WOUND CARE SYSTEM FOR NEGATIVE PRESSURE THERAPY
20200054491 · 2020-02-20
Inventors
- Axel HENTRICH (Wien, AT)
- Edda SIX-SUDERA (Wien, AT)
- Heinrich-Maria BRÜGGEMANN (Munderkingen, DE)
- Ludwig SCHRÖDER-DUBOIS (Erfurt, DE)
Cpc classification
A61M2039/246
HUMAN NECESSITIES
A61M2205/3344
HUMAN NECESSITIES
A61M1/966
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61M2039/2473
HUMAN NECESSITIES
A61F13/00059
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
A wound care system for reduced pressure therapy comprising a covering device that can be fixed to the skin surrounding a wound and serving to produce a closed wound space containing the wound, a valve system, designed on the one hand to suck gases out of the wound space and on the other hand to counter the penetration of gases into the wound space, being assigned to the covering device after fixing the covering device to the skin surrounding the wound, the valve system being able to be coupled detachably to a suction device that can be operated to suck gases out of the wound space.
Claims
1. A wound care system for reduced pressure therapy comprising a covering device, which is provided, at least in sections, with an adhesive agent designed to fix the covering device to the skin, preferably running around the wound space, that can be fixed to the skin surrounding a wound and serving to produce a closed wound space containing the wound, comprising a valve system is assigned to the covering device, said valve system being operable on the one hand to suck gases out of the wound space and on the other hand to counter the penetration of gases into the wound space after fixing the covering device to the skin surrounding the wound, the valve system being able to be coupled detachably to a suction device that can be operated to suck gases out of the wound space, wherein the valve system is coupled to the covering device by means of a fluid line, in particular a tube characterised in that the valve system has a valve body with a valve chamber serving to receive gases from the wound space, wherein the tube coupled to the covering device leads into the valve chamber, the valve system comprises a film valve and the valve chamber is at least partially delimited by a rigid housing.
2. The wound care system according to claim 1, characterised in that the one-way valve has at least one valve slot formed in a preferably film-like limiting element delimiting the valve chamber.
3. The wound care system according to claim 1, characterised in that the valve chamber is approximately lens-shaped before gases are released from it and is delimited by two film-like limiting elements connected, gas-tight, to one another in the region of their edges, at least one, preferably both of which limiting elements are provided with at least one valve slot in order to form a film valve.
4. The wound care system according to claim 2, characterised in that at least one limiting element has a reinforcement layer provided with a recess in the region of the at least one valve slot.
5. The wound care system according to claim 1, characterised in that the fluid line is attached to the boundary surface of the covering device provided with the adhesive agent.
6. The wound care system according to claim 1, characterised in that the fluid line passes through the covering device and/or leads into an opening that passes through the sealing device and/or the covering device has a suction port designed for coupling the fluid line.
7. The wound care system according to claim 1, characterised in that an indicator device that can be operated to display the reduced pressure status in the wound space is assigned to the covering device.
8. The wound care system according to claim 7, characterised in that the indicator device is integrated into the covering device.
9. The wound care system according to claim 7, characterised in that the indicator device is coupled by means of a fluid line to the covering device.
10. The wound care system according to claim 7, characterised in that the indicator device is integrated into the valve system, in particular into the valve chamber of the valve system.
11. The wound care system according to claim 7, characterised in that the indicator device has two indicator layers spaced apart from one another and running approximately parallel to one another, which can be compressed, at least in some areas, against a pre-tensioning force, so as to reduce the spacing.
12. The wound care system according to claim 11, characterised by at least one in particular elastically deformable spacer layer, disposed between the indicator layers and that can be compressed by overcoming a pre-determined pre-tensioning force, preferably having at least one window.
13. The wound care system according to claim 9, characterised in that the fluid line leads into an indicator space formed between the indicator layers, and preferably at least partially passes through the spacer layer.
14. The wound care system according to claim 11, characterised in that a boundary surface of one indicator layer facing the other indicator layer has profiling and/or graphical representation which can be seen from the outside when the distance between the indicator layers is reduced.
15. The wound care system according to claim 7, characterised in that the indicator device has an at least partially rigid housing which at least partially delimits an indicator chamber serving to receive gases from the wound space.
16. The wound care system according to claim 15, characterised in that two chambers separated from one another by a gas-tight and moveable, in particular deformable, separating device are formed in the indicator chamber, the first chamber of which can preferably be connected to the wound space by means of a fluid line, and the second chamber of which can preferably be connected to the surrounding area by means of a recess in the housing.
17. The wound care system according to claim 16, characterised by a pre-tensioning device preferably accommodated in the first chamber, in particular comprising a compression spring, by means of which the separating device, preferably made in the form of a deformable membrane, is held in an initial position and against the pre-tensioning force of which the separating device is moved to a final position when reduced pressure is applied to the first chamber.
18. The wound care system according to claim 17, characterised in that the separating device comes at least partially into contact with a preferably plane boundary surface of the preferably cylindrical, in particular circular cylindrical, housing upon reaching the end position.
19. The wound care system according to claim 16, characterised in that there are disposed in one of the chambers, preferably in the first chamber, two sleeves that engage in one another and that can be displaced relative to one another against the pre-tensioning force of the pre-tensioning device, one of which sleeves is coupled to a housing wall, and the other of which is coupled to the separating device.
20. The wound care system according to claim 16, characterised in that a housing wall delimiting the first chamber of the housing is provided with a one-way valve, in particular a film valve, by means of which reduced pressure can be applied to the first chamber and to the wound space.
21. The wound care system according to claim 1, characterised by a chamber that is fluidically connected to the wound space, preferably a substantially cylindrical chamber, such as for example the valve chamber and/or the indicator chamber, which is delimited by a circumferential chamber jacket and has an indicator wall preferably forming a front side of the chamber and moveable between an initial position and a final position, the indicator wall being able to be moved from the initial position into the final position by applying reduced pressure to the chamber.
22. The wound care system according to claim 1, characterised in that in the initial position the indicator wall is curved convexly outwards towards the space lying outside of the chamber.
23. The wound care system according to claim 21, characterised in that the indicator wall is curved into the chamber in the final position.
24. The wound care system according to claim 21, characterised in that the indicator wall has an outwardly curved snap disc in the unstressed state.
25. The wound care system according to claim 24, characterised in that a recess preferably positioned in the crest region of the curve and serving to apply reduced pressure to the chamber and the wound space passes through the snap disc.
26. The wound care system according to claim 21, characterised in that a circumferential edge region of the indicator wall is accommodated in an inner groove of the chamber jacket that is open towards the chamber.
27. The wound care system according to claim 26, characterised in that in the initial position and/or the final position of the indicator wall a space is formed between the bottom of the inner groove and the edge region of the indicator wall.
28. The wound care system according to claim 26, characterised in that regions of the walls of the inner groove coming into contact with the circumferential edge region of the indicator wall are formed at least partially from a flexible material.
29. The wound care system according to claim 21, characterised in that a circumferential collar for the form-locking coupling of a suction head of a suction device is formed in the region of the cross-over between the indicator wall and the chamber jacket, the collar preferably forming a stop limiting the approach of the suction head to the recess passing through the snap disc.
30. The wound care system according to claim 25, characterised in that the indicator wall has a valve system covering the recess of the snap disc, preferably in the form of a film valve, serving to suck gases out of the chamber and countering the penetration of gases into the chamber.
31. The wound care system according to claim 21, characterised in that a channel leading into the chamber passes through the chamber jacket.
32. The wound care system according to claim 27, characterised in that a circumferential outer groove for accommodating a tube connecting the chamber to the wound space, and that is preferably wound up in the outer groove, is provided in the boundary surface of the chamber jacket facing away from the chamber, the channel leading into the outer groove on its side facing away from the chamber.
33. The wound care system according to claim 21, characterised in that the groove has locking means for locking the tube emerging out of the groove.
34. The wound care system according to claim 32, characterised in that a recess passes through at least one wall of the outer groove in order to discharge liquid from said recess.
35. The wound care system according to claim 21, characterised in that the chamber is delimited by an at least partially transparent monitoring wall on the side facing away from the indicator wall.
36. The wound care system according to claim 35, characterised in that an indicator element coupled to the indicator wall is disposed in the chamber, which indicator element is moved towards the monitoring wall upon reaching the final position and preferably comes into contact with the monitoring wall.
37. The wound care system according to claim 35, characterised in that the monitoring wall is deformable and comes into contact with the boundary surface of the indicator wall facing the chamber when a pre-determined reduced pressure is applied to the chamber.
38. The wound care system according to claim 7, characterised in that the indicator device has a tube connected fluidically to the wound space, which tube has a reduced pressure-stable section facing the wound space and a compressible section facing away from the wound space and which is closed fluid-tightly on its end facing away from the wound space, the tube being filled partially with a liquid, in particular white oil.
39. The wound care system according to claim 1, characterised by a suction device that can be coupled detachably to the valve system.
40. The wound care system according to claim 39, characterised in that the suction device comprises a sealing flange passing around at least one one-way valve of the valve body and/or of the indicator device in order to establish a sealing connection between the valve chamber and/or a chamber of the indicator device and the suction chamber enabling gases to pass out of the valve chamber and/or a chamber of the indicator device into at least one suction chamber of the suction device, the suction device preferably having a receiver for the valve body.
41. The wound care system according to claim 39, characterised in that the suction device can be operated to suck gases out of the valve chamber of the valve body that is preferably held in the receiver.
42. The wound care system according to claim 39, characterised by at least one suction piston that can preferably be introduced into the suction chamber against the pre-tensioning force of a pre-tensioning device.
43. The wound care system according to claim 42, characterised in that at least one further valve system is assigned to the at least one suction piston, which valve system allows gases to be released from the suction chamber to the surrounding area when the suction piston is introduced into the suction chamber and counters the penetration of ambient air into the valve chamber when the suction piston is removed from the suction chamber.
44. The wound care system according to claim 1, characterised by a wound filling material, preferably comprising an absorbent material, such as for example a superabsorber, that can be inserted into the wound space.
45. The wound care system according claim 39, characterised in that the suction device has a pump, in particular an electromechanical pump.
46-55. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0068] The invention is explained below with reference to the drawings to which reference is explicitly made with regard to all of the details which are essential to the invention and are not elaborated any further in the description. The drawings show as follows:
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DETAILED DESCRIPTION
[0082] The wound care system illustrated in
[0083] In
[0084] Due to a pressure difference between the pressure in the indicator space, which because of the connection via the tube 8 corresponds to the pressure in the wound space, and the ambient pressure, the indicator layer 4 is pushed against the pre-tensioning force brought about by the spacer layer 5 against the indicator layer 6. The spacer layer 5 bringing about the pre-tensioning force can have different types of elastic elements with a defined restoring force, such as for example springs, e.g. helical or disc springs. However, foam materials or spacer fabrics may also be used which can be compressed against a pre-defined pre-tensioning force. On the boundary surface of the indicator layer 6 facing the indicator layer 4 an image motif is provided which is visible when the indicator layer 4 comes into contact with the indicator layer 6. It can thus be monitored whether the reduced pressure in the wound space, which corresponds to the pressure in the indicator space, still meets the requirements.
[0085] The embodiment of the invention illustrated in
[0086] The valve systems of the embodiments of the invention illustrated in
[0087] The valve system of a wound care system according to the invention illustrated in
[0088] In
[0089] If the sleeves 620 and 630 are coloured differently, for example by the sleeve 630 being coloured red and the sleeve 620 being coloured green, it can be seen through the transparent jacket 530 of the housing 500 that there is insufficient reduced pressure in the chamber 510 and so also in the wound space. If reduced pressure is generated in the chamber 510, for example by means of the suction port 512, the membrane 600 may be lifted from the front wall 550 of the chamber 520 due to the corresponding suction effect, pressure equalisation being able to take place in the chamber 520 by means of the opening 622 in this front wall. By lifting the membrane 600 from the front wall 550, the sleeve 620 accommodated in the chamber is pushed towards the front wall 540 of the housing 500 against the pre-tensioning force of the compression spring 640 and so overlaps the sleeve 630. By means of the different colourings of the sleeves 620 and 630, it can thus be signalled through the transparent housing 500 that there is sufficient reduced pressure in the chamber 510, and so also in the wound space.
[0090] When the reduced pressure drops, the compression spring 640 pushes the sleeve 620 back in the direction of the front wall 550. The jacket of the sleeve 630 can be seen once again. It is thus signalled through the transparent jacket 530 of the housing 500 that action is necessary in order to obtain the desired reduced pressure status. The concept explained by means of
[0091] By applying reduced pressure to the chamber 520 with the aid of an appropriate suction device, air flows through the lip seal from the direction of the chamber 510 and the dressing connected thereto (not illustrated). After completion of the active evacuation the position of the piston (with seal) shifts, according to the equilibrium, from the force resulting from the reduced pressure and the force of the compression spring countering the latter. As a result, the positional relationship of the sleeves 620 and 630 also shifts. The system can be set up so that with the desired reduced pressure status, the sleeve 630 is completely covered by the sleeve 620, and so is no longer visible.
[0092] In the indicator device illustrated in
[0093] The tip of the tube 700 which is produced by closing the end of the tube section 702 facing away from the tube section 701 is filled up to a pre-specified mark with a liquid 703. Medical white oil, for example, can be used here. Preferably, the tube as a whole is produced from a polymer which only has a small degree of wettability due to the oil so as to enable a rapid outflow of the liquid if there is a decrease in reduced pressure. The tube section 702 collapses due to the reduced pressure that is generated upon evacuating the wound space. The liquid 703 is pushed out of this region and flows to a second mark 704 on the pressure stable tube section 701. The position of this mark corresponds to the desired reduced pressure level. The reduced pressure status can thus be qualitatively displayed and monitored. In order to avoid any negative impact upon the functional capability of the indicator device illustrated in
[0094] The suction device illustrated in
[0095] If the suction piston 10 is pushed out of the suction chamber 11 by the pre-tensioning force of the spring 12, the valve ring 13 lies against the flange once again and seals off the suction chamber from the surrounding area. The suction that is produced by pushing the suction piston out of the suction chamber by expanding the volume of the suction chamber causes gases from the valve chamber of the valve body 15 to be introduced and so the generation of a reduced pressure in the wound space connected to the valve body 15 by the tube 8. As soon as sufficient reduced pressure has been generated in the wound space, when the counter-holder 14 is open the valve body 15 can be removed from the receiver and the suction device as a whole is mounted independently of the valve system connected to the covering device by the tube 8 and transported. The valve system or the valve body 15 can then be locked in the region of the covering device close to the wound. As soon as a rise in pressure is determined in the valve body 15 or in the wound space with the aid of the indicator device which may be integrated into the valve system, the valve body 15 can once again be coupled to the suction device and gases can once again be sucked out of the wound space.
[0096] The embodiment of the invention illustrated in
[0097] On its side facing away from the chamber 1005 the recess 1024 is covered by a film valve identified as a whole by 1026. The film valve 1026 makes it possible to suck fluids out of the chamber 1005, but counters the penetration of fluids into the chamber 1005. In this way the chamber 1005 can be evacuated with the aid of a schematically indicated suction device identified as a whole by 1100. On a boundary surface facing the indicator wall in the operating position the suction device 1100 has a seal system 1120 passing around a suction channel 1110 which can be applied to the indicator wall 1020 such that a gas-tight connection between the suction channel 1110 and the indicator wall 1020 is established.
[0098] The seal system 1120 passes around a schematically indicated valve slot of the film valve 1026 by means of which a fluid can be sucked out of the chamber 1005 via the suction channel 1110. As soon as reduced pressure is generated in the chamber 1005, there is a pressure difference between the pressure in the chamber 1005 and the pressure outside of the seal system 1120 outside of the seal system 1120. In this way a force pushing the indicator wall 1020 into the chamber 1005 is generated. As soon as the pressure difference is sufficiently great, the snap disc 2011 together with the film valve 1026 disposed on top of it folds down from the initial position illustrated in
[0099] The automatic release of the suction channel from the indicator wall is assisted by the chamber jacket having a circumferential collar 1060 made in the form of an annular protrusion which is held in a recess of the suction head of the suction device 1100 so that a front side boundary surface of the suction device 1100 comes into contact with a boundary surface of the chamber jacket 1010 passing around the annular protrusion. The chamber jacket then forms a stop limiting the approach of the seal system 1120 to the snap disc 1022 or the recess 1024 passing through the snap disc so that the seal system 1120 cannot follow the snap disc 1022 into the end position when folded over from the initial position.
[0100] It can be determined haptically whether the indicator wall 1020 is curved outwardly (
[0101] Provided within the chamber 1005 is an additional indicator element 1040 which is coupled to the snap disc 1022. If upon reaching a desired reduced pressure status in the chamber 1005 the snap disc 1022 is folded down from the initial position illustrated in
[0102] As can be seen in
[0103] The walls of the groove 1012 can be provided with indentations in the region of their ends facing away from the groove bottom. In the region of the indentations the groove width may correspond approximately to the diameter of the tube. Outside of the indentation the groove width may be smaller than the diameter of the tube. Locking of the tube emerging out of the tube at a desired length can thus be brought about. It is then only possible to change the length by slightly squeezing the tube and/or deforming the groove walls, i.e. with additional expenditure of force.
[0104] The embodiment of the invention illustrated in
[0105] In the embodiment of the invention illustrated in
[0106]
[0107] In
[0108] As can be seen in
[0109] The suction device 2000 illustrated in
[0110] A total of two suction chambers 2011 running parallel to one another are provided in the housing 2040. The grip part 2030 that can be inserted into the housing 2040 has two suction pistons 2010 which can be introduced into the suction chambers 2011. Upon introducing the suction pistons 2010 into the suction chambers 2011, sealing rings 2013 passing around the suction pistons 2010 are lifted from an inner boundary surface of the suction chambers 2011 and thus make it possible for gases to escape from the suction chambers 2011. By introducing the suction pistons 2010 into the suction chambers 2011, compression springs 2012 accommodated in the suction chambers 2011 are compressed. When the suction pistons 2010 are pushed onto the suction chambers 2011 by the effect of the compression springs 2012, the sealing rings 2013 rest against the inner boundary surfaces of the suction chambers 2011. By increasing the volume of the suction chambers 2011, suction is produced in suction channels 2050 which are connected to the suction head 2042. By means of the film valve on the outer boundary surface of the snap disc and the valve system 2044 in the suction head 2042, gases can thus be sucked out of the chamber of the indicator device, and so also out of the wound space, and reduced pressure is established in the chamber and in the wound space.
[0111] The invention is not restricted to the exemplary embodiments explained by means of the drawings. For example, the following modifications of the embodiment illustrated by the drawings is also conceivable:
[0112] The valve system, possibly in the form of a film valve, and the indicator device are integrated, in combination, directly into the dressing.
[0113] The valve system and the indicator device, in combination, as illustrated by the drawings, are connected by a tube to the dressing.
[0114] The valve system and the indicator device are connected individually by means of at least one tube to the dressing.
[0115] The valve system and the indicator device are incorporated individually directly into the dressing.
[0116] The valve system is connected by a tube to the dressing, the indicator device being incorporated directly into the dressing.
[0117] The indicator device is connected by a tube to the dressing, the valve system being incorporated directly into the dressing.
[0118] The valve system and the indicator device, already pre-fabricated in combination, are applied adhesively to the dressing. For this purpose, the dressing or the covering device is provided at the appropriate point with a recess or is made to be permeable to gas.
[0119] The valve system and the indicator device, already individually pre-fabricated, are applied adhesively to the covering device. For this purpose, the covering device is respectively provided at the appropriate points with a recess and a region that is permeable to gas.
[0120] With systems according to the invention the following advantages are achieved:
[0121] A pump securely connected to the wound care system is not required. In fact, if so required, a suction device can be coupled to the valve system from the outside. After reaching the desired reduced pressure in the wound space the suction device can be removed.
[0122] Clearly improved comfort results for the user if the otherwise required connection tube to the pump can either be totally dispensed with or, instead of this connection tube or the fluid line, a clearly shortened tube to the valve system can be used.
[0123] The patient's mobility is not, as with other systems, additionally restricted by this tube. Even with a tube-bound valve system of the covering device, in comparison with a conventional system provided with a pump, the overall system is much lighter and smaller. The risk of detachment due to inadvertent tearing on the connection tube between the covering device and the pump and associated leakage of the adhesive covering device is thus considerably reduced.
[0124] The system with the valve system and the indicator device, in combination, but also separated, is flexible due to its structure. It can be bent and buckled, and so can be worn discretely on the patient and under clothing. The patient can be informed discretely at all times of the reduced pressure status by means of the indicator device and, if need be, re-pump with the aid of a separate suction device.
[0125] The system does not require any additional energy sources such as voltage sources (e.g. battery/socket). In this way allowance is made for the defect that single-use devices with electrical voltage sources may lead to constraints relating to operability and sustainability for the users.
[0126] The length of a tube or some other connection can be made variable by using an appropriate connection element. The lack of flexibility, which restricts and possibly discourages the mobile users named as the target group, can be reduced. Even after detaching the suction device the valve system is sealed from the outside with respect to water, dust and air.
[0127] The suction device can be designed, for example, as an open piston or bellows system. Therefore, in addition to a favourable production and/or purchase price, it is insensitive to water, dust, dirt, etc. However, it can also be realised in the form of an electromechanical, mechanical, hydraulic and/or pneumatic pump.
[0128] The design of a combination of a valve system and an indicator device, as illustrated, for example, in
[0129] By using phosphorescent (luminescent) paints or elements when producing valve systems and/or indicator devices, the reduced pressure status can also be made to be visible in the dark.
[0130] The wound care system may be designed as a single-use product or the suction device may be designed as a single-patient-use product. Thus, in terms of sustainability, the amounts of consumable materials can be reduced to the greatest possible extent.
LIST OF REFERENCE NUMBERS
[0131] 1 reinforcement strip [0132] 2 limiting element [0133] 3 film [0134] 4 indicator layer [0135] 5 spacer layer [0136] 6 indicator layer [0137] 7 limiting element [0138] 8 tube [0139] 9 housing [0140] 10 piston [0141] 12 spring [0142] 13 sealing ring [0143] 14 counter-holder [0144] 15 valve body [0145] 16 sealing flange [0146] 17 hole [0147] 100 covering device [0148] 120 wound filling material [0149] 200 valve system [0150] 300 suction device [0151] 500 housing [0152] 530 jacket [0153] 600 membrane [0154] 640 pre-tensioning device [0155] 700 tube [0156] 701 reduced pressure-stable tube section [0157] 702 compressible tube section [0158] 703 liquid [0159] 704 mark [0160] 510, 520 chambers [0161] 540, 550 front surface [0162] 620, 630 sleeve [0163] 622, 632 hole in the front wall [0164] 1000 valve and indicator system [0165] 1005 chamber [0166] 1010 chamber jacket [0167] 1012 outer groove [0168] 1014 inner groove [0169] 1016 sealing rings [0170] 1020 indicator wall [0171] 1022 snap disc [0172] 1024 recess [0173] 1026 film valve [0174] 1030 monitoring wall [0175] 1032 upwardly curved ring [0176] 1040 indicator element [0177] 1050 channel [0178] 1060 annular protrusion (collar) [0179] 1100 suction device [0180] 1110 suction channel [0181] 1120 seal system [0182] 1200 tube [0183] 2000 suction device [0184] 2010 suction piston [0185] 2011 suction chamber [0186] 2012 compression spring [0187] 2013 sealing rings [0188] 2030 grip part [0189] 2040 housing [0190] 2042 suction head [0191] 2044 one-way valve [0192] 2050 suction channel