Collagenase clostridium histolyticum for treatment of bladder dysfunction
Inventors
Assignees
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Publication Number
US-11369667-B2
Publication Date
2022-06-28
Expiration Date
Abstract
Collagenase Clostridium histolyticum (EN3835) is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions. EN3835 targets the collagenase structural matrix at the site of injection and does not require systemic exposure. Embodiments include methods of lysing subdermal and submucosal collagen to treat various conditions such as bladder dysfunction, esophageal stenosis, benign prostatic hyperplasia, tracheal stenosis, subglottic stenosis and scleroderma.
Core Innovation
The invention relates to treating a patient with bladder dysfunction by injecting an effective amount of collagenase from Clostridium histolyticum at or near the bladder and/or the detrusor muscle of the bladder. The collagenase is described as a locally acting protease that hydrolyzes triple-helical collagen at or near the injection site without systemic exposure.
The problem addressed is bladder dysfunction associated with urinary incontinence and urinary retention, supported by a rationale that increased detrusor collagen contributes to bladder dysfunction with age. The disclosed treatment framework includes localized injections into or near the bladder and/or the detrusor muscle, including multiple injections at a plurality of sites at or near the target region.
The disclosed formulation and administration refinements include a collagenase composition containing equal amounts of Clostridial class I collagenase (AUX-I) and Clostridial class II collagenase (AUX-II). The document also describes an optional endoscopic dilation step and an injection device framework including a syringe with a rack and pinion component, and further includes bladder obstruction indications by injecting an effective amount of collagenase at or near the bladder, the detrusor muscle, and the prostate.
Claims Coverage
The partial claims provided include three independent claims. Across these claims, the inventive coverage centers on localized injection of Clostridium histolyticum collagenase into or near the bladder/detrusor, with repeat dosing/monitoring and specific collagenase composition and administration refinements.
Localized injection at or near bladder and/or detrusor muscle
injecting an effective amount of collagenase from Clostridium histolyticum at or near the bladder and/or the detrusor muscle of the bladder
Patient selection, monitoring, and repeat plurality-site injection until symptoms subside
identifying a patient with signs and/or symptoms of bladder dysfunction; injecting an effective amount of collagenase from Clostridium histolyticum at a first plurality of sites at or near the bladder and/or the detrusor muscle of the bladder; monitoring signs and/or symptoms of bladder dysfunction; injecting an effective amount of collagenase at a second plurality of sites at or near the bladder and/or the detrusor muscle of the bladder; repeating steps c) and d) until the signs and/or symptoms of bladder dysfunction subside; wherein the bladder dysfunction causes one or more of urinary incontinence and urinary retention
Injection for bladder obstruction at bladder, detrusor muscle, and prostate
injecting an effective amount of collagenase from Clostridium histolyticum at or near one or more of: a) the bladder of the patient, b) the detrusor muscle of the patient, and c) the prostate of the patient
Claim coverage spans treating bladder dysfunction, including urinary incontinence and urinary retention, by locally injecting Clostridium histolyticum collagenase at or near the bladder and/or detrusor muscle, including methods with patient identification, monitoring, and repeat injections at different pluralities of sites until symptoms subside. Separate coverage treats bladder obstruction by injecting at or near the bladder, detrusor muscle, and prostate.
Stated Advantages
Local action at or near the injection site without systemic exposure.
Hydrolyzes triple-helical collagen at or near the injection site.
Documented Applications
Treatment of bladder dysfunction, including urinary incontinence and urinary retention, by injecting collagenase from Clostridium histolyticum at or near the bladder and/or the detrusor muscle.
Treatment of bladder obstruction by injecting collagenase from Clostridium histolyticum at or near one or more of the bladder, detrusor muscle, and prostate.
Additional collagen-scarring indications described include tracheal/subglottic stenosis, esophageal stricture, scleroderma, and benign prostatic hyperplasia (BPH).
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