Abstract:
Generally described herein are certain embodiments directed to an orientation-independent injection port fluidly coupled to a gastric banding system. The injection port may be configured to simplify the port-targeting process when a medical professional attempts to penetrate the injection port with a needle during a gastric band-adjusting procedure. For example, the injection port may be orientation-independent with the entire outer shell acting as the needle access point. Alternatively, and/or in addition, the inner core of the injection port may be hard or firm, thereby allowing for easier locating (e.g., when the medical professional performs palpation). Furthermore, the hard inner core may prevent needle over-throws, and help stabilize pressure.

Description:
FIELD 
     The present invention generally relates to medical systems and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and specifically relates to injection ports penetrable by a needle to add or remove saline and/or other appropriate fill materials to a gastric banding system. 
     BACKGROUND 
     Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Unlike gastric bypass procedures, gastric band apparatus implantations are reversible and require no permanent modification to the gastrointestinal tract. Moreover, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient&#39;s stomach forming a stoma that restricts food&#39;s passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference. 
     Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid injection port connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction. 
     However, medical professionals frequently encounter difficulty with the process of targeting the injection port, including problems with locating the access port, determining the appropriate angle at which the needle should penetrate the access port, and determining whether the needle has sufficiently penetrated the access port. 
     Some attempts have been made to overcome these difficulties. For example, with reference to  FIG. 1A , the Heliogast® EV3 implantantable port (“EV3 port”) may allow needle penetration at a portion A of the EV3 port. However, the surface area of portion A constitutes only a fraction of the surface area of the entire outer surface of the EV3 port. In addition, the EV3 port still requires very precise needle insertion angles and locations such that they are in a discrete septum, as shown in  FIG. 1B , and cannot facilitate a directionless or virtually directionless needle injection port, as shown in  FIG. 1C . Indeed,  FIG. 1C  appears to illustrate that the EV3 port requires that needle insertions be orthogonal to the surface. 
     SUMMARY 
     This Summary is included to introduce, in an abbreviated form, various topics to be elaborated upon below in the Detailed Description. 
     In certain embodiments, it may be desirable to develop an injection port that is virtually or entirely orientation-independent such that the entire composite outer shell acts as a viable access point. By allowing needle penetration at various angles over a greater surface area of the injection port, such embodiments improve the process of targeting the injection port, among other benefits. 
     Generally described herein are certain embodiments directed to an orientation-independent injection port fluidly coupled to a gastric banding system, the injection port for simplifying the port-targeting process when a medical professional attempts to penetrate the injection port with a needle during a gastric band-adjusting procedure. 
     In one embodiment, the present invention is an injection port for the treatment of obesity or obesity-related diseases, the injection port implantable in a patient&#39;s body and fluidly coupled to tubing connected to an inflatable portion of a gastric band, the injection port comprising (1) an inner core made of a material to prevent a needle from penetrating the inner core, (2) an outer shell surrounding the inner core, and having a lower durometer than the inner core, the outer shell configured to allow penetration by the needle from any location on a surface of the outer shell and at any angle, and (3) a fluid conduit positioned between the inner core and the outer shell, the fluid conduit accessible by the needle to inject or remove fluid from the injection port of the gastric band. 
     In one embodiment, the injection port may be orientation independent with the entire outer shell or core acting as the needle access point. Alternatively, and/or in addition, the inner core of the injection port may be hard or firm (e.g., impenetrable by the needle), thereby allowing medical professionals to easily locate the injection port (e.g., when performing palpation). Furthermore, the hard inner core may prevent the needle from penetrating too deeply and exiting the injection port (e.g., preventing needle over-throws). 
     In one embodiment, a fluid conduit entirely or substantially encompasses the inner core. For example, the fluid conduit might not encompass the flange portion. 
     In one embodiment, the outer shell is concentric with the inner core. 
     In one embodiment, the outer surface of the inner core does not contact the inner surface of the outer shell. 
     In one embodiment, the outer shell may be a self-sealing membrane configured to be penetrable by a needle. 
     In one embodiment, the injection port may include internal features that allow fluid to flow when the outer shell or core of the injection port is under compression and/or when a vacuum is applied. 
     In one embodiment, the injection port may require less needle targeting when trying to penetrate the outer shell or core for saline removal/injection. 
     In one embodiment, the injection port may prevent pressure spikes (intentional or unintentional) from occurring due to volume occupation of the inner core. 
     In one embodiment, the injection port may be implanted without stitching during the implantation process. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The features, obstacles, and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein: 
         FIG. 1A  illustrates a prior art injection port; 
         FIG. 1B  illustrates the access locations of the injection port of  FIG. 1A ; 
         FIG. 1C  illustrates the allowable and non-allowable access angles of the injection port of  FIG. 1A ; 
         FIG. 2  illustrates a perspective view of a gastric banding system according to an embodiment of the present invention; 
         FIG. 3A  illustrates a perspective view of a directionless needle injection port according to an embodiment of the present invention; 
         FIG. 3B  illustrates a cross-sectional view of a directionless needle injection port according to an embodiment of the present invention; 
         FIG. 3C  illustrates a close-up view of an inner core of a directionless needle injection port according to an embodiment of the present invention; 
         FIG. 4A  illustrates a top view of an inner core of a directionless needle injection port according to an embodiment of the present invention; 
         FIG. 4B  illustrates a perspective view of an inner core of a directionless needle injection port according to an embodiment of the present invention; 
         FIG. 5  illustrates a perspective view of an inner core of a directionless needle injection port according to an embodiment of the present invention; and 
         FIG. 6  illustrates a perspective view of a directionless needle injection port according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Apparatus, systems and/or methods that implement the embodiments of the various features of the present invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate some embodiments of the present invention and not to limit the scope of the present invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. 
     The present invention generally provides a directionless needle injection port having a hard inner core and a soft outer shell. The soft outer shell may be made from a needle penetrable and self-sealing material and may make available the entirety of its outer surface for needle penetration, replacing the need to target a restricted septum area of prior art ports, and thereby making the injection port easier to access when a medical professional needs to inject or remove fluids via the injection port. 
     While discussed herein as related to a gastric banding system, one skilled in the art will understand that the present invention is versatile and may be implemented with respect to any medical system, gastric-band related or not, which may be enhanced with a directionless needle injection port. For example, cancer patients who require an access port for frequent access to their veins may benefit from the implementation of an embodiment of a directionless injection port as described herein. 
     Turning to  FIG. 2 , an implanted gastric banding system  200  is illustrated as implanted within a patient&#39;s body  230 , and more specifically, forming a stoma around an upper region of a stomach  225  of the patient&#39;s body  230 . The gastric banding system  200  may include a gastric band  205  having an inflatable portion  210 . The gastric band  205  may be fluidly coupled with an injection port  215  via a tubing  220 . A fluid injection device  245  may include a syringe  240  and a needle  235  which may penetrate the patient&#39;s body  230  at a location proximal to the injection port  215  to add or remove fluid. The fluid added or removed may either inflate (if fluid is added) or deflate (if fluid is removed) the inflatable portion  210  of the gastric band  205 , thereby increasing (if fluid is added) the degree of constriction that the gastric band  205  imparts on the upper region of the stomach  225  or decreasing (if fluid is removed) the degree of constriction that the gastric band  205  imparts on the upper region of the stomach  225 . In this manner, adjustments to the gastric banding system  200  may be performed via the injection port  215 . 
       FIG. 3A  is an injection port  300  attached to a tubing  305 . In one embodiment, the injection port  300  may be the injection port  215  of  FIG. 2 , and the tubing  305  may be the tubing  220  of  FIG. 2 . The rest of the gastric banding system has been omitted for clarity. The injection port  300  may include an outer shell  310  and an inner core  315 . A fluid conduit  320  may be formed between an inner surface  311  of the outer shell  310  and an outer surface  316  of the inner core  315 . In one embodiment, the fluid conduit  320  may be the entire spatial gap between the inner surface  311  of the outer shell  310  and the outer surface  316  of the inner core  315 . The inner core  315  may further include channels  325  for fluid flow. The channels  325  may be grooves or indentations formed on the outer surface  316  of the inner core  315  to improve fluid flow. In addition, the injection port  300  may include an attachment flange  330  to prevent the fluid from leaking out of the fluid conduit  320  and to hold the tubing  305  in place at the location where the tubing  305  is coupled to the injection port  300 . 
     As shown, the fluid conduit  320  wraps around virtually the entire outer surface  316  of the inner core  315 , thereby allowing a medical professional access to the fluid conduit  320  by inserting a needle (e.g., the needle  335 ) virtually anywhere and at any angle on the outer shell  310 . In this manner, the medical professional may be able to add or remove fluid via the injection port  300  without regard to the orientation or direction that the injection port  300  is facing. Accordingly, the injection port  300  may be deemed orientation-less and/or direction-less. In one embodiment, the outer surface  316  of the inner core  315  does not contact the inner surface  311  of the outer shell  310  thereby forming the fluid conduit  320 . 
     The outer shell  310  may be constructed out of a soft plastic, polymer or other material penetrable by a needle since the outer shell  310  is designed to be punctured by a needle (e.g., the needle  235 ) to allow for the addition or removal of fluid. In addition, the soft plastic, polymer or other material used to construct the outer shell  310  may have self-sealing characteristics as it may be desirable to allow the outer shell  310  to withstand repeated, periodic insertion and withdrawal of needles. The outer shell  310  may be shaped as an ellipsoid or an “olive”, but other geometric configurations may be possible such as a sphere, etc. 
     In one embodiment, the outer shell  310  may be a membrane having a characteristic of being penetrable by a needle to allow for fluid addition or removal to the injection port  300  while acting as a barrier to prevent the leakage of the fluid from within the injection port  300  (i.e., the fluid conduit  320 ). 
     In one embodiment, the outer shell  310  may have a composite build and may incorporate a micro-mesh to allow for leak-free needle insertions and removals. The entire outer surface of the outer shell  310  may also be loosely covered in a polypropylene bio-integrating mesh to allow for stitch-free implantation, thereby reducing procedural complexity and duration. 
     In addition to and/or alternatively, other materials of low durometer may be used. The outer shell  310  may also be designed such that a medical professional, in performing palpation with his or her fingers, may be able to locate the injection port  300  by feeling the inner core  315  (which is hard) through the outer shell  310  (which is soft). 
     Once the needle (e.g., the needle  335 ) is inserted through the outer shell  310 , the inner core  315  may prevent the needle (e.g., the needle  335 ) from unintentionally overshooting (and/or unintentionally exiting) the fluid conduit  320 , as the inner core  315  is constructed out of a relatively high durometer plastic core, titanium, stainless steel, composite ceramics, and/or other suitable material, configured to withstand and/or prevent needle penetration. In one embodiment, the durometer of the inner core  315  is greater than the durometer of the outer shell  310 . 
       FIG. 3B  is a cross-sectional view of the injection port  300  illustrating the operation of the injection port  300 . Also shown is a fluid injection device  345  which may include a syringe  340  and a needle  335 . The needle  335  may penetrate the outer shell  310  before being stopped by the inner core  315 . The stoppage of the needle  335  by the inner core  315  serves to ensure that the needle  335  is correctly inserted because if the needle  335  has reached the outside surface  316  of the inner core  315 , the needle  335  is necessarily at a location configured to access the fluid conduit  320 . Accordingly, the medical professional need not guess whether the needle  335  is correctly inserted. Once positioned, the needle  335  may be utilized to access the fluid conduit  320  to add or remove fluid from the injection port  300 . As shown, the fluid conduit  320  may be in fluid communication with the tubing  305  via a fluid conduit-tubing connection path  350  at an opening  355 . In this manner, fluid communication between the injection port  300  and the rest of the gastric banding system (not shown) is achieved via the tubing  305 . 
     The fluid within the fluid conduit  320  is prevented from leaking out of the gastric banding system (e.g., the gastric banding system  200 ) by the attachment flange  330 . The attachment flange  330  may be constructed out of a fluid-impenetrable material and may include a cylindrical portion which attaches to the outside of the tubing  305  and a flange portion which attaches to the inside surface  311  of the outer shell  310 . In this manner, fluid within the fluid conduit  320  is prevented from exiting or leaking out of the injection port at a location designated by arrows  360 . The attachment flange  330  may further provide strain relief for the injection port  300 . The tubing  305  is connected to and inserted into the inner core  315 . The tubing  305  and/or the attachment flange  330  are used to hold the inner core  315  in place within the outer shell  310 . 
       FIG. 3C  illustrates the inner core  315  with the outer shell (e.g., the outer shell  310 ) omitted for clarity. As shown, the inner core  315  may be shaped as an ellipsoid or an “olive”, but other geometric configurations may be possible such as a sphere, etc. The inner core  315  may include channels  325  spaced apart extending from one end of the inner core  315  to another, and culminating at the opening  355 , which may be an interface to a lumen (e.g., the fluid conduit-tubing connection path  350 ) for fluid flow between the injection port  300  and the rest of the gastric banding system (not shown). As shown, all the channels  325  may be spaced apart from one another but may converge at the ends and come into contact with one another at single end points such as at the opening  325 . The channels  325  allow the fluid to converge at the opening  325  to better and more easily flow into and out of the path  350 . 
     In one embodiment, the geometry of the channels  325  may be configured to optimize the overall volume of the fluid conduit  320 . For example, deeper and/or wider channels  325  may increase the overall volume capabilities of the fluid conduit  320 , whereas shallower and/or narrower channels  325  may decrease the overall volume capabilities of the fluid conduit  320 . Similarly, the lumen (e.g., the fluid conduit-tubing connection path  350 ) may be configured and sized to support a larger volume of fluid or a smaller volume of fluid. 
     In one embodiment, additional lumens may be included to provide additional conduits between the access or injection port  300  and the inflatable portion (e.g., the inflatable portion  210 ) of the gastric band (e.g., the gastric band  205 ). 
     In one embodiment, the inner core  315  may be further modified to include any of a number of features. For example, pressure relief holes (not shown) may be beneficial in a situation where one side of the outer shell (e.g., the outer shell  310 ) is under compression, thereby allowing fluid to still flow to the opening  340 . Alternatively, non-smooth geometry may provide better tactile feedback to the medical professional when the needle (e.g., the needle  335 ) penetrates the outer shell (e.g., the outer shell  310 ). 
     In one embodiment, the inner core  315  may have multiple functionalities. For example, the inner core  315  may prevent needle overthrows by offering a hard surface impenetrable by the needle  335 . Also, the inner core  315  may enhance patient safety and discomfort by limiting unintentional pressure spikes. By preventing the injection port from collapsing, unintentional constriction by the inflatable portion (e.g., the inflatable portion  210 ) of the gastric band (e.g., the gastric band  205 ) may be stopped. Furthermore, the mass and/or hardness of the inner core  315  may enable medical professionals to more easily locate the injection port  300  under the patient&#39;s skin. 
     In one embodiment, a fluid conduit (e.g., the fluid conduit  320 ) may entirely or substantially encompasses the inner core  315 . For example, the fluid conduit  320  might not encompass the attachment flange  360 . 
     In one embodiment, the outer shell  310  is positioned concentric with the inner core  315 . 
       FIGS. 4A and 4B  illustrate a top view and a side perspective view, respectively, of one embodiment of an inner core  415 . Here, the other portions of the gastric banding system including the tubing have been omitted for clarity. In addition, certain parts of an injection port  400  such as the outer shell and/or the attachment flange have also been omitted for clarity. In this embodiment, the inner core  415  may be flattened, thereby providing the benefit of flip-resistance immediately after the implantation procedure. As shown, the inner core  415  may have a smooth surface. 
       FIG. 5  illustrates another embodiment of an inner core  515 . Again, for clarity, the other portions of the gastric banding system, and certain parts of an injection port  500  have been omitted for clarity. However, as shown, the inner core  515  may include alternative fluid channels created by protrusions  525  (e.g., formed in the shape of circles or ovals) which allow fluid flow and pressurization of the fluid layer during a needle penetration procedure while the outer shell (not shown) is compressed over the inner core  515 . Arrow  520  illustrates an example of one such fluid channel that the fluid may take along the exterior of the inner core  515 . In addition, the protrusions  525  may prevent an outer shell (not shown) from collapsing against the inner core  515  during vacuum. The size and spacing of the protrusions  525  may be designed to allow for more efficient fluid flow. For example, in one embodiment, the protrusions  525  may be unevenly spaced apart and have varying heights and diameters. In another embodiment, the protrusions  525  may have uniform spacing, heights and diameters. 
       FIG. 6  illustrates an embodiment of an injection port  600 . In one embodiment, an injection port  600  may be the injection port  215  of  FIG. 2  and a tubing  605  may be the tubing  220  of  FIG. 2 . The rest of the gastric banding system has been omitted for clarity. As shown, the injection port  600  may include an outer shell  610  surrounding virtually the entirety of an inner core  615 . A fluid conduit  620  may be formed between an inner surface of the outer shell  610  and an outer surface of the inner core  615 . The inner core  615  may further include ridges  645  having ridge interruptions  650 . 
     As shown, the ridges  645  may be oriented longitudinally about the exterior of the inner core  615 , and may form channels  625  between adjacent ridges  645  for fluid flow. The ridges  645  may be multi-functional. For example, in addition to forming the channels  625  for fluid flow (e.g., which may occur when the fluid volume is under vacuum, such as when the medical professional is removing fluid from the injection port  600 ), the ridges  645  may further provide exaggerated needle-stopping structures to prevent needle over-throws when the medical professional is attempting to insert a needle (e.g., the needle  235 ) into the fluid conduit  620 . In one embodiment, the ridges  645  and the rest of the inner core  615  may be constructed out of a relatively high durometer plastic core configured to withstand and/or prevent a needle (e.g., the needle  235 ) from puncturing through. The one or more ridge interruptions  650  on each ridge  645  may provide for fluid flow circumferentially to ensure volume and/or pressure stability when portions of the injection port  600  are collapsed (e.g., when the patient is in a sitting position, a portion of the injection port  600  may be compressed on one side). 
     The channels  625  may include one or more fluid holes  655  between the ridges  645  which allow for fluid communication between the injection port  600  and the gastric band (not shown) via the tubing  605  even when the injection port  600  is under compression or a vacuum. In addition, the channels  625  may allow for easier fluid travel to and from an opening  640  (which is configured to fluidly couple the injection port  600  to the rest of the gastric banding system). 
     In addition, the injection port  600  may include an attachment flange  630  to prevent fluid from leaking out of the fluid conduit  620  and to hold the tubing  605  in place at the location where the tubing  605  is coupled to the injection port  600 . 
     Similar to the injection port  300  of  FIG. 3 , the fluid conduit  620  may wrap around virtually the entire surface of the inner core  615  including the ridges  645 , thereby allowing a medical professional to access the fluid conduit  620  by inserting a needle (e.g., the needle  235 ) virtually anywhere and at any angle on the outer shell  610 . In this manner, the medical professional may be able to add or remove fluid via the injection port  600  without regard to the orientation or direction that the injection port  600  is facing. Accordingly, the injection port  600  may be deemed orientation-less and/or direction-less. 
     In addition, as the outer shell  610  is designed to be punctured by a needle (e.g., needle  235 ), the outer shell  610  may be constructed out of a soft plastic and may, in one embodiment, have a composite build and incorporate a micro-mesh to allow for leak-free needle insertions and removals. The entire outer surface of the outer shell  610  may also be loosely covered in a polypropylene bio-integrating mesh to allow for stitch-free implantation, thereby reducing procedural complexity and duration. 
     In addition and/or alternatively, other materials of low durometer may be used. The outer shell  610  may also be designed such that a medical professional in performing palpation with his or her fingers may be able to locate the injection port  600  by feeling the ridges  645  of the inner core  615  through the outer shell  610 . 
     Unless otherwise indicated, all numbers expressing quantities of ingredients, volumes of fluids, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
     The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
     Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
     Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. 
     Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety. 
     Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. 
     In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.