Patent Publication Number: US-10779977-B2

Title: Variable scale stent deployment device

Description:
This application is a Continuation of application Ser. No. 14/858,881, filed on Sep. 18, 2015, which is a Continuation-in-Part of U.S. patent application Ser. No. 12/545,982, filed on Aug. 24, 2009, now U.S. Pat. No. 9,439,652. The entirety of the aforementioned application is incorporated herein by reference. 
    
    
     FIELD 
     This application generally relates to medical devices. In particular, the application relates to a delivery system for introducing implantable medical devices into a body cavity. 
     BACKGROUND 
     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 thrombi 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 order to assist with placement accuracy, many practitioners utilize scopes, such as bronchoscopes or endoscopes, ultrasound, CT scanning, or other imaging modalities however, handling the imaging modality and the delivery catheter can often be a clumsy process when the two devices easily disassociate from each other. Moreover, since many delivery catheters, for one reason or another, cannot be adequately managed with one hand, additional personnel are required when handling the scope and the delivery catheter. Therefore, there is an existing need for a delivery system that allows a physician to deploy an implantable device with one hand. Furthermore the additional need for a device that can be easily adapter to handle varying French scale catheters is important. 
     In view of the foregoing disadvantages inherent in conventional deployment systems, the invention provides a novel system and method for deployment of implantable devices. 
     SUMMARY 
     One aspect of the present application directs to a variable scale stent deployment device comprising: a variable inner diameter scale sleeve insert, a base handle comprising a base tubular member with a central longitudinal lumen, a proximal palm rest handle and a deployment extension, and a first tubular member having a first tubular body with a distal floating luer fitting and a first handle, wherein the base tubular member has a proximal end and a distal end, wherein the variable inner diameter scale sleeve insert is inserted into central longitudinal lumen of the base tubular member from the proximal end of the base tubular member, and wherein the first tubular member slides over the base tubular member of the base handle from the distal end of the base tubular member. 
     Another aspect of the present application is directed to a kit comprising the variable scale stent deployment device comprising: a variable inner diameter scale sleeve insert, a base handle comprising a base tubular member with a central longitudinal lumen, a proximal palm rest handle and a deployment extension, and a first tubular member having a first tubular body with a distal floating luer fitting and a first handle, wherein the base tubular member has a proximal end and a distal end, wherein the variable inner diameter scale sleeve insert is inserted into central longitudinal lumen of the base tubular member from the proximal end of the base tubular member, and wherein the first tubular member slides over the base tubular member of the base handle from the distal end of the base tubular member. 
     The application also directs to a method for implanting an implantable device into a body lumen of a subject in need thereof, comprising: attaching the proximal end of a catheter of the desired scale size to the variable scale stent deployment device, wherein the catheter comprises an implantable device at or near its distal end, establishing an entry portal, introducing the distal end of the catheter through the entry portal, advancing the catheter to the desired body lumen such that the implantable device is located in the desired location, and deploying the implantable device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate one or more embodiments of the present application and, together with the written description, serve to explain the principles of exemplary embodiments of the present application. 
         FIG. 1  is an isometric view of an embodiment of a primary trigger perspective of the variable scale stent deployment device. 
         FIGS. 2A &amp; 2B  show top plan and longitudinal section views of an embodiment of a primary trigger variable scale stent deployment device. 
         FIG. 3  is a scaled up partial detail view of the distal area of the longitudinal section in  FIG. 2 . 
         FIG. 4  is a scaled up partial detail view of the proximal area of the longitudinal section in  FIG. 2 . 
         FIGS. 5A &amp; 5B  are isometric views of the proximal and distal perspectives of an embodiment of a base member having a base handle (the handle). 
         FIGS. 6A &amp; 6B  are isometric views of the proximal and distal perspectives perspective of an embodiment of a first tubular member (primary trigger). 
         FIGS. 7A &amp; 7B  are isometric views of the proximal and distal perspectives of an embodiment of a luer seal insert. 
         FIGS. 8A &amp; 8B  are isometric views of the proximal and distal perspectives of an embodiment of a luer end cap fitting. 
         FIG. 9  is an isometric view of an embodiment of a central lumen support. 
         FIG. 10  is an isometric view of an embodiment of a central adapter sleeve. 
         FIG. 11  is an isometric view of the dual trigger perspective of an embodiment of a variable French scale stent deployment device. 
         FIGS. 12A &amp; 12B  show top plan and longitudinal section views of an embodiment of a dual trigger variable scale stent deployment device. 
         FIG. 13  is a scaled up partial detail view of the distal area of the longitudinal section in  FIG. 12 . 
         FIGS. 14A &amp; 14B  are isometric views of the proximal and distal perspectives of an embodiment of a secondary tubular member (secondary trigger). 
         FIGS. 15A &amp; 15B  are isometric views of the proximal and distal perspectives of an embodiment of a dual trigger retractor tab. 
         FIGS. 16A &amp; 16B  are isometric views of the primary trigger and dual trigger spool embodiment&#39;s perspective of an embodiment of a variable scale stent deployment device. 
     
    
    
     DETAILED DESCRIPTION 
     The following detailed description is presented to enable any person skilled in the art to make and use the object of the present application. For purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that these specific details are not required to practice the object of the present application. Descriptions of specific applications are provided only as representative examples. The present application is not intended to be limited to the embodiments shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein. 
     All publications, patents and patent applications referenced in this specification 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. 
     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 “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. 
     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. 
     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. 
     The present application relates to a delivery 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 scale size of the device. As used herein, the term “scale” refers to a measurement of the diameter of the outside of a catheter or the inside of a lumen. The scale can be measured in any type of practicable unit including, but not limited to, metric, U.S. Customary Units, gauge, and French scale. 
     As used herein, “French scale,” also known as “Charriere&#39;s system,” relates to a system of measure of the external diameter of a catheter, not to the diameter of the internal channel. French sizing has uniform increments starting with 1 Fr with no upper end point. Each increment of French sizing equals 0.33 mm, for example, a 3 Fr catheter equals 1 mm outer diameter. 
     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 application. Such definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     The full advantage of the variable scale stent deployment device in accordance with the application is realized when optimal scale deployment size and ergonomically simplified functionality combine to result in a superior system. Thus, these capabilities allows for the implant to be applied as effectively as possible while minimizing the challenging ergonomic issues communally associated with the current deployment devices and methods. 
     One aspect of the present application relates to a device for deploying an implantable medical device into a body lumen comprising a base member with a variable inner diameter (ID) sleeve insert that accommodates varying scale lumens, and luer end cap, having a base handle and a deployment extension (the handle), a first tubular member having a first tubular body with distal floating luer fitting and a first handle (primary trigger), and a second tubular member having a second tubular body with distal floating luer fitting and a second handle (dual trigger). 
     In some embodiments, the first tubular member (primary trigger) fits over the deployment extension and is longitudinally slidable over the deployment extension, and the second tubular member (dual trigger) fits over the first tubular member and is longitudinally slid able over the first tubular member (primary trigger). 
     In some embodiments, the distal ends of the deployment extension, the first tubular body, and the second tubular body are adapted to hold and deploy the implantable medical device. In some embodiments, the proximal end of the base member (handle) is configured to accept a sleeve insert which houses an internal rigid support tube and a luer fitting. 
     In some embodiments, the distal end of the first and second tubular members (triggers) has a floating luer lock connection that joins a luer hub with strain relief and outer sheath to the trigger. Internal workings include a rigid support tubr joined to an inner lumen with distally located positioning bands and a distal tip. 
     In some embodiments, the device comprises a handled base member and finger pull primary trigger configuration to better accommodate the shortened travel required to deploy a stent of &lt;60 mm in length. 
     In other embodiments, the device comprises a handled base member and finger pull dual trigger configuration with a primary and a secondary trigger for deploying a stent of &gt;60 mm in length. 
     In yet other embodiments, the device comprises a finger grip base member and spool pull primary trigger configuration for deploying a stent of &lt;60 mm in length. 
     In yet other embodiments, the device comprises a finger grip base member and spool pull dual trigger for deploying a stent of &gt;60 mm in length. 
     In all embodiments the device has the capability of accommodating varying French scale lumens/catheters. 
     Reference is now made to  FIGS. 1-10  in which a variable scale stent deployment device of the application, generally designated by reference numeral  10 , is shown. 
     One aspect of the present application relates to a variable scale stent deployment device  10  as shown in  FIGS. 1 and 2A -B. In this embodiment, the device  10  has a primary trigger configuration comprising a handle  30 , a luer end cap  40 , a primary trigger  20  and a distal floating luer  25 . The proximal end of the luer  25  is joined to a distal area  20   a  of the primary trigger  20  with two opposing pins  26  passing through groove  20   b . The distal end of the luer  25  is connected to the proximal end of the luer hub  60  through a luer seal  61 . The distal end of the Luer hub  60  is connected to a strain relief  71  which is connected to the outer sheath  70  and the tubular tip  72 . As shown in  FIG. 4 , the handle  30  contains a tubular base  31  that holds a varying scale sleeve having a rigid support tube  41  having a body  41   a , a flare  41   b  on one end of the body and an internal lumen  41   c . The tube  41 , together with lumen  30   h  of the handle  30  and inner lumen  73  on the distal end of the device  10 , forms a lumen that allows a guide wire to pass through the device  10 . 
     A premature deployment prevention tab  50  (or safety tab  50 ) that rests against the proximal edge  20   g  of the primary trigger  20  and travel stop  30   g  of the handle  30  all elements comprised for deployment of a vascular implant. Pushing the safety tab release  52  from a lock position to an unlock position releases the safety tab  50 . As shown in  FIG. 1 , the safety tab  52  may comprise a number of holes  54  on the tab body indicating where the safety tab  50  will be cut off for the applicable length of stent being deployed. 
     In an embodiment illustrated in  FIGS. 5A-B , the handle  30  is defined by a tubular base member  31  having a central longitudinal lumen  30   h  and a proximal sleeve insert orifice  30   a , a proximal palm rest handle  30   c  and a deployment extension  30   d  extending distally with a symmetrical travel stop  30   g , and opposing slide arm  30   e  extending distally. As shown in  FIGS. 2A-B  and  4 , the proximal sleeve insert orifice  30   a  accommodates a varying scale sleeve  42  resting on an internal edge/shoulder  30   b  ( FIGS. 2A-B ). The base member  31  contains at its proximal end a female luer fitting  30   f . In one embodiment, the fitting  30   f  is in compliance with ISO 594-1 and -2 standard for 6% taper luer fittings. 
     The primary trigger  20 , detailed in  FIGS. 6A-B , is composed of a distally extending tubular body  20   f , a proximal finer pull  20   c  with slide orifice  20   e , a proximal travel stop surface  20   g , and a distal floating luer fitting  25  with luer threads  25   d  in compliance with ISO 594-1 and -2 standard for 6% taper luer fittings. The slide orifice  20   e  accommodates the slide  30   e  of handle  30 . The travel stop surface  20  contacts the travel stop  30   g  of handle  30  and stops the movement of handle  30 . 
     As shown in more detail of an embodiment in  FIG. 3 , luer hub  60  is connected to the distal floating luer  25  of the primary trigger  20 . The hub thread  60   c  is configured per ISO 594-1 and -2 and mates with the luer threads  25   d . The luer hub  60 , as exemplified, is joined with the outer sheath  70  and strain relief  71  and travels as a comprised unit when joined with the primary trigger  20 . The primary trigger  20  is retracted by pulling the finger pull  20   c  in a proximal linear motion over the handle extension  30   d  and slide arm  30   e  with the proximal edge  20   g  coming to rest up against the handle stop  30   g  in a fully deployed position (see  FIGS. 1 and 2A -B). 
     As shown in more detail in  FIG. 4 , in one embodiment the internal elements of the device are comprised of the inner lumen  73  joined to the rigid support tube  41  and distal tip  72 , the shaft  42   c  of the variable ID scale sleeve insert  42  inserted in the longitudinal orifice  30   a  and seated with the shoulder  30   b  of the handle  30 . The taper  61   b  of the luer hub seal  61  is seated in the luer hub cavity  60   a  and the flange  61   a  of the luer seal  61 , shown in  FIG. 7 , confined between the proximal surface  60   b  of the luer hub  60  and the distal edge  20   h  of the primary trigger  20 . 
     The inner lumen  73  extends distally from the proximal flare  41   b  of the rigid support tube  41 , through the internal lumen  41   c  of the rigid support tube  41 , to the tip  72  ( FIG. 2 ). The rigid support tube  41   a  traverses through the longitudinal orifice  42   b  of the varying scale sleeve  42  and through orifice  30   h  of the handle  30  (see  FIGS. 5A-B ), continuing through the tubular body  20   f  of the primary trigger  20 , continuing through the central longitudinal orifice  61   c  (see  FIG. 3 ) of the luer seal  61 , and through the longitudinal channel  60   d  of the hub  60  with the rigid support lumen terminating just distal of the hub channel  60   d  while the inner lumen  73  continues through the lumen channel  70   a  of the outer sheath  70  terminating distal of the most distal edge of the outer sheath and joining at the distal tip  72  (see  FIGS. 1 and 2A -B). 
     The luer thread  40   c  of the luer end cap  40  is joined to the proximal luer thread  30   f  of the handle  30 ; the distal surface  40   a  of the luer end cap joins with the proximal flare  41   b  of the rigid support tube  41  shown in  FIG. 9 . Tightening the cap  40  compresses the proximal surface  42   a  of the variable ID scale sleeve insert  42 , detailed in  FIG. 10 , against the proximal flare  41   b  in turn compressing the distal surface  42   d  against the shoulder  30   b  ( FIGS. 2A-B ) of the handle  30  thus securing the joined internal components within the handle  30 . 
     As detailed in  FIG. 8 , the central longitudinal orifice  40   d  of the luer end cap  40  aligns with the internal lumen  41   c  ( FIG. 9 ) of the rigid support tube  41  and the central orifice  73   a  of the inner lumen  73  ( FIG. 4 ). This allows for the passage of a guide wire through the device. Further, again turning to  FIGS. 8A-B , the proximal female luer  40   b  of the end cap  40  provides a connection fitting for auxiliary devices e.g. syringe. 
     The variable ID scale sleeve insert  42  shown in  FIG. 10  is an interchangeable element of the device. The external diameter of the varying scale sleeve  42  is such that it fits securely within the longitudinal lumen  30   h  of base member  31 . The diameter of the internal channel  42   b  of the variable ID scale sleeve insert  42  is selected by a practitioner to accommodate the rigid support tube  41  which, in turn, has an internal lumen  41   c  to accommodate a catheter having a desired scale size. The rigid support tube  41  is inserted into the internal channel  42   b  of the of the variable ID scale sleeve insert  42 . In some embodiments, the rigid support tube  41  has an internal lumen  41   c  of a diameter measured in French scale units and selected from 1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr or 20 Fr. In other embodiments, the rigid support tube  41  has a an internal lumen  41   c  of a diameter measured of a diameter in French scale units of between 1 Fr and 50 Fr. In some embodiments, the varying scale sleeve  42  is made of a rigid material, such as acrylonitrile butadiene styrene. 
       FIGS. 11-15B  show another embodiment of a variable scale stent deployment device of the present application. In some embodiments, the configuration of a primary trigger shares many features shown in  FIGS. 1-10 , but can optionally be configured as a dual trigger combination depending on device travel requirements for deployment of a vascular implant. Device  10 . 1  exemplifies a dual trigger (primary and secondary) configuration allowing increased deployment travel while maintaining a single handed operation. 
     In some embodiments, as shown in  FIGS. 11 and 12A -B, the device comprises a handle  30  with luer end cap  40 , a primary trigger  20 , and a secondary trigger  80  with distal floating luer  25  joined in the distal area  80   a  with two opposing pins  26  passing through groove  80   b . Joined to 25 of the secondary trigger  80  is a luer seal  61  and a luer hub  60 , strain relief  71  and outer sheath  70 , joined to luer thread  25   d  of floating luer  25  of the primary trigger  20  by luer thread  85   c  of the retractor tab  85 , internally a variable ID scale sleeve  42 , a rigid support tube  41  and inner lumen  73  with a tubular tip  72 . In particular embodiments, a premature deployment prevention safety tab  50  rests against the proximal edge  20   g  of the primary trigger  20  and travel stop  30   g  of the handle  30 . 
     In an illustrated embodiment; the handle  30  is defined by a base member  31  with a central longitudinal lumen  30   h  having a proximal sleeve insert orifice  30   a  that accommodates a varying scale sleeve  42  within a rigid support tube  41  resting on an internal edge/shoulder  30   b . In some embodiments, the proximal male luer fitting  30   f  is in compliance with ISO 594-1 and -2 standards for 6% taper luer fittings. In some embodiments, the handle  30  comprises a proximal palm rest handle  30   c  and a deployment extension  30   d  extending distally with a symmetrical travel stop  30   g  and opposing slide arm  30   e  extending distally. 
     The primary trigger  20  with a distally extending tubular body  20   f  a proximal finger pull  20   c  with slide orifice  20   e  which accommodates the slide  30   e  of handle  30 , a proximal travel stop surface  20   g  which contacts the travel stop  30   g  of handle  30 , and a distal floating female luer fitting  25  with female threads  25   d  in compliance with ISO 594-1 and -2 standard for 6% taper luer fittings. In this embodiment, both the primary trigger  20  and the secondary trigger  80  comprise a distal luer fitting. The primary trigger  20  now holds the retractor and the secondary trigger  80  holds the Y-hub and seal. 
     As shown in  FIGS. 12A-B  and  14 A-B, the secondary trigger  80  comprises a distally extending tubular body  80   f  a proximal finger pull  80   c  with slide relief  80   e  which accommodates the slide  30   e  of handle  30 , and a distal floating female luer fitting  25  with female threads  25   d  in compliance with ISO 594-1 and -2 standard for 6% taper luer fittings. Joined to the distal floating female luer  25  mated to the secondary trigger  80  is the luer hub  60 . The hub thread  60   c  configured per ISO 594-1 and - 2  mates with the luer threads  25   d , the luer hub as illustrated in  FIGS. 12A-B  is joined with the outer sheath  70  and strain relief  71  and which travels as a unit when joined with the secondary trigger  80 . 
     The primary trigger  20  with joined retractor tab  85  is inserted in the tubular opening  80   f  of the secondary trigger  80  and located with the retractor tab arms  85   a  and  85   b  resting in the orifices  80   g  and  80   h  of the secondary trigger  80 . The retractor tab arms  85   a  and  85   b  grip the secondary trigger as it is retracted by pulling the finger pull  20   c  of the primary trigger  20  in a proximal linear motion over the handle extension  30   d  and slide arm  30   e  with the proximal edge  20   g  coming to rest up against the handle stop  30   g  in a fully retracted position. The retractor tab arms  85   a  and  85   b  (see  FIG. 13 ) compress as the secondary trigger is retracted by pulling the finger pull  80   c  (see  FIGS. 14A-B ) in a proximal linear motion over the primary trigger extension  20   f  and slide arm  30   e  with the proximal inner surface  80   h  coming to rest up against the finger pull  20   c  of the primary trigger  20  in a fully deployed position. 
     The internal elements of the device are comprised of the inner lumen  73  which includes the internal lumen  41   c  of the rigid support tube  41  and distal tip  72 , the shaft  42   c  of the variable ID scale sleeve  42  inserted in the longitudinal orifice  30   a  and seated with the shoulder  30   b  of the handle  30 . The taper  61   b  of the luer hub seal  61  seated in the luer hub cavity  60   a  and the flange  61   a  of the luer seal  61  is confined between the proximal surface  60   b  of the luer hub  60  and the distal edge  80   h  of the secondary trigger  80 . As in  FIG. 4 , described above, the inner lumen  73  extends from the proximal flare  41   b  of the rigid support tube  41  distally and joins to the tip  72 . 
     As shown in  FIGS. 2A-B , described above, the inner lumen of the device traverses through the longitudinal orifice  42   b  of the variable ID scale sleeve insert  42  and through orifice  30   h  of the handle  30 , continuing through the tubular body  20   f  of the primary trigger  20  and orifice  85   d  of the retractor tab  85  (see  FIGS. 13 and 15A -B). The lumen continues through the tubular body  80   f  of the secondary trigger  80  ( FIGS. 14A-B ), the central longitudinal orifice  61   c  of the luer seal  61  ( FIGS. 11 and 12A -B), and through the longitudinal channel  60   d  of the hub  60  with the rigid support lumen, terminating just distal of the hub channel  60   d , while the inner lumen  73  continues through the lumen channel  70   a  of the outer sheath  70  terminating distal of the most distal edge of the outer sheath  70  and joining at the distal tip  72 . 
     The luer thread  40   c  of the luer end cap  40  is joined to the proximal luer thread  30   f  of the handle  30  (see  FIG. 4 ). The distal surface  40   a  of the luer end cap joins with the proximal flare  41   b  of the rigid support tube  41  tightening the cap  40  compresses the proximal surface  42   a  of the variable ID scale sleeve insert  42  against the proximal flare  41   b  in turn compressing the distal surface  42   d  against the shoulder  30   b  of the handle  30  thus securing the joined internal components within the handle  30 , as shown in previously described  FIG. 2 . The central longitudinal orifice  40   d  of the luer end cap  40  ( FIGS. 8A-B ) aligns with the central orifice  73   a  of the inner lumen  73  ( FIG. 4 ) allowing for the passage of a guide wire, the proximal female luer  40   b  of the end cap  40  provides a connection fitting for auxiliary devices e.g. syringe. 
     Reference is now made to  FIGS. 16A-B , in which yet another two embodiments of a variable French scale stent deployment device, generally designated by reference numeral  10 . 2  and  10 . 3 , in accordance with the invention are shown. Device  10 . 2  is of a primary pull configuration, while  10 . 3  has a dual pull configuration allowing for increased deployment travel. These two embodiments differ from embodiments  10  and  10 . 1  mainly in the configuration of the finger pulls  80   c  and  20   c  of the primary trigger  20  and secondary trigger  80 , respectively. The handle  30  differs in respect to the palm rest  30   c , internal workings in all embodiments are identical to embodiments  10  and  10 . 1 . Device  10 . 2  primary pull comprised of a primary deployment pull  95  with a proximal flare pull  95   a  and primary deployment extension  90  with finger grip  90   a . Device  10 . 3  dual pull comprised of a primary deployment pull  95  with a proximal flare pull  95   a , a secondary deployment pull  100  with a proximal flare pull  100   a , and primary deployment extension  90  with finger grip  90   a . in some embodiments, two-handed operation is contemplated. 
     Kit 
     Another aspect of the present application relates to a kit comprising a variable scale stent deployment device. In some embodiments, the device comprises a variable ID French scale sleeve insert for insertion into the device, a base handle and a deployment extension, a first tubular member having a first tubular body with a distal floating luer fitting and a first handle, wherein the first tubular member slides over the base handle. In some further embodiments, the device further comprises a second tubular member having a second tubular body with a distal floating luer fitting and a second handle, wherein the second tubular body slides over the first tubular body. 
     In some embodiments, the kit comprises a catheter. 
     In another embodiment, the kit comprises a guide wire. 
     In still another embodiment, the kit comprises a plurality of variable ID scale sleeve inserts for insertion into the variable scale stent deployment device, the variable ID scale sleeve inserts having internal channels of different diameters to accommodate catheters of different scale sizes. 
     In yet another embodiment, the kit comprises an implantable device for insertion into a body lumen. In a further embodiment, the implantable device is a stent. 
     Method 
     Another aspect of the present application relates to a method for inserting an implantable device in a desired body lumen of a subject in need thereof using a variable scale stent deployment device. In some embodiments, the device comprises a variable ID French scale sleeve insert for insertion into the device, a base handle and a deployment extension, a first tubular member having a first tubular body with a distal floating luer fitting and a first handle, wherein the first tubular member slides over the base handle. In some further embodiments, the device further comprises a second tubular member having a second tubular body with a distal floating luer fitting and a second handle, wherein the second tubular body slides over the first tubular body. 
     The method comprises attaching the proximal end of a catheter of the desired scale size to the variable scale stent deployment device, wherein the catheter comprises an implantable device at or near its distal end. In some embodiments, the catheter is glued to the Y-Hub which is attached via the distal lure. In some further embodiments, the implantable device is a stent. In some still further embodiments, the stent is a self-expanding stent. 
     The method further comprises establishing an entry portal and introducing the distal end of the catheter comprising an implantable device at or near its distal end through the entry portal. The catheter is advanced to the desired body lumen such that the implantable device is located in the desired location. 
     In some embodiments, the implantable device is deployed by pulling the first handle of the first tubular member in a proximal direction, thereby sliding the first tubular member in a proximal direction over the base handle thereby resulting in deployment of the implantable device. 
     In other embodiments, the sliding of the first tubular member results in a partial deployment of the implantable device, such as when the implantable device is of great length. Accordingly, a variable scale stent deployment device comprising a second tubular member having a second tubular body with a distal floating Luer fitting and a second handle, wherein the second tubular body slides over the first tubular body. The implantable device is partially deployed by pulling the first handle of the first tubular member in a proximal direction, thereby sliding the first tubular member in a proximal direction over the base handle. The second handle of the second tubular member is then pulled in a proximal direction, thereby sliding the second tubular member proximally over the first tubular member, thereby resulting in deployment of the implantable device. 
     Exemplary body lumens treatable with the device and methods of the present application include, but are not limited to, the aorta, the superior vena cava, the inferior vena cava, coronary artery, pulmonary artery, pulmonary vein, carotid artery, jugular vein, biliary tract, colorectal tract, esophageal tract, ureteral tract, urethral tract, or upper airway. Exemplary conditions treatable with the device and methods of the present application include, but are not limited to, aneurism, fistula, thrombus, laceration and plaque formation. 
     The above description is for the purpose of teaching the person of ordinary skill in the art how to practice the present invention, and it is not intended to detail all those obvious modifications and variations of it which will become apparent to the skilled worker upon reading the description. It is intended, however, that all such obvious modifications and variations be included within the scope of the present invention, which is defined by the following claims. The claims are intended to cover the components and steps in any sequence which is effective to meet the objectives there intended, unless the context specifically indicates the contrary.