Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
1999-03-03
2001-02-20
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
C128S200240, C128S858000
Reexamination Certificate
active
06191334
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the field of perforation repair in body tissues, and more particularly relates to a dissolvable device and a method utilizing the dissolvable device, for repairing perforations in body tissues. The dissolvable repair device and associated method have particular use for repairing perforations in nasal septums, as well as in the repair of fistulas that form between the maxillary sinus and the oral cavity.
BACKGROUND OF THE INVENTION
The septum is a structure that separates the two nasal passages within the nose. The septum consists of cartilage anteriorly and bone posteriorly, which are sandwiched between nasal mucosa. Perforations or holes in the nasal septum may result from trauma, infection or exposure to certain drugs such as cocaine. Perforations may also result from medical illnesses such as Wegener's Granulomatosis, or after septoplasty surgery to straighten or repair the nasal septum. The consequences of a perforated nasal septum include the chronic accumulation of crusts and scabs within the nose which obstruct nasal breathing; recurrent epistaxis or nose bleeds from the edge of the perforations; and abnormal airflow through the perforation(s) resulting in a whistling sound as the patient breathes.
The repair of septal perforations is very difficult, with such procedures often times failing and the perforation recurring and even becoming larger as a result of the attempted repair. One conventional repair procedure involves the rotation of flaps of nasal mucosa to cover the perforation(s).
An additional perforation or hole that can form in body tissue comprises fistulas that may form between the maxillary sinus and the oral cavity. Fistulas or connections often times result from infections of the tooth sockets after the extraction of teeth. Fistulas can be extremely difficult to close, and surgical repair is difficult and often fails repeatedly.
The present invention provides an alternative to existing measures for repairing septal perforations, fistulas and other perforations in body tissues.
SUMMARY OF THE INVENTION
The invention provides a dissolvable repair device, and a method utilizing the same, that is intended to aid in the repair and healing of a perforation in body tissue, such as a nasal septum. The repair device is intended to be placed over the area of the perforation to act as a scaffolding for the regrowth of tissue over the perforation. The repair device is made from a bioerodable material that is dissolvable upon exposure to certain fluids, including body fluids. Over time, the repair device will dissolve, allowing sufficient time for tissue to regrow over the area of the perforation. Since the repair device is dissolvable, a surgical procedure is not required in order to remove the repair device.
In one embodiment in accordance with the invention, a perforation repair device is provided which comprises a member made from a bioerodable material. The member is in the form of a sheet having a thickness of between about 0.25 mm and about 2.0 mm.
In another embodiment in accordance with the invention, a method of repairing a perforation in body tissue is provided. The method comprises placing a member made from a bioerodable material over the perforation in the body tissue, securing the member in place over the perforation, and allowing the member to dissolve over a period of time.
The preferred bioerodable material that is used to form the member is collagen, which is a natural architectural component of the tissues of the human body. The collagen can be in the form of a gelatin material that is prepared and manufactured in various ways, thus allowing for the creation of a generally rigid, but slightly malleable device that has some elasticity and memory of structure. These characteristics allow for the device to be temporarily deformed upon the application of a significant force during the positioning of the device. However, in the absence of the force, the device will return to its original configuration, thus providing a generally straight, generally planar support device over which body tissue, such as mucosa, can grow, thereby closing a perforation. One suitable gelatin material is called GELFILM®.
Another advantage of the dissolvable repair device is that it can be impregnated with various materials that enhance the capabilities of the repair device. In one version, the bioerodable material can be impregnated with gluteraldehyde to vary the rate at which the repair device dissolves. Thus, the repair device can be designed to remain for a sufficient time to allow the desired amount of tissue growth over the perforation to occur. The bioerodable material can also be impregnated with antibiotics which will be released in the area of the perforation as the repair device dissolves, thereby assisting in the prevention of infection.
A variety of additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
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patent: 4588400 (1986-05-01), Ring et al.
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patent: 4650488 (1987-03-01), Bays et al.
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patent: 5584799 (1996-12-01), Gray
Acoustic Technologies Inc.
Brown Michael A.
Hamilton Lalita
Merchant & Gould P.C.
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