Site-selective durability-enhanced catheter and methods of manufacturing and using same
First Claim
1. A central venous access catheter for long-term indwelling implantation in the body of a patient, the catheter when implanted traversing an anatomical pinch-off region in the body of the patient between the clavicle and the first rib that subjects the portion of the length of the catheter disposed through the anatomical region to intermittent, repeated compressive and abrasive forces, said catheter comprising:
- (a) a flexible tube comprised of a compliant medical grade material enclosing a fluid accommodating lumen extending longitudinally through substantially the entire length of said flexible tube, said flexible tube having a distal tip for residence at a preselected location within the cardiovascular system of the body of the patient when said catheter is implanted, and a proximal end through which to afford access to said fluid accommodating lumen when said catheter is implanted, the portion of the length of said flexible tube traversing the anatomical region when said catheter is implanted defining a wear region along the length of said flexible tube, said wear region being distanced from said proximal end and from said dismal tip of said flexible tube; and
(b) safety means positioned within said fluid accommodating lumen of said flexible tube at least at said wear region and terminating proximal of said distal tip of said flexible tube(i) for permitting fluid flow in said lumen when said wear region is free of the compressive and abrasive forces,(ii) for yielding with said flexible tube when said wear region is exposed to the compressive or abrasive forces, and(iii) for maintaining the integrity of said lumen following the fracture or severance of said flexible tube at the wear region due to the compressive or abrasive forces.
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Accused Products
Abstract
The present invention is directed to novel methods and apparatus for structurally enhancing a catheter which can be employed to withstand the damaging stresses experienced by catheters implanted in bodily tissues, particularly catheters implanted in the compressed area between the clavicle and first rib of a patient. The enhanced catheter includes a nonmetallic inner tubular sleeve comprised wholly of a compliant material that is inserted in frictional engagement with the interior of the walls of the catheter. The inner sleeve has an outer diameter greater than the inner diameter of the catheter.
The structurally enhanced catheter can be manufactured by immersing a portion of a catheter in freon which causes the immersed portion to swell to have an inner diameter temporarily greater than the outer diameter of the tubular sleeve. Thereafter, the tubular sleeve is advanced site-selectively to a position within the catheter. Finally, the portions of the exposed catheter are allowed to return to their normal size around the inserted reinforcing sleeve.
Alternatively, the structurally enhanced catheter can be manufactured by advancing a reinforcing sleeve site-selectively to a position within the catheter while the catheter is inflated by introducing pressurized gas. The tubular sleeve is oriented on a hollow rod connected to an air pump and moved to the open end of the catheter. This forces air ahead of and around the tubular sleeve, increasing the diameter of the catheter surrounding the reinforcing sleeve so that the reinforcing sleeve may be advanced. After the reinforcing sleeve is in position, the rod is removed and the catheter returns to its normal position frictionally engaging the exterior of the reinforcing sleeve.
88 Citations
40 Claims
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1. A central venous access catheter for long-term indwelling implantation in the body of a patient, the catheter when implanted traversing an anatomical pinch-off region in the body of the patient between the clavicle and the first rib that subjects the portion of the length of the catheter disposed through the anatomical region to intermittent, repeated compressive and abrasive forces, said catheter comprising:
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(a) a flexible tube comprised of a compliant medical grade material enclosing a fluid accommodating lumen extending longitudinally through substantially the entire length of said flexible tube, said flexible tube having a distal tip for residence at a preselected location within the cardiovascular system of the body of the patient when said catheter is implanted, and a proximal end through which to afford access to said fluid accommodating lumen when said catheter is implanted, the portion of the length of said flexible tube traversing the anatomical region when said catheter is implanted defining a wear region along the length of said flexible tube, said wear region being distanced from said proximal end and from said dismal tip of said flexible tube; and (b) safety means positioned within said fluid accommodating lumen of said flexible tube at least at said wear region and terminating proximal of said distal tip of said flexible tube (i) for permitting fluid flow in said lumen when said wear region is free of the compressive and abrasive forces, (ii) for yielding with said flexible tube when said wear region is exposed to the compressive or abrasive forces, and (iii) for maintaining the integrity of said lumen following the fracture or severance of said flexible tube at the wear region due to the compressive or abrasive forces. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 38)
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13. A central venous access catheter for long-term indwelling implantation in the body of a patient, the catheter when implanted traversing a pinch-off region in the body of the patient between the clavicle and the first rib that subjects the portion of the length of the catheter disposed through the pinch-off region to intermittent, repeated compressive and abrasive forces, said catheter comprising:
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(a) a flexible tube comprised of a compliant medical grade material enclosing a fluid accommodating lumen extending longitudinally through substantially the entire length of said flexible tube, said flexible tube having a closed distal tip for residence at a preselected location within the cardiovascular system of the body of the patient, when said catheter is implanted, a proximal end through which to afford access to said fluid accommodating lumen when said catheter is implanted, and a two-way valve responsive to pressure differentials capable of permitting the ingress and egress of fluids into and from said fluid accommodating lumen, respectively, the portion of the length of said flexible tube traversing the pinch-off region when said catheter is implanted defining a wear region along the length of said flexible tube, said wear region being distanced from said proximal end and from said distal tip of said flexible tube; and (b) a flexible, resilient tubular sleeve disposed inside said fluid accommodating lumen of said flexible tube at least at said wear region in frictional engagement with the walls of said fluid accommodating lumen so as to terminate proximal of said two-way valve. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 27, 28, 39)
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26. A central venous access catheter for long-term indwelling implantation in the body of a patient, the catheter when implanted traversing an anatomical pinch-off region in the body of the patient between the clavicle and the first rib that subjects the portion of the length of the catheter disposed through the anatomical region to intermittent, repeated compressive and abrasive forces, said catheter comprising:
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(a) a flexible tube comprised of a compliant medical grade silicone rubber enclosing a single fluid accommodating lumen extending longitudinally through substantially the entire length of said flexible tube, said flexible tube having a distal tip for residence at a preselected location within the cardiovascular system of the body of the patient, when said catheter is implanted, and a proximal end through which to afford access to said fluid accommodating lumen when said catheter is implanted, the portion of the length of said flexible tube traversing the anatomical pinch-off region when said catheter is implanted defining a wear region along the length of said flexible tube, said wear region being distanced from said proximal end and from said distal tip of said flexible tube; and (b) a flexible resilient tubular sleeve having chamfered ends and an outer diameter greater than the inner diameter of said flexible tube, said sleeve being positioned within said fluid accommodating lumen of said flexible tube at least at said wear region in frictional engagement with said walls of said fluid accommodating lumen so as to terminate proximal of said distal tip of said flexible tube. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 40)
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Specification