WO2013058828A1

WO2013058828A1 - Antimicrobial catheter cover

Info

Publication number: WO2013058828A1
Application number: PCT/US2012/034686
Authority: WO
Inventors: Shannon L. BEARDSLEY
Original assignee: Roo Healthcare Solutions, Llc
Priority date: 2011-10-21
Filing date: 2012-04-23
Publication date: 2013-04-25

Abstract

A disposable, antimicrobial catheter cover configured for use with a vascular catheter. The catheter cover including an internal cavity and an opening to receive the distal portions of the vascular catheter, wherein the catheter is made from a single panel of antimicrobial material, including a distal end that is wider than the proximal end to accommodate substantially all of the external components of the vascular catheter.

Description

ANTIMICROBIAL CATHETER COVER [0001] This application claims the benefit of priority of U.S. Provisional

Application No. 61/549,904, entitled "ANTIMICROBIAL CATHETER COVER," and filed on October 21, 2011, the entire contents of which being incorporated herein by reference. BACKGROUND OF THE INVENTION

[0002] Vascular catheters are commonly used with individuals that require frequent dialysis, allowing dialysis patients to avoid repeated insertion and removal of needles and tubes into their veins by having a semi-permanent access point. However, when not in use, the catheter remains extended from the body, causing discomfort to the patient as well as being exposed to the environmental elements, which can increase the risk of infection through the catheter. The traditional method of securing and protecting the catheter utilizes a combination of gauze wrapped around the tubing of the catheter and adhesive tape applied to the gauze and catheter before the next dialysis session. This method has several limitations and shortcomings.

[0003] The adhesive tape leads to a buildup of adhesive residue on the catheter that collects dirt, hair, blood, dead skin cells and other environmental contagions, greatly increasing the risk of infection as well as reducing the life of the catheter. Also, the adhesive tape and gauze combination do not fully cover the exposed catheter, leaving clamps and caps associated with such catheters exposed and in direct contact with the patient's skin, causing discomfort and skin irritation. In addition, the adhesive residue can cause further irritation and discomfort to the patient. While the adhesive tape and gauze provide a partial and passive barrier to dirt and other contaminants, they do not actively fight microbes that can cause infection. Therefore, there is a need for a device that can be used to defend catheters from exposure of and fight off infection from environmental contaminants while limiting the discomfort of the catheter's owner. SUMMARY OF THE INVENTION

[0004] The present invention is a catheter cover configured for use with the external portions of an inserted catheter, the catheter cover comprising a main body defining an internal cavity that includes a proximal end, a distal end that is opposite the proximal end, an antimicrobial substance, and an opening to the internal cavity that is associated with the proximal end and configured to receive the external portions of the catheter, wherein the internal cavity is configured to retain external portions of the catheter. The catheter cover also includes a securing mechanism associated with the opening and configured to secure the catheter.

[0005] These and other objects and advantages of the invention will become apparent from the following detailed description of the preferred embodiment of the inv ention. DESCRIPTION OF THE DRAWINGS

[0006] This invention is further understood by reference to the drawings wherein:

[0007] Fig. 1 is a perspective view of a vascular catheter known in the prior art.

[0008] Fig. 2 is a perspective view of a catheter cover according to one embodiment of the present invention.

[0009] Fig. 3 is a top plan view of the catheter cover of Fig. 2.

[0010] Fig. 4 is another perspective view of the catheter cover of Fig. 2.

[0011] Fig. 5 is a top plan view of a single panel used to form a catheter cover according to one embodiment of the present invention.

[0012] Fig. 6 is a perspective view of the catheter of Fig. 1 and the catheter cover of Fig. 2.

[0013] Fig. 7 is another perspective view of the catheter of Fig. 1 and the catheter cover of Fig. 2.

[0014] Fig. 8 is a perspective view of another example catheter cover in accordance with this disclosure.

[0015] Fig. 9 is a perspective view of another example catheter cover in accordance with this disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] Referring to Figs. 1-9 for a clearer understanding of the invention, embodiments of the invention provide an antimicrobial, disposable catheter cover 10 configured for use with a vascular catheter 20. The following examples are intended to illustrate but not to limit the invention.

[0017] Fig. 1 is a perspective view of a vascular catheter 20 known in the prior art. Figs. 2-9 illustrate a catheter cover 10 configured for use with the exposed portions of the catheter 20 according to one embodiment of the present invention. The catheter cover 10 as depicted in Figs. 2-9 is configured to cover and protect the external portions of an indwelling, tunneled, central venous catheter 20 implanted and used for dialysis treatments, commonly referred to as a tunneled dialysis catheter or "Permcath." The external portions of the catheter 20 includes a single line, dual chambered tube 22 that is configured to be inserted partially into a dialysis patient's body and connected to a vein or artery. The insertion usually occurs on the front torso of the patient, but can be inserted at other locations based upon the patient's needs and condition including the groin, back or flank. The distal end 22a of the dual chambered tube 22 connects to a hub 24, which divides the dual chambered tube 22 into a pair of single chambered tubes 26, 28 that extend from the hub 24 opposite the dual chambered tube 22. As shown in Fig. 1, each single chambered tube 26, 28 includes a distal end 30, 32 configured to be connectable to another set of tubes (not illustrated) for use in dialysis. A respective end cap 34, 36 is attached to each distal end 30, 32 when the catheter 20 is not in use. Clamps 38, 40 are associated with each single chamber tube 30, 32 to prevent any bodily fluids from exiting the catheter 20 when not in use. While the catheter cover 10 of one embodiment according to the present invention is configured for use with the dialysis catheter 20 shown in Fig. 1, it is not limited to such a use. The catheter cover 10 in other embodiments can be used with other indwelling catheters, including, but not limited to, tunneled and non-tunneled vascular catheters, peritoneal dialysis catheters or other catheter devices utilized for the purpose of introducing or removing various fluids to or from the body.

[0018] The catheter 20 may be protected from microbes by the catheter cover 10 as shown in Figs. 2-4 and 6-9. The catheter cover 10 includes a main body 100 having an outer surface 101, a distal end 102 and a proximal end 104 opposite the distal end 102. The proximal end 104 may include a flat edge 105. A first side 106 and a second side 108 connect the distal and proximal ends 102, 104. The first side 106 includes a seamless edge 107, discussed in further detail below. The second side 108 includes a fully secured edge 109 and an unsecured edge 1 10. The secured edge 109 includes an upper portion 109a beginning perpendicularly at the seamless edge 107 at the distal end 102. The upper portion 109a of the secured edge 109 continues into a lower portion 109b that ends at the beginning of the unsecured edge 110. The secured edge 109 is secured by a seam 11 1, discussed in further detail below. The unsecured edge 1 10 begins at the end of the seam 111 of the secured edge 109 and continues to the flat edge 105 of the proximal end 104. The unsecured edge 1 10 meets the flat edge 105 at an angle, tapering the main body 100 of the cover 10 from the proximate end of the secured edge 109 to the flat end 105 of the proximal end 104. This tapering of the main body 100 results in a bigger width 102a occurring close to the distal end 102 and a smaller width 104a near the proximal end 104.

[0019] The proximal end 104 includes an opening 1 14, beginning at the proximal end of the seamless edge 107, through the flat edge 105 and continuing to the unsecured edge 110. The opening 114 allows access into an interior cavity 116 of the catheter cover 10. The interior cavity 116 is shaped to receive the catheter 20, with the interior cavity 116 associated near the distal end 102 of the cover 10 configured to retain the larger portions of the catheter 20, including the end caps 34, 36 and the clamps 38, 40 of the tubes 26, 28, and the interior cavity 116 at the proximal end 104 configured to retain the hub 24 and the tubing 26, 28 extending from the hub 24. While the interior cavity 116 is tapered at the proximal end 104 of the cover 100, the opening 114 is easily manipulated to expand to allow the components of the catheter 20 to pass through into the interior cavity 1 16 without substantially jostling the catheter 20. See Figs. 4 & 6. A securing mechanism 120 is associated with the proximal end 104 of the cover 100 at its narrowest point. In one example, the securing mechanism 120, shown in Figs. 4 and 6, can be a hook and loop system 120 coupled to the surface of the internal cavity 116 approximate the proximal end 104. However, in other embodiments, the securing mechanism 120 may include, but is not limited to, adhesive tape, applied adhesives, snaps, clips, clamps, clasps, buttons, and other fastening means. Regardless of the type, it is preferable that the securing mechanism 120 be easy to disengage and reengage repeatedly. The securing mechanism 120 is configured to secure the opening 114 of the catheter cover 100, preventing the catheter cover 10 from disengaging from the catheter 20. Additionally, looking at Fig. 7, the securing mechanism 120 is configured to engage the catheter's hub 24 to prevent the catheter cover 10 from shifting along the catheter 20.

[0020] The main body 100 of the catheter cover 10 can be formed from an antimicrobial material or substance. The antimicrobial material or substance repels, shields, and in some cases, kills bacteria, fungus, mildew, viruses and other microbes that could possibly lead to infection at the catheter 20.

According to one embodiment of the present invention, the catheter cover 10 is formed from material with fibers that utilize silver and copper ions to repel and kill microbes. For example, the cover can be made from a material called Fosshield ® supplied by Foss Manufacturing. The antimicrobial substance can be incorporated into at least some of the fibers of the material during or prior to formation of the fibers.

[0021] Another embodiment of the present invention uses a material treated with an antimicrobial substance from Agion ® that utilizes silver ions to kill and repel microbes. Such an antimicrobial treatment can be applied to the material of the cover as it is being formed, so as to retain the substance internally within the fibers to prolong the antimicrobial effectiveness as the fibers degrade through wear and tear thus exposing new antimicrobial to the environment surrounding the fibers. Applying the antimicrobial in this manner can result in antimicrobial material within the fiber that remains unexposed to the environment and therefore does not contribute directly to antimicrobial activity until so exposed.

[0022] Alternatively, the material of the catheter cover 10 can be placed in a carrier solution that contains the antimicrobial substance. Then, the material can be pressed and dried, resulting in the antimicrobial substance being adhered to the surface of the fibers of the material of the catheter cover 10. In examples of catheter covers 10 that are intended for a single use over a few days, and are therefore disposable, the degradation of the antimicrobial properties through normal wear is limited. In such examples, the antimicrobial treatment applied by way of the carrier solution applied to the material of the cover can reduce the amount of antimicrobial substance used and therefore significantly reduce manufacturing costs.

[0023] Embodiments of the catheter cover 10 are not limited to the antimicrobial materials discussed above. The catheter cover 10 can be formed from, but not limited to, bamboo cloth, charcoal impregnated cloth, plastic sheet, silver-lined fabrics, and other materials that have or are treated to have antimicrobial properties. However, in order to minimize or prevent any patient irritant, immune-mediated or other unwanted reactions, any antimicrobial properties should be non-transdermal. Further, the catheter cover 10 is preferably formed from, but is not limited to, a non-woven material. While woven materials may be used, non-woven materials are preferred due to their relatively low costs, consistent properties and ease of adding antimicrobial properties. In one embodiment of the present invention, the material is recycled plastic fibers. However, in other embodiments of the present invention, the material may comprise polypropylene, polyester, and other polymer fibers.

[0024] The main body 100 of the catheter cover 10 may be formed from a single panel of material 200 as shown in Fig. 5. The single panel 200 has a first surface 201 and a second surface (not illustrated). The single panel 200 is symmetrical along a central axis 202 running through the middle of the single panel 200, wherein the profile of a first securing edge 204 mirrors the profile of a second securing edge 206. To form the catheter cover 10, the panel 200 is folded along the central axis 202, with the first securing edge 204 aligning with the second securing edge 206. The panel 200 along the central axis 202 forms the seamless edge 107 of the first side 106 of the main body 100 of the catheter cover 10. The first and second securing edges 204, 206 are then secured to one another to form the secured edge 109 and unsecured edge 110 of the second side 108 of the catheter cover 10. The first surface 201 of the single panel forms the surface of the internal cavity 116, with the second surface forming the outer surface 101 of the main body 100. While the main body 100 of the catheter cover 10 is formed from a single panel 200, other embodiments of the current invention may be made from multiple panels. However, making the catheter cover 10 from a single panel of material 200 is more cost and time efficient and uses less material. Further, using a single panel 200 creates a seamless edge 107 for the catheter cover 10, which greatly increases the comfort factor for the patient.

[0025] As shown in Figs. 2-4, the first and second securing sides are secured to one another using a flat or abutted seam 11 1 to form the secured edge 109 of the catheter cover 10. However, in other embodiments of the invention, the seam 11 1 may include, but is not limited to, plain, lapped, French, bound, and other seam types. Further, in other embodiments of the invention, the secured edge 109 may be secured through other means other than sewn seams. For example, the first and second securing sides 204, 206 may be secured by, but not limited to, heat sealing, ultra-sonic bonding, radiofrequency (RF) welding, chemical bonding, adhesives, and other securing means. In particular, ultrasonic bonding or radiofrequency welding can allow for automation of the joining and cutting process in a manner that can improve consistency of the product and contribute to reducing cost of manufacture. The only limiting factor considered in the means by which the sides are secured is the possible irritation that the seam 11 1 or bond could have on the patient's skin.

[0026] Before applying the catheter cover 10, the catheter 20 should be cleaned and dried, with the end caps 34, 36 and clamps 38, 40 firmly secured. The securing mechanism 120 is disengaged before inserting any part of the exposed catheter 20 into the catheter cover 10, as shown in Fig. 4. The opening 114 is spread apart to receive the external portions of the catheter 20, and can be expanded horizontally by applying pressure at the seamless edge 107 and the secured edge 109 near the proximal end 104 or by bending back the main body 100 at the unsecured edge 110. While holding the catheter 20, the opening 114 of the catheter cover 10 receives the distal ends 30, 32 of the catheter 20. As shown in Fig. 6, the catheter cover 10 is advanced towards the dual chambered single tube 22 of the catheter 20 until the components are within the internal cavity 1 16, with the tubes 26, 28, clamps 38, 40, and end caps 34, 36 associated with the distal end 102 of the cover 10 and the hub 24 associated with the proximate end 104. The opening 114 is then closed around the hub 24 with the securing mechanism 120 engaging the hub 24 to prevent the catheter cover 10 from shifting along the catheter 20, as shown in Fig. 7. If the catheter cover 10 is not in an ideal position on the catheter 20, the securing mechanism 120 may be disengaged, allowing the catheter cover 10 to be repositioned for a better fit. [0027] Fig. 8 is a perspective view of another example catheter cover in accordance with this disclosure. In the example configuration of Fig. 8, the main body 100 of the catheter cover 10 can define a second opening, shown generally at 1 13. The second opening 113 can, for example, allow a clinician to access one of the chambered tubes 26, 28 of catheter 20 without disengaging the securing mechanism 120 (Fig. 4) that closes the first opening 114, thereby allowing the other chambered tube to remain covered within the catheter cover 10. The second opening 113 can be partially defined by the secured edge 109 and a secured portion 117 of first side 106 (near the proximal end 104).

[0028] In Fig. 8, the second opening 113 can be covered by a flap 1 15, which folds over the second opening 1 13 and adheres to the cover 10 via a securement mechanism. For instance, the cover 10 can include a securement mechanism 1 18A that adheres to a securement mechanism 118B on the flap 1 15. The securement mechanisms 1 18A, 118B can include, for example, adhesive tape, applied adhesive, hook and loop systems, etc.

[0029] Fig. 9 is a perspective view of another example catheter cover in accordance with this disclosure. In the example configuration of Fig. 9, the main body 100 of the catheter cover 10 can define a second opening, shown generally at 1 13. The second opening 113 can, for example, allow a clinician to access one of the chambered tubes 26, 28 of catheter 20 without disengaging the securing mechanism 120 (Fig. 4) that closes the first opening 114, thereby allowing the other chambered tube to remain covered within the catheter cover 10. The second opening 113 can be partially defined by the first edge 106 and a secured region 119 of second side 108.

[0030] In Fig. 9, the second opening 113 can be formed by an inner flap

122 and an outer flap 124, which are secured to one another via a securement mechanism. For instance, the inner flap 122 can include a securement mechanism 126A that adheres to a securement mechanism 126B on the outer flap 122. The securement mechanisms 126A, 126B can include, for example, adhesive tape, applied adhesive, hook and loop systems, etc.

[0031] The catheter cover 10 discussed above is not limited to the shapes shown in Figs. 2-9. In some example configuration, the catheter cover 10 can be formed such that there are no sharp corners. In other example configurations, the catheter cover 10 can be formed such that the securement region between first and second sides 104, 106, e.g., ultra-sonic bond, RF weld, sewn seam etc., can be set inward from the edges of the sides 104, 106 so that the edges are unsecured, thereby providing a soft interface between the cover 10 and the skin of the patient.

[0032] Having thus described exemplary embodiments of the present invention, it should be noted by those skilled in the art that the within disclosures are exemplary only and that various other alternatives, adaptations, and modifications may be made within the scope of the present invention.

Accordingly, the present invention is not limited to the specific embodiments as illustrated herein, but is only limited by the following claims.

Claims

WHAT IS CLAIMED IS:

1. A catheter cover (10) configured for use with a catheter (20), the catheter cover (10) comprising:

a. a main body (100) defining an internal cavity (116), the main body comprising:

i. a proximal end (104);

ii. a distal end ( 102) opposite the proximal end ( 104);

iii. an antimicrobial substance; and

iv. an opening (114) to the internal cavity (1 16) associated at the proximal end (104) configured to receive the external portions of the catheter (20); and

b. a securing mechanism (120) associated with the opening (114) configured to secure the catheter (10),

wherein the internal cavity is configured to retain external portions of the catheter (20).

2. The catheter cover (10) of claim 1, wherein the catheter cover (10) is configured to be disposable.

3. The catheter cover ( 10) of claim 1 , wherein the main body ( 100) is formed from a plurality of panels.

4. The catheter cover ( 10) of claim 1 , wherein the main body ( 100) is formed from a single panel (200).

5. The catheter cover (10) of claim 4, wherein the single panel (200) comprises:

i. a first edge (204);

ii. a second edge (206); and

iii. a central axis (202) oriented between the first edge (204) and the second edge (206), wherein the single panel (200) is folded in half along the central axis (202) to form a first side (106) having a seamless edge (107) along the central axis (202) and the first edge (204) and the second edge (206) form a second side (108) of the catheter cover (10), the first edge (204) and the second edge (206) secured to each other, wherein the first side (106) is oriented opposite the second side (108).

6. The catheter cover ( 10) of claim 1 , wherein the antimicrobial substance (200) utilizes silver ions to kill and/or repel microbes.

7. The catheter cover ( 10) of claim 1 , wherein the main body ( 100) further comprises a first width (102a) associated near the distal end (102) and a second width (104a) associated near the proximal end (104), wherein the first width (102a) is greater than the second width (104a).

8. The catheter cover (10) of claim 1, further comprising a first side (106) and a second side (108), wherein the first side (106) and the second side (108) are oriented opposite each other between the proximal end (104) and the distal end (102).

9. The catheter cover (10) of claim 8, wherein the first side (106) comprises a seamless edge (107).

10. The catheter cover (10) of claim 8, wherein the second side (108) comprises;

i. a secured edge (109); and

ii. an unsecured edge ( 110), the secured edge ( 109) extending from the distal end (102) to the unsecured edge (1 10) and the unsecured edge (1 10) extending from the secured edge (109) to the proximal end (104) and the opening (1 14) to allow the catheter (10) access to the internal cavity (116).

11. The catheter cover ( 10) of claim 1 , wherein the securing mechanism (120) comprises an adhesive (120) associated with the opening (1 14) of the proximal end (104).

12. The catheter cover (10) of claim 1, wherein the main body (100) further defines a second opening (113), wherein the second opening is configured to provide access to the external portions of the catheter (20) without disengaging the securing mechanism (120).

13. The catheter cover (10) of claim 1, wherein the catheter cover (10) is disposable.

14. The catheter cover ( 10) of claim 1 , further comprising a plurality of fibers, wherein the antimicrobial substance is incorporated into at least some of the plurality of fibers during or prior to formation of the fibers.

15. A method of protecting external portions of a catheter (20) from microbes, comprising:

a. cleaning and drying the external portions of the catheter (20); b. fitting a catheter cover (10) over the external portions of the catheter (20), the catheter cover (10) comprising:

i, a main body (100) comprising:

A. a proximal end ( 104);

B. a distal end ( 102) opposite the proximal end ( 104);

C. an antimicrobial substance;

D. an internal cavity (1 16) configured to retain the external portions of the catheter (10); and

E. an opening (114) to the internal cavity (1 16) associated at the proximal end (104) configured to receive the external portions of the catheter (10); and

ii. a securing mechanism (120) associated with the opening (1 14) configured to secure the catheter (20); and

c. engaging the securing mechanism (120) to secure the external portions of the catheter (20) within the catheter cover (10).

16. The method of claim 15, wherein the external portions of the catheter (20) comprise a hub (24) connected to tubes (26, 28), each tube comprising a distal end (30,32), an end cap (34,36), and a clamp (38, 40), and wherein fitting the catheter cover (10) over the external portions of the catheter (20) comprises:

i. expanding the opening (114) to receive the external portions of the catheter (20); and

ii. inserting and advancing the external portions of the catheter (20) into the internal cavity (1 16) through the opening (114) until the hub (24), the tubes (26, 28), the distal ends (30, 32), the end caps (34, 36), and the clamps (38, 40) are within the catheter cover (20), with the distal ends (30, 32), the end caps (34, 36), and the clamps (38, 40) are associated with the distal end (102) and the hub (24) is associated with the proximal end (104).