Surgery – Internal organ support or sling
Reexamination Certificate
2002-11-04
2004-09-14
Jones, Mary Beth (Department: 3736)
Surgery
Internal organ support or sling
C601S153000
Reexamination Certificate
active
06790172
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is generally directed to an apparatus and method for resectioning body tissue. The present invention is more particularly directed to such an apparatus and method which may be used on various types of body tissue and which greatly simplifies resection procedures.
Chronic Obstructive Pulmonary Disease (COPD) has become a major cause of morbidity and mortality in the United States over the last three decades. COPD is characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction in COPD is due largely to structural abnormalities in the smaller airways. Important causes are inflammation, fibrosis, goblet cell metaplasia, and smooth muscle hypertrophy in terminal bronchioles.
About 40 years ago, it was first postulated that the tethering force that tends to keep the intrathoracic airways open was lost in emphysema and that by surgically removing the most affected parts of the lungs, through lung volume reduction surgery (LVRS), the force could be partially restored. Although the surgery was deemed promising, the procedure was abandoned.
Lung volume reduction surgery was later revived. In the early 1990's, hundreds of patients underwent the procedure. However, the procedure has fallen out of favor due to the fact that Medicare stopped remitting for LVRS. Unfortunately, data is relatively scarce and many factors conspire to make what data exists difficult to interpret. The procedure is currently under review in a controlled clinical trial. However, what data does exist tends to indicate that patients benefited from the procedure in terms of an increase in forced expiratory volume, a decrease in total lung capacity, and a significant improvement in lung function, dyspnea, and quality of life.
Improvements in pulmonary function after LVRS have been attributed to at least four possible mechanisms. These include enhanced elastic recoil, correction of ventilation/perfusion mismatch, improved efficiency of respiratory musculature, and improved right ventricular filling.
The improvements in pulmonary function resulting from LVRS cannot be ignored. However, the surgery is very invasive and fraught with complications. Among the complications is the potential for lung air leaks. Lung tissue is very thin, and fragile hence difficult to suture together. After a lung portion is sectioned and removed, the remaining lung is most often restructured with suture staples. In about thirty percent (30%) of the cases, the difficulty with suturing lung tissue results in air leaks. Treatment for such air leaks depends upon their severity and often, in the most serious cases, requires further open chest surgery.
Air leaks in lungs can be caused by other causes. With increasing age, a patient may develop a weakened section of lung which may then rupture due to an extreme pressure differential, such as may result from simply a hard sneeze. Patients with AIDS and pulmonary complications can suffer from air leaks. Air leaks in lungs can further be produced by direct trauma such as a puncture from a broken rib or a stab wound.
The invention disclosed and claimed in copending U.S. Pat. No. 6,328,689 B1 provides an improved therapy for treating COPD. The improved therapy includes a lung constriction device and method for suppressing such air leaks in lung tissue which does not require any suturing of the effected lung tissue. Still further, by constricting a large enough portion of a lung, lung volume reduction with the concomitant improved pulmonary function may be obtained without the need for any suturing of lung tissue at all.
More specifically, the lung constriction device includes a jacket of flexible material configured to cover at least a portion of a lung. The jacket has a pair of opened ends to permit the lung portion to be drawn into the jacket. The jacket is dimensioned to constrict the lung portion after the lung portion is drawn therein. The lung constriction device is preferably formed of expandable material for receiving the lung portion when forced into an expanded enlarged condition by an expansion force, and then contractible about the lung portion upon release of the expansion force for constricting the lung portion.
An important aspect of the device and method disclosed in U.S. Pat. No. 6,328,689 B1 is the ability to sever the constricting device intermediate its ends. This allows a significant portion of the constricted lung tissue to be removed altogether while permitting a portion of the constricting device to remain in the body for continued suppression of air leaks and maintenance of the remaining lung tissue integrity.
Devices and methods similar to those disclosed in U.S. Pat. No. 6,328,689 B1 may be employed to advantage in other and different procedures such as in general resection procedures and for body tissue. Resection procedures are commonly performed for such body tissue as, for example, atrial appendage tissue, ovarian tissue, gall bladder tissue, pancreatic tissue, appendix tissue and spleen tissue. Resection procedures may be required to treat cancer, organ damage, or organ disease, for example.
Common to all resection procedures is the need to isolate the body tissue to be removed, resection the body tissue to be removed, and then suture the incision. All the while, great care must be taken to avoid infection from external sources and from the diseased tissue being removed. Frequent aspiration of blood and other body fluids, some of which may be contaminated, is often essential. The present invention provides an improved method for use in body tissue resection.
SUMMARY OF THE INVENTION
The invention therefore provides a method of resectioning body tissue which may find many applications for encapsulation, isolation, and resection of body tissue. More particularly, among its many applications, the present invention may be employed for removal of diseased tissue, nodules and tumors, for example. The method includes the steps of providing a sheath formed of severable material having opposed opened ends, drawing the body tissue to be resectioned into the sheath to confine and constrict the soft tissue within the sheath, and severing the sheath and the body tissue within the sheath intermediate the opposed opened ends of the sheath.
The invention further provides a device for use in resectioning body tissue. The device comprises a sheath of severable material, the sheath having a pair of opened ends for receiving the body tissue and the sheath being dimensioned for containing and constricting the body tissue.
The invention further provides a system for resectioning body tissue. The system includes a sheath of severable material, the sheath having a pair of opened ends for receiving the tissue and the sheath being dimensioned for containing and constricting the tissue, means for drawing the tissue into the sheath to constrict and isolate the tissue, and means for severing the sheath to resection the tissue.
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Alferness Clifton A.
Gonzalez Hugo X.
Jones Mary Beth
Knobbe Martens Olson & Bear LLP
Spiration, Inc.
Veniaminov Nikita R
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