Surgery – Instruments – Blood vessel – duct or teat cutter – scrapper or abrader
Reexamination Certificate
1998-10-09
2001-12-11
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Blood vessel, duct or teat cutter, scrapper or abrader
Reexamination Certificate
active
06328749
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a device or assembly for the treating of blood vessels and more specifically to a device or assembly for performing a remote endarterectomy or dilatation and to an endarterectomy method using the device.
It is known that narrowing or blockages (thromboses) can occur in blood vessels, particularly in older people. This is often caused by the effects of deposits on the inside walls of the blood vessels leading to hardening or calcifying of the blood vessels. This has dangerous consequences for the health, because the quantity of blood now able to flow through the blood vessel is drastically reduced. In order for effective blood circulation to occur, and to avoid possible limb amputation for example, any blockage or obstacle in the blood vessels must be removed.
One conventional method for treating hardening of the blood vessels involves a complicated operation. In the case of the artery between the groin and knee, this is quite a severe operation. The patient is cut open at the groin and the knee, whereafter the artery is completely removed and replaced by an artificial artery. This can be especially hard on and dangerous for older people, particularly because of the duration of the operation. The operation is also expensive and requires a lengthy hospital recovery period for the patient. Additionally, there is a danger of rejection of the artificial blood vessel by the body, which can lead to further post operation complications.
Another procedure for treating totally or partially blocked blood vessels, called endarterectomy, separates the inner layer of the blood vessel, the so called tunica-intima or intimal lining or intima, from the blood vessel wall using a ring stripper. The intimal lining, which has been separated from the vessel wall over the length of the blockage, is then removed from the patient along with the blockage. A new intimal lining then grows back to replace the removed intimal lining. See, for example, U.S. Pat. Nos. 2,944,552 and 4,621,636.
Conventional endarterectomy procedures are typically carried out using two incisions, one on either side of the blockage. The first incision permits access to the vessel by the instrument; the second incision permits access to the distal end of the separated intima so the separated intima may be severed from the vessel wall and then removed through the first incision.
SUMMARY OF THE INVENTION
The present invention is directed to a remote endarterectomy ring stripper which requires only one incision and provides for quicker, less expensive, more patient-friendly endarterectomy procedures.
The remote endarterectomy ring stripper includes an elongate shaft having distal and proximal ends. An intima stripping ring, having an open interior, is mounted to the distal end of the elongate shaft. The ring stripper also includes an intima cutter assembly having a cutting element and a cutting element actuator. The cutting element is located at the stripping ring and is movable along a cutting path across at least a portion of a cutting region. The cutting region passes through the open interior of the stripping ring.
The cutting element actuator has a first end, at the proximal end of the shaft, and a second end, operably coupled to the cutting element. The cutting element actuator is manipulated by the user to permit the user to cause the cutting element to move along the cutting path so to sever a length of intima, which has been separated from the wall of the blood vessel and passes through the open interior of the stripping ring.
The cutting element can take a number of different forms. In one embodiment the stripping ring is formed by a pair of stripping ring portions positioned adjacent to one another. The two stripping ring portions are movable with adjacent surfaces sliding against one another; the sliding surfaces have appropriately positioned cutting edges which sever the intima passing through the interior of the stripping ring. In another embodiment the cutting element includes an intima-severing wire initially positioned adjacent to the stripping ring; the cutting element is actuated by pulling on the wire to cause the wire to sever the intima passing through the stripping ring. Further embodiments use pivotal, retractable, or otherwise movable blades to cut the intima passing through the stripping ring. Still other types of cutting elements can be used as well.
A blocked blood vessel is able to be cleaned using the present invention so that the need for a time consuming, expensive bypass operation, which is harsh on the patient, is eliminated. The requirement of using an artificial replacement blood vessel is no longer present, because the old vessel is now in a state to again effectively fulfill its function. Therefore, rejection of an artificial blood vessel by the body, and its ensuing problems, do not play a role here. The hospital recovery period is shortened due to the less exacting nature of this operation, whereby the costs decrease and more hospital beds become available.
The stripping ring preferably has a cross section in the form of a truncated cone, the nose of which comprises a blunt edge which projects in the direction of the incision. In this way the blunt edge separates the intima from the blood vessel wall when the instrument is pushed between the intima and the blood vessel wall. The intima is thus peeled further away from the blood vessel wall and is subjected to a sort of bottle neck effect, caused by the cone form, between the two sides of the ring.
The length of the shaft may depend on the length of the blood vessel to be cleaned, and/or the extent of calcification in the blood vessel.
The cutting element actuator, in one embodiment, comprises a part that can take the form of a filament or a wire, that extends through the shaft, which can be moved with respect to the shaft by a user-actuated manipulator. In one embodiment the manipulator comprises a lever associated with the shaft. In this way the intima can be separated from the blood vessel wall and cut through at the required distance by the instrument, which is operable from outside the body.
The separation of the intima from the blood vessel wall and the cutting through and severing of the intima is consequently quick and able to be carried out in an elegant and simple manner. After cutting through of the intima, the intima plus blockage are removed through the single incision.
Further advantages, characteristics and details of the present invention will become clear from the following description which refers to the accompanying drawings.
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Ho, G. et al., “The Mollring Cutter™ Remote Endarterectomy
Cox Brian J.
Fogarty Thomas J.
Glynn Brian A.
Kalmann Menno
Lenker Jay A.
Hann James F.
Haynes Beffel & Wolfeld
Thaler Michael H.
Vascular Architects, Inc.
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