DE102020212711A1 - Lead-through element for the sealed passage of a thread through a foil for use in negative pressure wound therapy and foil for use in negative pressure wound therapy - Google Patents

Abstract

The present invention relates to a lead-through element (2') for the sealed passage of a thread (8) through a film (1) for use in negative pressure wound therapy, which has a sealing section (12) for airtight sealing between the lead-through element (2') and the Thread (8) and a self-adhesive connecting section (11) for connecting the lead-through element (2') to the film (1). The invention also relates to a film (1) for use in negative pressure wound therapy, having a plurality of lead-through areas (2) for the sealed passage of a thread (8) through the film (1).

Description

field of invention

The present invention relates to a feedthrough element for the sealed passage of a thread through a film for use in negative pressure wound therapy. Another object of the invention is a film for use in negative pressure wound therapy.

The invention also relates to a set for use in negative pressure wound therapy, with one or more films for covering a wound area. A further object of the invention is a wound care device with a suction connection for generating a negative pressure in a soft tissue defect.

State of the art

Negative pressure wound therapy (NPWT) is commonly used for open soft tissue defects, such as abdominal wall defects, dorsal wall defects, or soft tissue defects in the hip or limb area. A spongy material is inserted into the soft tissue defect and this is sealed with one or more foils. A negative pressure is generated in the area sealed by the foils and excess liquid is sucked off. Negative pressure wound therapy in the case of an open soft tissue defect supports wound healing, but has the disadvantage that the edges of the soft tissue defect, in particular the edges of the opened fascia, can pull back towards the sides. This makes primary closure of the soft tissue defect more difficult or impossible.

Devices for reducing the retraction of the edges of a patient's opened fascia are known from US Pat WO 2015/155176 A1 and the WO 2017/216 224 A1 famous. Using such devices, a tensile force can be applied to the edges of the opened fascia via threads. The edges of the opened fascia are kept at a distance so that access to the body interior lying under the soft tissue defect, e.g. B. the abdomen, is possible to carry out the negative pressure wound therapy. The traction force maintains tension in the fascia, thereby reducing retraction of the edges of the fascia. After completion of the negative pressure wound therapy, the edges of the fascia can be placed against each other and closed directly.

In WO 2015/155176 A1 and WO 2017/216 224 A1 it is proposed to arrange the entire device or the parts of this device directly connected to the threads within the vacuum area sealed off by the foil. However, this is often not possible or desirable. For example, the device cannot be completely removed from the patient without detaching the foil.

Disclosure of Invention

The object of the present invention is to enable the sealing of an open soft tissue defect during negative pressure wound therapy with the simultaneous use of a device for reducing the retraction of the edges of the opened fascia such that said device can be removed from the patient without the seal to open.

To solve the problem, a feed-through element for the sealed passage of a thread through a film for use in negative pressure wound therapy is proposed, which has a sealing section for airtight sealing between the feed-through element and the thread and a self-adhesive connecting section for connecting the feed-through element to the film.

The lead-through element can be connected to a film by means of the self-adhesive connecting section, under which a wound, in particular a soft tissue defect, of a patient is arranged. The sealing section of the lead-through element is designed in such a way that sealing can take place between a thread that is passed through the lead-through element and the thread-through element. The thread can be guided through an opening in the foil, which is sealed by the lead-through element. With the lead-through element according to the invention it is possible to guide a thread connected to the edge of the fascia from the vacuum area through the foil to the device for reducing the retraction of the edges of the opened fascia outside the vacuum area. The negative pressure area can remain sealed even if the device to reduce retraction of the fascial margins is temporarily removed.

The lead-through element, in particular the sealing section, is preferably designed in such a way that one or more, for example two, threads can be passed through in an airtight manner. Such a configuration makes it possible to bundle one or more threads onto a lead-through element, so that the number of lead-through elements required can be reduced.

According to an advantageous embodiment of the invention, it is provided that the sealing section comprises a sealing body, in particular a septum, which can be pierced by a non-piercing needle. A thread attached to a needle can be passed through the sealing body. The pierced sealing body can form a seal with the thread, so that an airtight seal of the vacuum area can be achieved despite the thread being led out of the vacuum area. The sealing body is preferably designed as a sealing disk. The sealing disc can have a surface which is arranged essentially parallel to the surface of an adhesive surface of the self-adhesive connecting section or to the surface of the film. The sealing body preferably has an elastomer, in particular a silicone, or a shape memory polymer, in particular a polyurethane or a block copolymer comprising polyethylene terephthalate (PET) and polyethylene glycol (PEO). After the needle has been pierced, the elastomer can push back into its original shape and thereby sealingly enclose the thread attached to the needle. The elastomer can be coated with a barrier layer. Due to a high chemical resistance, a barrier layer made of polytetrafluoroethylene (PTFE) has proven particularly advantageous.

According to an alternative advantageous embodiment, it is provided that the sealing section comprises a flexible, elongate hollow body configured for the passage of the thread, and a closure element for sealing the flexible, elongate hollow body with respect to the thread. The flexible, elongate hollow body can be gathered so that it forms folds. The flexible, elongate hollow body can then be sealed off from the thread by the closure element, in particular in such a way that the thread is fixed relative to the flexible, elongate hollow body at the location of the closure element. When the thread moves, the closure element can move with the thread without the fear of the flexible, elongate hollow body tearing open. The flexible, elongate hollow body can be designed, for example, as a film tube. The closure element is preferably designed in such a way that it can exert pressure in the radial direction on the flexible, elongate hollow body in order to constrict it. The closure element can include a loop or a clip, for example. An elastic ring element is preferably additionally provided, which can be compressed by the pressure of the loop or clip in order to constrict the flexible, elongated hollow body. Alternatively, the closure element can include a closure pin and/or a quick-release fastener and/or a rotary fastener and/or a pressure fastener and/or a clip.

According to an advantageous embodiment of the invention, it is provided that the connecting section includes a feed-through opening through which the thread can be passed. The connecting section is preferably ring-shaped, so that the thread can be passed through a ring opening. In order to enable a compact configuration of the lead-through element, provision can be made for the connecting section to be connected directly to the sealing section.

A set for use in negative-pressure wound therapy, which has one or more foils for covering a wound area and at least one feed-through element described above for the sealed feed-through of a thread through the foil, also contributes to the solution of the task mentioned at the outset.

The same advantages can be achieved with the set as have already been described in connection with the lead-through element according to the invention.

A further object of the invention is a film for use in negative pressure wound therapy, with a plurality of lead-through areas for the sealed passage of a thread through the film.

The lead-through areas of the film are designed in such a way that a thread guided through the lead-through area is sealed. The film according to the invention makes it possible to guide a thread connected to the edge of the fascia from the vacuum area through the film to the device for reducing the retraction of the edges of the opened fascia outside the vacuum area. The negative pressure area can remain sealed even if the device to reduce retraction of the fascial margins is temporarily removed.

The lead-through areas are preferably designed in such a way that several, for example two, threads can be passed through in an airtight manner. Such a configuration makes it possible to bundle a plurality of threads onto a lead-through area, so that the number of lead-through areas of the film required can be reduced.

It is preferably provided that the feedthrough areas are each separated from one another by a film area that is flexible. By gathering or stretching an area of the film, the The distance between the implementation areas can be changed.

According to an advantageous embodiment of the invention, it is provided that the lead-through areas are arranged spaced apart from one another in at least two straight or curved lines. A film designed in this way is particularly suitable for use with the WO 2015/155176 A1 and the WO 2017/216 224 A1 devices described in which several threads are guided to attachment points on the device, which are arranged on at least two straight or curved lines.

An advantageous embodiment of the invention provides that the lead-through areas each include a sealing body, in particular a septum, which can be pierced by a non-piercing needle.

According to an advantageous embodiment of the invention, it is provided that the lead-through areas each comprise a sealing body, in particular a septum, which can be pierced by a non-piercing needle. A thread attached to a needle can be passed through the sealing body. The pierced sealing body can form a seal with the thread, so that an airtight seal of the vacuum area can be achieved despite the thread being led out of the vacuum area.

The sealing body is preferably designed as a sealing disk. The gasket may have a surface that is substantially parallel to the surface of the foil.

The sealing body preferably has an elastomer, in particular a silicone. After the needle has been pierced, the elastomer can push back into its original shape and thereby sealingly enclose the thread attached to the needle. The elastomer can be coated with a barrier layer. Due to a high chemical resistance, a barrier layer made of polytetrafluoroethylene (PTFE) has proven particularly advantageous.

According to an advantageous embodiment of the invention, it is provided that the sealing bodies of the lead-through areas are arranged on one, in particular common, surface of the film. Such a configuration offers the possibility of initially producing a film without lead-through areas during production and then attaching the sealing bodies to the surface of the film to form the lead-through areas, for example by gluing and sealing, in particular heat sealing.

An alternative, advantageous embodiment provides that the foil comprises a first and a second layer and the sealing bodies of the lead-through areas are arranged between the first and the second layer. In such an embodiment, the sealing bodies are embedded in the foil and thus have an improved hold. The risk of the sealing body unintentionally detaching from the film can be reduced.

The sealing bodies are preferably connected to a surface and/or layer of the film, in particular by a respective adhesive connection, a respective sealed seam or a respective sealed surface.

A preferred embodiment of the invention provides that the lead-through areas each comprise a flexible, elongate hollow body configured for the passage of the thread and a closure element for sealing the flexible, elongate hollow body against the thread. The flexible, elongate hollow body can be gathered so that it forms folds. The flexible, elongate hollow body can then be sealed off from the thread by the closure element, in particular in such a way that the thread is fixed relative to the flexible, elongate hollow body at the location of the closure element. When the thread moves, the closure element can move with the thread without the fear of the flexible, elongate hollow body tearing open. The flexible, elongate hollow body can be designed, for example, as a film tube. The closure element is preferably designed in such a way that it can exert pressure in the radial direction on the flexible, elongate hollow body in order to constrict it. The closure element can include a loop or a clip, for example. An elastic ring element is preferably additionally provided, which can be compressed by the pressure of the loop or clip in order to constrict the flexible, elongated hollow body.

A wound care device with a suction connection for generating a negative pressure in a soft tissue defect also contributes to the solution to the task mentioned at the outset, which also has a film as described above for use in negative pressure wound therapy or a set as described above for use in negative pressure wound therapy.

The same advantages that have already been described in connection with the film according to the invention or the set according to the invention can be achieved with the wound care device.

According to an advantageous embodiment of the wound care device according to the invention, this comprises a device for reducing the retraction of the edges of an opened fascia of a patient with an open soft tissue defect, the device comprising a connection element which has a large number of connection points which are set up for the connection of threads which can be connected to an edge of the fascia, with at least one thread being passed through a lead-through element of the set or through a lead-through area of the film.

The films described above are preferably gas-impermeable. The films are preferably transparent. The films are preferably designed as polymer films. The foils can be self-adhesive or non-self-adhesive.

The device for reducing the retraction of the edges of the opened fascia can be used with threads which are in the form of textile threads. Alternatively, in connection with the invention, such threads can also be used which are formed from an elastomer, are designed as a vessel loop or as a wire.

In the objects according to the invention explained above, the thread can be connected indirectly to the fascia, for example via a further tensile force transmission element, such as a mesh sewn into the fascia.

Further details, features and advantages of the invention result from the drawings and from the following description of preferred embodiments with reference to the drawings. The drawings only illustrate exemplary embodiments of the invention, which do not limit the inventive concept.

character list

• the 1 shows an opened abdomen during the implementation of a negative pressure wound therapy with a device for reducing facial retraction in a sectional view.
• the 2 shows a film according to a first embodiment of the invention in a plan view.
• the 3 shows the slide according to 2 in a sectional view.
• the 4 shows a film according to a second embodiment of the invention in a sectional view.
• the 5a and 5b show an example of the processes when passing a thread through a sealing area of a film according to the invention.
• the 6 shows a film with feedthrough areas according to a third embodiment of the invention in a sectional view.
• the 7 shows a leadthrough element according to a first exemplary embodiment of the invention in a perspective view in an insertion state.
• the 8th shows the lead-through element according to FIG 7 in a sealed state.
• the 9 shows a feedthrough element according to a second embodiment of the invention in a sectional view.

Embodiments of the invention

In the various figures, the same parts are always provided with the same reference symbols and are therefore usually named or mentioned only once.

In the 1 A transverse section through an opened human abdomen of a patient 100 is shown. The abdominal wall consists essentially of the skin 103 and the abdominal muscle 105 lying under the skin 103, as well as the fascia 104. Subcutaneous tissue, not shown in the figures, is arranged between the skin 103 and the abdominal muscle 105. The fascia 104 are of great importance for the stability of the abdominal wall. The fascia 104 envelops the abdominal muscle 105 and lies on the side of the skin 103 facing the abdominal cavity 101.

In some clinical pictures, which are associated with an increase in intra-abdominal pressure, an abdominal compartment syndrome, it may be necessary to reduce the pressure by opening the abdominal wall of the patient 100 and excess gases and / or liquids through surgical measures created soft tissue defect, here an abdominal wall opening 102 , to be removed from the abdomen 101 . In this case, internal organs, for example the intestine 106, can protrude through the opening 102 in the abdominal wall.

In order to counteract the development of infections in the abdomen 101 and to make it easier to care for the open abdomen, the abdominal wall opening 102 is temporarily sealed and at the same time negative pressure wound therapy is carried out. The abdominal cavity 101 is covered, for example, by one or more sponges 108 arranged below the abdominal wall. The opening 102 in the abdominal wall is sealed with a gas-impermeable film 1 . The river Oder the sponges 108 are connected to a vacuum pump via a suction port 110 . A negative pressure is applied via the vacuum pump, so that unwanted liquids and/or gases can be removed from the abdominal cavity 101 through the suction connection 110 . This negative pressure wound therapy is usually carried out over a period of a few days to several weeks.

To ensure that the edges 107 of the fascia 104 do not retract excessively during this period of time and that the fascia 104 can be closed, i.e. the connection of the fascia edges 107, after the period of the open abdomen with unproblematic wound healing, a wound care device is used after the abdominal wall 102 has been opened , which in addition to the suction connection 110 comprises a device 111 for reducing the retraction of the fascia 104. The device 111 for reducing the retraction of the edges 107 of the opened fascia 104 of the patient 100 comprises at least one attachment element 112 which has a large number of attachment points which are set up for attachment of threads 8 which can be connected to an edge 107 of the fascia 104 . The threads 8 can be connected either directly to the fascia edge 107 or to the fascia edge 107 by means of a net 116 sewn onto the fascia edge 107 .

As a further component of the wound care device, either a film 1 according to the invention or a set according to the invention comprising a film and at least one lead-through element can be used. Suitable foils 1 are to be referred to below in connection with the illustrations in 2 until 6 To be received. Implementation elements for sets according to the invention are described in connection with the illustrations in 7 until 9 explained.

In the film 1 according to the invention, a passage area 2 is provided, through which the threads 8 are guided in a sealed manner. The set according to the invention comprises corresponding lead-through elements 2' for the sealed lead-through of the threads 8 through the film 1.

The representation in 2 shows a film 1 suitable for use in negative pressure wound therapy. The film 1 according to the exemplary embodiment can be placed on a soft tissue defect to seal it and connected to the skin 103 of the patient 100 by suitable adhesives, for example adhesive strips. Alternatively, the film 1 can be self-adhesive.

The film 1 according to the exemplary embodiment comprises a plurality of lead-through areas 2 for the sealed passage of a thread 8 through the film 1. These lead-through areas 2 are arranged at a distance from one another in two straight lines. This makes it possible to use it together with the in 1 device 111 shown, which comprises two connection elements 112, starting from which a plurality of threads 8 are connected to the fascial edges 107 of the patient 100.

the 3 shows the slide according to 2 in a sectional view. In this exemplary embodiment, the lead-through areas 2 each include a sealing body 4, in particular a septum, which can be pierced by a non-piercing needle. The sealing bodies 4 are each designed as a sealing disk and comprise an elastomer, preferably a silicone. As shown in 3 can be seen further, the sealing bodies 4 of the lead-through areas 2 are arranged on a common surface of the film 1 . The sealing bodies 4 are firmly connected to the layer 5 on the surface of the film 1, for example by an adhesive bond or a sealed seam or sealed surface. The film 1 is flexible in the film regions 3 between the lead-through regions 2, so that the film can form folds here, for example in order to reduce the distance between the lead-through regions. In this respect, the distance between the lead-through areas 2 can be adapted to the distance between the threads 8 .

the 4 shows a film 1 according to a second embodiment of the invention in a sectional view. This film essentially corresponds to film 1 according to FIG 3 with the difference that the film 1 according to the second exemplary embodiment comprises a first layer 5 and a second layer 6 and the sealing bodies 4 of the feedthrough regions 2 are arranged between the first layer 5 and the second layer 6 . The sealing bodies 4 are connected both to the first layer 5 and to the second layer 6, for example by means of an adhesive connection or a sealed seam or sealed surface.

Based on the illustrations in 5a and 5b it is made clear how a thread 8 can be passed through one of the sealing bodies 4 of the sealing areas 2 . The thread 8 is connected to a non-punching needle 7 . This needle 7 creates a feed-through opening in the sealing body 4, which is widened by the needle 7, cf. 5a . The thread 8 is pulled through the widened feed-through opening. The material of the sealing body 4 pushes back in the direction of the thread and seals it off from the thread, cf. 5b .

The representation in 6 shows a further exemplary embodiment of a film according to the invention with a plurality of feedthrough areas 2. These can, for example, be as in 2 shown. The lead-through areas 2 according to this exemplary embodiment each comprise a flexible, elongated hollow body 9 configured to lead through the thread 8 and a closure element 10 for sealing the flexible, elongated hollow body with respect to the thread. The hollow body 9 is preferably a film tube. Such a film tube can be compressed by the closure element 10 in order to create a seal against a thread guided through the film tube.

the 7 and 8th show a separate lead-through element 2' which can be used in a set according to the invention together with a foil in negative-pressure wound therapy. This implementation element 2 'comprises - similar to the implementation areas 2 according to 6 a sealing section 12 for airtight sealing between the lead-through element 2 ′ and the thread 8 , which comprises a flexible, elongate hollow body 9 configured for the passage of the thread 8 , and a closure element 10 for sealing the flexible, elongate hollow body 9 with respect to the thread 8 . The hollow body 9 is preferably a film tube. Such a film tube can - as in 8th shown - are pressed together by the closure element 10 in order to effect a seal against a guided through the film tube 8 thread.

A further component of the lead-through element 2' is a self-adhesive connecting section 11 for connecting the lead-through element 2' to the film 1. The connecting section 11 is preferably formed in one piece with the flexible, elongated hollow body 9. The connecting section 11 includes a—here ring-shaped—through-opening through which the thread 8 can be passed.

The lead-through element 2` can be used as in 7 and 8th shown, provided separately and attached to a film by a user, such as a surgeon. Alternatively, it is possible for the lead-through element 2' to be provided, preferably attached to a film together with other lead-through elements 2', as is the case, for example, in 2 is shown.

In 9 a further exemplary embodiment of a lead-through element 2' for the sealed lead-through of a thread 8 through a film 1 for use in negative-pressure wound therapy is shown. In contrast to the embodiment according to 7 and 8th This lead-through element 2 ′ includes a sealing section 12 with a sealing body 4 which can be pierced by a non-piercing needle 7 . A connecting section 11 is provided on an underside of the sealing section, which is designed to be self-adhesive and enables the lead-through element 2 ′ to be connected to a film 1 .

The films 1 identified in the figures described above can alternatively be part of a set which includes separate lead-through elements 2'. These separate lead-through elements 2' can be connected to the film 1 in order to enable the threads 8 to be passed through in a sealed manner during negative-pressure wound therapy.

Reference List

1

foil

2

implementation area

2'

feedthrough element

3

slide area

4

sealing body

5

layer

6

layer

7

needle

8th

thread

9

Hollow body, film tube

10

closure element

11

connection section

12

sealing section

100

patient

101

abdomen

102

Soft tissue defect, abdominal wall opening

103

skin

104

fascia

105

abdominal muscle

106

colon

107

fascial edge

108

sponge

110

suction port

111

Device for reducing the retraction of the fascia

112

connection element

116

network

QUOTES INCLUDED IN DESCRIPTION

This list of the documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• WO 2015/155176 A1 [0004, 0005, 0019]
• WO 2017/216224 A1 [0004, 0005, 0019]

Claims (15)

Feedthrough element (2') for the sealed passage of a thread (8) through a film (1) for use in negative pressure wound therapy, which has a sealing section (12) for airtight sealing between the feedthrough element (2') and the thread (8) and has a self-adhesive connecting section (11) for connecting the lead-through element (2') to the film (1). Feedthrough element (2 ') after claim 1 , characterized in that the sealing section (12) comprises a sealing body (4), in particular a septum, which can be pierced by a non-piercing needle (7). Feedthrough element (2 ') after claim 1 , characterized in that the sealing section (12) comprises a flexible elongate hollow body (9) configured for the passage of the thread (8) and a closure element (10) for sealing the flexible elongate hollow body (9) against the thread (8). Lead-through element (2') according to one of the preceding claims, characterized in that the connecting section (11) comprises a feed-through opening through which the thread (8) can be passed. Set for use in negative pressure wound therapy, with one or more foils (1) for covering a wound area, characterized by at least one feed-through element (2') for the sealed feed-through of a thread (8) through the foil (1) according to one of Claims 1 until 4 . Foil (1) for use in negative pressure wound therapy, characterized by a plurality of feedthrough areas (2) for the sealed feedthrough of a thread (8) through the foil (1). Slide (1) after claim 6 , characterized in that the lead-through areas (2) are spaced from each other in at least two straight or curved lines. Foil (1) according to one of Claims 6 or 7 , characterized in that the lead-through areas (2) each comprise a sealing body (4), in particular a septum, which can be pierced by a non-punching needle (7). Slide (1) after claim 8 , characterized in that the sealing body (4) is designed as a sealing disc. Foil (1) according to one of Claims 8 or 9 , characterized in that the sealing body (4) comprises an elastomer, preferably a silicone. Foil (1) according to one of Claims 8 until 10 , characterized in that the sealing bodies (4) of the lead-through areas (2) are arranged on one surface, in particular a common surface, of the film (1). Foil (1) according to one of Claims 8 until 10 , characterized in that the foil (1) comprises a first and a second layer (5, 6) and the sealing bodies (4) of the lead-through regions (2) are arranged between the first and the second layer (5, 6). Foil (1) according to one of Claims 6 or 7 , characterized in that the lead-through areas (2) each comprise a flexible, elongate hollow body (9) configured to lead through the thread (8) and a closure element (10) for sealing the flexible, elongate hollow body (9) with respect to the thread (8). Wound care device with a suction connection (110) for generating a negative pressure in a soft tissue defect (102), characterized by a film (1) for use in negative pressure wound therapy according to one of Claims 5 until 12 or a kit for use in negative pressure wound therapy according to Claim 13 . wound care facility Claim 14 , characterized by a device (111) for reducing the retraction of the edges (107) of an opened fascia (104) of a patient (100) with an open soft tissue defect (102), the device (111) comprising a connection element (112) which has a large number of attachment points which are set up for attaching threads (8) which can be connected to an edge of the fascia (107), with at least one thread (8) passing through a lead-through element (2) of the set or through a lead-through area ( 2) the film (1) is passed through.

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