Abstract:
An adapter for an introducer comprises a medical device having a tubular port on a proximal end such as a splittable hemostatic valve. A tubular fitting is provided on a proximal end of the introducer. An elastomeric member is disposed between the port of the medical device and the tubular fitting of the introducer for providing a fluid tight and mechanically secure connection therebetween. The introducer and valve are manually connectable and reconnectable with each other while maintaining the fluid tight connection between them. A side port may communicate with the hemostatic valve, the side port having a controllable valve ending. In the preferred embodiment the introducer comprises a splittable introducer. In the illustrated embodiment the elastomeric member provides a slip fit between the medical device and the tubular fitting of the introducer. A tab extends from the tubular fitting of the introducer to facilitate manual manipulation of the tubular fitting. In the preferred embodiment, the introducer is torqueable and the tab is used to rotate the introducer.

Description:
RELATED APPLICATIONS 
     This application is related to U.S. Provisional Patent Application, Ser. No. 60/400,004, filed Jul. 31, 2002, which is incorporated herein by reference and to which priority is claimed pursuant to 35 USC 119. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to the field of endovascular introducers used in combination with hemostatic valves, catheters and medical instruments of any kind. 
     2. Description of the Prior Art 
     Introducers are generally used with indwelling catheters and electrode leads and more particularly to introduce catheters and electrode leads into a desired portion of a patient&#39;s body. Catheters and leads are typically placed in a desired location in a patient&#39;s body, particularly within the patient&#39;s vasculature, by means of introducer systems. These introducer systems typically include an elongated sheath which is inserted into the blood vessel, artery or other portion of the patient&#39;s body, through which sheath the catheter or lead is introduced. In those circumstances in which the lead or catheter is to remain in the patient&#39;s body for a considerable period of time, it is desirable to be able to remove the introducer sheath over connectors or fittings on the leads or catheters, which may have diameters greater than the inner diameter of the introducer sheath. In many circumstances, it is also desirable that a hemostasis valve be provided at the proximal end of the introducer sheath, allowing the introducer to be sealed around the lead or catheter body. The presence of the hemostasis valve, which typically includes a rigid housing containing a compressible seal, which engages the circumference of the lead body, can pose a problem with regard to removal of the introducer sheath. In some introducers, the introducer sheath is provided with a luer hub on its proximal end, allowing interconnection both to the removable hemostasis valve and to other devices such as valves, T-fittings and the like, using the luer hub. 
     While allowing a variety of devices to be fitted to the introducer, the limitation exists that all such devices must be provided with a luer connector. While luer connectors are well known they are not compatible with all devices. 
     What is needed is some kind of connector for an introducer that is widely universal in its design compatibility and which is inexpensive and simple to manufacture. 
     BRIEF SUMMARY OF THE INVENTION 
     The invention is an adapter for an introducer comprising a medical device having a port on a distal end and a fitting provided on a proximal end of the introducer The port and fitting may have any mutually conforming shape desired, such as a tubular, conical or mutually conforming straight or tapered prismatic shape of any cross-section, such as round, square, rectangular, star shaped, oval, or helical. The introducer and medical device are manually connectable and reconnectable with each other while maintaining the fluid tight connection between them. The collar can be coated with a lubricant such as silicone fluid or any other medical grade lubricant that facilitates the insertion and removal of the collar into the mating fitting. 
     In one embodiment, an elastomeric member is disposed between the port of the medical device and the tubular fitting of the introducer for providing a fluid tight and mechanically secure connection therebetween. The elastomeric member may be inserted in, on or around the port of the medical device or the fitting. Thus, the fitting may provide either a male or female type connection to the medical device with or without the elastomeric member and if with the elastomeric member, then with the elastomeric member combined either with the medical device or with the fitting or with neither. The elastomeric member may be fixed to a distal end of the port of the medical device, to the tubular fitting, or may be a separate piece alternatively slip fit either into the distal end of the port of the medical device or into tubular fitting. 
     In the illustrated embodiment the medical device comprises a hemostatic valve, which preferably is a splittable hemostatic valve, but also expressly includes nonsplittable valves within the scope of the invention. A side port may communicate with the hemostatic valve, the side port having a controllable valve ending. In the preferred embodiment the introducer comprises a slittable introducer. 
     In one embodiment the elastomeric member is separable and is comprised of a resilient material with a durometer between 20 shore A and 100 shore A. More particularly, the elastomeric member is comprised of silicone rubber and has a line of fissure defined therein or is pre-slit. In the preferred embodiment, the elastomeric member has a lubricated surface. For the purposes of this specification, “separable” is defined to mean that the object so described can be split open, cut open, torn open, cracked open, popped open, snapped open, opened on a hinge or otherwise physically configured to allow the removal from the object of an elongate member, wire or catheter which is disposed through the object. 
     In the illustrated embodiment the elastomeric member provides a slip fit between the medical device and the tubular fitting of the introducer. The slip fit allows for a quick, simple, repeatable and reliable connection and reconnection action between the introducer and medical device with a minimum of construction complexity and expense. A tab extends from the tubular fitting of the introducer to facilitate manual manipulation of the tubular fitting. In the preferred embodiment, the introducer is reinforced with braid so that it is torqueable and the tab is used to rotate the introducer. 
     While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112. The invention can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side elevational view of the invention showing a splittable valve separated from or unengaged from the introducer. 
         FIG. 2  is a side elevational view of the invention showing the embodiment of  FIG. 1  with the splittable valve inserted into or engaged with the introducer. 
         FIG. 3  is a side elevational view of the invention showing an embodiment where a medical device or valve without a side port is directly slip fit into the proximal fitting of the introducer without any sealing elastomeric member. 
     
    
    
     The invention and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the invention defined in the claims. It is expressly understood that the invention as defined by the claims may be broader than the illustrated embodiments described below. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     As shown in side elevational view of  FIG. 1  a cardiac or endovascular apparatus  10  is shown in the illustrated embodiment as comprised of a splittable and preferably, a rigid hemostatic valve  12  with an introducer  14 . Introducer  14  is comprised of an elongated hollow tubular member  18 , which is coupled with tapered fitting  16  on its proximal end. Any type of introducer  14  now known or later devised may be used in the claimed combination of the invention. For example, introducer may be reinforced or unreinforced so that it is torqueable or torsionally flexible. Introducer  14  may be splittable, slittable, tearable or separable by some means or may be integral and inseparable. Introducer  14  may be straight, curved, biased, unbiased, moldable, unmoldable or characterized variations in length, diameter, stiffness, resiliency, softness, hardness or composition along its longitudinal extent. In other words, introducer  14  should be understood in the present specification to be generally inclusive of all and any type of introducer structure or characterization. 
     Tapered fitting  16  is comprised of a thin walled cylindrical hollow proximal portion  20 , which tapers down through a funnel-shaped portion  24  to connect with or integrally extend into or with tubular member  18 . 
     In the illustrated embodiment, tapered fitting  16  includes a molded tab  22  extending from its lower portion in a generally perpendicular direction. Tab  22  is firmly connected to fitting  16  and provides a convenient means for manually holding, pushing, pulling, and turning fitting  16 . Tapered fitting  16  slip fits or is snugly telescopically disposed in a fluid tight sealing relationship with distal end  26  of valve  12 . Distal end or portion  26  of valve  12  is provided with an elastomeric collar  28  which serves to enhance the slip fit with fitting  16  and provide the fluid tight seal. Elastomeric collar  28  may be composed of any material now known or later devised to provide quick, fluid tight engagement with the interior walls of fitting  16 , such as silicone rubber or any rubberized plastic or polymer. Collar  28  can be coated with a lubricant such as silicone fluid or any other medical grade lubricant that facilitates the insertion and removal of collar  28  into a mating fitting, such as tapered fitting  16 . 
     Except for its modification at its distal end  26 , valve  12  is conventional and may also include any type of hemostatic valve now known or later devised. In the illustrated embodiment a splittable or slittable valve  12  is employed which is molded or formed from two valve halves  30   a  and  30   b . Valve  12  is held or manipulated by means of a pair of opposing upper tabs  34   a  and  34   b  extending at right angles to the axis of longitudinal symmetry of valve  12 . Tabs  34   a  and  34   b  can be used to snap or tear valve  12  apart. While valve  12  is shown as splittable, it is to be expressly understood that valves comprised of separate halves, which are resiliently opened or closed like a clam shell, are also contemplated. Alternative constructions, such a valves which open against a resilient spring mechanism, are cut apart, break apart on weakened seams, or any other means for separating or opening the body of the valve are deemed to be equivalent to the illustrated embodiment. The proximal portion of valve  12  is provided with a conventional splittable or separable hub  36  having an elastomeric sealing membrane  38  therein. Again hub  36  may be provided with any type of design desired or needed to connect with other medical devices or tubing. 
     In the illustrated embodiment, fitting  16  has a smooth interior bore or surface  44  with which collar  28  makes intimate contact. The outer diameter of collar  28  and the inner diameter of fitting  16  are such that given the elasticity of both collar  28  and fitting  16 , a tight sealing fit is achieved through which not only is a fluid tight seal made, but valve  12  and introducer  14  are mechanically coupled together with sufficient strength so that they will not easily be disconnected from each other by the forces encountered in normal handling. However, their coupling is not so strong, that the physician has any substantial difficulty in either making or disconnecting the coupling between valve  12  and introducer  14 . Hence, collar  28  of valve  12  and fitting  16  of introducer  14  may be coupled and uncoupled multiple times without losing the ability to make a fluid tight and mechanically secure connection. 
       FIG. 2  is a side elevational view of the invention which illustrates apparatus  10  in an assembled configuration. Collar  28  is telescopically forced or Inserted into fitting  16  deeply enough to cause circular circumferential hard ridge  46  on valve halves  30   a  and  30   b  to be inserted into the upper portion of fitting  16  to provide a compression fit. Collar  28  is illustrated in  FIGS. 1 and 2  as fixed to the distal end or port of valve  12 , but it is entirely within the scope of the invention that collar  28  may be fixed within proximal portion  20  of fitting  16 , or may be a free piece which is alternatively slip fit either on distal end or port of valve  12  or into proximal portion  20  of fitting  16  according to user choice. 
     Fitting  16  can be forced further up valve halves  30   a  and  30   b  until its upper proximal edge  20  comes into contact with a circular circumferential hard stop  48 . This serves to limit the degree of insertion and to avoid overstressing fitting  16 , which has a slight inner tapering or cone shape. 
     While the illustrated embodiment is shown as being coupled together by slip fit elastic members, it is also to be understood that similar couplings using Luer lock structures or other positive screw or locking structures can be added or combined with the disclosed fitting/collar combination. In other words, the coupling of a cylindrical or slightly conical elastomeric plug into a cylindrical or slightly conical hollow tube end may be further modified to include additional structure such as locking structures, threading, rings, keyways, guides, collars and any other type of connection mechanism. 
     The inner chamber within valve  12  may be communicated with a side port  40 , which terminates in a conventional three-way valve  42 . Valve  42  communicates with tubular ports  50  for connection to external tubing and is operated by manually turning a cylinder valve element (not shown) by means of a lever  52 . This allows the infusion of fluids into valve  12  and ultimately introducer  14 . Further details of the design of valve  42  is immaterial to the scope of the invention. 
     Thus, it can now be readily appreciated that introducer  14  with fitting  16  is provided with an adapter which allows introducer  14  to be quickly and securely connected to multiple alternative medical devices according to the medical application at hand. For example, in the simplest embodiment introducer  14  may be combined with a splittable valve  12  and a pacemaker lead implanted into a patient through valve  12  and introducer  14 . In such a procedure, valve  12  would normally be broken open after the pacemaker lead was implanted. After implantation if for any reason it should be desired to remove the first pacemaker lead and replace it with a second lead, then a new valve  12  can be inserted into introducer  14 , which might be left in place, and the procedure repeated. In prior art embodiments where the valve and introducer were integral, such a replacement procedure would require subcutaneous reinsertion of the introducer with the attendant risk of additional tissue trauma and complication. 
       FIG. 3  is a simplified side elevational view of another embodiment where valve  12  is connected to introducer  14  by a slip fit of a hard plastic distal port  54  that wedges into the proximal end of a hard plastic fitting  16 . The distal port  54  is shown as generally tubular or conical and as slip fitting into a conforming tubular or conical bore  56  defined in the proximal end of a hard plastic fitting  16  without the mediation of any elastomeric gasket or seal between them. It is within the scope of the invention that the relationship may be reversed, i.e. the proximal end of a hard plastic fitting  16  may be formed as a male-type tubular or conical port which inserts into a female-type tubular or conical port of valve  12 . 
     The medical device may be any type hemostatic valve now know or later devised. While splittable and nonsplittable valves have been described above, the invention expressly contemplates being used as an adapter for translatable or slideable valves which are moved or rotated into and out of an operative position, such as shown in U.S. Pat. No. 5,441,504 or PCT Publication WO 02/05867, both of which are incorporated herein by reference. 
     Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. 
     The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself. 
     The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination. 
     Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. 
     The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.