Patent Application
20240260739
The present invention relates to the field of medical technology, in particular devices and methods for use in the surgical cleaning of infected tissue.
The subject matter of the invention is in particular a surgical cleaning device which can be usable as a single-use device for the mechanical cleaning and irrigation of infected joint endoprostheses within the scope of DAIR procedures. The cleaning device is suitable for the manual brushing of surfaces of joint endoprostheses; the mechanically detached contaminants can be removed by at the same time by cleaning liquid jets exiting the cleaning device. The cleaning liquid can be connected to a conventional jet lavage system, whereby a cleaning liquid can be pumped into the cleaning device. The cleaning liquid can preferably exit the cleaning device in a pulsed manner.
In septic bone surgery, the cleaning of debrided bone and soft tissue areas in the revision of infected joint endoprostheses and the cleaning of infected osteosynthesis plates by means of lavage is known. Medical irrigation devices, so-called lavage systems, are used for this purpose. These lavage systems are also referred to herein as “lavage devices.” Known cleaning liquids are physiological saline solution, Ringer's solution, and Ringer's lactate solution. The aim of lavage is to remove residues of the infected tissue, biofilm residues, blood, and wound secretions. Lavage systems have long been known. Devices according to the patent specifications EP3187208, U.S. Pat. No. 4,583,531, U.S. Pat. No. 5,779,702, U.S. Pat. No. 6,059,754 and U.S. Pat. No. 20,191,51531 are examples thereof. However, a problem is that firmly adhering biofilms and particularly biofilms in undercut regions can be detached only conditionally or even not at all by means of the conventional jet lavage systems.
In septic surgery, the so-called DAIR procedures (debridement, antibiotics and implant retention) for treating infected knee joint endoprostheses, hip joint endoprostheses and shoulder joint endoprostheses are on the rise. The aim of this surgical technique is to fight the infection of the joint endoprosthesis and of the surrounding tissue, after opening the joint, by debridement and subsequent local application of antibiotics such that the artificial joint is preserved. The implantation of a revision joint endoprosthesis, which is cost-intensive and puts the patient under strain, is to be avoided.
These procedures are used in particular in the case of artificial joint endoprostheses that are infected at an early stage. Movable implant components, such as PE inlays, are first removed from the artificial joint. Infected tissue is debrided and an attempt is made to remove biofilms, which adhere to the metal surfaces of the joint endoprosthesis, as completely as possible by means of brushing and lavage. New movable joint components, such as PE Inlays, are then inserted into the cleaned joint endoprosthesis. The removal of the biofilms on the metal surfaces, in particular on the condyles of knee joints, is problematic here. Biofilms can be extremely sticky and adherent. This means that, despite brushing and subsequent lavage, biofilms or biofilm residues can remain on the metal surfaces. These biofilm residues contain living microorganisms and can lead to a reinfection of the joint endoprosthesis and the surrounding tissue.
The object of the present invention is to solve one or more of the above-described and other problems of the prior art. An object of the invention is to detach biofilms by brushing the implant surface and simultaneously to remove the detached biofilm residues from the implant surface using a cleaning liquid. As a result, after being mechanically detached, the sticky biofilms cannot adhere to the implant surface again. A further object of the invention is to immediately remove the biofilm residues mixed with the cleaning liquid from the joint site, so that a deposition of the detached biofilm residues on the surrounding tissue, the joint capsule, can be effectively prevented.
The device can preferably allow manual brushing, also in undercuts, and at the same time the contaminants, such as biofilm residues, which are detached by brushing can be immediately removed by jets of irrigation liquid, so that the contaminants cannot attach to the cleaned surfaces. The device itself can preferably be without an active drive device of its own and also without a pump. The device can preferably be manufactured as simply and cost-effectively as possible from plastic parts. Furthermore, the device can preferably be sterilized by ethylene oxide or gamma sterilization.
Some or all objects are achieved by methods and devices described herein, in particular those described in the claims.
Preferred embodiments of the invention are described below.
A first embodiment describes a device for the surgical cleaning of infected implants, containing a brush head containing a bristle region having a plurality of bristles; a supply element configured to transport a cleaning liquid to the brush head; a discharge element configured to remove liquid from the brush head; and a connecting element configured to releasably connect the supply element and the discharge element to an external lavage device.
A second embodiment describes a device according to the first embodiment, wherein the device is configured to achieve a ratio of the delivery rate of the discharge element to the delivery rate of the supply element of at least 1.
A third embodiment describes a device according to the first or second embodiment, wherein the brush head is configured to exert an oscillating force on the bristles.
A fourth embodiment describes a device according to any one of the preceding embodiments, wherein the device comprises a drive element for generating the oscillating force, the drive element preferably being configured for driving by means of the flow of the cleaning liquid through the supply element.
A fifth embodiment describes a device according to any one of the preceding embodiments, further comprising a valve, which is arranged between the connecting element and the brush head and is configured to control the flow of a cleaning liquid through the supply element.
A sixth embodiment describes a device according to any one of the preceding embodiments, wherein the brush head comprises bristles of different lengths in order to facilitate the cleaning of undercuts, the bristles preferably being arranged arcuately in the bristle region.
A seventh embodiment describes a device according to any one of the preceding embodiments, wherein the supply element comprises an outlet opening arranged within the bristle region.
An eighth embodiment describes a device according to any one of the preceding embodiments, wherein the discharge element has a suction opening arranged at the proximal end of the bristle region.
A ninth embodiment describes a device according to any one of the preceding embodiments, wherein the device is configured to guide cleaning liquid from the supply element through the bristles and to release said cleaning liquid at the tip of the bristles.
A tenth embodiment describes a device according to any one of the preceding embodiments, wherein the device does not comprise a pump.
An eleventh embodiment describes a device according to any one of the preceding embodiments, wherein the supply element, and preferably also the discharge element, are guided through the connecting element.
A twelfth embodiment describes a device according to any one of the preceding embodiments, further comprising a handle element arranged between the connecting element and the bristle element, the handle element being configured for a user to manually guide the device.
A thirteenth embodiment describes a device according to the twelfth embodiment, further comprising a stem element which connects the handle element to the brush head.
A fourteenth embodiment describes a device according to the thirteenth embodiment, wherein the stem element has a length of 5 to 10 cm and/or has a diameter of at most 10 mm.
A fifteenth embodiment describes a device according to any one of the preceding embodiments, wherein the supply element comprises a flexible tube and/or has a length of at least 80 cm.
With respect to the embodiments described herein, the elements of which “contain,” or “comprise,” a particular feature (for example, a material), in principle a further embodiment is always contemplated in which the relevant element consists solely of the feature, i.e., does not comprise any other constituents. The word “comprise” or “comprising” is used herein synonymously with the word “contain” or “containing.”
In one embodiment, if an element is denoted by the singular, an embodiment is also contemplated in which more than one such element is present. The use of a term for an element in the plural in principle also encompasses an embodiment in which only a single corresponding element is included.
Unless otherwise indicated or clearly excluded from the context, it is possible in principle, and is hereby clearly contemplated, that features of different embodiments may also be present in the other embodiments described herein. Likewise, it is contemplated in principle that all features described herein in connection with a method are also applicable to the products and devices described herein, and vice versa. All such considered combinations are not explicitly listed in all instances, simply in order to keep the description brief. Technical solutions known to be equivalent to the features described herein are also intended in principle to be encompassed by the scope of the invention.
A first aspect of the invention relates to a device for the surgical cleaning of infected implants, the device containing a brush head containing a bristle region having a plurality of bristles; a supply element configured to transport a cleaning liquid to the brush head; a discharge element configured to remove liquid from the brush head; and a connecting element configured to releasably connect the supply element and the discharge element to an external lavage device.
The device is provided in particular for cleaning bacterially infected tissue, for example during a surgical procedure. The device can preferably be used for cleaning infected implants.
The device comprises a brush head on which a plurality of bristles is arranged in a bristle region. The bristles are preferably formed from a biocompatible polymer, for example polyethylene, polypropylene, polyamide, or the like.
The device comprises a supply element which is configured to transport a cleaning liquid. In particular, a cleaning liquid can be guided from a connecting element to the brush head by means of the supply element in order to be released in the region of the brush head.
The device comprises a discharge element which is designed to receive and transport liquid. The discharge element can be used to remove cleaning liquid in the used or contaminated state, said cleaning liquid having been initially released at the brush head via the supply element. Infected tissue and biofilms can thereby be removed from a patient, so that there is no risk of pathogens remaining or even being distributed in the patient. In particular, a re-adhering of bacteria from biofilms to an implant can be avoided.
The devices described herein are particularly suitable for operation with an external lavage device. Examples of lavage devices with which the devices described herein can be operated are described, for example, in EP2662146A2, U.S. Pat. No. 4,583,531A, U.S. Pat. No. 4,278,078A, and U.S. Pat. No. 5,542,918A. Such lavage devices can comprise a pump, which can be equipped, for example, with an electric motor or a compressed air motor. The devices described herein can preferably be operated with lavage devices which can generate pulsed bursts of spray. The lavage devices can, for example, comprise pumps such as are described in EP2619415A1, EP2910270A1 or EP2873856A1.
The device described herein is equipped with a connecting element for connection to such a lavage device. The connecting element can be connectible to an external lavage device in a form-closed or force-closed connection. For example, the connecting element can comprises a latching element in order to connect the device to a lavage device. The connecting element can in particular be configured to connect the supply element and the discharge element in a liquid-conducting manner to a lavage device. The connecting element can in particular comprise an opening configured to dispense liquid from the discharge element to a lavage device. The connecting element can furthermore comprise an opening configured to receive a cleaning liquid from a lavage device in order to guide the cleaning liquid into the supply element.
For this reason, the devices described herein do not themselves require a pump. Accordingly, the devices described herein preferably do not have their own pump. A pump is a device which can bring about the transport of a liquid by actively changing the pressure of the liquid to be transported.
In some embodiments, the device is configured to achieve a ratio of the delivery rate of the discharge element to the delivery rate of the supply element of at least 1. This means that the device is configured to simultaneously discharge at least as much liquid via the discharge element as is released at the brush head via the supply element. It can thereby be better ensured that loosened biofilms and detached infected tissue can be effectively removed from the patient.
In some embodiments, the ratio of the delivery rate of the discharge element to the delivery rate of the supply element is at least 1.0; 1.2; 1.5; or at least 2. This can be achieved, for example, in that the inner diameter of the discharge element is dimensioned to be correspondingly greater compared to the inner diameter of the supply element.
In some embodiments, the brush head is configured to exert an oscillating force on the bristles. For example, the brush head can be movable, for example due to elastic material properties of the device or due to the incorporation of joints. The bristles can thereby be set in vibration. Better detaching of infected tissue or of biofilms can thereby be achieved.
In some embodiments, the device comprises a drive element for generating such an oscillating force. The drive element can be an active drive element, for example an electric motor, or a passive drive element can be used. An example of a passive drive element is a vibration motor which is operated by the flow of a cleaning liquid through the supply element.
For example, a blade wheel which is driven by a liquid flow and which has a non-symmetrical mass distribution can be used for this purpose.
Further examples of drive elements are ball vibration motors and roller vibration motors. A circular movement of a spherical mass body can create an imbalance which leads to vibrations of the stem element and/or of the brush head, as a result of which the cleaning effect can be intensified.
The oscillating force can also be generated by bursts of spray of a cleaning liquid. For this purpose, the device can be connected to a lavage device which allows the pulsed dispensing of a cleaning liquid. For this purpose, the external lavage device can be equipped with a pump and a controller which enables such pulsed operation.
In some embodiments, the device comprises a valve configured to control the flow of a cleaning liquid through the supply element. The valve can preferably be arranged between the connecting element and the brush head.
The brush head can comprise bristles of different lengths in order to facilitate the cleaning of undercuts. For example, the bristles of different lengths can be arranged arcuately on the brush head, as shown, for example, in
In some embodiments, the supply element comprises an outlet opening arranged within the bristle region. The device preferably comprises a plurality of outlet openings. The outlet openings can be arranged on the brush head in the vicinity of the bristles, preferably within the bristle region, or on the bristles themselves, or both. The bristles can be hollow in order to allow the transport of a cleaning liquid. The device can be configured to guide cleaning liquid from the supply element through the bristles and to release said cleaning liquid at the tip of the bristles.
The supply element and/or the discharge element is preferably guided through the connecting element. They preferably run within the connecting element and are thereby better protected against damage or disturbance.
The device can comprise a handle element configured for a user to manually guide the device. The handle element can be arranged between the connecting element and the brush head. Using the handle element, a user can securely grasp and hold the brush head, and can manually position and guide the brush head in a suitable manner during use.
The device can furthermore comprise a stem element which connects the handle element to the brush head. Accordingly, the stem element is arranged between the handle element and the brush head. The stem element can preferably be flexible in order to enable a movement of the brush head, as described in more detail above. The stem element can, for example, have a length of 5 to 10 cm. The stem element can have a diameter of 10 mm or less, for example less than 9 mm or less than 7 mm. This can make it easier for the user to better reach body regions that are difficult to access, for example in the case of DAIR procedures on infected knee joint endoprostheses. The stem element preferably has a greater outer diameter than the discharge element.
Preferably, the stem element and the discharge element are arranged parallel to one another.
Preferably, the stem element and the discharge element are directly connected to one another. The stem element and the discharge element are preferably flexible. In some embodiments, the device is made partially or completely of plastic. In particular, the brush head, stem element, handle element, and/or connecting element can each comprise a plastic, or consist completely of plastic.
In some embodiments, the device is configured for sterilization using ethylene oxide or gamma sterilization, i.e., it can be sterilized by the methods mentioned without functional impairment.
The supply element can comprise a flexible tube. The supply element can have a length of at least 80 cm. In some embodiments, the length of the supply element in the region between the connecting element and the handle element or the brush head is at least 80 cm. This affords the user better movability of the device without the need to move the external lavage device at the same time.
In some embodiments, the brush head comprises an angled outflow channel. In relation to the orientation of the bristles, the outflow channel can be arranged at an angle of more than 15°, for example approximately 45°. Bursts of spray of the cleaning liquid can thereby be released into the region next to the brush head in order to improve the cleaning performance of the brush. The cleaning liquid can be released at the outer end of the outflow channel via an outflow opening.
A further aspect relates to a therapy method in which a device described herein is used to remove biofilms or infected tissue. In this case, biofilms or infected tissue is removed by means of the bristles and by means of a cleaning liquid released via the supply element, and the cleaning liquid together with the material to be removed is taken out of the patient via the discharge element. The device can be connected to an external lavage device. In one embodiment, pulsating bursts of spray of the cleaning liquid are released via the brush head. In one embodiment, an oscillating force is applied via the bristles, as described herein.
The cleaning liquid can comprise a detergent, a buffer substance, and/or an antibacterial active substance. The cleaning liquid can comprise a physiological saline solution, Ringer's solution or Ringer's lactate solution.
The device can be used for a debridement and in particular for DAIR procedures. The device can be used, for example, in the context of a knee or hip joint operation, in particular in the case of revision surgery.
The invention is further illustrated below using examples which are, however, not to be understood as limiting. It will be apparent to a person skilled in the art that other equivalent means may be used similarly in place of the features described here.
During a surgical procedure, the device can, for example, be used as follows for debridement, wherein the following steps a) to l) are carried out in the order indicated:
| Number | Date | Country | Kind |
|---|---|---|---|
| 23154817.3 | Feb 2023 | EP | regional |
This application claims priority pursuant to 35 U.S.C. 119(a) to European application Ser. No. 23/154,817.3, filed Feb. 3, 2023, which application is incorporated herein by reference in its entirety.
