Abstract:
The invention provides a device for threading an end of a guidewire into a catheter, the catheter having a tip connected to an inner lumen of the catheter, the inner lumen dimensioned to receive the guidewire therethrough. The device comprises: a guidewire receiving port; a catheter tip receiving port; a channel connecting the guidewire receiving port to the catheter tip receiving port. The channel is dimensioned to pass the outer thickness of the guidewire therethrough and the channel is dimensioned to block passage of the outer thickness of the catheter therethrough. A contiguous section of the guidewire receiving port, the catheter tip receiving port and the channel form an open passageway from which the guidewire and catheter, once the guidewire is threaded into the catheter, are disengaged from the device. The open passageway may be covered by a flap mounted to the device which releasably cover,s the contiguous open section of the guidewire receiving port, the catheter tip receiving port and the channel.

Description:
FIELD OF THE INVENTION  
       [0001]     This invention relates to a device facilitating the insertion of a guidewire into the lumen of a catheter through the tip of the catheter. Catheters that are threaded in this manner are commonly called over the wire catheters or monorail catheters and are presently used in cardiology, radiology, and neurology. They are used in cardiology in procedures such as percutaneous transluminal coronary angioplasty (PTCA).  
       BACKGROUND  
       [0002]     PTCA is a technique used to dilate an area of arterial blockage with the help of a catheter that has an inflatable balloon at its tip.  
         [0003]     In classical PTCA procedures, a guiding catheter is percutaneously introduced into the cardiovascular system of a patient and advanced therein until the distal tip of the guiding catheter is disposed within the aorta adjacent the ostium of the desired coronary artery. A guidewire is an extremely thin wire with a flexible tip. Typically the physician or operator inserts a guidewire through the guiding catheter into the coronary arteries of the heart. The tip of the guidewire is then guided across the blockage and advanced beyond it. The physician controls the movement and direction of the guidewire by gently manipulating the end that sits outside of the patient.  
         [0004]     This guidewire can now serve as a “guide” over which a catheter may be threaded. The catheter will have a hollow lumen extending from the end that first enters the patient through all or a portion of the length of the catheter. To insert the catheter into a patient, the proximal tip of the guidewire (the end outside the patent) is fed into the lumen of the catheter through the distal Lip of the catheter. The distal tip of the catheter is then fed along the guidewire, into the patient&#39;s body and through the cardiovascular system until the tip of the catheter is positioned at a target site in the coronary arteries. The end of the catheter may be variously modified to include a balloon to expand arterial narrowings, to deploy a cylindrical device known as a stent to prevent arterial wall recoil after balloon expansion, or to do other intraarterial manipulations.  
         [0005]     As will be appreciated by those skilled in the art, threading the one end of the guidewire into the lumen of the catheter through the catheter tip can be physically challenging because of the miniscule dimensions of the parts involved. Typically the guidewire bas a diameter of 0.004″ and the catheter tip has an inner diameter of approximately 0.016″-0.017″. The current approach relies on the technical ability of the physician to insert or thread the guidewire into the catheter at its tip.  
         [0006]     Threading the guidewire into the lumen of the catheter through a small opening at the tip of the catheter can be difficult and time consuming, creating a potentially dangerous delay when quick action is required to safeguard the patient.  
         [0007]     Additional damage can be encountered during manual insertion of the guidewire into the catheter tip, including kinking, crimping, or otherwise injuring the catheter tip, balloon or stent.  
         [0008]     Some of the latest generations of stents have a drug coating on their surface. Since the stent is close to the tip of the catheter, typically, the physician must tip the catheter tip to assist in guiding the guidewire into the tip, thereby touching the stent. However, touching the stent may alter the effectiveness of the drug because some of the drug may be displaced.  
         [0009]     Accordingly, what is needed is a hands-off approach, permitting the operator to rapidly and safely thread the guidewire into the catheter lumen without touching the stent located at the tip of the catheter. The present invention provides a device that (i) relieves the technical skill factor required to effectively thread the guidewire into the catheter lumen and (ii) provides a barrier to minimize hand contact with the stent when the catheter is being threaded onto the guidewire.  
       SUMMARY OF THE INVENTION  
       [0010]     In accordance with one aspect of the present invention, there is provided a device for threading an end of a guidewire into a catheter, the catheter having a tip corrected to an inner lumen of the catheter, the inner lumen dimensioned to receive the guidewire therethrough, wherein each of the guidewire and the catheter has an outer thickness, the device comprising: a guidewire receiving port; a catheter tip receiving port; and a channel connecting the guidewire receiving port to the catheter tip receiving port; wherein the channel is dimensioned to pass the outer thickness of the guidewire therethrough and the channel is dimensioned to block passage of the outer thickness of the catheter therethrough, and wherein a contiguous section of the guidewire receiving port, the catheter tip receiving port and the channel form an open passageway from which the guidewire and catheter, once the guidewire is threaded into the catheter, are disengaged from the device.  
         [0011]     In accordance with another aspect of the present invention, there is provided, a device as described herein, further comprising a flap mounted to the device which releasably covers the contiguous open section of the guidewire receiving port, the catheter tip receiving port and the channel.  
         [0012]     In accordance with another aspect of the present invention, there is provided a device as described herein wherein the flap is hingedly affixed to the device.  
         [0013]     In accordance with yet a further aspect of the present invention, there is provided a device as described herein wherein the flap is deformable and releasably covers the contiguous open section of the guidewire receiving port, the catheter receiving port and the channel, through pressure applied externally to the flap.  
         [0014]     In accordance with yet another aspect of the present invention, there is provided a device as described herein wherein the flap is fully releasable from the device.  
         [0015]     In accordance with still another aspect of the present invention, there is provided a device as described herein wherein the fully releasable flap is mounted to the device by a heat seal or by adhesive.  
         [0016]     In accordance with another aspect of the present invention, there is provided a device as described herein wherein the flap is tearable.  
         [0017]     In accordance with yet a further aspect of the present invention, there is provided the device as described herein wherein the guidewire receiving port and the catheter tip receiving port are each funnel shaped with each funnel narrowing towards the channel.  
         [0018]     In accordance with another of the present invention, there is provided the device as described herein wherein the channel is dimensioned where the channel meets the catheter tip receiving port to hold the outer thickness of the catheter at the tip of the catheter in a snug fit.  
         [0019]     Additional aspects of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]     The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements shown. In the drawings, the same reference numerals are employed for designating the same elements throughout the several figures. In the drawings:  
         [0021]      FIG. 1  is a top plan view of one embodiment of the invention without a flap or from which the releasable flap has been removed;  
         [0022]      FIG. 2A  is a top plan view of tie embodiment of  FIG. 1  with one embodiment of the releasable flap shown in place;  
         [0023]      FIG. 2B  is a top plan view of a variation of the embodiment shown in FIGS.  1 : and  2 A, wherein the releasable flap is not fully releasable;  
         [0024]      FIG. 3  is a perspective view of the embodiment shown in  FIG. 1 ;  
         [0025]      FIG. 4  is bottom plan view of the embodiment shown in.  FIG. 1 ;  
         [0026]      FIG. 5  is a front elevational view of the embodiment shown in  FIG. 1 ;  
         [0027]      FIG. 6  is a rear elevational view of the embodiment shown in  FIG. 1 ; and  
         [0028]      FIG. 7  is a top plan view of the embodiment shown in  FIG. 1  illustrating a guidewire being thread into a catheter. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0029]      FIG. 1  shows an embodiment of device  10 , as viewed from the top. In this embodiment, device  10  has the basic form of a rectangular block with a guidewire receiving port  20  at one end thereof  12  and a catheter receiving port  30  at the opposite end thereof  14  with a channel.  40  joining guidewire receiving port  20  to catheter receiving port  30 . As can best be seen in the perspective view of  FIG. 3 , each of guidewire receiving port  20 , catheter receiving port  30  amid channel  40  is a recessed void space at the top surface  16  of device  10 , opposite from bottom surface  18  of device  10 . The three of guidewire receiving port  20 , catheter receiving port  30 , and channel  40  together form a passageway  50  from one end  12  of device  10  to the other  14 .  
         [0030]     Device  10  may take any shape that allows for a passageway to be placed therein joining one end  12  to the other  14 . In the embodiment of  FIG. 1 , device  10  is more narrow at end  12  than at end  14 . The shape could be described as “bottle-shaped” or “violin shaped”. This shape merely allows a person using device  10  to more easily tell end  12  from end  14 . In the embodiment of  FIG. 1 , guidewire receiving port  20  is found at end  12 , the more narrow end of device  10 . As a person using the device will know that a guidewire is more narrow than a catheter, it will help him or her remember that guidewire receiving port  20  is found at end  12 , which is more narrow.  
         [0031]     Passageway  50  may be covered by means of flap  60  (not shown in  FIG. 1 ). Flap  60  can take any form so long as it releasably covers passageway  50 . Flap  60  can be fully detachable from device  10  or partially detachable from device  10 . In an embodiment where flap  60  is fully detachable, flap  60  cain take the form of a film or tape that is attached to top surface  16  of device  10  that can be peeled off of the top surface  16  of device  10 . In such an embodiment, flap  60  can be attached to top surface  16  of device  10  by means of a heat seal or adhesive.  FIG. 2A  shows a top plan view of such an embodiment wherein flap  60  is in the form of a clear film  62 , mounted on the top surface  16  of device  10 . Clear film may be removed by pulling on tab  64 . In the Embodiment shown in  FIG. 2A , tab  64  is shown at end  12  of device  10 , towards guidewire receiving port  20 . However, tab  64  may be located anywhere on film  62  to allow access for the person using device  10  to grip tab  64  to remove film  62 . In this embodiment, film  62  is fully removable from top surface  16  of device  10 , but it need not be fully removable in a broader aspect of the invention. All that is required for this embodiment is that film  62  release from top surface  16  to such a degree to allow passageway  50  to be fully open along top surface  16 . The importance of flap  60 , it, this embodiment in the form of film  62 , covering the open surface of passageway  50  comprising guidewire receiving port  20 , catheter receiving port  30 , and channel,  50 , being releasable to an extent to allow passageway  50  to be open along top surface  16  will be seen below when use of the device to thread a guidewire into the lumen of a catheter is explained in detail. In the embodiment shown in  FIG. 2B , film  62  is only partially removable from top surface  16  of device  10 . Film  62  may be fixedly attached to top surface  16  at a seam  66  on the opposite side of tab  64 . By being fixedly attached at seam  66 , one can release film  62  by lifting tab  64  to separate film  62  from top surface  16  of device  10 . Once lifted to expose passageway  50 , film  62  stays attached to top surface  16  along seam  66 . Because film  62  does not fully disengage from device  10 , film  62  does not have to be disposed of as a separate piece of material, which is helpful in an operating room setting, where tidiness call be important.  
         [0032]     Use of device  10  to thread end  102  of guidewire  100  into lumen  202  of catheter  200  through tip  204  of catheter  200  will be described with the aid of  FIG. 7 . Tip  204  of catheter  200  is placed in catheter receiving port  30 . In the embodiment shown in  FIG. 7 , catheter receiving port  30  is funnel-shaped, with the base of the triangular funnel being at end  14  of device  10 , and the funnel narrowing as catheter receiving port  30  approaches channel  40 . At the point  42 , where catheter receiving port  30  meets channel  40 , channel is preferably dimensioned to hold tip  204  of catheter  200  in a snug fit. The snug fit will allow catheter to be held in place in catheter receiving port  30  while end  102  of guidewire  100  is threaded into lumen  202  of catheter  200 . However, the snug fit will still allow easy disengagement of catheter tip  204  from point  42  of channel  40  when catheter  200  is detached from device  10  once guidewire  100  is threaded into lumen  202  of the catheter. Once catheter tip  204  has been placed into catheter receiving port  30  and positioned adjacent to channel  40  at point  42 , guidewire  100  may be threaded into the catheter. End  102  of guidewire  100  is fed into guidewire receiving port  20 . In the embodiment shown in  FIG. 7 , guidewire receiving port  20  is funnel-shaped, with the base of the triangular funnel being at end  12  of device  10 , and the funnel narrowing as guidewire receiving port  20  approaches channel.  40 . Guidewire receiving port  20  narrows to point  44 , where it meets channel  40 . Channel  40  is dimensioned so that it has a diameter that is wider than that of guidewire  100 , so as to allow guidewire to freely slide through channel  40 . Guidewire end  102  is fed into guidewire receiving port  20 , into channel  40 , past point  44 ., towards point  42 , where catheter tip  204  is being held. As guidewire end  102  is fed past point  42 , it will be fed through catheter tip  204 , into lumen  202  of catheter  200 . In this embodiment guidewire receiving port  20  and catheter receiving port  30  are described as being in the shape of triangular funnels. However, any other shape that allows end  102  of guidewire  100  to be placed in guidewire receiving port  20  and tip  204  of catheter  200  to be placed in catheter receiving port  30 , and end  102  and tip  204  to be fed towards channel  40 , may be suitable.  
         [0033]     Once guidewire end  102  is threaded into lumen  202  of catheter  200 , device  10  may be disengaged from the threaded guidewire  100  catheter  200  combination by releasing flap  60 . Flap  60  is not shown in  FIGS. 1 and 7 , but one can easily understand that if flap  60  took the form of film  62  illustrated in either of the embodiments of  FIGS. 2A and 2B , all that one would have to do to release nap would be to pull back film  62  via tab  64 . In the embodiment shown in  FIG. 2A , film  62  is peeled back from top surface  16  of device  10 , thereby exposing passageway  50 . Device  10  can then be removed from the threaded guidewire  100  catheter  200  combination, thereby exposing catheter tip  204  which can be fed into an artery of a patent, for example, by further threading catheter  200  along guidewire  100 . In the embodiment shown in  FIG. 2B , film  62  is peeled back in a similar manner, exposing passageway  50 . In this embodiment, however, film  62  does not filly disengage from device  10 . Passageway  50  is still exposed, but film  62  still remains attached to device  10  along seam  66 . Then device  10  can be disengaged as a unitary item with film  62 , allowing for more easy disposal of device  10 .  
         [0034]     A person skilled in the art will realize that flap  60  can take other forms than the embodiments discussed above. All that is necessary is that the flap be able to releasably coffer a contiguous surface of passageway  50  that may be disengaged from the passageway, allowing for disengagement of the guidewire  100  catheter  200  combination once guidewire  100  has been threaded into lumen  202  of catheter  200 . Flap  60  could take the form of a hinged cover that is hinged on one side of device  10  and is releasably attached to another side of device  10  on an opposite side of passageway  50 . The releasable means of attachment could be by way of a snap fit of a groove on flap  60  and a tab on the “another” side of device  10 , or other similar arrangement. In this embodiment, flap can be of unitary construction with remainder of device  10  such that all of device  10  is made of one material, and the hinge between flap  60  and the remainder of device  10  is a seam. This embodiment is possible when device  10  is made of a plastic material.  
         [0035]     Device  10  docs not have to be fully disengageable from guidewire  100  catheter  200  combination. In this embodiment, flap  60  is deformable. Once guidewire  100  is threaded into lumen  202  of catheter  200 , flap  60  may be deformed by bending or stretching to release the contiguous surface of flap  60  covering passageway  50 . Alternatively, flap  60  may be arched, or otherwise loosely cover passageway  50  so that the operator may press down, for example with his or her thumb to cover passageway  50 . In this embodiment, release of thumb pressure will cause flap  60  to separate from passage  50 . Any of these embodiments of flap  60  will allow guidewire  100  catheter  200  combination to be released from the tight fit of passageway  50 . Tip  204  of catheter  200  can be slid out from under flap  60  of device  10 , thereby exposing tip  204  for insertion into the patient through the femoral artery. For example. The deformed, arched or lose embodiment of flap  60  has the effect of widening passageway  50 , allowing device  10  to be disengaged from tip  204  of catheter  200 , allowing device to be slid over catheter  200  to a site removed from tip  204 , and the patient, as tip  204  is fed further into the patient.  
         [0036]     In an alternative embodiment, flap  60  can take the form of a tearable film. Once guidewire  100  is fed into lumen  202  of catheter  200 , the guidewire  100  catheter  200  combination may be simply pulled away from device  10 , thereby ripping the tearable film and disengaging device  10 .  
         [0037]     When flap  60  takes the form of a film, the person skilled in the art would understand that the film may be attached to device  10  by means of adhesive, a heat seal or other suitable means. When flap  60  takes the form of a hinged cover, the person skilled in the art would understand that the non-hinged side of the cover may be attached to device  10  by means of adhesive, a releasable snap lock or other suitable means. When flap  60  takes the form of a deformable, arched or loose cover, the person skilled in the art would understand that such a cover may be attached to device by any suitable means on both sides of passageway  50  so long as the portion of the cover between the attachment means on both sides of passageway  50  is sufficiently deformable, arched or loose to permit guidewire  100  catheter  200  combination to disengage from the tight fit in passageway  50 .  
         [0038]     In a preferred embodiment, flap  60  will leave portions of one or both of guidewire receiving port  20  and catheter tip receiving port  30  uncovered a portion thereof close by ends  12  and  14  of device  10 , respectively. These uncovered portions can assist an operator in placing catheter tip  204  in catheter tip receiving port  30  and guidewire  100  in guidewire receiving port  20 , by effectively forming a guiding lip to assist in insertion.  
         [0039]     In another embodiment, the flap does not have to be present as part of device  10 . In this embodiment, a flap that is external to the device may be placed over open passageway  50 . External flap can be any surface which can removably cover passageway  50 . The external flap may even be the operator&#39;s thumb. However, when the operator uses his or her thumb, the thumb may come in contact with a stent which may be close to catheter tip  204 . However, even when used with the operator&#39;s thumb as a flap, hand contact with the stent will be reduced from the alternative of not using device  10 , since then the operator could likely handle the stent with both the thumb and the index finger when gripping catheter tip  204 .  
         [0040]     In the embodiment shown in the bottom plan view of  FIG. 4 , device  10  is fitted with a series of ridges  70 . Having ridges  70  on the bottom surface  18  of device  10  allows one to pick up device  10  more easily once it has been placed on a surface, such as a table.  
         [0041]     Device  10  is preferably made of sterilizable material. Device  10  may comprise sterilizable plastic, stainless steel, nitinol, latex, wood, or a combination thereof.  
         [0042]     From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the true spirit and scope of the novel concept of this invention.