Abstract:
A gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device for use in thrombectomy or other vascular procedures includes a multiple element valved guidewire assembly having an occlusive balloon removably and sealingly connectible to an included manifold assembly where a guidewire tube defines a lumen for inflation or deflation of the occlusive balloon. A first syringe for evacuating the lumen and a second syringe for introducing a biocompatible gas into the lumen to inflate the occlusive balloon that is in fluid communication with the lumen a plurality of times are included. A sealing valve arrangement selectively seals the proximal portion of the guidewire tube to control inflated or deflated states of the occlusive balloon.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     None. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to the field of vascular medical devices. More specifically, the present invention relates to a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device for selectively, rapidly and repeatedly inflating and deflating an occlusive balloon and for sealing the proximal end of a guidewire tube during a vascular procedure where the invention is incorporated for unencumbered hubless use as a guidewire with inflated occlusive balloon without any protruding features upon which thrombectomy catheters or other devices may align for thrombectomy or other procedures. 
     2. Description of the Prior Art 
     Arterial disease involves damage that happens to the arteries in the body. Diseased arteries can become plugged with thrombus, plaque, or grumous material that may ultimately lead to a condition known as ischemia. Ischemia refers to a substantial reduction or loss of blood flow to the heart muscle or any other tissue that is being supplied by the artery and can lead to permanent damage of the affected region. While arterial disease is most commonly associated with the formation of hard plaque and coronary artery disease in the heart, similar damage can happen to many other vessels in the body, such as the peripheral vessels, cerebral vessels, due to the buildup of hard plaque or softer thrombus or grumous material within the lumen of an artery or vein. 
     A variety of vascular medical devices and procedures have been developed to treat diseased vessels. The current standard procedures include bypass surgery (where a new blood vessel is grafted around a narrowed or blocked artery) and several different types of nonsurgical interventional vascular medical procedures, including angioplasty (where a balloon on a catheter is inflated inside a narrowed or blocked portion of an artery in an attempt to push back plaque or thrombotic material), stenting (where a metal mesh tube is expanded against a narrowed or blocked portion of an artery to hold back plaque or thrombotic material), and debulking techniques in the form of atherectomy (where some type of high speed or high power mechanism is used to dislodge hardened plaque) or thrombectomy (where some type of mechanism or infused fluid is used to dislodge grumous or thrombotic material). In each of these interventional vascular medical procedures, a very flexible guidewire is routed through the patient&#39;s vascular system to a desired treatment location and then a catheter that includes a device on the distal end appropriate for the given procedure is tracked along the guidewire to the treatment location. 
     Although interventional vascular procedures avoid many of the complications involved in surgery, there is a possibility of complications if some of the plaque, thrombus or other material breaks free and flows downstream in the artery or other vessel, potentially causing a stroke, a myocardial infarction (heart attack), or other tissue death. One solution to this potential complication is to use some kind of occlusive device to block or screen the blood flowing downstream of the treatment location. Examples of catheter arrangements that use a pair of balloons as occlusive devices to create an isolated space in the blood vessel are described in U.S. Pat. Nos. 4,573,966, 4,636,195, 5,059,178, 5,320,604, 5,833,644, 5,925,016, 6,022,336 and 6,176,844. Examples of catheter arrangements that use a single balloon as an occlusive device either upstream or downstream of the treatment location are described in U.S. Pat. Nos. 5,171,221, 5,195,955, 5,135,482, 5,380,284, 5,688,234, 5,713,917, 5,775,327, 5,792,179, 5,807,330, 5,833,650, 5,843,022, 6,021,340, 6,159,195 and 6,248,121. An example of a catheter arrangement that uses a mechanically expanded occlusive device is shown in U.S. Pat. No. 6,231,588. Occlusive balloons also have been used on non-over-the-wire catheters without any guidewire internal to the catheter as described, for example, in U.S. Pat. Nos. 4,838,268 and 5,209,727. 
     The use of an occlusive device as part of a vascular procedure is becoming more common in debulking procedures performed on heart bypass vessels. Most heart bypass vessels are harvested and transplanted from the saphenous vein located along the inside of the patient&#39;s leg. The saphenous vein is a long straight vein that has a capacity more than adequate to support the blood flow needs of the heart. Once transplanted, the saphenous vein is subject to a buildup of plaque or thrombotic materials in the grafted arterial lumen. Unfortunately, the standard interventional vascular treatments for debulking are only moderately successful when employed to treat saphenous vein coronary bypass grafts. The complication rate for a standard balloon angioplasty procedure in a saphenous vein coronary bypass graft is higher than in a native vessel with the complications including embolization, “no-reflow” phenomena, and procedural related myocardial infarction. Atherectomy methods including directional, rotational, and laser devices are also associated with a high degree of embolization resulting in a greater likelihood of infarction. The use of stents for saphenous vein coronary bypass grafts has produced mixed results. Stents provide for less restenosis, but they do not eliminate the risk of embolization and infarction incurred by standard balloon angioplasty. 
     In order to overcome the shortcomings of these standard nonsurgical interventional treatments in treating saphenous vein coronary bypass graft occlusion, embolic protection methods utilizing a protective device distal to the lesion have been developed. The protective device is typically a filter or a balloon. Use of a protective device in conjunction with an atherectomy or thrombectomy device is intended to prevent emboli from migrating beyond the protective device and to allow the embolic particles to be removed, thereby subsequently reducing the risk of myocardial infarction. When the occlusive device is a balloon, the balloon is inserted and inflated at a point distal to the treatment site or lesion site. Therapy is then performed at the treatment site and the balloon acts to block all blood flow which prevents emboli from traveling beyond the balloon. Following treatment, some form of particle removal device must be used to remove the dislodged emboli prior to balloon deflation. U.S. Pat. No. 5,843,022 uses a balloon to occlude the vessel distal to a lesion or blockage site. The occlusion is treated with a high pressure water jet, and the fluid and entrained emboli are subsequently removed via an extraction tube. U.S. Pat. No. 6,135,991 describes the use of a balloon to occlude the vessel allowing blood flow and pressure to prevent the migration of emboli proximally from the treatment device. 
     There are various designs that have included an occlusive balloon on the end of a guidewire. U.S. Pat. Nos. 5,520,645, 5,779,688 and 5,908,405 describe guidewires having removable occlusive balloons on a distal end. U.S. Pat. No. 4,573,470 describes a guidewire having an occlusive balloon where the guidewire is bonded inside the catheter as an integral unit. U.S. Pat. Nos. 5,059,176, 5,167,239, 5,520,645, 5,779,688 and 6,050,972 describe various guidewires with balloons at the distal end in which a valve arrangement is used to inflate and/or deflate the balloon. U.S. Pat. No. 5,908,405 describes an arrangement with a removable balloon member that can be repeatedly inserted into and withdrawn from a guidewire. U.S. Pat. No. 5,776,100 describes a guidewire with an occlusive balloon adhesively bonded to the distal end with an adapter on the proximal end to provide inflation fluid for the occlusive balloon. 
     Except in the case of the normal cerebral anatomy where there are redundant arteries supplying blood to the same tissue, one of the problems with using an occlusive device in the arteries is that tissue downstream of the occlusive device can be damaged due to the lack of blood flow. Consequently, an occlusive device that completely blocks the artery can only be deployed for a relatively short period of time. To overcome this disadvantage, most of the recent development in relation to occlusive devices has focused on devices that screen the blood through a filter arrangement. U.S. Pat. Nos. 5,827,324, 5,938,672, 5,997,558, 6,080,170, 6,171,328, 6,203,561 and 6,245,089 describe various examples of filter arrangements that are to be deployed on the distal end of a catheter system. While a filter arrangement is theoretically a better solution than an occlusive device, in practice, such filter arrangements often become plugged, effectively turning the filter into an occlusive device. The filter arrangements also are mechanically and operationally more complicated than an occlusive balloon device in terms of deployment and extraction. 
     As is the case in almost all angioplasty devices or stenting catheter devices where a balloon is used to expand the blood vessel or stent, most catheter occlusive balloons as well as most guidewire occlusive balloons utilize a liquid fluid such as saline or saline mixed with a radiopaque marker for fluoroscopic visualization (i.e., contrast) as the inflation medium. Generally, a liquid fluid medium for expanding vascular balloons has been preferred because the expansion characteristics of a liquid are more uniform and predictable, and because a liquid medium is easier to work with and more familiar to the doctors. In the case of angioplasty balloons, for example, high pressure requirements (up to 20 atmospheres) necessitate that the inflation fluid be an incompressible fluid for safety reasons. While having numerous advantages, liquid fluids do not lend themselves to rapid deflation of an occlusive balloon because of the high resistance to movement of the liquid in a long small diameter tube. In the context of angioplasty procedures, the balloon catheter has a much larger lumen than a guidewire. Consequently, rapid deflation is possible. In the context of a guidewire, however, liquid filled occlusive balloons typically cannot be deflated in less than a minute and, depending upon the length of the guidewire, can take up to several minutes to deflate. Consequently, it is not practical to shorten the period of total blockage of a vessel by repeatedly deflating and then re-inflating a liquid filled occlusive balloon at the end of a guidewire. 
     Gas-filled balloons have been used for intra-aortic occlusive devices where rapid inflation and deflation of the occlusive device is required. Examples of such intra-aortic occlusive devices are shown in U.S. Pat. Nos. 4,646,719, 4,733,652, 5,865,721, 6,146,372, 6,245,008 and 6,241,706. While effective for use as an intra-aortic occlusive device, these occlusive devices are not designed for use as a guidewire as there is no ability to track a catheter over the intra-aortic occlusive device. 
     An early catheter balloon device that utilized a gas as an inflation medium and provided a volume limited syringe injection system is described in U.S. Pat. No. 4,865,587. More recently, a gas-filled occlusive balloon on a guidewire is described as one of the alternative embodiments in U.S. Pat. No. 6,217,567. The only suggestion for how the guidewire of the alternative embodiment is sealed is a valve type arrangement similar to the valve arrangement used in a liquid fluid embodiment. A similar gas-filled occlusive balloon has been described with respect to the Aegis Vortex™ system developed by Kensey Nash Corporation. In both U.S. Pat. No. 6,217,567 and the Aegis Vortex™ system, the gas-filled occlusive balloon is used for distal protection to minimize the risk of embolization while treating a blocked saphenous vein coronary bypass graft. Once deployed, the occlusive balloon retains emboli dislodged by the atherectomy treatment process until such time as the emboli can be aspirated from the vessel. No specific apparatus are shown or described for how the gas is to be introduced into the device or how the occlusive balloon is deflated. 
     Although the use of occlusive devices has become more common for distal embolization protection in vascular procedures, particularly for treating a blocked saphenous vein coronary bypass graft, all of the existing approaches have significant drawbacks that can limit their effectiveness. Liquid filled occlusive balloons can remain in place too long and take too long to deflate, increasing the risk of damages downstream of the occlusion. Occlusive filters are designed to address this problem, but suffer from blockage problems and can be complicated to deploy and retrieve and may allow small embolic particles to migrate downstream. Existing gas-filled occlusive balloons solve some of the problems of liquid filled occlusive balloons, but typically have utilized complicated valve and connection arrangements. It would be desirable to provide for an occlusive device that was effective, simple, quick to deploy and deflate, and that could overcome the limitations of the existing approaches. 
     Some of these problems have been previously addressed in three commonly owned and assigned co-pending applications, which are hereby incorporated by reference herein: U.S. patent application Ser. No. 10/838,464, filed Apr. 29, 2004, entitled “Gas Inflation/Evacuation System and Sealing System for Guidewire Assembly Having Occlusive Device,” which is a continuation-in-part of patent application Ser. No. 10/012,903, filed Nov. 6, 2001, entitled “Guidewire Occlusion System Utilizing Repeatably Inflatable Gas-Filled Occlusive Device,” U.S. patent application Ser. No. 10/012,891, filed Nov. 6, 2001, entitled “Guidewire Assembly Having Occlusive Device and Repeatably Crimpable Proximal End,” U.S. patent application Ser. No. 10/007,788, filed Nov. 6, 2001, entitled “Gas Inflation/Evacuation System and Sealing System for Guidewire Assembly Having Occlusive Device,” and U.S. patent application Ser. No. 10/455,096, filed Jun. 6, 2003, entitled “Thrombectomy Device With Self-Sealing Hemostasis Valve,” all of which are hereby incorporated herein by reference. 
     SUMMARY OF THE INVENTION 
     Disclosed herein is a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device includes a manifold assembly removably connectible to a multiple element valved guidewire assembly having an occlusive device, and in addition thereto includes syringe means operated in cooperation with the manifold assembly for selectively evacuating the multiple element valved guidewire assembly and syringe means operated in cooperation with the manifold assembly for introducing a biocompatible gas under pressure into the multiple element valved guidewire assembly to selectively inflate the occlusive device, such as an occlusive balloon, a plurality of times. The multiple element valved guidewire assembly is inserted and maneuvered within the manifold assembly to position a controllable valve therewithin for inflational and deflational control of the occlusive balloon. The multiple element valved guidewire assembly can be removed from influence of the manifold assembly subsequent to occlusive balloon inflation to serve as a stand-alone guidewire while providing occlusive protection within a blood vessel. 
     An embodiment set forth herein comprises a manifold assembly removably connectible to the multiple element valved guidewire assembly. The multiple element valved guidewire assembly includes a braided polyimide guidewire tube which defines a lumen, where the distal end of the braided polyimide guidewire tube includes an occlusive balloon, inflation orifices, a flexible distally located tip and a proximal end which includes an internally located seal. Also included as a part of the multiple element valved guidewire assembly is a one-piece flexible sealing rod having a reduced radius support extension extending therefrom, such being a part of the multiple element valved guidewire assembly and being slidably accommodated by the braided polyimide guidewire tube. More specifically, the sealing rod is intimately and slidingly accommodated by the seal internal to the proximal end of the braided polyimide guidewire tube to either seal or unseal the lumen leading to the occlusive balloon when inflating or deflating the occlusive balloon. Such an arrangement comprises a valve at the proximal end of the braided polyimide guidewire tube incorporating interaction of a portion of the multiple element valved guidewire assembly sealing rod. The reduced radius support extension extends along the lumen of the braided polyimide guidewire tube to add a degree of stiffness to the braided polyimide guidewire tube, thereby adding to the pushability of the multiple element valved guidewire assembly through the vasculature. 
     The manifold assembly removably receives the multiple element valved guidewire assembly. Multiple resilient seals are incorporated within the manifold assembly to seal against the elements of the multiple element valved guidewire assembly and to seal about the needles of the evacuation and inflation syringes. The valve of the multiple element valved guidewire assembly is accommodated and sealed within the manifold assembly and opened or closed during phases of inflation and deflation in coordinated operation of the evacuation and inflation syringes. Operation of the invention involves placement of the multiple element valved guidewire assembly into the vasculature to position a deflated occlusive balloon beyond a buildup of thrombus, plague, lesions or other foreign material buildup followed by the inflation of the occlusive balloon therein and then by removal of the manifold assembly from the multiple element valved guidewire assembly, thereby leaving in place a guidewire tube having an inflated occlusive balloon and a guidewire tube over which thrombectomy catheters or other devices may track for the purpose of thrombectomy or other procedures. 
     An advantage of the present invention is that the occlusive device can be repeatably inflated and deflated a plurality of times during a vascular procedure where the proximal end of the guidewire tube is alternately free of mechanical connections and obstructions and, therefore, the guidewire tube can function as a conventional exchange guidewire for one or more over-the-wire catheters. Alternatively, the guidewire tube can be shorter in length for use with rapid exchange catheter systems. Unlike operation of existing liquid filled occlusive devices, the present invention enables repeated and quick inflation and deflation which allows an operator to deploy the gas-filled occlusive device numerous times during a procedure for shorter periods of time, thereby reducing the risk of potential damage to downstream tissue. There are no complicated mechanical arrangements or complicated valve systems internal to the guidewire tube that increase the cost, complexity, and potential for failure of the system. Preferably, the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device constitutes a handheld apparatus. Each time a deflation of the occlusive device is desired in order to reestablish blood flow to the vessel downstream of the occlusive device, the sealing rod can be repositioned to open the valve to quickly deflate the occlusive device and after a determined period can be repositioned to repeat the inflation procedure again. Multiple inflations, evacuations and deflations can be performed as required. 
     One significant aspect and feature of the present invention is the provision of a multiple element valved guidewire, a manifold assembly, an evacuation syringe and an inflation syringe. 
     Another significant aspect and feature of the present invention is a removably attached manifold assembly which is accommodated by a multiple element valved guidewire assembly. 
     Another significant aspect and feature of the present invention is the provision for repeatable inflation and deflation of an occlusive balloon multiple times. 
     Another significant aspect and feature of the present invention is the use of a multiple element valved guidewire assembly which, subsequent to inflation of an occlusive balloon, can removed from influence of a manifold assembly to serve as a guidewire for accommodation of various devices. 
     Another significant aspect and feature of the present invention is a positionable valve in a multiple element valved guidewire assembly incorporated for selective supplying of inflational medium from an inflation syringe and for selective pressurization of various components of the invention or for selective evacuation thereof by the use of an evacuation syringe. 
     Another significant aspect and feature of the present invention is a multiple element valved guidewire assembly having structure including a sealing rod which interacts with a seal located proximally in a guidewire tube to constitute a valve where the closing or opening of the valve is accomplished by longitudinal movement of the sealing rod. 
     Yet another significant aspect and feature of the present invention is a guidewire tube and a sealing rod which together serve as a guidewire. 
     Another significant aspect and feature of the present invention is the incorporation of an evacuation syringe which cooperatively interacts to evacuate a multiple element valved guidewire assembly and a manifold assembly. 
     Another significant aspect and feature of the present invention is the incorporation of an inflation syringe which cooperatively interacts to pressurize a guidewire tube in order to inflate an occlusive balloon. 
     Another significant aspect and feature of the present invention is the use of a sealing rod having a support extension extending therefrom into a braided polyimide guidewire tube, whereby the support extension lends support to the braided polyimide guidewire tube and enhances pushability and deliverability of the braided polyimide guidewire tube through the vasculature. 
     Another significant aspect and feature of the present invention is the incorporation of a check valve in an evacuation syringe to prevent air injection. 
     Another significant aspect and feature of the present invention is the incorporation of a check valve in an inflation syringe to prevent air injection. 
     Still another significant aspect and feature of the present invention is the use of self and automatic sealing resilient seals or hemostatic valves in sealing relationships with elongated elements of a multiple element valved guidewire assembly passing therethrough. 
     Another significant aspect and feature of the present invention is a balloon on a commonly used and sized guidewire tube which gives the physician many options in using such a device to control the environment within a blood vessel while other procedures can take place more safely and effectively. Furthermore, having the device sealable or hubless facilitates complete freedom for use as a primary guidewire with the option of inflating an occlusive balloon for containment or mechanical usage. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube which is provided with an occlusive balloon that can be used as a distal protection device. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon, the hubless guidewire tube with occlusive balloon being useful during embolectomy. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon, the hubless guidewire tube with occlusive balloon being useful in conjunction with an ablative device to remove clots, thrombus, plaque and the like from blood vessel walls. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon that can be inflated and used as a positioning tool to center other devices in a blood vessel. 
     Another significant aspect and feature of the present invention is an occlusive balloon on a hubless guidewire tube which can be used as an ordinary guidewire. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon that can be used as a containment device to minimize hemolysis or release of hemolytic blood components that may cause arrhythmia or organ damage. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon that can be used as a containment device for infused drugs or lysins to enhance their effect or improve safety. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon that can be used as one-half of an isolation system which contains materials more effectively where the other half could be a balloon on a device such as a thrombectomy catheter or a balloon on a guide catheter type device. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon which can be used as a containment device for infused drugs or lysins to enhance their effect or improve safety when injected via a specialized infusion catheter. 
     Another significant aspect and feature of the present invention is a hubless guidewire tube having an occlusive balloon which can be used as a containment device for infused drugs or lysins to enhance their effect or improve safety when injected via a high pressure thrombectomy catheter which employs cross stream technology power pulse spray with distal protection or containment therapy. 
     Another significant aspect and feature of the present invention is the incorporation of a pressure gauge to monitor inflation and evacuation procedures. 
     Having thus described embodiments of the present invention and enumerated significant aspects and features thereof, it is the principal object of the present invention to provide a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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 view showing the overall outwardly visible structure of a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device, one embodiment of the present invention; 
         FIG. 2  is an exploded vertical cross section view through the manifold assembly; 
         FIG. 3  is an assembled vertical cross section view through the manifold assembly; 
         FIGS. 4   a  and  4   b  are isometric views of one of the self-sealing hemostatic valves which align in and which are housed in a proximal cavity, a distal cavity, and an inflation/evacuation branch cavity; 
         FIG. 5  is a cross section view of a valve along line  5 - 5  of  FIG. 1  where the valve is in the closed position; 
         FIG. 6  is a cross section view of the valve along line  5 - 5  of  FIG. 1  where the valve is in the open position; 
         FIG. 7  is a view of the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device in use within a blood vessel; 
         FIG. 8  is a cross section view like  FIG. 3  but showing the valve of the multiple element valved guidewire assembly sealingly located in the main passageway of the manifold; 
         FIG. 9  is a view like  FIG. 7  but showing the occlusive balloon inflated to occlude a blood vessel; and, 
         FIG. 10 , an alternative embodiment, is a view showing the overall outwardly visible structure of a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device using an attached vacuum syringe and an attached inflation syringe. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to  FIG. 1 , the overall outwardly visible structure of the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10 , one embodiment of the present invention, is now described. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10  comprises a multiple element valved guidewire assembly  12 , a manifold assembly  14 , an evacuation syringe  16  and an inflation syringe  18 . 
     The multiple element valved guidewire assembly  12  preferably includes, amongst other components described herein, a flexible guidewire tube  20  of braided polyimide, an occlusive device being an occlusive balloon  22  located at the distal end of guidewire tube  20 , a plurality of inflation orifices  24  extending through the wall of the guidewire tube  20  in communication between a lumen  26  ( FIGS. 5 ,  6  and  8 ) of the guidewire tube  20  and the occlusive balloon  22 , a flexible tip  28  located distal to the occlusive balloon  22 , and a seal  30  ( FIGS. 5 and 6 ) of flexible compliant material located and fixed internally within the proximal end  27  of the guidewire tube  20 . 
     Also included in the multiple element valved guidewire assembly  12  is a sealing rod  32  which is flexible and of a round cross section in close tolerance slidable and sealing fit with opening  29  ( FIG. 5 ) provided by the seal  30 . A flexible support extension  34  having a round cross section less than the round opening provided by the seal  30  and being continuous with the sealing rod  32  extends distally from the sealing rod  32 . The support extension  34  and the sealing rod  32  are positionable within and through the seal  30  at the proximal end of the guidewire tube  20 . The arrangement of components as just described also constitutes and makes possible the operation of a valve  37 , as described in detail with reference to  FIGS. 5 and 6 . Additionally, the flexible support extension  34  extends into and through the seal  30  and further into and along a major portion of the lumen  26  of the guidewire tube  20  whereby the distal end of the support extension  34  comes in close proximity to the occlusive balloon  22  and can be positioned coaxially with the occlusive balloon  22  to lend support along and within the guidewire tube  20 . When the valve  37  is closed, the sealing rod  32  is utilized in the same capacity as the guidewire tube  20  for accommodation of a thrombectomy catheter, i.e., the guidewire tube  20  and the sealing rod  32  together constitute a guidewire structure. 
     The manifold assembly  14  removably accommodates and attaches to and cooperates with the multiple element valved guidewire assembly  12  and cooperates with the evacuation syringe  16  and the inflation syringe  18  to provide for inflation and deflation of the occlusive balloon  22  at the distal end of the guidewire tube  20 . Readily visible components of the manifold assembly  14  include a manifold  36  of tubular configuration, a manifold body  38 , a plurality of similarly constructed hemostatic nuts including a proximal hemostatic nut  40   a  opposing a distal hemostatic nut  40   b  at the ends of the manifold body  38 , and an inflation/evacuation branch hemostatic nut  40   c  located at the end of an inflation/evacuation branch  42 . A pressure monitor branch  44  also extends from the manifold body  38  for connection to a pressure gauge  45  by an interceding connector  46 . The evacuation syringe  16  includes a plunger  48 , a check valve  50 , a connector  52  and a needle  54  which preferably is a blunt needle. The inflation syringe  18  includes a plunger  56 , a check valve  58  and a needle  60  which preferably is a blunt needle. 
       FIGS. 2 and 3  are exploded and assembled vertical cross section views through the manifold assembly  14 . The manifold assembly  14  includes structure for accommodation of the multiple element valved guidewire assembly  12  and for use of the evacuation and inflation syringes  16  and  18 , respectively. Accordingly, the manifold body  38  of the manifold  36  includes connected and communicating passageways and cavities including a longitudinally oriented main passageway  62  being tapered in opposing directions extending through the central and tubular region of the manifold body  38  to communicate with opposed proximal and distal cavities  64  and  66 , which preferably are cylindrical, located centrally in opposed proximal and distal cavity bodies  68  and  70  at the ends of the manifold body  38 . An inflation/evacuation branch passageway  72 , which is tapered, extends along the interior of the inflation/evacuation branch  42  between the main passageway  62  and an inflation/evacuation branch cavity  74 , which preferably is cylindrical, located in an inflation/evacuation branch cavity body  76 . A pressure monitor branch passageway  78  extends along the interior of the pressure monitor branch  44  between the main passageway  62  and a flange  80  for connection with the connector  46  and the pressure gauge  45 . 
     The proximal cavity body  68 , the distal cavity body  70 , the inflation/evacuation branch cavity body  76  and accordingly, the associated proximal cavity  64 , distal cavity  66 , and the inflation/evacuation branch cavity  74 , respectively, are fashioned similarly and as such contain like components and features identified by like reference numerals. 
     The proximal cavity  64 , the distal cavity  66  and the inflation/evacuation branch cavity  74  are tubular, each including a cavity wall  82  and a planar surface  84  which is annular and circular and which intersects the cavity wall  82 . An orifice  86  in each is located central to the surface  84  and is common either to the proximal cavity  64  and the main passageway  62 , to the distal cavity  66  and the main passageway  62 , or to the inflation/evacuation branch cavity  74  and the inflation/evacuation branch passageway  72 . 
     The proximal cavity body  68 , the distal cavity body  70 , and the inflation/evacuation branch cavity body  76  each includes a ring  88  having an angled annular surface  90  located around and about the outwardly facing end of the cavity body, as well as external threads  92  being outwardly located with respect to the ring  88  and angled annular surface  90 . The rings  88  and angled annular surfaces  90  provide in part for snap engagement of the manifold  36  to the proximal, distal and inflation/evacuation branch hemostatic nuts  40   a ,  40   b  and  40   c , respectively. 
     Each of the hemostatic nuts  40   a - 40   c  includes a centrally located cylindrical boss  94  and a beveled entryway  95  leading to a passageway  96  extending through and in part defining the cylindrical boss  94 . An annular cavity  100  is located about a portion of the cylindrical boss  94 . Internal threads  98  of the hemostatic nuts  40   a - 40   c  and the annular cavities  100  of the hemostatic nuts  40   a - 40   c  accommodate the outwardly facing ends of the proximal and distal cavity bodies  68  and  70  and the inflation/evacuation branch cavity body  76 , including the external threads  92  and the rings  88 , respectively. A ring  102  is located inwardly of the internal threads  98  and about the inwardly facing interior region of each of the hemostatic nuts  40   a - 40   c  for the purpose of snap engagement with and beyond the rings  88  of the proximal cavity body  68 , the distal cavity body  70 , and the inflation/evacuation branch cavity body  76 . The angled annular surface  90  adjacent to each ring  88  facilitates snap engagement of each ring  88  along and beyond a respective ring  102  of the hemostatic nuts  40   a - 40   c . Such snap engagement ( FIG. 3 ) loosely attaches the hemostatic nuts  40   a - 40   c  to the manifold  36  where the internal threads  98  of the hemostatic nuts  40   a - 40   c  can subsequently be made to engage the external threads  92  of the manifold  36 , whereby the cylindrical bosses  94  are brought to bear against and bring pressure as required against self-sealing hemostatic valves  106 , as shown in  FIG. 3 . The self-sealing hemostatic valves  106  are captured in the proximal cavity body  68 , the distal cavity body  70  and the inflation/evacuation branch cavity body  76  by engagement of the hemostatic nuts  40   a - 40   c  to the proximal cavity  64 , the distal cavity  66  or the inflation/evacuation branch cavity  74  of the manifold  36 . Also included in the hemostatic nuts  40   a - 40   c  is an annular lip  104  which can be utilized for snap engagement of particular styles or types of introducers as required. Beneficial to the instant invention is the use of self-sealing hemostatic valves  106 , the shape of which and the functions of which are described later in detail. The self-sealing hemostatic valves  106 , which are slightly oversize with respect to the proximal cavity  64 , the distal cavity  66  or the inflation/evacuation branch cavity  74 , are aligned in and housed in such cavities at locations about the manifold  36 . 
       FIGS. 4   a  and  4   b  are isometric views of one of the self-sealing hemostatic valves  106  which align in and which are housed in the proximal cavity  64 , the distal cavity  66 , and the inflation/evacuation branch cavity  74  adjacent to and in contact with the planar surface  84  in such cavities at the ends of the manifold  36  and the end of the inflation/evacuation branch  42 .  FIG. 4   a  is a proximal view of the self-sealing hemostatic valve  106 , and  FIG. 4   b  is a distal view of such self-sealing hemostatic valve  106  associated with the proximal cavity  64 . The self-sealing hemostatic valve  106  is compressible and multi-dimensional and sealingly expandable. The self-sealing hemostatic valve  106  is formed of medical grade silicone material and is symmetrically fashioned to include opposing mirror-like planar and circular-shaped faces  108  and  110  having opposing radiused recessed surfaces  112  and  114  extending therebetween and a circumferential edge  116  between the circular-shaped faces  108  and  110 . The medical grade silicone material between the opposing radiused recessed surfaces  112  and  114  is increasingly thinner in a direction towards the center and is parted or otherwise separated to form a plurality of slits  118   a - 118   n , each slit extending outwardly in radial fashion from the center of the self-sealing hemostatic valve  106  part of the distance along and between the radiused recessed surfaces  112  and  114 , thus creating boundaries beneficial in defining lobes  120   a - 120   n . That is to say, lobe  120   a  is located between slits  118   a  and  118   b , lobe  120   b  is located between slits  118   b  and  118   n , and lobe  120   n  is located between slits  118   n  and  118   a . Adjacent lobes  120   a - 120   n  are in mutual contact along the slits  118   a - 118   n  to effect a seal from side-to-side of the self-sealing hemostatic valve  106 . Although three lobes  120   a - 120   n  and three slits  118   a - 118   n  are shown, any number of each in correspondence can be utilized as desired and shall not be limiting to the scope of the invention. In the alternative, the silicone material of the self-sealing hemostatic valve  106  could be pierced between the recessed surfaces  112  and  114  to yet maintain a self-sealing quality. The self-sealing hemostatic valve  106  is preferably constructed of medical grade silicone or can be fashioned of other suitable flexible, pliable and resilient material which can conform to and about existing shapes or forms as required, such as to a guidewire or needle. The degree of flexibility of the lobes  120   a - 120   n , is influenced by the thickness of the lobes  120   a - 120   n  each of which contains a portion of the radiused recessed surfaces  112  and  114 . A guidewire, guidewire tube  20  or other round cross section device or member can pass between the inner tips of the lobes  120   a - 120   n  while maintaining a seal therebetween with the self-sealing hemostatic valve  106 . Due to the similar geometrical configuration of the opposing faces and associated structure therebetween, the self-sealing hemostatic valve  106  can be inserted into a cavity without regard to orientation of the self-sealing hemostatic valve  106 . The diameter of the self-sealing hemostatic valve  106  can be slightly larger than that of the cavities  64 ,  66  or  74  to provide for flexible, but snug, frictional engagement of the self-sealing hemostatic valve  106  within the cavities  64 ,  66  or  74 , as well as providing for circumferential sealing of the self-sealing hemostatic valve  106  to the cavities  64 ,  66  or  74 . Compressive force is transmitted into the self-sealing hemostatic valve  106  by tightening action of the proximal, distal and inflation/evacuation branch hemostatic nuts  40   a - 40   c  to compress the self-sealing hemostatic valve  106  around tubes, guidewires, or other elongated elements that pass through the self-sealing hemostatic valve  106 . The self-sealing hemostatic valve  106  operates automatically; that is, when the self-sealing hemostatic valve  106  is penetrated by a tube, wire, or other elongated element inserted therethrough, the compressed self-sealing hemostatic valve  106  automatically causes sealing around the element that has penetrated it. U.S. patent application Ser. No. 10/455,096 filed Jun. 6, 2003, entitled “Thrombectomy Device With Self-Sealing Hemostasis Valve,” which is incorporated herein by reference, includes a complete discussion of various structures and methods of incorporation of the self-sealing hemostatic valve  106 . 
       FIG. 5  is a cross section view of the valve  37  along line  5 - 5  of  FIG. 1  where the valve  37  is in the closed position such as for maintaining pressure within the lumen  26  of the guidewire tube  20  to maintain the occlusive balloon  22  in an inflated state, as later described in the mode of operation. The opening  29  of the seal  30  forms a close tolerance interference slidable sealed fit with the exterior surface of the sealing rod  32  to seal the portion of the lumen  26  distal to the seal  30  from the portion of the lumen  26  proximal of the seal  30 . 
       FIG. 6  is a cross section view of the valve  37  along line  5 - 5  of  FIG. 1  where the valve  37  is in the open position such as for relieving pressure within the lumen  26  of the guidewire tube  20  to allow collapsing of the occlusive balloon  22 , as later described on the mode of operation. As illustrated, urging of the sealing rod  32  proximally removes the sealing rod  32  from the influence of the seal  30 , thereby equalizing pressures distal and proximal of the seal  30 . 
     Alternatively, any number of other alloys or polymer materials and attachment techniques could be used in the construction of the multiple element valved guidewire assembly  12  provided the materials offer the flexibility and torque characteristics required for a guidewire and the attachment techniques are sufficiently strong enough and capable of making an airtight seal. These materials include, but are not limited to, Ni—Ti, 17-7 stainless steel, _304 stainless steel, cobalt superalloys, or other polymer, braided or alloy materials. The attachment techniques for constructing multiple element valved guidewire assembly  12  include, but are not limited to, welding, mechanical fits, adhesives, sleeve arrangements, or any combination thereof. 
     The occlusive balloon  22  may be made of any number of polymer or rubber materials. Preferably, the occlusive balloon  22  is preinflated to prestretch it so that expansion is more linear with pressure. Preferably, the pressure supplied by the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10  is designed to stay well within the elastic limit of the occlusive balloon  22 . A two-layer occlusive balloon arrangement, adding gas and/or liquid between balloon layers, may be used as an alternative to increase visibility of the distal end of the multiple element valved guidewire assembly  12  under fluoroscopy. 
     MODE OF OPERATION 
     The instant invention is generally used in the following manner where a patient is prepared for a common interventional procedure involving the ablative removal of thrombus, plaque, lesions and the like, for instance, via a femoral arterial access or other suitable vascular site. The distal end of the multiple element valved guidewire assembly  12  is inserted alone or through a pre-positioned sheath, a guide catheter or an introducer and is tracked to a preferred location distal to the buildup site. Subsequent to such positioning, the occlusive balloon  22  can be repeatedly inflated and deflated as required to controllingly and appropriately allow blood flow, to actively function as an occlusive device. The multiple element valved guidewire assembly  12  can serve as a guidewire for loading of and for use with ablation catheter devices, for placement of stents, or for other procedures. Subsequent to placement of the multiple element valved guidewire assembly  12  in the vasculature, the proximal end of the sealing rod  32  is loaded into the proximal hemostatic nut  40   a  of the manifold assembly  14  and thence through the distal hemostatic nut  40   b  and advanced until the valve  37  is contained therebetween in the main passageway  62  of the manifold  36 . Then vacuum is utilized by operation and subsequent removal of the evacuation syringe  16  to purge the manifold assembly  14  and the multiple element valved guidewire assembly  12  of air or other gaseous substances. Then metered biocompatible, highly blood soluble gas, such as CO 2 , helium, or other biocompatible gas, is introduced into the interior of the manifold  36  and through the open valve  37  by action of the inflation syringe  18  to inflate the occlusive balloon  22  to a desired size. The sealing rod  32  is then activated to close the valve  37 . The manifold assembly  14  then is removed from the multiple element valved guidewire assembly  12  leaving the multiple element valved guidewire assembly  12  including the inflated occlusive balloon  22  and the guidewire structure composed of the guidewire tube  20  and sealing rod  32  in place at the vascular site without the manifold (hubless) to be used with any other compatible interventional device, such as a thrombectomy catheter or a stent, in the manner desired. Thus, having a basic understanding of the present invention, the mode and method of operation and other features of the instant invention are now described with particular reference to  FIGS. 7 ,  8  and  9  and understood reference to other illustrations where  FIGS. 7 ,  8  and  9  are described below. 
       FIG. 7  is a view of the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10  in use within a blood vessel  124  having a buildup of thrombus, plaque, or lesions  122  (or other undesirable foreign material) where the flexible tip  28  and the occlusive balloon  22  have been advanced to a location distal of the thrombus, plaque, or lesions  122  within the blood vessel  124 . 
       FIG. 8  is a cross section view like  FIG. 3  but showing the valve  37  of the multiple element valved guidewire assembly  12  sealingly located in the main passageway  62  of the manifold  36 . 
       FIG. 9  is a view like  FIG. 7  but showing the occlusive balloon  22  inflated to occlude the blood vessel  124 . The method and manner of operation of the present invention is now set forth. 
     1. Prior to or subsequent to placement of the distal end of the multiple element valved guidewire assembly  12  into the vasculature, the proximal end of the multiple element valved guidewire assembly  12  (more specifically, the proximal end of the sealing rod  32 ) is inserted into the proximal hemostatic nut  40   a  to seal within the self-sealing hemostatic valve  106  therein and to pass into and through the main passageway  62  of the manifold body  38  until passing through and sealing within the self-sealing hemostatic valve  106  of the distal hemostatic nut  40   b  to position the valve  37  between the proximal and distal hemostatic nuts  40   a  and  40   b  in the main passageway  62 . The valve  37  within the main passageway  62  is in a location to selectively allow communication between the lumen  26  and attached occlusive balloon  22  of the guidewire tube  20  with the main passageway  62 , with the inflation/evacuation branch passageway  72  of the inflation/evacuation branch  42 , and with the pressure monitor branch passageway  78  of the pressure monitor branch  44 . The self-sealing hemostatic valves  106  in the proximal cavity  64 , in the distal cavity  66 , and in the inflation/evacuation branch cavity  74  seal the ends of the main passageway  62  and the end of the inflation/evacuation branch passageway  72 , respectively, to provide for a sealed but accessible interior of the manifold assembly  14 . 
     2. The needle  54  of the evacuation syringe  16  is inserted through the self-sealing hemostatic valve  106  associated with the inflation/evacuation branch hemostatic nut  40   c , and the plunger  48  of the evacuation syringe  16  is withdrawn to evacuate the main passageway  62 , the inflation/evacuation branch passageway  72  and the pressure monitor branch passageway  78  of the manifold assembly  14  where the vacuum (or pressure) is observed on the pressure gauge  45 . Accordingly, when the valve  37  is in the open position by positioning of the sealing rod  32 , such as shown in  FIG. 6 , the lumen  26  of the guidewire tube  20  and the occlusive balloon  22  are in common communication with main passageway  62  of the manifold body  38  and also subjected to the applied vacuum and are also evacuated. Such evacuation also minimizes the profile of the occlusive balloon  22 . The check valve  50  of the evacuation syringe  16  functions to stabilize and maintain the outwardly advanced position of the plunger  48  during evacuation. The evacuation syringe  16  is then withdrawn from engagement with the automatically self-sealing hemostatic valve  106  associated with the inflation/evacuation branch hemostatic nut  40   c  leaving the manifold assembly  14  and the multiple element valved guidewire assembly  12  in a sealed and evacuated state. 
     3. The needle  60  of the inflation syringe  18 , is then inserted through the self-sealing hemostatic valve  106  associated with the inflation/evacuation branch hemostatic nut  40   c , and the plunger  56  of the inflation syringe  18  is depressed to dispel and urge a suitable quantity of biocompatible inflation medium, preferably a gaseous medium, from the interior of the inflation syringe  18  into the interior of the manifold  36  and thence through the open valve  37  and through lumen  26  of the guidewire tube  20  to inflate the occlusive balloon  22  while observing the pressure gauge  45  where appropriately used volumes can be observed by viewing a displaceable piston  61  located in the inflation syringe  18 . Preferably, the inflation medium is a gas such as carbon dioxide or helium which are biocompatible and which dissolve easily in blood or which will not form a gas embolus. The check valve  58  of the inflation syringe  18  functions to stabilize and maintain the inwardly advanced position of the plunger  56  during inflation. 
     4. When suitable inflation of the occlusive balloon  22  is attained, the valve  37  is then closed by urging the sealing rod  32  in a distal direction to achieve closure of the valve  37 , as depicted in  FIG. 5 , wherein the multiple element valved guidewire assembly  12  maintains pressure within the lumen  26  and within the occlusive balloon  22 , and wherein the occlusive balloon  22  maintains an inflated state in intimate and sealing contact with the interior of the blood vessel  124 , as shown in  FIG. 9 . 
     5. Upon desired inflation of the occlusive balloon  22  and after ensuring the closed position of the valve  37 , the inflation syringe  18  can be withdrawn from the automatically self-sealing hemostatic valve  106  associated with the hemostatic nut  40   c . The manifold assembly  14  is then disengaged in a proximal direction from the multiple element valved guidewire assembly  12  leaving the pressurized multiple element valved guidewire assembly  12  undisturbed in the vascular site, i.e., the inflated occlusive balloon  22  is left in place in the blood vessel  124  with the guidewire tube  20 , whereupon the guidewire tube  20  can function as a guidewire. 
     6. The guidewire tube  20  along with the sealing rod  32  of the multiple element valved guidewire assembly  12  is then utilized unitarily for guidance of other devices, such as catheters, thrombectomy catheters, stents, and the like, to a vascular site proximal of the inflated occlusive balloon  22 . 
     7. An ablation or other procedure is performed for a time period consistent with the desired maximum length for blockage of the particular vessel after which the valve  37  may be opened by repositioning the sealing rod  32 , such as shown in  FIG. 6 , to equalize internal pressure with atmospheric pressure to rapidly deflate the occlusive balloon  22 , thereby reestablishing blood flow within the vessel  124 . The occlusive balloon  22  can be re-inflated and the valve  37  reclosed to continue with thrombus removal or to initiate another procedure. Depending upon the nature of the procedure, the multiple element valved guidewire assembly  12  may be removed from the vessel or left in place. Preferably, an evacuation of any plaque material or other debris dislodged by the therapy is accomplished before deflation of the occlusive balloon  22 . 
     8. Removal of the multiple element valved guidewire assembly  12  from the vasculature is accomplished by repositioning of the sealing rod  32  to open the valve  37  to atmosphere to collapse the occlusive balloon  22  for withdrawal. A further reduction of the physical cross section of the occlusive balloon  22  for minimum profile removal of the multiple element valved guidewire assembly  12 , i.e., the occlusive balloon  22 , can be accomplished by reinserting the proximal end of the sealing rod  32  of the multiple element valved guidewire assembly  12  into the manifold assembly  14 , if not already present, and accomplishing the evacuation steps outlined in steps 1 and 2 above. 
     9. Further and repeated use of the invention can be accomplished by repetition of steps 1 through 7 utilizing additional inflation syringes  18  as required. 
       FIG. 10 , an alternative embodiment, is a view showing the overall outwardly visible structure of a gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10   a  incorporating many of the principles and components of the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10 . In this alternative embodiment, the evacuation syringe  16  and the inflation syringe  18  are threadingly engaged to a manifold assembly  14   a  via an intermediate positionable valve  130 , thus negating the use of the needles  54  and  60  previously shown. The use of the inflation/evacuation branch cavity body  76  is not required, nor is the associated self-sealing hemostatic valve  106 , as sealing is accomplished by the positionable valve  130 . Accordingly, the inflation/evacuation branch hemostatic nut  40   c  and associated self-sealing hemostatic valve  106  are not incorporated therein. Operation of the gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device  10   a  is much the same as previously described, but differs in that the positionable valve  130  determines whether the evacuation syringe  16  or the inflation syringe  18  is in communication with the main passageway  62  through the inflation/evacuation branch  42 . 
     The present invention may be embodied in other specific forms without departing from the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention. 
     Various modifications can be made to the present invention without departing from the apparent scope hereof. 
     PARTS LIST 
     
         
           10  gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device 
           10   a  gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device 
           12  multiple element valved guidewire assembly 
           14  manifold assembly 
           14   a  manifold assembly 
           16  evacuation syringe 
           18  inflation syringe 
           20  guidewire tube 
           22  occlusive balloon 
           24  inflation orifice 
           26  lumen 
           27  proximal end 
           28  flexible tip 
           29  opening 
           30  seal 
           32  sealing rod 
           34  support extension 
           36  manifold 
           37  valve 
           38  manifold body 
           40   a  proximal hemostatic nut 
           40   b  distal hemostatic nut 
           40   c  inflation/evacuation branch hemostatic nut 
           42  inflation/evacuation branch 
           44  pressure monitor branch 
           45  pressure gauge 
           46  connector 
           48  plunger 
           50  check valve 
           52  connector 
           54  needle 
           56  plunger 
           58  check valve 
           60  needle 
           61  displaceable piston 
           62  main passageway 
           64  proximal cavity 
           66  distal cavity 
           68  proximal cavity body 
           70  distal cavity body 
           72  inflation/evacuation branch passageway 
           74  inflation/evacuation branch cavity 
           76  inflation/evacuation branch cavity body 
           78  pressure monitor branch passageway 
           80  flange 
           82  cavity wall 
           84  planar surface 
           86  orifice 
           88  ring 
           90  angled annular surface 
           92  external threads 
           94  cylindrical boss 
           95  beveled entryway 
           96  passageway 
           98  internal threads 
           100  annular cavity 
           102  ring 
           104  annular lip 
           106  self-sealing hemostatic valve 
           108  face 
           110  face 
           112  recessed surface 
           114  recessed surface 
           116  circumferential edge 
           118   a - n  slits 
           120   a - n  lobes 
           122  thrombus, plaque, or lesions 
           124  blood vessel 
           130  positionable valve