AU2005202672A1 - Improvement in Adjustable Gastric Band - Google Patents

Description

P/00/011 28/5/91 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Name of Applicants: Actual Inventors Address for service is: Bruno Zilberstein Jaime Anger Bruno Zilberstein Jaime Anger WRAY ASSOCIATES Level 4, The Quadrant 1 William Street Perth, WA 6000 Attorney code: WR Invention Title: Improvement in Adjustable Gastric Band The following statement is a full description of this invention, including the best method of performing it known to me:- -2- IMPROVEMENT IN ADJUSTABLE GASTRIC BAND Background of the Invention More specifically, the present invention relates to technical and functional improvements especially developed, whose aim is to characterize an adjustable gastric band with advantageous characteristics comparison with the currently known adjustable gastric bands.

Summary of the Invention As it is known in the art, there is an assortment of adjustable gastric bands types currently available, wherein all of them are indicated for use in the treatment for weight loss in patients with severe obesity, having a body mass index (BMI) of 35 or higher. Its use is designed exclusively for obese patients who have not responded to prior clinical treatments, such as supervised diet, physical exercises and behavior modifications programs.

Adjustable gastric bands, in a general way, are destined to induce weight loss in patients with severe obesity, by means of limitation of food ingestion.

Many of adjustable gastric bands are projected to be introduced laparoscopically into the patient, being placed around the stomach as an "adjustable belt", producing, therefore, a reduced volume gastric pouch and a stoma, that is, an adjustable passage to the rest of the gastric chamber. A surgical procedure for the introduction of the gastric band is a low-risk surgery, when compared to other bariatric surgeries.

As mentioned previously, there is an assortment of adjustable gastric bands types currently available. All of them present practically similar constructions, including a membrane, which is inflatable with an appropriate fluid, such as a physiological solution, in order that, after placed into the patient, a tube system and a subcutaneous valve allow the said membrane to be adjusted to restrict or enlarge the stoma or passage.

There is no doubt that the known gastric bands are capable to achieve -3the desired objectives; however, in researches carried out by the present Applicant, it was detected an undesired behavior for the membrane, specifically, in relation to its sector referred to herein merely as "internal diameter", that is the portion of the inflatable membrane that "strangulates" the stoma. Independent of other details, this portion of conventional membranes does not have any additional constructive details, limiting only to the wall or wall surface, which forms the inflatable membrane. Consequently, after a certain period of time that it was placed in the patient, the interaction between the band and the stomach tissue can cause its erosion or corrosion. Therefore, a mechanism could be generated to prevent such inconvenience.

Based on the above-mentioned circumstances and with the objective to overcome them, the present improved gastric band was created with constructive modifications, which resulted in a significant improvement to ensure its perfect functioning. In a general way, such improvement consists in foreseeing a kind of "interface" between the "internal diameter' of the membrane and the stomach tissue. This interface consists of a properly fastened thin layer of expanded polyurethane foam, whose function is to establish an efficient form of interaction between the gastric band and the stomach tissue, so that one does not interfere with the function of the other, thus producing the desired postoperative effects, as well as during the period of use of the gastric band.

Brief Description of the Drawings For a better understanding of the present invention, it will be described in more detail with reference to the accompanying drawings, in which: FIGURE 1 represents a perspective view obtained from a superior angle, showing the external details of the set; FIGURE 2 is a cross sectional view across line as shown in Figure 1 above, in which is detailed the assembly arrangement of all layers that compose the gastric band; FIGURE 3 shows another cross sectional view, but across line -4as shown in Figure 1 above, in which is detailed the same assembly arrangement of all layers that compose the gastric band; however, in this more enlarged view, details of the membrane under inflation condition are evidenced, as well as the intemrnal interface located in its internal diameter and the reinforcement strap applied to its external diameter are identified in details; FIGURE 4 illustrates another perspective view, but obtained from an inferior angle, thus completing a panoramic view of the entire set; FIGURE 5 is an enlarged perspective view similar to that illustrated in Figure 1; FIGURE 6 represents a perspective view, showing the gastric band in closed and partially inflated conditions; FIGURE 7 is an enlarged view of the cut line FIGURE 8 shows the same previous view, however, with the gastric band in a closed position; FIGURE 9 is an enlarged view of the cut line and, FIGURE 10 is a schematic perspective view, showing the gastric band positioned in the stomach, also illustrating the valve and how the set is inflated with a traditional hypodermic syringe.

Detailed Description of the Invention In accordance with the above-mentioned illustrations and their details, more specifically Figures 1 to 5, the IMPROVEMENT IN ADJUSTABLE GASTRIC BAND of the present invention is characterized by the fact that it comprises: a) a membrane made of silicone or an appropriate polymeric material, having a unique and continuous wall, which is structurally shaped to form a pouch with a stable and specific geometry, generally semicircular or a semicircular ring shape, wherein the said walls define the internal diameter and the external diameter which are closed by lateral roundings and ends wherein the latter are substantially distant one from the other, in accordance with a spacing thus defining a band having already a semicircular shape; b) a reinforcement strap properly fastened to the external diameter wherein the said strap presents a slightly lesser width than the membrane while its length extends beyond the ends where the said strap forms male coupling tips and female coupling tips wherein the male coupling tips have a spear-shaped tip, including a distal hole (10a) and a base with lateral notches similar to harpoons while male coupling tips generally present a rectangular shape with another hole (10b) and a rectangular groove (12) for insertion and locking of the male coupling tip wherein yet a third tip having a safety catch shape (13) and a hole (14) is coplanarly integrated at the same side of the female coupling tip and constitutes an auxiliary part to fasten the closure of the gastric band; c) a tubular connection which is integrated and strategically positioned to establish an inflation and deflation communication with the interior of membrane and, for such, the said connection is connected to a very flexible and substantially long calibration tube having or not an intermediate connection whose another end includes an usual conical-shaped magnetic valve with a small ceramic tray, and a disc-like magnetic device, which is encapsulated in silicone and polyester tissue; and d) a kind of "interface" between the "internal diameter" of the membrane and the stomach tissue.

The said interface (19) is preferably a properly fastened thin layer of expanded polyurethane foam, extending to cover entirely the internal side of the membrane and in accordance with an appropriate thickness. The function of such layer is to establish an efficient form of interaction between the gastric band and the stomach tissue, so that one does not interfere with the function of the other, thus producing the desired postoperative effects, as well as during the period of use of the gastric band in the patient.

As mentioned previously, the adjustable gastric band of the present invention is formed by two basic parts: body of the gastric band, which is -6constituted by the following basic components: an internal face made of polyurethane foam a membrane with a capacity of approximately 12 mL (1) and an external face with polyester reinforcement allowing the closure of the gastric band around stomach by means of the tips (8 and The body of the gastric band is connected to a silicone tube (16) that can have its length adjusted, if necessary, and a conical valve which is connected to the said tube, using a plastic connector having a disc-like magnetic device for its localization.

Of course, a magnetic localizer takes part of the set to locate the valve as well as the calibration tube, allowing the control of the gastric pouch (1) volume, gastric band position, and gastrc content aspiration.

The set in question is made with appropriate materials, wherein all of them are made of medical grade, as recommended by international standards. The environmental conditions of manufacturing and productive techniques are rigorously controlled by a quality management system, in accordance with the Good Manufacturing Practice (GMP) for medical products and related norms.

Component: Material: Membrane Vinyl dimethyl polydimethylsiloxane basic elastomer Coating (19) Polyurethane foam Tube (16) Polydimethylsiloxane Connector (17) Plastic Tubular Connection Polydimethylsiloxane Reinforcement strap Polyester coated with silicone elastomer (7) Conical-shaped Polydimethylsiloxane, as the basic elastomer, with a small magnetic valve (18) ceramic tray, and a disc-like magnetic device, which is encapsulated in silicone and polyester tissue.

The adjustable gastric band of the present invention is indicated for use in the treatment for weight loss in patients with severe obesity, having a body mass index (BMI) of 35 or higher. Its use is designed exclusively for obese patients who

I

-7have not responded to prior clinical treatments, such as supervised diet, physical exercises and behavior modifications programs.

The adjustable gastric band of the present invention is destined to induce weight loss in patients with severe obesity, by means of limitation of food ingestion. It was projected to be introduced laparoscopically into the patient and placed around the stomach, producing, therefore, a reduced volume gastric pouch and a gastric stoma. A surgical procedure for the introduction of the gastric band is a low-risk surgery, when compared to other bariatric surgeries.

As illustrated in Figures 6, 7, and 8, the closure of the gastric band is carried out by means of its tips (8 and that is, the said tip is introduced through the groove (12) of the opposing end until its locking, which is provided by the notches and, after that, the safety catch (13) is fastened with about four non-absorbable sutures. Of course, the fastening and stabilization of the band are made in conjunction with other surgical procedures at the moment in which the set is placed into the patient.

As illustrated schematically in Figure 10, the valve (18) is used to adjust (to inflate or deflate) the membrane consequently, it is used to restrict or increase the strangulation of the stoma. In this way, the procedure for such adjustment is carried out by means of perforating the valve at the correct point, and, as a consequence, it is possible to remove or place a little of saline solution.

Once the needle is correctly positioned, the increase or reduction of the stoma is carried out by means of injecting or removing a certain volume of saline solution.