Method, system and device for treating disorders of the pelvic floor by electrical stimulation of and the delivery of drugs to the left and right pudendal nerves

Abstract

Described are devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal nerves, and means for delivering one or more drugs in association with such electrical stimulation therapies. One or more electrical stimulation signals are applied, and one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient's pelvic floor and the pudendal nerves or portions thereof in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary voiding dysfunction, fecal voiding dysfunction, constipation, stress incontinence, urge incontinence, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Description

RELATED APPLICATIONS [0001] This application is a continuation-in-part of each of the following U.S. Patent Applications, and claims priority and other benefits from each such Application: (1) U.S. patent application Ser. No. 10 / 236,578 to Gerber et al. entitled “Electrical and / or Magnetic Stimulation Therapy for the Treatment of Prostatitis and Prostatodynia” filed Sep. 6, 2002 and having Attorney Docket No. P-10974; (2) U.S. patent application Ser. No. 10 / 723,316 to Gerber et al. entitled “Method, System and Device for Treating Disorders of the Pelvic Floor by Electrical Stimulation of the Pudendal Nerves and Associated Nerves, and the Optional Delivery of Drugs in Association Therewith” to Spinelli et al. filed Nov. 26, 2003 and having Attorney Docket No. P-11358.00; (3) U.S. patent application Ser. No. 10 / 723,903 to Gerber entitled “Method, System and Device for Treating Various Disorders of the Pelvic Floor by Electrical Stimulation of the Pudendal Nerves and the Sacral Nerves ...

AI Technical Summary

Benefits of technology

[0045] Simultaneous, concurrent or sequential electrical stimulation of and drug delivery to the left and right pudendal nerves has been discovered to provide a means of more directly or effectively treating various pelvic floor disorders than has been possible heretofore through means of employing conventional therapeutic techniques. Various combinations and permutations of pudendal nerve or nerve portion electrical stimulation and the delivery of one or more drugs to a tissue volume in proximity to a pudendal nerve or nerve portion, provide particularly efficacious means of delivering therapies for a number of different pelvic floor disorders.

[0046] It has been discovered that electrical stimulation of the pudendal nerves and / or portions thereof, in combination with the infusion of one or more drugs to or near at least one target tissue volume in proximity to at least one of such nerves or nerve portions, where the drugs are provided to or near such a target tissue volume by one or more implantable drug delivery devices, provides beneficial effects and therapies for various disorders of the pelvic floor over a wider anatomical region than merely electrically stimulating the pudendal or sacral nerves or portions thereof, or than may be attained through conventional sacral nerve stimulation. Because the present invention provides for more targeted electrical stimulation of the pelvic floor or portions thereof in combination with the targeted delivery of drugs, at least some of the undesirable side effects of sacral nerve stimulation may be avoided or minimized.

[0051] Various embodiments of the present invention are capable of providing one or more advantages, which may include, but are not necessarily limited to: (a) targeting the delivery of therapies with a high degree of specificity; (b) having the ability to change the therapy delivered on-demand or instantaneously; (c) lowering medical care costs in respect of pharmaceutical products; (d) having the potential to delivery superior therapy; (e) a patient not having to remember to take a drug daily or according to a predetermined regimen; (f) permitting stimulation lead implantation surgical procedures to be completed more quickly; (d) reducing trauma or damage to a patient's pelvic floor anatomy; and / or (g) improved physical and electrical coupling of one or more stimulation electrodes to a pertinent nerve or nerve portion.

Problems solved by technology

Although the majority of patients receiving sacral nerve stimulation obtain satisfactory relief of their voiding dysfunction, some patients (less than 50%) do not experience adequate relief from sacral nerve stimulation techniques or desire to obtain better results from the therapy.

Although such stimulation has shown therapeutic effects, electrode placement and on-going stimulation do not lend themselves easily to chronic stimulation.

The invasiveness of the surgical procedure for implanting electrical stimulation leads and other reasons have made stimulation of the pudendal nerve impractical, however.

Images