Patent Publication Number: US-2022225914-A1

Title: Guidewire Delivery Device and Related Devices, Systems and Methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims priority to U.S. Provisional Application Ser. No. 63/139,656, entitled “Guidewire Delivery Device and Related Devices, Systems and Methods”, filed Jan. 20, 2021, the entire disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. 
     The catheter may include a peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. 
     In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may remove the introducer needle, leaving the catheter in place for future fluid infusion. 
     Overtime, thrombosis may accumulate at the catheter, and the catheter may narrow, collapse, or clog, leading to failure of the catheter. The thrombosis makes it difficult to draw blood through the catheter that is indwelling. In response to patency of the catheter being compromised, the catheter may need to be removed from the patient. The catheter may then be replaced with another catheter, which is usually introduced via another needle stick, leading to discomfort for the patient. Moreover, typical methods of blood collection through the catheter that is indwelling often result in insufficient blood volume and blood coagulation. 
     The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. 
     SUMMARY 
     The present disclosure generally relates to a blood collection device and related devices, systems, and methods. In particular, the present disclosure relates to a guidewire delivery device and related devices, systems, and methods. In some embodiments, the guidewire delivery device may include a housing, which may include a distal end, a proximal end, and a lumen extending through the distal end of the housing and the proximal end of the housing. In some embodiments, the housing may include a slot disposed between the distal end of the housing and the proximal end of the housing. 
     In some embodiments, the guidewire delivery device may include a tab moveable with respect to the slot. In some embodiments, the tab may extend through the slot and/or may be movable along the slot. In some embodiments, the guidewire delivery device may include a penetration cannula coupled to the tab and extending in a distal direction. In some embodiments, the guidewire delivery device may include an adapter proximal to and in fluid communication with the penetration cannula. In some embodiments, the adapter may include a Y-adapter or another suitable adapter. In some embodiments, the penetration cannula and the adapter may be configured to receive a guidewire therethrough. 
     In some embodiments, the guidewire delivery device may include a lumen extending from a proximal end of the penetration cannula to the adapter. In some embodiments, the lumen may extend through the proximal end of the housing. In some embodiments, in response to movement of the tab with respect to the slot in a distal direction, the adapter may be closer to the proximal end of the housing. In some embodiments, the guidewire delivery device may include a body and an extension tube extending proximally from the body to the adapter. In some embodiments, the tab may extend from the body. In some embodiments, the penetration cannula may extend distally from the body. 
     In some embodiments, the distal end of the housing may include a luer adapter configured to couple to a side port or a distal end of a catheter adapter. In some embodiments, the penetration cannula may be 20 G or another suitable gauge. In some embodiments, the guidewire delivery device may include the guidewire extending distally through the adapter. 
     In some embodiments, the guidewire may be coiled. In some embodiments, a distal end of the guidewire may include multiple elongated arms. In some embodiments, the elongated arms may be configured to separate in response to removal of an inward biasing force. 
     In some embodiments, a method of blood collection may include coupling the guidewire delivery device to a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the catheter assembly may include a septum configured to seal a fluid pathway through the catheter assembly. 
     In some embodiments, the method may include advancing the tab distally within the slot. In some embodiments, in response to advancing the tab distally, the penetration cannula may penetrate the septum. In some embodiments, after advancing the tab distally with respect to the slot, the method may include advancing the guidewire distally through the penetration cannula and/or distal to the catheter. In some embodiments, the septum may be disposed within the lumen of the catheter adapter. In some embodiments, coupling the guidewire delivery device to the catheter assembly may include coupling the proximal end of the housing to the proximal end of the catheter adapter. 
     In some embodiments, the catheter adapter may include the side port, which may be disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include another adapter. In some embodiments, the catheter assembly may include an extension tube, which may include a distal end coupled to the side port and a proximal end coupled to the other adapter. In some embodiments, the septum may be disposed within the other adapter. 
     In some embodiments, coupling the guidewire delivery device to the catheter assembly may include coupling the proximal end of the housing to the other adapter. In some embodiments, the catheter assembly may include a wedge disposed within the lumen of the catheter adapter. In some embodiments, the catheter may be secured within the distal end of the catheter adapter by the wedge. In some embodiments, in response to advancing the tab distally with respect to the slot, a distal end of the penetration cannula may be disposed within the wedge. 
     In some embodiments, the distal end of the guidewire may include the elongated arms, and the elongated arms may be biased together in response to the elongated arms being in the catheter. In some embodiments, the elongated arms are configured to separate in response to the elongated arms moving distal to the catheter, wherein after the tab is advanced distally with respect to the slot, the guidewire is advanced distally through the penetration cannula and distal to the catheter and rotated. 
     In some embodiments, the adapter may include a distal port, a first proximal port, and a second proximal port. In some embodiments, a needleless connector may be coupled to the first proximal port. In some embodiments, a blood collection device is coupled to the second proximal port. In some embodiments, after advancing the tab distally with respect to the slot, the guidewire may be advanced distally through the first proximal port. 
     In some embodiments, after advancing the tab distally with respect the slot, the guidewire may be advanced distally through the penetration cannula and distal to the catheter. In some embodiments, the method may include retracting the guidewire proximally such that a distal end of the guidewire is disposed within the penetration cannula. In some embodiments, after retracting the guidewire proximally such that the distal end of the guidewire is disposed within the penetration cannula, the method may include collect blood through a blood collection device coupled to the adapter. In some embodiments, the method may include retracting the tab proximally with respect to the slot. In some embodiments, in response to retracting the tab proximally with respect to the slot, the penetration cannula is withdrawn proximally through the septum. 
     It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1A  is a cross-sectional view of an example guidewire delivery device, according to some embodiments; 
         FIG. 1B  is an upper perspective view of the guidewire delivery device with an example housing removed for illustrative purposes, according to some embodiments; 
         FIG. 2A  is an upper perspective view of an example catheter system, illustrating the guidewire delivery device coupled to a proximal end of an example catheter adapter, according to some embodiments; 
         FIG. 2B  is a cross-sectional view of the catheter system of  FIG. 2A , illustrating the guidewire delivery device coupled to the proximal end of the catheter adapter, according to some embodiments; 
         FIG. 2C  is an enlarged view of a distal end of the catheter system of  FIG. 2A , illustrating an example guidewire in an example advanced position, according to some embodiments; 
         FIG. 3A  is an upper perspective view of an example catheter system, illustrating the guidewire delivery device coupled to a proximal port of another example adapter, according to some embodiments; 
         FIG. 3B  is an upper perspective view of a distal portion of the catheter system of  FIG. 3A , illustrating the guidewire in the advanced position, according to some embodiments; 
         FIG. 3C  is an enlarged view of a distal end of the catheter system of  FIG. 3A , illustrating the guidewire in the advanced position, according to some embodiments; 
         FIG. 3D  is a cross-sectional view of a portion of the catheter system of  FIG. 3A , according to some embodiments; 
         FIG. 4A  is an upper perspective view of the catheter system of  FIG. 2A , illustrating an example catheter assembly ready for insertion into vasculature of a patient, according to some embodiments; 
         FIG. 4B  is an upper perspective view of the catheter system of  FIG. 2A , illustrating an example tab in an example advanced position, according to some embodiments; 
         FIG. 4C  is an upper perspective view of the catheter system of  FIG. 2A , illustrating the guidewire in the advanced position and the catheter system ready for blood draw, according to some embodiments; 
         FIG. 4D  is an upper perspective view of the catheter system of  FIG. 3A , illustrating the guidewire in the advanced position and the catheter system ready for blood draw, according to some embodiments; 
         FIG. 5A  is an upper perspective view of a distal end of an example guidewire disposed in the advanced position within an example catheter, according to some embodiments; 
         FIG. 5B  is an upper perspective view of the catheter system of  FIG. 2A , illustrating the catheter assembly ready for insertion into the vasculature of the patient, according to some embodiments; 
         FIG. 5C  is an upper perspective view of the catheter system of  FIG. 2A , illustrating the tab in the advanced position, according to some embodiments; 
         FIG. 5D  is an upper perspective view of the catheter system of  FIG. 2A , illustrating the guidewire of  FIG. 5A  in the advanced position and the catheter system ready for blood draw, according to some embodiments; and 
         FIG. 5E  is an upper perspective view of the catheter system of  FIG. 2A , illustrating the guidewire of  FIG. 5A  in a retracted position, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIGS. 1A-1B , a guidewire delivery device  10  is illustrated, according to some embodiments. In some embodiments, the guidewire delivery device  10  may include a housing  12 , which may include a distal end  14 , a proximal end  16 , and a lumen  18  extending through the distal end  14  of the housing  12  and the proximal end  16  of the housing  12 . In some embodiments, the housing  12  may include a slot  20  disposed between the distal end  14  of the housing  12  and the proximal end  16  of the housing  12 . 
     In some embodiments, the guidewire delivery device  10  may include a tab  22  moveable with respect to or along the slot  20 . In some embodiments, the tab  22  may extend through the slot  20 . In some embodiments, the guidewire delivery device  10  may include a penetration cannula  24  extending in a distal direction. In some embodiments, the penetration cannula  24  may be coupled to the tab  22  such that the penetration cannula  24  moves along with the tab  22 . 
     In some embodiments, the guidewire delivery device  10  may include an adapter  26  proximal to and in fluid communication with the penetration cannula  24 . In some embodiments, the adapter  26  may include a Y-adapter or another suitable adapter. In some embodiments, the adapter  26  may include a distal port  28 , a first proximal port  30 , and a second proximal port  32 . In some embodiments, the penetration cannula  24  and the adapter  26  may be configured to receive a guidewire  34  therethrough. In some embodiments, after advancing the tab  22  distally with respect to the slot  20 , the guidewire  34  may be inserted and/or advanced distally through the first proximal port  30 . 
       FIG. 1A  illustrates the tab  22  in an advanced position, according to some embodiments. In some embodiments, in response to the tab  22  being in the advanced position, the tab  22  may be disposed at a distal end of the slot  20 , which may act as a stop to prevent further movement of the tab  22  in the distal direction. 
     In some embodiments, a blood collection device may be coupled to the second proximal port  32 . In some embodiments, the blood collection device may be coupled to the second proximal port  32  via a blood collection adapter  36 , which may be directly coupled to the second proximal port  32 . In some embodiments, the blood collection device may include a blood collection tube or the BD VACUTAINER® Blood Collection Tube, available from Becton Dickinson &amp; Company. In some embodiments, the blood collection adapter  36  may include a needle  37  extending from a luer adapter  38 . In some embodiments, an elastomeric sheath  40  may cover the needle  37 . In some embodiments, in response to coupling the blood collection device to the blood collection adapter  36 , a sharp tip of the needle  37  may pierce the elastomeric sheath  40 , the elastomeric sheath  40  may be compressed towards the luer adapter  38  and the needle  37  may be inserted into the blood collection device. 
     In some embodiments, the guidewire delivery device  10  may include a lumen  42  extending from a proximal end  44  of the penetration cannula  24  to the adapter  26 , which may include another lumen. In some embodiments, the lumen  42  may extend through the proximal end  16  of the housing  12 . In some embodiments, in response to movement of the tab  22  with respect to the slot  20  in the distal direction, the adapter  26  may be closer to the proximal end  16  of the housing  12 . In some embodiments, the penetration cannula  24  may be 20 G or another suitable gauge. In some embodiments, the penetration cannula  24  may include a tube. 
     In some embodiments, the guidewire delivery device  10  may include a body  46  and an extension tube  48  extending proximally from the body  46  to the adapter  26 . In some embodiments, the tab  22  may extend from the body  46 . In some embodiments, the penetration cannula  24  may extend distally from the body  46 . In some embodiments, a fluid pathway  50  of the guidewire delivery device  10  may extend through one or more of following: the penetration cannula  24 , the body  46 , the extension tube  48 , and the adapter  26 . In some embodiments, the lumen  42  may extend through the body  46  and/or the extension tube  48 . In some embodiments, the fluid pathway  50  may extend through the lumen  42 . 
     In some embodiments, the distal end  14  of the housing  12  may include a luer adapter  52  configured to couple to a side port or a distal end of a catheter adapter. In some embodiments, the guidewire delivery device  10  may include the guidewire  34  extending distally through the adapter  26 . In some embodiments, a proximal end of the guidewire  34  may be secured within another tab  54 . In some embodiments, a clinician may pinch the tab  22  to advance or retract the penetration cannula  24 . In some embodiments, the clinician may pinch the other tab  54  to advance and/or withdraw the guidewire  34 . 
     In some embodiments, a needleless connector  56  may be coupled to the first proximal port  30 . In some embodiments, the needleless connector  56  may include a septum  58 . In some embodiments, the guidewire  34  may be inserted through the needleless connector  56 . 
     Referring now to  FIGS. 2A-2B , in some embodiments, the guidewire delivery device  10  may be coupled to a catheter assembly  60 .  FIGS. 2A-2B  illustrate an example catheter system  61 , according to some embodiments. In some embodiments, the catheter assembly  60  may include a catheter adapter  62 , which may include a distal end  64 , a proximal end  66 , and a lumen  68  extending through the distal end  64  of the catheter adapter  62  and the proximal end  66  of the catheter adapter  62 . In some embodiments, coupling the guidewire delivery device  10  to the catheter assembly  60  may include coupling the proximal end  16  of the housing  12  to the proximal end  66  of the catheter adapter  62 , as illustrated, for example, in  FIG. 2A . In some embodiments, the catheter assembly  60  may include a catheter  70  extending distally from the distal end  64  of the catheter adapter  62 . In some embodiments, the catheter assembly  60  may include a septum  72  configured to seal a fluid pathway through the catheter assembly  60 . 
     In some embodiments, the tab  22  may be advanced distally within the slot  20 . In some embodiments, in response to advancing the tab  22  distally, the penetration cannula  24  may penetrate the septum  72 . In some embodiments, after advancing the tab  22  distally with respect to the slot  20  and the penetration cannula  24  penetrating the septum  72 , the guidewire  34  may be advanced distally through the penetration cannula  24  and/or distal to the catheter  70 . In some embodiments, the guidewire  34  may be advanced distally a length of the catheter  70 . 
     In some embodiments, the septum  72  may be disposed within the lumen  68  of the catheter adapter  62 . In some embodiments, coupling the guidewire delivery device  10  to the catheter assembly  60  may include coupling the proximal end  16  of the housing  12  to the proximal end  66  of the catheter adapter  62 . 
     As illustrated, for example, in  FIG. 2B , the catheter assembly  60  may include a wedge  74  disposed within the lumen  68  of the catheter adapter  62 . In some embodiments, the catheter  70  may be secured within the distal end  64  of the catheter adapter  62  by the wedge  74 . In some embodiments, in response to advancing the tab  22  distally with respect to the slot  20 , a distal end  78  of the penetration cannula  24  may be disposed within the wedge  74 . 
     In some embodiments, the adapter  26  may include the distal port  28 , the first proximal port  30 , and the second proximal port  32 . In some embodiments, a needleless connector  86  may be coupled to the first proximal port  30 . In some embodiments, the blood collection device  88  may be coupled to the second proximal port  32 . In some embodiments, after advancing the tab  22  distally with respect to the slot  20 , the guidewire  34  may be advanced distally through the first proximal port  30 . 
     In some embodiments, after advancing the tab  22  distally with respect the slot  20 , the guidewire  34  may be advanced distally through the penetration cannula  24  and distal to a distal end of the catheter  70 . In some embodiments, advancing the guidewire  34  distally through the penetration cannula  24  and distal to the distal end of the catheter  70  may facilitate removal of thrombus accumulated on the distal end of the catheter  70  prior to blood collection. In some embodiments, the penetration cannula  24  may prevent damage to the septum  72  by the guidewire  34 . 
     In some embodiments, after thrombus removal at the distal end of the catheter  70 , the guidewire  34  may be retracted proximally such that a distal end  90  of the guidewire  34  is disposed within the penetration cannula  24 . In some embodiments, after retracting the guidewire  34  proximally such that the distal end  90  of the guidewire  34  is disposed within the penetration cannula  24 , blood may be collected into the blood collection device  88 , which may be coupled to the adapter  26 . In some embodiments, the blood collection device  88  may be coupled to the adapter  26  after the guidewire  34  is retracted proximally. 
     In some embodiments, catheter  70  may be indwelling, and the guidewire delivery device  10  may facilitate blood collection or draw from the catheter  70  that is indwelling. In some embodiments, the guidewire  34  may facilitate small gauge blood draw with a limited impacted on blood draw efficiency. In some embodiments, drawing blood through the guidewire delivery device may reduce a risk of hemolysis. In some embodiments, after blood collection, the tab  22  may be retracted proximally with respect to the slot  20 . In some embodiments, in response to retracting the tab  22  proximally with respect to the slot  20 , the penetration cannula  24  may be withdrawn proximally through the septum  58 . 
     Referring now to  FIGS. 2A-2C , in some embodiments, the guidewire  34  may be coiled, which may reduce thrombosis at the distal end of the catheter  70  and/or within the catheter assembly  60 . In some embodiments, the guidewire  34  that is coiled may also reduce a risk of collapse of the catheter  70 . In some embodiments, blood may flow through the catheter  70  into the blood collection device  88  around and/or through the guidewire  34 . In some embodiments, an entirety of a length of the guidewire  34  may be coiled, from the distal end  90  to a body  92  from which the other tab  54  may extend. In some embodiments, at least the distal end  90  of the body  92  may be coiled and/or a proximal end of the guidewire  34  may be straight. In some embodiments, coils of the guidewire  34  may be spaced apart, which may facilitate blood flow through the guidewire  34 . In some embodiments, all or a portion of the guidewire  34  may be constructed of metal or another suitable material. 
     Referring now to  FIGS. 3A-3D , a catheter system  94  that includes a catheter assembly  95  is illustrated, according to some embodiments. In some embodiments, the catheter system  94  may be similar or identical to the catheter system  61  of  FIGS. 2A-2C  in terms of one or more components and/or operation. In some embodiments, the catheter adapter  62  may include the side port  97 , which may be disposed between the distal end  64  of the catheter adapter  62  and the proximal end  66  of the catheter adapter  62 . In some embodiments, the catheter assembly  95  may include another adapter  96 . In some embodiments, the catheter assembly  95  may include an extension tube  98 , which may include a distal end  100  coupled to the side port  97  and a proximal end  102  coupled to the other adapter  96 . In some embodiments, the septum  72  may be disposed within the other adapter  96 . In some embodiments, coupling the guidewire delivery device  10  to the catheter assembly  60  may include coupling the proximal end  16  of the housing  12  to the other adapter  96 . 
     In some embodiments, after the tab  22  is advanced distally with respect to the slot  20 , the guidewire  34  may be advanced distally through the penetration cannula  24  and distal to the catheter  70 . Additionally, in some embodiments, after the tab  22  is advanced distally with respect to the slot  20 , the guidewire  34  may be rotated by the clinician. 
     In some embodiments, the guidewire  34  may be coiled. In some embodiments, an entirety of a length of the guidewire  34  may be coiled, from the distal end  90  to a body  92  from which the other tab  54  may extend. In some embodiments, at least the distal end  90  of the body  92  may be coiled and/or a proximal end of the guidewire  34  may be straight. In some embodiments, coils of the guidewire  34  may be spaced apart, which may facilitate blood flow through the guidewire  34 . 
     Referring now to  FIG. 4A , the catheter assembly  60  is illustrated ready for insertion into vasculature of the patient, prior to coupling of the guidewire delivery device  10  to the catheter assembly  60 . Referring now to  FIG. 4B , the tab  22  is illustrated in the advanced position, according to some embodiments. Referring now to  FIG. 4C , the guidewire  34  is illustrated in the advanced position and the catheter system  61  is ready for blood collection. Referring now to  FIG. 4D , the guidewire  34  is illustrated in the advanced position and the catheter system  94  is ready for blood collection. In some embodiments, the catheter assembly  60  may be replaced with the catheter assembly  95  in  FIGS. 4A-4C , and the guidewire delivery device  10  may be coupled to the other adapter  96 . 
     Referring now to  FIG. 5A , in some embodiments, the distal end  90  of the guidewire  34  may include multiple elongated arms  104 . In some embodiments, the elongated arms  104  may be configured to separate in response to removal of an inward biasing force. In some embodiments, the elongated arms  104  may be biased together in response to the elongated arms  104  being in the catheter  70 . In further detail, in some embodiments, the elongated arms  104  may be touching each other or close together due to contact with an inner surface of the catheter  70 . In some embodiments, the elongated arms  104  may be configured to separate or move apart from each other in response to the elongated arms  104  moving distal to the catheter  70 . 
     In some embodiments, the elongated arms  104  may extend from a distal end of a generally cylindrical portion of the guidewire  34 . In some embodiments, the generally cylindrical portion of the guidewire  34  may be monolithically formed with the elongated arms  104  as a single unit. In some embodiments, the elongated arms  104  may be constructed of a shape memory material configured to recover its original shape from a deformation when a force is applied. In some embodiments, the elongated arms  104  may be constructed of memory metal or metal. 
     In some embodiments, after the tab  22  is advanced distally with respect to the slot  20 , the guidewire  34  may be advanced distally through the penetration cannula  24  and distal to the catheter  70 . Additionally, in some embodiments, after the tab  22  is advanced distally with respect to the slot  20 , the guidewire  34  may be rotated by the clinician. In some embodiments, the guidewire  34  may be used with the catheter system  61  and/or the catheter system  94 . 
     Referring now to  FIGS. 5B-5E , the guidewire  34  is illustrated in various positions to facilitate blood collection.  FIG. 5E  illustrates the guidewire  34  in a retracted position after blood collection in the blood collection device  88 , according to some embodiments. 
     All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.