Retention balloon and corporeal access tube assembly

• US 5,910,128 A
• Filed: 05/01/1997
• Issued: 06/08/1999
• Est. Priority Date: 01/11/1996
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Quinn, David G.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/847,116
• Time in Patent Office: 768 Days
• Field of Search: 604/96, 604/100, 604/103, 604/264, 604/280, 604/282, 604/174, 604/176, 604/153, 604/180, 128/DIG. 26
• US Class Current: 604/93.01
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0019 inserted by using a pull-wire
• CPC Class Codes: A61J 15/0026 Parts, details or accessories for feeding-tubes external tubes from medical containers to a connector outside of the body A61M39/08
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61J 15/0057 fixing a tube end, i.e. tube not protruding the fixing means
• CPC Class Codes: A61J 15/0061 fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
• CPC Class Codes: A61J 15/0073 Multi-lumen tubes
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: Y10S 128/26 Cannula supporters
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A retention balloon for a corporeal access tube assembly which includes a tube segment. The balloon is secured to the tube segment around a portion of the segment. The balloon is preformed in its expanded shape. When in normal retention operation it contains air trapped but under ambient pressure whereby its walls are not stretched to any noticeable extent.

Claims

1. A corporeal access tube assembly, comprising:

a) a tube segment having an outer surface; and

b) a retention balloon mounted on said tube segment and being preformed so as to extend radially outwardly from said tube segment;

c) said preformed retention balloon including a generally tire-shaped casing having opposed side walls extending generally parallel to each other and annular, inner beads;

d) each of said side walls being fastened to said outer surface of said tube segment at a corresponding inner bead;

e) one of said side walls having a retaining surface which is substantially perpendicular to said tube segment and relatively flat for a predetermined distance outwardly from a corresponding bead when said balloon is in said preformed configuration;

f) said balloon containing a gas under substantially ambient pressure which supports the balloon in said preformed configuration whereby it is effective to prevent withdrawal of the tube segment from a stoma when in its preformed configuration.

2. The corporeal access tube assembly of claim 1 further characterized in that:

g) said casing side walls are formed unitarily with a connecting tread from silicone film having a thickness of at least 0.012 inches.

3. The corporeal access tube assembly of claim 1 further characterized in that:

g) said casing is made of silicone film and said walls have a uniform thickness of approximately 0.030 inches.

4. A corporeal access tube assembly, comprising:

a) a tube segment formed of silicone rubber;

b) said tube segment including a wall having an outer surface and an inner surface;

c) said inner surface defining a generally cylindrical passage through said tube segment;

d) a coil spring embedded in said wall between said surfaces in one portion of said tube segment; and

e) a retention balloon encircling another portion of said tube segment and fastened to said tube segment;

f) said balloon being preformed in an inflated configuration and normally containing fluid under approximately ambient pressure when in said inflated configuration;

g) said preformed retention balloon including a generally tire-shaped casing having opposed side walls;

h) each of said side walls having an annular inner bead which is fastened to a surface of said tube segment; and

i) one of said side walls having a flat retaining surface which extends substantially perpendicular to said tube segment for a distance of at least approximately 0.100 inches from a corresponding bead when said balloon is in said inflated configuration.

5. The tube assembly of claim 4 further characterized in that:

j) said balloon casing walls are formed of silicone rubber film having a thickness of at least approximately 0.012 inches.

6. The tube assembly of claim 5 further characterized in that:

k) the retaining surface on said one side wall and an outer surface on the other side wall are spaced about 0.200 inches from each other.

7. The tube assembly of claim 5 further characterized in that:

l) the outside diameter of said tire-shaped casing is approximately 0.600 inches.

8. A corporeal access tube assembly, comprising:

a) a tube segment having an outer surface and adapted to extend through a corporeal stoma; and

b) a retention device mounted on said tube segment and adapted to prevent said tube segment from being withdrawn from the stoma;

c) said retention device including a generally tire-shaped casing preformed of rubber-like material in retaining configuration and having opposed side walls fastened to said outer surface in fluid tight relationship at annular beads defining the inner extremities of said side walls;

d) said retention device further including a treadwall which is substantially semicircular in cross-section and interconnects said side walls;

e) said opposed side walls including a retaining wall which has a substantially flat retention surface extending perpendicular to said tube segment;

g) the radius of said substantially semi-circular treadwall being substantially equal to the width of said retention surface; and

g) fluid being trapped inside said casing when it is fastened to said outer surface whereby said casing is supported in said preformed configuration so as to prevent withdrawal of the tube segment from a stoma.

9. A gastrostomy tube assembly, comprising:

a) a tube segment having a silicone rubber body and adapted to extend through a stoma;

b) said body including one elongated body portion containing a coil spring extending along its length;

c) said one body portion and said spring forming a generally cylindrical wall having an inner surface and an outer surface, said wall in said one body portion being supported by said coil spring;

d) said body including another body portion which is adjacent to said one body portion and forms a generally cylindrical wall having an inner surface and an outer surface, said wall in said other body portion having no coil spring support;

e) a retention balloon mounted on said tube segment and adapted to prevent said tube segment from being withdrawn from the stoma;

f) said retention balloon including a casing preformed of silicone rubber in generally tire-shaped configuration, the thickness of the silicone rubber casing being sufficient to cause said casing to tend to retain said preformed configuration;

g) said casing including opposed side walls fastened in fluid tight relationship to said outer surface of said tube segment wall in said other body portion at annular beads defining the inner extremnities of said casing side wall;

h) said casing further including a treadwall which is substantially semi-circular in cross-section and interconnects said casing side walls;

i) a gas at substantially ambient pressure trapped inside said casing being effective to support said casing in its preformed configuration;

j) one of said opposed casing side walls including a retaining wall which has a substantially flat retention surface extending perpendicular to said tube-segment;

k) the radius of said substantially semi-circular casing treadwall being substantially equal to the width of said retention surface.

10. A tube assembly for providing corporeal access through a stoma, comprising:

a) a tube segment formed of silicone rubber and adapted to extend through a stoma;

b) said tube segment including a wall having an outer surface and an inner surface;

c) said inner surface defining a generally cylindrical passage through said tube segment;

d) a coil spring embedded in said wall between said surfaces in one portion of said tube segment; and

e) a retention balloon encircling another portion of said tube segment and including side walls fastened to said outer surface of said tube segment whereby said other portion of said tube segment extends through said retention balloon, one of said side walls having a flat retaining surface;

f) said balloon being preformed in a fully inflated configuration and normally containing fluid under approximately ambient pressure which supports said balloon in said fully inflated configuration so as to prevent withdrawal of said tube segment from the stoma.

11. A tube assembly for providing corporeal access through a stoma, comprising:

a) a tube segment formed of silicone rubber and adapted to extend through a stoma;

b) said tube segment including a wall having an outer surface and an inner surface;

c) said inner surface defining a generally cylindrical passage through said tube segment;

d) a coil spring embedded in said wall between said surfaces in one portion of said tube segment; and

e) a retention balloon encircling another portion of said tube segment and fastened only to said tube segment, said balloon being preformed in a fully inflated configuration;

g) said preformed retention balloon including a generally tire-shaped casing having opposed side walls;

g) each of said side walls having an annular inner bead which is fastened to a surface of said tube segment; and

h) one of said side walls having a flat retaining surface which extends substantially perpendicular to said tube segment for a distance of at least approximately 0.100 inches from a corresponding bead when said balloon is in said inflated configuration;

i) said preformed retention balloon normally containing fluid under approximately ambient pressure in said fully inflated configuration so as to prevent withdrawal of said tube segment from the stoma.

12. The tube assembly of claim 11 further characterized in that:

j) said balloon casing walls arc formed of silicone rubber film having a thickness of at least approximately 0.012 inches.

13. The tube assembly of claim 12 further characterized in that:

k) said balloon casing walls are formed of silicone rubber film having a thickness of approximately 0.030 inches.

14. A corporeal access tube assembly, comprising:

a) a tube segment having an outer surface; and

b) a retention balloon mounted on said tube segment and being preformed so as to extend radially outwardly from said tube segment;

c) said preformed retention balloon including a generally tire-shaped casing having opposed side walls extending generally parallel to each other and annular, inner beads;

d) each of said side walls being fastened to said outer surface of said tube segment at a corresponding inner bead;

e) one of said side walls having a retaining surface which is substantially perpendicular to said tube segment and relatively flat for a predetermined distance outwardly from a corresponding bead when said balloon is in said preformed configuration;

f) said relatively flat retaining surface having a radial dimension of at least 0.100 inches outwardly of a corresponding bead;

g) said balloon containing a gas under substantially ambient pressure which supports the balloon in said preformed configuration whereby it is effective to prevent withdrawal of the tube segment from a stoma when in its preformed configuration.

15. A corporeal access tube assembly, comprising:

a) a tube segment having an outer surface; and

b) a retention balloon mounted on said tube segment and being preformed so as to extend radially outwardly from said tube segment;

c) said preformed retention balloon including a generally tire-shaped casing having opposed side walls extending generally parallel to each other and annular, inner beads;

d) each of said side walls being fastened to said outer surface of said tube segment at a corresponding inner bead;

e) one of said side walls having a retaining surface which is substantially perpendicular to said tube segment and relatively flat for a predetermined distance outwardly from a corresponding bead when said balloon is in said preformed configuration;

f) the distance between said retaining surface and a corresponding outer surface on the other casing wall being approximately 0.200 inches;

g) said balloon containing a gas under substantially ambient pressure which supports the balloon in said preformed configuration whereby it is effective to prevent withdrawal of the tube segment from a stoma when in its preformed configuration.