A DEVICE FOR PROVIDING A STERILE LIMITED SPACE FOR SURGERY
20230240791 · 2023-08-03
Assignee
Inventors
Cpc classification
A61B50/10
HUMAN NECESSITIES
A61B90/40
HUMAN NECESSITIES
A61B17/3423
HUMAN NECESSITIES
A61B50/20
HUMAN NECESSITIES
A61B90/30
HUMAN NECESSITIES
A61B17/3431
HUMAN NECESSITIES
International classification
A61B90/40
HUMAN NECESSITIES
A61B50/10
HUMAN NECESSITIES
Abstract
The invention relates to a device for establishing and maintaining a sterile environment for conducting surgical procedures. In particular, the invention is related to a tent-like device providing an interior space and being attachable to a patient's skin to allow surgical treatment of the patient. Several aspects of the invention are directed to devices to be used in connection with such a surgical procedure using the tent-like device. According to the invention, an isolation device for providing a sterile operation chamber above a skin region of a patient is provided, in particular for performing a surgical procedure, said isolation device comprising an inflatable bag coupled to a support frame, the support frame having a transport configuration and an operation configuration, wherein in the transport configuration, the first inflatable bag is confined, such as to have compact dimensions; in the operation configuration, the first inflatable bag is extended, such as to form said sterile operation chamber.
Claims
1. An assisting device for donning and removing a surgical glove, comprising: at least one fluid-tight wall arrangement encompassing an inner space having a volume of such a size that at least a palm portion and finger portions of the surgical glove can be arranged in the space; and an opening adapted to sealingly engage a cuff portion of the surgical glove if the palm portion and the finger portions are arranged in the space; wherein the fluid tight wall arrangement is adapted to be transformed from a first configuration into a second configuration and vice-versa, wherein in the first configuration the inner space has a first inner volume, and in the second configuration, the inner space has a second inner volume, wherein the first volume is smaller than the second volume.
2. The assisting device according to claim 1, wherein the wall arrangement comprises at least one flexible wall section, and wherein in the first configuration the flexible wall section has a first shape, thus defining the first inner volume, and in the second configuration the flexible wall section has a second shape, thus defining the second inner volume.
3. The assisting device according to claim 2, wherein the flexible wall section is biased into the first shape or the flexible wall section is biased into the second shape.
4. The assisting device according to claim 2, further comprising: a second flexible wall section, wherein the second flexible wall section is coupled to the first flexible wall section along two opposed edges of the first and second flexible wall sections, wherein in the first configuration the first and second flexible wall sections form a flat pocket-like geometry with the first inner space being inside the pocket and in the second configuration the first and second wall section are bent outward to both form outer convex surfaces.
5. The assisting device according to claim 1, wherein: the fluid-tight wall arrangement comprises a first tube segment and a second tube segment, the second tube segment being slidable attached to the first ring segment so as to form a telescope-like arrangement, wherein the second tube segment can be displaced in a fluid-tight sealing engagement towards an outer surface of the first tube segment and the second ring segment can be displaced onto the first ring segment in an axial direction from the first configuration into the second configuration, and in the first configuration the total length in the axial direction of the fluid tight wall arrangement comprised of the first and second ring segment is shorter than in the second configuration.
6. The assisting device according to claim 1, wherein the fluid-tight wall arrangement comprises an elastic tube segment which can be elastically deformed from an elliptic cross-sectional shape in the first configuration to a circular cross-sectional shape in the second configuration.
7. The assisting device according to claim 1, wherein a fluid-tight seal is provided for providing the sealing engagement of the opening and the cuff portion, the fluid tight seal comprising a strap having an outer ring, an inner ring and at least one snap ring; and wherein the at least one snap ring is adapted to secure the cuff portion of the surgical glove between an inner surface of the outer ring and an outer surface of the inner ring, the outer ring having an outer surface which can be partially inserted into the opening to sealingly engage the opening.
8. Assisting device according to claim 1, wherein the inner space comprises a first region adjacent to the opening and adapted to accommodate the palm portion of the surgical glove and a second region adjacent to the first region and adapted to accommodate the finger portions of the surgical glove; and wherein in the first region the wall arrangement restricts the elastic stretching of the glove in the second configuration such that the palm region is stretched to an extent of less than 150%, and the elastic stretching is restricted by a contact of an inner surface of the wall arrangement to the surgical glove in the first region.
9. The assisting device according to claim 1, wherein the fluid-tight wall arrangement is elastically deformed without an external vacuum source.
10. The assisting device according to claim 1, wherein the assisting device is disposable.
11. The assisting device according to claim 1, wherein the assisting device is disposed within an isolation device for providing a sterile operation chamber above a skin region of a patient, the isolation device comprising a first inflatable bag delimiting the sterile operation chamber against an ambient environment, a first and a second access opening to allow a user to insert a first and a second arm into the operation chamber, a chamber operation opening to allow access to the skin region of the patient out of the operation chamber, and a window for observing handling operations inside the sterile operation chamber; wherein the first inflatable bag is coupled to a support frame, the support frame having a transport configuration and an operation configuration, and wherein in the transport configuration, the first inflatable bag is confined, such as to have compact dimensions, and in the operation configuration, the first inflatable bag is extended, such as to form the sterile operation chamber; and wherein the support frame comprises hollow support frame members having at least one connector for introducing a fluid material into the support frame members; and a. in the transport configuration, the support frame members are deflated and slack and in the operation configuration the support frame members are inflated to a pressurized state such that the support members are rigid, or b. in the transport configuration, the support frame members are deflated and slack and in the operation configuration a curable liquid is inserted into the support frame member, the curable liquid being cured to a hardened condition.
12. The assisting device of claim 11, wherein the assisting device can be used inside the inflatable bag arranged above a surgical site on a patient's skin and is completely independent from any pressure or vacuum condition inside such inflatable bag.
13. The assisting device of claim 11, wherein the assisting device is a disposable device equipped with one glove and is provided inside a pre-packed package within the inflatable bag to allow a surgeon to take off a glove provided inside the assisting device without the need for any help by an assisting personal or the like.
14. An assisting device for donning and removing a surgical glove, comprising: at least one fluid-tight wall arrangement, encompassing an inner space having a volume of such a size that at least a palm portion and finger portions of the surgical glove can be arranged in the space; and an opening adapted to sealingly engage a cuff portion of the surgical glove if the palm portion and the finger portions are arranged in the space; wherein the fluid tight wall arrangement is adapted to be transformed from a first configuration into a second configuration and vice-versa, such that in the first configuration the inner space has a first inner volume, and in the second configuration, the inner space has a second inner volume, wherein the first volume is smaller than the second volume; wherein the fluid-tight wall arrangement comprises a first tube segment and a second tube segment, the second tube segment being slidable attached to a first ring segment to form a telescope-like arrangement, wherein the second tube segment can be slid in a fluid-tight sealing engagement towards an outer surface of the first tube segment; and wherein the second ring segment can be slid onto the first ring segment in an axial direction from the first configuration into the second configuration, and in the first configuration the total length in the axial direction of the fluid tight wall arrangement comprised of the first and second ring segment is shorter than in the second configuration.
15. The assisting device according to claim 14, wherein the wall arrangement comprises at least one flexible wall section, and wherein in the first configuration the flexible wall section has a first shape, thus defining the first inner volume; and in the second configuration the flexible wall section has a second shape, thus defining the second inner volume.
16. The assisting device according to claim 15, wherein the flexible wall section is biased into one of the first shape, or the second shape.
17. The assisting device according to claim 15, further comprising: a second flexible wall section, wherein the second flexible wall section is coupled to the first flexible wall section along two opposed edges of the first and second flexible wall sections, wherein in the first configuration the first and second flexible wall sections form a flat pocket-like geometry with the first inner space being inside the pocket and in the second configuration the first and second wall section are bent outward to both form outer convex surfaces.
18. The assisting device according to claim 14, wherein: the fluid-tight wall arrangement comprises an elastic tube segment which can be elastically deformed from an elliptic cross-sectional shape in the first configuration to a circular cross-sectional shape in the second configuration.
19. The assisting device according to claim 14, wherein: a fluid-tight seal provides the sealing engagement of the opening and the cuff portion; and the fluid tight seal comprises a strap having an outer ring, an inner ring and at least one snap ring, wherein the at least one snap ring is adapted to secure the cuff portion of the surgical glove between an inner surface of the outer ring and an outer surface of the inner ring, and the outer ring having an outer surface which can be partially inserted into the opening to sealingly engage the opening.
20. The assisting device according to claim 14, wherein: the inner space comprises a first region adjacent to the opening and adapted to accommodate the palm portion of the surgical glove and a second region adjacent to the first region and adapted to accommodate the finger portions of the surgical glove; and wherein in the first region the wall arrangement restricts the elastic stretching of the glove in the second configuration such that the palm region is stretched to an extent of less than 125%, and the elastic stretching is restricted by a contact of an inner surface of the wall arrangement to the surgical glove in the first region.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0070] Preferred embodiments of the invention are described with reference to the enclosed figures. In the figures:
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0095] As referenced in the Figures, the same reference numerals may be used herein to refer to the same parameters and components or their similar modifications and alternatives. For purposes of description herein, the terms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,” “horizontal,” and derivatives thereof shall relate to the present disclosure as oriented in
[0096] Referring first to
[0097] The first frame defines a lower adhesion surface 12 in the horizontal plane 1 which can be attached to the patient's skin. The frame members surround an inner opening 20 of rectangular shape which is the opening serving the surging to conduct the surgical operation.
[0098] A first foil 30 is provided at the first frame 10 and covers the whole inner opening 30 being attached or coupled to the frame members 11a-d of the first frame on all four sides. As can be seen in
[0099] In at least one region, the first foil 30 is in a short distance to the lower adhesion surface 12 of the first frame to the skin. In other regions, the first foil 30 may lay in the plane of the adhesion surface. Thus, a small sterilizing space is defined between the first foil 30 and the skin of the patient if the first frame is attached to the skin and the first frame.
[0100] A first channel 40 with a first connector 41 is arranged in the frame member 11b of the first frame and reaches through the frame member. The first connector 41 has an outer connector dimension of circular cross-section allowing to adapt a standardized connector to the first conduit like a luer lock or the like. The first channel 40 opens into the space established between the first foil 30 and the skin of the patient with an elongated cross-section, such as to be adapted in cross-section to the small distance between the first foil and the skin of the patient.
[0101] A second fluid channel 50 with connector 51 is provided in frame member 11d in the opposite corner region to the first channel 40. The second channel 50 is designed in a similar manner as the first channel 40 and connector 41. Whereas the first channel 40 serves to insert a sterilizing agent from outside the frame into the space between the first foil 30 and the skin of the patient, the second channel 50 serves to remove such sterilizing agent after a certain activating time when a complete sterilization of the skin of the patient and of the bottom surface of the first foil 30 has been reached.
[0102] A second frame 60 is provided and composed of four L-shaped frame members 61a-d. The second frame 60 has a slightly smaller dimension than the first fame 10 such as to allow the second frame 60 to be inserted into the first fame 10. As can be seen in detail in
[0103] Generally, it is to be understood that both the first frame 10 and the second frame 60 can be collapsed in such a way that the legs of the L-shaped profiles of the frame members can be brought from the rectangular arrangement to each other to a parallel arrangement to each other wherein the legs lie directly onto each other.
[0104] The sterilizing device shown in
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[0106] The device shown in
[0107] An upper window region 101 is made of a fully crystal clear transparent material to allow precise observation of any handling processes inside the inflatable bag 100.
[0108] The inflatable bag 100 further comprises access ports 105, 106 in the inflatable bag 100. The access ports 105, 106 are combined with sleeves and gloves to define a sealed interior space, but allows a surgeon or assisting personnel to reach into the inner space from outside the inflatable bag 100.
[0109] Still further, an introducing and exporting device 130 is provided in the inflatable bag 100 at the lower bottom region. This introducing and exporting device comprises two rotatable rollers 131, 132 which can be moved apart from each other to open a gap between the rollers 131, 132 allowing the surgeon or assisting personnel to introduce instruments or the like from outside into the interior space. This introducing and importing device 130 is specifically adapted to conduct such an insertion or exporting action without affecting the sterile environment inside the inflatable bag 100 even if a non-sterile environment is present outside the inflatable bag 100. The insertion and exporting device 130 is explained in further detail hereafter with reference to
[0110] In a first configuration,
[0111] The fluid-tight wall 200 may be deformed from the flattened configuration with an approximately elliptical cross-sectional shape, as shown in
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[0113] A surgical glove 350 can be attached sealingly to the opening 330 of the first component 310 and may reach into an interior space 340 defined by the first and second components 310, 320. By this, the interior space 340 is divided into a completely sealed region 340a against the atmosphere by the first and the second components 310, 320 and the surgical glove 350 and a region 340b inside the surgical glove 350.
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[0115] As can be seen, the device comprises a frame 510 having a flange 511 which can be mounted to the inflatable bag 100 in a sealing arrangement. In the frame 510, two rollers 520, 530 are mounted rotatably along its longitudinal axis. The rollers 520, 530 are shown in a closed condition of the device and in this condition the rollers 520, 530 are in contact to each other and in contact to the frame 510 to completely seal an opening 540. In this closed condition, the rollers 520, 530 are biased versus each other by a spring 550.
[0116] The axis or shafts of the rollers 520, 530 are positioned in a curved groove or curved opening 521, 531, respectively. The curved grooved/openings 522, 532 allow the two rollers 520, 530 to slide along a curved travel path wherein the two rollers 520, 530 are pushed away from each other, thus giving an insertion/exporting opening between the two rollers 520, 530. As can be seen in dashed lines when being pushed towards the end the travel path, the two rollers 520, 530 give way for an instrument or a device having the size of the opening 540 as a maximum dimension.
[0117] By this, an instrument or device may be pushed from the left side in
[0118] The device shown in
[0119] As can be seen, the two rollers 520, 530 are pushed or drawn back into the closed position by the spring 550 after such an insertion procedure.
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[0121] A flexible hose 630 is attached to the frame and has a certain length. The flexible hose 630 may extend to one side with a first portion 631, may then be reversed to be directed to an opposite direction with a second portion 632 and have a wrapped portion 633, wherein the flexible hose 630 is wrapped around its own to define a sealing. In a portion 634, an object 640, e.g., infectious waste or the like, may be positioned and may be sealed on both sides by such wrappings in hose regions 633, 635. A remaining length portion 636 of the flexible hose 630 may be used to further seal such objects with additional wrap regions. By this, the flexible hose 630 may be used to seal multiple such objects and to allow transfer of such objects from the inside to the outside, or vice versa, by moving the flexible hose 630 through the opening 620.
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[0124] The sheets 810a-f are adapted to receive instruments, devices, or the like on the top surface, and allow a user to simply access such instruments by moving the sheets 810a-f into a position wherein those instruments required by the user are accessible from the respective sheet. It is to be understood that the sheets 810a-f may be movable independently from each other or may be interconnected to each other such that a synchronous movement of the sheets is possible.
[0125] The moving mechanism, like the frame defining the travel path of the sheets, is mounted to a base plate 820 for a safe and secure standing of the mechanical cabinet.
[0126] Generally, the mechanical cabinet shown in
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[0132] It will be understood by one having ordinary skill in the art that construction of the described present disclosure and other components is not limited to any specific material. Other exemplary embodiments of the disclosure disclosed herein may be formed from a wide variety of materials, unless described otherwise herein.
[0133] For purposes of this disclosure, the term “operably coupled” (in all of its forms, couple, coupling, coupled, etc.) generally means the joining of two components (electrical or mechanical) directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two components (electrical or mechanical) and any additional intermediate members being integrally formed as a single unitary body with one another or with the two components. Such joining may be permanent in nature or may be removable or releasable in nature unless otherwise stated.
[0134] For purposes of this disclosure, the term “operably connected” (in all of its forms, connect, connecting, connected, etc.) generally means that one component functions with respect to another component, even if there are other components located between the first and second component, and the term “operable” defines a functional relationship between components.
[0135] It is also important to note that the construction and arrangement of the elements of the present disclosure as shown in the exemplary embodiments is illustrative only. Although only a few embodiments of the present innovations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible, e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc. without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown in multiple parts may be integrally formed, the operation of the interfaces may be reversed or otherwise varied, the length or width of the structures and/or members or connector or other elements of the system may be varied, the nature or number of adjustment positions provided between the elements may be varied. It should be noted that the elements and/or assemblies of the system may be constructed from any of the wide variety of materials that provide sufficient strength or durability, in any of the wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present innovations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the desired and other exemplary embodiments without departing from the spirit of the present innovations.
[0136] It will be understood that any described processes or steps within described processes may be combined with other disclosed processes or steps to form structures within the scope of the present disclosure. The exemplary structures and processes disclosed herein are for illustrative purposes and are not to be construed as limiting.
[0137] It is to be understood that variations and modifications can be made on the aforementioned structure and method without departing from the concepts of the present disclosure, and further it is to be understood that such concepts are intended to be covered by the following claims unless these claims by their language expressly state otherwise.