the material into the mammal. 
         [0006]    In one embodiment, the present invention may be directed towards a device, system or method, for administering a material to an individual comprising a dispensing device having a first end, a second end, and an elongated body. The elongated body is sized and shaped to hold a vial containing a material to be distributed and stored within a vial. The device, system or method further comprises or uses a mechanism adapted to dispense material within said vial to a mammal. A dispensing tip cap is secured to one end of the dispensing device. The device, system or method may further contain a vial or container comprising a dispensable material and may include a dose setting mechanism configured to dispense a predetermined amount of material to be dispensed. The device or system therefore allows an individual to easily and independently dispense materials without the use of a needle. 
         [0007]    Accordingly, it is a primary objective of the present invention to teach a dispensing device for dispensing materials, fluids, or solutions. 
         [0008]    It is a further objective of the present invention to teach a system for dispensing materials, fluids, or solutions. 
         [0009]    It is yet another objective of the present invention to teach a method for dispensing materials, fluids, or solutions. 
         [0010]    It is a still further objective of the invention to teach a dispensing device for dispensing materials, fluids, or solutions utilizing a new applicator tip to deliver materials, fluids, or solutions using a needleless delivery system. 
         [0011]    It is a further objective of the present invention to teach a dispensing device for dispensing materials, fluids, or solutions utilizing a new applicator tip to deliver materials, fluids, or solutions which provide a safer and more effective manner of administrating controlled doses of drugs, vitamins, solutions and other materials. 
         [0012]    It is yet another objective of the present invention to teach a device or system for dispensing materials, fluids, or solutions providing a mechanism or assembly to provide dose metering of the dispensing materials, fluids, or solutions. 
         [0013]    It is a still further objective of the invention to teach a device or system for administering doses of drugs, vitamins, solutions and other materials to various anatomical structures or body orifices such as nostrils, mouth, ear, anus, vagina, or urinary opening. 
         [0014]    It is a further objective of the present invention to teach a device or system for administering doses of drugs, vitamins, solutions and other materials to various anatomical structures or orifices without the use of a needle. 
         [0015]    Other objects and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0016]      FIG. 1  is perspective view of an illustrative embodiment of a dispensing pen in accordance with the present invention; 
           [0017]      FIG. 2  is a exploded view of the dispensing pen shown in  FIG. 1 ; 
           [0018]      FIG. 3A  is a front perspective view of an illustrative embodiment of a dispensing tip cap; 
           [0019]      FIG. 3B  is a back perspective view of the dispensing tip cap illustrated in  FIG. 3A ; 
           [0020]      FIG. 4  is perspective view of dispensing pen in accordance with the present invention adapted to provide a mechanism for dose metering; 
           [0021]      FIG. 5  is an exploded view of the dispensing pen capable of dose metering illustrated in  FIG. 4 ; 
           [0022]      FIG. 6  is a perspective view of the dispensing pen having dose metered capability to dispense the material in a predetermined amount; 
           [0023]      FIG. 7  is a cross-sectional view of an embodiment of the first, upper elongated body component illustrating components of an illustrative example of a dose setting dispensing mechanism; 
           [0024]      FIG. 8  is a sectional elevation of an embodiment of the dose setting dispensing mechanism. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated. 
         [0026]    Referring to  FIG. 1 , an illustrative example of a device for delivering a material, referred to generally as a dispensing pen  10 , is shown. The present invention will be described for use with humans, however, such use of humans is illustrative only, and the dispensing pen  10  may be used with non-human mammals or other animals. The dispensing pen comprises a first end  12 , a second opposing end  14 , and an elongated body  16 . The elongated body  16  is shown having a generally tubular shape. The elongated body is composed of two components, a first, upper elongated body component  18  and a second, lower elongated body component  20 . The upper elongated body component  18  is secured to the lower elongated body component  20  via securing mechanisms known to one of skill in the art, such as but not limited to male and female threading or via frictional fits or snap fitting. 
         [0027]    The upper elongated body component  18  is sized and shaped to house an actuating mechanism which allows for dispensing a material out of the second, opposing end  14 . The material may be for example, a liquid drug, such as insulin, or vitamins, electrolytes, amino acids, herbal products, antibodies solutions, water or other hydrating solutions, and other materials or substance for which an human may want to use for health benefits. The materials dispensed are substances need by an individual, but need not be obtained through injection. The lower elongated body component  20  comprises an interior  24  and is sized and shaped to hold a vial or cartridge  26 . The vial or cartridge  26  contains the material or solution  28  to be dispensed to the individual. The lower elongated body component contains a cylindrical portion  30  extending outwardly and having threading  32 . The threading  32  accepts threading  33  (see  FIG. 3B ) of a dispensing tip cap  34 , thereby tightly securing the dispensing tip cap  34  to the lower elongated body component  20 . 
         [0028]    The dispensing tip cap  34  contains an external surface  31  an a continuous side wall  35  extending away from the external surface  31 , and terminating in an open end. A fluid dispensing member  36 , illustrated as a non-sharp or blunted member extends outwardly away from the external surface  31 . The fluid dispensing member  36  is designed to allow movement of the material or solution  28  stored within the vial or cartridge  26  to the individual via opening  38 , see also  FIG. 3A . While opening  38  allows for the material or solution  28  to move through the external surface  31 , the fluid dispensing member  36  does not extend therethrough. 
         [0029]    On the opposite side of the external surface  31  compared to the location of the fluid dispensing member  36 , and in alignment with the fluid dispensing member  36  to form a fluid path, is a fluid distributing member, illustrated herein as a needle  40  having a sharp or piercing end  42 . While shown as a needle, the fluid distributing member can be any object that has a lumen or interior passageway to allow fluid the flow through. The sharp or piercing end  42  extends within the interior portion formed by the external surface  31  and continuous side wall  35 , see  FIG. 3A  or  3 B. However, unlike traditional dispensing pens, i.e. insulin pens, the sharp or piercing end  42  only extends within the interior of the dispensing tip cap  34 . The needle does not extend outwardly towards or through the fluid dispensing member  36 . The needle is designed to contact or pierce a septum  37  of the vial or cartridge  26 . Fluid moves within the needle and through opening  38  of the fluid dispensing member  36 . The dispensing pen  10  is secured together by mating female/male threading  43  of the lower elongated body component  20  with the corresponding male/female threading  45  of the upper elongated body component  18 , see  FIG. 2 . 
         [0030]    In use, when a user pushes the button  22  positioned at the first end  12 , a shaft  46  (see  FIG. 2 ) inside of the elongated body  16  travels a precisely controlled distance. The shaft  46  pushes a plunger or piston  48  within open portion  50  of the vial or cartridge  26 , contacting a movable stopper  52 . movable stopper  52  may be made of a rubber. The movable stopper prevents the dispensing material or solution  28  from dispensing from the vial towards in the wrong direction. However, when pushed the movable stopper  52  applies a pressure towards the opposing end  14 . The force results in pushing the dispensing material or solution  28  from the vial into the needle  40 , and out to the individual via the fluid dispensing member  36 . As there is no needle in the exterior portion of the dispensing tip cap  34 , fluid can be dispensed to various anatomical human orifices (mouth, anal opening, urinary opening, vaginal opening, ear, nose or nasal passage opening, or eye) without the fear of piercing directly thought the skin or other organ. As such, the dispensing pen  10  can be used to self administer or dispense fluid safely and easily into one&#39;s body orifice. 
         [0031]    The dispensing pen  10  can be adapted to dispense a material, such as a fluid, solution, gel, or other materials in a metered mechanism.  FIGS. 4-8  illustrate the dispensing pen  10  having dose metered capability to dispense the material in a predetermined amount. In this manner, an individual can dispense predetermined doses or amounts, such as 2 ml to 4 ml, each time the device is used. Having the capability of delivering predetermined doses at each use allows the user to more accurately deliver the needed material when required. Moreover, by knowing that a predetermined amount is being dispensed, the user can leave a certain amount of material, say a 30 day supply, within the device, using only the amount required per usage/dosage. 
         [0032]    Referring to  FIGS. 4 and 5 , the dispensing pen  10  is shown having dose metering capability. The dispensing pen  10  has most of the same features as that previously described, with the same features having the same reference number as previously described. The upper elongated body component  18  of the dispensing pen  10  is adapted to provide the mechanism for delivering metered amounts of the material or solution  28 . Such metering capability of distributing predetermined amounts can be achieved by using a device have metering components as described in U.S. Pat. No. 5,104,380, (more fully described in  FIGS. 7 and 8 ) the disclosure of which is herein incorporated by reference. Instead of using a push button mechanism to dispense materials all at once, the dispensing pen  10  illustrated in  FIGS. 4 and 5  use a mechanism in which the user rotates a dose setting cap  54  concentrically mounted to the upper elongated body component  18 . The dose setting cap  54  can be traversed from a first set position to a second selected set position by rotating the dose setting cap  54 . Positioned on the dose setting cap  54  are one or more indicating references, illustrated as long or short lines  56  and numbers  58 . The long or short lines  56  and numbers  58  indicate the amount of material or solution  28  to be discharged, such as 4 ml or 8 ml. A set selected amount indicator  60  may be included to allow the user visual confirmation as to the actual amount selected. The dosage setting mechanism may further utilize a latch configured to retain the device in the set position and a mechanism to release the latch to allow the dosed material to be discharged. 
         [0033]    The upper elongated body component  18  acts as a plunger guide. The elongated body component  18  further comprises a cylindrical boss  62  extending out way from the body and is externally threaded to accommodate the lower elongated body component  20  (screws into the threading  43  of the lower upper elongated body component  20 ). An opening or bore  66  allows a shaft  68  with plunger  70  to move from end  12  into the vial or cartridge  26 . As the shaft  68  with plunger  70  moves forward, it engages the movable stopper  52  placed within the vial or cartridge  26 . As the movable stopper  52  moves, it exerts a force on the material or solution  28 , pushing it to the dispensing tip cap  34 , expelling the fluid out to the individual through the fluid dispensing member  36 . The opening or bore  66  may contain opposed flats to preventing rotation of the plunger  70  as it moves into the vial or cartridge  26 . 
         [0034]      FIG. 7  illustrates a cross sectional view of an embodiment of the internal components which comprise the dose setting dispensing mechanism or assembly. The components which comprise the dose setting dispensing mechanism or assembly shown in  FIG. 7  is an illustrative embodiment described in U.S. Pat. No. 5,104,308, and have been included to provide an illustrative embodiment of a dose setting dispensing mechanism or assembly. As shown, the upper elongated body component  18  is closed at one end by plunger guide  72  screwed into the body and having a cylindrical boss extending to the left and being externally threaded to accommodate the lower elongated body  20 . The plunger guide  72  guides longitudinal movement of the plunger from a recess in the end of the plunger guide  72 , progressively into the open end of the vial or cartridge  26 . Movement of the plunger  70  may be accomplished by energy stored in a helical spring  74 , which is twisted as a pre-set dose of the material or solution  28  to be dispensed. The amount to be injected can be set by rotation of the dose setting cap  54  which can turn about a graduated sleeve  76  at the right-hand end of the upper elongated body component  18 . 
         [0035]    The dose setting cap  54  maybe formed integral with a drive sleeve  78 . The drive sleeve  78  can turn in a plain bearing defined by the graduated sleeve  76  and has an annular ring  80  projecting at its left-hand end and formed with a ring of ratchet teeth. The helical spring  74  may be secured, respectively, at its ends to a flange at the left-hand end of the drive sleeve  78  and a flange on the sleeve  72  so that, as dose setting cap  54  is turned, the helical spring  74  is strained by being partially wound up. The helical spring  74  may be a compression spring, and when strained torsionally (and unstrained) urges the teeth on the annular ring  80  of the drive sleeve  76  into engagement with cooperating ratchet teeth  82  formed on a ratchet gear  84 . The arrangement of the ratchet teeth  82  is such that the dose setting cap  54  and drive sleeve can be turned in relation to the ratchet gear  84  in one direction only, with turning being accompanied by a series of clicks, as each successive ratchet tooth  82  is engaged. The ratchet gear  84  is normally held against rotation by engagement of external teeth on the ratchet gear  84  with internal teeth on a locking cage  86 . The locking cage  86  has legs which extend through slots in the plunger guide  72  to prevent rotation of the locking cage  86  in relation to the upper elongated body component  18 . The locking cage  86  can slide axially. When the preset or dose of dispensable material or solution  28  is to be injected, the locking cage  86  can be slid axially out of engagement with the ratchet gear  84  so that the gear can rotate, driven by the torque of the helical spring  74  through the drive sleeve  78  and the ratchet teeth  82 . Rotation continues until the dose setting cap  54  returns to its initial position defined by a positive stop between the dose setting cap  54  and the upper elongated body  18 . 
         [0036]    Within the ratchet gear  84  are a pair of opposed drive tapers  88  which are externally splined to be capable of axial sliding in relation to the ratchet gear  84  and are internally threaded with a quick pitch thread to cooperate with a corresponding external thread on the stem of the plunger  70 . Rotation of the ratchet gear  84  and drive tapers  88  is accompanied by axial movement of the plunger along the quick pitch thread since the plunger stem cannot turn in the plunger guide  72 . Thus, the plunger is driven into the vial or cartridge  26 , expelling the preset dose of the dispensable material or solution  28 . When the dose setting cap  54  stops turning on the upper elongated body component  18 , the plunger  70  remains part-way along the inside of the vial or cartridge  26 . The procedure can be repeated until the vial or cartridge  26  is exhausted, after which the vial or cartridge  26  can be replaced by unscrewing the lower elongated body component  20  from the plunger guide  72 . A reset ring  90  normally holds the drive tapers  88  in the tapered splines in the ratchet gear  84  against a compression spring  92  so that the quick pitch thread drive is normally engaged. However, when the lower elongated body component  20  has been unscrewed from the plunger guide  72 , the reset ring  90  can be slid by the action of the compression spring  92 , acting through the drive tapers  88 . The reset ring  90  has legs  94  which can slide in the same slots in a plunger guide  72  which accommodate the legs of the locking cage  86 . The drive tapers  88  can be pushed by the compression spring  92  until a counter-sink  96  formed in the left-hand face of the two joined drive tapers  88  move over an inclined projection  98  on the right-hand end of the plunger guide  72 . Such action opens the drive tapers  88  so that the quick pitch thread connection with the plunger stem is removed and the plunger  70  can be pushed back into the upper elongated body component  18 . 
         [0037]      FIG. 8  a sectional elevation of the second embodiment described in U.S. Pat. No. 5,104,380. The dose is preset by turning the dose setting cap  54  about the upper elongated body component  18 . The dose setting cap  54  may be coupleable with an end cap  100  and the drive sleeve  102  and one end of the helical spring  74 . The other end of the helical spring  74  may be locked to a spring retainer  104 , which fits inside the upper elongated body component  18  and may be keyed against rotation in relation to the upper elongated body  18  by an external key  106  seated in a notch formed in the body. At the left-hand end of the drive sleeve  102  is an annular flange site within the right-hand end of a drive gear  85  and the flange on the drive sleeve  102  and the drive gear  85  have cooperating ratchet teeth, enabling the drive sleeve to be turned in one direction only in relation to the drive gear  85 , which is keyed against rotation in the upper elongated body component  18  by means of a trigger slide  108 . The trigger slide  108  has an internal spline  110  engaging with an external spline on the drive gear  85 . The drive sleeve  102  may be formed integrally at the left-hand end with a circumferentially extending arm having at its free end a radially outwardly extending ratchet tooth, which is urged by the resilience of the arm into engagement with a ring of ratchet teeth on the drive gear  85 . As the dose setting cap  54  is turned, the user can count the clicks as the ratchet tooth moves over successive teeth on the drive gear  85  and can also observe the movement of a scale on the dose setting cap  54  in relation to a pointer ( 60 ) on the upper elongated body component  18  so that he can set the preset dose visually and aurally. A spring  112  urges the trigger slide  108  to the right to maintain its engagement with the drive gear  85  and prevents unwinding of the helical spring  74  until the dose has been set. 
         [0038]    The user can slide the trigger slide  108  to the left as defined by stops at the end of a slot formed in the upper elongated body component  18  so that an internal flange on the trigger slide  108  moves to the left compressing the spring  112  and moving the spline  110  out of engagement with the drive gear  85 . The spline  110  is no longer retained against rotation so that the helical spring  74  can unwind rotating the drive sleeve  102  and the drive gear  85 . The plunger  70  is formed with an integral quick pitch screw thread cooperating with a corresponding internal thread in the bore of the drive gear  85  so that rotation of the drive gear  85  is accompanied by axial movement of the plunger  70 . Rotation continues until an external projection on the drive sleeve  102  comes against a stop consisting of an internal projection formed in the spring retainer  104  when the preset dose will have been discharged from the vial or cartridge  26  by the plunger  70 . The plunger  70  may be prevented from rotating during that movement by two opposed axial flats formed on the plunger  70  and locating in a correspondingly shaped hole in the plunger guide  72 , which also acts as a rewind knob. The plunger guide  72  is normally retained against rotation in the upper elongated body component  18  by a locking bar  114  fitted into an axially extending slot in the plunger guide  72  and having an external tooth cooperating with an internal tooth at the left-hand end of the upper elongated body component  18 . The locking bar  114  has a radially inwardly extending piece fitted in a notch in the bottom of the slot and acting as a pivot. When the locking bar  114  is unrestrained, the natural position of its left-hand end is radially outwardly of the position shown so that the tooth at the right-hand end is pivoted radially inwardly out of engagement with the corresponding tooth at the left-hand end of the upper elongated body component  18 . When a housing connector  116  is fitted over the plunger guide  72  and the left-hand end of the upper elongated body component  18 , it deflects the left-hand end of the locking bar  114  radially inwardly in which the tooth at the right-hand end is in engagement with the upper elongated body component  18 . 
         [0039]    For another dose, the dose setting cap  54  is rotated through the desired number of stops after the trigger slide  108  has been moved by the spring  112  back to the right-hand position, and then when the trigger slide  108  is operated, a further dose is ejected. This continues until the vial or cartridge  26  is exhausted, after which the lower elongated body component  20  is removed from the body by unscrewing the housing connector  116 . That releases the plunger guide  72  for rotation in relation to the body so that it acts as a rewind knob and can be turned by hand to drive the plunger  70  back to the right to allow a new vial or cartridge  26  to be inserted. When the housing connector  116  is re-engaged, the rewind knob is locked in position ready for further operation. The right-hand end of the plunger  70  may carry a C clip  118  for defining the extreme left-hand position of the plunger  70 . A removable cover  120  with a cap  122  and a pen type clip  124  may be sued and are fitted over the left-hand end when the device is not in use. Turning the dose setting cap  54  through the desired number of clicks in accordance with the preset dose and sliding the slide trigger  108  to the left allows release of the preset dose. 
         [0040]    All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. 
         [0041]    It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. 
         [0042]    One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.