Abstract:
The present invention relates generally to medical devices and, in particular, to a self-dilating catheter introducer and obturator system for introducing implantable medical devices into a body cavity. Depending on the size of the orifice or opening in which the device is required to pass through determines the French scale size of the device (e.g. The French scale is a measure of the external diameter of a catheter not internal channel).

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit under 35 U.S.C. §119(e) of U.S. Non-Provisional Application N/A. 
       FIELD OF THE INVENTION 
       [0002]    The present invention relates to a Self-Dilating Catheter Introducer and Obturator. Introducers are used for placing medical devices, including catheters, into a patient. This specification details an introducer that greatly minimizes the need to exchange introducers during a medical procedure with the focus on reducing Vascular Access Site Complications “VASC”. 
       INTRODUCTION 
       [0003]    Implants may be placed in the human body for a variety of reasons. For example, stents are placed in a number of different body lumens such as blood vessels and biliary ducts; vena cava filters are implanted in the vena cava to catch thrombus sloughed off from other sites within the body; and vaso-occlusive devices are used for the treatment of intravascular aneurysms. Interventional practitioners, regardless of subspecialty have always had to demonstrate profound dexterity in order to effectively and accurately perform invasive procedures. This is particularly the case with the delivery and deployment of implantable devices where there is very little room for error with respect to placement. In some medical procedures, tubular structures such as sheath introducers are inserted into tissue to allow access to a particular body structure, and medical devices are then passed through the tubular structure to a desired site. A guiding catheter is often passed through an introducer to place the catheter into the vasculature of a patient as a common practice in a catheter based medical procedure. A common scenario where the physician first perform a diagnostic procedure using a relatively smaller French scale e.g. 5F diagnostic device requiring a smaller French scale introducer e.g. 5F. Then in order to insert the interventional device required to complete the procedure e.g. stent delivery device, the physician may need to replace the smaller French scale introducer with one of larger French scale e.g. 8F that will allow the passage of the interventional device, resulting in an increase of procedural time and revision that may increase complications. Relative to the current most common method the single most frequent cause of complications during coronary angioplasty and interventions are those related to Femoral Access Interventions “Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization; Journal of Vascular Surgery”. With Manual Compression is the most common form of closure globally for Femoral Access Interventions historical advice on bedrest with sheath and introducer size dependent with the corresponding leg straight for a minimum of 1 Hour for each French size of the arterial sheath. (e.g. 10F=10 hours). Ambulation post sheath removal for 5Fr Sheath is approximately 1 Hour “Ambulation 1 hour after diagnostic cardiac catheterization, a prospective study of 1009 patients; Mayo Clinic, 2006”. In many institutions manual compression is associated with the lowest VASC rates and instrument related procedural cost. Relative a newer more progressive approach the Transradial Access Interventions continues to rise even replacing femoral access as the preferred choice in some countries. Globally Transradial Access Intervention is utilized in 20% of the total cases for PCI, 29% when excluding the US market, Norway, Malaysia, and Bulgaria have the highest rates in excess of 70% while Central and South America at an estimated 15% rate. As the evolution of PCI&#39;s have progressed to incorporate targeted anticoagulants and antiplatelet agents that have led to a steady decrease in ischemic complication there has been a renewed focus on nonischemic complications especially VASCs and ambulation time associated with increased patient stay and cost which has driven a large focus to the Transradial Approach. Transradial access is the preferred choice for upper extremity access because of its easy compressibility, distance from major veins and nerves, companion blood flow through the ulnar artery to the palmar arch. Use of Radial Artery for diagnostic and interventional procedures has been compared with femoral and brachial approach in both randomized trials and observational studies, and has consistently demonstrated statistically significant reductions in bleeding and access site complications. The improvements are even more pronounced in women who have a 2-3 times higher risk of femoral access complications compared to men. Reduced complications lead to reduced lengths of stay and reduced procedural cost and improved clinical outcomes. Although femoral devices have also improved early ambulation and reduced patient discomfort, they have not demonstrated a reduction in bleeding and VASCs. Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures “International Journal of Cardiology, 2009”. There is a significant difference in VASC&#39;s related to Transradial approach using 5F verse 6F introducers. Routine vascular ultrasound after radial artery cauterization detects clinically silent access site complications: “Prospective registry of 425 consecutive patients; University of Leipzig, Herzzentrum”. 
         [0004]    In summary VASC&#39;s (Vascular Access Site Complications): VASC&#39;s are defined as vascular complications such as pseudoanneuryism, ateriovenus fistula, femoral neuropathy, retroperitoneal hematoma, any complication requiring surgical repair, and hematoma requiring transfusion, prolonged hospital stay, or causing a drop in Hgb&gt;10 g/dl. This does not include excessive closure time associated with standard closure techniques, impact on the location of femoral access, or number of attempts to gain access, reported incidence of VASC&#39;s is 5.4 to 20%, procedure Cost for PCI when bleeding complications arouse can result in more than double that of uncomplicated cases. Managing the risk of complications at a femoral access site in percutaneous coronary interventions; “Critical Care Nurse Vol. 32, No. 5, 2012” complications are related to a number of factors: Patent, Procedure, Operator, Institutional, and other related variables. Vascular access site complications are more common in larger access devices regardless if closure devices are being utilized. The data from this study suggest that the use of smaller guiding/introducer catheters during PCI is associated with significantly better outcome, including improved post procedural morbidity and reduced mortality. Percutaneous Coronary Interventions Complications &amp; Guide Catheter Size “Bigger is not Better”; JACC Vol. 2, No. 7, 2009. It has long been documented that the larger the access site introducer/guide catheter the higher the rate of complications especially in VASC&#39;s (Vascular Access Site Complications). 
         [0005]    Percutaneous Coronary Interventions Complications &amp; Guide Catheter Size “Bigger is not Better”;  JACC  Vol. 2, No. 7, 2009 
         [0006]    Managing Risk of Complications at. Femoral Access Sites in Percutaneous Coronary interventions;  Critical Core Nurse  Vol. 32, No. 5, 2012 
         [0007]    Economic Burden of Complications During Percutaneous Coronary Interventions;  Qual Saf Healthcare,  2007 
         [0008]    Major Femoral Bleeding Complications After Percutaneous Coronary Interventions: incidence, Predictors, and Impact on Long Term Survival;  JACC,  Vol. 1, No. 2, 2008 
         [0009]    Peripheral Vascular Complications Following Coronary Percutaneous Interventional Procedures;  Clinical Cardiology,  1995 
         [0010]    Hospital Resources Consumed in Treating Complications Associated with Percutaneous Coronary Interventions;  American Journal or Cardiology,  2006 
         [0011]    Risk Factors for the Development of Retroperitoneal Hematoma after Percutaneous Coronary Interventions:  Journal of American College,  2005 
         [0012]    Femoral Access ad Closure:  American Heart Association Journal    
         [0013]    Transradial Arterial Access for Coronary and Peripheral Procedures;  Executive Summary by the Transradial Committee of the SCAI    
         [0014]    Routine vascular ultrasound after radial artery cauterization detects clinically silent access site complications: Prospective registry of 425 consecutive patients; University of Leipzig, Herzzentrum 
         [0015]    Ambulation 1 Hour after diagnostic cardiac catheterization, a prospective study of 1009 patients;  Mayo Clinic,  2006 
         [0016]    Radial versus femoral access for coronary angioplasty or intervention and the impact on major bleeding and ischemic events, a systemic review and meta analysis of randomized trials;  American Heart Journal  2009 
         [0017]    Transradial vs transfemoral approach tor coronary angiography interventions for patients above 75 years of age;  Catheter Cardiovascular interventions  2008 
         [0018]    Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures;  International Journal of Cardiology,  2009 
       BRIEF DESCRIPTION 
       [0019]    This specification discloses a self-dilating catheter introducer and obturator device. The self-dilating catheter introducer is comprised of a proximal hub with a central orifice and internal seal; the hub also having a purge valve port joined with an extension tube and external purge valve, joined to and extending distally and longitudinally from the hub is a multi-layer lumen configuration with an overmold compliance coating/sheath with properties of elasticity. Preferably the lumen is formed of two tubular shaped and longitudinally extending layers which are covered with an external layer of compliance/elastomeric material. The inner and middle layers of the lumen are capable of radial expansion when the obturator is proximally inserted while the outer layer of compliance/elastomeric material accommodates this expansion due to its expansion properties. The obturator comprised of female luer fitting compliant to ISO 594-1 and -2, a pliable tube with tapered tip and extending distally is joined to the fitting. The disclosure also relates to a method of using a catheter introducer where the catheter introducer is inserted through an incision and positioned in the body of a patient such that its proximal end is accessible to a medical professional and its distal end is positioned to allow a medical device to be inserted at a desired location in the patient. Additionally the lumen of the catheter introducer may be expanded from a first inner diameter to a second inner diameter by insertion of the desired obturator allowing for an instrument for diagnostic or for deploying an implantable medical device e.g. stent into a body lumen. 
         [0020]    The present invention relates generally to medical devices and, in particular, to a self-dilating catheter introducer and obturator system for introducing implantable medical devices into a body cavity. Depending on the size of the orifice or opening in which the device is required to pass through determines the French scale size of the device (e.g. The French scale is a measure of the external diameter of a catheter not internal channel). 
         [0021]    In one embodiment, the invention utilizes a dual lumen configuration with an overmold compliance coating/sheath with properties of elasticity, one lumen inserted internally in and joined to the other with each lumen being split longitudinally along the central axis; the splits of each lumen are positioned opposite each other yielding a closed circumference. 
         [0022]    In another embodiment, the invention utilizes a single lumen configuration with an overmolded compliance coating/sheath with properties of elasticity, the lumen wall having a fluted profile extending longitudinally and radially around the circumference and length of the lumen. 
         [0023]    In yet another embodiment, the invention utilizes a plurality of identical interdigitating/overlapping fingers/leafs/blades joined radially about a central axis and extending longitudinally along the central axis with an overmold compliance coating/sheath with properties of elasticity. 
         [0024]    In yet another embodiment, the invention utilizes, a self-dilating catheter comprised of a proximal access fitting with a central orifice and internal seal, joined to and extending distally and longitudinally from the fitting is a multi-layer lumen configuration with an overmold compliance coating/sheath with properties of elasticity. 
         [0025]    In all afore mentioned embodiments the device has the capability of accommodating varying French scale lumens/catheters. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    The invention may be better understood and appreciated by reference to the detailed description of specific embodiments presented herein in conjunction with the accompanying drawings of which: 
           [0027]      FIG. 1  is an isometric view of the self-dilating introducer with purge valve and obturator, device, all in accordance with the invention; 
           [0028]      FIG. 2  is a side plan and cross section view of the, self-dilating introducer device, all in accordance with the invention; 
           [0029]      FIG. 3  is a scaled up partial detail view of the proximal hub area of cross section  2 - 2  in  FIG. 2 , all in accordance with the invention; 
           [0030]      FIG. 4  is a scaled up cross section view of the lumen profile of side view in  FIG. 2 , all in accordance with the invention; 
           [0031]      FIG. 5  is a front plan view of the inner lumen profile, all in accordance with the invention; 
           [0032]      FIG. 6  is a front plan view of the outer lumen profile, all in accordance with the invention; 
           [0033]      FIG. 7  is an isometric view of the distal and proximal perspective of the obturator, all in accordance with the invention; 
           [0034]      FIG. 8  is a side plan and cross section view of the, self-dilating introducer, non-purge valve device embodiment, all in accordance with the invention; 
           [0035]      FIG. 9  is a front plan view of the fluted lumen profile embodiment, all in accordance with the invention; 
           [0036]      FIG. 10  is as front plan view of the identical interdigitating/overlapping fingers/leafs/blades lumen profile embodiment, all in accordance with the invention; 
       
    
    
     DETAILED DESCRIPTION 
       [0037]    While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. 
         [0038]    Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of the structure and function set forth in the following description or illustrated in the appended drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. “Comprising” also encompasses the terms “consisting of” and “consisting essentially of.” The use of “consisting essentially of” means, e.g., that a method may include additional steps, but only if the additional steps do not materially alter the basic and novel characteristics of the claimed method. Unless specified or limited otherwise, the terms “mate”, “mated”, “joined”, “mounted,” “connected,” “supported,” and “coupled” and variations thereof herein are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings. The use of “compliance” the ability of an object to yield elastically when a force is applied “flexibility” (Merriam-Webster). The use of “overmold” is the process of molding over an insert, which becomes integral to the part on cooling. 
         [0039]    No admission is made that any reference, including any patent or patent document, cited in this specification constitutes prior art. In particular, it will be understood that unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what the author asserts and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. 
         [0040]    As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
         [0041]    Unless otherwise noted, technical terms are used according to conventional usage. However, as used herein, the following definitions may be useful in aiding the skilled practitioner in understanding the invention. Such definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
         [0042]    In view of the foregoing disadvantages inherent in conventional introducer systems, the invention provides a novel system and method for introduction of intravascular devices. 
         [0043]    The lull advantage of the Self-dilating Catheter Introducer and Obturator Device in accordance with the invention is realized when optimal French scale deployment size and ergonomically simplified functionality combine to result in a superior system. Thus these capabilities allows for the intravascular procedure to be accomplished as effectively as possible while minimizing the challenging issues communally associated with the current introducer systems. 
         [0044]    Reference is now made to  FIGS. 1-10  in which a Self-dilating Catheter introducer and Obturator Device, generally designated by reference numeral  10 , in accordance with the invention is shown. Device  10  with split lumen embodiment comprises a dilating obturator  30  with female luer fitting  31  and a introducer  20  with joined proximal hub  21 , the hub side port  21   c  joined in the distal area with an extension tube  41  having a joined purge valve  40  on opposite end of extension tube  41 . 
         [0045]    Illustrated in  FIG. 7  the obturator  30  has a flexible French scale lumen  30   a  extending distally from the female luer fitting  31  and terminating with a tapered tip  30   c,  the lumen  30   a  has a central orifice  30   b  which traverses along the longitudinal centerline and joins to the tapered internal aperture  31   b  of the female luer fitting resulting in an unobstructed channel for passage of fluids or devices e.g. saline solution or catheters or guidewires, the set of threads  31   a  and the tapered internal aperture  31   b  of the female luer fitting all compliant with ISO 594-1 and -2 standard for 6% taper luer fittings the female luer  31  provides a connection fitting for auxiliary devices e.g. syringe. The obturator can be made from any suitable biocompatible materials e.g. plastics or metals (e.g. nitinol, spring steel). 
         [0046]    Illustrated in  FIGS. 2, 3, 4, 5, and 6  the introducer  20  comprised of dual split lumen configuration having a mated and joined inner lumen  20   d  and outer lumen  20   c  and mated to an external compliance coating/sheath  201  which exhibits elastic properties, the dual split lumens and external compliance coating/sheath extending, distally from and including the hub  21  and terminating with a tapered tip  20   b . 1 , the dual split lumen configuration  20  has it central orifice  20   a  which traverses from the distal tip along the longitudinal centerline and joins with the hub in an area distally of the hub integrated static seal  21   a  aligning to the internal aperture  21   e  of the hub which extends to the distal surface  21   a . 1  of the integrated static seal  21   a  resulting in an unobstructed closed channel for passage of fluids through the purge channel  21   b  then traversing through the extension tube  41  joined to the hub purge port  21   c  allowing passage to the purge valve  40  providing for the purging of the system e.g. air. Positioned on the most proximal end of the hub  21  a perimeter flange  21   g  for gripping and a tapered orifice  21   d  terminating at the proximal surface  21   a . 2  of the integrated static seal  21   a  allows for insertion of the obturator  30 . A tab  21   f  extends outbound from the hub surface and with an orifice  21   e  for anchoring the introducer in position as required. Additionally illustrated the mating of the inner lumen  20   d  and outer lumen  20   c  joined to the external compliance coating/sheath  20   b.  The inner lumen  20   d  illustrated in  FIG. 5  with a split  20   d . 2  with equally spaced ends  20   d . 2 . 1  and  20   d . 2 . 2  about the longitudinal centerline and extending longitudinally from the most distal edge  20   d . 4  to the most proximal edge  20   d . 3 , a rail  20   d . 1  positioned opposite the split and facing outbound with equally spaced recessed channels  20   d . 1 . 1  and  20   d . 1 . 2  about the longitudinal centerline and extending longitudinally from the most distal edge  20   d . 4  to the most proximal edge  20   d   3 . The outer lumen  20   c  Illustrated in  FIG. 6  with a split  20   c   2  with equally spaced ends  20   c . 2 . 1  and  20   c . 2 . 2  about the longitudinal centerline and extending longitudinally from the most distal edge  20   e . 4  to the most proximal edge  20   c   3 , a rail  20   c . 1  positioned opposite the split and facing inbound with equally spaced recessed channels  20   c . 1 . 1  and  20   c.   1 . 2  about the longitudinal centerline and extending longitudinally from the most distal edge  20   c . 4  to the most proximal edge  20   c   3 . The split end surfaces  20   d . 2 . 1  and  20   d . 2 . 2  of the inner lumen  20   d  join with the recessed channels  20   c,   1 . 1  and  20   c . 1 . 2  respectively of the outer lumen  20   c,  the split end surfaces  20   c . 2 . 1  and  20   c . 2 . 2  of the outer lumen  20   c  join with the recessed channels  20   d . 1 . 1  and  20   d   1 . 2  respectively of the inner lumen  20   d.  This lumen configuration allows the lumen orifice  20   a  to dilate/expand when the obturator  30  of the desired. French scale is inserted the configuration allows the orifice  20   a  to return to its normal state when the obturator  30  is removed. The introducer can be made from any single and/or combination of suitable biocompatible materials e.g. plastics or metals, and compliance materials. 
         [0047]    As presented in this specification reference is now made to  FIG. 8  in which another embodiment of the introducer  70  wherein the hub side port and anchor tab have been omitted, the introducer  70  comprised of dual split lumen configuration having to mated and joined inner lumen  70   d  and outer lumen  70   c  and mated to an external compliance coating/sheath  70   b  which exhibits elastic properties the dual split lumens and external compliance coating/sheath extending distally from a hub  71  and terminating with a tapered tip  70   b . 1 , the dual split lumen configuration  70  has a central orifice  70   a  which traverses front the distal tip along the longitudinal centerline and joins with the hub in an area distally of the hub integrated static seal  71   a  aligning to the internal aperture  71   e  of the hub which extends to the distal surface  71   a . 1  of the static seal  71   a.  Positioned on the most proximal end of the hub  71  a perimeter flange  71   g  for gripping and a tapered orifice  71   d  terminating at the proximal surface  71   a . 2  of the static seal  71   a  allows for insertion of the obturator  30 . 
         [0048]    As presented in this specification reference is now made to  FIG. 9  in which yet another embodiment wherein the lumen of the introducer  20  is comprised of a single lumen  50  with a wave pattern profile configuration having an inner lumen  50   b  and mated to an external compliance coating/sheath  50   a  which exhibits elastic properties, the single lumen and external compliance coating/sheath extending distally from a hub  21  and terminating with a tapered tip  20   b . 1 , the single lumen configuration  50  has a central orifice  50   c  which traverses from the distal tip along the longitudinal centerline and joins with the hub in an area distally of the hub static seal  21   a  aligning to the internal aperture  21   e  of the hub which extends to the distal surface  21   a . 1  of the static seal  21   a  resulting in an unobstructed closed channel. This lumen configuration allows the lumen orifice  50   c  to dilate/expand when the obturator  30  of the desired French scale is inserted; the configuration allows the orifice  50   c  to return to its normal state when the obturator  30  is removed. 
         [0049]    As presented in this specification reference is now made to  FIG. 10  in which yet another embodiment wherein the lumen of the introducer  20  is comprised of identical interdigitating/overlapping fingers/leafs/blades resulting in a multi-layer lumen  60  with an interdigitating/overlapping radial pattern profile configuration having an inner multi-layer lumen  60   b  and mated to an external compliance coating/sheath  60   a  which exhibits elastic properties, the multi-layer lumen and external compliance coating/sheath extending distally from as hub  21  and terminating with a tapered tip  20   b . 1 , the multi-layer lumen configuration  60  has a central orifice  60   c  which traverses from the distal tip along the longitudinal centerline and joins with the hub in an area distally of the hub static seal  21   a  aligning to the internal aperture  21   e  of the hub which extends to the distal surface  21   a . 1  of the static seal  21   a  resulting in an unobstructed closed channel. This lumen configuration allows the lumen orifice  60   c  to dilate/expand when the obturator  30  of the desired French scale is inserted; the configuration allows the orifice  60   c  to return to its normal state when the obturator  30  is removed. 
         [0050]    As presented in this specification the method of use for but not limited to a Vascular Access procedure. Once a local anesthesia has been administered make an incision using a  21   g  needle, then insert a angiographic guidewire and advance to desired location, check the position with fluoroscopy once in position remove the needle and insert the sheath introducer over the guidewire. Once introducer is in position insert the appropriate French scale obturator and complete the procedure. 
         [0051]    The foregoing description is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes may readily occur e.g. tapered or multiple split lumen etc., to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents are considered to fall within the scope of the invention. Various features and advantages of the invention are set forth in the following claims. 
         [0052]    All publications, patents and patent applications referenced in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications, patents and patent applications are herein expressly incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference. In case of conflict between the present disclosure and the incorporated patents, publications and references, the present disclosure should control.