A watertight burr-hole covering and deep brain electrode cable fixing device

Abstract

The invention particularly relates to a watertight burr hole cover device that ensures the safe closure of the burr hole opened into the patient's skull during neurosurgical operations, prevents the electrode from slipping and displacing; provides additional protection alongside the fixation of the placed electrode and the pulling force that may develop later, reduces the complication rate and infection risk of the surgery by preventing cerebrospinal fluid leakage in the postoperative period, and also eliminates the problem of precision in targeting in the second side electrode placement, which is the second stage of electrode implantation surgery.

Description

[0001] DESCRIPTION

[0002] A WATERTIGHT BURR-HOLE COVERING AND DEEP BRAIN ELECTRODE CABLE FIXING DEVICE

[0003] Technical Field

[0004] The invention particularly relates to a watertight burr hole cover device that ensures the safe closure of the burr hole opened into the patient's skull during neurosurgical operations, prevents the electrode from slipping and displacing; provides additional protection alongside the fixation of the placed electrode and the pulling force that may develop later, reduces the complication rate and infection risk of the surgery by preventing cerebrospinal fluid leakage in the postoperative period, and also eliminates the problem of precision in targeting in the second side electrode placement, which is the second stage of electrode implantation surgery.

[0005] Background of the Invention

[0006] In the practice of brain surgery, surgical treatment of pathologies within the skull and brain tissue (tumors, abscesses, vascular masses, hydrocephalus, etc.) is performed by removing an appropriate bone window from the skull (craniotomy) or opening a hole (burr-hole opening, trephination) at the skull.

[0007] Deep brain stimulation (DBS) is a neurosurgical method that has been used in the treatment of movement disorders, epilepsy and various neuropsychiatric diseases since 1987. The basic components of the system placed in the body in this surgery are;

[0008] a) A “lead” that is used to apply electrical stimulation to the targeted point in the brain, b) A “pulse generator” (battery) that provides electricity to the system and contains an electronic circuit and a processor that also includes the function of adjusting the stimulation characteristics of the system, and

[0009] c) A conductive “extension cable” that connects the electrode and the pulse generator.The burr hole opened in the skull to place the electrode on the target in the brain is called the “Burr hole”, or “Surgical Skull Hole”. The apparatus that fixes the electrode to the opening in the skull bone so that it maintains its current location for many years after the electrode is placed on its final target during surgery; while doing this fixation, it also does not cause any physical damage to the electrode and aims to physically close the opened burr hole is called the “burr hole cover”

[0010] The most common complication in these surgeries is wound problems and infection due to the foreign system implanted in the body. This problem is also frequently seen in the part where the burr hole is covered. The fact that the current systems that bulge from the skull which erode the scalp can give raise to the disruption of wound healing. This is an important factor in the development of this complication.

[0011] In addition, DBS surgery is a procedure that takes around 3-4 hours. The leakage of cerebrospinal fluid (CSF) from the burr hole opened during surgery causes some undesired complications. There is no mechanism in the current burr hole cover systems in use that prevents CSF leakage during surgery.

[0012] As a result, excessive air entry into the head (pneumocephalus) due to excessive CSF leakage, leads to a shift in the desired target and an increase in the risk of infection. In addition, complications such as wound healing problems, CSF fistula and infection may develop as a result of this prolonged leakage after surgery. However, these burr hole cover and electrode fixation systems must be sensitive enough not to damage the electrode and strong enough to prevent the electrode from displacement due to further tensile forces.

[0013] Moreover, cerebrospinal fluid (CSF) may go on leaking from the burr hole and surgical wounds; and this may cause further complications and may cause failure of the surgery at the end.

[0014] In current technologies, the burr hole cover system basically has three components. The first component includes a base part that is fixed to the skull by screwing. Initial steps of the surgery is performed via passing through the tunnel formed by this base which is screwed onto the burr hole drilled at the skull.Then, the second component of the system - the internal mechanism - fixed to the base, is placed to fix the lead electrode. Finally, the fixed electrode is extended outward from the openings on the edge of the base and the third component of the mechanism - the cover part - is placed to fix the electrode.

[0015] For the standard burr hole covering systems in the current system, a skull hole of at least 14 mm and more must be opened, which causes a larger burr hole and a greater risk of CSF leakage. This situation increases the risk of CSF leakage in DBS surgeries.

[0016] Since the recent burr hole closure systems do not have a fluid seal feature, CSF leakage may occur during and after the surgery, which paves the way for complications such as pneumocephalus, target shift, and infection.

[0017] In other current designs, the internal locking mechanisms compress the electrode unilaterally. This fixes the electrode only from one side, and therefore, sometimes causes the electrode to shift, i.e. slipping, while being fixed.

[0018] Previous systems do not have the ability to fix the electrode in position in 5 different directions (anterior, posterior, lateral, medial and inferior directions).

[0019] There are also results in the literature that present the problems created by the application of chemical-based electrode fixation techniques that were frequently used and applied before, only with external support without actual fixation.

[0020] In addition, the products in the current technique are only plastic raw material products. Plastic implants have the risk of degenerating more quickly and potentially lead to infection.

[0021] In the literature, the US patent application numbered US12029451 B states the following regarding the subject: " The present disclosure provides a burr hole cover (e.g., burr hole cover) and method of manufacturing such apparatus. The burr hole cover disclosed herein may be multi-functional in that it may be used to: (a) form a burr hole which provides access to the brain, and (b) facilitate concealing the burr holewithout employing any fastening devices (e.g., surgical screws, wires, etc.). In embodiments, the burr hole cover may include a sleeve having an outer surface, an inner surface, and a hollowed portion. In embodiments, the outer surface of the sleeve may define external serrations. The sleeve may be configured to create a burr hole in a skull, and the external serrations may be configured to secure the sleeve within the burr hole. The burr hole cover may also include a plate configured to fit with the sleeve and conceal the burr hole."

[0022] In said application, a burr hole cover embodiment including external gears is disclosed.

[0023] Again, in the literature, in the US patent application numbered US2012221109A1, the following statements are included regarding the subject: “A cranial burr hole plug with an insertion tool and method of implantation is provided. The burr hole plug includes a shell; a collet interlocked within the shell; a clamp compressing the collet around an elongated medical device exiting the skull of a patient, such as a catheter or lead; and a cover over the clamp, collet, and shell. The insertion tool inserts the collet within the shell and locks the collet around the clamp. The method of implantation includes inserting the burr hole plug components in a cranial burr hole using the insertion tool and securing the exiting medical device without disturbing the position of the medical device.”

[0024] In said application, the cranial burr hole plug and insertion tool embodiment are disclosed.

[0025] Again, in the literature, in the US patent numbered US2021330359A1, the following statements are included regarding the subject: “A burr hole cover is provided that is constructed to be positioned within a recessed region formed on a patient's skull in order to conceal a burr hole. The burr hole cover may be affixed to the patient's skull in the recessed region. For instance, surgical fastening devices may be inserted through apertures defined in the burr hole cover. The burr hole cover may have a thickness and curvature that enables it to be substantially flush with the surface of the skull when affixed in the recessed region. The burr hole cover's curvature follows the contour of the patient's skull. The burr hole cover may include one or more perforations sized to allow air (or moisture) to flow towards the burr hole, which promotes skin / bonegrowth. Some of the perforations may be large enough to permit access to the brain with leads and / or drainage devices.” Additionally, in none of the devices proposed previously, have no protective technical properties against the CSF leakage.

[0026] In the application in question, burr hole covers and methods for attaching such trepanation hole covers to a patient's skull are generally disclosed.

[0027] Again, in the literature, in the US patent application numbered US2022184383A1, the following statements are included regarding the subject: " A burr hole plug includes a base member shaped arid dimensioned for position withing an aperture defined by a burr hole and a cover member shaped and dimensioned for placement over the base member to fully close the bur hole and retain a stimulation lead passing through the burr hole in place."

[0028] Due to the above-mentioned disadvantages, it was mandatory to develop a new watertight burr hole covering device.

[0029] Disclosure of the Invention

[0030] Based on this state of the art, the purpose of the invention is to provide a watertight burr hole covering device that eliminates the existing disadvantages.

[0031] Another purpose of the invention is to create a structure that prevents CSF leakage thanks to its sealing feature and prevents accuracy problems in targeting in the second side electrode placement, which is the next stage.

[0032] Another purpose of the invention is to create a structure that provides the possibility of fixing the lead at more than one angle; prevents slipping in the anterior, posterior, lateral, medial inferior and especially superior directions, which prevents the electrode from coming back out while allowing a smooth passage of the DBS lead and cannula system along the path with sufficient and delicate fixation at the same time.

[0033] Another purpose of the invention is to provide a structure that enables to perform surgery through a smaller (12 mm) diameter hole.Another purpose of the invention is to provide a structure that prevents complications that may occur due to CSF leakage during and after surgery owing to its watertight feature.

[0034] Another purpose of the invention is to present a structure that enables better cosmetic results thanks to its smaller diameter design.

[0035] Another purpose of the invention is to present a structure that eliminates the risks of degenerating more quickly and causing infection compared to plastic materials by using titanium material.

[0036] Another purpose of the invention is to present a main burr hole design that has a more oval design and fits more comfortably into the skull and does not create a protrusion like a horn.

[0037] Another purpose of the invention is to present a structure that allows CSF leaks to be reduced thanks to its structure that can be placed in smaller dimensions such as 10 mm -12 mm.

[0038] Another purpose of the invention is to present a structure with a material design that can minimize problems such as migration and fracture.

[0039] Explanation of Figures

[0040] Figure - 1 Perspective view of the burr hole covering device, which is the subject of the invention

[0041] Figure - 2 Perspective bottom view of the watertight burr hole covering device, which is the subject of the invention

[0042] Figure - 3 Disassembled perspective view of the burr hole covering device, which is the subject of the invention

[0043] Figure - 4 Disassembled perspective bottom view of the burr hole covering device, which is the subject of the inventionReference Numbers

[0044] 1. Upper Body

[0045] 2. Silicone Layer

[0046] 3. Silicone Channel

[0047] 4. Deep Brain Stimulation Electrode

[0048] 5. Screw

[0049] 6. Middle Space

[0050] 7. Flat Fixation Element

[0051] 8. Clawed Fixation Element

[0052] 9. Screw Housing

[0053] 10. Silicone Top Cover

[0054] 11. Outer Cover

[0055] Detailed Explanation of the Invention

[0056] In this detailed explanation, the innovation in question is explained only with examples that will not create any limiting effect on the better understanding of the subject.

[0057] The invention is a watertight burr hole covering device that ensures the safe closure of the burr hole opened into the patient's skull during brain surgery operations, provides additional protection to the fixation of the placed electrode and against the pulling force which may develop later, and also prevents cerebrospinal fluid leakage and eliminates the problem of precision in targeting in the second side electrode placement, which is the next stage of surgery, characterized in that, comprises an upper body (1) made of titanium and its alloys that constitute the main body of the said burr hole covering device, a silicone layer (2) formed on the underside of the said upper body (1) and prevents any possible CSF leakage by providing complete sealing, a deep brain stimulation electrode (4) formed to perform the stimulation process three silicone channels (3) formed as a continuation of the said silicone layer (2) and wrapping the said deep brain stimulation electrode (4) in a bow-tie shape, enabling each of them to be used separately in a leak-proof manner, a silicone top cover (10) positioned on the upper side of the middle space (6) region as the outermost layer of the said burr holecovering device and providing sealing, and an outer cover (11) positioned on the said silicone top cover (10).

[0058] Figure - 1 shows a perspective view of the watertight burr hole covering device, which is the subject of the invention.

[0059] Figure - 2 shows a perspective bottom view of the watertight burr hole covering device, which is the subject of the invention.

[0060] Figure - 3 shows a disassembled perspective view of the watertight burr hole covering device, which is the subject of the invention.

[0061] Figure - 4 shows a disassembled perspective bottom view of the watertight burr hole covering device, which is the subject of the invention

[0062] The watertight burr hole covering device according to the invention includes main parts of, a upper body (1) made of titanium and its alloys that constitute the main body of the said, burr hole covering device a silicone layer (2) formed on the underside of the said upper body (1) and prevents any possible CSF leakage by providing complete sealing, a deep brain stimulation electrode (4) formed to perform the stimulation process three silicone channels (3) formed as a continuation of the said silicone layer (2) and wrapping the said deep brain stimulation electrode (4) in a bow-tie shape, enabling each of them to be used separately in a leak-proof manner, a screw (5) positioned in the screw housing (9) to fix the said burr hole covering device to the burr hole, a middle space (6) created to allow the said deep brain stimulation electrode (4) to enter the burr hole, a clawed fixation element (8) and a flat fixation element (7) positioned in such a way as to create the said middle space (6) between them, which ensures that the deep brain stimulation electrode (4) remains fixed without slipping, a silicone top cover (10) positioned on the upper side of the middle space (6) region as the outermost layer of the said burr hole covering device and providing sealing, and an outer cover (11 ) positioned on the said silicone top cover (10).

[0063] The burr hole covering device which is the subject of the invention, unlike the existing systems, provides the possibility of fixing the deep brain stimulation electrode (4) at more than one angle; prevents slipping in the anterior, posterior, lateral, medial inferiorand especially superior directions, that is, prevents the deep brain stimulation electrode (4) from coming out, enables easier passage through the DBS deep brain stimulation electrode (4) and cannula system and includes a mechanism which can compress the deep brain stimulation electrode (4) by advancing.

[0064] In addition, the system prevents CSF leakage due to its watertight structure. This feature is not found in any other produced systems so far.

[0065] In current systems, a burr hole of 14 mm diameter is usually required to be able to fit the closing system, however, with this developed system, it will be possible to perform the surgery through a smaller hole (12 mm) in diameter. After fixing the mentioned deep brain stimulation electrode (4) to the slots (not numbered in the figures) created on the upper body (1), it allows additional fixation in the form of a ring in the silicone channel (3), thus preventing complications such as the deep brain stimulation electrode (4) slipping.

[0066] This invention provides a system with 3 silicone channels (3) with a silicone-supported watertight locking mechanism developed to prevent all CSF leaks that may be encountered during stereotactic neurosurgery and to fix the deep brain stimulation electrodes (4) placed in DBS surgeries. The biomaterials used in the invention are biocompatible and can be easily used in postoperative radiological imaging, especially during Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).

[0067] The outer cover (11) in question is located at the entry point of the deep brain stimulation electrodes (4) placed in the skull and provides sealing. The silicone upper cover (10), which is made of silicone material to prevent CSF leaks, is integrated into the interior. This silicone upper cover (10) has a structure that prevents fluid leakage.

[0068] There is a silicone channel (3) around the DBS electrodes (4) as a silicone-supported fixation mechanism. The silicone channel (3) holds the DBS electrodes (4) tightly using soft silicone layers (2) instead of mechanical systems. In this way, sealing is ensured while preserving the sensitivity of the surgical procedure.

[0069] The silicone layer (2) is located at the base of the area where the DBS electrodes (4)are placed and provides complete sealing.

[0070] The DBS electrodes (4) mentioned are wrapped in a bow-tie shape and pass through the silicone channels (3). All three silicone channels (3) are used, which allows the DBS electrodes (4) to be securely fixed and the sealing to be increased. While the fourth channel remaining empty in other conventional systems creates problems, all silicone channels (3) are actively used in this invention.

Claims

CLAIMS1. The invention is a watertight burr hole closing device that ensures the safe closure of the burr hole opened into the patient's skull during brain surgery operations, provides additional protection against the fixation of the placed electrode and the pulling force that may develop later, and also prevents cerebrospinal fluid leakage and eliminates the problem of precision in targeting in the second side electrode placement, which is the next stage in surgery, characterized in that, comprises an upper body (1) made of titanium and its alloys that constitute the main body of the said burr hole closing device, a silicone layer (2) formed on the underside of the said upper body (1) and prevents any possible CSF leakage by providing complete sealing, a deep brain stimulation electrode (4) formed to perform the stimulation process three silicone channels (3) formed as a continuation of the said silicone layer (2) and wrapping the said deep brain stimulation electrode (4) in a bow-tie shape, enabling each of them to be used separately in a leak-proof manner, a silicone top cover (10) positioned on the upper side of the middle space (6) region as the outermost layer of the said burr hole closing device and providing sealing, and an outer cover (11) positioned on the said silicone top cover (10).

2. A watertight burr hole closing device according to claim 1, comprises a middle space (6) created to allow the said deep brain stimulation electrode (4) to enter the burr hole.

3. A watertight burr hole closing device according to any preceding claims;comprises a clawed fixation element (8) and a flat fixation element (7) positioned in such a way as to create the said middle space (6) between them, which ensures that the deep brain stimulation electrode (4) remains fixed without slipping.

4. A watertight burr hole closing device according to any preceding claims;comprises; a screw (5) positioned in the screw housing (9) to fix the said burr hole closing device to the burr hole.

5. A watertight burr hole closing device according to any preceding claims; comprises; slots formed on the upper body (1) to fix the said deep brain stimulation electrode (4) on the upper body (1).

6. A watertight burr hole closing device according to any preceding claims; said burr hole closing device contains titanium material to reduce the risk of postoperative complications and infection.

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