A protector for placement over a patient body site

Abstract

A cannulation site protector comprising adhesive mounting foot pads. A protector for placement over a patient body site, the protector including: a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient; a plurality of foot pads connected to or integral with the peripheral portions and spaced apart from one another at peripheral mounting positions on the peripheral portions, the foot pads being configured to mount the protective cover over the patient body site so that at least a main portion of the protective cover is disposed in an elevated position relative to the cannulation site, wherein the foot pads include adhesive to adhere to skin of the patient adjacent the cannulation site. A method of protecting a patient body site, the method including the steps of: providing a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient; sticking a plurality of foot pads connected to or integral with the peripheral portions to the skin of the patient adjacent the cannulation site.

Description

A protector for placement over a patient body siteTechnical Field

[0001] The present technology relates generally to cannula protectors.Background Art

[0002] Cannulae are very useful devices for introducing fluid to veins and arteries, but they are known to fail, from various failure mechanisms.

[0003] First, cannula failure can arise from the tip of the cannula bumping up against the tunica intima (lining) of the vein. This circumstance generally results in infiltration, which is where fluid enters the tissue surrounding the vein, rather than the vein itself. Also, the failure can result in phlebitis (inflammation) and other issues.

[0004] Having a protective dome over a cannulation site can protect against mechanical bumps delivered to the cannula. Also, being able to see the cannulation site, and therefore any associated redness and swelling that may arise, are good ways to inhibit at least some of the abovementioned complications.

[0005] Known cannula protectors have tiltable and clear domes, and thus do provide visibility and access to a cannulation site, but do not provide suitable protection for difficult or different cannulation sites. Three known difficult cannulation sites include: the inside of the elbow (cubital fossa); the back (dorsum) of the hand; and the thumb side of the wrist (cephalic).

[0006] Known cannula protectors also are heavy, expensive and overcomplex.

[0007] Others are too simple and inflexible, in that they can be just a dome strapped and taped to the patient over and around the site. The straps and / or tape can be applied too tightly, or too loosely, and thus it requires too much operator input, relying on the skill of the physician to secure the cannula protector. Also the dome is not removable without removing all that tape, which is clearly undesirable. The dome has to then be reapplied with the same degree of caution, and several reapplications may be needed each time a new inspection of the site has to be carried out.

[0008] The present invention seeks to ameliorate one or more of the above mentioned disadvantages or at least provide a new alternative product.Summary of Invention

[0009] Broadly, the present invention seeks to provide a cannulation site protector comprising adhesive mounting foot pads.

[0010] In accordance with one aspect of the present invention therefore there is provided a protector for placement over a patient body site, the protector including:a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient;a plurality of foot pads connected to or integral with the peripheral portions and spaced apart from one another at peripheral mounting positions on the peripheral portions,the foot pads being configured to mount the protective cover over the patient body site so that at least a main portion of the protective cover is disposed in an elevated position relative to the cannulation site,wherein the foot pads include adhesive to adhere to skin of the patient adjacent the cannulation site.

[0011] The arrangement is such that in use, the protector remains on the skin for a few days, perhaps a week or two. The feet are pads, of a selected area, limited in such a way that they are pads, not straps or bands, to reduce dermatitis, trauma and infection risk.

[0012] Even though the feet are pads, they do provide secure mounting and improved structural strength for the protective cover. The feet pads, being adhered to the skin, use the skin as a foundation or base member to stiffen the protective cover. This means there is a reduced tendency for the protective cover to splay outwards if there is a bump or other force applied to it from above.

[0013] In one embodiment the protective cover includes a frame and a closure.

[0014] In one embodiment the frame includes a plurality of peripheral portions in the form of frame elements to inhibit access to the cannulation site.

[0015] In one embodiment the peripheral frame elements include a plurality of legs to elevate the closure above the cannulation site.

[0016] In one embodiment the plurality of legs include foot mounts at a base thereof, to mount a foot.

[0017] In one embodiment the foot mounts and feet pads include a coupler or joint to facilitate foot movement about one or more axes relative to the leg.

[0018] In one embodiment the coupler or joint is a ball joint to facilitate movement about a plurality of axes relative to the leg.

[0019] In one embodiment the main cover portion includes the closure.

[0020] In one embodiment the closure is movable between an open position distal the cannulation site, and a closed position over the cannulation site.

[0021] In one embodiment the frame includes at least one closure retention element extending between two portions of two frame elements to retain the cover.

[0022] In one embodiment the frame includes a hinge to facilitate the closure moving between the open and the closed positions.

[0023] In one embodiment the frame includes an arch to elevate the hinge. This is advantageous because it provides frame clearance to provide room for cannula lines and to keep pressure off the cannulated vein or artery.

[0024] In one embodiment the hinge is integral with the arch, in that the arch itself is configured to twist along its length during movement between the open position and the closing positions. This one arrangement further advantageously provides a biasing means for the closure, which biases the closure to the open position.

[0025] In one embodiment the closure retention element is resilient to facilitate opening and closing of the closure.

[0026] In one embodiment the closure retention element is extensible to facilitate stretching over the end of the closure during the act of closing the closure in the closed position.

[0027] In one embodiment the closure retention element is arched to facilitate patency of an associated vein or artery.

[0028] In one embodiment the closure retention element is a rubber material.

[0029] In one embodiment the hinge is a rubber material.

[0030] In one embodiment the hinge is TPE or silicone or suitable material.

[0031] In one embodiment the frame is constructed from elongate elements of TPE, silicone or other suitable flexible and resilient material.

[0032] In one embodiment the one or more legs are disposed on opposite sides of the frame and extend upwards from the feet to elevate the closure.

[0033] In one embodiment the closure is transparent to facilitate ready visualisation and inspection of the cannulation site.

[0034] In one embodiment the closure is at least partially domed to accommodate the cannula and to inhibit and deflect impacts.

[0035] In one embodiment a strap retainer is provided to retain the closure in a closed position, and is in the form of a retaining saddle which keeps an end strap in a saddle channel between two saddle walls.

[0036] In one embodiment there is provided a lock arrangement provided for the strap retainer.

[0037] In one embodiment the lock system includes a lock receiver and an actuator.

[0038] In one embodiment there the lock receiver is disposed on the closure and is in the form of a guide, and can take the form of a channel, a hook, or a pair of ribs, or a groove.

[0039] In one embodiment the lock receiver is provided to more securely lock the closure to the frame.

[0040] In one embodiment the lock receiver also minimizes lateral drift of the closure relative to the frame.

[0041] In one embodiment the lock receiver is a hole in a retainer neck, in the base of the saddle channel, which is configured to receive the lock actuator, which is disposed on the retainer strap.

[0042] In one embodiment the lock system further includes one or more further lock receivers disposed on the closure.

[0043] The further lock receivers are configured to receive the retainer strap and are configured to inhibit the closure moving laterally and axially relative to the elongate elements.

[0044] In one embodiment the further lock receivers are also configured to inhibit removal of the strap from the saddle in that they securely receive the strap and retain it.

[0045] In one embodiment, to facilitate that secure retention the further lock receivers are in the form of notches, disposed in edges of the cover, and the notches include a neck and a bight and arranged such that the strap is inhibited from removal from the bight by the neck.

[0046] In one embodiment on the retainer strap is a grab element for use by a user in grabbing the strap. The grab element is in the form of a tab extending from the retainer strap so thatthe user can more easily lift the retainer strap out of the saddle so that the lock tab is released from the lock receiver and over the saddle wall to release the cover and provide access to the cannulation site.

[0047] In accordance with one aspect of the present invention therefore there is provided a method of protecting a patient body site, the method including the steps of:providing a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient;sticking a plurality of foot pads connected to or integral with the peripheral portions to the skin of the patient adjacent the cannulation site.Brief Description of Drawings

[0048] Figure l is a perspective view of a site protector suitable in accordance with an embodiment for a cannulation site on a patient, the site protector being in a closed configuration;

[0049] Figure 2 is a plan view of the site protector of Figure 1 suitable for a cannulation site on a patient, the site protector being in a closed configuration;

[0050] Figure 3 is a perspective view of a site protector of Figures 1 and 2, the site protector being in an open configuration;

[0051] Figure 4 is a perspective view of a site protector in accordance with another embodiment, suitable for a cannulation site on a patient, the site protector being disposed in an open configuration;

[0052] Figure 5 is a plan view of a site protector suitable of Figure 4, for a cannulation site on a patient, the site protector being in an open configuration;

[0053] Figure 6 is a plan view of a site protector of Figures 4 and 5 (some feet pads not shown for clarity), the site protector being shown with a jig or spacer for setup, and the site protector being in a closed configuration;

[0054] Figure 7 is a plan view of a site protector of Figures 4 and 5 and 6 (some feet pads not shown for clarity), the site protector being shown with a jig or spacer for setup, the jig being shown rotated relative to the one shown in Figure 6 and the site protector being in a closed configuration; and

[0055] Figure 8 is a perspective view of a site protector of Figures 4 and 5 and 6 and 7 (some feet pads not shown for clarity), the site protector being shown with a jig or spacer for setup, and the site protector being in a closed configuration.Description of Embodiments

[0056] Referring to the drawings there is shown a cannulation site protector generally indicated at 10. The cannulation site protector 10 includes adhesive mounting feet 20. The feet 20 are pads 22, and are about 10mm by 10mm. There is a range of suitable shapes and areas: 5mm at one end, tapering out to 20mm at the other end, say 20mm along from the one end. More details of the shape and size of the feet are discussed below.

[0057] The protector 10 is suitable for placement over a patient body site 99, and includes a protective cover assembly 30 including a main cover portion 40 and peripheral portions 50, suitable for protectively covering a cannulation site 98 of a patient (not shown). The feet 20 are in the form of a plurality of foot pads 22 connected to the peripheral portions 50 and spaced apart from one another at peripheral mounting positions 52 on the peripheral portions 50. The foot pads 22 are configured to mount the protective cover 30 over the patient body site 99 so that at least a main portion of the protective cover 30 is disposed in an elevated position relative to the cannulation site 98. The foot pads 22 include adhesive on a bottom face to adhere to skin of the patient adjacent the cannulation site 98.

[0058] The arrangement is such that in use, the protector 10 remains on the skin for a few days, perhaps a week or two. The feet 20 are pads 22, of a selected area, limited in such a way that they are pads, not straps or bands, to reduce dermatitis, trauma and infection risk.Foot pads - more details

[0059] The feet 20 are pads 22, so they provide secure mounting and improved structural strength for the protective cover 30. The feet pads 22, being adhered to the skin, use the skin as a foundation or base member to stiffen the protective cover 30. This means there is a reduced tendency for the protective cover 30 to splay outwards if there is a bump or other force applied to it from above.[0059a] The foot pad 22 is in the form of a laminated structure, wherein there is provided a semi soft foam substrate for receiving and mounting the foot mounts, and a thin layer of adhesive on an underside for fastening to the skin of the patient. The thin adhesive is useful so that the foot pad moves with the skin; in contrast to using a thicker material that forces the skin to come with it, en masse.Cover assembly

[0060] The protective cover 30 includes a frame 60 (part of the peripheral portions 50) and a closure 70 (part of the main cover portion 40). The frame 60 includes a plurality of frame elements 62 to support and elevate the closure 70 to provide a dome-like structure which provides clearance between it and the cannula so that any bumps are less likely to hit the cannula or move it around, and also to inhibit access to the cannulation site 98.

[0061] The peripheral frame elements 62 include a plurality of legs 64 to elevate the closure 70 above the cannulation site 98. The legs 64 are arched to facilitate a truss-like structure when combined with the base feet which are adhered to the skin, to anchor them; the skin or base forms a third arm of the truss-like structure. The plurality of legs 64 include foot mounts 66 at a base region, to mount each foot 20.

[0062] The peripheral frame elements 62 are of Shure A hardness about 65 to 75, moulded from TPU, to reduce infections and patient damage, cuts and the like. The device is light and easy to use, and is flexible enough until the feet are secured to the skin, and then the device 10 becomes more rigid, without causing skin trauma from long term strapping.Foot mount coupler

[0063] The foot mounts 66 and feet pads 22 include a coupler or joint 68 to facilitate foot movement about one or more axes relative to the leg 64. The coupler or joint is a ball joint 69 to facilitate movement about a plurality of axes relative to the leg. There are cutaways 67 to facilitate mounting the foot coupler in the base of the leg and to allow a greater degree of pivoting, to facilitate mounting on a greater range of sites (elbow, wrist, and others).[0063a] In the embodiment shown there are provided guides or cheeks 67a beside the cutaways 67 to limit the pivoting movement of the foot pads 22 in a single plane, or at least provide greater pivoting in the plane of the cutaway and less pivoting normal to that plane.Closure

[0064] The closure 70 is movable between an open position distal the cannulation site, and a closed position over the cannulation site 98. The frame 60 includes at least one closure retention element 80 extending between two portions of two frame elements to retain the main cover portion 40 in the closed position (shown in Figures 1 and 2).

[0065] The frame 60 also includes a hinge 82 to facilitate the closure moving between the open and the closed positions. There is an arch 83 to elevate the hinge. This provides frame clearance to provide room for cannula lines and to keep pressure off the cannulated vein or artery. The hinge is integral with the arch, in that the arch itself is configured to twist along its length during movement between the open position and the closing positions. This one arrangement further advantageously provides a biasing means for the closure, which biases the closure to the open position.

[0066] The closure retention element 80 is resilient to facilitate opening and closing of the closure 70. The closure retention element 80 is also extensible to facilitate stretching over the end of the closure during the act of closing the closure 70. The closure retention element 80 is also arched to facilitate patency of an associated vein or artery. The closure retention element is a rubber material, as is the hinge and frame elements, which can be rubber, TPE, or silicone or other suitable material.

[0067] The main cover portion 40 is transparent to facilitate visual inspection of the cannulation site. It could be at least partially domed to accommodate the cannula and to inhibit and deflect impacts. It could be broad or fine mesh or cage, or other suitable transparent or translucent covering.[0067a] The main cover portion 40 includes side edges which are integral with or are fastened or otherwise engage with spaced apart cover frame elements 71 and 72.[0067b] The cover 40 further includes a plate 77 on a rear edge 41 with a heart indicator 78 to indicate the correct disposition for the protector 10. The heart indicator 78 is a heart shaped aperture for durability and for clarity. The indicator 78 end is intended to be more proximal the heart of the patient. This is to indicate the direction of flow of blood into the catheter and to reinforce such biological arrangements to users.[0067b] The cover plate 40 is a suitable transparent and strong polymer, thin, about 0.5mm in thickness.Lock

[0068] A strap retainer 85 is provided to retain the closure in a closed position, and works with a retaining saddle 87 which keeps an end strap 83 in a saddle channel between two saddle walls. There is also a lock arrangement 91 provided for the strap retainer, the lock arrangement including a lock receiver 92 and an actuator 83 which is the same element as the end strap 83. The lock receiver 92 is disposed on the closure 70 and is in the form of a guide, and can take the form of a channel, a hook 94 , or a pair of ribs, or a groove. The lock receiver is provided to more securely lock the closure 70 to the frame 60 and provides more strength and stiffness to the structure when in the closed configuration.

[0069] The retainer strap 83 includes a grab element 89 for use by a user in grabbing the strap.The grab element is in the form of a tab extending from the retainer strap so that the user can more easily lift the retainer strap out of the saddle so that the lock tab is released from the lock receiver and over the saddle wall to release the cover and provide access to the cannulation site.[0069a] There is a strengthener provided , shown at 65. The strengthener 65 is to strengthen the frame 60 by fastening it to the closure 70. In the arrangement shown, the frame legs 64 are fastened to the closure frame elements 71 and 72 by a fastener 73. This improves rigidity of the assembly 10. Given the inherent flexibility of the frame elements, such strengthening measures are useful, to provide additional protection to the cannulation zone 99. The fastener 73 is in the form of a clip 74, one provided each leg 64.[0069b] There are also provided guides 76 so that the clips 74 have a stronger grip on the legs 64. The guides 76 are in the form of flanges 78 to form a channel 79 to receive the clips 74. This arrangement provides increased strength and rigidity for the protector 10.[0069c] The clips 74 are in the form of c-shaped elements 75 sized to fit around the leg 64 in one firm snap action, and to also readily release with a small force with the fingers. The flanges 78 also inhibit inadvertent release of the clips 74 from the legs 64.IN OPERATION

[0070] To protect a patient body site, a health professional or user takes the protective cover 10 and, if the site is relatively easy, adheres a plurality of foot pads 22 on the skin. On a relatively flat site the location of the pads 22 are easy to assess, but if the site is difficult, a jig 77 may be used to fit over the cannula 55 and under the patient adjacent the cannulation site.

[0071] The jig 77 includes a cooperating roof to support the frame 60 during installation and includes recesses to receive proximal edges of the feet 20 to indicate their preferred setup location. The jig also includes cooperating archways to accommodate the cannula 55. The cooperating archways extend in two directions to allow installation across the device 10 or along the device 10.

[0072] It will be understood to persons skilled in the art of the invention that many modifications may be made without departing from the spirit and scope of the invention.

[0073] It is to be understood that any prior art publication referred to herein does not constitute an admission that the publication forms part of the common general knowledge in the art.

[0074] In the claims which follow and in the preceding description of the invention, exceptwhere the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

CLAIMS:

1. A cannulation site protector comprising adhesive mounting foot pads.

2. A protector for placement over a patient body site, the protector including:a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient;a plurality of foot pads connected to or integral with the peripheral portions and spaced apart from one another at peripheral mounting positions on the peripheral portions, the foot pads being configured to mount the protective cover over the patient body site so that at least a main portion of the protective cover is disposed in an elevated position relative to the cannulation site,wherein the foot pads include adhesive to adhere to skin of the patient adjacent the cannulation site.

3. The protector in accordance with claim 2 wherein the protective cover includes a frame and a closure.

4. The protector in accordance with claim 3 wherein the frame includes a plurality of peripheral portions in the form of frame elements to inhibit access to the cannulation site.

5. The protector in accordance with claim 4 wherein the peripheral portions in the form of frame elements include a plurality of legs to elevate the closure above the cannulation site.

6. The protector in accordance with claim 5 wherein the plurality of legs include foot mounts at a base thereof, to mount a foot.

7. The protector in accordance with claim 6 wherein the foot mounts and feet pads include a coupler or joint to facilitate foot movement about one or more axes relative to the leg.

8. The protector in accordance with claim 7 wherein the coupler or joint is a ball joint to facilitate movement about a plurality of axes relative to the leg.

9. The protector in accordance with any one of claims 2 to 8 wherein the main cover portion includes the closure.

10. The protector in accordance with claim 9 wherein the closure is movable between an open position distal the cannulation site, and a closed position over the cannulation site.

11. The protector in accordance with any one of claims 2 to 8 wherein the frame includes at least one closure retention element extending between two portions of two frame elements to retain the cover.

12. The protector in accordance with any one of claims 2 to 8 wherein the frame includes a hinge to facilitate the closure moving between the open and the closed positions.

13. The protector in accordance with claim 12 wherein the frame includes an arch to elevate the hinge.

14. The protector in accordance with claim 13 wherein the hinge is integral with the arch, in that the arch itself is configured to twist along its length during movement between the open position and the closing positions.

15. The protector in accordance with any one of claims 11 to 14 wherein the closure retention element is resilient to facilitate opening and closing of the closure.

16. The protector in accordance with any one of claims 11 to 15 wherein the closure retention element is extensible to facilitate stretching over the end of the closure during the act of closing the closure in the closed position.

17. The protector in accordance with any one of claims 11 to 16 wherein the closure retention element is arched to facilitate patency of an associated vein or artery.

18. The protector in accordance with any one of claims 11 to 17 wherein the closure retention element is a rubber material.

19. The protector in accordance with any one of claims 12 to 18 wherein the hinge is a rubber material.

20. The protector in accordance with any one of claims 12 to 19 wherein the hinge is TPE or silicone or suitable material.

21. The protector in accordance with any one of claims 2 to 20 wherein the frame is constructed from elongate elements of TPE, silicone or other suitable flexible and resilient material.

22. The protector in accordance with any one of claims 5 to 21 wherein the one or more legs are disposed on opposite sides of the frame and extend upwards from the feet to elevate the closure.

23. The protector in accordance with any one of claims 3 to 22 wherein the closure is transparent to facilitate ready visualisation and inspection of the cannulation site.

24. The protector in accordance with any one of claims 3 to 23 wherein the closure is at least partially domed to accommodate the cannula and to inhibit and deflect impacts.

25. The protector in accordance with any one of claims 3 to 24 wherein a strap retainer is provided to retain the closure in a closed position, and is in the form of a retaining saddle which keeps an end strap in a saddle channel between two saddle walls.

26. The protector in accordance with any one of claims 3 to 25 wherein there is provided a lock arrangement provided for the strap retainer.

27. The protector in accordance with any one of claims 3 to 26 wherein the lock system includes a lock receiver and an actuator.

28. The protector in accordance with any one of claims 3 to 27 wherein there the lock receiver is disposed on the closure and is in the form of a guide, and can take the form of a channel, a hook, or a pair of ribs, or a groove.

29. The protector in accordance with any one of claims 3 to 28 wherein the lock receiver is provided to more securely lock the closure to the frame.

30. The protector in accordance with any one of claims 3 to 29 wherein the lock receiver also minimizes lateral drift of the closure relative to the frame.

31. The protector in accordance with any one of claims 3 to 30 wherein the lock receiver is a hole in a retainer neck, in the base of the saddle channel, which is configured to receive the lock actuator, which is disposed on the retainer strap.

32. The protector in accordance with any one of claims 3 to 31 wherein the lock system further includes one or more further lock receivers disposed on the closure.

33. The protector in accordance with any one of claims 3 to 32 wherein the further lock receivers are configured to receive the retainer strap and are configured to inhibit the closure moving laterally and axially relative to the elongate elements.

34. The protector in accordance with any one of claims 3 to 33 wherein the further lock receivers are also configured to inhibit removal of the strap from the saddle in that they securely receive the strap and retain it.

35. The protector in accordance with any one of claims 3 to 34 wherein, to facilitate that secure retention the further lock receivers are in the form of notches, disposed in edges of the cover, and the notches include a neck and a bight and arranged such that the strap is inhibited from removal from the bight by the neck.

36. The protector in accordance with any one of claims 3 to 35 wherein on the retainer strap is a grab element for use by a user in grabbing the strap.

37. The protector in accordance with any one of claims 3 to 36 wherein the grab element is in the form of a tab extending from the retainer strap so that the user can more easily lift the retainer strap out of the saddle so that the lock tab is released from the lock receiver and over the saddle wall to release the cover and provide access to the cannulation site.

38. A method of protecting a patient body site, the method including the steps of:providing a protective cover including a main cover portion and peripheral portions, suitable for protectively covering a cannulation site of a patient;sticking a plurality of foot pads connected to or integral with the peripheral portions to the skin of the patient adjacent the cannulation site.

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