Anti-infective surgical devices and biofilm stirring methods

Abstract

A stirring device that uses various mechanical, acoustic, electrical, and chemical means to effectively remove biofilm from infected implants. The brush head embodiments have numerous shapes and dimensions to suit specific applications. Irrigation aspiration, drug delivery, and capture capabilities are also provided.

Description

Technical Field

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 63 / 484,115, filed on February 9, 2023, entitled "Anti-infection Surgical Device for Biofilm Agitation," which is incorporated herein by reference in its entirety.

[0002] The present invention generally relates to surgical devices, methods, and systems for use in surgical procedures for identifying, destroying, and removing microbial infections, such as biofilms, harbored in medical devices or implants and tissues within the human body.

[0003] The present invention generally relates to surgical devices, methods, and systems for use in surgical procedures for identifying, destroying, and removing microbial infections, such as biofilms, harbored in medical devices or implants and tissues within the human body.

Background Art

[0004] Modern technology has enabled the development of surgical implants, grafts, and devices that improve the health and lifespan of patients suffering from various diseases and injuries. Over time, advancements in these medical devices have improved their ease of implantation into the human body and their biocompatibility. The lifespan of such devices within the human body has increased, and in some cases, they are intended for final or permanent implantation.

[0005] Despite their success in terms of ease of implantation, biocompatibility, lifespan, and effectiveness as a therapeutic tool, medical devices still pose a serious risk of failure through infection. Medical implants are particularly susceptible to infection because they are composed of foreign materials such as non-natural tissues, metals, or synthetic materials (e.g., human allografts, porcine or bovine grafts, stainless steel, cobalt-chromium, titanium, plastics, synthetic meshes, etc.) that can serve as focal points for infection. Microorganisms such as bacteria and fungi often find themselves favorably positioned to adhere to and proliferate on the surfaces of these foreign implants. The microorganisms then multiply and eventually disperse into the human body, exacerbating and worsening the infection (e.g., causing conditions such as sepsis or bacteremia). Infection of medical devices or implants can have devastating consequences for patients, as it significantly impacts patient morbidity and mortality and drastically increases healthcare costs associated with treating the infection.

[0006] Orthopedics is a disproportionate example of a medical field that frequently utilizes implants for patient care. Surgeons in this field use plates and screws for fractured bones, arthroplasty implants for knee and hip replacements, and spinal hardware such as rods and pedicle screws for vertebral support. While orthopedic implants aim to improve health and function, they can also become reservoirs for infections that compromise the patient's health. The bacteria involved in these infections can form biofilms of complex bacterial communities that adhere to the surface of the implants. These biofilms have unique attributes, including protective extracellular macromolecules (EPS) that are highly adaptable and make treatment with antibiotics alone extremely difficult.

[0007] Standard treatment for orthopedic implant infections consists of medical intervention based on diagnosis (including various methods such as medical history, examinations, and clinical tests), resuscitation, and antibiotic therapy. Medical intervention is often combined with surgical intervention to combat the infection. This type of intervention typically involves surgical exposure of the infected site and wound cleaning of necrotic and contaminated tissue to address the device-related infection. Due to the established difficulty of removing biofilm from devices, surgical removal of devices with biofilm is often considered a necessary course of action to eliminate the host from infection. Unfortunately, despite these efforts, it results in a high morbidity in patients, and several examples include increased blood loss, damage to surrounding soft tissue or neurovascular structures, bone damage, or bone loss at the site. These problems associated with device removal can have devastating consequences for the patient's overall health and function. Furthermore, these medical and surgical management strategies often fail entirely, forcing patients and healthcare workers to continue emotionally, physically, and economically disastrous and costly efforts to eradicate or control device-related infections.

[0008] Device-related infections are not unique to the orthopedic specialty. All devices or implants carry the potential for infection, particularly those used in cardiology, general surgery, radiologic therapy, otolaryngology ("ENT"), urology, and plastic surgery. In general surgical procedures, pain can be alleviated through interventions such as hernia repair with prosthetic mesh. In the cardiac space, implantable cardiac devices such as pacemakers and defibrillators have successfully provided life-extending and life-sustaining interventions for people with underlying cardiovascular diseases. There are many other examples of innovative medical devices, implants, grafts, and prostheses that have significantly improved patients' quality of life and lifespan. Despite the success of biomedical engineering and the application of these inventions to the surgical space, the possibility of life-threatening infections remaining with implants, as outlined above, remains. Each surgical specialty must combat infections through various preventive and therapeutic measures.

[0009] Current standard care, which involves irrigation and wound cleaning with possible removal of the device, is occasionally effective in combating device-related infections, but this method is unpredictable and yields unsatisfactory results. In some cases, the risks associated with implant removal are so high that irrigation and wound cleaning are performed as a standalone surgical strategy. Current surgical tools for device-related infections are limited, and none effectively treat the device itself. Furthermore, surgical instruments with intentional specifications or design elements to deliberately handle biofilm agitation and removal are not available.

[0010] However, within the surgical environment, there are a few products that attempt to eradicate infection from the host, but do so without specific biofilm-targeting characteristics. In the irrigation space, there are several solutions that physicians use to help flush away infections (i.e., bacteria, fungi, etc. that may have formed a biofilm). The most commonly used solution is sterile saline. Sterile saline offers the advantages of an aqueous solution, washing away debris and susceptible pathogens, or cleaning weak biofilms from implant surfaces where there is little risk of the solution damaging human tissue. Unfortunately, because biofilms are fixed to the surface, infections caused by biofilms agglomerating on the device surface are hardly washed away by irrigation alone.

[0011] Furthermore, there are several solutions and surfactants that possess the ability to kill or weaken the pathogens they encounter. One such solution is a proprietary solution called Bactisure® wound irrigation, which is an aqueous solution consisting of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water. Bactisure® is used to remove debris and defibrillate the protective EPS of biofilms. When the EPS of a biofilm is destroyed, the bacteria are eliminated or weakened, making them more susceptible to medical interventions such as antibiotics and the patient's immune system. Numerous iodine solutions or disinfectants exist that aim for similar effects. While these surfactants, soaps, and disinfectants are effective means of cleaning surgical infections, they also carry the risk of harmful side effects to patients because they can be corrosive to natural human tissue. In addition, their handling, processing, and removal often require specific equipment and processes that can be cumbersome and expensive. Similar to sterile saline irrigation, these surfactant or soap solutions often have limited results because they do not penetrate or destroy biofilms held in medical devices.

[0012] Commercially available pulse irrigation and irrigation devices are available as irrigation solutions and are widely used in infected cases due to their cleaning effectiveness. Pulse irrigators, such as the Interpulse Irrigation System by Stryker, offer powered irrigation devices that deliver high to low pressure by allowing for the exchange of irrigators and suction spouts. Pulsatile irrigation destroys necrotic tissue, disrupts biofilms, and removes them through suction from the surgical field. While irrigation solutions and the devices that deliver them play a role in the fight against biofilms, well-documented studies have demonstrated that irrigation and suction alone are insufficient to effectively remove biofilms from implant surfaces.

[0013] Nevertheless, methods such as scrub brushes or bristle brushes are mechanically deployed to physically remove or weaken biofilms and their protective EPS shields. These can mechanically break down biofilms and remove surrounding necrotic or contaminated tissue. However, they do not provide the more advanced agitation of biofilms assisted by technology. Furthermore, these brushes are often not specific in their design for maneuvering and mechanically scraping surgical sites or instrument surfaces. Their intraoperative use is inconsistent, and they are not adopted in widespread clinical protocols for infectious surgical interventions. This is likely partly due to the lack of consistent biofilm disruption that cannot be achieved by mechanical scraping alone, as well as the lack of product availability and education regarding the importance and challenges of biofilm disruption.

[0014] A device specifically designed for the mechanical removal of biofilm has recently emerged. The Biobrush®, developed by OsteoRemedies®, is an electric brush consisting of a round brush head that rotates when mounted on an electric shaft. However, this device does not appear to be small enough to clean the junction percutaneously. Furthermore, in addition to the mechanical rotation of bristles on the implant surface, the device does not include any means of biofilm removal.

[0015] Some medical devices feature distinctive technologies such as ultrasonic treatment to break down biofilms. One such device is SonicOne®, which incorporates ultrasonic technology to cleanse unhealthy tissue from wounds or chronically infected sites. This innovative device easily dissolves and removes bacteria and biofilms while attempting to preserve healthy tissue and living structures such as nerves and vascular systems. The device technology provides various attachments depending on the type and shape of the wound. While this is an innovative device, its focus is on addressing chronic wounds and it does not employ additional technologies such as mechanical scraping features (e.g., brushes or bristles) or advanced technologies such as radio frequency, electromagnetic wave therapy, or laser therapy. Furthermore, this device is not designed for deep surgical wounds and is not scaled to treat the device surface.

[0016] Biofilms are not only a problem in the medical industry, but are also rampant in the dental field. The dental industry has several advanced technology products aimed at cleaning the oral cavity and its associated structures (e.g., teeth, gums, etc.). Electric toothbrushes have established uses for breaking down plaque (i.e., dental biofilms) through ultrasonic treatment and mechanical scraping using brush heads. Philips Sonicare® and Oral-B Pro® are two examples of at-home toothbrushes, but these brushes incorporate not only sonic treatment and brush heads, but also additional user feedback technologies such as timers, pressure sensors, sonic treatment mode control units, and companion apps. The brush heads are also replaceable.

[0017] Furthermore, scientific research has led to the emergence of radio frequency (RF) strategies for the disruption of biofilms. One such application in toothbrushes is the product ToothWave®, which combines ultrasonic and RF technologies to clean biofilms from within the oral cavity. Additionally, there are products in the dental space that reflect the intent of the aforementioned surgical pulse irrigators. These oral irrigators are designed for home use and are specifically engineered to penetrate interdental grooves, physically disrupting biofilms attached to hard-to-reach areas. One such device is WaterPik®. However, while these devices are effective dental hygiene measures for addressing plaque and other biofilms in the oral cavity, they lack many of the design specifications that would make them suitable surgical instruments for treating device-related infections. For example, the dimensions, shape, and composition of the brush head are not optimized for the surgical field or device surface. Finally, the aforementioned devices do not incorporate all of the technologies and features outlined above (i.e., radio frequency, ultrasonic treatment, bristles / nub, replaceable brush heads, handheld sterile packaging, suction, washing / solution applicators, etc.) into a single device or biofilm agitation system. [Overview of the project]

[0018] The present invention provides improved configurations applicable to many clinical and surgical settings for addressing infections. This disclosure is generally directed toward apparatus, methods and systems for cleaning surgical site infections and wound cleansing (i.e., washing). The concepts presented herein are particularly suited to treating and removing biofilm from the surface of implant-related infections and can be combined with mechanical scraping or brushing, sonication, radiofrequency, suction, and irrigation or dye application.

[0019] One aspect of the present invention relates to an electrosurgical device for effectively agitating biofilms attached to medical devices, implants, or human tissue. The electrosurgical device is an instrument equipped with ultrasonic treatment (i.e., various ultrasonic frequencies or energies including ultrasonic treatment) and radio frequency technology. The electrosurgical device is a rod-shaped or handheld structure having a contoured surface and edges for ease of use and control. This is an important consideration because handling the device under surgical conditions can be difficult, given that users frequently wear surgical gloves, as well as considering wet or slippery environments. The ultrasonic treatment and radio frequency delivery technology of the device is located at the front end of the device and delivered to the surface to be treated through an attachment such as a disposable attachment in the form of a brush head.

[0020] Another aspect of the present invention provides a number of designs for brush head attachments. Generally, brush heads have bristle elements, radio frequency transmitters and / or ultrasonic lithograph electronic elements. Brush heads are attachment pieces that can be easily replaced with different brush heads featuring various dimensions, shapes, and brush head designs, and are particularly intended to access and manipulate intended surgical fields and instrument surfaces. This removable brush head allows the user to select the most advantageous brush head design for maneuvering specific exposure situations, implant specifications, and human tissue characteristics. The back of the brush head may feature additional bristle heads, sweepers or squeegees, agitators or scraping nub, which are further beneficial for mechanical agitation and removal of unwanted microbial biofilms, debris, etc.

[0021] Another aspect of the present invention is a conduit for applying solutions that can be pulsated or delivered under various high or low pressures to deliver irrigation and wash away and destroy biofilms. Furthermore, this channel can deliver special solutions or dyes that can identify and adhere to biofilms, and thus generate (1) a target that the user can direct the disclosed invention to, and (2) feedback for appropriate biofilm removal. The device has a vacuum suction channel used to remove wash, solution, unwanted debris, serous and bloody drainage, suppuration, etc. The irrigation channel and suction may be located at the bottom of the device in a more distal portion.

[0022] In one aspect of the present invention, the body of the device features buttons and dials for controlling the on / off of power, as well as setting levels (e.g., high, medium, low; various numerical values) for ultrasonic treatment of the hair follicle, radio frequency, and irrigation channels and suction elements. In at least one embodiment, the device is electrically powered and can be connected to a specific power box in addition to the irrigation bag pump and suction tank.

[0023] Another embodiment of the present invention provides a device manufactured for single-use versions powered by batteries. The device is subjected to a sterilization method and housed in easily accessible packaging to allow for sterile opening of the device for use in a sterile surgical field.

[0024] Another embodiment provides a single-use power plant that is battery-powered or can be plugged into an outlet to access a main power source.

[0025] Further embodiments are not limited to these, Laser technology that works synergistically with ultrasonic and radio frequency measurements to destroy biofilms. Illumination systems that identify and illuminate the presence of biofilm on implant surfaces (may be used in conjunction with specific applicators / solutions or dyes that adhere to the biofilm, and illumination may include ultraviolet frequencies), Periodic feedback for warning the user about various special usage times, which feedback is characterized in the lighting system or can be mechanically perceived by the user via pulses / vibrations (e.g., when 2 minutes have elapsed or when the 30 - second mark has been reached, light is illuminated or the device generates a pulse / ultrasonic treatment stops), periodic feedback A pressure sensor that can warn the user when the pressure applied to the device is too high or too low, which can negatively affect the pressure optimized for the delivery of ultrasonic treatment, radio frequency, or mechanical bristles / brushes of abrasion A barb on the front of the brush head that helps the user measure the distance from the implant or the target surface and ensures that the present invention meets (or does not exceed) the optimal contact or distance for performing ultrasonic treatment, radio frequency, or mechanical abrasion. The barb is used for treatment Thermal uses in the brush head for heating or cooling the implant Brush heads in various arrangements and associated bristles / nubs / squids Reusable parts of the present invention (e.g., reusable power source), or a fully reusable version of the present invention Brush heads, hand - held rods, various shapes, forms, dimensions of the power source Various shapes, forms, designs, colors, and dimensions of the entire device Additional power sources (e.g., AC power extension, chemical reaction, and non - battery - operated power source) Additional mechanisms in addition to buttons or dials for starting the power source (e.g., on / off buttons, switches, etc.) Various shapes, forms, dimensions, and positions of ultrasonic treatment, radio frequency transmitters, or beacons A packaging form that can confirm that the device is sterilized when the sterilization packaging is opened, and A packaging configuration that allows the possibility of turning on the device while still contained in the packaging (i.e., allowing the device to be turned on and operated in a sterile environment through the packaging). It may include these.

[0026] Refer to the drawings, where the same number represents the same part across several drawings. [Brief explanation of the drawing]

[0027] [Figure 1] Figure 1 is a side view of a stirring device according to one embodiment of the present invention. [Figure 2] Figure 2 is a side view of a stirring device according to one embodiment of the present invention. [Figure 3] Figure 3 is a plan view of a stirring device according to one embodiment of the present invention. [Figure 4] Figure 4 is a side view of a stirring device according to one embodiment of the present invention. [Figure 5] Figure 5 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 6] Figure 6 is a front view of a brush head of one embodiment used in conjunction with the stirring device of the present invention. [Figure 7] Figure 7 is a front view of the brush head from Figure 6, showing its movement after activation. [Figure 8] Figure 8 is a front view of a brush head of one embodiment used with the stirring device of the present invention. [Figure 9] Figure 9 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 10] Figure 10 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 11] Figure 11 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 12] Figure 12 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 13] Figure 13 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 14] Figure 14 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 15] Figure 15 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 16] Figure 16 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 17] Figure 17 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 18] Figure 18 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 19] Figure 19 is a front view of one embodiment of a brush head used with the stirring device of the present invention. [Figure 20] Figure 20 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 21] Figure 21 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 22] Figure 22 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 23] Figure 23 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 24] Figure 24 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 25] Figure 25 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 26] Figure 26 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 27] Figure 27 is a front view of a brush head of one embodiment used with the stirring device of the present invention. [Figure 28] Figure 28 is an end view of a brush head of one embodiment used in conjunction with the stirring device of the present invention. [Figure 29]Figure 29 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 30] Figure 30 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 31] Figure 31 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 32] Figure 32 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 33] Figure 33 is a side view of a brush head of one embodiment for use with the stirring device of the present invention. [Figure 34] Figure 34 is a diagram of a control system according to one embodiment of the present invention. [Figure 35] Figure 35 shows an infected knee implant with an enlarged area indicating infection. [Figure 36] Figure 36 is a diagram of an infected knee implant from Figure 35 being treated according to the present invention. [Figure 37] Figure 37 is a diagram of the knee implant shown in Figure 35 after treatment according to the present invention, and includes an enlarged area demonstrating the effectiveness of the treatment. [Figure 38] Figure 38 shows a knee implant that is treated percutaneously using the device of the present invention. [Figure 39] Figure 39 shows a spinal implant being treated with a stirring device according to one embodiment of the present invention. [Figure 40] Figure 40 shows an ankle plate being processed in a stirring device according to one embodiment of the present invention. [Figure 41] Figure 41 shows an electronic heart transplant being treated with a stirring device according to one embodiment of the present invention. [Modes for carrying out the invention]

[0028] Various embodiments of the present invention have been described above for the purpose of illustrating its details and enabling those skilled in the art to make and use the invention. The details and features of the disclosed embodiments are not intended to limit many changes and modifications that would be readily apparent to those skilled in the art. Accordingly, the technical scope of the disclosure of the present invention is intended to be interpreted broadly and to include all changes and modifications that fall within the technical scope of the claims and their statutory equivalents.

[0029] Handle embodiment Referring to the drawings, Figure 1 shows an agitator 10 of one embodiment. Generally, each agitator discussed herein has a handle 12 and a tool 14, typically in the form of a brush head. The handles and tools of the various embodiments are independently numbered, and for clarity, a general reference to the handle is represented as handle 12, and a general reference to the brush head or other attachment is represented as tool 14.

[0030] Each handle 12 may have at least one control unit, numbered in a general sense as control unit 16, and a supply cord 18 that can supply power, fluid, suction, and / or other forms of energy, such as ultraviolet light. In at least one embodiment, the handle 12 is designed as a non-disposable component to reduce waste. In this regard, the handle 12 is configured to be easily disinfected and is not intended to be inserted into a patient. Disposable plastic sleeves, not shown, may further be provided to prevent contaminants from coming into contact with the treatment site. Alternatively, the handle 12 may be intended as a single-use device and may be powered by batteries. Single-use embodiments may be supplied with or without tool 14, treated in a sterile manner, sterilized, and presented in sterile, easily-open packaging that allows for sterile opening of the device for use in a sterile surgical field.

[0031] Inside the handle 12 is a stirring mechanism 19 used to activate the stirring head 22. The stirring mechanism 19 converts electric current and / or signals from the electrical leads 23 into mechanical motion, which is then converted into a tool 14 via the shaft 21. Examples of stirring mechanisms include, but are not limited to, motors, piezoelectric transducers, and electromagnetic oscillators.

[0032] Figures 2 and 3 provide a side view and a top view, respectively, of the stirring device 10 according to the first embodiment. The stirring device 10 comprises a handle 30 having a distal end 32 and a proximal end 34. The distal end 32 has a locking connector 35 that can be used to attach and lock a tool 14 to the distal end 32 of the handle 30. The locking connector 35 is shown to have a release button 36 that allows the tool 14 to be released from the handle 30 when pressed down. The locking connector 35 may be provided as a component of the handle 30 such that the locking connector 35 remains with the handle 30 when the tool 14 is removed. Alternatively, the locking connector 35 may be provided as a component of the tool 14, as can be realized by those skilled in the art.

[0033] The handle 30 at the proximal end of the distal end 32 has an on / off control unit 38 positioned to be operated by the user's thumb when gripped, and a corresponding power indicator light 39 located just far from the on / off control unit 38 so that the corresponding power indicator light 39 is visible even when the thumb covers the on / off control unit 38. A trigger control unit 40 is provided and positioned for activation by the user's index finger. The trigger control 40 is configured to open and close the irrigation supply lumen 42 provided by the supply cord 18. A trigger lock 44 is also provided to release the trigger 40 without closing the irrigation supply lumen. To improve the handling of the agitator 10, one or more gripping surfaces 46 may be provided.

[0034] The proximal end 34 of the handle 30 is connected to a supply cord 18. The supply cord 18 has the aforementioned irrigation supply lumen 42 which leads to a source of irrigation fluid (not shown). The irrigation fluid can be any fluid known to those skilled in the art and may include antibiotics or other drugs or chemicals that help remove and / or prevent the reappearance of biofilms.

[0035] The supply cord 18 further comprises an electrical cable 48 and a suction lumen 49 for removing irrigation fluid, blood, and other substances as needed to prevent blockage of fluid accumulation and / or visualization components as needed.

[0036] Figure 4 provides an agitator 10 of another embodiment, having a handle 60 having a distal end 62 and a proximal end 64. The distal end 62 has a locking connector 65 that can be used to attach and lock a tool 140 to the distal end 62 of the handle 60. The locking connector 64 is shown to have a threaded collar 66 that prevents the tool 140 from being unintentionally removed from the handle 60. The locking connector 65 may be provided as a component of the handle 60 such that the locking connector 65 remains with the handle 60 when the tool 140 is removed. Alternatively, the locking connector 65 may be provided as a component of the tool 140, as those skilled in the art will realize. The handle 60 further comprises an infusion trigger 68 and thumb control units 70 and 72 provided for functions such as power control and auxiliary functions, such as suction control.

[0037] Features of the tool Each tool 14 will have a body 20 for attaching the tool 14 to the handle 12. The tool 14 further comprises a stirring head 22 using various parts such as brush bristles, one or more picks, or other contact surfaces which will be described in detail below. In at least one embodiment, the tool 14 is a disposable component.

[0038] For the sake of brevity, it should be further understood that the various embodiments of the tool 14 and the various embodiments of the handle 12 can be used interchangeably to the extent that the handle 12 is configured for compatibility with the mode in which it is used by the tool 14, as will be understood by those skilled in the art. It should also be understood that combinations of the various embodiments of the stirring head 22 described herein can be coupled or separated on a given tool 14 without departing from the spirit of the invention.

[0039] Figure 2 further illustrates a tool 14 of Embodiment 100, having a body 102 and an agitation head 22 in the form of a brush 120. The body 102 has a top 104 with a textured finger pad 106 to assist in controlling the device. The underside 110 of the tool of Embodiment 100 has a connectable extension to an irrigation supply lumen 42 and a suction lumen 49, which ends with the brush 120 following the body 102. The body 102 can be shaped to form an angle 112 to assist in providing desired access to the surface to be cleaned. As will be seen below, various body shapes are provided for various applications. These shapes have angles of varying degrees and curves of various shapes and radii. The body ends at a rigid distal end 26 that forms that portion of the head, i.e., a portion of the agitation head 22, i.e., a portion of the head to which various cleaning features are attached, such as bristles, bases, sponges, and other components. The rigid distal end 26 can have various shapes and angles relative to the rest of the body 20, as can be seen below.

[0040] Embodiment 100 includes a brush head 120 for agitating a biofilm. The brush head 120 has a plurality of bristles 122 arranged in a parallel configuration and sized to create a flattened brush surface 124. When the handle 30 is operated, a vibrating device (not shown) housed within the handle 30 causes the brush 120 to vibrate rapidly, eliminating the need for the user to move the 120 back and forth across the surface to remove the biofilm, thus eliminating the possibility of user fatigue or unintentional patient injury. The plurality of bristles 122 in Embodiment 100 can be formed from materials such as wire, synthetic materials (e.g., nylon®), rubber, natural fibers, and other materials known in the art and suitable for use in a medical setting, as in many other embodiments of the agitation head 22 design described herein.

[0041] Figures 5 to 8 show examples of stirring heads 22 having various stirring features that may be provided individually or in any combination with any of the heads described herein. As previously mentioned, the stirring head 22 may have a plurality of bristles 80 coupled to form a brush 82 having various shapes as described below. In addition, it is shown that the stirring head 22 has a radio frequency (RF) transmitter 84. It is shown that the transmitter 84 has two RF elements 86 separated by a barrier bar 88. The barrier bar 88 is provided by the invention to help the user measure the distance from the implant or targeting surface for ultrasonic treatment, radio frequency, or mechanical scraping, ensuring that the optimal contact or distance is met (or not exceeded).

[0042] As best seen in Figures 6 and 7, the irrigation port 90 is located immediately proximal to several bristles 80 to provide a fluid, such as an irrigation fluid, to keep the treatment site clean of detached biofilm particles, to aid in the visualization of the washing coating, during the washing process, with washing agents, antibacterial agents or other drugs, and / or dyes. Proximal to the irrigation port 90 is a suction port 92 used to remove debris and prevent fluid from accumulating at the site.

[0043] Figures 6 and 7 are distinguished by the depiction of movement in the bristles 80 in Figure 7, which is represented by an indistinct region 94. As discussed throughout, bristle movement is a component of the present invention that helps break down biofilms and can be provided to the bristles using vibration, rotation, shaking, ultrasonic treatment, etc.

[0044] Figure 8 shows a stirring head 50 with further features. The stirring head 50 has an ultraviolet (UV) source 52 at its distal end. A thermal element 54 is embedded within the head, which can be used to heat or cool the head using thermal technologies such as infrared (IR), resistance coils, and cryogenic treatment lumen. An electromagnetic element 56 is also shown, which can be used to deliver electromagnetic waves to the implant being cleaned. An irrigation port 90 and a suction port 92 are also shown.

[0045] Stirring head Figures 9 to 30 show various non-limiting examples of stirring heads 22 that can be used with the handle 12 of one or more embodiments of the present invention. Figures 9 to 30 are provided to illustrate various shapes of stirring heads 22, and it should be understood that each of these heads may have ultrasonic treatment, cleaning, suction, vibration, RF energy, optical energy, etc., to enhance the biofilm removal effect of the tool 14. Furthermore, it should be understood that each of the stirring heads 22 described herein may be provided in various dimensions so that the stirring head 22 is ideally combined with a given procedure and patient.

[0046] Figure 9 shows a stirring head 150 that utilizes a cylindrical brush formed from multiple bristles 152 branching off from a wire 154. The wire 154 has a first end 156 and a second end 158. The wire 154 is curved to form a U-shape, with each of the first end 156 and the second end 158 being attached to the distal end of the tool body 20.

[0047] Figure 10 shows a stirring head 170 having a plurality of elastomer fingers 172 extending distally from the distal end of the main body 20.

[0048] Figure 11 shows an angled stirring head 180 having a plurality of relatively parallel bristles 182 that extend perpendicularly to the angled surface 184 of the stirring head 180 to which a plurality of relatively parallel bristles 182 are attached.

[0049] Figure 12 shows a stirring head 190 formed from a pair of twisted wires 192, which are connected at a proximal end 194 for connection to the main body 20 and separate distally to form a U-shape. Each of the wires 192 has several bristles 196 that branch outward from the wire 192, forming a brush.

[0050] Figure 13 shows a stirring head 200 having a plurality of relatively parallel bristles 202 extending distally from the distal end of the main body 20.

[0051] Figure 14 shows a stirring head 210 having multiple branched bristles 212 that extend from the distal end of the main body 20 and form a cluster.

[0052] Figure 15 shows a stirring head 220 having a tube brush 222 with bristles branching outward from a twisted wire core 224. In at least one embodiment, the handle 12 to which the stirring head 220 is attached has rotational, oscillating, and / or vibrating motion relative to the stirring brush 222.

[0053] Figure 16 shows a stirring head 230 of another embodiment, which has a disc-shaped plate 232 attached to the body 20, which has curves 236 of various radii and a number of bristles 234 extending relatively parallel to either the perimeter of the plate or the entire plate 232. When energized by the handle 12, the plate 232 rotates, swings, and / or vibrates relative to the body 20.

[0054] Figures 17 and 18 provide stirring heads having elastomer or rubber characteristics similar to those of the embodiment shown in Figure 10. The stirring head 240 in Figure 17 has multiple bases 242 that allow the user to increase pressure on the surface being cleaned. This embodiment can provide the user with additional tactile feedback because the interface between the rubber and the biofilm is slippery, while the rubber tends to rub or "squeak" against a wet, clean surface. Thus, the user may feel or even hear the transition between the two senses during the cleaning process. The embodiment in Figure 18 provides a stirring head 250 with multiple conical stretches 252 of rubber or elastomer, which are longer and more flexible than the bases 242 and are similar to the multiple elastomer fingers 172 of the embodiment shown in Figure 10.

[0055] Figure 19 shows an stirring head 260 of another embodiment, which has a disc-shaped plate 262 attached to the main body 20 and a plurality of relatively branched bristles 264 extending from the periphery of the plate 262 to form a brush roller. When energized by the handle 12, the plate 262 rotates, shakes, and / or vibrates relative to the main body 20.

[0056] Figure 20 shows an agitator head 270 of one embodiment, having a plurality of small, angled brushes 272 extending from the distal end of the main body 20. Each of the brushes 272 has a twisted wire core 274 angled between 0 and 90 degrees, more preferably between 20 and 70 degrees, with respect to the longitudinal axis 24 of the main body 20. Each twisted wire core 274 has bristles 276 branching outward from the twisted wire core 274. When energized by the handle 12, the angled brushes 272 rotate, swing, and / or vibrate as a single unit relative to the main body 20.

[0057] Figure 21 shows an agitator head 280 of one embodiment that uses a combination of agitators. Similar to the agitator head 240 of Figure 17, three spaced-apart rubber or elastic bases 282 are provided. Between adjacent elastomer bases 282 are concentrated bristles 284 that extend beyond the elastomer bases 282, so that the bristles 284 come into contact with a surface that is to be cleaned before the elastomer bases 282 come into contact with it.

[0058] Figure 22 shows an embodiment of a stirring head 290, which has a uniform set of bristles 292 near the proximal end 294 of the stirring head 290, similar in configuration to the bristles of a toothbrush, and a hemispherical cluster of bristles 296 near the distal end 298 of the stirring head 290.

[0059] Figure 23 shows a stirring head 300 in one embodiment using a sponge 302 as a stirring medium. The sponge may contain an antibacterial agent or other drug, a biocompatible surfactant or detergent, and may be absorbent such that the biofilm is captured by the sponge 302.

[0060] Figure 24 shows another example of how two or more stirring media described herein can be combined. A stirring head 310 is depicted having a sponge 312 on one side of the stirring head 310 and a brush 314 and a rubber base 316 on the opposite side of the stirring head 310.

[0061] Figure 25 shows an embodiment of a stirring head 320 having a brush 322 on one side and a wiper 324 on the other side. The wiper 324 can be made of a biocompatible elastomer or rubber material.

[0062] Figure 26 shows an embodiment of a stirring head 330 having a brush 332 on one side and a rubber or elastic cone 334 on the other side.

[0063] Figures 27 and 28 show a non-limiting example of an agitation head 340 in one embodiment, having a brush 342 shaped for a specific task. The brush 342 has bristles 344 extending parallel from a U-shaped element 346. To further customize the brush 342 for use, the bristles 344 are of varying lengths and are arranged so that the distal working ends of the bristles 344 join to form an arc 348. This brush 342 may be ideally suited for cleaning rod-shaped or split implants.

[0064] Figures 29 and 30 show stirring heads of further embodiments that use a brush having bristles sized and arranged to form a contoured working surface. The stirring head 350 of the embodiment shown in Figure 28 has bristles 352 sized and arranged to form an inclined working surface 354. Figure 29 shows a stirring head 360 having bristles 362 sized and arranged to form a working surface including a pair of juxtaposed arcuate sections 364 that form vertices 366 useful for extending between adjacent surfaces of an implant.

[0065] Figure 31 shows a stirring head 370 of one embodiment having a flexible body 372 with a controllable curve 374. The controllable curve 374 is adjustable using a control unit on a handle which activates a steering mechanism such as a steerable guide wire, as is well known in the art.

[0066] Figure 32 shows an stirring head 380 of one embodiment, having a distal rubber cone 382 and bristles 384 proximal to the rubber cone 382. Two base portions 386 are embedded within the bristles 384.

[0067] Figure 33 shows an stirring head 390 of one embodiment that provides a pick 392 instead of a brush.

[0068] control system Figure 34 shows an example of a control system 400 used to supply power to and control the stirring device 10 in various embodiments of the present invention. The control system 400 generally includes a control unit 402 with a display device 420 and an irrigation and suction system 450. The control unit 402 has a power outlet 404 for receiving a plug 406 from a power source. Next to the power outlet 404 is an on / off switch 408 for controlling the power supplied to the stirring device 10.

[0069] The display device 420 provides information and control related to ultrasonic processing and radio frequency. The ultrasonic processing readout 422 displays the selected ultrasonic processing level. The ultrasonic shredder selector button 424 is located next to the ultrasonic processing readout 422, allowing the user to set the ultrasonic shredder to a desired frequency. Similarly, the RF (radio frequency) readout 430 displays the selected RF frequency, and next to it is an RF selector button 432, allowing the user to select a desired frequency.

[0070] Furthermore, the control unit 402 includes irrigation level selectors 440, 442, and 444, which allow the user to select various flow rates for an irrigation / suction system 450 mounted on the side of the control unit 402. The irrigation / suction system 450 includes a pump 452, such as a diaphragm pump, with an inlet port 454 and an outlet port 456. The pump 452 may have a pump handle 458 that can be used to prepare the pump as needed before energizing the system.

[0071] The inlet port 454 is connected to a supply line 460 having a distal end featuring a spiked connector 462, which is used to establish fluid flow communication with the source of the irrigation fluid, which in this case is an irrigation fluid bag 464. The outlet port 456 is connected to the irrigation supply lumen 42.

[0072] The irrigation and aspiration system 450 may be equipped with a fluid sampling tap 466 connected to the aspiration lumen 49. The fluid sampling tap 466 allows for the collection of a sample during the procedure. The fluid sampling tap 466 can be opened to slowly and carefully fill a vial with fluid, which can then be sent to a laboratory for bacterial identification and other tests.

[0073] method Figures 35 to 41 show examples of how the agitator 10 of the present invention was used on infected implants with positive results. Figure 35 shows a knee implant 500 infected with a biofilm. A magnified microscopic detail of region 502 of the knee implant 500 is shown. In the upper right corner of the magnified view, the implant / human tissue surface 504, which is not yet infected, is shown as a reference. Below the human tissue surface 504, the depth of the biofilm layer is evident at reference number 506. The surface of the biofilm shows that it is composed of individual bacteria 508, such as Staphylococcus aureus, in a biofilm state. Between the individual bacteria 508, there is extracellular macromolecules (EPS) or extracellular matrix (ECM) 510.

[0074] Figure 36 shows a knee implant 500 being treated with a stirring device 10. In this example, ultrasonic treatment and RF-based mechanical scraping and brushing were applied to the knee implant 500 using the stirring device 10. Dye-based irrigation was also used.

[0075] The treatment results are shown in Figure 37. The same region 502 is magnified again, showing that the biofilm has been removed at 512.

[0076] Figure 38 shows a knee implant 500 being treated percutaneously using a stirring device 10 having a small stirring head 22.

[0077] Figure 39 shows an agitator 10 of one embodiment used to clean a spinal implant 510.

[0078] Figure 40 shows an agitator 10 of one embodiment used for cleaning the ankle plate 520.

[0079] Figure 41 shows an agitator 10 of one embodiment used to clean an electronic cardiac implant 530.

[0080] While the present invention has been described in relation to specific embodiments and uses, those skilled in the art will be able to generate further embodiments and modifications in light of this teaching without departing from or exceeding the spirit of the claimed invention. Therefore, it should be understood that the drawings and description herein are provided as examples to facilitate understanding of the invention and should not be construed as limiting its scope. Similarly, the technical scope of the following claims should be interpreted in light of the above drawings and description in accordance with the knowledge of those skilled in the art and the practices and practices employed thereby.

Claims

1. In a stirring device for cleaning implants, The stirring device is A handle having a proximal end and a distal end, the handle being, At least one control unit, The stirring mechanism inside the handle, A supply cord attached to the proximal end of the handle, A tool attached to the distal end of the handle, the tool is The main unit and The stirring head at the distal end of the main body, which is activated when the stirring mechanism is energized, A stirring device for cleaning an implant, comprising a handle and a tool, the stirring device having an irrigation lumen, the irrigation lumen extending from a source of irrigation fluid through a supply cord, through a handle, and along the body, to which the irrigation fluid can be supplied to a site of the implant being cleaned by the stirring head.

2. The stirring device according to claim 1, further comprising a suction lumen extending along the main body through the supply cord and the handle, so as to be able to remove the irrigation fluid from the implant site being cleaned by the stirring head.

3. The stirring device according to claim 1, wherein the stirring head is equipped with an ultraviolet light source.

4. The stirring device according to claim 1, wherein the stirring head is provided with a plurality of bristles.

5. The stirring device according to claim 1, wherein the stirring head comprises a conical stretched portion of elastomer.

6. The stirring device according to claim 1, wherein the stirring head is equipped with a radio frequency transmitter.

7. The stirring device according to claim 1, wherein the stirring head comprises a plurality of bristles and a plurality of rubber bases.

8. In a stirring device for cleaning implants that uses multiple mechanisms to remove biofilm, The stirring device is A supply cord constructed to supply electricity and at least one of fluid and suction, A handle connected to the proximal end of the aforementioned supply cord, A tool connected to the distal end of the handle, A first mechanism for removing the biofilm from the implant, having a stirring mechanism in the handle that activates the tool when energized by electricity from the supply cord, such that the tool mechanically agitates the biofilm on the implant when it comes into contact with the implant, A stirring device comprising a second mechanism for assisting the tool in removing the biofilm from the implant.

9. The stirring device according to claim 8, wherein the second mechanism comprises an irrigation fluid applied to the biofilm using the tool.

10. The stirring device according to claim 9, further comprising a suction lumen for removing the irrigation fluid and the stirred biofilm from the implant.

11. The stirring device according to claim 10, further comprising a fluid sample collection tap associated with the suction lumen that can be used to capture a fluid sample.

12. The stirring apparatus according to claim 8, wherein the second mechanism comprises a thermal element.

13. The stirring device according to claim 8, wherein the second mechanism comprises an electromagnetic element.

14. The stirring apparatus according to claim 8, wherein the second mechanism comprises an ultraviolet light source.

15. The stirring apparatus according to claim 8, wherein the second mechanism comprises a radio frequency transmitter.

16. In a method for removing biofilm from an implant, The aforementioned method, The implant is brought into contact with a stirring device having at least one stirring mechanism, At the distal end of the stirring device, the stirring device is energized to shake, vibrate, rotate, or ultrasonically treat the tool by the at least one stirring mechanism. Moving the tool across the implant until the biofilm is removed, A method comprising, in addition to the stirring mechanism, utilizing at least a second mechanism of the stirring device to remove the biofilm.

17. The method according to claim 16, wherein at least the use of the second mechanism of the stirring device is provided for irradiating the biofilm with an ultraviolet light source.

18. The method according to claim 16, wherein the use of at least the second mechanism of the stirring device is provided for irrigating the biofilm.

19. The method according to claim 16, wherein the use of at least the second mechanism of the stirring device is provided to perform suction on the biofilm.

20. The method according to claim 16, wherein at least the second mechanism of the stirring device is used to discharge onto the biofilm.

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