Surgery – Instruments – Blood vessel – duct or teat cutter – scrapper or abrader
Reexamination Certificate
1996-09-16
2001-02-27
Kamm, William E. (Department: 3737)
Surgery
Instruments
Blood vessel, duct or teat cutter, scrapper or abrader
C600S585000
Reexamination Certificate
active
06193735
ABSTRACT:
BACKGROUND OF THE INVENTION
The subject invention is directed to a catheter system and apparatus for opening a totally or partially occluded blood vessel.
In my prior U.S. Pat. Nos. 4,936,845, issued Jun. 26, 1990, for “Catheter System Having Distal Tip For opening Obstructions,” and 5,116,350, issued May 26, 1992, under the same title, I have disclosed methods and apparatus for opening an occluded blood vessel through the use of a catheter with a drive shaft having a distal tip portion that is impinged against the occlusion with an axial or rotary reciprocatory motion. The patents disclose two separate devices, one capable of producing an axially reciprocated movement and the other capable of producing a rotary reciprocal movement.
There are numerous other arthrectomy devices for opening vascular obstructions such as the Kinsey catheter disclosed in U.S. Pat. No. 4,749,376. These other prior devices that use rotary rotation all have the common problem of “wrapping” or “twisting” tissue because of the unidirectional rotation. The reciprocal rotation of my device prevents this from happening.
In my prior U.S. Pat. No. 4,854,325, issued Aug. 8, 1989, for “Reciprocating Guidewire Method,” I have disclosed the use of a conventional guidewire for use in forming a passageway through a vascular obstruction. This system utilizes a conventional guidewire and catheter which is already in the patient's vascular system, such as in a coronary artery. This patent discloses a system for reciprocating the guidewire back and forth.
It now appears that it would be most desirable if the drive shaft tip or the guidewire tip were subjected to both forms of reciprocation (i.e., axial and rotary) simultaneously. The combined motions seem to produce more efficient and effective opening of the occlusions than either motion performed by itself.
SUMMARY OF THE INVENTION
The subject invention provides a system and apparatus that produces combined axial and rotary reciprocatory movements of the drive shaft tip or the guidewire tip in an effective, controllable manner.
My prior U.S. Pat. Nos. 4,936,845 and 5,116,350, issued Jun. 26, 1990 and May 26, 1992, respectively, are dedicated systems with a single purpose and are meant for use in the larger vessels. The disclosure of these patents are incorporated herein by reference. Briefly, however, the catheter system generally comprises the previously-mentioned drive catheter wire which terminates in a distal tip that can have a variety of known configurations to assist in penetration through obstructions such as plaque in the blood vessel to be opened. Typical designs are shown, for example, in my above-mentioned prior U.S. patents.
My prior U.S. Pat. No. 4,854,325, issued Aug. 8, 1989, titled “Reciprocating Guidewire Method” now appears to be the preferred method and will be the method described in detail. The apparatus generally comprises a conventional catheter having a guidewire protruding from the tip of the catheter. The guidewire has a sufficient length to extend from a region outside a patient to the obstructed region. The catheter acts as a guide for free axial and rotary movement. Positioned outside the patient are power means including an output shaft coupled to the guidewire. The power means includes plural motor means for simultaneously axially reciprocating and rotating the guidewire to impart simultaneous axial reciprocation and rotary reciprocation to the guidewire.
In addition, and in accordance with a further aspect of the invention, there are means provided for varying the rate of axial reciprocation imparted to the guidewire. Also, it is preferable that the power means includes a first motor for rotating the guidewire and a second motor for axially reciprocating the guidewire. Means are also provided for periodically reversing the direction of rotation of the first motor to produce rotary reciprocation of the guidewire.
In its preferred form, the first motor is mounted for reciprocation and the second motor is drivingly connected to cause axial reciprocation of the first motor.
As can be seen from the foregoing, a primary object of the invention is the provision of a catheter system and apparatus that can produce combined axial and rotary reciprocatory movements of the guidewire in a manner to facilitate opening of obstructions in a patient's blood vessels.
A further object of the invention is the provision of an apparatus of the type described wherein the rate of axial reciprocation can be readily varied without varying the rate of rotary reciprocation.
A still further object is the provision of an apparatus of the general type discussed which is relatively simple to use, and efficient and effective in operation. The use of a guidewire in place of a drive shaft with tip is very desirable. By using a guidewire to do both the axial and rotary reciprocatory movements, no change of catheter or other device is necessary during a procedure. In other words, the angiographic catheter and the guidewire are already in the patient's vascular system (example: a coronary artery). If the attempted angiographic study or angioplasty is successful, there is no need for additional devices. However, when an obstruction is encountered that cannot be crossed with the conventional catheter and guidewire which is being used in the patient, additional help is needed. Having to remove the catheter and guidewire already in the patient and exchanging it for another system doubles the risk to the patient.
With my new system, all you need is to attach the guidewire, which is already in the patient, to the external motorized device in order to impart the axial and rotary reciprocating movements.
Another advantage to the new system is in placing the guidewire and catheter at the beginning of the procedure. There are multiple branching vessels in the coronary system. Pushing a guidewire (0.014″ in dia) with a very flexible (“floppy”) tip section is difficult at best. We are talking about a 6 foot long guidewire being pushed through a catheter not much larger than the guidewire itself. The guidewire must also be able to be turned from side to side. Physical things, such as guidewires, at rest tend to remain at rest. However, if the guidewire is in motion such as being moved backward and forward and from side to side in a controlled manner, the guide will be easier to advance when the desired vessel opening is reached.
Still other advantages and benefits of the invention will become apparent to those skilled in the art upon a reading and understanding of the following detailed description.
REFERENCES:
patent: 4749376 (1988-06-01), Kensey et al.
patent: 4854325 (1989-08-01), Stevens
patent: 4936845 (1990-06-01), Stevens
patent: 5116350 (1992-05-01), Stevens
patent: 5234451 (1993-08-01), Osypka
patent: 5431673 (1995-07-01), Summers et al.
patent: 5490859 (1996-02-01), Mische et al.
Evanisko George R.
Fay Sharpe Fagan Minnich & McKee LLP
Kamm William E.
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