Surgical cleaning device with an adapter

Abstract

To provide a surgical cleaning device which can be used as a disposal device for mechanical cleaning and affusion of an in-joint prothesis infected in a range of DAIR treatment.SOLUTION: A device for a surgical cleaning of an infected implant, includes: a brush head 101 having a brush region 102 with a plurality of brushes 103; a supply element 104 configured to deliver cleaning liquid to the brush head; a discharge element 105 configured to remove the liquid from the brush head; and a connect element 106 configured to release the supply element and the discharge element from the external cleaning device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and more particularly to an apparatus and method for use in the surgical cleaning of infected tissue.

Summary of the Invention

Problems to be Solved by the Invention

[0002] The subject of the present invention is a surgical cleaning device that can be used, in particular, as a disposable device for the mechanical cleaning and perfusion of infected joint endoprostheses within the scope of DAIR treatment. The cleaning device is suitable for manually brushing the surface of the joint endoprosthesis. Mechanically separated contaminants can be simultaneously removed by the cleaning liquid jets exiting the cleaning device. The cleaning liquid can be connected to a conventional jet cleaning system, thereby enabling the cleaning liquid to be pumped into the cleaning device. The cleaning liquid can preferably exit the cleaning device in a pulsed manner.

[0003] In septic osteosurgery, the cleaning of the debrided bone and soft tissue areas in the replacement of infected joint endoprostheses, as well as the cleaning of infected bone plates by lavage, is known. For this purpose, medical perfusion devices, so-called cleaning systems, are used. These cleaning systems are also referred to herein as "cleaning devices". As cleaning liquids, physiological saline, Ringer's solution, and lactated Ringer's solution are known. The purpose of cleaning is to remove residues of infected tissue, biofilm residues, blood, and wound secretions. Cleaning systems have been known for a long time. Examples are the devices according to European Patent No. 3187208, US Patent No. 4583531, US Patent No. 5779702, US Patent No. 6059754, and US Patent Application Publication No. 2019151531. However, the problem is that firmly adhering biofilms, especially those in undercut areas, can only be conditionally separated or not at all by conventional jet cleaning systems.

[0004] In septic surgery, there has been an increase in the so-called DAIR procedure (debridement, antibiotics and implant retention) for treating infected knee, hip, and shoulder joint prostheses. The aim of this surgical technique is to combat infection of the joint prosthesis and surrounding tissues after opening the joint by debridement and subsequent local application of antibiotics so that the artificial joint can be preserved. Implants for replacement joint prostheses, which are costly and burdensome to the patient, should be avoided.

[0005] These procedures are used, in particular, in the case of prostheses of artificial joints infected at an early stage. Removable implant components such as PE liners are first removed from the artificial joint. An attempt is made to completely remove, as much as possible by brushing and washing, the biofilm adhering to the metal surface of the joint prosthesis of the infected tissue. Then, new removable joint components such as PE liners are inserted into the washed joint prosthesis. The problem here is the removal of the biofilm on the metal surface, especially on the joint eminences of the knee joint. The biofilm can be very sticky and adherent. This means that biofilm or biofilm residues can remain on the metal surface despite brushing and subsequent washing. These biofilm residues contain living microorganisms and can cause reinfection of the joint prosthesis and surrounding tissues.

[0006] Preferred Embodiment The object of the present invention is to solve one or more of the above and other problems of the prior art. The object of the present invention is to separate the biofilm by brushing the implant surface, and at the same time, remove the separated biofilm residue from the implant surface using a cleaning liquid. As a result, after being mechanically separated, the sticky biofilm cannot reattach to the implant surface. A further object of the present invention is to immediately remove the biofilm residue mixed with the cleaning liquid from the joint site, and as a result, effectively prevent the deposition of the separated biofilm residue on the surrounding tissue and joint capsule.

[0007] The device can preferably enable manual brushing even in undercuts. At the same time, contaminants such as biofilm residues separated by brushing can be immediately removed by the injection of the perfusion liquid. As a result, the contaminants cannot adhere to the cleaned surface. The device itself preferably does not need its own active drive device and does not need 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 sterilization or gamma-ray sterilization.

[0008] Some or all of the objects are achieved by the methods and devices described herein, particularly the methods and devices described in the claims.

[0009] Preferred embodiments of the present invention are described below.

[0010] The first embodiment is a device for surgical cleaning of an infected implant, a brush head including a hair region having a plurality of hairs, a supply element configured to convey a cleaning liquid to the brush head, a discharge element configured to remove liquid from the brush head, a connection element configured to removably connect the supply element and the discharge element to an external cleaning device, Describe an apparatus including

[0011] The second embodiment describes an apparatus according to the first embodiment, wherein the apparatus is configured such that the ratio of the delivery rate of the discharge element to the delivery rate of the supply element is at least 1.

[0012] The third embodiment describes an apparatus according to the first or second embodiment, wherein the brush head is configured to apply a vibration force to the bristles.

[0013] The fourth embodiment describes an apparatus according to any one of the first to third embodiments, wherein the apparatus includes a drive element for generating a vibration force, and the drive element is preferably configured to be driven by the flow of the cleaning liquid passing through the supply element.

[0014] The fifth embodiment describes an apparatus according to any one of the first to fourth embodiments, further comprising a valve disposed between the connection element and the brush head and configured to control the flow of the cleaning liquid passing through the supply element.

[0015] The sixth embodiment describes an apparatus according to any one of the first to fifth embodiments, wherein the brush head includes bristles of different lengths to facilitate the cleaning of undercuts, and the bristles are preferably arranged in an arc within the bristle region.

[0016] The seventh embodiment describes an apparatus according to any one of the first to sixth embodiments, wherein the supply element includes an outlet opening disposed within the bristle region.

[0017] The eighth embodiment describes an apparatus according to any one of the first to seventh embodiments, wherein the discharge element has a suction opening disposed at the proximal end of the bristle region.

[0018] The ninth embodiment describes an apparatus according to any one of the first to eighth embodiments, wherein the apparatus is configured to guide the cleaning liquid from the supply element through the bristles and discharge the cleaning liquid at the tips of the bristles.

[0019] Embodiment 10 describes an apparatus according to any one of Embodiments 1 to 9, in which the apparatus does not include a pump.

[0020] Embodiment 11 describes an apparatus according to any one of Embodiments 1 to 10, in which the supply element, and preferably also the discharge element, are guided through the connecting element.

[0021] Embodiment 12 describes an apparatus according to any one of Embodiments 1 to 11, which further includes a handle element disposed between the connecting element and the brush element, and the handle element is configured such that a user can manually guide the apparatus.

[0022] Embodiment 13 describes an apparatus according to Embodiment 12, which further includes a stem element connecting the handle element to the brush head.

[0023] Embodiment 14 describes an apparatus according to Embodiment 13, in which the stem element has a length of 5 to 10 cm and / or a diameter of at most 10 mm.

[0024] Embodiment 15 describes an apparatus according to any one of Embodiments 1 to 14, in which the supply element includes a flexible tube and / or has a length of at least 80 cm.

Mode for Carrying Out the Invention

[0025] Regarding the embodiments described in this specification, when an element "contains" or "comprises" a specific feature (e.g., material), in principle, further embodiments in which the related element consists only of that feature, i.e., does not include other components, are always contemplated. The terms "comprise" or "comprising" are used synonymously with the terms "contain" or "containing" in this specification.

[0026] In one embodiment, when an element is shown in the singular, embodiments in which two or more such elements exist are also contemplated. The use of terms for plural elements basically also encompasses embodiments in which only a single corresponding element is included.

[0027] Unless otherwise indicated or clearly excluded by the context, it is in principle possible for the features of different embodiments to also be present in other embodiments described herein, and this is clearly contemplated by this specification. Similarly, all features described herein in relation to a method are also applicable to the products and devices described herein, and vice versa is in principle contemplated. For the sake of brevity of description, not all such contemplated combinations are explicitly listed in all cases. Technical solutions known to be equivalent to the features described herein are also intended to be encompassed in principle by the scope of the present invention.

[0028] A first aspect of the present invention is an apparatus for the surgical cleaning of an infected implant, the apparatus comprising: a brush head including a hair region having a plurality of hairs; a supply element configured to convey a cleaning liquid to the brush head; a discharge element configured to remove liquid from the brush head; a connection element configured to releasably connect the supply element and the discharge element to an external cleaning device; and is described.

[0029] This apparatus is provided in particular for cleaning infected tissue, for example during a surgical procedure. The apparatus can preferably be used for cleaning an infected implant.

[0030] The apparatus comprises a brush head in which a plurality of hairs are arranged in a hair region. The hairs are preferably formed from a biocompatible polymer such as polyethylene, polypropylene, polyamide, etc.

[0031] The device comprises a supply element configured to convey a cleaning liquid. In particular, the cleaning liquid can be guided by the supply element from a connecting element to the brush head in order to be discharged in the region of the brush head.

[0032] The device comprises a discharge element designed to receive and convey a liquid. The discharge element can be used to remove the used or contaminated cleaning liquid, which is initially discharged at the brush head via the supply element. Thereby, infected tissue and biofilm can be removed from the patient, as a result of which there is no risk that pathogens remain in or are even dispersed in the patient's body. In particular, reattachment of bacteria from the biofilm to the implant can be avoided.

[0033] The device described herein is particularly suitable for operation using an external cleaning device. Examples of cleaning devices capable of operating the device described herein are described, for example, in European Patent Application Publication No. 2662146 (A2), U.S. Patent No. 4,583,531 (A), U.S. Patent No. 4,278,078 (A), and U.S. Patent No. 5,542,918 (A). Such cleaning devices can comprise, for example, a pump that can comprise an electric motor or a compressed air motor. The device described herein can preferably operate with a cleaning device capable of generating a spray pulse burst. The cleaning device can comprise, for example, a pump as described in European Patent Application Publication No. 2619415 (A1), European Patent Application Publication No. 2910270 (A1) or European Patent Application Publication No. 2873856 (A1).

[0034] The device described in this specification comprises a connection element for connecting to such a cleaning device. The connection element may be connectable to an external cleaning device by a form-closed connection or a force-closed connection. For example, the connection element can include a latch element for connecting the device to the cleaning device. The connection element can in particular be configured to connect the supply element and the discharge element to the cleaning device in a manner that conducts liquid. The connection element can in particular comprise an opening configured to dispense liquid from the discharge element to the cleaning device. The connection element can further comprise an opening configured to receive cleaning liquid from the cleaning device for guiding the cleaning liquid into the supply element.

[0035] For this reason, the device described in this specification itself does not require a pump. Thus, the device described herein preferably does not have its own pump. A pump is a device that can effect the conveyance of a liquid by actively changing the pressure of the conveyed liquid.

[0036] In some embodiments, the device is configured to achieve a ratio of the delivery rate of the discharge element to the delivery rate of at least one supply element. This means that the device is configured to simultaneously discharge via the discharge element at least the same amount of liquid as is discharged via the supply element at the brush head. This can better ensure that loosened biofilm and separated 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 larger compared to the inner diameter of the supply element.

[0037] In some embodiments, the brush head is configured to apply a vibrating force to the bristles. For example, the brush head may be movable, e.g., due to the elastic material properties of the device or due to the incorporation of joints. Thereby, the bristles can be vibrated. Thereby, better separation of the infected tissue or biofilm can be achieved.

[0038] In some embodiments, the device comprises a drive element for generating such a vibrating force. The drive element can be an active drive element, such as an electric motor, or a passive drive element can be used. An example of a passive drive element is a vibrating motor operated by the flow of the cleaning liquid through a supply element. For example, a turbine having an asymmetric mass distribution and driven by a liquid flow can be used for this purpose.

[0039] Further examples of drive elements are ball vibrating motors and roller vibrating motors. The circular motion of the spherical mass can generate an imbalance that results in the vibration of the stem element and / or the brush head, thereby enhancing the cleaning effect.

[0040] The vibrating force can also be generated by a burst of the spray of the cleaning liquid. For this purpose, the device can be connected to a cleaning device that enables pulsed dispensing of the cleaning liquid. For this purpose, the external cleaning device can comprise a pump and a controller that enables such a pulsed operation.

[0041] In some embodiments, the device comprises a valve configured to control the flow of the cleaning liquid through a supply element. The valve can preferably be arranged between the connecting element and the brush head.

[0042] The brush head can be provided with bristles of different lengths to facilitate the cleaning of undercuts. For example, bristles of different lengths can be arranged in an arc on the brush head, as shown in FIG. 3 for example. For example, the bristles in the distal region of the brush head can be longer than the bristles in the proximal region of the brush head. The distal region of the brush head is the side that is arranged farthest from the connecting element. The proximal region of the brush head is the side that faces the handle element (if present) and the direction of the connecting element.

[0043] In some embodiments, the supply element comprises an outlet opening disposed within the bristle region. The device preferably comprises a plurality of outlet openings. The outlet openings can be arranged in the vicinity of the bristles on the brush head, preferably within the bristle region, or on the bristles themselves, or both. The bristles may be hollow to enable the conveyance of the cleaning liquid. The device can be configured to guide the cleaning liquid from the supply element through the bristles and discharge the cleaning liquid at the tips of the bristles.

[0044] The supply element and / or the discharge element are preferably guided through the connecting element. They preferably extend into the connecting element, thereby being better protected against damage or interference.

[0045] The device can comprise a handle element configured for the user to manually guide the device. The handle element can be arranged between the connecting element and the brush head. By using the handle element, the user can securely grip and hold the brush head and manually position and guide the brush head in a suitable manner during use.

[0046] The device can further comprise a stem element that connects the handle element to the brush head. Thus, the stem element is disposed between the handle element and the brush head. The stem element can preferably be flexible to allow movement of the brush head, as described in more detail above. The stem element can have a length, for example, 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 allows the user to more easily reach body areas that are difficult to access, for example, in the case of DAIR treatment for an infected knee prosthesis. The stem element preferably has an outer diameter larger than that of the discharge element.

[0047] Preferably, the stem element and the discharge element are arranged parallel to each other. Preferably, the stem element and the discharge element are directly connected to each other. The stem element and the discharge element are preferably flexible.

[0048] In some embodiments, the device is made at least partially or completely from plastic. In particular, the brush head, the stem element, the handle element, and / or the connection element can each comprise plastic or consist entirely of plastic.

[0049] In some embodiments, the device is configured to be sterilized using ethylene oxide sterilization or gamma ray sterilization, i.e., it can be sterilized by the methods mentioned without functional impairment.

[0050] 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 connection element and the handle element or the brush head is at least 80 cm. This provides the user with better mobility of the device without the need to simultaneously move the external cleaning device.

[0051] In some embodiments, the brush head comprises an inclined outflow channel. With respect to the direction of the bristles, the outflow channel can be arranged at an angle greater than 15°, for example, at an angle of about 45°. Thereby, in order to improve the cleaning performance of the brush, the burst of the spray of the cleaning liquid can be discharged to the area adjacent to the brush head. The cleaning liquid can be discharged at the outer end of the outflow channel through the outflow opening.

[0052] A further aspect relates to a treatment method in which the device described herein is used to remove biofilm or infected tissue. In this case, the biofilm or infected tissue is removed by the bristles and by the cleaning liquid discharged through the supply element, and the cleaning liquid is removed from the patient through the discharge element together with the substance to be removed. The device can be connected to an external cleaning device. In one embodiment, a pulsating burst of the spray of the cleaning liquid is discharged through the brush head. In one embodiment, a vibrational force is applied through the bristles as described herein.

[0053] The cleaning liquid can contain a detergent, a buffering substance, and / or an antibacterial active substance. The cleaning liquid can contain physiological saline, Ringer's solution or lactated Ringer's solution.

[0054] This device can be used for debridement, especially for DAIR treatment. The device can be used, for example, in connection with knee surgery or hip surgery, especially in the case of revision surgery.

Examples

[0055] Hereinafter, the present invention will be further described by way of examples, but it should be understood that the present invention is not limited to these examples. It will be apparent to those skilled in the art that other equivalent means can be used in place of the features described herein.

Brief Description of the Drawings

[0056]

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[0057] The modifications shown in Figures 13 and 14 can be used alternatively or in combination in the device according to the invention.

[0058] Application Example 1 During a surgical procedure, the device can be used, for example, for debridement as follows, in the following steps a) to l), namely, a) connecting the cleaning device to the cleaning liquid reservoir, b) connecting the adapter of the device to the cleaning device, c) starting the motor of the cleaning device, d) pumping the cleaning liquid through the supply element to the brush head of the device by the cleaning device, e) opening the valve in the handle element, f) as a result, introducing the perfusion liquid into the brush head along the stem element, g) manually brushing the surface to be cleaned while the cleaning liquid exits the brush head or the hollow hair in the form of a spray jet, h) flushing away the contaminants separated from the surface to be cleaned by the cleaning liquid, i) sucking the used cleaning liquid from step h) into the cleaning device through the suction element and the connection element, j) switching off the pumping function of the cleaning device, k) The step of separating the connection element from the cleaning device, l) The step of disposing of the device, are executed in the order shown.

Explanation of Signs

[0059] 100 Device 101 Brush head 102 Hair area 103 Hair 104 Supply element 105 Discharge element 106 Connection element 107 Valve 108 Outlet opening 109 Suction opening 110 Tip of the hair 111 Handle element 112 Stem element 114 Grommet 115 Latch element (on the handle element) 120 Driving element 121 Inlet opening 122 Outlet opening 123 Ball 124 Outlet channel 125 Latch element (on the connection element) 200 Cleaning device

Claims

1. A device (100) for surgical cleaning of an infected implant, comprising: a brush head (101) including a bristle region (102) having a plurality of bristles (103); a delivery element (104) configured to deliver cleaning fluid to said brush head (101); an evacuation element (105) configured to remove liquid from said brush head (101); a connecting element (106) configured to releasably connect the supply element (104) and the discharge element (105) to an external cleaning device (200); Equipped with The brush head (101) is configured to apply a vibratory force to the bristles (103); The device comprises a handle element (111) disposed between the connecting element (106) and the brush head (101); the handle element (111) is configured for a user to manually guide the device; The device further comprises a flexible stem element (112) connecting the handle element (111) to the brush head (101).

2. 2. The device of claim 1, wherein the device is configured such that the ratio of the delivery rate of the discharge element (105) to the delivery rate of the supply element (104) is at least 1.

3. 3. The apparatus of claim 1 or 2, comprising a drive element (120) for generating the vibration force, the drive element (120) being configured to be driven by a flow of the cleaning liquid through the supply element (104).

4. 3. The device according to claim 1 or 2, further comprising a valve (107) arranged between the connecting element (106) and the brush head (101) and configured to control the flow of cleaning liquid through the supply element (104).

5. 3. The device of claim 1 or 2, wherein the brush head (101) comprises bristles (103) of different lengths to facilitate the cleaning of undercuts, the bristles (103) being arranged in an arc within the bristle region (102).

6. 3. The device according to claim 1 or 2, wherein the supply element (104) comprises an outlet opening (108) arranged within the bristle region (102).

7. 3. The device according to claim 1 or 2, wherein the ejection element (105) comprises a suction opening (109) arranged at a proximal end of the bristle region (102).

8. 3. The device according to claim 1 or 2, wherein the device is configured to conduct cleaning liquid from the supply element (104) through the bristles (103) and to expel the cleaning liquid at the tips (110) of the bristles.

9. 3. The apparatus of claim 1 or 2, wherein the apparatus does not include a pump.

10. 3. The device according to claim 1 or 2, wherein the supply element (104) and the discharge element (105) are also guided through the connecting element (106).

11. The device of claim 1, wherein the stem element (112) has a length of 5 to 10 cm and / or a diameter of at most 10 mm.

12. 3. Apparatus according to claim 1 or 2, wherein the supply element (104) comprises a flexible tube and / or has a length of at least 80 cm.

13. 3. The device according to claim 1 or 2, wherein the supply element (104) comprises an outlet opening (108) arranged in the bristle region (102), the outlet opening (108) including at least an outlet opening (122) which is the opening of an outlet channel (124) arranged at an oblique angle with respect to the orientation of the bristles (103).

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