Enterocutaneous fistula management device
OwnerJeffrey Marks, Steve Schomischinventors
Life of this patent
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Abstract
A device for bypassing an enterocutaneous fistula in a patient includes a flexible tube extending from a first axial end to a second axial end and defining a passage extending the entire length of the tube, inflatable cuffs located at each of the first axial end and the second axial end of the tube, the inflatable cuffs configured to seal the first axial end and the second axial end to the internal wall of a bowel, at least one inflation tube fluidly connected to the inflatable cuffs for supplying inflation liquid to and from the inflatable cuffs, the inflatable cuffs are configured to inflate to a fluid pressure effective to create a fluid seal to the internal wall of the bowel.
Claims31
1:
- A device for bypassing an enterocutaneous fistula in a patient, comprising:
- a flexible tube extending from a first axial end to a second axial end and defining a passage extending the entire length of the tube;
- inflatable cuffs located at each of the first axial end and the second axial end of the tube, the inflatable cuffs configured to seal the first axial end and the second axial end to the internal wall of a bowel;
- at least one inflation tube fluidly connected to the inflatable cuffs for supplying inflation liquid to and from the inflatable cuffs, wherein the inflatable cuffs are configured to inflate to a fluid pressure effective to create a fluid seal to the internal wall of the bowel;
- an auxiliary tube fluidly connected with the flexible tube, the auxiliary tube extending from the flexible tube at a location between the first axial end and the second axial end;
- a support wire engaging an inner surface of the flexible tube and extending axially along the inner surface between the first axial end and the second axial end.
2:
- The device of claim 1, wherein the inflatable cuffs provide a fluid barrier against the internal bowel wall while substantially minimizing ulceration or abrasion of the bowel.
3:
- The device of claim 1, wherein the inflatable cuffs are configured to allow an internal fluid pressure range of about 30 mmHg to about 50 mmHg at a volume of about 20 mL when implanted and confined in the bowel.
4:
- The device of claim 1, wherein the inflatable cuffs allow for expansion without a substantial increase in internal fluid pressure.
5:
- The device of claim 1, wherein the fluid pressure effective to create a fluid seal to the internal wall of the bowel allows for substantially normal intestinal blood perfusion, peristalsis, and mucosal secretion in the bowel.
6:
- The device of claim 1, wherein the inflatable cuffs are configured to:
- allow the bowel to deform the inflatable cuffs rather than the cuff causing deformation of the bowel;
- and/or
- distribute a substantially equal radial force to the internal wall of the bowel in contact with the inflatable cuffs;
- and/or
- seal the first axial end to the internal wall of a bowel upstream of the fistula and the second axial end to the internal wall of the bowel downstream of the fistula.
(canceled)
(canceled)
9:
- The device of claim 1, wherein the inflatable cuffs are located circumferentially about the flexible tube.
10:
- The device of claim 1, wherein the at least one inflation tube extends from the inflatable cuff along the passage of the flexible tube and extends radially from the outer surface of the flexible tube at about the midpoint between the first axial end and the second axial end.
11:
- The device of claim 1, the inflatable cuffs having an axial width ranging from about 20 mm to about 60 mm.
12:
- The device of claim 1, wherein at least one inflation tube having a port fluidly connected to the inflation cuffs.
(canceled)
14:
- The device of claim 1, comprising a first inflation tube fluidly connected to a first inflation cuff and a second inflation tube fluidly connected to a second inflation cuff.
15:
- The device of claim 1, wherein at least one inflation tube comprising a manometer.
(canceled)
(canceled)
18:
- The device of claim 1, wherein the auxiliary tube extends from the flexible tube at about the midpoint between the first axial end and the second axial end and at a location between the inflatable cuffs.
(canceled)
20:
- The device of claim 1, wherein the at least one inflation tube and the auxiliary tube are positioned substantially parallel to a centerline and against an outer surface of the flexible tube to facilitate insertion of the device in a unidirectional fashion into the bowel without folding of the device.
21:
- The device of claim 1, wherein the support wire is a wire coil of medical grade stainless steel or a shape memory alloy having a pitch ranging from about 0.5 mm to about 10 mm provided within the passage of the flexible tube.
(canceled)
(canceled)
24:
- The device of claim 1, wherein the support wire is configured in a pattern to allow the support wire to move from an expanded position to a collapsed or insertion position, wherein the collapsed or insertion position decreases the outer diameter of the flexible tube.
25:
- The device of claim 24, wherein the support wire is configured in a pattern:
- to allow elongation, compression, and/or collapse of the support wire to decrease the outer diameter of the flexible tube prior to insertion of the device through the fistula;
- and/or
- to allow expansion of the support wire to increase the outer diameter of the flexible tube after insertion into the bowel.
26-29. (canceled)
30:
- The device of claim 1, the flexible tube having a length ranging from about 10.0 cm to about 20.0 cm, an outer diameter ranging from about 8.0 mm to about 26.0 mm, and/or an inner lumen diameter ranging from about 6.0 mm to about 20.0 mm.
31-34. (canceled)
35:
- The device of claim 1, wherein the shape of first axial end and/or second axial are configured to reduce the risk of bowel obstruction by having at least one of a blunt or square edge, a beveled tip or edge, or wavy edge forming two, three or more protrusions.
36:
- A method of managing fistula output using the fistula management device of claim 1, the method comprising the steps of:
- (a) inserting the first and second axial ends of the flexible tube in a bowel via a fistula opening such that:
- (i) a first section of the bowel located upstream of the fistula opening overlaps a first one of the inflatable cuffs;
- and (ii) a second section of the bowel located downstream of the fistula opening overlaps a second one of the inflatable cuffs;
- and
- (b) creating a fluid seal between each of the inflatable cuffs and the bowel by inflating each of the inflatable cuffs into engagement with the internal wall of the bowel.
37-50. (canceled)
Dependencies are inferred from the claim text.