Suctioning system, method and kit

Abstract

A suction head in fluid communication with a pump head provides a sub-ambient working pressure to a medical site, enabling drainage thereof to a waste container and/or enhancing healing at the site. A passive pressure regulator enables the working pressure to be maintained at a desired level independent of the fluid flow through the system.

1 - 38 . (canceled) 
   
   
       39 . A vacuum system for providing a sub-ambient pressure to a medical target volume, comprising:
 a suction head having an inlet arrangement adapted for being in fluid communication with said target volume;   a vacuum pump in fluid communication with said suction head, said vacuum pump being adapted for providing a working pressure in said suction head below external ambient pressure;   a waste container defining a collection volume for collection of materials that may be drained from said target volume in fluid communication with at least one of said vacuum pump and said inlet arrangement; and   a passive pressure regulation system for passively regulating said working pressure, said passive pressure regulation system configured to be driven directly in an unpowered manner by a pressure difference across the pressure regulation system being within or exceeding a predetermined threshold, and said passive pressure regulation system being in direct fluid communication with said suction head upstream of the said waste container.   
   
   
       40 . A vacuum system according to  claim 39 , wherein said pressure regulation system comprises a venting valve arrangement adapted for enabling ingress of external ambient air into the system responsive to a reduction in said working pressure below a predetermined datum pressure with respect to said external ambient pressure and for discontinuing said ingress when said datum pressure is restored. 
   
   
       41 . A vacuum system according to  claim 40 , wherein said venting valve arrangement comprises an inlet port having a valve seat and in fluid communication with said ambient air, an outlet port in fluid communication with said vacuum system, and a valve seal biased for sealingly closing with respect to said valve seat by means of a resilient element generating a biasing force of magnitude substantially less than and in a direction generally opposed to a pressure-induced force acting on said valve seal when said working pressure is less than said datum pressure. 
   
   
       42 . A vacuum system according to  claim 40 , wherein said venting valve arrangement comprises an adjustment mechanism for adjusting said datum pressure. 
   
   
       43 . A vacuum system according to  claim 42 , wherein said venting valve arrangement comprises an inlet port in fluid communication with said ambient air and an outlet port in fluid communication with said vacuum system, and a valve seal biased for sealingly closing said inlet port by means of a resilient element generating a biasing force of magnitude substantially less than and in a direction generally opposed to a pressure-induced force acting on said valve seal when said working pressure is less than said datum pressure, and wherein said adjustment mechanism comprises a bias adjusting arrangement for adjusting the magnitude of said biasing force. 
   
   
       44 . A vacuum system according to  claim 43 , wherein said resilient element comprises a compression spring mounted in a suitable housing such as to urge said valve seal towards said valve seat, and said bias adjusting arrangement comprises a compression control mechanism for adjusting the compression of said spring. 
   
   
       45 . A vacuum system according to  claim 39 , wherein said pressure regulation system is connected to said suction head permitting selective fluid communication between said target volume and said external ambient air, enabling ingress of external ambient air into said target volume responsive to a reduction in said working pressure below a predetermined datum pressure and discontinuing said ingress when said datum pressure is restored. 
   
   
       46 . A vacuum system according to  claim 45 , wherein said pressure regulation system is connected to said suction head via a suitable conduit. 
   
   
       47 . A vacuum system according to  claim 46 , wherein said pressure regulation system is in selective fluid communication with an outlet port of said vacuum pump and said external ambient air such as to allow ingress of at least one of fluid from said vacuum pump outlet port and said external ambient air when said working pressure is below said datum pressure. 
   
   
       48 . A vacuum system according to  claim 39 , wherein said vacuum pump comprises a pump head releasably operatively coupled to a pump drive unit, wherein said pump head is one of fixed to and integral with said waste container. 
   
   
       49 . A vacuum system according to  claim 48 , wherein said pump head comprises a pump inlet port and a pump outlet port, and further comprises a suitable deformable diaphragm arrangement, reciprocable by means of said pump drive unit, to induce said working pressure in said vacuum system. 
   
   
       50 . A vacuum system according to  claim 49 , wherein said drive unit comprises a reciprocation drive for driving a reciprocating member, and said diaphragm is releasably engagable with said reciprocating member responsive said pump head being coupled to said pump unit. 
   
   
       51 . A vacuum system according to  claim 50 , wherein said reciprocating member and said diaphragm are conformally shaped such that when coupled one with the other a vacuum is created therebetween. 
   
   
       52 . A vacuum system according to  claim 49 , wherein a part of said pump head is accommodated in said waste container, wherein said diaphragm is facing a direction generally away from said collection volume, and wherein said pump inlet port and a pump outlet port are at least partially within said collection volume. 
   
   
       53 . A vacuum system according to  claim 52 , wherein said pump inlet port is in fluid communication with said suction head via a conduit, said pump outlet port is in fluid communication with said collection volume and wherein said waste container is vented to said external ambient air. 
   
   
       54 . A vacuum system according to  claim 52 , wherein said pump inlet port is in fluid communication with said suction head via said collection volume, and said pump outlet port is vented to said external ambient air. 
   
   
       55 . A vacuum system according to  claim 54 , wherein said pressure regulation system is operatively connected to said suction head via a suitable first conduit and wherein said pressure regulation system is in selective fluid communication with said pump outlet port and said external ambient air such as to allow ingress of at least one of fluid from said vacuum pump outlet port and external ambient air into said target volume responsive to a reduction in said working pressure below a predetermined datum pressure and such as to discontinue said ingress when said datum pressure is restored. 
   
   
       56 . A vacuum system according to  claim 55 , wherein said waste container is in fluid communication with said suction head via a suitable second conduit. 
   
   
       57 . A vacuum system according to  claim 56 , wherein said first conduit and said second conduit are in fluid communication one with another. 
   
   
       58 . A vacuum system according to  claim 52 , wherein said pump head, waste container and suction head are configured for being disposable. 
   
   
       59 . A vacuum system according to  claim 39 , wherein said target volume is associated with a wound, burn or the like, and said suction head comprises an enclosure sealable to a perimeter of the wound so as to define a confined volume comprising said target volume. 
   
   
       60 . A vacuum system according to  claim 39 , wherein said suction head comprises a drain catheter having at least one lumen in fluid communication with said pump, and said inlet arrangement comprises at least one aperture adapted for providing fluid communication between said target volume and said at least one lumen. 
   
   
       61 . A vacuum system according to  claim 39 , wherein said pressure regulation system is in fluid communication with said suction head one of actually and effectively upstream of the said suction head, such as to enable, in operation of said regulator ambient air to flow from the suction head in a downstream direction to said waste container, or to cause fluid to flow from the suction head in a downstream direction to aid waste container, respectively. 
   
   
       62 . A method for providing a sub-ambient pressure to a medical target volume, comprising:
 (a) inducing a working pressure in said target volume below external ambient pressure;   (b) providing a collection volume for collection of drained materials from said target volume; and   (c) regulating the working pressure in said target volume to provide a positive pressure gradient between said target volume and said collection volume such as to aid flow of said materials from said target volume to said collection volume, wherein said regulation is provided upstream of said collection volume.   
   
   
       63 . Method according to  claim 62 , wherein step (c) comprises allowing ingress of external ambient air at or near to the target volume responsive to a reduction in said working pressure below a predetermined datum pressure with respect to said external ambient pressure and discontinuing said ingress when said datum pressure is restored. 
   
   
       64 . Method according to  claim 63 , further comprising allowing recirculation of fluid between said collection volume and said target volume together with said ingress of external ambient air. 
   
   
       65 . A kit for use with a vacuum system for providing a sub-ambient pressure to a medical target volume, comprising:
 a vacuum pump head adapted for releasable operative connection to a pump drive unit, said pump head comprising a pump inlet and a pump outlet for enabling working fluid to be pumped through the pump during operation thereof;   a waste container defining a collection volume for collection of drained materials in fluid communication with at least one of said pump inlet and said pump outlet of said vacuum pump head;   wherein said vacuum pump head is one of attached to or integral with said waste container such that at least one of said pump inlet and said pump outlet is accommodated in said collection volume.   
   
   
       66 . A kit according to  claim 65 , further comprising a suction head having an inlet arrangement adapted for being in fluid communication with said target volume. 
   
   
       67 . A kit according to  claim 65 , wherein said suction head comprises an enclosure sealable to a perimeter of a wound so as to define a confined volume comprising said target volume, said enclosure being in fluid communication with at least one of said waste container and said pump inlet. 
   
   
       68 . A kit according to  claim 65 , wherein said suction head comprises a drain catheter having at least one lumen in fluid communication with said pump, and said inlet arrangement comprises at least one aperture adapted for providing fluid communication between said target volume and said at least one lumen, said drain catheter being in fluid communication with at least one of said waste container and said pump inlet. 
   
   
       69 . A kit according to  claim 65 , further comprising a passive pressure regulation system for regulating said working pressure. 
   
   
       70 . A kit according to  claim 65 , comprising:
 a suction head having an inlet arrangement adapted for being in fluid communication with said target volume;   a pump head adapted for being releasably operatively connected to a pump drive unit, said pump head comprising a pump inlet port, a pump outlet port and a suitable deformable diaphragm arrangement adapted for reciprocable operation by means of said pump drive unit when connected thereto;   a waste container defining a collection volume for collection of drained materials from said target volume, wherein said pump head is one of fixed to or integral with said waste container such that said pump inlet port and said pump outlet port are accommodated in said collection volume, wherein said pump inlet port is in fluid communication with said suction head via a conduit connecting said pump inlet port with said suction head, at least a portion of said conduit being accommodated in said collection volume, wherein said pump outlet port is adapted for discharging into said collection volume, and wherein said waste container is vented to external ambient air; and   a venting valve arrangement mounted to one of said conduit and suction head adapted for enabling ingress of external ambient air into the system responsive to a reduction in said working pressure below a predetermined datum pressure with respect to said external ambient pressure, such as to induce suction flow of materials from said target volume when in use, and for discontinuing said ingress when said datum pressure is restored.   
   
   
       71 . A vacuum system according to  claim 70 , wherein said diaphragm comprises a suction cup arrangement for engagement with said pump drive unit. 
   
   
       72 . A kit according to  claim 65 , comprising:
 a suction head having an inlet arrangement adapted for being in fluid communication with said target volume;   a pump head adapted for being releasably operatively connected to a pump drive unit, said pump head comprising a pump inlet port, a pump outlet port and a suitable deformable diaphragm arrangement adapted for reciprocable operation by means of said pump drive unit when connected thereto;   a waste container defining a collection volume for collection of drained materials, wherein said pump head is fixed to said waste container such that said pump inlet port and said pump outlet port are accommodated in said collection volume, wherein said pump inlet port is in fluid communication with said suction head via said collection volume, and said waste container is in fluid communication with said suction head via a first conduit, and wherein said pump outlet port is vented to external ambient air; and   a venting valve arrangement in fluid communication with said target volume via a second conduit, said valve arrangement being mounted to said waste container and in selective fluid communication with said pump outlet port for enabling ingress of at least one of fluid from said vacuum pump outlet port and external ambient air into the system responsive to a reduction in said working pressure below a predetermined datum pressure with respect to said external ambient pressure, such as to induce suction flow of materials from said target volume, and for discontinuing said ingress when said datum pressure is restored.   
   
   
       73 . A vacuum system according to  claim 72 , wherein said diaphragm comprises a suction cup arrangement for engagement with said pump drive unit.