Abstract:
A device for treating obesity by limiting absorption of food through a wall of a duodenum of a patient including a sleeve inserted into the duodenum of a patient. The sleeve includes a plurality of first blocking areas and a plurality of first food absorption areas, the first blocking areas providing duodenum wall covers to prevent food absorption through the duodenum wall and the first blocking areas together defining a first total blocking area. The first food absorption areas providing access to the duodenum wall to enable food absorption through the duodenum wall and the first food absorption areas together defining a first total absorption area.

Description:
[0001]    This application claims priority from provisional application Ser. No. 61/975,764, filed Apr. 5, 2014, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The application relates to a sleeve for treating obesity, and, more particularly, to a sleeve placed in the duodenum to limit absorption of food. 
         [0004]    2. Background of the Related Art 
         [0005]    The duodenum is the proximal portion of the small intestine extending from the pylorus to the jejunum. It is the shortest path of the small intestine where most chemical digestion takes place, and is typically between 10-15 inches long. The superior part of the duodenum is connected to the liver. The inferior part passes to the left. The pancreatic duct and common bile duct enter the descending part of the duodenum thought the major duodenal papilla. The ascending part of the duodenum joins with the jejunum at the duodenojejunal flexure. 
         [0006]    Inside the duodenum occurs the mixing of acid chyme from the stomach, bile from the liver and gallbladder, pancreatic juice and intestinal juices. The entry of acid chyme into the duodenum brings about discharge of bile from the gallbladder and the secretion of pancreatic juice by the pancreas. 
         [0007]    The duodenum is largely responsible for the breakdown of food in the small intestine, using enzymes. The duodenum also regulates the rate of emptying the stomach via hormonal pathways. Secretin and cholecystokinin are released from cells in the duodenal epithelium in response to acidic and fatty stimula present there when the pylorus opens and releases gastric chyme into the duodenum for further digestion. These cause the liver and gall bladder to release bile, and the pancreas to release bicarbonate and digestive enzymes such as trypsin, lipase, and amylase into the duodenum as needed. 
         [0008]    The incidence of obesity continues to increase worldwide. Obesity has been defined in terms of a body mass index greater than 30, with body mass index defined by weight in kilograms divided by the square of the height in meters. (Overweight is defined as a body mass index of over 25). Obesity can cause a number of serious health conditions such as hypertension, diabetes, certain forms of cancer, coronary artery disease, stroke, congestive heart failure, and venous disease. Obesity can also cause orthopedic problems, skin problems and respiratory difficulties. 
         [0009]    A variety of methods are currently being utilized to treat obesity. In general, these procedures fall into two categories: procedures which restrict food intake or procedures which alter the anatomy of the small intestine or divert the peristalsis of a person&#39;s food intake past the small intestine to decrease caloric absorption. 
         [0010]    Some methods are designed to reduce the stomach by partition or bypass such as by stapling or tying off portions of the large or small intestine or stomach to reduce the amount of food desired by the patient, and the amount absorbed by the intestinal tract. In gastric banding, an adjustable band is placed externally of the stomach to constrict a portion of the stomach. Such treatments are designed to reduce the caloric intake of the individual by more rapidly triggering the satiety impulse or limiting the amount of food the individual can ingest. Complications can occur as the individual, due to the stomach restriction, may not be intaking sufficient nutrients. 
         [0011]    Laparoscopic methods of banding and vertical banded gastroplasty have been developed, which although provide the advantages of minimally invasive surgery compared to open surgery, are complicated to perform and oftentimes cannot be utilized, as well as can lead to adverse effects due to long term failure to ingest sufficient nutrients. 
         [0012]    Additionally, many of these surgical procedures for treating obesity have the disadvantage of being irreversible. 
       SUMMARY OF THE INVENTION 
       [0013]    The present invention advantageously provides a minimally invasive fully reversible device and method for treating obesity. The device and method limit food absorption from the duodenum thereby leading to weight reduction. The device is advantageously inserted minimally invasively, does not require reconstructive surgery of the digestive system, and is easily removable. The treatment method is also adjustable as a series of devices can be selectively inserted to actively control and maintain a desired amount of food absorption from the duodenum. 
         [0014]    More particularly, in accordance with one aspect, the present invention provides a device for treating obesity by limiting absorption of food through a wall of a duodenum of a patient. The device comprises a sleeve configured and dimensioned for insertion into the duodenum of the patient, the sleeve having a proximal portion, a distal portion and an intermediate portion between the distal and proximal portions. The sleeve includes a plurality of first blocking areas and a plurality of first food absorption areas, the first blocking areas providing duodenum wall covers to prevent food absorption through the duodenum wall and the first blocking areas together defining a first total blocking area. The first food absorption areas provide access to the duodenum wall to enable food absorption through the duodenum wall and the first food absorption areas together define a first total absorption area. 
         [0015]    In some embodiments, the first blocking areas include a plurality of spiral sections and the first food absorption areas include a plurality of gaps between the spiral sections. The sleeve can include a retrieval structure at a proximal portion and/or at a distal portion for retrieval of the sleeve. 
         [0016]    In some embodiments, the sleeve is in the form of a spiral configuration having a double helix configuration. 
         [0017]    In some embodiments, the intermediate portion of the sleeve has a transverse dimension less than a transverse dimension of a proximal portion, the intermediate portion adapted to be positioned adjacent a sphincter of the patient. 
         [0018]    In some embodiments, some of the blocking areas have a dimension different than a dimension of other of the blocking areas. 
         [0019]    In some embodiments, the first blocking areas are formed by a covering material positioned over an internal support, and the first absorption areas are formed by a plurality of pores formed in the covering material. In some embodiments, the internal support includes a series of spirals; in other embodiments, the internal support includes a mesh material. 
         [0020]    In accordance with another aspect of the present invention, a kit comprising first and second devices for treating obesity by limiting absorption of food through a wall of a duodenum of a patient is provided. The kit comprises: 
         [0021]    a first device having a first sleeve configured and dimensioned for insertion into the duodenum of the patient, the first sleeve having a proximal portion, a distal portion and an intermediate portion between the distal and proximal portions, the first sleeve including a plurality of first blocking areas and a plurality of first food absorption areas, the first blocking areas providing duodenum wall covers to prevent food absorption through the duodenum wall and the first blocking areas together defining a first total blocking area, the first food absorption areas providing access to the duodenum wall to enable food absorption through the duodenum wall and the first food absorption areas together defining a first total absorption area; and 
         [0022]    a second device having a second sleeve configured and dimensioned for insertion into the duodenum of a patient, the second sleeve having a proximal portion, a distal portion and an intermediate portion between the distal and proximal portions, the second sleeve including a plurality of second blocking areas and a plurality of second food absorption areas, the second blocking areas providing duodenum wall covers to prevent food absorption through the duodenum wall and the second blocking areas together defining a second total blocking area, the second food absorption areas providing access to the duodenum wall and together defining a second total absorption area to enable food absorption through the duodenum wall, wherein the second total blocking area is greater than the first total blocking area and the second total absorption area being less than the first total absorption area. 
         [0023]    In some embodiments, the first absorption areas include a first plurality of pores formed in a first covering material of the first sleeve and the second absorption areas include a second plurality of pores formed in a second covering material of the second sleeve. In some embodiments, the number of pores in the first plurality of pores is greater than a number of pores in the second plurality of pores. In some embodiments, a size of the pores in the first plurality of pores is greater than a size of the pores in the second plurality of pores. In some embodiments, the first blocking areas include a first plurality of spiral sections and the second blocking areas include a second plurality of spiral sections. In some embodiments, a width of the spiral sections of the first plurality of spiral sections is less than a width of the spiral sections of the second plurality of spiral sections. In some embodiments, a pitch of the spiral sections of the first plurality of spiral sections is greater than a pitch of the spiral sections of the second plurality of spiral sections. 
         [0024]    The present invention in accordance with another aspect provides a method for treating obesity comprising: 
         [0025]    providing a sleeve having a series of blocking areas and a series of non-blocking areas; 
         [0026]    inserting the sleeve into the duodenum; and 
         [0027]    leaving the sleeve in the duodenum so that food absorption through a wall of the duodenum is blocked by the series of blocking areas and allowed by the series of non-blocking areas. 
         [0028]    In some embodiments, the method further comprises the step of removing the sleeve after a period of time. In some embodiments, the method further comprises the step of inserting a second sleeve having a total blocking area different than a total blocking area of the removed sleeve. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0029]    So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein: 
           [0030]      FIG. 1  is a perspective view of a first embodiment of the duodenum sleeve of the present invention shown positioned in the duodenum; 
           [0031]      FIG. 2A  is a side perspective view of an alternate embodiment of the sleeve of the present invention; 
           [0032]      FIG. 2B  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0033]      FIG. 3  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0034]      FIG. 4  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0035]      FIG. 5  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0036]      FIG. 6A  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0037]      FIG. 6B  is a side perspective view of another alternate embodiment of the sleeve of the present invention; 
           [0038]      FIG. 7  is a perspective view of another alternate embodiment of the sleeve of the present invention shown positioned in the duodenum; and 
           [0039]      FIG. 8  is a perspective view of yet another embodiment of the duodenum sleeve of the present invention shown positioned in the duodenum. 
           [0040]      FIG. 9  is a perspective view of a first kit of the present invention containing two different sleeves; and 
           [0041]      FIG. 10  is a perspective view of a second kit of the present invention containing two different sleeves. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0042]    Referring now to the drawings wherein like reference numerals identify similar structural features of the apparatus disclosed herein, there is illustrated in  FIG. 1  a duodenum sleeve in accordance with one embodiment of the subject invention and designated generally by reference numeral  10 . As shown, the sleeve  10  is positioned in the duodenum  2  of a patient. The duodenum sleeve  10  is positioned and configured to limit the amount of food absorbed by the blood vessels by diffusion from the walls of the duodenum or the proximal jejunum. That is, the sleeve  10  limits the absorption area, meaning less food is absorbed and therefore leading to weight loss as the non-absorbed food passes through the intestines and out the body. Stated another way, in the absence of the sleeve, a given amount of food would be absorbed through the bowel walls; in the presence of the sleeve less amount of food will be absorbed through the walls. The amount of food absorbed is dependent on the total area of the sleeve which blocks the wall of the duodenum. This is described in more detail below. 
         [0043]    The sleeve  10  is composed of a body formed into a spiral shape and having a first proximal portion  12  and a second distal portion  14 . The sleeve  10  can be formed of a metal or plastic material. The spirals (coils)  16  obstruct the duodenum wall and therefore prevent absorption of the food from the duodenum  2 . The spirals  16 , as do the spirals of the other sleeves disclosed herein, also exert a radial force on the duodenum wall to retain the sleeve in place. Absorption of the food is limited to the space or gaps  18  between the spiral bands  16 . Therefore, the coils or spirals each form a blocking area, with the total blocking area being the total surface area of all the coils. Conversely, the total food absorption area is defined by the total area between the coils since the food can be absorbed through the duodenum wall in this area. 
         [0044]    The sleeve  10  is removable to advantageously provide a temporary device for treating obesity. Removability also enables sleeves with different structures to be utilized. This is described in detail below. Consequently, the sleeve  10 , or any other of the sleeves disclosed herein, can be placed in the body for a limited amount of time if desired. If complications arise from lack of food absorption, or for other reasons, the sleeve  10  can easily be removed. 
         [0045]    The sleeve in some embodiments can have a retrieval structure, such as retrieval structure  17  at proximal portion  12 ′ and retrieval structure  19  at distal portion  14 ′ of sleeve  10 ′ of  FIG. 2B . In this embodiment, the retrieval structure  17 ,  19  is in the form of a hook which can be grasped by a retrieval tool. In this way, the sleeve  10 ′ can be easily removed from the duodenum, thereby advantageously providing a temporary device for treating obesity. In all other respects, sleeve  10 ′ is identical to sleeve  10 . 
         [0046]    In the embodiment of  FIG. 2A , the retrieval structure is in the form of a ball tip rather than a hook. More specifically, sleeve  20  has a proximal portion  22 , a distal portion  24  and an intermediate portion  26 . A ball tip  27  is provided at the proximal portion  22  and a ball tip  29  is provided at the distal portion  24  for grasping by a retrieval tool for removal of the sleeve  20 . Note the hook, ball or other retrieval structure can be utilized with any of the sleeves disclosed herein. In all other respects, sleeve  20  is identical to sleeve  10 . 
         [0047]    The amount of spacing between the spirals of the sleeve determines the amount of food absorption and can be adjusted to adjust the amount of food absorbed. That is, since food is absorbed only through the regions of the duodenum wall not blocked by the sleeve, i.e., the non-blocking or food absorption areas defined herein, the sleeve configuration and/or geometry can be varied to achieve the desired amount of food blockage and absorption. Stated another way, the greater the sleeve surface area, the greater the weight loss. In this manner, the desired amount of food absorption can be regulated by selection of the optimal sleeve geometry and in certain instances, sleeves of progressively greater or less food absorption areas (gaps between the spirals) can be progressively replaced so the amount of food absorption is progressively increased or decreased as desired. For example, to incrementally treat obesity, a sleeve having larger gaps can be the initial sleeve inserted so that a relatively larger amount of food is absorbed. After a period of time, the sleeve is removed and replaced by a sleeve having smaller gaps (wider spirals) so that less food is absorbed. The second sleeve can be removed and replaced by a third sleeve having even smaller gaps so that even less food is absorbed. By having smaller gaps, a smaller total non-blocking (food absorption) area is provided and a larger blocking area is provided. Conversely, by having larger gaps, a larger total non-blocking area (and smaller blocking area) is provided, allowing more absorption and less weight loss. Therefore, it is also contemplated to start with a sleeve with smaller gaps and replace it with sleeve(s) of larger gaps. To summarize:
       ↑width or number of spirals→↓absorption more→weight loss   ↓width or number of spirals→↑absorption→less weight loss   ↑gap between spirals→↓absorption→↓weight loss   ↓gap between spirals→↓absorption→↑weight loss       
 
         [0052]      FIG. 3  illustrates an example of a sleeve with thicker (wider) spirals to create smaller gaps for food absorption. As shown, the width w 2  of the spiral bands  23  of sleeve  21  is greater than the width w 1  of the spiral bands  16  (or  16 ′) of sleeve  10  (or  10 ′) of  FIGS. 1 and 2B . This provides a smaller gap  28  for less food absorption and greater weight loss. 
         [0053]    It should be appreciated that although each of the sleeves are shown with a uniform configuration, it is also contemplated that the pitch and/or width of the coiled sections can vary in the individual sleeve to provide regions of the sleeve with different absorption rates. 
         [0054]    In the embodiment of  FIG. 4 , the sleeve  30  has a proximal portion  32 , a distal portion  34  and an intermediate portion  36 . The intermediate portion  36  has a reduced diameter to accommodate the narrowed diameter of the sphincter. In all other respects sleeve  30  is identical to sleeve  10 , i.e., has spiral sections  37  with gaps  38  therebetween. 
         [0055]    Another way to adjust the gaps (non-blocking area) to affect the amount of food absorption is to vary the pitch of the spirals. That is, instead of changing the width of the spiral, the space between the spirals is altered to provide a larger or smaller gap. This is shown for example in the embodiment of  FIG. 5  where the pitch has been decreased so that the gaps  46  between the spirals  42  of sleeve  40  are less than that of the embodiment of  FIG. 2B . In this manner, reduced food absorption leading to greater weight loss is achieved. In all other respects, sleeve  40  is identical to sleeve  10 . 
         [0056]    In the alternate embodiment of  FIG. 6A , sleeve  50  is in the form of a double spiral  52  and  54 , each wound in the same direction, with the gaps between the spirals  52 ,  54  designated by reference numeral  56 . The width of the spirals and/or pitch can be varied to adjust food absorption as described above. In the alternate embodiment of  FIG. 6B , a double helix structure is provided, with helix  72  and  74  wound in opposite directions forming sleeve  70 . Gaps  76  define the non-blocking areas for food absorption. 
         [0057]    The sleeves described herein can be formed of a metallic or non-metallic, e.g., plastic, material. Additionally, the sleeves described herein can be provided with the hook, ball tip or other retrieval structure to facilitate removal. Moreover, the sleeves can have areas of different cross sectional dimension. 
         [0058]    Preferably, the sleeve has a cross-sectional dimension (or diameter) in its normal state that is slightly greater than the internal diameter of the duodenum. For delivery, the sleeve is placed within a delivery device and compressed to a smaller cross-sectional dimension providing a reduced profile for delivery. The delivery device is advanced into or adjacent the duodenum. The delivery device (and sleeve) can be advanced transorally in some embodiments. The sleeve is exposed from the delivery device and then expands to its normal cross-sectional dimension. Being slightly greater than the internal diameter of the duodenum wall, in its normal position it provides a sufficient radial force against the duodenum wall to thereby be retained within the duodenum. 
         [0059]    In alternate embodiments, the duodenum sleeves described above can include an outer sleeve placed over the spirals. This is shown for example in the embodiment of  FIG. 7 . The sleeve  60  has an internal spiral section  62  and an external covering material  64 . The covering material  64  is attached to the spiral section in a variety of known methods. The spiral section thereby forms the support section (internal support) for the covering material  64 . Pores  66  are formed in the covering material  64 , preferably in the region between the spirals  65 , although they can be formed in all portions of the covering material as illustrated. The size and/or number of pores can be varied to adjust the amount of food absorption to regulate the weight loss. For example, a larger number of pores will result in greater food absorption and less weight loss. Conversely, a smaller number of pores will result in less food absorption and greater weight loss. Larger pore size will cause greater food absorption and less weight loss. Consequently, different sleeves having varying covering material pores can be used to control weight loss by adjusting the amount of food absorption at various times for the patient as described herein. To summarize:
       ↑number of pores→↑absorption→less weight loss   ↓number of pores→↓absorption→more weight loss   ↑pore size→↑absorption→less weight loss   ↓pore size→↓absorption→more weight loss       
 
         [0064]    Note that pores can vary in different parts of the covering material. 
         [0065]    The spiral section provides a support for the covering section  64 . In an alternate embodiment, a stent can be positioned within the covering material  64 . In another alternate embodiment, a mesh material can provide an internal supporting structure for the covering section  64 . This is shown in  FIG. 8  where mesh  70  supports covering material  72 . Pores in covering material  72  allow for food absorption as in the embodiment of  FIG. 7 . 
         [0066]    In the foregoing manners, the weight loss can be monitored in some instances so that wider spirals provide wider wall covering area to provide greater weight loss, smaller width spirals would correlate to moderate weight loss and then even smaller width spirals, creating less wall covering area, can then be utilized for maintenance. Thus, controlled weight loss can be achieved utilizing minimally invasive surgery and in a fully reversible manner. Such monitoring can also be provided with different pitches, pores, etc., as described above. 
         [0067]      FIGS. 9 and 10  show examples of kits utilized to achieve the aforedescribed absorption adjustability of the present invention. In the kit of  FIG. 9 , two sleeves are provided, both of which have spiral sections. The sleeves are different in that the sleeves have spiral sections of differing widths. For example, the kit can include the sleeve  10  of  FIG. 1  and the sleeve  21  of  FIG. 3 . In this manner, if greater weight loss is desired, sleeve  10  can be withdrawn from the patient&#39;s body and sleeve  21  inserted into the duodenum so that there are smaller gaps between the spirals or coiled sections. If less weight loss is desired, sleeve  21  can be removed and replaced by sleeve  10 . In the kit example of  FIG. 10 , the two sleeves  80 ,  90  include a coiled section  82 ,  92  and a cover material  84 ,  94 , respectively, overlying the coiled section. The two coiled sections are identical; however the sleeves are different because the amount and size of the pores differs. In sleeve  80 , the pores are larger and more numerous than the pores in sleeve  90 . In this manner, if greater weight loss is desired, sleeve  80  can be withdrawn from the patient&#39;s body and sleeve  90  inserted into the duodenum so that there are smaller openings for food absorption. If less weight loss is desired, sleeve  90  can be removed and replaced by sleeve  80 . 
         [0068]    In use, the sleeve delivery device is preferably inserted transorally and advanced into the duodenum. The sleeve is withdrawn to expose the sleeve (or the sleeve is moved distally out of the delivery device) for placement of the sleeve in the duodenum. In some embodiments, the delivery device can include an endoscope to provide visualization during advancement and placement of the sleeve. 
         [0069]    The foregoing sleeves can alternatively be inserted via a jejunal access or through open surgery. 
         [0070]    Although the apparatus and method of the subject invention have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present invention as defined by the appended claims.