Skin port connector and method of installation

A method of connecting a skin port connector to a flexible percutaneous gastrostomy tube that passes from and through a patient's stomach, and exits through an external stoma on the patient's abdominal wall, said flexible percutaneous gastrostomy tube having a distal end within the patient's stomach and a proximal end to be connected outside of the patient's body, wherein the proximal end of the flexible percutaneous gastrostomy tube, outside of the patient's body has an inner cross-sectional dimension, an outer cross-sectional dimension, and an uncompressed tube wall thickness, said method comprising:

• (a) clamping the flexible percutaneous gastrostomy tube between the external stoma and the proximal end of the flexible percutaneous gastrostomy tube to be connected, so as to substantially prevent the flow of material out of the stomach;
• (b) passing the gastrostomy tube through a clamp plate/tray having an area that contacts the patient's skin;
• (c) locating the proximal end of the flexible percutaneous gastrostomy tube within a through-hole channel of a skin flange at a pre-determined height relative to the through-hole channel, said through-hole channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the channel, said through-hole channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel;
• the circumferential ridge protruding into the channel of the through hole defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;
• and
• (d) press fitting a coupler into the open proximal end of the flexible percutaneous gastrostomy tube, said coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the outer surface of the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second outer mean cross-sectional dimension and area;
• so that at least a portion of the coupler fits within the through-hole channel and the center-line axes of the through-hole channel and the coupler are substantially coaxial;
• wherein the clamp plate/tray is capable of distributing any pressure associated with inserting the coupler over the area of the clamp plate/tray that contacts the patient's skin;
• wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the outer surface of the sleeve body in closest approach to one another comprise mating surfaces with respect to one another and wherein the circumferential ridge protruding from the main inner surface into the through-hole channel of the skin flange is distally positioned relative to the circumferential ridge protruding from the outer surface of the sleeve body of the coupler;
• wherein the second outer mean cross-sectional area defined by the circumferential ridge protruding from the outer surface of the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole channel but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole channel;
• and
• wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of the tube wall of the uncompressed percutaneous gastrostomy tube;
• so as to compress the tube radially between the through-hole channel and the coupler;
• wherein the coupler is press fit into the open proximal end of the flexible percutaneous gastrostomy tube to a distance defined by further inability of the circumferential ridge protruding from the outer surface of the sleeve body to pass beyond the circumferential ridge protruding from the main inner surface into the channel of the through-hole in the presence of the compressed percutaneous gastrostomy tube;
• and
• wherein the coupler is guided into the open proximal end of the flexible percutaneous gastrostomy tube using a guide pin, said guide pin having an external cross-sectional area substantially similar to the inner cross-sectional area of the coupler, said coupler being slidably detachable from the guide pin.

A device for connecting a skin port connector for use on a flexible percutaneous gastrostomy tube to the flexible percutaneous gastrostomy tube, said flexible percutaneous gastrostomy tube having a tube wall thickness when uncompressed,

• said skin port connector comprising:
• (a) a skin flange containing a through-hole channel, said through-hole channel having (i) a main inner surface, (ii) a mean cross-sectional dimension and area, (iii) proximal and (iv) distal ends and (v) a center-line axis along the longitudinal axis of the through-hole channel, said through-hole channel further comprising (vi) a circumferential ridge protruding from the main inner surface into the channel of the through-hole at a position within the channel;
• the circumferential ridge defining a second mean cross-sectional dimension and area that are each less than the mean cross-section dimension and area of the main inner surface;
• and
• (b) a coupler comprising a sleeve body having a bore therethrough and a circumferential ridge protruding from the outer surface of the sleeve body, said coupler having (i) proximal and (ii) distal ends and (iii) a center-line axis coincidental with the longitudinal axis of the bore, said sleeve body having (iv) inner and (v) outer surfaces and (vi) an inner mean cross-sectional dimension and area defined by the inner surface and (vii) a first outer mean cross-sectional dimension and area defined by the outer surface of the sleeve body, and wherein the circumferential ridge protruding from the outer surface of the sleeve body is located (viii) nearer the proximal end of the sleeve body than the distal end and defines (ix) a second outer mean cross-sectional dimension and area;
• wherein at least a portion of the coupler fits within the through-hole channel so that the center-line axes of the through-hole channel and the coupler are substantially coaxial;
• wherein the surface(s) of the circumferential ridge protruding from the main inner surface into the channel of the through-hole and the surface(s) of the circumferential ridge protruding from the outer surface of the sleeve body in closest approach to one another comprise mating surfaces with respect to one another and wherein the circumferential ridge protruding from the main inner surface into the through-hole channel of the skin flange is distally positioned relative to the circumferential ridge protruding from the outer surface of the sleeve body of the coupler;
• wherein the second outer mean cross-sectional area defined by the circumferential ridge protruding from the outer surface of the sleeve body is less than the corresponding mean cross-section area defined by the main inner surface of the through-hole channel but more than the corresponding second mean cross-sectional area defined by the circumferential ridge of the through-hole channel;
• and
• wherein the difference between the second mean cross-sectional area defined by the circumferential ridge of the through-hole channel and the first outer mean cross-sectional area defined by the sleeve body defines an annulus, said annulus having a width that is less than the thickness of a tube wall of an uncompressed percutaneous gastrostomy tube, such that when the percutaneous gastrostomy tube is coupled to the skin port connector by press fitting the coupler in the annulus, the tube is compressed radially between the through-hole channel and the coupler,
• said device comprising:
• a clamp plate/tray having a base thickness less than about 10 mm, and comprising a tube opening, through which may pass the flexible percutaneous gastrostomy tube;
• a movable clamp jaw attached to said clamp plate/tray and configured to reversibly clamp the flexible percutaneous gastrostomy tube which may pass through the clamp plate/tray, such that when clamped, the position of the flexible percutaneous gastrostomy tube opening is fixed with respect to the position of the clamp plate/tray;
• and
• an attachable coupler installation tool comprising a sliding guide pin insertable into the flexible percutaneous gastrostomy tube opening so as to be capable of delivering the coupler into the flexible percutaneous gastrostomy tube opening.