Abstract:
A distal tip protector, protection shield, or packaging insert to protect the distal segment of a guidewire projecting from a guidewire carrier.

Description:
BACKGROUND OF THE INVENTION 
     This invention relates to devices, or apparatuses for transporting, storing and dispensing wire from substantially cylindrical or tubular containment or carrier structures. This invention also relates to wire-containing or transporting apparatuses or carriers and in particular, a carrier for guidewires having delicate extreme distal ends or tips. 
     Guidewires have been described in a number of patents, representative examples of which are U.S. Pat. No. 4,545,390 to Leary, U.S. Pat. No. 3,973,556 to Fleischhacker et al., and U.S. Pat. No. 4,538,622 to Samson et al. Guidewires have many different structural features and configurations depending upon the medical procedure with which they are to be used. Generally speaking, guidewires are used in the process of directing a catheter to identified locations or sites within a patient&#39;s cardiovascular or peripheral vascular system for the purpose of diagnosis or treatment. Typically, the guidewire is placed percutaneously into a patient&#39;s blood vessel and is directed to a previously identified site. A catheter selected to provide the particular medical procedure at the site then is advanced over the guidewire until the functional structure, working surface or operating portion of the catheter is located in the proximity of the previously identified site. The catheter then is utilized to accomplish the selected medical procedure. The guidewire may be withdrawn from the vascular system before, during, or after utilization of the catheter. 
     A typical example of the above process would be to utilize a guidewire to direct an angiographic catheter to a site of a vascular obstruction. Thereafter an angioplasty procedure, e.g., balloon angioplasty, may be carried out by means of, e.g., a balloon angioplasty catheter. Other catheters are designed to perform procedures such as application of ultrasound to an obstruction, delivery of drugs, execution of therapeutic or diagnostic procedures, or any of a number of applications of drugs, energy or other forces, generally less invasively, within the body. 
     The present invention is intended to be used with essentially all guidewires. However, this invention is particularly applicable to the containment, transportation, and dispensing of guidewires in a coiled tubular dispenser assembly or carrier where the extreme distal end or tip of the guidewire is of a sufficiently delicate or complicated structure to require protection from damage during handling. A guidewire tip also may be intentionally maintained outside the carrier, e.g., a J-tip or hooked guidewire where straightening and holding the “J” in a tubular carrier could reduce or inhibit its “memory” to return to a “J” configuration. 
     For reasons of device protection, ease of handling and dispensing, and fluid flushing, guidewires tend to be stored and transported in tubular dispenser assemblies, carriers, or containers. Generally speaking, the tubular dispenser assembly or loop of tubing will have a substantially larger inside diameter than the outside diameter of a guidewire contained therein. To utilize a guidewire contained within such an assembly in a medical procedure, the guidewire must be partially and ultimately, totally removed therefrom. 
     During the transportation and handling of guidewires contained within a shipping or dispenser assembly, a problem has sometimes developed in that at least the guidewire tip may migrate or emerge from the dispenser. The tip of a guidewire can be relatively structurally fragile, comprising core/coil bonds, bulbous tip (usually) and exhibiting a tendency or memory tending to curve, cf. U.S. Pat. No. 5,279,573. 
     Whether having a tendency to curve or not, the extreme distal tip may project from the carrier assembly. In such instances, it is desirable to protect the guidewire distal tip from being bent or otherwise damaged during shipping, storage and use. 
     The present invention provides an apparatus for protecting a wire, particularly a guidewire distal end extending from a tubular, elongate, or cylindrical transfer, transportation, or carrier assembly e.g., a carrier tube having where at least a partial segment of the wire or guidewire projects from the carrier at any time during its manufacture, shipping, storage, or use. 
     BRIEF DESCRIPTION OF THE INVENTION 
     Briefly, in one aspect, the present invention is a protective shield or protective packaging insert for the extreme distal end of a guidewire projecting from a carrier therefor. The insert of the invention is primarily used when the guidewire carrier and guidewire are contained within a shipping and storage envelope. 
     Generally a protective shield of this invention is used with a tubular guidewire carrier by itself or in conjunction with a guidewire containment apparatus such as that shown in U.S. Pat. No. 5,279,573 to Klosterman, the teaching of which is incorporated by reference herein. 
     Thus, a protective packaging insert of this invention comprises a substantially flat generally quadrilateral base having a carrier side and an outside. Other base shapes are within the contemplation of this invention. The carrier side of the base has thereon, upstanding or substantially perpendicularly disposed carrier engagement means. Carrier engagement means according to this invention may be of any configuration that retains the carrier, particularly its dispensing end, adjacent to the carrier side of the base so as to protect a guidewire distal tip projecting therefrom. In one embodiment carrier engagement means take the configuration of separated, L-shaped, oppositely displaced hooks, the hooks extending from the base a distance, roughly comparable to the outside diameter of the carrier. In this embodiment of the invention, the oppositely displaced hooks are separated a distance which permits one coil of the wound carrier to be mated to or “snapped” or slid to a position adjacent the base carrier side between the hooks and the carrier to be rotated into the hooks to engage the coil to be retained adjacent the base while a second coil or coils of the carrier engage optional other carrier structure coils on the base carrier side to, in essence, retain or lock the carrier adjacent thereto and to provide distal tip protection for the guidewire oppositely aligned upstanding structures, e.g., with carrier-cooperating structures such as carve outs, and grooves. 
     At various points in the disclosure of this invention, it is noted that the base of a protective packaging insert of this invention is said to be located “adjacent” to the guidewire carrier and in particular the extreme distal end of a guidewire projecting therefrom. “Adjacent” as used herein means sufficiently close or sufficiently proximate that any guidewire structure intended to be protected by the base during transportation, storage and utilization is so protected. Thus, “adjacent’ as used herein means, in actual contact, slightly separated, in substantially parallel deployment with respect thereto, and various other special configurations and relationships to the limit of not providing the guidewire distal tip protection which is the raison d&#39;état for this invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A better understanding of the present invention as well as other objects and advantages thereof will become apparent upon consideration of the detailed description, especially when taken with the accompanying drawings wherein like numerals designate like parts throughout, and wherein: 
         FIG. 1  is a plan view of a guidewire contained within a standard dispenser coil assembly or carrier distal tip of, the guidewire being protected by a protector of this invention; 
         FIG. 2  is a detailed perspective view of a protector of this invention showing its interaction with a lengthy coiled guidewire carrier; 
         FIG. 3  is a perspective view of a distal tip protector of this invention; 
         FIG. 4  is a detailed view of the oppositely disposed carrier engagement structure which projects upwardly from the distal tip protector base; 
         FIG. 5  through  FIG. 7  illustrate how a distal tip protector of this invention engages and attaches to a coiled guidewire carrier; 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Thus, there is shown in  FIG. 1  a coiled, tubular guidewire carrier  1  having attached, coupled, or “clipped” thereto a guidewire distal tip protector  10  of this invention. In this embodiment, the carrier  1  comprises 5 or 6 coils  2  and a space clip  3  which holds the coils in a suitably flat or planar and separated arrangement so the coils can locate sufficiently closely adjacent to the tip protector  10  base  12  to be aligned and thereby retained. At the delivery end  4  of carrier  1  is a dispensing sleeve or containment tip which can be used to manage that process of dispensing a guidewire (not shown in  FIG. 1 ) from carrier  1  c.f., U.S. Pat. No. 5,279,573. 
     Also shown in  FIG. 1  is guidewire tip protector  10  of the invention. Tip protector  10  comprises a substantially flat base  12  having a carrier side  14  and a backside or outside  17 , the dashed lead line intending to designate protector backside  17  not necessarily visible in  FIG. 1 . The tip protector  10  has 4 sides which may or may not be parallel. Carrier side  14  of protector  10  has carrier engagement mechanism  16  comprising oppositely disposed upwardly-protecting hooks, that are shown in greater detail in  FIG. 2 . Protector  10 , generally is made of a formable plastic material and is about 5 inches by 3 inches in length and width. Base  12  has an arc optional or contour side  18  that generally follows the curve of the inside most carrier coil  20 . 
     Tip protector base  12  is about ⅛ inches thick. The diameter of the entire carrier coil structure is about eight to 12 inches, its exact diameter being determined by the length of the guidewire to be transported and the circumference of the coils. 
     Also shown in  FIG. 1  is a package or envelope  22  with which the tip protector/carrier assembly would be contained during processing, shipment, and storage prior to use. In practice envelope  22  and the protector/carrier assembly should be sterile. Envelope  22  has an adhesive field  24  (inside edge shown in dashed lines) which holds its opposite sides together. Tip protector  10  is disposed near the edge of the adhesive field and obtains support therefrom. As is shown, tip protector  10  generally fits within a corner of envelope  22 . 
     As is discussed below (and shown in later Figures) base  12  may have optional additional alignment and support projections which provide a more controlled and stable coupling or connection between the tubular carrier  1  and protector  10 . 
       FIG. 2  shows a partial perspective view of protector  10  coupled to carrier  1 .  FIG. 2  shows optional upwardly projecting (from base  12  carrier side  14 ) arcuate tabs or retainers  30 . Retainers  30  help to stabilize carrier  1  helical coil bundle adjacent carrier side  14  of protector  10  (and vice versa). 
       FIG. 3  is a perspective view of one configuration of a tip protector  10  of this invention. Carrier engagement structure, e.g., separated, oppositely disposed hooks  16  and optional tabs  30  (which also engage one or more coils of a coiled guidewire carrier) also are shown. Numerous variation of carrier engagement structures will occur to one skilled in this art in view of this disclosure. Generally carrier engagement structure will provide either a physical engagement (e.g., hooks  16 ) or a frictional engagement such as tabs, teethed-structures, or tethering structures. Any such structures will project upwardly from base  12 . 
     Specifically,  FIG. 4  shows oppositely-disposed, upwardly projecting (from protector  10  carrier side  14 ) carrier engagement structure, i.e., hooks  40 ,  40 ′. Hooks  40 ,  40 ′ comprise a linear portion  42  projecting approximately perpendicular from carrier side  14  of base  12  coupled to a curved portion  44 . The radius of curvature of curved portion  44  approximates that of the outside tubular carrier  1 . 
     Referring now to  FIGS. 5, 6, and 7  it is to be noted that hooks  40 ,  40 ′ are separated by a distance that is slightly greater than the outside diameter of carrier tube  1  (best seen in  FIG. 4 ). This arrangement permits an advantageous rotating lock procedure to engage the protector  10  to the carrier  1  as is shown in  FIG. 5 , one coil of carrier  1  is placed between hooks  40 ,  40 ′ on carrier side  14  of protector  10 . Protector  10  then is rotated clockwise (in this engagement scenario) in the direction of arrow  50 . 
     In  FIG. 6  hooks  40 ,  40 ′ of proctor  10  are shown to be engaging the outside coil  52  of carrier  1  as protector  10  is rotated. As protector  10  continues to be rotated clockwise in relation to carrier  1 , hooks  40 ,  40 ′ engage coil  52  so that coil  52  “snaps” into engagement with hooks  40 ,  40 ′ as coil  52  passes therewithin. 
     Thus, in  FIG. 7 , protector  10  is shown to be connected or coupled to carrier  1 , optional engagement structure or tabs  30 , adding additional support. In  FIG. 7  there is shown the delicate extreme distal end of a guidewire  60 . Protector  10  then provides support and protection to guidewire distal end  60  so that it is not damaged e.g., bent, during handling of the guidewire. As is noted, an overlying envelope contains the guidewire carrier/protector with the tip protector generally being deployed in one corner of the envelope. Thus, guidewire tip protection is there when it is time for the guidewire to be used during a medical procedure. Tip protector  10  is detached from carrier  1  by simply rotating tip protector  10  counterclockwise with respect thereto (i.e., in the direction of arrow  60 ). Protector  10  unsnaps from helical tube carrier  1 , the guidewire being deployed therefrom for use in a procedure.