Tube securement assembly and uses thereof

Abstract

A securement assembly for a medical catheter inserted into an organ, including an adhesive base having an opening and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a first channel extending through a first opening in the cap and a second channel extending through a second opening in the cap.

Description

TUBE SECUREMENT ASSEMBLY AND USES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No.63 / 612,732, filed December 20, 2023, which is incorporated herein by reference in its entirety for all purposes.BACKGROUNDFIELD OF THE DISCLOSURE

[0002] The present disclosure pertains to securement devices for securing a tube, such as a medical catheter which is inserted into the body for passage of fluids into or out of the body.DESCRIPTION OF THE RELATED ART

[0003] Medical catheters are inserted into the body to drain fluids from the body or deliver fluids into the body. There is a need to properly secure a medical catheter to prevent movement relative to its insertion site and to maintain a desired depth of insertion. Examples of securement assemblies are described in PCT application PCT / US2022 / 052394, filedDecember 19, 2022.

[0004] The foregoing “Background” description is for the purpose of generally presenting the context of the disclosure. Work of the inventors, to the extent it is described in this background section, as well as aspects of the description which may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present invention.SUMMARY

[0005] The foregoing paragraphs have been provided by way of general introduction and are not intended to limit the scope of the following claims. The described embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.

[0006] In one embodiment, the present disclosure is related to securement assembly for a medical catheter inserted into an organ, comprising an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a first channel extending through a first opening in the cap and a second channel extending through a second opening in the cap.

[0007] In one embodiment, the present disclosure is related to a securement assembly for a medical catheter inserted into an organ, comprising an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a channel extending through at least one opening in the cap.

[0008] In one embodiment, the present disclosure is related to a securement assembly for a medical catheter inserted into an organ, comprising an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, the cavity includes a channel extending through at least one opening in the cap, and the cap includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] A more complete appreciation of the disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0010] FIG. 1A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0011] FIG. IB is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0012] FIG. 1C is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0013] FIG. ID is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0014] FIG. IE is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0015] FIG. 2A is a securement assembly for a medical catheter in use, according to one embodiment of the present disclosure;

[0016] FIG. 2B is a securement assembly for a medical catheter in use, according to one embodiment of the present disclosure;

[0017] FIG. 3 A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0018] FIG. 3B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0019] FIG. 4A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0020] FIG. 4B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0021] FIG. 5 is a method of using a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0022] FIG. 6A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0023] FIG. 6B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0024] FIG. 6C is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0025] FIG. 6D is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0026] FIG. 6E is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0027] FIG. 7 A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0028] FIG. 7B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0029] FIG. 7C is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0030] FIG. 7D is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;|00031] FIG 8A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0032] FIG. SB is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;|00033] FIG. 8C is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0034] FIG. 8D is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0035] FIG. 8E is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0036] FIG. 8F is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0037] FIG. 9A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0038] FIG. 9B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0039] FIG. 10A is a securement assembly for a medical catheter, according to one embodiment of the present disclosure;

[0040] FIG. 10B is a securement assembly for a medical catheter, according to one embodiment of the present disclosure; and

[0041] FIG. 10C is a securement assembly for a medical catheter, according to one embodiment of the present disclosure.DETAILED DESCRIPTION OF THE INVENTION

[0042] The terms “a” or i”, as used herein, are defined as one or more than one. The term“plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and / or “having”, as used herein, are defined as comprising (i.e., open language). Reference throughout this document to “one embodiment”, “certain embodiments”, “an embodiment”, “an implementation”, “an example” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same embodimentFurthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

[0043] In one embodiment, the present disclosure is directed towards a securement assembly for a medical catheter, the medical catheter being, for example, a urinary catheter, an abdominal catheter, a thoracic catheter, an endotracheal tube, a feeding tube, a nasogastric tube, an orogastric tube, a laryngeal mask airway tube, a tracheostomy tube, a Jackson-Pratt drain, a Davol drain, a biliary drain, a gastrostomy tube, a cecostomy tube, a peritoneal tube, a T-tube, a rectal tube, an angiocatheter, a central line, a tunneled catheter, buttons, or the like. A medical catheter can be inserted into the body as a non-surgical intervention to drain fluid from or administer fluid to the body. In some conditions, a medical catheter can be used to treat infection, bleeding, or leakage of pulmonary or gastrointestinal air or fluid within the body. Medical catheters can also be used as part of a surgical procedure or to prevent postoperative complications. A urinary catheter is an example of a medical catheter that can be inserted into a patient's urethra to drain the bladder before or after a radical prostatectomy, which is performed to treat prostate cancer. The urinary catheter is typically left in place or regularly replaced over a period of one to two weeks to allow the bladder and urethra toproperly heal after the procedure. The positioning of a medical catheter and various characteristics of the medical catheter (e.g., caliber, size, flexibility, drainage type, means of suction) are variable and dependent on the type and usage of the medical catheter. Medical catheters can be inserted into the body temporarily, for a number of days or weeks, or even indefinitely.|00044] It is important that a medical catheter is properly secured at or near the insertion site in order to prevent complications, including, but not limited to, improper drainage, malpositioning, tissue damage, fistula formation, infection, pain, or trauma to the skin or tissue. The medical catheter should be secured within the insertion site such that It does not move independently of the body or relative to the site or organ of insertion. The insertion site can be an orifice of the body or can be an incision or opening made in the skin. Maintaining a known depth and location of an internal drain opening at the end of the medical catheter that is inserted into the body is crucial to ensure proper drainage and to avoid serious complications. It is also important to secure the medical catheter at the insertion site (also referred to as the exit site) to prevent pain or trauma, including infection. The tubing can rub against the skin and cause irritation when the medical catheter moves in and out of the insertion site or when the angle of insertion changes. Proper securement of the medical catheter can include securement while the patient is in motion. In certain cases, patients expect to have full mobility and to be able to maintain their typical lifestyles while the medical catheter is inserted. Therefore, the securement of the medical catheter should prevent any independent movement of the medical catheter throughout a wide range of patient motion and activity. In many use cases, there may be a wound at or near the insertion site. The wound may need to be accessible in order to monitor healing, apply medication, change a dressing, etc. while still protecting the wound from exposure or irritation that may lead to infection. In addition, a catheter may need to be regularly removed or replaced in order toremove drainage, maintain patient hygiene, and provide access to insertion site or surrounding areas.

[0045] A conventional method for securing a medical catheter is to suture the tubing to the skin at the exit site of the medical catheter, often with multiple throws through the patient's skin. These sutures can be uncomfortable and can eventually pull through the skin, causing tissue damage and releasing the tubing from the suture site. Adhesive dressings and medicalgrade tapes are also suboptimal as they are typically applied in a piecemeal fashion and do not completely secure the medical catheter in place, resulting in increased risk of drain dislodgement and patient discomfort.

[0046] In one embodiment, the present disclosure is directed towards a medical catheter securement assembly including a first component for securing the medical catheter and a second component for attachment to or securing of the skin, organ, or body part at or near the insertion site. The first component can be referred to herein as a cap, a first holding portion, a first holding component, or a medical catheter holder. The second component can be referred to herein as a base, a second holding portion, a second holding component, or an organ attachment. In one embodiment, the second component can be an adhesive pad. The securement assembly can prevent movement of the medical catheter relative to the insertion site and the surrounding body parts. In one embodiment, the securement assembly can absorb shock from impact or force on the body to prevent movement of the medical catheter. In one embodiment, the base can absorb residual fluid exiting from the patient. Each of the first component and the second component can include, for example, anchors, fasteners, aligners, locking mechanisms, and / or attachments, which will be described in greater detail herein. In one embodiment, the first component can secure G-buttons of different sizes and medical catheters of varying diameters, thicknesses, lengths, materials, orientations, and angles in a channel or opening. The second component can be securely fitted or fixed to a human bodypart, appendage, or organ where the G-button or medical catheter has been inserted. The human organ can include an area of skin. The coupling of the first component and the second component can secure the medical catheter while reducing unwanted contact between the securement assembly and a wound or insertion site.|00047] In one embodiment, the first component and the second component can be removably coupled. In one embodiment, the second component can remain fixed to the human organ while the first component is detached from the second component to provide access to the insertion site and the medical catheter. The separation of the first component and the second component can enable the medical catheter to be exchanged and the insertion site or surrounding area to be treated. The first component can then be easily reattached to the second component to continue securing the medical catheter.

[0048] FIG. 1 A is an illustration of a securement assembly 10 for a medical catheter, according to one embodiment of the present disclosure. In one embodiment, the securement assembly of FIG. 1A can be used to secure a G-button. The secmement assembly of FIG. 1 can include a cap 100, wherein the cap 100 can secure a G-button inserted into the body through an incision, and a base 200, wherein the base 200 can be attached to the skin. The base 200 can include a hole or opening for the incision site. The cap can have, for example, a rounded or domed shape, a cuboid shape, a cylindrical shape, etc. In one embodiment, the securement assembly 10 can include a first half and a second half. The first half can include a first half of the cap 100 and a first half of the base 200, while the second half can include a second half of the cap 100 and a second half of the base 200. In one embodiment, the first half and the second half can be identical or symmetrical. In one embodiment, the first half and the second half can include one or more mating components. The first half and the second half can be removably coupled to each other to secure the G-button. In one embodiment, the first half and the second half can be locked together when coupled.

[0049] In one embodiment, the cap 100 can include one or more components or parts. For example, one or both halves of the cap 100 can include a snap lock with a hinge or joint, wherein the halves can be coupled and then locked together using the snap lock. For example, the snap lock can include an arm 110 that is attached to the cap 100 with a hinge or joint. The arm 110 can be rotatable around the hinge or joint. In one embodiment, the arm 110 can fit into or against a cavity in the opposing half of the cap with a snap fit. In one embodiment, the arm 110 can fit against the opposing half of the cap with a snap fit. The two halves can be substantially similar in design and size or identical. In one embodiment, the two halves of the cap 100 can include alignment features, locking features, and / or fastening mechanisms to secure the caps in a closed position. If the two halves are identical, the male and corresponding female alignment features on the cap can be symmetrical, so the identical halves have male and female features that can properly match with one another. In one embodiment, the snap lock and the corresponding fitting cavity can also be symmetrical so as to fit together. In one embodiment, a first half can be identical to a second half but can be rotated by 180° with respect to the second half so that the two halves can fit together.

[0050] FIG. IB is an illustration of the securement assembly 10 according to one embodiment wherein the first half and the second half are coupled together. In one embodiment, the securement assembly 10 can form an opening in the cap 100 and base 200 around a G-button that is inserted. FIG. 1C is an illustration of the securement assembly 10 according to one embodiment wherein the first half and the second half are coupled together and the snap lock arms 110 are closed. FIG. ID is a side view of the securement assembly 10 according to one embodiment wherein the first half and the second half are coupled together.The cap 100 can enclose a G-button in the space or cavity between the cap 100 and the base200. FIG. IE is an illustration of a single half of the securement assembly 10 according to one embodiment. The single half can include a first half of the cap 100 and a first half of thebase 200. Each half of the cap 100 can include alignment features, locking features, etc. For example, FIG. IE illustrates a protrusion 120a forming an alignment feature. The protrusion120a can be fitted into a corresponding cavity in the opposing half to align the two halves.The half illustrated in FIG. IE can also include a cavity 120b forming an alignment feature that is configured to receive a protrusion from the opposing half.

[0051] In one embodiment, the cap 100 can be a rigid plastic and the base 200 can be a flexible material such as silicon. In one embodiment, the cap 100 can be polylactic acid(PLA) or acrylonitrile butadiene styrene (ABS), which are plastics that can be used for 3D printing. In one embodiment, the cap 100 can be polyethylene. In one embodiment, the cap100 can be formed by injection molding using any suitable material.

[0052] FIG. 2A and FIG. 2B are illustrations of using the securement assembly 10 for a G- button, according to one embodiment of the present disclosure. In one embodiment, the cap can form an open space, such as an opening, a cavity, a chamber, and / or a channel around the incision site and the corresponding hole in the base. The cavity can be a space between the cap and the base. The channel can run through the cap, e.g., longitudinally from a first end of the cap to a second end of the cap. In one embodiment, the channel can be a cylindrical channel. The cavity and / or the channel can be shaped so that a medical catheter or G-button can be held in place in the channel or cavity when the cap is in a closed position. The tight fit of the cap around the medical catheter can reduce unwanted movement or bending of the medical catheter. In one embodiment, additional tubing can be attached to the G-button through the opening in die cap, as illustrated in FIG. 2B. In one embodiment, the base 200 of the securement assembly 10 can include a bio-compatible absorbent pad to absorb residual fluid exiting from the patient.

[0053] FIG. 3 A is an illustration of a securement assembly 10 for a medical catheter in an open position, according to one embodiment of the present disclosure. The cap 100 of thesecurement assembly 10 can include one or more locking structures. In embodiment, the locking structures can include a male component and a female component, wherein the male component on a first half of the cap can fit into a female component on a second half. The male component can be, for example, a protrusion, e.g., a button 231, on the inner wall of a first half. The female component can be, for example, a slot or receptor, e.g., the opening 241 in the inner wall of a second half. In one embodiment, each half can have at least one male and one female alignment feature. The male protrusion on a first half can fit into the female component of the second half.

[0054] In one embodiment, the locking structures can be a snap-fit joint, wherein a pushing force is applied to fit the male component into the opening of the female component. When the male component fits into the female component, a pulling or pushing forces must be applied to remove the male component from the opening of the female component. The pushing and the pulling forces slightly distort or deform the male component to fit through the opening of the female component. In one example, the opening of the female component can have approximately the same dimensions (e.g., circumference) its the male component.The male component fits snugly inside the female component and is not separated from the female component until a pulling force is applied. In one embodiment, a pulling force might not be required. The cap 100 can include one or more types of locking structures. The locking structures can be located along the inner walls of the cap or on the top, end, or sides of the cap.

[0055] FIG. 3B is a top view of a securement assembly 10 for a medical catheter in an open position, according to one embodiment of the present disclosure. The cap 100 can include the locking structures 231, 241. The cap 100 can also include an opening 250 in the center of the cap 100, wherein a medical catheter or G-button can be secured in the opening 251 when the cap is in a closed position. In one embodiment, the size of the opening 251 and the cylindricalchannel can be dependent on the medical catheter. In one embodiment, the size of the opening 251 and / or the channel can be modified (e.g., made smaller) by adding an insert part against the inner surface of the opening 251.

[0056] In one embodiment, the securement assembly of the present disclosure can be used to secure a catheter that is inserted into the abdomen, such as a suprapubic catheter or a drain.A suprapubic catheter is a type of urinary catheter that is inserted directly into the bladder through the skin rather than through the penis. Catheters can also be inserted into the abdomen to drain fluid in the abdominal cavity, biliary system, or hollow organs, or the like.

[0057] FIG. 4A is an illustration of a securement assembly 30 for a medical catheter, according to one embodiment of the present disclosure. The securement assembly 30 can be used to secure a medical catheter that is approximately straight at the insertion site and throughout the length that is external to the body. The securement assembly 30 can include a cap 310 and a base 320. The cap 310 of the securement assembly can be a rigid plastic component. The cap 310 can include one or more fasteners to hold the cap in a closed position around the medical catheter. The cap can be removably coupled to the base 320 of the securement assembly. The base can be affixed to a patient’s skin on the chest, abdomen, pelvis, or other body part where the tube is placed. In one embodiment, the base can be a biocompatible adhesive material such that the base can be adhered to human skin without the need for additional fixtures such as sutures or can be placed in addition to sutures. The base can be an approximately circular or square pad. The cap and the base can include one or more locking mechanisms 311, aligners, guides, and the like to secure the cap and the base to each other.

[0058] FIG. 4B is a half of the cap 310 of the securement assembly for an abdominal catheter, according to one embodiment of the present disclosure. In one embodiment, the cap can form an approximately cylindrical opening 350. In one embodiment, the cap can form anapproximately cylindrical vertical channel. In one embodiment, the cap 310 can have a cylindrical shape with an approximately cylindrical opening. In one embodiment, the cap 310 can have an angular structure. In one embodiment, the cap can include alignment features that can be used to align the first half of the cap with the second half of the cap. In one example, the alignment features can include one or more cavities and protrusions matching the shape and dimensions of the cavities and also in the inner wall of each half of the cap. The alignment features could also exist on the top, ends, or sides of the cap. The alignment features can guide a user to align the two identical halves properly so that the protrusions in one half fit into the cavity of the second half. In one example, the cavities can be round, and the protrusions can be spherical in shape, as illustrated in FIG. 4A.

[0059] In one embodiment, the base can be made of silicone or other soft biocompatible material, or paper / cloth, with an adhesive layer. In one embodiment, the base can include one or more layers. In one embodiment, the silicon can be a biocompatible silicon. In one embodiment, the thickness of a silicon layer or the number of silicon layers can depend on the anatomy of the patient. In one embodiment, attachments or inserts can be placed on or inside the cap for a tighter and more secure fit of the medical catheter for different size catheters. For example, the securement assembly can be used to secure a medical catheter with a smaller diameter than the diameter of the opening 350 in the cap. A ring, such as a hard plastic ring or a flexible silicon ring, can be inserted into the opening 350 to narrow the opening and / or the channel extending through the tip of the cap. The narrower opening restricts the movement of a thinner medical catheter.

[0060] In one embodiment, the inner walls of the cylindrical opening 350 of the cap can include gripping structures 360 to increase friction between the inner walls and a medical catheter secured by the cap. The gripping structures can include, for example, nubs, teeth, ridges, bumps, or similar raised structures along the inner wall of the cap. In oneembodiment, the gripping structures can be protrusions and can be located inside of the opening 350 of the cap. The gripping structures can be in contact with the medical catheter when the medical catheter is inserted in the cap and can prevent or limit translational as well as rotational movement of the medical catheter.|00061] FIG. 5 is a method 4000 for using a securement assembly for a catheter, according to one embodiment of the present disclosure. In step 4100, the catheter or G-button can be inserted into the body through an incision on skin. In step 4200, a first half of the securement assembly can be positioned around the catheter or G-button. For example, the catheter or G- button can be fitted into an open space of the first half. In step 4300, a second half of the securement assembly can be positioned around the catheter or G-button. The second half and the first half can complete the open space, e.g., opening, cavity, channel, etc. In one embodiment, the bases of the first half and the second half can be adhered to the human organ around the inserted catheter or G-button at step 4300. In step 4400, the halves can be closed.In one embodiment, a pushing force can be applied to the cap to lock the locking mechanisms. In one embodiment, snap locks can be used to lock the halves of the caps to each other. In one embodiment, a fastening mechanism of the cap can be wrapped around the cap and fastened in step 4500 to secure the cap in a closed position around the catheter. As an example, a fastening mechanism can include a strap that can be wrapped around a portion of the circumference of the cap. The securement assembly can be left on the patient until the catheter needs to be removed or replaced or when the securement assembly is needed to be replaced with a new one. In one embodiment, the cap of the securement assembly can be unfastened and opened to provide access to the catheter at a later point.

[0062] The securement assembly of the present disclosure can be compatible with various medical catheters and insertion sites. For example, the securement assembly can secure straight medical catheters, bent or curved medical catheters, curled (pigtail) medicalcatheters, G-buttons, etc. The medical catheters can be inserted into an orifice in the body or through an incision in the skin on any part of the body. Advantageously, the securement assembly can be attached to the patient and to the medical catheter after the medical catheter has been inserted. The securement assembly does not interfere with the insertion of various types of medical catheters into the body. The base of the securement assembly can be configured to attach to any part of the skin for securement of a medical catheter.

[0063] In one embodiment, the securement assembly can be used to secure a medical catheter inserted into the chest as shown in FIG. 6A and FIG. 6B. A thoracic catheter 610 can be inserted into the skin and through the chest wall to drain fluid or air from the intrathoracic space surrounding the lung. The cap 610 of the securement assembly can hold the thoracic catheter while the base 620 of the securement assembly can be attached to the chest. The securement assembly 60 can be used to secure thoracic catheters with varying sizes, fenestrations, shapes, suction types, and material compositions. For example, the thoracic catheter 601 can be a right-angle thoracic catheter, which is common for draining the pleural cavity, or the space between the chest wall and the lung. A right-angle or approximately right-angle bend in the thoracic catheter can provide better access to areas of fluid buildup and is more comfortable for patient use. The thoracic catheter can be connected to an evacuation system outside of the body. The evacuation system can apply a force to the thoracic catheter to encourage the fluid in the body to drain out of the body through the thoracic catheter in a unidirectional manner.

[0064] Attention to the securement and management of a thoracic catheter is important for reducing the risk of bleeding, injury to internal organs, or dislodgment of the thoracic catheter. A thoracic catheter must be fixed in place to avoid injury to nerves or vascular elements in the intercostal space where the thoracic catheter is inserted. The depth of placement of a thoracic catheter is also important. Certain thoracic catheters includefenestrations along the length of the thoracic catheter near the drain opening to increase fluid drainage. The fenestrations should remain inside the body for proper drainage. Movement of the thoracic catheter can result in dislodgement of the drainage opening of the thoracic catheter moving away from the site of fluid buildup, resulting in an ineffective drainage system. In addition, thoracic catheters require regular dressing changes, which must be done without disturbing the placement of the thoracic catheter.|00065] FIG. 6C illustrates a first half of a securement assembly 60 for a medical catheter according to one embodiment. The angled medical catheter can be, for example, a thoracic catheter. The cap 610 of the securement assembly can hold the thoracic catheter while the base 620 of the securement assembly can be attached to the chest. In one embodiment, the base 620 of the securement assembly can be a flat base, wherein the base can adhere to the skin of the chest at or around the insertion site of the thoracic catheter. In one embodiment, the base can act as a dressing or covering for a wound (e.g., the insertion site) or the area surrounding a wound. The cap and the base can be fixed to each other or removably coupled together to secure the thoracic catheter. In one embodiment, the base can be affixed to the chest while the cap can be removed to adjust the thoracic catheter or change a wound dressing. The cap of the securement assembly can be configured to hold a straight catheter or a bent catheter, including a right-angle catheter, or a profile catheter, which can also be referred to as a button.(00066] In one embodiment, the cap 610 can form a channel 650, such as a cylindrical channel running lengthwise through the body of the cap 610. In one embodiment, the channel650 can be horizontal, as illustrated in FIG. 6C. In one embodiment, the channel 650 can be at an angle between vertical and horizontal. In one embodiment, the inner walls of the channel 650 can include gripping structures 660 to increase friction between the inner walls and a medical catheter secured by the cap. In one embodiment, the channel 650 can extendfrom a first end of the cap 610 to an opposing second end of the cap 610. The cap 610 as illustrated in FIG. 6C can be configured to secure a medical catheter that runs along (e.g., horizontally along) the surface of the human organ to which the securement assembly 60 is attached. In one embodiment, the cap 610 can include a locking mechanism. The locking mechanism can be, for example, an arm 611 that is attached to a first half of the cap via a hinge or joint. The arm 611 can be locked to the opposing half of the cap via a snap-fit joint.In one embodiment, the arm 611 can be rotatable around a hinge or joint that forms an axis of rotation that is approximately parallel to the channel 650.

[0067] FIG. 6D is an illustration of the two halves of the securement assembly 60. The channel 650 formed by the two halves can include space for a catheter to emerge vertically from the body. The arms 611 can be positioned across the top surface of the cap 610. In this manner, the arms 611 can rotate and lock the halves of the cap without obstructing the channel 650.

[0068] FIG. 6E and FIG. 6F are illustrations of the two halves of the securement assembly60. An internal wall of the cap can include one or more alignment features. For example, the alignment features can include a protrusion 612 extending from an internal wall of a first half of the cap. The protrusion 612 can be inserted into a cavity in the internal wall of the opposing half to align the two halves.

[0069] The shape and dimensions of the cap can be configured to secure various medical catheters. According to one embodiment, the cap and / or the opening in the cap can be configured to fit around external structures attached to or integrated into a medical catheter.In one embodiment, the cap of the securement assembly can secure a low-profile medical catheter, such as a gastrostomy button. Low-profile medical catheters can be connected to structures inside the body, such as a balloon that can be used for feeding. In one embodiment, the cap can form a chamber in the shape of a low-profile medical catheter. For example, thecap can be shaped to fit around a safety plug, a port, and any other external features at the end of the low profile medical catheter that emerges from the insertion site. In one embodiment, the cap can enclose the end of a low-profile medical catheter. The cap can fit around the low- profile medical catheter to prevent any movement of the external portions of the low-profile medical catheter. According to one embodiment, the inner walls of the cap can be in contact with the external features of the low-profile medical catheter to reduce empty space surrounding the low-profile medical catheter. In one embodiment, a port of the medical catheter can be accessed while the medical catheter is secured in the cap of the securement assembly. Advantageously, the two halves of the cap can be separated to allow access to medical catheter find then rejoined to secure and protect the medical catheter.

[0070] In one embodiment, the securement assembly can include more than one open spaces, e.g., openings, chamber, cavities, channels. The securement assembly can be configured to secure more than one catheter or to secure different types of catheters that can be interchanged. FIG. 7 A is an illustration of a securement assembly 70 according to one embodiment. The securement assembly 70 can include a cap 710 and a base 720. The cap 710 can include a first channel and a second channel. In one embodiment, the first channel and the second channel can be angled relative to each other. For example, FIG. 7 A illustrates a first channel 751 that is perpendicular to a second channel 752. The first channel 751 can be a horizontal channel extending from a first end of the cap 710 to a second end of the cap 710.The second channel 752 can be a vertical channel extending from the base 720 through a top surface of the cap 710. The first channel and the second channel can have the same or different shapes, dimensions, etc. In one embodiment, the inner walls of the channels can include gripping structures. The cap can include locking features such as an arm 711 attached to the cap with a hinge or joint. The arm 711 can be positioned to lock the halves together without obstructing an opening of the first channel 751 or the second channel 752.

[0071] FIG. 7B is an illustration of a securement assembly 70 according to one embodiment.The securement assembly 70 can secure a horizontal medical catheter in the first channel 751.For example, the securement assembly 70 can secure a section of an abdominal tube at a distance from the insertion site. FIG. 7C is an illustration of a securement assembly 70 according to one embodiment. The securement assembly 70 can secure a vertical medical catheter in the second channel 752. FIG. 7D is an illustration of a securement assembly 70 according to one embodiment. The securement assembly 70 can secure an angled medical catheter in the first channel 751.

[0072] FIG. SA is an illustration of a securement assembly 80 according to one embodiment. The securement assembly 80 can include a first channel 851 and a second channel 852. The first channel 851 and the second channel 852 can be, for example, perpendicular to each other. In one embodiment, the cap 810 can include one or more locking features. For example, a locking feature can be a double arm latch 811. The double arm latch811 can be attached to the cap with a hinge or joint. In one embodiment, the double arm latch811 can rotate around a vertical rotational axis that is perpendicular to the base 820, as illustrated in FIG. 8A. The double arm latch 811 can include two arms that are vertically spaced apart. The space between the arms can accommodate a medical catheter that is secured in a first channel 851. The double arm latch 811 of a first half can be locked to an opposing half via a snap-fit joint. For example, the end of one or both arms can be fitted into a slot in the opposing half via a snap-fit joint In one embodiment, each arm of the double arm latch can include a tab at the end of the arm. Pressure can be applied to the tab to lock the arm to the opposing half. FIG. 8B is an illustration of a securement assembly 80 securing a horizontal medical catheter in a first channel 851 with the double arm latch 811 locked to secure the halves of a cap together.

[0073] FIG. 8C and FIG. 8D are illustrations of a securement assembly 80 according to one embodiment. The securement assembly 80 can be used to secure an angled medical catheter.A first portion of the angled medical catheter can fit into a vertical second channel 852 and a second portion of the angled medical catheter can fit into a horizontal first channel 851. The first channel 851 and the second channel 852 can intersect along the inner walls of the cap SO.

[0074] FIG. 8E and FIG. 8F are illustrations of a securement assembly 80 according to one embodiment. The securement assembly 80 can be used to secure a vertical medical catheter in a vertical second channel 852.

[0075] FIG. 9A and FIG. 9B are illustrations of a half of a cap having a horizontal first channel 751 and a vertical second channel 752. The cap illustrated in FIG. 9 A and FIG. 9B can have a locking feature that includes an arm 711 rotatable around an axis of rotation that is approximately parallel to the horizontal first channel 751. As illustrated in FIG. 9 A and FIG.9B, the internal walls of the channels can include gripping structures. In one embodiment, an opening of a channel can be sealed to preserve the sterility or cleanliness of the securement assembly. For example, an opening of the channel 751 can be sealed using a delicate layer of plastic 730 from the same material used for the cap. This plastic covering can be easily removed by chipping it away, allowing access to the desired opening as needed.

[0076] FIG. 10A illustrates a securement assembly 90 configured to secure a branching medical catheter or medical catheters according to one embodiment. For example, the cap910 can secure a gastrojejunostomy tube, which can have two or more access ports that branch from the insertion site. A gastrojejunostomy tube can have a first port (gastric port) and a second port (jejunal port). Each port can lead to a different tubing or section of tubing that is inserted into the body. FIG. 10A illustrates a cap 910 that is affixed to a base 920 and configured to secure a dual-opening port 91. In one embodiment, each half of the cap 910 can include a frame that secures the port 91 within the cavity formed by the cap 910 and the base920 without obstructing the openings. In one embodiment, the frame can include one or more approximately curved, jointed, or angled arms that can extend over the port 91. In one embodiment, the frame of each half of the cap 910 can be joined together by one or more alignment features, locking features, etc. For example, a first half of the cap can include a projection 911 that can be fitted into a slot 912 in the second half of the cap. In one embodiment, the cap 910 can include a locking mechanism. For example, the locking mechanism can be an arm 915 that is attached to the cap via a hinge or a joint. The arm 915 can rotate around an axis of rotation formed by the hinge or joint, e.g., a vertical axis of rotation. FIG. 10B illustrates the securement assembly 90 wherein the first half and the second half are joined together and locked with the arm 915.

[0077] FIG. 10C illustrates a first half of a securement assembly 90. The cap 910 of the securement assembly 90 can include two angled arms 901, 902 that extend upwards at an angle. Each angled arm can terminate in a horizontal portion. A first angled arm 901 can include a projection that can be fitted into a slot of an opposing half. A second angled arm902 can include a slot that can receive a projection from the opposing half.

[0078] In one embodiment, the securement assembly can include a dock. In one embodiment, the cap can be coupled to the base via the dock. The dock can be positioned around the hole in the center of the base. In one embodiment, the dock can be the same material as the cap. The dock can be affixed to the base using an adhesive or an array of hooks or pins. For example, the base of the dock can include an array of hooks that can be inserted into holes in the base to secure the dock in place. Hooks, pins, or other structures in the base of the dock can be inserted into the array of holes to fix the dock to the base. In one embodiment, the array of hooks or other insertable structures can be arranged on the base and can be inserted into a corresponding array of holes in the base of the dock. In oneembodiment, the dock can be hot-pressed to the base or otherwise affixed to the base by a pressure and / or temperature-activated mechanism.

[0079] The dock can include one or more locking or guiding mechanisms for alignment and attachment of the cap. The shape and size of the dock can be approximately the shape and size of the bottom edge (base) of the cap. In one embodiment, the dock can include a pin or a set of pins for alignment with the cap. The pins can extend vertically upwards from the dock.The pins can be inserted into corresponding slots in the cap when the cap is placed on the dock. The pins can limit the translational movement of the cap once the cap is aligned on the dock. In one embodiment, the pins can form axes of rotation for the halves of the cap. In one embodiment, the dock can include one or more docking structures. The docking structure can be used to lock the cap and the dock together. The docking structure can include, for example, a sliding fit, a snap-fit joint, or a snap fastener. The slots can run along a bottom portion of the outer edge of the dock such that the top surface of the dock remains a continuous surface. In one embodiment, the dock can be assembled from two halves. For example, the dock can be assembled from two semi-circle halves that are fitted together to form the circular dock. The two halves can be secured together using an adhesive, or any of the fastening or locking mechanisms that have been described herein.

[0080] In one embodiment, each half of the cap can include a docking structure that can fit into a corresponding structure on the dock to lock the cap to the dock in a closed position. In one embodiment, the docking structure can be an overhanging piece that can be fitted into a slot in the dock. In one embodiment, the docking structure can be a snap-fit mechanism. A pushing force can be applied to the cap to slightly distort or deflect the overhang so that the overhang fits into the slot of the dock. The pushing force can be applied to the side of the cap in a lateral direction approximately parallel to the plane formed by the pad. The overhang is secured in the slot and will not move unless a similar force is applied in an opposite, outward(pulling) direction to slightly distort or deflect the overhang and remove the overhang from the slot In one embodiment, each half of the cap can include the docking structure. Each half can be locked to the dock independently.

[0081] In one embodiment, the cap can be directly attached to the dock via the docking structure. The docking structure on each half of the cap can be aligned with the corresponding structure on the dock and fitted into the dock to attach the cap to the dock. Each half of the cap can also be directly removed from the dock by removing the docking structure from the corresponding structure of the dock. In this manner, only a single step of translational motion is needed to attach and remove the cap rather than an alignment and fitting of the alignment structure followed by the locking of the cap to the dock. The translational motion can be approximately parallel to the base rather than a vertical motion needed to align the alignment structure of the cap to the pin of the dock. The single step can be advantageous for quicker attachment and removal of the cap.

[0082] The cap of a securement assembly for a medical catheter can be made using any plastic manufacturing method, including, but not limited to, 3D printing, injection molding, and casting. In one embodiment, the dock can be made using a similar plastic manufacturing method. In one embodiment, the inner wall of a cap can be coated with a biocompatible layer, such as biocompatible silicon, in case there is contact between the cap and human skin. In one embodiment, the base of the securement assembly can be a flexible material, as has been described herein. In one embodiment, the base of the securement assembly can be a rigid material, such as polylactic acid (PLA) or acrylonitrile butadiene styrene (ABS), with a layer of flexible, biocompatible material forming the bottom surface of the base. In one embodiment, the cap can be secured to the base via an adhesive.

[0083] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments.

[0084] Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination.Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

[0085] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Moreover, the separation of various system modules and components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single component or packaged into multiple components.

[0086] Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In some cases, multitasking and parallel processing may be advantageous.

[0087] Obviously, numerous modifications and variations are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, embodiments of the present disclosure may be practiced otherwise than as specifically described herein.

[0088] Embodiments of the present disclosure may also be as set forth in the following parentheticals.

[0089] (1) A securement assembly for a medical catheter inserted into an organ, comprising: an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a first channel extending through a first opening in the cap and a second channel extending through a second opening in the cap.

[0090] (2) The securement assembly of (1), wherein the cap further includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.

[0091] (3) The securement assembly of (1) to (2), wherein the locking structure includes an arm attached to the first or second half of the cap via a hinge forming an axis of rotation of the arm.

[0092] (4) The securement assembly of ( 1 ) to (3), wherein the first channel and the second channel are angled relative to each other.

[0093] (5) The securement assembly of (1) to (4), wherein the first channel is a vertical channel and the second channel is a horizontal channel.

[0094] (6) The securement assembly of (1) to (5), wherein an inner surface of the cap includes a silicon layer.

[0095] (7) The securement assembly of (1) to (6), wherein the first half and the opposing second half are identical.

[0096] (8) The securement assembly of (1) to (7), wherein the adhesive base is a biocompatible adhesive pad.

[0097] (9) The securement assembly of (1) to (8), wherein the adhesive base includes an absorbent layer.

[0098] (10) The securement assembly of (1) to (9), wherein an inner wall of the first channel or the second channel includes one or more protrusions extending from the inner wall into the first channel or the second channel.

[0099] (11) The securement assembly of (1) to (10), further comprising a dock coupled to the adhesive base, wherein the cap further includes a docking structure configured to couple to the dock.[000100] (12) A securement assembly for a medical catheter inserted into an organ, comprising an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a channel extending through at least one opening in the cap.[000101] (13) The securement assembly of (12), wherein the cap further includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.[000102] (14) The securement assembly of (12) to (13), wherein the locking structure includes an arm attached to the first or second half of the cap via a hinge forming an axis of rotation of the arm.[000103] (15) The securement assembly of (12) to (14), wherein the channel is a vertical channel or a horizontal channel.[000104] (16) The securement assembly of (12) to (15), further comprising a dock coupled to the adhesive base, wherein the cap further includes a docking structure configured to couple to the dock.[000105] (17) A securement assembly for a medical catheter inserted into an organ, comprising: an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cap includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.[000106] (18) The securement assembly of (17), wherein the locking structure includes an arm attached to the first half or the opposing second half of the cap via a hinge forming an axis of rotation.[000107] (19) The securement assembly of (17) to (18), wherein the cavity includes a channel extending through at least one opening in the cap.[000108] (20) The securement assembly of (17) to (19), wherein the channel is a vertical channel or a horizontal channel.[000109] Thus, the foregoing discussion discloses and describes merely exemplary embodiments of the present disclosure. As will be understood by those skilled in the art, the present disclosure may be embodied in other specific forms without departing from the spirit thereof. Accordingly, the disclosure of the present disclosure is intended to be illustrative, but not limiting of the scope of the disclosure, as well as other claims. The disclosure, including any readily discernible variants of the teachings herein, defines, in part, the scope of the foregoing claim terminology such that no inventive subject matter is dedicated to the public.

Claims

CLAIMS1. A securement assembly for a medical catheter inserted into an organ, comprising: an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a first channel extending through a first opening in the cap and a second channel extending through a second opening in the cap.

2. The securement assembly of claim 1 , wherein the cap further includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.

3. The securement assembly of claim 2, wherein the locking structure includes an arm attached to the first or second half of the cap via a hinge forming an axis of rotation of the arm.4, The securement assembly of claim 1, wherein the first channel and the second channel are angled relative to each other.

5. The securement assembly of claim 4, wherein the first channel is a vertical channel and the second channel is a horizontal channel.

6. The securement assembly of claim 1, wherein an inner surface of the cap includes a silicon layer.

7. The securement assembly of claim 1, wherein the first half and the opposing second half are identical.

8. The securement assembly of claim 1, wherein the adhesive base is a biocompatible adhesive pad.

9. The securement assembly of claim 1, wherein the adhesive base includes an absorbent layer.

10. The securement assembly of claim 1, wherein an inner wall of the first channel or the second channel includes one or more protrusions extending from the inner wall into the first channel or the second channel.1 L The securement assembly of claim 1, further comprising a dock coupled to the adhesive base, wherein the cap further includes a docking structure configured to couple to the dock.

12. A securement assembly for a medical catheter inserted into an organ, comprising: an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cavity includes a channel extending through at least one opening in the cap.

13. The securement assembly of claim 12, wherein the cap further includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.

14. The securement assembly of claim 13, wherein the locking structure includes an arm attached to the first or second half of the cap via a hinge forming an axis of rotation of the arm.

15. The securement assembly of claim 12, wherein the channel is a vertical channel or a horizontal channel.

16. The securement assembly of claim 12, further comprising a dock coupled to the adhesive base, wherein the cap further includes a docking structure configured to couple to the dock.

17. A securement assembly for a medical catheter inserted into an organ, comprising: an adhesive base having an opening; and a cap coupled to the adhesive base, wherein the cap includes a first half and an opposing second half, the first half and the opposing second half being removably coupled together to form a cavity between the cap and the opening in the adhesive base, and the cap includes a locking structure configured to secure the first half of the cap to the opposing second half of the cap.

18. The securement assembly of claim 17, wherein the locking structure includes an arm attached to the first half or the opposing second half of the cap via a hinge forming an axis of rotation.

19. The securement assembly of claim 17, wherein the cavity includes a channel extending through at least one opening in the cap.

20. The securement assembly of claim 19, wherein the channel is a vertical channel or a horizontal channel.

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