Medical coagulation device for treating spinal haemorrhages

Abstract

The present invention relates to a disposable coagulation device for treating haemorrhages during spinal surgery. The device is designed for uniportal endoscopic spinal surgery procedures. The main purpose of the device is to provide efficient coagulation in lateral areas of the bone and in anatomical areas that are difficult to reach with traditional coagulation.

Description

[0001] MEDICAL COAGULATION DEVICE FOR TREATING SPINAL BLEEDING

[0002] FIELD OF INVENTION

[0003] The present invention relates to a disposable coagulation device for treating hemorrhages in spinal surgeries. The device is designed for uniportal endoscopic spinal surgery procedures. Its main function is to efficiently coagulate lateral areas of the bone and anatomical corners that are difficult to reach with traditional coagulation.

[0004] BACKGROUND OF THE INVENTION

[0005] Until a few years ago, spinal surgery involved major operations and traumatic muscle dissections, as well as bone removal or fusion. However, the development of minimally invasive spinal surgery overcomes many of the disadvantages of traditional spinal surgery. Endoscopic spinal procedures provide minimally invasive access to the spinal canal, thus minimizing epidural bleeding and subsequent scarring. Nevertheless, there is still a significant risk of bleeding that must be controlled to avoid complications during the surgery and to protect the patient's health.

[0006] In endoscopic surgery, coagulation devices are key instruments for controlling bleeding in the surgical area. Through electrosurgery, the coagulation device uses high-frequency electrical currents to perform coagulation, cutting, or tissue dissection functions. This procedure helps to stop bleeding quickly and precisely, minimizing blood loss and providing the surgeon with a clear view of the intervention area. Monopolar and bipolar radiofrequency devices have been used for limited purposes in spinal surgery, primarily for hemostasis. Monopolar devices, however, have the disadvantage that the electrical current will flow through undefined pathways in the patient's body, increasing the risk of unwanted electrical stimulation in sensitive areas such as the spinal cord or peripheral nerves.Furthermore, when using monopolar electrodes, the return plate must be properly positioned to avoid skin burns; if the plate is not correctly attached, the current may disperse and cause burns at other contact points of the patient.

[0007] Since the defined pathway through the patient's body has a relatively high impedance (due to the large distance or the patient's body resistivity), large voltage differences between the return and active electrodes are typically required to generate a current sufficient for ablation or cutting of the target tissue. However, this current can inadvertently flow along body pathways that have lower impedance than the defined electrical path, substantially increasing the current flowing through these pathways and potentially causing damage to or destruction of surrounding tissue or neighboring peripheral nerves.

[0008] Another significant disadvantage of conventional radiofrequency devices, particularly monopolar devices, is that the device causes nerve stimulation and interference with nerve monitoring equipment in the operating room. Furthermore, these devices typically operate by creating a voltage difference between the active electrode and the target tissue, causing an electrical arc to form across the physical space between the electrode and the tissue. At the point of contact of the electrical arc with the tissue, rapid heating occurs due to the high current density between the electrode and the tissue. This high current density raises the temperature of the cells, causing the cellular fluids to vaporize rapidly, thus producing a "cutting effect" by causing cells to explode along the localized tissue heating pathway.Thus, as tissue is separated along the path of evaporated cellular fluid, the heating process induces undesirable thermal collateral damage to tissues in the regions surrounding the target tissue site. This collateral tissue damage often includes indiscriminate tissue destruction, resulting in thermal necrosis and loss of proper tissue function. Furthermore, the conventional device does not directly remove any tissue but relies on destroying a zone of tissue and allowing the body to encapsulate the area with scar tissue or eventually eliminate the destroyed tissue through phagocytosis.

[0009] Examples of coagulation equipment or devices for spinal surgery can be found in the prior art; for example, application W02022011177 discloses probes, methods, and apparatus that can provide improved hemostasis to bleeding tissue and can be used for the treatment of bleeding tissue with residual collagen fibers. In some embodiments, a probe is configured with a flushing port and an evacuation port arranged to establish a flow path for removing blood from resected tissue. In some embodiments, the probe comprises a balloon configured to expand and come into contact with the resected tissue to compress the filaments and improve access to the underlying blood vessels for coagulation with an energy source such as a laser beam.An endoscope can be used to view the tissue, and the balloon may be made of a transparent material to allow imaging of the bleeding tissue through the balloon. The endoscope may include a viewing port inside or outside the balloon to obtain images of the tissue through the balloon. In some embodiments, the probe includes a light source configured to illuminate the tissue with a beam oriented at an oblique angle to the tissue surface, which may reduce interference from blood and allow for more localized coagulation of the blood vessel.

[0010] The probe may comprise a shaft and one or more electrodes suitable for performing electrocautery. The electrode may comprise one or more monopolar, unipolar, or bipolar electrodes, or an electrode array, for example. In some embodiments, a bleeding tissue location is identified as described herein, and the electrode can be moved to the bleeding location in response to processor commands to cauterize the tissue at that location. The probe may be combined with one or more probes as described herein, for example, to provide fluid flow and visualization of the bleeding tissue region and to identify the tissue to be treated.

[0011] However, despite the above demonstrated by the state of the art, there remains a need to supply a disposable coagulation device for treating spinal injuries that is capable of efficiently coagulating lateral areas of the bone and anatomical corners that are difficult to reach with traditional coagulation.

[0012] BRIEF DESCRIPTION OF THE FIGURES

[0013] Figure 1 presents a perspective view of the disposable coagulation device.

[0014] Figure 2 presents an enlarged view of the coagulation device tip configuration.

[0015] Figure 3 is an enlarged side perspective view of the angle of attack configuration of the coagulation device tip.

[0016] Figure 4 is a detailed, enlarged view of the tip of the coagulation device. OBJECT OF THE INVENTION

[0017] The object of the present invention relates to a disposable coagulation device for treating hemorrhages in spinal surgeries. The device is designed for uniportal endoscopic spinal surgery procedures. Its main function is to efficiently coagulate lateral areas of the bone and anatomical corners that are difficult to reach with traditional coagulation devices known to date.

[0018] DETAILED DESCRIPTION OF THE INVENTION

[0019] More particularly, the present invention relates to a disposable coagulation device for treating hemorrhages in spinal surgeries, characterized in that it comprises a radiofrequency generator (1) that converts conventional electrical energy into high-frequency current, enabling the coagulation electrode to perform specific functions for controlling bleeding and cutting tissue. This generator is key to adjusting the amount and type of energy transmitted through the electrode and ensuring safe and effective application in the surgical area. The generator produces electrical currents at frequencies of 300 kHz to 4 MHz, sufficient to generate heat in the tissue without causing muscle contractions in the patient. The frequency employed converts the current into an agent capable of cutting and coagulating without unnecessarily damaging the area.The generator allows adjustment of the intensity, frequency, and type of current to induce the desiccation or denaturation of proteins, thereby sealing blood vessels and controlling bleeding. This radiofrequency generator allows power adjustments based on tissue type and the procedure's objective. For example, denser or moister tissues may require more energy to achieve adequate coagulation, while delicate areas need more precise control to avoid damage.

[0020] Attached to this radiofrequency generator (1) is a bipolar cable element (2). The bipolar cable serves as a conduit between the radiofrequency generator and the bipolar coagulation element, allowing the current to pass through the target tissue to perform localized coagulation or cutting. Unlike monopolar systems, where the current flows from the active electrode to a return plate in the patient, in bipolar systems the current travels between two closely spaced tips on the same instrument, providing a closed and more controlled circuit. Because it does not require a return plate and uses current in a confined area, the bipolar system is generally safer for patients with implanted medical devices (such as pacemakers) since the current remains in a small area without affecting the rest of the body.Another advantage of the present invention is that in the bipolar system, the cable (2), by not requiring said return plate in the patient's body, eliminates the risk of skin burns caused by contact problems with the plate, facilitating manipulation and positioning during the surgical procedure.

[0021] The bipolar cable element (2) allows for the bidirectional transmission of high-frequency current. The cable (2) connects the radiofrequency generator (1) to both electrode tips (one active and one return tip) on the same device, enabling the current to flow directly between the two tips, passing only through the target tissue area. By keeping the current in a very specific zone, the bipolar cable (2) helps prevent energy dispersion to other tissues, minimizing the risk of burns or injury to surrounding areas. This makes it ideal for procedures in delicate areas or tissues where localized coagulation is required.

[0022] This bipolar cable has specific connection modes for bipolar functions in its connection to the radio frequency generator (1), such as precise adjustments in the intensity and frequency of the current, optimized for procedures that require maximum precision.

[0023] The coagulation device of the present invention also has a manipulation and control element (3) through which said bipolar cable element (2) passes; to said manipulation and control element (3) is connected an electrode element (4) which has the function of transmitting the radiofrequency energy (provided by the generator) to the target tissue during surgery; the controlled thermal energy allows coagulation of blood vessels and effective control of bleeding.In hemostatic procedures, the electrode transforms high-frequency electrical current into heat upon contact with tissues, causing coagulation or desiccation and helping to stop bleeding. When the electrode makes contact with the tissue, the high-frequency current generates heat, causing the denaturation of proteins in the blood vessels, resulting in the closure or "sealing" of the vessels, stopping the flow of blood and achieving hemostasis. Depending on the type of electrode, the instrument can apply energy more broadly or in a more focused manner, allowing the surgeon to control the depth and extent of coagulation according to the size of the vessel or target area.

[0024] Coagulation electrodes, especially bipolar ones, are designed to apply energy only to the direct contact area where the current flows only between the two electrode tips, preventing energy dispersion and reducing the risk of burns to nearby tissues.

[0025] Continuing with the description of the coagulation device of the invention, it is noted that at the proximal end (5) of the electrode (4) is the electrode tip element (8), which has a cover element (6) to prevent energy conduction to unwanted tissues. This cover element (6) extends from the area of ​​the proximal element (5) to just before the electrode tip element (8), except for a concave region (9) at the end of the electrode and at the electrode tip (8). The cover element (6) is a partial coating that extends to just before the active zone (8, 9). This coating ensures that only the terminal end is in contact with the tissue for greater precision, which is especially important in delicate procedures or in areas with sensitive structures.This cover element (6) is an electrically conductive insulation element and is composed of materials such as silicone, which is a flexible, high-temperature resistant, and low-cost material; another material used is polytetrafluoroethylene (PTFE or Teflon), which is highly heat resistant and has excellent insulating properties. Furthermore, its non-stick surface prevents tissues and debris from adhering to the electrode, facilitating clean and precise coagulation; ceramic can also be used for the cover element (6) because it has excellent thermal resistance and insulation properties, helping to prevent heat from spreading to unwanted areas; polyamide or nylon is another desirable material.

[0026] Now, going into more detail, we see that from the proximal element (5) there is an elbow-shaped extension (10) that forms the end or intervention area of ​​the coagulation element. This end presents a 90° angle of attack (7) between the proximal element (5) and the electrode tip (8). The angle of attack or intervention of the electrode tip is fundamental in electrosurgery because it directly influences the precision, efficacy, and safety of the coagulation or cutting process. This angle refers to the inclination at which the electrode tip makes contact with the tissue and has a significant impact on how energy is transmitted and on the results obtained in the treated tissue. The angle at which the electrode touches the tissue determines the amount of energy that penetrates it.An optimal angle allows energy to be distributed evenly, achieving controlled coagulation and preventing excessive penetration that could damage deeper tissues. By reducing the possibility of burns in unwanted layers, the structure and function of the surrounding tissues are better preserved.

[0027] A very important advantage of the coagulation device of the present invention is that it efficiently coagulates lateral areas of bone and anatomical corners that are difficult to reach with traditional coagulation; in surgical areas that are difficult to access or close to sensitive structures, an appropriate angle of the electrode tip allows for a more focused application of the current, and this is especially useful in interventions near nerves, small vessels, or in areas where high precision is required to avoid damage to adjacent tissues.

[0028] Another effect achieved with the precise 90° angle of attack is that the current can be dispersed in a balanced way. For example, in other coagulation elements, the angles of attack are too steep, generating a wider contact area, which in turn reduces energy density and makes coagulation less effective or more diffuse. Conversely, a very perpendicular angle increases energy density, increasing the risk of burns or charring.

[0029] This 90° angle of attack minimizes the risk of charring, which occurs when tissue is excessively burned and becomes black and hard (scarification). Scarring can obstruct the surgeon's view and hinder healing, as well as increase the risk of infection. Applying the electrode at a controlled angle allows for clean and less traumatic coagulation, reducing the amount of tissue damage. This 90° angle of attack also optimizes energy transmission efficiency, ensuring that only the necessary amount of current reaches the contact area. This is particularly important for procedures requiring precise cutting and coagulation, such as sealing small blood vessels without compromising surrounding tissue.This angle, which characterizes the electrode of the present invention, also prevents excessive tissue adhesion to the electrode tip, which would interrupt the continuous flow of energy and may require frequent cleaning of the electrode during surgery. This controlled angle of attack also allows the surgeon to have a better view of the intervention area, a crucial factor in delicate procedures where a clear field of vision is needed to evaluate the electrode's effect in real time and make rapid adjustments as necessary.

[0030] Regarding the dimensions and measurements of the coagulation device of the present invention, the electrode element (4) has a length of between 25 and 40 cm and a diameter of between 2 and 3.5 mm. The electrode tip element (8) has a length of between 1.0 and 2.0 mm.

[0031] Although the present invention has been described with the preferred embodiments shown, it is understood that modifications and variations that preserve the spirit and scope of this invention are understood to be within the scope of the attached claims.

Claims

CLAIMS 1. A disposable coagulation device for treating spinal dysfunctions characterized in that it comprises a radiofrequency generator (1), a bipolar cable element (2) connected to said radiofrequency generator, a manipulation and control element (3) through which said bipolar cable element (2) passes; an electrode element (4) is connected to said manipulation and control element (3); at the proximal (5) intervention end of said electrode (4) is the electrode tip element (8) having a cover element (6) to prevent conduction of energy to unwanted tissues; said cover element (6) extends from the area of ​​the proximal element (5) to before said electrode tip element (8) except in a concave region (9) of the electrode end and at the electrode tip (8).From said proximal element (5) there is an elbow-shaped extension (10) that forms the end or intervention area of ​​said coagulation element; said end has, between the proximal element (5) and the tip of the electrode (8) an intervention or attack angle (7) of 90°.

2. The disposable coagulation device for treating spinal dysfunctions of claim 1 characterized in that said cover element (6) is an electrically conductive insulation element and is a material composed of materials such as silicone, polytetrafluoroethylene, ceramic and polyamide.

3. The disposable coagulation device for treating spinal dysfunctions of claim 1 characterized in that said electrode tip element (8) has said concave region (9) which is also active and which allows the conduction of the electrical current modulated by said radiofrequency generator (1).

4. The disposable coagulation device for treating spinal dysfunctions of claim 1, characterized in that the electrode element (4) has a length of between 25 and 40 cm and a diameter of between 2 and 3.5 mm.

5. The disposable coagulation device for treating spinal dysfunctions of claim 1, characterized in that the electrode tip element (8) has a length of between 1.0 and 2.0 mm.

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