Methods and devices for sutureless coupling of a device insertable within a mammalian body, with anchoring, stabilization and integrated strain relief features

Abstract

Methods and devices for a coupler adapted and configured for use with a device insertable within a mammalian body are disclosed. The coupler also can be used as a temporary holding device for indwelling catheters, cannula, introducers or other devices. The coupler may be used to hold a catheter or other, at a fixed or movable length from the outside of a patient. The catheter or other may be inserted through the center of the coupler, with the tissue contacting ridge attached to the skin using an adhesive, suture(s), combination or other. The inside of the coupler may have a valve, ring, gasket or other, that provides fluid sealing as well as mechanical interference fit between the inside of the coupler and the outside of the catheter or other device.

1 . A coupler for use with a device insertable within a mammalian body comprising: an elongate member having a lumen therethrough; a flange extending from the elongate member at a first end further comprising a tissue engaging surface; and an opening along a length of the elongate member having a width less than a diameter of the insertable device and adapted and configured to engage the insertable device within the lumen of the elongate member. 
     
     
         2 . The coupler of  claim 1  wherein the coupler has a single-molded assembly. 
     
     
         3 . The coupler of  claim 1  wherein the coupler is assembled from component parts. 
     
     
         4 . The coupler of  claim 1  wherein the insertable device is a catheter, cannula, sheath, introducer, trocar, tube or guide wire. 
     
     
         5 . The coupler of  claim 1  further comprising a strain relief mechanism. 
     
     
         6 . The coupler of  claim 1  wherein the coupler is adapted and configured to engage the insertable device after the device is deployed within the mammalian body. 
     
     
         7 . The coupler of  claim 1  further comprising a surface adherable to a tissue. 
     
     
         8 . The coupler of  claim 7  wherein the adherable surface has a skin contacting surface larger than a skin contacting surface of the flange. 
     
     
         9 . The coupler of  claim 7  wherein the adherable surface is positionable over the flange. 
     
     
         10 . The coupler of  claim 9  wherein the adherable surface positioned over the flange extends outwardly from the flange. 
     
     
         11 . The coupler of  claim 1  wherein the coupler is suturable to a tissue. 
     
     
         12 . The coupler of  claim 1  wherein the elongate member is positioned at an angle less than 90 degrees from a plane in which the flange is positioned. 
     
     
         13 . The coupler of  claim 1  further comprises one or more reinforcing members selected from a wire, a rod, a hoop, a tube, a coil, a sheet, a strip or a band. 
     
     
         14 . The coupler of  claim 1  further comprising one or more of a therapeutic or pharmacologic compound. 
     
     
         15 . The coupler of  claim 1  further comprising a fluid sealing member. 
     
     
         16 . The coupler of  claim 15  wherein the fluid sealing member is a valve, a ring or a gasket. 
     
     
         17 . The coupler of  claim 1  wherein the coupler is fabricated from one or more of silicone, polymer, rubber, metal, metal alloy, and shape memory material. 
     
     
         18 . The coupler of  claim 1  further comprising a securement member. 
     
     
         19 . The coupler of  claim 1  wherein the elongate member is adapted and configured to be snap fit together. 
     
     
         20 . The coupler of  claim 1  wherein the coupler is further comprised of two pieces adapted and configured to be engageable along a length. 
     
     
         21 . A method of coupling a device insertable within a mammalian body comprising the steps of: a. inserting the insertable device within the mammalian body; and b. engaging the insertable device with a coupler comprising, an elongate member having a lumen therethrough; a flange extending from the elongate member at a first end further comprising a tissue engaging surface; and an opening along a length of the elongate member having a width less than a diameter of the insertable device and adapted and configured to engage the insertable device within the lumen of the elongate member. 
     
     
         22 . The method of coupling of  claim 21  wherein the step of engaging the insertable device occurs before the inserting step. 
     
     
         23 . The method of coupling of  claim 21  further comprising the steps of positioning the opening of the coupler adjacent the insertable device and applying pressure along a length of the coupler until the insertable device is positioned within the lumen of the coupler. 
     
     
         24 . The method of coupling of  claim 21  further comprising the step of adhering the coupler along an end to the mammalian body. 
     
     
         25 . The method of coupling of  claim 24  wherein the step of adhering occurs on a skin surface. 
     
     
         26 . The method of coupling of  claim 21  wherein the insertable device is not perpendicular to the mammalian body. 
     
     
         27 . The method of coupling of  claim 21  wherein the coupler is snapped together around an exterior of the insertable device. 
     
     
         28 . The method of coupling of  claim 21  further comprising the step of holding the coupler in a fixed position along the length of the insertable device. 
     
     
         29 . The method of coupling of  claim 21  further comprising the step of moving the coupler from a first position along the length of the insertable device to a second position along the length of the insertable device. 
     
     
         30 . A coupler for engaging a device insertable within a body comprising: an elongate member having a lumen therethrough; and a flange extending from the elongate member at a first end; wherein the elongate member is adapted and configured to have a first configuration prior to engaging the device, a conformable second configuration enabling the elongate member to slide over the device during deployment, and a third configuration wherein the device is positioned within the lumen of the elongate member after deployment. 
     
     
         31 . The coupler of  claim 30  wherein the coupler has a single-molded assembly. 
     
     
         32 . The coupler of  claim 30  wherein the insertable device is a catheter, cannula, introducer, sheath, trocar, tube or guide wire. 
     
     
         33 . The coupler of  claim 30  further comprising a strain relief mechanism. 
     
     
         34 . The coupler of  claim 30  wherein the coupler is assembled from component parts. 
     
     
         35 . The coupler of  claim 34  wherein the coupler is adapted and configured to engage the insertable device after the device is deployed within the mammalian body. 
     
     
         36 . The coupler of  claim 30  further comprising a surface adherable to a tissue. 
     
     
         37 . The coupler of  claim 36  wherein the adherable surface has a skin contacting surface larger than a skin contacting surface of the flange. 
     
     
         38 . The coupler of  claim 36  wherein the adherable surface is positionable over the flange. 
     
     
         39 . The coupler of  claim 38  wherein the adherable surface positioned over the flange extends outwardly from the flange. 
     
     
         40 . The coupler of  claim 30  wherein the coupler is suturable to a tissue. 
     
     
         41 . The coupler of  claim 30  wherein the elongate member is positioned at an angle less than 90 degrees from a plane in which the flange is positioned. 
     
     
         42 . The coupler of  claim 30  further comprises one or more reinforcing members selected from a wire, a rod, a hoop, a tube, a coil, a sheet, a strip or a band. 
     
     
         43 . The coupler of  claim 30  further comprising one or more of a therapeutic or pharmacologic compound. 
     
     
         44 . The coupler of  claim 30  further comprising a fluid sealing member. 
     
     
         45 . The coupler of  claim 44  wherein the fluid sealing member is a valve, a ring or a gasket. 
     
     
         46 . The coupler of  claim 30  wherein the coupler is fabricated from one or more of silicone, polymer, rubber, metal, metal alloy, and shape memory material. 
     
     
         47 . The coupler of  claim 30  further comprising a securement member. 
     
     
         48 . The coupler of  claim 30  wherein the elongate member is adapted and configured to be snap fit together. 
     
     
         49 . The coupler of  claim 30  wherein the coupler is further comprised of two pieces adapted and configured to be engageable along a length. 
     
     
         50 . A method of coupling a device insertable within a mammalian body comprising the steps of: a. inserting the insertable device within the mammalian body; and b. engaging the insertable device with a coupler comprising, an elongate member having a lumen therethrough; and a flange extending from the elongate member at a first end; wherein the elongate member is adapted and configured to have a first configuration prior to engaging the device, a conformable second configuration enabling the elongate member to slide over the device during deployment, and a third configuration wherein the device is positioned within the lumen of the elongate member after deployment. 
     
     
         51 . The method of coupling of  claim 50  wherein the step of engaging the insertable device occurs before the inserting step. 
     
     
         52 . The method of coupling of  claim 50  further comprising the steps of positioning the opening of the coupler adjacent the insertable device and applying pressure along a length of the coupler until the insertable device is positioned within the lumen of the coupler. 
     
     
         53 . The method of coupling of  claim 50  further comprising the step of adhering the coupler along an end to the mammalian body. 
     
     
         54 . The method of coupling of  claim 53  wherein the step of adhering occurs on a skin surface. 
     
     
         55 . The method of coupling of  claim 50  wherein the insertable device is not perpendicular to the mammalian body. 
     
     
         56 . The method of coupling of  claim 50  wherein the coupler is snapped together around an exterior of the insertable device. 
     
     
         57 . The method of coupling of  claim 50  further comprising the step of holding the coupler in a fixed position along the length of the insertable device. 
     
     
         58 . The method of coupling of  claim 50  further comprising the step of moving the coupler from a first position along the length of the insertable device to a second position along the length of the insertable device.