Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-11-17
2003-12-09
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S507000, C604S522000, C424S093100
Reexamination Certificate
active
06659995
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to cardio myopathy and the treatment thereof.
2. Description of the Prior Art
By way of background, cardio myopathy, as caused for example by myocardial infarction, is a common disorder. Twenty thousand new cases are reported yearly in the United States and 25-50% of such cases will result in death after three years. The problem is that damaged adult heart muscle does not regenerate and myocardial functionality cannot be restored using the body's natural healing mechanisms. The myocardium tends to dilate and areas of the ventricular walls may become hypokinetic, or even akinetic, such that congestive heart failure often develops in affected individuals.
Previous medical techniques have not substantially reduced the morbidity or mortality of this condition. Past efforts in this area include removing autologous muscle cells, stem cells, etc., and culturing them to generate the large number of implantation cells necessary for myocardial repair. The cultured cells are then implanted via injection or the like into the myocardium, where they have an opportunity to regenerate new heart muscle. However, cell culturing requires sophisticated equipment, is expensive, and involves a delay of several weeks as the cell culture grows. This makes it impossible, for example, to use implantation treatment as an adjunct to emergency coronary bypass surgery. Instead, a separate implantation procedure is required that must await maturation of the patient's autologous cell culture.
Accordingly, a need exists for an improved treatment to repair, and restore functionality to, a damaged myocardium resulting from myocardial infraction or the like. What is required is an autologous myocardial implantation method that overcomes the foregoing disadvantages of conventional implantation procedures. What is especially needed is an implantation method that allows immediate use of harvested autologous implantation tissue for implantation during emergency coronary bypass operations and other procedures where time is of the essence.
SUMMARY OF THE INVENTION
The foregoing problems are solved and an advance in the art is obtained by a novel method and apparatus for autologous myocardial implantation treatment. According to the method, a donor area of a patient containing healthy skeletal muscle is located. Using a suitable retrieval device, the practitioner retrieves myocyte micro granules from the donor area and either transfers them to a suitable implantation device or leaves them in the retrieval device if that device is also adapted for micro granule implantation. After locating an implantation area of the patient's myocardium that contains damaged myocardial tissue, the myocyte micro granules are implanted into the implantation area. No intervening cell culturing is performed between myocyte micro granule retrieval and implantation.
A myocyte micro granule retrieval device is provided for retrieving the myocyte micro granules from a donor area. This device includes one or more extraction probes, each having a distal tip that can be advanced into the skeletal muscle of the donor area, and a retrieval system for causing the distal tips to each withdraw a myocyte micro granule upon removal thereof from the donor area.
A myocyte micro granule implantation device can also be provided for implanting the myocyte micro granules in a damaged area of a patient's myocardium. This device includes a tubular body, an injection tip on the body that is adapted to enter the damaged area and deliver the myocyte micro granules, and a plunger within the body for pushing myocyte micro granules through the injection tip. In one configuration of the implantation device especially adapted for implantation according to an epicardial approach, the device includes a handle extending laterally from the body for grasping by a medical practitioner when the injection tip is inserted in the beating myocardium.
In another configuration of the implantation device especially adapted for implantation according to a transfemoral approach, the device includes a retractable screen system for blocking myocyte micro granules from leaving the myocardium during implantation.
REFERENCES:
patent: 5902279 (1999-05-01), Powles et al.
patent: 6110459 (2000-08-01), Mickle et al.
patent: 6151525 (2000-11-01), Soykan et al.
patent: 6395016 (2002-05-01), Oron et al.
Suzuki, et al., Circulation. 2000; 102 [suppl III]: III-359-III-364.
Casler Brian L.
DeSanto Matthew
Duft Walter W.
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