Patent Application
20250152930
Briefly summarized, embodiments disclosed herein are directed to a vascular access system including a port, catheter, cathlock, or combinations thereof, and including a coating disposed on a surface thereof. The coating can include a lubricious and/or hydrophilic coating configured to reduce infection, reduce biofilm formation, and improve ease of insertion Embodiments include active ingredients formed within the coating and/or can include custom dips to activate the lubricious coating and load one or more active ingredients into the coating prior to subcutaneous placement. The active ingredients can be configured to prevent infection, prevent thrombi formation, prevent biofilm formation, combinations thereof, or the like.
Placing a vascular access system, or “port,” can generally include accessing the vasculature, placing a catheter, forming a tissue pocket, placing the port subcutaneously within the tissue pocket, and coupling the catheter to the port stem, before closing one or more insertion sites. The procedure can be susceptible to various complications including trauma, skin stretching or scar tissue formation during formation of the tissue pocket and/or placing of the catheter and port. Further, the placement procedure is susceptible to the introduction of pathogens leading to post placement infections and associated complications. Lastly, once the vascular access system has been placed, the presence of the foreign body placed subcutaneously can result in biofilm formation and or thrombosis formation.
Disclosed herein is a subcutaneous vascular access system including, an access port having a body defining a reservoir and a stem in fluid communication with the reservoir, and a coating disposed on an outer surface of the access port and configured for, (i) submersing in a solution to transition the coating to an activated state, (ii) absorbing an active ingredient from the solution, and (iii) eluting the active ingredient following subcutaneous implantation.
In some embodiments, the subcutaneous vascular access system further includes a catheter configured to engage the stem, the coating disposed on an outer surface of the catheter. In some embodiments, the subcutaneous vascular access system further includes a cathlock configured to secure the catheter to the stem, the coating disposed on an outer surface of the cathlock. In some embodiments, the coating is configured to be a lubricious coating in the activated state to facilitate insertion through an incision site. In some embodiments, the coating is configured for eluting the active ingredient over a period of 48 hours. In some embodiments, the coating includes a base layer bonded to the surface of the port, and a loose polymer matrix bonded to the base layer.
In some embodiments, the coating includes one or more of polyurethane, polyvinylpyrrolidone, hyaluronicacid, a UV Curable H-Coating, and a poly-N-vinylpyrrolidone H-coating. In some embodiments, the coating is between 100 μm and 500 μm thick. In some embodiments, the coating is configured for absorbing the active ingredient from the solution in a range of between two (2) mins and ten (10) mins. In some embodiments, the active ingredient includes one or more of an antibiotic agent, antifungal agent, anti-thrombotic agent, rifampin, gentamicin, minocycline, teicoplanin, glycopeptide teicoplanin, vancomycin, ceftazidime, and amphotericin B.
Also disclosed is a method of placing a subcutaneous vascular access assembly including, providing a vascular access assembly including an access port, a catheter, and a cathlock, the access port including a coating disposed on an outer surface thereof, the coating including a hydrophilic material, immersing a portion of the access port in a solution to transition the coating to an activated state, and subcutaneously implanting the vascular access assembly.
In some embodiments, the step of immersing further includes transitioning the coating to a lubricious coating in the activated state to facilitate insertion of the vascular access assembly through an incision site to place the vascular access assembly subcutaneously. In some embodiments, the solution includes an active ingredient, and the method further includes absorbing the active ingredient from the solution into the coating and eluting the active ingredient from the coating when placed subcutaneously.
In some embodiments, the active ingredient includes one or more of an antibiotic agent, antifungal agent, anti-thrombotic agent, rifampin, gentamicin, minocycline, teicoplanin, glycopeptide teicoplanin, vancomycin, ceftazidime, and amphotericin B. In some embodiments, the coating includes a base layer bonded to the surface of the vascular access assembly, and a loose polymer matrix bonded to the base layer. In some embodiments, the coating includes one or more of polyurethane, polyvinylpyrrolidone, hyaluronicacid, a UV Curable H-Coating, and a poly-N-vinylpyrrolidone H-coating. In some embodiments, the coating is between 100 μm and 500 μm thick. In some embodiments, the coating is submerged within the solution for between two (2) mins and ten (10) mins.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top.” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
In the following description, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
To assist in the description of embodiments described herein, as shown in
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
The cap 120 can engage the body 112 in a press-fit, interference fit, or snap fit engagement. In an embodiment, the cap 120 can be secured to the body 112 using adhesive, bonding, welding, or similar suitable means. In an embodiment, the cap 120 can be over-molded on to the body 112. In an embodiment, the cap 120 and the body 112 can be formed as a single monolithic piece formed of the same material.
In an embodiment, the body 112 can be formed of a substantially rigid or resilient material including, but not limited to, a plastic, polymer, thermoplastic, metal, alloy, composite, combinations thereof, or the like. In an embodiment, the cap 120 can be formed of a softer material relative to the body 112 including, but not limited to, a plastic, polymer, thermoplastic, elastomer, rubber, silicone rubber, metal, alloy, composite, combinations thereof, or the like. In an embodiment, the body 112 and the cap 120 can be formed of the same material and can display the same mechanical properties. In an embodiment, a catheter 130 can engage the stem 116 in one of a press-fit or interference fit engagement. Optionally a cathlock 140 can engage one or both of the catheter 130 and the stem 116 to further secure the catheter 140 to the stem 116.
In an embodiment, the port 110 can include a nose portion 118 extending from the port 110 along a longitudinal axis and disposed opposite the stem 116 across a central transverse axis of the reservoir 114. The nose portion 118 can define a substantially wedge shaped profile extending from the port 110 and can be configured to facilitate subcutaneous placement of the port 110. For example, as the port 110 is urged subcutaneously, the nose portion 118 can facilitate separation of subcutaneous tissues to form a tissue pocket. In an embodiment, one or both of the body 112 and the cap 120 can include a suture hole 124. The suture hole can include a plug 126 formed or silicone rubber, or similar suitable material and can be configured to prevent tissue ingrowth into the suture hole 124. As will be appreciated, the port 110 is an exemplary vascular access device and not intended to be limiting. As such, it is contemplated that various ports or access devices that include a rigid stem and configured to be coupled with a catheter or similar compliant tube are contemplated to fall within the scope of the present invention.
In an embodiment, as shown in
In an embodiment, the coating 150 can be a lubricious coating that is pre-wetted and configured to provide a reduced friction co-efficient to a surface of the system 100. Advantageously, the lubricious coating can facilitate inserting the system 100 through an insertion site in a skin surface of the patient, reducing stretching, trauma, and scar tissue formation. In an embodiment, the coating 150 can be a hydrophilic coating configured to transition between a deactivated state and an activated state. In an embodiment, a deactivated state can be a dehydrated state and an activated state can be a hydrated state. In an embodiment, a deactivated state can be defined as less than a threshold hydration level, and an activated state can be a defined as greater than a threshold hydration level. In an embodiment, a threshold hydration level can be between 1% and 99% hydration. In an embodiment, a threshold hydration level can be between 5% and 80% hydration. In an embodiment, a threshold hydration level can be substantially 50% hydration. However, it will be appreciated that greater or lesser hydration thresholds are contemplated.
In an embodiment, the coating 150 can transitioned from a deactivated state to an activated state by immersing the coating 150 in a solution 90. Exemplary solutions 90 can include water, saline, polar solutions, or similar biocompatible solutions. In an embodiment, a deactivated state can be defined as a dwell time of less than a threshold dwell time within the solution 90, and an activated state can be a defined as a dwell time as greater than a threshold dwell time. In an embodiment, a threshold dwell time can be between 1 secs and 10 mins. However, it will be appreciated that greater or lesser dwell time thresholds are contemplated. Once the (deactivated) hydrophilic coating 150 has been transitioned to an activated coating 160, the coating can provide a lubricious coating to provide a reduced friction co-efficient to a surface of the system 100. Advantageously, the activated hydrophilic coating 160 can facilitate inserting the system 100, through an insertion site in a skin surface of the patient reducing stretching, trauma, and scar tissue formation. Advantageously, the deactivated coating can be stored and transported in a dehydrated state extending the storage life, or “shelf-life,” of the device.
In an embodiment, the coating 150 can include an active ingredient formed within the coating during manufacture. Exemplary active ingredients can include antibiotic agents, antifungal agents, anti-thrombotic agents, rifampin, gentamicin, minocycline, teicoplanin, glycopeptide teicoplanin, vancomycin, ceftazidime, and amphotericin B, or combinations thereof.
In an embodiment, a deactivated state can be defined as a concentration of an active ingredient of less than a threshold concertation, and an activated state can be a defined as a concentration of an active ingredient greater than a threshold concertation. In an embodiment, a threshold concentration can be equal to or greater than a zero concentration of an active ingredient.
In an embodiment, the coating 150 can be submersed in the solution 90 and can absorb one or more of water and active ingredients from the activation solution 90, to transition the coating from a deactivated state coating 150 to an activated state coating 160. The activated state coating 160 can be a lubricious to facilitate subcutaneous placement. Further, once placed subcutaneously, the activated state coating 160 can elute the active into the surrounding tissues. As such, the activated state coating 160 can act as a reservoir for the one or more active ingredients, providing extended elution times for the active ingredient once the system 100 is placed subcutaneously.
For example, conventional methods of placing a vascular access system 100 can include washing the tissue pocket with a solution including an active ingredient prior to placing the port 110. The active ingredient can be configured to prevent infection, biofilm formation, thrombosis formation, or the like. However, the efficacy of the solution decreases sharply, over time, from the point where the clinician finishes washing the tissue pocket. Advantageously, embodiments disclosed herein provide a coating 150 that can act as a reservoir for one or more active ingredients. The active ingredients can be eluted into the surrounding tissues over an extended period of time, extending the efficacy of the active ingredient. Exemplary elution times can be up to 48 hours after the placement of the system 100, however greater or lesser elution times are also contemplated.
In an embodiment, the system 100 including the coating 150 can be disposed within the solution 90 transitioning the coating 150 to an activated coating 160. During activation of the coating, one or more active ingredients dissolved within the solution 90 can be loaded into the coating. Advantageously, a clinician can select one or more active ingredients, different concentrations of the active ingredients, and/or the length of dwell time the system 100 remains within the solution 90. As such, the clinician can modify the active ingredients and elution rates for the system 100 depending on the specific procedure being performed or the specific needs of the patient. As will be appreciated, such a system allows for a single device to be manufactured, transported and stored and the modified at the point of use to be applied to various different procedures and patients. This can provide a more versatile system 100 and prevent manufacturing and storing large inventories of different vascular access systems, reducing associated costs. Similarly, when activating the coating 150 to an activated state 160, a clinician can modify the dwell time of the system 100 within the solution 90 to modify a degree of lubricity of the system 100 as required by the procedure or needs of the patient. Similarly, this can provide a more versatile system 100 reducing excess inventory and associated costs.
In an embodiment, the degree of lubricity (i.e. friction coefficient), or the rate of active ingredient elution can be varied based on the thickness of the coating (1), or the relative thickness of one or more layers of the coating 150, i.e. the thickness of the base layer 152 (11) or the thickness of the polymer matrix 154 (12), or combinations thereof. Exemplary coating 150 thickness (1) can be between 100 μm and 500 μm.
In an embodiment, as shown in
In an embodiment, a clinician can modify the degree of lubriciousness based on the length of dwell time within the solution 90 Exemplary dwell times can be between two (2) mins and ten (10) mins, however greater or lesser dwell times are also contemplated. In an embodiment, a clinician can modify the drug elution time based on the length of dwell time within the solution 90 including the active ingredient. Exemplary dwell times can be between two (2) mins and ten (10) mins, however greater or lesser dwell times are also contemplated.
In an embodiment, a clinician can modify the number or combination of active ingredients in the coating by modifying the number, combination, or relative concentrations of active ingredients within the solution 90. Advantageously, the clinician can modify the degree of lubriciousness or active ingredient combinations at the point of placement based on the specifics of the procedure or various patient factors, or the like. This provides a more versatile system 100 that can be modified to suit various patient factors, reducing device inventory and associated costs. Advantageously, embodiments described herein allow for a system 100 to be modified at the point of placement with various combinations of active ingredients or degrees of lubricity and provide increased efficacy through the synergistic effects of the active ingredient combination. Advantageously, the coating can provide extended drug elution times by providing a reservoir for active ingredients, relative to washing the tissue pocket and/or system 100 with active ingredients prior to placement. For example, the system 100 can provide elution times of up to 48 hours after placement or longer.
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/065323 | 12/28/2021 | WO |
