WO2014014421A1

WO2014014421A1 - Device for external gastric restriction and tightening for prevention and treatment of obesity and diabetes

Info

Publication number: WO2014014421A1
Application number: PCT/SG2013/000300
Authority: WO
Inventors: Jing Jin; Whye Kei LYE; Shahrzad RAYATPISHEH; Davide LOMANTO
Original assignee: Nanyang Technological University; National University Hospital Singapore Pte Ltd
Current assignee: Nanyang Technological University; National University Hospital Singapore Pte Ltd
Priority date: 2012-07-20
Filing date: 2013-07-19
Publication date: 2014-01-23
Anticipated expiration: 2015-01-20

Description

Device for external gastric restriction and tightening for prevention and treatment of obesity and diabetes

Field of the invention The invention relates to devices and surgical techniques for applying forces to a stomach, to cause gastric restriction and tightening.

Background of the invention

Obesity has become a pandemic problem. According to the World Health Organization (WHO) most developing countries are facing a "double burden" of diseases due to under-weight and diseases to over-weight problems. However, 65% of the world's population is living in countries where mortality associated with obesity is higher than that for the underweight [1]. A series of articles have been published in the Lancet 201 1 which refer to the global obesity pandemic and the future challenges for reversing the tide of obesity [2]. Obesity is a well-known risk factor of diabetes type 2 and other metabolic diseases in which the body cells become resistant to insulin [3]. Also many diseases including cardiovascular diseases like atherosclerosis and several types of cancers such as colon, endometrial and breast cancers, are related to obesity [4-9].

Bariatric surgery has been emerging and growing quickly as the leading approach for weight loss. Moreover, it has been proven that these surgeries can avert type 2 diabetes not only by weight reduction but also other means that are not yet fully understood. To date bariatric surgery is the most effective treatment of morbid obesity which has proved to reduce the total mortality and morbidities related to obesity. Although surgery is costly, the reduction in direct and indirect costs of obesity co-morbidities makes this choice cost effective. However, the surgery imposes some life threatening risks. In order to reduce the rate of surgical mortality and morbidity, there is a need for new medical devices [10, 1 1].

Gastric sleeve surgery has recently proved effective for weight reduction and blood sugar control. In the past 5 years it has become the most popular weight loss operation worldwide. In this surgery, the lateral parts of stomach are permanently removed. One of the major drawbacks of gastric sleeve surgery is that there is a 3- 5% chance of leakage from the resected site which leads to death.

Other relevant surgical techniques employ a device which is connected to the stomach. A laparoscopic adjustable ring, known as Lap-Band (US 201 1/0270016 A1 ), is commercially available for restricting the amount of consumed food. This is an inflatable ring which is placed around the upper part of the stomach in a surgical operation. One of the dangers of having Lap-Band surgery is the risk of it causing an obstruction due to its position. This can be because the band can be too tight, or because of overeating. The obstruction requires immediate attention, generally a second surgery. Also the device might migrate downwards. Over time, the stomach pouch can be enlarged if patients eat too much, which will result in decreased or no weight loss. Long term effects are poor esophageal function known as dysmotility (1 1 %) which can lead to chest pain and swallowing difficulty. Nausea and/or vomiting, gastroesophageal reflux, diverticulosis, abdominal pain and asthenia are among the side effects of this device [12, 13].

The rising trend of obesity in many countries over the past decade has impacted health care costs. The increment associated to BMI increase from 25 to 45 kg/m2 in a US insurance registry was $1 19.7 for medical care and US $82.6 for pharmacological costs [14]. The annual direct cost related to obesity management was estimated to be 2-7% of the total world health costs [15]. Levi et al. estimated a total of US$139 billion for direct and indirect costs of obesity which translates to 5% of the 2009 US national health expenditure [16].

In morbidly obese patients, bariatric surgery has expanded longevity and decreased long-term mortality, morbidity and health care use [17, 18]. The analysis of cost- efficacy demonstrated that the cost of bariatric surgery is reasonable for the additional years of lives gained. In obese patients with very high obesity-related health costs like the presence of diabetes type 2, bariatric surgery required initial economic investment which in short time turned to saving money [1 1 ]. Nevertheless, the costs of the surgery are high. There is accordingly a need for new medical devices with reduced risks of morality and morbidity, and preferably ones which are sufficiently cost-efficient to make them suitable not only for morbidly obese patients but also patients with moderate obesity who suffer metabolic disorders or cardiovascular diseases.

Summary of the invention

The present invention aims to provide a new and useful medical device for applying a force to the stomach of a patient, as well as surgical techniques for connecting the device to the stomach of the patient, and for adjusting the device. In general terms, the present invention proposes that the device includes two elongate segments which can be fastened to each other at each of their ends, thereby embracing a section of the stomach. The connection at at least one of the ends uses an adjustable fastening mechanism which permits the device to be fitted against the stomach, with a size appropriate for the size of the individual's stomach. In one form, the adjustable fastening mechanism uses a strap attached to one of the segments, and a buckle attached to the other segment, the buckle being adapted to be connected to the belt any of a plurality of locations along the length of the strap. Many variations are possible within the scope of the invention in the shapes of the buckle and strap, and other forms of adjustable fastening mechanism may be used. The elongate segments are intended to be attached to the stomach with the segments directed generally parallel to the direction in which food passes through the entrance to the stomach (cardia) to the location where it exits the stomach (pyloric atrium). The device can therefore define a channel within the stomach extending between these two locations along which food can pass. Preferably, the segments are curved, so that the channel is curved. Pressure is applied to the stomach using cushions attached to the elongate segments. The cushions may provide complete resection of the stomach parts and at the same time not disrupt the blood flow of the stomach wall. The suggested device therefore has a different location and function in comparison with the Lap-Band discussed above. It serves to mimie the gastric sleeve surgery by clipping and isolating instead of cutting. The food passage is open and no obstruction is predicted. The design of the device is according to the anatomy and physiology of the stomach and its length is adjustable for different adult stomach sizes. The device is flexible and at the same time fixed for preventing migration of the device. The blood supply of the stomach is not affected due to the anatomical shape. This effect is enhanced if cushions are provided on the surfaces of the segments which face the stomach. The restriction of food intake is the same as gastric sleeve surgery; therefore the same outcomes and benefits of the sleeve surgery apply. However, an advantage of using the present device is that it eliminates the surgical mortality and morbidities associated with cutting and resecting the stomach in sleeve gasterectomy. Moreover, this device makes the process completely reversible and controlled. These benefits would be appealing for further reduction of health care costs due to the reduced mortality as well as reduced post operational side effects.

Optionally, the device can be provided with means for attaching one or more flexible laminar elements ("flaps") to each of the segments. For example, the flap(s) can be attached to one or more of the segments prior to the surgery. During the surgery the flaps are folded over the stomach and attached to the other of the segments. Preferably, the attachment mechanism is adjustable, for example permitting the segment to be attached to the flap at a plurality of different locations on the flap. This means that the flap is able to provide a selectable force to the stomach. The flaps may be shaped to provide desired advantages. For example, the part of one of the flaps which is close to the cadia may be shaped according to the shape of the fundus to inhibit (or even prevent) acid reflux.

The usage of the embodiment is not limited to those who are already obese. Instead it may be used to prevent future obesity, such as in individuals who have been determined to have a genetic disorder associated with obesity. For example, Prader- Willi syndrome is a genetic disorder occurring in one out of 15,000 to 20,000 live births. There is a disruption of chromosome 15, which leads to malfunction of the hypothalamus. These patients have muscular hypotonia and their stomach can expand until rupture due to overeating. They become obese due to their insatiable appetite which has a significant impact on their future health. There is presently no cure for these patients. However, such individuals may benefit from application of a device which is an embodiment of the present invention before they gain extra weight. It is expected that the present device can halt their risk of diabetes type 2 and cardiovasulcar disorders and well as cancers resulting from obesity.

Brief description of the figures

Embodiments of the invention will now be described for the sake of example only with reference to the following drawings, in which:

Fig. 1 is composed of Figs.1 (a) and 1 (b) which respectively show first and second segments of a device which is an embodiment of the present invention;

Fig. 2, which is composed of Figs. 2(a) and 2(b), illustrates how the device of Fig. 1 can be attached to the stomach of a patient; Fig. 3 is composed of Figs. 3(a) and 3(b) which respectively show first and second segments of a device which is a second embodiment of the invention;

Fig. 4, which is composed of Figs. 4(a) and 4(b), illustrates how the device of Fig. 3 can be attached to the stomach of a patient; and

Fig 5, which is composed of Figs. 5(a) to 5(c) shows three further ways in which embodiments of the invention can be connected to a stomach.

Detailed description of the embodiments

Fig. 1 shows the two segments of a device which is an embodiment of the invention. Specifically, Fig. 1 (a) shows a first segment 1 ("superior segment"), and Fig. 1 (b) shows a second segment 2 ("inferior segment). The superior segment 1 is to be placed on frontal surface of stomach and sutured to serosa (the outer layer of the stomach covering a muscular layer) using holes 3 provided formed in the superior segment 1 . The shape of the superior segment 1 follows the natural curvature of the stomach and serves to isolate lateral gastric segments which may include the whole or part of the fundus, body and pylorus of the stomach. The superior segment is formed with a first buckle 5 at a first end, and a second buckle 6 at a second end. The buckles 5, 6 are to allow the superior segment 1 to be attached to the inferior segment 2 as described below. The superior segment 1 carries a supportive soft cushion 4 with gradually reducing thickness from the first end towards the second end. This corresponds to the physiologic thickness of the stomach wall.

The inferior segment 2 has a first end 7 shaped for connection to the buckle 5. It further includes a strap 8 formed with a plurality of through-holes spaced apart along the length of the strap. The strap 8 can be connected to the buckle 6 by inserting the buckle 6 into one of the through-holes. According to which through-hole is selected, the device is adapted to the size of the stomach.

The inferior segment 2 is formed with a cushion 9. Like the cushion 4, the cushion 9 may have non-uniform thickness, and in particular it may be tapered from one end towards the other (opposing the thickness of the stomach muscles). The cushions 4, 9 reduce the resistance caused by the device to gastric muscle movements, and allow for proper circulation of the blood. They may be formed from a soft material. Optionally, one or both may be hollow and filled with air or saline solution.

Figs. 2(a) and (b) are two views of the device in the process of being connected to a stomach. The segments 1 , 2 have been placed embracing the stomach. The first end 7 of the inferior segment 2 is about to be connected to the buckle 5, and the belt 8 is about to be connected to the buckle 6. Once this is done, the device partitions the stomach into a channel 10 extending from the entrance to the stomach (cardia) to its exit (pyloric atrium), and a portion 1 1 which is isolated (at least near the cardia) from the channel 10. The portion of the stomach near the pyloric region is not compressed, to let stomach juices from the isolated portion 1 1 pass. The segments 1 , 2 are preferably curved according to the physiologic shape of the stomach. The segments 1 , 2 are preferably made from soft material, such as a plastics material, in order to reduce the resistance to the gastric peristaltic movements. The superior segment 1 is shorter than the inferior segment 2, and thus does not cover the whole of the length of the stomach, but instead leaves the lower portion 12 of the stomach open to permit discharge of stomach secretions from the isolated portion 1 1 of the stomach. According to which of the holes in the strap is selected, the size of the open portion 12 of the stomach is controlled. The segments 1 , 2 are curved, and device is placed to follow the natural curvature of the stomach. According to which portion of the stomach the device is connected to, the device serves to isolate a selected lateral gastric segment which may include whole or part of the fundus, body and pylorus of the stomach. Fig 3 shows a second embodiment of the invention. The inferior segment 22 shown in Fig. 3(b) is exactly like the inferior segment 2 in the first embodiment, except that it is connected by attachment means (not shown) to two flaps 24 of laminar, flexible material (in other embodiments, the number of flap(s) can be different). The flaps 24 are formed with elongate through-slots 25. The superior segment 21 of the second embodiment shown in Fig. 3(a) includes protrusions 23 for insertion into the through- slots 25.

Fig. 4(a) and (b) are two views of the second embodiment being connected to a stomach. The flaps 24 can be folded over the "greater curvature" side of the stomach, and attached to the protrusions 23. Thus, the flaps 24 can be used for tightening of the fundus or body of the stomach. 1. The flap(s) may be made out of synthetic materials, or natural fabrics such as silk.

One of the drawbacks of the restrictive bariatric surgeries or current devices like the Lap band is the ability of stomach wall to expand, so that after a few years the remaining part of the stomach regains its original size leading to weight gain. The flap(s) 24 of the second embodiment prevent this phenomenon.

Fig 5(a)-(c) shows how other embodiments of the invention may be placed. The embodiment of resembles the first embodiment, but is placed in a different position from that shown in Fig. 4. The embodiment of Fig. 5(b) includes three flaps instead of two, and in this case the device is positioned to isolate a portion of the "lesser curvature" side of the stomach, while the open channel through the stomach is provided on the "greater curvature" side. In Fig. 5(c) the device is the same as in Fig. 5(b), but the strap is connected to the upper segment on a different side of the pyloric atrium. The placement of the device determines which portion of the stomach functions as the food passage channel.

In certain embodiments of the invention the segments 1 , 2, 21 , 22 can be formed of, or include embedded elements (for example, the buckles 5 and/or 6) of, radio- opaque materials, so that the position of the device can be detected with a simple x- ray picture.

After the device has been connected to the stomach for a certain period, it can be adjusted, for example by altering the position of the strap 8 within the buckle 6, or by disconnecting the strap 8 from the buckle 6, or by altering or removing the connection between the flap(s) 24 and the protrusions 23. For example, the flap(s) 24 may be made to remain in place when the segments 21 , 22 are separated after achieving a desired weight loss, so the flap(s) will prevent overeating and weight regain. The alteration can be performed mechanically. Alternatively, in some embodiments the alteration may be performed by applying ultra-sound and/or electromagnetic radiation such as infra-red (IR) radiation to a component of the device, such as the buckle 5 and/or the buckle 6. The alteration can be performed endoscopically. Alternatively, in certain embodiments the alteration may be performed from outside the skin of the patient, for example by transmitting ultrasound or electromagnetic radiation through the skin.

In summary, devices which are embodiments of the invention may be primarily used for reducing the volume of stomach for less food intake. They can alternatively or additionally be used for isolating desired parts of the stomach leading to hormonal changes and reducing appetite. They can be adjusted after a certain weight loss has been achieved, for retaining the desired weight, and following the adjustment they may or may not isolate a portion of the stomach. The device can be applied to the stomach through laparoscopic or open surgery, and altered at later times via endoscopic approaches or indirectly through the skin. The device can further be used for a patient who is not already overweight. In this case, the device would be inserted with the segments not in a clipping configuration against the stromach, but rather loose. The segments would provide anchorage for the flap(s) 24 to perform a restrictive tightening function. With the change of device placement, the band segment and the flap(s) can work together since the food passage channel changes according to the placement. The upper part of the flap may be shaped according to the fundus shape to prevent acid reflux.

References:

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http://www.who.int/mediacentre/factsheets/fs31 1 /en/.

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http://www.thelancet.com/series/obesitv.

3. Weiss, R., Dziura, J., Burgert, T.S., Tamborlane, W.V., Taksali, S.E., Yeckel, C.W., Allen, K., Lopes, M., Savoye, M., Morrison, J., Sherwin, R.S., and Caprio, S., Obesity and the metabolic syndrome in children and adolescents. New England Journal of Medicine, 2004. 350(23): p. 2362-2374. 4. Must, A., Jacques, P.F., Dallal, G.E., Bajema, C.J., and Dietz, W.H., Long- term morbidity and mortality of overweight adolescents - A follow-up of the Harvard Growth Study of 1922 to 1935. New England Journal of Medicine, 1992. 327(19): p. 1350-1355.

5. Berenson, G.S., Srinivasan, S.R., Bao, W., Newman lii, W.P., Tracy, R.E., and Wattigney, W.A., Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. New England Journal of Medicine, 1998. 338(23): p. 1650-1656.

6. Mossberg, H.O., 40-year follow-up of overweight children. Lancet, 1989.

2(8661 ): p. 491 -493. 7. Attner, B., Landin-Olsson, M., Lithman, T., Noreen, D., and Olsson, H.,

Cancer among patients with diabetes, obesity and abnormal blood lipids: a population-based register study in Sweden. Cancer Causes and Control, 2012: p. 1 -9. Barone, M., Lofano, K., De Tullio, N., Licino, R., Albano, F., and Di Leo, A., Dietary, endocrine, and metabolic factors in the development of colorectal cancer. Journal of Gastrointestinal Cancer, 2012. 43(1 ): p. 13-19. Wang, D., Zheng, W., Wang, S.M., Wang, J.B., Wei, W.Q., Liang, H., Qiao, Y.L., and Boffetta, P., Estimation of cancer incidence and mortality attributable to overweight, obesity, and physical inactivity in China. Nutrition and Cancer, 2012. 64(1 ): p. 48-56. Abbatini, F., Rizzello, M., Casella, G., Alessandri, G., Capoccia, D., Leonetti, F., and Basso, N., Long-term effects of laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding on type 2 diabetes. Surgical endoscopy, 2010. 24(5): p. 1005-10. Terranova, L., Busetto, L., Vestri, A., and Zappa, M.A., Bariatric surgery: cost- effectiveness and budget impact. Obesity surgery, 2012. 22(4): p. 646-653. Sean Snow, M.B., SELF-ADJUSTING GASTRIC BAND, in USPTCZM A , ALLERGAN, INC.: United States of America. Fisher, B.L. and Schauer, P., Medical and surgical options in the treatment of severe obesity. American Journal of Surgery, 2002. 184(6 SUPPL. 2): p. 9S- 16S. Wang, F., McDonald, T., Bender, J., Reffitt, B., Miller, A., and Edington, D.W., Association of healthcare costs with per unit body mass index increase.

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Powers, K.A., Rehrig, ST., and Jones, D.B., Financial Impact of Obesity and Bariatric Surgery. Medical Clinics of North America, 2007. 91 (3): p. 321 -338. Levi, J., Vinter, S., and Richardson, L, F as in fat: how obesity policies are failing in America, 2009, Robert Wood Johnson Foundation: Princeton. Christou, N., Sampalis, J., and Liberman, M., Surgery decreases long-term mortality, morbidity and health care use in morbidly obese patients. Ann Surg, 2004. 240: p. 416-23. Pontiroli, A.E. and Morabito, A., Long-term prevention of mortality in morbid obesity through bariatric surgery. A systematic review and meta-analysis of trials performed with gastric banding and gastric bypass. Annals of Surgery, 201 1 . 253(3): p. 484-487.

Claims

1. A device for attachment to the stomach of a patient, the device comprising: an elongate first segment having first and second ends; an elongate second segment having first and second ends; a first fastening mechanism for attaching the first end of the first segment to the first end of the second segment; and a second fastening mechanism for attaching the second end of the first segment to the second end of the second segment, at least one of the first and second fastening mechanisms being adjustable so as to connect the corresponding ends of the first and second segments with a selected proximity; whereby in use the first and second segments are mutually attachable, using the first and second fastening mechanisms, in a location embracing a portion of the stomach of the patient, and the at least one adjustable fastening mechanism is adjustable to fit the stomach of the patient.

2. A device according to claim 1 in which the second fastening mechanism includes a strap formed on the second segment and a buckle on the first segment, the buckle being attachable to the strap at a selectable position along the length of the strap.

3. A device according to claim 2 in which the first segment is shorter than the second segment.

4. A device according to claim 1 , claim 2 or claim 3 in which the segments are curved, whereby the segments may be attached to the stomach in a configuration in which the portion of the stomach which is embraced by the segments defines a curved channel within the stomach between the cardia of the stomach and the pyloric atrium.

5. A device according to any preceding claim in which the segments are each formed with a respective attachment mechanism for attaching at least one flap of flexible material to the corresponding segment, whereby in use a flap of flexible material which is attached to one of the segments by the respective attachment mechanism can be folded over the stomach and attached to the other one of the segments.

6. A device according to claim 5 in combination with at least one flap of flexible, laminar material, the flap being attached to at least a first of the segments by the respective attachment mechanism.

7. A device according to claim 6 in which the flap is attachable to at least one of the segments at a selected position on the flap, thereby in use causing the flap to press against the stomach to a desired degree.

8. A device according to any preceding claim in which at least one of the two segments is formed with holes for suturing the segment to the stomach of the patient.

9. A device according to any preceding claim in which the segments are at least partially composed of radio-opaque materials.

10. A device according to any preceding claim in which at least one of the segments is formed with at least one cushion on the side which faces the other of the segments when the segments are fastened together.

1 1. A device according to any preceding claim in which at the at least one adjustable fastening mechanism is adjustable by application of ultra-sound or electromagnetic radiation.

12. A method for applying a force to the stomach of a patient, the method using a restriction device comprising an elongate first segment having first and second ends, and an elongate second segment having first and second ends, the method comprising: locating the first and second segments embracing a portion of the stomach of the patient, the first ends of segments being mutually connected; connecting the second ends of the segments with a selected proximity between the second ends of the first and second segments to fit the size of the stomach.

13. A method according to claim 12 in which the second ends of the segments are connected by connecting a strap formed on the second segment to a buckle on the first segment, the buckle being attached to the strap at a selectable position on the strap.

14. A method according to claim 12 or claim 13 in which the segments are curved and attached to the stomach in a configuration which the portion of the stomach which is embraced by the segments defines a curved channel within the stomach between the cardia of the stomach and the pyloric atrium.

15. A method according to any of claims 12 to 14 further including folding at least one flap of flexible material attached to one of the segments over the stomach and attaching it to the other one of the segments.

16. A method according to any one of claims 12 to 15 further including suturing at least one of the segments to the stomach of the patient.

17. A method according to any one of claims 12 to 15 in which at least one of the segments is formed with at least one cushion on the side which faces the other of the segments when the segments embrace the portion of the stomach.

18. A method according to any one of claims 12 to 15 in which the patient has been diagnosed with a genetic disorder resulting in a propensity to obesity.

19. A method of adjusting a force applied to the stomach of a patient, a portion of the stomach being embraced by a restriction device comprising an elongate first segment having first and second ends, and an elongate second segment having first and second ends, the first ends of segments being mutually connected, and the second ends of the segments being mutually connected; the method including adjusting at least one of: a fastening mechanism which connects the second ends of the segments, thereby varying a force with which the first and second elongate segments press against the stomach of the patient; or a connection between the segments and a flap of flexible, laminar material which is folded around the stomach and attached to both of the segments.

20. A method according to claim 19 in which the adjustment is effected by application of ultra-sound or electromagnetic radiation from the exterior of the body of the patient.