Patent Application
20130261382
Embodiments of the present invention relate generally to medical devices and methods and more particularly to minimally invasive devices, systems and methods for treating obesity.
Obesity has become a major health concern, both nationally and internationally. The National Center for Health Statistics (NCHS) estimates that over 120 million Americans are overweight, including about 56% of the adult population. Of these, about 52 million are considered obese, as measured by a body mass index (BMI) of 30% or greater. In Europe, an estimated 77 million people are obese, as measured by the same standard. This problem is not limited to western nations, as many developing countries are reported to have obesity rates over 75% of the adult population.
Co-morbidities that are associated with obesity include, but are not limited to type II Diabetes, high blood pressure, sleep apnea, stroke and arthritis, the symptoms of which often tend to be lessened or alleviated upon loss of weight by a person so affected.
In the U.S., options for treatment of obesity are currently quite limited. Current treatment methodologies typically rely upon surgically introducing a “malabsorptive” environment in the gastro-intestinal tract, a restrictive environment, or a combination of these. One available treatment method is gastric bypass surgery and another is referred to as gastric banding (one of these techniques if referred to as the LAPBAND™ procedure). These procedures are limited to only those patients with a BMI over 40 (or over 35, with co-morbidities present).
Gastric bypass procedures incur a great deal of morbidity and create a malabsorptive state in the patient by bypassing a large portion of the intestines. Serious side effects, such as liver failure have been associated with this procedure, as well as chronic diarrhea. Another surgical procedure that has a high degree of morbidity associated with it is known as the “Gastric Bypass Roux-en-Y” procedure. This procedure reduces the capacity of the stomach by creating a smaller stomach pouch. The small space holds only about one ounce of fluid. A tiny stomach outlet is also surgically created to slow the speed at which food leaves the stomach. Staples are used to create a small (15 to 20 cc) stomach pouch, with the rest of the stomach being stapled completely shut and divided from the stomach pouch. The small intestine is divided just beyond the duodenum, brought up, and connected to the newly formed stomach pouch. In addition to the considerable morbidity associated with this procedure, other disadvantages include “dumping syndrome”, where stomach contents are literally “dumped” rapidly into the small intestine which may lead to nausea, weakness, sweating, faintness, and diarrhea; hernias resulting from the surgery; gallstones; leakage of the connection between the pouch and the intestine; stretching of the pouch that was formed; nutritional deficiencies; and possible dehiscence of the staples.
The LAPBAND™ is a band that, when placed, encircles the fundus-cardia junction and is inflatable to constrict the same. It does not reduce the volume of the stomach, but rather restricts passage of food into the stomach, the theory being that the patient will feel satiety with a much less volume of food than previously. Although the LAPBAND™ procedure is less invasive than a gastric bypass procedure, it also typically achieves less weight loss. Further, it is not a simple procedure and requires a substantial amount of training by a surgeon to become proficient in performing the procedure. Also, a substantial amount of dissecting and suturing is required because the pathway by which the band is introduced is not an existing pathway, and must be established by dissection. Great care is required to avoid blood vessels and nerves that may be in the intended pathway to be created by the dissection. After placing the band around the fundus-cardia junction, the ends of the band must be connected together and then it must be cinched down into place. Additionally, complications such as erosion at the fundus-cardia junction, slippage of the band from its intended location, nausea/vomiting, gastroesophageal reflux, dysphagia and lack of effectiveness in causing weight loss have been reported.
Gastrointestinal sleeves have been implanted to line the stomach and/or a portion of the small intestines to reduce the absorptive capabilities of the small intestine and/or to reduce the volume in the stomach, by reducing the available volume to the tubular structure of the graft running therethrough. Although weight loss may be effective while these types of devices are properly functioning, there are complications with anchoring the device within the stomach/GI tract, as the stomach and GI tract function to break down things that enter into them and to move/transport them through. Accordingly, the integrity of the anchoring of the device, as well as the device itself may be compromised over time by the acids and actions of the stomach and GI tract.
A sleeve gastrectomy is an operation in which the left side of the stomach is surgically removed. This results in a much-reduced stomach that is substantially tubular and may take on the shape of a banana. This procedure is associated with a high degree of morbidity, as a large portion of the stomach is surgically removed. Additionally, there are risks of complications such as dehiscence of the staple line where the staples are installed to close the surgical incisions where the portion of the stomach was removed. Further, the procedure is not reversible.
In the laparoscopic duodenal switch, the size of the stomach is reduced in similar manner to that performed in a sleeve gastrectomy. Additionally, approximately half of the small intestine is bypassed and the stomach is reconnected to the shortened small intestine. This procedure suffers from the same complications as the sleeve gastrectomy, and even greater morbidity is associated with this procedure due to the additional intestinal bypass that needs to be performed. Still further, complications associated with malabsorption may also present themselves.
Although procedures to surgically reduce stomach volume can produce weight loss, in some patients the weight loss is not permanent. For example, in the case of vertical sleeve gastrectomies, the sleeve expands over time due to the patient overeating and at least some of the reduction in stomach volume is lost. Other procedures can have similar outcomes where the reduction in volume is lost due to patient overeating or partial failure of the device.
U.S. Patent Publication No. 2005/0261712 to Balbierz et al. describes capturing a device against the outer surface of the stomach wall to form a restriction that appears to function similarly to the restriction imposed by the LAPBAND™. The anchoring of the devices disclosed relies upon placement of features against the internal wall of the stomach to form an interlock with the device that is placed against the external wall of the stomach.
U.S. Patent Publication No. 2005/0267533 to Gertner discloses devices for treatment of obesity that use one or more anchoring mechanisms that are passed through the wall of the stomach to establish an anchor. The stomach is reduced in size by passing the devices through the stomach wall on opposite sides of the stomach and compressing the walls together to eliminate a portion of the interior space within the stomach. Gertner also discloses an embodiment in which an extra-gastric balloon is placed anteriorly of the stomach and attached to the abdominal wall using one of the anchoring mechanisms described.
U.S. Pat. No. 6,981,978 to Gannoe discloses devices for reducing the internal cavity of the stomach to a much smaller volume, which may be used to carry out a bypass procedure. Stapling is employed to isolate the smaller volume in the stomach, and thus the same potential disadvantages are present as with other stapling procedures described herein.
U.S. Pat. No. 6,186,149 to Pacella et al. describes an occluder device that can be used as a dietary control device (see
The risk and invasiveness factors of currently available surgeries are often too great for a patient to accept to undergo surgical treatment for his/her obesity. Accordingly, there is a need for less invasive, yet effective surgical treatment procedures for morbidly obese patients (patients having a BMI of 35 or greater). Also, since the current surgical procedures are currently indicated only for those patients having a BMI of 40 or greater, or 35 or greater when co-morbidities are present, it would be desirable to provide a surgical procedure that would be available for slightly less obese patients, e.g., patients having a BMI of 30 to 35 who are not indicated for the currently available surgical procedures. It would further be desirable to provide a surgical procedure that would be indicated for obese patients having a BMI in the range of 30-35, as well as for more obese patients.
There is a need for devices and methods for treating obesity with minimally invasive devices that substantially preserve the reduced volume of a stomach following a bariatric procedure and optionally provide an adjustable, constrictive force on the stomach.
Certain embodiments of the present invention are related to a device for the treatment of obesity. The device includes a reinforcing member with a cross-section that defines a channel. The channel is configured to reinforce a wound. The device further includes a constraining body attachable to the reinforcing member. The constraining body is configured to constrain a patient's stomach. In certain embodiments, the reinforcing member includes articulated segments. In certain embodiments, the reinforcing member includes pinching segments. In certain embodiments, the constraining body includes at least one inflatable bladder.
Certain embodiments of the present invention are related to a method for the treatment of obesity. The method is preferably performed as a laparoscopic procedure but it is within the scope of the invention for the method to be performed as an open surgical procedure or a trans-oral procedure. The method includes accessing an extra-gastric abdominal space of a patient and introducing a device into the extra-gastric abdominal space. The device includes a reinforcing member and a constraining body. The method further includes positioning the reinforcing member about a wound on the stomach of the patient and positioning the constraining member about at least a portion of the stomach of the patient. In certain embodiments, method further includes applying pressure on the closed wound via the reinforcing member. In certain embodiments, the method further includes applying a sealant material within the channel of the reinforcing member. The method further includes fastening at least a portion of the constraining member to another portion of the constraining member. In certain embodiments, the method further includes at least partially inflating at least one inflatable bladder included with the constraining body.
Embodiments of the present invention are useful in the surgical treatment of obesity. The description, figures, and examples herein relate to devices and methods for the containment or constriction of the stomach.
Before the present devices and methods are described, it is understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
Short summaries of certain terms are presented in the description of the invention. Each term is further explained and exemplified throughout the description, figures, and examples. Any interpretation of the terms in this description should take into account the full description, figures, and examples presented herein.
The singular terms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to an object can include multiple objects unless the context clearly dictates otherwise. Similarly, references to multiple objects can include a single object unless the context clearly dictates otherwise.
The terms “substantially,” “substantial,” and the like refer to a considerable degree or extent. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation, such as accounting for typical tolerance levels or variability of the embodiments described herein.
The terms “attach,” “attaching,” “attached,” “attachment” and the like refer to one part being coupled to another part in a substantially fixed manner. The two parts may be attached directly or through one or more intermediate parts provided that the intermediate parts preserve the substantially fixed manner of the coupling.
The terms “inflate,” “inflatable,” “inflated,” “inflating,” “inflation,” and the like refer to an object or region of an object becoming larger in size or volume. In certain cases herein, such inflation is accomplished by at least partially filling an internal volume of the object or region. However, it is understood that these terms include cases where an internal volume of the object or region is filled but the object or region does not stretch or grow. In such cases where filling the object does not cause the object or region to stretch or grow, the act of at least partially filling the internal volume of the object or region is the act of inflation. Conversely, the term “uninflated” and the like refer to both the condition of an object or a region prior to it becoming larger in size or volume and to the condition of an object or region prior to its internal volume being at least partially filled.
The term “channel” and the like refers to both the structure that defines a conduit with at least one open side or face and the void or negative space defined by such a structure, as the context dictates. For example, two side walls connected by a base wall can be referred to as a channel as can the void defined by these features. It is understood that the shape of a channel is not limited to u-shapes or v-shapes but can includes various other shapes both complex and simple.
The terms “reinforce,” reinforced,” “reinforcing,” and the like refer to one object supporting another to some degree. Such support includes providing a range of forces from active pressure to simple contact.
The terms “constrain,” “constrained,” “constraining,” and the like refer to both the application of active forces that apply pressure to reduce the size of an object and to the provision of a passive barrier that limits the expansion of an object to a larger size.
The term “wound” and the like refers to areas of iatrogenic trauma to tissue, including, but not limited to, incisions and punctures. It is understood that the term “wound” includes areas of recent trauma and those that have occurred during a past procedure.
The length and configuration of the reinforcing member can vary such that it reinforces just one closure device or multiple wound closure devices. The line of wound closure devices on a stomach may be fairly straight and a single reinforcing member may be able to be positioned about the majority of the wound closure device, preferably all of the wound closure devices, without placing undesired forces on the wound. Undesired forces include forces that distend the stomach or displace the line of wound closure devices in a way that increases the possibility of leakage or failure of the wound closure. In embodiments where the reinforcing member is configured to be positioned about one wound closure device or a few wound closure devices, more than one reinforcing member may be placed about the wound. In such embodiments, each reinforcing member may optionally have sealant applied to its channel via the methods described herein.
According to certain embodiments, the reinforcing member may apply pressure to the wound. Specifically, the reinforcing member may apply a pinching type of pressure to the wound that may facilitate the wound remaining closed and free from leakage. Reinforcing members may be configured to apply a pinching force in any suitable way. For example, reinforcing member 100 of
Reinforcing members may be formed from any suitable biocompatible material. Suitable materials include those that are capable of maintaining their shape and optionally applying suitable pinching force to a wound. Examples of such materials include biocompatible polymers (including but not limited to, polyteterafluoroethylene and similar fluorinated polymers, silicone rubbers, high and ultrahigh molecular weight polyethylene, and nylons), metals (including but not limited to, stainless steel, titanium, and nickel-titanium alloys), and ceramics. Reinforcing members may be formed from laminated materials or composites of materials. For example, a reinforcing member may be formed from a metal, such as a nickel-titanium alloy, that is encapsulated by a silicone rubber. The nickel-titanium alloy may be configured to supply a pinching force and the encapsulating silicone rubber may provide an atraumatic interface with the wound and surrounding tissue.
As depicted in
Some examples of suitable fastening devices for one or both such fastening regions include but are not limited to holes, grommets, loops, hooks, snaps, ties, knots, needles, pins, threaded bolts or screws, threaded nuts, clips, magnets, and the like. In certain embodiments of the invention, such as hook and loop, snaps, bolts and nuts, or similar paired fastening devices, it is necessary that both parts being fastened have a complementary fastening device. For example, first fastening region 210 may have a male part of a snap to be attached to a corresponding female part of a snap included in second fastening region 220. In certain embodiments, the fastening devices are varied in one or both fastening regions such that a single fastening region may have different types of coupling points.
According to certain embodiments, constraining body 200 includes selectively inflatable bladders 250 in which each bladder can be individually inflated to provide a customizable distribution of constraining or constricting forces on the reduced volume portion of the stomach of a patient.
According to embodiments of the invention, inflatable bladders can be inflated via inflation ports that may be located at any place on the inflatable bladders or on the constraining body that allows the inflation ports to be in fluid communication with the inflatable bladders. Multiple inflatable bladders may be in fluid communication with a single inflation port such that multiple inflatable bladders may be inflated via a single inflation port. In such embodiments where a single inflation port is in fluid communication with multiple inflatable bladders, valves may allow for the selective and independent inflation of the inflatable bladders. Alternately, inflatable bladders may each have their own inflation port. One advantage of embodiments of the invention having inflatable bladders is that the shape and constrictive forces of the constraining body may be adjusted over time and repeatedly using minimally invasive inflation techniques known in the art.
Inflation bladders can be formed using compliant, semi-compliant, and/or non-compliant materials according to conventional techniques. Examples of compliant materials suitable for use in an inflatable bladder as described herein include, but are not limited to: silicone, latex rubber, and polyurethane. Examples of semi-compliant materials include, but are not limited to: nylon, polyethylene, polyester, polyamide and polyurethane. Polyurethane, nylon, polyethylene and polyester can be compliant or semi-compliant materials, depending upon the specific formulation and hardness or durometer of the material as produced. Examples of noncompliant materials that can be used in the construction of inflatable members described herein include, but are not limited to: polyethylene terepthalate (PET) and urethane. Urethane can be a compliant, semi-compliant or non-compliant material depending upon its specific formulation and hardness or durometer. Compliant, semi-compliant and noncompliant categories are not solely material limited, but are better defined by their expansion characteristics. Some materials are best suited for use in one of these categories (e.g., silicone and latex work well to make compliant structures), but other materials can be formulated and/or constructed to provide compliant, semi-compliant or noncompliant properties.
In some embodiments of the invention, reinforcing members facilitate the attachment of other extra-gastric devices to the reduced volume portion of the stomach of a patient. For example, extra-gastric balloons could be fitted with attachment points that are capable of attaching to the attachment points on one or more reinforcing members. In another example, extra-gastric stimulation devices could be fitted with attachment points that are capable of attaching to the attachment points on one or more reinforcing members.
In some embodiments, one or more reinforcing members are positioned about the wound during an initial procedure to reduce the volume of a patient's stomach, but no constraining body is attached to the one or more reinforcing members. In these embodiments, a constraining body may be placed about the reduced volume portion of a patient's stomach in a later procedure. A constraining body, or any other extra-gastric device, may be introduced to the patient's abdominal space via conventional surgical techniques or via minimally invasive surgical techniques. Since the reinforcing members and their attachment points are already positioned about the wound, the constraining body can be more easily anchored to the reduced volume portion of the patient's stomach.
While the invention has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.
