Patent Application
20110125113
This invention relates to enclosures for covering a tissue, in particular damaged tissue, including for example wounds, burns and the like, in particular to such enclosures regarding which a vacuum may be applied.
Applying negative pressure to a physiological area such as a wound, for example, enhances drainage of fluids or exudate from the wound and promotes tissue growth and wound healing. This method of healing (known as “cupping”) was exercised since the times of ancient Greek physicians until the 19th century. Applying negative pressure to other physiological areas such as burn, for example, may be beneficial even when there is no drainage.
By way of general background, a number of systems and methods have been developed for providing suctioning and/or for treatment of wounds, for example as disclosed in the following publications.
U.S. Pat. No. 7,198,046 discloses a method of treating tissue damage, and a wound treatment apparatus in which a fluid impermeable wound cover is sealed over a wound site. A screen in the form of an open-cell foam screen or a rigid porous screen is placed beneath the wound cover over the wound. A vacuum pump supplies suction within the wound cover over the treatment site.
U.S. Pat. No. 5,645,081 discloses a method of treating tissue damage and apparatus for same, comprising applying a negative pressure to a wound.
WO 2003/057070 discloses a ventilated bandage system is provided for use with a wound. The system includes a bandage positioned adjacent the wound to create a sealed environment around the wound. A vacuum source of the system is in communication with the bandage to create negative pressure between the bandage and the wound. The system may also include a first passageway or vent in communication with the bandage and with the surrounding atmosphere, and a second passageway in communication with the bandage and with the vacuum source.
US 2006/025727 and WO 2006/052745 each discloses a system for treating a wound with suction, comprising a wound cover, a pump having an input port and an output port, the input port providing suction to the wound via the wound cover, and a reservoir coupled to the output port of the pump. The reservoir is adapted to receive effluent from the wound and the pump is capable of maintaining a controlled level of suction at the wound.
US 2004/064132 discloses a medical device that includes an enclosure to be placed over a wound, adhesively connected to the skin around the wound by a flange. Gauze type packing cylinders can be placed in the wound, and suction is provided either by a bulb type pump, or by a pair of regulators. When regulators are used, one alternates the suction that it provides, and the other is continuous, such that the level of suction is periodically varied.
US 2001/029956 discloses a method of treating tissue damage, comprising applying a negative pressure to a wound, and a wound treatment apparatus in which a fluid impermeable wound cover is sealed over a wound site. A screen made from open-cell foam or a rigid porous screen is placed beneath the wound cover over the wound. A vacuum pump supplies suction within the wound cover over the treatment site.
In WO 2006/025848 a medical device is disclosed comprising a suction portion, having both an inlet valve and an outlet valve, for suctioning fluids from the wound, and a sealing portion for sealing the wound by engaging the skin adjacent the wound, the suction portion and sealing portion being integral with one another. A method for draining a wound is also disclosed.
In WO 03/057307, a wound vacuum therapy dressing kit is provided for use with a wound drainage system having a vacuum source. The kit may include a wound dressing member, a sealing film, and a wound measurement device. The wound dressing member may include a wound contacting surface configured to be in contact with and generally conform to a wound surface of a patient. The member may be adapted to be coupled to the vacuum source for communicating suction from the vacuum source to the wound surface. The sealing film of the kit may be provided for placement over the member and may be configured to adhere to a patient's healthy skin surrounding the wound. The wound measurement device may include a transparent top portion and a transparent bottom portion configured for placement adjacent the wound surface. The top portion may include a drawing surface and a grid associated with the drawing surface.
US 2004/054338 discloses a portable closed wound drainage system that uses a pouch shaped dressing which is inserted into a wound. At least a portion of the outer surface of the pouch is porous to allow exudates to enter. Exudates are removed from the pouch by flexible tubing which is secured inside the pouch at one end, and secured at the other end to a portable drain/suction unit. The pouch contains porous material, and may optionally contain beads and fillers which are antibacterial in nature. The tubing can have a single or multi-lumen structure with perforations in the side walls of the end of the tube that is inserted in the pouch to allow body fluids to enter laterally. The portable drain/suction unit is preferably a portable battery powered device. The pouch and the tube are sealed by a flexible sealing material which is applied to the outer surface of the skin around the periphery of the pouch and the tubing as it exits the pouch.
WO 2008/048527 discloses a manually-activated reduced pressure treatment system, including a substantially rigid housing, and an end cap slidingly received by the housing. An inner chamber is disposed between the end cap and housing, and a volume of the inner chamber is variable in amount depending on the position of the end cap within the housing. The end cap is slidingly movable between an uncompressed position at which the volume of the inner chamber is at a maximum value and a compressed position at which the volume of the inner chamber is at a minimum value. A position indicating member is associated with the end cap and housing to indicate the position of the end cap relative to the housing at predetermined positions between the uncompressed position and the compressed position.
According to a first aspect of the invention; there is provided a kit for applying a vacuum to a tissue, which may facilitate treatment of the tissue when this is damaged tissue, for example, the kit comprising:
(A) a first tissue cover defining an internal volume at least in cooperation with the tissue in operation of said kit, said first tissue cover comprising a first peripheral portion adapted to be sealingly affixed to a first tissue portion circumscribing the tissue, said first tissue cover adapted for enabling a vacuum to be selectively applied to said internal volume in operation of said kit;
(B) a flowable sealing material configured for covering in a substantially contiguous layer at least a second tissue portion abuttingly adjacent at least part of said first peripheral portion, said sealing material configured for filling gaps between said first peripheral portion and said first tissue portion that may form leaks when a vacuum is applied to said internal volume, wherein said sealing material is uncoupled with respect to said peripheral portion at least prior to affixing said peripheral portion to said first tissue portion; and
(C) a second tissue cover for covering at least a portion of said layer therewith.
The kit may comprise one or more of the following features in any combination:
According to this aspect of the invention, the kit in operation is assembled to form a device for facilitating treatment of damaged tissue, for example as per the second aspect of the invention.
According to a second aspect of the invention, a device is provided for applying a vacuum to a tissue, which may facilitate treatment of the tissue when this is damaged tissue, for example, the device, comprising:
(A) a first tissue cover defining an internal volume at least in cooperation with the tissue in operation of said device, said first tissue cover comprising first peripheral portion having a tissue facing contact surface adapted to be sealingly affixed to a first tissue portion circumscribing the tissue, said device adapted for enabling a vacuum to be selectively applied to said internal volume in operation of said device;
(B) a substantially contiguous layer of flowable sealing material configured for covering, in use of the device, at least a second tissue portion abuttingly adjacent at least a part of said first peripheral portion, said sealing material configured for filling gaps between said contact surface and said first tissue portion that may form leaks by flowing towards said contact surface under suction provided when said vacuum is applied to said internal volume, wherein said sealing material is uncoupled with respect to said contact surface at least prior to affixing said contact surface to said first tissue portion; and
(C) a second tissue cover covering at least a part of said layer.
The device may comprise one or more of the following features in any combination:
The device may have the following configurations:
According to the second aspect of the invention, a system is provided for applying a vacuum to a tissue. For example for treatment of tissue that is damaged tissue, comprising a device according to configuration (I) and variations thereof, and further comprising a vacuum source configured for generating a vacuum and applying said vacuum to said internal volume. The system may comprise one or more of the following features in any combination:
According to the second aspect of the invention, a system is provided for applying a vacuum to a tissue, for example, for the treatment of tissue that is damaged tissue, comprising a device according to configuration (II) and variations thereof, and further comprising a powered drive apparatus comprising a drive unit coupled to a primary pump, in operation said powered drive apparatus being configured for operating said pump head via a non-mechanical coupling arrangement when driven by said drive unit and adapted for selectively providing said vacuum in said internal volume via operation of said pump head. The system may comprise one or more of the following features in any combination:
According to a third aspect of the invention, there is provided a method for providing a self sealing enclosure for use over a target body part. The method may facilitate application of a vacuum to a target body part that is a tissue, for example for facilitating treatment of the tissue wherein the tissue is a damaged tissue. The method comprises:
(a) providing an enclosure comprising a device including a first tissue cover defining an internal volume at least in cooperation with the body part in operation of said device, said first tissue cover comprising a first peripheral portion adapted to be sealingly affixed to a first tissue portion circumscribing the targeted body part, said device adapted for enabling a vacuum to be selectively applied to said internal volume in operation of said device;
(b) placing said first tissue cover over a the body part,
(d) sealingly affixing said first peripheral portion to the first tissue portion;
(e) subsequently applying a flowable sealing material to cover in a substantially contiguous layer at least a second tissue portion abuttingly adjacent at least a part of said first peripheral portion, said sealing material configured for filling gaps between said first peripheral portion and said first tissue portion that may form leaks when a vacuum is applied to said internal volume; and
(f) covering at least a portion of said layer with a second tissue cover.
The method may comprise one or more of the following features in any combination:
According to this aspect of the invention, there is provided a method for facilitating treatment of a target body part comprising a damaged tissue, said method comprising providing a self sealing enclosure for use over a target body part as disclosed.
According to this aspect of the invention, there is also provided a method for treating damaged tissue, comprising applying the aforesaid method for facilitating said treatment, and further comprising selectively applying a vacuum to said internal volume. Optionally, materials that may be drained from said damaged tissue may be collected via said device during operation thereof when a vacuum is applied to said internal volume. Optionally, these materials may be collected in a waste container, and these materials may be disposed with said waste container. The device can be removed from the body part after use, and disposed of.
It is to be noted that any features disclosed only for one of or two of the first or second or third aspect of the invention apply, mutatis mutandis, to one or more other aspects of the invention.
Thus, at least some embodiments of the present invention enable to overcome at least some of the difficulties often encountered in the prior art relating to sealably fixing a drape over a wound area, which often has irregular skin contours and which often results in voids being formed between the drape and skin in the prior art. When present, such voids form leaks and require higher suction flow rate to generate a vacuum to the desired level over a damaged tissue area, while many prior art vacuum pumps for generating a vacuum have limited flow.
At least some embodiments of the present invention avoid the need to apply various drape layers to ensure sealing, which need often arises in the prior art when attempting to cover a wound with a drape having a highly adhesive layer, which is difficult to handle and even more difficult to reposition onto the skin, and which results in many such voids being created, which are sealed in the prior art by the aforesaid plurality of overlapping drape layers.
In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
Referring to
The first tissue cover 110 is in the form of a drape, typically non-rigid, having a shape and size sufficient to cover the damaged tissue 102 as well as a first tissue portion 103 of preferably healthy tissue (typically skin) circumscribing the damaged tissue 102. The first tissue cover 110 comprises a first peripheral portion 112 having a tissue facing contact surface 114 adapted to be sealingly affixed to a first tissue portion 103. The first tissue cover 110 is made of a suitable pliant material that facilitates conforming the first tissue cover 110 to the part of the body 101 onto which it is to be applied. Referring in particular to
Having provided the first tissue cover 110 of the required shape and size, a suitable barrier member (not shown) may be provided and adhered to the generally central part of the first tissue cover 110 after the full protective layer 115 is removed, thereby effectively exposing only the tissue facing contact surface 114 to the tissue surrounding the damaged tissue, and again avoiding adhering the first tissue cover 110 directly to the damaged tissue 102. The barrier layer may comprise for example a screen material, such as open cell polyurethane foam, for example, which is inserted into the concavity of the wound to prevent tissue from growing above the body surface. Optionally, the barrier member may be non-porous and/or non-foam-like, for example including materials PVC (polyvinylchloride) or PVC free of DEHP (diethylhexyl phthalate, polyethylene, polyurethane, and so on. For example, the first tissue cover 110 may be made from an occlusive or semi-occlusive material which allows water vapor to permeate through, for example TEGADERM™ brand sealing film made by 3M Corporation, or OPSITE FLEXIGRID™ semi-permeable dressing made by Smith & Nephew.
As illustrated, the first tissue cover 110 is a single component in this embodiment. In alternative variations of this embodiment, however, the first tissue cover 110 may be formed from a plurality of strips of material, for example, which may be applied, in at least partial overlapping relationship with respect to one another, to the body part 101, together covering the damaged tissue 102.
In any case, the first tissue cover 110 may be made, for example, from any suitable medically compatible material, for example as used in the art for covering wounds burns and the like on the skin, and in particular as further used in conjunction with applying a sub-ambient pressure thereto.
In any case, a suitable damaged tissue interface may be provided for application to the damaged tissue, including for example any suitable medication, lotions, gauze, bandages, packing material, and so on, generally indicated at 160 in
Furthermore, additional sealing between the first peripheral portion 112 and the first tissue portion 103 may be provided by sticking suitable adhesive tape 129 (
The first tissue cover 110 creates a sealed environment between the tissue cover 110 and the damaged tissue 103 in which a vacuum or negative pressure with respect to ambient can be maintained, and thus defines an internal volume V at least in cooperation with the damaged tissue 102 in operation of said device. For example, at least some of this internal volume V may be provided by the natural concavity of the damaged tissue 102 which is often present in damaged tissue, and/or, at least some of this internal volume V may be provided by forming the first tissue cover 110 with a concavity, and/or by manipulating the first tissue cover and adhering the same to the tissue so as to provide a concavity.
The device 100 is adapted for enabling a vacuum to be selectively applied to the internal volume V in operation of said device, and comprises at least one conduit 140 having at one end thereof an inlet port 142 open to and in fluid communication with the internal volume V, and an outlet end 144 being configured for connection to a suitable vacuum source 900 (
The sealing material 122 is provided as a substantially contiguous layer 120 covering at least a second tissue portion 104 circumscribing and abutting adjacent the first peripheral portion 112. The sealing material 122 is a flowable, generally high viscosity fluid, and is configured for filling any gaps and plugging the ensuing leaks that may form between the contact surface 114 and the first tissue portion 103 as the device 100 is operated and a vacuum applied to the internal volume V, by flowing from layer 120 towards the contact surface under suction provided by the vacuum. In addition, such a material is medically compatible. Without being bound by theory, the size of such gaps to be filled may be determined by the amount and viscosity of material 122 that may flow thereinto during operation of the device. When each gap is filled, the flow of material 122 thereinto effectively terminates as the high viscosity of the material 122 requires a high pressure differential across the gap to continue flowing, which is not present in applications of the present invention. Small gaps between the contact surface 114 and the first tissue portion 103 at the same time provide a relatively large surface area of contact with the sealing material 122 with a relatively small flow cross-sectional area, reducing or preventing flow once the gap has been filled. The sealing material 122 is a non-putty, generally non-adhesive flowable liquid, though may be tacky, and while plugging leaks that may develop between the contact surface 114 and the first tissue portion 103, does not provide adhesion therebetween in the same manner as adhesive layer 111, and may even degrade the adhesive properties of said adhesive layer 111. When the material 122 is properly applied as disclosed herein, adhesion between the patient's tissue and the contact surface 114 via the adhesive layer 111 is already previously established. Thus the sealing material is uncoupled with respect to the adhesive layer 111 or the contact surface 114, i.e., the device is configured such that the sealing material is not in contact with the adhesive layer 111 or the contact surface 114, at least prior to adhesion of the contact surface to the first tissue portion 103. This uncoupling of the application of material 122 with the initial adhesion of the contact surface 114 to the first tissue portion 103 serves to avoid or minimize any migration and smearing of the material 122 onto the adhesive layer 111, prior to the initial adhesion of the contact surface 114 via the adhesive layer 111, which could otherwise form a barrier over at least part of the adhesive layer 111 preventing from the start that part of the adhesive layer 111 from being adhesively sealed to the tissue portion 103. Thus, the uncoupling feature also enables the contact surface 114 to be adhered to the first tissue portion 103 without interference from the material 122.
Such a material 122 may comprise, for example, a petroleum jelly, such as for example Vaseline, or a vacuum grease material such as for example Dow Corning 360 hydrophobic medical fluid lubricant for skin provided by Dow Corning. However, any other suitable high viscosity, medically compatible sealing material may be used, in the form of liquid, paste or gel, for example. On the other hand, highly adhesive, putty-like manually moldable materials are generally avoided, since their adhesive properties prevents flowing of such material from an outside of the peripheral portion 112 into gaps that may be required to be filled during operation of the device.
For example, the material 122 may be applied from a tube 125 (see
The sealing material 122 is applied after the first tissue cover 110 is adhesively sealed to the tissue, and thus the sealing material is uncoupled with respect to the contact surface at least prior to affixing the contact surface to the first tissue portion.
The second tissue cover 130 is configured for covering at least the sealant layer 120 after this has been applied, and comprises a second peripheral portion 134 configured for affixing said second peripheral portion to a third tissue portion 106 circumscribing and adjacent the second tissue portion 104. The second tissue cover 130 may be substantially as disclosed for the first tissue cover 130, mutatis mutandis, the main difference being that the second tissue cover 130 is substantially larger, and furthermore comprises an opening to 138 through which the conduit 140 passes. The second tissue cover 130 does not have to be, though may be, adhesively sealed against the third tissue portion 106, and it is often sufficient to affix the tissue cover 130 onto the third tissue portion 106. The second tissue cover 130 is thus configured to retain the sealing material 122 in a reservoir formed in the space between the first tissue cover 110 and the second tissue cover 130, so that the material is available to plug gaps that may form between the peripheral portion 112 and the first tissue portion 103, and does not instead migrate away from the area where leaks are likely to occur. Thus, for example, and referring to
In use, the protective layer 135 is removed, and the second tissue cover 130 is placed over the first tissue cover 110 including the sealant layer 120, and adhesively sealed onto the third tissue portion 106. As with the first tissue cover 110, mutatis mutandis, sealing tape 129 may optionally be used for facilitating sealing of the second peripheral portion 134, and may also be applied over the sealing material 122 of the sealant layer 120.
In alternative variations of this embodiment, the second tissue cover may be configured for partially covering the sealant layer 120 (after this has been applied), and the respective second peripheral portion is configured for affixing the second peripheral portion to a respective third tissue portion that partially circumscribes and is adjacent to the second tissue portion 104.
The first tissue cover 110 and the second tissue cover 130 may each be made from an impermeable material, or from a semi-permeable material that allows limited gaseous exchange therethrough. In the latter case, it is possible to effectively seal the outside of the first tissue layer 110 by coating the full extent or most thereof with said sealant material 122, for example as in the embodiment of
In operation, once the device 100 is adhesively sealed onto the body portion 101, if any leaks develop between the peripheral portion 112 and the tissue portion 103, the material 122 flows to plug the leak by means of the suction generated by the vacuum in the internal volume V. After use, the device 100 may be removed from the body portion 101 in any number of suitable ways. For example, the device may de destructively removed, or forced off the body part with the application of force higher than is normally experienced by the device during usage.
In the variation of the first embodiment illustrated in
In other variations of the first embodiment, the first tissue cover and/or the second tissue cover may be formed as a relatively rigid or semi rigid structure, for example made from rigid or semi rigid materials.
Referring to
A number of variations of the first embodiment of the device is illustrated in
Referring to
Referring to
Additionally or alternatively, one or more bleeding holes 152 may be provided in the first tissue cover 110′, as illustrated in the embodiment of
In a variation of the embodiment of the embodiment of
Optionally, a vent may be provided, for example in the form of a tube coupled at one end thereof to each respective bleed hole for each of the embodiments illustrated in
Referring to
In particular, a small length of tubing 69, having an inlet 61 and an outlet 62, is provided penetrating through the second tissue cover 130″, sealant layer 120, and the first tissue layer 110″ to provide a conduit between the internal volume V and the external environment E. The pressure regulator 35 comprises a vent valve arrangement having a valve seal 38 that cooperates with valve seat 68 in the inside surface of the first tissue layer 110″ for providing sealing engagement with inlet 61 when the regulator 35 is in the closed position. The valve seal 38 is mounted on a pin 72 having a nut 59 thereon, the axial position of which relative to the pin is adjustable. The pin 72 is reciprocably movable within the tubing 69 and the coaxial lumen of a helical spring 37, located between the nut and the outlet 62, between an open position in which the seal 38 is displaced from the seat 68, and the said closed position. The regulator 35 is urged to the open position when there is a pressure difference between the ambient air pressure of the external ambient environment E and the pressure within the internal volume V that exceeds a threshold value M. When this pressure difference is at or less than the threshold value M, the regulator 35 is urged to the closed position by means of the restoration force of the spring 37. The datum restoration force provided by spring 37 can be adjusted by means of nut 59, in order to control the threshold value M, and thus the vacuum conditions in the internal volume V at which the regulator 35 opens to the external environment E.
In the embodiment illustrated in
Optionally, the regulator 35 may also comprise a biological or other suitable filter to prevent possible contamination of the wound via the confined volume V, and/or possible contamination of the external environment E.
In a variation of the embodiment of the embodiment of
The device 100 according to the first embodiment or any variation thereof is formed as a disposable item, made from disposable materials, to be disposed of after use.
The device 100, according to the first embodiment or indeed any variation therefore as disclosed herein, may be used in a system for treating damaged tissue, in conjunction with a suitable vacuum source. Thus, a first embodiment of such a vacuum system, designated herein with reference numeral 180 and referring to
In this embodiment, the vacuum system 180 comprises a suction or vacuum pump apparatus or system, for example as disclosed in any one of the aforementioned publications WO 2007/088530, WO 2007/013064 and WO 2007/013049, and thus comprises a pump head 910 coupled to a powered drive 950 for driving the pump head, and the device 100 is connected to the pump head in a similar manner to the enclosure disclose in the aforesaid publications, mutatis mutandis. The pump head 910 comprises a reciprocating pump, such as for example a piston pump or a diaphragm pump, including pumping chamber, driven by the pump drive 950, a pump inlet 911 to which the conduit 140 is directly or indirectly coupled, and a pump outlet 912 coupled to the collection container 920, and in operation, exudates and other material is transported from the internal volume V to the waste container via the pumping chamber. The pump head 910 is a disposable part, and is configured for being releasably attachable to the drive 950, which is a reusable part, in a simple manner not requiring tools. In alternative variations of this embodiment, the pump head may be releasably attached to the drive in a manner requiring tools. In these or other variations of this embodiment, the pumping apparatus comprises a powered peristaltic pump arrangement rather than a reciprocation pump. In these or other variations of this embodiment, the waste container 920 may be omitted, and any exudates can be discharged from the pump head 910 directly to a sink or drain; alternatively, such variations of the embodiment without the container may be useful when treating damaged tissue that does not contain exudates.
Referring to
The container 820 is also disposable, and together with device 100 and with a length of tubing 840 for connection of the container to the vacuum source and including the biological filter 830, may be disposed of after use.
A device for facilitating treatment of damaged tissue according to a second embodiment of the invention, generally designated 400, is illustrated in
The first tissue cover 212 comprises an open end 230. The slave pump head 244 is in the form of a dual chambered diaphragm type pump head, having a substantially rigid or semi rigid casing 252 comprising a first part 256 and a second part 257, and a barrier member 215 essentially dividing the working volume of the casing 252 into a pumping chamber 229 and a juxtaposed actuation chamber 211. The first part 256 comprises a valved pump inlet port 213 and a valved pump outlet port 214, each provided with suitable one-way valves. The barrier member 215 is sealingly connected at its periphery to the wall of casing 252, and comprises a pump chamber facing surface 233 and an actuation chamber facing surface 232. The arrangement is such as to ensure fluid flow in one direction through the pump head 244 from inlet port 213 to outlet port 214 via pumping chamber 229.
The pump head 244 is configured for enabling pumping of fluids therethrough and the barrier member 215 is substantially impervious to the fluids being transported through the pump head 244 during operation thereof, and acts as a pumping member. The pumping chamber 229 provides a variable pumping volume P, the barrier member 215 being reversibly deformable and/or movable to provide any desired position between: a first position in general contact or close proximity to the rigid part 256, to define a nominal minimum pump volume and a second position, maximally spaced from the rigid part 256 during operation of the system, to define a maximum pump volume. At the same time, the actuation chamber 211 comprises a variable volume S that varies in inverse relationship with respect to pumping volume P. Also, barrier member 215 provides the function of isolating the pumping chamber 229 from the actuation chamber 211, such as to prevent any fluid communication or contamination therebetween, and is also configured for responding to changes in pressure between the pump chamber facing surface 233 and the actuation chamber facing surface 232 thereof such as to equalize the pressures acting on the surfaces 232 and 233 of the barrier member 215.
Thus, in pumping mode, the pump head 244 provides a pumping action by attempting to equalize the pressures acting on either surfaces 232 and 233 of the barrier member 215, i.e., between the two chambers 211, 229, by changing the relative magnitudes of the volumes thereof. A pulsating pressure pulse may be set up in the actuating chamber 211, by means of the system 500 via pneumatic coupling therebetween, which in turn drives the pumping action of the pump chamber 229.
The device 400 further comprises a vent valve 350 for selectively allowing and preventing fluid communication between the internal volume V and the outside environment E by enabling selectively venting therebetween. Valve 350 comprises a valve housing 351, having a valve outlet 354 to volume V, a valve inlet 353 in fluid communication with an outside of the device 400. The valve 350 comprises an actuable member 356 cooperating with said housing 351, biased in the closed position preventing fluid communication between the pumping chamber 229 and the valve inlet 353 until acted upon by an actuator. The actuator is in the form of a paddle 360 having a bar that projects into, and is accommodated in, a well formed in the valve stem 357, which is made from a resilient material, such as for example rubber. The barrier member 215 may be selectively used at the end of the pressure stroke also for mechanically actuating the valve 350 by further increasing the pressure in the actuating chamber, and thus enables to controllably vent the first tissue cover 212. At least a part 215′ of the barrier member 215 is displaced and/or translated and/or deformed beyond that required for providing the nominal minimum pump volume so as to apply a mechanical force to the valve stem 357 via the paddle 360, which results in stretching of the valve stem 357, and opening of the valve, and opening of the valve 350 thus occurs at a nominally constant minimum pump chamber volume, and while no actual pumping is taking place. During regular pumping mode of said system 500, when the valve 350 is in the closed position, the internal volume V is substantially sealed from the external environment E.
Optionally, one or more ports (not shown) may be provided at the enclosure 212 for one or more functions. For example, one such port may be provided for enabling the pressure thereat to be monitored directly, for example by connecting thereto a suitable pressure transducer. Optionally, another such port may be provided for connection to an irrigation source for selectively providing an irrigation fluid to the target volume.
The first tissue cover 212 has a peripheral portion in the form of a flexible outer rim or flange 251 that is sealable to the first tissue portion 103 on periphery of the damaged tissue 102, via contact surface 259. The flange 251 may be made of a compliant material, such as for example polyurethane, which facilitates conforming of the flange 251 to the perimeter of the body part comprising the damaged tissue. Optionally, the lower rim or contact surface 259 of the flange may comprise an adhesive coating, which prior to use may be covered with a protective covering such as a suitable removable tape or film for example, for facilitating application and sealing of the rim to the first tissue 103. Furthermore, the first tissue cover 212 comprises a screen 270 at or near the open end 230, the screen 270 having a plurality of openings 271 configured for allowing adequate fluid communication between the damaged tissue 102 and the cover 212, while preventing solid matter such as large particles that may be present at the target area, i.e. the damaged tissue 102, from being suctioned by the system 500 during operation thereof, and thus minimize the risk of the valves and/or pumping chamber 229 becoming clogged with such matter. In this embodiment, the flange 251 and screen 270 are in the form of a unitary body, which is adapted for being mounted to the enclosure 212 by any suitable means, for example, heat welding, bonding, and so on, but in alternative embodiments alternative constructions may be provided.
Alternatively, and in other variations of this embodiment, the screen 270 may be omitted, and in any case a suitable interface may be provided in volume V, for example comprising one or more of any suitable medication, lotions, gauze, bandages, packing material, and so on, for application to the damaged tissue. The interface may be applied directly to the damaged tissue, or provided with the first tissue cover 212, prior to the first tissue cover 212 being adhesively sealed onto the tissue. In these or other alternative variations of this embodiment, the valve 350 may be omitted, and optionally one or more bleeding holes, and/or a pressure regulator, may be provided, in a similar manner as disclosed for the first embodiment of the device and variations thereof, mutatis mutandis.
The device 400 further comprises sealant layer 420 of said sealing material 122, as already disclosed for the first embodiment and variations thereof, mutatis mutandis. The sealant layer 420 is also applied after the flange 251 is adhesively sealed onto the first tissue portion 103, and covers a second tissue portion 104 and the outside 258 of the flange 251 in a contiguous manner.
The sealing material 122 is applied after the first tissue cover 212 is adhesively sealed to the tissue, and thus the sealing material is uncoupled with respect to the contact surface at least prior to affixing the contact surface to the first tissue portion.
A second tissue cover 430 is configured for covering at least the sealant layer 420 after this has been applied, and comprises a second peripheral portion 434 configured for sealingly affixing said second peripheral portion to a third tissue portion 106 circumscribing and adjacent the second tissue portion 104. The second tissue cover 430 may be substantially as disclosed for the embodiment of the device or variations thereof, mutatis mutandis, the second tissue cover 430 comprising an opening 438 through which the pump head 244, or at least ports 258 and 210, projects. The second tissue cover 430 also comprises an adhesive layer having a layer of adhesive that enables any part of the second tissue cover 430 that contacts the body tissue or the outside 428 of the first tissue cover 212 to be adhesively sealed in the area of mutual contact. The adhesive layer is initially covered with a protective layer, comprising a film or strip of paper for example, that is removed prior to adhering the second tissue cover 430 onto the tissue portion 106. In use, the protective layer is removed, and the second tissue cover 430 is placed over the first tissue cover 212 including the sealant layer 420, and adhesively sealed onto the third tissue portion 106, and sealing tape may also optionally be used for facilitating sealing of the second peripheral portion 434. As with the first embodiment, mutatis mutandis, the second tissue cover 430 may be affixed in place without sealing onto the third tissue portion 106, and is configured for containing the sealant material 122 and for enabling the same to be used for plugging leaks that may form between the first tissue cover 212 and the body part 101.
As with the first embodiment, the material 122 may be applied and dressed over an external portion 428 of the first tissue cover 212 abuttingly adjacent to the flange 251, as well as over the second tissue portion 104. In this embodiment, this external portion 428 constitutes a part of the outside of the first tissue cover 212, while preventing interference with at least the ports 258 and 210. The second tissue cover 430 comprises an inner peripheral portion 439 that is configured for being adhesively sealed onto the outside of the first tissue cover 212, over an area 427 not covered by the generally annular sealant layer 420.
In this embodiment, the second tissue cover 430 and the first tissue cover 212 (or at least the flange 434 thereof) is generally compliant such that it may conform to the shape of the surface of the body part 101 on which it is to be used.
As with the first embodiment and variations thereof, mutatis mutandis, the device 400 may also be provided as a kit, comprising the slave pump head 244 integrated with a first tissue cover 212, the sealant material 122 comprised in a suitable container such as a tube, and the second tissue cover 430, and optionally sealing tape and wound packing materials.
Referring to
A reciprocating mechanism 248, is provided for converting the rotary drive of the motor 239 to reciprocating motion of rod 20, although in other variations of the first embodiment of the invention, the powered drive of the powered pump apparatus 240 may comprise a linear motor, for example, for providing reciprocating motion optionally controllably variable in speed.
The drive unit 239 is coupled to primary pump 249, which in this embodiment is in the form of a piston pump (although in variations of this embodiment, a diaphragm pump may be used instead), to provide a master pump chamber 223 having a variable pumping volume Q, and the second part 257 of device 400 comprises a port 258 that provides fluid communication between the actuation chamber 211 and the powered pump apparatus 240, in particular the master pump chamber 223, via a conduit 218 or the like having internal volume R.
The pumping volume Q, volume S and the internal volume R together define a control volume T of working fluid that couples the piston 222 with the barrier member 215. Typically, the working fluid is air, and thus the control volume T pneumatically couples the master pump chamber 223 with the actuation chamber 211.
Thus, as the motor 239 operates and drives reciprocation of the piston 222, a corresponding pulsating flow is set up in the control volume T, alternately increasing and decreasing the volume of the actuation chamber 211, which in turn respectively decreases and increases the volume P of slave pump chamber 229, providing a periodic suction force in the volume V via the first tissue cover 212.
The control volume T is in fluid communication with at least one pressure sensor or transducer 216, or other suitable air pressure measuring device, for monitoring the pressure therein, operatively connected to the control system 300.
In the illustrated embodiment, a waste container 231 is accommodated in housing 241, and may be selectively removed therefrom for disposal, for example, optionally while still connected to the device 400 via conduit 219 coupled to exit port 210. The container 231 defines a collection volume adapted for collecting waste materials, particularly liquids and other flowable materials, from the damaged tissue 102 to which the system 500 is coupled. Concurrently with removal of the container 231 is the disconnection of conduit 218 from the drive unit 240. In alternative variations of the embodiment, the waste container 231 may be attached to the housing 241, or alternatively unattached thereto, and in any case positioned at any point between the pump head 244 and the housing 241.
A controllable pressure venting arrangement may be provided, comprising a solenoid 457 coupled to a valve 459 that serves to selectively vent the control volume T to the atmosphere when desired. For example, the controllable pressure venting arrangement may be used for synchronizing pump head 244 with the primary pump 249. Alternatively, such synchronization may be achieved by providing a controlled leakage outlet in the master pump chamber 223, which may also allow for controlling the pressure induced at the actuation chamber 211.
Thus, a number of embodiments have been disclosed, in which a device is provided for providing a vacuum to a tissue, for example for facilitating treatment of tissue that is damaged tissue, including: a first tissue cover for covering the damaged tissue and having first peripheral portion with a tissue facing contact surface adapted to be sealingly affixed to a first tissue portion surrounding the damaged tissue, the device being adapted for enabling a vacuum to be selectively applied to the damaged tissue in operation of said device; a substantially contiguous layer of flowable sealing material configured for covering a second tissue portion abuttingly adjacent at least a part of the first peripheral portion, wherein the sealing material is configured for filling gaps between said contact surface and said first tissue portion that may form leaks, by flowing towards said contact surface under suction provided when said vacuum is applied to the damaged tissue in operation of the device, and wherein said sealing material is uncoupled with respect to said contact surface at least prior to affixing said contact surface to said first tissue portion; and a second tissue cover covering at least said layer. The device may be provided in the form of a kit. A system and method including the device are also provided.
In the method claims that follow, alphanumeric characters and Roman numerals used to designate claim steps are provided for convenience only and do not imply any particular order of performing the steps.
It should be noted that the word “comprising” as used throughout the appended claims is to be interpreted to mean “including but not limited to”.
While there has been shown and disclosed example embodiments in accordance with the invention, it will be appreciated that many changes may be made therein without departing from the spirit of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0811457.1 | Jun 2008 | GB | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL09/00618 | 6/23/2009 | WO | 00 | 12/17/2010 |
