Abstract:
A vascular dilatation catheter including an elongated catheter shaft having a distal and a proximal end and a first lumen extending therethrough fluid connection with a distally located balloon and a second lumen capable of receiving a guidewire is provided with a clip device attached about a proximal portion of the catheter shaft and adapted to releasibly secure the catheter shaft in a coiled configuration between uses.

Description:
This application is a division of application Ser. No. 08/885,533, now U.S. Pat. No. 5,830,183 filed Jun. 30, 1997, entitled “CLIP DEVICE FOR VASCULAR CATHETER”. 
    
    
     BACKGROUND OF THE INVENTION 
     I. Field of the Invention 
     The present invention relates generally to vascular catheter systems and particularly to catheter systems that employ inflatable balloon devices to accomplish mechanical dilitation of vascular stenoses, more particularly those occurring in coronary arteries. The invention itself involves a clip device for convenient temporary retention of a catheter shaft in coiled form during interim periods when one of possibly several catheters being used in a procedure is temporarily removed from a guidewire between uses during the procedure. The clip device is preferably a single piece and includes a hub. 
     II. Related Art 
     Percutaneous dilitation of coronary stenoses by balloon dilitation catheter devices has evolved into an acceptance or a standard approach to alleviating many types of arterial blockages, especially partial coronary blockages, as it has, over the years, been demonstrated to be an effective, relatively low-risk procedure. During such procedures, often several different types of dilitation catheters are employed sequentially utilizing the same guidewire and, in some cases, the catheters may be alternately used several times, being inserted through the vascular system over an already indwelling guidewire. The catheter shafts are typically quite long, i.e., from about 70 cm. to about 150 cm. Once removed from the guidewire, the entire catheter may be set aside and kept within the sterile field for reuse. The length of the catheter shaft makes this quite inconvenient and awkward. No convenient device has been available to retain the catheter shaft in the coiled configuration until the next use. Thus, there remains a need for a system, particularly one integral with the catheter device itself for the temporary storage of the catheter shaft between uses which is easily operable and does not in any way interfere with the designed use of the catheter system. 
     Accordingly, it is a primary object of the present invention to provide an retention system for retaining a vascular catheter shaft in a relatively compact coiled configuration between the uses thereof. 
     Another object of the present invention is to provide a retention system for a coiled catheter shaft which is an integral part of and does not otherwise interfere with the normal operation of the catheter. 
     Yet another object of the present invention is to provide an integral hub/clip retention system for a coiled catheter shaft that is inexpensive and easy to operate. 
     Other objects and advantages of the invention will become apparent to those skilled in the art upon familiarization with the specifications, drawings and claims contained in this application. 
     SUMMARY OF THE INVENTION 
     According to the present invention, there is provided a convenient, easy to operate combination hub and clip device for releasibly securing an associated catheter shaft in a coiled configuration between deployments thereof. According to the invention, a hollow clip device is mounted at the proximal end of the catheter shaft and is designed to connect the catheter shaft to any associated external devices such as combined guidewire and inflation fluid input manifolds, or the like. The clip is designed with a hollow interior which allows the manifold or other connected device to access the various catheter lumens as desired. The clip device may incorporate a hub which, in turn, may be provided with an integral leuer proximal fitting to engage the manifold or other such connectable device. Of course, any other desired fitting may be molded to the body of the clip, without limitation. 
     The clip device particularly includes a system for releasibly securing the catheter shaft in a coiled configuration of one or more loops. This includes the provision of an external recess for accommodating a plurality of loops of the catheter shaft in the coiled configuration and a hinged clasp lid for providing a reclosable snap-fit latch over the coiled shaft to retain the coiled catheter shaft in the recess. The hinge attaching the clasp lid to the body of the clip is a flexible but preferably integral part of the clip device. 
     The clip including the hinged clasp lid is preferably molded as a single-piece system with the hinge being a “living” hinge capable of easy flexure and capable of being flexed a plurality of times during which the clasp lid is repeatedly opened and closed. The clip and clasp lid may be molded from a single polymer material in a one-shot injection molding operation. It is further contemplated, however, that a plurality of materials could be used, including a material for the hinge and clip that is somewhat softer and more pliable than that utilized for the main body of an associated hub. It should be recognized further that any appropriate moldable plastic material can be used for the device that is capable of being formed with internal passages and retaining its shape during use. These include many acrylic and polycarbonate materials, styrenes, ABS and other materials. The hinge and clip may be made of the same or rather softer polyester materials such as polyesters including Hytrel (Dupont), nylons, and other polymer materials such as polyethylenes, polypropylenes and other compatible materials. If two different materials are used, the device can be made by a two-shot process whereby both materials are injected at different gates into the mold cavity. Other processes are also feasible, such as insert molding. 
     An aspect of the integral hub and clip system of the invention is the harmonious manner in which the device can be incorporated in the catheter system without affecting the catheter itself or the devices to be attached to the proximal end of the catheter. In addition, it utilizes an easily operable snap lid latch and the overall configuration is one which does not interfere with the normal use and operation of the catheter system or get in the way during its use in a procedure. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the drawings, wherein like parts are represented by like reference numerals throughout the same: 
     FIG. 1 depicts a rapid exchange balloon dilitation catheter including the clip device of the invention; 
     FIG. 2 depicts an over the wire balloon dilitation catheter including the clip device of the invention; 
     FIG. 3 is an enlarged view of the clip of FIG. 1 with the clasp lid latched in the closed position and illustrating several loops of a coil of the catheter shaft shown broken and secured to the hub by the closed clasp lid; 
     FIG. 4 is a bottom view of the hub of FIG. 3 without the illustrated coils; 
     FIGS. 5 and 6 illustrate views of the hub device of FIGS. 3 and 4 with the clasp lid open; and 
     FIGS. 7 and 8 are enlarged perspective views of a hub device with the clasp lid in the open and closed positions, respectively, showing a possible latch. 
    
    
     DETAILED DESCRIPTION 
     In the detailed description, the combination hub clip is illustrated with regard to one or more particular embodiments. These embodiments are intended merely to illustrate the principles of the invention and not to limit the outward appearance or possible uses of the system. It is contemplated, for example, that the hub may be mounted on different catheter devices. 
     FIG. 1 illustrates a rapid exchange balloon dilitation catheter device of a class suitable for and, in fact, incorporating the hub clip system of the invention. The catheter device is generally represented by the number  20 . 
     The connecting hub is depicted at  22 , including a body element  24  and a clasp lid  26  suitably and integrally hinged at  28  to the body element  24 . The proximal end  30  of the hub device  22  may be connected removably to any suitable accessory such as a manifold in the form of an integral Y-adaptor (FIG. 2) as a leuer fitting  62 , or the like. The distal end  32  is adapted to receive the catheter shaft  34  utilizing a reinforcing or strengthening transition segment  35 . A shive or guidewire port for the rapid exchange catheter device is shown at  37 . A dilitation balloon or expander device  38  incorporated as part of the catheter  20  in a well-known manner. Radiopaque markers useful for assisting placement and positioning of the expander  38  are depicted by  40  and  41 . 
     FIG. 2 illustrates the over the wire dilitation catheter device of FIG. 1 incorporating the clip system of the invention in which the proximal end of the hub device includes an integral Y-adaptor shown generally as  42 . The adaptor  42  connects and accesses external devices using tubular ports, examples of which are depicted at  44  and  45  with connecting members  46  and  47 , respectively. Separation between access via Y-adaptor  42  is maintained internally in a well-known manner. 
     The illustrated catheter shaft  34  of FIG. 2 is typically a two-lumen shaft that includes a guidewire lumen through which a guidewire, the tip of which appears at  36 , can be threaded using one of the accesses  44  and  45 . Of course, any rethreading of a catheter for a second or third use involves threading the catheter over a guidewire already in place in the vascular system. The other access  44  or  45  is connected with a pressure lumen which serves to conduct fluid reversibly from a source to inflate the dilitation balloon or expander device  38 . 
     The clip device itself is depicted in greater detail in FIGS. 3-8. As can be seen from the figures, the body  24  of the hub device  22  is provided with a shallow recess at  50  (FIG. 5) to accommodate a portion of the clasp lid  26  thereby maintaining relatively smooth outer configuration for the hub when the clasp lid is closed. The hub device is further provided with a longitudinal open-ended recess  52  which is designed to accommodate and capture one or more turns or coils of the catheter shaft  34  as shown in FIG. 3. A snap-fitting clasp or catch lip is illustrated on the lid at  54  which cooperates with a catch  56  on the clip body to provide a finger-operable snap-fit closure. These features are shown exaggerated in FIGS. 7 and 8 for the purposes of illustration only. 
     The configuration and operation of snap latches of the class is quite well known and it will be appreciated that the force required to open and close such a latch can be varied with respect to the construction of the device such that the desired closure tension is achieved. It will be appreciated that the hinge member  28  is preferably rather thin and able to accommodate a number of repeated flexings while functioning so that it remains intact in a manner such that the clasp lid  26  may be operated a number of times to capture and release turns of the catheter shaft as necessary during the use of the catheter in a procedure. It will further be noted that the system can readily be operated occupying but one hand of the user. 
     The device itself is preferably molded in a one or two-shot molding operation with the hinge and lid portion being integrally formed. The entire assembly may be constructed of a single molded polymeric material in a oneshot process or may utilize diverse materials for the main body of the hub and the hinge and clip. In this manner, the system may be formed using a multi-step process with a plurality of materials possibly in a two-shot process in which both materials are injected at separate accesses into the mold cavity. Of course, other established processes of fabricating such devices, such as insert molding, may be employed by those skilled in the art as well. 
     It will be appreciated that any moldable polymer material susceptible of forming the hub with the required internal passages and external recess, together with the integral living hinge and clasp lid and which is compatible with the remainder of the catheter device may be utilized. The list of materials includes, but clearly is not limited to, acrylic materials, polyester materials, polycarbonate materials, styrene, ABS and many others. A slightly softer material such as Hytrel polyester and various polyalkene materials such as polyethylene and polypropylene may be utilized for the hinge and clip portion, assuming that a harder material is used for the associated hub itself, if desired. 
     The clip device of the present invention may form the proximal end of a catheter. Alternatively, it may be attached to a catheter shaft at a point distal of the proximal end of the catheter, such as within 10 cm. of the proximal end of the catheter in which case the catheter shaft would pass through and be bonded to an inner lumen of the clip. 
     This invention has been described herein in considerable detail in order to comply with the Patent Statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment details and operating procedures, can be accomplished without departing from the scope of the invention itself.