1. A connection device for at least one tube end so as to convey a fluid flow, the device comprising a body defining a channel having at least one tube end reception segment, the reception segment being provided with an annular sealing element arranged to surround the tube end while leaving a portion of the tube end projecting from the sealing element towards an end of the segment, the device being characterized in that centering means for the projecting portion are arranged in a zone extending between the outer surface of the projecting portion, a facing surface of the segment, and the sealing element, and in that the centering means include positioning elements that are arranged to co-operate with a surface of the segment and an outer surface of the projecting portion and to define at least one sweeping duct for sweeping the zone, the duct having at least one inlet in the vicinity of which there extends at least one deflector arranged to insert, into the sweeping duct, fluid diverted from the flow traveling through the device, and at least one outlet for returning the fluid that has passed through the sweeping duct back to the flow.
2. A device according to claim 1, wherein the centering means comprise a ring housed in the zone.
3. A device according to claim 2, wherein the ring comprises a band connecting together fins forming the positioning element, the fins projecting from the band firstly axially, and secondly radially both towards the inside and towards the outside.
4. A device according to claim 3, wherein the band has a tubular portion extending along the axis of the channel and a radial annular portion having an outer periphery secured to one end of the annular portion opposite from the sealing element, the annular portion projecting from the tubular portion towards the inside of the band.
5. A device according to claim 4, wherein the deflector is secured to an inner circumference of the annular portion.
6. A device according to claim 3, wherein at least some of the fins are not in contact with the sealing element.
7. A device according to claim 2, including two pipe end reception portions so as to unite the two pipe ends via the body of the device, each reception portion being provided with an annular sealing element and with a centering ring.
8. A device according to claim 7, wherein the centering rings are arranged in such a manner that the deflectors of the rings are angularly offset relative to one another.
9. A device according to claim 2, wherein the ring has at least one outer surface made of a material having bactericidal properties, e.g. silver or copper.
10. A device according to claim 1, wherein the ring has at least an outside surface made of a non-stick material such as polytetrafluoroethylene.
11. A centering ring for centering a tube end in a channel of a device according to any preceding claim 1, the ring comprising positioning elements that are arranged to co-operate with a surface of the channel and an outer surface of the tube and to define at least one sweeping duct having at least one inlet in the vicinity of which there extends at least one deflector arranged to insert, into the sweeping duct, fluid diverted from the flow traveling in the device, and at least one outlet for returning the fluid that has passed through the sweeping duct back to the flow.
12. A ring according to claim 11, including a band connecting together fins forming the positioning elements, the fins projecting from the band both axially and also radially inwards and radially outwards.
13. A ring according to claim 12, wherein the band has a tubular portion extending along the axis of the channel and a radial annular portion having an outer periphery secured to an end of the annular portion that is opposite from the sealing element, the annular portion projecting from the tubular portion towards the inside of the band.
14. A ring according to claim 13, wherein the deflector is secured to an inner circumference of the annular portion.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen of the body by insertion through a stoma from outside the body, the retention system comprising:
a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen; and
an indwelling retainer in the form of an inflatable balloon located on the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, a predetermined spheroid shape, a reserve volume having a lower limit that is greater than 0.5 milliliters of a fluid and an upper limit at a transition between a non-distended state and a distended state of the balloon in which a fluid in the balloon is under no pressure, and a predetermined fill volume about 1.01 to about 1.5 times greater than an upper limit of the reserve volume, such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 40% greater than its predetermined fill volume, the balloon remains stable.
2. The inflatable retention system of claim 1, wherein the balloon has a collapsed, non-inflated state such that the tube and the thin, flexible walls of the balloon can pass through an orifice having a diameter not more than about 20 percent greater than the external diameter of the tube.
3. The inflatable retention system of claim 1, wherein the substantially linear pressure versus volume curve corresponds to a fluid pressure in the balloon between 2 to about 9 pounds per square inch (14 to 64 kilopascals).
4. The inflatable retention system of claim 3, wherein the balloon has volumes from about 2 milliliters to about 6 milliliters.
5. The inflatable retention system of claim 1, wherein the wall of the balloon has a thickness of from about 5 micrometers to about 100 micrometers.
6. The inflatable retention system of claim 1, wherein the spheroid shape is an oblate spheroid shape.
7. The inflatable retention system of claim 1, wherein the tube has an external tube diameter of from about 3 mm to about 9 mm and the balloon has a diameter of from about 15 mm to about 30 mm at a major axis of the spheroid when under pressure and wherein the ratio of the said balloon diameter to the external tube diameter is greater than three.
8. The inflatable retention system of claim 1, wherein the tube is formed of a material having an elongation of less than about 100 percent at a load of 300 pounds per square inch.
9. The retention system of claim 1 further comprising:
a base located at the proximal end of the tube, the base defining an opening to the feeding lumen, the base having a first end and a second end;
an inflation valve located on the base, the inflation valve in fluid communication with the balloon through the inflation lumen; and
an indicator located on the base in fluid communication with the balloon, the indicator configured to provide a discrete visual signal that the volume of the balloon is different from a predetermined volume or from a reserve volume.
10. The inflatable retention system of claim 1, wherein the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 25% greater than its predetermined fill volume, the balloon remains stable.
11. An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen of the body by insertion through a stoma from outside the body, the retention system comprising:
a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen; and
an indwelling retainer in the form of an inflatable balloon located on the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, each wall ranging from about 5 micrometers to about 100 micrometers in thickness, and a collapsed, non-inflated state such that the tube and the thin, flexible walls of the balloon can pass through an orifice having a diameter not more than about 20 percent greater than the external diameter of the tube, a predetermined spheroid shape, a reserve volume having a lower limit that is greater than 0.5 milliliters of a fluid and an upper limit at a transition between a non-distended state and a distended state of the balloon in which a fluid in the balloon is under no pressure, and a predetermined fill volume about 1.01 to about 1.5 times greater than an upper limit of the reserve volume, such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 40% greater than its predetermined fill volume, the balloon remains stable.
12. The inflatable retention system of claim 11, wherein the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 25% greater than its predetermined fill volume, the balloon remains stable.
13. An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen of the body by insertion through a stoma from outside the body, the retention system comprising:
a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen; and
an indwelling retainer in the form of an inflatable balloon located on the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, a predetermined spheroid shape, a reserve volume having a lower limit that is greater than 0.5 milliliters of a fluid and an upper limit at a transition between a non-distended state and a distended state of the balloon in which a fluid in the balloon is under no pressure, and a predetermined fill volume that is greater than an upper limit of the reserve volume and corresponds to a fluid pressure in the balloon between 2 to about 9 pounds per square inch (14 to 64 kilopascals), such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume.
14. The inflatable retention system of claim 13, wherein the predetermined fill volume corresponds to a fluid pressure in the balloon between 2 to about 7 pounds per square inch (14 to 49 kilopascals).
15. The inflatable retention system of claim 13, wherein the predetermined fill volume corresponds to a fluid pressure in the balloon between 2 to about 5 pounds per square inch (14 to 35 kilopascals).
16. The inflatable retention system of claim 13, wherein the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 40% greater than its predetermined fill volume, the balloon remains stable.
17. An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen of the body by insertion through a stoma from outside the body, the retention system comprising:
a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen; and
an indwelling retainer in the form of an inflatable balloon located on the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, a predetermined spheroid shape, a reserve volume having a lower limit that is greater than 0.5 milliliters of a fluid and an upper limit at a transition between a non-distended state and a distended state of the balloon in which a fluid in the balloon is under no pressure, and a predetermined fill volume that is greater than an upper limit of the reserve volume and is from about 2 milliliters to about 8 milliliters, such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume.
18. The inflatable retention system of claim 17, wherein the predetermined fill volume is from about 2 milliliters to about 6 milliliters.
19. The inflatable retention system of claim 17, wherein the predetermined fill volume is from about 2 milliliters to about 5 milliliters.
20. The inflatable retention system of claim 17, wherein the predetermined fill volume is from about 2 milliliters to about 4 milliliters.
21. The inflatable retention system of claim 17, wherein the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 40% greater than its predetermined fill volume, the balloon remains stable.