US2004102761A1PendingUtilityA1

Portable pressure relief system & methods

Priority: Nov 27, 2002Filed: Nov 27, 2002Published: May 27, 2004
Est. expiryNov 27, 2022(expired)· nominal 20-yr term from priority
Inventors:A. Mateen Ahmed
A61M 2202/0464A61M 27/006
42
PatentIndex Score
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Cited by
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References
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Claims

Abstract

A portable systems release fluid pressure with a cavity within a patient. These systems include a drainage catheter, a pressure-responsive one-way valve, and a fluid reservoir all adapted to be mounted in proximity to the cavity being drained. One system in particular is used in relieving intracranial pressure. This intracranial pressure relief system may include a headband to which are mounted the one-way valve and reservoir. The drainage catheter may have mounted thereon a cranium seal formed of a soft material that contacts the inner wall of a cranium bore hole. The cranium seal may have threads to facilitate advancement into the bore hole.

Claims

exact text as granted — not AI-modified
1 . A system for relieving pressure resulting from fluid collecting in a cavity in the cranium of a patient, comprising: 
 a drainage catheter having a first end adapted to be inserted into the cavity and a second end that is external to the cranium;    a connector adapted to be attached to the cranium that holds the first end of the catheter in position in the cavity and prevents leakage of fluid past the connector, so that essentially all the fluid flowing from the cavity passes through the catheter with essentially no fluid bypassing the catheter and flowing around the connector;    a one-way pressure-responsive valve with an inlet in fluid communication with the catheter to permit pressure-regulated flow of fluid from the cavity through the catheter; and    a reservoir having an inlet in fluid communication with an outlet of the pressure-responsive valve so as to receive the fluid that passes through the catheter.    
     
     
         2 . The system according to  claim 1  where the pressure-responsive valve includes a pair of membrane members that overly each other to form a slit type opening at the outlet, said membrane members being in tensioned to close the opening when the differential in pressure between the inlet and outlet is at a predetermined difference and to open said opening when the differential in pressure between the inlet and outlet is greater than said predetermined difference.  
     
     
         3 . The system according to  claim 2  where the pressure-responsive valve includes a venturi chamber that has one end in communication with the second end of the catheter and another end in communication with the inlet of the reservoir.  
     
     
         4 . The system according to  claim 1  where the connector is integral with the catheter and includes a thread element on an external surface of the catheter at or nearby the first end of the catheter.  
     
     
         5 . The system according to  claim 1  where the connector fits snugly into a hole in the cranium to prevent any substantial leakage of fluid past the connector, said connector having a passageway therein through which the drainage catheter extends so that said second end of the catheter is external to the cranium.  
     
     
         6 . The system according to  claim 5  where the passageway is formed by a substantially cylindrical wall member with a cleft therein.  
     
     
         7 . The system according to  claim 5  where the connector has a body with external threads thereon enabling the connector to be screwed into the hole.  
     
     
         8 . The system according to  claim 7  where the body is made of a material that deforms upon compression and has a substantially truncated conical shape sized to fit into the hole and compress as the connector is screwed to the hole to provide a substantially fluid tight seal between the hole and the body, said passageway being constricted as connector is screwed into the hole to provide a substantially fluid tight seal between the catheter and the passageway.  
     
     
         9 . The system according to  claim 8  where the body has an enlarged head that acts as a stop adapted to bear against an external portion of the cranium surrounding the hole, said enlarged head having at least one suture orifice therein to enable the connector to be sutured to the cranium to prevent movement of the connector within the hole after insertion into the hole.  
     
     
         10 . The system according to  claim 1  where the outlet of the catheter, the inlet and outlet of the valve, and the inlet of the reservoir are substantially in a common plane.  
     
     
         11 . The system according to  claim 1  where the outlet of the catheter, the inlet and outlet of the valve, and the inlet of the reservoir are nearby each other so that there is essentially no hydrostatic pressure in the system affecting to flow of fluid from the cavity in the cranium of a patient.  
     
     
         12 . The system according to  claim 11  where the distance between the outlet of the valve and the inlet of the reservoir is no greater than 3 inches.  
     
     
         13 . The system according to  claim 1  where drainage catheter, pressure-responsive valve, and reservoir are connected to a mounting member that is adapted to be detachably coupled to the head of the patient.  
     
     
         14 . A connector that fits snugly into a hole in the cranium of a patient to prevent any substantial leakage of fluid past the connector, said connector adapted to hold a drainage catheter in position with a first end of the catheter inserted into a cavity in the cranium and a second end that is external to the cranium, said connector comprising 
 a body having 
 a substantially truncated conical shape sized to fit into the hole,  
 external threads on an external surface of the body enabling the connector to be screwed to the hole, and  
 a passageway therein for insertion therethrough of the drainage catheter so that said second end of the catheter is external to the cranium,  
   said body being made of a material that deforms upon compression and compress as the connector is screwed to the hole to provide a substantially fluid tight seal between the hole and the body, said passageway being constricted as connector is screwed to the hole to provide a substantially fluid tight seal between a catheter extending therethrough and the passageway.    
     
     
         15 . The connector of  claim 14  where the body has an enlarged head that acts as a stop adapted to bear against an external portion of the cranium surrounding the hole, said enlarged head having at least one suture orifice therein to enable the connector to be sutured to the cranium to prevent movement of the connector within the hole after insertion into the hole.  
     
     
         16 . In combination, 
 a drainage catheter having a first end adapted to be inserted into a cavity in the cranium of a patient and a second end that is external to the cranium, and    a connector adapted to be inserted into a hole in the cranium and sized to fit snugly into the hole in the cranium to prevent any substantial leakage of fluid past the connector, said connector having a passageway therein through which the drainage catheter extends so that said second end of the catheter is external to the cranium.    
     
     
         17 . The combination according to  claim 16  where the passageway is formed by a substantially cylindrical wall member with a cleft therein.  
     
     
         18 . The combination according to  claim 16  where the connector has a body with external threads thereon enabling the connector to be screwed to the hole.  
     
     
         19 . The combination according to  claim 18  where the body is made of a material that deforms upon compression and has a substantially truncated conical shape sized to fit into the hole and compress as the connector is screwed to the hole to provide a substantially fluid tight seal between the hole and the body, said passageway being constricted as the connector is screwed into the hole to provide a substantially fluid tight seal between the catheter and the passageway.  
     
     
         20 . The combination according to  claim 19  where the body has an enlarged head that acts as a stop adapted to bear against an external portion of the cranium surrounding the hole, said enlarged head having at least one suture orifice therein to enable the connector to be sutured to the cranium to prevent movement of the connector within the hole after insertion into the hole.  
     
     
         21 . A portable system for relieving fluid pressure from a body cavity of a patient, comprising: 
 a drainage catheter for insertion into the body cavity;    a one-way pressure-responsive valve with an inlet in fluid communication with the drainage catheter to permit pressure-regulated flow of fluid from the body cavity through the catheter; and    a reservoir having an inlet in fluid communication with an outlet of the pressure-responsive valve so as to receive the fluid that passes therethrough;    said drainage catheter, pressure-responsive valve, and reservoir connected to a mounting member that is adapted to be detachably coupled to the patient nearby the body cavity.    
     
     
         22 . The system of  claim 21  where the body cavity is within the cranium and the mounting member comprises a headband.  
     
     
         23 . The system of  claim 22  where the headband includes 
 a first component sized to fit around the circumference of the patient's head, and  
 a second component connected by opposed ends thereof to the first component and sized to fit over the top of the patient's head.  
 
     
     
         24 . The system of  claim 23  including a releasable chin strap to permit easy removal of the system.  
     
     
         25 . The system of  claim 21  where the first component is adjustable to different patient head circumferences.  
     
     
         26 . The system of  claim 22  where the headband comprises at least partially hollow member that functions as the reservoir.  
     
     
         27 . The system of  claim 26  where the hollow member is hoop-shaped.  
     
     
         28 . The system of  claim 22  where the reservoir is detachably connected to the headband.  
     
     
         29 . The system of  claim 28  where the headband and reservoir are connected by a snap-type connector.  
     
     
         30 . The system of  claim 22  where the pressure-responsive valve includes a pair of membrane members that overly each other to form a slit type opening at the outlet, said membrane members being in tensioned to close the opening when the differential in pressure between the inlet and outlet is at a predetermined difference and to open said opening when the differential in pressure between the inlet and outlet is greater than said predetermined difference.  
     
     
         31 . The system of  claim 21  where the outlet of the pressure-responsive valve is at substantially atmospheric pressure and the inlet pressure-responsive valve is at the pressure within the body cavity, said valve opening when the differential between atmospheric pressure and the pressure within the body cavity exceeds a predetermined difference and closes when said differential is less than said predetermined difference.  
     
     
         32 . The system according to  claim 31  where an outlet of the catheter, the inlet and outlet of the valve, and the inlet of the reservoir are nearby each other so that there is essentially no hydrostatic pressure in the system affecting to flow of fluid from the body cavity.  
     
     
         33 . The system according to  claim 32  where the distance between the outlet of the valve and the inlet of the reservoir is no greater than 3 inches.  
     
     
         34 . The system of  claim 33  where the drainage catheter has a distal end with drainage apertures therein, and said distal end of the drainage catheter, reservoir inlet, and pressure-responsive valve are at substantially the same height.  
     
     
         35 . A portable apparatus for relieving fluid pressure from a body cavity of a patient, comprising: 
 a drainage catheter having a distal end with drainage apertures; and    a substantially ring-shaped hollow reservoir having an inlet in fluid communication with the drainage catheter and being sized to mount to the patient immediately adjacent the body cavity.    
     
     
         36 . The apparatus of  claim 35  including a one-way pressure-responsive valve interposed between the drainage catheter and the reservoir inlet to permit pressure-regulated flow of fluid from the body cavity through the catheter to the reservoir.  
     
     
         37 . The apparatus of  claim 36  where the pressure-responsive valve includes an inlet, and outlet, and a pair of membrane members that overly each other to form a slit type opening at the outlet, said membrane members being in tensioned to close the opening when a differential in pressure between the inlet and outlet is at a predetermined difference and to open said opening when the differential in pressure between the inlet and outlet is greater than said predetermined difference.  
     
     
         38 . The apparatus of  claim 35  where the body cavity is within a cranium of a patient.  
     
     
         39 . The apparatus of  claim 38  where the distal end of the drainage catheter, the reservoir inlet, and the pressure-responsive valve are at substantially the same height.  
     
     
         40 . The apparatus of  claim 39  where the substantially ring-shaped hollow reservoir extends around to the circumference of the patient's head.  
     
     
         41 . A self-sealing catheter for insertion through a bore hole in a cranium of a patient, comprising: 
 an elongated tubular catheter body sized to fit through the bore hole in the cranium; and    a sealing member mounted on the exterior of the catheter body made of a material that deforms upon insertion into the bore hole,    said sealing member having along at least a portion thereof an outer diameter larger than the bore hole to provide a substantially fluid tight seal between said bore hole and the sealing member upon insertion of the catheter into the bore hole.    
     
     
         42 . The self-sealing catheter of  claim 41  where the sealing member includes a thread element that facilitates advancement into the bore hole.  
     
     
         43 . The self-sealing catheter of  claim 42  where the thread element comprises a helical bead formed on the exterior of the catheter body.  
     
     
         44 . The self-sealing catheter of  claim 43  where the helical bead is formed of silicone.  
     
     
         45 . The self-sealing catheter of  claim 42  where the sealing member comprises a generally tubular sleeve having a narrow passageway that fits snugly around the catheter body and an enlarged head sized larger than the bore hole.  
     
     
         46 . The self-sealing catheter of  claim 45  where an exterior surface of the tubular sleeve is conical having a narrow distal end and threads are formed on the exterior surface.  
     
     
         47 . The self-sealing catheter of  claim 45  where the tubular sleeve has a cleft that permits the sleeve to constrict upon insertion into the bore hole.  
     
     
         48 . The self-sealing catheter of  claim 42  where the sealing member comprises a body member made of a material that deforms upon compression and has a substantially truncated conical shape sized to fit into the bore hole and compress as the threaded element is screwed to the hole to provide a substantially fluid tight seal between the hole and the body, said passageway being constricted as the threaded element is screwed into the hole to provide a substantially fluid tight seal between the catheter and the passageway.  
     
     
         49 . The self-sealing catheter of  claim 48  where the body member has an enlarged head that acts as a stop adapted to bear against an external portion of the cranium surrounding the hole, said enlarged head having at least one suture orifice therein to enable the sealing member to be sutured to the cranium to prevent movement of the catheter within the hole after insertion into the hole.  
     
     
         50 . The self-sealing catheter of  claim 49  where the tubular catheter body is moveable axial within the passageway prior to screwing the threaded element into the hole.  
     
     
         51 . A portable system for relieving fluid pressure resulting from the fluid collecting in a cavity in the cranium of a patient, comprising: 
 means for draining fluid from the cavity including a drainage catheter having a first portion that is at least 4 inches in length for insertion into the cavity and a second portion that extends from the cavity;    a one-way pressure-responsive valve connected to the second portion with an outlet and an inlet in fluid communication with the drainage catheter to permit pressure-regulated flow of fluid from the cavity through the outlet of the valve;    means for collecting the fluid that passes through the valve including an inlet in communication with the outlet of the valve; and    means for detachably mounting to the patient nearby the cavity the collecting means and the drainage catheter, including the pressure-responsive valve connected thereto.    
     
     
         52 . The system of  claim 51  where the distal end of the drainage catheter, collecting means inlet, and pressure-responsive valve are at substantially the same height.  
     
     
         53 . A method of relieving fluid pressure resulting from fluid collecting within a cavity formed at least in part by the ventricle walls of the brain enclosed within the cranium of a patient, comprising: 
 forming a hole in the cranium to provide access to the cavity;    inserting into the hole a plug-type connector sized to fit snugly in the hole to prevent any substantial leakage of fluid past the connector, said connector having a passageway therein;    passing an elongated drainage catheter through the passageway so that a first end of the catheter is seated within the cavity and a second end of the catheter is external to the cranium, said first end having at least one drainage aperture therein, said drainage catheter fitting snug within the passageway to prevent any substantial leakage of between the catheter and the passageway; and    controlling the flow of fluid from the cavity so that the fluid pressure within cavity is maintained at a level that prevents the ventricle walls form making substantial contact with the drainage apertures.    
     
     
         54 . The method according the  claim 53  where the plug-type connector comprises a body member having a substantially truncated conical shape with an external threaded element thereon, said body member being made of a material that deforms upon compression to compress as the body member is screwed to the hole to provide a substantially fluid tight seal between the hole and the body member, said passageway being constricted as the threaded element is screwed into the hole to provide a substantially fluid tight seal between the catheter and the passageway.  
     
     
         55 . A method of relieving fluid pressure resulting from fluid collecting within a body cavity of a patient, comprising: 
 forming a hole to provide access to the cavity;    draining the fluid from the cavity by inserting a drainage catheter through the hole so that a distal end lodged within the cavity and a proximal end extending from the cavity;    said proximal end having a one-way pressure-responsive valve thereat with an outlet and an inlet in fluid communication with the drainage catheter to permit pressure-regulated flow of fluid from the cavity through the outlet of the valve;    collecting the fluid that passes through the valve in a reservoir with an inlet in communication with the outlet of the valve; and    positioning the proximal end of the catheter, the inlet and outlet of the valve, and the inlet of the reservoir nearby each other so that there is essentially no hydrostatic pressure affecting to flow of fluid from the cavity of a patient.    
     
     
         56 . The method according the  claim 55  where the distance between the outlet of the valve and the inlet of the reservoir is no greater than 3 inches.  
     
     
         57 . The method according the  claim 56  where the proximal end of the catheter, the inlet and outlet of the valve, and the inlet of the reservoir are at substantially the same height.

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