Patent Abstract:
An in-dwelling port for providing repeated entry to a body during and/or after an operation is described. The port may include an external portion secured to a body outside an incision and a collapsible insertion portion that is inserted through the incision. The collapsible portion collapses when no instrument or lumen is present to permits the body to return to substantially a normal profile around the incision.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Application No. 60/835,566 filed Aug. 4, 2006 and the entirety of that application is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    This application relates to medical devices for use in surgical applications. More specifically, this application relates to ports for use in accessing an area of a body during and/or after a surgical procedure. 
       BACKGROUND 
       [0003]    In minimally invasive surgical procedures, such as laparoscopic procedures, one or more small incisions are made in a body to allow access for the necessary surgical tools. If there is a need to re-enter the body after a surgical procedure, a mechanism for doing so must be put in place. For targeted or prophylactic chemotherapy, post-operative applications of a substance can be made by re-instituting an environment in the patient in which subsequent applications of the substance may be made. This may be accomplished by leaving a port device in the patient after the surgical procedure, or by surgically placing a port in the patient in preparation of a non-surgical treatment regimen. 
         [0004]    The port may be a device capable of providing a sanitary access point to a body, where the device is a resealable mechanism that attaches to the exterior of the skin and the interior wall of the skin. The port permits a device for applying a substance to the body to be reconnected to the patient at a later time to apply the substance or other treatment. One example of this type of port is an enteral feeding tube port. 
         [0005]    The design of re-entry ports typically focuses on semi-rigid tubes, such as feeding ports which are meant to transverse from out side the body into an organ such as the stomach. These devices often have a bulb or protrusion at the insertion end to maintain the location of the tube in the organ being accessed, and consist of a rigid or semi-rigid tube or lumen. Catheters, such as urethral catheters for access into the bladder tend to be flexible catheters, usually with a balloon or some type of protrusion that is used to anchor the catheter into the organ to prevent its movement back through the body channel. Intravenous ports, ports or needles that are inserted into a vein, are generally taped or perhaps sutured in place to prevent the accidental removal of the device. Other devices such as flat tubes with holes, sometimes under suction have been used as drains for wounds or to prevent fluid build up in the chest cavity. 
       SUMMARY 
       [0006]    An improved port is described below that can remain in place, for example between physical structures such as the abdominal wall and the organs below, or in the plural cavity between the ribs and the lungs, or in any other physical location where the separation of bodily spaces may be required on a recurring basis. 
         [0007]    According to a one aspect, an in-dwelling port is described having an external portion or flange configured for placement outside of an incision and defining a proximal port opening. A collapsible insertion portion having a distal port opening is attached to the external portion and positioned in a substantially coaxial relationship to the proximal port opening. The collapsible insertion portion is repeatably adjustable between an elongated position, where the collapsible insertion portion defines an elongated length and an elongated width, and a collapsed position, where the collapsible portion defines a collapsed length and a collapsed width. The elongated length is greater than the collapsed length and the elongated width is less than the collapsed width to allow for easy insertion, firmer placement in a collapsed position, and a less intrusive and disruptive way of leaving a port in a body when the port is not in use. 
         [0008]    Other features and advantages of the invention will become apparent upon review of the following drawings, detailed description and claims 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a perspective view of an in-dwelling port in an elongated position. 
           [0010]      FIG. 2  is a top plan view of the in-dwelling port of  FIG. 1 . 
           [0011]      FIG. 3  is a cross-sectional side view of the port of  FIG. 1 . 
           [0012]      FIG. 4  is a cross-sectional side view of the port of  FIG. 1  in a collapsed position. 
           [0013]      FIG. 5 . is a side view of a stylus suitable for use in inserting the port of  FIG. 1  into an incision. 
           [0014]      FIG. 6  is a top plan view of an alternative embodiment of the in-dwelling port of  FIG. 1 . 
           [0015]      FIG. 7  is a cross-sectional side view of the port of  FIG. 6  in an elongated position. 
           [0016]      FIG. 8  is a top plan view of a second alternative embodiment of the in-dwelling port of  FIG. 1 . 
           [0017]      FIG. 9  is a cross-sectional side view of the port of  FIG. 8  in an elongated position. 
           [0018]      FIG. 10  is a top plan view of a third alternative embodiment of the in-dwelling port of  FIG. 1 . 
           [0019]      FIG. 11  is a cross-sectional side view of the port of  FIG. 10  in an elongated position. 
           [0020]      FIG. 12  is a perspective view of the port of  FIG. 11 . 
           [0021]      FIG. 13  is a top plan view of a fourth alternative embodiment of the in-dwelling port of  FIG. 1 . 
           [0022]      FIG. 14  is a cross-sectional side view of the port of  FIG. 13  in an elongated position. 
           [0023]      FIG. 15  is a cross-sectional side view of a fifth alternative embodiment of the port of  FIG. 1  in an elongated position. 
           [0024]      FIG. 16  is a cross-sectional side view of the port of  FIG. 15  in a collapsed position. 
       
    
    
     DETAILED DESCRIPTION 
       [0025]      FIGS. 1-4  illustrate one version of an in-dwelling port  10  where separation of body spaces may be required on a recurring basis. This in-dwelling port  10  may be used to reinflate the space between the abdominal wall and the organs below (peritoneal cavity). The port  10  includes an outer flange  12  and a collapsible insertion portion  14 . The outer flange  12  may have a greater diameter than that of the collapsible insertion portion  14  to stabilize the port in the patient and prevent over-insertion into an incision. A proximal port opening  16  is defined by the flange  12  to allow one or more lumens or medical devices access into the collapsible insertion portion  14 . A distal port opening  18  is positioned at the end of the collapsible insertion portion  14  and permits access to the body cavity. 
         [0026]    A replaceable plug  20  is removably insertable into the proximal port opening to prevent an infection or other foreign substances to enter the body when the in-dwelling port  10  is not in use. The plug  20  may be attached to the outer flange  12  by a tether  22 . The tether may be formed from the same piece of material as the outer flange, or it may be a separate material attached to the outer flange  14 . The plug may be a compression-style plug that is elastic enough to fill the proximal port opening  16  when pressed in place. Alternatively, the plug  20  may be a discrete component unattached by a tether. Any of a number of other fastening means, such as threaded ends, collapsible detents or other mechanisms may also be used to connect the plug and the proximal port opening. 
         [0027]    The outer flange may include recessed regions  24  on one or more sides. The recessed regions may be sized to provide an anchor for sutures, adhesives or other devices for holding the in-dwelling port in place on the body. The outer flange may also be held in place by having an optional adhesive surface to keep it against the skin. The adhesive surface may be islands of adhesive positioned about the underside of the flange. Alternatively, to provide a more complete seal and to help prevent deterioration of the tissue through which the in-dwelling port is inserted, a continuous ring of adhesive or adhesive material may be positioned on the underside of the flange to prevent tearing and strengthen the integrity of the tissue surface. Thus, the in-dwelling port  10  may be affixed in a number of ways, individually or collectively, by suturing the recessed regions of the flange, adhering the underside of the flange to the outer tissue surface, and even covering the flange with an adhesive bandage (regular and medicated) to help keep it in place and to further help resist infection. 
         [0028]    The collapsible insertion portion  14  of the in-dwelling port  10  may be fabricated in any manner that permits it to collapse when not in use, for example in the form of a bellows or accordion-like structure. Once past the abdominal wall or other body structure, it can gently collapse back to an almost flat shape. The flat shape may assist in reducing irritation and trauma, as well as provide very little restriction to normal body motion and limited visibility of its presence. A feature of the bellows structure of the collapsible insertion portion is that it will present a reduced diameter when elongated and may more easily go through a relatively small incision or wound site, or even a natural body passage way. Once in place, the structure will allow the collapsible insertion portion to collapse into a larger diameter so as not to work itself out of the incision, wound, or body passage. Referring to  FIG. 4 , the collapsed state of the in-dwelling port expands the bellows portion to hold, for example, the abdomen wall between the flange  12  and the collapsible insertion portion  14  for a secure and low-profile point of re-entry. 
         [0029]    Referring to  FIG. 5 , a stylus  26  is designed to fit in the collapsible insertion portion  14  via the proximal port opening  16  and extend the in-dwelling port  10  to its smallest diameter for insertion into an incision. If, for example, the in-dwelling port was intended for insertion into an abdomen wall, the stylus would first be inserted into the proximal port, extending the collapsible insertion portion and thus reducing its diameter. The distal port opening  18  may be provided with a smaller diameter than the proximal port opening  16  so that the stylus  26  remains in the collapsible insertion portion during insertion. A physician may then push the in-dwelling port into position from outside the abdomen wall and into the peritoneum, for example via a trocar wound (not shown). 
         [0030]    Once inserted, and optionally secured at the flange to the abdomen, the stylus  26  would typically be removed and one or more lumens may be introduced and later reintroduced, through the in-dwelling port. The in-dwelling port  10  may allow for the insertion of medical devices after placement by maintaining one or more access lumens to pass a medical device through it such as a catheter, or a small needle or trocar, an optical endoscope, an operative instrument or any number of surgical, diagnostic, or palliative devices. 
         [0031]    When all lumens in the port  10  are removed and the port is not in use, the collapsible insertion portion will collapse down and allow the abdomen wall to collapse to a more relaxed position that may be substantially close to its pre-insertion shape. The plug  20  may then be inserted to provide a barrier to contaminants. Having a way to allow the separation (or re-separation) of the abdominal wall or cavity from the organs below for purposes of examination, application of medicines, or even operative tasks is desirable and is usually accomplished by insufflation of the peritoneal space. Because the port is intended for access to the bodily space for the purpose of re-expanding the separation of one layer or body structure from another the port also permits the body structure to return to its substantially normal (collapsed) position. 
         [0032]    An alternative embodiment of the in-dwelling port  30  is shown in  FIGS. 6-7 . In this arrangement, a re-sealable membrane  32  is positioned across the proximal port opening  34 . A needle or other sharp-ended introducing device may be used to pierce the membrane  32  or surface and introduce a lumen or instrument through the membrane and subsequently into the body via the distal port opening  36 . The membrane would reseal itself after removal. This pierceable membrane or cover may be manufactured from any of a number of materials, for example polysoprene, isoprene or silicone. In an alternative embodiment, the in-dwelling port may have a second proximal port opening that could be connected to a filter in order to release pressure from an expanded space, for example the peritoneum during a laparoscopic procedure, without permitting organisms to be released into the air. 
         [0033]    In an alternative embodiment shown in  FIGS. 8-9 , the in-dwelling port  40  may have a tear-away seam  44  disposed along the entire length of the port. The seam  44  may traverse the flange  42  and the collapsible insertion portion  45  to form a continuous line of perforations from the proximal port opening  46  to the distal port opening  48 . In one embodiment, the seam  44  may be a line of perforations extending longitudinally down the device from proximal  46  to distal  28  port opening, multiple parallel lines of perforations to allow for tearing the indwelling port from one or more sides of the flange  42 , or any desired pattern of perforations to allow segmented destruction and removal of the indwelling port. In alternative embodiments, the lines of perforations may be other types of weakened seams defining a continuous line of weakened or reduced thickness material that permit for a substantially clean tear when a user desires to remove the in-dwelling port. 
         [0034]    One advantage of an in-dwelling port as shown in  FIGS. 8-9  with a tear-away seam is that a new in-dwelling port may be inserted into an old indwelling port already positioned in a body and the old port could be removed by splitting and pulling out the old port. Alternatively, the old port could pulled into a sleeve device and removed, the sleeve serving to keep the space open to place a new port in place of the old port, or even a tool or a finger could be pushed along side the old port while a new port is positioned next to the tool or finger, and inserted. 
         [0035]    The in-dwelling ports in  FIGS. 1-9  are shown with one lumen through the center. In other implementations, two or more lumens may be fabricated so that more than instrument could be inserted into it, or one lumen could be attached to a pressure source such as an insufflator and the other to a suction source, or a commercially available pressure relief device (such as manufactured by Smart products), or a mini-endoscope may be inserted into one lumen an and instrument or catheter or some other operative device may be inserted into another. The device is not limited to a single useful lumen, and multiple lumens could be utilized with many other medical devices seeking entry into the body space. Other uses for the lumen(s) may include applications requiring the insertion of a fluid catheter, the use of an aerosolization or nebulizing device for the purpose of coating or treating organ cavity. 
         [0036]    As shown in  FIGS. 10-12 , an in-dwelling port  50  may be constructed with two proximal openings  52  that each lead to a respective half of the interior of a single collapsible insertion portion  62 . Each proximal opening  52  may have its own removable plug  54  attached to the flange  64  by respective tethers  56 . A collapsible partition  60  extending through the interior of the area enclosed by the collapsible insertion portion  62  defines two separate access paths  66  terminating at respective distal openings  58 . Although the access paths  66  are shown as equal in size in  FIGS. 10-12 , access paths of unequal size or more than two paths in the single collapsible portion  62  are contemplated as well. 
         [0037]      FIGS. 13 and 14  illustrate another version of an in-dwelling port  70  for allowing access for multiple devices such as noted above. In the version of  FIGS. 13-14 , two completely separate collapsible insertion portions  72  are formed in a single flange member  74 . Each collapsible portion has its own proximal and distal opening  76 ,  78 , where the proximal openings  76  may have a greater radius than the distal openings  78  or may be covered with a membrane suitable for piercing by a needle or other sharp instrument. Additionally, one or both collapsible portions may be partitioned internally as shown in  FIGS. 10-12  to provide separate access for even more devices or instruments into a body cavity. 
         [0038]    Although the example of in-dwelling ports described above include collapsible insertion portions, shown as bellows, that are expandable into a body cavity, there may be a need to insure that the collapsible insertion portion or bellows of the device stays up to the distal surface (i.e. the interior surface) of the tissue or organ into which the device is inserted.  FIGS. 15-16  illustrate an implementation of an in-dwelling port  80  that allows for the collapsible insertion portion  82  to remain secure, and prevent it from “relaxing” or loosening and becoming partially extended in the bodily cavity. This is accomplished by having one or more threads or tethers  84  attached to the distal portion of the insertion portion, which can be used to draw-up or retract the collapsible insertion portion  82 , either through holes  86  in the top flange  88 , or along the outside of the collapsible insertion portion  82  and the outside(s) of the top flange to be secured by some means such as tying, suturing, taping or any other method of securing the tether(s)  84  in such a way as to keep the collapsible insertion portion  82  collapsed, or loosening them to allow the collapsible insertion portion  82  to be expanded. The tethers  84  can be constructed of the same material as the in-dwelling port  80 , from thread, or from any other flexible thin material. It could be accomplished with one or more such tethers  84 . The tethers  84  can be attached to the collapsible insertion portion  82  in the molding process, by heat sealing (melting), tying, gluing, or any other method of attaching the tethers to the collapsible insertion portion of the device. 
         [0039]    In yet additional alternative embodiments, where additional rigidity of the collapsible insertion portion may be desired, a stylus such as shown in  FIG. 5  may include a central bore through which instruments or lumens may be inserted. Such a modified stylus may remain in the indwelling port during a procedure and removed to allow the in-dwelling port to collapse when not in use 
         [0040]    Any of the in-dwelling port versions described above may be coated or impregnated with antibacterial and or antimicrobial medications to prevent infection from occurring during its time in place. Such a coating for example could consist of, but is not limited to, Rifamacin, Rifampin, Minocycline, silver sulfadiazine, or Bardex R IC. 
         [0041]    The in-dwelling port may be constructed of a resilient material that has the ability to reform its shape or accept a “retracted” shape after it is in place. Suitable materials include, but are not limited to, silicone, rubber, latex, nylon, and fabric like materials. Although any number of in-dwelling port sizes and dimensions are contemplated, and may vary depending on intended use, the example shown in  FIG. 2  may have a flange major axis length A of 1.75 inches, a flange minor axis length B of 0.875 inches, and a tether length C of 0.875 inches. The proximal port opening diameter may be 0.196 inches and the distal port opening may be 0.112 inches. Accordingly, the stylus used to insert this specific version of the in-dwelling port would need to have a minimum diameter of greater than 0.112 inches and a maximum diameter of less than 0.196 inches. Referring again to  FIGS. 3 and 4 , the collapsible insertion portion in this example may have a collapsed depth G of 0.375 inches and a maximum extended depth F of 5.0 inches for a greater than 5 to 1 ratio. The extended diameter H of the collapsible insertion portion is preferably less than the collapsed diameter I, however the ratio may vary depending on, for example, the number and length of the folds that form the bellows or accordion-like structure of the collapsible insertion portion. 
         [0042]    It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

Technology Classification (CPC): 0