Abstract:
A gastrostomy device includes a tubular portion and an internal bolster having a radial wing secured to the tubular portion. The internal bolster is flexible and permits elastic deformation between a first orientation with the wing wrapped into a generally cylindrical configuration and a second orientation with the wing unfurled. A constraining member encases the internal bolster to retain the internal bolster in the first orientation and to cover at least a major portion of the wrapped wing. Removal of the casing permits the internal bolster to move from the first orientation to the second orientation. The internal bolster may be deployed by a ripcord, freeing the internal bolster into the patient&#39; stomach and deploying the internal bolster to the second orientation. Alternatively, the internal bolster may be deployed by the constraining member being dissolved by the patient&#39;s bodily fluids located inside the patient&#39;s stomach.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. patent application Ser. No. 10/016,532, which was filed on Dec. 10, 2001 and entitled PERCUTANEOUS GASTROSTOMY DEVICE. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates generally to a gastrostomy feeding device and specifically, to a novel and improved gastrostomy feeding device for deploying an internal bolster into a patient&#39;s stomach where a constraining member that encases the internal bolster takes the form of either a dissolvable capsule that is deployed using a ripcord or a sacrificial tape wrapping. 
     There are many medical applications in which a device or substance must be contained or constrained prior to placement in the body. Methods commonly used to insert non-balloon type entral feeding devices result in excessive patient discomfort. 
     It is known that devices are available for supplying food and/or medication to a patient within the stomach. For example, U.S. Pat. No. 4,666,433 discloses such a gastrostomy feeding device that is inserted through a stoma and into the patient&#39;s stomach. The &#39;433 device is secured in place by an inflatable balloon or mushroom tip within the stomach, and by an adjustable ring on the abdominal wall. 
     U.S. Pat. No. 5,941,855, which is included herein in its entirety by reference, discloses a gastrostomy device having a tubular portion, first and second fingers, a rod member and a suture member. The rod member and suture member cooperate to releasably retain the fingers in an installation configuration for insertion through a patient&#39;s stomach. Following insertion, the rod member and suture member release the fingers to permit the fingers to move to a deployed configuration. In the installation configuration, the fingers are generally in line with an axis of the tubular portion while, in the deployed configuration, the fingers are generally transverse to the tubular portion axis. 
     It is also known that emplacement of a gastrostomy tube is simplified by compressing the enlarged end into a capsule or binding of a material that dissolves in the body. U.S. Pat. No. 4,393,873 discloses a gastrostomy tube packaged for insertion using a gelatin capsule technique. The head is compressed and wrapped or bound in a soluble suture thread or other web or thread made of a material which is soluble in the stomach. 
     Certain medical devices called stents are well known and have a variety of forms. U.S. Pat. No. 5,234,457 discloses a stent which is maintained in a collapsed condition by a dissolvable material. When the stent is placed in a vessel and bounded by a vessel wall, the material changes from a solid to a liquid to permit the stent to expand into the vessel wall. 
     Although it is common in the art to use the medical devices described above, the present invention improves upon them by providing a technique wherein a dissolvable member and a ripcord are combined onto a gastrostomy feeding device. The ease and comfort of the patient improves greatly using the present invention and the ripcord gives the caregiver an immediate and positive indication that the internal bolster has been released into the patient&#39;s body unlike the prior art devices. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a percutaneous gastrostomy device comprising, a tubular portion defining a longitudinal axis, an internal bolster having a radial wing secured to the tubular portion, the internal bolster being flexible to permit elastic deformation between a first orientation generally aligned with the longitudinal axis, with the wing wrapped into a generally cylindrical configuration and a second orientation with the wing unfurled and extending generally transverse to the tubular portion longitudinal axis and a constraining member encasing the internal bolster to retain the internal bolster in the first orientation, with the wing wrapped into the generally cylindrical configuration, and to cover at least a major portion of the wrapped wing, wherein the removal of the casing permits the internal bolster to move from the first orientation to the second orientation. 
     In accordance with one aspect of this invention, a method and apparatus is provided to constrain a medical device or substance in a dissolvable material and release it inside the body. 
     In accordance with another aspect of this invention, a novel and improved medical device packaging and delivery method is provided. 
     In accordance with still another aspect of this invention, the novel and improved medical delivery method has a wide range of applications including, but not limited to, catheters, stents, invasive radiology, etc. 
     In normal operation of the illustrated embodiment, this invention gives the care giver a positive indication that the device has been released. 
     These and other aspects of this invention are illustrated in the accompanying drawings, and are more fully disclosed in the following specification. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of the gastrostomy feeding device with a capsuled constraining member and ripcord according to one aspect of the present invention; 
         FIG. 1A  is a perspective view of the gastrostomy feeding device according to the present invention deployed and installed in a patient&#39;s stomach; 
         FIG. 2  illustrates a rod member assembly according to the present invention; 
         FIG. 3  illustrates an internal bolster secured to a tubular portion; 
         FIG. 3A  illustrates the internal bolster secured to a tubular portion and the rod member&#39;s distal end received within a pocket of the internal bolster; 
         FIG. 3B  illustrates the internal bolster secured to a tubular portion and the rod member&#39;s distal end received within a pocket of the internal bolster and the internal bolster folded around the tubular portion; 
         FIG. 4  is an exploded view showing the internal bolster and a single loop ripcord deployment method; 
         FIG. 4A  illustrates the internal bolster folded with the rod member installed and with a capsule constraining member and single loop ripcord deployment method; 
         FIG. 5  illustrates the capsule loading fixtures according to the present invention; 
         FIG. 6  is an exploded view showing the installation of the ripcord into the capsule and through the assembly fixture according to the present invention; 
         FIG. 7  illustrates the capsule with ripcord in the assembly fixture according to one aspect of the present invention; 
         FIG. 8  illustrates an alternate embodiment of the gastrostomy feeding device with a wrapped constraining member; 
         FIG. 9  illustrates a partial perspective view of an alternate embodiment of the gastrostomy with the rod member outside the tubular portion and with a wrapped constraining member; 
         FIG. 10  illustrates an exploded view showing the internal bolster and a double loop ripcord deployment method 
         FIG. 10A  illustrates the gastrostomy device folded with the rod member installed and with a capsule constraining member and double loop ripcord deployment method; and 
         FIG. 11  is an end view of the capsule using the double loop deployment method for the ripcord of the present invention. 
         FIG. 12  illustrates the gastrostomy feeding device having a double loop ripcord arrangement according to an aspect of the present invention. 
     
    
    
     DESCRIPTION OF THE INVENTION 
     With reference to the drawing figures, a gastrostomy device  10  and a method of assembling the device  10  is illustrated. The gastrostomy device  10  with dissolvable capsule and ripcord is illustrated in  FIG. 1 . As shown in  FIG. 1A , once deployed, the gastrostomy device consists of a proximal extension  12  positioned outside the body and a distal extension  14  positioned within the body. 
     The gastrostomy device  10  is inserted inside the body and positioned on the patient&#39;s abdomen by an adjustable silicone locking ring  40 . As shown in  FIGS. 1 and 1A , the locking ring  40  is provided with a plurality of vent holes  42  and circular ridges  44  to permit air to contact the entry to the body and reduce infection and irritation. Use of the ring  40 , prevents the gastrostomy device  10  from being drawn into the body. 
     The gastrostomy device  10  includes a tubular portion  16  having a distal end  18  and a proximal end  17 . The distal end  18  has an internal bolster  30  secured thereto. The tubular portion  16  and the internal bolster  30  may be integrally molded together from a bio-compatible material, such as a silicone rubber. 
     Referring to  FIG. 2 , rod member  20  comprises a hollow tube  21  having a proximal end  22  and a distal end  24 . The rod member  20  is positioned inside the tubular portion  16  of device  10 , as will be discussed more fully hereinafter. As shown in  FIG. 2 , the rod member  20  is hollow along its longitudinal axis and includes a handle  25  at its proximal end  22 . 
     Referring to  FIG. 3 , an internal bolster  30  has a first part  31  and a second part  33 . The first and second parts  31 ,  33  cooperate to provide lateral regions  34 . The lateral regions  34  are secured in a deformed condition when the internal bolster  30  is in an installed configuration. 
     The first part  31  of the internal bolster  30  is generally semi-oval. The second part  33  of the bolster is integrally connected to the first part and defines a radial wing  35 . The radial wing  35  includes, on its outer surface, a pocket  32  for receipt of the rod member  20  ( FIG. 2 ) to permit deformation of the internal bolster  30  from a first orientation, to a second orientation, as will be discussed more fully hereinafter. 
     With specific reference to  FIG. 3 , the tubular portion  16  includes a proximal end  17 , through which food is fed and a distal end  18  that is positioned within the body for insertion in a patient&#39;s stoma. The internal bolster  30  is located on the distal end  18  of tubular portion  16 . A pocket  32  for receipt of the proximal end  24  of the rod member  20  ( FIG. 2 ) is also located on the internal bolster  30 . 
     With specific reference to  FIG. 3A , the rod member  20  extends within the tubular portion  16  and includes a projecting end  26  that extends beyond the tubular portion opening  19  at the distal end  18  of the tubular portion. The rod member projecting end  26  is removably inserted into the pocket  32  provided on the radial wing  35 . As shown in  FIG. 3A , the radial wing  35  of the internal bolster  30  is bent or deformed by the rod member  20  to be in-line with an axis A of the tubular portion  16 , as illustrated. 
     As shown in  FIG. 3B , the internal bolster  30  is folded around the distal end  18  of the feeding tube  16 , therefore allowing the internal bolster  30  to be inserted inside a capsule as will be discussed more fully hereinafter. 
     Referring now to  FIG. 4 , a capsule  62  encases the internal bolster to retain the internal bolster  30  in the first orientation, with the wing wrapped into a generally cylindrical configuration and to cover at least a major portion of the wrapped wing. The constraining member may be in the form of a capsule  62 . The capsule  62  is formed into a hollow tubular shape with one open end and one end rounded to a hemispherical shape. On the rounded end of the capsule  62  is located a hole  66  through which a ripcord  50  is threaded as will be described in further detail below. The capsule  62  is located on the distal extension  14  of the gastrostomy device  10 . The capsule  62  is placed over the folded internal bolster  30  as shown in  FIG. 4 . The capsule  62  maintains the internal bolster  30  in its folded position until the gastrostomy device  10  is deployed inside of the body. 
     The gastrostomy feeding device  10  as described, employs a ripcord  50 . The ripcord  50 , as shown in  FIG. 4A , is provided with a pull tab  52 . The ripcord  50  is threaded through the hollow tube  21 , through the opening  36  in pocket  32  ( FIG. 4 ) on internal bolster  30 , through the passage in the pocket, and out through pocket exit hole  38 , through capsule  62 , through hole  66  in the capsule, along the sidewall of the capsule and back through pocket exit hole  38  and back through hollow tube  21 . Both ends of the ripcord  50  extend through the handle  25  of rod member  20  and are fastened to a pull tab  52 . The pull tab  52  is positioned at the proximal extension  12  of the completed gastrostomy feeding device  10 . 
     Referring now to  FIG. 5 , an assembly fixture  70  includes a capsule holder  72  and funnel  74 , employed to assemble a folded internal bolster  30  inside of the capsule  62 . The capsule holder  72  is a rigid cylindrical body containing a cylindrical recess  73  for accommodating an empty capsule  62  and an air pocket relief aperture  75  at the end section  78  of the cylinder recess  73 . The funnel  74  is defined by a conical recess  79  at one end, and cylindrical recess  76  at the other end. During assembly, the capsule  62  ( FIG. 7 ) is placed in the capsule holder  72 . The capsule holder  72  is then fitted into the cylindrical recess  76  of funnel  74 , and the conical shape of conical recess  79  acts as a funnel to guide the internal bolster  30  into the open end of the capsule  62 . 
     Referring now to  FIG. 6 , the assembly of the gastrostomy  10  device with the dissolvable capsule  62  and the ripcord  50  will now be described. The rod member  20  is inserted into the end of the tube  16 , and out through the hole in the center of the internal bolster  30  and into the pocket  32 . 
     A length of ripcord  50  is threaded through a hole  66  ( FIG. 4 ) located in the end of capsule  62 . Both ends of the ripcord  50  are then threaded through the funnel  74  ( FIG. 6 ) of assembly fixture  70 , through pocket  32  on internal bolster  30  ( FIG. 4 ), though the hollow tube  21 , and through the handle  25  and fastened to the pull tab  52 . The capsule  62  and ripcord  50  are then inserted into the assembly fixture  70  as shown in  FIG. 7 . The sides of the internal bolster  30  are folded by the conical recess  79  as the rod member  20  and ripcord  50  are inserted into the assembly fixture  70  and into the capsule to the position shown in  FIG. 7 . 
     The feeding tube assembly, as shown in  FIG. 4 , is removed from the assembly fixture  70  with the folded internal bolster  30  contained inside the capsule  62  and the ripcord  50  exposed. 
     The constraining member  60  may also be a wrapping  64  as shown in  FIG. 8 . The wrapping  64  acts to contain the internal bolster  30  in its folded position in a similar way as is achieved with the capsule  62 . Prior to assembly, the wrapping  64  is in the form of a long narrow strip. The strip of wrapping is manually wrapped about the folded internal bolster  30  to secure it in the folded position for insertion into the body. The wrapping forms the constraining member  60  around the folded internal bolster  30  in any thickness, shape or manner desired. A ripcord  50  may also be employed with the wrapper in a manner similar to that of the capsule  62  as discussed above as the first embodiment for deployment. The capsule  62  or wrapping  64  may be made of a material such as vegetable cellulose (HPMC). The material is such that upon insertion of the capsule or wrapping inside the body, the capsule  62  or wrapping  64  may dissolve inside the body. 
     One technique for emplacement of the gastrostomy device  10  is to insert the distal end  14  of the gastrostomy device through the stoma and into the stomach. The constraining member  60  (either the capsule  62  or the wrapping  64 ) is released by grasping the handle  25  with one hand and pulling the tab  52  of the ripcord  50  with the other hand. This action tightens up the loop in the ripcord  50  to tear through the sidewall of the constraining member  60 . The projecting member  26  of the rod is withdrawn from the pocket  32  by grasping the proximal extension  12  of the device  10  and pulling the handle  25 . This frees the bolster  30  and the bolster returns to its original shape as illustrated in  FIG. 1A . The torn member  60  then dissolves inside the body. 
     Another technique for emplacement of the gastrostomy device  10  is to insert the distal end  14  of the gastrostomy device through the stoma and into the stomach and then the constraining member  60  (either the capsule  62  or the wrapping  64 ) is released by the dissolution of the constraining member by the patient&#39;s bodily fluids located inside the patients stomach to free the bolster  30 . The constraining member  60  is made of a material dissolvable in the patient&#39;s stomach at a temperature range of between 50-100 degree F. 
     Using this technique, the ripcord  50  acts as a deployment indicator, when the ripcord can be withdrawn with little or no resistance, the bolster  30  has returned to its original shape as illustrated in  FIG. 1A . 
     With specific reference to  FIG. 9 , a partial perspective view of an alternate embodiment of the present invention is shown where the rod member  20  preferably extends alongside and generally parallel to the tubular portion  16  at the distal end  18  of the gastrostomy device  10 . In this alternative embodiment, the constraining member  60  may be either a wrapping  64  or a capsule  62  and will operate as described above in the previous embodiment. In addition, the emplacement technique to free the bolster  30  may be either by the use of a ripcord  50  or from the dissolution of the constraining member  60  by the patient&#39;s bodily fluids located inside the patient&#39;s stomach as described above in the previous embodiment. 
     When using the dissolution technique, the time necessary for dissolution of the constraining member  60  may be controlled by injecting a diluent, such as water, through the tube  16 . The diluent travels along axis A ( FIG. 3 ) and into the capsule  62  ( FIG. 4 ), out of the hole  66  and into the patient&#39;s stomach ( FIG. 1A ). Controlling how and when the dissolution takes place may be achieved in a number of ways, for example, by varying the dissolution temperature of the constraining member, by varying the molecular weight and degree of hydrolysis of the diluent, by varying the rate of diluent delivery, and by varying the amount of exposed surface area used on the constraining member. 
     With specific reference to  FIG. 10 , the ripcord is shown using a double loop deployment arrangement. In using the double loop arrangement, the ripcord  50  is laced though the capsule  62  twice. The exposed ripcords are positioned 180 degrees apart ( FIG. 11 ) and when the ripcord  50  is pulled, the capsule is cut into two halves. The emplacement technique to free the bolster  30  in the double loop arrangement may be either by the use of a ripcord  50  or from the dissolution of the constraining member  60  by the patient&#39;s bodily fluids. In addition, in the double loop arrangement as shown in  FIG. 12 , the ripcord  50  can exit the tube  16  through hollow tube  21  of rod member  20  (path I as illustrated in  FIG. 12 ) or through the end of the tube  16  (path O as illustrated in  FIG. 12 ). 
     In addition as shown in  FIG. 12 , the ripcord  50  as it loops in either the double loop or single loop arrangement around capsule  62  engages in a slot section  58  that enables the ripcord to tightly fit along the outside of capsule  62 . 
     Although the invention has been shown and described with respect to a certain embodiment, it is obvious that equivalent alterations and modifications will occur to others skilled in the art upon reading and understanding of the specification. The present invention includes all such equivalent alterations and modifications, and is limited only by the scope of the claims.