Surgically implanted line device shower cover kit

Abstract

A shower cover kit 10 for preventing water ingress to a surgically implanted line device, such as a central venous access (CVA) and peritoneal dialysis (PD) catheter, comprises a domed cover 20 having

Description

TECHNICAL FIELD The present disclosure relates to a surgically implanted line device shower cover kit. Particularly, but not exclusively, the disclosure relates to a central venous access (CVA) device shower cover kit and a peritoneal dialysis (PD) catheter shower cover kit. BACKGROUND Various surgically implanted line devices are used with patients to treat and manage a variety of medical conditions. These devices include, but are not limited to, central venous access (CVA) devices, peritoneal dialysis (PD) catheters, chemo ports, arterial catheter, central venous catheter (CVC) implanted port, epidural catheter, peripheral intravenous (PIV) device. Patients with such surgically implanted lines devices are advised not to shower due to risk of water borne bacteria (Staphylococcus Aureus, Escherichia Coli and Pseudomonas Aeruginosa) coming into contact with external portions of the device This advice is not followed by the majority of patients and is not practical for patients with a long-term device. The benefits of showering are well known and include reducing levels of potentially harmful bacteria on the skin, improving circulation, improving mood, relieving muscular aches and pains, reducing stress and insomnia, improving respiratory function, reducing nausea and lowering blood pressure. A CVA device typically comprises a venous catheter terminating in two exposed lumens 104, 106, 114, 116, and a dressing that is changed weekly. The dressing may be a 3M Tegaderm IV Advanced 1685 or 1681 Dressing having an outer adhesive portion 108 and an inner window portion 110. The dressing may be a Smith &Nephew IV 3000 dressing. A PD catheter comprises a small plastic tube inserted into the peritoneal cavity of the patient’s abdomen, with a single exposed lumen, and a dressing that is changed weekly. The currently available protocols to address this need are pouches with medical grade adhesives that claim to provide a watertight seal around the CVA device or PD catheter. US 1 2008 / 208145 discloses a disposable shower guard for renal access catheter. Other solutions are waterproof dressings such as the patient medical access opening protection device disclosed in US 2020 / 046570. These products can have variable effectiveness due to the skin condition of the patient - for example oily skin, hairy skin, allergy to adhesives. Furthermore, the pouches and dressings may risk damaging the dressing of the device, due to the proximity of the adhesive on the pouch and dressing when removing from the region of the device. The pouches and dressings are single use products. Other types of pouches and dressings require the removal of the dressing before application of the pouch by a clinician or trained medical practitioner. There is therefore a need for improvements in the above described devices. SUMMARY OF THE INVENTION Aspects and embodiments of the invention provide a shower cover kit. According to an aspect of the invention, there is provided a shower cover kit comprising: a cover having a peripheral seal; and an adjustable harness arranged to apply pressure to the cover so as to compress the peripheral seal against a patient’s skin in use. The seal may have a U-shaped skin engaging surface. The U-shaped skin engaging surface may comprise an inner skirt and an outer skirt, where the outer skirt is longer than the inner skirt. The seal may have a balloon. The seal may be removeable from the cover. The cover may be domed to define a cavity. The cover may define a centrally aligned recess. The shower cover kit may further comprise a clip arranged to engage with the centrally aligned recess and to releasably connect the adjustable harness to the cover. 2 The clip may engage with the centrally aligned recess with a snap fit. The clip may have a cylindrical step to extend the depth between a point of contact of the adjustable harness with the clip and the patient’s skin in use. The adjustable harness may include an elastic portion. The elastic portion may include a centrally aligned hole sized to fit over an annular lip of the clip. The clip may have an annular extension that is ramped to extend the pressure applied by the harness to the cover in use toward the peripheral seal. The elastic portion may be made of an elastomer. The elastomer may be die-cut or moulded. The elastomer may be made of silicon orTPE. The shower cover kit may further comprise a lumen clip. The lumen clip may comprise a first arm and a second arm. The shower cover kit may further comprise a moisture detecting membrane. The moisture detecting membrane may have a layer of medical adhesive. The moisture detecting membrane may be provided as a ring to at least partially encircle a surgically implanted line device. BRIEF DESCRIPTION OF THE DRAWINGS One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a schematic view of a surgically implanted line device shower cover kit according to an embodiment of the invention; Figure 2 is a schematic view of the surgically implanted line device shower cover kit of Figure 1 fitted to a patient; Figure 3 is a cross-sectional view of the surgically implanted line device shower cover kit of Figure 1; Figure 4 is a plan view of a location harness clip according to an embodiment of the invention; Figure 5 is a cross-sectional view of the location harness clip of Figure 4; Figure 6 is a schematic view of a surgically implanted line device shower cover kit according to another embodiment of the invention; Figure 7 is a close-up partial view of the surgically implanted line device shower cover kit of Figure 6; Figure 8 is a schematic view of the surgically implanted line device shower cover kit of Figure 6 fitted to a patient; Figure 9 is a cross-sectional view of the surgically implanted line device shower cover kit of Figure 6; Figure 10 is a rear-isometric view of the surgically implanted line device shower cover kit of Figure 6; Figure 11 is a plan view of a location harness clip according to another embodiment of the invention; Figure 12 is a side view of the location harness clip of Figure 11; Figure 13 is an isometric view of the location harness clip of Figure 11; Figure 14 is an isometric view of a lumen clip according to an embodiment of the invention; Figure 15 is a schematic view of the lumen clip of Figure 14 partially fitted to a patient; Figure 16 is a schematic view of the lumen clip of Figure 14 fully fitted to a patient; Figure 17 is an isometric view of an indicator ring according to an embodiment of the invention; Figure 18 is a schematic view of the indicator ring of Figure 17 fitted to a patient; and Figure 19 is a plan view of a pack of indicator rings. DETAILED DESCRIPTION A surgically implanted line device shower cover kit 10 according to a first embodiment is shown in Figures 1 to 5. The kit 10 comprises a cover 20 having a peripheral seal 30 and an adjustable harness 50. The cover 20 is a rounded rectangle in plan-view. Referring to Figure 3, the cover 20 has a perimeter 22 which includes a first flange 24 and a second flange 26. A perimeter recess is 4 defined between the first flange 24 and the second flange 26. The perimeter recess extends axially with respect to the cover 20. The cover 20 is domed. As shown in Figure 2, the cover 20 is shaped to fit over the exposed region of the surgically implanted line device of a patient 100, including any exposed lumen and the entirety of any dressing. A centrally aligned recess 28 is provided in an outer surface 21 of the cover 20. The centrally aligned recess 28 includes an annular step 29 approximately halfway into the depth of the recess 28. The annular step 29 protrudes radially inwardly with respect to the centrally aligned recess 28. The seal 30 is a continuous ring. The seal 30 has substantially the same circumferential dimensions as the cover 20. The seal 30 has a constant cross-section. As part of the constant cross-section, the seal 30 has a U-shaped skin engaging surface 32. The skin engaging surface 32 comprises in inner skirt 33 and an outer skirt 34. As best shown int he cross-sectional view of Figure 3, the outer skirt 34 is longer than the inner skirt 33 such that the outer skirt 34 extends further towards the patient’s skin as the cover 20 is used. The seal 30 has a protrusion 35 opposite the U-shaped skin engaging surface 32. The protrusion 35 has a first slit 36 and second slit 38. The seal 30 is connected to the cover 20 by engaging protrusion 35 in the perimeter recess defined between the first flange 44 and the second flange 46 of the cover 20. The first slit 36 and second slit 38 allow the protrusion 35 to deform slightly as the seal 30 is pressed into the perimeter recess. The protrusion may be further affixed using an adhesive. The harness 50 comprises an arm loop 51 and a shoulder loop 53. The loops are connected to a back piece 54 which is slotted to receive the loops 51, 53. The arm loop 51 and the shoulder loop 53 are each adjustable. The harness 50 connects to the cover 20 via a clip 40. Referring to Figures 4 and 5, the clip 40 is disc-shaped in plan, with a stepped profile in cross-section. The clip 40 has a centrally aligned segmented portion 42, which rises to a first centrally aligned annular portion 44 with a first stepped surface 43. The annular portion 44 rises to a second centrally aligned annular portion 46 with a second stepped surface 45. The segmented portion 42 is flat. The annular portion 44 is flat. The first stepped surface 43 and the second stepped surface 45 both 5 define a draw angle. The draw angle of the second stepped surface 45 is greater than the draw angle of the first stepped surface 43. The annular portion 46 extends towards the plane of the annular portion 44 at a peripheral edge 48 of the annular portion 46. The annular portion 46 includes three slots 52, 54, 56 which are distributed circumferentially. The clip 40 is divided circumferentially into four arms, with respective portions of the centrally aligned segmented portion 42, first stepped surface 43, first centrally aligned annular portion 44 and second stepped surface 45 forming an arm of the four arms. A barb 49 is provided on the radially outer end of the first stepped surface 43, with each arm have a portion of the barb 49. The clip 40 is housed in the centrally aligned recess 48 of the cover 20. The barb 49 engages with the annular step 29 of the recess 28 with a snap fit. The first centrally aligned annular portion 44 contacts the outer surface of the cover 20. This contact controls the depth to which the clip 40 can be inserted into the cover 20. The adjustable harness 50 is a strap material that is arranged to pass through the three slots 52, 54, 56 so as to create a portion that passes under the arms of the patient 100 and a portion that passes over the shoulder of the patient 100 on the side of the CVA device. In use, for example as applied to cover a central venous access (CVA) device, the shower cover 20 is secured in place on the patient’s upper body using the adjustable harness 50. The cover 20 is positioned over the exit side dressing and lumens of the CVA device. The cover 20 is pressed into the skin creating a suction effect at the seal 30 to provide a watertight seal. A surgically implanted line device shower cover kit 210 according to another embodiment is shown in Figures 6 to 19. Similar reference numbers are used as for the first embodiment, prefixed with a “2” to indicate that those reference numbers refer to the second embodiment. The kit 210 comprises a cover 220 having a peripheral seal 230 and an adjustable harness 250. The cover 220 is a rounded rectangle in plan-view. Referring to Figure 9, the cover 220 has a perimeter 222 which includes a first flange 224 and a second flange 226. A perimeter recess is defined between the first flange 224 and the second flange 226. The perimeter recess extends axially with respect to the cover 220. The cover 220 is domed. The cover 220 is shaped to fit over the exposed region of the surgically implanted line device, including any exposed lumen and the entirety of any dressing. A centrally aligned recess 228 is provided in an outer surface 222 of the cover 220. The centrally aligned recess includes an annular step 229 approximately halfway into the depth of the recess 228. The annular step 229 protrudes radially inwardly with respect to the centrally aligned recess 228. The seal 230 is a continuous ring. The seal 230 has substantially the same circumferential dimensions as the cover 220. The seal 230 has a constant cross-section. As part of the constant cross-section, the seal 230 has a U-shaped skin engaging surface 232. The skin engaging surface 232 comprises in inner skirt 233 and an outer skirt 234. As best shown in the cross-sectional view of Figure 9, the outer skirt 234 is longer than the inner skirt 233 such that the outer skirt 234 extends further towards the patient’s skin as the cover 220 is used. The seal has a protrusion 235 opposite the U-shaped skin engaging surface. The protrusion 35 has a first slit 236 and an annular barb 239. The seal 230 has a central balloon 237 which is presented as a contoured surface extending radially, i.e. in the same direction as the outer skirt 234. The central balloon 237 extends around the full circumference of the seal 230. The central balloon 237 is located between the skin engaging surface 232 and the protrusion 235. The seal 230 is connected to the cover 220 by engaging protrusion 235 in the perimeter recess defined between the first flange 224 and the second flange 226 of the cover 220. The slit 236 allows the protrusion 235 to deform slightly and accommodate the annular barb 239 as the seal 230 is pressed into the perimeter recess. The deformation of the annular barb 239 applies an outward force on the perimeter recess of the cover 230, to grip the seal 230 to the cover 220. The protrusion 235 may be further affixed using an adhesive. Referring to Figures 6 to 8, the harness 250 comprises a three-armed cover retainer 252. The cover retainer 252 is elastic. The three-armed cover retainer 252 has a centrally aligned disc shaped hole 253. The three-armed cover retainer 252 is fastened to a left arm loop, a 7 right arm loop and a shoulder loop. The loops are connected to a back piece 254 which is slotted to receive the loops. The right arm loop and shoulder loop are each adjustable bv means of glides 258. The left arm loop is adjustable by means of a centre release buckle 259 as shown. In an alternate embodiment, the left arm loop, right arm loop and shoulder loop are each adjustable by means of a centre release buckle 259. The harness 250 connects to the cover 220 via a clip 270. Referring to Figures 11 to 13, the clip 270 is disc-shaped in plan, with a stepped profile in cross-section. The clip 270 has a cover engagement portion 272 and a harness engagement portion 273. The cover engagement portion 272 and the harness engagement portion 273 are separated by a cylindrical step 271. The cover engagement portion 272 has four arms 274, each having a protrusion 276 on an outer surface thereof. The four arms are separated by slots 278, which allow the arms 274 to resile when the cover engagement portion 272 of the clip is pressed into the centrally aligned recess 228 of the cover 220. The harness engagement portion 273 has an annular extension 280. The annular extension 282 has a ramped surface. The harness engagement portion 273 also terminates in an annular lip 284. Referring back to Figure 9, the clip 270 is housed in the centrally aligned recess 228 of the cover 220. The protrusions 276 engage with the annular step 229 of the recess 228 with a snap fit. The step 271 controls the depth to which the clip 270 can be inserted into the cover 220. The centrally aligned hole 253 of the three-armed cover retainer 252 of the harness 250 is passed over the annular lip 284 of the clip 270 such that is rests against the ramped surface of the annular extension 282. Through adjustment of the harness 250 and given the elastic nature of the three-armed over retainer 252, a downward pressure is applied to the cover 220 by the harness 250. This downward pressure causes the skin engagement surface 232 to engage with the patient’s skin and create a water-tight suction effect. The downward pressure on the balloon 237 amplifies this effect. The balloon 237 also accommodate further variable in patient 100 body shape. Furthermore, the ramped surface of the annular extension 282 ensures the downward pressure is applied to all parts of the seal 230. The step 271 of the clip 270 allows for a reduced height of the dome of the cover 220, whilst applying the same downward pressure via the harness 250. The surgically implanted line device shower cover kit 10, 210 can further comprise a lumen clip 280. Referring to Figures 14 to 16 the lumen clip is serpentine in form and comprises a pair of arms 282, 284, which are joined in the centre. The first and second arms 282, 284 are symmetrical in form. The first arm 282 defines a first lumen slot 283 sized to retain the tube of the catheter. The first arm 282 further defines a C-shaped region 285 defining a second lumen slot 286. Equally the second arm 284 defines a first lumen slot 283 sized to retain the lumen of the catheter. The second arm 284 further defines a C-shaped region 285 defining a second lumen slot 286. In use, the lumen clip 280 is placed on the patient’s 100 chest such that the catheter tubes 104, 106 are frictionally held in the respected first lumen slots 283 (as shown in Figure 15) and then the ends of the lumen 114, 116 are fed around the C-shaped regions 285 on either end of the clip 280 to be retained in the second lumen slots 286 (as shown in Figure 16). This tidies the lumen 114, 116 such that they are within the footprint of the dressing 108, 110. The lumen clip 280 may be used with either surgically implanted line device shower cover kit 10, 210. The surgically implanted line device shower cover kit 10, 210 can further comprise a single use moisture detecting membrane 90, 290. In a first embodiment, referring to Figure 3, the moisture detecting membrane 90 comprises a ring shaped membrane having a first layer comprising a release film, a second layer comprising a medical adhesive and a third layer comprising a moisture indicator fabric. The ring-shaped membrane is applied to the outer portion of the dressing, adjacent where the seal 30 sits against the patient’s skin. In a second embodiment, referring to Figures 17 to 19, the moisture detecting membrane 290 is a C-shaped membrane having a slot 292. The membrane 290 has a first layer comprising a release film, a second layer comprising a medical adhesive and a third layer comprising a moisture indicator fabric. The C-shaped membrane is applied to the dressing 108, with the slot 292 aligned with the lumen of the surgically implanted line device. When suppled, the C-shaped membrane may be supplied on a single sheet (comprising the release film), with the C-shaped form interlocking as shown in Figure 19. The cover 20, 220 may be a polymer. The cover 20, 220 may be made of a clear polypropylene moulding. The seal 30, 230 may be an elastomer. The seal 30, 230 may be made from silicone. The seal 30, 230 may be made of TPU. The seal 30, 230 may be removed from engagement with the cover 20, 220 to allow for cleaning. In an alternate embodiment, the seal may be fitted to a radially extending peripheral recess of the cover, rather than to a recess that extends axially. The three-armed cover retainer 252 may be made of silicone. The cover retainer 252 may be die-cut. Alternatively the cover retainer 252 may be moulded. The harness 250 may be made of polyester webbing or polymer material coated webbing. The lumen clip 280 may be made of a polymer material. The lumen clip 280 may be made of acetal. In a further embodiment of the invention, a manual or electro-mechanical pump may be used to create additional negative pressure with the cavity defined by the cover 20, 220 and the patient’s skin. The centre release buckle 259 may be easier to use and adjust for patients with dexterity issues such as arthritis. Whilst the described embodiments show the patient 100 having a right-sided central venous access (CVA) device, the skilled person will appreciate that the invention is not limited to the specific location of the device, nor to the precise type of surgically implanted line device.

Claims

1. A shower cover kit comprising:a cover having a peripheral seal; andan adjustable harness arranged to apply pressure to the cover so as to compress the peripheral seal against a patient’s skin in use.

2. The shower cover kit of claim 1 wherein the seal has a U-shaped skin engaging surface.

3. The shower cover kit of claim 2 wherein the U-shaped skin engaging surface comprises an inner skirt and an outer skirt, where the outer skirt is longer than the inner skirt.

4. The shower cover kit of any of claims 1 to 3 wherein the seal has a balloon.

5. The shower cover kit of any preceding claim wherein the seal is removeable from thecover.

6. The shower cover kit of any preceding claim wherein the cover is domed to define a cavity.

7. The shower cover kit of claim 6 wherein the cover defines a centrally aligned recess.

8. The shower cover kit of claim 7 further comprising a clip arranged to engage with thecentrally aligned recess and to releasably connect the adjustable harness to the cover.

9. The shower cover kit of claim 8 wherein the clip engages with the centrally aligned recess with a snap fit.

10. The shower cover kit of claim 9 wherein the clip has a cylindrical step to extend the depth between a point of contact of the adjustable harness with the clip and the patient’s skin in use.

11. The shower cover kit of any preceding claim wherein the adjustable harness includes an elastic portion.

12. The shower cover kit of claim 11 wherein the elastic portion includes a centrally aligned hole sized to fit over an annular lip of the clip.

13. The shower cover kit of claim 12 wherein the clip has an annular extension that is ramped to extend the pressure applied by the harness to the cover in use toward the peripheral seal.

14. The shower cover kit of any of claims 11 to 13 wherein the elastic portion is made of an elastomer.

15. The shower cover kit of claim 14 wherein the elastomer is die-cut or moulded16. The shower cover kit of any preceding claim further comprising a lumen clip.

17. The shower cover kit of claim 16 wherein the lumen clip comprises a first arm and a second arm.

18. The shower cover kit of any preceding claim further comprising a moisture detecting membrane.

19. The shower cover kit of claim 18 wherein the moisture detecting membrane has a layer of medical adhesive.

20. The shower cover kit of claim 18 or claim 19 wherein the moisture detecting membrane is provided as a ring to at least partially encircle a surgically implanted line device.13

Images