System and method for flushing external ventricular drains

Abstract

A flush assembly for an external ventricular drain (EVD) system, comprising a collapsible upper body and a base, the flush assembly being connected to the EVD via a connector adjacent to the lower end of the flush assembly, and a connecting tube surrounding the connector, the connector crossing the collapsible upper body and / or the base crossing the connector, the flush assembly storing 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 the flushing site to perform flushing of the EVD.

Description

Technical Field

[0001]

[0001] System and method for flushing an external ventricular drain.

Background Art

[0002]

[0002] External ventricular drains (EVDs) are used to transfer body fluid from a region of the body to an external reservoir. Such systems are used, for example, in the treatment of hydrocephalus, and in order to relieve the fluid pressure in the brain, excess cerebrospinal fluid is drained from a patient tissue site such as the ventricles of the brain to an external reservoir such as a drainage bag using a tube. A typical EVD system has components that connect to a ventricular catheter implanted in the brain to drain fluid out of the brain via a patient line. However, after use for a period of time, solids and components in the fluid, such as blood (including clotted blood), cells, and proteinaceous components, may adhere to and deposit in the tube, thereby restricting or blocking the flow of fluid passing through the catheter member, necessitating removal and replacement of the EVD, thereby exposing the patient to unnecessary risks associated with such surgery and increasing the cost of treatment using EVDs.

Summary of the Invention

Means for Solving the Problems

[0003]

[0003] Generally, the present disclosure provides a flush assembly for an external ventricular drain (EVD) system. The flush assembly comprises a collapsible upper body and base, the flush assembly being connected to the EVD via a connector, and a connecting tube surrounding the connector, the connector crossing the collapsible upper body and / or base, the flush assembly storing 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 in order to perform flushing of the EVD. The flushing site includes either a tissue site and / or a drain site from which fluid can be pushed out of the flush assembly to remove an obstruction in a catheter or patient line.

[0004]

[0004] The flush assembly may further include a stopcock valve, which can be turned on and off depending on the orientation of the stopcock valve. The stopcock valve may further allow the introduction of sterile saline or various thrombolytic agents such as tissue plasminogen activator (tPA). The connector of the flush assembly may be made of plastic or urethane and may be attached by a Luer lock connector.

[0005]

[0005] The bonding tube can be made from a flexible polymer material and provide a surface for chemical bonding to other similar materials.

[0006] The fluid flow through the flash assembly may be bidirectional, and may be discharged in both equal and uneven amounts in each direction. The fluid flow through the flash assembly may be adjustable.

[0006]

[0007] The flash assembly may include tactile features.

[0008] The disclosure can further provide a flush assembly for an EVD system. The flush assembly comprises a hemispherical structure having a flat top, a connector located on one side having a connecting tube surrounding the connector, and a drainage tube located on the opposite side, the flush assembly being connected in series with the EVD system, the connector being connected to an external ventricular catheter and the drainage tube being connected to the EVD system. The flush assembly stores 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 the flushing site to perform flushing of the EVD or drainage line. The flush assembly may further comprise a flat top having a tactile feature.

[0007]

[0009] This disclosure further provides a flush assembly for an EVD system. The flush assembly comprises two hemispherical structures, a connector located on one side and having a connecting tube surrounding the connector, and a drainage tube located near the apex of one hemisphere and following the contour of that hemisphere until reaching the opposite side of the connector, the flush assembly being connected in series with the EVD system, the connector being connected to an external ventricular catheter, and the drainage tube being connected to the EVD system. The flush assembly stores 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 the flushing site to perform flushing of the EVD or drainage line. The flush assembly may comprise one or both hemispheres having tactile features.

[0008]

[0010] The accompanying drawings are included to provide a further understanding of this disclosure, to be incorporated herein and to constitute part of this specification, to illustrate embodiments of this disclosure, and to explain the principles of this disclosure together with a detailed description. [Brief explanation of the drawing]

[0009] [Figure 1]

[0011] This is a plan view and side view of the flash assembly according to the subject of disclosure. [Figure 2]

[0012] This is an isometric view of the bottom of the flash assembly according to the subject of disclosure. [Figure 3]

[0013] Figures 1 and 2 are cross-sectional views of the flash assembly. [Figure 4]

[0014] This is an isometric view of the bottom of the flash assembly according to the subject of disclosure. [Figure 5]

[0015] This is a plan view and side view of the flash assembly according to the subject of disclosure. [Figure 6]

[0016] Figures 4 and 5 are cross-sectional views of the flash assembly. [Figure 7]

[0017] This is a plan view and side view of the flash assembly according to the subject of disclosure. [Figure 8]

[0018] Figure 7 is a cross-sectional view of the flash assembly. [Figure 9]

[0019] This is an isometric view of the bottom of the flash assembly according to the subject of disclosure. [Figure 10]

[0020] Figure 9 is a cross-sectional view of the flash assembly. [Figure 11]

[0021] This is a top isometric view of the flash assembly according to the subject of disclosure. [Figure 12]

[0022] Figure 11 is a cross-sectional view of the flash assembly. [Figure 13]

[0023] This is a top isometric view of the flash assembly according to the subject of disclosure. [Figure 14]

[0024] Figure 13 is a cross-sectional view of the flash assembly. [Figure 15]

[0025] This is a cross-sectional view of another embodiment of the flash assembly according to the subject of disclosure. [Figure 16]

[0026] It is a top plan view of the flash assembly of FIG. 15. [Figure 17]

[0027] It is a top isometric view of the flash assembly according to the disclosed subject matter. [Figure 18]

[0028] It is a bottom isometric view of the flash assembly according to the disclosed subject matter. [Figure 19]

[0029] It is a cross-sectional view of the flash assembly of FIGS. 17 and 18. [Figure 20]

[0030] It is a bottom view of the flash assembly with the base removed. [Figure 21]

[0031] It is a bottom view of the upper body. [Figure 22]

[0032] It is an isometric view of FIG. 18. [Figure 23]

[0033] It is an isometric view of the valve and the channel member. [Figure 24]

[0034] It is an isometric view of the channel member. [Figure 25]

[0035] It is a bottom isometric view of the valve. [Figure 26]

[0036] It is a front view of the flash assembly according to the disclosed subject matter. [Figure 27]

[0037] It is a cross-sectional view of an embodiment of the flash assembly according to the disclosed subject matter, including an enlarged cross-sectional view of A-A. [Figure 28]

[0038] It is a cross-sectional view of an embodiment of the flash assembly according to the disclosed subject matter. [Figure 29]

[0039] It is an enlarged view of FIG. 28. [Figure 30]

[0040] It is a bottom view of an embodiment of the flash assembly of FIG. 27 with the base removed. [Figure 31]

[0041] This is an isometric view from above of one embodiment of a flash assembly according to the subject of disclosure. [Figure 32]

[0042] Figure 31 is a front view of the flash assembly. [Figure 33]

[0043] This is an isometric view from above of one embodiment of a flash assembly according to the subject of disclosure. [Figure 34]

[0044] Figure 33 is an end view of the flush assembly. [Figure 35]

[0045] This is a plan view of one embodiment of a drain catheter according to the subject of disclosure. [Modes for carrying out the invention]

[0010]

[0046] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and systems configured to perform the intended functions. In other words, other methods and systems can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated in order to illustrate various aspects of this disclosure, and in this respect, these drawings should not be construed as limiting. Finally, although this disclosure may be described in relation to various principles and views, this disclosure should not be bound by theory.

[0011]

[0047] With this in mind, with reference to Figures 1 to 3, one embodiment of the flash assembly 100 according to the subject of disclosure is illustrated and described. For example, the flash assembly 100 includes an upper body 101 and a base 102, a connector 103 at the lower end, and a connecting tube 104 surrounding the connector 103. In one embodiment, the flash assembly 100 is connected to the patient's EVD system. During use, the flash assembly 100 is used as a component of the EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flash assembly 100 to either upstream location such as a tissue site or downstream location such as a drain site, thereby removing occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates.

[0012]

[0048] According to one aspect of the present disclosure, the flush assembly 100 is connected to the EVD system by connector 103 using a standard Luer lock connector. In some embodiments, fluid communication with the flush assembly 100 can be turned on or off depending on the orientation of a stopcock valve in the EVD system. The stopcock valve may further allow the introduction of sterile saline or various thrombolytic agents such as tissue plasminogen activator (tPA).

[0013]

[0049] According to various aspects of this disclosure, the upper body 101 is manufactured from a flexible material such as silicone or other thermoplastic elastomer and is therefore a crushable upper body 101. The crushable upper body 101 forms an internal fluid reservoir 105 on the base 102.

[0014]

[0050] According to various aspects of this disclosure, the base 102 is manufactured from a flexible material such as silicone or other thermoplastic elastomer, or a rigid material such as plastic (e.g., ABS, polycarbonate, PEEK, polyurethane, etc.). A connector 103 crosses the base 102, and the connector 103 is surrounded by a coupling tube 104. This forms a fluid channel from the internal fluid reservoir 105 to the EVD system, for example (among others) by a standard Luer lock connection.

[0015]

[0051] According to various aspects of this disclosure, the connector 103 may be manufactured from a rigid material such as plastic or urethane. The coupling tube 104 may be manufactured from a flexible material such as silicone or thermoplastic elastomer, and can provide a surface for chemical bonding to other similar materials, such as the material of the base 102. According to various aspects of this disclosure, the coupling tube 104 may further form a mechanical bond to the connector 103 if a chemical bond cannot be established otherwise. In some embodiments, threads 106 may be formed around the coupling tube 104 to form a stronger mechanical lock. This effect may further be achieved by using laser welding, heat welding, press-fitting, etc.

[0016]

[0052] When flushing is required, 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 in order to perform flushing. In some embodiments, flushing can be performed bidirectionally, and fluid can be pushed to both sites at once. The amount of fluid released in both directions can be processed to be evenly divided or to direct an uneven volume in one direction or the other. According to some embodiments, the fluid flow of the flush assembly may be adjustable.

[0017]

[0053] According to various aspects of this disclosure, the upper body 101 and / or base 102 of the flash assembly 100 may be provided with tactile features to assist in grasping and using the flash assembly 100. Among other structures, the tactile features may include continuous rings, interrupted rings, full-surface scoring, partial-surface scoring, raised wave patterns, and the like. These tactile features can improve the use of the device by enabling proper finger placement and minimal movement relative to the EVD system, which helps ensure patient safety.

[0018]

[0054] According to various aspects of this disclosure, the flash assembly 100 may include a material that can be resealed after needle puncture. This allows the flash assembly 100 to function as a delivery system for various therapeutic agents, such as tissue plasminogen activator (tPA), other dissolving agents (e.g., streptokinase, alteplase, leteplase, tenecteplase, urokinase, prourokinase, anistreplase, etc.), and heparinized saline. The therapeutic agent can be injected into the flash assembly 100. After the flash assembly 100 is activated, the therapeutic agent is pushed into the catheter occlusion and erodes the occlusion. The therapeutic agent can then be aspirated back after the flash assembly 100 has been activated.

[0019]

[0055] Next, with reference to Figures 4 to 6, one embodiment of the flush assembly 200 according to the subject of the disclosure is illustrated and described. The flush assembly 200 comprises an upper body 201 and a lower body 203, the lower body 203 including a Luer connector 204. According to various aspects of the disclosure, the flush assembly 200 is connected to a patient's EVD system. In use, the flush assembly 200 is used as a component of the EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flush assembly 200 to either an upstream location such as a tissue site or a downstream location such as a drain site, thereby removing occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates. According to various aspects of the disclosure, when the upper body 201 is pushed down toward the lower body 203, a spring 208 is compressed and fluid is released from the internal fluid reservoir 207. Next, the spring 208 acts on the upper body 201, extending it and returning it to its starting position.

[0020]

[0056] According to various aspects of this disclosure, the upper body 201 comprises an outer casing 209 and an internal plunger 205. The internal plunger 205 has a gasket 206 at its end, made of, for example, rubber. The gasket 206 fits into the flush body internal casing 210 by a geometry that conforms to the inner surface of the flush body internal casing 210. The outer casing 209 fits into the lower body 203. The gasket 206 may include silicone or urethane to form a mechanical seal within the flush body internal casing 210. The upper body 201, outer casing 209, internal plunger 205, lower body 203 and flush body internal cavity may include rigid plastics such as PET, PE, PP, PC or other suitable materials.

[0021]

[0057] According to various aspects of this disclosure, the lower body 203 comprises an outer surface 211 and an internal casing 210 of the flash body. A finger handle 202 protrudes outward from the upper outer ring of the lower body 203 to allow gripping of the lower body 203. According to various aspects of this disclosure, there may be a space between the outer surface 211 and the internal casing 210 of the flash body to accommodate a spring 208. The external casing 209 engages the spring 208 with the walls of the outer surface 211 that surround the internal casing 210 of the flash body and the external casing 209 and the spring 208.

[0022]

[0058] According to various aspects of this disclosure, the spring 208 typically includes a material used in the spring structure, such as spring steel or stainless steel. The flush body internal casing 210 and gasket 206 form an internal fluid reservoir 207, which contains the fluid used for flushing.

[0023]

[0059] According to various aspects of the present disclosure, an embodiment of the flash assembly 300 according to the subject of the disclosure is illustrated and described with reference to Figures 7 and 8. In this embodiment, the flash assembly 300 forms a sphere 301 having a connector 304 and a connecting tube 305 surrounding the connector 304 on one side. Ridges 302 may be provided on both sides of the sphere 301 to indicate finger rests. According to various aspects of the present disclosure, the flash assembly 300 is connected to a patient's EVD system. In use, the flash assembly 300 is used as a component of an EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flash assembly 300 to either upstream location such as a tissue site or downstream location such as a drain site, thereby removing occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates.

[0024]

[0060] According to various aspects of the present disclosure, one embodiment of the flush assembly 400 according to the subject of the disclosure is illustrated and described with reference to Figures 9 and 10. In this embodiment, the flush assembly 400 forms a hemisphere 402 having a flat top 401 including a cross mark 403 (or similar tactile feature), a connector 404 on one side, and a connecting tube 406 surrounding the connector 404. According to various aspects of the present disclosure, the flush assembly 400 is connected to a patient's EVD system. In use, the flush assembly 400 is used as a component of the EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flush assembly 400 to either upstream location such as a tissue site or downstream location such as a drain site, thereby removing occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates.

[0025]

[0061] According to various aspects of this disclosure, with reference to Figures 11 and 12, one embodiment of the flash assembly 500 according to the subject of the disclosure is illustrated and described. In this embodiment, the flash assembly 500 forms a hemisphere 502 having a flat top 501 including a cross mark 506 (or some other tactile or visual feature), a connector 503 on one side, and a connecting tube 505 surrounding the connector 503. According to various aspects of this disclosure, the flash assembly 500 is connected to a patient's EVD system. In use, the flash assembly 500 is used as a component of an EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flash assembly 500 to either location to remove occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates.

[0026]

[0062] According to various aspects of the present disclosure, an embodiment of the flash assembly 600 according to the subject of the disclosure is illustrated and described with reference to Figures 13 to 16. In this embodiment, the flash assembly 600 forms one or two hemispherical 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).

[0027]

[0063] According to the flat-topped embodiment (Figures 13 and 14), there is a cross mark 603 (or other tactile feature), a connector 605 on one side, a connecting tube 606 surrounding the connector 605, and a drainage tube 607 on the opposite side of the connector 605. According to various aspects of the present disclosure, the flush assembly 600 is connected in series with the patient's EVD system. The connector 605 is attached to an external ventricular catheter (see Figure 35), while the drainage tube 607 is connected to the EVD system. In use, the flush assembly 600 is used as a component of the EVD system to store fluid and perform retrograde prevention and / or emergency flushing by allowing the fluid to be pushed out of the flush assembly 600 to either upstream location such as a tissue site or downstream location such as a drain site, thereby removing occlusions in the catheter due to the accumulation of debris found in the fluid or from tissue infiltrates.

[0028]

[0064] According to various aspects of this disclosure, an embodiment of the flush assembly 100 according to the subject of the disclosure is illustrated and described with reference to Figures 17 to 20. The flush assembly 100 comprises an upper body 802 and a base 882, a connector 860 at a proximal end 884, and a drain tube 888 at a distal end 886. In this embodiment, the flush assembly 100 is placed subcutaneously in a patient or is externally connected. In use, the flush assembly 100 is used as a component of an EVD system to perform retrograde prevention flushing by transferring fluid from an upstream location, such as a tissue site, to a downstream location, such as a drain site, and by pushing the fluid upstream from the flush assembly 100 to remove obstructions in the upstream catheter due to the accumulation of debris in the fluid or tissue infiltrates into the upstream catheter.

[0029]

[0065] According to various aspects of this disclosure, the flush assembly 100 diverts cerebrospinal fluid from the ventricles of the brain to a drainage site, typically the abdomen, in the treatment of hydrocephalus. The proximal connector 860 may be connected to a fluid collection tube or ventricular catheter 1200 (see Figure 35) having a drain hole 1208 at its terminal 1202, which provides fluid communication between the tissue site and the catheter 1200. Alternatively, the drain tube 888 may be connected to other distal components of the EVD system that terminate the EVD system at the drain site. Or, the drain tube 888 may be a drain catheter terminating at the drain site. The flush assembly 100 allows fluid to flow unimpeded from the connector 860 through the collapseable fluid passage 837 in the collapseable dome 804 to the drain tube 888. When the flush assembly 100 is activated, the collapsible fluid channel 837 is simultaneously shut off, thereby allowing the contents of the flush assembly 100 to flush proximal through the connector 860 to remove any debris or tissue from the ventricular catheter 1200. The unique integration of this collapsible fluid channel into the wall of the dome 804 significantly reduces the possibility of skin erosion that can occur with conventional flushing systems.

[0030]

[0066] According to various aspects of this disclosure, the dome 804 is manufactured from a flexible material such as silicone and forms a flush cavity 852 on a base 882. The collapsible fluid channel may be hemispherical, but alternatively, the collapsible fluid channel may have other configurations, such as being substantially cylindrical, substantially rectangular, or generally curved.

[0031]

[0067] According to various aspects of this disclosure, base 882 is manufactured from an elastic material such as polyetheretherketone (PEEK), polyethylene (PE), or acetal.

[0068] According to various aspects of this disclosure, referring to Figures 21 and 22, a flanged connector 854 extends from the base of the dome 804 and forms a proximal channel 815 extending from the flash cavity 852 to a proximal opening 814, and a distal channel 817 extending from the flash cavity 852 to a distal opening 816. A connector 860 is positioned in the proximal channel 815, and a drain tube 888 is positioned in the distal channel 817. In one embodiment, the connector 860 is formed as a single unit and integrated with the base 882. In one embodiment, the connector 860 is not used, and the ventricular catheter 1200 is in fluid communication with the flash assembly 100 adjacent to the proximal channel 815, thereby achieving fluid communication between the tissue site and the flash cavity 852.

[0032]

[0069] According to various aspects of this disclosure, 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 for draining tissue. A sleeve 876 around the tube 862 positions the connector 860 within a proximal channel 815, and an O-ring 878 circumscribing the sleeve 876 forms a seal between the sleeve 876 and the upper body 802. The head 872 is located within the flush cavity 852 and separates it from structures immediately upstream of the assembly 100, and prevents the connector 860 from being pulled out from the proximal end 884 of the flush assembly 100 when the dome 804 is pressed down during a flushing procedure. The head has a convex proximal surface 874 that fits into the dome 804 and provides a seal between them.

[0033]

[0070] According to various aspects of this disclosure, the drain tube 888 extends from a proximal end 890 located within a distal channel 817 to a distal end 892. The proximal end 890 communicates with a passage 846 formed by the dome 804 and the channel member 836. The passage 846 provides fluid communication between the drain tube 888 and the flash cavity 852, allowing fluid discharged from the tissue site into the flash cavity 852 to move out of the flash assembly 100 to the drain site. The passage 846 can be sealed away from the drain tube 888 by pressing the dome 804 against an occluder valve 820 located between the dome 804 and the channel member 836. The occluder valve 820 is manufactured from an elastic material such as silicone.

[0034]

[0071] According to various aspects of this disclosure, the first half of the passage 846 is formed by an upper channel 812 on the inner surface 810 of the dome 804, extending from the distal opening 816 to a valve seat 822 formed on the inner surface 810 of the central part of the dome 804. Specifically referring to Figures 23 and 25, the second half of the passage 846 is formed by a lower channel 840 formed on the concave upper surface 838 of a channel member 836, extending from the distal end 844 of the distal opening 816 to the proximal end 842 of the valve 820. The channel member 836 is manufactured from a flexible material such as silicone, with the distal end 844 creating a sealing relationship with the proximal end 890 of the drain tube 888, and the concave upper surface 838 coinciding with the concave inner surface 810 of the dome 804, sealing the passage 846 from the flush cavity 852. In one embodiment, the channel member 836 is a flexible tube.

[0035]

[0072] Referring to various aspects of this disclosure, specifically Figures 23 and 24, the valve 820 is a circular disk extending between the upper surface 824 and the bottom surface 832 of the disk, forming a centrally located downstream port 828. A valve channel 830 formed on the bottom surface 832 extends from the downstream port 828 to the edge of the valve 820. An upstream port 826 adjacent to the downstream port 828 extends between the upper surface 824 and the bottom surface 832. A valve seat 822 receives the valve 820, and thus the bottom surface 832 around the downstream port 828 and the valve channel 830 seal-engages with the proximal end 842 of the channel member 836, while the upstream port remains freely in communication with the upper chamber 834 and the flush cavity 852. The outer edge of the upper surface 824 of the valve 820 seal-engages with the upper rim of the valve seat 822, forming a seal engagement between them. The inner surface 810 of the dome 804 is positioned away from the upper surface 824 of the valve 820, forming the upper chamber 834.

[0036]

[0073] According to various aspects of this disclosure, the flash assembly 100 can be implanted subcutaneously in a patient using conventional procedures known to those skilled in the art and used as a component of an EVD system; otherwise, the flash assembly 100 is located outside the skin.

[0037]

[0074] When the flush assembly 100 is stopped, the upper chamber 834 allows fluid in the flush cavity 852 to flow unrestricted through the upstream port 826 to the downstream port 828, through the passage 846, and out of the dome through the drain tube 888. When the flush assembly 100 is activated by pressure activation using one or more fingers pushing the dome 804 toward the base 882, the valve 820 closes when a pressure threshold is reached, preventing fluid from flowing toward the drain site. Before this pressure threshold is reached, the fluid can move toward either the drain site or the tissue site. After the pressure threshold is reached, the continued pressure releases the fluid in the dome 804 toward the drain site, facilitating the flushing procedure.

[0038]

[0075] According to various aspects of this disclosure, the dome 804 material in the palpitation ring 108 forms the upper wall 133 of the upper chamber 834. When the dome 804 is pushed down, the upper wall 133 engages with the downstream port 828 at the upper surface 824 of the valve 820, thereby sealing the flush cavity 852 from the passage 846 and preventing fluid from escaping from the dome 804 through the passage 846. When the dome 804 is pushed further down toward the base 882, the fluid in the flush cavity 852 is discharged from the cavity through the connector 860 into the upstream structure.

[0039]

[0076] When the downward pressure is released from dome 804, the elastic properties of dome 804 allow it to return to its original hemispherical shape, enabling it to begin receiving fluid from the tissue site into the flush cavity 852. In one embodiment, a velocity limiting mechanism in the inlet channel prevents dome 804 from returning too quickly by restricting the flow until a sufficient amount of fluid fills dome 804 or until sufficient fluid pressure is achieved within dome 804. In one embodiment, valve 820 divides the flush cavity 852 into two separate fluid reservoirs when pressure is applied. The continuous pressure releases the fluid volume to both the tissue site catheter and the drainage site catheter to remove any blocking or infiltrating material.

[0040]

[0077] According to various aspects of this disclosure, when the flushing assembly 100 is activated by the downward pressure of the dome 804, fluid is pushed into the ventricular catheter 1200, thereby causing movement of the catheter 1200, which removes debris from the catheter 1200. A tubular tissue site drain catheter, such as the ventricular catheter 1200, has a sealed tip 504 and a terminal 1202 that forms a plurality of drainage holes 1208. A large amount of fluid flushed from the flushing assembly 100 travels perpendicular to the catheter tip 1204, thereby generating a force that pushes the tip 1204, causing the fluid to be released from the catheter 1200 through the drainage holes 1208 into the tissue site, thereby causing mechanical vibration of the terminal 1202 at the overmolded joint, which removes debris from the terminal 1202 and prevents cellular and protein adhesion of the debris to the drainage holes 1208.

[0041]

[0078] According to various aspects of this disclosure, either the patient or the physician may use the flash assembly 100 to prophylactically flush the shunt in order to maintain the flash assembly 100 and the upstream structures free from obstruction, and to remove debris adhering to the surfaces of the flash assembly 100 and other upstream EVD components, including the ventricular catheter 1200. Prophylactic flushing can be performed at any time, such as before or after complete or partial occlusion of the drainage port 1208 or the catheter 1200.

[0042]

[0079] The flash assembly 100 can be used to access a tissue site from outside the patient. In one embodiment, the dome 804 is manufactured from a resealable material, thereby enabling the flash assembly 100 to be used as a drug delivery route to the tissue site. In such an embodiment, the drug is injected into the flash cavity 852 by a needle, and the dome 804 is pushed down in the manner described above, thereby allowing the drug to flow from the flash cavity 852 to the tissue site. The drug includes, among other things, pharmaceuticals, hydrogels, drug-eluting polymers, pre-loaded boluses, antibiotics, biologics, and gene therapies. According to various aspects of this disclosure, the flash cavity 852 is accessed by a needle inserted through the dome 804.

[0043]

[0080] According to various aspects of this disclosure, the flush assembly 100 can be used in conjunction with other shunt components, such as a catheter, a valve, and an anti-siphon device for draining fluid from a tissue site.

[0044]

[0081] According to various aspects of this disclosure, the flush assembly includes additional components, and the fluid pathway from the tissue site to the drain site is a ramp. Next, referring to Figure 26, a flush assembly 901 is shown connected to a tissue site such as a ventricle 903 of the brain. The tissue site is accessed through a burr hole in the patient's skull 905. The flush assembly 901 forms a fluid pathway at a 90-degree angle from the tissue site out 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, a channel member 836, and a drain tube 888. Here, a catheter 907 descends from the flush assembly 901 and connects the tissue site to a flush cavity 852. In one embodiment, the catheter 907 includes a burr hole cover 909 at the base of the flush assembly 901, which provides an attachment point for the catheter 907.

[0045]

[0082] Referring to various aspects of this disclosure, specifically Figures 27–30, one embodiment of the subject of the disclosure is illustrated, in which the flash assembly 100 includes an upper body 1002 and a base 1082, including a collapsible fluid channel 1037 integrally molded in a dome 804 between an outer surface 806 and an inner surface 810. Fluid flows into the flash cavity 852 from a connector 860 and exits the flash cavity 852 through the collapsible fluid channel 1037 and a drain tube 888. When the dome 804 is pressed from the outer surface 806, the collapsible fluid channel 1037 closes, and when the upper body 1002 is further pressed toward the base, the fluid in the flash cavity 852 flows out of the flash assembly 1000 through the connector 860, thereby removing debris from the ventricular catheter 1200 connected thereto.

[0046]

[0083] According to various aspects of the present disclosure, the flash assembly is embedded such that when pressed in the manner described above, the fluid volume in the flash cavity 852 flows out of the flash assembly 1000 through the connector 860, thereby removing debris from the ventricular catheter 1200.

[0047]

[0084] According to various aspects of this disclosure, in the acute phase, treatment of hydrocephalus or head injury involves using either an internal or external drain site for the patient. The acute condition results in increased intracranial pressure, necessitating the use of a drainage assembly that fluid-communicates with a tissue site, such as a ventricle, to drain fluid from the tissue site. The drainage assembly includes one or more fluid collection tubes that fluid-communicate with the tissue site. The fluid collection tubes may include a drainage catheter connected to one or more auxiliary drainage components, such as a catheter, and other assemblies used during treatment of the acute condition, leading to a collection site that is either internal or external to the patient. A flushing assembly may be used to push fluid from the catheter or auxiliary drainage component into the tissue site or drain site. Referring to Figures 31 and 32, one embodiment of a flushing assembly 1100 according to the subject of the disclosure is illustrated and described. In one embodiment, the flushing assembly 1100 forms an upper body 1101 that forms a closing element 1102 and a flushing element 1103.

[0048]

[0085] In use, according to various aspects of this disclosure, the flushing assembly 1100 is positioned to engage with the drainage assembly. First, the closure element 1102 engages with a fluid collection tube, such as a ventricular catheter, or a drain tube, such as a drain catheter, thereby stopping the fluid flow at the closure element 1102 due to compression of the tube. Next, the flushing element 1103 compresses a component of the drainage assembly. For example, this component may be a collection tube, a drain tube, or a flush assembly, such as a flush assembly 100, 901, 300, in which fluid is placed between the collection tube and the drain tube. The compression of the component by the flushing element 1103 pushes the fluid through the drainage assembly away from the closure element 1102. For example, if the flushing element 1103 is upstream of the closure element 1102 and therefore in series, and the flushing element 1103 is closer to the origin of the fluid collection tube, the fluid is pushed towards the origin of the fluid collection tube, such as a tissue site. If the flushing element 1103 is downstream of the closing element 1102 and therefore in series, and the flushing element 1103 is closer to the end of the drain tube, the fluid will be pushed towards the end of the drain tube, such as the drain section.

[0049]

[0086] According to various aspects of this disclosure, with reference to Figures 33 and 34, in one embodiment, the flushing assembly 1110 forms a lower body 1114 facing a flushing element 1113 for compressing an auxiliary 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. A closing element 1112 on the edge of the upper body 1111 engages with a receiving portion 1118 on the edge of the lower body 1114.

[0050]

[0087] In use, the flushing assembly 1110 is positioned to engage with a fluid collection tube, such as a ventricular catheter, or a drain tube, such as a drainage catheter. The flushing assembly 1110 has an engagement surface that fits the outer surface of the tube. The upper body 1101 then compresses the tube. The closure element 1112 contacts the tube and presses the tube against the receiving portion 1118, first stopping the fluid flow at the compression point. Next, the flushing element 1113 engages with the tube and compresses the tube, thereby pushing the fluid out of the tube and generating a fluid flush. This flush may be directed towards the tissue site or drainage site. The compression of the tube by the flushing element 1113 pushes the fluid through the drainage assembly away from the closure element 1112. For example, if the flushing element 1113 is upstream of the closing element 1112 and therefore in series, and the flushing element 1113 is closer to the beginning of the fluid collection tube, the fluid is pushed in the direction of the beginning of the fluid collection tube, such as a tissue site. If the flushing element 1113 is downstream of the closing element 1112 and therefore in series, and the flushing element 1113 is closer to the end of the drain tube, the fluid is pushed in the direction of the end of the drain tube, such as a drain site. In one embodiment, the closing element 1112 is located in the center of the flushing element 1113, thereby causing fluid movement toward both tissue sites and drainage sites due to the compression of the tube by the flushing element 1113.

[0051]

[0088] Detailed aspects of the subject matter of this disclosure are disclosed herein upon request. However, it should be understood that the disclosed aspects are merely illustrative of the subject matter of this disclosure and can be embodied in various forms. Accordingly, the specific structural and functional details disclosed herein should not be constrained, but rather should be interpreted merely as the basis for the claims and as a representative basis for teaching those skilled in the art how to use the subject matter of this disclosure in various forms in substantially any appropriately detailed structure.

[0052]

[0089] Similarly, the foregoing description includes numerous features and advantages, along with various alternatives, as well as details of the structure and function of the device and / or method. This disclosure is intended to be illustrative only and is therefore not exhaustive. It will be apparent to those skilled in the art that various modifications may be made within the principles of the present invention, particularly with respect to the composition, components, structure, materials, elements, components, shape, size, and arrangement of parts, including combinations, to the maximum extent indicated by the broad general meaning of the terms used in the appended claims. These various modifications are intended to be included in the claims, without departing from the spirit and scope of the appended claims.

Claims

1. A flash assembly for an external ventricular drain (EVD) system, The crumpleable upper body and base, the flash assembly is connected to the EVD via a connector located near the lower end of the flash assembly, A coupling tube surrounding the connector, the base being crossed by the connector and Equipped with, The flash assembly stores fluid in an internal fluid reservoir, and when the flash assembly is activated, the collapsible upper body pushes the fluid from the internal fluid reservoir to the flushing area in order to perform the flashing of the EVD. Flash assembly.

2. A flash assembly according to claim 1, A flush assembly in which the flushing portion is at least one of a tissue portion and a drainage portion from which the fluid can be pushed out of the flush assembly to remove an obstruction in a catheter or drainage line.

3. A flash assembly according to claim 1, It is further equipped with a stopcock valve, The flush assembly is a flush assembly that can be turned on and off depending on the orientation of the stopcock valve.

4. A flash assembly according to claim 1, A flush assembly in which the aforementioned connector is attached by a Luer lock connector.

5. A flash assembly according to claim 1, A flush assembly in which the connector is manufactured from plastic or urethane.

6. A flash assembly according to claim 1, A flash assembly in which the bonding tube is manufactured from a flexible material and provides a surface for chemical bonding to other similar materials.

7. A flash assembly according to claim 1, A flash assembly where the fluid flow is bidirectional.

8. A flash assembly according to claim 1, A flash assembly in which the fluid is discharged in each direction in at least one of an equal or uneven amount.

9. A flash assembly according to claim 1, A flush assembly in which the amount of fluid discharged in each direction is adjustable.

10. A flash assembly according to claim 1, A flush assembly in which the crushable upper body is manufactured from a flexible material, the base is manufactured from at least one of a flexible material and a rigid material, and when assembled, the crushable upper body and the base form the internal fluid reservoir.

11. A flash assembly according to claim 10, A flash assembly in which the flexible material comprises at least one of silicone or thermoplastic elastomer, and the rigid material comprises at least one of ABS, polycarbonate, PEEK, polyurethane, and plastic.

12. A flash assembly according to claim 1, A flash assembly further equipped with tactile features.

13. A flash assembly for an external ventricular drain (EVD) system, At least one hemispherical structure, A connector located on one side, having a coupling tube surrounding the connector, The drainage tube located on the opposite side and Equipped with, The flash assembly is connected in series with the EVD system, the connector is connected to an external ventricular catheter, and the drainage tube is connected to the EVD system. The flash assembly stores fluid in an internal fluid reservoir, and when the flash assembly is activated, in order to perform the flashing of the EVD, the flash assembly pushes the fluid from the internal fluid reservoir to the flashing area. Flash assembly.

14. A flash assembly according to claim 13, A flush assembly in which the hemispherical structure has a flat top.

15. A flash assembly according to claim 14, A flash assembly in which the flat top portion has tactile features.

16. A flash assembly according to claim 13, A flush assembly comprising two hemispherical structures.

17. A flash assembly according to claim 13, A flush assembly in which the flushing portion is at least one of a tissue portion and a drainage portion from which the fluid can be pushed out of the flush assembly to remove an obstruction in a catheter or drainage line.

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