Soft tip drug-eluting urinary drainage catheter
Inventors
Pinchuk, Leonard • Pinchuk, Bryan • Kalser, Gary A.
Assignees
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Publication Number
US-11911572-B2
Publication Date
2024-02-27
Expiration Date
Abstract
A balloon retention urinary catheter includes a porous and spongy distal tip. In one method, a polymer is mixed with sacrificial particles and the mixture is molded in the form of the tip, and then cured. The cured tip is then placed in a solvent in which the sacrificial particles elute from the tip but in which the polymer is insoluble. Once the particles elute out of the polymer in the tip, a softer porous polymeric structure results. The tip may be structured to be softer prior to use or for transformation to a softer state once in the bladder.
Core Innovation
A balloon retention urinary catheter for insertion into a bladder includes an elongate catheter shaft, a balloon adjacent the distal end, a drainable port distal of the balloon, and a distal tip at the distal end. The distal tip includes a polymer component that is insoluble in urinary fluid in the bladder and is combined with an eluting component that is dissolvable by urinary fluid and adapted to elute from the distal tip in the presence of urinary fluid, thereby increasing flexibility of the distal tip.
The distal tip is also described as a porous spongy distal tip formed by combining a polymer component mixed with sacrificial elutable particles and then curing, such that upon immersion in a solvent or urine the sacrificial particles elute and create pores. This pore-forming transformation produces a softer, atraumatic structure at the leading end after exposure to urinary fluid, and embodiments are described in which the distal tip is semi-rigid for urethral tracking and becomes softer once particles elute in the bladder.
The eluting component is further described as being provided to elute therapeutic agents from the distal tip in the presence of urinary fluid, with categories including antibiotics, antifibrotics, antimicrobials, anti-inflammatories, and antispasmodics. The content also states that examples of such eluting particles include pH buffering particles such as a phosphate buffered system and potassium citrate salts, with the stated purpose of reducing irritation, encrustation, and infections.
Claims Coverage
The document includes two independent claims, both focused on a balloon retention urinary catheter with a distal tip having an insoluble polymer component combined with a dissolvable eluting component adapted to elute in urinary fluid to increase distal-tip flexibility. Across these claims, the inventive features cover the catheter structure elements, the distal-tip configuration, and an improved catheter embodiment with proximal hub ports.
Urinary catheter with balloon retention structure elements
An elongate catheter shaft extending between a proximal end and a distal end, a balloon adjacent the distal end, a drainable port distal of the balloon, and a distal tip at the distal end located distal of the drainable port.
Insoluble polymer distal tip combined with dissolvable eluting component
A distal tip at the distal end including a polymer component that is insoluble in urinary fluid in the bladder and combined with an eluting component dissolvable by urinary fluid and adapted to elute from the distal tip in the presence of urinary fluid to increase flexibility of the distal tip.
Improved balloon retention catheter with proximal hub ports
A proximal hub at the proximal end with a first port for communication with the balloon and a second port for communication with the drainable port, wherein the improvement comprises a distal tip including a polymer component insoluble in urinary fluid and combined with a dissolvable eluting component adapted to elute in the presence of urinary fluid to increase flexibility of the distal tip.
Overall claim coverage centers on a balloon retention urinary catheter whose distal tip uses an insoluble polymer combined with a dissolvable eluting component that elutes in urinary fluid to increase distal-tip flexibility, with an improved catheter embodiment further specifying a proximal hub with ports for balloon and drainable-port communication.
Stated Advantages
Increase flexibility of the distal tip in the presence of urinary fluid.
Reduce irritation, encrustation, and infections.
Documented Applications
Use as a balloon retention urinary catheter for insertion into a bladder of a patient, including a urethral tracking leading-end transformation described as semi-rigid-to-soft after particle elution in the bladder.
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