WO2024256977A2 - Systèmes et procédés de rinçage de drains ventriculaires externes - Google Patents

Systèmes et procédés de rinçage de drains ventriculaires externes Download PDF

Info

Publication number
WO2024256977A2
WO2024256977A2 PCT/IB2024/055727 IB2024055727W WO2024256977A2 WO 2024256977 A2 WO2024256977 A2 WO 2024256977A2 IB 2024055727 W IB2024055727 W IB 2024055727W WO 2024256977 A2 WO2024256977 A2 WO 2024256977A2
Authority
WO
WIPO (PCT)
Prior art keywords
flush assembly
flush
fluid
connector
assembly according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/055727
Other languages
English (en)
Other versions
WO2024256977A3 (fr
Inventor
Jacob SCHULER
Matt Casiraro
David Szabo
Elsa Chi Abruzzo
David A. Watson
Marc-Alan Levine
Dary C. DESERNE
Ethan Ryan LANGLAND
Madisyn N. HAWKINS
Hannah J. OMAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Anuncia Medical Inc
Original Assignee
Anuncia Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Anuncia Medical Inc filed Critical Anuncia Medical Inc
Priority to AU2024302278A priority Critical patent/AU2024302278A1/en
Priority to KR1020267001125A priority patent/KR20260021786A/ko
Priority to CN202480043479.9A priority patent/CN121419810A/zh
Publication of WO2024256977A2 publication Critical patent/WO2024256977A2/fr
Publication of WO2024256977A3 publication Critical patent/WO2024256977A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

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
    • A61M25/00—Catheters; Hollow probes
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009—Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • A61M2039/0018—Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation designed for flushing a line, e.g. by a by-pass
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1083—Tube connectors; Tube couplings having a plurality of female connectors, e.g. Luer connectors
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1088—Tube connectors; Tube couplings having a plurality of male connectors, e.g. Luer connectors
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/229—Stopcocks
    • 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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves

Definitions

  • External ventricular drains are used to transport body fluids from one region of the body to an external reservoir.
  • Such systems are used, for example, in the treatment of hydrocephalus use tubes to drain excess cerebrospinal fluid from a patient tissue site, such as the ventricles of the brain, to an external reservoir, such as a drainage bag, to relieve fluid pressure on the brain.
  • Common EVD systems have components that connect to ventricular catheters that have been implanted in the brain to drain fluid out of the brain via patient line.
  • the present disclosure provides a flush assembly for an external ventricular drain (EVD) system comprising a collapsible upper body and a base, the flush assembly connected to the EVD using a connector, a bonding tube surrounding the connector, wherein the connector intersects the collapsible upper body and/or base, and wherein the flush assembly stores a fluid in an internal fluid reservoir and when the flush assembly is activated, the collapsible upper body pushes the fluid from the internal fluid reservoir to a flushing site to perform a flush of the EVD.
  • the flushing site includes either a tissue site and/or a drain site allowing the fluid to be forced from the flush assembly to remove blockages in a catheter or patient line.
  • the flush assembly may comprise a stop cock valve, wherein the flush assembly can be turned on and off depending on an orientation of the stop cock valve.
  • the stop cock valve may also allow the introduction of a sterile saline or various thrombolytics such as a tissue plasminogen activator (tPA).
  • tPA tissue plasminogen activator
  • the flush assembly connector may be manufactured from a plastic or urethane and may be attached with a luer lock connector.
  • the bonding tube may be manufactured from a flexible polymer material and provide a surface for chemical bonding to other similar materials.
  • the fluid flow through the flush assembly may be bidirectional and may be expelled in even amounts or non-even amounts in each direction.
  • the fluid flow through the flush assembly may be adjustable.
  • the flush assembly may comprise a tactile feature.
  • the present disclosure may also provide a flush assembly for an EVD system comprising a hemi-spherical structure having a flat top, a connector located on a side, the connector having a bonding tube surrounding the connector, a drainage tube located on an opposite side, and wherein the flush assembly is connected to the EVD system in-line, and wherein the connector is connected to an externalized ventricular catheter while drainage tube is connected to the EVD system.
  • the flush assembly stores a fluid in an internal fluid reservoir and, when the flush assembly is activated, the flush assembly pushes the fluid from the internal fluid reservoir to a flushing site to perform a flush of the EVD or drainage line.
  • the flush assembly may also comprise a flat top having a tactile feature.
  • the present disclosure may also provide a flush assembly for an EVD system comprising two hemi-spherical structures, a connector located on a side, the connector have a bonding tube surrounding the connector, a drainage tube located near the top of one hemisphere and following the contour of that hemisphere until reaching the side opposite the connector, wherein the flush assembly is connected to the EVD system in-line, and wherein the connector is connected to an externalized ventricular catheter while the drainage tube is connected to the EVD system.
  • the flush assembly stores a fluid in an internal fluid reservoir and, when the flush assembly is activated, the flush assembly pushes the fluid from the internal fluid reservoir to a flushing site to perform a flush of the EVD or drainage line.
  • the flush assembly may also comprise one or both hemispheres having a tactile features.
  • FIG. 1 is a planar sideview of a flush assembly according to the disclosed subject matter.
  • FIG. 2 is a bottom isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 3 is a cross-section of the flush assembly of FIGS. 1 and 2.
  • FIG. 4 is a bottom isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 5 is a planar sideview of a flush assembly according to the disclosed subject matter.
  • FIG. 6 is a cross-section of the flush assembly of FIGS. 4 and 5.
  • FIG. 7 is a planar sideview of a flush assembly according to the disclosed subject matter.
  • FIG. 8 is a cross-section of the flush assembly of FIG 7.
  • FIG. 9 is a bottom isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 10 is a cross-section of the flush assembly of FIG 9.
  • FIG. 11 is a top isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 12 is a cross-section of the flush assembly of FIG 11 .
  • FIG. 13 is a top isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 14 is a cross-section of the flush assembly of FIG. 13.
  • FIG. 15 is a cross-section of another embodiment of a flush assembly according to the disclosed subject matter.
  • FIG. 16 is a top planar view of the flush assembly of the flush assembly of FIG 15.
  • FIG. 17 is a top isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 18 is a bottom isometric view of a flush assembly according to the disclosed subject matter.
  • FIG. 19 is a cross-section of the flush assembly of FIGS. 17 and 18.
  • FIG. 20 is a bottom view of the flush assembly with the base removed.
  • FIG. 21 is a bottom view of the upper body.
  • FIG. 22 is an isometric view of FIG. 18.
  • FIG. 23 is an isometric view of the valve and channel member.
  • FIG. 24 is an isometric view of the channel member.
  • FIG. 25 is a bottom isometric view of the valve.
  • FIG. 26 is an elevation view of a flush assembly according to the disclosed subject matter.
  • FIG. 27 is a cross-section of an embodiment of a flush assembly according to the disclosed subject matter, with an enlarged cross-section A-A.
  • FIG. 28 is a cross-section of an embodiment of a flush assembly according to the disclosed subject matter.
  • FIG. 29 is an enlarged view of FIG. 28.
  • FIG. 30 is a bottom view of an embodiment of the flush assembly of FIG. 27 with the base removed.
  • FIG. 31 is an isometric view from above of an embodiment of a flushing assembly according to the disclosed subject matter.
  • FIG. 32 is an elevation view of the flushing assembly of FIG. 31 .
  • FIG. 33 is an isometric view from above of an embodiment of a flushing assembly according to the disclosed subject matter.
  • FIG. 34 is an end view of the flushing assembly of FIG. 33.
  • FIG. 35 is a plan view of an embodiment of a drain catheter according to the disclosed subject matter.
  • the flush assembly 100 forms an upper body 101 and a base 102, with a connector 103 at a bottom end, and a bonding tube 104 surrounding the connector 103.
  • the flush assembly 100 is connected to an EVD system of a patient.
  • the flush assembly 100 is used as a component of the EVD system to store and transfer fluid from and internal fluid reservoir 105, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 100 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the flush assembly 100 is connected to the EVD system by a connector 103 using a standard luer lock connector.
  • fluid communication to flush assembly 100 can be turned on or off depending on the orientation of a stop cock valve of the EVD system.
  • the stop cock valve may also allow the introduction of a sterile saline or various thrombolytics such as a tissue plasminogen activator (tPA).
  • tPA tissue plasminogen activator
  • the upper body 101 is manufactured from a flexible material, such as silicone, or other thermoplastic elastomer and is therefore a collapsible upper body 101 .
  • the collapsible upper body 101 forms an internal fluid reservoir 105 above the base 102.
  • the base 102 is manufactured from a flexible material such as silicone, or other thermoplastic elastomer or a hard material such as a plastic (e.g., ABS, polycarbonate, PEEK, polyurethane, or the like).
  • the base 102 is intersected by the connector 103, which is in turn surrounded by a bonding tube 104. This creates a fluid pathway from the internal fluid reservoir 105 to the EVD system, for example, by a standard luer lock connection (among others).
  • the connector 103 may be manufactured from a hard material such as plastic or urethane.
  • the bonding tube 104 may be manufactured from flexible materials, such as silicone or a thermoplastic elastomer, and may provide a surface for chemical bonding to other similar materials, such as those of the base 102.
  • the bonding tube 104 may also create a mechanical bond to connector 103 in the case that a chemical bond cannot otherwise be established.
  • a thread 106 may be tied around the bonding tube 104 to create a stronger mechanical lock. This effect could also be achieved through the use of laser welding, thermal welding, press fitting or the like.
  • the flush assembly 100 When flushing is necessary, the flush assembly 100 is in fluid communication with the flushing site (i.e. , the tissue site or drainage site). When the flush assembly 100 is activated, the collapsible upper body 101 pushes fluid from the internal fluid reservoir 105 to the flushing site to perform a flush.
  • the flush can be performed bidirectionally and push fluid to both sites at once. The amount of fluid expelled in both directions can be evenly split or engineered to direct volumes in non-even amounts in either direction.
  • the fluid flow through the flush assembly may be adjustable.
  • the upper body 101 and/or the base 102 of the flush assembly 100 may comprise tactile features to aid in the gripping and use of the flush assembly 100.
  • the tactile features may comprise, among other structure, a continuous ring, interrupted ring, full surface scoring, partial surface scoring, raised wave like patterns and the like. These tactile features may improve use of the device by allowing for proper finger placement and minimize movement to the EVD system helping to ensure patient safety.
  • the flush assembly 100 may comprise a material that is resealable after being punctured by a needle.
  • the therapeutics may be injected into the flush assembly 100.
  • the therapeutic Upon actuation of the flush assembly 100, the therapeutic is pushed into a catheter obstruction eroding the obstruction. The therapeutic may then be sucked back after actuation of the flush assembly 100 has occurred.
  • the flush assembly 200 forms an upper body 201 and a lower body 203, with a luer connector 204 at the lower body 203.
  • the flush assembly 200 is connected to the EVD system of a patient.
  • the flush assembly 200 is used as a component of an EVD system to store and transfer fluid from an internal fluid reservoir 207, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 200 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the upper body 201 is depressed into the lower body 203, compressing a spring 208 and expelling fluid from the internal fluid reservoir 207. The spring 208 then acts on the upper body 201 extending it back to its starting position.
  • the upper body 201 comprises an outer casing 209 and an inner plunger 205.
  • the inner plunger 205 has a gasket 206, for example, comprised of rubber, on the end.
  • the gasket 206 fits within a flush body inner casing 210 with a geometry that conforms with the interior surfaces of the flush body inner casing 210.
  • the outer casing 209 fits within lower body 203.
  • the gasket 206 may comprise a silicone or urethane to create a mechanical seal within the flush body inner casing 210.
  • the upper body 201 , outer casing 209, inner plunger 205, lower body 203, and the flush body inner cavity may comprise a rigid plastic such as PET, PE, PP, PC, or other suitable material.
  • the lower body 203 consists of an outer surface 211 and a flush body inner casing 210.
  • finger handles 202 protrude outwardly to allow for gripping of the lower body 203.
  • the outer casing 209 engages the spring 208 with the walls of the flush body inner casing 210 and the outer surface 211 surrounding the outer casing 209 and the spring 208.
  • the spring 208 comprises materials typically used for spring construction such as, for example, spring steel, stainless steel or and the like.
  • the flush body inner casing 210 and the gasket 206 form an internal fluid reservoir 207.
  • the internal fluid reservoir 207 contains fluid used for flushing.
  • the flush assembly 300 forms a sphere 301 , comprising a connector 304 on one side, and a bonding tube 305 surrounding the connector 304. Ridges 302 may be provided to denote finger placement on either side of sphere 301 .
  • the flush assembly 300 is connected to the EVD system of a patient.
  • the flush assembly 300 is used as a component of an EVD system to store and transfer fluid from and internal fluid reservoir 303, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 300 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the flush assembly 400 forms a hemi-sphere 402 having a flat top 401 with a cross mark 403 (or similar tactile feature), a connector 404 on one side, and a bonding tube 406 surrounding the connector 404.
  • the flush assembly 400 is connected to the EVD system of a patient.
  • the flush assembly 400 is used as a component of an EVD system to store and transfer fluid from and internal fluid reservoir 405, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 400 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the flush assembly 500 forms a hemi-sphere 502 having a flat top 501 with a cross mark 506 (or some other tactile or visual feature), a connector 503 on one side, and a bonding tube 505 surrounding the connector 503.
  • the flush assembly 500 is connected to the EVD system of a patient.
  • the flush assembly 500 is used as a component of an EVD system to store and transfer fluid from and internal fluid reservoir 504, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 500 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the flush assembly 600 forms one or two hemi-spherical structures 602 which may have a flat top 601 (in the case of one hemisphere) or a rounded top (in the case of two hemispheres).
  • a cross mark 603 (or other tactile feature), a connector 605 on one side, a bonding tube 606 surrounding the connector 605, and a drainage tube 607 opposite the connector 605.
  • the flush assembly 600 is connected to the EVD system of a patient in-line.
  • the connector 605 is attached to an externalized ventricular catheter (see FIG. 35) while the drainage tube 607 is connected to the EVD system.
  • the flush assembly 600 is used as a component of an EVD system to store and transfer fluid from and internal fluid reservoir 604, to an upstream location such as a tissue site, or to a downstream location, such as a drain site, and thus perform retrograde prophylactic and/or emergency flushing by allowing fluid to be forced from the flush assembly 600 to either location to remove blockages in a catheter due to the accumulation of debris found in the fluid or from tissue infiltration.
  • the flush assembly 100 forms an upper body 802 and a base 882, with a connector 860 at a proximal end 884, and a drain tube 888 at a distal end 886.
  • the flush assembly 100 is disposed beneath the skin of a patient or externally connected.
  • the flush assembly 100 is used as a component of an EVD system to transport fluid from an upstream location, such as a tissue site to a downstream location, such as a drain site, and to perform retrograde prophylactic flushing by allowing fluid to be forced from the flush assembly 100 to the upstream location to remove blockages in an upstream catheter due to the accumulation of debris found in the fluid or from tissue infiltration into the upstream catheter.
  • the flush assembly 100 shunts cerebrospinal fluid from the ventricles of the brain to a drainage site, typically the abdomen, in the treatment of hydrocephalus.
  • the proximal connector 860 can be connected to a fluid collection tube or ventricular catheter 1200 (see FIG. 35) with drain holes 1208 at a terminal end 1202 providing a fluid communication between the tissue site and catheter 1200, and the drain tube 888 can be connected to other distal components of an EVD system that terminate the EVD system at a drain site, or the drain tube 888 can be a drain catheter terminating at the drain site.
  • the flush assembly 100 enables fluid to flow unobstructed from the connector 860 to the drain tube 888 through a collapsible fluid pathway 837 within the depressible dome 804.
  • the collapsible fluid pathway 837 is simultaneously obstructed allowing for flushing of the contents of the flush assembly 100 proximally through the connector 860 to clear any debris or tissues from the ventricular catheter 1200.
  • the unique integration of this collapsible fluid pathway within the wall of the dome 804 significantly decreases the potential for skin erosion that may occur with conventional flushing systems.
  • the dome 804 is manufactured from a flexible material, such as silicone, and forms a flush cavity 852 above the base 882.
  • the collapsible fluid pathway may be hemispherical, though alternatively, the collapsible fluid pathway may have other configurations, such as generally cylindrical, generally rectangular, or generally curvilinear.
  • the base 882 is manufactured from a resilient material, such as polyetheretherketone (PEEK), polyethylene (PE), or Acetal.
  • PEEK polyetheretherketone
  • PE polyethylene
  • Acetal Acetal
  • a flanged connector 854 extends from the base of the dome 804 forming a proximal channel 815 extending from the flush cavity 852 to a proximal opening 814, and a distal channel 817 extending from the flush cavity 852 to a distal opening 816.
  • the connector 860 is located at the proximal channel 815, and the drain tube 888 is located at the distal channel 817.
  • the connector 860 is formed as one piece and is integrated with the base 882.
  • the connector 860 is not used, and the ventricular catheter 1200 fluidly communicates with the flush assembly 100 adjacent to the proximal channel 815, providing a fluid communication between the tissue site and the flush cavity 852.
  • the connector 860 forms a tube 862 extending from a proximal end 864 forming a barb 866, to a head 872 at a distal end 870.
  • the barb 866 allows the flush assembly 100 to be connected to a tube or catheter draining a tissue site.
  • a sleeve 876 around the tube 862 positions the connector 860 within the proximal channel 815, and an O-ring 878 circumscribing the sleeve 876 creates a seal between the sleeve 876 and upper body 802.
  • the head 872 is disposed within the flush cavity 852 preventing the connector 860 from being pulled through the proximal end 884 of the flush assembly 100 when being separated from the structure immediately upstream from the assembly 100, and when the dome 804 is depressed during a flushing operation.
  • the head has a convex proximal face 874 conforming to the dome 804 and providing a seal there between.
  • the drain tube 888 extends from a proximal end 890 disposed within the distal channel 817 to a distal end 892.
  • the proximal end 890 communicates with a passage 846 formed by the dome 804 and a channel member 836.
  • the passage 846 provides a fluid communication between the drain tube 888 and the flush cavity 852, and allows fluid draining into the flush cavity 852 from a tissue site to exit the flush assembly 100 and travel to a drain site.
  • the passage 846 can be sealed off from the drain tube 888 by depressing the dome 804 against an occluder valve 820 disposed between the dome 804 and channel member 836.
  • the occluder valve 820 is manufactured from a resilient material, such as silicone.
  • the first half of the passage 846 is formed by an upper channel 812 at an interior surface 810 of the dome 804 extending from the distal opening 816 to a valve seat 822 formed in the interior surface 810 of the central part of the dome 804.
  • a second half of the passage 846 is formed by a lower channel 840 formed in a concave upper face 838 of the channel member 836 extending from a distal end 844 at the distal opening 816 to a proximal end 842 at the valve 820.
  • the channel member 836 is manufactured from a flexible material, such as silicone, and the distal end 844 creates a sealing relationship with the drain tube 888 proximal end 890, and the concave upper face 838 conforms to the concave interior surface 810 of the dome 804 sealing the passage 846 from the flush cavity 852.
  • the channel member 836 is a flexible tube.
  • the valve 820 is a circular disc forming a centrically located downstream port 828 extending between a top surface 824 and a bottom surface 832 of the disc.
  • a valve channel 830 formed in the bottom surface 832 extends from the downstream port 828 to the edge of the valve 820.
  • An upstream port 826 adjacent the downstream port 828 extends between the top surface 824 and bottom surface 832.
  • the valve seat 822 receives the valve 820 whereby the bottom surface 832 around the downstream port 828 and valve channel 830 sealingly engage the proximal end 842 of the channel member 836, leaving the upstream port freely communicating with an upper chamber 834 and flush cavity 852.
  • the outer edge of the top surface 824 of the valve 820 sealingly engages an upper rim of the valve seat 822 creating a sealing engagement therebetween.
  • the interior surface 810 of the dome 804 is set off from the top surface 824 of the valve 820 creating the upper chamber 834.
  • the flush assembly 100 can be implanted beneath the skin of a patient using conventional procedures known to persons of ordinary skill in the art, and is used as a component of the EVD system; otherwise, the flush assembly 100 is exterior to the skin.
  • the upper chamber 834 allows fluid within the flush cavity 852 to flow unrestricted through the upstream port 826 into the downstream port 828, through the passage 846, exiting the dome through the drain tube 888.
  • the valve 820 closes and prevents fluid flow to the drain site when a pressure threshold is reached. Before this pressure threshold is reached, fluid can travel both towards the drain site and the tissue site. After the pressure threshold is reached, continued pressure will expel the fluid in the dome 804 to the drain site facilitating a flushing operation.
  • the dome 804 material at a palpitation ring 108 forms an upper wall 133 of the upper chamber 834. Depressing the dome 804 causes the upper wall 133 to engage with the downstream port 828 at the valve 820 top surface 824, sealing the flush cavity 852 from the passage 846 and preventing fluid from exiting the dome 804 via the passage 846. Further depressing the dome 804 toward the base 882 causes the fluid within the flush cavity 852 to be expelled from the cavity through the connector 860 into the upstream structures.
  • the elastic nature of the dome 804 allows it to rebound to its original hemispherical configuration to begin receiving fluid within the flush cavity 852 from the tissue site.
  • a rate limiting mechanism within the inlet channel prevents the dome 804 from rebounding rapidly by limiting the flow until a sufficient volume of fluid has filled the dome 804, or a sufficient fluid pressure within the dome 804 is achieved.
  • the valve 820 separates the flush cavity 852 into two distinct fluid reservoirs when pressure is applied. Continued pressure expels fluid volume both towards the tissue site catheter and the drainage site catheter for the purpose of dislodging occluding or infiltrating materials.
  • the flushing assembly 100 when the flushing assembly 100 is activated by depressing the dome 804, fluid is forced into the ventricular catheter 1200, causing movement of the catheter 1200 that dislodge debris from the catheter 1200.
  • the tubular tissue site drain catheters such as the ventricular catheter 1200, has a terminal end 1202 forming a plurality of drainage holes 1208 and a sealed tip 504.
  • the mass of fluid being flushed from the flush assembly 100 travels orthogonal to catheter tip 1204, creating a force pressing against the tip 1204, expelling fluid from the catheter 1200 through the drainage holes 1208 into the tissue site, and causing the terminal end 1202 to mechanically oscillate at an over molded joint, dislodging debris from the terminal end 1202, and preventing cellular and protein adhesion of debris to the drainage holes 1208.
  • either the patient, or a physician can use the flush assembly 100 to prophylactically flush the shunt to maintain the flush assembly 100 and upstream structures free from blockages, and remove debris that attach to the surfaces of the flush assembly 100 and other upstream EVD components including the ventricular catheter 1200.
  • the prophylactic flushing can occur at any time, such as prior to, or upon, full or partial occlusion of the drainage holes 1208 or catheter 1200.
  • the flush assembly 100 can be used for access to the tissue site from outside the patient.
  • the dome 804 is manufactured from a re- sealable material, allowing the flush assembly 100 to be used as an agent delivery pathway to the tissue site.
  • an agent can be injected into the flush cavity 852 by a needle, and the dome 804 can be depressed in the manner described above causing the agent to flow from the flush cavity 852 to the tissue site.
  • the agents include, among others, pharmaceuticals, hydrogels, drug eluting polymers, pre-loaded bolus, antibiotics, biologies, and gene therapies.
  • the flush cavity 852 is accessed by a needle inserted through the dome 804.
  • the flush assembly 100 can be used with other shunt components, such as catheters, valves, anti-siphoning devices to drain fluid from the tissue site.
  • the flush assembly includes additional components, and the fluid pathway from the tissue site to the drain site is an angular pathway.
  • flush assembly 901 is shown connected to a tissue site, such as a ventricle 903 of the brain.
  • the tissue site is accessed via a burr hole in the skull 905 of a patient.
  • the flush assembly 901 forms a 90-degree fluid pathway from the tissue site to the exterior of the skull 905.
  • the flush assembly 901 includes features found in flush assembly 100, including a collapsible fluid pathway, such as a dome 804, a valve 820, channel member 836, and drain tube 888.
  • a catheter 907 descends from the flush assembly 901 connecting the tissue site to the flush cavity 852.
  • the catheter 907 includes a burr-hole cover 909 providing an attachment point for the base of the flush assembly 901 to the catheter 907.
  • a flush assembly 100 includes an upper body 1002 and a base 1082, with a collapsible fluid pathway 1037 integrally molded into the dome 804 between the exterior surface 806 and interior surface 810. Fluid flows into the flush cavity 852 from the connector 860 and fluid exits the flush cavity 852 through the drain tube 888 via the collapsible fluid pathway 1037.
  • the flush assembly is implanted such a way that when pressed in the manners described above the fluid volume within the flush cavity 852 exits the flush assembly 1000 via the connector 860, clearing debris from the ventricular catheter 1200.
  • the treatment of hydrocephalus or head trauma utilizes a drain site that is either internal or external to the patient.
  • the acute condition results in increased intracranial pressure, requiring use a drainage assembly in fluid communication with a tissue site, such as the ventricles, to drain fluid from the tissue site.
  • the drainage assembly includes one or more of a fluid collection tube in fluid communication with the tissue site.
  • the fluid collection tube can include a drainage catheter connected to one or more ancillary drainage components, such as catheters, and other assemblies used during the treatment of the acute condition, leading to a collection site that is either internal or external to the patient.
  • a flushing assembly can be used to force fluid within the catheters or ancillary drainage components toward the tissue site or the drain site.
  • FIGS. 31 -32 an embodiment of a flushing assembly 1100 according to the disclosed subject matter is shown and described.
  • the flushing assembly 1100 forms an upper body 1101 forming an occlusion element 1102 and a flushing element 1103.
  • the flushing assembly 1100 is placed in engagement with the drainage assembly.
  • the occlusion element 1102 engages a fluid collection tube, such as a ventricular catheter, or a drain tube, such as a drain catheter, stopping fluid flow at the occlusion element 1102 by compressing the tube.
  • the flushing element 1103 compresses a component of the drainage assembly.
  • the component may be the collection tube, the drain tube, or a flush assembly fluidly disposed between the collection tube and drain tube, such as flush assemblies 100, 901 , 300.
  • the compression of the component by the flushing element 1103 pushes fluid through the drainage assembly in a direction away from the occlusion element 1102.
  • the flushing element 1103 is upstream from the occlusion element 1102, whereby in-line, the flushing element 1103 is closer to the origin of the fluid collection tube, the fluid is pushed in the direction of the origin of the fluid collection tube, such as the tissue site. If the flushing element 1103 is downstream from the occlusion element 1102, whereby in-line, the flushing element 1103 is closer to the termination of the drain tube, the fluid is pushed in the direction of the termination of the drain tube, such as the drain site.
  • a flushing assembly 1110 forms a lower body 1114 that opposes the flushing element 1113 for compressing an ancillary drainage component.
  • the upper body 1111 slidably receives the flushing element 1113, and the lower body 1114 is pivotally attached to the upper body 1111 by a hinge 1116.
  • An occlusion element 1112 at the edge of the upper body 1111 engages a receiver 1118 at the edge of the lower body 1114.
  • the flushing assembly 1110 is placed in engagement with a fluid collection tube, such as a ventricular catheter, or a drain tube, such as a drain catheter.
  • the flushing assembly 1110 has engagement surfaces that conform to exterior of the tube.
  • the upper body 1101 then compresses the tube.
  • the occlusion element 1112 contacts the tube compressing it against the receiver 1118, first stopping fluid flow at the compression point.
  • the flushing element 1113 engages the tube, compressing the tube, pushing fluid out of the tube creating a fluid flush. This flush can be directed towards the tissue site or the drainage site.
  • the compression of the tube by the flushing element 1113 pushes fluid through the drainage assembly in a direction away from the occlusion element 1112.
  • the flushing element 1113 is upstream from the occlusion element 1112, whereby in-line, the flushing element 1113 is closer to the origin of the fluid collection tube, the fluid is pushed in the direction of the origin of the fluid collection tube, such as the tissue site. If the flushing element 1113 is downstream from the occlusion element 1112, whereby inline, the flushing element 1113 is closer to the termination of the drain tube, the fluid is pushed in the direction of the termination of the drain tube, such as the drain site.
  • the occlusion element 1112 is in the center of flushing element 1113 whereby compression of the tube by the flushing element 1113 causes a movement of fluid both toward the tissue site and toward the drainage site.

Landscapes

  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Neurology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • External Artificial Organs (AREA)

Abstract

Ensemble de rinçage pour un système de drainage ventriculaire externe (EVD), comprenant un corps supérieur pliable et une base, l'ensemble de rinçage étant relié à l'EVD à l'aide d'un connecteur à proximité de l'extrémité inférieure de l'ensemble de rinçage, un tube de liaison entourant le connecteur, le connecteur croisant le corps supérieur pliable et/ou la base étant coupé par le connecteur, et l'ensemble de rinçage stockant un fluide dans un réservoir de fluide interne et lorsque l'ensemble de rinçage est activé, le corps supérieur pliable poussant le fluide du réservoir de fluide interne à un site de rinçage pour effectuer un rinçage de l'EVD.
PCT/IB2024/055727 2023-06-13 2024-06-12 Systèmes et procédés de rinçage de drains ventriculaires externes Pending WO2024256977A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2024302278A AU2024302278A1 (en) 2023-06-13 2024-06-12 Systems and methods for flushing external ventricular drains
KR1020267001125A KR20260021786A (ko) 2023-06-13 2024-06-12 뇌실외 배액관 플러싱용 시스템 및 방법
CN202480043479.9A CN121419810A (zh) 2023-06-13 2024-06-12 用于冲洗外部脑室引流管的系统和方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363507904P 2023-06-13 2023-06-13
US63/507,904 2023-06-13
US202363609460P 2023-12-13 2023-12-13
US63/609,460 2023-12-13

Publications (2)

Publication Number Publication Date
WO2024256977A2 true WO2024256977A2 (fr) 2024-12-19
WO2024256977A3 WO2024256977A3 (fr) 2025-01-23

Family

ID=93852736

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/055727 Pending WO2024256977A2 (fr) 2023-06-13 2024-06-12 Systèmes et procédés de rinçage de drains ventriculaires externes

Country Status (4)

Country Link
KR (1) KR20260021786A (fr)
CN (1) CN121419810A (fr)
AU (1) AU2024302278A1 (fr)
WO (1) WO2024256977A2 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5167615A (en) * 1990-05-15 1992-12-01 Pudenz-Schulte Medical Research Corporation Flow control device having selectable alternative fluid pathways
US8562583B2 (en) * 2002-03-26 2013-10-22 Carmel Pharma Ab Method and assembly for fluid transfer and drug containment in an infusion system
US20120302938A1 (en) * 2010-03-19 2012-11-29 University Of Washington Drainage systems for excess body fluids and associated methods
CA2898881C (fr) * 2013-01-22 2021-01-05 Alcyone Lifesciences, Inc. Systemes et procedes de derivation de fluide
US20160030728A1 (en) * 2014-07-31 2016-02-04 Tekni-Plex, Inc. Extrudable tubing and solvent bonded fitting for delivery of medicinal fluids
JP2019530539A (ja) * 2016-10-13 2019-10-24 アルキオーネ・ライフサイエンシズ・インコーポレイテッドＡｌｃｙｏｎｅ Ｌｉｆｅｓｃｉｅｎｃｅｓ， Ｉｎｃ． シャントフラッシャおよび関連方法
WO2024116088A1 (fr) * 2022-12-01 2024-06-06 Anuncia Medical, Inc. Systèmes et méthodes de rinçage de dérivation

Also Published As

Publication number Publication date
KR20260021786A (ko) 2026-02-13
CN121419810A (zh) 2026-01-27
AU2024302278A1 (en) 2026-01-22
WO2024256977A3 (fr) 2025-01-23

Similar Documents

Publication Publication Date Title
US7981090B2 (en) Luer activated device
US8277424B2 (en) Needle-less syringe adapter
US6883778B1 (en) Apparatus for reducing fluid drawback through a medical valve
CA1165655A (fr) Systeme de derivation non emcombrant
JP3090082B2 (ja) 医用装置用の弁付きアダプタ
US4464168A (en) Low profile shunt system
KR200421308Y1 (ko) 유체 탈출 공간을 구비한 의료용 밸브
US7037303B2 (en) Urinary flow control valve
JP5014803B2 (ja) 押し込み変位洗浄注射器
US10779840B2 (en) Hemostatic device
JPH10507946A (ja) バルブ付き静脈流体管注入装置
JP2009533144A (ja) 移動部材を有する医療弁および方法
JP2002355318A (ja) 弁体付コネクター
EP1171187B1 (fr) Appareil pour reduire le retour du liquide a travers une valve medicale
WO2018209996A1 (fr) Cathéter urinaire capable d'éliminer un bloc
WO2024116088A1 (fr) Systèmes et méthodes de rinçage de dérivation
JP4970430B2 (ja) 留置針組立体
AU2024302278A1 (en) Systems and methods for flushing external ventricular drains
US20020029020A1 (en) Apparatus for reducing fluid drawback through a medical valve
US12144957B2 (en) Medical connector
JP2006512967A (ja) 尿流通制御バルブ
JP4433141B2 (ja) 医療用混注管

Legal Events

Date Code Title Description
REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112025027724

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 1020267001125

Country of ref document: KR

Free format text: ST27 STATUS EVENT CODE: A-0-1-A10-A15-NAP-PA0105 (AS PROVIDED BY THE NATIONAL OFFICE)

WWE Wipo information: entry into national phase

Ref document number: 2024822926

Country of ref document: EP

Ref document number: 1020267001125

Country of ref document: KR

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2024822926

Country of ref document: EP

Effective date: 20260113

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24822926

Country of ref document: EP

Kind code of ref document: A2

ENP Entry into the national phase

Ref document number: 2024302278

Country of ref document: AU

Date of ref document: 20240612

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2024822926

Country of ref document: EP

Effective date: 20260113

WWE Wipo information: entry into national phase

Ref document number: 11202508445S

Country of ref document: SG

WWP Wipo information: published in national office

Ref document number: 11202508445S

Country of ref document: SG

ENP Entry into the national phase

Ref document number: 2024822926

Country of ref document: EP

Effective date: 20260113

ENP Entry into the national phase

Ref document number: 2024822926

Country of ref document: EP

Effective date: 20260113

WWP Wipo information: published in national office

Ref document number: 1020267001125

Country of ref document: KR