Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Including means for graft delivery
Reexamination Certificate
1999-08-04
2001-03-27
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Including means for graft delivery
C606S108000, C623S903000
Reexamination Certificate
active
06206912
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to grafts for use in the repair, replacement, or supplement of a medical patient's natural body organ structures or tissues.
The invention also relates to methods for making graft structures. The invention further relates to methods and apparatus for delivering a graft to an operative site in a patient, and for installing the graft at that site. Some aspects of the invention may have other uses such as for viewing the interior of a patient, providing access to the interior of a patient for other procedures, etc. An example of the possible uses of the invention is a minimally invasive cardiac bypass procedure. This example will be considered in detail, but it will be understood that various aspects of the invention have many other possible uses.
Several procedures are known for revascularizing the human heart in order to treat a patient with one or more occluded coronary arteries. The earliest of these procedures to be developed involves exposing the heart by means of a midline sternotomy. Following surgical exposure of the heart, the patient's aorta and vena cava are connected to a heart/lung machine to sustain vital functions during the procedure. The beating of the heart is stopped to facilitate performance of the procedure. Typically, a suitable blood vessel such as a length of the patient's saphenous (leg) vein is harvested for use as a graft. The graft is used to create a new, uninterrupted channel between a blood source, such as the aorta, and the occluded coronary artery or arteries downstream from the arterial occlusion or occlusions.
A variation of the above procedure involves relocating a mammary artery of the patient to a coronary artery.
Although the above-described sternotomy procedures are increasingly successful, the high degree of invasiveness of these procedures and the requirement of these procedures for general anesthesia are significant disadvantages. Indeed, these disadvantages preclude use of sternotomy procedures on many patients.
More recently, less invasive procedures have been developed for revascularizing the heart. An example of these procedures is known as thoracostomy, which involves surgical creation of ports in the patient's chest to obtain access to the thoracic cavity. Specially designed instruments are inserted through the ports to allow the surgeon to revascularize the heart without the trauma of a midline sternotomy. Drugs may be administered to the patient to slow the heart during the procedure. Some thoracostomy procedures involve relocating a mammary artery to a coronary artery to provide a bypass around an occlusion in the coronary artery.
Thoracostomy bypass procedures are less traumatic than sternotomy bypass procedures, but they are still too traumatic for some patients. Also, the number of required bypasses may exceed the number of mammary arteries, thereby rendering thoracostomy procedures inadequate to fully treat many patients.
Another technique for revascularizing the human heart involves gaining access to the thoracic cavity by making incisions between the patient's ribs. This procedure is known as thoracotomy. It is also substantially less traumatic than midline sternotomy, but it is still too traumatic for some patients.
In view of the foregoing, it is an object of this invention to provide less traumatic methods and apparatus for revascularizing a patient.
It is another object of the invention to provide minimally invasive methods and apparatus for repairing, replacing, or supplementing the blood vessels or other body organ tubing or tissues of a patient.
It is still another object of the invention to provide improved graft structures for use in the repair, replacement, or supplementing of natural body organ structures or tissues, and to provide methods for making such graft structures.
It is yet another object of the invention to provide improved methods and apparatus for transporting or delivering and installing graft structures for use in the repair, replacement, or supplementing of natural body organ structures or tissues of a patient.
SUMMARY OF THE INVENTION
These and other objects of the invention are accomplished in accordance with the principles of the invention by providing methods and apparatus for substantially non-surgically installing a new length of tubing in a patient between two sections of the patient's existing body organ tubing, the new length of tubing being delivered to the operative site by passing along existing tubing, but installed at the operative site so that it is at least partly outside the existing tubing. (As used herein, references to a patient's existing body organ tubing or the like include both natural and previously installed graft tubing (whether natural, artificial, or both). A previous installation of graft tubing may have occurred in a previous procedure or earlier in a current and on-going procedure. References to a length of tubing also include plural lengths of tubing.) At one end of the operative site, the new length of tubing is caused to extend out through an opening made in the existing tubing. The outwardly extending end portion of the new tubing is guided to the other end of the operative site. At that other end another opening is made in the existing tubing and the extending end portion of the new tubing is attached to the existing tubing via that opening. The other end portion of the new tubing (remote from the extending portion) is similarly attached to the existing tubing at the first-described opening. The new tubing installation is now complete, and the apparatus used to make the installation can be withdrawn from the patient.
In the most preferred embodiment, all or substantially all necessary apparatus is inserted into the patient via the patient's existing body organ tubing. In addition, all or substantially all apparatus functions at the operative site are remotely controlled by the physician (a term used herein to also include supporting technicians) from outside the patient's body.
Preferred apparatus in accordance with the invention includes a first elongated instrument for extending through the patient's existing body organ tubing to a first end of the operative site, and a second elongated instrument for similarly extending through the patient's existing tubing to a second end of the operative site. Each instrument includes a structure capable of penetrating the existing tubing at the associated end of the operative site. In addition, these structures are capable of interengaging with one another outside the existing tubing to provide a substantially continuous structural path from outside the patient, along the patient's existing tubing, and then outside that tubing from one end to the other of the operative site. This structure is used to guide the new length of tubing into the patient and into position at the operative site.
At least one of the elongated instruments preferably includes mechanisms for fastening each end portion of the new length of tubing to the adjacent existing body organ tubing. For example, these mechanisms may activate fasteners on or associated with the new tubing.
The new tubing may be artificial graft tubing. Alternatively, the new tubing may be natural body organ tubing (e.g., tubing harvested from another location in the patient's body). As still another alternative, the new tubing may be a combination of artificial and natural tubing (e.g., natural tubing disposed substantially concentrically inside artificial tubing).
A preferred form of artificial tubing includes a tube frame of a first highly elastic material (such as nitinol) covered with a second highly elastic material (such as silicone rubber) to substantially fill in the apertures in the frame. This combination produces an artificial graft that is distensible like natural body organ tubing such as a natural artery. The covering on the frame is preferably made porous to a predetermined degree to improve its bio-utility in this context. A preferred method of pr
Bachinski Thomas J.
Goldsteen David S.
Mazzocchi Rudy
Sullivan Daniel J.
Fish & Neave
Isabella David J.
Jackson Robert R.
Koh Choon P.
St. Jude Medical Anastomotic Technology Group Inc.
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