Abstract:
An apparatus and method for the treatment of intravascular medical conditions is provided. The device comprising a handle assembly, an expandable portion defined by a plurality of struts oriented along a longitudinal axis and a tip member affixed to a distal end of the struts. The struts are moveable between a collapsed and an expanded position. A catheter tube extends from the handle assembly to the expandable portion. An elongate member is disposed within the catheter tube and is in communication with the handle assembly and the tip member.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 62/102,747, filed Jan. 13, 2015, the disclosure of which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    Exemplary embodiments of the present invention relate generally to devices and methods for intravascular catheters. 
       BACKGROUND AND SUMMARY OF THE INVENTION 
       [0003]    This invention relates in general to intravascular catheters, such as can be used during minimally invasive surgical procedures. In particular, this invention relates to an intravascular catheter having an expandable incising portion. 
         [0004]    Atherosclerosis is a chronic condition in which atheromatous plaque accumulates on the inner walls of a blood vessel. As a result, the blood vessel walls can become inflamed and, over time, may harden to form atherosclerotic lesions that cause a narrowing of the vessel lumen. In severe cases, the atherosclerotic lesions can rupture and induce the formation of thrombus (i.e., blood clots), which can prevent blood flow through the narrowed vessel lumen. 
         [0005]    There are known procedures and devices for treating or otherwise reducing the risks associated with atherosclerosis. For example, an angioplasty is a procedure in which a balloon catheter is inserted into a narrowed region of the vessel lumen via a delivery catheter. The balloon catheter includes a flexible tube having an inflatable balloon at an end thereof. Once positioned in the narrowed region, the balloon is inflated in order to dilate the narrowed vessel lumen. The pressure in the balloon is generally sufficient to compress the accumulated plaque. However, in some cases it would be desirable to fragment the atherosclerotic lesions. Thus, it would be desirable to provide an intravascular catheter having an expandable portion that can be selectively controlled by a user and adapted to create incisions in atherosclerotic material to facilitate fragmentation of the material during an angioplasty procedure. 
         [0006]    Additionally, endovascular surgery is a form of minimally invasive surgery that is used to diagnose and treat many diseases. Endovascular surgery requires the deployment of catheter devices containing medical treatment tools. These catheters can be inserted intravenously and manipulated to specific sites for medical intervention. This form of minimally invasive surgery is becoming an ever more popular surgical technique due to reduced side effects such as scarring and infection. Examples of endovascular surgery include aneurysm repair, angioplasty, and carotid stenting. Endovascular surgical techniques are utilized by radiologists, neurologists, neurosurgeons, cardiologists, and vascular surgeons, among other medical professionals. Endovascular surgeons would benefit from a stable, maneuverable catheter platform device that can be used to deliver medical treatment. 
         [0007]    This invention relates to an intravascular catheter device for use during a surgical procedure. The catheter device includes a catheter tube having an expandable portion with a plurality of struts each defining an outer surface. The expandable portion is operable between a closed position, wherein the expandable portion has a first diameter, and an opened position, wherein the expandable portion has a second diameter that is larger than the first diameter. An incising element is provided on the outer surface of at least one of the struts. The incising element has a blade that extends outwardly in a radial direction from the outer surface of the strut for creating an incision in atherosclerotic material located within a blood vessel when the expandable portion is in the opened position. 
         [0008]    The present invention additionally relates to a catheter platform device for use during endovascular surgery. The expandable portion is configured to provide a stable, flexible platform for medical treatment. The distal end of the catheter, including the expandable portion and the surrounding non-expandable portion, is capable of receiving a plurality of various medical treatment tools. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    In addition to the features mentioned above, other aspects of the present invention will be readily apparent from the following descriptions of the drawings and exemplary embodiments, wherein like reference numerals across the several views refer to identical or equivalent features, and wherein: 
           [0010]      FIG. 1  is a plan view of another exemplary embodiment of the catheter device; 
           [0011]      FIG. 2  is a cross-section end view of the device of  FIG. 1  taken along section line  1 - 1  with the sliding mechanism located in the forward position relative to the expandable portion; 
           [0012]      FIG. 3  is a cross-section end view of the device of  FIG. 1  taken along section line  11 - 11  with the sliding mechanism retracted to the read position relative to the expandable portion; 
           [0013]      FIG. 4  is an enlarged side view of the distal end of the catheter, with the expandable portion in a closed position; 
           [0014]      FIG. 5  is the device of  FIG. 4  with the expandable portion expanded in an open position; 
           [0015]      FIG. 6  is the device of  FIG. 5  illustrated inside a blood vessel having atheromatous plaque accumulation; 
           [0016]      FIG. 7  is a cross-section end view of the device of  FIG. 5  taken along section line  2 - 2 ; 
           [0017]      FIG. 8  is a cross-section end view of the device of  FIG. 6  taken along section line  3 - 3 ; 
           [0018]      FIG. 9  is another exemplary embodiment of the present invention illustrating a side view of the distal end of the catheter, expanded into an open position; 
           [0019]      FIG. 10  contains a side view of the device of  FIG. 9  with the expandable portion in a closed position; 
           [0020]      FIG. 11  is an end view of the device of  FIG. 9 ; and 
           [0021]      FIG. 12  is a side view of another exemplary embodiment of the device of  FIG. 4  with the expandable portion in a closed position and a sheath partially retracted. 
       
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0022]    Various embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, specific details such as detailed configuration and components are merely provided to assist the overall understanding of these embodiments of the present invention. Therefore, it should be apparent to those skilled in the art that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness. 
         [0023]    Referring now to the drawings, there is illustrated in  FIG. 1  a catheter device, indicated generally at  10 , in accordance with the present invention. The illustrated catheter device  10  is configured to treat or reduce the risks associated with various medical ailments by providing a stable, expandable platform for the performance of endovascular surgery, which may include the introduction of medical treatment devices. In general, the catheter device  10  includes an expandable portion on the distal end of the catheter, indicated generally at  90 , which can be inserted into a blood vessel and expanded to create a stable platform. This stable platform can be configured to receive a plurality of medical treatment devices that may be manipulated by operating the catheter device. 
         [0024]    Although the present invention will be described in the context of a number of embodiments, some of which may have particular medical applications, it should be appreciated that the present invention can be used in any desired environment and for any desired purpose. 
         [0025]    The illustrated catheter device  10  includes a handle assembly, indicated generally at  20 . The illustrated handle assembly  20  includes an elongated, cylindrical handle body  21 . The handle body  21  may alternatively have any other shape that is suitable for easy handling by a surgeon. Further, the handle body  21  can be made from any suitably rigid material including, but not limited to, stainless steel or polymers. The handle assembly  20  is configured to selectively control the expansion and contraction of the expandable portion  90  by operation of a control mechanism  25 . In the present embodiment, the control mechanism is shown as a slide that operates in slot  24 . The slide permits the surgeon to operate the control mechanism  25  along the slot  24  in the handle body  21 . This mechanism will be described in greater detail in the proceeding sections. 
         [0026]    Additionally, the handle body  21  contains an information display that indicates information about the expandable portion  90 . In the present embodiment, the information display takes the form of graduated marks  24 A on the handle body  21 . In the present embodiment, the graduated marks correspond to and indicate the diametric expansion of the expandable portion  90 . In the present embodiment, the slide is configured to be operated by the surgeon&#39;s thumb and may be any shape that is suitable for easy thumb operation by a surgeon. 
         [0027]    Other embodiments of the control mechanism  25  may include, but are not limited to, a knob, lever, or electronically controlled motor, or any other known device configured to permit the surgeon to control the expansion and contraction of the expandable portion  90 . Other embodiments of the display include, but are not limited to, numbers, other markings and digital displays. Other information that may be displayed includes, but is not limited to, the status and location information of any attached medical treatment devices and protective sheaths. 
         [0028]    The catheter device  10  also contains a catheter tube  30 . The catheter tube is attached to and is in communication with the interior cavity of the handle body  20  and extends to and is in communication with the interior cavity of the expandable portion  90 . The catheter tube  30  may be secured to the handle body  20  using a flanged connection, a fused connection, an adhesive, a press fit connection, a threaded connection, or any other securing means. Alternatively, the catheter tube  30  may be secured to the handle body  20  using a connector or any other type of attachment device. The catheter tube  30  can have any outer diameter, length, or wall thickness. The catheter tube  30  may be secured to the expandable portion  90  using a flanged connection, a fused connection, an adhesive, a press fit connection, a threaded connection, or any other securing means. Alternatively, the catheter tube  30  may be secured to the expandable portion  90  using a connector or any other type of attachment device. The catheter tube  30  may further be configured to facilitate communication between the control mechanism  25  and the expandable portion  90  via an inner lumen that allows the passage of control and communication means, such as wire. The inner lumen of catheter tube  30  is further configured for sliding movement along an outer surface of a guide wire  52 . This will be further explained in the proceeding sections. 
         [0029]    The catheter tube  30  may extend through a protective sheath  42  that is configured for sliding movement along an outer surface of the catheter tube  60 . The protective sheath  42  can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, or stainless steel. Further, the protective sheath  42  can have any outer diameter, length, or wall thickness suitably configured for sliding along an outer surface of the catheter tube  60 . 
         [0030]    The protective sheath  42  includes a flange  44  that facilitates sliding movement of the protective sheath  42  relative to the catheter tube  30 . The flange  44  is an annular member located at the proximal end of the protective sheath  42  nearest the handle assembly  20 . The flange  44  may be integrally formed with the protective sheath  42  or may otherwise be secured thereto in any manner, such as by an adhesive, threaded connection, or any other suitable attachment means. It should be appreciated that the flange  44  can have any shape or may alternatively be configured in any manner to accomplish the functions described herein and below. 
         [0031]    The catheter device  10  may be guided into position by use of a guide wire  52 . The guide wire  52  is inserted intravenously by the surgeon and manipulated through the blood vessels to a desired site. The catheter device  10  may then be inserted over the guide wire  52 , specifically such that the inner lumen of catheter tube  30  surrounds the guide wire  52 . The catheter device  10  may then be further inserted, following the guide wire  52 , until the catheter device  10  is properly located intravenously at the desired site. The surgeon may further manipulate the position of the expandable portion  90  at any time by further retracting or extending the catheter tube  30 , optionally including protective sheath  42 , along guide wire  52 . Alternatively, the surgeon may further manipulate the position of the expandable portion  90  by pulling on or further extending the handle assembly  20 . 
         [0032]    Referring now additionally to  FIG. 2 , the handle assembly  20  is enlarged and shown in a cross sectional view along section line  1 - 1 . The handle body  21  defines an interior chamber, indicated generally at  22 . The control mechanism  25  is embodied in the present illustration as a slide mechanism. A portion of the slide mechanism  26  protrudes vertically into the interior chamber  22  and surrounds the guide wire  52 , control member  40 , and catheter tube  30 . The portion of the slide mechanism  26  is configured to permit the guide wire  52  to pass through horizontally and slide along an outer surface thereof. The control member  25  passes into the slide mechanism portion  26  and is configured to terminate and be secured therein such that the slide mechanism portion  26  is in communication with the control member  25  and when the control member  25  is operated by the surgeon, the control member  26  is likewise manipulated. In the present embodiment, when the slide mechanism is advanced along slot  24 , the control member  25  is likewise advanced relative to the handle  20 . 
         [0033]    The catheter tube  30  is terminated in the handle body  21  such that the catheter tube  30  is secured to and in communication with the handle body  21 . The catheter tube  30  is secured such that manipulation of the handle body  21  results in the likewise manipulation of the catheter tube  30 . The catheter tube  30  is configured such that it can slide along an outer surface of the inner tube  40  and guide wire  52 . 
         [0034]    The slide mechanism  30  can be temporarily secured into a number of positions by the use of locking devices  27 . In the present embodiment, the locking devices  27  are located in the exterior wall of the handle body  21  in the slot  24  of the aperture configured for the control member  25  and the portion  26  to extend into the interior chamber  22 . In the present embodiment, the locking mechanism  27  is illustrated as a series of protrusions that are spaced apart from one another along the inner surface of the slot  24 . The control member  25  frictionally engages the protrusions  27  to temporarily secure the control member  25  in a desired position. Alternatively, the locking mechanism  27  may be a threaded fastener, a pivotal latch, a push-button release, or any other mechanism that is configured to temporarily secure the control member  25  in a desired position. 
         [0035]    The optional protective sheath  42  surrounds the catheter tube  30  and includes annual member  44  configured to slide over the catheter tube  30 . 
         [0036]      FIG. 2  corresponds to the expandable portion  90  being operated in the closed position as the control member  25  is located proximally to the expandable portion  90 . Correspondingly, the control member  25  is advanced proximally relative to the expandable portion  90 . The operation of the control member  25  and the expandable portion  90  will be explained further in the proceeding sections. 
         [0037]    The structure of the device pictured in  FIG. 3  corresponds to that of the device pictured in  FIG. 2 , where  FIG. 3  corresponds to the expandable portion  90  being operated in the open position. As indicated by the arrow in the present figure, the control member  25  and portion  26  are located distally relative to expandable portion  90 . The operation of the control member  25  and the expandable portion  90  will be explained further in the proceeding sections. 
         [0038]    Referring now to  FIGS. 4 and 5 , the expandable portion  90  may be defined by a plurality of outer struts, illustrated herein as  134 A,  134 B,  134 C, and  134 D, which may be separated by longitudinally extending slits  135 A,  135 B,  135 C, and  135 D ( 135 C and  135 D are illustrated in  FIG. 7 ). In the present embodiment, the expandable portion is defined by four struts terminated in an end cap  138 . The end cap  138  may be in communication with the control member  40 . Alternative embodiments are contemplated that contain any number of a plurality of struts. As illustrated in the figure, the struts may contain an elongated depression, as can be seen at  160 , near the midpoint of struts  134 A and  134 B. An elongated depression may be located on the other struts, but is not visible in the present figures. The elongated depressions  160  may be configured such the depressed area remains substantially parallel to guide wire  152  when the expandable portion is in the open position. The elongated depressions  160  may be configured to receive a medical treatment device  131 . In other exemplary embodiments of the present invention, there may be no such depression or there may be an elevation. 
         [0039]    The struts  134 A,  134 B,  134 C, and  134 D, may be configured to receive a plurality of medical treatment device attachments  131 . An attachment device  132  may be located on at least one of the struts  134 A,  134 B,  134 C, or  134 D to facilitate the attachment of the medical treatment device  131 . The attachment device  132  may be a clamp, magnet, clip, mated fastener, corresponding slot or groove, or any other attachment means for facilitating the attachment of the medical treatment device  131 . In exemplary embodiments, the elongated depression  160  or the strut  134 A,  134 B,  134 C, or  134 D may also serve as the attachment device  132  or the attachment device  132  may be integrated with the strut  134 A,  134 B,  134 C, or  134 D. In still other exemplary embodiments, the attachment device  132  may not be required, as the medical treatment device  131  may be integrated with the strut  134 A,  134 B,  134 C, or  134 D. 
         [0040]    In an exemplary embodiment, the medical treatment device may be an atherectomy tool, which may be attached to the outer strut  134 A. The atherectomy tool may be a straight line appendage. In other embodiments, the atherectomy tool may be an arcuate blade, or other shape configured for atherectomy. The atherectomy tool may be configured such that when the expandable portion  90  is in the closed position, the atherectomy tool lays substantially flush with the outer surface of the outer strut  134 A. The medical treatment devices may include, but are not limited to, drug delivery devices including needles or targeted delivery systems, incising and scoring elements, heating and cooling elements such as cauterizing and ablation devices, diagnostic devices such as biopsy and imaging tools, and surgical devices such as cutting devices, clamps, and stitching tools. Skilled artisans will appreciate that this list is merely exemplary and that other medical device attachments may be utilized with the present invention and other embodiments of the present invention may be realized. In exemplary embodiments, the medical treatment device  131 , such as but not limited to the atherectomy tool, may extend beyond the outer diameter of the expandable portion  90  when the expandable portion  90  is in the open position. 
         [0041]    Referring to  FIG. 6  and  FIG. 8 , the device is illustrated in the open position as located inside a blood vessel  270 . The struts  134 A,  134 B,  134 C, and  134 D are illustrated as being located in contact with or near to the atheromatous plaque accumulation  260  along the blood vessel walls  270 . The expandable portion  90  may be moved along the blood vessel  270  while in the open or closed position by further inserting or retracting the catheter tube  130  by inserting or retracting the handle  20  as manipulated by the user. In exemplary embodiments the medical treatment device  131 , such as but not limited to the atherectomy tool, may protrude into the atheromatous plaque accumulation  260  along the blood vessel walls  270 . The device may be further inserted or retracted along blood vessel  270  to facilitate the excise of the atheromatous plaque accumulation  260  by atherectomy tool. In other exemplary embodiments, the device  10  may otherwise treat the atheromatous plaque accumulation  260 . In still other exemplary embodiments, the device  10  may otherwise treat the blood vessel  270  not necessarily containing the atheromatous plaque accumulation  260 . As previously discussed, other medical tools are expressly contemplated. 
         [0042]    Referring to  FIG. 7  and  FIG. 8 , a cross section of the expandable portion  90  of the catheter device  10 , is shown in the open position. The cross section is taken along section line  12 - 12  of  FIG. 5 . In  FIG. 8 , the device of  FIG. 7  is illustrated as located inside a blood vessel  270 . The struts  134 A,  134 B,  134 C, and  134 D, are illustrated as being located in contact with or near to the atheromatous plaque accumulation  260  along the blood vessel walls  270 . Alternatively, the struts  134 A,  134 B,  134 C, and  134 D may be expanded in order to place a medical treatment device attachment  131  (not pictured in the present figures) in contact with or near to the blood vessel wall  270 . The expandable portion  90  may be moved along the blood vessel  270  while in the open or closed position by further inserting or retracting the catheter tube  130  by inserting or retracting the handle as manipulated by the user. 
         [0043]    Referring to  FIG. 9  through  FIG. 11 , another exemplary embodiment of the present invention is illustrated. These figures illustrate the expandable portion  90  of the catheter device  10  with the struts  243 A,  234 B,  234 C, and  234 D embodied as flat, rigid surfaces. In the present embodiment, the struts  243 A,  234 B,  234 C, and  234 D make up two outer struts. The outer struts are each comprised of two beams; the beams  234 D and  234 A, comprising one strut, while the beams  234 B and  234 C comprise the other strut. The outer beams may be attached together and to the catheter tube  230  by a joining section  232 . The joining section  232  may be attached to catheter tube  230  by a threaded fastener, adhesive, or be formed as one piece. The outer beams may be joined to the joining section  232  by the weakened regions or pivoting means  237 A and  237 B or alternatively be formed as one piece. Likewise, on the distal end of the expandable portion  90 , the outer beams may be joined to the tip member  238  by the weakened regions or pivoting means  237 A,  237 B,  239 A, and  239 B or alternatively be formed as one piece. 
         [0044]    It should be appreciated that any number of outer struts and corresponding beams may be utilized. Additionally, the struts are attached to the tip member  238  and may be attached by a threaded fastener, an adhesive, a press fit, or other attachment means. 
         [0045]    Like the previous exemplary embodiments, the outer beams may be configured to receive and manipulate any medical treatment devices  131 . 
         [0046]    Referring now to  FIG. 12 , another exemplary embodiment of the present invention is illustrated. A protective sheath  231  surrounds the expandable portion  90  of the device  10 . The protective sheath  231  may be of any thickness. The protective sheath  231  may surround the expandable portion  90  and the catheter tube  230  until the protective sheath  231  is withdrawn by the user. The protective sheath  231  may be withdrawn relative to the expandable portion  90  by operation of the handle  20 . The protective sheath  231  may be operated via a linkage in communication with said handle  20  via the catheter tube  100 . The linkage may be mechanical or electrical. 
         [0047]    In certain embodiments of the present invention, the outer struts, referred to collectively here as  250 , may contain no bias to expand or collapse, and their expansion and contraction is operated by the same mechanisms as previously described herein. In other exemplary embodiments, the outer struts  250  may be made of a suitable material, such as spring steel, such that they are biased in the expanded position. 
         [0048]    In another exemplary embodiment, the outer struts  250  of the expandable portion  90  are biased in the expanded position. When the protective sheath  231  is retracted, as indicated by the arrow in the figure, the outer struts  250  are permitted to expand into an open position. Likewise, when the protective sheath  231  is extended relative to the expandable portion  90 , in the opposite direction of the arrow indication, the outer struts  250  are forced into a collapsed position. The protective sheath  231  may also serve to enclose and protect the outer struts  250 . Further, the protective sheath  320  may also be configured to enclosure and protect an attached medical device  131  if one is utilized with the present invention. 
         [0049]    While the present embodiment is illustrated with the device of  FIG. 4 , it should be appreciated that the protective sheath  231  may be utilized with any of the embodiments disclosed herein. 
         [0050]    Any embodiment of the present invention may include any of the optional or preferred features of the other embodiments of the present invention. The exemplary embodiments herein disclosed are not intended to be exhaustive or to unnecessarily limit the scope of the invention. The exemplary embodiments were chosen and described in order to explain the principles of the present invention so that others skilled in the art may practice the invention. Having shown and described exemplary embodiments of the present invention, those skilled in the art will realize that many variations and modifications may be made to the described invention. Many of those variations and modifications will provide the same result and fall within the spirit of the claimed invention. It is the intention, therefore, to limit the invention only as indicated by the scope of the claims.