Abstract:
A non-sharp vascular infusion device and related method are disclosed. The non-sharp vascular infusion device permits medicine to be introduced into an IV assembly without creating a danger to healthcare personnel.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/464,260 filed Apr. 21, 2003, and which is hereby incorporated by reference in its entirety. 
     
    
     
       BACKGROUND  
         [0002]    In the field of medicine, there are many instances when a health care provider will need to aspirate medicine from a medicine vial or to inject medicine into an intravenous fluid assembly to permit it to flow into a patient. In the past, typically sharp metal needles were used for such tasks presents a danger to both the health care provider and the patient. During use, a sharp can inadvertently impale a patient or a health care provider, potentially transmitting disease. If a sharp is not disposed of properly, it may inadvertently impale housekeeping staff, raising the same disease concerns.  
           [0003]    There is a need for a simple, inexpensive and disposable non-sharp vascular infusion cannula. A user may choose to use the cannula to aspirate medicine from a medicine vial once or repeatedly, and to inject medicine into an I.V. apparatus once or repeatedly.  
         SUMMARY  
         [0004]    In the various embodiments disclosed, a non-sharp cannula is provided. The non-sharp cannula may have a square, blunt, tapered or rounded distal end, and a proximal end configured for attachment to a syringe or other fluid source. The non-sharp cannula can have an elongate body with a hollow fluid passageway in its interior for transporting fluid from either of the proximal or distal end to the other. The non-sharp cannula can have a fluid exit orifice in the vicinity of the cannula distal end, but located to the side of the cannula distal end so that fluid that exits the exit orifice may not be traveling parallel to the path of fluid that is travelling through the hollow fluid passageway of the cannula interior. Use of a side exit orifice allows the cannula to penetrate a soft rubber or plastic membrane, such as would be found on a medicine vial or an intravenous fluid assembly, without cutting a section from the fluid membrane.  
           [0005]    As desired the non-sharp vascular infusion cannula may be configured with a mechanical connection for attaching to a syringe. Example connections include a luer lock, a tapered friction fit, and other known mechanical attachments. In some embodiments it may be desired to include an optional one-way valve or seal within the non-sharp cannula so that fluid may only flow in one direction through the cannula. In other embodiments, such a one-way valve or seal may be omitted.  
           [0006]    The non-sharp vascular infusion cannula may be used in conjunction with a syringe, or it may be used in conjunction with any one-time, repetitive or continuous drug infusion process, such as may be employed in the field of anesthesiology. It may also be permanently placed into a medicine vial to permit multiple syringes to aspirate medicine from the vial.  
           [0007]    The non-sharp vascular infusion cannula is user friendly in that it permits all medical care providers with a medicine aspiration and infusion device that will not inadvertently impale them or the patient. The cannula is not a sharp, so it may be disposed of with ordinary refuse, rather than being placed in a sharps container for more expensive disposal. If housekeeping staff come into contact with the non-sharp vascular infusion cannula, they are not placed at risk of injury or of contracting disease. If made of modern materials, the non-sharp vascular infusion cannula is environmentally friendly in that it is recyclable. It is also inexpensive to manufacture and therefore presents an economical disposable solution to many problems that heretofore only expensive devices attempted to solve. Finally, the non-sharp vascular infusion cannula is a non-sharp, it will not be attractive for acquisition by substance abusers who may be seeking a sharp for self-injection.  
           [0008]    The non-sharp vascular infusion cannula may be made from any appropriate materials, but at the present time it is expected that the most desirable material may be plastic. The non-sharp vascular infusion cannula presents a physical form that is highly unlikely to injure either the user or the patient. The non-sharp vascular infusion cannula can be used to penetrate a multiple use drug vial for drug aspiration, it can be used to penetrate the infusion port of an infusion tube or intravenous assembly to inject medicine therein, and it can be used to penetrate the drug adding port of an I.V. bag to inject medicine therein. Other objects, features and advantages of the non-sharp vascular infusion cannula will become apparent to the reader upon reading the specification in light of the appended drawings. 
       
    
    
     DETAILED DESCRIPTION  
       [0009]    Referring to FIG. 1A, a side view of a non-sharp vascular infusion cannula  101  is depicted. FIG. 1 B depicts a cross-sectional view of the non-sharp fluid cannula of FIG. 1A. The non-sharp vascular infusion cannula  101  includes a proximal end  102  and a distal end  103 . The proximal end  102  may include a mechanical connection  104  for attaching to a syringe or other fluid source. The mechanical connection  104  may be a threaded fitting such as a luer lock (as depicted), a tapered receptacle for friction fit with a syringe tip or other fluid source protuberance, or any other mechanical fitting. The distal end  103  of the non-sharp vascular infusion cannula  101  has a non-sharp tip  105  which may be square, blunt, tapered or rounded. The non-sharp tip will not impale human skin when placed thereagainst with ordinary finger pressure, thereby avoiding inadvertent impalement and the attendant health concerns.  
         [0010]    Between the proximal end  102  and the distal end  103  of the non-sharp fluid cannula  101  there is an elongate body  106  with a hollow fluid passageway  107  in its interior for transporting fluid from either of the proximal or distal end to the other. The non-sharp cannula  101  has one or more fluid exit orifices  108  that may be located along the elongate body  106  and hollow fluid passageway  107 , such as in the vicinity of the cannula distal end. The exit orifices may be located to the side of the cannula distal end so that fluid that exits the exit orifice may not be traveling parallel to the path of fluid that is travelling through the hollow fluid passageway of the cannula interior. Use of a side exit orifice allows the cannula to penetrate a soft rubber or plastic membrane, such as would be found on a medicine vial or an intravenous fluid assembly, without cutting a section from the fluid membrane.  
         [0011]    In some embodiments it may be desired to include a one-way valve or seal  109  within the non-sharp cannula so that fluid may only flow in one direction through the cannula. In the example shown, a one-way valve is employed so that fluid may flow from the proximal to the distal end of the non-sharp vascular infusion cannula, but not the reverse. More detail concerning the example valve  109  is presented in FIG. 1C. Many valves and seals are known in the field of hydraulics which may be employed. Alternatively, the non-sharp vascular infusion cannula may be used without a valve or seal.  
         [0012]    The non-sharp vascular infusion cannula  101  has a radial bulge, radial protuberance, obstruction or obturation  110  located along its body  106 . The radial bulge serves two purposes. First, when the non-sharp vascular infusion cannula penetrates the membrane of a medicine vial or a vascular infusion cannula port, if desired, the radial bulge may be pushed past such membrane in order to anchor the non-sharp vascular infusion cannula in position for multiple uses. Second, if it is desired to remove the non-sharp vascular infusion cannula from a membrane such as the membrane on a medicine vial or the membrane on a vascular infusion cannula port after one use, then the non-sharp vascular infusion cannula may be used to penetrate the membrane up to but not past the radial bulge  110  in order for the non-sharp vascular infusion cannula to be easily removed from the membrane.  
         [0013]    Referring to FIGS. 2A and 2B, another embodiment of a non-sharp fluid cannula  201  is depicted. The non-sharp vascular infusion cannula  201  includes a proximal end  202  and a distal end  203 . The proximal end  202  includes a receptacle  204  for insertion of a syringe tip or other projection therein for forcing fluid into the cannula or for receiving fluid from the fluid cannula. The receptacle  204  may be presented with tapered cylindrical walls  205  if desired for creating a friction fit with the structure placed into the receptacle. A valve or seal  206  may be provided within the non-sharp vascular infusion cannula, or the valve or seal may be omitted and a hollow passageway substituted therefor.  
         [0014]    Referring to FIGS. 3A and 3B, another embodiment of a non-sharp fluid cannula  301  is depicted. In this embodiment, the radial bulge  302  is depicted as being partially oval or elliptical, rather than spherical as in FIGS. 1A and 2A. If desired, it is also possible to present a radial bulge  302  which has a steeper or sharper curvature or radius at its proximal side  302   a  than at its distal side  302   b.  Using a mild curvature or radius or slope on the distal side of the radial bulge will allow it to easily penetrate a membrane of a vascular infusion cannula port or medicine vial. Using a steeper or sharper curvature, radius or slope on the proximal side of the radial bulge will tend to make it difficult to withdraw the non-sharp fluid cannula from a medicine vial or vascular infusion cannula port once the non-sharp vascular infusion cannula has been inserted into the membrane of the medicine vial or vascular infusion cannula port past the radial bulge. Such a configuration is desirable when the non-sharp vascular infusion cannula is to be placed into a medicine vial or vascular infusion cannula port to be fixed there for multiple uses. The reader should note that the non-sharp vascular infusion cannula of FIGS. 3A and 3B includes both a luer lock and a tapered friction receptacle for fitting to a syringe or other appropriate device.  
         [0015]    Referring to FIGS. 4A and 4B, an alternative radial bulge  402  on a non-sharp vascular infusion cannula  401  is depicted. The radial bulge  402  depicted is generally triangular in cross section or conical in 3-D so that it presents a relatively gentle slope at its distal side  402   a  for penetrating a membrane of a medicine vial or vascular infusion cannula port, but it presents a flat surface  402   b  at the proximal side  402   b  of the radial bulge  402  so that withdrawing the non-sharp vascular infusion cannula from a membrane once it has been inserted past the radial bulge  402  will be very difficult or impossible.  
         [0016]    Referring to FIGS. 5A and 5B, an alternative radial bulge  502  on a non-sharp vascular infusion cannula  501  is depicted. The radial bulge  502  depicted has a rebated or hooked proximal side  502   b,  but has a relatively gentle slope at its distal side  502   a  for penetrating a membrane of a medicine vial or vascular infusion cannula port. This configuration makes it easy to insert the non-sharp vascular infusion cannula through a membrane past the radial bulge  502 , but difficult or impossible to withdraw the non-sharp vascular infusion cannula from the membrane.  
         [0017]    Referring to FIGS. 6A and 6B, an alternative radial bulge  602  on a non-sharp vascular infusion cannula  601  is depicted. The radial bulge  602  depicted is heart-shaped, so it has a gentle slope, curvature or radius on its distal side  602   a  for easy insertion into a membrane of a medine vial or vascular infusion port. But it has a steep curvature or radius on its proximal side  602   b  to make it very difficult or impossible to withdraw from the membrane.  
         [0018]    Referring to FIGS. 7A and 7B, an alternative radial bulge  702  on a non-sharp vascular infusion cannula  701  is depicted. The radial bulge  702  depicted is turnip or top-shaped, so it has a gentle slope, curvature or radius on its distal side  702   a  for easy insertion into a membrane of a medine vial or vascular infusion cannula port. But it has a steep curvature or radius on its proximal side  702   b  to make it very difficult or impossible to withdraw from the membrane.  
         [0019]    Referring to FIGS. 8A and 8B, an alternative radial bulge  802  on a non-sharp vascular infusion cannula  801  is depicted. The radial bulge  802  depicted is diamond-shaped in cross section. It has a gentle slope on its distal side  802   a  for easy insertion into a membrane of a medicine vial or vascular infusion cannula port. But it has a radius on its proximal side  802   b  to make it very difficult or impossible to withdraw from the membrane.  
         [0020]    Referring to FIGS. 9A and 9B, an alternative radial bulge  902  on a non-sharp vascular infusion cannula  901  is depicted. The radial bulge  902  depicted is presented in a fish hook configuration (in cross section). It has a gentle radius or curvature on its distal side  902   a  for easy insertion into a membrane of a medicine vial or vascular infusion cannula port. But it has a reverse cut radius on its proximal side  902   b  that presents a sharp or barbed outer rim to make it very difficult or impossible to withdraw from the membrane.  
         [0021]    Referring to FIG. 10A, a non-sharp vascular infusion cannula  1001  is depicted attached to a syringe  1002 . This assembly is being used to aspirate medicine  1004  from a medicine vial  1003 . The distal end of the non-sharp vascular infusion cannula has been thrust deep enough into the medicine vial so that the orifice  1006  of the cannula is in the medicine  1004  in order aspirate the medicine  1004  through the orifice  1006  through the cannula  1001  and into the interior of the syringe  1002 . In FIG. 10A, the cannula has been inserted through the rubber membrane  1005  of the medicine vial up to but not beyond the radial bulge  1007  of the cannula. This permits aspiration of medicine from the vial and into the syringe and withdrawal of the cannula from the medicine vial after the aspiration is complete. Thereafter, the syringe with non-sharp vascular infusion cannula may be transported to an I.V. apparatus in order to inject the aspirated medicine therein.  
         [0022]    Referring to FIG. 10B, the same configuration is depicted, but the cannula has been inserted deeply enough into the medicine vial so that the radial bulge  1007  of the cannula has been projected past the rubber membrane of the medicine vial. The shape of the radial bulge  1007  will present significant resistance to any attempt to remove the cannula from the medicine vial. Thus, the non-sharp vascular infusion cannula  1001  may be left in the medicine vial for multiple uses, while the syringe can be removed from the non-sharp fluid cannula and another syringe affixed to it for aspiration of additional medicine from the medicine vial. This allows repetitive use of the non-sharp vascular infusion cannula with various syringes.  
         [0023]    Referring to FIG. 11A, a non-sharp vascular infusion cannula  1101  is depicted attached to a syringe  1103  for injecting medicine into a vascular infusion cannula port  1104  of an intravenous assembly. The vascular infusion cannula port  1104  includes a membrane  1105  which may be penetrated by the non-sharp vascular infusion cannula. The cannula is depicted as having penetrated the membrane up to but not past the radial bulge  1102  so that the non-sharp vascular infusion cannula may be easily removed from the infusion port.  
         [0024]    Referring to FIG. 11B, the same configuration is depicted, but the non-sharp vascular infusion cannula  1101  has been inserted into the infusion port  1104  so deeply that the radial bulge  1102  of the non-sharp vascular infusion cannula  1101  projects beyond the membrane  1105 . If an attempt is made to remove the non-sharp vascular infusion cannula from the infusion port  1104  past the membrane  1105 , it will be difficult or impossible to do so because of the size and shape of the radial bulge  1102 .  
         [0025]    Referring to FIG. 12A, a non-sharp vascular infusion cannula is shown being used for continuous infusion of medicine in an I.V. environment. The non-sharp fluid cannula  1201  is projecting through a membrane  1205  of an infusion port  1204  of an I.V. arrangement. I.V. fluid  1207  passes through the infusion port  1204 , and a drug or medicine  1206  also passes through the infusion port to a patient. The non-sharp vascular infusion cannula projects through the membrane  1205  up to but not beyond the radial bulge  1202  of the non-sharp vascular infusion cannula so that the cannula may be later removed.  
         [0026]    Referring to FIG. 12B, the same configuration is depicted, but the radial bulge  1202  has been projected beyond the membrane  1205  so that the non-sharp vascular infusion cannula cannot easily be removed from the infusion port. In such an arrangement, drug bags may be replaced as often as desired without replacing or moving the non-sharp vascular infusion cannula and without exposing medical care providers to use of a sharp.  
         [0027]    Referring to FIG. 12C, use of a non-sharp vascular infusion cannula attached to a syringe  1253  is depicted for injecting a medicine or drug directly into an I.V. bag  1250  through a membrane  1251  to that the drug or medicine will travel with the I.V. fluid through passageway  1254  to a patient.  
         [0028]    Although the distal end of the non-sharp vascular infusion cannula has been described as being blunt, round, or radiused, its lack of a sharp tip does not mean that it is completely incapable of impalement. The tip of the non-sharp vascular infusion cannula usually will not be sharp enough to impale human skin under pressures normally applied by fingers or the human hand, but it will be capable of penetrating the softer membranes of medicine vials and vascular infusion cannula ports. Placement of the fluid exit orifice to the side of the tip of the non-sharp vascular infusion cannula improves the ability of the cannula to impale a soft rubber or plastic membrane, but the exit orifice may be placed at any desired location.  
         [0029]    The non-sharp vascular infusion cannula may be made from any appropriate materials, but at the present time it is expected that the most desirable material will be plastic. The non-sharp vascular infusion cannula presents a physical form that is highly unlikely to injure either the user or the patient.  
         [0030]    Referring to FIG. 13, a method for using a non-sharp vascular infusion cannula is depicted as a series of steps. First, the user should obtain or make a non-sharp vascular infusion cannula  1301 . The user should attach the non-sharp vascular infusion cannula to a syringe  1302  and impale a fluid membrane on a medicine vial  1303  with the non-sharp vascular infusion cannula. Then the non-sharp vascular infusion cannula should be used to aspirate medicine from the medicine vial  1304 , and the non-sharp vascular infusion cannula should be removed from the medicine vial  1305 . Medicine is at that time contained within the syringe. Next, the non-sharp vascular infusion cannula should be used to impale an appropriate location on an I.V. assembly  1306 , and medicine should then be injected from the syringe through the non-sharp vascular infusion cannula into the I.V. assembly  1307  where it can flow to a patient. Then either the non-sharp vascular infusion cannula and the syringe may be removed from the I.V. assembly, or the non-sharp vascular infusion cannula can be left in place on the I.V. assembly but the syringe removed so that medicine may later be introduced into the I.V. assembly through the non-sharp vascular infusion cannula.  
         [0031]    Referring to FIG. 14, another method for using a non-sharp vascular infusion cannula is depicted. First, a non-sharp vascular infusion cannula must be made or obtained  1401 . Then the non-sharp vascular infusion cannula is used to impale a fluid membrane  1402  so that the radial bulge of the non-sharp vascular infusion cannula passes through the membrane, thereby anchoring the non-sharp vascular infusion cannula in place on the fluid membrane. At that point, the radial bulge of the non-sharp fluid cannula holds the non-sharp vascular infusion cannula in place at the membrane  1403 . The membrane can be located at a medicine vial or other location. Then a syringe or medicine retrieval device is attached to the non-sharp vascular infusion cannula  1404 . Medicine is aspirated past the membrane through the non-sharp vascular infusion cannula  1405  and the syringe can then be removed from the non-sharp vascular infusion cannula with the medicine located within it. Steps  1404  through  1406  can be repeated as desired to that the non-sharp vascular infusion cannula is used multiple times to dispense medicine.  
         [0032]    Referring to FIG. 15, first a user obtains or makes a non-sharp vascular infusion cannula  1501 . Then the non-sharp vascular infusion cannula  1502  is used to implane a fluid membrane on an I.V. assembly so that the radial bulge of the non-sharp vascular infusion cannula passes the membrane. At that time, the radial bulge of the non-sharp vascular infusion cannula holds the non-sharp vascular infusion cannula in place on the I.V. assembly  1503 . Next, the user attaches a syringe or other medicine dispenser device to the non-sharp vascular infusion cannula  1504 . Medicine is permitted to enter the I.V. assembly from the medicine dispenser through the non-sharp vascular infusion cannula  1505 . Next, the medicine dispenser is removed from the non-sharp vascular infusion cannula  1506  while the non-sharp vascular infusion cannula remains held in place at the membrane by the radial bulge. Steps  1504  through  1508  may be repeated as desired  1507  to facilitate multiple instances of medicine being added to an I.V. assembly using a non-sharp vascular infusion cannula and multiple medicine dispensers.  
         [0033]    While the present devices and methods have been described and illustrated in conjunction with a number of specific configurations, those skilled in the art will appreciate that variations and modifications may be made without departing from the principles herein illustrated, described, and claimed. The present invention, as defined by the appended claims, may be embodied in other specific forms without departing from its spirit or essential characteristics. The configurations described herein are to be considered in all respects as only illustrative, and not restrictive. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.