Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-05-03
2001-03-20
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S535000, C604S905000, C604S921000
Reexamination Certificate
active
06203532
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a cannula used in surgery to divert blood from a patient's blood vessels to a separate device, to shunt a patient's blood from one blood vessel to another blood vessel or to infuse a solution into the patient's blood vessel.
BACKGROUND OF THE INVENTION
Many cardiovascular surgical procedures require that the patient's blood flow be diverted from a vein or artery to a blood treating or flow supporting device. Infusion of particular solutions or liquids into the patient's vascular system is essential to the success of many important cardiovascular procedures. Techniques and methods of using cannulas of many sizes and materials are well known in the art.
In spite of the many years of use of cannulas in surgery and the hundreds of cannula connectors and fittings, the problem of having readily at hand cannulas of the proper size to interconnect with each other, to permit a change in the size of the cannula and to permit the cannula to be introduced into and retained by a blood vessel remains. It is common to provide a cannula fitting which has one or more tapered ridges of the same diameter proximate the end of and extending from the surface of the cannula for being inserted into another cannula. A cannula fitting of this type is illustrated in, for example, U.S. Pat. No. 4,883,455 to Leonard, Nov. 28, 1989. Another type of cannula connector that comprises a double-tapered enlargement is shown in U.S. Pat. No. 4,323,072 to Rosenbluth et. al., Apr. 6, 1982. For many applications, no special structure is required to form a liquid-tight seal of adequate strength between cannulas or between valves other devices and cannulas. For example, U.S. Pat. No. 5,084,031 to Todd, et. al., Jan. 28, 1992, discloses a device in which a plane right cylindrical tube is used to connect a valving device to a cannula. This is entirely satisfactory in many applications—provided the tube on the valve is of the proper size to mate with the cannula to form a liquid tight seal of adequate strength. Therein, however, lies the problem.
It is not economically feasible to manufacture a series of complex or expensive devices which differ only as to outlet or inlet tube size. Even if such devices could be manufactured economically, having a full array of different sized devices in the operating room conveniently accessible to the surgeon is not practicable.
Frequently, the surgeon needs to shunt blood or fluid flow from one size vessel to a different size vessel. While special fittings can be, and are, available, the need to anticipate the need for various sizes and to have them on hand in the operating room is an added complexity.
It is to this problem that the present invention is addressed.
SUMMARY OF THE INVENTION
A multi-diameter, multi-purpose cannula-to-vessel connector, which may be in the form of a shunt, occluder, or perfusion cannula intended for use as an aid in the execution of selected cardiovascular surgical procedures is described and claimed here.
The present invention has specific application in coronary artery bypass graft surgery. It is common surgical practice to use bypass grafts to help reestablish coronary artery circulation. In most patients one or usually more segments of the saphenous vein taken from the patient's legs will be implanted between the aorta near its base and just distal to the blockage of the branch of the stenosed coronary artery.
In some patients, the internal mammary artery is also utilized for bypassing the most important coronary artery which is stenosed. The aorta is cross clamped during the period of actual coronary artery surgery to minimize bleeding from the anastomotic sites of the coronary arteries. However, when an incision is made into the stenotic coronary artery a significant amount of hemorrhage may occur. The hemorrhage is thought to be due to the presence of collateral circulatory channels, probable emanating from the bronchial arteries. In such circumstances the surgeon's delicate task of producing a competent, yet leak tight, anastomosis between the bypass graft and the semi-occluded vessel in a reasonably short time, is made difficult.
Vessel occluders are known in the art. For example Mullen, D. C., Lepley, D. Jnr., and Flemma, R. J. described the use of a coronary occluder in their paper “Coronary artery surgery without global ischemia.” (Ann Thorac Surg 24:90, 1977. This device is a “T” shaped device with a bulbous tip placed at either end of the “T”. The device was manufactured from silicon rubber. A similar device, the Florester® coronary artery occluder is presently produced, and described in a brochure, by Bio-Vascular, Inc. St Paul, Minn. The device which is the subject of this invention does not have these disadvantages.
It is an objective of this invention to provide a vessel shunt that may be used with vessels of various diameters.
It is a further objective of this invention to provide a vessel occluder that may be used with vessels of various diameters.
It is a further objective of this invention to provide a vessel perfusion cannula that may be used with vessels of various diameters.
The simplicity and design of the multudiameter, multipurpose vessel shunt, occluder and perfusion cannula are such that it is quite inexpensive and hence may be disposable, hereby eliminating the necessity of cleaning and sterilizing between uses.
In a specific sense, this invention is directed to a multi-diameter, multi-purpose vessel shunt, occluder and perfusion cannula vessel occluder comprising one or several small flexible cannulas each with several circumferential flanges, spaced a short distance apart and located near the proximal end of the cannula. The outside diameters of the flanges are graduated such the largest diameter flange lies near the proximal end of the cannula, while the smallest diameter flange lies most distal from the proximal end of the cannula. Intermediate diameter flanges are located between the largest and smallest flange such that larger diameter intermediate flanges lie proximate to the largest flange and smaller diameter intermediate flanges lie between the largest and smallest flange but closest to the smallest flange. Thus the largest flange lies close to the proximal end of the cannula, the next smaller flange lies near the largest flange, next lies the next smaller flange, and so on until the smallest flange which is the flange most distal from the proximal end of the cannula.
The distal ends of the cannula are, typically, terminated with Luer fittings, although the distal end may terminate in any fitting or connected to a valve or other device. The cannula may by attached to a multi-way (usually four-way) stopcock. Guide members may be introduced into the cannula to provide sufficient rigidity to allow the cannula to be introduced into the vessel.
In a preferred embodiment, the present invention is cannula-to-vessel connector or occluder that comprises an elongate cylindrical member having an external cylindrical surface of a predetermined diameter and having first and second spaced apart ends, and connector means on the first end for connection to a tube or blood vessel or vein, said connector means comprising a tip portion of substantially the same diameter as said predetermined diameter and, spaced closely adjacent said tip portion, a plurality of circumferential flanges of different diameters spaced a short distance apart from each other, said flanges being configured, dimensioned and constructed such that the largest diameter flange lies immediately adjacent the tip portion and the smallest diameter flange lies more distant from the tip portion than the largest diameter flange, said flanges being configured, dimensioned and constructed such that the diameters of the flanges are larger than the diameter of said closely adjacent tip portion and preferably comprises an intermediate diameter flange located between said largest and said smallest flanges.
In another preferred embodiment, the invention is a cannula-to-vessel connector or occl
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