A sutureless device for securing procedural drains

Abstract

A sutureless device and methods for deployment of a procedural drain are provided. The sutureless device may comprise an internal component configured to be inserted within an opening in skin of a patient, comprising an internal holding mechanism and an opening configured to receive a procedural drain. The sutureless device may comprise an external component configured to be secured to the internal component, comprising an external holding mechanism and an opening configured to receive the procedural drain. The sutureless device may comprise a securing mechanism configured to secure the internal component to the external component. The internal holding mechanism and the external holding mechanism may be configured to securing a position of the sutureless device within the opening in the skin of the patient. The internal component and the external component may be configured to secure the procedural drain within the opening of the internal component and the opening of the external component.

Description

348358.15502 (Patent) A SUTURELESS DEVICE FOR SECURING PROCEDURAL DRAINS

[0001] The present application claims the benefit of U.S. provisional application no.63 / 621,941 filed January 17, 2024 which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present disclosure relates to a sutureless device for securing procedural drains to a patient and methods of using the same. BACKGROUND

[0003] Following surgery, fluid, such as, e.g., plasma, pus, and blood, may collect. Procedural drains may be used to precent or address this fluid collection. Procedural drains are tubes placed into surgical sites to help remove fluid from accumulating in the body. Procedural drains may be kept in place between days to weeks, and the output of the procedural drains is often used to assess for patient progress.

[0004] There are multiple types of procedural drains, including, e.g., Jackson-PrattTMdrains, RedivacTMdrains, PigtailTMdrains, and PenroseTMdrains. The choice of procedural drain depends on the indication, anatomy of the patient, and the situation.

[0005] Procedural drains are ubiquitous across surgical and medical fields and are most often seen in general surgery and surgical subspecialties (ie cardiac surgery, neurosurgery, orthopedics, vascular surgery, otolaryngology, and plastic surgery). Furthermore, drains are used regularly in interventional radiology. The care of procedural drains is seen in hospital, clinical, and ambulatory settings. The use of procedural drains is extensive and, with increases in the number of surgeries performed, and global increases in chronic diseases, the global use of procedural drains is projected to increase. Additionally, many patients have multiple drains following procedures.

[0006] Currently, the protocol for the placement and use of drains is that a drain is placed within an anatomic cavity, and often exits thru the patient’s skin (ie at incision, ambiguously selected location) during surgery while the patient is still under anesthesia. The procedural drain is often secured by suturing through the skin on the exterior, and then intricately tying the suture into a lattice structure to secure the drain, as shown, e.g., in FIG.1. Alternatively, drains can be placed by interventional radiologists using image guidance, or bedside or in clinic by minor procedures. 1 167135316.1348358.15502 (Patent)

[0007] As shown in FIG.1, traditionally, procedural drains are placed intraoperatively through a wound or through a hole through the skin of the patient. The procedural drain is then secured using a suture, configured to hole the procedural drain in place, that is punctured through the patient’s skin, and then intricately tied into a lattice structure to secure the procedural drain. Alternatively, drains can be secured using adhesive dressings. The wound is then closed, and the output of the procedural drain is monitored.

[0008] As the procedural drain is often placed towards the end of long procedures, it may be prone to many errors, which may increase the time needed to complete the procedure. This is especially the case if the deployer is a surgical trainee. The procedural drain suture may break or pull through the patient skin, increasing the risk of the drain falling out or being uncomfortable to the patient. The drain stitch and needle increases the number of sharps on the field, and thus increases the risk for a stick injury to the surgeons and staff, or incorrect surgical instrument count. Furthermore, due to the manual tying of the procedural drain to the patient’s skin, patients often report discomfort with range in drain movement due to skin strangulation or other aspects of the manual tying. This sometimes becomes the primary complaint for patients and may affect their quality of life, and may sometimes result in the need for reintervention (e.g., some patients may remove their own procedural drains against medical recommendations, some patients may require minor bedside procedures to re-suture or re-secure the drain, etc.). Additionally, the drain site of the procedural drain may also be complicated by infection. The skin around the procedural drain may also become macerated due to prolonged exposure to moisture, tension, and friction, resulting in poor wound healing or cosmetic deformity.

[0009] Pending protocol of the provider, the procedural drain may be “advanced” slowly over days. In this case, the suture may be cut, the drain may be pulled out by small amounts, and then the procedural drain may be re-secured to the patient’s skin using either suture, pins, adhesives, or other methodologies. This may be very uncomfortable for the patient.

[0010] Following adequate resolution of drainage, the procedural drain may then be “pulled” and removed from the patient by providers. “Pulling a drain” is uncomfortable and may be complicated by provider removal of incorrect procedural drains, as the procedural drains may be inadequately labeled, or outputs may have been incorrectly recorded due to poor labeling,

[0011] Despite how ubiquitous procedural drains are, there are large ranges of complications and morbidities associated with procedural drains. These complications further require the use of 2 167135316.1348358.15502 (Patent) accessory components needed to address the complications. These accessory components would not be needed were the complications not to occur.

[0012] Consequently, a device is needed to assist with the placement of procedural drains and decrease the associated complications and patient morbidities by streamlining and standardizing a procedural drain placement and protocol for providers while improving patient comfort. SUMMARY

[0013] According to an object of the present disclosure, a sutureless device is provided. The sutureless device may comprise an internal component configured to be inserted within an opening in skin of a patient. The internal component may comprise an internal holding mechanism and an opening configured to receive a procedural drain. The sutureless device may comprise an external component configured to be secured to the internal component. The external component may comprise an external holding mechanism and an opening configured to receive the procedural drain. The sutureless device may comprise a securing mechanism configured to secure the internal component to the external component. The internal holding mechanism and the external holding mechanism may be configured to secure a position of the sutureless device within the opening in the skin of the patient. The internal component and the external component may be configured to secure the procedural drain within the opening of the internal component and the opening of the external component.

[0014] According to an exemplary embodiment, the opening of the internal component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain.

[0015] According to an exemplary embodiment, the opening of the external component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain.

[0016] According to an exemplary embodiment, the internal holding mechanism may comprise a plurality of protrusions.

[0017] According to an exemplary embodiment, the external holding mechanism may have a round circumferential shape. 3 167135316.1348358.15502 (Patent)

[0018] According to an exemplary embodiment, the securing mechanism may be configured to enable a distance between the external holding mechanism and the internal holding mechanism to be adjusted.

[0019] According to an exemplary embodiment, the securing mechanism may comprise a male screw component and a female screw component. According to an exemplary embodiment, the male screw component is coupled to the internal component or the external component, and the female screw component is coupled to the other of the internal component or the external component.

[0020] According to an exemplary embodiment, the external component may comprise an external surface configured to enable the procedural drain to be labeled upon the external surface.

[0021] According to an object of the present disclosure, a sutureless device is provided. The sutureless device may comprise an internal component configured to be inserted within an opening in skin of a patient. The internal component may comprise an internal holding mechanism and

[0022] an opening configured to receive a procedural drain. The sutureless device may comprise an external component configured to be secured to the internal component. The external component may comprise an external holding mechanism and an opening configured to receive the procedural drain. The sutureless device may comprise a sheath component configured to slide between the internal holding mechanism and the external holding mechanism and compress the internal holding mechanism when slid toward the internal holding mechanism, decreasing a diameter of the internal holding mechanism. The internal holding mechanism and the external holding mechanism may be configured to securing a position of the sutureless device within the opening in skin of the patient. The internal component and the external component may be configured to secure the procedural drain within the opening of the internal component and the opening of the external component.

[0023] According to an exemplary embodiment, the opening of the internal component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain.

[0024] According to an exemplary embodiment, the opening of the external component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain. 4 167135316.1348358.15502 (Patent)

[0025] According to an exemplary embodiment, the internal holding mechanism may comprise a plurality of protrusions.

[0026] According to an exemplary embodiment, the external holding mechanism may have a round circumferential shape.

[0027] According to an object of the present disclosure, a method for deploying a sutureless device is provided. The method may comprise inserting a procedural drain into an internal component of a sutureless device. The sutureless device may comprise the internal component, configured to be inserted within an opening in skin of a patient. The internal component may comprise an internal holding mechanism and an opening configured to receive a procedural drain. The sutureless device may comprise an external component configured to be secured to the internal component. The external component may comprise an external holding mechanism and an opening configured to receive the procedural drain. The sutureless device may comprise a securing mechanism configured to secure the internal component to the external component. The method may comprise inserting the procedural drain into the opening in the skin of the patient and advancing the procedural drain until the internal component is positioned such that the securing mechanism of the internal component is traversing the opening in the skin. The method may comprise inserting an external side of the procedural drain into an opening of the external component and advancing the external component down the external side of the procedural drain until it comes into contact with the internal component, and securing the internal component to the external component via the securing mechanism.

[0028] According to an exemplary embodiment, the internal component may be positioned such that the internal holding mechanism of the internal component is positioned under the skin

[0029] According to an exemplary embodiment, the securing mechanism may comprise a male screw component and a female screw component, and the securing the internal component to the external component via the securing mechanism may comprise screwing the male screw component into the female screw component.

[0030] According to an exemplary embodiment, the securing mechanism may be configured to enable a distance between the external holding mechanism and the internal holding mechanism to be adjusted. 5 167135316.1348358.15502 (Patent)

[0031] According to an exemplary embodiment, the securing the internal component to the external component via the securing mechanism may comprise adjusting the distance between the internal holding mechanism and the external holding mechanism.

[0032] According to an exemplary embodiment, the opening of the internal component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain.

[0033] According to an exemplary embodiment, the opening of the external component may comprise one or more procedural drain holding protrusions configured to engage the procedural drain.

[0034] According to an exemplary embodiment, the internal holding mechanism may comprise a plurality of protrusions.

[0035] According to an exemplary embodiment, the method may further comprise labeling the procedural drain across an external surface of the external component. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings, which are incorporated in and form a part of the Detailed Description, illustrate various non-limiting and non-exhaustive embodiments of the subject matter and, together with the Detailed Description, serve to explain principles of the subject matter discussed below. Unless specifically noted, the drawings referred to in this Brief Description of Drawings should be understood as not being drawn to scale and like reference numerals refer to like parts throughout the various figures unless otherwise specified.

[0037] FIG.1 illustrates a procedural drain placed within a patient’s skin.

[0038] FIG.2 illustrates an exploded view of a sutureless device for securing procedural drains to a patient, according to an exemplary embodiment of the present disclosure.

[0039] FIG. 3 illustrates a front view of a sutureless device for securing procedural drains to a patient, according to an exemplary embodiment of the present disclosure.

[0040] FIG.4 illustrates a perspective view of a sutureless device for securing procedural drains to a patient, according to an exemplary embodiment of the present disclosure.

[0041] FIG.5 illustrates a view of a sutureless device for securing procedural drains to a patient with a procedural drain positioned within the sutureless device, according to an exemplary embodiment of the present disclosure. 6 167135316.1348358.15502 (Patent)

[0042] FIG.6 illustrates a view of a sutureless device for securing procedural drains to a patient positioned within a patient’s skin, according to an exemplary embodiment of the present disclosure.

[0043] FIG.7 illustrates a view of a sutureless device for securing procedural drains to a patient positioned within a patient’s skin, with a procedural drain positioned within the sutureless device, according to an exemplary embodiment of the present disclosure.

[0044] FIG. 8A illustrates a sutureless device for securing procedural drains to a patient with a sheath component in a first position, according to an exemplary embodiment of the present disclosure.

[0045] FIG. 8B illustrates a sutureless device for securing procedural drains to a patient with a sheath component in a second position, according to an exemplary embodiment of the present disclosure.

[0046] FIG. 9 illustrates a flowchart of a method for deploying a sutureless device for securing procedural drains to a patient, according to an exemplary embodiment of the present disclosure.

[0047] FIG.10 illustrates a flowchart of a method for deploying a sutureless device for securing procedural drains to a patient, according to an exemplary embodiment of the present disclosure.

[0048] It should be understood that the appended drawings are not necessarily to scale, presenting a somewhat simplified representation of various features illustrative of the basic principles of the disclosure. The specific design features of the present disclosure as disclosed herein, including, for example, specific dimensions, orientations, locations, and shapes will be determined in part by the particular intended application and use environment. DETAILED DESCRIPTION

[0049] The following Detailed Description is merely provided by way of example and not of limitation. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding background or in the following Detailed Description.

[0050] Reference will now be made in detail to various exemplary embodiments of the subject matter, examples of which are illustrated in the accompanying drawings. While various embodiments are discussed herein, it will be understood that they are not intended to limit to these embodiments. On the contrary, the presented embodiments are intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the various 7 167135316.1348358.15502 (Patent) embodiments as defined by the appended claims. Furthermore, in this Detailed Description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present subject matter. However, embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail as not to unnecessarily obscure aspects of the described embodiments.

[0051] Some portions of the detailed descriptions which follow are presented in terms of procedures, logic blocks, processing, and other symbolic representations of operations on data within an electrical device (e.g., computing devices comprising a processor and / or memory, and / or other suitable computing devices). These descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. In the present application, a procedure, logic block, process, or the like, is conceived to be one or more self-consistent procedures or instructions leading to a desired result. The procedures are those requiring physical manipulations of physical quantities. Usually, although not necessarily, these quantities may take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated in an electronic system, device, and / or component.

[0052] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. 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. These terms are merely intended to distinguish one component from another component, and the terms do not limit the nature, sequence or order of the constituent components. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, 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. Throughout the specification, unless explicitly described to the contrary, the word “comprise” and variations such as “comprises” or “comprising” will be understood to imply the inclusion of stated elements but not the exclusion of any other elements. In addition, the terms “unit”, “-er”, “-or”, and “module” 8 167135316.1348358.15502 (Patent) described in the specification mean units for processing at least one function and operation, and can be implemented by hardware components or software components and combinations thereof.

[0053] Although exemplary embodiment is described as using a plurality of units to perform the exemplary process, it is understood that the exemplary processes may also be performed by one or plurality of modules. Additionally, it is understood that the term controller / control unit refers to a hardware device that includes a memory and a processor and is specifically programmed to execute the processes described herein. The memory is configured to store the modules and the processor is specifically configured to execute said modules to perform one or more processes which are described further below.

[0054] Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from the context, all numerical values provided herein are modified by the term “about”.

[0055] Referring now to FIGs. 2-4, an exploded view (FIG. 2) a front view (FIG. 3), and a perspective view (FIG.4) of a sutureless device 100 for securing procedural drains 124 to a patient are illustratively depicted, in accordance with exemplary embodiments of the present disclosure. As shown in FIGs. 5-6, the sutureless device 100 with a procedural drain 124 positioned within the sutureless device 100 (FIG.5), a view of the sutureless device 100 positioned within a patient’s skin 126 (FIG.6), and a view of the sutureless device 100 positioned within a patient’s skin 126, with a procedural drain 124 positioned within the sutureless device 100 (FIG.7) are illustratively depicted, in accordance with exemplary embodiments of the present disclosure.

[0056] The sutureless device 100 may be configured to hold a procedural drain 124 in place without the traditional use of sutures to secure the procedural drain 124 to the skin 126 of the patient. By holding the procedural drain 124 in place without the traditional use of sutures, the sutureless device 100 minimizes the need for an additional puncture through the patient’s skin 126 to secure the procedural drain 124. According to an exemplary embodiment, while the sutureless device 100 is described as securing a procedural drain 124 to the skin 126 of the patient, it is noted that the sutureless device 100 may be able to secure one or more other types of transcutaneous devices, while maintaining the spirit and functionality of the present disclosure. 9 167135316.1348358.15502 (Patent)

[0057] According to an exemplary embodiment, the sutureless device 100 may comprise an external component 102 and an internal component 104. According to an exemplary embodiment, the external component 102 and the internal component 104 may form one singular piece. According to an exemplary embodiment, the external component 102 and the internal component 104 comprise two or more pieces.

[0058] According to an exemplary embodiment, the internal component 104 may be configured to be positioned within the body of the patient (e.g., under the patient’s skin 126). According to an exemplary embodiment, the internal component 104 may be configured to trap the procedural drain 124 from slipping out of the body of the patient. The internal component 104 may comprise an internal holding mechanism 106 configured to hold the internal component 104 within the body of the patient. According to an exemplary embodiment, the internal holding mechanism 106 may be configured to minimize contact with internal tissues of the patient, while maintaining adequate force to prevent slippage of the procedural drain 124 and the sutureless device 100 from the body cavity of the patient. According to an exemplary embodiment, the internal holding mechanism 106 may comprise one or more protrusions 108 (e.g., the star-shaped holding mechanism 106 as shown in FIGs. 2-4) and / or tacking devices (e.g., hooks, pins, and / or other suitable tacking devices). According to an exemplary embodiment, the holding mechanism 106 may be configured to move with the application of an appropriate degree of pressure, as shown, e.g., in FIG.3.

[0059] According to an exemplary embodiment, the internal component 104 may be configured to be secured to the external component 102. According to various embodiments, the sutureless device 100 may comprise a securing mechanism 110 configured to secure the internal component 104 to the external component 102. According to an exemplary embodiment, as shown, e.g., in FIG. 1, the securing mechanism 110 may comprise a male screw component 112 and a female screw component 114, enabling the internal mechanism 104 to screw into the external mechanism 104. It is noted, however, that other suitable securing mechanisms 110 (e.g., snapping mechanisms, locking mechanisms, adhesives, and / or other suitable securing mechanisms) may be incorporated while maintaining the spirit and functionality of the present disclosure.

[0060] The external component 102 is configured to be wholly or partially positioned externally to the patient’s body and configured to prevent the procedural drain 124 from slipping into the body of the patient. According to an exemplary embodiment, the external component 102 may comprise an external holding mechanism 116. The external holding mechanism 116 may be 10 167135316.1348358.15502 (Patent) configured to hold the external component 102 wholly or partially exterior to the patient’s skin 126. According to an exemplary embodiment, as shown, e.g., in FIGs.2-4, the external holding mechanism 116 of the external component 102 may comprise a circular design (e.g., having a round circumferential shape) configured to maximize surface area of which a force of the procedural drain 124 may be distributed across the patient’s skin 126 surface 128, thus minimizing discomfort associated with procedural drain 124 movement and twisting. According to an exemplary embodiment, the external holding mechanism 116 may be configured to be marked (e.g., with a pen and / or other suitable mechanism). This enables the procedural drain 124 to be labeled, minimizing the pulling of an incorrect procedural drain 124. According to an exemplary embodiment, the external holding mechanism 116 may comprise one or more shapes and / or colors and / or patterns configured to label and / or identify the procedural drain 124, enabling ease of identification for patients.

[0061] According to an exemplary embodiment, the securing mechanism 110 may be configured to enable a distance between the external mechanism 102 and the internal mechanism 104 to be adjusted, enabling the external mechanism 102 and internal mechanism 104 to be attached with varying degrees of length and / or tightness in order to accommodate varying thicknesses of skin 126 and preferences of the provider and patient on tightness.

[0062] According to an exemplary embodiment, the external component 102 and / or the internal component 104 may comprise one or more procedural drain 124 securement components 118 configured to engage the procedural drain 124. As shown, e.g., in FIGs.2 and 4, the one or more procedural drain 124 securement components 118 may comprise one or more protrusions configured to grip and / or apply pressure to the procedural drain 124. As the procedural drain 124 passes through an opening 120 in the external component 102 and an opening 122 in the internal component 104, the one or more procedural drain 124 securement components 118 prevent the procedural drain from slipping from the sutureless device 100. However, as this is not a permanent attachment, the one or more procedural drain 124 securement components 118 may be configured to allow for advancement of the procedural drain 124, per a protocol of the provider (e.g., to advance the procedural drain daily to slowly remove). According to an exemplary embodiment, the openings 120, 122 may have a diameter of approximately 10.00 mm. It is noted, however, that that other diameter openings 120, 122 may be incorporated while maintaining the spirit and functionality of the present disclosure. 11 167135316.1348358.15502 (Patent)

[0063] According to an exemplary embodiment, the sutureless device 100 may comprise an antibiotic and / or antimicrobial coating over one or more components of the sutureless device 100 in order to reduce the risk of procedural drain site infections. It is noted that other suitable forms of coating to aid in the prevention of infection and / or promote wound healing may be incorporated, while maintaining the spirit and functionality of the present disclosure. According to an exemplary embodiment, the sutureless device 100 may comprise one or more components of fluid detection (e.g., one or more sensors configured to detect pH changes for infection, one or more sensored configured to detect volume to signal and / or indicate that the procedural drain is ready to be removed, etc.). According to an exemplary embodiment, the one or more sensors configured to detect pH changes may comprise one or more coatings configured to sense pH changes, a pH detection tab comprising a material configured to change colors based on pH, and / or other suitable pH detection mechanisms. Lower pH’s (more acidic) may indicate a potential infection and / or a leak of acids (if the procedural drain 124 is positioned in the abdomen).

[0064] According to an exemplary embodiment, the external holding mechanism 116 and / or the internal holding mechanism 108 may comprise a soft material configured to allow for flexibility of the procedural drain 124 internally and externally. According to an exemplary embodiment, the securing mechanism 110 may comprise a relatively hard material (e.g., hard plastic, metal, and / or other suitable materials) to allow for a durable hold between the external mechanism 102 and internal mechanism 104. According to an exemplary embodiment, the material of the securing mechanism is configured to allow for the manipulation of the internal structure, such that manually squeezing the securing mechanism collapses the softer internal holding mechanism 108, allowing for the easy removal of the internal component 104 at time of procedural drain 124 removal.

[0065] According to an exemplary embodiment, the sutureless device 100 may comprise a sheath component 130, as shown, e.g., in FIGs. 8A-8B. According to an exemplary embodiment, the sheath component 130 may be configured to compress the internal holding mechanism 106 resulting in the collapse or partial collapse of the protrusions 108 of the internal holding mechanism 106 when slid in direction 132 towards the internal holding mechanism 106, decreasing a diameter of the internal holding mechanism 106. The collapsing of the protrusions 108 and resulting decrease in the diameter of the internal holding mechanism 106 make it easier to insert the sutureless device 100 through an opening in the skin 126 of the patient through an incision 134 in the skin 126. 12 167135316.1348358.15502 (Patent)

[0066] Referring now to FIG.9, a flowchart of a method 200 for deploying a sutureless device for securing procedural drains to a patient is illustratively depicted, in accordance with an exemplary embodiment of the present disclosure.

[0067] At 205, the patient’s skin may be punctured and / or otherwise incised per traditional procedural drain deployment protocol, creating an opening in the patient’s skin. According to an exemplary embodiment, when the procedural drain is placed at an incision, the incision may be closed up to the procedural drain, allowing for a small opening in the incision for the procedural drain.

[0068] At 210, the procedural drain is inserted within an opening in the internal component of the sutureless device, causing the internal component to be positioned around the procedural drain. According to an exemplary embodiment, when the internal component is positioned around the procedural drain, one or more procedural drain holding protrusions are pressed up against the procedural drain.

[0069] At 215, the procedural drain, with the internal component of the sutureless device positioned around it, is inserted into the opening in the patient’s skin and, at 220, the procedural drain is advanced until the internal component is positioned such that an internal holding mechanism of the internal component is positioned under the skin (e.g., immediately proximal to the internal side of the skin) and the securing mechanism (e.g., the screw component) of the internal component is traversing the opening in the skin.

[0070] At 225, an external side of the procedural drain is inserted into an opening of the external component of the sutureless device and, at 230, the external component is moved down the external side of the procedural drain until it comes into contact with the internal component.

[0071] At 235, the internal component and external component of the sutureless device are secured together via a suitable securing mechanism (e.g., the two parts may be screwed together). Securing the internal component to the external component secures the procedural drain in place. According to an exemplary embodiment, the securing mechanism may be configured to enable a distance between the internal holding mechanism and the external holding mechanism to be adjusted and securing the internal component to the external component may comprise adjusting the distance between the internal holding mechanism and the external holding mechanism.

[0072] At 240, the procedural drain may be labeled across an external surface of the external component. This may be done in ink or through other suitable means. 13 167135316.1348358.15502 (Patent)

[0073] At 245, the procedural drain may be advanced through the sutureless device via the application of gentle pressure placed to pull the procedural drain through the sutureless device.

[0074] According to an exemplary embodiment, to remove the procedural drain and the sutureless device, the securing mechanism may be disconnected (e.g., the external component may be unscrewed from the internal component), enabling the external component to be removed. The internal component may then be removed by squeezing the securing mechanism (e.g., the male screw part of the internal component), thus collapsing the internal holding mechanism, allowing the internal component and the procedural drain to be pulled out of the patient.

[0075] Referring now to FIG.10, a flowchart of a method 300 for deploying a sutureless device for securing procedural drains to a patient is illustratively depicted, in accordance with an exemplary embodiment of the present disclosure.

[0076] At 305, the patient’s skin may be punctured and / or otherwise incised per traditional procedural drain deployment protocol, creating an opening in the patient’s skin.

[0077] At 310, a sheath of a sutureless device may be advanced toward an internal holding mechanism of the sutureless device causing, at 315, the internal holding mechanism to collapse and decrease in diameter.

[0078] At 320, the internal holding mechanism, in the collapsed state, may be inserted into the opening in the patient’s skin and advanced until the internal holding mechanism is positioned under the skin. At 325, the sheath is advanced toward an external holding mechanism of the sutureless device, causing a diameter of the internal holding mechanism to expand. The sutureless device, at 330, is then positioned such that an internal holding mechanism is positioned under the skin (e.g., immediately proximal to the internal side of the skin) and the external holding mechanism is positioned exterior to the skin.

[0079] What has been described above includes examples of the subject disclosure. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the subject matter, but it is to be appreciated that many further combinations and permutations of the subject disclosure are possible. Accordingly, the claimed subject matter is intended to embrace all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

[0080] In particular and in regard to the various functions performed by the above described components, devices, systems and the like, the terms (including a reference to a “means”) used to 14 167135316.1348358.15502 (Patent) describe such components are intended to correspond, unless otherwise indicated, to any component which performs the specified function of the described component (e.g., a functional equivalent), even though not structurally equivalent to the disclosed structure, which performs the function in the herein illustrated exemplary aspects of the claimed subject matter.

[0081] The aforementioned systems and components have been described with respect to interaction between several components. It can be appreciated that such systems and components can include those components or specified sub-components, some of the specified components or sub-components, and / or additional components, and according to various permutations and combinations of the foregoing. Sub-components can also be implemented as components communicatively coupled to other components rather than included within parent components (hierarchical). Additionally, it should be noted that one or more components may be combined into a single component providing aggregate functionality or divided into several separate sub- components. Any components described herein may also interact with one or more other components not specifically described herein.

[0082] In addition, while a particular feature of the subject innovation may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application. Furthermore, to the extent that the terms “includes,” “including,” “has,” “contains,” variants thereof, and other similar words are used in either the detailed description or the claims, these terms are intended to be inclusive in a manner similar to the term “comprising” as an open transition word without precluding any additional or other elements.

[0083] Thus, the embodiments and examples set forth herein were presented in order to best explain various selected embodiments of the present invention and its particular application and to thereby enable those skilled in the art to make and use embodiments of the invention. However, those skilled in the art will recognize that the foregoing description and examples have been presented for the purposes of illustration and example only. The description as set forth is not intended to be exhaustive or to limit the embodiments of the invention to the precise form disclosed. 15 167135316.1

Claims

348358.15502 (Patent) WHAT IS CLAIMED IS:

1. A sutureless device, comprising: an internal component configured to be inserted within an opening in skin of a patient, comprising: an internal holding mechanism; and an opening configured to receive a procedural drain; an external component configured to be secured to the internal component, comprising: an external holding mechanism; and an opening configured to receive the procedural drain; and a securing mechanism configured to secure the internal component to the external component, wherein: the internal holding mechanism and the external holding mechanism are configured to securing a position of the sutureless device within the opening in the skin of the patient, and the internal component and the external component are configured to secure the procedural drain within the opening of the internal component and the opening of the external component.

2. The sutureless device of claim 1, wherein the opening of the internal component comprises one or more procedural drain holding protrusions configured to engage the procedural drain.

3. The sutureless device of claim 1 or 2, wherein the opening of the external component comprises one or more procedural drain holding protrusions configured to engage the procedural drain.

4. The sutureless device of any one of claims 1 to 3, wherein the internal holding mechanism comprises a plurality of protrusions. 16 167135316.1348358.15502 (Patent) 5. The sutureless device of any one of claims 1 to 4, wherein the external holding mechanism has a round circumferential shape.

6. The sutureless device of any one of claims 1 to 5, wherein the securing mechanism is configured to enable a distance between the external holding mechanism and the internal holding mechanism to be adjusted.

7. The sutureless device of any one of claims 1 to 6, wherein: the securing mechanism comprises a male screw component and a female screw component; the male screw component is coupled to the internal component or the external component, and the female screw component is coupled to the internal component or the external component.

8. The sutureless device of any one of claims 1 to 7, wherein the external component comprises an external surface configured to enable the procedural drain to be labeled upon the external surface.

9. A sutureless device, comprising: an internal component configured to be inserted within an opening in skin of a patient, comprising: an internal holding mechanism; and an opening configured to receive a procedural drain; an external component configured to be secured to the internal component, comprising: an external holding mechanism; and an opening configured to receive the procedural drain; and a sheath component, configured to: slide between the internal holding mechanism and the external holding mechanism, and 17 167135316.1348358.15502 (Patent) compress the internal holding mechanism when slid toward the internal holding mechanism, decreasing a diameter of the internal holding mechanism, wherein: the internal holding mechanism and the external holding mechanism are configured to securing a position of the sutureless device within the opening in skin of the patient, and the internal component and the external component are configured to secure the procedural drain within the opening of the internal component and the opening of the external component.

10. The sutureless device of claim 9, wherein the opening of the internal component comprises one or more procedural drain holding protrusions configured to engage the procedural drain.

11. The sutureless device of claim 9 or 10, wherein the opening of the external component comprises one or more procedural drain holding protrusions configured to engage the procedural drain.

12. The sutureless device of any one of claims 9 to 11, wherein the internal holding mechanism comprises a plurality of protrusions.

13. The sutureless device of any one of claims 9 to 12, wherein the external holding mechanism has a round circumferential shape.

14. A method for deploying a sutureless device, comprising: inserting a procedural drain into an internal component of a sutureless device, wherein the sutureless device comprises: the internal component, configured to be inserted within an opening in skin of a patient, comprising: an internal holding mechanism; and an opening configured to receive a procedural drain; an external component configured to be secured to the internal component, comprising: 18 167135316.1348358.15502 (Patent) an external holding mechanism; and an opening configured to receive the procedural drain; and a securing mechanism configured to secure the internal component to the external component; inserting the procedural drain into the opening in the skin of the patient and advancing the procedural drain until the internal component is positioned such that the securing mechanism of the internal component is traversing the opening in the skin; inserting an external side of the procedural drain into an opening of the external component and advancing the external component down the external side of the procedural drain until it comes into contact with the internal component; and securing the internal component to the external component via the securing mechanism.

15. The method of claim 14, wherein: the securing mechanism comprises a male screw component and a female screw component, and the securing the internal component to the external component via the securing mechanism comprises screwing the male screw component into the female screw component.

16. The method of claim 14 or 15, wherein: the securing mechanism is configured to enable a distance between the external holding mechanism and the internal holding mechanism to be adjusted, and the securing the internal component to the external component via the securing mechanism comprises adjusting the distance between the internal holding mechanism and the external holding mechanism.

17. The method of any one of claims 14 to 16, wherein the opening of the internal component comprises one or more procedural drain holding protrusions configured to engage the procedural drain. 19 167135316.1348358.15502 (Patent) 18. The method of any one of claims 14 to 17, wherein the opening of the external component comprises one or more procedural drain holding protrusions configured to engage the procedural drain.

19. The method of any one of claims 14 to 18, wherein the internal holding mechanism comprises a plurality of protrusions.

20. The method of any one of claims 14 to 19, further comprising labeling the procedural drain across an external surface of the external component. 20 167135316.1

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