Patent Publication Number: US-6905482-B2

Title: Safety IV catheter infusion device

Description:
RELATED APPLICATIONS 
     This application is a continuation to application Ser. No. 10/174,246 filed Jun. 18, 2002, now U.S. Pat. No. 6,726,658. 
    
    
     BACKGROUND OF THE INVENTION 
     a. Field of Invention 
     This invention pertains to a device used to establish an IV catheter in a patient. More particularly, the invention pertains to a safety infusion device that includes a handpiece used to store and to selectively extend the IV catheter so that it can be introduced into the patient, the handpiece being constructed and arranged to insure that the IV catheter and the so-called underlying needle can be retracted into the barrel at will to protect clinicians from accidental needlesticks. 
     b. Description of the Prior Art 
     IV infusion is one of the most widely used procedures performed in hospitals and other healthcare provider sites. These infusions involve continuously injecting one or more liquids into the veins of a patient to achieve various results. Simple infusion systems may consist of a catheter inserted into the vein and secured to the patient, a pole holding a bottle or bag used as the source of the liquid, a flexible tube feeding the liquid to the catheter either directly, or though some kind of fluid control device. More complex devices include fusion pumps that can deliver fluids to the patient at carefully metered rates using specific profiles. 
     However, independent of which infusion system is used, the IV catheter must first be established. Many different devices are used to perform this step. A popular system consists of a cylindrical receptacle. A hollow steel needle is attached co-axially to one end of the receptacle. A hollow catheter is mounted on the steel needle in a coaxial arrangement. The hollow catheter has a shaft, preferably made of a plastic material and terminating in a standard connector, such as a male Luer lock. A spring is disposed in the receptacle so that when a latch mounted on the receptacle is activated, the steel needle separates from the catheter and is snapped into the receptacle. Once the steel needle is snapped into the receptacle, it is locked in place so that it cannot be extended and reused. Since the needle and the catheter are normally exposed, a protective cap is generally provided over the needle. 
     Using this type of system a catheter is established as follows. First, the clinician finds and preps a proper site on the skin. Next, the system is removed from a sealed enclosure, and its protective cap is removed. The needle and the catheter mounted thereon are inserted through the skin until the tip of the needle and the catheter reaches a predetermined site. The catheter is then secured with the forefinger of one hand and the latch is activated to cause the needle to snap into the receptacle before a needlestick. The receptacle with the captured needle is then disposed. Systems of this kind are available from Becton Dickinson of Franklin Lakes, N.J.; Johnson &amp; Johnson Medical, Inc. of Arlington, Tex., and described in the following patents, incorporated herein by reference: 
     
       
         
           
               
               
               
               
               
             
               
                   
                   
               
             
            
               
                   
                 5,688,249 
                 5,520,654 
                 5,304,136 
                 5,700,250 
               
               
                   
                 5,141,497 
                 5,683,365 
                 5,755,709 
                 D378,405 
               
               
                   
                 5,348,544 
                 5,749,857 
                 5,755,709 
                 5,411,486 
               
               
                   
                 5,792,122 
                 5,795,339 
                 5,676,658 
                 D381,418 
               
               
                   
                 5,690,619 
               
               
                   
                   
               
            
           
         
       
     
     However, these systems are not satisfactory for several reasons. As is well known in the art, the catheter has to extend into a vein and must be oriented properly in order for it to be effective. However, very often clinicians cannot find the proper vein or the proper infusion site on their first try. Therefore, after the needle and catheter have been inserted, the whole system becomes contaminated. Often, before the system can be reinserted, a new site has to be found and prepared. 
     The clinician, especially if she is alone, cannot select and prepare a new site while holding the contaminated system and therefore must make a decision on what to do with it. At least one manufacturer suggests that the system should be discarded. However, obviously, this is a wasteful step. 
     The clinician can also decide to recap the needle and then place it on a horizontal position. However, this process requires two hands and is exactly the situation that subjects people to inadvertent needlesticks. 
     Another disadvantage of existing systems is that they normally require a linear or translational motion of the needle during insertion. This is disadvantageous because it causes the needle to bend thereby causing pain to the patient. Moreover, if the needle bends during insertion, it will miss the vein and the process has to be repeated. 
     Commonly assigned application Ser. No. 09/506,484 filed Feb. 17, 2000, entitled HAND-PIECE FOR INJECTION DEVICE WITH A RETRACTABLE AND ROTATING NEEDLE, now U.S. Pat. No. 6,428,517 issued Aug. 6, 2002 and incorporated herein by reference, discloses an injection device with a barrel from which a needle is selectively extended and retracted using a translational and rotational motion for dispensing an anesthetic to a patient. 
     Commonly assigned patent application Ser. No. 09/745,751 filed Dec. 21, 2000, entitled METHOD OF PERFORMING AN INJECTION USING A BI-DIRECTIONAL ROTATIONAL INSERTION TECHNIQUE, now 2001/10051,798 and incorporated herein by reference discloses the advantages of using a bi-directional rotational technique for dispensing anesthetics. 
     OBJECTIVES AND SUMMARY OF THE INVENTION 
     An objective of the present invention is to provide a system for establishing a catheter which overcomes the above-mentioned disadvantages. 
     A further objective is to provide a system that can be used easily by clinicians. 
     Other objectives and advantages will become apparent from the following description. 
     Briefly, the subject application pertains to a device for establishing an IV catheter by a clinician. The device includes a housing sized and shaped to fit in the hand of the clinician; a catheter assembly including a catheter member with a front portion adapted to be inserted into the vein of a patient; and a control member adapted to reciprocate the catheter assembly within said housing between a retracted position in which said catheter assembly is completely contained in said housing and an extended position in which said catheter member extends outwardly of said housing. 
     A catheter member can be removably attached to the catheter assembly so that it can be removed in the extended position. 
     The catheter assembly includes a needle member with a needle extending outwardly of the housing when the catheter member is in the extended position. The needle is arranged and constructed for insertion in the vein with the catheter member being telescopically associated with the needle member. The catheter member is removably attached to the needle member. 
     In one embodiment the catheter member and the housing cooperate to rotate the catheter assembly about a longitudinal axis as the catheter assembly is reciprocated by said control member. 
     The device also can include locking means for locking the catheter assembly or the needle after the catheter replacement with respect to the housing. These locking means can be adapted to lock the catheter assembly in either the retracted position or the extended position. In addition, the control member can be disabled by the use of the same, or a different locking means so that after the catheter element is properly established, the needle used to establish the catheter cannot be reused. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a sectional side view of a device in a retracted position constructed in accordance with this invention; 
         FIG. 2  shows a sectional side view of the device of  FIG. 1  in the extended position; 
         FIG. 3  shows a sectional side view of the device of  FIG. 1  in the extended position with the catheter partly removed; 
         FIG. 4  shows a sectional side view of the device of  FIG. 1  in the extended position with the catheter completely removed; 
         FIG. 5  shows a sectional side view of the device of  FIG. 1  with the needle retracted and the catheter removed; 
         FIG. 6  shows an orthogonal view of a barrel for the device of  FIG. 1 ; 
         FIG. 6A  shows a plan view of a barrel for the device of  FIG. 1 ; 
         FIG. 7  shows an orthogonal view of a control button; 
         FIG. 8  shows an orthogonal view of the piston for the device of  FIG. 1 ; 
         FIG. 9  shows a side view of the needle member for the device of  FIG. 1 ; and 
         FIG. 10  shows a side view of the catheter for the device of FIG.  1 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the Figures, a device  10  constructed in accordance with this invention consists of a cylindrical housing or barrel  12  having an outer surface  14 , an inner surface  16 , a front end  18  and a rear end  20 . An end piece  22  is attached to the rear end  20  of the barrel. The barrel  12  defines a cylindrical housing. 
     As shown in  FIG. 1 , a catheter assembly  21  is provided in the barrel  12 . This catheter assembly is biased toward a retracted position by a biasing means such as a coil spring  23 . 
       FIGS. 6 and 6A  show more details of the barrel  12 . It includes a longitudinal slot  24 . The slot  24  is formed with two ledges  26  extending along the sides of the slot  24 . These ledges terminate at a gap near the front end  18  to define a front key  28 . In addition, gaps in the ledges  26  near the rear end  20  define a rear key  32 . Two radial ribs  32 A form an outer surface  14  of the barrel  12  to provide a better grip. At the rear end of the slot  24  a portion of the barrel is cut to form an arcuate tongue  34 . The purpose of this tongue  34  is described in more detail below. The barrel is preferably made of a plastic material and is preferably transparent so that the clinician can see its contents. For example, the barrel could be made of an acrylic-based multipolymer such as Cyrolite #GS-90. 
     As seen in  FIG. 1 , the inside surface  16  of the barrel  12  is formed with a helical groove  36 . The rear end  20  is threaded. The front end  18  is formed with an annular end wall  38  with an orifice  40 . 
     The catheter assembly  21  consists of a piston  50  shown in detail in  FIG. 8 , a catheter member  52  and a needle member  54 . The piston is formed of an axle  56  supporting a rear hub  58 , a center hub  60  and a front hub  62 . The rear and front hubs  58 ,  62  have approximately the same radial dimension and they are sized to allow the piston  50  to fit into the barrel  12  with the hubs  58 ,  62  slidingly engaging the inner surface  16 . The axial spacing between the two hubs is sufficient to stabilize the piston  50  and the elements attached thereto (and described below) as they reciprocate through the barrel  12 . The center hub  60  has a smaller diameter and a somewhat curved cross section. The circumferential surface of hub  62  is optionally provided with a knob  64  which is sized and shaped to fit into helical groove  36 . Therefore, as the piston  50  is reciprocated through the barrel, it is also rotated about its longitudinal axis by the caming action on the knob  64  as it travels through groove  36 . 
     Hub  62  also includes a tubular wall  66  disposed about an end portion  68  of axle  56 . The inner surface of the tubular wall  66  is formed with a helical groove  70 . The wall  66  and the end portion  68  cooperate to define a female Luer lock  72 . 
     Details of the needle member  54  are shown in FIG.  9 . It includes a disk  80 , a cylindrical body  82 , a frustoconical extension  84  and a hollow steel needle  86 . These elements are attached to each other as shown. The disk  80  is sized and shaped so that it can be introduced into the Luer lock  72 . In this manner, the needle member  54  is firmly attached to the piston  50 . The needle member  54  can be secured to the piston  50  by other means as well, for example, by using an adhesive. 
     As best seen in  FIGS. 3 and 10 , the catheter member  52  is formed with a hollow substantially cylindrical body  90  with a rear portion  92  which has a relatively large diameter. The body  90  also has a front portion  94  which is much thinner than the rest of the body  90 . The body  90  also includes several circumferential ribs  96  forming a grip for the catheter. A portion of one of the ribs is extended radially to form a tab  98 . 
     The catheter member  52  is made of a flexible plastic material. Preferably catheter member  52  is somewhat translucent. 
     The catheter member  52  and the needle member  54  are sized and shaped so that the catheter member  52  fits over the needle member  54  as shown in  FIG. 2  with the steel needle  86  extending through and beyond the front portion  94 . Moreover, the rear portion  92  is sized to form an interference fit with the extension  84 . The catheter member  52  is freely removable by a clinician from the needle member  54 . Of course, there is sufficient interference fit provided to insure that the catheter member  54  does not separate easily from the needle member without substantial force applied thereto. This force may be applied to tab  98  as explained in more detail below. 
     Finally, the device  10  includes a control member or control means  100  shown in more detail in FIG.  7 . The control member  100  is formed of an upper body  102 , a lower body  104  and an intermediate portion  106 . The lower body  104  is formed with an arcuate surface  108  designed to conform to the shape of the hub  60  on piston  50 . The upper body  102  is formed with two wings  110 ,  112  and a depression  114  defined therebetween. The depression  114  is sized and shaped to accommodate the finger of a clinician. The wing  112  is formed with a tab  116  extending downwardly and is sized and shaped to fit into the keys  30  and  32  on barrel  12 . The control member  100  is made of a plastic material. 
     The control member  100  is sized and shaped to fit into the slot  24  with the upper body  102  disposed outside the barrel  12  and riding on the ledges  26  and the lower body  104  being disposed inside the barrel with the hub  60  being captured by curved surface  108 . 
     The device  10  is assembled by attaching the catheter member  52  to the needle element  54  and attaching the needle element to the piston  50 , thereby completing the catheter assembly  21 . The spring  23  and catheter assembly  21  are then inserted through a hole (not shown) in the rear end  20  of barrel  12 . The control member  100  is also mounted on the barrel  12 . Next, the end piece  22  is attached thereto by screwing the same over the threads of the rear end. Preferably an adhesive is also used to insure that the end piece  22  does not separate from the barrel. Alternatively, the end piece  22  is attached to the barrel  12  without any threading action. Once the end piece is installed, the elements described above are captured by the barrel (except for the catheter member  52 ) and cannot be removed without breakage. 
     Initially the elements of the device  10  are arranged in a closed or retracted position as shown in FIG.  1 . Spring  23  has a diameter which is slightly larger than the diameter of wall  66 . In this retracted position, the spring  23  is expanded and applies a biasing force between the end wall  38  of the barrel  12  and the wall  66  on piston  50 . The control member  100  is positioned over the piston  50  with the hub  60  being captured by the curved surface  108 . 
     The control member  100  is formed so that its tab  116  extends downwardly in the rear key  32  of slot  26 . Moreover the control member  100  is formed and arranged so that as the control member  100  is shifted to the right to the retracted position, a bottom wail  118  of wing  110  (shown in  FIG. 7 ) comes into contact with the end of tongue  34 . The tongue  34 , being slightly higher, and in effect pushes the wing  110  slightly upward as well. As a result, the opposite wing  112  with the tab  116  is pushed downward into the key  30 . In this manner the control member  100  and the catheter assembly  21  is locked into the retracted position by the locking means formed by the cooperation between the control member  100  and key  32 . The device  10  is sealed in a suitable package (not shown) and stored in this position. 
     The device  10  is used to establish the catheter member  52  as follows. Typically, an infusion procedure is initiated by a clinician by selecting and prepping the infusion site. The clinician then removes the device  10  from its package and holds it in a pinching grip. In this grip the thumb is positioned on the control member  100 , and the remaining fingers being wrapped around the barrel to stabilize it. The device  10  is sized and shaped so that in this pinching grip, the pinky finger wraps around the end piece  22 . 
     The clinician then pushes on the wing  110  axially inward causing the top body to twist slightly radially inward, and lift the tab  116  out of rear key  32 . This action unlocks the control member  100 . Next, the clinician advances the control member  100  slightly forward. Because the surface  108  captures the hub  60 , this movement forces the whole catheter assembly  21  to move forward as well. The clinician continues the translation of the control member  100  forward until a portion of the needle  96  extends through the hole  40  (FIG.  6 ). 
     Next, the clinician positions the device  10  next to the infusion site with the tip of the needle  86  resting against the skin. The clinician then continues to advance the control member  100  until it reaches the front key  30 . The clinician can lock the control member  100  and the catheter  21  by pushing the wing  112  inwardly thereby causing the tab  112  to pivot counterclockwise and engage front key  30 . In this position, a portion of needle member  54  and most of the catheter member  52  extend out of the barrel  12  as shown in FIG.  2 . This position is the extended position of the device and the control member  100  and front key  30  provide a locking means for locking the catheter assembly in the extended position. 
     It should be appreciated that as the control member  100  is advanced from the rear key  32  to the front key  30  in a translational motion through the slot  26 , because of the caming action between the knob  64  and spiral groove  36 , the catheter assembly  21  is translated forward as well from the retracted to the extended position, and is simultaneously rotated about its longitudinal axis and the longitudinal axis of the barrel  12 . Thus, the knob  64  and spiral groove  36  provide a means of rotating the catheter assembly  21 . As explained in the above-identified application Ser. No. 09/506,484 filed Feb. 17, 2000, and in application Ser. No. 09/745,751 filed Dec. 21, 2000, this combined or bidirectional motion is very advantageous because as the needle  86  penetrates the skin and the tissues and advances to the vein, its simultaneous rotation insures that the patient suffers less pain. In addition, it prevents the needle  86  from bending and insures that the needle advances precisely in the direction and to the location desired by the clinician. 
     The needle  86  must be advanced sufficiently so that the front portion  94  is in fluid communication with the vein as well. The front portion  94  is thin enough so that it slips easily through the sidewalls of the vein. As discussed above, needle  86  is hollow and has an opening at its tip. A second opening may be provided on the needle  86  under the front end  94 . When the needle  86  and front end  84  are inserted into the vein, blood from the vein flows into the needle  86  and oozes out of this second opening, under the front end  94 . Since the catheter  52  is translucent, this blood is easily visible to the clinician. Moreover, since the needle  86  is hollow, some of the blood also flows back in the housing where it becomes visible as well. This provides confirmation that the needle  86  and the catheter member  52  are properly positioned in the vein. 
     If for any reason the clinician has to move to a different infusion site, he can withdraw the needle from the patient. If this motion occurs before the control member  100  reached front key  30  then the clinician can merely release the control member  100  and the catheter assembly  21  is then automatically returned to the retracted position by the spring  23 . If this motion is desired after the front key  30  is reached, then the clinician must first unlock the control member from the front key by pressing inwardly on wing  110 . 
     Once the catheter assembly  21  is returned to its retrieved position, the device  10  can be rested on a flat surface and the clinician can go on with other tasks (such as prepping the new site) without fear of needlesticks even if the needle  86  has been contaminated. 
     After the needle  86  and the catheter member  52  are properly positioned in the vein, the needle  86  is withdrawn as follows. The clinician shifts his forefinger to rest on the front end  94  of the catheter member  52 . The rest of his fingers are still wrapped around the barrel  12 . In this position, the clinician unlocks the control member  100  as discussed above and releases it. The spring  23  forces the needle member  54  to withdraw telescopically and separate from the catheter  52 . The needle member  54  and the piston  50  are then snapped back to the retracted position. During this motion, the clinician holds the catheter member  52  in place (i.e., inserted in the vein). Thus, the clinician needs to use only a single hand from the beginning of the process until the catheter member  54  is established in the vein and is separated from device  10 . As explained above, in prior art devices this same operation requires the use of two hands. 
       FIG. 3  shows the catheter member  52  being removed from the needle member  54 . 
       FIG. 4  shows the catheter member  52  being separated from the rest of the device  10 . 
       FIG. 5  shows the catheter assembly  21  without the catheter member  52  in the retracted position. 
     Once the device  10  is in the retracted position of  FIG. 5 , it can be disposed. The catheter member  52  can be connected to a standard IV tube by attaching to a standard Luer lock, or by using other well known means. 
     Importantly, in many instances the clinician may want to insure that once its catheter member  54  has been properly established, the device  10  is not reused in any way and that the needle member  54  stays in the retracted position. This is accomplished by providing a control disabling means for the device which insures that the control member  100  is inoperative and cannot be used to advance the needle. This disabling means can be implemented by making the intermediate portion  106  of the control member  100  frangible. Then, once the catheter member  52  is properly established in the vein, the top body  102  is broken off from the bottom body  104 . Once this step is completed, the piston  50  and the needle member  54  are trapped inside the barrel  12  and cannot be removed without breaking the barrel. 
     The device may be used in a different manner as well. For example, if the clinician does not want to take advantage of the simultaneous translation and rotation of the needle member  54 , he can advance the catheter assembly  21  from the retracted to the extended position first, and then with the needle member being fully extended, he can start inserting the needle  86  through the skin toward the selected vein. For this type of operation, since the rotation of the needle  86  is not required, the knob  64  and the groove  26  may be omitted. 
     Other modifications may be made to the device  10  as well. For example, the means for locking the control member  100  either in the retracted position, the extended position, or both, may be omitted. 
     While the invention has been described with reference to several particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles of the invention. Accordingly, the embodiments described in particular should be considered as exemplary, not limiting, with respect to the following claims.