Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2000-04-14
2002-09-10
Schaetzle, Kennedy (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06449511
ABSTRACT:
FIELD OF INVENTION
This invention relates to a device for electrical stimulation of smooth muscle comprising a portion of the gastro-intestinal tract, a method for using the device of the within invention and a method for electrical stimulation of the smooth muscle.
BACKGROUND OF THE INVENTION
Many different ways of stimulating gastro-intestinal function have been explored, including pharmacological, neural, purely electrical, and combined methods. In particular, gastric electrical stimulation has been a subject of research investigation for many years:
1. Bellahsene, B. E., C. D. Lind, B. D. Schirmer, O. L. Updike, and R. W. McCallum, “Acceleration of gastric emptying with electrical stimulation in a canine model of gastroparesis”
Am. J. Physiol
. 262(5 Pt 1):G826-34, 1992;
2. Berger, T., J. Kewenter, and N. G. Kock, “Response to Gastrointestinal Pacing: Antral, Duodenal and Jejunal Motility in Control and Postoperative Patients” Annals of surgery 161:139-44, 1966;
3. Chen, J. D., B. D. Schirmer, and R. W. McCallum “Serosal and cutaneous recordings of gastric myoelectrical activity in patients with gastroparesis”
Am. J Physiol
. 266(1 Pt 1):G90-8, 1994;
4. Daniel, E. E. and S. K. Sarna “Distribution of Excitory Vagal Fibers in Canine Wall to Control Motility”
Gastroenterology
71:608-13, 1976;
5. Familoni, B. O., T. L. Abell, G. Voeller, A. Salem, 0. Gaber, and D. Nemoto “Long-term electrical stimulation of the human stomach”
Gastroenterology
106(2):A496, 1994;
6. Sama, S. K., K. L. Bowes, and E. E. Daniel “Gastric Pacemakers”
Gastroenterology
70:226-31, 1976;
7. Quast, D. C., Beall, A. C., and DeBakey, M. E., “Clinical Evaluation of the Gastrointestinal Pacer”
Surg. Gynec. Obstet
. 120:35-40, 1965;
8. Miedama, B. W., Sarr, M. G., and Kelly, K. A. “Pacing the Human Stomach”
Surgery
111:143-50, 1992;
9. Hocking M. P., Vogel, S. B., and Sininsky, C. A. “Human gastric myoelectric activity and gastric emptying following gastric surgery and with pacing”
Gastroenterology
103:1811-1816, 1992;
10. Familoni, B. O., Abell, T. L., Nemoto D., Voeller, G., and Johnson, B. “Efficacy of electrical stimulation at frequencies higher than basal rate in canine stomach”
Digestive Diseases and Sciences
42:892-897, 1997;
11. Christensen, J. “Responses of the smooth muscle segment of the opossum esophagus to distention and electrical stimulation, and their modification by antagonist” In: Gastrointestinal Motility, International Symposium on Motility of the Gastrointestinal tract, pp. 167-174, Erlangen, July 15-16, 1969).
It is now well known that gastric contractions are controlled by gastric electrical activity (“GEA”) (Sarna et. al., 1976). Moreover, when contractions are present, their temporal and propagation organization is strongly related to the organization of GEA. Therefore, electrical stimulation of the stomach may have particular application to a condition known as gastroparesis, in which the stomach is incapable of grinding, mixing and transmitting the food to the duodenum, and to other conditions in which gastric emptying time is abnormally delayed (Bellahsene et. al., 1992; Chen et. al., 1994).
Recently, gastric electrical pacemaking has once again become a subject of intensive investigation (Eagon J C and Kelly K A “Effect of electrical stimulation on gastric electrical activity, motility and emptying”
Neurogastroenterology
&
Motility
. 7:39-45, 1995; The GEMS Group “Electrical stimulation for the treatment of gastroparesis—preliminary report of a multicenter international trial”
Gastroenterology
, 110:A668, 1996; Chen J D Z, Lin Z Y, Schirmer B D, Williams R D, Ross B and McCallum R W “Effect of gastric pacing with optimal parameters on gastric emptying in patients with gastroparesis” In: Proceedings of XV Int. Symposium on Gastrointestinal Motility, p. 42, Rome, Italy, October 1995; McCallum, R. W., Chen, J. D. Z., Lin, Z., Schirmer, B. D., Williams, R. D., and Ross R. A. “Gastric pacing improves emptying and symptoms in patients with gastroparesis”
Gastroenterology
114:456-61, 1998).
In 1963, Bilgutay et. al. (Bilgutay A M, Wingrove R, Griffin W O, Bonnabeau R C and Lillehei C W “Gastro-intestinal Pacing. A New Concept in the Treatment of Ileus”
Ann. Surg
., 158;338-43, 1963) described marked shortening of the duration of postoperative ileus in patients using neural electric gastric stimulation (“NEGS”) with a single antral intraluminal electrode and a single cutaneous reference electrode. However, subsequent well-controlled studies have failed to confirm any significant effect of single-electrode NEGS on antral contractions or postoperative ileus (Quast et. al., 1965 and Miedama et. al., 1992).
Later studies have focused upon Electrical Control Activity (“ECA”) entrainment, termed Gastric Electrical Pacing (“GEP”) by Sama et. al., 1976. Distal antral stimulation in dogs produced a delay in emptying of liquids and solids. Proximal stimulation to entrain ECA to a higher frequency was found to have no effect on antral emptying. These findings were confirmed by Kelly K A, and Code CF “Duodenal-gastric reflux and slowed gastric emptying by electrical pacing of the canine duodenal pacesetter potential”
Gastroenterol
., 72:429, 1977. Kelly et. al., 1977 demonstrated retrograde propulsion of duodenal contents with distal duodenal stimulation and entrainment of the duodenal pacesetter potential.
J. C. Eagon et. al., 1995 studied carefully the effects of low-frequency (0-20 Hz) electrical stimulation on canine gastric electrical activity (GEA), motility and emptying and concluded that although an increment of GEA frequency was observed when stimulating at 6 and 30 cycles-per-minute (cpm), gastric contractions and emptying were not affected by stimulation in the low frequency range. More optimistic findings were reported by The GEMS Study Group, 1996 in improvement of nausea and vomiting in humans, but no dramatic change in gastric emptying was evident.
Chen et al., October 1995, described slight acceleration of gastric emptying in a pilot study of a small number of patients with gastroparesis by performing GEP at one site on the greater curvature of the stomach and entraining ECA to a frequency 10% higher than the electrophysiological or basal. Further, Bellahsene et. al., 1992, in a canine model of gastroparesis, showed acceleration of gastric emptying after glucagon-evoked dysrhythmia and GEP in five vagotomized dogs. However, the study failed to show significant improvement in gastric emptying without the artificially created dysrhythmia thus questioning the ability of GEP alone to accelerate gastric emptying.
Familoni et al., 1997 in a more recent investigation using a canine model of GEP described some increased contractile activity when stimulating with frequency 4-5 times higher than the electrophysiological, but they did not measure gastric emptying. In addition, another study (The GEMS Group, 1996) reported diminished nausea and vomiting in patients treated with GEP, but the impact of pacing on gastric emptying remained questionable.
In 1998 McCallum et al., 1998 described acceleration of gastric emptying in patients with gastroparesis by performing GEP at a single site on the greater curvature of the stomach and entraining ECA to a frequency 10% higher than the basal. However, the experimental protocol in this study provided for continuing prokinetic drug therapy during the stimulation, and therefore the effect of GEP alone remained obscured.
The within invention specifically utilizes a mathematical or computer model of gastric stimulation in order to derive the parameters of the electrical stimuli required to produce artificially propagated contractions in the stomach.
Mirrizzi et. al., 1985 (Mirrizzi N., R. Stella, U. Scafoglieri “A model of extra cellular wave shape of the gastric electrical activity”
Med. Biol. Eng. & Comput
, 23:33-37, 1985) and Mirrizzi et. al., 1986 (Mirrizzi N., R. Stella, U. Scafoglieri “Model to stimulate the gastric electrical control activity on the stomach wall and on abdominal surface”
Med. Biol. Eng
. &
Comput
, 24:157-163,
Bowes Kenneth L.
Mintchev Martin P.
Kuharchuk Terrence N.
Rodman & Rodman
Schaetzle Kennedy
University Technologies International Inc.
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