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(12) Patent Application Publication (10) Pub. No.: US 2009/0171317 A1 Versi (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2009/0171317 A1 Versi (43) Pub US 20090171317A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0171317 A1 Versi (43) Pub. Date: Jul. 2, 2009 (54) SELF-CATHETERIZATION DEVICE TO Publication Classification ADMINISTES COMPOUNDS TO THE BLADDER (51) Int. Cl. A6M 25/14 (2006.01) A6139/08 (2006.01) (76) Inventor: Ebrahim Versi, Gladstone, NJ (US) A6IPI3/10 (2006.01) Correspondence Address: W SCOTT MCNEES (52) U.S. Cl. ....................... 604/517; 604/246; 424/236.1 P.O. BOX 124 PENNINGTON, NJ 08534 (US) (57) ABSTRACT (21) Appl. No.: 12/225,084 Devices and methods for self catheterization and for instilling fluid into the bladder are disclosed. A catheter device is pro (22) PCT Fled: Mar. 10, 2006 vided for inserting into the urethra of an individual by the subject him or herself for the purpose of instilling a therapeu (86) PCT NO.: PCT/US2007/005785 tic compound into the bladder. The catheter assembly includes a catheter that has an opening near the tip, a valve S371 (c)(1), mechanism, and a reservoir at the opposite end from the tip. (2), (4) Date: Sep. 10, 2008 The catheter may be provided with separate channels for draining the bladder and instilling a therapeutic compound Related U.S. Application Data into the bladder. Methods for self catheterization and self (60) Provisional application No. 60/781,244, filed on Mar. administration of a therapeutic compound into the bladder by 10, 2006. a patient are disclosed. 16 Patent Application Publication Jul. 2, 2009 US 2009/0171317 A1 Fig.1 16 US 2009/0171317 A1 Jul. 2, 2009 SELF-CATHETERIZATION DEVICE TO the expense of in-patient care, treatment protocols have not ADMINISTES COMPOUNDS TO THE been set up and research studies have not been done to BLADDER develop treatment regimens for many potentially beneficial intravesical therapies. 0006. Some patients (male and female) who are unable to 0001. This application is a national phase application of voluntarily void (empty the bladder) have been taught the PCT/US07/005785 and claims priority of U.S. Application technique of self-catheterization to empty the bladder. In the No. 60/781,244, filed Mar. 10, 2006: U.S. Application No. past the treatment was with an indwelling urinary catheter 60/790,730, filed Apr. 10, 2006; and U.S. Application No. with all its complications such as infection, encrustation and 60/802,069, filed May 19, 2006. even erosion. Clean intermittent self catheterization (CISC) as a treatment for these patients has revolutionized therapy as FIELD OF THE INVENTION many of these patients no longer require prolonged indwell ing catheters. Paradoxically these patients using CISC actu 0002 The present invention relates to devices and meth ally have a lower urinary tract infection rate despite the theo ods for a patient to self catheterization and self-administer retical risk of the catheter introducing infection. One reason therapeutic agents into the urinary bladder. may be that stagnant urine does not remain in the bladder to act as a reservoir for culture of bacteria that could cause BACKGROUND OF THE INVENTION infection. 0003 Bladder disease afflicts a large and diverse patient 0007 Treatment protocols involving self catheterization population and includes infectious, functional and malignant and self-instillation of therapeutic agents into the bladder disorders. Infectious disorders of the bladder are usually have not been developed because physicians have thought caused by a bacterium. Most of the acute infections can be that patients would not be able to carry out such procedures. adequately treated with antibiotics but recalcitrant cases Further there is a concern that patients who are not medically could be treated by intravesical instillation of antibiotic. Fur trained are more likely to introduce infection into the bladder ther, in patients who have recurrenturinary tract infection, the during the catheterization procedure. Also, because for many cause may be a deficiency of the defense mechanism Such as conditions where such an option may be viable (see above), an impaired barrier to infection in the lining of lumen of the the patients would find the procedure uncomfortable or pain bladder (e.g., glycosaminoglycans (GAG) layer) or an immu ful. All these objections can be overcome. Patients can be nological deficiency. In these cases, instillation of atherapeu taught to catheterize themselves as they have for bladder tic compound into the bladder would be beneficial. Examples emptying and the additional act of instilling a therapeutic of functional diseases are urge incontinence or neurogenic compound into the bladder should not be difficult to teach. incontinence, unstable bladder, detrusor overactivity, overac The use of a local anesthetic such as lidocaine to insert the tive bladder, frequency urgency syndrome and interstitial cys catheter would mitigate the pain or discomfort. The addition titis. Malignant disorders of the bladder include carcinoma in of an antibiotic or anti-microbial to the instillation medium situ, transitional cell carcinoma, squamous cell carcinoma would reduce the probability of any infective organism intro and adenocarcinoma. The bladder is the most common site of duced by the catheterization procedure from proliferating and cancer in the urinary tract. Initial treatment is often with local causing an infection. excision and fulguration but follow up treatment with anti 0008. Whereas CISC and intravesical instillation of thera cancer drugs instilled into the bladder would become more peutic agents by care givers have been suggested, self-admin widespread if it was practical. istered therapy by instillation by the patient has not been 0004 Medical treatment of these disorders has tradition advocated. The reason for this is that within the medical ally been by systemic therapy. This results in side effects due paradigm, Such a logical leap is not obvious and physicians to action on other body systems and in many cases not enough are reluctant to advocate such therapy. However by introduc of the active compound gets to the lumen of the bladder where ing self administration, many different untried therapies will its effect would be more pronounced. Intravesical instillation become possible with consequent improvement in patient of therapeutic compounds in many cases is a better approach Ca because the therapeutic agent is delivered locally to the target 0009. In dexterous individuals it has become relatively tissue and also because higher doses can be used as systemic commonplace for intermittent catheterization of an individu side effects are avoided or minimized in cases where there is al’s urinary bladder to be employed, as opposed to placement absorption from the lumen of the bladder. Also this route of and maintenance of an indwelling catheter that continuously administration allows the use of therapeutic compounds that drains urine from the bladder. This can be done in a hospital might be toxic if given systemically. In addition this method setting, a nursing home, doctor's office, rehabilitation facility of delivery can resultinadequate concentrations getting to the or, more commonly, in the home. For the latter, patients are lumen of the bladder which may not beachieved by systemic often trained to catheterize themselves, a procedure called administration with excretion via the renal system. intermittent self-catheterization. This is usually done to treat 0005. The problem with intravesical therapy is that it is Such conditions as urinary retention, the inability to evacuate impractical in terms of healthcare policy. Many of these thera urine, but can also be employed to produce a sample of urine. pies require repeated administration and in some cases the 0010. There arise many clinical situations where it is nec administration would have to be daily or more frequently. essary to instill a therapeutic agent directly into the bladder. Also in some cases such as compounds used to augment the An example of this might be the instillation of a local anes GAG layer, it may be desirable for the bladder instillate to be thetic into the bladder to treat bladder pain or a chemothera in contact with the urothelium for a protracted time. This peutic agent to treat bladder cancer. This is done by a health could be achieved by instillation last thing at night. Such care providerina healthcare setting. Given the inconvenience treatments would only be possible for in-patients. Because of to patients, such a therapeutic modality is not popular or US 2009/0171317 A1 Jul. 2, 2009 feasible for long term repeated therapies. Also, in Some cases, contact with the inner lining of the bladder for as long as the ideal application would necessitate the instilled com possible to allow adequate penetration of the HA into the pound to remain in contact with the lining of the bladder for GAG layer and possibly deeper for maximal effect. as long as possible before the bladder is emptied. The best 0017. To date the treatment regimens of HA advocated time to perform such a procedure would be last thing prior to have involved the induction phase to consist of weekly sleep. For Such a regimen, the patient would need to self administrations followed by monthly administrations for the administer the treatment in the home. maintenance phase within a healthcare setting. It is possible 0011 Intermittent self-catheterization followed by blad that the sub-optimal efficacy of HA in the treatment of inter der instillation would be a solution for the above difficulties Stitial cystitis is a result of this infrequent administration and the present invention will allow patients to self-adminis regimen and because the HA is not held within the bladder for ter. In this way various new therapies that were hitherto alongtime. Patients with interstitial cystitis tend to void more impractical will become possible and even desirable. How frequently and diurnal frequency is greater than nocturnal ever for this to occur, a device needs to be available which frequency.
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