| CPC A61B 17/320725 (2013.01) [A61B 2017/22061 (2013.01); A61M 2025/109 (2013.01); A61M 2025/1086 (2013.01); A61M 2025/1095 (2013.01)] | 16 Claims |
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1. A catheter apparatus for arterial plaque removal in an isolated environment while maintaining continuous blood flow in a bloodstream during a treatment procedure, with the catheter apparatus being insertable over a guide-wire and positioned at a target site during the treatment procedure, the catheter apparatus comprising:
a. a catheter head at a proximal end of the catheter apparatus;
b. a catheter body;
c. a catheter end cap at a distal end of the catheter apparatus; and
d. a balloon within the catheter body, the balloon being biased in a deflated configuration, and with the balloon being selectively inflated or deflated with an inflating mechanism;
e. the catheter head and the catheter end cap each being biased in a deflated configuration, the catheter head and the catheter end cap each being selectively expandable or retractable in response to the inflation or deflation of the balloon; wherein when the catheter head and the catheter end cap are expanded, the catheter head and the catheter end cap are configured to each anchor an arterial wall at the target site to further provide the isolated environment for arterial plaque removal; the catheter head and the catheter end cap each defining a corresponding plurality of openings therethrough for maintaining continuous blood flow during use of the catheter apparatus within the arterial wall; and the catheter head comprising a tubular array extending therefrom, the tubular array comprising an inflow tube for transporting a treatment solution to the target site, an outflow tube for removing the treatment solution containing the plaque from the target site, and a guide tube for receiving the guide-wire therethrough for positioning the catheter apparatus at the target site;
f. the catheter body being separated into a first layer, a second layer, and a third layer, and the catheter end cap further defining an opening at a distal end of the guide tube for receiving the guide-wire therethrough, wherein the plaque, the treatment solution, or the treatment solution containing the plaque do not enter into the second layer or the third layer of the catheter body and do not enter the bloodstream;
g. the first layer of the catheter body comprising a plurality of flap members arranged and spaced apart along a length of the first layer of the catheter body, each of the plurality of flap members defining at least one pore therethrough, and a distal portion of both the inflow tube and the outflow tube extending within the first layer for the treatment solution to pass from the inflow tube through the at least one pore of each of the plurality of flap members to the target site and to remove the treatment solution containing the plaque back out the at least one pore of each of the plurality of flap members out the outflow tube and away from the target site;
h. the second layer of the catheter body comprising (i) an outer surface, (ii) an inner surface, (iii) a plurality of strut members defining a plurality of chamber gaps among the plurality of strut members, each of the plurality of strut members being spaced apart and affixed along a length between the inner surface of the second layer of the catheter body and an outer surface of the third layer of the catheter body to allow for continuous blood flow during the treatment procedure; and
i. the third layer of the catheter body comprising a core sheath defining a core having the guide tube therein for receiving the guide-wire therethrough, with the core sheath extending a length of the catheter body, with the core further defining opposing open ends; and with the third layer comprising the outer surface;
j. wherein the guide tube of the tubular array of the catheter apparatus is removably insertable over the guide-wire as the catheter apparatus is drawn to and positioned at the target site for the treatment procedure;
k. wherein the inflating mechanism is configured to be actuated to selectively inflate the balloon which laterally expands and supplies tension to the catheter head and the catheter end cap to outwardly flare, expand, and inflate both the catheter head and the catheter end cap thereby removably anchoring the catheter apparatus to the arterial wall to provide structural support, and wherein the catheter apparatus is configured to isolate the target site for arterial plaque removal within the first layer of the catheter body using the treatment procedure for providing an inflow of the treatment solution through the inflow tube and for removing the treatment solution containing the plaque out the outflow tube while simultaneously maintaining continuous blood flow through the plurality of openings defined in the catheter head, the catheter end cap, and through the second layer of the catheter body; wherein the treatment procedure can be selectively repeated to remove the arterial plaque, or the catheter apparatus can be selectively adjusted about the target site or the arterial wall before repeating the treatment procedure to remove the arterial plaque; and
wherein after completion of the treatment procedure, the balloon can be selectively deflated with the tension upon the balloon being removed from the catheter head and the catheter end cap to return each of the catheter head and catheter end cap to the biased, deflated configuration, before slidably withdrawing the catheter apparatus along the guide-wire from the target site.
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