Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/64—Containers with integrated suction means
  • A61M1/68—Containers incorporating a flexible member creating suction
  • A61M1/684—Containers incorporating a flexible member creating suction bellows-type
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
  • A61M1/604—Bag or liner in a rigid container, with suction applied to both
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/78—Means for preventing overflow or contamination of the pumping systems
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/04—Liquids
  • A61M2202/0464—Cerebrospinal fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
  • A61M2205/0272—Electro-active or magneto-active materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
  • A61M2205/106—General characteristics of the apparatus with powered movement mechanisms reciprocating

Definitions

• the invention relates to a device for drainage, in particular for drainage of a chronic subdural hematoma (CSH).
• CSH chronic subdural hematoma
• Chronic subdural hematoma is a condition typically triggered by a traumatic event in elderly patients. There is a hemorrhage under the dura mater (dura) into the subdural space (the space below). Bleeding usually stops under the pressure in the hematoma, but it bleeds as the blood is broken down. It is therefore a chronic disease that can only be controlled surgically. For this purpose, the skull is opened, the blood from the bruise is drained or, depending on the size also cleared or washed out. After this procedure there is a high likelihood of rebleeding and the reappearance of the condition.
• the difficulty here is that the wound cavity is not completely filled with liquid, so that air can be sucked in as well. This then forms bubbles or foam in the tube system and the gravity drainage comes to a standstill.
• cerebrospinal fluid Cerebrospinal fluid, in short: cerebrospinal fluid
• the object of the invention is to provide a device for draining the chronic subdural hematoma using a reservoir, which by design produces an approximately constant negative pressure, in particular of the order of less than 30 mmHg.
• a further object of the invention is, in particular, to provide a device of the type mentioned, in which the volume flow, that is, the volume drawn off per unit time, is limited.
• the problem is solved by the combination of a tubular reservoir with flexurally soft wall and rigid lid and bottom with at least one inside or outside spring.
• the at least one spring is arranged so that it can push apart floor and lid or move away from one another.
• the at least one spring is preferably biased such that it is deformed only over part of its spring travel, so that its force, and thus the negative pressure generated by it changes only slightly.
• the at least one spring according to an embodiment of the invention is preferably biased so that the path between the initial position and a predetermined by the length of the reservoir end position of at least one spring only a part of the total spring travel of the at least one spring.
• the said length of the reservoir is in this case its maximum extent in the direction of movement of the spring.
• one or more magnets are provided, which are configured to exert an additional force on the reservoir in addition to the spring force such that a resultant force pushing apart the lid and the bottom is substantially constant over that part of the spring travel is or is preferably constant.
• suitable magnet arrangements is possible, with particularly preferred arrangements are given below.
• Substantially constant here means that the amount of force over that part of the spring travel is preferably not more than 50%, preferably not more than 40%, preferably not more than 30%, preferably not more than 20%, preferably not more than 10%. , preferably not more than 5%, preferably not more than 1%, deviates from the average amount of force over that part of the spring travel.
• substantially constant means that the force corresponds to a negative pressure in the reservoir which lies above that part of the spring travel of the at least one spring between the initial and final position of the at least one spring in the range from 20 to 40 mmHg, preferably in a range of 25 to 35 mmHg, preferably in a range of 27 to 33 mmHg, preferably in a range of 28 to 32 mmHg, preferably in a range of 29 to 31 mmHg.
• these apply preferred pressure ranges also, where always the upper limit is formed by 30mmHg.
• the tubular reservoir with flexurally soft wall and rigid lid and bottom is arranged with at least one internal spring in a housing.
• the tubular reservoir is provided with one or more ports for each hose, via which ports each a hose in flow communication with the reservoir can be brought.
• connections preferably penetrate a wall of the housing and are tightly connected to this and the reservoir or sealed in by means of sealing means.
• the housing is provided with at least one connection.
• the port in the housing is opened, the tubular reservoir is free to expand and contract. If the connection is closed, the expansion and contraction is blocked, since in an interior of the housing, in particular between a wall of the housing and a wall or the lid of the tubular reservoir an over or under pressure builds up, which obstructs the movement of the wall of the tubular reservoir ,
• a flow restriction is provided in the port in the housing, e.g. in the form of a flow resistance, e.g. a semipermeable membrane, a nozzle or a perforated plate which limits the outflow of ambient air from the space between the housing wall and that wall of the tubular reservoir.
• a flow resistance e.g. a semipermeable membrane, a nozzle or a perforated plate which limits the outflow of ambient air from the space between the housing wall and that wall of the tubular reservoir.
• At least one magnet is mounted in or on the lid. Furthermore, in the wall of the Housing, which is opposite to the lid, attached at least one magnet or a paramagnetic, preferably superparamagnetic or ferromagnetic, body, which is oriented so that it exerts an increasing attraction force as the lid approaches the opposite wall. With decreasing force of the at least one spring, so an increasing magnetic force is exerted, which compensates for the decrease of the spring force in whole or in part. Furthermore, the arrangement can also be carried out the other way around, ie any paramagnetic, superparamagnetic or ferromagnetic body may also be arranged on the cover and the at least magnet on that wall of the housing.
• the magnet or paramagnetic, superparamagnetic or ferromagnetic body cooperate so that a resulting, the soil and the lid apart moving force is substantially constant, preferably constant (see also above).
• the reservoir can be sucked empty by means of a syringe.
• the device is tensioned by the movable cover by hand against the spring and possibly magnetic force is moved.
• an opening is provided in the housing through which e.g. a rod or the like is pressed against the movable plate, wherein the rod is sealed against the housing in a cylindrical guide by a seal.
• a disc is mounted under the opening, which is sealed with a bellows or an elastic membrane against the housing.
• the disc is preferably larger in diameter than the opening, so that it can rest in a rest position on a peripheral edge of the opening on the inner wall of the housing.
• the opening is preferably dimensioned so that the user can insert a finger or a suitable object through the opening, wherein he or she the disc of the Inner wall of the housing pushes away against the movable lid of the reservoir and thus spans the device.
• an elastic pumping chamber is provided in or on a wall of the housing for clamping, which is connected via a check valve to the atmosphere and via a further check valve with an interior of the housing.
• the check valves are oriented to allow flow from the atmosphere into the resilient pumping chamber and out of the pumping chamber into the interior of the housing and block flow in the opposite direction. If the pumping chamber is actuated, air is pumped into the interior of the housing and compressed by the pressure building up the reservoir (cocked).
• the at least one spring has a plurality of turns and is arranged on a periphery of the lid and the bottom so that the reservoir is supported by the turns of the at least one spring.
• the device to have at least one expansion element in order to prevent collapse of the flexible wall of the reservoir, in particular when the cover is moved in the direction of the ground.
• This spreading element may be e.g. to act around a connected to the wall of the reservoir ring.
• the at least one expansion element is a plate arranged in an inner space of the reservoir, which preferably extends transversely to the direction of movement of the at least one spring.
• a further aspect of the invention according to item 1 also relates to a device for drainage:
• Point 1 Drainage device, with: - A tubular reservoir (100) comprising a flexurally soft wall (1) and a rigid lid (3) and a rigid bottom (2), and
• At least one spring (4) which exerts a lid (3) and the bottom (2)moimulde force, wherein the lid (3) in the direction of the bottom (2) is movable to bring the spring in an initial position ,
• Item 2 A device according to item 1, wherein the device comprises one or more magnets (11, 12) configured to exert an additional force on the reservoir (100), such that a resulting, the lid (3 ) and the soil (2) is force substantially constant over that part of the spring travel.
• Item 3 Device according to item 1 or 2, wherein the at least one spring (4) is biased so that the path between the initial position and a predetermined by the length of the reservoir (100) end position of the at least one spring (4) only a part the total spring travel of the at least one spring (4) makes.
• Item 4 Device according to one of the items 1 to 3, wherein the tubular reservoir (100) has at least one connection (5, 6) for connecting a hose.
• Item 5 Device according to item 4, wherein the reservoir (100) is arranged in a housing (7) of the device, and that the at least one connection (5, 6) penetrates the housing (7) and is sealed to the housing (7). and the reservoir (100) is connected or sealed by means of sealing means in this.
• Item 6 Device according to item 5, wherein the housing (7) has at least one connection (8) via the ambient air into an interior space (102) of the housing (7) between a wall (7a) of the housing (7) and a wall (3) of the reservoir (100) is on and auslassbar.
• Item 7 Device according to item 6, wherein in the at least one connection (8) a flow resistance (9) is arranged, which limits the volume flow of the ambient air.
• Item 8 Device according to item 7, wherein the flow resistance (9) is formed by one of the following elements: a nozzle,
• a membrane which consists of a gas-permeable material or has a gas-permeable material
• Silicone rubber has.
• Item 9 Device according to one of the preceding points, wherein the bottom (2) of the reservoir (100) is fixedly connected to a wall (7b) housing (7) and the cover (3) is movable relative to the housing (7) in the housing ( 7) is arranged.
• Item 10 Device according to item 9, wherein at least one magnet (11) is arranged on the cover (3), and at least one further magnet (12) is provided on a wall (7a) of the housing (7) opposite the cover (3). is arranged, wherein the at least one magnet (11) and the at least one further magnet (12) are oriented so that they attract each other.
• Item 11 Device according to item 9, wherein on the cover (3) at least one magnet (11) is arranged, and wherein on a lid (3) opposite wall (7a) of the housing (7) at least one body of a magnetic, in particular paramagnetic, superparamagnetic or ferromagnetic material, wherein there is an attractive force between the at least one magnet (11) and the at least one body (12).
• Item 12 Device according to item 9, wherein on the lid (3) at least one body (11) of a magnetic, in particular paramagnetic, superparamagnetic or ferromagnetic, material is arranged, and wherein on a lid (3) opposite wall (7a) of Housing (7), at least one magnet (12) is arranged, wherein between the at least one magnet (11) and the at least one body (12) is an attractive force.
• a magnetic, in particular paramagnetic, superparamagnetic or ferromagnetic, material is arranged, and wherein on a lid (3) opposite wall (7a) of Housing (7), at least one magnet (12) is arranged, wherein between the at least one magnet (11) and the at least one body (12) is an attractive force.
• Item 13 Device according to one of the preceding points, wherein the at least one spring (4) has a plurality of turns (40) and is disposed on a periphery of the lid (3) and the bottom (2) such that the reservoir (100) is supported by the turns (40) of the at least one spring (4).
• Item 14 Device according to one of the preceding points, wherein the device has at least one spreading element (13, 14) for supporting the reservoir (100).
• Item 15 Device according to item 14, wherein the at least one expansion element (13, 14) is a ring connected to the wall (1) of the reservoir (100).
• Item 16 Device according to item 14, wherein the at least one expansion element is a plate (25) arranged in an interior space (103) of the reservoir (100).
• Item 17 Device according to one of the preceding points, wherein in an opposite the cover (3) wall (7 a) of the housing (7) has an opening (15) is mounted.
• Item 18 Device according to item 17, wherein the device comprises a movable disc (16) which is arranged in an inner space (102) of the housing (7) and the opening (15) opposite, wherein the disc (16) for sealing the Housing via a diaphragm (17) or a bellows (17) is connected to the housing (7), so that it is for pressing the at least one spring (4) manually against the lid (3) can be pressed.
• the device comprises a movable disc (16) which is arranged in an inner space (102) of the housing (7) and the opening (15) opposite, wherein the disc (16) for sealing the Housing via a diaphragm (17) or a bellows (17) is connected to the housing (7), so that it is for pressing the at least one spring (4) manually against the lid (3) can be pressed.
• Item 19 Device according to one of the preceding points, wherein an elastic pumping chamber is provided in or on the wall of the housing, which is connected via a check valve to the atmosphere and is connected via a further check valve with an interior of the housing such that the Non-return valves allow flow from the atmosphere into the elastic pumping chamber and out of the pumping chamber into the interior of the housing and block flow in the opposite direction.
• Fig. 1 is a sectional view of an inventive
• FIG tured spring 2 is a sectional view of the device according to FIG tured spring
• Fig. 3 is a sectional view of another invention
• Fig. 4 is a sectional view of another invention
• Fig. 5-6 are detailed sectional views of an opening of a device according to the invention for tensioning the spring (s) of the device
• Fig. 7 is a graphical representation of the course of the negative pressure
• FIG. 1 shows the basic mode of operation of a device according to the invention.
• the device has a reservoir 100, which has a rigid bottom 2 and a rigid lid 3 opposite the bottom 2.
• the bottom 2 and the cover 3 are connected to each other via a soft bendable wall 1, so that the said reservoir 100 is formed.
• the flexible wall 1 of the reservoir 100 is e.g. designed as a cylindrical tube made of thin plastic film.
• the tube 1 is closed at its ends by the rigid bottom 2 and a rigid lid 3.
• a spring 4 preferably in the form of a helical spring 4, is arranged, which is biased against the bottom and the lid so that it tries to move the bottom 2 and lid 3 apart.
• the bottom 2 and the lid 3 of the reservoir 100 are thus opposite each other in the direction of movement 101 of the spring 4.
• the spring 4 is biased against the bottom 2 and the lid 3 so that it is already compressed in the fully expanded position shown in Figure 1 (end position) to preferably 50% to 70%, preferably 60% of their relaxed length. In the compressed position of the reservoir 100 and the spring 4 shown in FIG. 2, the spring 4 is complete in its initial position pressed together. Their travel is thus utilized in particular to 50% to 70% or 60%.
• the spring 4 is preferably further designed so that in the fully compressed position (see Fig. 2), the maximum possible spring force generates the desired negative pressure.
• the negative pressure is 50% to 70% and 60% of the desired value, respectively.
• the negative pressure does not change between zero and 100%, but only between zero and 50% to 70% or zero and 60%.
• the turns of the spring 4 further prevent collapse of the reservoir 100, in particular the flexible wall 1, when the reservoir 100 is compressed.
• the device or the reservoir 100 has a first port 5, via which drained fluid can be sucked into the reservoir 100, and a second port 6 can be withdrawn from the reservoir 100 via the said fluid.
• FIG. 3 shows a further embodiment of a device according to the invention, in which the reservoir 100 shown in FIGS. 1 and 2 is arranged in a housing 7.
• the two terminals 5 and 6 penetrate the housing 7 in this embodiment.
• the bottom 2 is connected to a wall 7 b of the housing 7, whereas the lid 3 is movably arranged in an inner space 102 of the housing 7.
• the housing 7 is further provided with a connection 8 in which a flow resistance 9 is arranged.
• a valve 10 is provided, which, when opened, allows the unimpeded inflow of air into the interior 102 of the housing 7, between housing 7 and a wall 1, 3 of the reservoir 100 allows.
• the device according to FIG. 3 preferably has a magnet 11, which is arranged in the movable cover 3 of the reservoir 100, and a magnet 12, which is fixedly arranged in the wall 7a of the housing 7 opposite the cover 3.
• the magnet 11 approaches the magnet 12 and exerts an increasing force on this, which compensates for the decrease of the spring force, so that a resultant force, the cover 3 from the bottom is as constant as possible (see above).
• the embodiment of the device or reservoir 100 shown in FIG. 4 uses a plurality of springs arranged between the edges of the bottom 2 and the cover 3.
• two spreader rings 13 and 14 are additionally preferably arranged on the peripheral wall 1 which allow the collapse of the tubular reservoir 100, e.g. similar to a bellow or accordion.
• one or more plates 25 may be provided in the interior of the reservoir 100, which extend transversely to the springs 4 and to the direction of movement 101 and abut the wall 1.
• Such plates 25 can be penetrated by the springs 4.
• the springs 4 can also be divided accordingly, in which case the resulting spring sections 4a, 4b, 4c are supported on the then continuous plates 25.
• the e.g. instead of the expansion rings 13, 14 provided plates 25 are indicated in Figure 4 with dashed lines.
• Figure 5 shows in detail a possible arrangement for clamping the device, which can be used in all embodiments with housing 7.
• housing 7 In the lid 3 opposite wall 7a of the housing 7 while an opening or bore 15 is arranged.
• a movable disk 16 is disposed in the inner space 102 of the housing 7 and connected to the wall 7 a of the housing 7 by an elastic membrane 17 or a bellows 17. If, as shown in FIG. 6, the user inserts a finger 18 or a suitable object into the opening 15, he or she can press the disc 16 against the lid 3 and thus press the device or its spring (s). 4 tension.
• FIG. 7 shows the course of the negative pressure in the reservoir 100 as a function of the aspirated volume of the device according to FIG. 3 with and without magnets 11, 12.

Landscapes

• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• External Artificial Organs (AREA)
• Reciprocating Pumps (AREA)

Priority Applications (6)

Applications Claiming Priority (2)

Publications (1)

Family

ID=56097952

Family Applications (1)

Country Status (10)

Families Citing this family (3)

Citations (3)

Family Cites Families (24)

• 2015
  • 2015-06-02 DE DE102015108754.5A patent/DE102015108754B8/de active Active
• 2016
  • 2016-04-18 ES ES16726764T patent/ES2899223T3/es active Active
  • 2016-04-18 PL PL16726764T patent/PL3302599T3/pl unknown
  • 2016-04-18 HU HUE16726764A patent/HUE056758T2/hu unknown
  • 2016-04-18 EP EP16726764.0A patent/EP3302599B1/de active Active
  • 2016-04-18 US US15/579,017 patent/US11065370B2/en active Active
  • 2016-04-18 JP JP2017562059A patent/JP6774431B2/ja active Active
  • 2016-04-18 CN CN201680032464.8A patent/CN107666917B/zh active Active
  • 2016-04-18 PT PT167267640T patent/PT3302599T/pt unknown
  • 2016-04-18 WO PCT/DE2016/100183 patent/WO2016192705A1/de not_active Ceased

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