Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
1998-08-13
2001-04-03
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C128S899000, C600S032000
Reexamination Certificate
active
06210347
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
The present invention relates to a food intake restriction device for the treatment of morbid obesity. More specifically, the invention relates to a food intake restriction device for surgical application in the abdomen of a patient for forming a stoma opening in the stomach or esophagus of the patient.
Food intake restriction devices in the form of gastric banding devices, in which a band encircles a portion of the stomach, have been used in surgery for morbid obesity to form a small gastric pouch above the band and a reduced stoma opening in the stomach. Although such a band is applied around the stomach to obtain an optimal stoma opening during surgery, some prior gastric banding devices are provided with an adjustment means enabling a minor post-operation adjustment of the size of the stoma opening. In all such prior devices, such as disclosed in U.S. Pat. No. 4,592,339, European Patent No. 0611561 and International Patent Application WO 94/27504, the adjustment means comprises an inflatable cavity in the band and an injection port in fluid connection with the inflatable cavity for adding fluid to or withdrawing fluid from the inflatable cavity. In practice, the band is made of silicone rubber which is a material approved for implantation and the fluid is a liquid such as an isotonic salt solution.
It has been found that the volume of said gastric pouch above the band increases in size up to ten times after the operation. Therefore the pouch volume during surgery needs to be very small, approximately 7 ml. To enable the patient to feed the stomach with sufficient nutrition immediately after the operation considering such a small gastric pouch, the stoma initially needs to be relatively large and later needs to be substantially reduced, as the pouch volume increases. Furthermore, the size of the stoma opening has to be gradually reduced during the first year after surgery as the gastric pouch increases in size. As indicated above, the reduction of the stoma opening using the prior art gastric banding devices is achieved by adding liquid to the cavity of the band via the injection port to expand the band radially inwardly.
A great disadvantage of repeatedly injecting liquid via the injection port is the increased risk of the patient getting an infection in the area surrounding the injection port. If such an infection would occur the injection port has to be surgically removed from the patient. Moreover, such an infection might be spread along the tube interconnecting the injection port and the band to the stomach causing even more serious complications. Thus, the stomach might be infected where it is in contact with the band, which might result in the band migrating through the wall of the stomach. Also it is uncomfortable for the patient when the necessary, often many, post-operation adjustments of the stoma opening are carried out using an injection needle penetrating the skin of the patient into the injection port.
Further, the patient may swallow pieces of food that are too large to pass the restricted stoma opening. At such an occasion the patient has to visit a doctor who can remove the food pieces, if the band design so permits, by withdrawing some liquid from the band to enlarge the stoma opening to allow the food pieces to pass the stoma. Then, the doctor has to add liquid to the band in order to restore the restricted stoma opening. These measures also require the use of an injection needle penetrating the skin of the patient, which is uncomfortable for the patient.
The invention provides an adjustable food intake restriction device which permits regular post-operation adjustments that are comfortable for the patient. The present invention provides an adjustable food intake restriction device which is easy to adjust and does not require the use of an injection needle for accomplishing post-operation adjustments of the stoma opening.
In accordance with the invention a new food intake restriction device is provided for forming a stoma opening in the stomach or esophagus of a patient, comprising: an elongated restriction member, formed into at least a substantially closed loop around the stomach or the esophagus, the loop defining a restriction opening; a controllable adjustment device which adjusts the restriction member in the loop to change the size of the restriction opening; and a wireless remote control means for controlling the adjustment device from outside the patient's body (i.e. in a non-invasive manner). Thus, the new device does not require use of an injection needle for later adjustments of said restriction opening, thereby eliminating the infection risk discussed above in connection with prior art food intake devices. [An injection port may be provided for enabling, normally a single, once-and-for-all, calibration of the amount of fluid in adjustment device if it utilizes pneumatic or hydraulic components.] Furthermore, the use of the wireless remote control of the new device for controlling the adjustment device is comfortable for the patient.
In accordance with a broad aspect of the invention, the wireless remote control means comprises separate signal transmitting means and signal receiving means, the receiving means for controlling the adjustment device in response to signals received from the signal transmitting means. The remote control means comprises a motor for operating the adjustment device and an energizer unit for providing energy. The signal receiving means comprises a control unit adapted to power the motor with energy provided by the energizer unit in response to signals received from the signal transmitting means. Any known or conventional signal transmitting or receiving device that is suitable for use with a human or mammal patient may be provided s the signal transmitting or receiving means.
The invention also relates to a method of treating morbid obesity, comprising: (a) surgically implanting in the abdomen of a patient with morbid obesity a food intake restriction device which forms a stoma opening in the stomach or esophagus, by forming an elongated restriction member (e.g. of bio-compatible material, or covered with bio-compatible material) into at least a substantially closed loop around the stomach or the esophagus of the patient, the loop defining a restriction opening; and then (b) when necessary for the patient's health or desired progress, in a non-invasive procedure, using a wireless remote control device to adjust the restriction member to change the size of the restriction opening. In the method (a) may be practiced in part by implanting an electric motor which is part of an adjustment device for acting on the restriction member to control the size of the restriction opening; and (b) may be practiced by transmitting electromagnetic wave signals from outside the patient's body to inside the patient's body, and ultimately transforming the electromagnetic wave signals into electrical energy for powering the motor.
In the method, (a) may be practiced using laparoscopic techniques, e.g. (i) inflating the patient's abdomen with gas by penetration of the patient's skin, (ii) introducing at least two laparoscopic trocars into the abdomen to introduce the elongated restriction member and one or more medical instruments, and then (iii) forming the elongated restriction member into the at least substantially closed loop. Further, (b) may be practiced by sending electromagnetic waves through the skin into the abdomen, and in the abdomen transforming the waves into an electric current which is used to adjust the restriction member.
The motor may be any type of motor, such as a pneumatic, hydraulic or electric motor, and the energizer unit may power the motor with pressurized gas or liquid, or electrical energy, depending on the type of motor. Where the motor is an electric motor, it may power pneumatic or hydraulic equipment.
In accordance with a first particular embodiment of the invention, the energizer unit comprises a power supply and the control un
Nixon & Vanderhye P.C.
O'Connor Cary
Wingood Pamela L
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