In-dwelling port for access into a body

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 permit the body to return to substantially a normal profile around the incision.

TECHNICAL FIELD

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

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.

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.

The design of re-entry ports typically focuses on semi-rigid tubes, such as feeding ports which are meant to transverse from outside 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 buildup in the chest cavity.

SUMMARY

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.

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. An insertion portion includes a non-collapsible portion attached to the external portion and positioned in a substantially coaxial relationship to the proximal port opening, as well as a collapsible portion attached to the non-collapsible portion on one end and having a distal port opening on the other end. The collapsible insertion portion is repeatably adjustable between an elongated position, where the collapsible insertion portion defines an elongated length, and a collapsed or retracted position where the collapsible portion defines a collapsed length. The elongated length is greater than the collapsed length. In different embodiments, a membrane with a predefined slit may cover the proximal port opening. A pair of tethers fastened to the collapsible portion, passing through external portion or flange, and attaching on the outside of the flange opposite the insertion portion to a retaining ring may assist in retracting the collapsible portion evenly and repeatably. An inserter with a hollow tube sized to fit in the proximal port opening and wider than the distal port opening may be used to both extend and retract the collapsible portion in conjunction with the retaining ring and tethers.

Other features and advantages of the invention will become apparent upon review of the following drawings, detailed description and claims.

DETAILED DESCRIPTION

FIGS. 1-4illustrate one version of an in-dwelling port10where separation of body spaces may be required on a recurring basis. This in-dwelling port10may be used to reinflate the space between the abdominal wall and the organs below (peritoneal cavity). The port10includes an outer flange12and a collapsible insertion portion14. The outer flange12may have a greater diameter than that of the collapsible insertion portion14to stabilize the port in the patient and prevent over-insertion into an incision. A proximal port opening16is defined by the flange12to allow one or more lumens or medical devices access into the collapsible insertion portion14. A distal port opening18is positioned at the end of the collapsible insertion portion14and permits access to the body cavity.

A replaceable plug20is removably insertable into the proximal port opening to prevent an infection or other foreign substances to enter the body when the in-dwelling port10is not in use. The plug20may be attached to the outer flange12by a tether22. 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 flange14. The plug may be a compression-style plug that is elastic enough to fill the proximal port opening16when pressed in place. Alternatively, the plug20may 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.

The outer flange may include recessed regions24on 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 port10may 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.

The collapsible insertion portion14of the in-dwelling port10may 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 toFIG. 4, the collapsed state of the in-dwelling port expands the bellows portion to hold, for example, the abdomen wall between the flange12and the collapsible insertion portion14for a secure and low-profile point of re-entry.

Referring toFIG. 5, a stylus26is designed to fit in the collapsible insertion portion14via the proximal port opening16and extend the in-dwelling port10to 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 opening18may be provided with a smaller diameter than the proximal port opening16so that the stylus26remains 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).

Once inserted, and optionally secured at the flange to the abdomen, the stylus26would typically be removed and one or more lumens may be introduced and later reintroduced, through the in-dwelling port. The in-dwelling port10may 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.

When all lumens in the port10are 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 plug20may 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.

An alternative embodiment of the in-dwelling port30is shown inFIGS. 6-7. In this arrangement, a re-sealable membrane32is positioned across the proximal port opening34. A needle or other sharp-ended introducing device may be used to pierce the membrane32or surface and introduce a lumen or instrument through the membrane and subsequently into the body via the distal port opening36. 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.

In an alternative embodiment shown inFIGS. 8-9, the in-dwelling port40may have a tear-away seam44disposed along the entire length of the port. The seam44may traverse the flange42and the collapsible insertion portion45to form a continuous line of perforations from the proximal port opening46to the distal port opening48. In one embodiment, the seam44may be a line of perforations extending longitudinally down the device from proximal46to distal 28 port opening, multiple parallel lines of perforations to allow for tearing the in-dwelling port from one or more sides of the flange42, or any desired pattern of perforations to allow segmented destruction and removal of the in-dwelling 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.

One advantage of an in-dwelling port as shown inFIGS. 8-9with a tear-away seam is that a new in-dwelling port may be inserted into an old in-dwelling 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 alongside the old port while a new port is positioned next to the tool or finger, and inserted.

The in-dwelling ports inFIGS. 1-9are 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.

As shown inFIGS. 10-12, an in-dwelling port50may be constructed with two proximal openings52that each lead to a respective half of the interior of a single collapsible insertion portion62. Each proximal opening52may have its own removable plug54attached to the flange64by respective tethers56. A collapsible partition60extending through the interior of the area enclosed by the collapsible insertion portion62defines two separate access paths66terminating at respective distal openings58. Although the access paths66are shown as equal in size inFIGS. 10-12, access paths of unequal size or more than two paths in the single collapsible portion62are contemplated as well.

FIGS. 13 and 14illustrate another version of an in-dwelling port70for allowing access for multiple devices such as noted above. In the version ofFIGS. 13-14, two completely separate collapsible insertion portions72are formed in a single flange member74. Each collapsible portion has its own proximal and distal opening76,78, where the proximal openings76may have a greater radius than the distal openings78or 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 inFIGS. 10-12to provide separate access for even more devices or instruments into a body cavity.

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. 15-16illustrate an implementation of an in-dwelling port80that allows for the collapsible insertion portion82to 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 tethers84attached to the distal portion of the insertion portion, which can be used to draw-up or retract the collapsible insertion portion82, either through holes86in the top flange88, or along the outside of the collapsible insertion portion82and 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)84in such a way as to keep the collapsible insertion portion82collapsed, or loosening them to allow the collapsible insertion portion82to be expanded. The tethers84can be constructed of the same material as the in-dwelling port80, from thread, or from any other flexible thin material. It could be accomplished with one or more such tethers84. The tethers84can be attached to the collapsible insertion portion82in 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.

In yet additional alternative embodiments, where additional rigidity of the collapsible insertion portion may be desired, a stylus such as shown inFIG. 5may include a central bore through which instruments or lumens may be inserted. Such a modified stylus may remain in the in-dwelling port during a procedure and removed to allow the in-dwelling port to collapse when not in use

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.

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 inFIG. 2may 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 toFIGS. 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.

Referring now toFIGS. 17-20, an alternative embodiment of an in-dwelling port is disclosed. The in-dwelling port100, as seen inFIG. 17A, includes a flange102and an insertion portion104, but differs from the prior embodiments in that the insertion portion104incorporates both a collapsible portion106and a non-collapsing portion108. The non-collapsing portion108connects directly to the flange102and may provide for a tighter fit against an opening of the abdominal wall. The non-collapsible portion108can provide a firmer fit and better maintain an opening for subsequent re-introduction of medical equipment into the in-dwelling port100. The embodiment ofFIGS. 17-18also includes a pair of tethers110that connect to the distal end of the insertion portion104, specifically the distal end of the collapsible potion106of the insertion portion104, to aid in retraction of the collapsible portion106of the insertion portion104when the in-dwelling port is not in use. The collapsible region106is collapsible down to the end of the non-collapsible portion by virtue of the bellows structure of the collapsible portion. Although a bellows structure is illustrated for the collapsible portion106, or collapsible structures, including but not limited to collapsible overlapping ring sections or stretchable materials, are contemplated in different embodiments.

As shown inFIG. 17B, each arm112of the flange102includes a tethered guide slot114extending from the end of the arm112toward the center area of the flange102outside of the non-collapsible portion108. A pair of recessed regions116are positioned toward the ends of the arms112outside of the tethered guide slots114to allow for sutures or other fastening mechanisms to help hold the flange102against the skin of a patient while the in-dwelling port100is installed in a patient. When the in-dwelling port100is assembled for use, the tethers110are each positioned in a respective tether guide slot114. The distal end of the collapsible region106of the insertion portion104includes a distal port opening118(seeFIG. 17C). A difference between the in-dwelling port ofFIGS. 17-18and that of the earlier tether version shown inFIGS. 15 and 16is the addition of a retention ring120that is attached to the tethers110and includes a central textured passage122as best seen inFIG. 17D. As shown inFIGS. 18A-18C, the proximal port opening124of the in-dwelling port100is covered by a membrane126having a predefined slit128configured to resealably close after removal of medical equipment from the proximal port opening124. In one embodiment, the proximal port opening has a larger diameter than the distal port opening118. In yet other embodiments, the membrane126may be a pierceable membrane rather than a pre-slit membrane. Multiple slits arrayed in a radial pattern may be used, and other self-closing or hinged configurations are also contemplated over the proximal port opening124. An embodiment with no membrane, and instead using a tethered plug sized to resealably close the proximal port opening, is also contemplated.

For ease of reference,FIGS. 17-18illustrate an expanded view of in-dwelling port100prior to configuration for insertion into a body cavity, whileFIGS. 19-20show the orientation of the in-dwelling port assembled and ready for use. Referring now toFIGS. 19-20, when the in-dwelling port100is assembled and ready for use, the retaining ring120is positioned on the opposite side of the flange102from the insertion portion104with the tethers110positioned respectively in the tether guide slots114on opposite sides of the proximal port opening124.FIG. 19illustrates the fully extended position for the in-dwelling port100where the maximum throw of the tether110is limited by the retention ring120, where the retention ring120contacts the outside portion of the flange102.FIG. 20illustrates the in-dwelling port100when it is in a collapsed position and the collapsible region106has been retracted by pulling on the tethers110via the retention ring120attached to the end of the tethers110and located outside of the flange102. An advantage of the retention ring120being attached to both tethers110is that the collapsible portion106of the insertion portion104may be retracted evenly and symmetrically. In one embodiment, the tethers are sized to slide freely in the tether guide slots. In other embodiments, the diameter of the tethers and the width of the slot are sized to provide sufficient friction to maintain a current position of the collapsible portion absent a force applied to the retention ring120to retract, or a force applied by an introducer or medical instrument inserted into the in-dwelling port to expand, the collapsible portion. The tethers may be made from a rigid material or a flexible material in different embodiments. In one embodiment, the hardness of the tether material may be in the range of 30-85 durometer on the Shore A scale, and more preferably in the range of 60-65 durometer on the Shore A scale.

Although not required, the in-dwelling port100ofFIGS. 17-20may be used with an introducer200as illustrated inFIGS. 21-22. Similar to the stylus26ofFIG. 5, the introducer200is designed to fit into the proximal port opening124and be extended into the in-dwelling port100so that the distal end of the collapsible portion106of the insertion portion104is extended by contact of the introducer200to the inside of the collapsible portion106surrounding the distal port opening118. Again, the proximal port opening124is sized larger than the distal port opening of the in-dwelling port such that the introducer may fit within the proximal opening through the slit and the distal end214of the introducer, which is at the far end of the extended tube portion204is larger than the distal port opening of the in-dwelling port and will not pass through the distal port opening Referring toFIG. 21A, the introducer200may have any of a number of additional features associated with it. The introducer200may include an upper housing202aligned with an extended tube portion204such that one or more lumens may be passed through one or more openings defined by the upper housing and the extended tube. The upper housing202may include a first proximal opening206for receiving medical instrumentation and a second proximal opening208for receiving additional instrumentation or for connecting to a fluid source, such as an insufflation gas or irrigation liquid supply.

As shown inFIG. 21B, the extended tube portion204of the introducer200may include dimensioned ribs210that are evenly spaced and have a diameter greater than the outer diameter of the extended tube204. Optional markings212may also be included next to one or more of the dimensioned ribs to indicate a depth of insertion from the distal end214of the introducer200. The distal end of the introducer202is sized with a greater diameter than the diameter of the distal opening118of the in-dwelling port100such that the in-dwelling port may extended by contact of the distal end of the introducer202against the inside of the in-dwelling port100. Additionally, the dimensioned ribs210that extend beyond the diameter of the main shaft of the extended tube portion204are sized to fit within the proximal port opening124of the in-dwelling port100.

Operation of the in-dwelling port ofFIGS. 17-20, in cooperation with an introducer such as the introducer200ofFIGS. 21-22, is now described with respect toFIGS. 23-24. The in-dwelling port100, when assembled for use, may be packaged such that the tethers110are positioned in the tether guide slots114on the flange102. The bellows of the collapsible region106of the insertion portion104may be in, or placed in, a collapsed position and the distal end of the introducer200would then be inserted into the donut-shaped retention ring120through the textured passage122of the retention ring120. In one embodiment, the spacing of the dimensioned ribs210on the introducer200may be such that the thickness of the retention ring120is captured between adjacent dimensioned ribs. Alternatively, the textured passage122of the retention ring120may be sized with recessed circumferential rings, or extended detents or rings, such that an individual dimensioned rib212would be captured within the textured passage122. In yet other alternative implementations, an introducer without any dimensioned ribs may be used and the fictional fit of the retention ring120with or without a texture in the passageway122may frictionally fit against the outside of the introducer.

Once the retention ring120is attached to the desired portion (e.g., a desired portion being the portion that will allow for intended insertion depth of the introducer) a catheter, instrument, scope or whatever other medical device that is desired to be introduced through the introducer200may be pushed down into the port100, where the bellows of the collapsible region106would be expanded to the desired length within an abdominal cavity. The extension of the collapsible portion may be limited by the retaining ring contacting the flange (FIG. 24). Once the procedure for which the in-dwelling port100was needed is completed, the introducer200may be removed and the retaining ring120, held in place against the introducer by any of the mechanisms noted above, or by a user maintaining a finger between the retaining ring and the flange, may pull with it the tethers and raise the collapsible portion towards the flange until the collapsible portion is sufficiently collapsed against the non-collapsible portion108(FIG. 23). After the collapsible portion has been fully retracted and the introducer is fully removed from the port, the port may be secured to the top surface of the abdomen (e.g., the outer surface of the skin of a patient) either by an adhesive surface on the bottom side of the flange102, by placing stitches into the recessed portions114of the flange102or by folding and taping the tether110and retaining ring120and the complete flange surfaces to the patient in order to help prevent misplacement or other movement of the port. Securing of the port100to prevent movement will also likely reduce chance of infection.

As in the embodiments previously discussed, the material for the in-dwelling port may be silicone or other flexible or somewhat-flexible material. In alternative embodiments, the in-dwelling port may be constructed from a polycarbonate or metal material, or a combination of silicone, polycarbonate and/or metal material. The in-dwelling port100may be radio opaque and may have printed indicators showing size or position. Furthermore, the in-dwelling port may be made of, or coated with an antimicrobial substance, or all of the above options combined.

The embodiment ofFIGS. 17-24may provide a more efficient and reliable mechanism for allowing the collapsible portion to collapse in a straighter and more repeatable manner. The non-collapsible portion of the insertion portion may provide added security to the positioning of the in-dwelling port in an incision and may provide a better opening for re-introduction of the introducer200than a fully collapsible insertion portion. The tether guides in the flange may assist in the prevention of twisting of the collapsible portion and provide improved repeatability of movement and positioning of the collapsible portion. Finally, the pre-slit membrane may assist in preventing contamination and infection, while providing a repeatedly usable opening that only need be covered by a common adhesive bandage between insertions of an introducer and or medical instrument.

The dimensions (such as extended and collapsed length, and the diameter (exterior or interior) of the collapsible portion) of the in-dwelling may be varied according to the desired use. In one embodiment, the proximal port opening124and distal port opening118may have the same respective diameters as described with respect to the embodiment ofFIGS. 1-3. The extendibility of the collapsible portion may such that the fully extended length is a factor of 2-3 times the fully collapsed length. Similarly, the length of the inserter200may be sized to permit full extension of the in-dwelling port100, if desired, with graduated markings212and/or ribs along the hollow tube of the extended tube portion204sufficient to guide a user to the exact depth of the distal port opening relative to the flange at the outer surface of the body cavity it is installed on.

The different length or diameter in-dwelling port designs may be selected based on patient body type or incision location. For example, it is contemplated that a set of different size in-dwelling ports may be produced to allow caregiver selection at the time of use based on patient characteristics and desired incision location. The range of lengths achievable from a particular in-dwelling port having both non-collapsible and collapsible portions may be, in one embodiment, 30 mm-82 mm inclusive of the collapsible and non-collapsible portion lengths, and the outer diameter of the insertion portion may be in the range of 5 mm-11 mm. As noted previously, other in-dwelling port range lengths are contemplated. Although any of a number of outer diameter ratios between the outer diameter of the non-collapsing portion and the collapsible portion are contemplated, in one embodiment, the maximum outer diameter of the collapsible portion106, when in the collapsed position (i.e., where the collapsible portion is at its shortest, retracted length), is preferable greater than the outer diameter of the non-collapsing portion. In one implementation, the diameter of the collapsible portion in a collapsed position may be 20%-50% greater than the diameter of the non-collapsing portion. This disparity in diameters may aid in keeping the in-dwelling port from sliding out of the incision when not in use because the collapsible portion, when collapsed, may have a greater diameter that the incision through which the insertion portion was inserted.