Adhesive support devices and methods of making and using them

Abstract

Described herein are adhesive support devices, which may include adhesive medical devices. In particular, three-dimensional adhesive medical devices from a single layer of material, typically by stamping or pressing (including cold pressing) a sheet of the material to form rigid and complex 3D shapes capable of use for a variety of medical and non-medical purposes. These adhesive support devices typically also include an adhesive material allowing the device to be attached to a subject's skin and/or mounted on a surface (e.g., wall, etc.). In particular, described herein are methods of manufacturing, assembling, and using adhesive support devices.

What is claimed is: 
     
         1 . An adhesive support device for holding a catheter to a patient's body, the device having a three-dimensional shape and comprising:
 a body portion comprising a sheet of material having an elastic modulus of greater than 0.4 GPa, wherein the sheet has been stamped from a flat plane to form:   a first base region and a second base region, wherein the first and second base regions extend in the flat plane, the first and second base regions each having a first thickness; and   a cavity region having a maximum wall thickness that is equal to or less than the first thickness, the first and second base regions extending from either side of the cavity region, wherein the cavity region extends out of the flat plane at an angle that is greater than 90° relative to an adjacent base region, the cavity region forming an open channel between the first and second base regions through which a catheter may extend and one or more lateral openings into the open channel; and   a first adhesive substrate coupled to the first base region and a second adhesive substrate coupled to the second base region.   
     
     
         2 . The device of  claim 1 , further wherein the open channel comprises a narrower diameter region against which a portion of a catheter may abut to prevent longitudinal movement of the catheter through the open channel. 
     
     
         3 . The device of  claim 1 , wherein a volume of material in any section of a continuous portion of the first or second base regions bounded by an arbitrary shape projected from a plane that is parallel to the flat plane is approximately equal to a volume of material in any section of a continuous portion of the cavity region bounded by the arbitrary shape projected from the plane that is parallel to the flat plane. 
     
     
         4 . The device of  claim 1 , further comprising one or more ridges in a wall of the cavity region. 
     
     
         5 . The device of  claim 1 , further comprising a cut-out section on a wall of the cavity region, wherein the wall is angled greater than 90° relative to an adjacent base region. 
     
     
         6 . The device of  claim 1 , wherein a ratio of a maximum length of the cavity region in the flat plane to a maximum depth of the cavity region perpendicular to the flat plane is greater than 2:1. 
     
     
         7 . The device of  claim 1 , wherein the first and second base regions form a lip of greater than 0.5 mm adjacent to the cavity region. 
     
     
         8 . The device of  claim 1 , wherein all surfaces of the cavity region projecting from the flat plane have rounded edges. 
     
     
         9 . The device of  claim 1 , wherein the cavity region extends up from the adjacent base region by between about 1 mm and about 50 mm. 
     
     
         10 . The device of  claim 1 , wherein the material of the sheet of material comprises a polycarbonate, a polyethylene, or polyethylene terephthalate. 
     
     
         11 . An adhesive support device for holding a catheter to a patient's body, the device having a three-dimensional shape and comprising:
 a body portion comprising a sheet of material having an elastic modulus of greater than 0.4 GPa, wherein the sheet has been stamped from a flat plane to form:   a first base region and a second base region, wherein the first and second base regions extend in the flat plane, the first and second base regions each having a first thickness, and   a cavity region having an average wall thickness that is less than the first thickness, the first and second base regions extending from either side of the cavity region, wherein the cavity region extends out of the flat plane at an angle that is greater than 90° relative to an adjacent base region, the cavity region forming an open channel between the first and second base region through which a catheter may extend and one or more lateral openings into the open channel, further wherein a wall of the cavity region comprises a plurality of ridges; and   a first adhesive substrate coupled to the first base region and a second adhesive substrate coupled to the second base region.   
     
     
         12 . An intraosseus needle securement device stamped from a sheet of material into a three-dimensional shape, the device comprising:
 a body portion comprising a sheet of material having an elastic modulus of greater than 0.4 GPa, wherein the sheet has been stamped from a flat plane to form:   a base region extending in the flat plane, the base region having a first thickness, and a hub region surrounded by the base region, the hub region having a maximum wall thickness that is equal to or less than the first thickness, wherein the hub region extends from the flat plane at an angle that is greater than 90° relative to an adjacent base region, the hub region having an opening configured to secure an intraosseus needle, and   a plurality of ridges in the hub region extending from the base region towards the opening and configured to increase stability of the hub region relative to the base region; and   an adhesive substrate coupled to the base region and configured to secure the device to a patient's skin.   
     
     
         13 . The device of  claim 12 , wherein the base region comprises a raised pattern extending in parallel to the flat plane to enhance stiffness. 
     
     
         14 . The device of  claim 12 , wherein a volume of material in any section of a continuous portion of the base region bounded by a shape projected from a plane that is parallel to the flat plane is approximately equal to a volume of material in any section of a continuous portion of the hub region bounded by the shape projected from the plane that is parallel to the flat plane. 
     
     
         15 . The device of  claim 12 , wherein a ratio of a maximum length of the hub region in the flat plane to a maximum depth of the hub region perpendicular to the flat plane is greater than 1:1. 
     
     
         16 . The device of  claim 12 , wherein the base region forms a lip of greater than 0.5 mm adjacent to the hub region. 
     
     
         17 . The device of  claim 12 , wherein all surfaces of the hub region projecting from the flat plane have rounded edges. 
     
     
         18 . The device of  claim 12 , wherein the hub region extends up from the base region by between about 1 mm and about 50 mm. 
     
     
         19 . The device of  claim 12 , wherein the hub region is continuous with the base region. 
     
     
         20 . The device of  claim 12 , wherein the material comprises a polycarbonate, a polyethylene, or polyethylene terephthalate.