DE9320582U1 - Device for stimulating tissue regeneration in large and deep tissue defects - Google Patents

Description

The invention relates to a device for stimulating the formation of new tissue in large-area wounds and deep tissue defects according to the preamble of patent claim 1.
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Large wounds caused by open fractures or external influences are particularly exposed to pathogens, as the deeper tissue layers down to the injured bone are exposed to the surrounding area.

Even an infection caused by staphylococci or streptococci can be life-threatening for the injured person. Contamination of the large wound by Proteus, Pseudomonas or Klepsiella usually leads to a life-threatening septic condition. The healing process is also affected by the necrosis of the destroyed tissue. These highly toxic protein breakdown products are liquefied and expelled from the body as wound secretion. Depending on the severity of the injury, extremely painful follow-up treatment of the wound is therefore more or less often necessary for the injured person.

The technique of vacuum sealing has recently been used for the surgical treatment of large wounds. After the initial surgical treatment of the wound, the tissue defect or skin incision and any tissue pockets are filled with layers of polyvinyl foam, with so-called Redon drains being inserted directly into the foam material in the adjacent foam layers. Care must be taken to ensure that the drainage perforations do not come into contact with soft tissue, as they would otherwise become stuck when a vacuum is applied and lose their drainage function. The layers of polyvinyl foam inserted in this way are then

Finally, it is sealed with a transparent, water vapor-permeable but bacteria-impermeable polyurethane film in such a way that the polyurethane film covers the wound and the uninjured skin adjacent to the wound edges. After connecting the Redon drains to a vacuum system, the wound secretion is sucked out and at the same time intensive contact is created between the wound and the foam, which - as experience has shown - significantly improves wound cleansing and promotes the formation of new granulation tissue.

However, it has been shown that the atmospheric pressure acting on the tissue impairs blood circulation in the peripheral area of the wound and often leads to muscle necrosis and devitalization of tissue regions. Chambers often form in the damaged tissue in which toxic protein breakdown products accumulate, which can lead to a life-threatening septic condition in the injured person.

Recovery can only be achieved - if at all - through difficult surgical interventions that place additional strain on the organism, accompanied by lengthy, costly and painful wound care.

Another disadvantage is that the growth of the corium cannot be adequately controlled, so that the wound edges retract, forming tissue defects that lead to unsightly scars. The healed injured person is thus reminded of the traumatic events of the accident for the rest of his life. Depending on the individual constitution of the person affected, this often leads to psychosomatic symptoms and, in some cases, to severe depression, often with a suicidal outcome.

The aim of the invention is to remedy this situation, namely to treat the tissue defect by means of safety

to improve tissue vitality, to avoid the complications that frequently occur with large wounds, and in particular to ensure that the healing of the corium is significantly improved.

This object is achieved according to the invention by opposing segments of a horizontal distractor engaging in the cutis close to the wound edges, which can be moved towards and/or away from each other for the purpose of applying adjustable tensile forces that take effect in the plane of the wound edges of the tissue defect and/or by tension anchors that lie flat on the surface of one of the polyvinyl foam layers, are tightly overlapped by the polyurethane cover film, or are flatly connected to the polyurethane cover film, which engage a holder spanning the tissue defect (vertical distractor) and have adjusting means for the purpose of applying distraction forces that are adjustable in amount and direction and relieve the tissue surrounding the tissue defect.

Further features of the invention emerge from the subclaims.

The invention uses the knowledge that a tensile stress acting in the plane of the wound edges leads to a continuous reduction in the size of the wound with the formation of new tissue, while at the same time forming a uniformly structured granulation lawn and filling the tissue defect, resulting in a faster reduction in the size of the wound. The tensile stress is applied approximately parallel to the extent of the wound and, depending on the spherical conditions, approximately perpendicular to the wound, individually or in combination. This significantly improves the blood flow to the tissue, which leads to a

The healing process is shortened and in many cases additional operations for definitive wound closure can be dispensed with.

By applying tensile forces to the tissue defect using the device according to the invention, accelerated tissue regeneration can be achieved. Furthermore, even during a long post-traumatic and post-operative edema phase, tissue blood flow is maintained.

The protected wound also remains well conditioned for secondary interventions over a longer period of time.

The large and deep tissue defects treated in this way are therefore more effectively detoxified and better supplied with blood, which significantly reduces mortality. The healing of the cutis can be controlled by empirically determining the distraction or traction forces both horizontally on the wound edges and vertically on the tissue defect, so that even with large tissue defects, scarring remains small and post-traumatic sequelae can be avoided.

Finally, the painful dressing change can be reduced when using the method according to the invention. Overall, the healing time is shortened.

The invention is described below with reference to an embodiment shown more or less schematically in the drawing.

Show it:

Figure 1 shows a device according to the invention for

Stimulation of the superficial and

deeper tissue regeneration in large and deep tissue defects, consisting of a horizontal and vertical distractor in perspective view;

Figures 2 to 4 Distractor segments of the horizontal distractor according to the invention with different spinous processes in a pluggable modular design and

Figure 5 a horizontal universal distractor

according to the invention for stimulating the formation of new tissue.

Figure 1 shows the basic arrangement of the device for the formation of new tissue 50 in a large, deep wound W, which is lined with polyvinyl foam layers S, into which drainage pipes R are inserted, which are operatively connected to a vacuum system (not shown). The polyvinyl foam layers S are covered over a large area by a transparent, water vapor-permeable but bacteria-impermeable polyurethane cover film F, which largely covers the wound edges and which, after a vacuum V is applied via the drainage pipes R, is pressed tightly against the wound edges by the atmospheric air pressure, thus sealing the wound. A horizontal distractor 10 is assigned to opposite sides of the wound edges, which comprises two distractor segments 12, which can be moved towards or away from each other by means of a threaded spindle 11 in accordance with the pitch of the threaded spindle. The distractor segments 12 have spikes 20 which are embedded in the cutis in the area of the wound edges.

A vertical distractor 50 is also provided. For this purpose, one or more tension rods are arranged on the cover film F. These consist of plates 21 that can be cut to any size and lie flat on the cover layer. On one side, eyelets 22 are attached in an approximately vertical position and on the opposite side, they are provided with an adhesive layer 23, by means of which the plates 21 are attached flat on the cover film F by gluing.

Furthermore, in the area of the distractor segments 12 on the sides facing away from the wound, holding members 51 are provided that support the vertical distractor 20, each of which has a support bearing 52 in the middle, in which a cylindrical bore 53 is made centrally. Threaded bores 54 are made in the support bearing 52 at a distance from the bore 53. The holding members are preferably fixed to the body by means of cuffs, longuettes or prefabricated shells, with the holding members being glued to the cuffs, longuettes or shells in accordance with the requirements of the injury to be treated.

The support bearings 52 are assigned a semi-circular bracket 55, which rests in the holes 53 of the bearings 52 by means of bolts 56 pointing inwards attached to its ends - of which only the right one is shown. The bracket 55 has a knurled screw 57 at each of its ends, arranged at a distance from the bolt 56, with which the bracket 55 can be fastened to the bearings 52 by screwing the knurled screws 57 into the threaded holes 54 in different angular positions. The bracket 55 also has a series of axial threaded holes 58. Sliding blocks 60 are movably mounted on the bracket 55, each of which has a knurled screw 61 in the middle, with which the sliding block 60 can be fastened by screwing in the knurled screw 61.

can be fixed in one of the threaded holes 58 of the bracket 55. In addition, each sliding block 60 has an eyelet 62 on its side facing the wound.

Hooks 71, 72 of a turnbuckle 70 or the threaded spindle of the horizontal distractor are hooked into the eyelets 62 of the sliding blocks 60 and into the eyelets 22 of the tension anchors 20. For the purpose of adjusting the tensile force, the hooks 71 and 72 of the turnbuckle 70 are each surrounded by a turnbuckle middle part 73 with a right-hand and left-hand thread.

Depending on the circumstances of the injured person's wound, the bracket 55 can be pivoted around the bolts 56 and secured to the support bearings 52 using the knurled screws 57. The sliding blocks 60 can be arranged on the bracket 55 in such a way that they are placed in the position required to control the stimulation of the new tissue formation, and the tension locks 70 can then be used to exert the desired pulling force on the distractor segments 12 in an almost vertical direction, even on spherically curved skin surfaces, specifically on a wound area or the entire wound, in order to effectively control the revitalization of deeper tissue regions in particular.

Depending on the requirements of the wound, one or more vertical and/or horizontal distractors can be provided in modules or in the form of a universal distractor with a plurality of tension anchors 20 in different levels of the polyvinyl foam layer in order to be able to exert tensile stress on the wound in any desired direction via the associated turnbuckles 70.

The support bearings 52 are therefore abutments of the vertical distractor for transmitting the tensile forces of the vertical

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Distractor. To adapt to the spherical conditions in the area adjacent to the tissue defect, moldable supports can be provided between the support flaps and the uninjured tissue to fix the distraction device, which enables the even distribution of the tensile forces acting there as compressive forces. The brackets 51 of the device can be attached to conventional plaster, plastic bandages or to shock- and break-resistant, hypoallergenic polyvinyl alcohol products that can be molded into the desired shape during processing.

In the horizontal distractor, the distraction force that pushes the distractor segments towards or away from each other is applied via the threaded spindle 11, with the help of which the growth together of the corium is controlled.

The tensile forces applied via the horizontal and vertical distractor or distractors complement each other.

As can be seen from Figures 2, 3 and 4, the distractor segments 12 of the horizontal distractor 10 have a central bore 13 in which the threaded spindle 11 is guided. On the side of the distractor segment 12 facing the wound, a threaded nut 15 serving as a functional stop is provided on the threaded spindle. On one of the sides of the distractor segments 12 facing away from the wound, a compression spring 17 is arranged on the threaded spindle 11, which is acted upon by an associated threaded nut 16 adjustably mounted on the threaded spindle 11 in such a way that the spring force with which the distractor segments 12 are acted upon can be adjusted.

The distractor segments 12 and 13 each have a groove 18 on one side and a spring 19 on the opposite side. The lower edge facing the wound, on the other hand, has several needle-shaped spikes 20. The design of the spikes 20 depends on the area of application of the body surface. Figure 2 shows a hook-shaped spike, Figure 3 a claw-shaped spike and Figure 4 a spike set at approx. 20° towards the wound. As Figure 4 in particular shows, the spikes are embedded in the cutis in the area of the wound edges.

This design of the distractor segments 12 allows the modular construction of a horizontal distractor adapted to the individual wound extent by joining together several distractor modules 10 ₇ in which they are connected to one another by inserting the groove 18 of one distractor segment into the spring 19 of the adjacent distractor segment.

The further embodiment of a universal skin distractor 30 shown in Figure 5 comprises two distractor segments 32 that can be moved towards and away from each other by means of two threaded spindles 31. The threaded spindles each have a right-hand thread at one end and a left-hand thread at the other. As Figure 5 also shows , the right-hand and left-hand threads of the threaded spindle 31, which serve to change the pulling force, are each operatively connected to corresponding threaded holes in bases 34 and 35, to which rotary segments 36 and 37 are assigned, each of which is mounted so as to be pivotable about the vertical axes Z. The rotary segments 36 and 37 are connected in a force-locking and form-locking manner by means of two flexible struts 38 and 39. Each strut 38 carries a row of spikes 20 that are aligned towards the wound by approximately 20° to the Z axis.

All components of the device are made of titanium or osteosynthesis steel. However, plastics or carbon fiber composites that meet the requirements can also be used.
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The device described for stimulating new tissue formation in large and deep tissue defects significantly reduces mortality and the frequency of complications.

In addition, the device described according to the invention allows the scar formation to be specifically controlled.

Finally, consistent use of the device described in bell. 5 will shorten the overall recovery period.

Claims (9)

Protection claims 1. Device for stimulating the formation of new tissue in the case of large-area and deep tissue defects, using open-pored foam layers (S) in particular made of polyvinyl foam, in which drainage pipes (R) are inserted to fill the tissue defect, and using a water vapor-permeable but bacteria-impermeable transparent polyurethane film (F) covering the wound edges of the tissue defect to cover the foam layers, whereby a sealing of the tissue defect can be achieved by applying a vacuum (V) to the drainage pipes (R), characterized by opposing segments (12, 32) of a horizontal distractor engaging in the cutis near the wound edges, which can be moved towards and/or away from each other for the purpose of applying adjustable, in the plane of the wound edges of the Tissue defect by means of distraction forces acting on it and/or by means of tension rods (21) resting flat on the surface of one of the foam layers (S), sealed by the polyurethane cover film (F) or flatly connected to the polyurethane cover film (F), which engage a holder (vertical distractor) spanning the tissue defect and have adjusting means (70) for the purpose of applying distraction forces that are adjustable in amount and direction and relieve the tissue surrounding the tissue defect. 2. Device according to claim 1, characterized in that the adjusting means are designed as screw connections (11, 15, 16, 70) and the means engaging in the cutis are designed as mandrels (20). 3. Distractor segment for a device according to claims 1 and 2, characterized in that the distractor distractor segments (12) each have a cylindrical bore (13) in the middle, in which a threaded rod (11) is guided so as to be longitudinally displaceable, on which a threaded nut (15) serving as a stop for the distractor segment (12) is arranged, while on the opposite side a further threaded nut (16) applies force to the distractor segment (12) via a compression spring (17), and that the distractor segments (12) have a row of mandrels (20) on their lower side and a tongue and groove connection (18, 19) on the end faces lying at right angles to them. 4. Distractor segment for a device according to claims 1 and 2, characterized in that each distractor segment (32) comprises two rotary segments (36, 37) which are connected to flexible struts (38, 39) which are force-fitting and/or form-fitting at both ends, the lowermost strut carrying the spikes (20) facing the wound edges, and that the rotary segments (36, 37) are mounted in bases (34, 35) so as to be pivotable about a Z axis, each of which has a left-hand and right-hand thread which enables relative movement to one another. 5. Device according to claims 1 to 4, characterized in that two distractor segments (12) and a threaded spindle form a distractor module (10). 6. Device according to claim 1, 2 and 4, characterized in that two distractor segments (32) are provided with two threaded spindles (31) each having a left-hand and a right-hand thread, which engage in corresponding threads of the bases (34, 35) of the distractor segments (32) for the purpose of adjusting the distraction forces. · * I 7. Device according to claim 1, characterized in that the vertical distractor (50) has an arched holder in the form of a bracket (55) which can be pivoted at both ends about a bolt (56) lying perpendicular to the surface of a support bearing (52) and can be fixed in different setting positions by means of knurled screws (57) in the support bearings (52). 8. Device according to claim 7, characterized in that the bracket (55) is assigned a plurality of threaded holes, that sliding blocks (60) are slidably mounted on the bracket, which can be adjusted in a force-fitting and/or form-fitting manner via knurled screws (61) on the bracket, and that the sliding blocks (60) have eyelets (62) on the sides facing the center of the bracket. 9. Device according to claim 1, characterized in that the tie rod (20) consists of a flat plate (21) on which a vertical eyelet (22) is fixedly arranged and which is provided with an adhesive layer on the opposite side.