Protective devices used during surgery

Abstract

A protective assembly for use during laparoscopic surgery, the assembly comprising: a film formed of a non-toxic material, the film being thin enough and capable of being easily manipulated to pass through the cannula of a trocar; a flexible connector extending from the film; and an insertable shaft sized to pass through the cannula, wherein a distal portion of the shaft is anchored to the flexible connector.

Description

Technical Field

[0001] The present invention relates to a medical device for insertion into a patient's body and a surgical apparatus for inserting a device into a patient's body. Background Art

[0002] Minimally invasive surgery, or keyhole surgery, is a common surgical technique in which a surgeon makes one or more small incisions about 5mm to 12mm long in the skin, through which surgical tools, lights, and cameras are inserted to operate on tissue structures in the patient's body. In contrast, in traditional or open surgery, a surgeon may make an incision that is 15cm to 30cm long. As a result, patients who undergo minimally invasive surgery may experience less postoperative pain, recover more quickly after surgery, and have less visible scars than patients who undergo open surgery.

[0003] However, minimally invasive surgery requires different hand-eye coordination skills than open surgery and requires the surgeon to view the operating space in two dimensions on a monitor, limiting depth perception. In addition, the surgeon has limited tactile feedback about the tissue structure being treated, and due to the restricted operating space, the surgeon may have limited ability to retract obstructed tissue structures and expose tissue structures to be treated. Therefore, there may be a risk of accidental burning or perforation of tissue structures during minimally invasive surgery.

[0004] It would therefore be advantageous if it were possible to provide a device for use during keyhole surgery that reduced or eliminated the risk of injury to the patient.

[0005] It should be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or any other country. Summary of the invention

[0006] The present invention is directed to a medical device for insertion into a patient's body which may at least partially overcome at least one of the above-mentioned disadvantages or provide a useful or commercial choice to the consumer.

[0007] In a first aspect, there is provided a protective assembly for use during laparoscopic surgery, the assembly comprising:

[0008] A membrane formed of a non-toxic material that is thin enough and can be easily manipulated to pass through the cannula of a trocar; a flexible connector extending from the membrane; and an insertable plunger to facilitate insertion of the membrane into the cannula and subsequently passing the membrane through an outlet of the cannula so that the membrane can be deployed over the patient's internal organs, the plunger including a shaft sized to be inserted into and through the cannula, wherein a distal portion of the shaft is anchored to the flexible connector.

[0009] In another aspect, the present invention provides a protective assembly for use during laparoscopic surgery, the assembly comprising: a film formed of a non-toxic material, the film being thin enough and easily operable to pass through the cannula of a trocar, wherein the film comprises opposing major film surfaces separated by the thickness of the film, each film surface comprising rows of protrusions and recesses such that any two adjacently positioned protrusions are separated by a recess.

[0010] In an embodiment, the flexible connector is connected to a peripheral portion of the membrane.

[0011] In an embodiment, the proximal end portion of the insertable shaft includes an enlarged head to limit inward movement of the shaft into the cannula of the trocar and prevent the shaft from falling through the trocar.

[0012] In an embodiment, the membrane comprises a plurality of folded regions to facilitate rolling or folding of the membrane so that the membrane can be passed through the sleeve in a folded configuration.

[0013] In an embodiment, the membrane comprises at least two linear peripheral portions which are substantially transverse and preferably perpendicular to each other.

[0014] Preferably, the two linear peripheral portions are connected by at least one curved bridge portion to orient the linear peripheral portions in a transverse configuration.

[0015] In an embodiment, a first curved bridge portion having a first arc length and a second curved bridge portion having a second arc length such that the first arc length is less than the second arc length to define a wing-shaped membrane.

[0016] In an embodiment, the width of the connector is substantially smaller than the overall width of the membrane.

[0017] In an embodiment, the length of the flexible connector is greater than the length of the cannula of the trocar.

[0018] In an embodiment, the length of the flexible connector is at least twice the length of the cannula of the trocar.

[0019] In an embodiment, the film comprises opposing major film surfaces separated by a thickness of the film, each film surface comprising rows of protrusions and recesses such that any two adjacently positioned protrusions are separated by a recess.

[0020] Preferably, each recess on one of the major film surfaces is shaped to form a groove and is aligned with a protrusion on the other of the major film surfaces.

[0021] In an embodiment, each of said protrusions on a major surface of the membrane extends substantially in a transverse direction relative to the direction of the rows of protrusions and recesses.

[0022] In an embodiment, the average height of the protrusions is substantially equal to the average depth of the recesses.

[0023] In an embodiment, the thickness of the membrane portion between adjacently located protrusions and recesses is substantially less than or equal to the average height of the protrusions and / or the average depth of the recesses.

[0024] In embodiments, portions of the film between adjacent protrusions and recesses facilitate folding or rolling the film into a folded configuration.

[0025] Preferably, the connector is fused to the membrane.

[0026] Preferably, the film has sufficient heat resistance to reduce or minimize accidental damage due to ablation.

[0027] In an embodiment, the flexible connector is attached to the converging peripheral portions of the membrane such that the converging peripheral portions converge generally in a direction toward the axis to facilitate rolling or folding of the membrane when the membrane is drawn into the cannula of the trocar during use.

[0028] In an embodiment, the width of the membrane tapers from where the connector is attached to the membrane.

[0029] In an embodiment, the length of the flexible connector is adjustable.

[0030] On the other hand, the present disclosure broadly provides a protective device for use during a surgical procedure, the protective device comprising: an expandable body adapted to be at least partially inserted into a patient's body; and an internal component at least partially located within the expandable body, wherein, once expanded, the protective device is configured to protect tissue structures within the patient's body during the surgical procedure.

[0031] The protective device may be used for any suitable type of surgery. Preferably, the protective device may be used for surgery performed on tissue structures in the body of a patient. For example, the surgery may be a minimally invasive surgery (such as laparoscopy, thoracoscopic surgery, arthroscopy, hysteroscopy, appendectomy, etc.), an open surgical procedure (such as laparotomy, cholecystectomy, etc.), or any suitable combination thereof. Preferably, the protective device may be used for surgery performed on tissue structures in the body of a patient, wherein adjacent tissue structures may require protection.

[0032] The protective device can be used with any suitable type of surgical equipment. Preferably, the protective device can be used with surgical equipment, where there may be a risk of the surgical equipment injuring the patient, or where the treatment of tissue structures with the surgical equipment may cause damage to adjacent tissue structures, etc. For example, the protective device can be used with surgical equipment, which includes cutting tools (such as scalpels, blades, scissors, dissectors, cutters, etc.), puncture tools (such as needles, cannulas, probes, etc.), grasping tools (such as graspers, forceps, etc.), energy supply devices (such as heat, cold, electricity, etc.), trocars, and any suitable combination thereof.

[0033] As previously mentioned, the protective device is adapted to be at least partially inserted into the patient's body. In an embodiment of the present invention, the protective device can be inserted into the patient's body so that the protective device is at least partially received therein. In a preferred embodiment of the present invention, the protective device can be inserted into the patient's body so that the protective device is substantially received within the patient's body. In this case, it is envisaged that at least a portion of the protective device may extend out of the patient's body, such as through a wound, a surgical incision, etc. Preferably, the protective device may be adapted to be removably inserted into the patient's body. In this case, it is envisaged that the protective device may be temporarily inserted into the patient's body during the operation and then removed at the end of the operation (and especially before the wound or incision is closed), rather than being permanently inserted into the patient's body.

[0034] The protective device may have any suitable size, shape or configuration. Preferably, the size, shape and configuration of the protective device may be determined at least in part by the tissue structure to be protected and / or treated during the surgical procedure. For example, if a tissue structure having a large surface area is to be protected, a larger protective device may be required than when a smaller tissue structure is to be protected. However, it should be understood that the size, shape and configuration of the protective device may vary depending on several factors, such as the size of the surgical incision, access hole or body orifice into which the protective device is to be inserted, the type of surgical procedure to be performed, the type of surgical equipment to be used, and the tissue structure to be treated.

[0035] As previously described, the protective device is configured to protect the tissue structure during the surgical procedure. The protective device can protect the tissue structure by any suitable method. For example, the protective device can at least partially surround the tissue structure, can substantially surround the tissue structure, can be used as a blanket to at least partially cover the tissue structure, can be used as a blanket to substantially cover the tissue structure, can be used as a curtain to at least partially cover the tissue structure, can be used as a curtain to substantially cover the tissue structure, etc. However, preferably, the protective device can provide a physical, thermal and / or electrical barrier between the surgical device and the tissue structure.

[0036] In an embodiment of the present invention, the protective device may be attached to the tissue structure during surgery. Preferably, the protective device may be temporarily attached to the tissue structure during surgery. In use, it is envisioned that the protective device may be temporarily attached to the tissue structure in the patient's body during surgery, and then separated and removed at the end of surgery (and especially before the wound or incision is closed). In an embodiment of the present invention, the protective device may be attached to the tissue structure during surgery so that the protective device acts as a curtain. In this case, it is envisioned that the protective device may cover the tissue structure. Alternatively, the protective device may protect the tissue structure by at least partially enclosing the tissue structure in the protective device. In this case, it is envisioned that a part of the protective device may be temporarily attached to another part of the protective device, and then separated and removed at the end of surgery. A part of the protective device may be temporarily attached to the tissue structure and / or another part of the protective device by any suitable technology, such as a temporary adhesive (such as a non-adhesive adhesive, a positioning agent, etc.), a mechanical fastener (such as a suture, a staple, a suture clip, a suture anchor, a tack, a clip, etc.), a tether or a tether, or a combination thereof. However, it should be understood that how a portion of the protective device is attached to a tissue structure and / or another portion of the protective device may vary depending on the type and size of the tissue structure to be protected, the location of the tissue structure in the patient's body, the type of material from which the protective device may be made, the size, shape and configuration of the protective device, and the duration of the procedure.

[0037] Any suitable portion of the protective device may be temporarily attached to the tissue structure and / or another portion of the protective device. For example, the protective device may be provided with an attachment portion, wherein the attachment portion of the protective device may be configured to be attached to the tissue structure. Any suitable attachment portion may be provided, such as an edge portion extending around at least a portion of the periphery of the protective device, one or more areas suitable for being penetrated by a mechanical fastener, one or more tabs or attachment portions, etc. Alternatively, the protective device may be provided with one or more tethers, ropes, wires or filaments, hooks or barbs, which are configured to attach the protective device to the tissue structure. In this case, it is contemplated that secondary mechanical fasteners may not be required to attach the protective device to the tissue structure.

[0038] Alternatively, the protective device may be provided with one or more weighted portions, such that, in use, the weighted portions may reduce movement of the protective device during the surgical procedure. In this case, it is contemplated that the weighted portions may assist in expanding the protective device from an insertion state to a use state, assist in adapting the protective device to the shape of a tissue structure, or any suitable combination thereof. The weighted portions may have any suitable size, shape, and configuration. For example, the weighted portions may be edge portions, tabs or attachment portions, areas adapted to receive an inflation fluid, and the like.

[0039] The protective device includes an expandable body. The cross-section of the expandable body can be any suitable shape. For example, the cross-section of the expandable body can be roughly circular, elliptical, square, rectangular, stadium-shaped, triangular, hexagonal or octagonal. However, preferably, at least one corner radius of the expandable body can be round. It is envisioned that in use, providing rounded corners can eliminate weaknesses in the expandable body, reduce the risk of the protective device tearing a surgical incision or body orifice during insertion into the patient's body, or reduce the risk of the expandable body cutting and / or perforating tissue structures. In an embodiment of the present invention, the cross-section of the expandable body can be roughly triangular. For example, the expandable body can be a triangle with rounded corners, a trilobate shape, a three-petal shape, a Reuleaux triangle, etc.

[0040] In use, the expandable body can be moved to an insertion state for insertion into the patient's body. It is envisioned that, in the insertion state, the expandable body can be folded, rolled up, or otherwise compressed or compacted so that the expandable body can be inserted into the patient's body through a relatively small incision, wound, etc. In a specific embodiment, the roughly triangular expandable body (i.e., the use state) can be moved to an insertion state (in the form of a roughly square configuration) by folding the corners of the triangular expandable body toward the center of the triangular expandable body. In this way, it is envisioned that the square expandable body can be rolled up or folded to form an expandable body in the insertion state. It is envisioned that, in the insertion state, the outer diameter or width of the expandable body can be roughly the same along the length of the expandable body.

[0041] The expandable body may have any suitable size. However, preferably, the expandable body has a sufficient size to protect and / or treat tissue structures during surgery. In addition, it is envisioned that the size of the expandable body enables the expandable body to be inserted through a surgical incision, an access hole, or a body orifice. The expandable body may have any suitable size. However, it should be understood that the cross-sectional surface area of ​​the expandable body and the thickness of the expandable body may affect the outer diameter of the expandable body in the inserted state. For example, a thicker expandable body may have a larger outer diameter in the inserted state than a thinner expandable body in the inserted state. For example, in the inserted state, an expandable body with a relatively small cross-sectional surface area may have a smaller outer diameter than an expandable body with a larger cross-sectional surface area.

[0042] Preferably, the outer diameter of the expandable body in the inserted state may be smaller than the inner diameter of the surgical incision, access hole or body orifice into which the protective device is to be inserted. In an embodiment of the present invention, the outer diameter of the expandable body in the inserted state may be smaller than the inner diameter of a 12 mm trocar access hole, may be smaller than the inner diameter of a 10 mm trocar access hole, may be smaller than the inner diameter of an 8 mm trocar access hole, or may be smaller than the inner diameter of a 5 mm trocar access hole. In a preferred embodiment of the present invention, the outer diameter of the expandable body in the inserted state (and preferably the cross-section has a substantially triangular shape) may be smaller than the inner diameter of a 12 mm trocar access hole.

[0043] The expandable body can have any suitable thickness. However, preferably, the thickness of the expandable body is sufficient to physically, thermally and / or electrically insulate the tissue structure from the surgical device. However, it should be understood that the physical, thermal and / or electrical insulation properties of the expandable body may vary according to several factors, such as the type of material from which the expandable body is made and the structure of the expandable body. It is envisioned that when in the inserted state, the thickness of the expandable body may have a direct impact on the outer diameter of the expandable body. For example, an expandable body with a relatively high thickness may need to have a smaller cross-sectional surface area in order to be inserted through a surgical incision, an access hole or a body orifice. In an embodiment of the present invention, the thickness of the expandable body may be about 0.5mm to 3.0mm, more preferably about 0.8mm to 2.8mm, even more preferably about 1.0mm to 2.5mm, and still more preferably about 1.2mm to 2.3mm. Most preferably, the thickness of the expandable body may be about 1.5mm to 2.0mm.

[0044] In an embodiment, the expandable body may be manufactured from one or more types of materials. For example, the expandable body may be manufactured from a single material or a single type of material. Alternatively, the expandable body may include different materials, or different types of materials. In an embodiment of the present invention, the expandable body may include two or more layers of different materials. For example, the expandable body may include a first layer manufactured from a first type of material and a second layer manufactured from a second type of material. Manufacturing the expandable body from different types of materials may enable the expandable body to be manufactured from two or more layers, which have different properties, such as permeability, conductivity, resistance, etc. In an embodiment of the present invention, the expandable body may be a multilayer structure, wherein one or more layers may be manufactured from different types of materials.

[0045] In an embodiment, the expandable body may be manufactured from one or more pieces of flexible sheet material. In an embodiment of the present invention, the expandable body may be manufactured from an upper sheet member of a flexible sheet material and a lower sheet member of a flexible sheet material. It is envisioned that each of the upper sheet member and the lower sheet member may include one or more layers of material. Each of the upper sheet member and the lower sheet member may include the same material, the same type of material, different materials, or different types of materials. Each of the upper sheet member and the lower sheet member may include two or more layers of different materials. In an embodiment of the present invention, the expandable body may be manufactured from a flexible sheet material, wherein the flexible sheet material may be folded to form the upper sheet member and the lower sheet member.

[0046] As previously mentioned, the protection device includes an internal component that is at least partially located within the expandable body. It is contemplated that in some embodiments of the present invention, the expandable body may include a cavity therein, with the internal component at least partially located within the cavity.

[0047] In some embodiments, wherein the expandable body comprises an upper sheet member and a lower sheet member, it is envisioned that a cavity is formed between the upper sheet member and the lower sheet member. Thus, in this embodiment of the invention, the upper sheet member and the lower sheet member may be connected to each other around at least a portion of their periphery to form the expandable body. The upper sheet member and the lower sheet member may be connected to each other using any suitable technique, such as an adhesive, a mechanical fastener (such as sutures, staples, etc.), a heat treatment, a chemical treatment, a mechanical treatment (such as ultrasonic welding, compression, etc.), or a combination thereof.

[0048] In some embodiments, the expandable body may include a sleeve member. It is contemplated that the sleeve member may be open at only one end so that a cavity is formed within the interior of the expandable body. In some embodiments, the expandable body may be manufactured with a single-layer sleeve member, but it is contemplated that the sleeve member may include two or more layers.

[0049] The internal member may have any suitable form. However, preferably, the internal member may have sufficient mechanical properties (compressible, elastic, etc.) so that the expandable body is configured to be suitable for being inserted into the patient's body, so that the expandable body can expand to the initial shape of the expandable body when placed in the patient's body, and so that the expandable body is configured to be suitable for being retracted or removed from the patient's body. For example, the internal member may include a substantially solid sheet material, a sheet material including a plurality of cavities, a structure formed by an elongated material, a container for retaining an expansion fluid (such as a gas, a fluid, a gel, etc.) inside it, a granular material, and any suitable combination thereof. However, it should be understood that the type of internal member may vary according to several factors, such as the type of surgical device to be used and the desired characteristics of the expandable body. It is envisioned that in use, an internal member including a plurality of cavities and / or an internal member with respect to the lower surface area of ​​the expandable body may be more easily compressed and / or folded than a substantially solid internal member. Therefore, the internal member may include an integral structure, or may include two or more discrete parts. The two or more discrete parts may be connected to each other, or fluidly connected to each other, or may be placed apart from each other. However, preferably, the inner member may be configured such that it facilitates folding the protective device into an inserted state. For example, two or more discrete portions and / or multiple cavities may be oriented to reduce the amount of material in the fold line region.

[0050] The inner member may include a plurality of cavities, wherein the plurality of cavities may include an inflation fluid (such as a gas, a fluid, a gel, etc.) therein. The inflation fluid may fill the plurality of cavities temporarily or permanently, in whole or in part. The inflation fluid may be permanently contained within the inner member, or may be introduced into the inner member and / or the protective device before and / or after insertion into the patient's body. However, it should be understood that whether the plurality of cavities are temporarily or permanently filled with the inflation fluid, and whether the plurality of cavities are fully or partially filled, will depend on several factors, such as the type of material used to make the inner member, the tissue structure to be treated, and the type of surgical equipment to be used. In use, it is contemplated that the plurality of cavities may be at least partially filled with the inflation fluid during insertion and / or withdrawal of the protective device into the patient's body. The partially expanded inner member may help fold or roll the inflatable body into an inserted state, and provide some rigidity to the inflatable body to facilitate placement and deployment of the inflatable body in the patient's body. The partially expanded inner member may help reduce movement of the protective device during surgery. In this case, it is contemplated that inserting the inflation fluid into the plurality of cavities may provide a weighted portion.

[0051] In certain embodiments, the internal member may be made of an elastically deformable material. Thus, in preferred embodiments, the internal member may be an elastically deformable internal member. In embodiments of the present invention, the internal member may be compressed, deflated, or otherwise reduced in size, preferably in a vacuum, to be configured into a shape and / or size suitable for insertion into and / or retraction or removal from a patient's body.

[0052] The internal component may be at least partially encapsulated in a cavity in the expandable body. More preferably, the internal component may be substantially encapsulated in a cavity in the expandable body. In this way, for example, the thermal insulation capacity of the expandable body may be improved, and the expandable body may also have improved water resistance.

[0053] The internal member and the expandable body can be fastened to each other. This can be achieved using any suitable technology. However, it should be understood that the method of fastening the internal member to the expandable body can vary depending on the type of material used to make the internal member and the expandable body and / or the biocompatibility, thermal or electrical insulation properties of the method of fastening the internal member and the expandable body to each other. For example, the internal member and the expandable body can be fastened to each other using adhesives or mechanical fasteners (such as sutures, staples, etc.), heat treatment, chemical treatment, mechanical treatment (such as ultrasonic welding, compression, etc.). However, preferably, the method of fastening the internal member and the expandable body to each other can maintain, for example, the thermal insulation and water resistance of the expandable body.

[0054] In a preferred embodiment, the expandable body may be molded onto the internal component. In this case, the overmolded internal component may be encapsulated by the expandable body so that the internal component may be substantially surrounded by the expandable body. In this way, the thermal insulation capability of the expandable body may be improved, and the expandable body may have improved water resistance.

[0055] The internal component may be provided with at least one strut secured to a surface of the internal component. It is contemplated that during the molding process, at least one strut may contact the inner surface of the template, which strut may maintain the internal component in a central and generally planar orientation. In this case, it should be understood that at least one strut may not be covered by the material of the expandable body so that the surface of the strut may be exposed. Alternatively, at least a portion of the expandable body may be coated or treated so that at least one strut has antimicrobial properties, water resistance, ultraviolet (UV) resistance, chemical resistance, wear resistance, reduced conductivity, or a combination thereof.

[0056] The at least one support post may have any suitable size, shape and configuration. Preferably, however, the at least one support post may have sufficient size, shape and configuration to maintain the internal member in a central orientation and maintain, for example, the thermal insulation and water resistance of the expandable body.

[0057] At least one pillar may be made of any suitable material or combination of materials. However, preferably, at least one pillar may be made of a resiliently deformable and relatively tear-resistant, biocompatible and sterilizable material. For example, at least one pillar may be made of the same material as the expandable body, a different material from the expandable body, the same material as the internal component, a different material from the internal component, or any suitable combination thereof. Preferably, at least one pillar may be made of a material that is resistant to one or more techniques for processing the structure. For example, at least one pillar may be made of a material that is resistant to cutting, heat insulation, electrical conductivity, radiation opaque, ultrasound opaque, gas impermeable, fluid impermeable, etc. Alternatively, at least one pillar may be made of a material that is permeable to gas, permeable to fluid, etc. In this case, it is envisioned that a fluid or gas applied to the outer surface of the expandable body may enter the body cavity and / or the internal component through at least one pillar by capillary action.

[0058] In an embodiment, the internal member may be self-expanding. For example, when the expandable body is unrestricted, the internal member may expand from the insertion state to the use state. Alternatively, the internal member may expand with the help of a device such as a syringe. For example, a syringe may be used to inject an expansion fluid (such as a gas, a fluid, a gel, etc.) into the internal member, into the cavity of the internal member, into the hollow body of the internal member, or any suitable combination thereof. Alternatively, the internal member may expand when a fluid or gas applied to the outer surface of the expandable body is absorbed by at least one strut. In this way, it is envisioned that the expansion of the internal member may cause the expandable body to be transformed from the insertion state to the use state in which the expandable body is fully expanded. Of course, it should be understood that there may be several intermediate use states between the insertion state and the use state, in which the expandable body is partially expanded. These intermediate use states may be used in the following situations: for example, there is only limited space in the patient's body for the expandable body to expand, or when only a relatively small tissue area needs to be protected. It is contemplated that in use, an inflation fluid may be removed from the inner member using a device such as a syringe to deflate the inner member so that the protective device may be removed from the patient's body. Alternatively, the inflatable body may be manipulated to physically compress the inner member prior to removing the protective device from the patient's body. Alternatively, the inflatable body may be connected to a vacuum device to compress the inner member prior to removing the protective device from the patient's body.

[0059] The inner member can be made of any suitable material. However, preferably, the inner member can be made of relatively elastic and relatively tear-resistant, biocompatible and sterilizable materials. For example, the inner member can be made of extruded polymers, expanded polymers, foamed polymers or their combinations. Preferably, the inner member can be made of relatively flexible polymers, such as but not limited to polycarbonate, polyethylene, polypropylene, polystyrene, polyvinyl chloride (PVC), acrylonitrile butadiene styrene, ethylene vinyl acetate (EVA), polyvinyl alcohol (PVA), ethylene propylene diene terpolymer, chloroprene rubber, nitrile, silicone, fluoroelastomer, polyurethane, polyamide, nylon, polychloroprene (chloroprene rubber), polyurethane (memory foam) etc., or any suitable combination thereof.

[0060] The internal member may be made of a closed cell foam material or an open cell foam material. In an embodiment of the present invention, the internal member may include a closed cell foam material. The closed cell foam material has an open cell content of 20% or less, 10% or less, 5% or less, and may have an open cell content of zero percent. In an embodiment of the present invention, the internal member may be a closed cell ethylene vinyl acetate or polyvinyl alcohol foam core. In an embodiment, the internal member may be a closed cell neoprene. In an alternative embodiment of the present invention, the internal member may include an open cell foam material. The open cell foam material has an open cell content of 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, and may have an open cell content of 100%. In an embodiment of the present invention, the internal member may be an open cell ethylene vinyl acetate or polyvinyl alcohol foam core. In an embodiment of the present invention, the internal member may be a memory foam. In an embodiment of the present invention, the internal member may be an open cell neoprene. It is envisioned that the user may expand the open cell foam material by injecting an expansion fluid into the open cell foam material. For example, the expansion fluid may be injected into an expansion portion associated with the open cell foam material, or alternatively, the expansion fluid may be injected directly into the open cell foam material.

[0061] The internal member may be made of a mesh of elongated material. Any suitable type of elongated material may be used. Preferably, however, the elongated material may be expandable or self-expanding. For example, the elongated material may include a flexible tube, a pneumatic tube, a balloon tube, an inner lumen tube, an expandable sleeve, a stent component, etc. In this case, it is contemplated that the user may expand the mesh of elongated material by injecting an inflation fluid into an opening in the mesh of elongated material. For example, the inflation fluid may be injected into an inflation portion associated with the mesh of elongated material, or alternatively, the inflation fluid may be injected directly into the mesh of elongated material.

[0062] Any suitable inflation fluid may be used. For example, the inflation fluid may be a gas, a fluid, a gel, or any suitable combination thereof. Preferably, however, the inflation fluid may be non-flammable and non-toxic. In embodiments where the inflation fluid may be a fluid, a gel, or a suitable combination thereof, it is contemplated that by injecting the inflation fluid into the internal components of the protective device, the weight of the protective device may be increased and movement of the protective device within the patient's body may be reduced.

[0063] The expandable body may be made of any suitable material or combination of materials. However, preferably, the expandable body may be made of a relatively elastic and relatively tear-resistant, biocompatible and sterilizable material. Preferably, the expandable body may be made of a non-adherent material. Preferably, the expandable body may be made of a material that is resistant to one or more techniques for treating tissue structures. For example, the expandable body may be made of a material that is resistant to cutting, heat insulating, electrically non-conductive, radiation-impermeable, ultrasound-impermeable, gas-impermeable, fluid-impermeable, etc.

[0064] Alternatively, the expandable body may be made of a material that focuses or directs one or more techniques for treating a tissue structure. For example, the expandable body may be made of a material that is cut-resistant, thermally conductive, electrically conductive, radiation permeable, ultrasound permeable, gas permeable, fluid permeable, etc. In this case, it is contemplated that the expandable body may be used to focus treatment on the tissue structure covered by the protective device.

[0065] The expandable body may be made of any suitable material. However, preferably, the expandable body may be made of a flexible material. For example, the expandable body may be made of a polymer, such as, but not limited to, polyvinyl chloride, silicone, polytetrafluoroethylene (PTFE), nitrile, thermoplastic elastomer, thermoplastic polyurethane, polyethylene, polyurethane, etc., or any suitable combination thereof. Preferably, the expandable body may be made of silicone. However, it should be understood that the type of material used may vary depending on a number of factors, such as the size of the surgical incision, access hole or body orifice into which the protective device is to be inserted, the type of surgical procedure to be performed, the type of surgical equipment to be used, and the tissue structure to be treated.

[0066] In an embodiment, one or more layers of the expandable body may be made of a thermally insulating, non-conductive material. Preferably, one or more layers of the expandable body may be made of a thermally insulating, non-conductive material that resists energy and / or contact burns from surgical tools. In this case, it is contemplated that the expandable body may reduce or minimize the risk of burns or damage to the tissue structure to be protected and insulate the tissue structure from energy leakage.

[0067] In an embodiment, the protective device may include a retaining member. Any suitable retaining member may be used. However, preferably, the retaining member is flexible, sterilizable, and non-conductive. For example, the retaining member may be a suture material, a rope, a cable, a guidewire, a tether, etc. However, preferably, the retaining member is of sufficient size and strength to remain connected to the protective device during surgery and to retrieve the protective device from the patient's body. It is envisioned that the purpose of the retaining member may be both to ensure that the user can use the retaining member to retrieve the device from the patient's body and to prevent the need to create a larger incision to retrieve the device from the patient's body.

[0068] The retaining member may be made of natural materials, synthetic materials, or a combination thereof. Any suitable material may be used, such as natural materials (including silk, gut, cotton, flax, hemp, etc.), metals or metal alloys (including wire, rope, etc.), polymers such as nylon, polypropylene, polyethylene (including HDPE, PET, etc.), polyamideimide (including glass-filled polyamideimide), polyphenylene sulfide, polyetheretherketone, polyetherimide, etc., or any suitable combination thereof. In some embodiments of the present invention, the retaining member may be coated or treated to impart antimicrobial properties, water resistance, ultraviolet (UV) resistance, chemical resistance, wear resistance, reduced electrical conductivity, or a combination thereof to the substrate.

[0069] The retaining member may be provided in the form of a monofilament, or may include multiple strands. In some embodiments, the retaining member may be made of metal and coated with or surrounded by a polymeric material (such as a polymeric sleeve or tube around a metal wire, cable, etc.), or provided in a biodegradable sleeve that is deemed suitable for the environment.

[0070] The retaining member may have any suitable length. However, preferably, the retaining member may have sufficient length so that at least a portion of the retaining member may remain outside the patient's body after the protective device is released into the patient's body and placed on the tissue structure to be protected. In this way, the protective device can be retrieved after the operation, which cannot be done if the retaining member does not have sufficient length. Therefore, preferably, the retaining member is relatively long. However, it should be understood that if the retaining member is too long, there may be a risk that the retaining member becomes stuck on the tissue structure in the patient's body or another surgical instrument. Therefore, more preferably, the excess length of the retaining member can be accommodated in or attached to the surgical device used to place the protective device in the patient's body.

[0071] The retaining member may be configured for attachment to the expandable body. The retaining member may be attached to the expandable body by any suitable means. For example, the retaining member may be provided with a connecting member, may be integrally formed with the expandable body, may be directly attached to the expandable body (such as by passing one end of the retaining member through an aperture in the expandable body), or any suitable combination thereof. However, preferably, the retaining member provides the user with the ability to maintain connection with the protector when the protector is inserted into the patient's body.

[0072] The retaining member may be provided with a connecting member to attach the retaining member to the expandable body. Any connecting member may be used. However, preferably, the connecting member facilitates attaching the retaining member to the expandable body. For example, the retaining member may be provided with a connecting member, such as an adhesive or a mechanical fastener (such as a screw, staple, pin, anchor, arrow, etc.).

[0073] Alternatively, the retaining member may be manipulated to form a connecting member, such as by tying a knot, or by applying a heat or chemical treatment that can melt one end of the retaining member to the upstanding portion of the retaining member. However, it should be understood that the type and number of connecting members used may vary depending on the type of retaining member used and the type of expandable body.

[0074] The protection device may comprise an expansion portion. The expansion portion may be of any suitable type. However, preferably, the expansion portion is capable of injecting and / or extracting an inflation fluid into the expandable body in order to transform the expandable body from an insertion state to a use state.

[0075] In preferred embodiments, the expansion portion includes one or more valves. Any suitable valves may be provided, such as one or more one-way (check) valves, etc. A one-way valve may be used to prevent unwanted or accidental discharge of the inflation fluid from the inflatable body. In these embodiments of the invention, it is contemplated that the expansion portion may include one or more additional valves adapted to allow the inflation fluid to leave the inflatable body to adjust the inflation of the inflatable body, or to discharge the inflation fluid from the inflatable body, for example at the end of a procedure.

[0076] In other embodiments, the expansion portion can include one or more two-way valves, a luer-actuated valve, etc. The expansion portion can be configured to expand the inner member and / or the expandable body.

[0077] In a preferred embodiment, the one or more valves in the expansion section may comprise the only point in the protection device through which fluid may enter or leave the device.

[0078] A source of inflation fluid may be connected to the inflation portion so as to inject inflation fluid into the inflatable body. The fluid source may be of any suitable type. For example, the fluid source may include a cylinder, a reservoir, an IV bag, a syringe, or the like, or any combination thereof. In embodiments of the present invention where the source of inflation fluid includes a syringe, it is contemplated that by injecting inflation fluid into the inflatable body, the inflatable body may be inflated such that the inflatable body can be used to protect tissue structures during surgery. The syringe may be connected to the inflation portion so as to extract inflation fluid from the inflatable body. In this case, it is contemplated that by extracting inflation fluid from the inflatable body, the inflatable body may be deflated such that the inflatable body can be removed from the patient's body.

[0079] On the other hand, the present disclosure provides a surgical device, comprising: a protective device, the protective device comprising an expandable body, wherein the expandable body comprises at least one internal component, the at least one internal component is located within the expandable body, wherein the at least one internal component is expandable; wherein the protective device is configured to protect tissue structures within a patient's body during surgery; and a surgical instrument, the surgical instrument is configured to receive at least a portion of the protective device, wherein the surgical instrument is configured to release the protective device into the patient's body during surgery.

[0080] Preferably, the protection device is the protection device of the first aspect of the invention.

[0081] The surgical device includes a surgical instrument configured to receive at least a portion of the protective device. The surgical device may be disposable. In this case, it is envisioned that the surgical device may be provided to the user as a sterilization system that includes the protective device, which is already inserted into the surgical instrument and is ready for use. Alternatively, the surgical device may be reusable. In this case, it is envisioned that the surgical instrument may be reusable and sterilizable, and the protective device may be single-use only. Alternatively, both the surgical instrument and the protective device may be reusable and sterilizable.

[0082] The surgical instrument may have any suitable configuration. In an embodiment of the present invention, the surgical instrument may include an end effector connected to a laparoscopic tool, wherein the end effector is configured to receive at least a portion of the protective device therein. In an alternative embodiment of the present invention, the surgical instrument may include a housing portion configured to receive at least a portion of the protective device therein. However, preferably, the configuration of the surgical instrument facilitates insertion of the protective device through a surgical incision, an access hole, or a body orifice.

[0083] In an embodiment, the surgical instrument comprises an end effector. The end effector may be connected to the surgical instrument. In an embodiment of the present invention, the end effector may be removably connected to the surgical instrument. In this case, it is envisioned that the end effector may be removably connected to the surgical instrument to facilitate replacement of the end effector. Preferably, the end effector may be operated by manipulating the surgical instrument. Therefore, in a preferred embodiment, the surgical instrument may include a handle, an elongated barrel, and an end effector.

[0084] The end effector may have any suitable size, shape or configuration. However, preferably, the end effector has sufficient size, shape and configuration to be inserted through a surgical incision, an access hole or a body orifice and to receive at least a portion of the protective device in the end effector. The end effector may have any suitable type. However, preferably, the end effector is configured to receive at least a portion of the protective device. For example, the end effector may include an internal compartment extending longitudinally, which is located at or toward one end of the surgical instrument. Alternatively, the end effector may include a detachable end member configured to be operably connected to one end of the surgical instrument. In this case, it is envisioned that the detachable end member may have a cross-sectional size similar to that of the surgical instrument. In use, it is envisioned that the end effector may include an opening so that the protective device can be deployed from the surgical instrument into the patient's body through the opening. The opening may have any suitable configuration. For example, the opening may extend longitudinally at least partially along the length of the end effector, may extend circumferentially at least partially around the end effector, may be located at one end of the end effector, or any suitable combination thereof.

[0085] In embodiments, the surgical instrument may include a housing portion configured to receive at least a portion of the protective device therein. The housing portion may have any suitable size, shape or configuration. Preferably, the housing portion may be an elongated housing portion. However, preferably, the housing portion has a sufficient size, shape and configuration to be inserted through a surgical incision, access hole or body orifice and receive at least a portion of the protective device in the end effector. Preferably, when the protective device is located in the housing portion, the protective device may be in an inserted (i.e., unexpanded) state.

[0086] The housing portion may be configured to receive the protective device by any suitable means. The housing portion includes a first end and an opposite second end, and a hole extending at least partially through the housing portion from the first end to the second end. Preferably, the hole may extend through the housing portion from the first end to the second end. Therefore, it is envisioned that the hole may include a pair of open ends, or an open end and a closed end. The hole may be substantially linear, or may have a curved or tortuous path. The hole may have any suitable length and any suitable diameter. The diameter of the hole may be substantially constant along the length of the hole, or may vary along the length of the hole. For example, the hole may gradually narrow along at least a portion of the length of the hole, may include a neck or similar narrowing portion, etc. In use, it is envisioned that the protective device may be deployed through the second end of the housing portion.

[0087] The housing portion may also include at least one protrusion extending outwardly from the housing portion. Any suitable protrusion may be provided, but in a preferred embodiment of the present invention, the protrusion may include a flange. In an embodiment of the present invention, at least one flange may be located on the outer surface of the housing portion. Preferably, the flange may be located on the outer surface of the housing portion toward the first end of the housing portion, or at the first end of the housing portion. It is envisioned that the flange located on the outer surface of the housing portion may prevent the housing portion from entering or passing through the surgical incision, access hole or body orifice and entering the patient's body. Therefore, it is envisioned that the flange may extend outwardly from the outer surface of the housing portion so that the diameter of the housing portion (including the flange) is at least equal to the diameter of the surgical incision, access hole or body orifice. The flange may extend at least partially around the circumference of the housing portion. Alternatively, the flange may extend substantially around the entire circumference of the housing portion. Therefore, in some embodiments, the flange may be an annular flange.

[0088] The surgical instrument may be configured to release the protective device into the patient's body. The mechanism for releasing the protective device into the patient's body may be of any suitable type. In embodiments where the surgical instrument of the present invention includes an end effector, the end effector may be actuated by manipulating the actuation portion to release the protective device. In alternative embodiments where the surgical instrument of the present invention includes a housing portion, the housing portion may be configured to receive a plunger in the housing portion, and wherein movement of the plunger within and relative to the housing portion releases the protective device.

[0089] In an embodiment, a surgical instrument may include an end effector, wherein the end effector may be actuated by manipulating an actuating portion. In this manner, it is contemplated that actuating the end effector may release the protective device into the patient's body. Any suitable actuating portion may be used. However, preferably, the actuating portion may move the end effector between an open configuration and a closed configuration. For example, the actuating portion may be a trigger device, a ratchet device, a spring-biased piston device, a cable tensioning device, etc. The actuating portion may be associated with the surgical instrument in any suitable manner. For example, the actuating portion may be part of the surgical instrument, or may be an independently operated surgical instrument. In use, it is contemplated that moving the end effector to an open configuration may enable the protective device to be removed from the end effector. The protective device may be manually removed from the end effector by a user or a robotic device, may fall off the end effector under the action of gravity, may be ejected from the end effector using a mechanism associated with the surgical instrument, and any suitable combination thereof.

[0090] In an embodiment, the surgical instrument may include a housing portion, wherein the housing portion may be configured to receive a plunger in the housing portion. In this manner, it is envisioned that the generally linear movement of the plunger within the housing portion may release the guard through the second end of the housing portion and allow the guard to enter the patient's body. More specifically, it is envisioned that a portion of the plunger may contact or engage with a portion of the guard within the housing portion. In this embodiment, the movement of the plunger relative to the housing portion may result in a corresponding movement of the guard relative to the housing portion. Preferably, the movement of the plunger relative to the housing portion (e.g., by pushing) causes the guard to move toward and out of the open end of the housing portion.

[0091] However, preferably, the plunger is of sufficient size, shape and configuration to be received within the bore of the housing portion and to move the protective device within the housing portion. The plunger may be fully received within the bore of the housing portion. Alternatively, a portion of the plunger may protrude from the bore of the housing portion. Preferably, the cross-sectional shape of the plunger may be substantially the same as the cross-sectional shape of the bore of the housing portion so that the plunger can be received within the bore.

[0092] The plunger may have any suitable size, shape or configuration. For example, the plunger may be substantially solid, may be at least partially hollow, may include a shaft having a plurality of longitudinally and radially extending blades, may include a shaft having a plurality of transversely extending ribs along the length of the shaft, and any suitable combination thereof. Preferably, the plunger may be an elongated plunger including a first end and an opposing second end. In an embodiment of the present invention, the plunger includes a groove portion, and preferably includes an elongated groove portion (such as a channel) that extends longitudinally along at least a portion of the length of the plunger between the first end and the second end of the plunger. The groove portion may have any suitable size, shape and configuration. However, preferably, the groove portion has sufficient size and configuration to accommodate at least a portion of the retaining member of the protective device within the groove portion. Alternatively, the plunger may include a hole that extends at least partially through the plunger between the first end and the second end. In use, it is envisioned that the retaining member of the protective device may pass through the hole of the plunger.

[0093] As previously mentioned, the plunger may include a first end and an opposing second end. It is envisioned that, in use, the second end may contact the guard to cause movement of the guard relative to the housing portion. In this embodiment of the invention, it is envisioned that a force may be applied to the first end of the plunger to actuate movement of the plunger relative to the housing portion. In some embodiments of the invention, the first end may be provided with a contact portion to which a force may be applied. The force may be applied by a user, a robotic device, or the like.

[0094] The plunger may also include at least one protrusion extending outwardly from the plunger. Any suitable protrusion may be provided, but in preferred embodiments of the present invention, the protrusion may include a flange. In embodiments of the present invention, at least one flange may be located on the outer surface of the plunger. Preferably, the flange may be located on the outer surface of the plunger towards the first end of the plunger, or at the first end of the plunger. It is envisaged that the flange located on the outer surface of the plunger may prevent the plunger from fully entering the hole of the housing portion. Therefore, it is envisaged that the flange may extend outwardly from the outer surface of the plunger so that the diameter of the plunger (including the flange) is at least equal to the diameter of the housing portion. The flange may extend at least partially around the circumference of the plunger. In embodiments of the present invention, the plunger may include two flanges provided on opposite sides of the plunger. Therefore, in some embodiments of the present invention, the two flanges may facilitate the removal of the anchoring device from the flange of the plunger. Alternatively, the flange may extend substantially around the entire circumference of the plunger. Therefore, in some embodiments of the present invention, the flange may be an annular flange. In embodiments of the present invention, the flange may be provided with a groove portion substantially aligned with a groove portion in the plunger.

[0095] In an embodiment, when the plunger is fully received in the hole of the housing portion, at least a portion of the flange of the plunger may contact at least a portion of the flange of the housing portion. In an embodiment of the present invention, when the plunger is fully received in the hole of the housing portion, at least a portion of the flange of the plunger may be at least partially received in at least a portion of the flange of the housing portion. In this case, it is envisioned that when the plunger is fully received in the hole of the housing portion, the flange of the plunger may abut the flange of the housing portion and may provide a seal to prevent the insufflation gas from escaping from the patient's body. The plunger may be formed integrally with the housing portion, or may be provided as a separate structure.

[0096] The surgical instrument may be provided with an anchoring portion. The anchoring portion may have any suitable size, shape or configuration. However, preferably, the anchoring portion may have sufficient mechanical properties to keep at least a portion of the retaining member of the protective device connected to the surgical instrument after the protective device has been released into the patient's body. The anchoring portion may be integral with the surgical instrument and configured to receive at least a portion of the retaining member. For example, the anchoring portion may be a protrusion, an aperture, a hole, a slot, a mechanical fastener (such as a clip, a set screw, etc.), or any suitable combination thereof. Alternatively, the anchoring portion may be provided as a separate structure that may be configured to temporarily connect the retaining member to a portion of the surgical instrument. In this case, it is envisioned that at least a portion of the anchoring portion may be at least partially received within at least a portion of the flange of the plunger. For example, the cross-section of the anchoring portion may be substantially circular, and the anchoring portion is configured to be received within at least a portion of the flange of the plunger. For example, the anchoring portion may include an enlarged area of ​​the retaining member that acts as a stop member. The enlarged region of the retaining member may be sized or shaped to substantially resist movement of the enlarged region relative to the flange of the plunger.

[0097] The anchoring portion may be configured to be attached to the retaining member. For example, the anchoring portion may be provided with a connecting member that facilitates the attachment of the retaining member to the surgical instrument. Alternatively, the retaining member may be directly attached to the anchoring portion (such as by passing one end or loop of the retaining member through a pore in the anchoring portion, or by surrounding one end or loop of the retaining member around the region of the anchoring portion), or any suitable combination thereof. In an embodiment of the present invention, the anchoring portion may be configured to be removably attached to the retaining member. For example, the anchoring portion may keep the retaining member in a frictional engagement caused by the pressure fit of the retaining member in the anchoring portion. For example, the anchoring portion may be provided with a groove portion, a notch, a slot, etc., which is configured to receive at least a portion of the retaining member in the frictional engagement. Therefore, in use, it is envisioned that after the protective device is deployed in the patient's body, the retaining member may be removed from the anchoring portion and / or the surgical instrument. Alternatively, the retaining member may be attached to the anchoring portion using an adhesive, a heat treatment, a chemical treatment, or any suitable combination thereof. Preferably, however, the retaining member provides the user with the ability to remain connected to the protective device when the protective device is inserted into the patient's body.

[0098] The protector may be secured with a sleeve. It is contemplated that the sleeve may be configured to maintain the expandable body of the protector in an inserted state during insertion of the protector into the patient's body. The sleeve may be manually removed from the protector by a user or a robotic device, or may be removed from the protector when the sleeve is ejected from the end effector. Alternatively, the protector may be secured with at least a portion of a retaining member. In this case, it is contemplated that when the protector is released into the patient's body, the retaining member may be deployed from the protector so that the expandable body can expand to a use state.

[0099] The present disclosure provides several advantages over the prior art. For example, the present disclosure provides a protective device for use during keyhole surgery that reduces or eliminates the risk of injury to the patient. In addition, the present disclosure is adapted to be removably inserted into the patient's body and is configured such that a connection to the protective device is maintained throughout the procedure so that the protective device is not inadvertently left in the patient's body.

[0100] Within the scope of the present invention, any feature described herein may be combined with any one or more other features described herein, in any combination.

[0101] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that the prior art forms part of the common general knowledge. BRIEF DESCRIPTION OF THE DRAWINGS

[0102] The preferred features, embodiments and variations of the present invention can be seen from the following detailed description, which provides sufficient information for those skilled in the art to carry out the present invention. The detailed description should not be construed as limiting the scope of the foregoing summary of the present invention in any way. The detailed description will refer to the following drawings:

[0103] Figure 1 A top perspective view of a protective device in use according to an embodiment is shown;

[0104] Figure 2 A top perspective view of a protective device in use according to an embodiment is shown;

[0105] Figure 3 A top perspective view of a protective device in use according to an embodiment is shown;

[0106] Figure 4 As shown in Figure 3 The expansion portion of the protective device shown in ;

[0107] Figure 5A A top view of a protective device in use according to an embodiment is shown;

[0108] Figure 5B shows a top view of a partially folded protective device according to an embodiment;

[0109] Figure 5C shows a top view of a protective device in an inserted state according to an embodiment;

[0110] Figure 6 shows a side view of a surgical device in a closed state according to an embodiment of the present invention;

[0111] Figure 7 A side view showing a surgical device in an open state according to an embodiment of the present invention is shown;

[0112] Figure 8 shows a side perspective view of a surgical device according to an embodiment;

[0113] FIG. 9A to FIG. 9G A side perspective view of a surgical device according to an embodiment of the present invention is shown, showing the steps of inserting the surgical device into a trocar until the protective device is deployed;

[0114] Fig. 10A is a top view of a protection assembly 1000 according to an embodiment;

[0115] Fig. 10B is a first side view of protection assembly 1000 .

[0116] Fig. 10Cis a second side view of protection assembly 1000 .

[0117] Fig. 10D is a bottom view of the protection assembly 1000.

[0118] Fig.11A is a first perspective view of protection assembly 1000 .

[0119] Fig. 11B is a second perspective view of protection assembly 1000 .

[0120] Fig.12 is a first cross-sectional side view of protection assembly 1000 .

[0121] Fig.13 is a second cross-sectional side view of protection assembly 1000 .

[0122] Fig.14A is a top view of protection assembly 1000, wherein plunger 1300 is shown in a retracted position.

[0123] Fig. 14B is a first side view of protection assembly 1000 , wherein plunger 1300 is shown in a retracted position.

[0124] Fig. 14C is a second side view of protection assembly 1000 , wherein plunger 1300 is shown in a retracted position.

[0125] Fig.14D is a bottom view of the protective assembly 1000, wherein the plunger 1300 is shown in a retracted position.

[0126] Fig.15A is a top perspective view of protection assembly 1000, wherein plunger 1300 is shown in a retracted position.

[0127] Fig. 15B is a side perspective view of protection assembly 1000, wherein plunger 1300 is shown in a retracted position.

[0128] Fig.16 is a top view (separately) of a protective film 1100 forming part of the protective assembly 1000 .

[0129] Fig.17 is a cross-sectional view of the protective film 1100 (separately). DETAILED DESCRIPTION

[0130] Figure 1A protective device for use during a surgical procedure is shown according to an embodiment. The protective device 100 includes an expandable body 10 and an internal member 12, which is at least partially located within the expandable body 10. The expandable body 10 includes a silicone layer 14, which is overmolded on the internal member 12 in the form of a PVA or EVA open-cell or closed-cell foam. In use, it is contemplated that the silicone layer 14 can provide resistance to energy and / or contact burns from surgical tools, and the internal member 12 can insulate the tissue to be protected. The internal member 12 includes at least one strut 16 that helps maintain the internal member 12 in a central and generally planar orientation during the overmolding process. The internal member 12 includes a plurality of cavities 17, which are oriented around a fold line (not shown), which can help compress or fold the protective device into an inserted state.

[0131] It is contemplated that in embodiments including a closed cell foam (e.g., memory foam) inner member, the expandable body 10 expands as the inner member 12 self-inflates. It is contemplated that in embodiments including an open cell foam inner member, the inner member 12 may be expanded by contacting at least one strut 16 with an inflation fluid or by injecting an inflation fluid directly into the inner member 12.

[0132] The protection device 100 also includes a retaining member 20 that is associated with the expandable body 10. In use, a user may use the retaining member 20 to retrieve the protection device 100 from the patient's body.

[0133] exist Figure 2 , a protective device for use during a surgical procedure according to an embodiment is shown. Protective device 200 includes an expandable body 30 and an inner member 22, which is at least partially located within the expandable body 30. The expandable body 30 includes a silicone layer 24, which is overmolded on the inner member 22 in the form of a PVA or EVA open-cell foam. In use, it is contemplated that the silicone layer can provide resistance to energy and / or contact burns from surgical tools, and the open-cell foam layer can insulate the tissue to be protected.

[0134] The inner member 22 includes at least one strut 26 that helps maintain the inner member 22 in a central and generally planar orientation during the overmolding process. The inner member 22 includes one or more portions oriented around a fold line (not shown) of the protective device 200. In this manner, the amount of material in the fold line area is reduced, which helps fold the protective device into an inserted state.

[0135] In use, it is contemplated that the inner member 22 may need to be compressed in a vacuum to facilitate folding the protective device into an inserted state or to deflate the inner member so that the protective device can be removed from the patient's body. In use, it is contemplated that in embodiments including an open-cell foam inner member, the inner member 22 may be expanded by contacting at least one strut 26 with an inflation fluid or by injecting the inflation fluid directly into the inner member 22. It is contemplated that in embodiments including a closed-cell foam (such as memory foam) inner member, the expandable body 30 expands as the inner member 22 self-inflates.

[0136] The protection device 200 also includes a retaining member 40 that is associated with the expandable body 30. In use, a user may use the retaining member 40 to retrieve the protection device 200 from the patient's body.

[0137] exist Figure 3 , a protective device for use during a surgical procedure according to an embodiment of the present invention is shown. The protective device 300 includes: an expandable body 50; an inner member 32, which is at least partially located within the expandable body 50; and an expansion portion 38, which is associated with the expandable body 50 and configured to facilitate expansion of the expandable body. The expandable body 50 includes a silicone layer 34, which is overmolded on the inner member 32 in the form of a slender material (such as a pneumatic tube). In use, it is contemplated that the silicone layer 34 can provide resistance to energy and / or contact burns from surgical tools, and the air pockets 37 between the slender materials 32 can insulate the tissue to be protected. The inner member 32 includes at least one strut 36, which helps to maintain the inner member 32 in a central and generally planar orientation during the overmolding process. The inner member 32 includes a plurality of slender materials, which are oriented along a fold line (not shown), which when deflated, can help to compress or fold the protective device into an inserted state. In use, it is contemplated that a user may inject an inflation fluid into the inflation portion 38, thereby inflating the pneumatic tube 32 and subsequently inflating the inflatable body 50. Alternatively, the user may inflate the inflatable body 50 by contacting at least one stent 36 with the inflation fluid or by injecting the inflation fluid directly into at least one stent 36.

[0138] The protection device 300 also includes a retention member 60 associated with the expandable body 50. In use, the user can use the retention member 60 to retrieve the protection device 300 from the patient's body. Figure 4 In FIG. 4 , the expansion portion of the protection device is shown. The syringe 42 is used to inject the expansion fluid into the expansion portion 38 of the protection device 300.

[0139] exist FIG. 5A to FIG. 5C, a protection device 400 is shown including an expandable body 44. In use, in a fully expanded state ( Figure 5A ) is deflated and then folded along fold line 46 to form a partially folded protective device ( Figure 5B ), and rolled into the inserted state ( Figure 5C ).

[0140] exist Figure 6 and Figure 7 , a surgical device is shown that includes a surgical instrument and a protective device for insertion into a patient's body. The surgical instrument 600 includes an end effector 54 that is configured to receive at least a portion of the protective device 500 in the end effector. The end effector 54 is actuated by an actuation portion 56 to move the end effector 54 between a closed configuration and an open configuration, the actuation portion being in the form of a trigger device attached to a handle 52 of the surgical instrument. It is contemplated that, in use, moving the end effector 54 to the open configuration enables the protective device 500 to be inserted into or removed from the end effector 54. The end effector 54 includes an anchoring portion 65 that is configured to keep at least a portion of a retaining member 64 of the protective device 500 connected to the surgical instrument 600.

[0141] exist Figure 8 , a surgical device is shown, which includes a surgical instrument and a protective device for insertion into a patient's body. The surgical instrument 800 includes a housing portion 90 and a plunger 102, the housing portion being configured to receive a protective device (not shown) in the housing portion, and the plunger being configured to release the protective device into the patient's body (not shown). The housing portion 90 includes: a hole (not shown) extending from a first end 92 to an opposite second end 94; and a flange 98 located at the first end 92 of the housing portion 90. The hole opening 96 of the housing portion 90 is configured to receive the plunger 102 in the hole opening. The plunger 102 includes: a first end 104; an opposite second end 106; a flange 110 located at the first end 104 of the plunger 102; and a groove portion 108 extending longitudinally along the length of the plunger 102. It is envisioned that in use, a retaining member (not shown) of the protective device may pass through a hole (not shown) in the housing portion 90 and the outer hole opening 96, the retaining member (not shown) may be located in the recessed portion 108 of the plunger 102, and may be removably secured to the anchor portion 112 via the slot 114 and the plug portion 86.

[0142] exist FIG. 9A to FIG. 9G, a side perspective view of a surgical device is shown, which includes a surgical instrument for inserting a protective device into a patient's body. For clarity, the patient's body is not shown, however, it should be understood that the sleeve 122 of the cannula needle can be inserted into the patient's body through an incision, while the upper portion 123 of the cannula needle will remain outside the patient's body. The surgical instrument 800 includes a housing portion 90, a plunger 102, and a protective device located in a hole of the housing portion 90, which can be inserted into the access hole 118 of the cannula needle 116 until the flange 98 located at the first end of the housing portion 90 abuts the upper surface of the cannula needle 116. The plunger 102 is depressed until the flange 110 located at the first end of the plunger 102 abuts the upper surface of the flange 98 of the housing portion 90. Due to the linear movement of the plunger 102 in the hole (not shown) of the housing portion 90, the protective device 80 is released into the patient's body through the second end 94 of the housing portion 90. As the expandable body 82 of the protection device 80 expands from the insertion state, the retaining member 84 unwinds into the patient's body. In use, the plug portion 86 and the anchor portion 112 of the retaining member 84 keep the retaining portion 84 connected to the surgical instrument 800.

[0143] After the protective device 80 is released into the patient's body cavity, the plunger 102 can be removed from the hole of the housing portion 90. In use, it is envisioned that the retaining member 84 and the anchoring portion 112 are removed from the groove portion 108 and the flange 110 of the plunger 102, respectively. Then, the housing portion 90 can be removed from the access hole 118 of the cannula 116. In use, it is envisioned that the retaining member 84 is removed from the slot 114 of the anchoring portion 112 so that the retaining member 84 can pass through the hole of the housing portion 90. The retaining member 84 is placed to the side so as to remain connected to the protective device 80 during the procedure. It is envisioned that, in use, the protective device 80 can be removed from the patient's body by deflation of the expandable body 82 and retrieving the expandable body 82 through the cannula 116. Alternatively, the cannula 116 can be removed so that the deflated expandable body 82 can be retrieved through the incision in the patient's body.

[0144] Refer to Figures 10 to Fig.17, another preferred embodiment of the protection assembly 1000 has been shown. The protection assembly 1000 includes a protection member, which includes a film 1100, which is formed by a non-toxic medical grade material, such as but not limited to medical grade silicone or any other type of elastic and flexible polymer material. The protective film 1100 includes an overall triangular or wing-shaped configuration with rounded corners or vertices. The importance of the shape of the film 1100 will be described in more detail in the aforementioned section. The thickness of the film 1100 is small enough relative to the overall size of the film. Therefore, the film 1100 is thin enough and can be easily manipulated so that the film 1100 can be rolled into the hollow sleeve of the laparoscopic trocar 1200. The film 1100 is configured to be once introduced into the patient's body through the trocar 1200, and then unfolded or expanded after passing through the sleeve of the trocar 1200, and expanded into a protective configuration. In this protective configuration, the film 1100 can be unfolded on the patient's internal organs to shield the patient's organs when performing laparoscopic surgery.

[0145] At least a peripheral portion of the membrane 1100 includes a flexible connector 1150 (of variable length) that connects the membrane 1100 to a distal portion 1310 of a plunger 1300 (shown in FIGS. 14 and 15 ). The plunger 1300 is configured to push the membrane 1100 (in a rolled-up configuration) into the cannula of the trocar 1200. Specifically, one end of the flexible connector 1150 is anchored to the distal tip 1310 of the plunger, and the other end of the flexible connector 1150 is fused to the base of the membrane 1100. The point 1152 (at Fig.16 ) is preferably reinforced or strengthened to further reduce the possibility of accidental separation of the flexible connector 1150 from the membrane 1100.

[0146] FIG. 10A to FIG. 10D and Fig.12 The plunger 1300 is shown in a fully inserted configuration, wherein the shaft portion 1320 of the plunger 1300 has been fully inserted into the cannula of the laparoscopic trocar 1200 . FIG. 14A to FIG. 14D The plunger 1300 is shown in a withdrawn position (withdrawn from the cannula of the trocar 1200). Fig.12 , the plunger 1300 includes an enlarged head 1330 that is sized to be received and seated on the entry portion 1220 of the trocar 1200. The entry portion of the trocar 1200 includes a flat flange seat 1205 having wings or tabs 1207 extending radially from the seat 1205 so that the surgeon can place their fingers under the tabs 1207 to grasp the trocar 1200. The plunger head 1330 is configured to be larger than the diameter of the cannula of the trocar 1200 to prevent the plunger 1300 from falling through the cannula within the patient's body.

[0147] The film 1100 includes two major surfaces separated by the thickness of the film 1100. The major surfaces of the film 1100 include substantially identical configurations with a plurality of folding regions to enable the film 1100 to be folded or bent (to enable rolling). Each major surface of the film 1100 (at Fig.16 and Fig.17 Detailed cross-sectional view shown in ). Each surface of the membrane 1100 includes alternating rows of protrusions 1120 and recesses 1140, so that any two adjacently positioned protrusions 1120 are separated by recesses 1140, thereby forming the alternating configuration. Each recess 1140 on one of the main membrane surfaces of the membrane 1100 is shaped to form a groove and is aligned with a protrusion 1140 on another of the main membrane surfaces of the membrane 1100. It is also important to note that each protrusion 1120 or recess 1140 on the main membrane surface extends in a transverse direction (preferably an orthogonal direction) relative to the direction of the rows of protrusions 1120 and recesses 1140. It is also obvious that the height of each protrusion 1120 (and the depth of the recess 1140) is approximately equal. In a preferred embodiment, the height of each protrusion 1120 and recess 1140 is in the range of 0.5mm to 1mm, more preferably between 0.25mm and 0.75mm. In at least some embodiments, the height can be 0.5mm. The region of film 1100 forms the matrix of protrusion 1120 and recess 1140, and these film regions 1130 have relatively low thickness compared with other regions provided with protrusion 1120 and recess 1140. Preferably, the thickness of these regions is between 0.5mm and 1mm. The film region with relatively low thickness is provided with multiple folding regions, along which film 1100 can be easily bent (for rolling up) or folded. The total thickness of film 1100 is the sum of the thickness of these film regions 1130, the height of protrusion 1120 and the depth of recess 1140. Therefore, if film region 1130 is 0.5mm, each protrusion has an average height of 0.5mm, and each recess has an average depth of 0.5mm, then the total thickness of film 1100 is 1.5mm.

[0148] The membrane 1100 in the preferred embodiment comprises a unique shape and provides a number of important advantages. Specifically, when the membrane 1100 is located on a flat surface, the membrane comprises two linear peripheral portions 1101 and 1103 that are substantially perpendicular to each other. The two perpendicular linear portions 1101 and 1103 are bridged by a first arc-shaped bridging portion 1102 (having a relatively short arc length) and a second bridging portion 1104 (having a relatively long arc length), thereby forming the membrane 1100, in particular, the membrane surface has a wing-shaped configuration.

[0149] The flexible connector 1150 may be formed of the same material as the film, and as previously described, the flexible connector may also be fused to the film 1100. The instantaneous width of the flexible connector 1150 (i.e., the width across the connector 1150 along any portion) is substantially less than the overall diameter of the cannula of the trocar 1200. This configuration enables the surgeon to insert the film 1100 (in a rolled configuration) through the cannula into the patient's body using the plunger 1300, and then unfold the film 1100 to shield the patient's internal organs before starting the laparoscopic procedure. While the procedure is being performed, the plunger 1300 may be pulled out, leaving a sufficient length of the flexible connector 1150 to pass through the cannula of the trocar 1200. The plunger 1300 may be pulled out and placed aside while still connected to the film 1100 by the long flexible connector 1150. Preferably, the length of flexible connector 1150 should be much greater than the length of the cannula of the trocar so that membrane 1150 can be placed within the patient's body while the flexible connector passes through the cannula with the flexible connector still coupled to the distal portion of plunger 1300 .

[0150] Due to the very small size of the flexible connector 1150, there is sufficient free volume within the cannula of the trocar 1200 to enable the insertion of other laparoscopic actuators to perform laparoscopic surgery while the film 1100 is present. Once the laparoscopic surgery is over, the surgeon can retrieve the film 1100 by pulling it out through the cannula. The flexible connector 1150 is attached to the converging peripheral portions of the film so that the converging peripheral portions converge generally in a direction toward the connector to facilitate rolling or folding of the film 1100 when the film is pulled into the cannula of the trocar 1200 during use. The film 1100 gradually widens from the attachment location of the connector 1150 on the film 1100, which causes the film 1100 to be easily rolled into the cannula of the trocar 1200, thereby facilitating the retrieval of the film 1100.

[0151] The membrane 1100 includes a 40 durometer medical grade silicone material that is formulated for healthcare applications. In a preferred embodiment of the membrane 1100, the silicone-based polymer used for the medical grade silicone material is a low volatility, peroxide-free, platinum-cured material that does not discolor over time. The 40 durometer medical grade silicone may perform well in extreme high temperatures and can operate in a range of between -65°C to +232°C. The silicone material of the membrane 1100 helps provide heat resistance to the membrane 1100. The configuration of the membrane 1100 with alternating rows of protrusions 1120 and recesses 1140 further improves thermal insulation and enables the membrane 1100 to bend and stretch, as well as prevent tearing across the membrane 1100.

[0152] In this specification and claims (if any), the word "comprise" and its derivatives (including "comprising" and "comprising") include each stated integer, but do not exclude the inclusion of one or more other integers.

[0153] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the present invention. Thus, the phrases "in one embodiment" or "in an embodiment" appearing in different places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

[0154] In accordance with the statute, the invention has been described in language more or less specific to structural or methodological features. It is to be understood that the invention is not limited to the specific features shown or described, since the apparatus described herein comprises a preferred form of carrying out the invention. The invention is therefore claimed in any form or modification thereof within the proper scope of the appended claims (if any) as appropriately interpreted by one skilled in the art.

Claims

1. A protective assembly for use during laparoscopic surgery, the assembly comprising: a membrane formed of a non-toxic material, the membrane being operable to pass through a cannula of a trocar; a flexible connector extending from the film, the flexible connector being fused to the film and formed entirely of the same material as the film; and an insertable plunger to facilitate insertion of the film into the cannula and subsequent passage of the film through the outlet of the cannula so that the film can be deployed over the patient's internal organs, the plunger comprising an insertable shaft sized to be inserted into and through the cannula, wherein a distal portion of the insertable shaft is fixedly anchored to the flexible connector, wherein the flexible connector is connected to an attachment point on a peripheral portion of the film to facilitate retrieval of the film from the cannula of the cannula when the flexible connector is pulled, and wherein the flexible connector extends to the plunger only from the attachment point at a converging portion of the peripheral portion of the film so that the converging peripheral portions converge generally in a direction toward the insertable shaft to facilitate rolling up or folding of the film as the film is pulled into the cannula of the cannula during use.

2. The protection assembly according to claim 1, wherein: The proximal end portion of the insertable shaft includes an enlarged head to limit inward movement of the insertable shaft into the cannula of the trocar and prevent the insertable shaft from falling through the trocar.

3. The protection assembly according to claim 1, wherein: The film includes a plurality of folded regions to facilitate rolling or folding of the film so that the film can pass through the sleeve in a folded configuration.

4. The protection assembly according to claim 1, wherein: The membrane comprises at least two linear peripheral portions that are generally transverse to each other.

5. The protection assembly according to claim 4, wherein: The at least two linear peripheral portions are connected by at least one curved bridge portion to orient the at least two linear peripheral portions in a transverse configuration.

6. A protective component according to claim 5, comprising a first curved bridging portion having a first arc length in the at least one curved bridging portion and a second curved bridging portion having a second arc length in the at least one curved bridging portion, so that the first arc length is smaller than the second arc length to define a wing-shaped portion of the film.

7. The protection assembly according to claim 4, wherein: The at least two linear peripheral portions are perpendicular to each other.

8. The protection assembly according to claim 1, wherein: The width of the flexible connector is substantially smaller than the overall width of the membrane.

9. The protection assembly according to claim 1, wherein: The length of the flexible connector is greater than the length of the cannula of the trocar.

10. The protection assembly according to claim 9, wherein: The length of the flexible connector is at least twice the length of the cannula of the trocar.

11. The protection assembly according to claim 1, wherein: The film comprises opposing major film surfaces separated by a thickness of the film, each of the film surfaces comprising rows of protrusions and recesses such that any two adjacently positioned protrusions are separated by a recess.

12. The protection assembly according to claim 11, wherein: Each of the recesses on one of the film surfaces is shaped to form a groove and is aligned with a protrusion of the row of protrusions and recesses on the other of the major film surfaces.

13. The protection assembly according to claim 12, wherein: Each of the protrusions on the major surface of the film extends generally in a transverse direction relative to the direction of the rows of protrusions and recesses.

14. The protection assembly according to claim 11, wherein: The average height of the protrusions is substantially equal to the average depth of the recesses.

15. The protective assembly of claim 11, the thickness of the portion of the film between any two adjacently positioned protrusions separated by a recess being substantially less than or equal to an average height of the protrusions and / or an average depth of the recesses.

16. The protection assembly according to claim 11, wherein: The portion of the film between any two adjacent protrusions separated by a recess facilitates folding or rolling the film into a folded configuration.

17. The protection assembly according to claim 1, wherein: The film has heat resistance.

18. The protection assembly according to claim 1, wherein: The width of the film tapers from the attachment point of the flexible connector on the film.

19. The protection assembly according to claim 1, wherein: The length of the flexible connector is adjustable.

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