DEVICE FOR SUBCUTANEOUS STITCHING OF SURGICAL WOUNDS

DESCRIPTION OF THE INVENTION Application area

The device is meant for the stitching of surgical wounds by subcutaneous technique and completely replaces classical way of surgical stitching.

Technical problem

The main intentions of every wound elaboration are: quick and adequate closing, prevention of infection and cosmetically acceptable and functional scar. The closing of the wound with as less visible scar as possible is the biggest problem in surgery. Therefore we pay the greatest attention to the way of stitching, aiming to leave the smallest possible scar after the healing. Considering that the classical ways of stitching leave scar on the skin surface, due to the stitching material, there is a constant intention to close the edges of the wound without visible scars on the skin surface.

The existing technique

Of all existing solutions for the skin stitching, we daily use more classical ways of the stitching by the curved surgical needles and suture, stitching with metal clips - stapler, connecting of the edges of the wound with adhesive stripes, adhesive foils, special tissue glues and finally by technique of subcutaneous stitching.

Classical stitching of the skin means connecting the edges of the wound with suture and requires surgical knowledge of the person who implements it;, It is also the most often used stitching technique. For that, we need surgical instruments, such as forceps, surgical scissors, needle holder, towel -forceps and curved needle with suture. Before the very act of stitching we must choose the sort of needle due to different sizes, radius of curve and cross- section. Besides, we have to choose the sort of suture and its thickness. In classical surgery there are more sorts of interrupted and running sutures. The interrupted suture is a suture that is cut after it goes through the skin and tightens. There are few kinds of interrupted sutures, such as:, simple interrupted suture, few kinds of mattress sutures, vertical and horizontal suture and so on. Running suture is a suture that closes the whole wound in continuity without interruption or suture cutting. There are also few techniques of the running suture combined with the interrupted sutures technique. ^" \

The act of stitching is executed on following way: the needle, which is inserted from one side of the wound edge is pulled out of the wound and inserted into other side of the wound; when it's point comes to the other side of the cutting line, the needle is pulled out and the suture fastened by the.→sp&cigl technique to get the wound edges closer, while the suture remains tied without possibility of loosening of the suture. In that technique the especial attention should be paid to the distance between the entry and the exit of the needle from the edge of the wound, distances between individual sutures along the wound, the angle under which the needle entries and exits, quantity and depth of the elaborated tissue /that dictates the choice of size, curve and cross-section of the needle/. Further, very important is the choice of the thickness of the suture, the strength of the tightening and tying ofj the suture and, of course, the tying technique and kind of the knot and its place on the wound. All mentioned is necessary to leave correctly adapted edges of the wound after tensing and tying of the suture. In case that the step occurs, due to irregular position of the edges of the wound, the wound will ii

heal more slowly and irregular scar will occur. In any case, no matter which kind of suture we implement, the suture which is above the surface of fhe.skin, due to its tension and because of the swollen tissue, causes damages on the surface layer of the skin under the suture, decaying of the upper layer of the skin and finally creates scars on the skin that come across the cutting line - so called railway-track scars. The scars are more visible if the suture . is more tightened, and in case of weaker tension of the suture, or even untying of it, comes to the splitting of the edges of the wound, prolongation of the healing and creation of even larger scar. It is important to mention that in case < of interrupted stitching of the skin it is not always possible to equally tighteri'.and tie each suture, so it makes irregular scar. The same is with the closure with running suture where it can come to that that one part of the elaborated area is more and the other less tensed.

By the extracting of the suture, one needs certain surgical knowledge, no matter which suture one talks about. It is performed so that one grips ends of the suture and pulls the knot in the opposite direction from the side on which it stands. The part of the suture which is under the skin is pulled out on. the surface and cut after that. All described regularly causes pain.

The closure by metal clips has its advantages because of the simplicity and speed of the implementation, lesser reactions of the tissue towards the metal

^■ V clips; it requires no special surgical technique, but also represents relatively expensive method because of the complicity of the production of the device. The main failure is lesser punctuality of positioning of the clips ¹ and adaption of the edges of the wound, it requires special forceps for the taking off the metal clips and leaves the scar. Taking off of the clips also causes smaller pain.

Connecting of the edges of the wound by strips represents very simple and quick way of treating smaller and non-gaping wounds, there is nq tissue reaction, the possibility of the infection is smaller, and it is cheap. The

imperfection \s the fact that wet, bloody or sweaty surface causes ungluing of strips, so there is danger of the splitting of the edges of the wound, it can not be implemented on bigger gaping wounds with big tension by closuring! the hair scalp nor on the skin with vesicles.

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Closing of the wound with adhesive foil is similar as the closing with the strips, however, the wound remains completely closed which causes the sweating under the foil, so the skin seems like "cooked"; further it causes the accumulation of secretion, the possibility for the infection is bigger.

The technique of closing of the edges of the wound with tissue glυe is painless, quick and simple method, with good cosmetic effect; there is no taking off of the closing material. The disadvantage is that that method is relatively expensive, the possibility for the allergy reaction is increased, it has little power by bigger tensions in the wound and the chances for the opening of the wound edges are larger, so it can not be implemented on the fist or on the foot. By more humidity it comes to the loosening of the glue power, and it takes great care and surgical knowledge to prevent the glue to penetrate into deeper layers of the wound because of the inflammatory reaction of the tissue. . I

By subcutaneous technique we use classical surgical instruments. The mentioned technique is mostly implemented for better cosmetics effect, because of avoiding of creating of growing scars provoked by the suture on the skin surface and because of the minor pain by suture removing. Among other things, it is used on bigger wounds for getting closer the edges of the wound by big wound tensions and for the closure of so called "dead space". The mentioned technique requires more surgical knowledge and special surgical technique. ^" - ^" \

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The problem in the wound-closure is alternately stitching of first one and then of other side of the wound in the layer of the skin, because of the determining

of the distance of entry and exit of the needle, so that both sides will be symmetrical and not folded over, because of the direction of the needle, that must always be parallel with the upper edge of the skin, because of the depth of every individual suture which can not be bigger than 3 mm and finally because of equal tension of the suture. In case of unsymmetricdl gripping of the tissue and different direction of the needle, the wound edges are not equally adapted, so there is danger of wrong healing, and, in case of the loosening of the suture, of the stretching of wound edges. With the development of the surgical technique for classical subcutaneous closure, on the market appeared a closure known under the commercial name "Securex". The closure consists of the thin nylon suture, special skin needle and two small clips in different colors for the fixating of the suture visible above the skin, to prevent stretching of the wound edges, after the suture is tightened. i _;

Exposing the essence

The primary aim of the invention is that it completely replaces classical surgical technique of subcutaneous stitching. ; ^~ _;

The secondary aim is equal stitching of the wound with as small scar as possible, and improved, simplified and fastened act of subcutaneous closure technique.

Further aim is the painless removing of the suture. ;. ^'

The additional aim is broad implementation of the invention.

The device is meant for subcutaneous closure of the wound and completely replaces classical surgical way of closure by subcutaneous technique. By its conception of wavy contours of inner side of both parts of the device after

I! closing and fixing of the device by the very edge of the wound, it presses the edges of the wound and places the skin in the wavy line identical to the wavy inner surface of the device. Positioning by the very edge defines the depth through which enters the surgical needle. We use straight surgical needle _; with

suture, which, after running through the device leaves linearly positioned suture in subcutaneous layer. After the device is opened, the skin returns to its normal position, what leaves snakelike wavy position of the suture in wanted skin layer, identical to the wavy surface of the device, which is the essence of the invention. Namely, the suture symmetrically grips both sides of the skin, and number and radius of concave/convex contours defines the distance between entering and exit of the suture. Different positioning in relation to the wound edge defines also the depth of the position of the suture. That gives equally closed wound, simplifies the way and speed of the stitching, requires no significant surgical knowledge and complicated surgical instruments. Finally, the removing of the suture is simplified because one simply takes the end of the suture on one side and simply pulls it out.

Short description of the drawing

Picture 1. The appearance of the closed device

Picture2a. The appearance of the enlarged part of the instrument

Picture2b. Enlarged survey of the opening for the guiding needle entrance on convex contour _;

Picture 2.c Presents side of the device and entrance in virtual straight-line area Picture 3. Scheme of the cutting wound

Picture 4. Scheme of the cutting wound and opened device

^■ Picture 5. Scheme of the closed and fixed device and starting position of straight surgery needle with suture Picture 6. Scheme of closed device and finishing position of the needle with run-through suture \ ^' ;'

Picture 7. Scheme of the cutting wound with run-through and loose suture Picture 8. Scheme of the cutting wound with run-through tight suture with fixing clasp

Detailed description of at least one of the ways of the realization of the device

Considering the picture 1 one can see closed device which comprehends two device parts Ia and Ib, connected by guiding part 3. Guiding parts 3 are, by a firm connection, fixated to the guiding part fixed holders 4b on the part Ib, while freely sliding through the guiding part shallow holders 4a on the part Ia. Both parts of the device Ia and Ib have, on the inner side; wavy surface made of convex 2a and concave 2b contours, and are constructed so that convex contours 2a of one part enter the concave contours 2b placed on the other part of the device. As one can see oft the picture 2a, wavy contours make wavy space 7 which on the beginning of each side has two pairs of narrowly positioned needles that function as an intake for straight surgical needle 8a and 8b, when the device is in the closed position. Wavy surface is defined by the number of convex and concave contours 2a and 2b. Number of convex and concave contours in the given length of the device can be bigger or smaller what understands bigger or smaller radius of them. Regarding the picture 2c one can see sidewjse position of the device and entry into virtual straight line space 16 Which originates of the wavy space 7 after the device is closed, framed from the upper and lower side by driving needles 5a and 5b and intake needles for straight surgical needle 8a and 8b, and by wavy surface on the sides. Regarding the picture 4, as is here realized, the closure is made so that the i! opened device is positioned on both sides of the cutting wound 13 distanced from the edges of the wound depending of the thickness of the skin. As seen on the picture 5, accordingly this invention, the device is closed so that the device parts Ia and Ib simply get closer to each other by sliding oil; the guiding parts 3. According to this device, the pairs of driving needles on concave contours 5a and 5b and narrowly placed two pairs of intake needles for straight surgical needle 8 a and 8b, placed on the ends of wavy contours, run through the skin and enter into belonging openings 6. on the convex side, what is sufficient for the fixation of the device on the cutting

wound 13 which gets snαke-like appearance. After closing the device, the pair of driving needles on concave contours, placed by upper and lower part end of the contour together with the wavy surface, transforms the wavy space 7 into virtual straight line space 16 through which runs a straight surgical needle with suture 9. As is best presented on the picture 6, according to this invention, one can see the device fixed on the cutting wound, after closing the device both sides of the wound are pushed into wavy line by wavy contour. One con also see a straight surgical needle with suture 9 that penetrates about ¹ λ cm from one corner of the wound 10 into subcutaneous space, then it is pulled through two pairs of intake needles for straight surgical needle 8a and 8b which are usually placed on both sides on the entry into virtual straight-line space 16, proceeds to pull through in a straight line 12 along virtual straight-line space 16 to the opposite side, to be pulled out of the subcutaneous space 11 on the skin surface, about Vz cm from, the opposite corner of the wound. As it is shown on the picture 7, accordingly to this device, after the opening of the device, after the skin of the wound returns from the wavy into normal position, there remains the suture in snake- like wavy flow 14, applied along the wound in subcutaneous layer. Further, by the tensing of the suture which seizes both sides of the wound, the edges of the wound are adapted. As one can see on the picture 8, as it is here realized, special clasps are put on the suture which is above the skin 15 that prevent loosening of the suture and opening of the edges of the wound. By application of the said device, the distances between grips of the skin in subcutaneous layer are equal, and depth and tension of the suture is uniform. All mentioned depends of the region where the closure is implemented and of the thickness of the skin. Namely, there are big differences between thickness of the skin of the face, neck, forearm or back, which dictates different positioning of the device in relation to the edge of the wound. By thinner skin, the device is positioned closer to the edge of the wound, while by the thicker skin it is distanced just for the thickness of the skin. If the wound is larger than the device, the device is, after the pulling through of the needle and suture, opened and moved further, and, in the same way positioned

along the wound, and the needle with the suture pulls through the device until the suture is positioned through the whole wound. . . ,

The device can be made in more sizes and thickness of the device out of the inox steel which is used by the production of surgical devices or of the special firm plastic material with metal needles. If the device is made out of the metal, it can be used repeatedly and if it is made of plastics it can be made

I ¹ . to be used only once or more times. The idea is to pack the device into sterile sets together with the device for holding and pushing of the needle, clips for the prevention of the pulling of the suture and "steri - strip" strips. The mentioned technique demands only short medical education. The device can be used outside of surgical institutes, in places where there is no surgically educated doctor. It can be used in ambulances of general practice and emergency rooms.

The technical realization of this device is performed through the prototype of the device, which was used in several experiments on the animals /10 of them/ with success.

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The mode of appliance

The simplicity of the appliance of the device enables completely new approach and large applicability, and, thanks to the simplicity of, the performance, the economical production which includes improvements relating to the given idea and does not demand bigger investments.

The success of the device will give the experts in the field of surgical devices ideas for numerous modifications and changes of the initial mode. _._ ,

Legend

H

1 α - part of the device

I b - part of the device 2a - concave contour 2b - convex contour

3 - Guiding part 4a - guiding part shallow holders 4b - guiding part fixed holders | 5a - lower needle of driving needles ή

5b - upper needle of driving needles

6 - opening for needle on convex contour wavy surface

7 - wavy space \ 8a - upper pair of intake needle for straight surgical ne;edle 8b - lower pair of intake needle for straight surgical needle

9 - Straight surgical needle

10 - place of penetrates straight surgical needle into subcutaneous area

I 1 - place of pool out surgical needle <

12 - straight line of suture 13 -cutting wound

14 - snake-like wavy flow of suture

15 - special clasp ^' ;

16 - virtual straight space