Surgery – Instruments – Sutureless closure
Reexamination Certificate
2001-07-21
2002-10-29
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S217000, C606S218000, C606S233000
Reexamination Certificate
active
06471715
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a suture tightening wound closure device and to a method for its use. In particular the device of the present invention is comprised of a suture and a suture loop tension means (for providing a controlled tension to the applied suture). The present invention also relates to method for closing open wounds using the device of the present invention. The suture is looped through the skin and underlying tissue around large open wounds, and tightened gradually (using the suture loop tension means) to bring the wound edges into proper alignment.
BACKGROUND OF THE INVENTION
Skin is a visco-elastic tissue that can be stretched by mechanical creep and by biological creep. Mechanical creep occurs when a constant load applied to the skin causes increasing amount of skin extension over time. Stress relaxation is another aspect of the mechanical creep that occurs when the force required to maintain skin stretched decreases over time. Gibson and Kenedi (Gibson T, Kennedi Rm.Biomechanical properties Surg Clin North Am 1967;47:279-94) have noted that skin can be stretched to four times its original length provided that the force applied is limited, and does not cause blanching or breakage of the collagen fibers in the dermis. Biological creep is the slow expansion of the tissue, accompanied with the generation of new collagen and elastic epithelium fibers.
In the case of large skin and tissue deficits (caused by trauma or by surgical resection), the skin and soft tissue defect cannot usually be closed by conventional suturing. Over the years some techniques have been developed to address the problem. The conventional surgical technique involves skin grafts and skin flaps which require skin elevation and removal from another part of the body. This technique is invasive, requires special hospitalization, and costs substantially.
Other techniques harness the visco-elastic properties of skin. The most known technique “Tissue Expansion” is based on the biological creep effect. The expander is implanted under the skin and inflated slowly to expand the skin. This procedure is also expensive and requires a second surgical procedure to transfer expanded skin to the wound area.
More recent techniques and devices are based on the mechanical creep effect of the skin. Hirshowitz et al. (Israel Patent No.097225) developed a skin stretching device that consists of two “U” shaped arms with sharp cutting hooks that engage two long pins that are threaded through the dermis on either side of the wound. The arms can then be pulled closer to each other and stretch the skin by a screw turned by a tension knob. Bashir (British Journal of Plastic Surgery 1987,40,582-587-Wound Closure By Skin Traction) applied the mechanical creep effect by threading steel wires through the edges of the defect and then over a period of days twisted them to apply tension to the skin. Cohen et al. discloses a Suture Tension Adjustment Reel that is applied to gradually tighten a suture that is passed through the two opposing skin edges of the wound (Dermatol Surg Oncol 1992;18:112-123 and U.S. Pat. No. 5,127,412).
The existing methods and devices that are based on the mechanical creep of the skin suffer from some shortcomings. They are bulky, restrict patient's movement, and hard to bandage over. Further, the tension is applied to the external surface of the skin without effectively affecting the underlying tissue. This is not sufficient when the tissue deficit is large and deep. The closure that will be achieved might be partial, leaving dead space under the skin in which contamination can occur. Also some of those technique require that sutures will be applied once the skin edges are close enough to withstand the tension exerted by the suture. The patient has to be left then in the operating room until the skin edges are brought together, or alternatively if the stretching procedure takes time he is transferred to a recovery room and returned later to the operating room.
Recently, some new methods have been developed for sternum repair based on using a band assembly (with a needle) secured by a buckle mechanism in a closed loop configuration about the sternum portions. Typical assemblies are described in U.S. Pat. Nos. 5,462,542, 5,330,489, 5,356,412 and more.
The devices described by the above mentioned patents could not be used effectively for large wound closure. In most of the methods the strap is not smooth enough for skin application, and therefore new tissue can grow into the strap during the period in which it is implanted in the body. Further, the buckle mechanism in some of the applications is usually designed to lock the band in one secure position, whereas for wound closure application a delicate and controlled movement exercised by the mechanism is required. Additionally, those devices are not provided with any means to indicate the tension applied to the skin.
Thus, there is a clear need for a wound closure (surgical) device and method which is simple in construction and application, permitting delicate and controlled wound edges and underlying tissue stretching by high-surface-area suture (or ordinary suture), and finally small and non obstructive.
The preferred embodiment of the device of the present invention is directed to a suture tightening wound closure device (a stretching mechanism assembly) including a base (suture tensioning means), a suture, a surgical needle, a specialized skin reinforcing staple, and a suture loop tension measuring and displaying means.
The method of the present invention is directed to using this suture tightening wound closure device by gradually applying a safe controlled tension to the in place suture, with intervals for skin stress self relaxation.
SUMMARY OF THE INVENTION
The present invention relates to a suture tightening wound closure device for use on mammals including humans. This device is comprising a smooth suture (to be sewn across an open wound through the skin and underlying tissue) and a suture loop tension means (for closing the wound). This tension means is by grasping one end of the suture, and pulling back its second end, forming a tensioned suture loop, enclosing the wound. In the context of the present invention, “one end” or “the first end” of the suture, relates to that end of the suture which is immovably fixed in the device as a beginning of the suture loop; “the second end” of the suture, relates to that portion of the suture which is variably controlled and driven by the suture tension means. Specifically, the device of the present invention is characterized by the tension means having a manual control mechanism (for pulling or releasing said second end).
Preferred embodiments of the device of the present invention have in addition a means for measuring and displaying the tension in the suture loop.
The smooth suture according to the preferred embodiment of the present invention is a suture band, which is flexible for bending along it's length and is resistant to bending along it's width.
Furthermore, the device of the present invention also relates to embodiments having in addition a pair of suture supporting skin reinforcing means (for preventing ripping of the skin when tension is applied to the suture loop). Each of these reinforcing means is comprised of a rigid plate (for placing on the skin near a suture's skin piercing point) and a means for preventing each plate from slipping. According to various embodiments of this skin reinforcing means, the suture passes over or passes through the plate. Embodiments of the means for preventing slipping according to the present invention include skin piercing stickers, adhesives, and the like.
The present invention also relates to a method for the closing of open wounds using of the suture tightening device of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a suture tightening wound closure device (for use on mammals including humans), comprising a smooth suture (to be sewn across an open wound t
Jackson Gary
Lilling & Lilling P.C.
Wisebands Ltd
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