Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-11-09
2001-05-01
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S165040
Reexamination Certificate
active
06224570
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a rheolytic thrombectomy catheter and method of using same to remove thrombus from a body vessel or other body cavity.
2. Description of the Prior Art
Procedures and apparatus have been developed for ease in removing tissue and various deposits. Several such devices employ a jet of saline as the working tool to help break up the tissue deposit and further provide a suction means to remove the deposit. U.S. Pat. No. 5,135,482 to Neracher describes a hydrodynamic device for removal of organic deposit from a human vessel. A supply of saline is delivered by a high pressure duct to the distal end of a catheter. The saline exits the duct as a jet that is directed generally forward and directly toward the tissue to be broken up. The duct is contained within and can move axially with respect to a hose that is positioned around the duct. A vacuum suction is applied to the hose to remove the debris that is created from the broken-up tissue. This device is not intended to pass through tortuous pathways found in the fragile vessels of the brain, and any attempt to employ the device for such purpose would be far too traumatic to the patient.
Another drainage catheter, described by Griep in U.S. Pat. No. 5,320,599, has a discharge channel and a pressure channel. The channels are formed into a single catheter tube such that the two tubes are fixed with respect to each other. This catheter could not provide the flexibility needed to negotiate the tortuous vascular pathways found in the vessels of the brain.
SUMMARY OF THE INVENTION
The general purpose of the present invention is to provide a rheolytic thrombectomy catheter and method of using same to remove thrombus from a body vessel or other body cavity.
The present invention, a rheolytic thrombectomy catheter, is a surgical device for removal of material such as thrombus from a vessel or other body cavity. As shown in one or more embodiments, a rheolytic thrombectomy catheter for removing tissue from a vessel or other body cavity includes an outer assembly comprising a first tube or catheter having a lumen with an open distal end and an internally and distally located stationary stop partially obstructing the lumen at the open distal end, the lumen being of a diameter sufficient to allow passage of a guidewire; and an inner assembly comprising a high pressure second tube or hypo-tube having a high pressure lumen and a distal end having one or more orifices, a distally located transitional stop fixed to the high pressure hypo-tube adjacent to the distal end, and a jet cap positioned at the hypo-tube distal end for directing one or more jets of saline toward the distal end of the catheter, the inner assembly being movable axially within the outer assembly such that the distally located transitional stop engages the distally located stationary stop to hold the jet cap in a desired relationship with respect to the distal end of the catheter.
In another embodiment, a rheolytic thrombectomy catheter for removing thrombus or other body tissue from an obstructed body vessel or other body cavity includes an outer assembly including an evacuation tube having a proximal end and an open distal end containing a distally located stationary stop and having an evacuation lumen that is of a diameter sufficient to allow passage of a standard coronary or interventional neuroradiological guidewire; and an inner assembly including a high pressure hypo-tube having a high pressure lumen, the high pressure hypo-tube having a proximal end and a distal end, the distal end having one or more orifices through which saline can exit from the high pressure lumen to be directed toward the open distal end of the evacuation tube, a distally located transitional stop fixed to the high pressure hypo-tube at a position closer to the distal end than to the proximal end, and a jet cap positioned at the distal end of the high pressure hypo-tube, the jet cap coacting with the high pressure hypo-tube to direct one or more jets of saline toward the open distal end of the evacuation tube.
Preferably, the rheolytic thrombectomy catheter has a guidewire coil attached at the distal end of the jet cap to allow advancement of the inner assembly and the outer assembly together within the vasculature. Preferably, the rheolytic thrombectomy catheter has a jet cap which directs a jet of saline toward the distal end of the catheter, which functions as an evacuation tube. Preferably, the rheolytic thrombectomy catheter includes a high pressure hypo-tube with at least one orifice and a jet cap configured and arranged for directing one or more jets of saline to impinge upon or near the distal end of the catheter. The rheolytic thrombectomy catheter preferably is flexible and can pass over a standard guidewire through tortuous vascular pathways.
The present invention also provides a method of removing thrombus from an obstructed body vessel. The method includes the steps of:
a. providing a guidewire and an outer assembly including a catheter having a distal end and an internally located stationary stop positioned adjacent to the distal end;
b. advancing the guidewire to a vascular site containing thrombus;
c. advancing the catheter over the guidewire to the vascular site containing thrombus to position the distal end at the vascular site;
d. removing the guidewire from the catheter;
e. providing an inner assembly including a hypo-tube carrying a jet cap and a transitional stop spaced apart from the jet cap;
f. advancing the inner assembly within the catheter of the outer assembly to engage the transitional stop with the stationary stop; and,
g. providing a high pressure saline supply to the hypo-tube so as to cause a jet of saline to emanate from the jet cap and to entrain thrombus into a gap or space where the thrombus is macerated and then pushed into the catheter for removal from the body; and,
h. providing impingement of the jet on the evacuation lumen to create sufficient stagnation pressure to allow evacuation of debris with no need for additional suction on the proximal end of the evacuation lumen.
In the method, preferably, the jet cap carries a distally projecting guidewire coil to facilitate further distal advancement of the inner assembly and the outer assembly together within the vasculature to a further vascular site containing thrombus so as to remove additional distally situated thrombus.
The present invention is also a catheter combination including a first tube or catheter, being a part of an outer assembly, the first tube having a proximal end, an open distal end, and a lumen extending between the proximal end and the open distal end; a second tube or hypo-tube, being a part of an inner assembly, the second tube being separable from the first tube and being insertable within the lumen of the first tube, the second tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; a jet cap, being also a part of the inner assembly, the jet cap being connected to the second tube at the distal end of the second tube for directing fluid exiting the lumen of the second tube, the jet cap being capable of passage through the lumen of the first tube and being characterized by the ability to provide a localized region of low pressure associated with a liquid flow directed generally proximally and into the lumen of the first tube through the open distal end of the first tube when the jet cap is located and oriented appropriately relative to the open distal end of the first tube; and means for indexing an appropriate positional relationship of the jet cap and distal end of the second tube relative to the open distal end of the first tube. The means for indexing preferably includes a distally located stationary stop projecting inward from the first tube and a distally located transitional stop projecting outward from the second tube. When the second tube is advanced within the first tube, the stops mutually engage to control the orientation and spacing and relati
Bonnette Michael J.
Dutcher Robert G.
Kozak Debra M.
Le Hieu V.
Morris John Edward
Jaeger Hugh D.
Possis Medical, Inc.
Seidel Richard K.
Thanh Loan H.
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