Patent Publication Number: US-2023133253-A1

Title: Inflatable occluder apparatus and method for using the same

Description:
TECHNICAL FIELD 
     This novel technology relates generally to the field of medicine and, more particularly, to an occluder for repairing atrial septal defects, Patent Foramen  Ovale  (PFO), ventricular septal defects, patent ductus arteriosus, paravalvular leaks, vascular communications, or the like, that allows access to the chamber on the other side of the occluder. 
     BACKGROUND 
     Catheter-based treatment for heart diseases is the fastest, and increasingly favorite, option for management of variety of common cardiac disorders such as atrial fibrillation, affecting about 2.3 million patients in the U.S., mitral valve repair for mitral regurgitation, affecting about 2% of the general population, and the like. These procedures are less invasive and better tolerated than alternative management options with overall better outcome. In the year 2020, over 38,000 left atrial appendage occluders were implanted in the US, over 31000 afib ablation procedures were performed, and an additional 80,000 percutaneous mitral valve clip procedures performed in the past few years. These numbers are expected to go up significantly in the next few years as doctors gain knowledge and experience in performing them. 
     What these cardiac problems have in common is that they affect the left atrium, a chamber that is difficult to reach with a catheter unless the doctor makes a hole in the atrial septum, the wall that separate the left from right atrium, resulting in iatrogenic Atrial septal defect (ASD). This hole enables the doctor to pass the catheter therethrough to the left atrium to perform the required procedure. Once the procedure is completed, over one third of these patients with iatrogenic ASD continue to have open ASD one year later. This number is also going up as larger holes are made to accommodate larger devices that are being implanted in the left atrium. 
     The residual ASD results in mixing of oxygenated and non-oxygenated blood, potentially causing low oxygen level, pulmonary hypertension, and eventually right sided heart failure. It can also be a conduit for a blood clot to travel to the brain from the venous side, resulting in stroke or worse. In addition, ASD has been associated with dangerous cardiac arrhythmia. 
     While surgery is a reasonable option in managing younger patients with congenital ASD, it is not appropriate in most patients with iatrogenic ASD due to the risk involved. So the remaining viable option most often contemplated is to use an ASD occluder device. 
     There are several ASD occluder known devices. These devices tend to be bulky and consist of nitinol (metallic memory) wire frame skeleton covered with a biocompatible membrane. These devices consist of a pair of relatively large self-expanding discs connected by a thinner waist. One disc is placed on the left atrial side and the other disc on the right atrial side of the hole while the waist spans the atrial septum. The discs are bulky and relatively stiff as they are meant to permanently block the ASD, forming a complete seal. However, as atrial septal defects are highly variable, the limitations of size and shape of the known occluder devices often means the matching of the device to the patient is less than ideal. As a result, in many cases there is at least some leakage. Moreover, it is very difficult to reposition the occluder device once the discs are deployed. While removal is possible, it is also very difficult due to the possibility of injury to adjacent cardiac structures from their metallic skeleton. Further, expanding stiff discs that can cause erosion to the atrial wall as well as potentially triggering arrhythmia due to irritation of the atrial wall. Because of the metallic skeleton, there is always a risk of perforation and pericardial effusion. Finally, there is a need for at least short-term anticoagulation treatment when implanting the known devices. 
     Despite potential risks of ASD and availability of these ASD occluder devices, their use is quite limited in patients with iatrogenic ASD and they are reserved to only patients with severe complications. A major contributor to the reluctance of doctors to use the known ASD occluder devices is the too common need to redo procedures, often requiring the need to make additional iatrogenic ASD. Currently, over half of the patients with afib ablation would go on to require a second ablation within one year. Likewise, most of the patients with mitral valve regurgitation will have recurrence of their disease within 7-10 years requiring another procedure. So, another puncture of the atrial septum and formation of another iatrogenic ASD is very common. This is why, the decision is made most of the time to leave an iatrogenic ASD open rather than risk an attempt to pass another catheter by making a hole in a large ASD occluder formed inside a metallic skeleton. 
     Because of this, doctors must be very selective in which patients have their iatrogenic ASD closed with an ASD occluder, and such procedures are only done sparingly in patients, typically those who are very high risk of low oxygen level and recurrent stroke. despite the potential risk involved. 
     This limitation does not only affect patients with iatrogenic ASD but also patients with congenital ASD/PFO. It is common to have afib in these patients in addition to mitral valve disease, which can present months or years after initial diagnosis of ASD. The decision to use one of the currently available PFO/ASD occluders often means that these patients will not able to undergo minimally invasive procedures that require atrial septal puncture because of the ASD occluders that have been implanted months or years before. 
     Thus, there is a need for an improved ASD/PFO occluder that may be easily repositioned or removed without excessive risk to the patient. The present novel technology addresses this need. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a first side elevation cutaway view of a first embodiment of the present novel technology, an inflatable hydrostatically supported atrial septal defect occluder device having a plurality of inflatable structural members disposed within an inflatable exterior membrane. 
         FIG.  2    is a front elevation cutaway view of the atrial septal defect occluder device of  FIG.  1   . 
         FIG.  3    is a front elevation view of a second embodiment atrial septal defect occluder device wherein the inflatable exterior membrane is the inflatable structural member. 
         FIG.  4    is a first side elevation cutaway view of a first embodiment of the present novel technology, an inflatable hydrostatically supported atrial septal defect occluder device having a plurality of inflatable structural members disposed within an inflatable exterior membrane wherein each portion of the device is independently inflatable. 
         FIG.  5    is a cutaway view of a section of the device showing multiple layers of different materials. 
         FIG.  6    is a partial cutaway view of the surface of the device showing a textured surface layer, multiple sublayers, and an inflatable chamber. 
         FIG.  7    is a cutaway view of a section of the device showing on-compliant layer embedded therein to define a predetermined shape un inflation. 
         FIG.  8    is a partial cutaway view of the surface of the device showing a compliant surface layer and a non-compliant sublayer that defines an inflated shape. 
         FIG.  9    is a front elevation cutaway view of the atrial septal defect occluder device of  FIG.  1    showing multiple check valves operationally connected to each inflatable structural member and fused layers of different materials defining the inflatable exterior membrane. 
         FIG.  10    is a cross section of the waist of the device of  FIG.  1    and showing multiple independent channels passing therethrough. 
         FIG.  11    is a front elevation cutaway view another embodiment of the atrial septal defect occluder device of  FIG.  1    showing an inflatable structural ring operationally connected to and surrounding a side disc portion. 
         FIG.  12    is a cutaway top elevation view of the device of  FIG.  1    showing inflatable structural members extending into both the left and right atrial portions and through the waist. 
         FIG.  13    is a first partial enlarged view of a structural member of  FIG.  12   . 
         FIG.  14    is a second partial enlarged view of a structural member of  FIG.  12   . 
         FIG.  15    is a side cutaway view of still another embodiment of the present novel technology, an atrial septal defect occluder device wherein each side portion includes a structural ring positioned thereabout. 
         FIG.  16    schematically illustrates the atrial septal defect occluder device of claim  1  as positioned blocking an atrial septal defect. 
         FIG.  17    schematically illustrates the atrial septal defect occluder device of claim  1  as positioned in a patient having PFO. 
         FIG.  18    schematically illustrates an occluder device embodiment having curved Tillable chambers within an outer membrane. 
         FIG.  19    schematically illustrates a hub portion of an occluder device embodiment having surface contours and magnetic portions for connection to a catheter. 
         FIG.  20    is a side cutaway view of an occluder device embodiment having contoured lobes connected by a bulged waist. 
         FIG.  21 A- 21 C  schematically illustrate an occluder embodiment having a fellable chamber portion for forming a skeleton. 
         FIG.  22    schematically illustrates a threaded hub portion of an occluder device embodiment having self-healing and two way valves for connection to a catheter. 
         FIG.  23    schematically illustrates a catheter operationally connected to the hub of  FIG.  22   . 
         FIG.  24    schematically illustrates a retrieval catheter operationally connected to the hub of  FIG.  22   . 
         FIGS.  25  and  26    schematically illustrate a catheter assembly for use with emplacing and filling an occluder device. 
         FIG.  27    schematically illustrates a retrieval catheter puncturing an occluder device. 
         FIG.  28    is a perspective vie of an occluder embodiment having an elongated waist. 
         FIG.  29 A  is a schematic view of a leaky valve. 
         FIG.  29 B  is a partial perspective view of a device lobe having curvature matching that of the leaky valve of  FIG.  19 A . 
         FIG.  29 C  is a partial side elevation view of the device of  FIG.  19 B . 
         FIG.  30    is a schematic view of an occluder embodiment having a single lobe. 
         FIG.  31 A  is a schematic view of a hubless occluder embodiment having a direct connection to a fluid source through a catheter. 
         FIG.  31 B  schematically illustrates the hubless occluder of  FIG.  21 A  having ben filled and sealed. 
         FIGS.  32 A- 32 F  are perspective views of occluder devices having various shapes. 
         FIG.  33    is a perspective view of an occluder embodiment having a tapered waist. 
         FIG.  34    is a perspective view of an occluder embodiment having an elongated tubular shape. 
         FIG.  35    is a cutaway view of an occluder device having sequential fillable discs. 
         FIG.  36 A  is a cutaway view of an occluder device having multiple channels or tubules extending therethrough. 
         FIG.  36 B  is a cutaway sectional view of the waist portion of  FIG.  26 A . 
         FIGS.  37 A- 37 H  schematically illustrate the use of an occluder device having multiple fillable chambers for anchoring within a target organ. 
         FIG.  38 A- 38 G  schematically illustrate occluder embodiments having various waist shapes and contours for avoiding putting pressure on pressure sensitive tissues. 
         FIG.  39    schematically illustrates a shaggy occluder embodiment. 
         FIG.  40    schematically illustrates an occluder embodiment having a bulging disc portion and a shaped memory metal disc portion. 
         FIG.  41    schematically illustrates an occluder embodiment wherein the occluder is a plug. 
         FIG.  42    is a top elevation view of an occluder embodiment having a spiral shape. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the claimed technology and presenting its currently understood best mode of operation, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the claimed technology is thereby intended, with such alterations and further modifications in the illustrated device and such further applications of the principles of the claimed technology as illustrated therein being contemplated as would normally occur to one skilled in the art to which the claimed technology relates. 
       FIGS.  1 - 27    illustrate various embodiments of the present novel technology, an inflatable hydrostatically supported atrial septal defect (ASD) occluder device  10  including a left atrial side portion or lobe  15 , a right atrial side portion or lobe  20 , and a waist or connection portion  25  extending therebetween. Although left and right side lobes  15 ,  20  typically have the shape of discs, the discs are not necessarily equal in size and shape and one or both may be asymmetric. The occluder device  10  is not limited to the repair of ASDs, but may also be applicable to the repair of other aperture defects, such as patent foramen  ovale , ventricular sepal defects, vascular openings, patent ductus arteriosus, and the like. The device  10  further includes at least one inlet hub or port  30  for introducing/removing fluid to inflating/deflating one more portions  15 ,  20 ,  25  of the device  10 ; the port  30  is typically positioned at the waist  25 , but may be positioned at any convenient location. The hub  30  may include break-away connection, detachable valve and/or a quick release mechanism. The hub  30  may also include a self-closing valve, duck valve, flap valve or other medical valves. Hub  30  may be operationally connected to multiple occluders  10  which may be oriented inn parallel or sequential to each other. The hub  30  may feature two way valves to enable inflating and deflating the device(s)  10 . The surface of the hub  30  may have additional padding or other materials for better attachment of a filling catheter and/or to enable better endothelial formation. 
     The hub  30  may have an internal chemical coating  37  that can fuse with opposing walls chemically or mechanically once inflation of the device  10  is complete. In some embodiments, the defect is sealed when one or both lobes  15 ,  20  are inflated against the surrounding tissue walls; in other embodiments, the defect is sealed when the waist  25  inflates sufficiently to fill the defect. 
     In some embodiments, the port  30  includes separate access channels  31 ,  32 , each respective access channel  31 ,  32  in fluidic communication a different respective portion  15 ,  20 ,  25  of the device  10 . Each portion  15 ,  20 ,  25 , may include hydrostatically inflatable portions  27  and non-inflatable portions  29 . 
     The device  10  further includes an outer portion  40  supported by inner support members  45 . The outer portion  40  extends over atrial side portions and the hub  15 ,  20 ,  25  and defines the exterior of the device  10  that is in contact with the atria tissue and blood flow. The outer portion may be a single layer, multiple layers of the same or different materials and/or as an inflatable exterior bubble defining an interior volume. The inner support members  45  are positioned within the outer portion  40  and may be filled with hydrostatic support material  5   o  to give the inner support members  45  their shape and structural properties. 
     The outer surface portion  40  and the inner support members  45  may not have homogeneous compliance so as to predetermine and control the shape of the individua members  45  and overall device  10  when inflated with hydrostatic fill material  50 . This may be accomplished by variations in materials, variations in thickness, variations in adhesion between layers, and/or the like. In some embodiments, the support members  45  and/or exterior portion  40  include multiple layers of different compliance properties to predetermine the inflated shape and size of the device  10 . 
     Support members  45  and outer layer  40  (when inflatable) are connected to the valve  33  via channels  47 , which may be unitary with the support members  45  or may be separate conduits for guiding and directing fill material  50 . Such hydrostatic support material  50  may include liquids, semi-liquids, hydrogels, gases, gas bubbles, beads, foams, fluid polymeric material, saline solution, blood, liquid polymer, polyethylene glycols, polyphosphazene, polyacrylates, polydiacrylates, polyurethane, polyacrylamide, polyvinylpyrrolidone collage, carbohydrate, polylactic acid and the like and combinations thereof. All hydrostatic fill materials  50  are biocompatible, as leaks may occur. The hydrostatic fill material may be made radiopaque (such as with the addition of an iodine-based contrast material or the like) to enhance x-ray imaging, filled with micro-bubbles to enhance ultrasound viewing, or the like. Properties of the injectable material can be changed by injecting additional material that will change the pH, cause precipitation, solidification, coagulation, ionization, change mechanical properties of the initial injectable material, change properties of the initially injectable material change properties when exposed to light, heat, cooling, laser, pressure, blood, and the like. 
     The members  45  and channels  47  may be shaped and oriented to give shape and support to the disks  15 ,  20  and the waist  25 . Typically, spaces are left between members and channels  45 ,  47  to accommodate puncturing if desired for moving and/or removing the device  10 . The exterior surface may include a marker, such as a target  49 , to guide a puncture tool to the desired puncture location. The device  10  is typically made of a pliable material to accommodate one or more punctures to accommodate repeat access if necessary. 
     The fluidic inlet valve  33  is positioned at the hub  30  and is typically a check valve to allow for unrestricted fluidic inlet (hydrostatic material  50  into the support members  45 ) but not allow egress of such materials  50  unless the valve is held open, such as by a filing needle or catheter. The inlet valve  30  may be any convenient check valve, such as spring loaded, magnetic, pressure sealed, or the like. 
     In some embodiments, the inlet port or hub  30  includes multiple fluidic inlets or pathways  31 ,  32 , each respective channel connected  31 ,  32 , in fluidic communication with a respective side  15 ,  20 , waist  25 , and/or member  45 . Each respective inlet channel  31 ,  32  may be separately accessed to inflate or deflate a side or member  15 ,  20 ,  25 ,  45 , independently of the others  15 ,  20 ,  25 ,  45 , and may include one or more check valves  33  connected in fluidic cooperation. Channels  31 ,  32  may be provided as single conduits or as pluralities of conduits cooperating with one another. The device  10  may be valved to inflate the various chambers/channels  15 ,  20 ,  25 ,  31 ,  32 ,  45  sequentially, simultaneously, or in any predetermined order. 
     The device  10  is non-metallic, with the outer surface  40  and interior support members  45  made of, typically biocompatible polymer materials such as PTFE, compliant, semi-compliant or noncompliant materials such as latex, rubber, silicone, polyurethane, Polyethylene terephthalate, polyamide, Polyethylene terephthalate, polypropylene, fluroelastomer, plastic, or any elastic or inelastic material. The outer surface  40  is typically made of a softer, more compliant material that will conform to the surface of the atrium, while the inner members  45  may be made of a stiffer material that will better withstand the pressure of the fill material  50 . The outer surface  40  may be smooth, contoured, roughened, and/or may include elongated structures extending therefrom to facilitate connection to the surrounding tissue. The device  10 , especially the outer surface  40 , may be made of biodegradable materials that dissolve over time to facilitate degradation over time and/or integration with surrounding tissue. 
     In some embodiments, small amounts of metal may be added to yield desired properties, such as a magnetic valve  30 , a magnetic engagement of a delivery catheter, structural reinforcement, and the like. 
     The surface  53  is typically a membrane and may include an inflatable edge or perimeter  54 , including one or more channels  47  for delivering and/or distributing hydrostatic support material  50 . 
     The wall of inflatable chambers can be made from compliant material such as Polycaprolactone (PCI), Pollactic acid (PLA), Polydioxanone (PDO or PDS), Polyglycolic acid (PGA). Inflatable members/chambers/channels  15 ,  20 ,  25 ,  31 ,  32 ,  45 , may be formed to take any predetermined shape, such as an H, X, Z, coil, or any like shape. 
     In some embodiments, the surface  53  of the device  10  may include one or more layers of medicinal coating  55 , such as hiruidin, fibronectin, anticoagulant, antithrombotic, antimitogens, antimitotoxins, gene therapy, nitric oxide, hirulog, heparin or the like, and/or the coating  55  may include a biocompatible adhesive. In some embodiments, the surface  53  is roughened to facilitate adherence to the surrounding tissue. In other embodiments, the surface  53  contains filaments or tentacles  60  extending therefrom to better facilitate attachment to the adjacent tissue and/or to better seal the atrial defect. 
     In operation, the occluder device  10  is loaded into a delivery catheter  100 . The device  10  is small enough to fit within delivery catheter  100 . The catheter  100  may include a suction mechanism so as to facilitate attachment to the hub  30 ; likewise, the catheter and hub  30  may be matably threaded and/or magnetically coupled to facilitate connection. The catheter  100  is guided to the site of the atrial septal defect, such as by using a magnetic stereotaxis approach, and the device  10  is deployed, positioned, and inflated with hydrostatic fill material  50 , such that respective sides  15 ,  20  are positioned on respective sides of the atrial septal defect with the waist  25  extending therebetween. 
     Catheter  100  includes a delivery tube portion  105  defining a cavity sufficiently large to enclose device  10  for in situ delivery of the device  10  through a distal end  107 . Catheter  100  further includes a proximal end  109  for connection in fluidic communication with a hydrostatic fill material source  110 . Catheter  100  may be an elongated straight member, may be curved or twisted, or may be of inconstant shape. In some embodiments, the delivery catheter  100  includes a first channel  105  for delivering the device  10  and a second channel  113  which may be used to transfer hydrostatic fill material no and/or to pump fluid therethrough. Pressure sensor  101  is disposed at or near the distal end  107 , while a pressure monitor  115  operationally connected to the pressure sensor  101 , such as via a wire  117 , is disposed at or near the proximal end  109 . Wire  117  may enjoy its own channel  119 . First channel  105  may have a syringe  121  disposed at its proximal end  109 , with one or more valves  123  connected in fluidic communication between the proximal and distal ends  109 ,  107 . 
     The catheter  100  is operationally connected in fluidic communication with one or more valves  30 , and the device  10  may be filled through one or multiple channels  31 ,  32 , with all members  45  filled simultaneously or separately. The device  10  may simply be filled with hydrostatic fil material  50  until the respective side  15 ,  20 , waist  25 , and/or structural members  45  attain their predetermined inflated shapes and/or structural support characteristics, or, more typically, the respective side  15 ,  20 , waist  25 , and/or members  45  are inflated to respective predetermined pressures equating to the desired structural shape and support strength. The pressure within the respective side  15 ,  20 , waist  25 , and/or members  45  is monitored through the catheter  100 , which includes a pressure sensor  101  operationally connected thereto. Target pressure may also be estimated based on the known properties of the respective side  15 ,  20 , waist  25 , and/or member  45  and the volume of material  50  injected. Inflation pressures may range from 0.00001 atmospheres to 1000 atmospheres, more typically from 0.01 to 1 atmospheres. The pressure used is based on the structural properties of the device, adjacent chamber pressure, adjacent tissue tolerance, and the like. 
     As more material injected into the device under pressure from the guide catheter through the hub, the volume and pressure go up in the connected chamber and/or channel, resulting in an increase in structural rigidity and formation of the desired shape. Shape is the result of radial and or longitudinal expansion based on the presence of compliant and noncompliant components of the inflatable chambers walls. 
     The device  10  may have to be partially deflated, repositioned, and re-inflated one or more times; the delivery catheter  100 , if previously disengaged, is reengaged with the device  10  and hydrostatic fill material  50  is removed from the device  10  through the catheter  100  to deflate the device  10  to a predetermined size/pressure until the device  10  is sufficiently small to remove and/or reposition. Pressure within the members  45  may be measured through the catheter  100  connected in fluidic communication therewith. In some embodiments, the hub valve(s)  30  is/are self-sealing check valves. In some embodiments, a plug  65  is engaged to seal the hub/valves  30 . In other embodiments, the hub valve(s)  30  may be sealed via a knot or clip, and in other embodiments the hub  30  is sealed via application of heat and/or cement and/or an adhesive. Once the device  10  is filled and properly positioned, the catheter  100  is disengaged from the hub  30  and withdrawn. 
     Another method to reenter the atrial septum in patients where the device  10  is stuck to the wall and cannot be safely removed, is by puncturing the device  10  in between the Tillable chambers  45  inside the left and right arial discs  15 ,  20  and making a new ASD through the space in between them. Likewise, the device  10  may be punctured using shape needle/device inside the fillable chambers  45  inside the left and right areal discs  15 ,  20  and making a new ASD through them. The device  10  may keep its shape because every fillable chamber  45  has its own valves  33  that prevent leaking from adjacent chambers  45 . Moreover, if the device  10  defines a single unitary fillable chamber, the device  10  may be punctured and drained of hydrostatic material  50  and a new ASD may be formed through the deflated device  10 . The device  10  will stay in place, and once the procedure is complete then additional ASD occluder  10  can be placed through the old one 10. 
     ASD device puncture can be done using fluoroscopy guidance or ultrasound (TEE and ICE) guidance or using fusion of different imaging modalities such as TEE and fluoroscopy, 3D echocardiography, CT derived 3D augmented fluoroscopy, real time MRI, or other imaging modality guidance. Iodinated contrast present in fillable chambers may help guide the puncture location. 
     Tools used to puncture through the ASD occluder  10  or the atrial septum include but are not limited to stainless steel needles, BRK needles, or the like, and may also include a needle-wire system, guidewire, Confida wire, Safari wire or other shape needles, wires or other sharp objects. Alternately, the puncture tool may use Radio Frequency (RF), NRG RF transseptal needle, or other needles using RF, laser, heat or other forms energy to achieve puncture. 
     After performing puncture then a guide wire may be advanced through the device then a sheath can be advanced into the left atrium using the guide wire. If larger sheath needs to be used, then further dilation of this defect can be done using dilator or balloon septostomy. 
     After completion of the procedure such as afib ablation or mitral valve repair then another ASD occluder can be implanted across the preexisting ASD occluder in a fashion similar to original technique 
     Inflatable elements can define a skeletal matrix of tubes, channels or fillable chambers  31 ,  32  in any particular pattern, radially, circular, curvature. They can in between the connecting tubes. This will enable the device  10  to unfold appropriately. These inflatable elements  31 ,  32  can be encased inside the device  10 . Once these inflatable elements  3 ,  32  are inflated at pressure and volume as described above then the device  10  gets its shape. Typically, fillable chambers  45  in the left and right atrial discs  15 ,  20  are oriented to be disposed parallel to each other  45  so that if the device  10  needs to be punctured, a puncture may be made through a space between the fillable chambers  45  in the right atrial disc  20  and continue to pass through a similar space in the left atrial disc  15 . 
     In some embodiments, the hub  30  is externally threaded  150  and/or equipped with a magnet/magnetizable portion  153 , and includes one or all of the following: a seal or plug  65  at its terminal end  155 , a self-healing valve  160 , a 2-way valve, and/or a check valve  33 . Retrieval catheter  167  may be internally threaded  170 , with internal threading matable with hub external threading  150  and/or include a magnetic/magnetizable portion  153  matable with the hub magnetic portion  153 . Retrieval catheter  167  further includes a suction line  175  terminating in a suction port  180  disposed at the distal end  185  of the catheter  167 . Catheter  167  further includes a puncture tool  190  disposed at or near the distal end  185 . Puncture tool  190  may be a sharpened elongated member, an RF delivery guide, or the like. Once engaged with the hub  30 , retrieval catheter  167  may be operated to puncture the hub seal  65  with the puncture tool  190  and deflate the device  10  by removal of hydrostatic material  50  through the suction port  180  and suction line  175 . 
     As mentioned above and illustrated in  FIGS.  28 - 42   , the device  10  is not limited to use as an atrial septal defect occluder. For example, the waist  25  may be elongated to accommodate fistulas such as urinary fistulas, gastro-intestinal (GI) fistulas, urinary GI fistulas, vaginal urinary fistulas, hepatic duct fistulas, biliary duct fistula, pulmonary fistula, and the like. Likewise, the device  10  may be curved when inflated so that it approximates or matches a perivalvular leak around a prosthetic valve. The device  10  may have one disc  15 ,  20  that can be deployed on one side of an abnormal communication, such as patent ductus arteriosus. 
     The device  10  may be made without a hub, per se, but rather having a direct connection to the filling catheter; once the device  10  is filled it is then directly sealed, as detailed above, and then disconnected from the filling catheter. The filling catheter can be advanced inside another guide catheter. 
     The device  10  may be made in any one of a variety of shapes when inflated, such as rectangular, oblong, star-like, cone, crescentic, curved, or the like, so as to accommodate different communications such as vascular malformation, arteriovenous (AV), and the like. 
     The discs  15 ,  20  and/or the waist  25  may be tapered when inflated for better anchoring and/or occlusion. The device  10  may consist of only one or a few tubes that may expand into a snake-like fillable chamber that expands to occluder an abnormal opening. This can be enclosed within a larger enclosure that forms the device  10 . 
     The device  10  may consist of sequential fillable discs  15 ,  20  that are connected to fill larger or longer chambers such as a left atrial appendage. Each disc  15 ,  20  may have its own fillable channel that is connected to the hub  25 . The discs  15 ,  20  also may expand to varying degrees for better anchoring of the device  10  based on the material in their walls and/or based on the filling pressure being applied in the respective filling channels. 
     The device  10  may include smaller fillable tubules within larger tubules inside each chamber. Likewise, the device  10  may consist of one or multiple, can be sequential or parallel, chambers connected to a disc-like fillable chamber. The distal chambers are used to anchor the device inside the targeted organ, such as left atrial appendage, while the disc is anchored at the opening. For example, closing off the atrial appendage from the left atrium. The device may not have to fully fill the cavity of the targeted organ, such as left atrial appendage, to achieve sealing of the targeted organ. 
     In some embodiments, the device  10  may be shaped so as to avoid critical structures adjacent to its desired emplacement. For example, the waist  25  may have a partial or half-circular cross-sectional shape, may be crescentic or tapered so that it does not compress adjacent structures. For example, for repair of a ventricular septal defect, the waist  25  may be shaped so that when inflated the waist  25  does not compress any adjacent cardiac conduction system. For left atrial appendage, certain parts of the device  10  may have limited expansion so that the device  10  does not compress adjacent left circumflex, cardiac veins, or the like. Part or all of the device  10  may be shaggy shaped when filled so that the device  10  matches the shape of the targeted organ, such as matching the left atrial appendage. 
     The device  10  may consist of multiple adjacent lobes so that it better fits multilobed organs, such as the left atrial appendage. In some embodiments, the device  10  has bulging segments that partially compress the adjacent wall for better anchoring. The device  10  may have an external disc made from metallic substance, such as nitinol, or non-metallic skeleton, that is covered with biocompatible surface, so that the distal Tillable chamber is used for anchoring while the proximal disc is used for sealing. 
     In some embodiments, the device  10  can have different configurations to avoid adjacent critical structures, for example the outside discs can be asymmetric or tapered design so as to not impinge on the aortic valve or tricuspid valve if the device is used in ventricular septal defects. There can be markers on the catheter or the device itself to inform the implanting doctor about the orientation of the device. 
     In some embodiments, the device  10  consists of only a plug that is implanted inside the abnormal communication, for example VSD or aneurysm. The plug can be curved when inflated so that it better anchors in. In other embodiments, the device  10  forms a partial loop, which may take on different shapes so as to minimize compression of adjacent structures. 
     The waist  25  may be smaller than the targeted opening, such as VSD itself, when inflated and may have a tapered shape or other shape so as to not compress critical structures such as the conduction system of the heart. In this case, the outside discs are used for sealing the device  10  in place. 
     The pressure applied within any chamber can be different than that applied in other chambers. For example, the pressure within the waist  25  may be less than within the discs  15 ,  20  so that it does not compress adjacent structures. 
     While the claimed technology has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It is understood that the embodiments have been shown and described in the foregoing specification in satisfaction of the best mode and enablement requirements. It is understood that one of ordinary skill in the art could readily make a nigh-infinite number of insubstantial changes and modifications to the above-described embodiments and that it would be impractical to attempt to describe all such embodiment variations in the present specification. Accordingly, it is understood that all changes and modifications that come within the spirit of the claimed technology are desired to be protected.