Patent Application
20120245504
1. Field of Invention
The present invention relates to improving the delivery, retention, and removal of separating devices implanted in hollow organs for the restrictive and malabsorptive functions they provide. More specifically, the invention improves long-term retention of separating devices, including gastrointestinal sleeves, by engaging them with tissue that has been altered to provide a restrictive function. Most specifically, the invention makes use of the interserosal fibrotic tissue created through formation of intussusceptions to retain conventional and improved separating devices in the gastrointestinal tract to provide short and long-term weight loss following minimally invasive bariatric surgery.
2. Description of the Related Art
Obesity has become a worldwide health epidemic. Estimates by the World Health Organization suggest that if the increasing incidence of obesity continues then by the year 2015 approximately 1.5 billion people will be affected. Bariatric surgery (or surgical treatment of obesity) has emerged as superior to behavioral and pharmacological treatment methods for significant and sustainable weight loss in affected individuals. The number of bariatric surgeries performed in the United States has increased 9 fold in the past decade. Outside of the United States, the number of bariatric surgeries performed in that same period has more than tripled. (See “Surgical treatment of obesity” by Marc Ward, MD and Vivek Prachand, MD, FACS in Gastrointestinal Endoscopy, Vol. 70, No. 5 (2009) pp. 985-990.)
Modern bariatric surgical procedures aim to induce weight loss in two main ways: (i) restriction, which means volumetric reduction of the gastrointestinal (GI) organs to decrease the volume of food and the amount of calories a patient can comfortably consume at a given time; and (ii) malabsorption, which limits energy absorption by effectively bypassing portions of the GI tract through which food is absorbed (and nutrients sequestered). Portions of the GI tract can be effectively bypassed with a separating device that creates a barrier to prevent secretions (from the GI tract walls) that breakdown food from entering the device to access food. Substantially undigested, residual food that cannot be broken down due to reduced exposure to digestive secretions and enzymes simply passes through the remainder of the tract until it is excreted. Two procedures that rely primarily upon the former principle, restriction, are the laparoscopic adjustable gastric band (LAGB) and the vertical sleeve gastrectomy (SG). Two procedures that rely primarily upon the latter principle, malabsorption, are Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion with or without duodenal switch (BPD and BPD/DS).
While bariatric surgical procedures appear to offer more promise for seriously obese patients than pharmaceutical approaches and behavioral modification, there are nonetheless shortcomings with currently available options. The laparoscopic adjustable gastric band (LAGB) involves embracing the upper portion of the stomach with a circular band to form a pouch. The band can be tightened and released (adjusted) to decrease and increase, respectively, the volume of the pouch and to control a rate of emptying from the pouch into the remainder of the stomach. While generally effective for moderately obese patients, the band has much lower rates of success in more seriously obese individuals. Additionally, the weight loss following band implantation is typically gradual which can be discouraging for some patients. Complications include mild upper GI symptoms, band slippage, prolapse, and more rarely erosion into the gastric lining and esophageal dilation.
Vertical sleeve gastrectomy (SG) is more invasive in that it involves excising much of the upper curvature or fundus portion of the stomach to leave behind a narrower, tubular shaped organ. The resected stomach resembles an elongated sleeve rather than a rounded body. Problems include risk of vitamin B12 deficiency and gastric leaks near the staple line at the gastroesophageal (GE) junction.
Roux-en-Y gastric bypass (RYGB) involves both restrictive and malabsorption aspects. First, a pouch is created in the upper portion of the stomach. Then, the jejunum (middle portion of the small intestine between the duodenum proximally and the ileum distally) is divided into two limbs and one of the limbs is anastomosed to the pouch. These structural modifications result in bypassing the release of food-stimulated gut hormones and absorption of food in the duodenum and proximal jejunum. Drawbacks of the procedure are that it takes longer and is more difficult compared to other contemporary procedures and there is a higher frequency of perioperative complications. Other downfalls include a likelihood of vitamin B12 and iron deficiency, and a strong association between RYGB and dumping syndrome (which may also be a benefit due to its deterrent effect on consumption of highly processed carbohydrates).
Biliopancreatic diversion with or without duodenal switch (BPD and BPD/DS) involves sleeve gastrectomy (SG) followed by transaction of the duodenum (upper portion of the small intestine) distal to the pylorus (lower portion of the stomach with a ring of smooth muscle, or sphincter, that controls emptying into the duodenum). For BPD/DS the ileum (lower portion of the small intestine) is typically divided proximal to the ileocecal junction and the distal limb of ileum is then anastomosed to the postpyloric duodenum with a distal anastomosis of the distal biliopancreatic limb proximal to the ileocecal junction. BPD/DS is more effective than other methods in treating super-obese patients. Nutritional deficiencies are a common negative side effect, including calcium malabsorption and an increase in parathyroid hormone, hypoalbuminemia, and fat soluble vitamin deficiencies (including vitamin A, vitamin K, and vitamin D).
The present invention seeks to provide a device and procedure that combines the restrictive and malabsorptive functions of the above procedures in a less invasive manner with a significantly improved effectiveness to invasiveness ratio that provides both immediate and continuing weight loss and facilitates long-term weight maintenance. Reduced invasiveness means less risk of perioperative complications and a lower mortality rate. Additionally, patients not healthy enough for traditional surgery may nevertheless be candidates for non-traditional minimally invasive procedures.
The present invention seeks to provide an alternative superior to reference art devices and methods for delivering, retaining, and removing separating devices in the gastrointestinal system. Setbacks of reference art devices and methods, including poor retention, are overcome in part by providing an improved anatomic platform of intussuscepted interserosal fibrotic tissue upon/against which to hold the separation device, as disclosed further herein.
It would be desirable to provide a device for weight loss that can be delivered with minimal invasiveness and remains in the same desired position over time. It would also be desirable to provide a device for weight loss that does not cut into linings of the GI tract and hollow organs therein. It would further be desirable to provide a device that does not detrimentally impair absorption of vitamins and nutrients. It would additionally be desirable to provide a device that induces prompt weight loss, maintainable over time, without requiring incising and reconstructing major portions of the stomach and intestines. Finally, it would be desirable to provide a weight loss device that does not require significant time off work and apart from normal daily activities for the implantation procedure.
The present invention addresses these problems and meets these and other needs.
Tissue can be altered to reduce the volume of a hollow organ or provide a restrictive function, such as by an intussusception. The terms “intussuscept,” “intussusception,” “intussuscepting,” “intussuscepted,” and the like refer to a geometry created by telescoping one part of a hollow organ onto or into another part of the hollow organ.
When an intussusception is formed, the tissue can be stabilized in that configuration through the use of temporary or permanent retaining members, including anchors, sutures, elastic retaining bands, glue, or cauterization or electrosurgery tools that seal or weld the tissue portions together. Serosal surfaces that become apposed in this configuration can then create interserosal fibrosis as part of the healing response. Various tissue growth-enhancing compositions and additives may, but need not, be added to the joined tissue portions to expedite and exacerbate this healing process to assist in the development and proliferation of interserosal fibrotic tissue. Also, by creating an intussusception, the volume of a hollow organ is reduced. Volume reduction limits the amount of food or other materials an organ can hold and reduces tolerance to excessive amounts, thereby inhibiting the ability or desire to consume. A preferred application of this process is in the stomach to reduce the amount of food it can hold before a person experiences discomfort and biological cues to stop eating. Forming one or more intussusceptions in stomach tissue makes it easier for the stomach to fill up and may increase gut hormones related to satiety (e.g. GLP-1 and peptide YY) and/or reduce blood ghrelin levels associated with early-phase intake.
In addition to volumetric reduction of hollow organs, another way to limit the amount of calories or other materials they effectively receive is to reduce processing of materials in the organs. Processing of materials typically occurs as enzymes and vitamins from the walls of an organ are secreted to the inside of the organ to digest or transform the materials. Further processing may occur as partially digested, transformed, or dissolved materials pass outward through the walls of an organ into the blood stream where more processing occurs at the cellular level along with distribution throughout the body. Medical devices that block the flow of digestive enzymes (or other compositions and fluids) from the outer walls of an organ to the hollow inside, and from the hollow inside of an organ outward through the walls, can be used to inhibit or limit processing and reduce absorption. Food and other materials that are not properly processed and absorbed will eventually be excreted.
The present application introduces the invention of integrating restriction (volume reduction) and malabsorptive (barrier layer) components for better long-term and short-term results and improved delivery, retention, and removal of the malabsorptive component. The naturally strong interserosal fibrotic tissue that forms with an intussusception provides a superior platform from which to retain a malabsorption sleeve.
When used in the stomach and intestines, the malabsorption sleeve has multiple functions,
including providing: i) a reduced tubular cavity or canal limiting the amount of food that can be received in the hollow organ(s), and ii) a protective slide that expedites movement of food through the GI system while reducing or inhibiting the natural process of digestion and absorption. To achieve the first function, the sleeve can have a smaller diameter than the diameter of the hollow organ in which it is implanted. To achieve the second function, the sleeve can have an inner lining that repels food contents and walls that selectively restrict entry of digestive enzymes and exit of broken down food.
According to the devices and methods described herein the malabsorption sleeve may be engaged with the tissue intussusception in a number of ways. According to one embodiment, the proximal end of the sleeve may be folded into the intussusception at the time the intussusception is formed. By enabling sleeve implantation and tissue intussusception in a single step the present invention could greatly reduce procedure time. If the proximal end of the sleeve is semi-porous it may permit tissue to grow or seal through it, or adhesives to bond through it. According to another embodiment, the proximal end of the sleeve can be retained to an outer wall of the intussusception, especially a mucosal surface, rather than sandwiched between the tissue that forms the intussusception. This may occur through a single-step or multi-step procedure in which a proximal end of the sleeve is retained to the intussusception at the time it is formed or attached after.
The devices and methods described herein may be especially useful for delivering, retaining, and removing a separating device within an intussuscepted hollow organ in the body. Separating devices provide a barrier layer that serves to delay, prevent, or reduce mixing of biological fluids on the two sides of the device.
According to one of several aspects of the present invention a method for retaining a malabsorptive component of a weight reduction system to a restrictive component of a weight reduction system is provided, which involves introducing the restrictive component in a hollow organ, introducing the malabsorptive component in the hollow organ, and attaching the malabsorptive component to the restrictive component. The restrictive component may be introduced in a hollow organ by either inserting it in a hollow organ or forming it in a hollow organ. For example, the restrictive component may be inserted in a hollow organ when it takes the form of a space-occupying or volume-occupying object that reduces stomach volume available for food. Insertion is preferably minimally invasive and transoral, for example delivery of inflatable space-occupying objects may be accomplished in this manner as they can be inserted transorally in a deflated state. As another example, the restrictive component may be formed in a hollow organ when it involves telescoping a first region of tissue into a second region of tissue resulting in an intussusception. The malabsorptive component may also be introduced in a hollow organ by either inserting it in a hollow organ or forming it in a hollow organ. For example, the malabsorptive component may be inserted in a hollow organ when it takes the form of an impermeable or semi-permeable separating device or sleeve which impedes flow of food and/or digestive enzymes across it. Insertion of a separating device or sleeve is preferably minimally invasive and transoral. As another example, the malabsorptive component may be formed in a hollow organ when it involves reconfiguring the shape, entry/exit points, or surface texture of one or more hollow organs to impede flow of food and/or digestive enzymes across a hollow organ to reduce absorbed calories. Attaching the malabsorptive component to the restrictive component may include, but is not limited to, attaching a separating device to an intussuception or hanging a sleeve from an intussusception as the intussusception makes a superior platform for retention of the malabsorptive component (separating device or sleeve).
According to another aspect of the present invention a method for retaining a separating device in a region of an intussusception is provided, which involves retaining the separating device in the region of the intussusception, in which the intussusception is formed by telescoping a first region of stomach tissue into a second region of stomach tissue. Retaining may involve attaching a proximal end of the separating device into the intussusception at the time the intussusception is formed. Retaining may involve at least one element selected from the group consisting of: inserting mechanical elements through the intussusception, enlarging a proximal portion of the separating device, delivering energy, activating an adhesive, and applying an adhesive.
According to another aspect of the present invention an apparatus for integrating a malabsorptive component and a restrictive component of a weight reduction system is provided, including a self-retaining separating device configured for attachment to an intussusception. The separating device may be deployable to self-retain by the separating device hanging from a stoma defined by the intussusception. The proximal end of the separating device may be enlargeable to the extent that it is larger than a stoma defined by the intussusception. The proximal end of the separating device may be elastic thereby enabling the proximal end to wrap around an outer surface of the intussusception. The proximal end of the separating device may be configured to bias outwardly. The separating device may have at least two states, an insertion/removal state and a retention state. The at least two states may be restricted to a proximal end of the separating device. The separating device may have an elastic portion that exerts a force (or forces) inwardly resulting in the retention state. The separating device may include retractable elements that exert a force (or forces) inwardly resulting in the retention state. The separating device may have a biasing portion that exerts a force (or forces) outwardly resulting in the retention state. The separating device may include extendable elements that exert a force (or forces) outwardly resulting in the retention state. A proximal portion of the separating device may have a surface structure capable of activation to engage with tissue adjacent the intussusception.
According to another aspect of the present invention an apparatus for integrating a malabsorptive component and a restrictive component of a weight reduction system is provided, including a separating device and a retaining member configured to secure the separating device to an intussusception. The retaining member may include any combination of tissue-penetrating elements, an adhesive, or a material configured to respond to energy application from an electrosurgical or electrocautery instrument. The apparatus may also include a means for dispersing pressure created by the retaining member. The means for dispersing pressure may be an intrastomal device, an extrastomal device, both an intrastomal device and an extrastomal device, balloons, springs, retractors, fluids, holes, channels, grooves, surface texture, variable thickness, variable materials, and the like. A distal portion of the retaining member may define the separating device. At least a portion of the retaining member may be configured to deploy. The retaining member may be elastic for engagement with an outer surface of a lumen defined by walls of the intussusception thereby securing the retaining member about the lumen.
According to another aspect of the present invention a separating device configured to be retained in a hollow organ, for altering absorption of one or more compositions through one or more walls of one or more hollow organs is provided, including an elongated tubular body enclosing a pathway along which one or more compositions can travel until reaching a distal end of the separating device and a means for retaining a proximal end of the separating device in a region of an intussusception. The means for retaining the proximal end of the device in a region of the intussusception may include interaction between a mucosal surface of an organ and the device. The means for retaining the proximal end of the device in a region of the intussusception may include fitting the device between tissue on one or more outside walls of the proximal end of the device. The means for retaining the proximal end of the device in a region of the intussusception may include engaging tissue that is or becomes interserosal fibrotic tissue. The means for retaining the proximal end of the device in a region of the intussusception may include engaging opposed tissue. The means for retaining the proximal end of the device in a region of the intussusception may include engaging an area of interserosal apposition formed by an intussusception. The means for retaining the proximal end of the device in a region of the intussusception may include a friction fit. The friction fit may involve the proximal end of the separating device wrapped around the intussusception so as to exert a force (or forces) inward. The friction fit may involve the proximal end of the separating device inserted within the intussusception and exerting a force (or forces) outward. The proximal end of the separating device may be elastic. The proximal end of the separating device may be disposed to bias outwardly, or “springy”. The proximal end of the separating device may be expandable. The means for retaining the proximal end of the separating device in a region of the intussusception may include one or more anchors. The separating device may be a distal part of a retaining member on an inside of a lumen formed by walls of the intussusception. The separating device may be a distal part of a retaining member on an outside of a lumen formed by walls of the intussusception. The means for retaining the proximal end of the separating device in a region of the intussusception may include retaining the proximal end of the separating device to a retaining member configured to fit inside the intussusception. The means for retaining the proximal end of the separating device in a region of the intussusception may include retaining the proximal end of the separating device to a retaining member configured to fit outside the intussusception. The proximal end of the separating device may be retained directly by the retaining member. The proximal end of the device may be retained indirectly by the retaining member through an intermediate connector. The means for retaining the proximal end of the separating device in a region of the intussusception may include a proximal end of the separating device that is enlargeable or enlarged such that it is larger than a stoma formed by the intussusception. The separating device may also include a means for dispersing pressure created by the means for retaining.
According to another aspect of the present invention an apparatus for retaining a device in a region of an intussusception formed in a hollow organ is provided, including one or more of a retaining member configured to fit inside walls formed by the intussusception and/or a retaining member configured to fit outside walls formed by the intussusception.
According to another aspect of the present invention a delivery device for implanting an apparatus as disclosed above in a hollow organ is provided, including an elongated shaft and a distal element that is both collapsible and deployable at a distal end of the shaft. The collapseable/deployable distal element is configured to be atraumatically introduced into the hollow organ in a collapsed configuration and deployment of the distal element causes the separating device to extend from a retracted configuration. The collapsible/deployable distal element may be umbrella-shaped.
According to another aspect of the present invention a method for delivering a separating device to a hollow organ is provided, which involves: inserting a delivery device into the hollow organ, with the separating device retained thereto in a retracted configuration; reconfiguring tissue around the delivery device thereby forming an intussusception; securing the separating device in a region of the intussusception, thereby using the intussusception to retain the separating device; removing the delivery device; and deploying the separating device from a retracted to a deployed configuration.
According to another aspect of the present invention an apparatus for removing a separating device, or any portion thereof, from an intussusception, is provided including a housing, a folding arm that fits within the housing, and a cutter at a distal end of the folding arm. The folding arm is configured to telescopically extend from the housing, swivel between an axis parallel to a shaft of the housing and an axis perpendicular to the shaft of the housing, and rotate around the axis parallel to the shaft of the housing.
According to another aspect of the present invention a method for removing all or a portion of a separating device from a hollow organ is provided, which includes: inserting a housing into the hollow organ, the housing comprising a folding arm therein with a cutter at a distal end of the folding arm, the folding arm configured to swivel between an axis parallel to a shaft of the housing and an axis perpendicular to the shaft of the housing; telescopically extending the folding arm from the housing along the axis of the shaft of the housing; swiveling the folding arm outward away from the shaft of the housing in a direction such that the folding arm approaches the axis perpendicular to the shaft of the housing; engaging the cutter on the distal end of the folding arm with the separating device; and rotating the folding arm around the separating device such that the cutter at the distal end moves through the perimeter of the separating device, thereby cutting off at least a portion of the separating device.
According to another aspect of the present invention a method for removing all or a segment of a separating device from an intussusception in a hollow organ is provided, which involves: cutting a suture that engages the separating device; grasping an end of the cut suture; and pulling while grasping to remove the suture, thereby detaching the separating device from the intussusception or detaching a segment of the separating device from another segment of the separating device.
These and other aspects and advantages of the invention will become apparent from the following detailed description, and the accompanying drawings which illustrate, by way of example, the features of the invention.
In its several embodiments, the present invention provides i) an improved separating device for implantation within a gastrointestinal (GI) tract of a patient to facilitate weight loss; ii) an apparatus for retaining the separating device; iii) a delivery device for implanting the separating device; iv) a removal device for retrieving the separating device (or a portion thereof); v) a method of delivering the separating device; vi) a method of retaining the separating device; and vii) a method of retrieving the separating device.
As used herein, the following terms are defined as indicated below, consistent with the principle that a patentee can be his own lexicographer.
The terms “hollow organs” include, but are not limited to, the organs of the gastrointestinal tract including the esophagus, the stomach, and the small intestines.
The terms “intussuscept,” “intussusception,” “intussuscepting,” “intussuscepted,” and the like refer to the geometry created by telescoping one part of a hollow organ onto or into another part of the hollow organ.
The phrase “in a region of an intussusception” refers to a location at or within a certain proximity to an intussusception formed in a hollow organ. As used herein, this proximity may be 1 cm or less, 2 cm or less, 3 cm or less, 4 cm or less, 5 cm or less, 6 cm or less, 7 cm or less, 8 cm or less, 9 cm or less, or 10 cm or less depending upon i) the particular hollow organ, ii) the specific medical application or purpose, and iii) the anatomy of a particular individual. Preferably, the proximity referred to by “in a region of an intussusception” is 0 to 3 cm from an intussusception.
The phrase “means for dispersing pressure” refers to any elements that disperse pressure in a region of an intussusception. For example, retention of the separating device in the region of the intussuception may result from a self-retaining separating device exerting one or more forces inwardly or outwardly, against, around, or adjacent to the intussusception. Such forces may result in pressure changes. A means for dispersing pressure may be relied upon to release and redistribute the pressure(s) resulting from retaining forces in order to restore the anatomy to mimic a natural biomechanical state with all pressures at acceptable levels. The phrase includes intrastomal and/or extrastomal devices that fit inside or outside walls formed by the intussuscepted tissue. However, other elements for dispersing pressure are also contemplated. These may include balloons, springs, retractors, fluids, holes, channels, grooves, surface texture, variable thickness, variable materials, etc. Pressure buildup may, but need not, be created by retaining members that function to hold the separating device in a region of the intussusception. Means for dispersing pressure may be provided to alleviate any unwanted pressure buildup created by the retaining members. Some types of retaining members may have an inherent pressure-dispersing function.
The term “restrictive component” is a broad term that may refer to tissue being reconfigured from its previous or natural configuration which may or may not actually restrict or decrease the volume of a hollow organ that includes the tissue. For example, an intussusception as a restrictive component may reconfigure tissue to restrict passageways in certain regions without decreasing volume or it may simply reconfigure tissue without even restricting passageways. In some, but not all, situations an intussusception may be used to restrict the volume of a hollow organ but this is not necessary or implied by the term “restrictive component”. Restrictive component may also refer to a volume-occupying object that takes up space in a hollow organ and restricts the remaining volume available for food without reconfiguring any tissue.
The terms “retaining member(s)” or “means for retaining” (in reference to retaining a separating device in position within or against intussuscepted tissue of a hollow organ) refer broadly to any feasible and biocompatible means for retaining. These means may include techniques that transform the protein structure of tissue and cause it to bond with itself such as tissue welding, cauterizing, and electrosurgery. These means may include sticky compositions such as resins, adhesives, glues, cements, and tissue-mimicking materials. These means may include elastic bands exerting tension inward (when stretched) that cause the separating device to friction fit with the intussusception directly or to an intermediate device (intrastomal device, extrastomal device, inner mesh, outer mesh) that itself retains the separating device near the intussusception. Accordingly, intrastomal and extrastomal devices are also considered as retaining members and means for retaining These means for retaining may also include springs or inflatable elements exerting outward forces that cause the separating device to expand outwardly against walls of a hollow organ (e.g. at the gastroesophageal junction) thereby friction fitting itself within a lumen of the GI tract. These means may also include traditional physical means for securing structures in the anatomy including anchors, staples, pins, clips, and sutures. The aforementioned examples are intended to be illustrative rather than exhaustive or limiting.
The terms “separating device” mean a device that divides two or more regions of a hollow organ to form a barrier between the regions. The barrier may be permanent or temporary (bioabsorbable, biodegradable, or bioerodible dissolving over time) and may also be complete, blocking all elements from crossing it, or selective (semi-permeable). The barrier may function to block transfer of materials in one direction or in both directions (inside to outside, outside to inside), or block some materials from moving in one direction and other materials from moving in a different direction. For example, block enzymes from coming in and block food from going out. The barrier changes the ability of materials to move freely throughout the hollow organ and to pass from one side of the hollow organ to another side (e.g. inside the cavity to outside into the bloodstream or outside from the walls to inside the cavity). Such a separating device may be a tubular sheath, a sleeve, or a liner with substantially open ends and impermeable or semi-permeable walls that inhibit or selectively inhibit passage of materials in/out. In this manner, the separating device thereby influences breakdown and absorption of food materials inside it within hollow organs of the GI tract.
Using the interserosal fibrotic tissue formed by one or more intussusceptions to retain the separating device improves long-term device stability and retention. The separating device can engage directly with this tissue, before, during, or after expected fibrosis formation, or indirectly by an intermediate element connecting the separating device and the intussusception or the interserosal fibrotic tissue.
Of note, all descriptions of utilization of interserosal fibrosis for retention of the separating device refer to interserosal fibrosis which may be pre-existing, may still be forming, or may not yet be formed but is reasonably expected to form as a result of the intussuscepted geometry.
Without penetrating the wall of a hollow organ the separating device will be adjacent to the inside mucosal surface of a hollow organ. However, the means for retaining can nevertheless engage or interact with the strong and supportive interserosal fibrotic tissue through penetration, although penetration is not essential as alternative techniques for engaging the interserosal fibrotic tissue to hold the separating device are available. For example, it is possible to friction fit the separating device to the intussusception with a non-penetrating or minimally penetrating retaining means. These include: (i) an elastic band at the proximal end of the separating device, placed outside of the intussusception closing in upon it, or (ii) a springy or expanding/swelling band at the proximal end of the separating device, placed inside a lumen of the intussusception pushing out against it. The inwardly directed elastic band or the outwardly directed springy or expanding/swelling bands may compress the device thereby retaining it. Alternatively, when tissue-penetrating elements, such as anchors, staples, or sutures, are used they physically extend into the interserosal fibrotic tissue. Preferably, tissue-penetrating retaining members enter interserosal fibrotic tissue of the intussusception through the mucosal surface of a hollow organ wall. Another alternative is for electrosurgical, electrocautery, or other energy-delivering surgical tools to weld or seal the proximal end of the separating device to the intussusception. Energy-delivery techniques may result in modifying the structure of the interserosal fibrotic tissue or other surrounding tissue.
The proximal end of the separating device may comprise one or more elements that are in themselves the means for retaining or that work together with other elements to become or assist the means for retaining For example, when a friction fit is used to secure the separating device around the outside or the inside of the intussusception, the proximal end of the separating device may comprise an elastic band (that hugs inwardly) or a springy band (that exerts pressure outwardly) built into it so that a separate step of inserting and attaching this component is not required. When energy-delivering surgical tools are used to weld the separating device to the intussusception, the proximal end of the device may be designed to perform appropriately upon energy application to bond well with the intussuscepted tissue or intermediate retaining elements (meshes, adhesives, stents, etc.) on the surface thereof. For example, the proximal end of the device may be made of or patterned with a material that forms an adhesive that bonds well with tissue upon application of energy from electrosurgical tools.
Tissue-penetrating elements, including anchors, staples, and sutures, may be less suited for incorporation directly within the proximal end of the separating device. However, in some embodiments, if the tissue-penetrating elements are housed or shielded appropriately so as not to compromise an atraumatic introduction of the separating device they too can be integrated. Including the means for retaining, or portions of it, in the proximal end of the separating device eliminates extra surgical steps and reduces procedure time as more elements are delivered at the same time and do not have to be separately inserted and positioned.
In any of these embodiments, the separating device 118 may have various geometries.
The separating device 118 need not be retained in a position outside of or within the intussuscepted tissue 116.
The devices described here serve to deliver and retain separating devices 118 within an intussuscepted hollow organ in the body. Also described here are devices which can remove the separating device 118 from the hollow organ after it has been previously delivered into position.
In analogous fashion,
In another manner of deployment, the separating device is connected to the inner mesh and is initially situated overlying the shaft of the delivery device in “inside-out” fashion, such that the most distal part of the separating device begins the procedure at the most proximal end of the device, close to the operator handle (like a sock which is flipped inside-out). The deployment mechanism is used as in typical fashion to deploy the inner and outer mesh, and secure these into place, and then the deployment mechanism is removed, leaving the separating device still in inverted fashion, now situated within the esophagus. Finally, a second device is used (either an endoscope, or other transoral device) to push the separating device distally, reversing its inverted configuration, such that the separating device is advanced out of the esophagus and into a more distal region of the GI tract.
After the separating device 118/119 is anchored in place, the separating device is expanded from its compacted or retracted configuration 119 to an expanded, extended, or deployed configuration. This can be done with any feasible means or device including using a physical unfurling element 138, fluid pressure (air pressure, a water stream), or using a biological, chemical, or physical catalyst to incite self-expansion of the separating device 118/119, etc. According to a preferred embodiment, a physical unfurling element 138 is used to deploy the separating device to its intended final position within the hollow organ.
Other embodiments utilize other, similar specialized anchoring or retention devices designed to facilitate detachment of the separating device from the intussuscepted tissue or intermediate retaining member (e.g. mesh). For example, the running suture shown in
The geometry of the proximal portion 130 of the separating device 118 need not be solid. For example, it may be a balloon which is air- or fluid-filled, such that when the balloon is filled, the geometry is too large to pass through the restrictive stoma. In such a case, puncture of the balloon using endoscopic instruments will then allow the user to deform it into a geometry with a small cross-sectional profile so as to allow retrieval endoscopically.
At the proximal end of the separating device, as shown in
At the distal end of the separating device, it may be secured by attachment to a second distal intussusception, as shown in
Shown in
Holder 304 is configured to hold, house, couple to or with, or otherwise engage anchor introducers 305 at their proximal ends (or at their proximal portions). Holder 304 should be made of a biocompatible material, and is typically in the form of a flexible tube. The holder may be made of the same or different materials, than those of the sheath. Anchor introducers 305 may be held or otherwise attached to holder 304 in any suitable manner. For example, the anchor introducers 305 may be held in grooves formed in holder 304, the grooves having shapes corresponding to the shapes of the outer surfaces of the anchor introducers 305. The anchor introducers 305 may be snap-fit into or with the holder 304, but need not be. Indeed, the anchor introducers may simply be held in a friction-fit fashion between the grooves in the holder 304 and the main shaft 307 of the device. The anchor introducers 305 may also be attached to the holder 304 mechanically (e.g., using pins, screws, etc.), by using glue or other adhesives, or the like. The anchor introducers may also be housed within a portion of the expandable member, or a housing off the expandable member 309.
The anchor introducers 305 shown in
The anchor introducers 305 are typically configured to radially expand and pierce through an intussusception, although as noted above, the anchor introducers need not be configured to pierce through tissue (e.g., may instead be used to position the anchors prior to deployment). In the variation shown in
The retaining material 308 should be made of a material capable of retaining the stomach tissue in its intussuscepted configuration. For example, the retaining material may be made of an elastomeric material, such as biocompatible rubbers, polyurethanes, polyesters, nylons, etc.), may be made of a super-elastic or shape memory material (e.g., nickel-titanium alloys and the like), or may be made of other suitable materials. The material may be porous (e.g., mesh like, or woven in nature), or may not be. The retaining material may be continuous, or may be non-continuous in nature (e.g., made from more than one interconnected or interlocked pieces). All, or any portion of the retaining material may be coated, impregnated, or otherwise include a radiopaque or echogenic tag or marker to aid in visualization. The material may be configured for permanent placement in a stomach (e.g., be biocompatible and able to withstand stomach acids and the stomach environment generally) or be configured for temporary placement (e.g., be made of a biodegradable material). In instances where sufficient fibrosis is expected to occur, the retaining material may be configured to degrade over time, leaving a permanent fibrosed intussuscepted configuration. In some variations, the retaining material 308 is configured for permanent placement and is made of a continuous band of material as shown in
The devices described here may further comprise a sizing component 312, shown in its delivery configuration in
Also shown in
Endoscope 314 may be any suitable endoscopic device to provide for visualization during the creation and securing of the intussusception. For example, the endoscope may be a pediatric endoscope, or similar endoscope having a low profile. Other scopes or devices may also be inserted through, or alongside of, the lumen of main shaft 307, if desirable or useful.
In accordance with an embodiment of the present invention the method of retaining a malabsorptive component of a weight reduction system to a restrictive component of a weight reduction system and the method of retaining a separating device in a region of an intussusception may begin with transorally advancing an intussusception-forming device, as shown in
Weight reduction is most effective when a restrictive component of a weight reduction system is integrated with a malabsorptive component of a weight reduction system. The restrictive component of a weight reduction system may be formed in one or more hollow organs, for example by folding tissue or forming an intussusception. Additionally, or alternatively, the restrictive component may also be a space-occupying or volume-occupying object that is inserted to take up space within the hollow organ thereby reducing or restricting the remaining volume of the hollow organ that is available to fill with food. The space-occupying object may be a solid, liquid, or gas and may be fixed in form or transformable. For example, a transformable space-occupying object may be an inflatable balloon or a device that swells. The malabsorptive component of a weight reduction system may be an implantable separating device, a sleeve, or a membrane that is impermeable or selectively permeable to restrict the passage of materials across it. Additionally, or alternatively, the malabsorptive component may also be created by painting a coating on a surface of a hollow organ. Further, the malabsorptive component may also be created by modifying a surface texture, shape, and the like, of a tissue or a hollow organ to impede the ability of the tissue or organ to absorb calories.
Although the primary focus and advancement of the present invention is estimated to be improved retention of gastrointestinal implants and/or devices by incorporating the interserosal fibrotic tissue of an intussusception in hollow organs, in some embodiments also provided herein are advances in sleeve design. Although the present invention is suited for use with traditional, conventional, and contemporary sleeves it is also suited for use with the novel sleeves as taught herein.
As an alternative to a flexible, floppy sleeve capable of unintended or iatrogenic deformation or inversion, the present invention provides a semi-supported sleeve to hold its shape and position better. The semi-supported structure may be provided through springs or struts. Rather than an unsupported distal end the sleeve may alternatively have a semi-supported or supported distal end. One advantage of an at least semi-supported distal end is that it would be less likely to invert upon the portion of sleeve above it. Additionally, a distally semi-supported sleeve would make it easier for food to eventually exit the sleeve to make its way through the rest of the GI tract and exit the body. According to preferred embodiments, a semi-supported sleeve may be self-deploying along parts of it, such as at a top and a bottom. Additionally, parts of the sleeve, such as the bottom and other portions within narrower tracts of the anatomy, can deploy to friction fit inside the GI canal.
It will be apparent from the foregoing that while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
This application is a division of U.S. Ser. No. 13/111,876, filed May 19, 2011, which is a continuation-in-part (CIP) of co-pending, commonly owned U.S. application Ser. No. 11/870,096, filed Oct. 10, 2007, all of which are incorporated herein by reference in their entirety. This application may also be related to U.S. application Ser. No. 12/265,509, filed Nov. 5, 2008; and U.S. application Ser. No. 12/265,539, filed Nov. 5, 2008; both of which are also herein incorporated by reference in their entirety. U.S. Ser. No. 13/111,876 claims priority from U.S. Ser. No. 61/347,089 filed May 21, 2010, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61347089 | May 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13111876 | May 2011 | US |
| Child | 13489875 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11870096 | Oct 2007 | US |
| Child | 13111876 | US |
