Abstract:
A venous access catheter is combined with a needle, guidewire, and actuator where the needle is disposed coaxially over the guidewire and the catheter is disposed coaxially over the needle. A hub at a proximal end of the access catheter includes a wiping element to clean blood from the needle and guidewire as they are removed and a side port to allow connection of fluids after the access catheter is placed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 13/358,099, now U.S. Pat. No. 8,690,833, filed Jan. 25, 2012, which claims the benefit of U.S. provisional patent application No. 61/438,197, filed Jan. 31, 2011, each of which is incorporated herein by reference in its entirety herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to devices and methods for insertion and placement of an access catheter into a vein or artery of a patient over a guidewire. 
     Safe placement of an access catheter into the patient&#39;s vein or artery is particularly difficult in the case of small, tortuous, collapsed, fragile, and/or difficult to locate vessels. The risk of accidental punctures and/or contamination by the needle after placement of an intravenous catheter is a particular problem. It is therefore of interest to provide devices and methods which protect medical personnel from potential exposure to blood from the movement of the retracting guidewire. 
     Of particular interest to the present invention, access catheters are often pre-packaged with both a needle and a guidewire where the needle is coaxially received over the guidewire and the catheter is coaxially received over the needle. The needle extends just beyond the distal tip of the catheter so that the assembly of the needle and catheter can be introduced into the vein or other vessel. As soon as entry into the vein is detected, typically by observing flashback, the guidewire can be advanced into the venous lumen, the catheter advanced over the guidewire, and both the needle and guidewire then removed from the catheter, leaving the catheter available for attachment to sources of fluids, drugs or other intravenous materials. 
     Removal of the needle and guidewire can be problematic as they have a tendency to carry patient blood and risk the treating personnel to exposure. This can be a particular problem in the case of guidewires having a helical or other shaped tip, such as those described in at least some of the published U.S. patent applications listed below. 
     For these reasons, it would be desirable to provide systems and methods for use with intravenous and other vascular access catheters to reduce the risk of blood loss and spattering where guidewires and/or needles are withdrawn from the catheter after placement. It would be particularly desirable if such methods and devices were compatible with venous catheters having automatic needle and guidewire retraction mechanisms, as described in the patent publications listed below. At least some of these objectives will be met by the invention as described herein. 
     2. Background Art 
     The subject matter of the present invention is related to the following U.S. patent applications, the disclosures of which are hereby incorporated by reference in their entirety. Each of the various embodiments of an intravenous catheter insertion device described in these patent applications can be combined with the intravenous catheter of the present invention to create an intravenous catheter system.
         US 20100210934 Intravenous catheter insertion and blood sample devices and method of use   US 20100094310 Intravenous catheter insertion device and method of use   US 20080300574 Intravenous catheter insertion device and method of use
 
Also of interest are the following U.S. patents that describe catheters having sidearm connectors: U.S. Pat. Nos. 5,704,914; 5,154,703; 5,084,023; 4,585,440; 4,509,534; and 4,177,809.
       

     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides venous and other vascular access catheters which are adapted to reduce the loss and spattering of blood upon withdrawal of needles and guidewires used to introduce the catheters. In particular, the present invention provides a catheter insertion device comprising an access catheter, a needle, a safety guidewire, and an actuator mechanism for selectively advancing the safety guidewire through the needle and selectively withdrawing both the needle and the safety guidewire from the catheter at desired points in the catheter insertion protocol. The present invention provides a chamber and a septum or other membrane as a “wiping” element on a proximal hub, housing, or other component of the access catheter. The chamber is preferably disposed at a proximal end of a hub having an interior chamber spaced apart from a proximal end of the catheter. A septum is preferably disposed on a proximal side of the chamber to wipe residual blood from the guidewire as the guidewire is withdrawn by the actuator. An insertion tool for the needle and/or guidewire is removably attached to the hub adjacent the septum so that the needle and guidewire may be advanced through the septum and into the catheter for selective advancement in order to permit introduction of the catheter into an artery or vein in a generally conventional manner. The actuator is further adapted to withdraw the needle and guidewire, typically under the force of a spring or other biasing element which rapidly withdraws the needle and catheter into and through the interior of the hub. Usually, the guidewire will be a “safety” guidewire having a helical or other preformed atraumatic shape at its distal end which is assumed when the safety guidewire exists from a distal tip of the needle in order to reduce the risk of damaging the vessel as the guidewire is advanced. As the guidewire is withdrawn, the safety tip will be straightened as it passes through the needle lumen and will resume the helical or other configuration within the interior of the hub, thus being able to shed blood which it may have picked up while in the artery or vein into the hub rather than into the surrounding tissue or housing. The guidewire can then be further withdrawn through the septum in order to remove any remaining blood before it is drawn back into the actuator for safe disposal. A side port, typically with a side tube, is provided on the hub in order to introduce desired fluids in order to accommodate the septum or other wiping element which is present on the proximal end of the hub. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows an exploded view of an intravenous catheter and insertion device according to the present invention. 
         FIG. 2  shows an assembly drawing of the intravenous catheter and insertion device in an undeployed state, ready for use. 
         FIG. 3  shows an intravenous catheter and insertion device in an undeployed state, ready for use. 
         FIG. 4  shows the intravenous catheter and insertion device of  FIG. 3  with the guidewire advanced. 
         FIG. 5  shows the intravenous catheter and insertion device of  FIG. 3  with the guidewire and needle retracted. 
         FIG. 6  is an enlarged view of the intravenous catheter of  FIG. 3 . 
         FIG. 7  shows an embodiment of the intravenous catheter and insertion device with a separate sidearm adapter. 
         FIG. 8  is an enlarged view of the sidearm adapter of  FIG. 7 . 
         FIG. 9  is an enlarged view of another embodiment of an intravenous catheter according to the present invention. 
         FIGS. 10 and 11  illustrate another embodiment of a guidewire for use with the intravenous catheter and insertion device.  FIG. 10  is a proximal end view of the guidewire, and  FIG. 11  is a side view of the guidewire. 
         FIG. 12  illustrates an embodiment of a steerable guidewire for use with the intravenous catheter and insertion device. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows an exploded view of one embodiment of an intravenous catheter  100  and insertion device  20  according to the present invention.  FIG. 2  shows an assembly drawing of the intravenous catheter  100  and insertion device  20  in an undeployed state, ready for use. Additional intravenous catheter insertion devices that can be used in the present invention are described in detail in the following patent applications: US 20100210934, US 20100094310 and US 20080300574, which have been incorporated by reference. 
     The intravenous catheter insertion device  20  has a housing  21 , which includes a proximal housing  1  that is adhesively joined or otherwise connected to a distal housing  11 . In the example shown, the proximal housing  1  is in the form of an elongated hollow cylinder. The distal housing  11  is optionally formed in an ergonomic handle shape designed to be held by the thumb and forefinger of a user. Other shapes are also possible. The housing  21  has an elongated slot  22  that extends from the proximal housing  1  to the distal housing  11  approximately parallel with a longitudinal axis of the housing  21 . A wire advance slider  3  slides in a longitudinal direction along an exterior of the proximal housing  1  and the distal housing  11  and has a tongue  23  that extends through the slot  22  into the interior of the housing  21 . A needle carrier  6  is slidable within the interior of the housing  21  and is positioned distal to the tongue  23  of the wire advance slider  3 . The distal end of the needle carrier  6  includes a luer slip fitting  16  or the like. There is a notch  24  in the needle carrier  6  just proximal to the luer slip fitting  16 . A button  25  is located on one side of the distal housing  11 , which has a tab  26  that is configured to engage the notch  24  in the needle carrier  6  when the needle carrier  6  is in its most distal position. A cylindrical guidewire stop  2  is adhesively bonded into the proximal end of the proximal housing  1 . 
     A tubular stainless steel hypodermic needle  7  with a sharpened, beveled distal end  29  is bonded with adhesive  13  or otherwise attached to the distal end of the needle carrier  6 . Preferably, the needle  7  has one or more slots  27  cut into the sides of it connecting to the needle lumen for the passage of blood. A guidewire  9  is bonded with adhesive  14  or otherwise attached to the tongue  23  of the wire advance slider  3 . The guidewire  9  is preferably made of a highly resilient material, such as a superelastic Nickel-Titanium alloy wire approximately 0.003-0.012 inches in diameter and most preferably approximately 0.004 inches in diameter. The guidewire  9  may be uniform in diameter or it may be made stepped or tapered in diameter, for example by grinding. For example, a 0.008 inch diameter wire can be centerless ground to create a 0.004 inch diameter distal portion with a short tapered transition. Optionally, a proximal portion of the guidewire  9  may be supported with a support tube  8  made from stainless steel or Nickel-Titanium alloy hypodermic tubing or a molded or extruded polymer tube. Another option for constructing the guidewire  9  would be to join a short distal portion of a highly resilient material, such as a superelastic Nickel-Titanium alloy wire, to a larger diameter, solid or tubular proximal portion, for example by welding, swaging, crimping and/or adhesive bonding. As best seen in  FIG. 9 , the distal end of the guidewire  9  is preformed into a tightly wound spiral  28  with an outer diameter smaller than the internal diameter of the target vessel into which it will be inserted. The spiral tip  28  acts as a safety bumper on the guidewire  9  to avoid puncturing or damaging the inside of target vessels. The coiled guidewire tip  28  is particularly useful in protecting fragile or delicate veins. Due to the extreme flexibility of the Nickel-Titanium alloy wire, the spiral distal curve  28  can straighten out when the guidewire  9  is withdrawn into the needle  7  and completely recover into the spiral configuration without plastic deformation when the guidewire  9  is advanced out of the needle  7 . In the example shown, the distal end of the guidewire  9  has a first, small diameter coil of approximately 0.167 inches in diameter for approximately 0.75 revolutions and a second, larger diameter coil of approximately 0.175 inches in diameter for approximately 1 revolution. The first and second coils are preferably approximately coplanar with one another and preferably approximately coplanar with the straight proximal portion  12  of the guidewire  9  also. Other configurations of the guidewire  9  may include: multi-planar, single coil, full radius on the end, and/or a balled end with a diameter less than the diameter of the needle. 
     The guidewire  9  is positioned to move coaxially through the lumen of the needle  7 . Optionally, a flexible tether  4  connects from the tongue  23  of the wire advance slider  3  to the proximal end of the needle carrier  6 . Optionally, a needle carrier cap  5  may be provided to facilitate adhesively attaching the tether  4  to the proximal end of the needle carrier  6 . The length of the tether  4  prevents the guidewire  9  from being withdrawn too far proximally with respect to the needle  7  because the small-diameter distal coil  28  would be difficult to reinsert into the proximal end of the needle  7  if it were to be completely withdrawn from the needle lumen. In another option, instead of using a tether, a plastic protrusion or another physical structure, such as a gate, can act as a detent to block the guidewire  9  from withdrawing beyond the desired point. Optionally, the detent may be configured so that it can be overrun when a forceful retraction occurs, such as the one that is initiated by the spring  10 , thus allowing complete retraction of the guidewire  9 . In another option, the housing  21  may be configured such that the guidewire  9  or the structure that is connected to the guidewire  9  will hit a positive stop, such as the guidewire stop  2  or the proximal end of the housing  21 , before the guidewire  9  gets to a position too proximal relative to the needle  6 . 
     The proximal housing  1 , distal housing  11 , wire advance slider  3 , button  25 , needle carrier  6 , guidewire stop  2  and needle carrier cap  5  may be formed from any material suited for use in medical applications. For example, some or all of these parts may be molded and/or machined from a rigid, transparent medical grade plastic, such as acrylic or polycarbonate. 
     A compression spring  10  or similar biasing member is positioned between the needle carrier  6  and the distal end of the housing  21  to urge the needle carrier  6  in a proximal direction. The force of the spring  10  is resisted by the tab  26  of the button  25 , which engages the notch  24  in the needle carrier  6  when the needle carrier  6  is in its most distal position. It should be noted that in  FIG. 1  the spring  10  is shown in a compressed condition as it would be in the assembled intravenous catheter insertion device  20  in an undeployed condition. 
     The intravenous catheter  100 , which is shown in an enlarged view in  FIG. 6 , has a catheter tube  102  with an inner lumen that fits coaxially around the needle  7  of the insertion device  20 . The catheter tube  102  is preferably extruded of a flexible medical grade polymer having a low coefficient of friction, for example PTFE, polypropylene or polyethylene. Preferably, the intravenous catheter tube  102  has a close fit with the needle  7  and a tapered distal end to minimize any step between the needle  7  and the catheter tube  102  as they are inserted through the wall of a vein. 
     The proximal end of the catheter tube  102  is connected to a proximal fitting  104  that connects to the distal end of a flexible sidearm tube  106 , which extends laterally from the side of the proximal fitting  104 . Preferably, the proximal fitting  104  is molded of a clear polymer so that blood flashback from the needle  7  can be observed in the proximal fitting  104 . A luer fitting  108  or the like is attached to the proximal end of the sidearm tube  106 . A fluid flow path is formed from the luer fitting  108  through the sidearm tube  106  to the proximal fitting  104  and the catheter tube  102 . Preferably, the fluid flow path is free of obstructions, sudden changes of diameter or dead spaces that would interfere with fluid flow or be a nidus for thrombus formation. Optionally, the intravenous catheter  100  may include wings  105 , which facilitate taping the intravenous catheter  100  to the patient&#39;s skin after insertion. The wings  105  may be rigid or flexible and, optionally, may be molded integrally with the proximal fitting  104 . 
     A hemostasis valve  110  is located on a proximal side of the proximal fitting  104 . The hemostasis valve  110  is preferably configured as an elastomeric membrane  112  with a small hole  114  at the center of the elastomeric membrane  112 . The hole  114  forms a sliding seal around the needle  7  of the insertion device  20 . Alternatively, the elastomeric membrane  112  may be intact and the needle  7  will form a hole  114  as it is inserted through the membrane  112 . The elastomeric membrane  112  can be made of latex, silicone, polyurethane or another medical grade elastomer. Optionally, a small amount of medical grade lubricant, such as silicone oil, may be used to reduce the friction of the needle  7  passing through the hemostasis valve  110 . Other configurations of hemostasis valves known in the industry, such as those having different configurations of membranes, holes, slits or duckbill valves, may also be used. Optionally, more than one or a combination of different hemostasis valves  110  may be used. 
     Optionally, located proximal to the hemostasis valve  110  is a wiping element  120 . The wiping element  120  is adapted to remove blood from the surface of the guidewire  9  and needle  7  as they are withdrawn from the intravenous catheter  100 . The wiping element  120  may be made of an absorbent or superabsorbent material to absorb blood from the surface of the needle  7  and guidewire  9 . Examples of suitable materials include, but are not limited to, cotton wool, gauze, felt, natural or artificial sponge, open-cell foam, etc. Alternatively, the wiping element  120  may be configured as an elastomeric membrane that acts like a squeegee to remove blood from the surface of the guidewire  9 . The elastomeric membrane will preferably be sufficiently elastic to adapt to the larger diameter of the needle  7  and then to the smaller diameter of the guidewire  9  when the needle  6  has been withdrawn. Preferably, the wiping element  120  is made with a hole or slit  122  in the center that is aligned with the hole  114  in the hemostasis valve  110 . Alternatively, the wiping element  120  may be intact and the needle  7  will form a hole  122  as it is inserted through the wiping element  120 . 
     Optionally, there may be a luer fitting  27  or the like on the proximal fitting  104  of the intravenous catheter  100  that fits onto a luer slip fitting  16  on the distal end of the needle carrier  6  with a slight interference fit to hold the intravenous catheter  100  in place, as shown in  FIGS. 1 and 2 . Alternative configurations of the device may use a luer lock or other locking mechanism to temporarily attach the intravenous catheter  100  to the insertion device  20 . Alternatively, the friction of the needle  7  passing though the hemostasis valve  110  and wiping element  120  may be sufficient to hold the intravenous catheter  100  onto the insertion device  20 . 
     An optional feature of the intravenous catheter  100  in any of the embodiments described herein is a means  142  for selectively blocking or occluding fluid flow through the flexible sidearm tube  106 . This can be in the form of a tubing clamp or stopcock located on the flexible sidearm tube  106  or on the luer fitting  108 , as shown in  FIGS. 1 and 2 . Alternatively, a separate stopcock can be connected to the luer fitting  108  for selectively blocking fluid flow. 
       FIGS. 3-5  illustrate steps in a method of inserting an intravenous catheter  100  using an intravenous catheter insertion device  20 , such as those described above in connection with  FIGS. 1, 2 and 6 . The intravenous catheter  100  and insertion device  20  are provided as a single-use, non-reusable device supplied to the physician or other medical practitioner sterile in a ready-to-use, undeployed condition, as shown in  FIG. 3 . In another option, the device can be stored with the distal spiral portion  28  of the guidewire  9  advanced distally from the tip of the needle  7  so that it is not straightened during storage. In this case, the operator will fully retract the guidewire  9  into the needle  7  before use. In use, the operator uses the housing  21  as a handle to manipulate the intravenous catheter  100  and insertion device  20 . With the device in the undeployed condition, the needle  7  is used to puncture a vein. When venous blood is observed in the proximal fitting  104 , the operator knows that the distal tip of the needle  7 , together with the distal part of the catheter tubing  102 , is in the lumen of the vein. The operator can then advance the slider  3  in the distal direction to extend the guidewire  9  out of the needle  7  into the lumen of the vein, as shown in  FIG. 4 . The distal portion of the guidewire  9  assumes its spiral configuration  28  to act as a safety bumper to prevent accidental puncture of the far wall of the vein or other damage to the vein and also to enable passage along obstructions such as valves or curves. With the guidewire  9  thus deployed, the operator can safely continue advancing the intravenous catheter  100  until it is inserted far enough into the vein, then the operator pushes the button  25 , which disengages the tab  26  from the notch  24  in the needle carrier  6 . The spring  10  urges the needle carrier  6  and the slider  3  in the proximal direction, thus simultaneously withdrawing the needle  7  and the guidewire  9  into the housing  21 , leaving only the intravenous catheter  100  in the lumen of the vein.  FIG. 5  shows the insertion device  20  with the needle  7  and the guidewire  9  withdrawn into the housing  21 . Preferably, the coil  28  on the distal tip of the guidewire  9  is visible when the insertion device  20  is in the deployed position, as shown in  FIG. 5 . This allows the operator to verify that the guidewire  9  is intact and that only the intravenous catheter  100  has been left in the patient&#39;s vein. 
     While it is desirable for the insertion device  20  to withdraw the needle  7  and the guidewire  9  simultaneously, the actuator mechanism could also be modified to withdraw the needle  7  and the guidewire  9  sequentially. For example, the actuator mechanism could withdraw the needle  7  first and then, after a slight delay, withdraw the guidewire  9 . Alternatively, the actuator mechanism could be modified to require two separate motions of one actuator member or selective movements of two separate actuator members to withdraw the needle  7  and the guidewire  9  selectively. As another alternative, the spring  10  may be omitted from the actuator mechanism, thus allowing the needle  7  and the guidewire  9  to be withdrawn manually using the slider  3 . Once the intravenous catheter  100  has been inserted into the patient&#39;s vein, the slider  3  is moved proximally along the slot  22  to withdraw the needle  7  and the guidewire  9  into the housing  21 . 
       FIG. 7  shows an embodiment of the intravenous catheter  100  and insertion device  20  with a separate sidearm adapter  130 .  FIG. 8  is an enlarged view of the sidearm adapter  130  of  FIG. 7 . The structure of the intravenous catheter  100  is similar to that described above in connection with  FIG. 6 , except that the proximal fitting  104  has a male luer connector  132  on its distal end that interlocks with a female luer connector  134  on the proximal end of the catheter tube  102 . 
       FIG. 9  is an enlarged view of another embodiment of an intravenous catheter  100  according to the present invention. The proximal fitting  104  and the sidearm  106  may be integral to the intravenous catheter  100 , as shown in  FIG. 9 , or they may be part of a separate sidearm adapter, similar to that shown in  FIGS. 7 and 8 . In this embodiment, the proximal fitting  104  has a first chamber  136  in fluid connection with the catheter tube  102  and a second chamber  138  separated from the first chamber  136  by the hemostasis valve  110 . Optionally, a wiping element  120  for removing blood from the guidewire  9  is located on the proximal side of the second chamber  138 . Preferably, the second chamber  138  is sized to allow the coiled tip  128  of the guidewire  9  to resume its coiled configuration after it is withdrawn through the hemostasis valve  110 . Any dripping or spattering of blood from the guidewire  9  will occur in the second chamber  138 . The optional wiping element  120  will help to remove any remaining blood from the guidewire  9  as it is withdrawn from the second chamber  138 . 
       FIGS. 10 and 11  illustrate another preferred embodiment of a guidewire  9  for use with the intravenous catheter  100  and insertion device  20  of the present invention.  FIG. 10  is a proximal end view of the guidewire  9 , and  FIG. 11  is a side view of the guidewire  9 . The guidewire  9  is preferably made of a highly resilient material, such as a superelastic Nickel-Titanium alloy wire with a uniform diameter of approximately 0.003-0.012 inches and most preferably approximately 0.004 inches. The distal end of the guidewire  9  is preformed into a tightly wound spiral  28  with an outer diameter smaller than the internal diameter of the target vessel into which it will be inserted. Due to the extreme flexibility of the Nickel-Titanium alloy wire, the spiral distal curve  28  can straighten out when the guidewire  9  is withdrawn into the needle  7  and completely recover into the spiral configuration without plastic deformation when the guidewire  9  is advanced out of the needle  7 . In the example shown, the spiral distal curve  28  of the guidewire  9  is in the form of a helix with approximately three coils or rotations of substantially uniform diameter. In a particularly preferred embodiment, the helical coils of the spiral distal curve  28  have an outer diameter of approximately 0.052 inches (approximately 1.3 mm). Alternatively, the spiral distal curve  28  may be in the form of a conical helix with coils that diminish or increase in diameter. In the example shown, the helical coils of the spiral distal curve  28  have a central axis that is perpendicular to and offset from an axis defined by the proximal portion  12  of the guidewire  9 . In other embodiments, the central axis of the spiral distal curve  28  may be skewed from the axis of the proximal portion  12  of the guidewire  9 . Other possible configurations of the spiral distal curve  28  of the guidewire  9  are described in patent applications US 20100210934, US 20100094310 and US 20080300574, which have been incorporated by reference. 
     The proximal portion  12  of the guidewire  9  is preferably supported with a support tube  8  made from stainless steel or Nickel-Titanium alloy hypodermic tubing or, alternatively, a molded or extruded tube made of a polymer, such as, but not limited to, FEP, PEEK or HDPE. The support tube  8  will preferably have an inner diameter sufficient for the proximal portion  12  of the guidewire  9  to be inserted through it, for example 0.006 inches inner diameter to accommodate a 0.004 inch diameter guidewire  9 . The support tube  8  will preferably have an outer diameter of approximately 0.012-0.016 inches and most preferably approximately 0.014 inches. Optionally, the support tube  8  may be adhesively bonded or otherwise attached to the proximal portion  12  of the guidewire  9  with the distal end of the support tube  8  positioned a short distance proximal to the spiral distal curve  28 . The support tube  8  may have a tapered distal end  144 , which may be formed by a molding process or by applying a filet of adhesive or other material during assembly. 
       FIG. 12  illustrates another embodiment of a guidewire  9  for use with the intravenous catheter  100  and insertion device  20  of the present invention. The guidewire  9  may be made from a uniform-diameter wire or a tapered wire and may optional be supported by a support tube  8  as described above. The spiral distal curve  28  of the guidewire  9  may be any of the configurations described or incorporated herein. There is a bend  140  of approximately 30 to 60 degrees in the guidewire  9  a short distance, for example 1 to 5 mm, proximal to the spiral distal curve  28 . The bend  140  may be located just at the distal end  144  of the support tube  8  or, optionally, the bend  140  may be located a short distance, for example 1 to 5 mm, distal to the distal end  144  of the support tube  8 . The bend  140  allows the guidewire  9  to be used in a steerable fashion to facilitate negotiating tortuous and/or branching blood vessels. 
     While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various features and embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof.