Surgery – Instruments – Means for removing tonsils – adenoids or polyps
Utility Patent
1999-09-21
2001-01-02
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Means for removing tonsils, adenoids or polyps
C606S113000, C606S127000, C606S110000
Utility Patent
active
06168604
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for removing clot and embolic material from vessels of the cardiovascular system and, more particularly, to a device having a deployable sack attached to a guide wire adjacent a distal end of the guide wire.
2. Description of the Prior Art
Within body canals, specifically vessels of the cardiovascular system, capture and removal of thromboemboli is of significant clinical importance. Thrombus is an aggregation of platelets, fibrin, clotting factors and cellular components of blood that spontaneously form and attach on the interior wall of a vein or artery, partially or completely occluding the lumen.
Thrombus formation is either acute or chronic. Chronic formation can be related to a genetic propensity or a physiologic response to foreign material such as atrio-ventricular grafts in dialysis patients. Chronic formation causes the gradual reduction in the lumen of a vessel with a reduction of oxygen delivery to associated tissue. Treatment may involve balloon angioplasty, balloon angioplasty with stenting, thrombolysis, or thrombolysis with thrombectomy. Acute formation may be a response to blunt force trauma or an embolic event. Acute formation immediately causes complete occlusion of the lumen of a vessel. In peripheral vessels, treatment in response to acute formation may involve lysis with, for example, urokinase, embolectomy, or both.
Embolic events occur randomly during certain practiced and emerging clinical procedures for treatment of chronic situations. They are attributed to thrombus or plaque (cholesterol and cellular debris) that becomes mobile within the blood stream during a procedure, only to relocate to other smaller vessels to obstruct blood flow. Resulting complications include stroke, myocardial infarction, kidney failure, limb loss or even death. These complications can be reduced through use of a device to capture emboli inadvertently created during the procedure.
Embolectomy is a well-accepted procedure. It is a through lumen, device mediated procedure to mechanically remove clot formations from a vessel. A Fogarty balloon catheter is a commonly used device to perform an embolectomy. Embolectomy is the procedure of choice for the patient with an acute embolus in the peripheral vasculature. Immediate treatment is often required to salvage limbs. Causes of acute embolus include rheumatic heart disease, arteriosclerotic heart disease, atrial fibrillation and blunt force trauma.
The Fogarty balloon catheter is meant for acute cases. The vessel in which an embolus has lodged is identified and the position of the embolus within the vessel located. The lumen of the vessel is then accessed, either through a cut-down or though an access port. If a cut-down is used, the vessel is clamped to the side of the cut-down away from the clot. The Fogarty catheter is then inserted into the vessel lumen and the unexpanded balloon advanced past the clot. The balloon is then inflated and pulled toward the cut-down. As the balloon nears the cut-down, the clot is pushed out the cut-down.
Approximately 6% of patients undergoing Fogarty catheterization experience complications, specifically, retrograde balloon pullback injury leading to intimal hyperplasia and vessel restenosis. Simply sliding the balloon against the intima causes damage thereto—the higher the pressure, the more severe the damage. Thus, manufacturers caution about maximum pull force applied when using a Fogarty balloon catheter.
Since the Fogarty balloon catheter is a high pressure balloon, it cannot remove small clots, particularly when the vessel lining is irregular. In addition, losses of 10% to 20% of clots with the balloon are attributed to various causes.
For the acute patient, treatment with urokinase is controversial. It is a treatment of convenience for the physician, but confines a patient to an intensive care unit (ICU) for up to 72 hours, exposing the patient to dangers associated with clot migration, such as renal failure, myocardial infarction, hematoma and even death. Also of issue are treatment costs due to confinement to the ICU and a large amount of urokinase.
Distal protection during interventional and surgical procedures is a concept of growing importance to reduce the risk of embolic events. Devices to mediate the risk of embolic events are just being asked for to a larger degree by interventionalists. These devices act as an intervening filter downstream between the source of clot or plaque and a vulnerable site. Procedures that experience substantial risk from embolic events and the proposed means to manage the risk, include percutaneous transluminal coronary angioplasty (PTCA) with or without stent placement and saphenous vein graft maintenance (placement of protection in coronary vessels); carotid angioplasty with stent placement (placement of protection in the carotid); and coronary artery by-pass grafts and aortic aneurysm repair (placement of protection in the aorta).
Stenosis or occlusion of coronary vessels is common. Treatment is either coronary artery by-pass graft (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA). CABG surgery is a widely used surgical procedure to reestablish normal blood flow to cardiac muscle beyond a stenosis or occlusion in a coronary artery by grafting another vessel to the artery to shunt blood around the occlusion. The graft is harvested from another site, usually the leg, in the patient. The saphenous vein is most frequently used for the graft.
PTCA is a preferable alternative to CABG in the treatment of stenosis. In this guide wire/catheter-based procedure, a high-pressure balloon is positioned across the stenosis and inflated to deform the stenotic lesion to augment the effective lumen of the vessel and thus return adequate blood flow. The vessel may receive additional radial support by positioning and expanding a coronary stent across the lesion.
Clinical experience now indicates that, within five to ten years of CABG, however, a saphenous vein graft (SVG) can become diseased as the saphenous vein develops in the low pressure venous system and is not sufficiently robust for the high pressure arterial system. The disease is expressed as an accumulation of plaque or thrombus in the graft that again reduces perfusion of the cardiac muscle.
In performing carotid angioplasty with stent placement, strokes can result. Stroke is the death of neurons attributable to reduced oxygenation due to interrupted blood flow. Resultant damage frequently is permanent.
While stroke is often a random, unpredicted occurrence, it may also be a component of procedures of the carotid artery leading to the brain. It is not uncommon for the carotid artery to become clogged with plaque. Treatment, until recently, has been carotid endarterectomy, the surgical removal of the obstructive material. Complication rate is 3% to 6%, depending on whether the patient is symptomatic or asymptomatic.
Recently, stent-supported carotid angioplasty has emerged as a potential alternative. Unfortunately, emboli are a potential by-product of the procedure, placing the patient at risk to stroke. Exacerbating the risk is the brain's susceptibility to even small particles. While the incidence of stroke may be at an acceptable level for the highly skilled practitioner, the incidence of stroke is likely to increase as the procedure is performed by the average practitioner. Consequently, wide use of the procedure is dependent upon a reasonably transparent means to intercept even very minute particles of plaque dislodged during the procedure. A temporary carotid filter will significantly reduce the likelihood of stroke as carotid stenting increases.
Coronary artery by-pass grafts (CABGs) surgery, the standard open-chest procedure to restore adequate blood flow to the heart muscle, involves stopping the heart, clamping the aorta near its origin at the top of the left ventricle, placing the patient on external by-pass, locating the coronary artery or arteries that are blocked, harvesting
Metamorphic Surgical Devices, LLC
Philogene Pedro
Webb Ziesenheim & Logsdon Orkin & Hanson, P.C.
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