WO2024226897A1

WO2024226897A1 - Port usable for peritoneal or pleural drainage and methods of use

Info

Publication number: WO2024226897A1
Application number: PCT/US2024/026409
Authority: WO
Inventors: Mircea Despa; Jake Smith; Mary Arwen BROUGHTON; Akiva Kirschner
Original assignee: Bard Peripheral Vascular, Inc.
Priority date: 2023-04-26
Filing date: 2024-04-26
Publication date: 2024-10-31

Abstract

A device may include an elongated catheter passage portion configured to have a distal end in a plural or peritoneal cavity with a proximal end outside of the plural or peritoneal cavity. A device may include a port apparatus at a proximal end of the elongated catheter, wherein the port has a connector interface for connection of a drainage device thereto and is configured to provide fluid communication with the catheter via a valve.

Description

PORT USABLE FOR PERITONEAL OR PLEURAL DRAINAGE AND METHODS

OF USE

CROSS REFERENCE TO RELA TED APPLICA TIONS

[0001] The present application claims the benefit of priority to U. S. Provisional Application No. 63/554292 entitled “SKIN MOUNTED PORT AND SYSTEM USABLE FOR PLEURAL OR PERITONEAL DRAINAGE AND METHODS OF USE THEREOF,” filed February 16, 2024, and U.S. Provisional Application No. 63/462069 entitled “PORT USABLE FOR PERITONEAL OR PLEURAL DRAINAGE AND METHODS OF USE THEREOF,” filed on April 26, 2023 the entirety of both of are hereby incorporated by reference in their entirety for all purposes.

TECHNICAL FIELD

[0002] This disclosure is related to access devices, methods of using access devices, and making access devices that provide improved access for the drainage of bodily fluids.

BACKGROUND

[0003] The current options for pleural or peritoneal drainage catheters typically require that the catheter exit through the skin and terminate in a portion of the catheter that remains outside of the body. To protect the exit site when the catheter is not being used to actively drain, a dressing (e.g., a 3M Tegaderm brand dressing) with gauze is typically placed over the catheter, which is to remain under the dressing when not in use. Additionally, a layer of foam typically needs to also be placed under the catheter to protect the skin from the hard components on the catheter end and increase patient comfort.

SUMMARY

[0004] The following presents a simplified summary of one or more aspects of the technology disclosed herein in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later.

[0005] In some aspects of the disclosure, a port system for pleural or peritoneal drainage is described. The port system including: an elongated catheter passage portion configured to have a distal end in a plural or peritoneal cavity with a proximal end outside of the plural or peritoneal cavity; and a port apparatus at a proximal end of the elongated catheter, wherein the port has a connector interface for connection of a drainage device thereto and is configured to provide fluid communication with the catheter via a valve.

[0006] In another aspect of the disclosure, a method of installing port system for pleural or peritoneal drainage is described. The method includes steps of installing an elongated catheter and removably fastening a port apparatus to a patient’s skin. The port system including: an elongated catheter passage portion configured to have a distal end in a plural or peritoneal cavity with a proximal end outside of the plural or peritoneal cavity; and a port apparatus at a proximal end of the elongated catheter, wherein the port has a connector interface for connection of a drainage device thereto and is configured to provide fluid communication with the catheter via a valve.

[0007] In another aspect of the disclosure, a method of making a port system is described. The port system including: an elongated catheter passage portion configured to have a distal end in a plural or peritoneal cavity with a proximal end outside of the plural or peritoneal cavity; and a port apparatus at a proximal end of the elongated catheter, wherein the port has a connector interface for connection of a drainage device thereto and is configured to provide fluid communication with the catheter via a valve.

[0008] To the accomplishment of the foregoing and related ends, the one or more aspects of the disclosure comprise the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail include certain illustrative features of the one or more aspects. These features are indicative, however, of but a few of the various ways in which the principles of various aspects can be employed, and this description is intended to include all such aspects and their equivalents.

BRIEF DESCRIPTION OF THE DRA WINGS

[0009] Features characteristic of aspects of the technology described herein are set forth as follows, in the appended claims, and in the drawings. In the descriptions that follow, like parts are marked throughout the specification and drawings with the same numerals, respectively. The drawing figures are not necessarily drawn to scale and certain figures can be shown in exaggerated or generalized form in the interest of clarity and conciseness. The disclosure itself, however, as well as a preferred mode of use, further objects and advances thereof, will be best understood by reference to the following detailed description of illustrative aspects when read in conjunction with the accompanying drawings.

[0010] Figures 1-2 show examples of port systems as described herein installed to a patient according to one aspect of the disclosure.

[0011] Figures 3A-3F show examples of a port system according to aspects of the disclosure.

[0012] Figures 4A-4C show examples of a port system according to aspects of the disclosure.

[0013] Figures 5 A-5F show another example of a system and use of a port system according to aspects of the disclosure.

[0014] Figure 6A and 6B show another example of a port according to aspects of the disclosure.

[0015] Figures 7A-7C show another example of a port system according to aspects of the disclosure.

[0016] Figures 8 A-8E show non-limiting examples of a valve that may be implemented into any of the port apparatuses described herein according to aspects of the disclosure.

[0017] Figure 9 shows one example of a port apparatus with a plug or cover according to aspects of the disclosure.

[0018] Figures 10 shows one example of a port apparatus according to aspects of the disclosure.

[0019] Figures 11 A-l 1H show additional examples of a port apparatus according to aspects of the disclosure.

[0020] Figure 12 shows one example of a monitoring apparatus according to aspects of the disclosure.

[0021] Figure 13 illustrates an example representative diagram of various components of an example controller usable with aspects of the disclosure.

[0022] Figure 14 illustrates an example of a computer system in accordance with aspects of the disclosure; [0023] Figure 15 illustrates an example of various system components in accordance with aspects of the present disclosure.

DETAILED DESCRIPTION

[0024] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts can be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

I. Terminology

[0025] Reference throughout this specification to one aspect, an aspect, one example or an example means that a particular feature, structure or characteristic described in connection with the embodiment or example may be a feature included in at least example of the present disclosure. Thus, appearances of the phrases in one aspect, in an aspect, one example or an example in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures or characteristics may be combined in any suitable combinations and/or subcombinations in one or more embodiments or examples.

[0026] Throughout the disclosure, the terms substantially or approximately may be used as a modifier for a geometric relationship between elements or for the shape of an element or component. While the terms substantially or approximately are not limited to a specific variation and may cover any variation that is understood by one of ordinary skill in the art to be an acceptable level of variation, some examples are provided as follows. In one example, the term substantially or approximately may include a variation of less than 10% of the dimension of the object or component. In another example, the term substantially or approximately may include a variation of less than 5% of the object or component. If the term substantially or approximately is used to define the angular relationship of one element to another element, one non-limiting example of the term substantially or approximately may include a variation of 5 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on the understanding of acceptable limits to one of skill in the relevant art.

[0027] For purposes of the disclosure, directional terms are expressed generally with relation to a standard frame of reference when the aspects or articles described herein are in an in-use orientation. In some examples, the directional terms are expressed generally with relation to a left-hand coordinate system.

[0028] Terms such as a, an, and the, are not intended to refer to only a singular entity, but also include the general class of which a specific example may be used for illustration. The terms a, an, and the, may be used interchangeably with the term at least one. The phrases at least one of and comprises at least one of followed by a list refers to any one of the items in the list and any combination of two or more items in the list. All numerical ranges are inclusive of their endpoints and non-integer values between the endpoints unless otherwise stated.

[0029] The terms first, second, third, and fourth, among other numeric values, may be used in this disclosure. It will be understood that, unless otherwise noted, those terms are used in their relative sense only. In particular, certain components may be present in interchangeable and/or identical multiples (e.g., pairs). For these components, the designation of first, second, third, and/or fourth may be applied to the components merely as a matter of convenience in the description.

[0030] The terms disposed on, disposed along, disposed with, or disposed toward and variations thereof may define one element can be integral with another element, or that one element can be a separate structure bonded to or placed with or placed near another element.

[0031] The term at, for example when referring to something being located at a specific location, is intended to include any one or more of: proximate, on, near, adjacent to or within the specific location. As used herein, the terms proximal is defined with respect to an object, element, or user. For example, the term proximal may refer to the part or portion closer to the user.

II. Overview

[0032] This overview, and the detailed description that follows, has been presented for purposes of illustration and description. It is not intended to be exhaustive nor to limit the disclosure to the forms described. Numerous modifications are possible considering the teachings herein, including any combination of the different examples described herein. Some of those modifications have been discussed and others will be understood by those skilled in the art. The various aspects were chosen and described to best illustrate the principles of the present disclosure and various aspects as are suited to the particular use contemplated. The scope of the present disclosure is, of course, not limited to the examples or aspects set forth herein but can be employed in any number of applications and equivalent devices by those of ordinary skill in the art. Rather, it is hereby intended the scope be defined by the claims appended hereto.

[0033] The current options for pleural or peritoneal drainage catheters typically require that the catheter exit through the skin and terminate in a portion of the catheter that remains outside of the body. To protect the exit site when the catheter is not being used to actively drain, a dressing (e.g., a 3M Tegaderm brand dressing) with gauze is typically placed over the catheter, which is to remain under the dressing when not in use. Additionally, a layer of foam typically needs to also be placed under the catheter to protect the skin from the hard components on the catheter end and increase patient comfort. It is noted that while throughout the disclosure drainage is discussed, the systems described herein may be used for infusion or other treatments where fluid or other materials or therapeutic agents are provided from port or port apparatus.

[0034] The current solution described above may be difficult for patients and/or caregivers to manage on their own and managing the catheter before and after drainage can be cumbersome. There are many steps and components which may be confusing for a patient and/or caregiver and frequently require one or more caregivers to apply and/or dress the catheter. These traits make it difficult for a patient or technician to dress the exit site on their own. Additionally, the current solution is bulky and obtrusive after the foam pad, gauze and dressing are placed over the catheter and exit site, which may result in misalignment and poor coverage of components or prevent the patient from maintaining a normal level of activity and feeling of independence during their day-to-day lives.

[0035] A catheter and port are disclosed herein. The catheter and port may significantly improve ease and efficiency of draining fluids from a patient’s body and may especially benefit a patient regularly requiring pleural or abdominal drainage (e.g., in treatment or management of pleural effusion or ascites). The disclosed port and catheter system may improve quality of life for patients who have a longer life expectancy and desire to stay more active by improving ease and efficiency of drainage. Further, a port as described herein may reduce instances or likeliness of infection. The port may further be designed for easy selfaccess using features described herein.

[0036] In one example implementation of this disclosure, a port could replace the long silicone tubing that protrudes from the patient during typical drainage treatment. In one aspect, the port may be located on the external surface of the skin (either on the chest for treatment of Pleural Effusion or abdomen for treatment of Ascites) and have a low-profile design so as not to cause or minimize discomfort for the patient. The port may also be provided with accessories for capping in between use and protecting the exit site, also designed to be low profile and comfortable while maintaining an aseptic environment around the catheter exit site when the patient is not actively draining fluid. The port may incorporate an easy-connect mechanism which would allow for quick and intuitive connection with an external drainage collection container as well as the custom accessories for exit site protection and maintenance.

[0037] The current disclosure also provides advantages over currently used solutions. One example advantage is increased stability of the exit site, which improves ease of use by providing a stable connection point. Providing a stable connection point may improve ease of connect! on/disconnecti on of an external draining device and may decrease stress at the skin and/or tunnel exit caused by movement of the catheter.

[0038] Another example advantage is that the catheter and fitted interface or port described herein may be low-profile and non-obtrusive, allowing the patient to go about their day-to- day lives comfortably and without the reminder that they have a catheter protruding from their body. The catheter would also require fewer components around the exit site and allow the patient to both dress the exit site on their own (even if it is in a hard-to-reach area) and more easily comprehend the steps to dressing the exit site. Improved ease of dressing would likely lead to increased compliance of proper aseptic technique during drainage and has the potential to reduce catheter associated infections.

[0039] In some examples, the catheter and/or access device is intended for providing fluid communication with or otherwise allowing for the drainage of fluid from a patient’s pleural or peritoneal space. Some example uses of the aspects and methods described herein may be used for the treatment of pleural effusions, ascites, or the treatment of pleural infection.

[0040] In one example, a catheter is fitted with an interface (herein described as "port") designed for both ease of connection and/or disconnection with external collection and for providing fluid communication with a site that requires drainage. The port may also provide a lower profile and less-obtrusive exit site than current solutions. The port apparatus may additionally be compatible with or include as a system (e.g., packaged system) a flexible sheet with adhesive on one side (e.g. 3M Tegaderm® dressing) and an opening that corresponds to the shape of the port apparatus. The system may include a reinforced area around the opening (e.g., a reinforcing flange) that aligns the adhesive sheet to the port apparatus and provides stability to the sheet during application. This reinforced area around the opening could be made out of a suitable polymer material, such as polymer foam, or could be cut into the carrier of the flexible sheet. It could be left in place for the duration of the dressing wear or removed after application of the dressing. This custom cut dressing of the system creates a fluid barrier around the port apparatus while still enabling access to the drainage connection point when applied.

[0041] Additional details and examples and advantages are described in the non-limiting examples below.

III. Detailed Examples

[0042] The present disclosure relates to a catheter may be connected to or otherwise fitted with an interface (herein described as "port" or “port apparatus”), which may significantly improve ease and efficiency of draining fluids from a patient’s body and may especially benefit a patient regularly requiring pleural or abdominal drainage. The disclosed port apparatus and catheter system may improve quality of life for patients who have a longer life expectancy and desire to stay more active by improving ease and efficiency of drainage. Further, a port apparatus as described herein may reduce instances or likelihood of infection. The port apparatus may further be designed for easy self-access using features described herein.

[0043] In some aspects of the disclosure, the port apparatus is designed to provide minimal protrusion from the body of the patient in which the catheter has been placed. It is noted that aspects described herein are applicable to all types of catheter systems and is not limited to pleural or abdominal drainage systems.

[0044] In one example implementation of this disclosure, a port apparatus could replace or shorten the long tubing that typically protrudes from the patient. In one aspect, the port apparatus may be located on the external surface of the skin (e.g., either on the chest for treatment of Pleural Effusion or abdomen for treatment of Ascites) and have a low-profile design so as not to cause discomfort for the patient. The port apparatus may also be provided with custom accessories and/or valves for blocking the flow path in between use and for otherwise protecting the exit site. The custom accessories and/or valves may also be designed to be low profile and comfortable while maintaining an aseptic environment around the catheter exit site when the patient is not actively draining fluid. The port may incorporate an easy-connect mechanism which would allow for quick and intuitive connection with an external drainage collection container as well as accessories for exit site protection and maintenance.

[0045] Some examples of catheter, port and/or port apparatus’s are shown in the drawing explanations that follow. It is noted that while examples shown in the drawings, various features are simplified in the drawings prevent obstruction of the views.

[0046] Figures 1 -3 show examples of a port system as described herein installed to a patient. The port system described herein may be used for pleural drainage (e.g., as shown in Figure 1) or for peritoneal drainage (e.g., as shown in Figures 2A-2B). As shown in Figures 1 and 2A-2B, a tube (e.g., a catheter) 112 or 212 may be installed into a patient through one or more incisions (e.g., incisions 55 and 65) with the distal end of the catheter in the pleural space 50 or in the abdominal cavity 60. In some instances, the catheter is tunneled under the skin, which may help with securing the system and to prevent infection.

[0047] As shown in Figures 1-3, the port (e.g., port 110 or port 210) may be removably mounted or otherwise emplaced on a patient’s skin proximal to or at the exit site of the tube or catheter. A dressing 120, such as one or more pressure sensitive adhesive sheets or other adhesive and or partially adhesive sheets (e.g., a 3M Tegaderm® brand dressing) may be placed over the incision and tube or catheter exit site. In some examples the aforementioned adhesive sheet may have an opening and/or a built-in interface that engages with or otherwise stabilizes the port on the patient’s skin. Additional examples are provided in the description that follows. Further, the dressing may include placement of a foam and/or gauze to either improve comfort of the dressing and/or to absorb any excretions or fluids associated with the incision site.

[0048] Figure 3 A-3F show one example of a port according to aspects of the disclosure. The port may share features with or may be analogous with any of the ports and/or aspects described herein. As shown in the example in Figures 3 A-3F, a port apparatus 310 may include a main body 312 and a connector interface 314, with an opening 316 for connecting a drainage device thereto. The connector interface 314 may be funnel-shaped or otherwise may taper from a larger dimension than the opening 316, to the opening to help guide the drainage device toward the opening 316, which may make connecting a drainage device to the port apparatus 310 easier for a user or technician. The port apparatus may further include a port connector 318 that is configured to be connected to or is permanently connected to a tube or catheter (e.g., tube or catheter 112 in Figure 1 and/or tube or catheter 212 in Figures 2A-2B) that is configured to extend into the abdominal cavity or a plural space of a patient.

[0049] The main body 312 of the port apparatus 310 may be low-profile and/or curved and devoid of sharp edges or corners to ensure that the port can be comfortably worn under clothing or other articles.

[0050] As shown in Figures 3A-3F, the port apparatus 310 may be configured to function in conjunction with a dressing 320. In one example, a dressing may include features that provide stabilization to the port apparatus 310 and prevent it from moving once the dressing 320 is installed. For example, the port apparatus 310 may include a flange 322 extending from the main body 312 of the port apparatus 310. The flange 322 may be configured to connect with or be covered or partially covered by a portion of the dressing 320.

[0051] Figures 3A, 3B, 3D, 3E, and 3F, show an example of a stabilization flange 320b usable with aspects of the disclosure. For example, the stabilization flange 320b may be integrated into or otherwise connected to the dressing 320. For example, the dressing may have an adhesive portion 320a which may have a larger area than the stabilization flange and may be formed of a pressure sensitive adhesive sheet or other adhesive and or partially adhesive sheets (e.g., a 3M Tegaderm® brand dressing). The dressing 320 may be sized to cover an incision at the exit site of the tube or catheter (e.g., tube or catheter 112 in Figure 1 and tube or catheter 212 in Figures 2A-2B) and may further be dimensioned large-enough so that the adhesive portion 320a may be placed over the incision and tube or catheter exit site. The stabilization flange 320b may be adhered to or otherwise connected to the adhesive portion 320a and in some examples may be formed of a material that is more rigid or otherwise stiffer than the adhesive portion 320a. In some examples, the material may include any one or combination of polypropylene, low density polyethylene, thermoplastic elastomer, thermoplastic polyurethane, or silicone rubber.

[0052] As shown in Figure 3F, the stabilization flange 320b may surround an opening 320c in the adhesive portion 320a. The stabilization flange 320b may be dimensioned to correspond with or engage with the flange 322 of the port apparatus 310. In some examples, the stabilization flange 320b may be configured to cover or partially cover the flange 322. Thus, when the dressing 320 is placed over the port apparatus 310 and adhered to a patient’s skin, for example as shown in Figures 3 A, 3B, or 3E, the contact between the stabilization flange 320b and the flange 322 prevents the port apparatus 310 from moving and is captively held within the opening 320c of the dressing 320. In some examples, the stabilization flange 320b and/or the flange 322 may have an adhesive to further secure the stabilization flange 320b to the flange 322. The flange 322 and/or the stabilization flange 320b may have one or more engagement features or other stabilization features that further limit movement between the dressing 320 and the port apparatus 310. Some non-limiting examples of stabilization features are described below with respect to Figures 4A-4C, 6A-7C, 10A, and 10B.

[0053] As shown in Figures 3A and 3B, the port system may further utilize a padded or foam dressing 321, which may include a slit/opening 321a configured to have the proximal end of a catheter (e.g., catheter 112 in Figure 1 or catheter 212 in Figures 2A and 2B) passed through for connection at the port connector 318. The padded or foam dressing 321 may have the adhesive portion 320a adhered or otherwise emplaced thereover as shown in Figures 3A and 3B. The padded or foam dressing 321 may further include an adhesive for adhering the padded or foam dressing 321 to a patient’ s skin before placing or adhering the adhesive portion 320a over the patient’s skin, the padded or foam dressing 321, the incision, and catheter 342 that passes through an incision in the patient’s skin, and the flange 322 of the port apparatus 310. The padded or foam dressing 321 may improve comfort of the dressing and/or absorb any excretions or fluids associated with the incision site.

[0054] As noted above, the port apparatus 310 may provide fluid communication with a drainage device (e.g., a drainage catheter) that can be connected to the port apparatus 310 at the connector interface 314 and the catheter 342 connected at the port connector 318. The inner body main body 312 of the port apparatus 310 may include a valve that closes and/or opens in response to a drainage device being inserted into the opening 316. Thus, during a draining operation, a drainage device (e.g., a needleless dilator) may be inserted into the opening 316 to open the valve inside the port apparatus 310, thus opening a fluid communication path between the port connector 318 and the opening 316, the drainage device may apply a negative pressure to the catheter 342 via the opening 316 to allow for drainage of fluid from a patient’s pleural or abdominal space. Once a drainage operation is complete, the drainage device may be removed from the port apparatus 310, thus closing the valve within the port apparatus 310 and blocking-off a fluid pathway within the port apparatus 310. Examples of valves that may be utilized inside main body 312 of the port apparatus 310 are described in further detail below with respect to Figures 8A-8E.

[0055] In some examples, once drainage is completed, a cover or plug may be installed into the connector interface 314, thus blocking-off and protecting the opening 316 from any contaminants. Examples of covers or plugs are described in further detail below with respect to Figures 6B and 8. However, any type of plug or cover that fits within connector interface 314 and/or creates a seal between the surfaces of the connector interface 314 and/or the opening 316 with the plug or cover is contemplated in this disclosure.

[0056] As noted above, Figures 4A - 4C show additional examples of a port 310 and/or dressing described herein. The port 310 may share features with or may be analogous with the port 310 described above with respect to Figures 3 A-3F, thus the features will not be repeated here. A dressing 420 of the aspects shown in Figures 4A-4C may share features with or may be identical to the dressing 320 described above with respect to Figures 4A-4C. However, the stabilization flange 420b connected to the adhesive portion 420a of the dressing 420 may have a stabilizing collar 420c that captively engages with the outer body of the port 310. The collar 420c may provide additional stabilization to the port 310. Further, unlike the stabilization flange 320b described above, the stabilization flange 420b shown in Figures 4A-4C may for example include an opening or cut-out portion near the connector interface of the port 310.

[0057] Figure 5A-5F show another example of a port according to aspects of the disclosure. The port may share features with or may be analogous with any of the ports and/or aspects described herein. As shown in the example in Figures 5A-5F, a port apparatus 510 may include a main body 512 and a connector interface 514, with an opening 516 for connecting a drainage 580 device thereto. The connector interface 545 may be dome-shaped or otherwise may taper from a smaller dimension at the opening 516, to a wider dimension further down the body 512 of the port help guide the drainage device 580 to be centered with respect to opening 516, which may make connecting a drainage device 580 to the port apparatus 310 easier for a user or technician. The port apparatus may further include a port connector 518 that is configured to be connected to or is permanently connected to a tube or catheter (e.g., tube or catheter 112 in Figure 1, tube or catheter 212 in Figures 2A-2B, and/or tube or catheter 342 in Figures 3A and 3B) that is configured to extend into the abdominal cavity or a plural space of a patient. [0058] The main body 512 of the port apparatus 310 may be low-profile and/or curved and devoid of sharp edges or corners to ensure that the port can be comfortably worn under clothing or other articles.

[0059] As shown in Figures 5A-5F, the port apparatus 310 may be configured to function in conjunction with a dressing 520. In one example, a dressing may include features that provide stabilization to the port apparatus 510 and prevent it from moving once the dressing 520 is installed. For example, the port apparatus 510 may include a flange 522 extending from the main body 512 of the port apparatus 510. The flange 522 may be configured to connect with or be covered or partially covered by a portion of the dressing 520.

[0060] Figures 5A-5E, show an example of a stabilization flange 520b usable with aspects of the disclosure. For example, the stabilization flange 520b may be integrated into or otherwise connected to the dressing 520. For example, the dressing may have an adhesive portion 520a which may have a larger area than the stabilization flange and may be formed of a pressure sensitive adhesive sheet or other adhesive and or partially adhesive sheets (e.g., a 3M Tegaderm® brand dressing). The dressing 520 may be sized to cover an incision at the exit site of the tube or catheter (e.g., tube or catheter 112 in Figure 1, tube or catheter 212 in Figures 2A-2B, and/or tube or catheter 342 in Figures 3A and 3B) and may further be dimensioned large-enough so that the adhesive portion 520a may be placed over the incision and tube or catheter exit site. The stabilization flange 520b may be adhered to or otherwise connected to the adhesive portion 520a and in some examples may be formed of a material that is more rigid or otherwise stiffer than the adhesive portion 520a. In some examples, the material my include any one or combination of polypropylene, low density polyethylene, thermoplastic elastomer, thermoplastic polyurethane, or silicone rubber.

[0061] As shown in Figure 5A, the stabilization flange 520b may surround an opening 520c in the adhesive portion 520a. The stabilization flange 520b may be dimensioned to correspond with or engage with the flange 522 of the port apparatus 510. In some examples, the stabilization flange 520b may be configured to cover or partially cover the flange 522. Thus, when the dressing 520 is placed over the port apparatus 510 and adhered to a patient’s skin, for example as shown in Figure 5B, the contact between the stabilization flange 520b and the flange 522 prevents the port apparatus 510 from moving and is captively held within the opening 520c of the dressing 520. In some examples, the stabilization flange 520b and/or the flange 522 may have an adhesive to further secure the stabilization flange 520b to the flange 522. The flange 522 and/or the stabilization flange 520b may have one or more engagement features or other stabilization features that further limit movement between the dressing 520 and the port apparatus 510. Some non-limiting examples of stabilization features are described below with respect to Figures 4A-4C, 6A-7C, 10A, and 10B.

[0062] While not shown in Figures 5 A and 5B, the port system may further utilize a padded or foam dressing (e.g., similar to 321 in Figures 3A, 3B, 4B and 4C), which may include a slit/opening (e.g., slit 321a) configured to have the proximal end of a catheter (e.g., catheter 112 in Figure 1 or catheter 212 in Figures 2 A and 2B) passed through for connection at the port connector 518. The padded or foam dressing may have the adhesive portion 520a adhered or otherwise emplaced thereover as shown in Figures 3 A, 3B, 4B, and 4C. The padded or foam dressing may further include an adhesive for adhering the padded or foam dressing to a patient’s skin before placing or adhering the adhesive portion 520a over the patient’s skin, the padded or foam dressing, the incision, and catheter that passes through an incision in the patient’s skin, and the flange 522 of the port apparatus 510. The padded or foam dressing may improve comfort of the dressing and/or absorb any excretions or fluids associated with the incision site.

[0063] As noted above, the port apparatus 510 may provide fluid communication with a drainage device (e.g., a drainage catheter) that can be connected to the port apparatus 510 at the connector interface 514 and the catheter connected at the port connector 518. Turning to Figures 5C-5F, the inner body main body 512 of the port apparatus 510 may include a valve 582 that opens and/or closes in response to a valve opening apparatus of a drainage device or connector 580 engaging the valve. For example, in Figure 5F, one example of a valve opening apparatus 584 is shown. The valve opening apparatus 584 may be a dilator of a plunger 586. Figures 5C-5E show one example operation of a port system according to aspects of the disclosure. The connector interface 514 may for example include an opening that is configured to receive the dilator 584 of the drainage device 580. The drainage device may have drainage tubing connected and in fluid communication with a channel 588 inside the dilator. If a user wishes to drain a pleural or abdominal space (e.g., by opening a fluid communication path within the port apparatus 510, the drainage device 580 can be installed onto the connector interface 514 of the port apparatus 510. Once the drainage device 580 is installed onto the connector interface 514 of the port apparatus 510 as shown in Figure 5D, a user may depress or press downward on the plunger in a direction DD. When the plunger 586 is pushed downward, the valve opening apparatus 584 or dilator is pressed through the valve 582 thus opening the fluid communication path from the indwelling catheter (e.g., tube or catheter 112 in Figure 1, tube or catheter 212 in Figures 2A-2B, and/or tube or catheter 342 in Figures 3A and 3B) connected to the port connector 518 of the port apparatus 510 to a drainage device connected at channel 588. Suction or a negative pressure may be provided at the channel 588 via the drainage device (i.e., using a negative pressure source such as a pump or depressurized bottle or container).

[0064] When drainage is complete, a user may then pull up on the plunger in direction UU as shown in Figure 5E, which then retracts the valve opening apparatus 584 or dilator from the valve 582 causing the valve to close and seal-off the passage within the port apparatus 510. The drainage device 580 may then be removed from the connector interface 514. Additional cleaning steps and dressing steps (i.e., covering the port apparatus with an adhesive dressing) may be implemented. In some examples, once drainage is completed, a cover or plug may be installed into the connector interface 514, thus blocking-off and protecting the opening 516 from any contaminants. Examples of covers or plugs are described in further detail below with respect to Figures 6B and 9. However, any type of plug or cover that fits over the connector interface 514 and/or creates a seal between the surfaces of the connector interface 514 and/or the opening 516 with the plug or cover is contemplated in this disclosure.

[0065] Further, as shown in Figures 5A-5F, the port apparatus 510 and/or the drainage device 580 may include an engagement mechanism to provide a tactile indicator that the drainage device 580 is properly installed onto the port apparatus 510. For example, a snap fit groove 517 may be implemented. The snap-fit groove may be configured to have an interference or snap fit with a protrusion or other engagement feature 587 of the drainage device 580. In one example implementation, the engagement mechanism may be analogous with or share features with the snap fit groove 517 and engagement feature 587 described above with respect to Figures 5 A-5F. The plug or cover may further ensure the port apparatus remains sanitary and may provide a smooth surface configured to be covered by a dressing or adhesive/partially adhesive cover. The plug or covering may also include adhesive that may additional provide further sealing properties.

[0066] Figure 6A and 6B show another example of a port according to aspects of the disclosure. The port may share features with or may be analogous with any of the ports and/or aspects described herein. As shown in the example in Figures 6A and 6B, a port apparatus 610 may include a main body and may be configured to have a drainage device 680 connected thereto. The port system may include a body mounted flange 622 that may have a funnel- shaped or tapered portion configured to removably hold the drainage device 680 during a drainage operation. The funnel-shape or tapered shape may help guide the drainage device 680 toward engagement with the body mounted flange 622, so that the drainage device 680 is held in place when connected to the port apparatus 610 during drainage, which may increase ease of use for drainage. The drainage device 680 and the port apparatus 610 may be connectable via twist-lock or other interface that creates a seal between the drainage device 680 and the port apparatus 610 and/or provides a user with tactile feedback that the port apparatus 610 and the drainage device 680 are properly connected.

[0067] The port apparatus 610 may further include a port connector 618 that is configured to be connected to or is permanently connected to a tube or catheter (e.g., tube or catheter 112 in Figure 1 and/or tube or catheter 212 in Figures 2A-2B) that is configured to extend into the abdominal cavity or a plural space of a patient.

[0068] In some examples, once drainage is completed, a cover or plug 690 may connected to the port apparatus 610 and may be installed into the connector interface 614, thus blocking- off and protecting an opening of the port apparatus 610 from any contaminants while holding the catheter 642 in place with respect to the body mounted flange 622. It so noted that any type of plug or cover that fits within connector interface 614 and/or creates a seal between the surfaces of the connector interface 614 and/or the opening of the port apparatus 610 with the plug or cover is contemplated in this disclosure.

[0069] The components of the port system may be low-profile and/or curved and devoid of sharp edges or corners to ensure that the port can be comfortably worn under clothing or other articles.

[0070] As shown in Figures 6A-6B, the port apparatus 610 may be configured to function in conjunction with a dressing. In one example, a dressing may include features that provide stabilization to the port apparatus 610 and prevent it from moving once the dressing is installed. For example, the port apparatus 610 may include an engagement flange extending from the body mounted flange 622. The engagement flange may be configured to connect with or be covered or partially covered and/or engaged with a stabilization flange 620b usable with aspects of the disclosure. For example, the stabilization flange 620b may be integrated into or otherwise connected to an adhesive portion 620a of the dressing. For example, the dressing may have an adhesive portion 620a which may have a larger area than the stabilization flange 620b and may be formed of a pressure sensitive adhesive sheet or other adhesive and or partially adhesive sheets (e.g., a 3M Tegaderm® brand dressing). The dressing may be sized to cover an incision at the exit site of the tube or catheter 642 (or for example, tube or catheter 112 in Figure 1 and tube or catheter 212 in Figures 2A-2B) and may further be dimensioned large-enough so that the adhesive portion 620a may be placed over the incision and tube or catheter exit site. The stabilization flange 620b may be adhered to or otherwise connected to the adhesive portion 620a and in some examples may be formed of a material that is more rigid or otherwise stiffer than the adhesive portion 620a. In some examples, the material my include any one or combination of polypropylene, low density polyethylene, thermoplastic elastomer, thermoplastic polyurethane, or silicone rubber.

[0071] As shown in Figures 6A and 6B, the stabilization flange 620b may surround an opening in the adhesive portion 620a. The stabilization flange 620b may be dimensioned to correspond with or engage with the flange 622. In some examples, the stabilization flange 620b may be configured engage and captively hold flange 622. Thus, stabilizing and holding the flange 622 in place, when the dressing is adhered to a patient’s skin, for example as shown in Figures 6A and 6B. In some examples, the stabilization flange 620b and/or the flange 622 may have an adhesive to further secure the stabilization flange 620b to the flange 622. The flange 622 and/or the stabilization flange 620b may have one or more engagement features or other stabilization features that further limit movement between the dressing 620 and the body mounted flange 622.

[0072] As shown in Figures 6A and 6B, the port system may further utilize a padded or foam dressing 621, which may include a slit/opening 621a configured to have the proximal end of a catheter 642 (additional examples are described above as catheter 112 in Figure 1 or catheter 212 in Figures 2A and 2B) passed through for connection at the port connector 618. The padded or foam dressing 621 may have the adhesive portion 620a adhered or otherwise emplaced thereover as shown in Figures 6 A and 6B. The padded or foam dressing 621 may further include an adhesive for adhering the padded or foam dressing 621 to a patient’s skin before placing or adhering the adhesive portion 620a over the patient’s skin, the padded or foam dressing 621, the incision, and catheter 642 that passes through an incision in the patient’s skin, and the flange 622 of the port apparatus 610. The padded or foam dressing 621 may improve comfort of the dressing and/or absorb any excretions or fluids associated with the incision site.

[0073] As noted above, the port apparatus 610 may provide fluid communication with a drainage device (e.g., a drainage device 680, with drainage tubing 690 connected thereto) that can be connected to the port apparatus 610 at the connector interface 614 and the catheter 642 connected at the port connector 618. The inner body main body 612 of the port apparatus 610 may include a valve that closes and/or opens in response to a drainage device being inserted into the opening 616. Thus, during a draining operation, a drainage device (e.g., a needless catheter) may be inserted into the opening of the port apparatus 610 to open the valve inside the port apparatus 610, thus opening a fluid communication path between the port connector 618 and the opening, the drainage device may apply a negative pressure to the catheter 642 via the opening 616 to allow for drainage of fluid from a patient’s pleural or abdominal space. Once a drainage operation is complete, the drainage device may be removed from the port apparatus 610, thus closing the valve within the port apparatus 610 and blocking-off a fluid pathway within the port apparatus 610. Examples of valves that may be utilized inside main body 612 of the port apparatus 610 are described in further detail below with respect to Figures 8A-8E.

[0074] Figures 7A-7C show another example of a port system according to aspects of the disclosure. The port system may share features with or may be analogous with any of the ports and/or aspects described herein. As shown in the example in Figures 7A-7C, a port apparatus 710 may include a main body and a connector interface 714, with an opening 716 for connecting a drainage device thereto. The connector interface 714 may be funnel-shaped or otherwise may taper from a larger dimension than the opening 716, to the opening to help guide the drainage device toward the opening 716, which may make connecting a drainage device to the port apparatus 710 easier for a user or technician. The port apparatus may further include a port connector 718 that is configured to be connected to or is permanently connected to a tube or catheter (e.g., tube or catheter 112 in Figure 1 and/or tube or catheter 212 in Figures 2A-2B, tube or catheter 342 in Figures 3 A, 3B, 4B, 4C, and/or tube or catheter 614 in Figures 6A and 6B) that is configured to extend into the abdominal cavity or a plural space of a patient.

[0075] The main body 712 of the port apparatus 710 may be low-profile and/or curved and devoid of sharp edges or corners to ensure that the port can be comfortably worn under clothing or other articles.

[0076] As shown in Figures 7A-7C, the port apparatus 710 may be configured to function in conjunction with a dressing 720. In one example, a dressing may include features that provide stabilization to the port apparatus 710 and prevent it from moving once the dressing 720 is installed. For example, the port apparatus 710 may include a flange 722 connected to the main body of the port apparatus 710. The flange 722 may be configured to connect engage with a portion of the dressing 720.

[0077] Figures 7A-7C, show an example of a stabilization flange 720b usable with aspects of the disclosure. For example, the stabilization flange 720b may be integrated into or otherwise connected to the dressing 720. For example, the dressing may have an adhesive portion 720a which may have a larger area than the stabilization flange and may be formed of a pressure sensitive adhesive sheet or other adhesive and or partially adhesive sheets (e.g., a 3M Tegaderm® brand dressing). The dressing 720 may be sized to cover an incision at the exit site of the tube or catheter (e.g., tube or catheter 112 in Figure 1 and/or tube or catheter 212 in Figures 2A-2B, tube or catheter 342 in Figures 3A, 3B, 4B, 4C, and/or tube or catheter 614 in Figures 6A and 6B) and may further be dimensioned large-enough so that the adhesive portion 720a may be placed over the incision and tube or catheter exit site. The stabilization flange 720b may be adhered to or otherwise connected to the adhesive portion 720a and in some examples may be formed of a material that is more rigid or otherwise stiffer than the adhesive portion 720a. In some examples, the material my include any one or combination of polypropylene, low density polyethylene, thermoplastic elastomer, thermoplastic polyurethane, or silicone rubber.

[0078] As shown in Figure 7A, the stabilization flange 720b may surround or partially surround an opening 720c in the adhesive portion 720a. As shown in the partial magnified view of Figure 7B, the stabilization flange 720b may be configured to correspond with and/or engage with the flange 722 of the port apparatus 710. For example, as shown in the zoomedin partial view of Figure 7B, the stabilization flange 720b may be configured to snap into place with a flange 722 of the port apparatus 710. In the non-limiting example shown in Figure 7B, the stabilization flange 720b may have engagement ridges that are configured to snap into place or otherwise engage with corresponding engagement ridges of the port apparatus 710.

[0079] The snap-fit of the stabilization flange 720b with the flange 722 prevents the port apparatus 710 from moving and is captively held within the opening of the dressing 720. The flange 722 and/or the stabilization flange 720b may have one or more engagement features or other stabilization features that further limit movement between the dressing 720 and the port apparatus 710.

[0080] The port system may further utilize a padded or foam dressing 721, which may be configured to isolate the port apparatus 710 and/or the port apparatus 710 from a patient’s skin. The padded or foam dressing 721 may be configured be emplaced or otherwise placed underneath the port apparatus 710 and/or the adhesive portion 720a.

[0081] While hidden from view in Figure 7 A, the padded or foam dressing 721 may include a slit/opening (e.g., 321a in Figures 3A and 3B) configured to have the proximal end of a catheter (e.g., tube or catheter 112 in Figure 1 and/or tube or catheter 212 in Figures 2A-2B, tube or catheter 342 in Figures 3 A, 3B, 4B, 4C, and/or tube or catheter 614 in Figures 6A and 6B) passed through for connection at the port connector 718. The padded or foam dressing 721 may have the adhesive portion 720a adhered or otherwise emplaced thereover as shown in Figure 7 A. The padded or foam dressing 721 may further include an adhesive for adhering the padded or foam dressing 721 to a patient’s skin before placing or adhering the adhesive portion 720a over the patient’s skin, the padded or foam dressing 721, the incision, and catheter that passes through an incision in the patient’s skin. The padded or foam dressing 721 may improve comfort of the dressing and/or absorb any excretions or fluids associated with the incision site.

[0082] As noted above, the port apparatus 710 may provide fluid communication with a drainage device (e.g., a drainage catheter) that can be connected to the port apparatus 710 at the connector interface 714 and the catheter connected at the port connector 718. The inner body main body of the port apparatus 710 may include a valve that closes and/or opens in response to a drainage device being inserted into the opening 716. Thus, during a draining operation, a drainage device (e.g., a needleless dilator) may be inserted into the opening 716 to open the valve inside the port apparatus 710, thus opening a fluid communication path between the port connector 718 and the opening 716, the drainage device may apply a negative pressure to the catheter via the opening 716 to allow for drainage of fluid from a patient’s pleural or abdominal space. Once a drainage operation is complete, the drainage device may be removed from the port apparatus 710, thus closing the valve within the port apparatus 710 and blocking-off a fluid pathway within the port apparatus 710. Examples of valves that may be utilized inside main body of the port apparatus 710 are described in further detail below with respect to Figures 8A-8E.

[0083] In some examples, once drainage is completed, a cover or plug may be installed into the connector interface 314, thus blocking-off and protecting the opening 316 from any contaminants. Examples of covers or plugs are described in further detail below with respect to Figures 6B and 8. However, any type of plug or cover that fits within connector interface 314 and/or creates a seal between the surfaces of the connector interface 314 and/or the opening 316 with the plug or cover is contemplated in this disclosure.

[0084] Figures 8 A-8E show non-limiting examples of a valve that may be implemented into any of the port apparatuses described herein. As shown in Figures 8A and 8B, a valve 822, may include a dilator seal opening 816a and may include a duckbill valve 816b, that is configured to open a fluid path when a dilator is pushed through. The valve 822 may be formed of a material that has an elastomeric quality or any material that regains its original shape when a load is removed from the material. In one example, the valve may be formed of any elastomeric material.

[0085] Figures 8C-8E show example of the valve 882 in use. As shown in Figure 8C, when the valve 882 is in a fluid path, the duckbill valve 816 is closed thus blocking the flow of fluid from a dilator 884 to in a first passage to a second passage 888. Once the dilator 884 is pushed through the valve a seal is created by the dilator seal opening 816a around the outer surface of the dilator 884. As the dilator 884 is advanced further and pushed through the duckbill valve 816b, the valve 882 opens thus opening a fluid path between the dilator passage 818 and the second passage 888, which allows fluid to flow through the passage for the drainage operations described herein.

[0086] It is noted that the valve described above is not intended to be limiting and any valve suitable for medical procedures may be used. Additional valves and features that may be implemented into the disclosure herein are described in any one or combination of the disclosures of U.S. patent application Ser. No. 14/162,113, filed Jan. 23, 2014, titled “Low- Profile Access Port,” U.S. Provisional Application No. 61/755,913, filed Jan. 23, 2013, and titled “Low Profile Access Port,” U.S. Provisional Application No. 62/421, 131, filed Nov. 11, 2016, titled “Low-Profile Vascular Access Device; and U.S. Provisional Application No. 62/552,681, filed Aug. 31, 2017, and titled “Low-Profile Single and Dual Vascular Access Device,” U.S. patent application Ser. No. 15/809,879, filed Nov. 10, 2017, and titled “Low- Profile Single and Dual Vascular Access Device,” U.S., patent application Ser. No. 17/890,146, filed Aug. 17, 2022, and titled “Low-Profile Single and Dual Vascular Access Device,” U.S. patent application Ser. No. 16/382,177, filed April 11, 2019, and titled “Low- Profile Single and Dual Vascular Access Device,” and/or U.S., patent application Ser. No. 17/963,813, filed Oct. 11, 2022, and titled “Low-Profile Single and Dual Vascular Access Device.” Each of the aforementioned applications is incorporated herein by reference in its entirety. In one example aspect, any one or combination of the features described in the applications above may scaled-up or otherwise modified to allow for increased flow rate. In one example, the modifications could include a larger septum and/or a larger port base for the patient to palpate the port through the skin. Further the features described in applications listed above could be modified as a subcutaneous or external port (i.e., port is at least partially or fully located outside of a patient’s skin).

[0087] As noted throughout the disclosure, a plug or cover may be implemented as part of any of the systems described above to cover an interface and/or opening of any of the disclosed port apparatuses described herein. One example of a plug or cover is shown in Figure 9. The plug or cover 980 may include a dome-shaped top portion and may further be configured to snap-fit or otherwise engage with a port apparatus 910 thus blocking-off and protecting the opening in the port apparatus 910 from any contaminants. In the example shown in Figure 9, the plug or cover 980 may have an engagement feature identical to the engagement feature 587 (Figure 5F) of the drainage device 580. Thus, when drainage is complete and the drainage device 580 is removed, the cover 980 can be placed and snapped into the snap fit groove 517 of the port apparatus to cover the opening (e.g., opening 516 in Figure 5C). While specific examples of plugs or covers are described, any type of plug or cover that fits within connector interfaces and/or creates a seal between the surfaces of the connector interfaces and/or the openings described herein are contemplated and are within the scope of this disclosure.

[0088] Figure 10 shows one example of a port apparatus 1010 according to aspects of the disclosure. Figure 10 is shown to reference features that may be implemented into any one or all of the port apparatuses described herein. For improved comfort, while ensuring that the passage, connections, and/or valve section do not deform or malfunction, the port apparatus

1010 may have an internal portion 1011 and an external portion 1013. In some examples, the internal portion may be formed of a material that is more rigid that the external portion 1013. In some examples, the external portion 1013 may be formed of a material with a high flexibility. Some examples of materials with a high flexibility that may form the external portion 1013 may include but are not limited to silicone, low density polyethylene, thermoplastic elastomer, or thermoplastic polyurethane. The internal portion 1011 may be formed of a material that has a higher rigidity. For example, the material of the inner portion

1011 may include but is not limited to polypropylene, polyethylene, acrylonitrile butadiene styrene, or acrylic.

[0089] It is noted that while specific port apparatus shapes and configurations are described in detail above, any shape or configuration that is consistent with the concepts described herein may be implemented without departing from the scope of the disclosure. For example, Figures 11A-11G, show some additional non-limiting examples of port apparatus configurations 1150a-l 150h that may share features with or may be analogous with any one or combination of the port apparatuses described herein.

[0090] Aspects of the disclosure further relate to installation and/or use of a port and catheter with aspects described herein. A method for installing the catheter and/or port according to the aspects described herein may include the following steps:

1. Select a site for port placement. Port site selection shall allow for port placement in an anatomic area that provides good port stability, does not interfere with patient mobility, creates pressure points, or interfere with clothing.

2. The catheter may be inserted into the pleural or peritoneal space either directly through the pocket incision or via a subcutaneous tunnel to a remote entry site.

3. Use catheter insertion accessories such as a peel-apart sheath and guidewire to insert the catheter into the pleural or peritoneal space

4. Create a subcutaneous tunnel to the desired port pocket site using a tunneler accessory

5. If the port is subcutaneous, create a subcutaneous pocket using blunt dissection.

Do a trial placement to verify that the pocket is large enough to accommodate the port.

6. Place the port in the subcutaneous pocket away from the incision line (if it is subcutaneous) or so that it extends through the skin and can be accessed externally. Close the incision site.

7. Apply dressing based on hospital practice

[0091] Further, once any one or combination of features described in this disclosure are installed and in-use, following steps may be completed to drain via the port: 1. Remove any dressing located on and perform aseptic site preparation

2. Utilizing a sterile, gloved hand, located port and remove any caps, coverings, or dressings on the port or exit site.

3. If subcutaneous, insert needle connected to drainage collection container perpendicular to port septum. Advance the needle through the skin and septum until reaching the bottom of the reservoir.

4. If external port, insert connector from the drainage collection system directly into port until tactile confirmation of complete connection is felt

5. Drain fluid into collection container

6. Remove needle or connector to drainage system. Perform aseptic site cleaning and replace any cap, coverings or dressing that was covering the port or exit site.

[0092] In another example of an installation and/or use of a port and catheter with aspects described herein. A method for installing the catheter and/or port according to the aspects described herein may include the following steps: a. Two incisions are made and the catheter is threaded through the subcutaneous tunnel. The length of exposed catheter is adjusted for the final placement of the port apparatus. The distal tip is fed into the respective cavity for pleural or peritoneal placement and this incision is sutured closed. Sutures are used to secure the proximal catheter at the skin exit. Dressing is applied to secure the port apparatus to the skin. The clinician may proceed directly to drainage or apply the plug/cover. b. Two incisions are made and a catheter with a connector is threaded through the subcutaneous tunnel. The length of exposed catheter is adjusted for the final placement of the port apparatus. The distal tip is fed into the respective cavity for pleural or peritoneal placement and this incision is sutured closed. The port apparatus has a mating connector to join to the exposed catheter. Sutures may be used to secure the proximal catheter at the skin exit. Dressing is applied to secure the port apparatus to the skin. The clinician may proceed directly to drainage or apply the plug/cover.

[0093] Further, once any one or combination of features described in this disclosure are installed and in-use, following steps may be completed to drain via the port: a. The plug/cover is removed. b. The port apparatus access port surface is cleaned. c. The drainage access tip is inserted into the port apparatus. d. The fluid is drained. e. The drainage access tip is removed and disposed. f. The port apparatus access port surface is cleaned. g. A new plug/cover is applied.

[0094] In any of the aforementioned examples, any one or combination of the features described herein could be labeled clearly with numbers and/or color coded and/or may include any combination of written and/or pictographic instructions thereon so that the user can comprehend the steps for installation and/or use of the port clearly.

[0095] In some examples, the aforementioned and/or a related procedure and/or method for installing the port and catheter or use of the port or catheter may be described in instructions provided with the port and any additional components included therewith (e.g., a catheter, drainage bag or bottle and/or any other components provide to assist with installation, use-of and/or maintenance of the devices or other catheter components). The instructions may be provided as a pamphlet or as written instructions on the packaging of the port or a kit including the port. The aforementioned instructions may also be provided as digital content (provided by accessing information on a network, such as a webpage on the Internet). In one example, port, packaging of the port and/or any components provided therewith may include an address and/or a quick response “QR” code for accessing instructions and/or digital content related to methods of installation and/or use thereof. In addition, the instructions may also be provided by salesperson via marketing materials to name another non-limiting example.

[0096] In some aspects of the disclosure, a monitoring system and/or one or more monitoring sensor(s) could be integrated into or otherwise associated with the port device (e.g., one or more sensors 1290 as shown in Figure 12) may be used to measure flow volume or flow rate of the fluid traveling through the port and/or properties of the fluid flowing through the port. For example, the port may include one or more flow sensor(s) 1290 configured to communicate with a monitoring system or apparatus. Any one or combination of the aspects described herein (e.g., a port, a catheter) may come as a set 1610 (Figure 16), which may include features (e.g., sensors) for analysis and/or monitoring of the fluid that is drainage from a patient. Any one or combination of the fluid properties, flow rate, pressure and/or volume of fluid may be communicated to a patient and/or a technician via a smartphone application 1620 and/or may be communicated to a database 1630 for monitoring by a clinician.

[0097] The aforementioned monitoring system and/or one or more monitoring sensor(s) could be integrated into or otherwise associated with the port device or otherwise output and be integrated with an application or other software implemented method to measure the amount, flow-rate, and/or pressure of fluid that is collected. Any of the aforementioned aspects may be monitored with respect to time and/or may be monitored with respect to a patient’s perceived pain or other patient observation(s).

[0098] In addition, the monitoring or analysis of the fluid through the port may be implemented using hardware, software, or a combination thereof and may be implemented in one or more computer systems or other processing systems. In an aspect of the present disclosures, features are directed toward one or more computer systems capable of carrying out the functionality described herein.

[0099] In some implementations, as part of or incorporating various features and methods described herein, one or more microcontrollers may be implemented for carrying out various operations in accordance with aspects of the present invention, e.g., for monitoring output of one or more of the sensor(s) 1290. Various components of such a controller 1100 are shown in representative block diagram form in Figure 13. In Figure 13, the controller 1100 includes a CPU 1102, clock 1104, RAM 1108, ROM 1110, a timer 1112, a BUS controller 1114, an interface 1116, and an analog-to-digital converter (ADC) 1118 interconnected via a BUS 1106.

[00100] The CPU 1102 may be implemented as one or more single core or multi-core processors, and receive signals from an interrupt controller 1120 and a clock 1104. The clock 1104 may set the operating frequency of the entire microcontroller 1100 and may include one or more crystal oscillators having predetermined frequencies. Alternatively, the clock 1104 may receive an external clock signal. The interrupt controller 1120 may also send interrupt signals to the CPU, to suspend CPU operations. The interrupt controller 1120 may transmit an interrupt signal to the CPU when an event requires immediate CPU attention.

[00101] The RAM 1108 may include one or more Static Random Access Memory (SRAM), Dynamic Random Access Memory (DRAM), Synchronous Dynamic Random Access Memory (SDRAM), Double Data-Rate Random Access Memory (DDR SDRAM), or other suitable volatile memory. The Read-only Memory (ROM) 1110 may include one or more Programmable Read-only Memory (PROM), Erasable Programmable Read-only Memory (EPROM), Electronically Erasable Programmable Read-only memory (EEPROM), flash memory, or other types of non-volatile memory.

[00102] The timer 1112 may keep time and/or calculate the amount of time between events occurring within the controller 1100, count the number of events, and/or generate baud rate for communication transfer. The BUS controller 1114 may prioritize BUS usage within the controller 1100. The ADC 1118 may allow the controller 1100 to send out pulses to signal other devices.

[00103] The interface 1116 may comprise an input/output device that allows the controller 1100 to exchange information with other devices. In some implementations, the interface 1116 may include one or more of a parallel port, a serial port, or other computer interfaces.

[00104] In addition, aspects of the present disclosures may be implemented using hardware, software, or a combination thereof and may be implemented in one or more computer systems or other processing systems. In an aspect of the present disclosures, features are directed toward one or more computer systems capable of carrying out the functionality described herein. An example of such the computer system 2000 is shown in Figure 12.

[00105] The computer system 2000 may include one or more processors, such as processor 2004. The processor 2004 may be connected to a communication infrastructure 2006 (e.g., a communications bus, cross-over bar, or network). Various software aspects are described in terms of this example computer system. After reading this description, it will become apparent to a person skilled in the relevant art(s) how to implement aspects of the disclosures using other computer systems and/or architectures.

[00106] The computer system 2000 may include a display interface 2002 that forwards graphics, text, and other data from the communication infrastructure 2006 (or from a frame buffer not shown) for display on a display unit 2030, which may be analogous with the display interface 102. Computer system 2000 also includes a main memory 2008, preferably random access memory (RAM), and may also include a secondary memory 2010. The secondary memory 2010 may include, for example, a hard disk drive 2012, and/or a removable storage drive 2014, representing a floppy disk drive, a magnetic tape drive, an optical disk drive, a universal serial bus (USB) flash drive, etc. The removable storage drive 2014 reads from and/or writes to a removable storage unit 2018 in a well-known manner. Removable storage unit 2018 represents a floppy disk, magnetic tape, optical disk, USB flash drive etc., which is read by and written to removable storage drive 2014. As will be appreciated, the removable storage unit 2018 includes a computer usable storage medium having stored therein computer software and/or data.

[00107] Alternative aspects of the present disclosure may include secondary memory 2010 and may include other similar devices for allowing computer programs or other instructions to be loaded into computer system 2000. Such devices may include, for example, a removable storage unit 2022 and an interface 2020. Examples of such may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an erasable programmable read only memory (EPROM), or programmable read only memory (PROM)) and associated socket, and other removable storage units 2022 and interfaces 2020, which allow software and data to be transferred from the removable storage unit 2022 to computer system 2000.

[00108] Computer system 2000 may also include a communications interface 2024. Communications interface 2024 allows software and data to be transferred between computer system 2000 and external devices. Examples of communications interface 2024 may include a modem, a network interface (such as an Ethernet card), a communications port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, etc. Software and data transferred via communications interface 2024 are in the form of signals 2028, which may be electronic, electromagnetic, optical or other signals capable of being received by communications interface 2024. These signals 2028 are provided to communications interface 2024 via a communications path (e.g., channel) 2026. This path 2026 carries signals 2028 and may be implemented using wire or cable, fiber optics, a telephone line, a cellular link, an RF link and/or other communications channels. In this document, the terms “computer program medium” and “computer usable medium” are used to refer generally to media such as a removable storage drive 2018, a hard disk installed in hard disk drive 2012, and signals 2028. These computer program products provide software to the computer system 2000. Aspects of the present disclosures are directed to such computer program products.

[00109] Computer programs (also referred to as computer control logic) are stored in main memory 2008 and/or secondary memory 2010. Computer programs may also be received via communications interface 2024. Such computer programs, when executed, enable the computer system 2000 to perform the features in accordance with aspects of the present disclosures, as discussed herein. In particular, the computer programs, when executed, enable the processor 2004 to perform the features in accordance with aspects of the present disclosures. Accordingly, such computer programs represent controllers of the computer system 2000.

[00110] In an aspect of the present disclosures where the method is implemented using software, the software may be stored in a computer program product and loaded into computer system 2000 using removable storage drive 2014, hard drive 2012, or communications interface 2020. The control logic (software), when executed by the processor 2004, causes the processor 2004 to perform the functions described herein. In another aspect of the present disclosures, the system is implemented primarily in hardware using, for example, hardware components, such as application specific integrated circuits (ASICs). Implementation of the hardware state machine so as to perform the functions described herein will be apparent to persons skilled in the relevant art(s).

[00111] Figure 12 is a block diagram of various example communication system components usable in accordance with an aspect of the present disclosure. The communication system 2100 includes one or more accessors 2160, 2162 (which may for example comprise any of the aforementioned systems and features) and one or more terminals 2142, 2166. In one aspect, data for use in accordance with aspects of the present disclosure is, for example, input and/or accessed by accessors 2160, 2162 via terminals 2142, 2166, such as personal computers (PCs), minicomputers, mainframe computers, microcomputers, telephonic devices, or wireless devices, such as personal digital assistants (“PDAs”) or a hand-held wireless devices coupled to a server 2143, such as a PC, minicomputer, mainframe computer, microcomputer, or other device having a processor and a repository for data and/or connection to a repository for data, via, for example, a network 2144, such as the Internet or an intranet, and couplings 2145, 2146, 2164. The couplings 2145, 2146, 2164 include, for example, wired, wireless, or fiberoptic links. In another example variation, the method and system in accordance with aspects of the present disclosure operate in a stand-alone environment, such as on a single terminal.

[00112] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. All structural and functional equivalents to the elements of the various aspects described herein that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

Claims

CLAIMS What is claimed is:

1. A port system for pleural or peritoneal drainage, the port system comprising: an elongated catheter passage portion configured to have a distal end in a plural or peritoneal cavity with a proximal end outside of the plural or peritoneal cavity; and a port apparatus at a proximal end of the elongated catheter, wherein the port has a connector interface for connection of a drainage device thereto and is configured to provide fluid communication with the catheter via a valve.

2. The port system of claim 1, wherein the port apparatus comprises a port connector that is connected to the proximal end of the elongated catheter and is configured provide fluid communication with the valve.

3. The port system of any one of claims 1 or 2, wherein the valve is a two-way valve.

4. The port system of any one of claims 1 to 3, wherein the port apparatus is configured to be directly or indirectly mounted to a patient’s skin.

5. The port system of any one of claim 1 to 4, further comprising: a flange extending from a body of the port apparatus, wherein the flange is configured to engage with a stabilization flange of a dressing.

6. The port system of claim 5, wherein the stabilization flange is configured to be placed over the flange when the dressing is adhered to a patient’s skin.

7. The port system of claims 5 or 6, wherein the stabilization flange is configured to at least partially cover the flange of the port apparatus.

8. The port system of any of claims 5 to 7, further comprising the dressing, wherein the dressing comprises an adhesive portion and a stabilization flange, wherein the stabilization flange is formed of a material that has a higher rigidity that the adhesive portion.

9. The port system of claim 8, wherein the stabilization flange at last partially surrounds an opening in the adhesive portion, wherein the opening is configured to have the port apparatus pass therethrough when mounting the port apparatus to a patient’s skin.

10. The port system of any one of claims 1 to 4, further comprising: a dressing configured to be emplaced on a patient’s skin and have the port apparatus mounted thereto.

11. The port system of any one of claims 1 to 10, wherein the port apparatus is configured to receive a port-cap, wherein the port-cap is configured to at least partially cover the connector interface of the port apparatus.

12. The port system of claim 11, wherein the port apparatus further comprises a snap-fit portion, wherein the snap-fit portion is configured to releasably engage with a corresponding engagement portion of the port-cap.

13. The port system of claim 12, wherein the snap-fit portion is configured to releasably engage with a corresponding connector engagement portion of an access device, wherein the engagement portion is configured to have drainage tubing connected thereto for draining the plural or peritoneal cavity via the port apparatus.

14. The port system of claim 13, wherein the access device further comprises a valve-opening mechanism for opening the valve of the port apparatus.

15. The port system of claim 14, wherein the valve-opening mechanism is a plunger, wherein pressing the plunger causes engagement of the plunger and the valve and opening of the valve within the port apparatus to provide a fluid path from the catheter to drainage tubing for draining the plural or peritoneal cavity of a patient.

16. The port system of any one of claims 1 to 15, wherein the port connector interface is cone shaped or funnel shaped.

17. A method of draining the pleural or peritoneal cavity of a patient using any one of claims

1 to 16.

18. A method of installing the port system of any one of claims 1 to 17 to a patient.