Surgical safety devices

Abstract

An apparatus (1) for use in a surgical procedure, the apparatus comprising a dock (2) for releasably securing a surgical device (3) by a releasable tether (4) of the device, the dock including one or more ports (5), the or each port adapted such that a visual indication of attachment or detachment is provided by the port or tether when the tether is secured.

Description

[Technical Field]

[0001] SURGICAL SAFETY DEVICE FIELD OF THE INVENTION The present invention relates to surgical safety devices, and more particularly to devices and methods for use in preventing foreign body retention in a patient following surgery. [Background technology]

[0002] According to the publication "Provisional Publication of Never Events reported as occurring between 1 April and 31 October 2022" published by NHS England on December 8, 2022, of the 243 Never Events, 58 events fell into the category of "Retained Foreign Object Post Procedure," and the two events with the highest incidence among them involved retained surgical swabs (10) and retained vaginal swabs (18).

[0003] Despite the establishment of a formal NHS Patient Safety Strategy in 2019, the overall level of Never Event occurrences has not significantly decreased, and foreign bodies left behind after procedures remain one of the most frequent.

[0004] In their patent application, WO 2020 / 084313, the inventors described concepts and devices intended to address such issues, and the solutions proposed thereby contribute to their mitigation. However, substantial problems remain, and a recurring theme is the role of human factors in such events. While the NHS Patient Safety Strategy recognizes strong systemic barriers that are crucial to preventing Never Events, it also recognizes that for some categories of events, design solutions that strengthen these barriers are also needed to further help mitigate the impact of these so-called human factors. In particular, optimizing the human-centered design of medical equipment, devices, EPMAs, electronic patient records, healthcare applications, and more to improve patient safety is recognized as important because it addresses one simple yet critical human factors problem: non-use. The most technologically innovative and successful design of a device is ineffective if it is never used, and generally, the more technically complex and involved a device is, the less likely it is to be used, especially in a busy, high-stress environment like an operating room.

[0005] In the publication "Reflecting on Why Surgical Swabs Are Being Left Behind and Exploring How This Could Be Prevented" (BJM, Volume 29, Issue 6, June 2, 2021), Spranzi suggests the introduction of anchoring points to connect the five swabs typically found in a swab pack. Each swab contains a length of web appropriate for patient use. The webs are connected by a suture at their proximal ends, which remain outside the patient's body. While the permanent connection feature has the advantage of reducing the likelihood of swabs being left behind, it can also be a disadvantage in some cases, as the connected web protruding from the patient's body can interfere with the clinician's work.

[0006] EP 1933795, EP 2399559, US 7795491 and US 7703674 relate to systems that include a barcode that can be attached to the swab. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2020 / 084313 [Patent Document 2] European Patent No. 1933795 [Patent Document 3] European Patent No. 2399559 [Patent Document 4] U.S. Patent No. 7,795,491 [Patent Document 5] U.S. Patent No. 7,703,674 [Non-patent literature]

[0008] [Non-Patent Document 1] Provisional Publication of Never Events reported as Occurring between 1 April and 31 October 2022 [Non-patent document 2] Reflecting on why Surgical Swabs are Being Left Behind and Exploring how this Could be Prevented” (BJM, volume 29, Issue 6, June 2, 2021) Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to seek to provide an improved surgical safety device that addresses the problem of non-use due to complexity while still achieving improved patient safety. [Means for solving the problem]

[0010] According to a first aspect of the present invention, there is provided an apparatus for use in a surgical procedure, the apparatus comprising a dock for releasably securing a surgical device by a releasable tether of the device, the dock including one or more ports, the or each port adapted such that a visual indication of attachment or detachment is provided by the port or tether when the tether is secured. Thus, the present invention is simple to operate yet reduces the never-ending occurrence of "foreign body left behind after the procedure" and allows a clinician to separate and manipulate the surgical device as needed during the procedure.

[0011] Preferably, the apparatus comprises one or more clips, the or each clip adapted to attach to the proximal end of the tether of each surgical device during use, and the or each clip adapted to releasably connect the tether to the dock.

[0012] In one embodiment, the dock may consist of only a plurality of clips, each adapted to connect with one another such that a complete dock is provided when all clips are connected, with a visual indication of the absence of a clip being provided by a gap between the clips. As will be appreciated, in this embodiment the clip and port are one and the same, resulting in a less complex device and therefore lower manufacturing costs.

[0013] Preferably, the or each clip is removably attachable to the tether to allow the clip to be reused.

[0014] To optimize the ergonomics of the device for use, it is preferred that the connected tethers be adapted to be positioned substantially parallel to one another during use. This can be achieved, for example, by an arrangement in which the ports are located along a single side or face of the device. When the device is used with substantially flat tethers, such as those present on surgical swabs, it is also preferred that each tether be connected to the device in the same plane.

[0015] In another embodiment, the dock may comprise a single part that includes a plurality of integrally molded ports, and the or each port may be configured such that the clip is received and retained within the or each port by the resilience of the material molded into the port or clip.

[0016] In one preferred embodiment, each port can include a user-visible opening positioned to receive a correspondingly shaped feature on the clip, with the opening being filled by a portion of the clip when the clip is properly inserted into the port. The part is preferably adapted so that release of the clip is effected by a user action applied to the part of the clip within the opening. This arrangement provides a visual indication that the clip is properly positioned within that port, thereby avoiding unintended release and loss of the surgical device. In one particularly preferred embodiment, the port can include resilient arms that describe a partial circle, and the corresponding clip can include a cylinder configured to fit within the arms. Each cylinder can include a circumferential groove positioned to receive the arms therein. Alternatively, each port can include a clip-receiving opening and a clip-release opening, and each corresponding clip can include a release portion adapted to engage the release opening and a tether locking location.

[0017] In another preferred embodiment, each port may include a keeper adapted to move from a first, unlocked state to a second, locked state, the keeper being arranged so that the keeper can only assume the locked state when the clip is in place within the port. Preferably, the keepers and / or ports are configured so that the position of the keeper, i.e., locked or unlocked, is visible to the user. In one configuration, the or each keeper may take the form of a door that can be opened and closed on a hinge, the door or each door including an opening through which the associated clip can be viewed.

[0018] According to another embodiment, the dock may comprise a tray. In one embodiment, the tray may comprise a lid. Preferably, the tray comprises a plastic material. Typically, the tray may include one or more recesses, the one or more recesses adapted to hold one or more clips. Preferably, the one or more clips may be secured to the dock. Advantageously, the one or more clips may be attached to the swabs during surgery, allowing the user to visually confirm how many swabs have been identified to ensure that no swabs are inadvertently left in the wrong position after the procedure.

[0019] In another embodiment of the invention, the dock may comprise a card for storing one or more clips before and / or after surgery. Advantageously, the card provides a means of storage for one or more clips before surgery and a means of visualizing the clips after the procedure to ensure that clips attached to the swab do not become lost after the procedure.

[0020] In another embodiment, the dock may include a clip including multiple recesses, each recess adapted to store one or more swabs. In this embodiment, one or more swabs can be placed into the one or more recesses, and once in place, the clip can be closed to retain the one or more swabs.

[0021] Preferably, the clip and / or dock includes a mechanism that prevents it from closing unless one or more swabs are engaged within the corresponding recesses.

[0022] Preferably, the clip comprises a metallic material which can be advantageously sterilized, hi one embodiment, the clip may be autoclaved.

[0023] In one embodiment, the clip may be reusable. Typically, the clip may have a smooth outer surface. Advantageously, providing a smooth outer surface on the clip may aid in sterilization of the clip. Typically, it may be easier to clean the clip when it is in the open configuration. In one embodiment, the clip may be washed with water after use and then sterilized.

[0024] Preferably, the one or more recesses are lined with a material that helps grip the swab and hold it in place within the recess. In one embodiment, the one or more recesses are lined with silicone.

[0025] Preferably, the clip comprises upper and lower arms joined by a hinge region, and preferably the ends of the upper and lower arms furthest from the hinge region comprise clip portions, preferably comprising a latch on the upper arm and a corresponding protrusion or recess on the lower arm, which protrusion or recess engages the latch, thus holding the clip in a closed position.

[0026] In another embodiment, the clip includes a button adapted to release the swab from the one or more recesses, for example, when the swab is to be discarded. In one embodiment, a user can press the button to open the clip and allow release of the swab. Advantageously, the button can be adapted to release the swab from the clip so that the swab can be sterilized.

[0027] According to a second aspect of the present invention, there is provided a kit for use in a surgical procedure comprising an apparatus as described above and a plurality of surgical devices, each surgical device including a tether receivable within a clip.

[0028] According to a third aspect of the present invention, there is provided a surgical method comprising tethering a surgical device to an apparatus as described herein above when used in a procedure.

[0029] According to a fourth aspect, there is provided a system comprising a dock and card combination for monitoring the removal of swabs after a surgical procedure.

[0030] Preferably, the system comprises one or more clips which may be removably attached to the card. Advantageously, the card provides storage for one or more clips prior to surgery and provides a means of visualising the clips after the procedure to ensure that clips attached to the swab do not become lost after the procedure.

[0031] According to a fifth aspect there is provided an image recognition system for detecting and / or counting the number of swabs in a dock according to the first aspect, the system comprising camera means, computer processing, image recognition means, with or without AI software.

[0032] Preferably, the system comprises a clip.

[0033] In one embodiment, the system can be connected to an electronic patient record system.

[0034] Preferably, the system communicates with the application. Preferably, the system is programmed to know the exact number of swabs that should be present. Preferably, the system prevents data from being uploaded to the electronic records system until the correct number of swabs are present. Advantageously, the system allows for independent verification of the number of swabs present.

[0035] Preferably, the clip and / or dock comprises a visual identifier that allows the clip and / or dock to be distinguished from the swab by a camera. Advantageously, providing a visual identifier on the clip and / or dock assists the user in identifying the swab after use (after use of a swab, it can be difficult for a medical professional to see the swab because the swab is typically contaminated with blood from the patient). Typically, the clip and / or dock is colored to distinguish it from the swab and make it visible to a camera. In one embodiment, the clip and / or swab comprise a material with a bright color that provides contrast with the background to help the camera detect the clip and / or swab.

[0036] In one embodiment, the system includes means for identifying whether there is blood on the clip and / or swab so that the blood can be removed from the clip and / or swab. Preferably, the system only allows data to be uploaded if the correct number of swabs are present. This advantageously provides an independent means of verifying that all swabs are present.

[0037] In one embodiment, the clip may include machine-readable information. In one embodiment, the machine-readable information may be a barcode or QR code printed on the clip and / or the dock. Advantageously, the system provides a digital counter for determining the number of swabs attached to the dock. Preferably, the swabs are provided in recesses in the dock, and once the correct number of swabs have been added, the clip or clips are closed. Preferably, the closed clips include machine-readable information that can be read by the system.

[0038] The invention will be further illustrated by way of example with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0039] [Figure 1]1A-1C show an example of a surgical device for use with the apparatus of the present invention. [Figure 2a] 1 is a perspective view of an apparatus according to a first embodiment of the present invention; [Figure 2b] 1 is a top plan view of an apparatus according to a first embodiment of the present invention; [Figure 3a] FIG. 2 is a perspective view of an apparatus according to a second embodiment of the present invention. [Figure 3b] FIG. 2 is a perspective view of an apparatus according to a second embodiment of the present invention. [Figure 3c] FIG. 2 is a top plan view of an apparatus according to a second embodiment of the present invention. [Figure 4a] FIG. 10 is a perspective view of an apparatus according to a third embodiment of the present invention. [Figure 4b] FIG. 10 is a perspective view of an apparatus according to a third embodiment of the present invention. [Figure 5a] FIG. 10 is a perspective view of an apparatus according to a fourth embodiment of the present invention. [Figure 5b] FIG. 10 is a perspective view of an apparatus according to a fourth embodiment of the present invention. [Figure 5c] FIG. 10 is a perspective view of an apparatus according to a fourth embodiment of the present invention. [Figure 6a] 1 is a perspective view of an apparatus according to a further embodiment of the present invention, the apparatus including a lid shown in an open configuration; [Figure 6b] FIG. 6b is a perspective view of the device of FIG. 6a, shown with the lid in a closed configuration. [Figure 7a] 1 is a perspective view of an apparatus according to a different embodiment of the present invention; [Figure 7b] 1 is a perspective view of an apparatus according to a different embodiment of the present invention; [Figure 7c] 1 is a perspective view of an apparatus according to a different embodiment of the present invention; [Figure 8] FIG. 10 is a perspective view of an apparatus according to another embodiment of the present invention. [Figure 9a] FIG. 10 is a top view of an apparatus according to another embodiment of the present invention. [Figure 9b] FIG. 9b is a top plan view of the device of FIG. 9a. [Figure 9c] FIG. 9b is a side view of the device of FIG. 9a. [Figure 10a] FIG. 10 is a top plan view of a further embodiment according to the present invention. [Figure 10b] FIG. 10b is a side view of the embodiment shown in FIG. 10a. [Figure 10c] FIG. 10b is a side view of the embodiment shown in FIG. 10a. [Figure 10d] FIG. 10b is a perspective view of the embodiment shown in FIG. [Figure 11a] FIG. 10 is a plan side view of an apparatus according to another embodiment of the present invention. [Figure 11b] FIG. 11b is a perspective view of an apparatus according to the embodiment of FIG. 11a. [Figure 12] FIG. 1 is a front view of a system according to one embodiment of the present invention. [Figure 13a] FIG. 10 is a top view of a system according to another embodiment of the present invention. [Figure 13b] FIG. 13b is a side view of the system of FIG. 13a. [Figure 14] FIG. 10 is a side view of a system according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0040] Referring to the drawings, there is provided an apparatus 1 for use in a surgical procedure, the apparatus comprising a dock 2 for releasably securing a surgical device 3 (FIG. 1) by a releasable tether 4 of the device, the dock including one or more ports 5, the or each port adapted such that when the tether is secured a visual indication of attachment or detachment is provided by the port or tether.

[0041] Referring initially to Figures 2a and 2b, a first embodiment of device 1 is shown. The device here comprises a hollow body 10 of generally rectangular square cross-section, which in this embodiment provides a dock 2. Body 10 includes a top surface 11, a bottom surface, a rear wall 12, and two short end walls 13. Instead of a front wall (in use and as viewed), the body defines five openings 14, each leading to a corresponding square cross-section bore 15 in the hollow interior of the body. Top surface 11 is substantially flat and includes five equally sized circular openings 16 regularly spaced across its surface, each aligned with a bore 15. Each bore 15 and its associated openings 14, 16 constitute a port 5. Rear wall 12 is substantially flat, except for a surface connecting piece 17.

[0042] In this embodiment, device 1 includes a clip 6 provided for forming a releasable connection between dock 2 and tether 4, as shown in FIG. 2b. Each clip comprises a body 18 sized and shaped to fit closely within bore 15. As can be seen, the top surface of each clip, adjacent its distal end, includes a circular button 19 that can be pressed into the hollow interior of body 18. Button 19 is connected to body 18 by a resiliently depressible flat 20. Adjacent its proximal end, each clip is provided with a tether attachment section 21, here consisting of a tether placement surface 22 and a hinged flap 23, both of which include a protrusion 24 on their inner surfaces and a lock formation 25 that allows the flap to be releasably locked in a closed position in use.

[0043] As will be appreciated, in Figure 2a, two docks are shown back to back.

[0044] In use, surgical device 3 is initially attached to clip 6 by tether 4. The end of tether 4 is placed within tether attachment section 21 of the clip, and hinged flap 23 is closed and locked via lock formation 25. Protrusion 24 helps prevent the tether from loosening.

[0045] Each clip 6 can then be releasably secured to dock 2 by inserting the clip into bore 15. Once the clip is inserted, button 19 is partially depressed by the mouth of bore 15 against the force of flat 20 until button 19 is aligned with opening 14, at which point it is allowed to spring back, thereby holding the clip in place to prevent accidental removal. The corresponding sizes and shapes of the bore and clip and the position of button 19 ensure that insertion is performed in the correct orientation. When it is desired to remove clip 6, button 19 is depressed, allowing clip 6 to be pulled outward from bore 15.

[0046] Referring specifically to Figure 2a, a degree of modularity is achieved by providing one additional port in addition to the usual five. The additional port 5 can be provided as a snap-off portion of the main body 10 if desired. Also, a surface connection 17 can be used to combine two docks.

[0047] All parts of the device shown in this embodiment may conveniently be manufactured by injection molding from a single plastic material, or alternatively, to achieve correct function, sterility and longevity of the depressible button 19, the dock 2 may be molded from a relatively hard Shore D hardness plastic material and the clip may be molded from a relatively softer Shore D hardness plastic material.

[0048] 3a-3c, a second embodiment of the device 1 is shown. The device here consists of a hexagonal, flat body 10 forming a dock 2. The body 10 comprises six clip segments, each of which is generally triangular and includes a front 101, a side 102, and bottom and top surfaces 103, 104. Each segment includes a connection formation on its side, which may be either a male formation 105 or a female formation 106. Each segment further includes a tether attachment section 107 which includes a tether port 108.

[0049] As will be readily apparent, this embodiment differs from the embodiment of Figures 2a and 2b in that it does not include separate dock and clip components. Instead, here the clips 6 together provide the dock 2 when connected together.

[0050] In use, the surgical device 3 is first attached to the clip 6 by a tether 4. The end of the tether 4 is placed into the tether attachment section 107 of the clip 6 via a tether port 108. Once all devices are tethered, the clips can be joined together by corresponding male and female formations 105, 106 to form a single dock 2.

[0051] The clip segments may conveniently be made by injection molding a suitable plastic material. Because there is no separate dock 2, the device of this embodiment is easier and cheaper to manufacture.

[0052] 4a and 4b, a third embodiment of the device 1 is shown. The device here consists of a generally flat rectangular body 10 forming a dock 2. The body 10 includes top and bottom surfaces 202, 203, front and rear long edges 204, 205, and a short edge 206. A port 5 is provided along the front edge 204, here in the form of a pair of arms 207, each pair forming a partial circle. In this embodiment, an additional port 5 is also formed in one of the short edges 206.

[0053] In this embodiment, the device includes clips 6 provided for forming a releasable connection between the dock 2 and the tether 4, as shown in Figure 4a. Each clip comprises a body 208, here in the form of a cylinder, including an equatorial groove 209 and front and rear end faces 210, 211. Each groove 209 is provided with a size and shape corresponding to an arm 207 of a port 5. The front end face 210 includes a tether attachment section 212 having a tether port 213.

[0054] In use, the surgical device 3 is initially attached to the clip 6 by the tether 4. The end of the tether 4 is placed into the tether attachment section 212 of the clip 6 via the tether port 213. Each clip 6 can then be releasably secured to the dock 2 by inserting the clip through the opening between the arms 207 of the port 5, which momentarily separates the arms. This is most conveniently done at the equatorial groove 209 so that the arms rest within the groove 209 when the clip 6 is fully received within the port 5.

[0055] All parts of the device shown in this embodiment can be conveniently manufactured by injection molding from a single plastic material, or, to achieve correct function, sterility and longevity of the resilient arm 207, the dock 2 can be molded from a relatively hard Shore D hardness plastic material and the clip can be molded from a relatively soft Shore D hardness plastic material.

[0056] 5a-5c, a fourth embodiment of the device 1 is shown. The device comprises five generally rectangular shallow trays 301, which together, in this embodiment, provide the dock 2. Each tray 301 comprises a side wall 302, a rear wall 303, and a front wall 304 that together define a central interior volume 305. A clip retaining formation 307 is disposed within the central volume 305. The trays are connected side-by-side via their side walls 302. Extending forwardly from the rear wall 303 of each tray is a keeper in the form of a hinged lid 306 (FIG. 5b), which is dimensioned to extend across the central interior volume 305 and thereby cover the central interior volume 305 in a closed position. The lid 306 includes an opening 309 and a resilient clip positioning formation 310 that, when viewed, extends downwardly into the central volume 305. The hinge of the lid may conveniently be a web of resilient material that biases the lid into an open position, sometimes known as a "live hinge." Each tray 301 defines a port 5 in this embodiment.

[0057] As in the previous embodiment, the device 1 includes clips 6 provided for forming a releasable connection between the dock 2 and the tether 4, as shown in Figure 5c. Each clip consists of a body 308 here in the form of upper and lower substantially square body faces connected along their edges and including tether ports 311 along opposite edges.

[0058] During use, the surgical device 3 is initially attached to the clip 6 by the tether 4. The end of the tether 4 is disposed within and captured in the clip 6 between the upper and lower body surfaces, protruding through the tether port 311. Each clip 6 can then be releasably secured to the dock 2 by inserting it into the port 5 when the hinged lid is in the open position. The clip body 308 is disposed within the clip retaining formation 307, which functions to precisely position the clip body within the central volume 305, and the hinged lid is moved to the closed position against the action of a bias. As the lid is pressed down toward the central volume, the clip positioning formation 310 on the lid descends to mate with the side of the clip body 308 and is held by an interference fit, thereby holding the lid closed against the force of the biased hinge.

[0059] All parts of the device shown in this embodiment can be conveniently manufactured by injection molding from a single plastic material, or, to achieve proper function, sterility and longevity of the elastic clip positioning formations 310, the dock 2 can be molded from a relatively hard Shore D hardness plastic material and the clip can be molded from a relatively softer Shore D hardness plastic material.

[0060] Referring to Figures 6a and 6b, the device includes a tray 300 having a lid 302, which can be in an open or closed configuration. In the embodiment shown in Figure 6a, the lid is in an open configuration, and in the embodiment shown in Figure 6b, the lid is in a closed configuration. The tray is substantially rectangular in shape and includes a base 304 having a plurality of walls 306. Preferably, the tray comprises a plastic material. The upper region of the tray walls is provided with a plurality of recesses 308. A clip 310 is preferably inserted into each of the recesses and secured in place. The clip 310 may be attached to a swab during a surgical procedure. Advantageously, the tray allows the user to determine if a swab is missing after the procedure.

[0061] 7a, 7b, and 7c illustrate an embodiment of the present invention in which a card 320 is provided that can be used to store clips 310 before and / or after surgery. In one embodiment, the card may comprise paper or card, while in another embodiment, the card may comprise a plastic material. Preferably, the clips are provided to the user in an embodiment attached to the card. When used during surgery, the clips are removed from the card 320 and applied to a swab. After surgery, the clips are reattached to the card. Advantageously, this arrangement means that the clips can be considered after surgery, ensuring that none of the clips are inadvertently left in the patient. In one embodiment, the clips may comprise a plastic material. In another embodiment, the clips may comprise a metallic material.

[0062] Figure 8 shows an embodiment in which a tray 300 is provided in combination with a card 320 that includes a plurality of clips 310. Prior to surgery, the clips and card are removed from the tray. The clips may then be secured in recesses provided in the top of the tray wall, as shown, for example, in Figures 6a and 6b.

[0063] The tray and / or clip in this embodiment may comprise a plastic material.

[0064] Figures 9a, 9b, and 9c show another embodiment of the invention in which a tray 300 includes a plurality of wells 330. The wells 330 are located along the edges of two parallel outer walls of the tray 300. A clip 310 is then placed within each well of the tray. In the embodiment shown in Figure 9a, the clips are positioned across the wells of the tray. In use, a user attaches the clips to swabs during surgery, and following the procedure, the clips are positioned across the wells of the tray. The embodiment shown in Figures 9a-9c provides an alternative arrangement that allows a user to visualize the clips, and therefore the swabs, used after surgery.

[0065] The tray and / or clip in this embodiment may comprise a plastic material.

[0066] Figures 10a-10d show a further embodiment of the invention in which a tray 300 includes a plurality of recesses that can be used to accommodate clips. The tray may also include a lid 350 for sealing the tray, for example for hygiene purposes.

[0067] 11a and 11b, a dock 450 comprises a clip 400 including a plurality of recesses 402, each adapted to store one or more swabs 404. FIGS. 11a and 11b illustrate a reusable swab counter. In this embodiment, one or more swabs are placed into one or more recesses, and once in place, the clip can be closed to hold the one or more swabs. The clip includes a mechanism that prevents the clip from closing if one of the swabs is not engaged in a corresponding recess. In this embodiment, the one or more recesses are lined with a material, such as silicone, that helps grip and hold the swab in place within the recess. As shown in FIGS. 11a and 11b, the clip includes an upper arm 406 and a lower arm 408, joined by a hinge region 410. Preferably, the ends of the upper and lower arms furthest from the hinge region include clip portions, preferably comprising a latch on the upper arm and a corresponding protrusion or recess on the lower arm that engages the latch, thus holding the clip in a closed position. In another embodiment, the clip includes a button 412 adapted to release a swab from one or more recesses, for example, when a swab is placed in it. In this embodiment, the clip comprises a metallic material and is preferably sterilizable.

[0068] Referring to FIG. 12, an image recognition system for detecting and / or counting the number of swabs in a dock is also provided, the system comprising a camera means, computer processing means, and image recognition software with or without AI software. As shown in FIG. 12, electronic means provide an additional method of counting the number of swabs in the dock to assist the medical professional during the procedure. In one embodiment, the system can be connected to an electronic record system for the patient. In the embodiment shown in FIG. 12, a clip is inserted into the dock and recorded by computer vision AI. The results are displayed on a computer screen for the medical professional to view. In this embodiment, the illustrated system recognizes that five swabs are attached to the dock.

[0069] Preferably, the system communicates with the application. Preferably, the system is programmed to know the exact number of swabs that should be present. Preferably, the system prevents data from being uploaded to the electronic records system until the correct number of swabs are present. Advantageously, the system allows for independent verification of the number of swabs present.

[0070] The clip and / or dock comprise a visual identifier that allows the clip and / or dock to be distinguished from the swab by a camera. Advantageously, providing a visual identifier on the clip and / or dock assists the user in identifying the swab after use (after use of a swab, it can be difficult for a healthcare professional to see the swab because the swab is typically contaminated with blood from the patient). Typically, the clip and / or dock are colored to distinguish the clip and / or dock from the swab and to make them visible to a camera. In one embodiment, the clip and / or swab comprise a material having a bright color that provides contrast with the background to help the camera detect the clip and / or swab.

[0071] In one embodiment, the system includes means for identifying whether there is blood on the clip and / or swab so that the blood can be removed from the clip and / or swab. Preferably, the system only allows data to be uploaded if the correct number of swabs are present. This advantageously provides an independent means of verifying that all swabs are present.

[0072] In one embodiment, the clip may include machine-readable information. In one embodiment, the machine-readable information may be a barcode or QR code printed on the clip or dock. Advantageously, the system provides a digital counter for determining the number of swabs attached to the dock. Preferably, the swabs are provided in recesses in the dock, and once the correct number of swabs have been added, the clip or clips are closed. Preferably, the closed clips include machine-readable information that can be read by the system.

[0073] The electronic means may be connected to an application that may be adapted to cumulatively count and detect clips using a camera with or without AI and image recognition software to detect and display the number of clips to the user.

[0074] Figure 13a is a top view of a swab counter system according to one embodiment of the present invention. Figure 13a shows a dock 450 with multiple recesses 460. Swabs are placed in the recesses in the dock, and clips 400 are provided to hold the swabs 404 in place. The clips include a barcode 480 that provides a unique identifier. Once the swab is placed in the recess, the clip is closed and the system reads the barcode. Figure 13b shows a side view of the system of Figure 13a.

[0075] 14 shows a side view of a system according to one embodiment of the present invention, in which a clip 400 is provided with multiple grooves 500. A swab 404 is placed in each groove, and the clip is closed once each swab is placed in its corresponding groove. The clip includes a barcode 480, which is then scanned to indicate that all of the swabs are present. The system advantageously provides a swab counter that independently verifies that all of the required swabs have been accounted for.

[0076] In use, a swab is placed into the recess in the dock in Figure 13 or the groove in the clip in Figure 14. Once the required number of swabs are held in place, the clip or clips are closed and the system reads the barcode, providing an independent means of verifying that all required swabs are present.

Claims

1. 1. An apparatus for use in a surgical procedure, the apparatus comprising a dock for releasably securing a surgical device by a releasable tether of the device, the dock including one or more ports, the or each port adapted such that a visual indication of attachment or detachment is provided by the port or tether when the tether is secured.

2. The device of claim 1 , wherein a tactile indication and a visual indication are provided.

3. 3. The apparatus of claim 1 or 2, further comprising one or more clips, the or each clip adapted to attach to a proximal end of a tether of a surgical device during use, and the or each clip adapted to releasably connect the tether to the dock.

4. 4. The device of claim 1, wherein the dock is comprised solely of a plurality of clips, each adapted to connect with each other such that a complete dock is provided when all clips are connected, and wherein the visual indication of the absence of a clip is provided by a gap between the clips.

5. 5. A device according to any preceding claim, wherein the or each clip is removably attachable to a tether.

6. 4. A device according to any one of claims 1 to 3, adapted so that, in use, the connected tethers are arranged substantially parallel to one another.

7. The device of claim 6 , wherein the ports are located along a single side or face of the device.

8. 8. A device according to claim 6 or 7, wherein when the device is used with substantially flat tethers, such as those present on a surgical swab, each tether is connectable to the device in the same plane.

9. 9. The device of any one of claims 1 to 3 and 5 to 8, wherein the dock is constructed from a single piece, the piece including a plurality of integrally molded ports.

10. 10. A device according to claim 9, wherein the or each port is configured such that a clip is received and retained within the or each port by the resilience of a moulding material of the port or clip.

11. 11. The device of claim 1, wherein each port can include a user-visible opening positioned to receive a correspondingly shaped formation of a clip, the opening being filled by a portion of the clip when the clip is properly inserted into the port.

12. 12. The device of claim 11, wherein the part is adapted such that release of the clip is effected by a user action applied to the part of the clip within the opening.

13. 13. A device according to any preceding claim, wherein the or each port comprises a resilient arm describing a part circle, and the corresponding clip comprises a cylinder configured to fit within the arm.

14. 14. The apparatus of claim 13, wherein each cylinder includes a circumferential groove positioned to receive the arm therein.

15. 13. The device of claim 1, wherein each port includes a clip receiving opening and a clip release opening, and each corresponding clip includes a release portion adapted to engage the release opening and a tether securing location.

16. 13. The device of claim 1, wherein each port includes a keeper adapted to move from a first unlocked state to a second locked state, the arrangement being such that the keeper can only assume the locked state when a clip is in place within the port.

17. 17. The device of claim 16, wherein the keeper and / or the port are configured so that the position of the keeper, i.e., locked or unlocked, is visible to a user.

18. 18. Apparatus according to claim 17, wherein the or each keeper is a door that can be opened and closed on a hinge, the or each door including an opening through which an associated clip can be viewed.

19. 19. The device of any one of claims 1 to 18, wherein the dock comprises a tray with one or more recesses, the one or more recesses configured to receive a clip.

20. 19. The apparatus of claim 1, wherein the dock comprises a card, and the one or more clips are reversibly attached to the card.

21. 19. The device of any one of claims 1 to 18, wherein the dock comprises a clip including a plurality of recesses, each recess adapted to store one or more swabs.

22. 22. The device of claim 21, wherein the clip comprises an upper arm and a lower arm, the upper arm and the lower arm being joined by a hinge region.

23. 23. The device of claim 21 or 22, wherein the clip comprises a button adapted to release the one or more swabs from the one or more recesses.

24. 24. The device of any one of claims 1 to 23, wherein the device is reusable.

25. 25. A kit for use in a surgical procedure comprising an apparatus according to any preceding claim and a plurality of surgical devices, each of the surgical devices including a tether receivable within a clip.

26. A system comprising a device according to any one of claims 1 to 20, said system comprising a dock and a card.

27. 25. A surgical method comprising tethering a surgical device to an apparatus as claimed in any one of claims 1 to 24 when used in a procedure.

28. 25. An image recognition system for detecting and / or counting the number of swabs in a dock according to any one of claims 1 to 24, said system comprising camera means and computer processing means, with or without AI software.

29. 30. The image recognition system of claim 28, further comprising a clip.

30. 30. The image recognition system of claim 28 or 29, wherein the system is capable of connecting to an electronic patient record system.

31. 31. The image recognition system of claim 28, 29, or 30, wherein the system is in communication with an application.

32. 32. The image recognition system of any one of claims 28 to 31, wherein the clip and / or dock is provided with a visual identifier.

33. 33. The system of claim 32, wherein the visual identifier is a color that enables the clip and / or dock to be distinguished from a swab.

34. 34. The system of claim 32 or 33, wherein the clip and / or swab comprises machine-readable information.

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