US20110004054A1

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Publication number: US20110004054A1
Application number: US12/839,250
Authority: US
Inventors: Peter Gingras
Original assignee: Proxy Biomedical Ltd
Current assignee: Proxy Biomedical Ltd
Priority date: 2003-10-23
Filing date: 2010-07-19
Publication date: 2011-01-06
Also published as: US20140179989A1; EP2246013A1; EP1682051B1; US20050119674A1; US20160324672A1; WO2005039458A2; DE602004028390D1; US7758493B2; ATE475385T1; WO2005039458A3; US10238517B2; EP1682051A2

Abstract

A gastric constriction device (160) comprises a sheet (131) extending over part of the wall of the stomach (24). Five bands (151) extend around the stomach (24) to fix the sheet (131) in position relative to the stomach (24). The lower two bands (151) extend from the first side (152) of the sheet (131) around the stomach (24) only partially towards the second side (153). These lower two bands (151) are not fixed to the second side (153). This arrangement results in an unconstricted portion of the stomach (161). In this manner, the device (160) restricts expansion of the majority of the stomach wall while facilitating expansion of this unconstricted portion (161). The unconstricted portion (161) is therefore free to expand or bulge outwardly upon ingestion. This expansion may trigger the feeling of satiation due to the presence of the vagal nerves in this portion (161) of the stomach (24).

Description

This application claims the benefit of U.S. Provisional Application No. 60/514,212, filed Oct. 23, 2003, the content of which is hereby incorporated by reference.

INTRODUCTION

This invention relates generally to a gastric constriction device, and more specifically to gastric implants that can be used to treat obese patients. In particular the invention relates to mechanical systems for treating morbid obesity, especially to devices that interface mechanically with a patient's digestive system in order to restrict food intake.

BACKGROUND

Obesity is a major public health challenge and financial burden for most industrialised countries. In the United States, the healthcare costs for treating obesity reached more than $238 billion in 1999. The Centers for Disease Control and Prevention estimates that nearly 40 million American adults (about 20% of the adult population) are obese. The prevalence of obesity in the United States increased from 12% in 1991 to 19.8% in 2000. The situation is similar in European countries, where 10-20% of the men and 10-25% of the women are obese. “Clinically severe obesity,” defined, as being 100 or more pounds overweight, is associated with a number of serious and life-threatening health problems including diabetes, heart disease, respiratory problems, hypertension, gastroesophageal reflux disease, stress urinary incontinence, infertility, osteoarthritis, and some cancers. Conservative treatment, such as dieting, exercise and lifestyle changes, typically fails, making surgery the only hope for these patients. The surgical procedures are designed to restrict the size of the stomach so that food intake is limited and/or bypass steps in the normal digestive process (such as by connecting the stomach to a lower segment of the small intestine) so that food is either poorly digested or is rapidly passed. The National

Institute of Health consensus conference in 1991 established widely accepted guidelines and indications for the surgical management of severe obesity (see Gastrointestinal Surgery for Severe Obesity: National Institutes of Health Consensus Development Conference Statement. Am J Clin Nutr 1992; 55: 615S-9S). Surgical methods currently in use are described below.

The relationship of gastric accommodation and satiety in obese individuals has been studied (see Independent Influences of Body Mass and Gastric Volumes on Satiation in Humans. Gastroenterology 2004; 126: 432-440). Increased body mass index has been associated with delayed satiation. Overweight and obese subjects ingest more at maximum satiation compared with normal weight individuals. Increased fasting gastric volume, however, was not associated with body mass index. Chemoreceptors and mechanoreceptors in the stomach wall signal satiation through vagal and splanchnic nerves. When the stomach is relaxed (increased volume at a constant pressure) within the physiological range, it requires higher increases in gastric pressure to activate stretch/tension receptors and thus induce symptoms such as satiation. Data suggests that satiation signals that inhibit ingestion are reduced with increased body mass and that is not due to increased capacity or the stomach's relaxation response to feeding. It has also been determined that the fasting volume of the distal stomach is greater in obese than control subjects (see Is There a Role for Gastric Accommodation and Satiety in Asymptomatic Obese People?. Obesity Research 2001; 9(11): 655-661). Gastric distention with eating contributes to the feeling of fullness or satiation. The mechanism is unclear, but distending the stomach stimulates gastric stretch receptors, which trigger vagal discharges that activate hypothalamic neurons and induce the feeling of satiety. Peptides like leptin, cholecystokinin, and glucagons-like peptide1 have been shown to evoke satiety, thereby reducing food intake.

The Roux-en-Y gastric bypass is used for surgical treatment of morbid obesity. This involves the partitioning the upper stomach with a surgical stapler and creating a 15 cc intact pouch along the lesser curvature of the stomach. After bypassing a 100 cm section of the bowel, the small intestine is attached to the gastric pouch.

Vertical banded gastroplasty is a simpler operation that involves only the creation of a gastric pouch but does not require extensive surgery of the small intestine. In this procedure, biomaterials that are sutured around the lumen to control stoma size and prevent late stretching of the opening. Biomaterials that are currently used for this procedure include Bard Mesh (C.R. Bard, Inc., Cranston, R.I., USA) and PeriStrips (Biovascular, Inc., St. Paul, Minn., USA).

Another technology used in bariatric surgery is laparoscopic banding. Gastric bands are commonly used to facilitate a reduction in food consumption. The bands are placed around the upper part of the stomach to create a small gastric pouch that limits food consumption and creates an earlier feeling of fullness. Some bands are inflated with saline and connected to an access port placed close to the skin that allows the band to be adjusted. Although the devices are intended to remain in place permanently, the procedure is completely reversible and does not require transection or stapling of the stomach and re-routing of the gastrointestinal tract.

Gastric bands have been developed and are commercially available. For example, Lap-Band™ is an implant that is made from silicone (Inamed, Santa Barbara, Calif., USA; see also U.S. Pat. No. 5,074,868; U.S. Pat. No. 5,226,429; U.S. Pat. No. 5,449,368; U.S. Pat. No. 5,910,149). The SAGB™ or Swedish Adjustable Gastric Band (Obtech Medical AG, Zug, Switzerland) is an inflatable device made of silicone reinforced with a textile.

Gastric pouches were developed by Wilkinson (see U.S. Pat. No. 4,403,604; U.S. Pat. No. 5,246,456). Gastric reservoir reduction was accomplished by wrapping the stomach with an inert fabric. The purported advantages of the gastric pouch include maintenance of restricted size, early satiety with eating, and passage of food through the whole intestine. Gastric wrapping has been shown to create excess body mass index loss of 49, 66, 73, and 66 percent at 6, 12, 24 and 60 months respectively (see A Comparison of the Gastric Bypass and the Gastric Wrap for Morbid Obesity. Surg. Gynecol. Obstet. 1993; 176: 262-266).

Electrical pacing has been applied with benefit in many areas of surgery. In the treatment of obesity, gastric myo-electric stimulation has been shown to produce satiety. Gastric pacing has been shown to create excess body mass index loss of 18.8, 24.1, 22.3, and 32.6 percent at 6, 12, 24 and 60 months respectively (see Gastric Pacing as Therapy for Morbid Obesity: Preliminary Results. Obesity Surgery 2002; 12: 12S-16S).

Each of the implants and procedures presently in use has one or more deficiencies. For example, their construction can result in characteristics that increase the risk of leakage, acute gastric dilatation, wound infection/seroma, obstruction, stoma narrowing/stenosis (with persistent vomiting), ulcer, band slippage or erosion, reservoir deflation/leak, anaemia, calcium deficiency/osteoporosis, and vitamin and mineral deficiencies. Additional disadvantages include the presence of a foreign body, possible difficulties with reversibility if needed, and the increased operative time required to complete the more difficult procedures. The procedures described above can also result in extended patient stay in the hospital due to the invasive nature of the procedures. Also, there is a 19% risk of incisional hernia post-operatively when the procedure is performed by open surgical techniques.

Accordingly, there remains a need for implants for treating obese patients and methods of making those implants.

SUMMARY

According to the invention there is provided a gastric constriction device for constricting the volume of a stomach, the device comprising a material for extending over at least part of the wall of a stomach to constrict the volume of the stomach, the device being configured to restrict expansion of a first region of the stomach wall and to facilitate expansion of a second region of the stomach wall.

In one embodiment the constricting properties of the device vary over at least part of the device. The material may be configured to extend partially around a stomach to restrict expansion of the first region of the stomach wall over which the material extends, and to facilitate expansion of the second region of the stomach wall which remains uncovered by the material. The material may be configured to extend substantially circumferentially partially around a stomach.

In one case the material comprises a sheet. The sheet may be substantially planar.

In one embodiment the sheet is configured to extend over only part of the wall of a stomach.

In another embodiment the sheet is configured to extend over substantially the entire wall of a stomach to enclose the stomach.

The constricting properties of the sheet may vary over the area of the sheet.

The device may comprise a fixation arrangement for fixing the sheet in position extending over at least part of the wall of a stomach. In one case a first region of the sheet is configured to be fixed to a second region of the sheet to fix the sheet in position extending over at least part of the wall of a stomach. The fixing arrangement may comprise at least one band for extending from a first region of the sheet partially around a stomach to a second region of the sheet. The band may be releasably fixed to the second region of the sheet. In one case the fixation of the band to the second region of the sheet is adjustable.

In one embodiment the device comprises a first opening to accommodate an oesophagus and a second opening to accommodate a pylorus. The sheet may be substantially shell-shaped.

According to another aspect, the invention provides a gastric constriction device for constricting the volume of a stomach, the device comprising a band for extending at least partially around a stomach in a spiral to constrict the volume of the stomach. The band may be a spiral band. The band may in one case be pre-formed as a spiral.

The band may be substantially elongated.

In one case at least one spiral turn at least partially overlaps an adjacent spiral turn.

The device may comprise a fixation arrangement for fixing the band in position extending at least partially around a stomach. In one case a first region of the band is configured to be fixed to a second region of the band to fix the band in position extending at least partially around a stomach. The first region may be located at an end of the band, and the second region may be located at an opposite end of the band. The first region may be located at an end of the band, and the second region may be located intermediate the ends of the band.

The invention also provides in another aspect a gastric constriction device for constricting the volume of a stomach, the device comprising a bio-absorbable material for absorption of at least some of the material into the stomach wall over time.

The device may be configured for absorption of substantially all of the device into the stomach wall over time. The absorption properties of the material may vary over the material. The absorption properties in one case vary through the depth of the material. In another case, the absorption properties vary across the area of the material.

The material may be at least partially of a laminate construction. In one case the material comprises a first layer and a second layer, the first layer having a higher absorption rate than the second layer. The first layer may be located adjacent to the second layer. The second layer may be configured to be located closer to a stomach wall than the first layer.

In one embodiment the material is at least partially porous to promote tissue in-growth. The first layer may have a higher pore density than the second layer. The first layer may have a smaller pore size than the second layer. In one case at least some of the pores form at least a partial gradient.

The material may comprise an anti-adhesion filler filling at least some of the pores. The material may comprise an anti-adhesion coating along at least part of the surface of the material.

In another case the material comprises a film.

The device may comprise a band for extending at least partially around a stomach to constrict the volume of the stomach. In one case the band is substantially elongated.

In another case the band comprises a loop band for extending at least partially around a stomach in a loop. The device may comprise a plurality of loop bands for extending at least partially around a stomach at a plurality of regions along the stomach. Each loop band may be disconnected from an adjacent loop band. At least one loop band may at least partially overlap an adjacent loop band.

In another embodiment the band is configured to be extended at least partially around a stomach in a spiral. The band may be a spiral band. The band may be pre-formed as a spiral.

At least one spiral turn may at least partially overlap an adjacent spiral turn.

In one case the device comprises a fixation arrangement for fixing the band in position extending at least partially around a stomach. A first region of the band may be configured to be fixed to a second region of the band to fix the band in position extending at least partially around a stomach. In one case the first region is located at an end of the band, and the second region is located at an opposite end of the band. In another case the first region is located at an end of the band, and the second region is located intermediate the ends of the band.

In a further embodiment the device comprises a sheet for extending over at least part of the wall of a stomach to constrict the volume of the stomach. The device may be configured to restrict expansion of a first region of a stomach wall and to facilitate expansion of a second region of the stomach wall.

The constricting properties of the device may vary over at least part of the device.

In another embodiment the material is configured to extend partially around a stomach to restrict expansion of the first region of the stomach wall over which the material extends, and to facilitate expansion of the second region of the stomach wall which remains uncovered by the material. The material may be configured to extend substantially circumferentially partially around a stomach.

In one case the constricting properties of the sheet vary over the area of the sheet.

The sheet may be configured to extend over only part of the wall of a stomach. The sheet may be configured to extend over substantially the entire wall of a stomach to enclose the stomach.

In one case device comprises a fixation arrangement for fixing the sheet in position extending over at least part of the wall of a stomach. A first region of the sheet may be configured to be fixed to a second region S of the sheet to fix the sheet in position extending over at least part of the wall of a stomach. The fixing arrangement may comprise at least one band for extending from a first region of the sheet partially around a stomach to a second region of the sheet. The band may be releasably fixed to the second region of the sheet. In one case the fixation of the band to the second region of the sheet is adjustable.

In another embodiment the device comprises a first opening to accommodate an oesophagus and a second opening to accommodate a pylorus.

In one case the sheet is substantially shell-shaped.

The device may comprise a gastric nerve stimulator.

In a further aspect, the invention provides a gastric constriction device for constricting the volume of a stomach, the device comprising a material for extending over at least part of the wall of a stomach to constrict the volume of the stomach, wherein the device comprises a gastric stimulator. The gastric stimulator may comprise a gastric nerve stimulator.

The invention also provides in a further aspect a gastric constriction device for constricting the volume of a stomach, the device comprising a sheet for extending over at least part of the wall of a stomach to constrict the volume of the stomach, and a band for extending at least partially around the stomach to constrict the volume of the stomach.

The band may be configured to be located between the sheet and the wall of a stomach.

According to another aspect, the invention provides a gastric constriction apparatus comprising:

- a gastric constriction device of the invention; and
- a collapsing device at least partially insertable into the interior of a stomach to at least partially collapse the stomach from a normal volume to a reduced volume.

The collapsing device may comprise a suction device to at least partially collapse a stomach by applying suction to the interior of the stomach.

In one case the collapsing device comprises a sealing member for sealing the entry to a stomach at the oesophagus. The collapsing device may comprise a sealing member for sealing the exit from a stomach at the pylorus. The sealing member may be inflatable.

The invention also provides in a further aspect a method of constricting the volume of a stomach, the method comprising the steps of:

- applying a collapsing force to the stomach to at least partially collapse the stomach from a normal volume to a reduced volume;
- positioning a gastric constriction device relative to the stomach; and
- releasing the collapsing force;
- the gastric constriction device then applying a constricting force to the stomach to constrict the volume of the stomach.

The method may comprise the step of inserting a collapsing device at least partially into the interior of the stomach before applying the collapsing force. The collapsing force may be applied by applying suction to the interior of the stomach. In one case the method comprises the steps of sealing the entry to the stomach at the oesophagus before applying suction. The method may comprise the step of sealing the exit from the stomach at the pylorus before applying suction. In one case the sealing is effected by inflating a sealing member. The collapsing force may be released by releasing suction of the interior of the stomach.

In one embodiment the gastric constriction device is positioned extending at least partially around the stomach. The gastric constriction device may be positioned extending at least partially around the stomach in a loop. The gastric constriction device may be positioned extending at least partially around the stomach in a spiral.

In another embodiment the gastric constriction device is positioned extending over at least part of the wall of the stomach. The gastric constriction device may be positioned extending over only part of the wall of the stomach.

The gastric constriction device may be positioned extending over substantially the entire wall of the stomach to enclose the stomach.

In a further embodiment a first part of the gastric constriction device is positioned extending at least partially around the stomach, and a second part of the gastric constriction device is positioned extending over at least part of the wall of the stomach. The first part may be positioned between the second part and the wall of the stomach.

The method may comprise the step of fixing the gastric constriction device in position relative to the stomach.

The method may comprise the step of adjusting the constricting force applied to the stomach.

In one case the gastric constriction device restricts expansion of a first region of the stomach wall and facilitates expansion of a second region of the stomach wall.

In a further embodiment the method comprises the step of stimulating gastric nerves.

The invention provides in another aspect a method of treating obesity comprising the steps of:

- constricting the volume of a stomach; and
- stimulating gastric nerves

The step of constricting the volume of the stomach may comprise a method of the invention.

The invention provides in one case a bariatric surgical method.

The present invention features a gastric harness implant that includes a biocompatible film. The film has a thickness of less than about 0.500 inches for non-porous films and less than 1.000 inches for microporous films. A given implant can include more than one film (e.g., more than one porous biocompatible film); for example, the invention features an implant that includes a first porous biocompatible film and a second porous biocompatible film, the thickness of the implant being less than about 1.000 inches. The implants, including the materials from which they are made and the cell patterns they can contain are described further below. It is not necessary to remove the gastric harness of the invention. The gastric harness can be produced with biodegradable materials that are resorbed by the body.

The implant is produced by processing a biocompatible polymer into a film and forming pores in the film. In alternative embodiments, the film can be stretched or otherwise manipulated (e.g., trimmed, shaped, washed or otherwise treated) before or after forming pores in the film. Where the implant contains more than one film, the methods of the invention can be carried out by extruding a first biocompatible polymer to form a first film, extruding a second biocompatible polymer to form a second film, attaching the first film to the second film to produce a implant, and forming pores in the implant. Alternatively, the pores can be formed before the two films are adhered to one another. In that instance, the method of making the implant can be carried out by: extruding a first biocompatible polymer to form a first film; forming pores in the first film; extruding a second biocompatible polymer to form a second film; forming pores in the second film; and attaching the first film to the second film to produce a gastric harness implant.

Where the implant contains more than one film, the methods of the invention can be carried out by extruding a first biocompatible polymer to form a first film, extruding a second biocompatible polymer to form a second film, attaching the first film to the second film to produce a implant, and forming pores in the implant. The pores can be formed before the two films are adhered to one another. The pores can have different dimensions, the films can have different thicknesses, and the films can have different compositions all of which vary the healing and biodegradation characteristics. In that instance, the method of making the implant can be carried out by: extruding a first biocompatible polymer to form a first film; forming pores in the first film; extruding a second biocompatible polymer to form a second film; forming pores in the second film; and attaching the first film to the second film to produce a gastric harness implant. The gastric harness implant can be designed with controlled tissue ingrowth and remodelling to permanently alter the tissue and mechanical properties of the stomach.

Where a film is obtained, rather than made, the methods of making the implant can simply require providing a given film that is then attached (e.g., reversibly or irreversibly bound by mechanical or chemical forces), if desired, to another film and/or processed to include one or more pores of a given size and arrangement. The single provided film (or adherent multiple films) can then be subjected to a process (e.g., laser ablation, die punching, or the like) that forms pores within the film(s). Accordingly, any of the methods of the invention can be carried out by providing a given biocompatible film, rather than by producing it by an extrusion or extrusion-like process.

The films can also be produced using casting, injection moulding or dip coating techniques.

Preferably, the gastric harness implants of the invention will include (or consist of) a film that has a low profile (or reduced wall thickness) and that is biocompatible. A biocompatible film is one that can, for example, reside next to biological tissue without harming the tissue to any appreciable extent. As noted above, the film(s) used in the implants of the invention can have pores (e.g., open passages from one surface of the film to another) that permit tissue ingrowth and/or cellular infiltration.

The implants of the present invention offer a combination of high porosity, high strength, and low material content, and they may have one or more of the following advantages. They can include pores or porous structures that stimulate fibrosis and reduce inflammation; they can reduce the risk of erosion and formation of adhesions with adjacent tissue (this is especially true with implants having a smooth surface and atraumatic (e.g., smooth, tapered, or rounded edges); they can simulate the physical properties of the tissue being repaired or replaced, which is expected to promote more complete healing and minimise patient discomfort; their surface areas can be reduced relative to prior art devices (having a reduced amount of material may decrease the likelihood of an immune or inflammatory response). Moreover, implants with a reduced profile can be produced and implanted in a minimally invasive fashion; as they are pliable, they can be placed or implanted through smaller surgical incisions. The methods of the invention may also produce implants with improved optical properties (e.g., implants through which the surgeon can visualise underlying tissue). Practically, the micromachining techniques that can be used to produce the implants of the present invention are efficient and reproducible. The implants described herein should provide enhanced biocompatibility in a low profile configuration while maintaining the requisite strength for the intended purpose.

The biocompatible films described above can be used to construct gastric harness implants that are designed to engage the outer surface of the stomach to reduce tension when food is consumed. The implant can be configured to encircle the stomach to act as a gastric harness. Ideally, the implant is inserted laparoscopically using minimally invasive techniques and instrumentation. The invention also features methods for producing gastric harness implants. These methods can include the step of applying a shape memory material, for example an alloy, such as nitinol, to the gastric harness implant to facilitate sizing, attachment, and implantation. The gastric harness implant can also be fabricated from a shape memory polymer (mnemoScience GmbH, Aachen, Germany).

The overall shape of the implants can vary depending on the size of the individual and the stomach to be restricted. The overall length, width, and shape of the implants of the present invention can be designed to impart a certain volume to the restricted stomach. Once the volume limit of the stomach is reached, the shaped gastric harness implant prevents an increase in tension on the stomach wall with the associated volume increase. This volume limit is typically approximately 15 cc or higher.

Because the volume of the stomach is determined at the time of surgery, the need to adjust the gastric harness implant is reduced. In addition, the gastric harness implant is in contact with a large area of the stomach, which reduces the potential for implant slippage. In one embodiment of the invention, the gastric harness implant consists of separate panels that are positioned individually to restrict the stomach. In another embodiment, the gastric harness implant consists of a strip of biocompatible material that is wrapped continuously around the stomach. In another embodiment, the gastric harness implant can be used in conjunction with a gastric banding device to restrict the size of the gastric pouch that is formed with the band. In addition, the gastric harness implant will reduce the size of the access incision with a laparoscopic or minimally invasive approach to help reduce peripoperative morbidity and to speed recovery. The improvements will come without creating a procedure that is too complex.

A further embodiment of the invention is to produce the gastric harness implant with variable elasticity such that certain areas of the implant expand more under pressure or load. In this instance, a feeling of satiety may be created by placing the more elastic zones adjacent to nerves that are responsible for signalling with increases in gastric pressure to activate stretch/tension receptors and thus induce symptoms such as satiation. The gastric implant may also be designed to wrap the stomach in select areas where the nerves responsible for signalling are not present. Therefore, the stomach would be constrained in certain areas that are not responsible for signalling. An early feeling of satiety would be realised due to preferential expansion and creation of stomach wall tension in the areas where the gastric harness is not present. Vagal nerves would be activated more readily creating a feeling of satiety.

A further embodiment of the invention is to produce the gastric implant from a bioresorbable or biodegradable material. The bioresorbable or biodegradable implant will stay in position and restrict the stomach volume over a predetermined time. The mechanical strength and shape of the gastric implant will restrict the stomach for the predetermined time. The gastric harness implant will create weight loss for the patient over the predetermined time period. After the predetermined time the gastric harness implant will be absorbed, and the implant will no longer be a risk for chronic wound complications. In this case a second procedure to remove the implant will not be required.

This invention provides an implant device comprising a biocompatible material that is configured to provide a gastric harness to constrain the volume of the stomach. The harness may be configured to conform generally to a patient's stomach. The harness may extend from the oesophagus to the small intestine.

In one embodiment the harness defines an internal volume between an upper end and a lower end, which conforms generally to the external geometry of the stomach to constrain circumferential expansion of the stomach beyond a maximum adjusted volume during eating/digestion.

The gastric harness can be used in conjunction with laparoscopic bands. In one embodiment the harness defines an internal volume between an upper end of the stomach and a gastric band, which conforms generally to the external geometry of the stomach pouch to constrain circumferential expansion of the stomach pouch beyond a maximum adjusted volume during eating/digestion.

In one embodiment the harness defines a means for accepting a gastric pacing device. The harness defines an internal volume between an upper end and a lower end, which conforms generally to the external geometry of the stomach to constrain circumferential expansion of the stomach beyond a maximum adjusted volume during eating/digestion. In addition, the gastric pacing device creates a feeling of satiety in the patient.

The biocompatible material may comprise a biocompatible film, which can be of laminate construction. The film may be non-porous or may be microporous.

In one embodiment the biocompatible material comprises polypropylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, or silicone.

In another embodiment the biocompatible material is biodegradable. The biocompatible material may be at least partially absorbable by the body. The biocompatible material may comprise an absorbable polymer or copolymer such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone, or polyhydroxyalkanoate.

The porous biocompatible film may comprise a biological material such as collagen.

The porous biocompatible film used to construct the implant may comprise an adhesion prevention material such as hyaluronic acid. The adhesion prevention material can either coat the porous film or fill the pores. The adhesion prevention material may degrade as surrounding tissue heals and minimises the risk of future adhesions.

In one embodiment the biocompatible material has a plurality of cells. The biocompatible material may have a plurality of cells and one or more of the cells in the plurality of cells has a diameter, measured along the longest axis of the cell, of about 10 to about 10,000 microns. The biocompatible material may have a plurality of cells and one or more of the cells of the plurality are essentially square, rectangular, sinusoidal, or diamond-shaped. One or more of the cells of the plurality may be substantially the same shape as the cell shown in Mesh2E.

In one embodiment each of the cells in the plurality of cells has a plurality of undulating elements in the form of a repeating pattern. The undulating elements may be in phase and the force-displacement characteristics may restrict stomach expansion. Typically the plurality of cells has a diameter greater than 50 microns and the implant has force displacement characteristics that restrict tissue movement in a controlled manner.

In one embodiment the thickness of the porous biocompatible film is less than about 0.014 inches, less than about 0.013 inches, less than about 0.012 inches, less than about 0.011 inches, less than about 0.010 inches, less than about 0.009 inches, less than about 0.008 inches, less than about 0.007 inches, less than about 0.006 inches, less than about 0.005 inches, less than about 0.004 inches, less than about 0.003 inches, less than about 0.002 inches or about 0.001 inch.

In one embodiment the restricted stomach volume is 10 cc or greater.

The harness may comprise attachment regions, which may be adapted to receive sutures, staples or the like.

The harness may comprise a fastener such as sutures for fastening the harness in position in use.

In one embodiment the biocompatible material is in the form of a strip for winding around a patient's stomach. The strip may have attachment points. The strip may form a circular band at the top of the stomach near the oesophagus and at the bottom near the pylorus. The circular bands prevent slippage and provide a smooth interface with the stomach to prevent erosion. The central portion of the strip is wrapped around the stomach in a circular fashion and is spaced such that the stomach will not distend through the spacings when food is ingested. The strip can be preformed and set to have three-dimensional qualities to facilitate sizing and placement around the stomach.

In one embodiment the biocompatible material is in the form of individual strips for placement around a patient's stomach. The strips may have attachment points. The strips may form circular bands from the top of the stomach near the oesophagus to the bottom near the pylorus. The individual strips can be placed and spaced evenly in a manner that accommodates different individual's anatomy. The circular bands provide a smooth interface with the stomach to prevent erosion. The individual strips are spaced such that the stomach will not distend through the spacings when food is ingested. The strips can be preformed and set to have three-dimensional qualities to facilitate sizing and placement around the stomach.

In another embodiment the implant further comprises a gastric band. The gastric band is of the same material as that of the harness or may be of a different material than that of the harness.

In one embodiment the harness has a support, which may be of a shape memory material such as a shape memory alloy material, for example Nitinol.

In another aspect the invention provides a gastric harness implant device for treating obesity, the device comprising: a biocompatible material configured to engage the (outer) surface of the stomach to relieve tension on the stomach.

In a further aspect the invention provides a biocompatible material forming a gastric harness implant defining an (internal) volume between an upper end and a lower end; said gastric harness implant adapted to be secured to the stomach to snugly conform to the external geometry of the stomach and to constrain circumferential expansion of the stomach beyond a maximum adjusted volume during eating/digestion; an adjustment mechanism; a fastening mechanism.

In another aspect the invention provides a gastric harness implant comprising an implantable material positioned around the stomach to restrict the volume of the stomach.

The biocompatible material may be configured to generally conform to a patient's stomach, the biocompatible material being configured to extend circumferentially around the stomach. The implantable material may be positioned from the oesophagus to the small intestine.

In another aspect the invention provides a method for treating obesity, the method comprising: inserting a balloon into the stomach with a predetermined volume; providing a gastric reinforcement device shaped and configured to engage at least a portion of the patient's stomach and to reduce the volume potential of the stomach; and placing the gastric reinforcement device on the patient's stomach such that said device extends circumferentially around the patient's stomach. The method may include the step of providing a securement means for the device to prevent slippage.

In another aspect the invention provides a method for treating obesity, the method comprising: inserting a gastric tube with or without perforations and with or without a lumen into the stomach with a predetermined volume; applying a vacuum source to the lumen of the gastric tube; providing a gastric reinforcement device shaped and configured to engage at least a portion of the patient's stomach and to reduce the volume potential of the stomach; and placing the gastric reinforcement device on the patient's stomach such that said device extends circumferentially around the patient's stomach. The method may include the step of providing a securement means for the device to prevent slippage.

In one aspect the invention provides a method for treating obesity, the method comprising; surgically accessing the stomach; inserting a balloon into the stomach with a predetermined volume; reducing the size of said stomach; placing a gastric support device on said stomach; securing said gastric support device to said stomach having a reduced size/volume, wherein said gastric support device comprises a biocompatible material configured to constrain expansion of the stomach; surgically closing access to said stomach while leaving said gastric support device in place on said stomach.

In a further aspect the invention provides a method for producing a gastric harness implant, the method comprising: extruding a biocompatible polymer into a film; and forming a plurality of cells in the film; wherein the method may further comprise the optional step of cleaning the implant.

The invention also provides a method for producing a gastric harness implant, the method comprising: extruding a biocompatible polymer into a film, stretching the film; forming pores in the film to produce a soft tissue implant; wherein the method may further comprise the optional step of cleaning the implant.

The invention further provides a method for producing a gastric harness implant, the method comprising: extruding a first biocompatible polymer to form a first film; extruding a second biocompatible polymer to form a second film; attaching the first film to the second film to produce an implant; forming pores in the implant; shaping the implant into a configuration that imparts a known volume to the stomach; attaching a shape memory element to the implant; wherein the method may further comprise the optional step of cleaning the implant.

In another aspect the invention provides a method for producing a soft tissue implant, the method comprising: extruding a first biocompatible polymer to form a first film; forming pores or cell patterns in the first film; extruding a second biocompatible polymer to form a second film; forming pores in the second film; attaching the first film to the second film to produce a soft tissue implant; wherein the method may further comprise the optional step of cleaning the implant.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art gastric banding device;

FIG. 2 is a perspective view of a gastric constriction device according to the invention;

FIG. 3 is a perspective view of the device ofFIG. 2 extending around a stomach;

FIG. 4 is a perspective view of a collapsing device according to the invention;

FIG. 5 is a perspective view of an unrestricted stomach;

FIGS. 6 to 8 are perspective views illustrating constricting the volume of the stomach ofFIG. 5 using the gastric constriction device ofFIG. 2 and the collapsing device ofFIG. 4;

FIG. 9 is a view along line IX-IX inFIG. 7;

FIG. 10 is a perspective view of another gastric constriction device according to the invention in a strip configuration restricting the stomach;

FIG. 11 is a perspective view of a further gastric constriction device according to the invention extending around a stomach;

FIG. 12 is a perspective view of a loop band of the device ofFIG. 11 in a release configuration;

FIG. 13 is a perspective view of the loop band ofFIG. 12 in a fixed configuration;

FIGS. 14 and 15 are perspective views similar toFIGS. 12 and 13 of a loop band of another gastric constriction device according to the invention;

FIG. 16 is a plan view of an end of the loop band ofFIG. 14;

FIG. 17 is a perspective view of a tool suitable for use with the loop band ofFIGS. 14 to 16;

FIG. 18 is a perspective view similar toFIG. 12 of a loop band of another gastric constriction device according to the invention;

FIG. 19 is a plan view of an end of the loop band ofFIG. 18;

FIG. 20 is a perspective view of another gastric constriction device according to the invention extending over the wall of a stomach to restrict the stomach;

FIG. 21 is a view along line XXI-XXI inFIG. 20;

FIGS. 22 and 23 are perspective views illustrating collapsing the volume of a stomach using the gastric constriction device ofFIG. 20 and another collapsing device according to the invention;

FIG. 24 is a view along line XXIV-XXIV inFIG. 23;

FIGS. 25(a) and25(b) are perspective views of a further gastric constriction device according to the invention;

FIG. 26 is a perspective view of the device ofFIG. 25 extending over the wall of a stomach;

FIG. 27 is a plan view of another gastric constriction device according to the invention;

FIG. 28 is a perspective view of the device ofFIG. 27 extending over the wall of a stomach;

FIG. 29 is a perspective view of another gastric constriction device according to the invention;

FIGS. 30 and 31 are perspective views illustrating constricting the volume of a stomach using a loop band according to the invention and the device ofFIG. 29;

FIG. 32 is a view along line XXXII-XXXII inFIG. 31;

FIGS. 33 and 34 are perspective views of the gastric harness implant ofFIG. 29 used with a gastric banding device;

FIG. 35 is a view along line XXXV-XXXV inFIG. 34;

FIG. 36 is a plan view of another gastric constriction device according to the invention in a strip configuration with attachment points;

FIG. 37 is a perspective view of the device ofFIG. 36;

FIG. 38 is a perspective view of a further gastric constriction device according to the invention extending around a stomach;

FIG. 39 is a perspective view of a material that can be machined to produce a gastric constriction device according to the invention;

FIG. 40 is a perspective view of a laminated film structure showing layers of biocompatible films bonded together;

FIGS. 41 and 42 relate to an implant designated Mesh2E, whereFIG. 41 is a diagram of an exemplary pore, andFIG. 42 is a display of various measured parameters within Mesh2E and the equations used to calculate the surface area;

FIG. 43 is a diagram of an exemplary pore structure for Mesh2E;

FIG. 44 is a micrograph of Mesh2E;

FIG. 45 is a side view of a material of another gastric constriction device according to the invention;

FIG. 46 is a side view of a first layer of the material ofFIG. 45;

FIG. 47 is a plan view of the first layer ofFIG. 46;

FIG. 48 is an enlarged, plan view of a part of the first layer ofFIG. 47;

FIGS. 49 to 51 are views similar toFIGS. 46 to 48 of a second layer of the material ofFIG. 45;

FIGS. 52 and 53 are plan views of materials of further gastric constriction devices according to the invention; and

FIG. 54 is a flow chart illustrating some of the steps in a method of producing a gastric constriction device according to the invention.

SELECTED REFERENCE NUMERALS IN DRAWINGS

10 gastric banding device

12 biocompatible film

14 laminated film structure

16 cell pattern

18 radius

20 cell pattern structure

22 machined film

24 unrestricted stomach

26 gastric harness implant

28 attachment points

32 strip configuration

34 gastric band

36 gastric pouch

DETAILED DESCRIPTION

FIG. 1 illustrates a prior artgastric banding device10 that can be used to perform gastric banding procedures.

Referring toFIG. 2 there is illustrated agastric constriction device100 according to the invention. Thedevice100 comprises a substantiallyelongate spiral band101 which may be extended around astomach24 in a spiral to constrict the volume of thestomach24, as illustrated inFIG. 3.

A fixation arrangement is provided at each end of theband101. In this case, each fixation arrangement is provided in the form of an arrow-head shapedmember103 at the end of theband101, which may be received in one of a plurality of correspondingslots104 in theband101. As illustrated inFIG. 2, theslots104 are located spaced a distance from the end of theband101. The plurality ofslots104 enable a degree of adjustment of the constriction force to be achieved.

It has been found that the spiral wrap of theband101 may be positioned around the blood vessels of the stomach wall in such an arrangement such as to preserve blood flow.

FIG. 2 illustrates thegastric harness strip101 in spiral wrap form. The strip material can be preformed with three-dimensional properties and may be made from a shape memory material. Thestrip101 can also form bands at the top and bottom for securement near the oesophagus and pylorus.Slits104 in thestrip101 can be used to create bands. The circular bands prevent slippage and provide a smooth interface with thestomach24 to minimise the risk of erosion. The central portion is wrapped around thestomach24 in circular fashion and is spaced such that thestomach24 will not distend through the spacings when food is ingested.

Multiple slits

104 in thestrip101 can be provided to adjust the diameter of the band. This permits a fit that prevents slippage while minimising the risk of erosion if the band is placed too tightly around thestomach24. Atapered point103 on thestrip101 facilitates placement through theslit104.Holes300 in the taperedpoint103 permit the use of instruments to facilitate grasping. Theholes300 also permit securement if a suture or a staple is used. The width of the taperedsecurement point103 is wider than theslit104 to create a mechanical lock.

FIG. 4 illustrates asuction device105 according to the invention suitable for use with thegastric constriction device100 to constrict the volume of thestomach24. Together thesuction device105 and thegastric constriction device100 provide a gastric constriction apparatus.

Thesuction device105 includes a plurality ofopenings106 along the length of thesuction device105 for applying suction to the interior of thestomach24.

With reference toFIGS. 5 to 9, in use thesuction device105 is inserted through theoesophagus107, into the interior of theunrestricted stomach24, until thedistal tip108 of thesuction device105 reaches the pylorus109 (FIG. 6). Thesuction device105 engages the tissue wall at theoesophagus107 and at the pylorus109 to effect a seal.

Suction is then applied to the interior of thestomach24 using thesuction device105. This suction exerts a collapsing force on thestomach24, and causes thestomach24 to partially collapse from the normal volume (FIGS. 5 and 6) to a reduced volume (FIGS. 7 and 8). A typical normal volume for the stomach is 750 cc, and a typical reduced volume is 100 cc.

Thespiral band101 is positioned relative to the partially collapsedstomach24 extending around thestomach24 in a spiral, and thespiral band101 is fixed in position by inserting each arrow-head shapedmember103 into a corresponding slot104 (FIG. 7).

The suction may then be released to release the collapsing force exerted on thestomach24, and thesuction device105 is removed from thestomach24 andoesophagus107. Thegastric constriction device100 remains fixed in position around thestomach24 constricting the volume of the stomach24 (FIG. 8).

FIGS. 6 to 8 illustrate the gastric harness with calibrated vacuum assisted deployment. A fixed volume/diametergastric tube105 is placed inside thestomach24 with or without perforations (illustrated with perforations). A means for applying a vacuum is also present.Perforations106 are positioned inside thestomach24 and a seal is created at theoesophagus107 andpylorus109. Thegastric tube105 may have fixed compliance and volume to replicate the pressure and volume relationship experienced when food is ingested. Thegastric harness implant100 is placed around thestomach24 with thegastric tube105 in position. Folds in the stomach wall are created as the surface area in the outer wall is reduced. Thegastric harness implant100 remains in position and thegastric tube105 is removed (FIG. 8).

InFIG. 10 there is illustrated anothergastric constriction device110 according to the invention, which is similar to thedevice100 ofFIG. 2, and similar elements inFIG. 10 are assigned the same reference numerals.

In this case thespiral band101 extends around thestomach24 in a spiral with each turn of the spiral partially overlapping an adjacent spiral turn.

FIG. 10 is a perspective view of agastric harness implant110 in astrip configuration101 which in this Case is wrapped around thestomach24. Theimplant110 may extend from theoesophagus107 beyond the pylorus109 to the small intestine. Thestrip configuration101 may be passed around thestomach24 and secured at the edges along attachment points28 with sutures or staples.

FIGS. 11 to 13 illustrate anothergastric constriction device120 according to the invention, which is similar to thedevice100 ofFIG. 2, and similar elements inFIGS. 11 to 13 are assigned the same reference numerals.

In this case thedevice120 comprises a plurality ofloop bands121. Eachband121 is suitable for being extended around thestomach24 in a loop. By extending the plurality ofloop bands121 around thestomach24 at a plurality of regions spaced along thestomach24, thedevice120 constricts the volume of thestomach24, as illustrated inFIG. 11.

FIGS. 11 to 13 illustrate the gastric harness implant formed from individual bands. Thegastric harness120 can be formed fromindividual bands121 or strips of material. Eachindividual band121 has an attachment point for variable adjustment. Thestrips121 can be placed from theoesophagus107 to thepylorus109. Thegastric bands121 provide a smooth interface with thestomach24. Thebands121 are spaced such that thestomach24 will not distend through the openings when food is ingested. The individualgastric bands121 have preformed curves and variable adjustment means with spacedslits104 to accommodate the taper point103 (FIGS. 12 and 13).

Alternative fixing arrangements for fixing theloop bands121 in position extending around thestomach24 are illustrated inFIGS. 14 to 19.

The preformedindividual bands121 have two different attachment means. Each has ahole300 for securement with a suture, staple, or other attachment means. Atool122 is illustrated for moving the taperedpoint103 through the slit104 (FIGS. 14 to 16), and for moving theratchet headpiece123 through thecorresponding slot104.

Referring toFIGS. 20 and 21 there is illustrated anothergastric constriction device130 according to the invention, which is similar to thedevice100 ofFIG. 2, and similar elements inFIGS. 20 and 21 are assigned the same reference numerals.

In this case thedevice130 comprises acontinuous sheet131 for extending over the entire wall of thestomach24. In this manner, thesheet131 may enclose thestomach24 and thereby constrict the volume of thestomach24.

FIG. 20 is a perspective view of agastric harness implant26 restricting the volume of thestomach24. In another case thegastric harness implant26 may extend from theoesophagus107 beyond the pylorus109 to the small intestine. Theimplant26 may be of a film material such as those described below, for example the mesh2E material.

InFIGS. 22 and 23, there is illustrated anothersuction device140 according to the invention, which is similar to thesuction device105 ofFIG. 4, and similar elements inFIGS. 22 and 23 are assigned the same reference numerals.

In this case thesuction device105 comprises adistal balloon member142 and aproximal balloon member141. In use, the

balloon members

141,142 are inflatable to engage the tissue wall to effect a seal prior to suction being applied.

FIGS. 25 and 26 illustrate a furthergastric constriction device150 according to the invention, which is similar to thedevice130 ofFIGS. 20 and 21, and similar elements inFIGS. 25 and 26 are assigned the same reference numerals.

In this case, thesheet131 is substantially shell-shaped, and extends over only part of the wall of thestomach24. Fivebands151 extend from afirst side152 of thesheet131 partially around thestomach24 to asecond side153 of thesheet131. In this manner, thebands151 fix thesheet131 in position extending over part of the wall of thestomach24.

Thebands151 are releasably fixed to thesecond side153 of thesheet131 by means of the arrow-head member103 andcorresponding slots104 arrangement.

FIGS. 25 and 26 illustrate the preformed gastric harness. The preformedgastric harness implant150 is designed to engage the outer surface of thestomach24 to reduce tension when food is ingested. The shape of theimplant150 can be adjusted such that the lesser and lower curvatures of thestomach24 can be preferentially reduced to accommodate less volume when food is ingested. The three dimensional properties can facilitate sizing and placement. Theimplant150 is curved to adjust to the shape of thestomach24.Bands151 are incorporated to wrap around the outer surface of thestomach24. The spacing betweenbands151 prevents stomach expansion when food is ingested.Slits104 are placed in theimplant150 to accept thebands151 with atapered point103, which permits instrument manipulation and placement. Thetapered point103 also has ahole300 for accepting a suture, or staple for securing theimplant150. Theimplant150 is positioned and thebands151 are adjusted using theslits104 in theimplant150 to adjust the tension.

InFIGS. 27 and 28, there is illustrated anothergastric constriction device160 according to the invention, which is similar to thedevice150 ofFIGS. 25 and 26, and similar elements inFIGS. 27 and 28 are assigned the same reference numerals.

In this case the lower twobands151 extend from thefirst side152 of thesheet131 around thestomach24 only partially towards thesecond side153. These lower twobands151 are not fixed to thesecond side153. This arrangement results in an unconstricted portion of thestomach161. In this manner, thedevice160 restricts expansion of the majority of the stomach wall while facilitating expansion of thisunconstricted portion161.

Theunconstricted portion161 is therefore free to expand or bulge outwardly upon ingestion. This expansion may trigger the feeling of satiation due to the presence of the vagal nerves in thisportion161 of thestomach24.

FIGS. 27 and 28 illustrate the gastric harness implant to modulate stomach expansion. A preformedimplant160 is designed such that areas of thestomach24 can preferentially expand more under pressure when food is ingested. Placing the more elastic zones adjacent to the nerves that are responsible for signalling when stretch/tension receptors are activated may create the feeling of satiety. Preferential expansion is created in the area where more elastic zones are present or where the implant material is not present to constrain thestomach24. Vagal nerves are more readily activated. An area for accepting a gastric pacing device may also be present. This may improve the efficacy of the concept.

Referring toFIG. 29 there is illustrated anothergastric constriction device170 according to the invention, which is similar to thedevice130 ofFIGS. 20 and 21, and similar elements inFIG. 29 are assigned the same reference numerals.

In this case, thesheet131 extends around the full circumference of thestomach24, but extends distally over only part of the wall of thestomach24 from theoesophagus107 approximately ⅓ to ⅔ of the distance towards thepylorus109.

In use, alaparoscopic band171 is extended around the stomach24 (FIG. 30), and thedevice170 is then extended around and along thestomach24 with theband171 located between thesheet131 and the stomach wall (FIGS. 31 and 32).

To fix thesheet131 in position extending over the wall of thestomach24, afirst region172 of thesheet131 is fixed directly to asecond region173 of thesheet131.

FIGS. 29 to 32 illustrate the gastric harness implant used in conjunction with laparoscopic banding. Thegastric harness170 is used to prevent expansion of the fixed volume pouch created during laparoscopic banding. Thegastric harness170 conforms generally to the outside surface of thestomach24 when the pouch is created.Holes175 are present for accepting sutures and/or staples. Thegastric harness170 can be flared to minimise the risk of erosion and irritation. The cross section (FIG. 32) demonstrates the interface between the stomach pouch andgastric harness170.

As illustrated inFIGS. 33 to 35, thelaparoscopic band171 may alternatively be extended around thesheet131, after thesheet131 has been extended around and along thestomach24. In this case, thesheet131 is located between theband171 and the stomach wall.

The arrangement ofFIGS. 29 to 32 is particularly advantageous. The technique used to insert theband171 inFIGS. 29 to 32 is a simple, easy to practise technique. In particular, this technique would be compatible with many alternative banding devices.

FIGS. 33 and 34 are perspective views of agastric harness implant170 forming agastric pouch36. Agastric band34 is provided. Theband34 may be a part of theimplant170 or separate from it. Thegastric harness implant170 in this configuration prevents thegastric pouch36 from dilatation.

InFIGS. 36 and 37 there is illustrated anothergastric constriction device180 according to the invention, which is similar to thedevice120 ofFIG. 11, and similar elements inFIGS. 36 and 37 are assigned the same reference numerals.

FIGS. 36 and 37 are perspective views of an implant material in astrip configuration32 with attachment points28.

FIGS. 36 and 37 illustrate the gastric harness strip with attachments. Astrip121 is disclosed for winding around thestomach24. Thestrip121 is intended to be placed laparoscopically using minimally invasive techniques and instrumentation. Thestrip121 has attachment points28 for accepting sutures, staples, or other securement means. The attachment points28 are rounded and are in the form of eyelets to minimise the risk of tissue reaction and erosion. Cell openings are present for tissue in-growth and fixation to the stomach wall.

In the embodiment ofFIG. 38, a plurality ofbands190 are provided extending around thestomach24 circumferentially and longitudinally along thestomach24 for constricting the volume of thestomach24.

FIG. 39 is a perspective view of a material that can be used to produce a gastric constriction device of the present invention. The material may be machined to produce a nonwoven gastric harness implant. The material illustrated inFIG. 39 is a perspective view of a nonwovenbiocompatible film12. Thefilm12 has known or discernible dimensions (width, length, and thickness), which can be modified or left intact in the manufacture of a gastric harness implant. In this case thefilm12 is a single-layer, smooth-edged film.

As shown inFIG. 40, thefilm12 can be laminated to produce afilm14, which can also be used, with or without further modification, to manufacture the implants of the present invention. Multiple layers ofbiocompatible film12 can be added together to improve the mechanical properties (e.g., tear resistance and burst strength) of the implant. For example, afirst film12 can be bonded to asecond film12. The bonding may be a thermal bond using hydraulic presses such as those manufactured by OEM Press Systems (Orange, Calif., USA).

Biocompatible materials useful infilm12 orfilm14 can include non-absorbable polymers such as polypropylene, polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyaryletherketone, nylon, fluorinated ethylene propylene, polybutester, and silicone, or copolymers thereof (e.g., a copolymer of polypropylene and polyethylene); absorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone, and polyhydroxyalkanoate, or copolymers thereof (e.g., a copolymer of PGA and PLA); or tissue based materials (e.g., collagen or other biological material or tissue obtained from the patient who is to receive the implant or obtained from another person.) The polymers can be of the D-isoform, the L-isoform, or a mixture of both. An example of abiocompatible film12 suitable for producing thelaminated film structure14 is expanded polytetrafluoroethylene.

In the case of a laminate14, the various layers may be of the same or different materials. For example, in the case of an absorbable material, the material of the layers may be selected to have varying rates of absorption.

FIGS. 41 and 42 relate to an implant designated Mesh2E. Referring toFIG. 41, asinusoidal cell pattern16 has been designed withradius18. The properties of thecell pattern16 are described in detail inFIG. 42.

FIG. 43 relates to acell pattern structure20 forcell pattern16. Thecell pattern structure20 has been constructed using computer-aided design.

FIG. 44 is a micrograph of a machinedfilm22. The machinedfilm22 is in this case constructed using a die-punching tool machined tocell pattern structure20. The machinedfilm22 has porosity, which can impart and support tissue ingrowth on high strength thin film substrates. Aradius18 may be applied to eachcell pattern16 corner to improve tear strength. Manufacturing methods to impartcell pattern16 include, but are not limited to, laser machining, die punching, water jet cutting, and chemical etching. The lasers preferred for creating smooth edges on plastic films include, but are not limited to, CO₂, diode ultraviolet, or excimer lasers. An implant havingcell pattern16 is expected to confer benefit to a patient in which it is implanted because of the substantially smooth edges ofcell pattern16. Openings between 10 and 10,000 microns can be created in thefilm22 with thegeometry cell pattern16. An opening of about 2000 microns creates an implant with adequate porosity for tissue ingrowth and good mechanical properties.

InFIGS. 45 to 51 there is illustrated abio-absorbable material200 suitable for use in forming the gastric constriction device of the invention. The bio-absorbable nature of thematerial200 facilitates absorption of the device into the stomach wall over time.

As illustrated inFIG. 45, thematerial200 has a laminate construction. Both thefirst layer201 and thesecond layer202 of thematerial200 are porous to promote tissue in-growth. Thefirst layer201 has a higher pore density and smaller pore size than the second layer202 (FIGS. 48 and 51). In this manner, thefirst layer201 has a higher absorption rate and permits faster tissue remodelling than thesecond layer202.

In use, thesecond layer202 is located closer to the wall of thestomach24 than thefirst layer201.

FIGS. 45 to 51 illustrate the three-dimensional gastric harness scaffold. Ascaffold200 comprising

layers

201,202 of porous material is assembled. Onelayer202 may have larger cells/pores with wider and/or thicker struts with longer degradation times. One layer may be composed of a material with a longer degradation time. The pores may be formed before the

layers

201,202 are attached to one another. The pores may have different dimensions and compositions, which vary the healing and degradation characteristics. Tissue will grow from the outside in and remodel at a controlled rate, which may permanently alter the volume potential of thestomach24 due to the mechanical properties of the gastric wall after tissue has been deposited.

Referring toFIG. 52 there is illustrated another bio-absorbable material210 suitable for use in forming the gastric constriction device of the invention.

In this case the material210 comprises an anti-adhesion coating along at least part of the surface of the material210.

InFIG. 53 there is illustrated a furtherbio-absorbable material220 suitable for use in forming the gastric constriction device of the invention.

In this case thematerial220 comprises ananti-adhesion filler221 filling at least some of the pores.

FIGS. 52 and 53 illustrate the gastric harness with adhesion prevention material. The adhesion prevention material fills the cells and/or coats the porous material used to construct the gastric harness implant. The adhesion prevention material is absorbed at a controlled rate or stays on the material permanently to prevent unwanted adhesions between the gastric harness and internal organs.

FIG. 54 is a flow chart illustrating some of the steps in a method of producing a gastric harness implant of the invention.

In an alternative method, the steps of laminating the films together may be repeated after the step of machining the film.

The implant can have enhanced physical properties along its peripheral edges to improve suture or staple retention strength. The strength of material along the peripheral edges may be higher to improve the physical properties in this region so that sutures do not pull out and cause failure. The material content in these regions can be increased to improve the physical properties. In addition, attachment points can be created along the edge for receiving sutures, staples, or adhesives. The attachment points can be used to attach separate panels to one another to create the gastric implant.

Polytetrafluoroethylene (PTFE) polymer has useful properties as an implant material. PTFE can be processed into a microporous form using an expansion procedure. Bard Vascular Systems (Tempe, Ariz., USA) manufactures ePTFE. Expanded PTFE offers a combination of strength and flexibility together with extensive biocompatibility.

Medical implant applications for the soft tissue implant technology described above may include but are not limited to gastric banding and stomach restriction procedures. The soft tissue implant may be produced in a variety of shapes and sizes for the particular indication. One may select a non-absorbable gastric implant for morbidly obese patients that require permanent treatment and long-term durability and strength. Alternatively, one may select an absorbable soft tissue implant for patients that require temporary treatment of obesity when one wants to avoid the potential complications associated with a permanent implant.

In addition, the soft tissue implant product design may be produced in three-dimensional forms to facilitate sizing. An example is an implant with a curvature to construct a substantially cylindrical shape. A three dimensional structure could be machined using a system incorporating a third axis for micromachining. Alternatively, a substantially two-dimensional soft tissue implant could be thermoformed into a three-dimensional shape after machining.

EXAMPLESExample 1

A nonwoven soft tissue implant was constructed using a biaxially oriented polymer film. Expanded PTFE film measuring 0.024 inches in thickness was obtained from Bard Vascular Systems (Tempe, Ariz., USA). Expanded PTFE was machined into the design Mesh2E cell patterns using a die punch produced by Elite Tool & Die (Smithstown, Ireland).

Example 2

A nonwoven soft tissue implant was constructed using biaxially oriented polymer films. Expanded PTFE film, part number 1TM22250, was obtained from BHA Technologies (Slater, Mo., USA). Twelve sheets of the film were placed between two sheets of DuPont Kapton 200HN film (Circleville, Ohio, USA). The sheet assembly was brought to 350° C. at 400 PSI of constant pressure for 15 minutes under vacuum. The laminated assembly was machined into the design Mesh2E cell patterns using a die punch produced by Elite Tool & Die (Smithstown, Ireland).

Example 3

A nonabsorbable gastric wrap was created using silicone tubing. A 100 cm length of tubing was perforated in 1 cm increments with a 2 mm punching tool. The gastric wrap was implanted into a canine at Charles River Laboratories (Ballina, Co. Mayo, Ireland). The assembly was used to wrap the stomach of a 22.8 kg canine. InterruptedMersilk 1 sutures (Ethicon, Somerville, N.J., USA) were used to secure the gastric wrap in position against the stomach. In addition, aMaxon 1 monofilament absorbable suture (United States Surgical, Norwalk, Conn., USA) was used to support the wrap by running the suture through the wrap perforations along the longitudinal axis of the stomach. The canine was fed an unrestricted high calorie diet and sacrificed at 30 days. The weight of the animal at sacrifice was 21.6 kg. The gastric wrap had incorporated into the stomach wall with a moderate degree of adhesion formation and inflammation present.

A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention.