Adjustable tension device for sutures

Surgery – Instruments – Suture retaining means

Reexamination Certificate

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Details

C606S233000

Reexamination Certificate

active

06241749

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to a medical device used in surgery. In particular, the device is a tension-adjusting device for sutures to be used in abdominal surgery and other surgeries involved in the closure of large incisions and wounds.
BACKGROUND OF THE INVENTION
Major invasive surgery, such as surgery on the trunk and the legs, require relatively large openings, i.e., openings longer than three inches. The closure of surgical openings and large holes in the trunk and legs has unique problems. Because of the articulation of the skeletal elements, muscular movement of the trunk and/or legs, and/or motion of body organs, such as the stomach, intestines, lungs, diaphragm, and the like, closure of such wounds or openings can be difficult to maintain until healed. Wounds are usually closed with sutures, surgical staples, adhesives, or a combination thereof. If a patient is active, restless or is subject to involuntary physical exertion, such as coughing, sneezing, and/or cramps, skeletal articulation, muscular movement, or organ motion can open such wounds-even those wounds which have partially healed. Such movement or exertions can cause the staples and/or the sutures to be torn out and/or the patient's skin to be torn, causing the wound to open.
It is an object of the present invention to provide a means to permit a large incision, wound, or opening to be sutured, especially an incision, wound, or opening (collectively, “wound” herein) in the trunk or leg, whereby the sutures are elastically tied to permit the trunk or leg to move, expand, and contract and yet still provide adequate tension of the sutures to maintain closure of the wound.
SUMMARY OF THE INVENTION
The present invention is directed to a tension-adjusting device for sutures and a method of closing off wounds, employing sutures using the tension-adjusting device.
The tension-adjusting device for sutures comprises a body having at least three legs extending outwardly and downwardly from the body, the body having a dorsal surface and a ventral surface, with peripheral sides connecting the dorsal surface and the ventral surface; at least two ducts, each duct having at least one opening on the dorsal surface and at least one opening on the ventral surface of the body.
The legs on at least one side of the body are partially bendable in a vertical direction. Each leg has proximal end connected to the body and a distal end; each leg has a foot at its distal end; and each foot has a sole or bottom surface to rest on the skin of the patient. Preferably, the sole of each foot on each leg has a frictional surface to restrict movement of the foot on the skin. Although the legs do not have to be the same length, preferably the feet of all the legs will rest on a common plane. In one embodiment of the invention, all the legs are same length. In another embodiment of the present invention, the legs on one side, i.e., on one half of the body, are longer than the legs on the other side or other half of the body.
Each duct can have a single opening at the dorsal surface and a single opening at the ventral surface. In another embodiment of the present invention, each duct has a plurality of openings on the ventral surface of the body. The body can have one or more grooves on its dorsal surface; preferably the duct openings on the dorsal surface open into the grooves. The sutures can ride in the grooves between the duct openings to protect the sutures or the knots tying the ends of two sutures.
In one embodiment of the present invention, the body is divided into two elements, the top element and the bottom element. The top element has a dorsal side and a bottom side and the bottom element has a top side and a ventral side. The top element has an engagement seat on its bottom side and the bottom element has an engagement seat on the top side. The engagement seat of each element is engageable in a mating relationship to form the body. The top element has a cavity opening to its bottom side, and the bottom element has a cavity opening to its top side. The engagement of the top element and bottom element forms an enclosed cavity between the bottom side of the top element and the top side of the bottom element. Alteratively, only one of the elements can have a cavity which becomes an enclosed cavity when the two elements are matingly engaged. The dorsal side of the top element constitutes the dorsal surface of the body, and the ventral side of the bottom element constitutes the ventral surface of the body.
The sutures are secured to the adjustable tension device by feeding the free end of a suture through one duct from the ventral surface and across the dorsal surface of the body to another duct and feeding the free end down through the duct from the dorsal surface or side to the ventral surface or side.
In one embodiment of the present invention, the engagement seats of the top element and the bottom element have a circular shape, and the top element is rotatably mounted on the bottom element when the two elements are engaged in a mating relationship. In this embodiment, the top element can be rotated on the bottom element permitting the sutures which are secured by the device to be rotated with the top element, thus tightening the tension of the sutures. This is accomplished because the sutures extend through the ducts in the top element and the bottom element. The top element has a plurality of ducts extending therethrough with openings on its dorsal side and bottom side, each duct having at least one opening on the dorsal side and at least one opening on the bottom side of the top element. The bottom element has a plurality of ducts extending therethrough, from its ventral side to its top side, each duct having at least one opening on the top side of the bottom element and at least one opening on the ventral side of the bottom element. Preferably, when the seats of the top element and the bottom element have circular shapes, the top element has a shaft extending downward from its bottom side, coaxial with the circular shaped seat, and the bottom element has a sleeve extending upwardly from its top side coaxial with its circular shaped seal, the shaft rotatably received within the sleeve when the top element and bottom element are matingly engaged. Alternatively, the top element can have a sleeve extending downwardly from its bottom side, coaxial with its circular shaped seat, and the bottom element can have the shaft extending upwardly from its top side coaxially with the circular shaped seat. The shaft of the bottom side is rotatably received within the sleeve of the top element when the top element and the bottom element are matingly engaged.
The ducts in the top element are coaxial with the ducts in the bottom element when the top and bottom elements are matingly engaged, and the duct openings in the bottom side of the top element and the duct openings in the top side of the bottom element are aligned or in register.
In another embodiment of the present invention, the seats of the top element and bottom element each have a shape which is symmetrical in at least two directions so that the two elements can be engaged in mating relationships with the top element positioned in either of at least two directions with respect to the bottom element. In this embodiment, the seats of the top element and the bottom element will be symmetrical in at least two directions. If the seat is rectangular or oval in shape, the top element can be rotated 180°, lifting it off the bottom element and turning it and then matingly engaging the two elements. If the engaging seats of the two elements are triangular in shape, the top element can be lifted off the bottom element and rotated in one of three directions. Similarly, if the engaging seats of the two elements have a square shape, the top element can be lifted off the bottom element, and the top element can be rotated in one of four directions and then matingly engage the bottom element again. The ducts in the top element are coaxial with the ducts in the bottom ele

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