Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-08-29
2004-01-06
Woo, Julian W. (Department: 3731)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S101030, C604S043000
Reexamination Certificate
active
06673041
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a catheter system that facilitates cardiopulmonary surgeries and enables prolonged circulatory support of the heart.
BACKGROUND OF THE INVENTION
Heart surgery has generally required major open chest surgical procedures that put the patient at risk. Relatively high mortality rates and complications result from such invasive surgeries. Further, the surgeries require extensive hospitalization and recuperation time.
Surgical methods to correct heart problems are desirable which do not require open chest approaches. Some surgical techniques have been described for particular applications employing an intra-aortic catheter introduced into the vascular system of the patient. An example of such a technique may be found in U.S. Pat. No. 5,458,574. Endovascular techniques described to date, however, typically are not designed for all heart surgical procedures and do not provide access for robotic instruments to both sides of the heart.
Catheters have been described which access the left ventricle, for example, but there are none that are capable of surgically functioning on the right side of the heart. Further, such described catheters do not provide for a means to cross the atrial septum or provide for prolonged right or left ventricular bypass using an external pump, to mechanically support a reversibly failed heart in a closed chest procedure. Such a system which could be placed in both sides of the heart could more effectively resuscitate many cardiac arrest victims than other devices because ventricular decompression would be achievable.
Current methods further do not provide for selective cerebral perfusion, antegrade aortic flow, pulmonary artery flow or peripheral access vessel perfusion and drainage. Such mechanisms are necessary to minimize complications of a vast array related to proper direction of blood flow in the body.
Current methods do not take into account the desirability of perfusing the pulmonary artery or draining the left ventricle for prolonged support of the contracting but failed ventricle, via peripheral access for prolonged isolated right or left or simultaneous biventricular support. A system is needed which enables a broader range of endovascular cardiac surgical procedures, a method for prolonging heart support for certain surgical procedures and a method to mechanically support a reversibly failed heart to achieve direct circulatory arrest, with isolated cerebral perfusion using conventional heart and lung support machines.
SUMMARY OF THE INVENTION
The present invention provides a peripheral vascular catheter system versatile enough to access both sides of the heart, provide for prolonged heart support (to mechanically support a reversibly failed heart) to achieve deep hypothermic circulatory arrest with isolated or compartmentalized perfusion enabling surgery on the heart while controlling blood flow, including rate of flow, pressure, temperature, and the perfusion of selected chemicals, to selected parts of the body including but not limited to the brain, spinal cord, lungs, and heart. The invention can also be used to decompress selected chambers of the heart, which may allow some procedures to be performed without the need to stop the heart. The invention can further be used to perfuse a saline solution or the like to selected chambers of the heart to create a clear or bloodless operating field.
The subject biventricular vascular catheter system comprises (a) an elongated catheter shaft configured to be advanceable from a peripheral vessel or artery to and through all chambers of the heart, including across the ventricular or atrial septum, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the patients arteries or vessels and the chambers of the heart, the distal end having multiple fenestrations and a first inner lumen extending therein from a port in the distal end of the shaft to a location in the proximal end; and (b) at least one and preferably a succession of flow control members positioned along the catheter shaft used to isolate or compartmentalize the blood flow to selected parts of the patient's body.
In one embodiment configured for entry through a femoral artery or vein, to the left or right heart respectively, the first flow control member is located at the proximal end of the catheter shaft proximate the site of entry of the shaft into the patient, the second flow control member is located distal to the first flow control member and is dimensioned and configured so that it sits in the proximal descending thoracic aorta, a third flow control member distal to the second flow control member is dimensioned and configured so that it seats between the coronary ostia and the brachiocephalic artery, and a fourth flow control member distal to the third flow control member is dimensioned and configured so that it seats in the left ventricular outflow tract. Useable flow control members include, but are not limited to, expandable or inflatable members such as an inflatable balloons and valves including collapsible/expandable valves of various configurations including retrograde valves, antegrade valves, and various central flow and peripheral flow valves. A combination of valves and inflatable members may be is used as appropriate for a given procedure, thus In some embodiments, the catheter body can include one or more antegrade and retrograde valves, as well as one or inflatable balloons.
Inflatable balloons and collapsible/deployable valves are well known in the industry and any desirable or practical such inflatable balloon or deployable valve may be used. Inflatable balloons typically include an interior chamber that is in fluid communication with an inflation lumen extending within the catheter shaft from a location from within the respective flow control member to a location in the proximal portion which is adapted to extend out of the patient.
Preferably, the catheter system will also include a second limb branch catheter connected to the catheter shaft at the proximal end, the limb catheter disposed to provide for drainage or perfusion of the peripheral vessel used as an entry for the catheter shaft in order to protect the limb vasculature. Such limb catheters allow drainage or perfusion of the vessel entered to permit continual placement of the catheter for several days, if necessary, for subacute cardiac assist. If neck vessels are accessed, for example, metabolic monitoring access to that limb or to cerebral circulation would be permitted.
In one preferred embodiment, the catheter system preferably includes a self-sealing dual diaphragm chamber instrument entry port branching from the more distal-ending channel of the catheter which has inflow and outflow ports to remove the air from the chamber to prevent an air embolus from occurring and to allow for the safe introduction of large devices.
In another preferred embodiment of the catheter system, the catheter has a catheter guide, preferably with at least one fenestration which enables the guidance of the catheter into and through the chambers of the heart and which may be removed from the catheter while the catheter is located within the heart.
A further preferred embodiment includes multiple circumferential rings which extend axially around the shaft along a portion of the distal end of the shaft, which rings facilitate the movement of the catheter through the heart. The rings are further supported by struts which connect the rings to one another. The struts are arranged so that they are positioned at varying points around the circumference of the catheter tip to prevent kinking.
The catheter system will further preferably accommodate the selective perfusion or drainage of blood either separately or at the same time from within chosen isolated portions of the patients arteries or vessels in which the catheter is deployed.
The system described here encompasses a number of benefits including the following:
(a) the ability to perform intravascular cardiac and pulmonary surgery through
Cardeon Corporation
Fulwider Patton Lee & Utecht LLP
Woo Julian W.
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