Exemplary embodiments of the present invention relate to a portable surgical system for regulating intra-operative environments over surgical sites and to methods for implementing and using the same.
Over 25% of the global disease burden requires surgical therapy, which could prevent over 18 million deaths per year. These range from obstetric complications to traumas to infections to cancer and beyond. Yet 2 billion people have no meaningful access to safe surgical care, and 2-3 billion more have access only to unsterile surgeries in contaminated environments, leading to disproportionate rates of surgical infections. Innovations in this field typically focus upon making operating rooms and operating room ventilation systems more mobile, such as in tent format. However, such systems remain costly to purchase and to maintain. Moreover, such systems are difficult to transport rapidly to remote areas. At the same time, over 85,000 medical providers are infected by patient bodily fluids annually, with 90% of infected providers worldwide having been exposed while working in low-resource settings. While personal protective equipment mitigates these risks to some extent, there is a definite trade-off between the level of protection and both the cost as well as the user comfort, which is well-documented to correspond to user compliance.
Exemplary embodiments of the present invention aim to address both challenges of patient and provider intraoperative exposure to infectious risks and airborne particulates by implementing an ultraportable, self-contained, passive and active, bilateral barrier against exchange of contaminants between incisions and the greater surgical area.
The above information disclosed in this Background section is only for enhancement of understanding of the background of the invention and therefore it may contain information that does not form any part of the prior art.
Exemplary embodiments of the present invention provide a portable surgical system for regulating intra-operative environments over surgical sites. The portable surgical systems disclosed herein address both challenges of patient and operator intraoperative exposure to infectious risks. Additionally, the portable surgical systems herein protects both patient and operators from exposure to fluids (e.g., blood, and other bodily fluids) and airborne particulates (e.g., dust in the environment, spores, viruses, bacteria) incident to the surgical procedures.
The surgical system ensures that the surgical site is kept sterile by preventing contaminants from the outer environment (i.e., outside of the surgical enclosure) from reaching the surgical site. Also, the surgical system is configured to ensure that contaminants on other areas of the patient body are not reaching the surgical site. The surgical system provides a barrier protecting operators from exposure to contaminants (e.g., blood) generated during the surgery inside the enclosure. The portable surgical system may be used to perform surgery in environments other than operating rooms, such as in the field, outdoors, tents, cottages, residential rooms, etc.
The portable surgical system may include a flexible surgical enclosure configured to be attached to the body of a patient. The enclosure may include an incise-drape configured to be disposed on the torso of the patient so as to cover a torso-surgical-site of the patient if surgery is needed on the torso-surgical-site. The enclosure may further include a patient-limb-port configured to enable the patient to insert an arm or a leg into the enclosure so that a limb-surgical-site is disposed inside the enclosure if surgery is needed on patient's arm or leg.
The enclosure may further include one or more arm-ports and arm sleeves enabling an operator to access and to perform surgery on the torso-surgical-site or on the limb-surgical-site disposed inside the enclosure. The enclosure may further include one or more transparent layers enabling the operator to view the torso-surgical-site or the limb-surgical-site during the surgery. The surgical enclosure may include an adhesive-surface disposed around the incise-drape and attached to the patient around the surgical-site so as to create a seal. Upon removal of the incise-drape the surgical-site of the patient becomes included in the inside of the enclosure and accessible by the operator from the inside of the enclosure whereas other surface areas of the patient are disposed outside the enclosure. The surgical enclosure may be sterilized by various known methods in the art, such as gamma sterilization, gas sterilization, UV sterilization, etc. The packaging of the surgical enclosure may be designed according to a wide variety of methods such as to preserve sterility of the enclosure. The incise drape may be designed by a variety of methods known to the art such as to preserve an airtight environment comprising of the inside of the enclosure and the now attached to the enclosure patient surgical site, such as adhesives, belts, Velcro attachments, etc.
The surgical enclosure may include a fluids-reservoir configured to collect the unwanted blood and fluids generated in the enclosure during surgery. The fluids-reservoir is disposed on the lower part of the enclosure and may be made as a fold of the enclosure material. The fluids reservoir may comprise fill sensors as well as rulers or other visual measuring aids to indicate to the operator the amount of fluid lost during surgery. This may indicate blood loss during the procedure. The fluids-reservoir may also be used to improve visibility during the use of the surgical enclosure as unwanted fluids accumulate in the reservoir as opposed to remaining around the surgical site. The fluids-reservoir may be disposed in such a manner as fluid flow to be guided by gravity into the reservoir or actively managed such as through the use of a suction device that would dispose unwanted fluids into the reservoir in low-gravity environments. A suction line may be attached to the fluid reservoir through a controlled one-way valve system.
The portable surgical system may include an environmental control system configured to supply and control air flow and pressure inside the enclosure such as to ensure a sterile environment inside the enclosure and over the surgical sites. The environmental control system may include a fan, an air-filter, a pressure sensor configured to measure the pressure inside the enclosure, a control-system, and an air-tube disposed at least partially inside the enclosure. The air-tube is configured to receive air from the air-supply-system. The air-tube may include one or more outlets disposed inside the enclosure and configured to generate air-flow over the surgical site. The control-system may be configured to receive a series of pressure readings from the pressure sensor and to control the air pressure and air-flow in the enclosure to desired values. The control system may include one or several microprocessors with programs customized to maintain desired pressure, airflow, temperature, or other environmental parameters in the enclosure through sensor control loops. The control system may include one or several pressure control loops, one or several temperature control loops, one or several humidity control loops, and one or several air-flow control loops. In the latter case, the control system may maintain a different pressure in an inflatable frame that supports the environment control system than the pressure inside the surgical enclosure. The control system may adjust based on the environment parameters outside of the enclosure, such as through differential pressure, temperature, and airflow sensors that would maintain desired parameters inside the surgical enclosure environment irrespective of the outside temperature, pressure, and wind speed. This control system may mitigate outside environment conditions such as use at high altitude, use in low temperature conditions, or windy conditions, to name a few scenarios.
The surgical system may include a frame attached to the flexible surgical enclosure. The frame is configured to provide stability to the flexible surgical enclosure without obscuring the visibility through the surgical enclosure. The frame is configured to provide a tension over an axial length of the enclosure and to create inside the enclosure an operating volume enabling operators to perform surgery on the surgical sites. The frame may have a loop shape including two rigid spacer-segments interspaced by two flexible tensioner-segments. The tensioner-segments are configured to bend so that the frame assumes essentially a saddle shape. While deployed for operation, the flexible enclosure attached to the frame acts on the frame so as to keep the frame into the saddle shape which includes bent tensioner-segments. The enclosure may be attached to the frame via a plurality of attachment-means of adjustable length. The width and other dimensions of the enclosure may be adjusted by adjusting the length of the attachment-means. The frame may include a plurality of segments where at least some of the segments of the frame are configured to have adjustable lengths so that an operator can adjust the dimensions of the frame by adjusting the lengths of the segments.
The portable surgical system may further include one or more lights configured to illuminate the surgical-site and one or more cameras configured to image the surgical-site. The one or more lights may be LED strip lights disposed on the enclosure or incorporated into the enclosure.
The surgical system is configured to be used for performing surgery outdoors (e.g., wounded soldiers in the field, inhabitants of remote regions, rescue operations in wilderness, etc.) and in environments which lack the sterility of hospital operating room (e.g., tents, cottages, residential rooms, non-operating rooms in hospitals, etc.). The surgical system is configured to be portable, light, ergonomic and easy to install. The surgical system may be configured to be packed into a portable bag (e.g., backpack) so as to be easy to carry in the field.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with the description serve to explain the principles of the invention.
The invention is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure is thorough, and will fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity. Like reference numerals in the drawings denote like elements.
The following detailed description is provided to gain a comprehensive understanding of the methods, apparatuses and/or systems described herein. Various changes, modifications, and equivalents of the systems, apparatuses and/or methods described herein will suggest themselves to those of ordinary skill in the art. Descriptions of well-known functions and structures are omitted to enhance clarity and conciseness.
It will be understood that when an element or layer is referred to as being “on” or “connected to” another element or layer, it can be directly on or directly connected to the other element or layer, or intervening elements or layers may be present. In contrast, when an element or layer is referred to as being “directly on” or “directly connected to” another element or layer, there are no intervening elements or layers present. It will be understood that for the purposes of this disclosure, “at least one of X, Y, and Z” can be construed as X only, Y only, Z only, or any combination of two or more items X, Y, and Z (e.g., XYZ, XY, YY, YZ, ZZ).
The configuration of an exemplary embodiment of a portable surgical system is described hereinafter with reference to
The surgical enclosure is configured to be disposed over the body of a patient 4 such that one or more operators 5 (e.g., a surgeon, a nurse, etc.) can access and perform a surgical procedure, from the inside of the enclosure, on a planned surgical-site 7 of the patient, such as on the abdomen, on the chest, on the back, etc. (see
The enclosure may further include one or more incise drapes configured to be removed prior to performing the surgical procedure so that the user can access the operating-field. The enclosure may include an adhesive-surface configured to be adhered to the patient 4 so as to encompass the surgical-site 7 of the patient during the operation. The adhesive-surface of the enclosure may encompass the one or more incise-drapes of the enclosure so that, after the enclosure is attached to the patient, the one or more incise-drapes can be removed thereby exposing the surgical-site from the inside of the enclosure. This way the operators will be able to access and operate on the surgical site from the inside of the enclosure.
The surgical enclosure is configured to be supplied with air, via the environmental control system 3, so as to form an inner sterile space/environment enclosed by the enclosure above the operating-filed, thereby enabling the user (e.g., a surgeon) to perform surgery in a sterile environment. The surgical enclosure may be configured to be supplied with air under positive pressure. The portable surgical system may be configured such that filtered air is blown into the enclosure.
The enclosure 1 integrates arm ports 6 to allow access to the inside of the enclosure by either operator arms or augmenting instrumentation taking the place of arms such as laparoscopes or robots. Material ports which can be repeatedly opened and closed are used to maintain enclosure environmental integrity but allow the passing of anatomical specimens, instruments, and other materials into and out of the enclosure during a procedure. The surgical system may incorporate into the enclosure, and within proximity of the surgical-site, materials and instruments needed during the surgical procedure.
The enclosure may be attached to a frame 2 which is at least partially rigid. The frame is configured to provide support to the flexible surgical enclosure 1 and may cause the enclosure to assume a desired shape. The frame may be modular and may include rigid materials, such as plastic, rigid polyvinyl tubes, aluminum tubing, etc.
In an exemplary embodiment, the portable surgical system may not include a rigid frame such as frame 2. In an exemplary embodiment the portable surgical system may include one or more inflatable-beams or inflatable-structures configured to be inflated at a relatively high pressure so as to acquire relative rigidity and to provide shape and support to the enclosure. The inflatable-beams and inflatable-structures may be either incorporated into the flexible enclosure or may be attached to the enclosure.
The portable surgical system allows the operators to perform surgical procedures while keeping the surgical-site in sterile conditions by preventing contaminants from the environment and from the patient to reach the surgical site. At the same time the enclosure forms a barrier preventing biological materials generated during the surgical procedure (e.g., blood) from exiting the enclosure and reaching the operators, thereby protecting the operators.
In an exemplary embodiment the surgical enclosure may be single use disposable enclosure. In an exemplary embodiment, prior to the set-up/deployment for operation, the surgical enclosure may be supplied folded, like a surgical gown, and packed so as to be easy to store and carry on the field.
Various features and configurations of the surgical enclosure are described hereinafter with reference to
The enclosure may include a top-part 10 consisting of the enclosure which may have approximately a semi-cylindrical shape and may incorporate both a top and the sides of the enclosure.
The top-part may comprise one or more top and side view regions or panels of transparent enclosure material including optically-clear plastic, such as polyvinyl chloride and/or thermoplastic polyurethane (TPU), so as to permit the operators to view inside the enclosure. In an exemplary embodiment the transparent enclosure material may be a thermoplastic polyurethane (TPU) of about 2 mil, or 4 mil, or 6 mil, or 8 mil, or 10 mil, or 12 mil thickness, or higher or other values as may be appropriate from a manufacturability, ease of use, visibility, flexibility, or other desirable material properties known in the art. The transparent enclosure material may be configured to have one or more of the following qualities: good resilience, abrasion resistance, hydrolytic stability and resistance to attack by microorganisms; durability (for puncture, tear resistance); clarity (for optimal viewing); and stickiness.
The remainder of the surgical enclosure may comprise a flexible, impermeable plastic, such as low-density polyethylene and/or opaque TPU. In an exemplary embodiment the reminder of the surgical enclosure material may be an opaque thermoplastic polyurethane (TPU) of about 2 mil, or 4 mil, or 6 mil, or 8 mil, or 10 mil thickness, or any other material thickness reasonable for manufacturability, visibility, and flexibility of the enclosure. The transparent enclosure material may be configured to have one or more of the following qualities: good resilience, abrasion resistance, hydrolytic stability and resistance to attack by microorganisms; stickiness (e.g., extremely low stickiness to facilitate airflow and prevent kinking in the tube), and durability (for puncture, tear resistance).
The enclosure may include a front-side 11 disposed proximate to the head of the patient (see
The enclosure may include a plurality of arm-ports 6 and sleeves 40 configured to enable operators to access the surgical-site. The surgical enclosure may further include one or more material ports configured to enable the moving of materials between the inside of the enclosure and the outside environment. The surgical enclosure may further include one or more line-ports configured to provide ongoing access for lines, tubes, wires, and drains requiring access to external resources (e.g., anesthesiology and breathing tubes, wires for medical devices, wires for sensors monitoring the patient).
With reference to
With reference to
Whereas for attachment 17a the frame portion has a straight cylindrical shape and the slab may conform neatly following the shape of the frame, the frame portion for attachments 17b and 17c may have a bent cylindrical shape on which a rectangular slab does not conform. The attachments 17b and 17c may be designed such as to conform to the bent shape of the frame in the upper front and back sides of the frame. It will be understood that various other attaching means may be used without changing the spirit of the invention.
In an exemplary embodiment of the invention each tensioner-segment of the frame may assume, substantially and approximately, the shape formed at the intersection between a hyperbolic paraboloid surface (such as the surface in
With reference to
It has been determined by the inventors herein that a tensioned saddle shape frame as described above provides an optimal shape to the surgical enclosure which translates into optimal operating conditions for the operators. This configuration allows for designing tensioned saddle shaped frames which are light-weight and portable (the frame uses reciprocal tension-constraint forces applied via spring constant rather than an otherwise necessary rigid frame).
With reference to
The shape of the flexible surgical enclosure 1 (e.g. configurations and distances between various parts of the flexible surgical enclosure) may be controlled via attachment-means such as 17. Multiple attachment-means may connect various sections of the flexible surgical enclosure 1 with various sections of the frame 2 such as to provide the desired form and shape of the enclosure. The shape of the surgical enclosure and tensions in the enclosure material may be further adjusted by adjusting the length of the attachment-means 17.
In an exemplary embodiment, the frame length “Lframe” and frame width “Wframe” (see
In an exemplary embodiment, the shape, volume and slack/tension in certain portions of flexible enclosure may be adjustable so as to fit patients of different sizes and different anatomical structures. For example, in the case of an adult patient having a broader than average chest, the width and/or slack of the bottom-side 13 may be adjusted (e.g., by adjusting the frame width and/or the length of the attachment means 17) so as to fit the chest. In the case of a young patient such as a child, the width and/or slack of the bottom-side 13 may be adjusted down (e.g., by adjusting the frame width and/or the length of the attachment means 17) such as to fit the patient.
In an exemplary embodiment, the bottom-side of the enclosure may include a material-fold 18 which may be deployed such as to provide different widths for the bottom-side 13 (see
With reference to
As described hereinafter with reference to
The inflatable-structure 25 may further include an inflation-port. An air/gas-source 29 (e.g., compressed gas cartridge, pump) may be attached to the inflatable-structure 25 via the inflation-port and may provide pressurized gas (e.g., CO2, Nitrogen, compressed air) to the inflatable-structure so as to create a relatively high pressure into the inflatable-structures. The inflatable-structures 25 may be configured to be inflated at significant higher pressures than the pressure inside the surgical enclosure 1. The inflatable-structures 25 may be made of flexible materials withstanding higher pressures than the enclosure material and more resistant to breaking (e.g., thicker plastic/polymer layers or textile layers). The inflatable-structures material may be a transparent material so as not to obstruct viewing inside the enclosure.
The gas source 29 may include a compressed gas cartridge or canister including pressurized gas such as CO2. The gas source 29 may provide pressurized gas generated via a chemical reaction between two or several compounds included in a container. Such a container could be attached directly to the frame and include multiple nesting containers which are designed to be rupturable and together comprise a compression-triggered mechanism to initiate a chemical reaction resulting in inflation. The gas source 29 may include an external air or gas pump. The gas source 29 may include a trigger-device configured to trigger the release of pressurized gas into the inflatable-structures 25 thereby autonomously and quickly inflating the inflatable-structures. The gas cartridge is configured to inflate the inflatable-structure to a desired inflatable-structure-pressure upon the activation of a trigger-device. The gas source 29 may include one or more pressure control devices for ensuring that appropriate pressure is created in the inflatable-structures 25 and for preventing overpressure in the inflatable-structures (e.g., pressure gauges, overpressure valves, regulators, shut-off valves). Pressurized gas cartridges have the advantage that they are small, light, easy to use, provide quick inflation at the desired pressure to the inflatable-structure.
In a deflated state the inflatable-structures 25 may collapse into a foldable flexible structure. As previously mentioned, prior to the set-up/deployment for operation the surgical enclosure 1 may be folded like a surgical gown. In the folded state, the inflatable-structure 25 may be folded together with the enclosure 1. Upon inflation of the inflatable-structure 25 at the desired pressure the inflatable-structure assumes the desired shape (e.g., saddle) and stretches the enclosure into the desired expanded operating shape for performing surgical procedures. The inflatable-structure will provide support to the walls of the enclosure and reinforce the enclosure into the desired shape.
The inventions herein are not limited by the particular shapes and configuration of the inflatable-structures. The skilled artisan would understand that various shapes, configurations and materials may be employed and are within the scope of the inventions.
The surgical-enclosure 1 may include a plurality of arm-ports 6 enabling the operators to access the surgical site from the inside of the enclosure as seen in
The enclosure may further include a plurality of sleeves 40 enabling the operator to access and operate on the surgical-site (see
It is understood that during surgery only some of the sleeves may be used by the operator(s) while some sleeves may not be used. The sleeves which are not in use during surgery may be folded and disposed (or attached) on the side of the enclosure such that the folded sleeves do not block the view of the surgical site, do not get in the way of the operators, and do not allow air flow through the sleeves between the inside and outside of the enclosure.
The material of the sleeves may be a two sided material: an inner side of the sleeve facing the arm and hand of the operator while in use by the operator; and an outer side of the sleeve facing towards the enclosure environment. The inner side of the sleeve may be configured to be comfortable on touch (e.g., soft, wicks up moisture). The outer side of the sleeve may be configured to be impermeable to fluids such as blood. The material of the sleeve may be a polyurethane laminate Spun Bonded Nonwoven. The sleeve material may have a thickness of about 2 mil, 4 mil, 6 mil, 8 mil, 10 mil, or other standard material thicknesses, as may be found appropriate for ease of use, comfort of operator, or manufacturability. The sleeve material may be a waterproof medical fabric. The sleeve material may be configured to have one or more of the following qualities: comfort; lack of permeability so as to prevent air/water from transferring between the patient and practitioner); and ease of attachment to the material of the enclosure).
The surgical enclosure may include one or more ports 33 disposed on the back-side 12 of the enclosure 1, as seen in
With reference to
With reference to
With reference to
Prior to use the two-layer port 80 may be substantially airtight sealed since the fine cut pattern 84 is airtight. The two-layer port 80 may be opened during operation by breaking the cross-cut pattern 84 along the fine cut pattern. An arm or a leg may be inserted into the enclosure 1 through the broken cross-cut-pattern 84 of the top-layer 83 and the hole 82 of the bottom-layer 81 (as seen in
The surgical enclosure may further include one or more material ports 15 configured to enable the moving of materials and instruments between the inside of the enclosure and the outside environment (as seen in
With reference to
The surgical enclosure may further include and one or more line-ports 16 configured to provide ongoing access for lines, tubes, wires, and drains of medical devices requiring access to external resources (e.g., anesthesiology and breathing tubes, wires for medical devices, wires for sensors monitoring the patient). As seen in
The first-layer 42 may include a series of circular-perforations 45. The second-layer 43 may include a series of cross-perforations 46 disposed essentially over the circular-regions 45, as shown in
Various lines (e.g., electricity wires, tubing, incubation lines, anesthesia lines, etc.) may be inserted into the enclosure from outside by, for example, penetrating/opening a circular perforation and its corresponding cross perforation. The line-ports 16 provide an easy and efficient way to insert tubes, lines, wires into the enclosure. At the same time the line-ports are ensuring a sufficiently tight seal between the lines/tubes and the layer materials 42-43 such as to provide the required barrier between the inner and outer environments and to ensure the required air sealing.
In exemplary embodiments of the invention, the surgical enclosure may include one or more fluids reservoirs 50, as described with reference to
The fluids reservoir may be made as a pocket or fold of the transparent enclosure material (e.g., they may be made from the same sheet as the transparent enclosure) so that the operators can view how much blood/fluids have been accumulated during the surgical procedure.
With reference to
With reference to
With reference to
The incise drape serves as the interface with the patient body. The size and shape of the incise drapes 60 may be configured to cover the surgical-site on the patient's body (e.g. the torso or the back) while essentially excluding body surface outside the surgical site. The surgical site on the torso may be referred hereinafter as a torso-surgical-site. Consequently, only the surgical site of the patient's body (i.e., area covered by the incise drape 60) is included within the surgical enclosure, while the remainder of the patient body is excluded from the surgical field (which may be kept as sterile as feasible). By excluding from the surgical enclosure the unnecessary body surface, the efficacy of the system is significantly improved since the patient's body surface contributes to environment contamination inside the enclosure. In particular, the exclusion of high-contaminant regions such as the oropharynx or the genitals is likely to significantly improve the efficacy of the system. The surgical enclosure may include one or more incise drapes of different shapes and sizes and may be disposed at different positions on the surgical enclosure such as to fit the needs of different types of medical procedures. The bottom of the surgical enclosure may include straps for securing the enclosure to the patient or to the operating table for additional stability.
The external-air-supply system may include a fan, a battery, an air filter (e.g., HEPA filter), a control-system, a connector-tube 71. The fan, the battery and the control-system may be incorporated into a control-device 70. The internal-air-supply system may include an air-tube 72 including an air-inlet 73 configured be connected to the connector-tube 71. The tube 72 may be disposed on the bottom of the enclosure in the proximity of the front end and may include one or more air-outlets 74 positioned such as to supply air-flow to the desired areas of the enclosure. During operation the air-supplied by the fan is directed through the connector-tube 71 into the tube 72, via inlet 73, and further into the surgical enclosure via the air-outlets 74. The air-outlets 74 may be disposed such as to direct air-flow over the surgical site 7. As seen in
The pressure sensing system may include a pressure sensor (which may be disposed in the control-device 70) and a pressure-tube 75 connected to the enclosure via connector 76 so as to allow air pressure from the enclosure to be measured by the pressure sensor (see
The air-tube 72 may be made of flexible plastic material layers (e.g., the same material as the enclosure material, polyethylene, PVC, etc.) including walls which are flexible and collapsible. The walls of the air-tube may act as a tubular two-way valve. For example, when the pressure inside the air-tube is larger than outside the tube the air-tube is expanded in an open state allowing air to flow through the tube. Conversely, when the pressure inside the air-tube is smaller than outside the tube the walls of the air-tube are collapsed in a closed state preventing and/or minimizing air flow through the tube.
The portable surgical system may include a plurality of LED lights disposed such as to illuminate the surgical site and the inside of the surgical enclosure. In an exemplary embodiment the LED lights may be LED strip lights. The LED strip lights may be disposed on the top of the surgical enclosure such as to illuminate the inside of the enclosure and the surgical site. The LED lights may be powered by the battery of the control device 70.
The portable surgical system may further include one or more cameras configured to receive images (e.g., video or stand still) and monitor the surgical-site. The cameras may be connected with a computer thereby enabling the operators to view the images taken by the camera. The cameras may be disposed either inside the enclosure or outside. The cameras and LED lights may be disposed on a frame-attachment-segment configured to be attached to the frame.
The surgical system disclosed in this application is configured and may be used by operators to perform surgical procedures on the torso, on the arms/hands, and on the legs/feet of a patient. An exemplary embodiment of the present invention also discloses a method for setting up and using the surgical system. The method may include the steps described hereinafter. The operators identify the surgical site to be operated on and disinfect the patient skin over the surgical site. The flexible enclosure is unfolded and disposed over the patient or adjacent to the patient. If the surgical system employs a rigid frame (such as shown in
The methods described herein are not limited to the specific steps and sequence of steps described above. The skilled artisan would recognize that the procedures/steps described herein can be performed in different sequences without departing from the spirit of the invention. The skilled artisan would recognize that many variations can be made to the steps and procedures described herein without departing from the spirit of the invention.
The portable surgical systems disclosed herein address both challenges of patient and operator intraoperative exposure to infectious risks. The surgical system ensures that the surgical site is kept in a relatively sterile state (e.g., as sterile as feasible under the conditions) by preventing contaminants from the outer environment (i.e. outside of the surgical enclosure) to reach the surgical site. When used for performing surgery on the torso, the surgical system is configured to ensure that contaminants on the patient body are not reaching the surgical site since, except for the surgical-site, all surface areas of patient body are kept outside of the enclosure. The surgical system provides a barrier protecting operators from exposure to contaminants (e.g., blood, pus, etc.) generated during the surgery inside the enclosure.
The surgical system is configured to be used for performing surgery outdoors such as on wounded soldiers in the field, on inhabitants of remote regions, during rescue operations in wilderness, and in environments which lack the sterility of a hospital operating room (e.g., tents, cottages, residential rooms, non-operating rooms in hospitals, etc.). The surgical system includes batteries configured to provide power to the environmental control system and other devices which may be needed during the surgery. Thus, the surgical system does not require access to electrical grid.
Prior to use, the surgical system is configured to be packed into a portable bag (e.g., backpack) so as to be easy to carry in the field. While packed, the surgical enclosure may be folded like a surgical gown while the frame may be disassembled into its modules. The surgical system is configured to be light, ergonomic and easy to install.
The surgical enclosure 1 is configured to be single use (i.e., after use it will be discarded) while the frame 2 and the external-air-supply system may be used multiple times.
Embodiments of the invention are described herein with reference to figures and illustrations that are schematic illustrations of idealized embodiments (and intermediate structures) of the invention. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, embodiments of the invention should not be construed as limited to the particular shapes of regions illustrated herein but are to include deviations in shapes that result, for example, from manufacturing.
The aspects of the invention in this application are not limited to the disclosed operations and sequence of operations. For instance, operations may be performed by various elements and components, may be consolidated, may be omitted, and may be altered without departing from the spirit and scope of the present invention.
The portable surgical systems disclosed herein may include alternate or additional sections which could be added based on procedural needs, such as to accommodate additional instrument trays or users. The above embodiments presented in this disclosure merely serve as exemplary embodiments and it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. The inventions herein may be embodied in many different forms and should not be construed as limited to the exemplary embodiments set forth herein. Rather, these exemplary embodiments are provided so that this disclosure is thorough, and will fully convey the scope of the invention to skilled artisans.
The following references are incorporated hereinafter as if fully set forth herein: PCT international patent application no. PCT/US 2017/04226 titled “Ultraportable system for intraoperative isolative and regulation of surgical site environments”; PCT international patent application no. PCT/US 2019/032148 titled “Sterile sleeves for portable surgical systems”; PCT international patent application no. PCT/US 2020/032280 titled “Systems and methods for intraoperative isolation and control of surgical site environments”; and PCT international patent application no. PCT/US 2019/051502 titled “Data analytics and interface platform for portable surgical enclosure”.
This application claims priority from and the benefit of the United States Provisional Patent Application No. 63/154,761 filed on Feb. 28, 2021 and titled “UTILITARIAN TASK-BASED CONTAINER AND INFLATABLE ISOLATION CHAMBER”, and the United States Provisional Patent Application No. 63/247,545 filed on Sep. 23, 2021 and titled “PORTABLE SYSTEM 10 FOR ISOLATION AND REGULATION OF SURGICAL SITE ENVIRONMENTS” which are hereby incorporated by reference for all purposes as if fully set forth herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/058496 | 11/8/2021 | WO |
Number | Date | Country | |
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63154761 | Feb 2021 | US | |
63247545 | Sep 2021 | US |