Medical catheter external bolster having strain relief member

• US 7,985,205 B2
• Filed: 09/14/2005
• Issued: 07/26/2011
• Est. Priority Date: 09/14/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Adams, Mark L.
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Carpenter; William
• Application Number:
  US11/226,807
• Publication Number:
  US 20070078441A1
• Time in Patent Office: 2,141 Days
• Field of Search: 604/174, 604/177, 604/178, 604/179, 604/180
• US Class Current: 604/174
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0061 fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

An external bolster for a medical catheter, the external bolster comprising an integral strain relief member for diminishing the effect of an externally-directed force applied to the medical catheter. In a preferred embodiment, the external bolster is a flexible, unitary member comprising a lower portion and an upper portion. The lower portion comprises an annular base, the base having a top surface, a bottom surface and a central opening. A plurality of spaced apart feet extend downwardly from the bottom surface of the base. A sleeve extends upwardly from the top surface of the base in alignment with the central opening, the sleeve and the central opening jointly defining a bore of uniform cross-section. The upper portion comprises an elbow-shaped tubular member having a vertical portion, a horizontal portion and a longitudinal lumen. The vertical portion of the tubular member is disposed on top of the sleeve, with its lumen aligned with the bore. The upper portion also includes a tether for maintaining the tubular member in a bent state, the tether having a first end secured to the horizontal portion and a second end secured to the vertical portion.

Claims

1. An external bolster for a medical catheter implanted in a patient at an insertion site, said external bolster comprising:

(a) a base, said base being enlarged relative to the insertion site of the medical catheter, said base having an opening through which the medical catheter may be inserted;

(b) a strain relief member, said strain relief member being coupled to said base and through which the medical catheter may be inserted, said strain relief member comprising a tube having a first end distal to said base, a second end proximal to said base, and a longitudinal lumen extending from said first end of said tube to said second end of said tube, said strain relief member further comprising a hook positioned on the exterior of said tube proximate to said second end of said tube; and

(c) a tether, said tether having a first end and a second end, said first end of said tether being secured to said tube at a point proximate to said first end of said tube, said second end of said tether comprising an opening through which said hook is removably received to maintain the tube in a bent shape, so that said tube is reversibly transformable between the bent shape comprising first and second arms positioned relative to one another at an angle greater than 0 degrees and less than 180 degrees and a straight shape comprising a single arm, wherein said tube, when in said bent shape, causes the medical catheter to assume a bent shape and, when in said straight shape, causes the medical catheter to assume a straight shape.

2. The external bolster as claimed in claim 1 wherein said first arm and said second arm are positioned relative to one another in said bent shape at an angle of approximately 90 degrees.

3. The external bolster as claimed in claim 1 wherein said second arm has an end aligned coaxially with said opening of said base.

4. The external bolster as claimed in claim 1 wherein said tether and said strain relief member form a unitary structure.

5. The external bolster as claimed in claim 1 wherein said strain relief member is made of a flexible material.

6. The external bolster as claimed in claim 1 wherein said base has a top surface and a bottom surface, said external bolster further comprising means extending downwardly from said bottom surface of said base for elevating said base relative to the patient.

7. The external bolster as claimed in claim 1 wherein said base is shaped to include a plurality of transverse air holes.

8. The external bolster as claimed in claim 1 wherein said base has a top surface, said external bolster further comprising a sleeve extending upwardly from said top surface, said sleeve being aligned with said opening in said base and jointly defining a central bore, said sleeve having a top end, said second end of said tube being coaxially disposed on said top end of said sleeve.

9. The external bolster as claimed in claim 8 wherein said strain relief member has a height of about 1-2 inches.

10. The external bolster as claimed in claim 8 wherein each of said central bore and said longitudinal lumen is dimensioned for an interference fit with the medical catheter.

11. The external bolster as claimed in claim 1 wherein said strain relief member is fixed relative to said base.

12. The external bolster as claimed in claim 1 wherein said second end of said tube is coaxially aligned with the opening in said base, said external bolster further comprising means for elevating said base relative to the patient to promote the circulation of air under said base.

13. The external bolster as claimed in claim 12 wherein said angle is approximately 90 degrees.

14. The external bolster as claimed in claim 12 wherein said base, said elevating means, said strain relief member and said tether form a unitary structure.

15. The combination of:

(a) a medical catheter, said medical catheter including a first end, a second end, and a longitudinal lumen; and

(b) an external bolster for the medical catheter, said external bolster comprising;

(1) a base, said base being enlarged relative to the insertion site of the medical catheter, said base having an opening through which the medical catheter is inserted;

(2) a strain relief device coupled to said base, said strain relief device comprising a flexible tubular member including a first arm terminating in a first end distal to said base, a second arm terminating in a second end proximal to said base, and a longitudinal lumen extending from said first end of said tubular member to said second end of said tubular member, said first arm and said second arm being disposed relative to one another at an angle greater than 0 degrees and less than 180 degrees, said medical catheter being inserted into said strain relief device, with said first end of said medical catheter extending beyond said first end of said first arm and said second end of said medical catheter extending beyond said second end of said second arm, said strain relief device further comprising a hook positioned on the exterior of said tubular member proximate to said second end of said tubular member; and

(3) a tether, said tether having a first end and a second end, said first end of said tether being secured to said tubular member at a point proximate to said first end of said tubular member, said second end of said tether comprising an opening through which said hook is removably received to maintain the tubular member in a bent shape, so that said tubular member is reversibly transformable between the bent shape comprising first and second arms positioned relative to one another at an angle greater than 0 degrees and less than 180 degrees and a straight shape, wherein said tubular member, when in said bent shape, causes the medical catheter to assume a bent shape and, when in said straight shape, causes the medical catheter to assume a straight shape.

16. The combination of claim 15 wherein said medical catheter is a feeding tube, an internal bolster being disposed at said second end of said medical catheter.

17. The combination as claimed in claim 15 wherein said strain relief device is dimensioned to provide an interference fit with said medical catheter.

18. The combination as claimed in claim 15 wherein said first arm and said second arm of said flexible tubular member are disposed relative to one another at an approximate right angle.

19. The combination as claimed in claim 15 wherein said strain relief device and said external bolster form a unitary structure.

20. The combination as claimed in claim 15 wherein said base is shaped to define a plurality of air holes, each air hole extending through said base from its top surface to its bottom surface.

21. The combination as claimed in claim 15 wherein said external bolster further includes a plurality of feet which extend downwardly from the bottom surface of said base in a spaced apart relationship.

22. An external bolster for a medical catheter implanted in a patient at an insertion site, said external bolster comprising:

(a) a base, said base being enlarged relative to the insertion site of the medical catheter, said base having an opening through which the medical catheter may be inserted; and

(b) a strain relief member, said strain relief member being coupled to said base, said strain relief member comprising a tube having a longitudinal lumen through which the medical catheter may be inserted, said strain relief member further including a catch positioned on the exterior of said tube; and

(c) a tether, said tether having a first end and a second end, said first end of said tether having means for releasably engaging said catch to maintain the tube in a bent shape, so that said tube is transformable between the bent shape comprising first and second arms positioned relative to one another at an angle greater than 0 degrees and less than 180 degrees and a straight shape comprising a single arm, wherein said tube, when in said bent shape, causes the medical catheter to assume a bent shape and when in said straight shape, causes the medical catheter to assume a straight shape.

24. The external bolster as claimed in claim 22 wherein said catch is a hook and wherein said means for releasably engaging said catch comprises an opening in said tether through which said catch is removably received.

23. An external bolster for a medical catheter implanted in a patient at an insertion site, said external bolster comprising:

(a) a base, said base being enlarged relative to the insertion site of the medical catheter, said base having an opening through which the medical catheter may be inserted;

(b) a strain relief member, said strain relief member being coupled to said base and through which the medical catheter may be inserted, said strain relief member comprising a tube having a first end distal to said base, a second end proximal to said base, and a longitudinal lumen extending from said first end of said tube to said second end of said tube, said strain relief member further comprising a hook positioned on the exterior of said tube; and

(c) a tether, said tether having a fixed end and a free end, said fixed end of said tether being fixedly secured to said tube, said free end of said tether having an opening through which said hook is removably received so that, when said hook is received within said opening and, thus, said free end of said tether is secured to said tube, said tube assumes a bent shape comprising first and second arms positioned relative to one another at an angle greater than 0 degrees and less than 180 degrees, and so that, when said hook is not received within said opening and, thus, said free end of said tether is not secured to said tube, said tube assumes a straight shape comprising a single arm.