Surgery – Means for introducing or removing material from body for... – With means for cutting – scarifying – or vibrating tissue
Reexamination Certificate
2001-06-25
2004-06-29
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
With means for cutting, scarifying, or vibrating tissue
C604S043000, C604S035000, C606S167000, C606S159000, C083S024000, C083S022000
Reexamination Certificate
active
06755803
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an interchangeable and separable catheter system for alternatively incorporating the principles of a rheolytic thrombectomy catheter or the principles of a crossflow thrombectomy catheter, or of the simultaneous use of the principles of both the rheolytic thrombectomy catheter and the crossflow thrombectomy catheter.
The present invention relates to apparatus for use in treatment of the human body. More particularly, the present invention relates to an elongated device which may be a single catheter assembly or a multiple component catheter assembly and which is suitable for use through percutaneous or other access, for endoscopic procedures, or for intraoperative use in either open or limited access surgical procedures. Still more particularly, the present invention relates to an elongated device in the form of a rheolytic thrombectomy catheter or, alternately, in the form of a fluid jet thrombectomy catheter, the latter hereinafter termed crossflow thrombectomy catheter, and having a commonly used outer catheter assembly, each device being incorporated for fragmentation and removal of thrombus or other unwanted material from blood vessels or body cavities, and each device using high velocity saline (or other suitable fluid) jets to macerate the thrombus or other unwanted material. The elongated device bears certain similarities to a known waterjet thrombectomy catheter and can be used as such, but differs therefrom in several material respects, a major distinction being in the provision of interchangeable alternate means which produce inwardly directed jets with or without crossflow jets. The crossflow jets create a recirculation flow pattern optimized for clearing a large cross section of mural thrombus or other similar material, the name crossflow thrombectomy catheter deriving from this major distinction. Further, the present invention also relates to a system constituted either by the combination of the elongated device with both pressurized fluid source means and exhaust regulation means or by the combination of the elongated device with only pressurized fluid source means.
2. Description of the Prior Art
Procedures and devices 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 body, 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.
Waterjet thrombectomy catheters have been described in which a distal-to-proximal-directed waterjet(s) flow(s) past a window, orifice or gap at the distal end of the catheter, re-entering the catheter and pushing flow through an evacuation lumen. When placed in a vessel containing thrombus and activated, the high velocity jet(s) will entrain surrounding fluid and thrombus into the window, orifice or gap region, where the high shear forces of the jet(s) will macerate the thrombus. The macerated particles will be removed from the body by the pressure generated on the distal end of the evacuation lumen by the impingement of the high velocity waterjet(s).
A limitation of these waterjet thrombectomy catheters has been the inability to remove organized, wall-adherent thrombus from large vessels. In accordance with the present invention, the single operator exchange fluid jet thrombectomy device described overcomes this limitation by optimizing the recirculation pattern at the tip of the device to increase the drag force exerted on the mural thrombus to break it free from the vessel wall and allow it to be removed by the device.
Prior art devices often required the use of more than one operator where one operator must stabilize the guidewire while the second operator introduces the catheter over the guidewire into the anatomy.
The present invention overcomes the disadvantages of the current devices by providing an interchangeable catheter system utilizing either the rheolytic thrombectomy catheter or the crossflow thrombectomy catheter, each of which can be operated by one practitioner, and which offers multiple advantages over previous rheolytic thrombectomy catheter designs. More specifically, the present invention is incorporated for removal of unwanted deposits in the body, such as, but not limited to, deposits in bile ducts, the brain or other hematomas, and brain ventricles, for example.
SUMMARY OF THE INVENTION
The present invention, a single operator exchange fluid jet thrombectomy device, 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, the single operator exchange fluid jet thrombectomy device can function as a rheolytic thrombectomy catheter for removing tissue from a vessel or other body cavity and includes an outer catheter assembly common to any mode of operation, the commonly used outer catheter assembly of which is comprised of a manifold and a first tube or guide catheter having a lumen with an open distal end, the lumen being of a diameter sufficient to allow passage of an inner catheter assembly. One such inner catheter assembly as incorporated in use with the single operator exchange fluid jet thrombectomy device is comprised of a high pressure second tube having a high pressure lumen and a geometrically configured distally located jet emanator having one or more rearwardly directed orifices for directing one or more jets of saline toward the distal end of a flow director, a proximally located transitional stop fixed to the second tube adjacent to the second tube proximal end, and an exhaust tube. The inner catheter assembly is movable axially within the outer catheter assembly such that the proximally located transitional stop engages the proximally located stationary stop to hold the jet emanator in a desired relationship with respect to the distal end of the outer catheter assembly.
The single operator exchange fluid jet thrombectomy device, the present invention, provides a catheter combination for use as a rheolytic thrombectomy catheter including the first tube or guide catheter, being a part of a common use outer assembly, the first tube or guide catheter having a proximal end, a manifold attached thereto, an open distal end, and a lumen extending between the proximal end and the open distal end; the second tube, being a part of an inner catheter assembly, the second tube being separable from the first tube or guide catheter and being insertable within the lumen of the first tube or guide catheter, the second tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; a flow director having an inner body and an exhaust tube which may or may not be expandable, each being located near but not at the second tube distal end, a pressure operated sealable or closely fit annulus between the outer surface of the exhaust tube and the interior annular surface of the first tube or guide catheter, a jet emanator integrally formed at the distal end of the second tube or attached thereto by a bonding operation into which at least one jet o
Bonnette Michael J.
Dutcher Robert G.
Kozak Debra M.
Le Hieu V.
Morris John Edward
Casler Brian L.
Jaeger Hugh D.
Maynard Jennifer
Possis Medical, Inc.
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