Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-12-05
2004-05-11
Kennedy, Sharon (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C600S486000
Reexamination Certificate
active
06733488
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device and method for delivering a therapeutic substance to the myocardium of a human heart.
BACKGROUND OF THE INVENTION
Tissue becomes ischemic when it is deprived of adequate blood flow. Ischemia causes pain in the area of the affected tissue and, in the case of muscle tissue, can interrupt muscular function. Left untreated, ischemic tissue can become infarcted and permanently non-functioning. Ischemia can be caused by a blockage in the vascular system that prohibits oxygenated blood from reaching the affected tissue area. However, ischemic tissue can be revived to function normally despite the deprivation of oxygenated blood because ischemic tissue can remain in a hibernating state, preserving its viability for some time. Restoring blood flow to the ischemic region serves to revive the ischemic tissue.
Although ischemia can occur in various regions of the body, often tissue of the heart, the myocardium, is affected by ischemia due to coronary artery disease, occlusion of the coronary arteries, which otherwise provide blood to the myocardium. Muscle tissue affected by ischemia can cause pain and lead to infarction of the tissue. Ischemia can be treated, if a tissue has remained viable despite the deprivation of oxygenated blood, by restoring blood flow to the affected tissue.
Treatment of myocardial ischemia has been addressed by several techniques designed to restore blood supply to the affected region. Coronary artery bypass grafting (CABG) involves grafting a venous segment between the aorta and the coronary artery to bypass the occluded portion of the artery. Once blood flow is redirected to the portion of the coronary artery beyond the occlusion, the supply of oxygenated blood is restored to the area of ischemic tissue.
Early researchers, more than thirty years ago, reported promising results for revascularizing the myocardium by piercing the muscle to create multiple channels for blood flow. Sen, P. K. et al., “Transmyocardial Acupuncture—A New Approach to Myocardial Revascularization”,
Journal of Thoracic and Cardiovascular Surgery
, Vol. 50, No. 2, August 1965, pp. 181-189. Although others have reported varying degrees of success with various methods of piercing the myocardium to restore blood flow to the muscle, many have faced common problems such as closure of the created channels. Various techniques of perforating the muscle tissue to avoid closure have been reported by researchers. These techniques include piercing with a solid sharp tip wire, hypodermic tube and physically stretching the channel after its formation. Reportedly, many of these methods still produced trauma and tearing of the tissue that ultimately led to closure of the channel.
An alternative method of creating channels that potentially avoids the problem of closure involves the use of laser technology. Researchers have reported success in maintaining patent channels in the myocardium by forming the channels with the heat energy of a laser. Mirhoseini, M. et al., “Revascularization of the Heart by Laser”,
Journal of Microsurgery
, Vol. 2, No. 4, June 1981, pp. 253-260. The laser was said to form channels in the tissue that were clean and made without tearing and trauma, suggesting that scarring does not occur and the channels are less likely to experience the closure that results from healing. U.S. Pat. No. 5,769,843 (Abela et al.) discloses creating laser-made TMR channels utilizing a catheter based system. Abela also discloses a magnetic navigation system to guide the catheter to the desired position within the heart. Aita U.S. Pat. Nos. 5,380,316 and 5,389,096 disclose another approach to a catheter based system for TMR.
Although there has been some published recognition of the desirability of performing transmyocardial revascularization (TMR) in a non-laser catheterization procedure, there does not appear to be evidence that such procedures have been put into practice. For example, U.S. Pat. No. 5,429,144 Wilk discloses inserting an expandable implant within a preformed channel created within the myocardium for the purposes of creating blood flow into the tissue from the left ventricle.
Performing TMR by placing stents in the myocardium is also disclosed in U.S. Pat. No. 5,810,836 (Hussein et al.). The Hussein patent discloses several stent embodiments that are delivered through the epicardium of the heart, into the myocardium and positioned to be open to the left ventricle. The stents are intended to maintain an open channel in the myocardium through which blood enters from the ventricle and perfuses into the myocardium.
Angiogenesis, the growth of new blood vessels in tissue, has been the subject of increased study in recent years. Such blood vessel growth provides new supplies of oxygenated blood to a region of tissue that has the potential to remedy a variety of tissue and muscular ailments, particularly ischemia. Primarily, the study has focused on perfecting angiogenic factors such as human growth factors produced from genetic engineering techniques. It has been reported that injection of such a growth factor into myocardial tissue initiates angiogenesis at that site, which is exhibited by a new dense capillary network within the tissue. Schumacher et al., “Induction of Neo-Angiogenesis in Ischemic Myocardium by Human Growth Factors”,
Circulation,
1998; 97:645-650. The authors noted that such treatment could be an approach to management of diffused coronary heart disease after alternative methods of administration have been developed.
SUMMARY OF THE INVENTION
The present invention provides a transthoracic drug delivery device that is specially configured to be precisely located in the myocardium for accurate placement of a therapeutic substance such as a drug. The device comprises a syringe having a delivery tube that is capable of penetrating the myocardium via the epicardium to access the left ventricle. Access to the heart is gained through the thorax. A pressure monitor associated with the device indicates the position of the distal tip of the delivery tube. It is noted that, throughout the discussion of the invention in the specification, “distal” is meant to indicate the direction along the access path of the device leading internal to the patient and “proximal” indicates the direction along the access path leading external to the patient. Pressure may be monitored through the delivery tube or through a separate pressure tube associated with the delivery tube. Specifically, the amount of pressure measured through the tube of the device informs the physician whether the distal port of the tube has penetrated the myocardium completely to reach the left ventricle. In the case of separate delivery and pressure tubes, the distance between the pressure tube opening and drug delivery tube opening is known, so the user can determine whether the drug delivery tube opening is still within the myocardium, and, therefore, appropriately placed to inject a drug into the myocardium. Multiple drug delivery tubes may be associated with the device to perfuse the drug more quickly through multiple ports into the myocardium. It is noted that throughout the specification “drug” includes all varieties of therapeutic substances that may be beneficial to the body, including pharmaceutical agents, genetically engineered substances or natural substances.
In another embodiment, a pressure sensing hypodermic tube, as in the first embodiment, is used to transthoracically access the heart and penetrate the left ventricle. However, the second embodiment is comprised of a single pressure sensing tube. The distal portion of the pressure tube is flexible and made controllable or steerable by mechanisms well known in the art of catheter manufacture such as a pull wire bonded to the distal end of the tube and extending proximally for manipulation outside the patient. After penetrating the left ventricle, the single pressure tube may be bent into a “J” configuration and the shaft withdrawn proximally to cause the curved tip of the J portion to penetrate t
Cafferata Robert
Choh Richard T.
Forcucci Stephen J.
Gambale Richard A.
C.R. Bard Inc.
Kennedy Sharon
Kirkpatrick & Lockhart LLP
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