Patent Application
20230338637
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Irrigation is used to remove debris and prevent infection during surgical outcomes. Breast augmentation is an example of a surgical procedure involving the formation of a subcutaneous pocket or space where an implant can be inserted. The pocket can be susceptible to increased bacterial activity and formation of biofilm resulting in capsular contracture, a condition whereby tissue around the implant thickens and tightens resulting in a distorted appearance that may require corrective intervention. Accordingly, irrigating a breast pocket can reduce the potential for capsular contracture and improve surgical outcomes.
Current irrigation techniques and mechanisms often rely on hand-operated wand or elongate tools to introduce antimicrobial or antiseptic irrigation fluids into a breast pocket. These tools fail to provide consistent and effective irrigation of a breast pocket and often introduce additional error associated with a lack of irrigation coverage.
For these reasons, it would be desirable to provide improved methods, systems, and tools for subcutaneous irrigation. It would be particularly desirable to provide simplified deployment systems with adjustable sizes, even more desirably, to provide consistent irrigation with flow rates and patterns to promote improved surgical outcomes. At least some of these objectives will be met by the various embodiments that follow.
In general, the subcutaneous irrigation apparatuses (e.g., devices, systems, etc.) described herein may include a flexible base comprising one or more size adjustment channels and a plurality of irrigation lumens and a hub coupled to the flexible base. The hub can comprise an inlet port, an outlet port, and a suction port, wherein the plurality of irrigation lumens extend from the hub. The hub may be central or offset.
In this and other examples, a subcutaneous irrigation apparatus can also include one or more of the following: one or more holes extending into each irrigation lumen through the flexible base. The hub can be integrated with the flexible base. The hub can be configured to distribute fluid through the plurality of irrigation lumens. The flexible base can comprise a perimeter configured to be reduced by the one or more size adjustment channels. Each of the plurality of irrigation lumens can be positioned at an angle between the hub and perimeter of the flexible base. The plurality of irrigation lumens can be configured to direct a vortex flow of irrigation fluid. The flexible base may comprise the hub. The plurality of irrigation lumens may extend radially from the hub. The subcutaneous irrigation apparatus may further comprise a flow control valve configured to adjust a flow rate of irrigation fluid. The flexible base can be configured to be inserted into a breast pocket.
In general, a breast pocket irrigation apparatus can include a flexible base with one or more size adjustment channels configured to reduce a perimeter of the flexible base, one or more irrigation tubes coupled to the flexible base, and a hub comprising an inlet port, outlet port, and suction port, wherein a proximal end of each irrigation tube is in communication with the hub. The hub may be a central hub.
In this and other examples, a breast pocket irrigation apparatus can also comprise one or more of the following: The one or more irrigation tubes can be angularly positioned around the flexible base and configure to provide a vortex flow of irrigation fluid into the breast pocket. Each irrigation tube can comprise one or more holes extending into a lumen of the irrigation tube. The inlet port can be configured to couple with an irrigation fluid source. The hub can be configured to distribute an irrigation fluid from the inlet port to each of the irrigation tubes.
In general, a method of irrigating a breast pocket can comprise adjusting a size of a breast pocket irrigation apparatus having a flexible base with size adjustment channels, then inserting the flexible base into the breast pocket, then initiating a flow of irrigation fluid through a hub of the breast pocket irrigation apparatus, wherein the hub distributes the irrigation fluid through irrigation tubes coupled to the flexible base.
In some examples, a method of irrigating a breast pocket can also comprise removing the irrigation fluid from within the breast pocket via a suction port coupled to the hub. The flow of irrigation fluid can be distributed by the irrigation tubes in a vortex pattern. Adjusting the size of the breast pocket irrigation apparatus comprises removing one or more segments of the flexible base via the size adjustment channels.
All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.
A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
Subcutaneous irrigation apparatuses (e.g., systems, devices, etc.), components thereof, and methods of use are described herein. These apparatuses may be configured to generate a vortex within the tissue into which they are inserted. By forming a vortex, the apparatus may more effectively wash and remove material from the region of tissue being treated, improving outcomes.
For example, a subcutaneous irrigation apparatus can include a flexible base with one or more irrigation tubes each extending outward at a vortex angle that is configured to result in a vortex, and a hub in communication with the irrigation tubes. The hub may be centrally positioned relative to the flexible base and can have an inlet tube (e.g., inlet port) and outlet tube (e.g., outlet port) configured to engage a fluid source and an irrigation removal (e.g. suction) source operably coupled with the outlet tube. The irrigation tubes can be integrated with the flexible base and are generally configured to direct a flow of irrigation fluid from the fluid source within a surgical site for irrigation, and in particular for forming a vortex in some modes of operation. Each of the fluid tubes can have a lumen extending therethrough from a distal end of the irrigation to the hub.
For example,
Irrigation tubes 115 can have a lumen extending from a distal end 116 to the hub 110 and are configured to direct a flow of irrigation fluid from the fluid source out of the irrigation apparatus 100 to irrigate the surgical site (e.g., a breast pocket). Although
The irrigation tubes 115 may be arranged on the flexible base in a manner to provide (e.g., direct) a flow pattern of the irrigation fluid around the subcutaneous irrigation system. In particular, the configuration of the irrigation tubes may be configured to result in a vortex flow around the tissue, e.g., breast pocket. For example,
As shown in
The flow rate may be varied. For example, period of high flow (vortex flow) may be alternated with periods of relatively low flow. In some examples high flow may result in a vortex, while low flow may result in saturating the region of tissue with fluid without an appreciable bulk flow, including vortex flow. High flow may be applied at 10× or more (e.g., 20×, 50×, 100×, 150×, etc.) the flow rate of the lower flow periods. High flow rate (vortex flow) may be applied oncer per day (e.g., twice pre day, three times per day, four times per day or more, every hour, etc.).
The size adjustment features (e.g., removal channels) may include sizing rings, marking, etc., and can be configured to provide or indicate optional adjustment of the dimensions of a subcutaneous irrigation system. In particular, the removal channels may guide a user, such as a doctor, nurse or medical technician, in removing a predetermined amount and location of material from the apparatus.
As illustrated in
In some examples, size adjustment channels (e.g., removal channels) may include a visual indication of where a user may cut or trim the flexible base. For example, a removal channels may include a color indicating a certain diameter that a user may select and cut or trim along the sized adjustment element to reduce the dimensions of the subcutaneous irrigation system. In some examples, each removal channels may identify or be identifiable as a predetermined diameter that a user can recognize and adjust or customize the size of the flexible base accordingly. Each removal channels may relate to a predetermined perimeter (e.g., circumference).
In
In some examples, a central hub can be configured to distribute fluid flowing from a fluid source, through the irrigation tubes. The central hub can also direct the suction or vacuum drawn on the outlet tube to the suction port (not shown in
The inlet tube 320 is shown in
In
As shown in previous examples, the irrigation tubes 410 extend from the central hub 420 to the perimeter of the flexible base 405. Each irrigation tube 410 extends the entire distance from the central hub to the outer perimeter of the flexible base. One can understand that when the size adjustment channels 430 are removed, the irrigation tube may have a distal end that then extends beyond the adjusted perimeter of the flexible base. For example, when the flexible base size is adjusted by tearing (e.g., removing) one or more of the size adjustment rings, the irrigation tube may remain in its original length (e.g., distance between the central hub and initial perimeter of the flexible base).
In some examples, when a size adjustment channel is removed (e.g., the flexible base is reduced), the size adjustment channel may include a corresponding section of irrigation tube. For example, when the flexible base is adjusted such that the outer ring is removed, the length of irrigation tube from the size adjustment channel to the perimeter may also me removed.
In
Irrigation tubes may have a lumen with a diameter configured to direct and distribute the irrigation fluid into the surgical site (e.g., breast pocket). The diameter of an irrigation tube may impact a flow rate of the irrigation fluid therethrough. Irrigation tubes may also have a length configured to impact the flow rate of irrigation fluid flowing therethrough. The calibration of the flow rate via the length of an irrigation tube, the diameter of the irrigation tube, the number of holes, or a combination thereof can predetermined or adjustable (e.g., via the size adjustment channels. For example, a larger diameter irrigation tube may provide a high flow rate and a smaller diameter irrigation tube may provide a lower flow rate. In some examples, the flow rate may also be influenced by the fluid source. A fluid source may be a bag of irrigation fluid and configured to distribute the irrigation fluid through the subcutaneous irrigation system via gravitational force (e.g., gravity fed). In some examples, the inlet tube may be in communication with a fluid source and a pump configured to pump or distribution irrigation fluid to the subcutaneous irrigation system at a flow rate, pressure, etc. based on the pump.
In some examples, a flexible base may comprise any number of irrigation tubes (e.g., fluid channels). The number of irrigation tubes may adjust a flow rate of irrigation fluid through the system. For example, increasing the number of irrigation tubes may provide a different flow rate. Increasing the number of irrigation tubes may allow for a decreased irrigation tube diameter of each of the irrigation tubes while maintaining the flow rate. As described herein, the angle of the irrigation tubes on the flexible base can provide an angular flow or vortex style flow pattern of the irrigation fluid flowing therefrom. The angular flow may swirl the fluid within the breast pocket and may improve washing and debridement of the surrounding tissue by increasing a Reynolds number and creating more turbulent flow. In some examples, non-angled irrigation tubes (e.g., irrigation tubes extending radially from the hub) may increase a laminar flow of the irrigation fluid.
In some examples, the central hub may comprise a valve configured to adjust flow rates. For example, a central hub may have an adjustment element configured to change a flow rate by adjusting the valve to increase or decrease a volume of fluid distributed through the central hub. The valve may be integrated into the central hub. In some examples, the valve may be adjusted by rotating one or more components of the central hub.
In some examples, the flexible base may be a flexible membrane comprised of silicone, TPU or other flexible material. The flexible base may be sufficiently flexible to allow for insertion through an incision into the breast pocket. The membrane may be colored for visibility or translucent to observe liquid flow through the channels, or a combination thereof.
It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
The process parameters and sequence of steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achie46ve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application claims priority to U.S. Provisional Patent Application No. 63/335,009, titled “BREAST POCKET IRRIGATION SYSTEM” filed on Apr. 26, 2022, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63335009 | Apr 2022 | US |
