Abstract:
An introducer and hemostatic valve for improved torsional guidance and kink resistance includes an entirely circumferentially reinforced introducer connected directly to a valve body formed of a plurality of separable portions and housing a valve element in a central chamber thereof. The plurality of portions may be attached to the introducer during formation of the introducer, the valve body, or both. Alternatively, the plurality of portions may be attached to the introducer by assembly of the portions together in a surrounding relation to the introducer. In use, the plurality of portions are separated from each other and the introducer is cut along its length in order to withdraw the introducer and hemostatic valve over an enlarged proximal end of an access device as the introducer is pulled from the patient&#39;s body.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The invention relates generally to introducers, sheaths, guides or catheters and hemostatic valves, and more specifically to a nonfrangible guide or introducer and hemostatic valve combination and the method of using the same. 
   2. Description of the Prior Art 
   For purposes of this specification a sheath is defined as an un-reinforced hollow tube, which may contain lines of weakness to aid in the peeling apart of the sheath. 
   A guide is a braid-reinforced hollow tube that cannot be peeled, or torn away simply by pulling on it, but must be sliced or cut open with a cutter, slicer, slitter or other tool. Further, while the guide is disclosed as braided, any construction of the guide, which allows the guide to be torsionally stiff enough such that a rotation of its proximal end is transmitted in its substantial entirety to its distal end when the guide is in use, is considered equivalent. Thus, the guide is termed, “nonfrangible”. 
   A catheter is a general term used to describe a tube that may be braided or not, and is generally used to inject or aspirate fluids. 
   An introducer is a general term used to describe a sheath or guide that is used to introduce another medical device into the body. 
   The prior art has a variety of guides, introducers and catheters in combination with hemostatic valves, wherein the catheters or introducers are of the frangible type. Most of these prior art devices also require introducers that are of a stiffer material to aid in insertion of a catheter sheath into a patient&#39;s vein. 
   Of particular interest is U.S. Pat. No. 6,083,207 to Heck, which is incorporated herein by reference. Heck&#39;s device incorporates a frangible introducer. Morris, U.S. Pat. No. 5,713,867 is directed to a braided introducer having a pair of symmetrically opposed tabs on its proximal end, which introducer is slit by a cutting tool or is torn along a weakened line. The tabs remain permanently affixed to each longitudinal half of the introducer. Morris does not clearly describe or show how the cutting tool is used to cut through the hub or the structure, which forms the base structure which connects the tabs to the introducer. In fact, it is believed that Morris is inoperable to function as a splittable introducer due to the barrier presented by the hub to any cutting step. 
   The frangible sheaths of the prior art cannot torqued as required to steer the distal end of the sheaths, namely to be steered through the subclavian vein into the right atrium, through the right ventricle, and into the pulmonary artery. This and other steering requirements necessitate that the sheath be reinforced to transmit the torsional forces applied to its proximal end to its distal end during guiding. 
   The prior art is further deficient in that it lacks an adequate showing or disclosure relating to removable or openable hemostatic valves directly and integrally connected to a guide. 
   The prior devices are also lack hemostatic valve bodies having weakened lines along which the valve body may be broken into at least two portions, wherein one of the portions are integrally connected with the introducer and one separable to allow for cutting of the reinforced introducer. 
   While the prior art shows some hemostatic valve bodies that open on a hinge, the prior art fails to show such valve bodies directly connected to a guide. 
   BRIEF SUMMARY OF THE INVENTION 
   The invention overcomes these deficiencies with an introducer and hemostatic valve combination for improved steering or transmission of torsional forces that includes an introducer having a fully reinforced construction. The hemostatic valve has a body comprised of a plurality of separable portions, which form a central chamber. A valve membrane is disposed in the central chamber to provide a fluid-tight seal with or without any elongate instrument being disposed through the chamber. A means is provided for holding the plurality of portions of the valve body together and the introducer is connected to the valve body by a fluid-tight connection. 
   The introducer and valve are also embodied by an introducer comprised of at least two components including a tube and a reinforcement. The reinforcement generally comprises at least one filament. The filament extends completely circumferentially around the tube a plurality of times. A plurality of filaments can be crisscrossed and oriented diagonally with respect to a length of the introducer. These filaments cause the introducer to be both torqueable and nonfrangible, thereby necessitating the introducer to be longitudinally separated or opened by longitudinally cutting or slitting the introducer in order to remove it over an enlarged lead connection on a proximal end of the lead. The introducer is “torqueable” in that it resists rotational deformation when a rotational or torqueing force is applied to the introducer. Alternatively stated, the introducer is capable of transferring a torsional force applied at one end to the other end. It is also contemplated that any means now known or later devised other than that set forth above may provide “torqueability” and be deemed equivalent. 
   A variety of embodiments are expressly contemplated with regard to the introducer&#39;s connection to the valve body. The introducer may be removably connected to the valve body by assembling the plurality of portions of the valve body together with the introducer, e.g. using a mechanical compression fitting. 
   Alternatively, the plurality of portions of the valve body may be integrally molded together and have a weakened line along which the body may be selectively broken into separate portions. In this case, the separate portions of the valve body may be integrally connected to the introducer by insert molding and remain attached to the introducer even after being separated from each other. 
   Alternatively, a first portion of the valve body may be permanently attached to the introducer while a second portion of the valve body is removably attached to the first portion of the valve body or removably attached to the introducer. 
   Other embodiments include the case where a plurality of portions of the valve body are connected to each other on one side of the body by a hinge, and are separably and sealingly fastened to each other the opposing side of the valve body. In these embodiments, the portions of the valve body are formed of or comprise a resilient material such that the portions snap fit together. 
   In one embodiment of the above described hinged version of the invention, a resilient means for biasing the first portion and the second portion together is included. Furthermore, in this embodiment a first finger grip is connected to a first portion of the valve body and a second finger grip is connected to a second portion of the valve body for use in manually separating the first and second portions from each other against the bias of the resilient means. 
   In another embodiment of the invention, the plurality of portions of the valve body comprises a first portion and a second portion together forming a nipple for receiving the introducer. 
   In any of the above described embodiments, the plurality of portions of the valve body may comprise a first portion and a second portion that are substantially mirror images of each other. Alternatively, the first and second portions can merely be complementary to each other. In either case, the first and second portion forms a seal therebetween when assembled together. 
   The method of using the invention is determined by the details of the structure of the hemostatic valve, which includes a housing forming a central chamber and a plurality of separably interconnected portions. The method of using a reinforced introducer and hemostatic valve combination for improved torsional guidance of the introducer may also be utilized for introducing medical devices other than pacemaker electrical leads into vessels and cavities of a body. While the invention deals specifically with introducing a pacemaker electrical lead having a lead tip at a distal end and possibly an enlarged lead connection at a proximal end, the scope of the invention is broad enough to include any elongated instrument disposed through the introducer. 
   The method includes the steps of: inserting a needle into a vessel; inserting a guide wire in to the vessel; removing the needle by sliding it off of a proximal end of the guide wire; inserting a distal end of the reinforced introducer into the vessel with the hemostatic valve integrally attached to a proximal end of the introducer; effectively guiding the introducer by torsional manipulation to position the distal end of the introducer at a specific point of operation; removing the guide wire; inserting a pacemaker lead, tip first, through the introducer with the enlarged lead connection remaining at the proximal end of the pacemaker lead outside of the introducer; continuing to move a distal end of the pacemaker lead to the point of operation; separating the plurality of portions of the valve housing; and removing the introducer by cutting the introducer along its length so that the introducer can be removed over the enlarged lead connection while the pacemaker lead is left undisturbed at the point of operation. 
   It should be noted that the steps involving the needle and guide wire may be bypassed. These optional steps are often advantageously used to improve introduction and guidance of devices into a body. 
   The invention also includes a method of using a reinforced introducer and a hemostatic valve combination for improved torsional guidance of the introducer. As can be appreciated, the reinforced introducer can be guided when used by itself even without a guide wire because of the reinforcement. Once again, the method of using is applied to guiding an electrical lead having a lead connection on a proximal end and a lead tip at a distal end. However, the invention may be used to insert other devices into a vessel or cavity of the patient&#39;s body. As with all of the embodiments, the hemostatic valve has a housing comprising a plurality of separably connected portions forming a central chamber. 
   The method of using the invention includes the step of removing or withdrawing the valve housing and the reinforced introducer once the electrical lead has been properly located in a patient&#39;s body. When the valve housing has at least first and second portions, the step of removing may further comprise one or more of the following: detaching the second portion from the first portion and leaving the first portion attached to the introducer; separating the first and second portions from each other while leaving the first and second portions attached to the introducer; breaking the housing along at least one weakened line defining a boundary between the at least first and second portions; resiliently releasing a snap fitting between the first portion and the second portion; hingedly moving the first and second portions away from each other; and releasing the first portion and the second portion from each other by releasing a band or tape. It is to be understood that typically two tabs are connected to the valve body to assist in the manual separation of the valve body portions. In the invention one of the tabs remains connected at least to the introducer to allow the introducer to be held and accessed while it is then being cut or sliced with a tool. 
   The step of withdrawing the valve housing and the reinforced catheter introducer once the electrical lead has been properly located in a patient&#39;s body includes additional steps. In the device of the invention, the introducer comprises a nonfrangible introducer and requires the additional step of cutting the introducer. In this case, the step of withdrawing comprises separating at least a second portion from a first portion, holding the introducer by one of the portions and/or its associated tab, and cutting the nonfrangible, reinforced introducer along its length as the introducer is withdrawn from the patient&#39;s body and slid past the enlarged lead connection. 
   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 diagrammatic view showing the introducer and hemostatic valve combination inserted through the subclavian vein and into the heart. 
       FIG. 2  is a diagrammatic view of the introducer and valve combination depicting the insertion of an electrical lead. 
       FIG. 3  is a diagrammatic view showing the removal of the valve and introducer. 
       FIG. 4  is a diagrammatic view showing the preliminary step of inserting a needle into the subclavian vein. 
       FIG. 5  is a diagrammatic view showing the preliminary step of inserting a guide wire and removing the needle shown in  FIG. 4 . 
       FIG. 6  is a perspective view of a hemostatic valve of the invention. 
       FIG. 7  is a sectional view taken along lines VII—VII of  FIG. 6 . 
       FIGS. 8A and 8B  are sectional views similar to  FIG. 7  and showing variations of the connection in the region indicated at VIII of  FIG. 7 . 
       FIGS. 9 and 10  are perspective views of embodiments in which the introducer remains attached to one portion of the valve housing. 
       FIGS. 11A ,  11 B and  11 C are perspectives views of an embodiment in which the introducer is made integral with and remains attached to both portions of the valve housing. 
       FIG. 12  is a perspective view of an additional embodiment of the introducer and valve. 
       FIG. 13  is a modified sectional view taken along lines XIII—XIII of  FIG. 12 . 
       FIG. 14A  is a sectional view taken along lines XIV—XIV of  FIG. 9 . 
       FIG. 14B  is a partial side elevation view of the introducer and valve embodiment of  FIG. 9 . 
       FIG. 14C  is a side elevation view of an introducer slitter. 
       FIG. 14D  is a perspective view of the introducer slitter cutting an introducer. 
   

   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 
   Consider first some background describing the context in which the illustrated embodiment is used.  FIG. 1  depicts the introducer and valve combination  10  comprising the reinforced introducer  12  and hemostatic valve  14 . As shown, the introducer  12  penetrates the patient  15  at the point of injection or insertion  16  and enters the subclavian vein  18 . From thence, the introducer  12  is directed into the heart  20  and positioned to reach a point of implantation or operation  22 . 
   As shown in  FIG. 1 , introducer  12  may be guided along previously inserted guide wire  24 . The guide wire  24  is a known means for aiding in the guidance of catheters and in  FIG. 1  guide wire  24  helps to guide introducer  12  in the direction of arrow  26  to point of operation  22 . Once introducer  12  is in position, guide wire  24  may be withdrawn from introducer  12  and valve  14  in the direction of arrow  28 . The guide wire  24  is optional in accessing point of operation  22 . This is especially so in the invention because introducer  12  is reinforced to withstand torsional deformation. As such, introducer  12  can be provided with appropriate bends and can be manipulated to navigate its way to a point of operation as desired. 
   While the introducer and hemostatic valve  10  of the invention may be used for a variety of types of access to different parts of the body, of particular interest is the insertion of an electrical lead  30  for a pacemaker as shown in  FIG. 2 . Electrical lead  30  has a lead tip  32  at its distal end that is threaded or disposed through valve  14  and introducer  12  in a direction of arrow  34  toward the point of operation  22  in the heart  20 . Electrical lead  30  has an electrical connector  36  at a proximal end thereof, which is of such a size and configuration that valve  14  and introducer  12  cannot be simply pulled over connector  36  off lead  30 . 
   As shown in  FIG. 3 , after the lead tip  32  has reached the point of operation  22 , the introducer and valve combination  10  must be removed while the lead  30  remains in place. Valve  14  is made of at least a first portion  38  and a second portion  40 , which include not only portions of the valve body surrounding, supporting and holding a valve membrane (not shown), but also include typically two opposing tabs  38   a  and  40   a  by which the portions  38  and  40  are held and manipulated. It is also expressly contemplated that at least one of the tabs  38   a  and  40   a  may be separable from remaining portions of the valve body and permanently attached to the introducer while the other tab is separable from the introducer with or separately from the removable valve body portions. The first and second portions  38 ,  40  can be separated at least enough to allow connector  36  to pass therebetween. The first and second portions  38 ,  40  are shown to completely separate from the introducer  12  in  FIG. 3 . However, in the preferred embodiments as discussed below, one of the first or second portions  38 ,  40  remains attached to the introducer  12  after relative separation. 
   The next step is to withdraw introducer  12 . However, the electrical connector  36  is too large to pass through the inner diameter of introducer  12 . Therefore introducer  12  is cut along its length by a slitter or cutting means  43 . As introducer  12  is cut or slit, electrical lead  30  is permitted to slide through cut  45  and introducer  12  can be withdrawn from the heart and vein of the patient  15  in a direction of arrow  46  while the electrical lead is left inserted. 
     FIGS. 4 and 5  depict preliminary steps, which may be omitted or replaced by alternative means by which introducer  12  is permitted to penetrate into the subclavian vein  18 . In  FIG. 4  syringe  49  is used to insert a hypodermic needle  53  into the subclavian vein of the patient  15 . The syringe  49  is then removed and a guide wire  24  is inserted through needle  53  in a direction of arrow  56  as shown in  FIG. 5 . Once guide wire  24  has been inserted, needle  53  may be withdrawn in a direction of arrow  59  and slid off of a proximal end of guide wire  24 . 
   As shown in  FIG. 6 , the hemostatic valve  14  has a body comprising first and second portions  38 ,  40  and a tab  40   a  protruding outwardly from the portions  38 ,  40 . First tab  38   a  extends from first the body portion  38 , and a second tab  40   a  extends from second the portion  40 . These tabs  38   a ,  40   a  are integral with the respective first and second portions  38 ,  40  and aid in separating portions  38 ,  40 . The first and second portions  38 ,  40  are separated from each other by a seam, score line or weakened line  68 . In some embodiments line  68  represents an actual physical discontinuity or break between first and second portions  38 ,  40  even when the portions are assembled together in use. In all cases, however, first and second portions  38 ,  40  define an aperture  69  at a distal end of valve  14 . Associated with aperture  69  and located slightly interiorly thereof relative to body  14  is a sealing valve membrane  72  for providing a fluid tight seal with any lead disposed through valve  14 . 
   As shown in  FIG. 6 , first and second portions  38 ,  40  of valve  14  form a central chamber  73  through which an electrical lead or other elongate instrument is passed during use. The first and second portions  38 ,  40  are depicted in  FIG. 6  as being held together by tape or a band  75 . However, as disclosed above by reference to weakened line  68 , other means for holding first and second portions  38 ,  40  together may also be employed and are discussed below. 
     FIG. 7  is a cross-section taken along lines VII—VII of  FIG. 6  and showing an alternative means of attachment including a tongue  77  and groove  79  serving as a latch or clasp. Also clearly shown in  FIG. 7  is valve membrane  80  that substantially prevents blood from escaping during use of the invention. Valve membrane  80  prevents blood from escaping by means of a slit  81  defined in a soft, resilient polymer plug or cylinder, which comprises the body of membrane  80  and which slit in this case is in the form a “Y”. The slit may of course have other shapes such as simple straight lines completely or partially extending across membrane  80 , or “X” shapes and the like. As can be appreciated, opposite sides of valve membrane  80  press against each other at slit  81  and thereby form a seal. The attachment means  82  diametrically opposed to tongue  77  and groove  79  may be any of a variety of means to be described hereafter. 
   One alternative attachment means  82  for region VIII of  FIG. 7 , is a hinge  85  as shown in  FIG. 8A . In this way, the first and second valve portions  38 ,  40  may be rotated together to clamp around an annular protrusion  86  of introducer  12  to form a fluid-tight seal, and be locked in place by tongue and groove  77 ,  79 . In this embodiment, valve membrane  80  is provided in two separate portions  91 ,  93 , which are cut away for convenience in the view of  FIG. 8A . 
     FIG. 8B  shows a second alternative attachment means  82  for region VIII of  FIG. 7  in the form of a second tongue  87  and groove  89  combination.  FIG. 8B  also shows that slit  81  may be of any length and may be simple or branchless. In each of the embodiments employing tongues and grooves, a resilient or elastomeric material is needed to provide the snap fit characteristics for locking the first and second portions  38 ,  40  together. As shown in  FIGS. 8A and 8B , one or both of the portions may be formed of a resilient material, or the tongue  77  may be formed of a resilient material. 
     FIG. 9  shows the embodiment of  FIG. 6  in which the first and second portions  38 ,  40  separate completely from each other and one of the portions  38 ,  40  separates from the introducer  12  while the other remains attached thereto. Preferably, the first portion  38  is permanently connected to the introducer  12 . As such, the first portion  38  can function as a handle by which the surgeon holds onto introducer  12  during cutting of introducer  12  by a cutting means  43 . In accordance with the completely separable portions of this embodiment, the valve comprises a first valve membrane  91  and a second valve membrane  93  each held integrally in respective first and second portions  38 ,  40 . 
     FIG. 10  shows an alternative embodiment  95  having a first valve portion  108  and a second valve portion  110 . In this embodiment, introducer  12  is permanently attached to first portion  108  by insert molding or adhesion to a first aperture sector  101  in a first end wall  97 . On the other hand, introducer  12  is removably and sealingly coupled to second portion  110  at a second aperture sector  103  in a second end wall  99  when the first and second portions  108 ,  110  are assembled together. A release agent can be applied to introducer  12  and/or sector  103  during manufacture so that when introducer  12  is insert molded to portions  108  and  110 , no bond or a weakened bond is formed between introducer  12  and portion  110 . Arrows  106  indicate directions of opening and closing the first and second portions  108 ,  110  relative to each other. 
   A preferred embodiment is comprised of a valve housing  38 ,  40 , in the example of  FIG. 9 , connected to the guide  12  with a fluid tight connection that permits the transmission of torque from the valve housing  38 ,  40 , to the guide  12 . Upon separation of the valve housing  12 , one portion,  38  for example, remains permanently attached to the guide  12  while the other portion  40  releasably separates from the guide  12  and the opposing valve portion  38  to expose the end of the guide  12  that is to be slit. 
   This is accomplished by the application of a release material onto the guide  12  prior to bonding the valve housing  38 ,  40  to the guide  12  either by insert molding (overmolding) or adhesive bonding. There are many suitable commercially available bonding release materials such as Silicone (MDX4-4159 manufactured by Dow Corning), Teflon, Lecithin, and Zinc Stearate. The release material is applied to the outer surface of the guide  12  as a coating, film, tape or extruded tube. It is applied only to the portion of the guide  12  that will be connected to the valve portion  40  that is to separate. This is performed with mechanical fixturing that allows alignment of the release material to the proximal portion of the guide  12  and subsequent alignment during insert molding or bonding to the valve housing  38 . 
     FIG. 11A  shows an embodiment having an introducer  132  integrally formed with the hemostatic valve  131  comprising a first portion  128  and a second portion  130 . In this embodiment, weakened line  68  runs into or is continuous with a line  133  on introducer  132 . Weakened line  133  on introducer  132  ends in a stop  134  that prevents further tearing along the length of introducer  132 . Stop  134  may be comprised of the beginning of the reinforcing braid in or on introducer  132 . Thus, there is a short proximal section of introducer  132  next to valve  131  running the length of line  133  which is free of reinforcement. The shortness of this section allows its inclusion in introducer  132 , because the amount of torsional deformation is limited by its short length and can be tolerated. 
     FIG. 11B  shows the embodiment of  FIG. 11A  with first and second portions  128 ,  130  separated from each other, yet still integrally connected to the introducer  132 . As can be appreciated, the integral configuration of the embodiment of  FIGS. 11A and 11B  may be achieved by a molding process and has the advantage of forming the combination of introducer  132  and valve  128 ,  130  in a single step. It can also be appreciated from  FIG. 11A  that without the separation or opening allowed by line  133  no part of the proximal portion of introducer  132  would effectively be exposed or accessible to a cutting or slitting tool. The separation of line  113  on one or both sides of the proximal portion of introducer  132  as shown in  FIG. 11A  allows a cutting tool to be inserted on a prestarted or beginning a slit or cut down the longitudinal length of introducer  132 . 
     FIG. 11C  shows an embodiment of a valve  135  similar to the embodiment of  FIGS. 11A and 11B  in that first and second portions  138 ,  140  may remain integrally attached to introducer  12  after separation from each other. A first seal retainer  142  on first portion  138  and a second seal retainer  144  on second portion  140  complement each other and provide a seal retainer  145  having an opening  146  for receiving reinforced introducer  12  in spaced relationship to valve  135 . This space between valve  135  and the reinforced introducer  12  is for receiving a molded seal  147  that sealingly and integrally connects reinforced introducer  12  to the valve  135 . Molded seal  147  may be reduced in size to be little more than a thin reinforcing ring of plastic or may be omitted all together in the case where reinforced introducer  12  is rigid enough to be insert molded to seal retainer  145 . In this case a separate tab  149  is permanently affixed to one side of reinforced introducer  12 , so that when both portions  138  and  140  of valve  135  are removed, reinforced introducer  12  can be held and restrained as a cutting tool is used to slit it open. 
     FIGS. 12 and 13  show a further additional alternative embodiment  155  of the hemostatic valve that includes a first portion  158  and a second portion  160 . A first finger grip  163  is integrally connected to the first portion  158 . A second finger grip  165  is integrally connected to the second portion  160 . A biasing means in the form of a spring  167  urges the finger grips  163 ,  165  apart. Spring  167  also urges the first and second portions  158 ,  160  together by virtue of the crossed configuration of the finger grips  163 ,  165 . This embodiment includes a tongue  169  and groove  170  for locking the first and second portions  158 ,  160  in a closed, sealed condition integral with the introducer  12  relative to the ambient when in use. Here again a tab  149  permanently affixed to introducer  12  is provided. 
     FIG. 13  is a modified sectional view taken along lines XIII—XIII of  FIG. 12 .  FIG. 13  shows the hemostatic valve  155  in an opening configuration. Like the various embodiments described above, the introducer  12  may be temporarily attached to one or both of the first and second portions  158 ,  160 . However, this particular embodiment is made functional by the hinge connection on one side of the valve  155 , which is in the form of the flexible web-type hinge  173  in the embodiment shown. 
   It is to be expressly understood that in all of the embodiments, the portion or portion of the valve body or separately provided tab that remains attached to the introducer is functional as a handle to hold and manipulate the introducer during steps after the insertion of the electrical lead or other accession device. Such a handle is especially important during steps of cutting or slitting the introducer and withdrawal thereof. 
     FIG. 14A  is a section taken along lines XIV—XIV of  FIG. 9 . However, the reinforcement details of the introducer apply to all the introducer embodiments of the invention. That is, the introducer  12 ,  132  is a non-frangible introducer along a major portion of its length by virtue of reinforcement filaments  150 . The reinforcement filaments  150  may be on an outside, an inside, or may be embedded in the introducer  12 ,  132 . The reinforcement of the introducer  12 ,  132  provides resistance against torsional deformation of the introducer. As such, the reinforced introducer  12 ,  132  can be better guided through vessels and through the heart. However, unlike the frangible sheaths of the prior art, the introducer  12 ,  132  of the invention requires slicing the wall and the reinforcement elements  150  of the introducer  12 ,  132  in order to move the introducer past an enlarged proximal end of an access device.  FIG. 14B  is a side elevation view. In  FIGS. 14A and 14B , the annular protrusion  86  is shown seated in the sealing means  72 , which in this case takes the form of a groove. The annular protrusion  86  may be formed integrally with the introducer  12 ,  132  or may be added to the introducer. In either case, the material of annular ring  86  must have properties that enable it to be cut once the first and second portions  38 ,  40  have been separated from each other. 
   However, it is to be understood that in the preferred embodiment when insert molding onto a bondable tube, there is typically no flare or tab. Adherence is obtained by a thermal bond between the plastic and the outer surface of the guide. A flare or tab would be used when connecting to materials which resist bond formation like Teflon®. 
     FIG. 14C  shows a cutting means in the form of a slitter  152  having a grip portion  154  and a blade  156 .  FIG. 14D  shows the slitter  152  in action forming cut  45  along the length of the introducer  12 . 
   While a variety of embodiments have been set forth, the preferred embodiment includes the score line or weakened line  68  for breaking or cracking open the valve body. Furthermore, preferably the introducer is integrally connected to at least one of the valve body portions. The integral connection of the valve body to the introducer is particularly advantageous when at least one of the portions and the introducer can be molded together in a single molding operation. It further follows that integrally molding all of the portions together is also advantageous. 
   The scope of the invention expressly includes the adherence of a portion of the valve body or hub to the guide or sheath and a portion of the valve body or hub to be easily removed, so that the valve body or hub need not be cut through in order to cut the guide or sheath. Direct access of the cutting tool to the guide or sheath is afforded and a means is still providing for conveniently holding on to the guide or sheath to restrain it in place during cutting and/or to draw it over the cutting tool. A release coating or film is disposed onto the portion of the guide or sheath where the valve body or hub is to release. During bonding of the valve body or hub to the guide, the guide or sheath is keyed so that the appropriate portion of the guide or sheath, namely the portion with the release coating, is positioned in the correct orientation relative to the portion of the valve body or hub that is to separate from the guide or sheath. The valve body or hub may be bonded with adhesive, by insert molding or any other means now known or later devised in the art. The physical properties of the coating allow a fluid tight seal, and still allow a portion of the valve body or hub to be easily removed exposing the end of the guide or sheath for subsequent cutting. 
   The valve may be any type hemostatic valve now know or later devised. While various type of splittable 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.