Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
1999-03-03
2001-02-13
Thaler, Michael H. (Department: 3731)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S006000, C606S199000
Reexamination Certificate
active
06186965
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the field of implantable splints, and more particularly relates to a dissolvable splint for supporting a septum, such as a nasal septum, as well as to a method for supporting a septum utilizing a pair of the dissolvable splints. The dissolvable splint has particular use for supporting the septum of the nose after it has been surgically repaired with a septoplasty procedure.
BACKGROUND OF THE INVENTION
The purpose of any septal splint is to provide stability and support to a septum, particularly while the septum is healing after a surgical procedure thereon. One common use of a septal splint is to support a nasal septum while it is healing after performing a septoplasty procedure. Typically, one septal splint is placed on each side of the nasal septum, and then the splints are secured into position using a non-dissolvable suture that traverses the nasal septum and each of the splints. The splints prevent the nasal septum from healing in a bent or curved position. The splints are thereafter removed within 5-10 days, along with the non-dissolvable suture.
A second purpose of the splints is to prevent blood from accumulating within the nasal septum after surgery has been performed. The two splints are pulled tightly together by the suture, squeezing the nasal septum therebetween. This prevents a septal hematoma from accumulating between the two reapproximated mucosal surfaces of the nasal septum. If such a hematoma does form, an infection may occur, which could result in the injury of the cartilaginous support structure of the nose, and thereby possibly result in the collapse of the nose.
However, conventional septal splints have to be removed after a period of time, typically 5-10 days, thereby necessitating that the patient return to the doctor for a follow-up visit for splint removal. In rural areas and small medical facilities at which a surgeon may visit at infrequent intervals, such as once per month, the requirement for a follow-up visit after implanting the septal splints can be problematic, and often times requires that special arrangements be made to permit the splint removal. Similarly, in cases where a patient must travel long distances to have surgery performed, the patient is required to make an additional trip back to their surgeon for splint removal. Furthermore, removal of septal splints can be difficult, particularly from children for whom such a procedure can be especially traumatic.
What is needed then is an improved septal splint and method of using the same that solves many of the problems of conventional septal splints, as well as providing additional benefits not found in existing septal splints.
SUMMARY OF THE INVENTION
The invention provides an improved septal splint that does not require removal after implantation. The septal splint is designed to be dissolvable over a period of time, thereby eliminating the need to remove the splint. Preferably, the splint dissolves within four weeks after placement. The dissolvable splint of the invention allows surgeons that provide services to rural and small medical facilities at infrequent intervals, such as once per month, to perform septoplasty procedures without requiring the surgeons to make special arrangements for follow-up visits to remove the splints. Furthermore, the dissolvable splint eliminates the need for a splint removal procedure.
In one embodiment in accordance with the invention, a septal splint for supporting a septum is provided which comprises a body having first and second side faces and a peripheral edge extending between the first and second side faces. One of the first and second side faces is substantially planar to enable disposition against the septum. The body is formed of a bioerodable material whereby the body does not have to be surgically removed.
In another embodiment in accordance with the invention, a method of supporting a septum is provided which comprises providing a pair of septal splints each of which is made of a bioerodable material; positioning the septal splints on each side of the septum; securing the septal splints in place with the septum disposed therebetween; and allowing the septal splints to dissolve over a period of time.
In yet another embodiment in accordance with the invention, a dissolvable splint to be surgically implanted for supporting body tissue is provided. The splint comprises a body having first and second side faces and a peripheral edge extending between the first and second side faces. The body is shaped to abut the body tissue and provide support thereto. The body is formed of a bioerodable material whereby the splint does not have to be surgically removed once it is surgically implanted.
The preferred bioerodable material that is used to form the septal splint 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, slightly malleable splint that has some measure of elasticity and memory of structure. The characteristics allow for the splint to be temporarily deformed upon the application of significant force during the positioning of the splint. However, upon removal of the force, the splint will return to its original configuration, thus providing a rigid support for the tissue to which it is attached. One suitable gelatin material is called GELFILM®.
Another advantage of the dissolvable septal splint is that it can be impregnated with various materials that enhance the capabilities of the splint. In one version, the splint can be impregnated with gluteraldehydes to vary the rate at which the splint dissolves. The splint can also be impregnated with antibiotics which will be released in the area of the septum as the splint dissolves, thereby assisting in the prevention of post-operative 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.
REFERENCES:
patent: 4378802 (1983-04-01), Ersek
patent: 4592357 (1986-06-01), Ersek
patent: 4650488 (1987-03-01), Bays et al.
patent: 5350580 (1994-09-01), Muchow et al.
patent: 5584799 (1996-12-01), Gray
patent: 3933217 (1991-04-01), None
Acoustic Technologies Inc.
Merchant & Gould P.C.
Thaler Michael H.
LandOfFree
Dissolvable septal splint and method of using the same does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Dissolvable septal splint and method of using the same, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Dissolvable septal splint and method of using the same will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2591115