Surgery – Instruments – Suture supported from engagement with incision
Reexamination Certificate
2001-11-01
2004-03-30
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture supported from engagement with incision
C606S215000, C606S216000
Reexamination Certificate
active
06712839
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention concerns a frame for use in suturing a wound where the frame is placed on each side of the wound and reaches over it. The frame includes a first and second foundation part for placing on the skin on each side of an along the wound, wound edges respectively, and a joining device between the first and second foundation parts.
Further, the invention concerns a method for suturing a wound by help of the above-mentioned frame.
Removal of moles/birthmarks and other minor operations performed on the upper body, upper arms and thighs can result in wide and ugly scars. The reasons for this are several, but the scars seem to be affected by the tension across the wound during the healing phase, the tightening and placing of the stitches, as well as the length of time the stitches remain in the skin. In addition, any infection in the wound will cause an uglier scar.
When a wound grows, it is important that the skin at the wound edges is sufficiently suited to each other (lying edge to edge) for optimal healing and minimal risk of infection. This is traditionally performed by different suture techniques. Stitches are necessary for adaption during the first part of the healing of the wound, but the stitches also leave marks and play a role in the final appearance of the scar. Sutures that are not too tight and not left in the wound too long, but lengthy, good and stable adaption of the skin edge, are therefore contradictory elements for optimal healing of a wound. Due to the elasticity and therefore the tension in the skin in some areas of the body, it is difficult to meet both criteria. Healing will either result in emphasized suture marks due to lengthy suture time, or the wound splits opens due to the sutures being removed too soon, and a stretch forces the wound edges apart. Stitches in the skin are also an entrance for bacteria, which can cause infections.
Varying techniques are used today to reduce the marks left by sutures.
Intradermal suture, suture tape and tissue adhesive are examples of these. On parts of the body with low tension in the skin, these arrangements are sufficient to hold the wound edges together until they have healed (stomach, face). On the upper body and the limbs, however, the tension is so great that it is difficult to keep the wound edges together with these arrangements. It is extra difficult for young doctors lacking experience and competence in suturing techniques. Subsequently, the wound often splits open. If one closes a wound by sewing in the traditional manner, with single stitches across the wound, the stitches often have to remain in place for 12-14 days before they can be removed. This often results in disfiguring suture marks. If the stitches are removed earlier, to avoid suture marks, the scar splits open and becomes wide and disfiguring.
One supplier of suture equipment within the area of the present invention is Johnson & Johnson, and in their “Wound Closure Manual” there is a description of sutures and equipment used to reduce the tension across the scar during suturing. A short resume of this suturing equipment will now be given.
“Retention Suture Bridge” described in U.S. Pat. No. 4,275,736 is a wide hollow plastic rib which is placed across the wound and which, with the help of a large needle, is fastened with sutures through the wound. This is to avoid necrosis in the skin around the stitch placed in the area with extreme tension, or to avoid them cutting through the skin. One disadvantage with this “suture bridge” is that it requires extra stitches, which in turn cause scars. It lies directly against the wound and must be removed when the wound is cleaned, and it needs the suture to keep it in place. Further, the suture bridge does not distribute the tension evenly over the whole scar, but rather distributes most of the tension in the middle and decreasingly outwards towards the ends. The equipment is designed to prevent tissue necrosis/dead tissue or the skin sutures cutting through the wound edges.
“Retention Suture Bolsters” are latex tubes which are placed across the wound and which the stitches are sewn round. This prevents the sutures lying directly on the skin and thus prevents suture marks. The problem is that the sutures have to remain there for 14 days and thus cause irritation around the scar. The method is little used, since it tends to cause infection around the wound and to cause necrosis if tightened too much. Furthermore, it causes poor airing and moisture removal.
“Skin Closure Tape” is a reinforced plaster, which is glued across the wound and which either alone, or with sutures, is intended to keep the wound edges together. The plaster is not strong enough alone to hold the wound edges together in areas with high tension in the skin, but when used together with sutures, it can help relieve the tension somewhat. When the stitches are removed, the plaster has to be removed, and it is often soaked with blood and has to be changed. One can always remove the stitches early and alternatively set new tape on, but one runs the risk of the scar reopening before the new tape is in place. The area will additionally be exposed to tension along the scar because the tape only stabilizes across the scar.
Another type of suture equipment on the market is the so-called “zip” (Medizip). This is placed on each side of the wound with tape and the zip is then closed. The tension across the wound will be reduced, but does not allow for checking the wound, as the wound cannot be seen without opening the zip. Neither can it be combined with the suture material, with the result that this equipment is difficult to use on skin where the tension is great, where skin has been removed, for example, in connection with the removal of moles.
U.S. Pat. No. 3,934,592 (“Suture Bridge”) is designed to prevent the sutures digging themselves down and causing necrosis in the skin during the closing of larger incisions, in particular after surgery on the abdomen/stomach. It lifts the sutures off the skin and distributes tension across the ribs, which lie along the scar. The aim here, as with the “Retention Suture Bridge” is to reduce the pull across the crossing stitches. This is to prevent necrosis in the skin around stitches set in areas of great tension, or to prevent them cutting into the skin. One drawback with this method is that it requires sutures to be kept in place. Further, it is not intended to be used with the intradermal method. The sutures have to be placed across the wound, which means there are many prick-like scars. The equipment is intended to prevent tissue necrosis or the skin sutures cutting into the edge of the wound in a larger scar with extreme tension.
SUMMARY OF THE INVENTION
One object of the present invention is to provide a suture frame which can stay in place by itself and create an area with low tension around the closed wound. This allows one to keep the wound edges together when using the intradermal technique. Further, it should be possible to check the pull in the thread easily, which can be difficult when one attaches the thread directly to the skin. Without the frame, strong pull will result in a puckering effect across the wound, because thread is attached to the skin on each side, and too loose tension will result in the wound splitting.
Another object of the invention is that the suture equipment is kept away from the wound itself, to avoid it growing into the wound.
Another object of the invention of the invention is that the suture equipment allows one to inspect the wound and remove the stitches without removing the suture frame itself, after a relatively short period of time (5-7 days).
Another object of the invention of the invention is that the frame in addition to the intradermal suture can also be used on normal, single sutures.
A further object of the invention is that the suture equipment is designed to allow airing of, and moisture removal from the wound. The wound should be easily accessible but at the same time be protected from pulling in all directions.
The above-me
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