Sealed sterile catheter dressings

Abstract

Devices and methods are provided for sealing a catheter insertion site to maintain sterility. In one embodiment, a catheter dressing is provided that includes an adhesive plate configured for attachment to the skin of a patient and a flexible sheath that extends proximally from the adhesive plate. The sheath can be capable of longitudinal extension from a compressed to an extended state and can be configured in its extended state to surround an external segment of a catheter implanted in the patient and circumferentially seal to a portion of the external segment at a distance from the adhesive plate. The dressing can also be configured to restrict longitudinal movement of the catheter while at the same time permitting non-longitudinal movement. One-piece rigid or semi-rigid dressing bodies are also disclosed, as are various methods and devices for facilitating removal and or replacement of a catheter dressing.

1 . A catheter dressing comprising:
 an adhesive plate configured for attachment to the skin of a patient; and   a flexible sheath having a proximal end and a distal end and extending proximally from the adhesive plate;   wherein the sheath is capable of longitudinal extension from a compressed to an extended state and configured in its extended state to surround an external segment of a catheter implanted in the patient and circumferentially seal to a portion of the external segment at a distance from the adhesive plate.   
     
     
         2 . The catheter dressing of  claim 1 , wherein the sheath defines a sealed chamber around the external segment of the catheter and a portion of the patient and, optionally, wherein the sealed chamber is sterile. 
     
     
         3 . The catheter dressing of  claim 1 , wherein movement of the catheter with respect to the patient does not disrupt a seal formed between the sheath and the catheter. 
     
     
         4 . The catheter dressing of  claim 1 , wherein the sheath further comprises a stretchable gasket ring at its proximal end for sealing to the portion of the external segment of the catheter and, optionally, wherein the portion of the external segment of the catheter further comprises an annular groove for receiving the stretchable gasket ring. 
     
     
         5 . The catheter dressing of  claim 1 , wherein the sheath further comprises an attachment mechanism selected from the group consisting of a friction coupler, a threaded coupler, an inflation coupler, an electromagnetic coupler, and an adhesive. 
     
     
         6 . The catheter dressing of  claim 1 , wherein the portion of the external segment of the catheter is selected from the group consisting of a catheter body, a catheter hub, a MicroCLAVE-type connector, and a Luer-type connector. 
     
     
         7 . The catheter dressing of  claim 1 , wherein at least a portion of the sheath is transparent and, optionally, wherein the sheath is formed of at least one of an antibiotic-impregnated material and an antimicrobial-impregnated material and, optionally, wherein the sheath comprises an access portal. 
     
     
         8 . The catheter dressing of  claim 1 , further comprising at least one of an antibiotic secreting member, an antimicrobial secreting member, and an absorbent member disposed within the sheath. 
     
     
         9 . The catheter dressing of  claim 1 , wherein the sheath is formed integrally with the catheter. 
     
     
         10 . The catheter dressing of  claim 1 , further comprising a clamp configured to secure at least one of the sheath and the external segment of the catheter to the patient and, optionally, wherein the clamp is configured to increase the integrity of a seal formed between the sheath and the external segment of the catheter and, optionally, wherein the sheath further comprises a stretchable gasket ring at its proximal end for sealing to the portion of the external segment of the catheter and wherein the clamp is configured to apply a compressive force to the gasket ring. 
     
     
         11 . The catheter dressing of  claim 1 , further comprising a coupling member configured for coupling to a terminal end of the external segment of the catheter, the coupling member having at least one lumen to provide a fluid flow path to or from the catheter and, optionally, wherein the sheath is extendable between the adhesive plate and the coupling member to surround a longitudinal segment of the catheter. 
     
     
         12 . The dressing assembly of  claim 11 , wherein the sheath is formed integrally with the coupling member and, optionally, wherein the coupling member is directly attached to the adhesive plate and, further optionally, wherein the coupling member is selected from the group consisting of a valve, a catheter body, a catheter hub, a Luer-type connector, a MicroCLAVE-type connector, a threaded fitting, and a friction fitting. 
     
     
         13 . The catheter dressing of  claim 1 , wherein the sheath has a splittable seam formed therein and is capable of being opened along the seam such that the catheter dressing can be removed from a catheter around which the dressing is installed and, optionally, wherein the seam comprises a non-full-thickness perforation. 
     
     
         14 . A kit comprising:
 the catheter dressing of  claim 1 ; and   a catheter having a mating feature for attachment of the catheter to the catheter dressing.   
     
     
         15 . The catheter dressing of  claim 1 , wherein the sheath is configured to restrict longitudinal movement of the external segment of the catheter relative to the patient while permitting non-longitudinal movement of the external segment of the catheter relative to the patient. 
     
     
         16 . A catheter dressing comprising:
 a unitary body having a planar distal adhesive surface defining a distal opening, a proximal portion defining a proximal opening, and an interior chamber extending from the proximal opening to the distal opening;   wherein the proximal opening is configured to form a circumferential seal around a catheter that is at least partially inserted into a patient,   the distal adhesive surface is configured to adhere to the patient's skin to form a circumferential seal around a skin site at which the catheter is inserted, and   the body includes a splittable seam along which the body can be selectively opened.   
     
     
         17 . The catheter dressing of  claim 16 , wherein the body is rigid or semi-rigid such that the body restricts movement of the catheter relative to the patient. 
     
     
         18 . The catheter dressing of  claim 16 , wherein the proximal opening is formed perpendicular to the planar distal adhesive surface. 
     
     
         19 . (canceled) 
     
     
         20 . A catheter and dressing assembly comprising:
 a catheter; and   an integrated dressing comprising an adhesive plate and a flexible sheath having a proximal end joined to the catheter and a distal end joined to the adhesive plate;   wherein the sheath is capable of longitudinal extension from a compressed to an extended state and configured in its extended state to surround an external segment of the catheter when implanted in the patient and the adhesive plate is configured for attachment to the patient's skin to provide a circumferential seal.   
     
     
         21 . The assembly of  claim 20 , wherein the sheath further comprises a stretchable gasket ring at its proximal end for sealing to the portion of the external segment of the catheter. 
     
     
         22 . The assembly of  claim 21 , wherein the portion of the external segment of the catheter further comprises an annular groove for receiving the stretchable gasket ring and, optionally, wherein the external segment of the catheter is selected from the group consisting of a catheter body, a catheter hub, a MicroCLAVE-type connector, and a Luer-type connector. 
     
     
         23 . A catheter dressing comprising:
 an adhesive plate configured for attachment to the skin of a patient; and   a flexible sheath having a proximal end and a distal end and extending proximally from the adhesive plate, the flexible sheath having a longitudinal opening formed therein;   wherein the sheath is capable of being placed around an installed catheter and closed along the opening to circumferentially seal an external portion of the installed catheter at a distance from the adhesive plate.   
     
     
         24 . The catheter dressing of  claim 23 , further comprising a mating mechanism selected from the group consisting of a friction-based closure, an adhesive closure, a latch-type closure, and a male-female closure, the mating mechanism being configured to selectively mate first and second free edges of the sheath to one another along the opening.