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United States Patent 19 11 Patent Number: 6,091,992 Bourgeois Et Al US006091992A United States Patent 19 11 Patent Number: 6,091,992 Bourgeois et al. (45) Date of Patent: *Jul.18, 2000 54 METHOD AND APPARATUS FOR Evaluation of the Intrinsic Innervation of the Internal Anal ELECTRICAL STIMULATION OF THE Sphincter using Electrical Stimulation-Gut, 1989, 30, GASTRONTESTINAL TRACT 935–938 (M.A. Kamm, J.E. Lennard-Jones, and R.J. Nicholls). 75 Inventors: Ivan Bourgeois, Verviers, Belgium; Enhancing Absorption in the Canine Short Bowel Syndrome Johan Ryden, Beek, Netherlands by Intestinal Pacing-Surgery, Aug. 1980 (H.E. Gladen and K.A. Kelly). 73 Assignee: Medtronic, Inc., Minneapolis, Minn. Pacing the Human Stomach-Surgery, Feb. 1992 (B.W. * Notice: This patent is Subject to a terminal dis Miedema, M.G. Sarr and K.A. Kelly). claimer. Ectopic Jejunal Pacemakers and Gastric Emptying after Roux Gastrectomy: Effect of Intestinal Pacing Surgery, 21 Appl. No.: 08/990,984 Nov. 1989 (L.Karlstrom and K.A. Kelly). A New Treatment for Rectal Prolapse (Abridged)-Proceed 22 Filed: Dec. 15, 1997 ings of the Royal Society of Medicine (K.P.S. Caldwell). (51) Int. Cl." ....................................................... A61N 1/36 Prognosis of Patients with an Ileostomy-Section of Proc 52) ... 607/40; 607/72 tology (A.G. Parks). 58 Field of Search .................................. 607/40, 41, 73, Differential Responses of the Canine Gastric Corpus and 607/133, 138, 143; 600/29, 30 Antrum to Electric Stimulation-American Journal of Physiology, Jan. 1974 (K.A. Kelly). 56) References Cited The Electrical Control of Sphincter Incompetence- The Lancet, Jul. 23, 1963 (K.P.S. Caldwell). U.S. PATENT DOCUMENTS Gastric Motor Physiology and Pathophysiology-Surgical 4,981,470 1/1991 Bombeck, IV. Clinics of North America, vol. 73, Dec. 1993 (J.J. Cullen and 5,188,104 2/1993 Wernicke et al.. K.A. Kelly). 5,292,344 3/1994 Douglas. The Role of the Extrinsic Antral Nerves in the Regulation of FOREIGN PATENT DOCUMENTS Gastric Emptying-Surgery, Gynecology & Obstetrics, Sep. 2 237 648 7/1973 France. 1977, vol. 145 (C.T. Mroz and K.A. Kelly). 2 453 630 4/1979 France. 0571 938A2 5/1993 Germany. (List continued on next page.) 1651918A1 of OOOO U.S.S.R. Primary Examiner Jeffrey R. Jastrzab WO 94/27672 5/1994 United Kingdom. Attorney, Agent, or Firm Thomas F. Woods; Michael J. OTHER PUBLICATIONS Jaro; Harold Patton Ergebnisse der Inneren Medizin und Kinderheilkunde 57 ABSTRACT 16:198 (1961) (cover page). Electric Stimulation of the Gastrointestinal Tract-GP Apr. A method and apparatus for providing electrical Stimulation 1994. of the gastrointestinal tract. The apparatus features an Gastrointestinal Pacing A New Concept in the Treatment implantable pulse generator which may be coupled to the of Ileus-Biomedical Sciences Instrumentation vol. 1. 1963 gastric System through one or more medical electrical leads. (A.M. Bilgutay, R. Wingrove, W.O. Griffen, R.C. Bonna In the preferred embodiment the leads couple to the circular beau and C.W. Lillehei). layer of the Stomach. Gastro-intestinal Pacing: Will It Work?-American Journal of Surgery, Feb. 1966 (J. Sonneland). 32 Claims, 12 Drawing Sheets Triggered mode Ge. OO is a slow wave sensed? N/ 102 Output higher energy pulse train N/ 104 Output tower energy pulse trains 6,091,992 Page 2 OTHER PUBLICATIONS Enhancing the Anti-Dumping Effect of Roux Gastrojejun ostomy with Intestinal Pacing-Ann. Surgery, Oct. 1983, A New Treatment for Rectal Prolapse-Geriatrics, Jan. 1968 vol. 198 (B. Cranley, K.A. Kelly, V.L.W. Go, L.A. McNi (K.P.S. Caldwell). chols). Incontinence-Transactions of The Medical Society of Lon The Roux Operation for Postgastrectomy Syndromes- The don, Ordinary Meeting, Apr., 1973 (K.P.S. Caldwell). American Journal of Surgery, vol. 161, Feb. 1991 (B.W. The Treatment of Incontinence-Hospital Management Miedema, K.A. Kelly). (K.P.S. Caldwell). Effect of Duodenal Cooling on Small Intestinal Pacing Control of Gastro-intestinal Motility with Electrical Pac ing Jap. J. Smooth Muscle Res. 21: Suppl., 125, 1985 Mayo Clin. Proc. Aug. 1982, vol. 57 (K.R. Berg, H.E. (H.M. Richter, III, S. Bjorck and K.A. Kelly). Gladen, K.A. Kelly). Effect of Electrical Stimulation on Gastric Electricla Activ Achieving Enteric Continence: Principles and Applica ity, Motility and Emptying-Neurogastroenterology and tions-Mayo Clin Proc. Jul. 1986, vol. 61 (J.H. Pemberton, Motility 1995 (J.C. Eagon and K.A. Kelly). K.A. Kelly). Independence of Canine Gastric and Duodenal Pacesetter Electrical Stimulation of the Human Stomach-Digestive Potentials Shown by Electric Pacing-May Clin. Proc, Jan. Diseases and Sciences, vol. 30, No. 8, Aug. 1985 (W.E. 1977, vol. 52 (H.E. Gladen and K.A. Kelly). Waterfall, D. Miller, D.N. Ghista). Duodenal-Gastric Refulx and Slowed Gastric Emptying by Gastric Electrical Stimulation as a Possible New Therapy for Electrical Pacing of the Canine Duodenal Pacesetter Poten Patients with Severe Gastric Stasis-Gastroenterology, vol. tial-Gastroenterology 72:429–433, Mar. 1977 (K.A. Kelly 100, No. 5, Part 2 (T.L. Courtney, B.D. Schirmer, B.E. and C.F. Code). Ballahsene, O.L. Updike and R.W. McCallum). Pacing the Human Gut-The American Journal of Gastro Temporary and Permanent Electrical Stimulation of the enterology, vol. 89, No. 3, 1994 (D.A. Johnson and E.L. Human Stomach Using High Frequency Pacing-Motility Cattau). and Nerve-Gut Interactions, Apr. 1993 (B.O. Familoni, T.L. Pacing the Gut-Gastroenterology, Dec. 1992 (K.A. Kelly). Abell, G. Voeller, A. Salem, O. Gaber, D. Nemoto). Human Gastric Myoelectric Activity and Gastric Emptying Long-Term Electrical Stimulation of the Human Stomach Following Gastric Surgery and With Pacing-1992 Gastro Gastroenterology, Vol.106, No. 4, Part 2 (B.O. Familoni, enterological (M.P. Hocking, S.B. Vogel and C.A. Sninsky). TL. Abell, G. Voeller, A. Salem, O. Gaber, D. Nemoto). Pacing the Canine Stomach with Electric Stimulation A Model of Gastric Electrical Activity in Health and Dis American Journal of Physiology, Mar. 1972 (K.A. Kelly and ease-IEEE Transactions on Biomedical Engineering, Vol. R.C. La Force). 42, No. 7, Jul. 1995 (B.O. Familoni, T.L., Abell, K.L. Gastric Emptying of Liquids and Solids: Roles of Proximal Bowes). and Distal Stomach-Editorial Review, The American Use of Spectral Analysis in the Detection of Frequency Physiological Society 1980 (K.A. Kelly). Differences in the Electrogastrograms of Normal and Dia Electric Pacing of Intact and Transected Canine Small betic Subjects-IEEE Transactions on Biomedical Engi Intestine and its Computer Model-American Journal of neering, vol. 35, No. 11, Nov. 1988 (C.J. Pfister, J.W. Physiology, vol. 229, Nov. 1975 (O.E. Akwari, K.A. Kelly, Hamilton, N. Nagel, P. Bass, J.G. Webster and W.J. Tomp J.H. Steinbach and C.F. Code). kins). Electrical Treatment for Anal Incontinence-The Lancet, Gastric Motility after Gastric Operations-Surgery Annual Feb. 5, 1966 (B.R. Hopkinson, R. Lightwood). 1974 (K.A. Kelly). Electrophysiology of Human Colon Motility in Health and Electrical Stimulation of Gastric Electrical Control Activ Disease-Clinics in Gastroenterology, vol. 15, No. 4, Oct. ity-American Journal of Physiology, vol. 225, No. 1, Jul. 1986 (J.D. Huizinga). 1973 (S.K. Sarna and E.E. Daniel). Cerebral Evoked Potentials. After Rectal Stimulation-Elec Electrical Pacing of the Roux Limb Resolves Delayed troencephalography and Clinical Neurophysiology, 80 Gastric Emptying Journal of Surgical Research 42, (1991) 490–495 (V. Loening-Baucke, N.W. Read and T. 635-641 (1987) (A. Sawchuk, D. Canal, J.L. Grosfeld, <. Yamada). Slaughter, G. Gardner, T. O'Connor and D. Behrman). Measurement of Gastric and Small Bowel Electrical Activity Gastrointestinal Pacing Staff Report Meeting University at Laparoscopy-Journal of Laparoendoscopic Surgery, of Minnesota Medical Bulletin 1965 (A.M. Bilgutay, R. vol.4, No. 5, 1994 (B.O. Familoni, T.L. Abell and G. Wingrove, W.O. Griffen, A. Nakib, R.C. Bonnabeau, C.W. Voeller). Lillehei). Electrical Stimulation of the Bowel-Arch Surg. vol. 91, Acceleration of Gastric Emptying with Electrical Stimula Sep. 1965 (J.M. Moran and D.C. Nabseth). tion in a Canine Model of Gastroparesis-1992 the Ameri Electrical Pacing for Short Bowel Syndrome-Surgery, can Physiology Society (B-E Bellahsene, C.D. Lind, B.S. Gynecology & Obstetrics-Nov. 1981, vol. 153 (H.E. Schirmer, O.L. Updike and R.W. McCallum). Gladen and K.A. Kelly). A Trial of a Gastro-intestinal Pacemaker-Journal of the The Treatment of Incontinence by Electronic Implants Irish Medical Association Jan. 1966 (PN. Fitzpatrick, and Annals of The Royal College of Surgeons of England, Dec. A.W. Chen). 1967 (K.P.S. Caldwell). Behavioral and Gastrointestinal Changes (Motility and The Future of Intestinal Pacing-Gastroenterology Clinics Blood Flow) Induced by Electrical Stimulation of the Lat of North America, vol. 23, No. 2, Jun. 1994 (J.J. Cullen and eral Hypothalamus in Cats-Abstr. XI Scand. Physiol. K.A. Kelly). Congr. Copenmhagen 1963, Suppl. No. 213 (F. Björn and Control of Muscle Tone in the Human Colon-Gut, 1992, E.H. Rubinstein). 33, 541-546 (C.J. Steadman, S.F. Phillips, M. Camilleri, Gastrointestinal Pacemaker-The Lancet, Dec. 7, 1963 N.J. Talley, A. Haddad, R. Hanson). (J.M. Sanchez). 6,091,992 Page 3 Gastrointestinal Pacing Modern Medicine, Mar. 15, 1965 An Improved Method for Recording and Analyzing the (A.M. Bilgutay, R. Wingrove, W.O. Griffen, A. Nakib, R.C. Electrical Activity of the Human Stomach-IEEE Transac Bonnabeau and C. W. Lillehei). tions on Biomedical Engineering, vol. 32, No. 11, Nov. 1985 Response to Gastrointestinal Pacing: Antral, Duodenal and (B.E. Bellahsene, J.W. Hamilton, J.G. Webster, P. Bass and Jejunal Motility in Control and Postoperative Patients M. Reichelderfer). Annals of Surgery, Jul.
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