Pneumatically-operated thrombectomy catheter deployment system

#This patent application is related to patent application Ser. No. 11/237,558 filed Sep. 28, 2005, entitled “Thrombectomy Catheter Deployment System”, which is pending.

#1. Field of the Invention

#In the human body, blockages in blood vessels, arteries and the like often oppose the free flow of blood therein, one such blockage of which is thrombus. Thrombus is coagulated blood that is developed in vivo. Thrombus blocks blood flow to living tissue leading to ischemia and eventually tissue death. Depending on the end organ and the amount of blocked blood flow, the effects of thrombus can range from unnoticeable to death. Thrombus residing in a variety of native vessels and grafts can be treated. The occurrence and presence of thrombus occurs in several ways. First, it occurs in coronary procedures where thrombus is associated with myocardial infarction or heart attack. Thrombus is also common in older saphenous vein bypass grafts. Second, peripheral artery interventional procedures can encounter thrombus as well. The use of synthetic grafts and stents for the treatment of peripheral arterial disease can produce thrombus as a result of blood material interactions. Furthermore, thrombus can be formed resulting from the progression of the peripheral artery disease itself. As the artery becomes blocked with atherosclerotic material, thrombus can result as blood passes through the restricted diseased vessel. Venous thrombus can result from either vessel injury or hypercoagulable blood chemistry. Finally, interventional procedures themselves can create thrombus. Access to the patient's arterial vascular system is commonly accomplished via a femoral artery puncture. At the end of the procedure, the puncture site must be closed by either applying pressure until a natural thrombotic plug forms or using an arterial closure product which typically uses some sort of collagen plug or suture. In either case, thrombus can form at the puncture site and move down the femoral artery. Furthermore, during the interventional procedure itself, foreign materials such as catheters and guidewires are introduced into the patient's blood stream. The patient needs anticoagulants, typically heparin, to prevent the occurrence of thrombus. On occasion, inattention to activated clotting times can result in the occurrence of thrombus during the procedure. Third, other parts that have been treated by thrombectomy catheters include arterial-venous access grafts for hemodialysis patients. Thrombectomy catheters have proven effective in opening these grafts that occasionally become blocked with thrombus. Thrombectomy catheters have also been used in the venous system for deep vein thrombosis and occasionally in neurological venous applications. Finally, thrombectomy catheters have been clinically investigated in neurological arterial applications as well. In general, thrombectomy catheters have a potential application wherever thrombus forms in native arteries, veins and grafts. Having developed such thrombectomy catheters, there exists a need for a deployment system to allow simple and rapid use of a thrombectomy catheter and the devices supporting use of the thrombectomy catheter.

#Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:

#FIG. 1 is a plan view of a pneumatically-operated thrombectomy catheter deployment system, the present invention;

#FIG. 2 is a semi-exploded plan view of the pneumatically-operated thrombectomy catheter deployment system;

#FIG. 1 is a plan view of the pneumatically-operated thrombectomy catheter deployment system 10, the present invention. The pneumatically-operated thrombectomy catheter deployment system 10 preferably includes a sterile package 11 schematically represented such as a sterile bag or other suitable sterile enclosure within the skill known in the art and multiple components synergistically operating to provide operating fluids and sufficient fluid operating pressures and to provide for removal of effluent involved in thrombectomy procedures incorporating the present invention. A major assembly of the present invention includes a centrally located drive unit 12 about which a plurality of components are attached and operated. The drive unit 12 includes a frame 14, a centrally located pneumatically-operated double-acting air cylinder 16 secured to the lower portion of the frame 14, a reciprocating assembly 18 slidingly engaging the frame 14 including a four-way valve 20 secured to the lower portion of the frame 14, an effluent pump 22 secured at the upper portion of the reciprocating assembly 18 and at the upper portion of the frame 14, such effluent pump 22 including a manifold 24, a check valve 26 connected to the outlet of the manifold 24, a check valve 30 connected to the inlet of the manifold 24, as well as a piston and a cylinder described later in detail. The drive unit 12 also includes a housing 34 secured to the lower portion of the double-acting air cylinder 16, an inspection window 35 in the lower region of the housing 34 for pump priming observation, a high pressure pump 36 including a portion aligned in the lower portion of the housing 34 and another portion including a pump base 37 which extends below and beyond the lower portion of the housing 34, a retainer clip 38 securing the high pressure pump 36 to and within the housing 34, a compressed air tank 40, a regulator/connector 42, a valve 44, a compressed air supply tube 46 connecting between the valve 44 and the four-way valve 20, an optional system pressure gauge 48 incorporated in the compressed air supply tube 46, if desired, a bracket 50, and hardware securing the regulator/connector 42 and the compressed air tank 40 to the frame 14.

#The plurality of components attached to or utilized in combination with the drive unit 12 include those components now described. An effluent collection bag 52 is connected to the check valve 26 of the effluent pump 22 by an effluent tube 54 and a connector 28. A saline supply bag 56 is connected to the pump base 37 of the high pressure pump 36 by a saline bag spike 58 and a saline supply tube 60. Other major components, assemblies or other features of the present invention include a thrombectomy catheter 62 having a manifold 64 and a catheter tube 66 connected to one end thereof. A high pressure saline delivery tube 68 connects between the pump base 37 of the high pressure pump 36 and the manifold 64 using a connector 69, and a connector 70 connects an effluent tube 71 to the effluent pump 22 through a connector 32.

#FIG. 2 is a semi-exploded plan view of the pneumatically-operated thrombectomy catheter deployment system 10 especially showing the features of the double-acting air cylinder 16 and components closely associated therewith, and FIG. 3 is a detail view showing the relationship of the frame 14, the double-acting air cylinder 16, the reciprocating assembly 18, the four-way valve 20, the effluent pump 22, and other closely associated components. Components of the centrally located double-acting air cylinder 16 interact directly with components of the reciprocating assembly 18 and indirectly through related interfacing with the four-way valve 20, whereby alternating direction operation of the double-acting air cylinder 16 is provided first in one direction and then in an opposite direction. Such alternating operation of the double-acting air cylinder 16 provides for powered operation of the high pressure pump 36 and the effluent pump 22.