Abstract:
The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to App. Ser. No. 61/858,881, entitled “Devices, Systems and Methods for an Atherectomy Device with Balloon Tipped Saline Sheath,” filed Jul. 26, 2013, and to App. Ser. No. 61/861,041, entitled “Devices, Systems and Methods for an Atherectomy Device with Balloon Tipped Saline Sheath and Having Adjunctive Low Pressure Balloon,” filed Aug. 1, 2013, the entire contents of each of which are hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure generally relates to methods, devices and systems relating to removing occlusions from vessels. More specifically, the present invention comprises providing a balloon 
       DESCRIPTION OF THE RELATED ART 
       [0003]    A variety of techniques and instruments have been developed for use in the removal or repair of tissue in arteries and similar body passageways, e.g., biological conduits. A frequent objective of such techniques and instruments is the removal of atherosclerotic plaques in a patient&#39;s arteries. Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (under the endothelium) of a patient&#39;s blood vessels. Very often over time, what initially is deposited as relatively soft, cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque. Such atheromas restrict the flow of blood, and therefore often are referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material. If left untreated, such stenoses can cause angina, hypertension, myocardial infarction, strokes and the like. 
       BRIEF SUMMARY OF THE INVENTION 
       [0004]    The present invention is directed in various methods, devices and systems relating to providing a balloon on a sheath in combination with orbital atherectomy in order reduce the number of steps in the procedure. In certain embodiments, the balloon comprises adjunctive low pressure balloon for prevention of vessel trauma during dilatation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]      FIG. 1  illustrates a perspective view of one embodiment of the present invention; 
           [0006]      FIG. 2  illustrates a front view of one embodiment of the present invention; 
           [0007]      FIG. 3  illustrates a side view of one embodiment of the present invention; 
           [0008]      FIG. 4  illustrates a cutaway side view of one embodiment of the present invention; 
           [0009]      FIG. 5  illustrates a side view of one embodiment of the present invention; and 
           [0010]      FIG. 6  illustrates a front view of one embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    While the invention is amenable to various modifications and alternative forms, specifics thereof are shown by way of example in the drawings and described in detail herein. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 
         [0012]      FIG. 1  illustrates an exemplary rotational atherectomy device of the invention. The device includes a handle portion  10 , an elongated, flexible drive shaft  20  having an abrasive section  28 , as will be readily understood by the skilled artisan, and an elongated catheter  13  extending distally from the handle portion  10 . The abrasive section  28  is disposed on the drive shaft  20 . The catheter  13  has a lumen in which the length of the drive shaft  20  may be disposed, including, in certain embodiments, the abrasive section  28  and, when present, a short section distal to the abrasive section  28 . The drive shaft  20  also contains an inner lumen, permitting the drive shaft  20  to be advanced and rotated over a guide wire  15 . A fluid supply line  17  may be provided for introducing a cooling and lubricating solution (typically saline or another biocompatible fluid) into the catheter  13  from a cooling and lubrication solution reservoir (not shown but as well understood by the skilled artisan). A separate inflation media reservoir  19  may be included for providing inflation media, preferably saline, to an inflatable balloon  100  on the tip of the catheter  13 . 
         [0013]    The handle  10  desirably contains an electric motor (or similar rotational drive mechanism, e.g., a turbine) for rotating the drive shaft  20  at low or high speeds. The handle  10  typically may be connected to a power source, such as compressed air delivered through a tube  16 . A pair of fiber optic cables  25  may also be provided for monitoring the speed of rotation of the turbine and drive shaft  20 . Details regarding such handles and associated instrumentation are well known in the industry. The handle  10  also desirably includes a control knob  11  for advancing and retracting the electric motor, or equivalent, and the drive shaft  20  with respect to the catheter  13  and the body of the handle. 
         [0014]    The inflatable balloon  100  mounted on the tip of catheter  13  allows for rotational atherectomy to proceed with abrasive section  28 , followed by advancement of the catheter  13  such that the inflatable balloon is within the treatment region of the vessel. Balloon  100  is illustrated in the various Figures as attached to outer surface of catheter  13  and as completely surrounding the outer surface of catheter  13  and this is the preferred embodiment. However, the skilled artisan will recognize that alternate embodiments may be provided to achieve the requisite dilatation. Inflation of the balloon  100  by introduction of the inflation media from inflation reservoir  19  is accomplished as is well understood by the skilled artisan to achieve dilatation of the treatment region post-atherectomy procedure. Such an arrangement eliminates the need to withdraw the atherectomy device and, subsequently, advance a balloon device back to the treatment site for dilatation. Thus, embodiments of the present invention eliminates the need for the extra time to remove the atherectomy device and insert and position a balloon. In addition, radiopaque dye and subsequent radiation exposure will be reduced. 
         [0015]    In the embodiment of  FIG. 1 , catheter  13  may comprise two lumens such as illustrated in  FIG. 2 . Catheter  13  of  FIG. 2  comprises a drive shaft lumen  102  wherein the drive shaft  20  is rotatable and translatable. Catheter  13  also comprises an inflation medium lumen  104 . Inflation medium lumen  104  is in fluid communication with inflation medium reservoir  19  and inflatable balloon  100 , serving as the conduit for inflation medium, e.g., saline, to be controllably moved through lumen  104  from the reservoir  19  to the inflatable balloon  100  by means that are well known to the skilled artisan. 
         [0016]    A system according to  FIGS. 1 and 2  may comprise:
       a rotatable drive shaft having an abrasive section and means for rotating and translating the drive shaft;   a catheter collinear with the rotatable drive shaft and comprising
           a distal end;   an inflatable balloon mounted proximate the distal end of the catheter;   a drive shaft lumen wherein the drive shaft is rotatable and translatable; and   an inflation lumen separated from the drive shaft lumen; and   
           an inflation media reservoir comprising an inflation medium, wherein the inflation lumen is in fluid communication with the inflation lumen and the inflatable balloon, and wherein a portion of the inflatable balloon may be pulled proximally within the drive shaft lumen to adjust the length of the inflated balloon exposed outside of the drive shaft lumen.       
 
         [0024]      FIG. 3  provides an alternative embodiment wherein the device of  FIGS. 1 and 2  further comprises sheath  200  having a lumen therethrough  202 . Catheter  13 , with balloon  100  disposed on or near catheter&#39;s distal tip, is rotatably and translatably disposed within lumen  202 . Catheter  13  further comprises drive shaft lumen  102  and inflation media lumen  104 , which is in fluid communication with inflation media reservoir  19  and inflation balloon  100  as shown and discussed in connection with  FIGS. 1 and 2 . Drive shaft  20  is, as also discussed above, rotatably and translatably disposed within drive shaft lumen  102 . 
         [0025]    In the embodiment of  FIG. 3 , sheath  200  with both drive shaft  20  and catheter  13  drawn proximally into lumen  202 , both being collinear, may be advanced to a point proximal of the treatment region, e.g., occlusion. Distal advancement of the drive shaft  20  allows distal translation of the drive shaft  20  and the abrasive section  28  (shown in  FIG. 3  as an exemplary eccentric abrasive crown) out of lumen  202  and, in certain embodiments, out of the drive shaft lumen  102  of catheter  13 . This allows the operator to initiate and complete the rotational atherectomy procedure using the exemplary eccentric abrasive crown. Once complete, the operator may simply advance catheter  13  so that the inflatable balloon  100  is positioned within the treatment region and initiate dilatation of same. The drive shaft  20  and exemplary abrasive crown may be left in place during dilatation or, alternatively, may be proximally translated into the drive shaft lumen  102 . Once dilatation is complete, the balloon  100  is deflated and catheter  13  and drive shaft  20  are once again moved proximally into the lumen  202  of sheath  200  for removal. A further use of lumen  202  may comprise dye or drug injection into the lumen at the localized treatment region, thereby eliminating the need for long introducers or settling for diffuse dye coverage or drug uptake. 
         [0026]      FIG. 4  provides a variation of the collinear device illustrated in  FIG. 3 , wherein sheath  200  may be used to adjust the inflated length of the inflatable balloon  100 . Here, as shown, catheter  13  is drawn proximally into lumen  202  so that at least a portion of the inflated balloon  100  is pulled within lumen  202 , thereby shortening the overall length of exposure of inflated balloon  100  to the vessel wall. Alternatively, sheath  200  may be advanced distally to enable movement of at least a portion of the balloon to enter lumen  202 . The length that the inflated balloon is shortened by the process of  FIG. 4  is equal to the length of the balloon that is pulled within the lumen  202 . As will be appreciated, this shortening of the balloon  100  may be initiated before inflation of balloon  100 , during inflation of balloon  100  and/or after inflation of balloon  100 . Lumen  202  may also be used to deploy self-expanding stents, stent graphs or distal filters. 
         [0027]    Thus, a system according to the embodiment of  FIG. 4  may comprise: 
         [0028]    A system for atherectomy and subsequent dilatation, comprising:
       a rotatable drive shaft having an abrasive section and means for rotating and translating the drive shaft;   a catheter collinear with the rotatable drive shaft and comprising
           a distal end;   an inflatable balloon mounted proximate the distal end of the catheter;   a drive shaft lumen wherein the drive shaft is rotatable and translatable; and   an inflation lumen separated from the drive shaft lumen;   
           an inflation media reservoir comprising an inflation medium, wherein the inflation lumen is in fluid communication with the inflation lumen and the inflatable balloon; and       
 
         [0036]    a sheath having a lumen therethrough, wherein the catheter and drive shaft are collinear with the sheath and wherein the catheter is rotatable and translatable within the sheath, wherein a portion of the inflatable balloon may be pulled proximally within the lumen of the sheath to adjust the length of the inflated balloon exposed outside of the lumen of the sheath. 
         [0037]      FIG. 5  provides another embodiment wherein the inflatable balloon  100  and drive shaft  20  are not collinear. Here, sheath  200  comprises at least two separate lumens as illustrated in  FIG. 6 : a drive shaft lumen  602  wherein the drive shaft and abrasive section  28  (illustrated as exemplary eccentric abrasive crown) are rotatably and translatably disposed; and an inflatable balloon lumen  610  wherein the balloon catheter and inflatable balloon affixed to the distal end of the balloon catheter, are rotatably and translatably disposed. 
         [0038]    In this embodiment, sheath  200  is positioned proximal to the treatment region, e.g., the occlusion, with balloon catheter and balloon  100  and drive shaft  20  and abrasive crown disposed within lumens  610  and  602 , respectively. The operator may extend the drive shaft  20  distally and out of the drive shaft lumen  602  to accomplish the rotational atherectomy procedure with the exemplary abrasive crown. When completed, the drive shaft  20  and exemplary abrasive crown may be proximally pulled back into drive shaft lumen  602 . At this point, the operator may extend the balloon catheter and balloon  100  distally and out of the balloon lumen  610  to the treatment region to inflate balloon  100  as described above and accomplish the required dilatation. When dilatation is complete, the operator deflates the balloon and withdraws the now-deflated balloon proximally into the balloon lumen  610  for removal. 
         [0039]      FIG. 5  illustrates the distal portion of the sheath  200  as comprising a partial cutaway section. Other embodiments of sheath  200  do not include this partially cutaway section and comprise sheath  200  as illustrated in  FIGS. 3 and 4 . 
         [0040]    In any of the above embodiments described above, or the equivalent, the balloon  100  may be micro-porous to enable delivery of a therapeutic agent to the vessel wall, e.g., an anti-restinosis agent. The balloon may also be coated with a drug for delivery of the therapeutic agent to the vessel wall. The balloon  100  of the present invention, when used for low-pressure dilatation comprises an acceptable fluid loss during the inflation cycle. Stent deployment may be an option in all embodiments described herein relating to balloon inflation. 
         [0041]    As discussed, generally, atherectomy procedures are followed up with a balloon procedure to remodel the artery and to provide a larger lumen internal diameter (ID). Rotational atherectomy allows for subsequent low-pressure balloon dilatations. Low-pressure balloon dilatations of e.g., 2 to 4 atmospheres of pressure are much less traumatic to the vessel wall than the more typical 10 to 13 atmospheres of pressure. A preferred low-pressure balloon range using the devices and methods of the present invention comprises 1 to 8 atmospheres, a more preferred range comprises 2 to 6 atmospheres, and a still more preferred range comprises 2 to 4 atmospheres of pressure. 
         [0042]    Various embodiments of the present invention may be incorporated into a rotational atherectomy system as described generally in U.S. Pat. No. 6,494,890, entitled “ECCENTRIC ROTATIONAL ATHERECTOMY DEVICE,” which is incorporated herein by reference. Additionally, the disclosure of the following co-owned patents or patent applications are herein incorporated by reference in their entireties: U.S. Pat. No. 6,295,712, entitled “ROTATIONAL ATHERECTOMY DEVICE”; U.S. Pat. No. 6,132,444, entitled “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”; U.S. Pat. No. 6,638,288, entitled “ECCENTRIC DRIVE SHAFT FOR ATHERECTOMY DEVICE AND METHOD FOR MANUFACTURE”; U.S. Pat. No. 5,314,438, entitled “ABRASIVE DRIVE SHAFT DEVICE FOR ROTATIONAL ATHERECTOMY”; U.S. Pat. No. 6,217,595, entitled “ROTATIONAL ATHERECTOMY DEVICE”; U.S. Pat. No. 5,554,163, entitled “ATHERECTOMY DEVICE”; U.S. Pat. No. 7,507,245, entitled “ROTATIONAL ANGIOPLASTY DEVICE WITH ABRASIVE CROWN”; U.S. Pat. No. 6,129,734, entitled “ROTATIONAL ATHERECTOMY DEVICE WITH RADIALLY EXPANDABLE PRIME MOVER COUPLING”; U.S. Pat. No. 8,597,313, entitled “ECCENTRIC ABRADING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”; U.S. Pat. No. 8,439,937, entitled “SYSTEM, APPARATUS AND METHOD FOR OPENING AN OCCLUDED LESION”; U.S. Pat. Pub. No. 2009/0299392, entitled “ECCENTRIC ABRADING ELEMENT FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”; U.S. Pat. Pub. No. 2010/0198239, entitled “MULTI-MATERIAL ABRADING HEAD FOR ATHERECTOMY DEVICES HAVING LATERALLY DISPLACED CENTER OF MASS”; U.S. Pat. Pub. No. 2010/0036402, entitled “ROTATIONAL ATHERECTOMY DEVICE WITH PRE-CURVED DRIVE SHAFT”; U.S. Pat. Pub. No. 2009/0299391, entitled “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”; U.S. Pat. Pub. No. 2010/0100110, entitled “ECCENTRIC ABRADING AND CUTTING HEAD FOR HIGH-SPEED ROTATIONAL ATHERECTOMY DEVICES”; U.S. Design Pat. No. D610258, entitled “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”; U.S. Design Pat. No. D6107102, entitled “ROTATIONAL ATHERECTOMY ABRASIVE CROWN”; U.S. Pat. Pub. No. 2009/0306689, entitled “BIDIRECTIONAL EXPANDABLE HEAD FOR ROTATIONAL ATHERECTOMY DEVICE”; U.S. Pat. Pub. No. 2010/0211088, entitled “ROTATIONAL ATHERECTOMY SEGMENTED ABRADING HEAD AND METHOD TO IMPROVE ABRADING EFFICIENCY”; U.S. Pat. Pub. No. 2013/0018398, entitled “ROTATIONAL ATHERECTOMY DEVICE WITH ELECTRIC MOTOR”; and U.S. Pat. No. 7,666,202, entitled “ORBITAL ATHERECTOMY DEVICE GUIDE WIRE DESIGN.” It is contemplated by this invention that the features of one or more of the embodiments of the present invention may be combined with one or more features of the embodiments of atherectomy devices described therein. 
         [0043]    The present invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the present specification.