Various embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:
FIG. 1 is an illustration of an operating environment in accordance with a preferred embodiment of the invention;
FIGS. 2A and 2B are illustrations of preferred embodiments of operating enclosures comprising different numbers of rigid panels;
FIGS. 3A to 3F illustrate the preferred operating enclosure in various stages of its construction;
FIGS. 4A to 4C illustrate the preferred operating enclosure as it is unfolded ready for inflation;
FIGS. 5A and 5B illustrate embodiments of preferred operating enclosures comprising flat windows and curved windows;
FIGS. 6A to 6C illustrate a portion of a preferred operating enclosure comprising support folds;
FIG. 7 illustrates a preferred operating enclosure attached to a patient and ready for use;
FIG. 8A illustrates a preferred operating enclosure comprising side compartments for attaching entrance/exit ports and FIGS. 8B and 8C illustrate methods of attaching entrance/exit ports to the side compartments;
FIG. 9A illustrates a preferred embodiment of a glove carrier comprising a finger compartment on the exterior surface;
FIG. 10 illustrates a preferred embodiment of a peripheral enclosure;
FIG. 11 illustrates a preferred embodiment of an operating dock or drape; and
FIG. 12 illustrates a preferred embodiment of an operating dock or drape comprising a sponge impregnated with a bactericidal substance.
FIG. 1 shows an example of the apparatus which may be used to operate on a patient 2. The apparatus may comprise a sterile enclosure 1, an operating dock/drape 3, one or more entrance/exit ports 4 at which the operating team may access the enclosure 1 and one or more glove carriers 5 and peripheral enclosures 6.
In use the operation dock/drape 3 may be placed over or fixed to the region of the patient 2 at which the incision is intended to be made. The sterile operating enclosure 1 may then be attached to the operation dock/drape 3. Various attachments such as peripheral enclosures 6 and entrance/exit ports 4 may then be fixed to the operating enclosure 1. The operating enclosure 1 preferably consists of a flexible membrane and two or more rigid or semi-rigid panels and will be described in more detail below. The operating enclosure 1 is preferably inflatable and can be inflated before or after it has been attached to the operation dock/drape 3. The operating enclosure 1 may also comprise a gas entry port 7 which may be supplied with a gas to inflate the enclosure 1 and/or to circulate gas within the enclosure 1 during use. The gas supplied to the gas entry port 7 is preferably a sterilised gas such as air or a bactericidal gas. The composition of the gas may also be selected so as to control physiological parameters, for example, temperature or fluid balance.
FIGS. 2A and 2B show preferred embodiments of the operating enclosure 1′,1″. The operating enclosure 1,1″ comprises a flexible membrane comprising at least a pair of rigid or semi-rigid panels 13 which are pivotable in relation to each other and which may extend along the length of the operating enclosure 1′ as shown in FIG. 2A. In the embodiment shown in FIG. 2B the operating enclosure 1″ comprises three rigid or semi-rigid panels 13. At least one of the panels 13, more preferably all of the panels 13, are transparent and serve as windows to see into the operating enclosure 1′,1″. The operating enclosure 1′,1″ may be supported by maintaining the gas inside it at a pressure above atmospheric pressure. Alternatively, or in addition, the operating enclosure 1′,1″ may be partially or completely supported by the rigid panels 13 and/or by a support frame.
In a preferred embodiment, the window panels 13 need not extend continuously along the entire length of the operating enclosure 1. Preferably, two or more panelled sections 13 are provided on each side of the enclosure 1. The provision of multiple shorter window panels 13 on each side of the operating enclosure 1 enables it to flex longitudinally such that when the operating table or patient 2 is elevated or lowered the operating enclosure 1 is not undesirably distorted, broken or pulled away from the patient 2.
FIGS. 3A to 3F show schematics of the various steps in the construction of the preferred operating enclosure 1. FIG. 3A shows a plan view of the upper 10 and side 12 portions of the enclosure 1 in a completely unfolded state. Preferably, the upper 10 and side 12 portions of the operating enclosure 1 are formed of a flexible membrane. The window panels 13 may then be attached to the upper 10 and/or side 12 portions of the enclosure 1. The window panels 13 may be attached to the enclosure 1 by robotically controlled infra-red laser welding or by any other conventional means. Preferably, the windows 13 are attached to the enclosure 1 by an adhesive region 9 at the outer edge of the windows 13. The adhesive region 9 is preferably approximately 1 cm in width. Most preferably, the window panels are arranged in co-operating pairs along the length of the enclosure 1, each window 13 in a pair being pivotable with respect to each other. The windows 13 in each pair may be hinged together but are preferably pivotable as they are slightly spaced apart on the enclosure 1 with a region of flexible membrane between them, for example spaced apart by 2 cm. The pairs of windows 13 are also preferably spaced apart from each other along the length of the enclosure 1, for example by 8 cm. This region of flexible membrane between the pairs of windows 13 enables the enclosure 1 to flex longitudinally and hence accommodate elevation of the patient 2 without it being broken or pulled away from the patient. In the preferred embodiment, the membrane of the upper 10 and side 12 portions of the enclosure 1 is substantially transparent, although the portions of the membrane beneath the window panels 13 may be removed before or after the windows 13 are attached.
FIG. 3B shows a plan view of the upper 10 and side 12 portions of a preferred operating enclosure 1 in an embodiment where side compartments 14 have been attached to the outer surface of the side portions 12 of the enclosure 1. These side compartments 14 are provided to assist in the attachment of entrance/exit ports 4 to the enclosure 1 and will be described in more detail below. The side compartments 14 are preferably provided on the side portions 12 of the enclosure 1 below the window panels 13. The side compartments 14 may be attached to the enclosure 1 at approximately 34 cm from the longitudinal centre line.
FIG. 3C shows a plan view of the upper 10 and side 12 portions of a preferred operating enclosure 1 in an embodiment wherein structural support rods 15,15a,15b have been provided on the enclosure 1. In use, the support rods 15,15a,15b serve as a frame to support the enclosure 1 once it has been inflated. In the illustrated embodiment four support rods 15a are provided parallel to and just below the window panels 13. These support rods 15a may be positioned approximately 35 cm from the longitudinal centre line of the enclosure 1 and when the enclosure 1 is constructed for use the support rods 15a extend between the two side portions 12 of the enclosure 1. Further support rods 15b may be provided on each side portion 12 of the enclosure 1 to maintain the structure of the enclosure 1 when in use. Any number, configuration and length of support rods 15,15a,15b may be provided on the enclosure 1 to give the desired support frame.
In another embodiment, the support members comprise inflatable means. As described above in relation to the support rods 15,15a,15b any number, configuration and length of inflatable support members may be provided on the enclosure 1 to give the desired support frame. Advantageously the inflatable support members do not interfere with the folding of the enclosure 1 when deflated and therefore provide an enclosure 1 which can be folded more compactly and hence is more convenient to store and transport. In a particularly preferred embodiment a single, continuous inflatable support member may be provided which when inflated provides a support frame for the entire enclosure 1.
FIG. 3D shows a view of one of the upper 10 and side 12 portions of the enclosure 1 at a stage where the lower portion of the enclosure 1 is attached. A flexible membrane may be arranged in facing relationship to the inner surface of the upper 10 and side 12 portions of the enclosure 1. The flexible membrane is then preferably attached to the peripheral region of the upper 10 and side 12 portions of the enclosure 1 as shown by the dashed line 16. The flexible membrane may further be attached to the side portions 12 of the enclosure 1 as shown by the broken dashed line 17 in order that the lower surface of the enclosure 1 maintains a desirable configuration in use. Preferably, this attachment region 17 is intermittent and may be provided approximately 15 cm inward of the peripheral attachment 16.
FIG. 3E shows the completed enclosure 1 in a configuration where the lower portion 18 of the enclosure 1 which contacts the patient 2 in use has been folded up between the upper 10 and side 12 portions of the enclosure 1.
FIG. 3F shows a side view of the enclosure 1 in an embodiment having support rods 15,15a, 15b which act as a frame when the enclosure 1 is inflated. The number, arrangement and length of the support rods 15,15a,15b and window panels 13 can be selected so that the enclosure 1 can fold into any desired compact configuration.
FIGS. 4A to 4C show a preferred operating enclosure 1 comprising two pairs of window panels 13, the adjacent window panels 13 being hinged or pivotable with respect to each other. FIG. 4A shows the preferred operating enclosure 1 in its folded, compact configuration. The windows 13 in each pair are pivotable relative to each other about the apex of the operating enclosure 1 and about a transverse axis so that they can be folded into a condition lying one above the other. In this configuration the side 12 and lower 18 portions of the operating enclosure 1 have been folded up between the pairs of window panels 13. In embodiments where the side portions 12 of the enclosure 1 comprise support rods 15,15a,15b then these may be arranged and sized such that they may also be folded between the pairs of window panels 13. In this embodiment the pairs of window panels 13 are slightly spaced apart and/or hinged together so that the enclosure 1 may be folded longitudinally in order to reduce the length of the enclosure 1. As such, it can be seen that the preferred enclosure 1 provides for convenient carrying and storage.
FIG. 4B shows the preferred enclosure 1 when it has been unfolded to its full length. Once the enclosure 1 has been unfolded to its full length it may be expanded such that it is suitable for use. This may be achieved, for example, by inflating the enclosure 1. Alternatively, the process of inflating the enclosure 1 may unfold it to its full length. Preferably, the inflated length of the enclosure 1 is approximately 130 cm. However, the folded enclosure 1 may be much smaller, for example, 65 cm in length.
FIG. 4C shows a preferred embodiment in which the enclosure 1 is provided with a container of compressed gas 19, for example CO2 or air, which may be released into the enclosure 1 to inflate it. Alternatively, gas may be supplied to the enclosure 1 at a pressure above atmospheric pressure through an inlet port 7. The gas may be sterilised or contain a bactericidal agent to sterilise the enclosure 1. Inflation of the enclosure 1 causes the lower 18 and side 12 portions of the enclosure 1 folded between the window panels 13 to expand. The rigid window panels 13 automatically pivot away from each other as the enclosure 1 inflates such that it expands to the desired shape. The enclosure 1 may be maintained in its expanded state by maintaining the pressure of the gas inside the enclosure 1 above atmospheric pressure and/or by a support frame. The enclosure 1 may be attached to a conventional support frame although preferably support members are provided on the enclosure 1. The support members may be interconnected to support the expanded enclosure 1.
Once the enclosure 1 is expanded sterile air or gas may be circulated within it. The air or gas may have a bactericidal substance added to it in order to maintain sterility of the enclosure 1. The gas or air may also be continually recirculated through a sterilising filter. A pump and filter arrangement may therefore be attached to the operating enclosure 1 for this purpose.
FIGS. 5A and 5B show embodiments of the enclosure 1′,1″′ after inflation and having flat and carved window panels 13 respectively. In these embodiments rigid support rods 15 (as shown in FIG. 3C) are provided on the side portions 12 of the enclosure 1 and may be interconnected after inflation to provide a support frame for the enclosure 1.
FIGS. 6A to 6C show a portion of a preferred embodiment of the enclosure 1. As shown in FIG. 6A, the upper portions 10 of the enclosure 1 may be connected together by a foldable material 20. When the enclosure 1 is in its folded, compact configuration the material 20 which connects the upper portions 10 of the enclosure 1 may be folded between the panels 13. FIG. 6B shows how the material 20 may be unfolded before or during inflation of the enclosure 1. The material 20 may further comprise relatively rigid portions 21 which may remain folded between the panels 13 until the enclosure 1 is ready to be used. The rigid portions 21 are preferably provided attached and extending from the lower edges of the material 20 and the lower edges of the upper portions 10 of the enclosure 1. FIG. 6C shows the relatively rigid portions 21 in their unfolded state. The ridged portions 21 may be unfolded before or after inflation of the enclosure 1 and provide means for stabilising the enclosure 1 structure when unfolded and/or may provide legs for the enclosure 1. Preferably, the rigid portions 21 when unfolded are biased outwardly to maintain the enclosure 1 in its unfolded configuration.
FIG. 7 shows a cross-section through an embodiment of the operating enclosure 1 when in place over a patient 2. It can be seen that in this embodiment the lower side regions of the enclosure 1 may over-hang the sides of the patient 2. This portion of the enclosure 1 may also overhang the operating table and may provide a region 22 into which waste material may be stored.
In use various interfaces and/or ports 4 may be connected to the operating enclosure 1, for example, entrance/exit ports 4 for the surgeon or operating team and peripheral enclosures 6 containing gases, fluids or instruments and tools.
FIGS. 8A-8C show an embodiment in which side compartments 14 are provided on the enclosure 1. Referring to FIG. 8A, the side compartments 14 preferably comprise a rupturable, flexible material which may be single or double folded to defined pleats which enable easy attachment of entrance/exit ports 4. FIGS. 8B and 8C show how the one or more folds in the side compartments 14 enable the entrance/exit ports 4 to be attached relatively easily with one hand whilst applying a counter-pressure with the other hand. The interior of the compartment is sterile, and the entrance/exit port 4 is provided with a bactericidal adhesive to secure it to the compartment surface, whereby sterility can be maintained when the membrane defining the compartment which is engaged with the entrance/exit port 4 is severed to provide access to the interior. The membrane wall on the interior of the compartment can then be severed to gain access to the operating enclosure without contaminating it.
In order to perform operations inside the enclosure 1 one or more, and usually at least two, glove carriers 5 are attached to the outside of the enclosure 1. However, it is often difficult for a user to fit such glove carriers over both hands. In particular after the first glove carrier has been fitted on one hand it obstructs that hand fitting a glove carrier over the other hand.
FIG. 9 shows an embodiment of a preferred glove carrier 5 before it has been attached to the enclosure 1. Glove carriers 5 comprise a glove portion 25 and an enclosing membrane 26 which extends from the cuff of the glove portion 25 and around the outside of the glove portion 25 to form the glove carrier 5. Thus, a surgeon is free to put his hand into the glove portion 25 whilst the eventual outer surface of the glove portion 25 remains sealed and sterile. The enclosing membrane 26 of the glove carrier 5 preferably comprises at least one exterior thumb and/or finger compartment 27 protruding from the outside of the glove carrier 5. This exterior compartment 27 assists the user in fitting a pair of glove carriers 5 over both hands.
In use, after one hand has been fitted into the glove portion 25 of a first glove carrier 5, the user may extend their thumb and/or any number of fingers into the one or more exterior compartments 27 of the first glove carrier 5. In this manner the user is able to use their first hand to grip the second glove carrier 5 between the exterior compartments 27 or between exterior compartment 27 and the enclosing membrane 26 of the first glove carrier 5. As such, once one hand of the user has been fitted with a first glove carrier 5 it is relatively easy for the user to use that hand to assist the fitting of a second glove carrier 5 on the other hand. Furthermore, the exterior compartment(s) 27 of the second glove carrier 5 also provide a portion which can be gripped to help pull the second glove carrier 5 over the second hand. The exterior compartments 27 also enable the user to perform other actions whilst wearing the glove carriers 5, for example, picking up objects or sterilising surfaces outside of the enclosure. At this stage the eventual outer surface of the gloves (which will eventually contact the patient) remain sterile.
It is contemplated herein that any number of exterior compartments 27 for the fingers or thumb of the user may be provided on the exterior surface of the glove carrier 5.
The glove carriers can then be attached to the enclosure 1, or to one of the side compartments 14, at a forward attachment region 28 distal from the cuff or proximal to the fingers of the glove portion 25, and the user may then enter the enclosure 1. At this point the fingers and thumbs of the user must be retracted from the exterior compartments 27 such that the hand can pass through the attachment region 28 and hence enter the enclosure 1 with the glove portion 25 acting as a barrier between the hand and the atmosphere of the enclosure 1.
The attachment region 28 of the glove carrier 5 preferably comprises an initially sealed opening surrounded by an adhesive or adhesive tape, impregnated with a bactericidal substance. The opening may be sealed e.g. with a rupturable membrane (not shown) and the adhesive tape may have a removable backing tape (not shown) over it. Once the membrane is ruptured, the hand and glove can be moved into the enclosure with the glove surface remaining sterile. In addition, this end of the glove carrier 5 may be provided with a resealable seal inwardly of the opening such that the opening can be resealed once the membrane has been broken. Hence the glove carrier 5 could be detached from the enclosure if necessary without compromising the sterility of the glove portion 25.
In order to perform the operating procedure it may be necessary to enter various sterile objects into the operating enclosure 1. These objects may be contained in and kept sterile by a peripheral enclosure 6 which may be attached to the operating enclosure 1 at any stage. The surfaces between the operating 1 and peripheral 6 enclosures may then be cut through to gain access to the objects.
FIG. 10 shows an embodiment of a peripheral enclosure 6. The peripheral enclosure 6 comprises a container region 29 which may be a flexible tubular sack and a joining region. The portion of the peripheral enclosure 6 which is circled shows an enlarged view of the joining region. Preferably, the joining region comprises a protective layer 30 and a sterilising layer 31. In order to attach the peripheral enclosure 6 to the operating enclosure 1 the protective layer 30 is removed. The peripheral enclosure 6 may then be joined to the operating enclosure 1 in the region of the sterilising layer 31.
The sterilising layer 31 is intended to maintain the joining region of the peripheral enclosure 6 and any of its contents sterile during its attachment to the operating enclosure 1. In one embodiment, the sterilising layer 31 comprises a sponge layer which is impregnated with a bactericidal agent, for example, iodine. Alternatively, or in addition, the sterilising layer may comprise a film preferably having a bactericidal substance on the surface which in use contacts the enclosure 1. The joining region may further comprise an adhesive or bactericidal adhesive for attaching the peripheral enclosure 6 to the operating enclosure 1. These adhesives may be provided around the periphery of the joining region. In this embodiment the region of contact between the peripheral enclosure 6 and operating enclosure 1 is sterilised during the attachment of the peripheral enclosure 6, i.e. by the bactericidal substance impregnated in the sponge and/or film layer and/or adhesive. Once the peripheral enclosure 6 and operating enclosure 1 are attached the region of join or the region within the joined portions may be cut through in order to gain access to the peripheral enclosure 6. In this manner tools, instruments organs or any other objects may be removed from or introduced into the peripheral enclosure 6.
In one embodiment the peripheral enclosure comprises a flange portion 32 which extends radially outward from the container portion 29 in the joining region of the peripheral enclosure 6. The flange portion 32 may be a relatively rigid material and is preferably provided with the adhesive or bactericidal adhesive. In this embodiment the sponge and/or film having a bactericidal agent may seal an opening in the end of the container region 29 inward of the flange portion 32.
In order to perform an operation, an operating enclosure 1 is preferably attached to the patient 2 via an operation dock/drape 3. In use, the area around the incision that is intended to be made to perform the operation is prepared by treating it with a bactericidal substance. As quickly as possible, an operation dock/drape 3 is then placed over the area such that it covers the intended incision region. The incision area is thus isolated and should remain sterile. The enclosure 1 may then attached to the operation dock/drape 3.
FIGS. 11A and 11B show preferred embodiments of an operation dock/drape 3,3′. Referring to FIG. 11A, the operation dock/drape 3 may be formed from a docking layer which has a bactericidal adhesive on at least a portion of both the lower and upper surfaces which in use contact the patient 2 and operating enclosure 1 respectively. Most preferably, the bactericidal adhesive is provided on the lower side of the operation dock/drape in the area which in use covers the area of the patient 2 where the incision is to be made. The bactericidal adhesive is also preferably provided on the corresponding portion of the upper surface of the operation dock/drape 3 above the intended area of incision. In this manner the operating enclosure 1 may be fixedly attached to the patient 2 via the operation dock/drape 3 whilst simultaneously sterilising the surfaces therebetween. Thus, when it is desired to make the incision in the patient the wall of the operating enclosure 1, the operating dock/drape 3 and the patient 2 may be cut through without rendering the incision area of the patient 2 susceptible to infection.
In one embodiment, the docking layer may be relatively rigid and may have an opening which in use is placed over the intended incision area of the patient 2. In the preferred embodiment the opening preferably comprises a sponge 35 impregnated with a bactericidal substance. The opening in the docking layer may alternatively, or in addition, be covered by one or more film layers for example, a film layer may be provided on the upper and/or lower surface of the docking layer to cover the opening or sponge 35. The film layer may also be provided with a bactericidal substance. In this embodiment, in use, the sponge 35 or film layer(s) may serve to sterilise the region of contact between the operation dock/drape 3 and the patient 2 where the incision is intended to be made and the corresponding region of the operating enclosure 1.
FIG. 11B shows an enlarged portion of the outer region of an embodiment of an operation dock/drape 3 wherein the outer region comprises separate docking 36 and patient 37 layers. In use the docking layer 36 is attached to the operating enclosure 1 and is preferably a relatively rigid material and the patient layer 37 is adhered to the patient 2 and may comprise a flexible drape material. This embodiment enables the operation dock/drape 3 to provide a rigid docking layer 36 for providing stable attachment of an enclosure 1 whilst also providing a lower flexible patient layer 37 which readily conforms to the patient 2. Accordingly, the enclosure 1 is able to move or flex slightly relative to the patient 2 without pulling the patient layer 37 away from the patient 2. As such, the external atmosphere is prevented from contaminating the incision region of the patient 2.
Preferably, the upper and lower surfaces of the operation dock/drape 3 are provided with protective covering layers (now shown) which are removed prior to attachment to the patient 2 and operating enclosure 1.
FIG. 12 shows another embodiment of a preferred operation dock/drape 3′ similar to that described above in relation to FIG. 11A. In this embodiment the operation dock/drape 3′ comprises an upper cover 38, a disinfecting layer 39, a layer having an opening 40 and an lower cover 41. In use the lower protective cover 41 may be removed and the operation dock/drape 3′ placed on the patient 2 with the opening in layer 40 arranged over the intended area of incision. The inner region of the disinfecting layer 39 preferably comprises a sponge 35′ impregnated with a bactericidal substance. In use the sponge 35′ protrudes through the opening in layer 40 and contacts the intended incision region of the patient 2 to sterilise that area. Once attached to the patient 2 the upper cover 38 may be removed. Preferably, an operating enclosure 1 is then attached to the operation dock/drape 3′. Preferably, at least part of the disinfecting layer 39 serves to sterilise the portion of the operating enclosure 1 which is directly above the intended incision region. Once the operation dock/drape 3 is attached to the patient 2, the enclosure 1 and operation dock/drape 3′ may be cut through to gain access to the incision region. In the preferred embodiment, this entails cutting through the sterilising sponge to communicate the operating environment with the patient 2.
It is also contemplated herein that the operation dock/drape 3′ may be attached to the operating enclosure 1 prior to being attached to the patient 2. In this method the lower cover 41 remains attached to the layer having the opening 40 until immediately prior to connecting the operation dock/drape 3′ and enclosure 1 to the patient 2.
Although the present invention has been described with reference to preferred embodiments and arrangements described for illustrative purposes only, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the scope of the invention as set forth in the accompanying claims.
Patent Application
20080041399
