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(12) United States Patent (10) Patent No.: US 6,650,943 B1 Whitehurst Et Al

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(12) United States Patent (10) Patent No.: US 6,650,943 B1 Whitehurst Et Al USOO6650943B1 (12) United States Patent (10) Patent No.: US 6,650,943 B1 Whitehurst et al. (45) Date of Patent: Nov. 18, 2003 (54) FULLY IMPLANTABLE OTHER PUBLICATIONS NEUROSTIMULATOR FOR CAVERNOUS NERVE STIMULATION ASATHERAPY FOR Cameron, et al., “Micromodular Implants to Provide Elec ERECTILE DYSFUNCTION AND OTHER trical Stimulation of Paralyzed Muscles and Limbs”, IEEE SEXUAL DYSFUNCTION Transactions on Biomedical Engineering, Vol. 44, No. 9 (Sep.1997), pp. 781-790. Lue, et al., “Electrostimulation and Penile Erection', Urol. (75) Inventors: Todd K. Whitehurst, Sherman Oaks, Int. 40 (1985), pp. 60–64. CA (US); James P. McGivern, Martinez-Pineiro, et al., Rat Model for the Study of Penile Stevenson Ranch, CA (US) Erection: Pharmacologic and Eletrical-Stimulation Param eters, Eur Urol 25 (1994), pp. 62–70. (73) Assignee: Advanced Bionics Corporation, Shafik, A., “Extrapelvic Cavernous Nerve Stimulation in Sylmar, CA (US) Erectile Dysfunction”, Andrologia 28 (May-Jun. 1996), pp. (*) Notice: Subject to any disclaimer, the term of this 151-156. patent is extended or adjusted under 35 Stief, et al., “The Influence of Anterior Root Stimulation (S2) in Deafferented Spinal Cord Injury Men on Cavernous U.S.C. 154(b) by 274 days. Electrical Activity”, The Journal of Urology 148 (Jul. 1992), (21) Appl. No.: 09/799,988 pp. 107-110. (22) Filed: Mar. 6, 2001 (List continued on next page.) Related U.S. Application Data Primary Examiner Mark Paschall (60) Provisional application No. 60/195.533, filed on Apr. 7, (74) Attorney, Agent, or Firm-Laura Haburay Bishop; 2000. Bryant R. Gold (57) ABSTRACT (51) Int. Cl. .................................................. A61N 1/36 An implantable Stimulator(s) with at least two electrodes, (52) U.S. Cl. ............................................ 607/39; 607/72 which is Small enough to have the electrodes located adja cent to a cavernous nerve(s) or other nerve(s) innervating the (58) Field of Search ................................ 607/2, 72, 60, reproductive organs, uses a power Source/storage device, 607/118, 15-24, 39-59; 128/901 Such as a rechargeable battery. Periodic recharging of Such a battery is accomplished, for example, by inductive cou (56) References Cited pling with an external appliance. The Small Stimulator provides means of Stimulating a nerves) when desired, U.S. PATENT DOCUMENTS without the need for external appliances during the Stimu 3,941,136 A 3/1976 Bucalo ....................... 128/422 lation Session. When necessary, external appliances are used 4,167.466 A * 9/1979 Orr, Jr. et al. .............. 204/176 for the transmission of data to and/or from the Stimulator(s) 4,542,753 A 9/1985 Brenman et al. ........... 128/788 and for the transmission of power. In a preferred embodiment, the System is capable of open-and closed-loop (List continued on next page.) operation. In closed-loop operation, at least one implant FOREIGN PATENT DOCUMENTS includes a Sensor, and the Sensed condition is used to adjust WO 9837926 3/1998 Stimulation parameters. WO 98.437OO 8/1998 WO 98.43701 8/1998 24 Claims, 3 Drawing Sheets US 6,650,943 B1 Page 2 U.S. PATENT DOCUMENTS OTHER PUBLICATIONS 4,585,005 4/1986 Lue et al. ................... 128/419 Tai, et al., “Penile Erection Produced by Microstimulation of 4.954,321 9/1990 Jenren .............. ... 422/186.19 the Sacral Spinal Cord of the Cat", IEEE Transactions 5,193,539 3/1993 Schulman et al. - - - - - - - - - - 128/419 Rehabilitation Engineering 6 (Dec. 1998) pp. 374-381. 5,193,540 3/1993 Schulman et al. - - - - - - - - - - 128/419 Shafik A., “Perineal Nerve Stimulation: Role in Penile 5,312.439 5/1994 Loeb ............................. 607/2 Erection”, International Journal of Impotence Research. 9 5.439,938 8/1995 Snyder et al. ... ... 514/565 (Mar. 1997), pp. 11-16. 5,454,840 10/1995 Krakovsky et al. - - - - - 607/39 Shafik A., “Cavernous Nerve Stimulation Through an 5,571,118 11/1996 Boutos ....................... 607/138 Extrapelvic Subpubic Approach: Role in Penile Erection”, 5,756,054 * 5/1998 Wong et al. ........... 422/186.08 Eur Urol 26 (1994), pp. 98-102. 5,775,331 7/1998 Raymond et al. - - - - - - - 128/741 Creasey GH., “Electrical Stimulation of Sacral Roots for 5,938,584 8/1999 Ardito et al. ..... - - - - - 600/38 Micturition. After Spinal Cord Injury', Urologic Clinics of 5,977.715 11/1999 Li et al. .... ... 315/111.51 North America 20 (Aug. 1993), pp. 505–515. 6,051,017 4/2000 Loeb et al. .... - - - - - - 607/1 6,169,924 1. 1/2001 Meloy et al. ................. 607/39 * cited by examiner U.S. Patent Nov. 18, 2003 Sheet 1 of 3 US 6,650,943 B1 U.S. Patent Nov. 18, 2003 Sheet 2 of 3 US 6,650,943 B1 116 116 152 R 160 ? re- Y(N NY L.E.) U.S. Patent Nov. 18, 2003 Sheet 3 of 3 US 6,650,943 B1 lo) SN US 6,650,943 B1 1 2 FULLY MPLANTABLE the three cylinders of erectile tissue in the penis (i.e., the NEUROSTIMULATOR FOR CAVERNOUS corpora cavernosum and the corpus Spongiosum). As the NERVE STIMULATIONAS A THERAPY FOR corpora cavernosum and the corpus Spongiosum expand, the ERECTILE DYSFUNCTION AND OTHER venous Structures draining the penis are compressed against SEXUAL DYSFUNCTION the fascia Surrounding each of the erectile tissues (i.e., the tunica albuginea of the corpora cavernoSum and the tunica albuginea of the corpus spongiosum). Thus, the outflow of The present application claims the benefit of U.S. Pro blood is restricted, and the internal pressure increases. This visional Patent Application Serial No. 60/195.533, filed Apr. vein-obstruction process is referred to as the corporal veno 7, 2000, which application is incorporated herein by refer occlusive mechanism. ence in its entirety. Conversely, constriction of the Smooth muscle and heli FIELD OF THE INVENTION cine arteries induced by Sympathetic innervation (i.e., stimu lation by nerves) from the hypogastric nerves, for example, The present invention generally relates to implantable from certain nerves of the inferior hypogastric plexus, may Stimulator Systems, and more particularly relates to an make the penis flaccid. implantable Stimulator System utilizing one or more implant 15 Erectile dysfunction has a number of causes, both physi able microStimulators as a therapy for erectile dysfunction. ological and psychological, and in many patients the disor der may be multifactorial. The causes include Several that BACKGROUND OF THE INVENTION are essentially neurologic in origin. Damage to the pathways Recent estimates Suggest that the number of U.S. men used by the autonomic nervous System to innervate the penis with erectile dysfunction may be near 10 to 20 million, and may interrupt "psychogenic' erection initiated by the central inclusion of individuals with partial erectile dysfunction nervous System. Psychogenic erection has a mental or emo increases the estimate to about 30 million. The male erectile tional origin, rather than a physical basis. Lesions (e.g., response is initiated by the action of neurons, or nerve cells injury, infection, or disease) of the Somatic nervous path (i.e., neuronal action), and maintained by a complex inter ways (i.e., any of the nerves associated with Sensation or play between events involving blood vessels (i.e., vascular 25 motion) may impair reflexogenic erections (i.e., involuntary, events) and events involving the nervous System (i.e., neu instinctive physiological response to a stimulus) and may rological events). interrupt tactile Sensation needed to maintain psychogenic The part of the nervous System that regulates involuntary erections. Spinal cord lesions may produce varying degrees action (e.g., the intestines, heart, glands) is called the auto of erectile failure depending on the location and Severity of nomic nervous System. The autonomic nervous System is the lesions. divided into two mutually antagonistic, physiologically and Not only lesions affect erectile ability; disorders leading anatomically distinct Systems: the Sympathetic nervous SyS to peripheral neuropathy may also impair neuronal innerva tem and the parasympathetic nervous System. The Sympa tion of the penis. Peripheral neuropathy is a disorder or thetic nervous System originates in the thoracic and lumbar abnormality of the part of the nervous System constituting regions of the Spinal cord, and in general, opposes the 35 the nerves outside the central nervous System and including physiological affects of the parasympathetic nervous System. the cranial nerves, the Spinal nerves, and the Sympathetic For instance, the Sympathetic nervous System will tend to and parasympathetic nervous Systems. Peripheral neuropa reduce digestive Secretions or Speed up the heart, usually thy may also impair neuronal innervation of the Sensory when an individual is in an active State. The parasympathetic 40 afferents-the nerves that conduct impulses from the periph nervous System originates in the brain Stem and the lower ery of the body to the brain or Spinal cord, transmitting part of the Spinal cord, and, in general, opposes the physi impulses from Sense organs to nerve centers. Peripheral ological effects of the Sympathetic nervous System. Thus, the neuropathy is a potential Sequela of a number of diseases, parasympathetic nervous System will tend to Stimulate e.g., diabetes mellitus. digestive Secretions or slow the heart usually when an 45 The endocrine System (glands Such as the thyroid, individual is in a relaxed State. adrenal, or pituitary, having hormonal Secretions that pass It is parasympathetic neuronal action that initiates the directly into the bloodstream), particularly the production of male erectile response. Specifically, this parasympathetic androgens (Steroid hormones, Such as testosterone or input originates from the nerve plexus (i.e., a structure in the androsterone, that control the development and maintenance form of a network) called the pelvic splanchnic nerve 50 of masculine characteristics), appears to play a role in plexus. The pelvic Splanchnic nerve plexus is comprised of regulating Sexual interest, and may also play a role in branches from the Second, third, and fourth Sacral nerves erectile function.
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