Wearable medical devices

Abstract

A wearable medical device and a catheter assembly are provided. In an exemplary embodiment, the catheter assembly comprises a catheter elbow and a catheter passing through the catheter elbow. The catheter comprises an external catheter portion on a first side of the catheter elbow and an internal catheter portion on a second side of the catheter elbow. The assembly further comprises a cuff covering a portion of the internal catheter portion extending from the catheter elbow, a delivery module connected to a pump and attached to one end of the catheter, and a retaining module holding the delivery module.

Description

Technical Field

[0001] The present disclosure relates to wearable medical devices.

Background Art

[0002] In the treatment of many diseases, there is a problem that drugs such as antibiotics, chemotherapeutic agents or other tumor therapeutic agents, and biotechnology preparations need to be administered locally or in the vicinity of the treatment target site regularly and safely for long-term treatment. One such drug delivery method is repeated continuous local administration by a clinician (e.g., subcutaneous injection, intramuscular injection, intra-articular injection, intravenous injection). Other methods include drug delivery via a reservoir / pump system, where delivery from the reservoir can be automated and the dosing frequency by the clinician can be reduced. Furthermore, for many diseases, better therapeutic effects can be obtained when the therapeutic agent is administered in a way that can achieve a specific concentration or level in the area of interest.

[0003] In many cases, medical drugs can pose a risk of harmful side effects to patients through systemic exposure. For example, the use of antibiotics for treating systemic joint infections such as PJI (periprosthetic joint infection), fracture-related infections, other implant-related infections, and / or other joint diseases can be cited. In current treatment standards, PJI patients are usually administered antibiotics such as vancomycin through a PICC (peripherally inserted central catheter) line with the intention of raising the serum concentration of the antibiotic to a level close to (but below) the safe AKI (acute kidney injury) limit value.

[0004] However, because joint infections reside within the synovial barrier of the joint capsule, a protective anatomical structure, the relative lack of local blood vessels inhibits the transfer of antibiotic concentrations from the bloodstream to the synovial fluid, which is necessary to directly treat the infection. As a result, even achieving low concentrations within the joint capsule can expose the patient to high systemic concentrations, which can contribute to other side effects. On the other hand, at the site of infection, only concentrations low enough to be therapeutically effective can be achieved. Exposure at ineffective levels is considered a major cause of antibiotic resistance development. Without a means to directly apply antibiotics to bacterial infections within the joint capsule, indirect systemic treatment is not optimal and may even be counterproductive.

[0005] Polymer implants, osmotic pumps, and diffusion reservoirs can provide a stable, albeit decaying, drug release rate over a period of time; however, some medical drugs are more effective when administered at intervals or as bolus doses over time. Implantable electromechanical infusion pumps can be programmed to deliver drugs at a constant and specific dosage, delivery rate, and interval. These implantable electromechanical infusion pumps are surgically placed and typically removed at the end of treatment or when the pump reaches the end of its lifespan and requires replacement. Due to their complexity, these pumps are expensive and therefore not economically viable for certain applications, such as PJI treatment. Furthermore, their complexity increases the likelihood of device failure, potentially requiring patient injury and / or more frequent surgical removal and replacement.

[0006] Another commonly used method of drug administration is port-a-cass, where a catheter is surgically inserted into the synovial space and left implanted for the duration of treatment. A septum is then placed under the skin to facilitate access to the internal catheter for the injection or drainage of medication or bodily fluids. However, existing port-a-cass systems have limitations in the devices that can be connected (i.e., generally, port-a-cass systems only provide access for nurses to insert needles or other related devices).

[0007] Surgically inserted catheter systems are often more economical than implantable pumps. However, patients often have tubes hanging down from their skin, which can be not only inconvenient but also dangerous. Furthermore, because the catheter is exposed outside the body and not secured, it can move or be moved, which can further enlarge or irritate the puncture site and increase the risk of infection. In addition, if the catheter gets caught on something or becomes entangled, the entire catheter may become dislodged, potentially leading to disastrous consequences for the patient. [Overview of the Initiative]

[0008] A wearable medical device and a catheter assembly can be provided. In one embodiment, the catheter assembly may comprise a catheter elbow and a catheter passing through the catheter elbow, the catheter having an external catheter portion on a first side of the catheter elbow and an internal catheter portion on a second side of the catheter elbow. The assembly may further comprise a cuff covering a portion of the internal catheter portion extending from the catheter elbow, a delivery module connected to a pump and attached to one end of the catheter, and a holding module for holding the delivery module. [Brief explanation of the drawing]

[0009] The advantages of the embodiments of the present invention will become apparent from the following detailed description of the embodiments. The following detailed description should be considered in conjunction with the accompanying drawings.

[0010] [Figure 1] This figure shows one embodiment of a wearable medical device and catheter assembly. [Figure 2] This figure shows one embodiment of a method for using a wearable medical device and catheter assembly. [Figure 3] This figure shows one embodiment of a catheter assembly. [Figure 4A] This figure shows an exemplary catheter assembly comprising a storage module and an extended catheter. [Figure 4B] This figure shows an exemplary catheter assembly comprising a storage module and a retracted catheter. [Figure 5A] This figure shows one embodiment of a catheter elbow. [Figure 5B] This figure shows one embodiment of a catheter elbow equipped with a retaining ring. [Figure 6] This figure shows one embodiment of a catheter assembly connected to a wearable medical device. [Figure 7] This figure shows one embodiment of a method for using a catheter assembly and a wearable medical device. [Figure 8A] This figure shows another embodiment of the catheter assembly. [Figure 8B] This is a view of another embodiment of the catheter assembly from a different direction. [Modes for carrying out the invention]

[0011] Aspects of the present invention are disclosed in the following description and related drawings relating to specific embodiments of the present invention. Other embodiments can be devised without departing from the spirit or scope of the present invention. Furthermore, detailed descriptions of well-known components of exemplary embodiments of the present invention are omitted or omitted so as not to obscure the relevant details of the present invention. Furthermore, some terms used herein are explained below to facilitate understanding of this specification.

[0012] In this specification, the term “exemplary” means “serving as an example, case, or illustration.” The embodiments described herein are not limiting but merely illustrative. It should be understood that the embodiments described should not be construed as necessarily preferable or advantageous to other embodiments. Furthermore, the terms “embodiment of the invention,” “embodiment,” or “invention” do not require that all embodiments of the invention include the discussed features, advantages, or modes of operation. It should be understood that some of the embodiments and methods described may be implemented in the context of any other embodiment or method.

[0013] In one or more exemplary embodiments, a wearable medical device may be provided.

[0014] In one exemplary embodiment, this wearable assembly may be used, for example, in the treatment of peri-prosthetic joint infection (PJI). The wearable assembly comprises a fluid delivery mechanism, which is attached to a subcutaneous septum. This subcutaneous septum is located inside the patient's skin and is attached to a base connector, which may be located on the outer surface of the patient's skin. The base connector is further connected to pump hardware, such as an infusion pump. In some embodiments, the infusion pump may accept a fluid cartridge. The fluid cartridge may be filled with a combination of fluids, such as an antibiotic, a saline flush, another fluid with clinical merit, or a mixture of saline and an antibiotic.

[0015] This describes one exemplary use of a wearable medical device and catheter assembly. In the first step, the fluid delivery mechanism and subcutaneous septum are implanted in the patient. This implantation may be performed during surgery, for example, during a surgical procedure such as lavage or revision for joint infection. In the next step, the subcutaneous septum, located inside the patient's skin, is connected to a base connector located outside the patient's skin. In the next step, the pump hardware is connected to the base connector and worn by the patient. In the next step, the fluid cartridge is connected to the pump hardware. In the next step, the pump hardware is activated and the fluid from the fluid cartridge is delivered to the treatment site through the fluid delivery mechanism. In the next step, when the entire dose has been delivered, i.e., when the fluid cartridge is empty, when a predetermined amount of fluid has been delivered, and / or when a predetermined time has elapsed, the pump hardware is detached from the base connector and stored. In some embodiments, these steps may be repeated regularly, for example, once a day or every other day, until the treatment is completed. In the final step, the treatment is completed, and for example, the fluid delivery mechanism may be removed.

[0016] Referring to Figure 1, an exemplary wearable medical device and catheter assembly 100 is shown. In one exemplary embodiment, the wearable assembly 100 is used, for example, to treat peri-arthritis of a prosthesis (PJI). The wearable assembly 100 comprises a fluid delivery mechanism 102, which is a catheter equipped with, for example, a balloon and a catheter tip capable of injecting fluid into, for example, an infected joint or other part of the body. The fluid delivery mechanism 102 is attached to a subcutaneous septum 104. The subcutaneous septum 104 is located inside the patient's skin and is attached to a base connector 106 located on the outer surface of the patient's skin. The base connector 106 may further comprise a cannula or other means that allows for the transfer of fluid between the base connector 106 and the subcutaneous septum 104. The base connector 106 is then further connected to pump hardware 108, such as, for example, an infusion pump, a vibratory pump, or a plunger. In some embodiments, the infusion pump may accept a fluid cartridge 110, and in other embodiments, the pump may accept drugs or fluids from different sources. The fluid cartridge 110 is filled with a combination of fluids, such as antibiotics, saline flush, different fluids with clinical benefits, or a mixture of saline and antibiotics.

[0017] Referring to Figure 2, one exemplary method of using the wearable medical device and catheter assembly 200 is shown. In the first step 202, the fluid delivery mechanism 102 and subcutaneous septum 104 are implanted in the patient. This implantation is performed during surgery, for example, during a surgical procedure such as a lavage or revision procedure for joint infection. In the next step 204, the subcutaneous septum 104, which is located inside the patient's skin, is connected to a base connector 106, which is located outside the patient's skin. In the next step 206, the pump hardware 108 is connected to the base connector 106 and worn by the patient. In the next step 208, the fluid cartridge 110 is connected to the pump hardware 108. In the next step 210, the pump hardware 108 is activated and fluid from the fluid cartridge 110 is injected into the patient. In the next step 212, when the pump operation ends, such as when the fluid cartridge 110 is empty, when a predetermined amount of fluid has been delivered, and / or when a specified time has elapsed, the pump hardware 108 is removed from the base connector and stored. In some embodiments, steps 206 to 212 may be repeated regularly, for example, once a day or every other day, until the treatment is completed. In the final step 214, the treatment is completed. The treatment may be completed after a predetermined period, for example, six weeks or two months, or after the initial problem, for example, PJI, has healed or been sufficiently treated. In some embodiments, an examination may be performed after a predetermined period to determine whether further treatment is necessary. It may be understood that after treatment, additional surgery may be performed to remove the fluid delivery mechanism 102 and the subcutaneous septum 104.

[0018] Next, a specific example of the fluid delivery mechanism 102 will be described in more detail. The fluid delivery mechanism 102 is a catheter, such as a port-a-cas, and is equipped with a subcutaneous septum 104. The fluid delivery mechanism may have a special tip for supplying fluid, such as a balloon tip or an open tip. Furthermore, the catheter tube may have a rigid tube or tip, such as a trocar tip, to facilitate the placement of the catheter tube. The rigid tip or tube is easier to place because it does not deform as easily as the catheter tube. These are used exclusively for placement and may be removed after the catheter has been inserted into the desired position. In other embodiments, a guidewire may be used to place the catheter. The guidewire (different from the rigid tube of the catheter tip) may not be connected to the catheter. The guidewire may first be inserted into the desired position, and then the catheter may be placed on the guidewire and pushed through. A more flexible catheter tube deforms and bends along the path of the guidewire. After the catheter has been placed into the desired position, the guidewire is removed. The fluid delivery mechanism 102 and the subcutaneous septum 104 may be specifically configured to connect to certain hardware, such as a base connector 106. In some embodiments, the subcutaneous septum 104 may include means for positioning and securing the fluid delivery mechanism 102, such as a magnet. In some embodiments, the fluid delivery mechanism 102 may be fixed to the patient's tissue so that the base connector 106 and the pump mechanism 108 are supported by the fluid delivery mechanism 102 when fitted by the patient. The fluid delivery mechanism 102 is directed to a specific area requiring treatment, such as an infected joint in the case of PJI treatment. The tip may need to be fixed to the treatment site, for example, a balloon tip may be used to ensure that the delivery tip is properly fixed to the joint requiring treatment. In some embodiments, the fluid delivery mechanism 102 may have an adjustable length, for example, by being cut to a specific size before and / or during surgery.In some cases, the fluid delivery mechanism 102 may not be disposed throughout the patient's body, and a hybrid system is envisioned where a portion of the mechanism is disposed subcutaneously and another portion of the mechanism penetrates the skin and is connected directly or indirectly to the pump hardware 108.

[0019] Next, the exemplary base connector 106 will be described in more detail. The base connector 106 is inserted or connected to the subcutaneous septum 104 after a surgical procedure in which the subcutaneous septum 104 is implanted. In one embodiment, the base connector 106 may be a pressure-sensitive adhesive disposed on the skin side of a flexible disk or membrane, and may be further covered by a protective member. To apply the base connector 106, the flexible disk or membrane is pulled back and the protective member is removed to expose a small-diameter needle or other connector. Thus, the small-diameter needle or other connector is connected to the subcutaneous septum 104, and the flexible disk or membrane may be adhered to the patient's skin via the pressure-sensitive adhesive. In some embodiments, the connector may be a cannula with a luer lock fitting for connecting to the pump.

[0020] In some embodiments, the base connector 106 may need to be replaced periodically, e.g., weekly, daily, every three days, etc. The replacement may be performed by the patient or a clinician depending on the details of the treatment being performed. The base connector 106 may have a guiding function that assists in connecting the base connector 106 to the subcutaneous septum 104. For example, the subcutaneous septum 104 has a conical shape with a flat end that is not pointed, and once implanted, forms a slight conical protrusion on the patient's skin. The base connector 106 may be provided with an equivalent recess that matches the protrusion on the patient's skin, making it easier to visually identify the installation position of the base connector 106 and useful for the actual installation operation. In this embodiment, the needle is arranged along the periphery rather than at the center of the base connector, thereby avoiding repeated punctures at the same location on the skin and thus being more comfortable and less invasive for the patient in the long term. Each time the base connector 106 is replaced, it may be possible to change the puncture position by slightly rotating it.

[0021] In an exemplary embodiment, the base connector 106 may be directly integrated into the pump mechanism 108 and may be worn and removed each time the pump is used. In some cases, the probability of infection occurrence may be reduced. [[ID=*5]] [[ID=*6]]

[0022] [[ID=*7]] Next, an exemplary pump mechanism 108 will be described in more detail. In some embodiments, the pump mechanism 108 may be snap-connected or matable to the base connector 106. For example, snaps or fasteners may be used to guide the connection, and in some embodiments, buttons may be used to disconnect after fluid delivery is complete. In other embodiments, the pump mechanism 108 may be magnetically connected and coupled to the base connector 106 by, for example, providing a hole in one component and a short magnetic pin corresponding to the hole in the other component. The magnetic strength should be sufficient to ensure a secure connection without causing excessive stress on the fluid delivery mechanism 102. In yet another embodiment, other connection methods known to those skilled in the art may be used, or, for example, a mechanical interface combined with magnetic coupling may be used. In an exemplary embodiment, the fluid delivery mechanism may be partially exposed outside the skin and directly connected to the pump mechanism, for example, through a Luer lock fitting, and the base connector 106 may be unnecessary.

[0023] In some embodiments, the pump mechanism 108 may be connected to the base connector 106 before it is attached to the subcutaneous septum 104. The connection to the pump mechanism 108 enables the base connector 106 to receive power, activating the electronic induction function of the pump mechanism 108 to assist in connecting the base connector 106 to the subcutaneous septum 104. The electronic induction function includes, for example, multiple feedback signals and scanning functions. In an exemplary embodiment, the pump mechanism 108 includes, for example, a display. The display shows, for example, the position of the subcutaneous septum 104 and alerts the user through audible, visual, and / or tactile notifications when the needle from the base connector is aligned.

[0024] The pump mechanism 108 may further include information related to, for example, the progress of fluid delivery, battery status information, and related sensor information.

[0025] Next, an exemplary fluid cartridge 110 will be described in more detail. In some embodiments, a dual reservoir cartridge may be used. The pump mechanism 108 may be configured to supply from the dual reservoir cartridge, for example, by supplying sequentially from each reservoir. Each reservoir may contain a different fluid or a mixture of fluids; for example, one may contain an antibiotic or other drug, and the other may contain saline or a saline mixture. The reservoirs may also be of different sizes; for example, the saline reservoir may be 5 to 10 ml while the drug reservoir is 3 to 5 ml, or in other embodiments they may be the same size.

[0026] In other embodiments, a single reservoir may be used, and if it is necessary to inject multiple fluids, the entire fluid cartridge 110 may be replaced with a new fluid cartridge 110 containing a second fluid. In some embodiments, a single fluid may be injected via a pump mechanism, while at the same time, a saline flush or other cleaning method may be used, for example, by applying a pre-filled syringe directly to the base connector 106.

[0027] In one embodiment, the fluid cartridge 110 may have one or more syringe-type reservoirs, which may be driven, for example, by an electric reed screw to move the plunger of the syringe. In other embodiments, the plunger may instead be driven, for example, by a compression spring. If there are two or more reservoirs, each reservoir may require its own drive mechanism. In different embodiments, an elastomer container having a single outlet with a check valve that allows only the discharge of fluid may be used. Pumping from the elastomer container is performed, for example, by vibrating the container, thereby forcibly opening the check valve to discharge some or all of the fluid, and after the vibration ends, the check valve closes to prevent the fluid from re-inflowing. In other embodiments, other methods known to those skilled in the art, such as bellows, may be used to discharge the fluid.

[0028] In some embodiments, the amount of fluid injected into the patient may be controlled by the amount of fluid contained in the fluid cartridge 110. This simplifies operation for the user, and adjustments may be made by changing to fluid cartridges 110 of different sizes or types.

[0029] In some embodiments, the fluid pathway from the fluid cartridge 110 to the treatment site may be sterile at each use, meaning that with each new cartridge, the formulation does not come into contact with any of the pump's reusable components. This connection is assisted by ensuring that the fluid cartridge 110 is in close contact with the pump mechanism 108. In some embodiments, sterility may be ensured by the fluid cartridge 110 having a short catheter line with a Luer lock or similar feature that allows connection to the base connector 106. This pathway can also be used as a backup, for example, if the connection between the cannula and the fluid delivery mechanism 102 is deemed too fragile.

[0030] In some embodiments of antibiotic use, antibiotics may be stored as lyophilized powder because they have a relatively short shelf life when reconstituted in aqueous solution. In such cases, the fluid cartridge 110 comprises multiple chambers and membranes / barriers between the chambers. In some embodiments, one or more chambers contain the powder, one or more other chambers contain the diluent, and the barriers are rupturable by the patient or a nurse / other healthcare worker. This allows the powder to be mixed with the diluent to produce a pharmaceutical fluid.

[0031] In another embodiment, two separate syringes may be connected via a manually operated valve, with the first syringe containing the powder and the second syringe containing the diluent. The syringe containing the powder has sufficient extra space to contain the resulting mixture of the powder and the diluent, and mixing is initiated by a patient or other person manually opening the valve between the two syringes, which may then be inserted, for example, into a fluid cartridge 110.

[0032] In exemplary embodiments, a liquid-tight connection may be required between a reservoir or a plurality of reservoirs and a base connector. In exemplary embodiments, this connection may be formed, for example, using a Luer lock. In other embodiments, the connector may be a rigid tube protruding from the fluid cartridge 110, for example, the reservoir may be connected to a cylinder made of soft elastomer having an axially penetrating hole, the diameter of which is slightly larger than the diameter of the surrounding sealing tube. In this embodiment, since the entire surface of the soft elastomer cylinder except the inner diameter is constrained, when a compressive force is applied along the cylindrical axis, the material can expand toward the unconstrained inner diameter side. When the rigid tube is placed in the inner bore of the soft elastomer cylinder before pressure is applied, the inner diameter of the cylinder shrinks, clamping the outer wall of the rigid tube. This allows the tube from the container to be liquid-tightly connected to the tube on the rear side of the pump mechanism 108.

[0033] Referring to Figure 3, an exemplary catheter assembly 300 is shown. The catheter 300 allows for the delivery of drugs, saline solution, and / or other clinically beneficial fluids to a patient's treatment site, e.g., an infected joint cavity. The catheter 300 has a catheter tube 302, the portion of which is inserted into the patient's body during use, and the portion which is placed outside the patient's body. This implantation is performed during surgery, e.g., during surgical procedures for joint infections, such as lavage or revision procedures. The catheter tube 302 is a continuous flexible tube and may be made of, for example, a flexible polymer, silicone, polyvinyl chloride (PVC), pellatan (TPU), isoplast (ETPU), polypropylene, etc. In some embodiments, the length of the catheter tube 302 is adjustable, e.g., by cutting the catheter tube 302. In some embodiments, the tip of the catheter tube 302 may have a special tip for delivering fluid to a specific location, e.g., a balloon tip may be used to hold the catheter tube 302 in place within the synovial cavity. In other embodiments, a different tip, such as an open tip, may be used with or without the balloon tip, or the catheter tube may have a rigid tube or a tip attached thereto, such as a trocar tip to facilitate the placement of the catheter tube. The rigid tube is easier to place because it is less deformable than the catheter tube (i.e., it may be used only for placement and removed after the catheter has been inserted into the desired position). In other embodiments, a guidewire may be used to place the catheter. The guidewire may not be connected to the catheter (unlike the rigid tube at the catheter tip). The guidewire may be inserted first into the desired position, and then the catheter may be placed on the guidewire and pushed through. A softer catheter tube will deform and bend along the path of the guidewire. Once the catheter is in the desired position, the guidewire is removed.

[0034] The catheter 300 may include a catheter cuff 304 positioned around the area where at least the catheter tube 302 exits the patient's body. The catheter cuff 304 may be made of a material that promotes wound healing of the skin and subcutaneous soft tissue, and / or may include an adhesive member that promotes skin closure around the cuff 304, thereby reducing the risk of infection at the skin / catheter interface. The cuff 304 may be made of a material that includes, but is not limited to, polyester materials such as Dacron, and / or metal mesh materials such as titanium or stainless steel, and in exemplary embodiments, it may be a woven or braided sleeve. In other embodiments, the cuff 304 may be a polymer extruded product that promotes healing and adhesion.

[0035] The catheter may have a catheter elbow 306. The catheter elbow 306 allows the catheter tube 302 to exit the patient's body at a predetermined angle, for example, the catheter tube may be set to exit the patient's body at a 90° angle, thereby maintaining the low profile of the catheter 300 and reducing the possibility of the catheter tube 302 getting caught on external objects. Since kinking can reduce the fluid transport capacity of the catheter tube 302, the catheter elbow 306 further contributes to preventing kinking of the catheter tube 302 due to sharp bends. The catheter elbow 306 also increases the exposed area of ​​the cuff 304, thereby allowing for wider wiping, cleaning, and easier application of disinfectants and ointments. In exemplary embodiments, the catheter elbow 306 may have one or more suture points applied when the catheter 300 is implanted in order to secure the catheter 300 to the patient's skin. The catheter elbow 306 may be designed to be separable so as to be easily removed from the catheter 300, thereby facilitating the removal of the implanted portion of the catheter 300 at the end of the patient's treatment. For example, in exemplary embodiments, a tool may be used to separate and remove the catheter elbow 306, and then a coring tool may be used to incise the skin and soft tissue around the portion of the catheter tube 302 that is exposed outside the patient's body, thereby removing the catheter 300 from the patient. In some embodiments, the catheter tube 302 may be cut so as to secure the coring tool on the catheter tube 302 during the removal process.

[0036] The catheter may be fixed to a catheter tube 302 and may include a catheter tube collar 308 provided in the external region of the catheter tube 302. The catheter 300 may further include a connector assembly 310, which may connect the catheter tube 302 to, for example, a pump or syringe. The connector assembly 310 may be provided at the external end of the catheter 300 and may connect the catheter 300 to a pump, cartridge, or other mechanism and provide means for capping the catheter 300 when it is not in use. In some embodiments, the connector assembly 310 may include a check valve, which allows fluid to flow only into the catheter 300 and prevents backflow to the pump, and helps reduce fluid loss, for example, if a patient forgets to cap the catheter 300 after use. In exemplary embodiments, the connector assembly 310 may include, for example, a Luer lock with a cap. The cap may include a magnet that enables a secure connection between the cap and other components, for example, a storage module. In some embodiments, the cap may be connected to the connector assembly by a string or the like to prevent loss of the cap. In other exemplary embodiments, different methods for forming a liquid-tight connection between the catheter 300 and the pump or other device may be used, such as an O-ring seal, a connection between the needle and the septum, any other method known to those skilled in the art, or a combination thereof.

[0037] In exemplary embodiments, the connector assembly 310 may have one or more of the following features: means for reducing fluid loss from the catheter 300 when not connected to a pump or other device; a cap that provides visual or tactile feedback when fitted; a liquid-tight seal between the catheter 300 and the pump or other device; and easy connection and disconnection of the pump or other device to the catheter 300.

[0038] Referring to Figures 4A and 4B, exemplary catheter assemblies comprising a storage module and an extension catheter 400, and exemplary catheter assemblies comprising a storage module and a retraction catheter 450, are shown. The assembly 400 may include an adhesive patch 402 that is attached to the patient's skin and holds, for example, the storage module 404. In some embodiments, the adhesive patch 402 may be replaceable if the adhesive weakens or if the patch 402 becomes unclean or soiled. For example, the patch may be replaced every 3 to 5 days or once a week, and in some further embodiments, the application site may be changed each time the patch is replaced to help reduce skin irritation. In one embodiment, the adhesive patch 402 is a pressure-sensitive adhesive disposed on a flexible disc and may be covered with a protective member. In this embodiment, the storage module 404 may be attached by removing the protective member and applying pressure to adhere the adhesive patch 402 to the patient's skin. The storage module 404 can be attached to the adhesive patch 402, for example, via a snap, magnetic coupling, bayonet connection, and / or hook-and-loop fastener. In other embodiments, the storage module 404 may be secured to the patient's arm or leg, for example, via hook-and-loop fasteners. Once the storage module 404 is secured, the patient or another individual may engage the catheter tube collar 308 with the storage module 404. This may secure the catheter tube 302 to the storage module 404 and reduce stress and movement of the catheter tube 302 at the skin puncture site.

[0039] The storage module 404 may be a housing that stores the external portion of the catheter tube 302 when not in use. In exemplary embodiments, the storage module 404 may be a passive member without moving parts, and in other embodiments, the storage module 404 may have active members that implement various functions. For example, the storage module 404 may have a mechanism to forcibly pull back the catheter tube 302, or it may have a hinged lid. This allows the entire external portion of the catheter tube 302 and connector assembly 310 to be stored within the storage module 404, reducing the risk of accidental snagging. In some embodiments, the storage module 404 may have rounded edges, thereby reducing snagging of the storage module 404 itself. The storage module may be attached to the patient's skin before, during, or after the implantation of the catheter 300.

[0040] Furthermore, the storage module may be connected to the catheter tube collar 308, and in an exemplary embodiment, the catheter tube 302 may be removed from the storage module 404 by disengaging the catheter tube collar 308.

[0041] Referring to Figures 5A and 5B, an exemplary two-part catheter elbow 500 and a catheter elbow with an exemplary retaining ring 550 are shown. In exemplary embodiments, the catheter elbow 500 may consist of two halves. The first half 502 has a pin 504 protruding therefrom, the pin 504 corresponding to a hole 508 at a corresponding position in the second half 506, and the two halves may be joined together when aligned and pressure is applied. When assembled, the catheter elbow 500 may have a small upper groove 510, which may allow the catheter elbow 500 to be separated into two halves again using a tool, such as a flathead screwdriver. In some embodiments, the two halves may instead have a hole 508 and be fastened using, for example, self-tapping screws and / or bolts and nuts. Furthermore, one of the holes may be threaded and fastened only by bolts. In other embodiments, the two halves may instead be joined using, for example, self-tapping screws, bolts and nuts, bolts and threaded holes, or adhesives such as glue or solvent adhesives. In yet another embodiment, a retaining ring 552 may be used to join the two halves. The retaining ring 552 may be, but is not limited to, a processed metal, an extruded product of a metal or other material, or an injection-molded polymer. In some embodiments, the retaining ring 552 may be cut with an oblique cutter to separate the two halves. In some embodiments, instead of a retaining ring, the two halves may be joined together with adhesive or glue.

[0042] Figures 6 and 7 provide an overview, illustrating exemplary embodiments of a wearable medical device and a method of using the wearable medical device in which the catheter described above may be implemented. It is understood that the catheter described above may be implemented in other embodiments and / or other medical devices, and the following is merely an illustrative description.

[0043] Referring to Figure 6, an exemplary catheter assembly connected to a wearable medical device 600 is shown. In an exemplary embodiment, the catheter assembly 600 may be used, for example, to treat peri-arthritis of a prosthetic joint (PJI). The catheter assembly 600 may include, for example, a fluid delivery mechanism 602, which is a balloon and a catheter tip, that can inject fluid through the catheter into, for example, an infected joint or other part of the body. The catheter tip may be positioned at the desired delivery site by, for example, a trocar or guidewire that can be removed after the catheter tip has been properly positioned. The fluid delivery mechanism 602 may be attached to a housing mechanism 604 on the outside of the patient's skin. The housing mechanism 604 may be capable of accommodating the portion of the fluid delivery mechanism 602 that is exposed on the outside of the patient's skin when the fluid delivery mechanism 602 is not in use. The housing mechanism may be attached to the patient's skin by, for example, an adhesive patch 606.

[0044] A base connector 608 may be located at the end of the fluid delivery mechanism 602. This base connector 608 may be further connected to pump hardware 610, such as an infusion pump. In some embodiments, the pump hardware 610 may be capable of receiving a fluid cartridge 612, and in other embodiments, the pump may receive drugs or fluids from different sources, such as syringes. The fluid cartridge 612 may be filled with a combination of fluids, such as antibiotics, saline flushes, different fluids with clinical merit, or a mixture of saline and antibiotics.

[0045] Referring to Figure 7, an embodiment of a method for using the catheter assembly and wearable medical device 700 is shown. In the first step 702, the catheter assembly 600 is implanted in the patient and sutured to the surface. In the next step 704, the portion of the fluid delivery mechanism 602 that is outside the patient's skin is housed in the storage module 604 upon implantation. In the next step 706, the fluid cartridge 612 may be connected to the pump hardware 610 when the patient requires administration. In the next step 708, the pump hardware 610 is connected to the catheter assembly 600 via the base connector 608, and the pump hardware 610 is worn by the patient during fluid delivery. In the next step 710, the pump hardware 610 is activated, and fluid from the fluid cartridge 612 is delivered to the treatment site through the fluid delivery mechanism 602. In the next step 712, when the pump operation is complete (i.e., when the fluid cartridge 612 is empty, when a predetermined amount of fluid has been delivered, and / or when a specified time has elapsed), the pump hardware 610 is detached from the base connector and stored. In some embodiments, steps 706 to 712 may be repeated periodically (e.g., once a day or every other day) until the treatment is completed. In the final step 714, the treatment is terminated, for example, after a predetermined period (e.g., 6 weeks, 2 months) has elapsed after the completion of the entire course of treatment, or after the initial problem (e.g., PJI) has healed or been sufficiently treated. In some embodiments, an examination may be performed after a predetermined period to determine whether treatment should be continued. It may be understood that after treatment, additional surgery may be performed to remove the catheter system 600.

[0046] Referring to Figures 8A and 8B, alternative catheter assemblies in the deployed position 800 and the locked position 850 according to one embodiment are shown and described. The catheter assembly 800 may comprise an indwelling catheter 802 that is implanted in the patient and leads, for example, to an infected joint cavity. When in use, it can be understood that the indwelling catheter 802 is positioned inside the patient's body. The indwelling catheter 802 may be connected to the first side of a catheter elbow 804. The catheter elbow 804 can be understood to be located on the surface of the patient's skin. The catheter elbow 804 may further be connected to a cuff 806 that covers a portion of the indwelling catheter 802. For example, the length of the cuff 806 is about 15 to 30 mm. The cuff 806 can be understood to be capable of allowing tissue intrusion. The second side of the catheter elbow 804 may further be connected to an external catheter portion 808 that leads to a delivery module 810. In some embodiments, the indwelling catheter 802 and the external catheter portion 808 may be two parts of the same catheter component that continuously penetrate the catheter elbow 804. On the other hand, in other embodiments, the indwelling catheter 802 and the external catheter portion 808 may be separate catheters that are fluid-tightly connected to both sides of the catheter elbow 804, for example by being bonded. The delivery module 810 may include, for example, a cap 812 to protect the site when not in use, and an infusion line connector, which in one embodiment is a Luer lock connector. In some embodiments, the cap 812 may include a magnet and / or a locking screw to secure the cap 812 to the retaining module 814. The delivery module 810 is held in the retaining module 814, which may be held in place by the patient by an adhesive patch 816, which is, for example, a pressure-sensitive adhesive patch. The retaining module 814 may be attached to the adhesive patch 816, for example, via a hook-and-loop fastener pad or patch. In some embodiments, the cap 812 may be secured to the retaining module 814 with a string to prevent loss.

[0047] In some embodiments, the indwelling catheter 802 and the external catheter portion 808 may be a single catheter that extends from the patient's body to the outside via a catheter elbow 804. In one embodiment, the catheter may be a continuous flexible tube having a diameter of about 1.0 to 3.0 mm. The cuff 806 may be formed from a material that provides adhesion to promote skin healing and enhance the closure of the surrounding skin, thereby reducing the risk of infection. In some embodiments, the cuff 806 may be formed from, but is not limited to, polyester materials such as Dacron, and / or metal mesh materials such as titanium or stainless steel. In other embodiments, the cuff 806 may instead be a polymer extruded product.

[0048] The catheter elbow 804 ensures that the catheter bends sharply out of the body, thereby preventing accidental snagging or kinking of the catheter. The catheter elbow 804 may also be configured to maximize the exposed area of ​​the cuff 806, which facilitates cleaning and disinfection of the cuff 806. The catheter elbow 804 may also have two or more suture points for fixation to the skin during catheter implantation. It may also be designed to be separable and easily removed from the catheter to facilitate removal at the end of treatment. After the catheter elbow 804 has been removed, it will be understood that the catheter assembly 800 can be completely removed by using a coring tool to incise the skin and soft tissue around the cuff 806 and position it on the catheter tube.

[0049] Furthermore, the delivery module 810 may be equipped with a check valve to prevent backflow of fluid. This check valve reduces the leakage of medication, saline solution, or body fluids from the patient through the infusion line connector when connecting, disconnecting, or not using the infusion line. In some embodiments, the delivery module 810 may have an operating position 820 and a storage position 860. In the storage position 860, the delivery module 810 is folded and secured within the retaining module 814, thereby reducing the contour of the delivery module 810 when not in use and preventing snagging or entanglement.

[0050] The retention module 814 reduces fluid loss from the catheter when the infusion line is not connected, for example, through a cap 812, a check valve, or both. In some embodiments, the cap 812 may provide visual or tactile feedback when properly fitted, for example, by using a magnet. The retention module 814 may further secure a portion of the external catheter section 808 at a position several centimeters away from the pivot point or catheter elbow 804. This provides tension relief and, in combination with suturing to the skin, can provide tension relief as the catheter enters the body.

[0051] It can be understood that the catheter assembly 800 is connected to an external pump and can be used for treatment of areas within the patient's body. Examples include lavage procedures, such as cleaning infected joints that do not require removal of artificial joints, or replacement procedures, such as cleaning, removal, and replacement of artificial joints. It can be understood that the connections between the catheter, infusion line, and external structure (such as the pump) are liquid-tight.

[0052] In some embodiments, the systems and methods described above may be used for the treatment of PJI. In other embodiments, it may be understood that the systems and methods may be additionally used for the treatment of the following: other orthopedic infection conditions (e.g., osteomyelitis, septic arthritis, fracture-associated infections), surgical site infections, other implant-associated infections, and / or other joint diseases.

[0053] The above description and accompanying drawings illustrate the principles, preferred embodiments, and operating modes of the present invention. However, the present invention should not be construed as being limited to the specific embodiments discussed above. Additional modifications of the embodiments discussed above will be understood by those skilled in the art.

[0054] Therefore, the above embodiments should be considered illustrative and not restrictive. Accordingly, those skilled in the art should understand that modifications to these embodiments are possible without departing from the scope of the invention as defined in the following claims.

Claims

1. Catheter elbow and, A catheter extending through the catheter elbow, having an external catheter portion on the first side of the catheter elbow and an internal catheter portion on the second side of the catheter elbow, A cuff covering a portion of the internal catheter portion extending from the catheter elbow, A delivery module is attached to one end of the catheter and configured to connect to a pump, A catheter assembly comprising a retaining module configured to hold the catheter.

2. The invention further includes an adhesive patch configured to adhere to the patient's skin, The catheter assembly according to claim 1, wherein the retaining module is attached to the adhesive patch via one or more hook-and-loop fastener pads.

3. The catheter elbow, The first catheter elbow component, A second catheter elbow component is included, The catheter assembly according to claim 1, wherein the first catheter elbow component and the second catheter elbow component are combined in such a way that the catheter can be passed through the catheter elbow.

4. The first catheter elbow component further comprises a pin, and the second catheter elbow component further comprises a hole. The catheter assembly according to claim 3, wherein the pin is configured to engage with the hole so that the first catheter elbow component and the second catheter elbow component are coupled to each other.

5. The catheter assembly according to claim 3, wherein the first catheter elbow component further comprises a pin, and the second catheter elbow component is joined via a retaining ring or adhesive.

6. The catheter assembly according to claim 3, wherein the catheter elbow is provided with a groove that allows the catheter elbow to be separated into the first catheter elbow component and the second catheter elbow component using a tool.

7. The catheter assembly according to claim 3, wherein the catheter elbow has two or more suture points for securing the catheter elbow to the patient's skin.

8. The delivery module is configured to be connectable to the pump via a Luer lock, The catheter assembly according to claim 1, wherein the pump is configured to deliver a drug and / or a saline solution through the catheter via the delivery module.

9. Furthermore, an infusion line connecting the pump and the external catheter section, The catheter assembly according to claim 8, further comprising a cap that covers the delivery module when the delivery module is not connected to the pump.

10. The catheter assembly according to claim 9, wherein the cap provides tactile and auditory feedback when fixed to the delivery module.

11. The catheter assembly according to claim 10, wherein the cap is equipped with a magnet.

12. The catheter assembly according to claim 9, wherein the delivery module further comprises a check valve for preventing backflow through the catheter.

13. The catheter assembly according to claim 9, wherein the infusion line forms a liquid-tight connection between the pump and the catheter.

14. The catheter assembly according to claim 8, wherein the delivery module can switch between a storage position within the holding module and an deployed position connected to the pump.

15. The catheter assembly according to claim 1, wherein the cuff is made of a polyester material such as Dacron and / or a metal mesh material such as titanium or stainless steel.

16. The catheter assembly according to claim 3, wherein the catheter elbow exposes the cuff and allows for easy wiping.

17. The catheter assembly according to claim 1, wherein the external catheter portion is bonded to the first side of the catheter elbow, and the internal catheter portion is bonded to the second side of the catheter elbow.

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