Abstract
Certain embodiments are directed to accessories for the use of portable probes, tablets and smartphones during ultrasound guided procedures requiring real-time visualization and sterile precautions. The embodiments include sterile procedural kits allow the placement of tablets or smartphone into sealed compartment that maintain sterility, allow for touch screen adjustments and continuous visualization.
Claims
1. A kit comprising a procedural tray configured for assembling and sterile use of a smartphone, a tablet, a portable imaging system, or wireless technologies during needle guided interventions or surgery.
2. A sterile drape comprising compartments configured to allow visualization and sterile manipulation of smartphone, tablet, or portable imaging systems during a procedure, the sterile drape configured and aligned with a package tray for opening and sealing of the drape in sterile fashion.
3. (canceled)
4. A mount system for a smartphone to be attached directly on the top of a portable ultrasound probe, the mount system having an adaptor configured to fit over the proximal end of an ultrasound probe, the adaptor having a reversable attachment portion that is configured to attach to a viewing device and then be reversibly coupled to the adaptor.
5. The system of claim 4, wherein the adaptor is coupled to the attachment portion by a disk/slot, ball/cup, cradle, threaded, or magnetic coupling.
6. The system of claim 4, wherein the system is configured to allow tilting, rotation, and orientation of the viewing device.
7. The system of claim 4, wherein the adaptor has a belt or waistband clip allowing the mount system to work interchangeably as a holster for transport of the portable probe.
8. The system of claim 4, wherein the adaptor comprises a tread, groove, or spool configured to hold cabling.
9. The system of claim 4, comprising a clear sterile cover that is positioned over and contains a probe, mount, and smartphone assembly and is configured to allow screen visualization and touch screen manipulation of the viewing device when in use.
10. (canceled)
11. (canceled)
Description
DESCRIPTION OF THE DRAWINGS
[0039] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of the specification embodiments presented herein.
[0040] FIG. 1 illustrates the sterile package or tray containing all the sterile supplies needed for a procedure.
[0041] FIG. 2 illustrates the peel off the smaller cover, the edges of the small cover contain adhesive material and removal is performed by continuous lift of tab.
[0042] FIG. 3 illustrates the sterile insertion of the ultrasound probe (6) and cable (7) into the respective slot (5).
[0043] FIG. 4 illustrates the smartphone or tablet with display screen (8) insertion on the slot (4).
[0044] FIG. 5 illustrates the probe (6) and the tablet (8) located in separate compartments inside the drape before the opening of the large cover (3).
[0045] FIG. 6 illustrates the opening of the large cover (3) of the package or tray (1) giving access to the sterile supplies to perform the procedure and the drape (14).
[0046] FIG. 7 illustrates the step after removal of the sterile supplies, the peel away cover (15) is removed and a plastic film (16) with adhesive substance is flipped over to provide sterile cover for the slots (4 & 5) where the probe, cable and tablet viewer were inserted.
[0047] FIG. 8 illustrates the adhesive on the plastic film (16) facing the drape and provides complete sterile seal of the slots (4 & 5) and adjacent face where the probe and tablet had contact during the insertion.
[0048] FIG. 9 illustrates the drape 14 with surface entirely sterile, being removed from the package or tray (1) by the sterile gloved hands (17) of the health care provider.
[0049] FIG. 10 illustrates the drape (14) surface that will be in contract with the patient.
[0050] FIG. 11 illustrates the placement and opening of the drape (14) on the patient (22), the fenestration (20) should aim the final expected position of the procedure site (21).
[0051] FIG. 12 illustrates the process of unfolding the drape (14).
[0052] FIG. 13 illustrates the final position of the drape (14) on the patient (22).
[0053] FIG. 14 illustrates the opening the compartment (24) on the drape that will give access to the probe (6), tablet (8), and central line supplies (27).
[0054] FIG. 15 illustrates the probe (6) placement on the patient's neck displaying the images of neck vessels on the tablet screen (8).
[0055] FIG. 16 illustrates the process of imaging using portable ultrasound probe (6), respective cable (7), and the smartphone used as a display screen or viewer for real time imaging.
[0056] FIG. 17 illustrates the parts of mounting system that connects the probe (6), with the ultrasound system.
[0057] FIG. 18 illustrates the assembly of probe (6), smartphone (8), and mounting system (30 and 36).
[0058] FIG. 19 illustrates the sterile package or tray (40) containing all the sterile supplies needed for a procedure (1).
[0059] FIG. 20 illustrates the small cover (42) opening by peeling off from the large cover (41) of the tray (40).
[0060] FIG. 21 illustrates the insertion of the assembly probe (6), smartphone and mount (30) inside the package through the package opening.
[0061] FIG. 22 illustrates the aligning plate on the back of the mounting system (44), is aligned and attached to the two alignment pins (43).
[0062] FIG. 23 illustrates the large cover (41) being peeled off from the package (40) showing the internal components of the package.
[0063] FIG. 24 illustrates the open tray (40) with the probe now inside the cover (47) and the top closure (45) in open position.
[0064] FIG. 25 illustrates the top cover (45) folded in a half closing the compartment.
[0065] FIG. 26 illustrates the clear film (46) that allows visualization and touchscreen manipulation of the smartphone (8) by the provider using sterile gloves (48).
[0066] FIG. 27 illustrates an example of real time ultrasound guided procedure where the provider is using sterile gloves (48) holding the assembly with the left hand and the syringe (52) with needle attached (51) with the right hand.
[0067] FIG. 28 front view of one example of an ultrasound adaptor device.
[0068] FIG. 29 back view of one example of an ultrasound adaptor device.
[0069] FIG. 30 top view of one example of an ultrasound adaptor device.
[0070] FIG. 31 bottom view of one example of an ultrasound adaptor device.
[0071] FIG. 32 side view of one example of an ultrasound adaptor device.
[0072] FIG. 33 perspective view of one example of an ultrasound adaptor device.
[0073] FIG. 34 side view of one example of an ultrasound adaptor device with viewing device attachment, e.g., smart phone, assembled with an ultrasound probe.
[0074] FIG. 35 front view of an ultrasound probe, adaptor device, and a smart phone assembly.
DESCRIPTION
[0075] The following discussion is directed to various embodiments of the invention. The term “invention” is not intended to refer to any particular embodiment or otherwise limit the scope of the disclosure. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.
[0076] FIG. 1 illustrates the sterile package or tray containing all the sterile supplies needed for the procedure (1), showing two covers, one small (2) covering a smaller area and one large (3) covering the remaining top package or tray.
[0077] FIG. 2 illustrates the peel off the smaller cover, the edges of the small cover contain adhesive material and removal is performed by continuous lift of tab. The removal will detach the small cove (2), from the large cover (3) and tray (1). Upon removal of the small cover (2) access of two slots for respective insertion of probe (5) and smartphone or tablet viewer (4) become available. The slots will communicate with respective compartment inside the drape.
[0078] FIG. 3 illustrates the sterile insertion of the ultrasound probe (6) and cable (7) into the respective slot (5). The tablet or viewer display (8) should face down before the insertion on slot respective slot (4).
[0079] FIG. 4 illustrates the smartphone or tablet with display screen (8) insertion on the slot (4). The insertion of the probe (6) and tablet (8) into the respective slots is performed with the large cover (3) for the tray (1) in place.
[0080] FIG. 5 illustrates the probe (6) and the tablet (8) located in separate compartments inside the drape before the opening of the large cover (3). Prior to using the kit and initiating the procedure any auxiliary equipment's or devices will need to be assembled and/or prepared. In certain aspects an ultrasound probe and tablet or smartphones devices be acquired and prepped for use. In certain aspect ultrasound conducting gel material is positioned inside and outside of the transducer cover in order to enhance ultrasound transmission to the transducer.
[0081] FIG. 6 illustrates the opening of the large cover (3) of the package or tray (1) giving access to the sterile supplies to perform the procedure and the drape (14). The sterile supplies include sterile mask (9), hat (10), gown (11), gloves (12) and sponge stick (13) with antiseptic solution such as alcoholic chlorohexidine and alcoholic iodine to perform skin antisepsis. The sterile supplies are located on top of a peel-off paper and plastic film cover (15) that is attached to the drape (14).
[0082] FIG. 7 illustrates the step after removal of the sterile supplies, the peel away cover (15) is removed and a plastic film (16) with adhesive substance is flipped over to provide sterile cover for the slots (4 & 5) where the probe, cable and tablet viewer were inserted.
[0083] FIG. 8 illustrates the adhesive on the plastic film (16) facing the drape and provides complete sterile seal of the slots (4 & 5) and adjacent face where the probe and tablet had contact during the insertion. The seal also creates a physical closure for the opening of the respective slots (4 & 5) preventing the probe (6) and tablet (8) from dropping out of respective compartment during the manipulation of the drape (14).
[0084] FIG. 9 illustrates the drape 14 with surface entirely sterile, being removed from the package or tray (1) by the sterile gloved hands (17) of the health care provider. The hands will hold each side and simultaneously lift the drape from package. The plastic film (16) covering the respective slots are facing up.
[0085] FIG. 10 illustrates the drape (14) surface that will be in contract with the patient. This surface is the opposite side of the drape displayed in all the previous figures. This surface of the drape contains a fenestration (20) with adhesive material of the edges covered by a peel off paper cover (18). The paper cover (18) should be removed before placement of the drape (14) on the patient's body surface.
[0086] FIG. 11 illustrates the placement and opening of the drape (14) on the patient (22), the fenestration (20) should aim the final expected position of the procedure site (21). FIG. 11 is an example of central line catheterization of a neck vein, the internal jugular vein.
[0087] FIG. 12 illustrates the process of unfolding the drape (14), the edges of the drape contains respective labeling (23) from which direction the edge should be directed in relation to the patient's body. The labels on the edges contains arrows and words such as top, bottom, right and left. The labels also contain numbers to give directives for sequence and order in which the edges should be opened.
[0088] FIG. 13 illustrates the final position of the drape (14) on the patient (22), Note the fenestration (20) giving access to the patient's neck. The compartment (24) will give access to the probe, tablet and line placement supplies.
[0089] FIG. 14 illustrates the opening the compartment (24) on the drape that will give access to the probe (6), tablet (8), and central line supplies (27). The compartment for the tablet contains a clear and transparent film (25) that allows visualization of the images on the table display, the film also does not interfere with the tablet touch screen functionality. The probe compartment contains a flexible plastic cover (26) that allows placement of ultrasound gel on both sides of the cover. Rubber bands can be used to maintain close contact between the cover, gel and probe (6).
[0090] FIG. 15 illustrates the probe (6) placement on the patient's neck displaying the images of neck vessels on the tablet screen (8). Note the probe (6) and cable (7), are covered by flexible cover (26). Note the images of neck vessels displayed on the tablet (8) are visualized through the transparent film (25). The film (25) also prevents contamination of the sterile field. The ultrasound probe and tablet will be accessible inside the respective sterile compartments. When the ultrasound is appropriately positioned instrument package (24) containing the necessary supplies for the central line placement is opened to access intervention supplies. The instrument package (24) will be configured to be inside the drape (14) when the drape is folded for packaging of the kit. Once the kit is accessed and drape deployed the instrument package (24) will be positioned in a convenient location relative to the opening for ultrasound transducer. The ultrasound is used to guide placement of central line, the placement finalized and secured. The instrument package can contain one or more surgical or medical tools necessary to perform a particular medical or surgical procedure. This can be most any type of surgical or medical equipment or tools such as, for example, needle(s), cannula(s), sponge(s), wipe(s), sutures, forceps, scissor(s), and scalpels of various configurations. Other non-limiting examples of supplies or tools include sponges, syringes, anesthetics, needles, clamps, cannulas, vials, gauze pads, swabs, stapling devices, dissectors, and sutures to name a few.
[0091] FIG. 16 illustrates the process of imaging using portable ultrasound probe (6), respective cable (7), and the viewing device (8), e.g., a smartphone used as a display screen or viewer for real time imaging. The use of such portable devices during sterile invasive procedures can be achieved with the embodiments herein described.
[0092] FIG. 17 illustrates the parts of one example of a mounting system that connects the probe (6), with the ultrasound system. A conical cup like part (30) in which the internal surface mirrors or conforms to the top or proximal external surface of the probe (6). The external surface of the part (30) contains a thread (32) for the placement and stabilization of a cable in a loop fashion. The dimension of the thread root (31) allows pressure fit and stabilization of the cable. A first attachment component (33), e.g., ball, attaches to a second attachment component (35), e.g, a socket, with, in this circumstance, a threaded bolt and nut (34) for tightening the mounting (36) for the smartphone.
[0093] FIG. 18 illustrates the assembly of probe (6), smartphone (8), and mounting system (30 and 36). The thread (32) for the placement and stabilization of the cable in a loop fashion. The dimension of the thread root (31) allows pressure fit and stabilization of the cable (7).
[0094] FIG. 19 illustrates the sterile package or tray (40) containing all the sterile supplies needed for the procedure (1), showing two covers, one small (42) covering a smaller area and one large (41) covering the remaining top package or tray.
[0095] FIG. 20 illustrates the small cover (42) opening by peeling off from the large cover (41) of the tray (40). Two pins (43) for alignment and attachment to the back of the mounting (36) for the smartphone.
[0096] FIG. 21 illustrates the insertion of the assembly probe (6), smartphone and mount (30) inside the package through the package opening. The opening is created by removal of the small cover (42). Note the rest of package is sealed with the large cover (41)
[0097] FIG. 22 illustrates the aligning plate on the back of the mounting system (44), is aligned and attached to the two alignment pins (43). Note the placement of the assembly inside the package (40), alignment and attachment of the plate (44) to the pins (43) is performed before opening of the large cover (41). Note the cover (41) is in place and not removed from the package (40).
[0098] FIG. 23 illustrates the large cover (41) being peeled off from the package (40) showing the internal components of the package.
[0099] FIG. 24 illustrates the open tray (40) with the probe now inside the cover (47) and the top closure (45) in open position. The top cover (45) folds in a half, the first half is an open frame where the assembly will be inserted, and the second half is covered by a clear film (46).
[0100] FIG. 25 illustrates the top cover (45) folded in a half closing the compartment. The external surface is all sterile sealing the non-sterile assembly on the inside.
[0101] FIG. 26 illustrates the clear film (46) that allows visualization and touchscreen manipulation of the smartphone (8) by the provider using sterile gloves (48). Note the cover (45) for the probe (6) and the cover (45) for the smartphone (8) provides complete sealing of the assembly.
[0102] FIG. 27 illustrates an example of real time ultrasound guided procedure where the provider is using sterile gloves (48) holding the assembly with the left hand and the syringe (52) with needle attached (51) with the right hand. Note the cover (47) over the probe (6) and the cover (45) over the smartphone (8).
[0103] FIGS. 28 to 35 illustrate various views of an ultrasound adaptor for mounting a device on an ultrasound prove and a system incorporating the ultrasound adaptor (mounting system).
[0104] FIG. 28 illustrates the front view of mount or attachment system showing favorite embodiment in which the mount system fits over the ultrasound probe 51—Outer shell that fits over the probe 53—frame with slot for disk attachment. 60—Clip feature that gives the mount system additional feature to be used as a holster to facilitate transport of the portable probe.
[0105] FIG. 29 illustrates the back view of mount or attachment 51—Outer shell that fits over the probe, 52-53—frame with slot for disk attachment. 60—Clip feature.
[0106] FIG. 30 illustrates the top view—of mount or attachment system showing favorite embodiment in which the mount system fits over the ultrasound probe 51—outer shell that fits over the probe, 52—central opening for probe placement, 53—frame with slot for disk attachment. 60—Clip feature.
[0107] FIG. 31 illustrates the bottom view of mount or attachment system showing favorite embodiment in which the mount system fits over the ultrasound probe, 51—outer shell that fits over the probe, 52—central opening for probe placement, 53—frame with slot for disk attachment. 60—Clip feature.
[0108] FIG. 32 illustrates side view showing 51—Outer shell that fits over the probe, 53—frame with slot for disk attachment. 60—Clip feature.
[0109] FIG. 33 illustrates the perspective view—51—outer shell that fits over the probe, 52—central opening for probe placement, 53—frame with slot for disk attachment. 60—Clip feature.
[0110] FIG. 34 illustrates the side view showing the assembly process using 6—the portable ultrasound probe, 8 the smartphone and 52 the mount system by inserting 54—the disk into the frame 53. On the left showing the alignment of the disk with the slot into the frame. On the right coupling the disk into the slot, to combine the smartphone with mounting system and portable ultrasound.
[0111] FIG. 35 illustrates the front view—showing the assembly 51—outer shell of attachment or mount system, 8—smartphone, ultrasound probe. Note the smartphone is now attached to the proximal end of the smartphone. The display of the smartphone provides continuous visualization of the ultrasound images and does not interfere with the scanning given by the transducer located on the distal end of the ultrasound probe.
[0112] The adaptor (e.g., FIG. 28) for a smartphone or other viewing device can be attached directly on the top or proximal end of the portable ultrasound probe (6) to provide a stable and continuous image, contain the cable, and not interfere with the scanning process. The viewing device's (8), e.g., a smartphone, position on top of the probe (6) puts the screen display on the same field of vision to perform real-time ultrasound-guided procedures. The attachment (53/54) encompasses physical or magnetic embodiment methods. The physical attachments include ball and socket, disk and slot, cradle, threading system, etc. The mounting system also can contain a magnetic connection between the smartphone (8) and the probe (6). The mounting system allows smartphone tilt, rotation, and different portrait orientations. The mount feature contains a tread, groove, or spool feature to hold the cable and prevent contamination.
[0113] A sterile cover is shaped to fit or conform to the assembly (probe (6), mount (53/54), and smartphone (8)), inside a clear sterile cover that allows screen visualization and touch screen manipulation of the smartphone display. The final assembly (portable probe (6), smartphone (8), and adaptor, with or without a probe cover) is entirely handheld for scanning using one hand.
