Spinal needle with expandable cerebrospinal fluid sensor

Abstract

The present invention relates to a spinal needle that clearly identifies the presence of cerebrospinal fluid (CFS) to dispense a drug or anaesthetic in the correct direction and site of the meninges. The response of the sensor to the presence of CFS does not depend on environmental factors and is performed quickly to prevent excessive loss of CFS in the patient. The spinal needle comprises a hub having a proximal end and a distal end, said hub comprising a transparent tank arranged at the proximal end of the hub that is configured to receive CFS, an expandable CFS sensor arranged inside the transparent tank and a connection port arranged at the distal end of the hub configured to couple to a device for medical fluids, and a cannula comprising a tip fluidically connected to the proximal end of the hub.

Description

SPINAL NEEDLE WITH EXPANDABLE CEREBROSPINAL FLUID DETECTOR Field of invention

[0001] The present invention relates to the field of medicine, particularly to the design of medical devices and equipment for anesthesia or analgesia procedures, and more particularly, it relates to a spinal needle with an expandable cerebrospinal fluid (CSF) detector. Background of the invention

[0002] There are two basic techniques for administering medication to a patient's spinal area during neuraxial regional anesthesia: epidural and subdural. These can be used to create spinal anesthesia or analgesia. In these procedures, an anesthetic is injected into the spinal cord and nerve roots to block pain sensations in a region of the body, such as the abdomen, hips, legs, or pelvis, during various surgical or invasive procedures.

[0003] These medical techniques involve some risks for patients. For this reason, it is important to consider the main parts of the human body involved in these procedures, such as the meninges and cerebrospinal fluid (CSF), which protect the central nervous system. As is well known, the meninges are composed of three layers: the dura mater, the arachnoid mater, and the pia mater. The dura mater is the strongest, most inflexible, and outermost layer of the three; the arachnoid mater is the middle membrane; and the pia mater is the innermost and most delicate layer of the meninges. CSF is a clear, colorless, watery body fluid that occupies the subarachnoid space, which is the space between the arachnoid and pia mater layers of the meninges.

[0004] Epidural anesthesia involves accessing the tissues with a hollow spinal needle (such as a Tuohy needle) and inserting a flexible catheter into the space between the spine and the outer membrane of the spinal cord (epidural space) in the mid or lower back. The area where the needle is inserted is blocked with local anesthetic. The needle is then inserted and removed after the catheter has passed through the epidural space, leaving the catheter in place. Anesthetic is injected into the catheter to block the area of ​​the body above or below the injection site, as needed. The catheter is secured to the back so it can be reused if more anesthetic is required.

[0005] Subdural or spinal anesthesia is performed in the same way, except that the anesthetic is injected directly into the cerebrospinal fluid (CSF) surrounding the spinal cord with the aid of a second spinal needle, such as a Whitacre, Quincke, or Sprotte needle. This second needle is inserted inside the first spinal needle (Tuohy needle). Subdural anesthesia blocks the part of the body below the injection site, depending on the anesthetic dose and the technique used.

[0006] Sometimes, a spinal catheter can be inserted and left in place at the injection site to provide continuous spinal anesthesia instead of using the second needle.

[0007] Any spinal needle must pierce the skin, subcutaneous fat, supraspinous ligament, intraspinous ligament, ligamentum flavum, epidural space (in the case of epidural anesthesia), dura mater, and arachnoid layer until the needle reaches the subarachnoid space, in which the spinal cord and nerve roots are surrounded by CSF (in the case of subdural anesthesia).

[0008] On the other hand, there is also mixed anesthesia, which consists of applying a combination of two anesthetic techniques, for example, the combination of epidural and subdural anesthesia. In mixed anesthesia, balanced anesthesia can be achieved by first administering a dose to the subdural space; this dose will have the anesthetic effect on the entire area. surgery, and subsequently, if necessary, supplying small booster doses through the epidural catheter to the epidural space itself, this balanced technique avoids the use of large volumes of anesthetic, in addition to minimizing the toxicity of anesthetics to the patient during the procedure.

[0009] In epidural or subdural anesthesia, it is crucial to ensure the injection reaches the intended area correctly; otherwise, the anesthetic can affect the nervous, cardiovascular, and respiratory systems. Both epidural and subdural anesthesia can significantly impair breathing, heart rate, and other vital functions. Furthermore, there is a potential risk of toxicity from administering large doses of medication that are not necessary to achieve adequate blockade. As mentioned, the direction of flow in which the anesthetic is delivered into the epidural or subarachnoid space is critical to achieving the desired blockade of the body part.

[0010] In an effort to improve the methods and devices for locating the epidural or subarachnoid space, several proposals have been developed, as revealed in the state of the art below:

[0011] U.S. Patent No. 6,925,323, relating to a System for Increasing Visibility in the Epidural Space, discloses a method of epidural surgery that improves visibility in a patient's epidural space to effectively conduct therapeutic surgery in that space. The method includes the steps of distending a portion of the patient's epidural space by filling it with a fluid administered through a catheter; placing an optical viewfinder in the distended portion of the epidural space by inserting the viewfinder through the same catheter that delivers the fluid for distension, thereby providing a visual image of the epidural space.

[0012] U.S. Patent No. 6,773,417 discloses an epidural space locator device comprising a body section having a first end and a second end; a channel extending between said ends, wherein the first end is attachable to a Luer connector; and a collapsible back chamber having one end coupled to the second end of the One end of the chamber is exposed in such a way that it allows pressure to be applied with one or more fingers of the hand, so that when there is positive pressure inside the chamber, it maintains its shape and when the pressure is negative or zero inside the chamber, it collapses, indicating the location of the epidural space through a needle that is attached to a Luer connector; and the loss of pressure inside the chamber is detected with the fingers of the hand as the shape of the chamber collapses, so highly trained personnel are required to detect the change in pressure.

[0013] U.S. Patent No. 6,558,353 discloses a needle comprising a needle hub disposed at the proximal end of a hollow needle. The needle hub has port indicators that provide visual and tactile verification to a user regarding the orientation of the needle tip, and more specifically, the needle hub includes projections for tactile verification and a magnifying window for visual verification. However, both the projections and the window are very small, and visual detection of cerebrospinal fluid (CSF) through the needle is not always achieved. In fact, on some occasions, small air bubbles concentrate below the window, distorting the view when a user looks through it.

[0014] Additionally, the Whitacre and Tuohy needles, known in the prior art, include a small groove that helps the surgeon determine the needle tip's orientation; however, with these simple needles, as well as with the needle described in U.S. Patent 6,925,323, the presence of cerebrospinal fluid (CSF) has not been effectively detected visually through the needle. The magnifying eyepiece of U.S. Patent 6,925,323 is very small compared to the needle hub. A common medical practice for detecting CSF has been to allow CSF to drip from the proximal end of the spinal needle; however, excessive CSF loss can cause headaches. For this reason, it is essential to clearly detect the presence of CSF to accurately dose the medication or anesthetic to the correct location and direction within the meninges. Otherwise, if CSF cannot be obtained through the needle, the surgical procedure must be delayed or abandoned.

[0015] Mexican patent application MX / a / 2007 / 006751 describes a needle useful for determining the direction of the needle tip once the CSF is inside the needle in a chamber incorporated therein; however, because the CSF is clear and almost transparent, optical identification is difficult, repeating many of the problems mentioned above.

[0016] Additionally, to make the presence of cerebrospinal fluid (CSF) within the spinal needle evident, technologies have been developed that include materials capable of reacting upon contact with CSF. For example, international application WO2024 / 047375 comprises a thermochromic detector capable of changing color upon contact with CSF due to its temperature. This device assumes that operating rooms maintain a constant temperature of around 25°C, and that the thermochromic detector begins to change color at 30°C. Therefore, it could change color only upon contact with CSF, which has a temperature of approximately 36°C. However, visualizing the color change of the thermochromic detector can be difficult due to the lighting conditions in an operating room.Furthermore, although the temperature within these types of spaces must be controlled, this adds an additional aspect that requires special attention to ensure the detector performs its function correctly.

[0017] Therefore, although there are some devices and methods to locate the epidural or subarachnoid space, as well as devices that attempt to make the presence of CSF evident through spinal needles with thermochromic detectors or magnifying viewports, there is a need for devices that make the presence of CSF evident in a clearer way without depending on environmental factors, such as temperature or humidity, and whose response to the presence of CSF is carried out quickly to avoid excessive CSF loss in the patient. Objects of the invention

[0018] Taking into account the defects of the prior art, it is an object of the present invention to provide a spinal needle with a CSF detector that allows clear identification of the presence of CSF in order to dose a drug or anesthetic in the correct direction and location of the meninges, wherein the detector exhibits a response to the presence of CSF that is not dependent on environmental factors and that is carried out quickly to avoid excessive CSF loss in the patient.

[0019] These and other objects are achieved by means of a spinal needle with expandable CSF detector in accordance with the present invention. Brief description of the invention

[0020] To overcome the problems of the prior art regarding the correct detection and visualization of CSF in conjunction with the orientation of the spinal needle tip, a spinal needle has been developed comprising: a hub having a proximal end and a distal end, which comprises: a transparent reservoir disposed at the proximal end of the hub and configured to receive CSF, an expandable CSF detector disposed within the transparent reservoir, and a connection port disposed at the distal end of the hub and configured to couple with a medical fluid device; and a cannula comprising a tip and fluidically attached to the proximal end of the hub. Brief description of the figures

[0021] The novel aspects that are considered characteristic of the present invention will be set forth in detail in the appended claims. However, some of its features, characteristics, and some of its objects and advantages will be better understood in the detailed description, when read in conjunction with the accompanying drawings, in which: Fig.1

[0022] [Fig.1] Figure 1 illustrates an isometric view of a spinal needle according to an embodiment of the present invention. Fig.2

[0023] [Fig.2] Figure 2 illustrates an exploded isometric view of a spinal needle according to an embodiment of the present invention. Fig. 3

[0024] [Fig.3] Figure 3 illustrates an exploded isometric view of a spinal needle according to an embodiment of the present invention. Fig.4

[0025] [Fig.4] Figure 4 illustrates an isometric view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 5

[0026] [Fig.5] Figure 5 illustrates an isometric view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 6

[0027] [Fig.6] Figure 6 illustrates a side view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 7

[0028] [Fig.7] Figure 7 illustrates a top view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 8

[0029] [Fig.8] Figure 8 illustrates a longitudinal cross-sectional side view of a pinhole of a spinal needle according to an embodiment of the present invention. Fig. 9

[0030] [Fig.9] Figure 9 illustrates an exploded isometric view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 10

[0031] [Fig.10] Figure 10 illustrates an exploded isometric view of a spinal needle pavilion according to an embodiment of the present invention. Fig. 11

[0032] [Fig.11] Figure 11 illustrates a longitudinal cross-sectional side view of a spinal needle according to an embodiment of the present invention. Detailed description of the invention

[0033] It should be understood that the present invention is not limited to the methodologies, protocols, and elements provided in the detailed description, as these may vary. It should also be understood that the terminology used herein is merely to describe particular embodiments and is not intended to limit the scope of this disclosure, which is limited only by the appended claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by a person skilled in the art.

[0034] It has been found that a spinal needle capable of facilitating the detection of CSF within the needle is required to deliver a drug or anesthetic to the correct direction and location within the meninges and to prevent excessive CSF loss by the patient. Therefore, the present invention relates to a spinal needle (10) comprising: a) a hub (20) having a proximal end (21) and a distal end (22), which comprises: i) a transparent reservoir (30) disposed in the proximal end (21) of the hub (20) and configured to receive CSF, i) an expandable CSF detector (40) disposed within the transparent reservoir (30), iii) a connection port (24) disposed at the distal end (22) of the hub (20) and configured to couple with a medical fluid device (not illustrated); and b) a cannula (50) comprising a tip (52) and fluidically attached to the proximal end (21) of the hub (20).

[0035] For explanatory purposes and in accordance with the context of the present invention, the proximal direction is the one that is closest to the patient, while the distal direction is the one that is closest to the medical personnel, when the needle is in use.

[0036] An objective of the present invention is to provide a needle that allows and facilitates the visualization of CSF, so that the design and structure of the needle hub that receives the CSF is of particular importance for medical personnel to notice the presence of CSF in order to perform the corresponding procedure.

[0037] In this sense, the pavilion (20) comprises a transparent reservoir (30) that receives and houses the CSF, which is located at the proximal end (21) of the pavilion (20), as close as possible to the junction with the cannula (50) to avoid excessive CSF loss.

[0038] With reference to what is illustrated in Figures 4 to 10, a spinal needle pavilion (20) is shown in accordance with an embodiment of the present invention, the components of which will be described later.

[0039] According to one embodiment of the present invention and as can be seen in Figures 4 to 10, the transparent reservoir (30) protrudes from the pavilion (20), so that a portion of it extends perpendicularly with respect to the longitudinal axis of the pavilion (20), which facilitates visualization by medical personnel when using the needle to carry out a procedure.

[0040] It can also be observed that the transparent deposit (30) is made up of a proximal wall (31), a distal wall (32), left (33) and right (34) lateral walls, a base (35) and a top wall (36).

[0041] The geometry of the transparent reservoir (30) is not particularly limited, provided that it includes a portion that protrudes from the hub (20) of the needle, allowing for easy handling by medical personnel. According to a non-limiting embodiment, and as can be seen in Figures 4 to 10, the upper wall (36) of the transparent reservoir (30) has a convex geometry, while its proximal (31), distal (32), lateral (33, 34) walls and base (35) have a flat geometry. In this respect, the flat base (35) of the transparent reservoir (30) allows the spinal needle (10) to be placed statically on a surface.

[0042] Additionally, in accordance with a non-limiting embodiment of the present invention, the edges joining the walls of the transparent tank (30) are rounded.

[0043] The transparent reservoir must be designed to hold the expandable CSF detector and ensure rapid contact between the detector and the CSF, thus avoiding the need for a large quantity of CSF. In this regard, and in accordance with an additional, non-limiting embodiment, the transparent reservoir (30) has an internal volume capacity of 0.05 mL to 5 mL, preferably 0.05 mL to 0.1 mL.

[0044] The transparent reservoir design (30) shown in Figures 4 to 10 illustrates a version of the reservoir with which better conditions were observed with respect to the assembly of the parts that make up the spinal needle (10), arrangement of the CSF expandable detector (40), ease of expansion by the CSF expandable detector (40) and visualization of both the CSF and the CSF expandable detector (40) in operation.

[0045] To arrive at the transparent reservoir design (30) shown in Figures 4 to 10, different geometries were tested, mostly cylindrical or polygonal, protruding radially from the pavilion. These presented problems with visibility and placement of the CSF detector. It was determined that most of these designs required additional parts. additional for the placement of the LCR detector, which in turn hindered its expansion response upon contact with the LCR, so a greater quantity was required to be able to observe a visually evident expansion.

[0046] Now, with respect to the CSF detector, one of the objectives of the present invention is to provide a spinal needle that allows for the detection of CSF in a manner readily apparent to medical personnel, and whose operation is independent of the environmental conditions in which it is used, such as temperature or humidity within an operating room. In this regard, the researchers of the present invention undertook the task of testing different materials capable of detecting the presence of CSF, seeking materials that do not shed particles or chemical substances that could cause contamination, deterioration of their physical and functional properties during manufacturing, or deterioration of their physical and functional properties during storage.

[0047] In this regard, after testing different materials such as pH measurement paper or plastics, glucose detection paper or plastics, and hydrophilic materials, it was determined that the most suitable material to serve as a CSF detector (40), taking into account its ease of visualization, is a material capable of expanding upon contact with CSF. Furthermore, these materials must meet the requirement of not releasing particles or chemical substances during storage or use to avoid contamination. Therefore, and as a particularly preferred but not exclusive option, the material for the expandable CSF detector (40) is hydrophilic cellulose.

[0048] Once the researchers selected the appropriate material to detect the presence of CSF, they looked for a way to make the response take place as quickly as possible in order to avoid excessive CSF loss, for which different geometries and arrangements were tested within the transparent reservoir.

[0049] In conjunction with the geometry of the transparent tank, tests were carried out using different geometries of the hydrophilic material in different positions within the transparent reservoir, seeking that in addition to having an immediate response to detect the presence of CSF, its expansion is carried out without any difficulty and is clearly visible.

[0050] Among the combinations tested to achieve the objectives mentioned in the previous paragraph, square or rectangular geometries of the CSF detector were tested, attached to the base or proximal wall of the transparent reservoir, which presented problems in the ease of expansion by the detector and visualization during the use of the spinal needle.

[0051] Therefore, in accordance with one embodiment of the present invention, the LCR expandable detector (40) has a rounded flat geometry, so that it expands longitudinally upon contact with the LCR, preferably the geometry is selected from circular, oval and elliptical, particularly preferably and as shown in Figures 9 and 10, the LCR expandable detector (40) has a flat circular geometry, so that it expands forming a cylinder upon contact with the LCR.

[0052] Additionally, and in accordance with a preferred embodiment of the present invention, as illustrated in Figure 8, the CSF expander detector (40) is arranged in the lower region of the distal wall (32) of the transparent reservoir (30), on an axis parallel to the longitudinal axis of the cannula (50), so as to avoid any friction with the walls of the same transparent reservoir (30) during its expansion.

[0053] The combination of features related to the geometry of the transparent reservoir (30), the material of the CSF expandable detector (40), and its geometry and arrangement within the transparent reservoir (30), ensures that the detector responds with minimal CSF extraction. The CSF falls to the bottom of the transparent reservoir (30) and instantaneously causes the CSF detector (40) to expand. This expansion occurs in the direction of the proximal end (21) of the ear canal (20), facilitating visualization by medical personnel. Unlike other methods of detecting the presence of CSF described in the prior art, the effectiveness and / or responsiveness of the CSF expandable detector (40) depends solely on the presence of CSF. inside the tank, regardless of ambient temperature or humidity.

[0054] The LCR expandable detector must be fixed inside the transparent tank to ensure its effectiveness and visibility. Therefore, it was necessary to conduct tests with different types of adhesives to select a material that does not detach from the tank or release chemicals, and that has high adhesion capacity in humid conditions and high fixation capacity of the LCR detector during its shelf life and during use.

[0055] The researchers of the present invention carried out tests with different types of adhesives to determine which ones can meet the requirements described in the previous paragraph, within which it was determined that epoxy or gel adhesives are not suitable for this type of device, since there is a risk of contamination of both the sample taken from the patient and the medication to be supplied.

[0056] Now, in accordance with a preferred embodiment of the present invention, the expandable LCR detector (40) is arranged inside the transparent tank (30) by means of a contact film adhesive, since this material performs well by not detaching or causing contamination, and also has a high capacity for fixing in humid conditions.

[0057] In the context of the present invention, the contact film adhesive is understood to be a transparent tape coated on both sides with an adhesive, so that it is able to adhere to the wall of the pavilion and to the LCR expandable detector, in particular, but not limiting, the ink is made of a polyester material coated with a synthetic rubber-based adhesive.

[0058] The spinal needle hub is provided with a section designed to prevent the spinal needle from rotating when placed on a surface, thus avoiding any incidents while the needle is not in use. To this end, an anti-rotation protruding section (25) is provided, consisting of a plate arranged perpendicular to the longitudinal axis of the hub (20), whose dimensions protrude from the perimeter of the pavilion (20) and where the perimeter of the plate comprises a flat portion that gives the spinal needle (10) the ability to be placed on a surface in a static manner.

[0059] According to a non-limiting embodiment of the present invention, and as can be seen in Figures 4 to 10, the protruding anti-rotation section (25) consists of a plate that protrudes around the perimeter of the pavilion (20), comprising a flat-based fin oriented towards the bottom of the pavilion (20) configured to prevent the spinal needle (10) from rotating when placed on a surface, and a flat-based fin oriented towards the top of the pavilion (20).

[0060] In anesthesia procedures, whether subdural or epidural, knowing the orientation of the tip of a spinal needle cannula is vital for a successful and safe procedure. The cannula tip orientation precisely determines where the anesthetic is deposited. Incorrect orientation can cause complications such as incomplete anesthesia, damage to nerve structures, or inappropriate spread of the anesthetic to unintended areas. Additionally, if the tip orientation is incorrect, the anesthetic may not be distributed evenly, resulting in inadequate anesthetic block and the need for additional procedures. Therefore, knowing the orientation helps the healthcare professional adjust and maneuver the cannula efficiently during the procedure, which is especially important in a clinical setting where time and precision are critical.

[0061] Therefore, in accordance with a preferred embodiment of the present invention, the pavilion (20) comprises a first tactile mark (27) that provides guidance on the direction of the cannula tip (52).

[0062] According to a non-limiting embodiment of the present invention, and as can be seen in Figures 4, 5, 9 and 10, the first tactile mark (27) consists of a groove oriented in the same direction with respect to the tip of the cannula (52) and is located on the upper part of the flat-based fin facing the upper part of the pinna (20) of the anti-rotation protruding section (25), which gives the pinna (20) an ergonomic design that It allows the user to easily manipulate it so that with at least one finger they can feel the tactile mark and thus know the orientation of the cannula tip (52) in order to direct it appropriately.

[0063] The spinal needle (10) comprises a connection port (24) disposed at its distal end and configured to couple with a medical fluid device, such as a syringe or catheter containing a drug or anesthetic to be dispensed (not illustrated).

[0064] In accordance with a non-limiting embodiment of the present invention, and as can be seen in Figures 4 to 10, the connection port (24) of the pavilion (20) is a Luer type connector.

[0065] According to a further embodiment of the present invention, the cannula (50) of the spinal needle (10) has a pencil-point configuration, particularly preferably selected from the group consisting of a Whitacre pencil point, a Quincke point, or a Sprotte point.

[0066] In relation to the previous paragraph, the cannula (50) is very thin because it is designed to pierce the dura mater, thus reducing post-procedure headaches for the patient. Furthermore, the cannula (50) provides precise access and greater control for patient safety and comfort. The tip of the cannula (52) has the same orientation as the first tactile mark (27).

[0067] Referring to Figures 1 to 3, a spinal needle (10) assembled in accordance with an embodiment of the present invention is illustrated, which will be described in detail later.

[0068] Now, the connection of the cannula (50) to the hub (20) is made at the proximal end (21) of the hub (20), according to one embodiment of the present invention, and as can be seen in Figures 1 to 3, this connection is made by means of a coupling region (37) located at the most proximal end (21) of the hub (20). This coupling region (37) consists, without limitation, of an essentially hollow cylindrical portion with a textured perimeter and fluidically coupled to the cannula (50) and to the transparent reservoir (30) of the hub (20).

[0069] Additionally, to ensure the connection between the cannula (50) and the coupling region (37) of the hub (20), according to a preferred embodiment of the present invention, an adhesive material is provided. This material is placed in the coupling region (37) of the hub (20), inside an opening (38) located at its proximal end, and is used to fix the cannula (50) to said region. Preferably, the adhesive material is a UV adhesive (53), i.e., a glue that cures upon exposure to ultraviolet light.

[0070] Now, in order to avoid any type of incident when the spinal needle (10) is not in use, according to a further embodiment of the present invention, a protector (51) for the cannula (50) is included, which is capable of coupling with the coupling region (37) of the pavilion (20).

[0071] The pavilion (20) of the spinal needle (10) of the present invention is composed of two main elements, namely a transparent reservoir (30) and a connection port (24), and a preferred element that provides stability, namely an anti-rotation protruding region (25), which are fluidically joined together by transition sections.

[0072] In accordance with a non-limiting embodiment of the present invention and as can be seen in Figures 4 to 10, the pavilion (20) is configured with a first cylindrical transition section (23) located between the connection port (24) and the anti-rotation protruding section (25) and a second conical transition section (26) located between the anti-rotation protruding section (25) and the transparent reservoir (30).

[0073] Additionally, in accordance with a preferred but not limiting embodiment of the present invention, the spinal needle (10) comprises a second tactile mark (28), preferably located on the first transition section (23), which is oriented in the same direction with respect to the tip of the cannula (52).

[0074] According to a non-limiting embodiment of the present invention, the second tactile mark (28) consists of a relief that can have a shape selected from letters, numbers, and geometric figures.

[0075] In this sense, the spinal needle manipulation technique (10) by medical personnel is carried out using the middle finger and thumb to hold the spinal needle (10), while the index finger is used to locate the first tactile mark (27) and the second tactile mark (28).

[0076] Additionally, and with the aim of preventing the introduction of any foreign material into the spinal needle (10) before its use, according to one embodiment of the present invention, the spinal needle (10) comprises a mandrel guide (61) within the cannula (50), wherein said mandrel guide (61) runs along the entire longitudinal axis of the hub (20) to couple to the inner part of a mandrel base (60), which in turn couples to the connection port (24) at the proximal end (21) of the hub (20).

[0077] Referring to Figure 1, a coupled spinal needle (10) is illustrated, showing part of the hub (20), highlighting that the transparent reservoir (30) protrudes to facilitate its visualization. As part of the hub (20), the protruding anti-rotation section (25) is also visible. The figure shows the spinal needle (10) in a stored or unused state, comprising a cannula (50) protector (51) and a mandrel base (60) coupled to the connection port.

[0078] Now, Figures 2 and 3 illustrate an exploded view of the spinal needle (10) shown in Figure 1, where elements such as the mandrel guide (61), the expandable CSF detector (40), and the UV adhesive (53) can be seen.

[0079] Figures 4 to 7 illustrate a pavilion (20) of a spinal needle (10) as illustrated in Figures 1 to 3, from different perspectives, where the geometry and arrangement of elements can be appreciated in greater detail, such as the anti-rotation protruding section (25) with the respective first tactile mark (27), the transition sections (23, 26), the second tactile mark (28), the connection port (24) and the coupling region (37).

[0080] Referring to Figure 8, this illustrates a longitudinal section of the pin (20) of the spinal needle (10) shown in Figures 4 to 7, so that the fluidic connection between its components can be clearly seen, in addition to illustrating the position of the CSF expansion detector (40) within the transparent reservoir (30), which is attached to the distal wall (32) of the transparent reservoir (30) so that it expands towards the proximal end of the pavilion (21) avoiding friction with the rest of the walls.

[0081] Figures 9 and 10 illustrate exploded views of the pin (20) of the spinal needle (10) shown in Figures 4 to 7, where the CSF expander (40) can be seen. In these figures, it can be observed that the transparent reservoir (30) consists of two pieces that will be joined after the placement of the CSF expander (40). The joining technique of the two pieces of the transparent reservoir (30) must ensure proper functioning, preventing leaks and contamination.

[0082] In accordance with a non-limiting embodiment of the present invention, the joining technique used is ultrasound.

[0083] Figure 11 illustrates a cross-sectional view of the attached spinal needle (10).

[0084] With regard to the above, the spinal needle (10) operates as follows: the medical staff must locate the subarachnoid space and insert the cannula. Once this occurs, the CSF flows through the inside of the cannula (50) into the transparent reservoir (30), where a small amount of CSF is collected by contacting the CSF expander detector (40). This then expands towards the proximal end (21) of the auricle (20), which can be clearly seen from any of the walls of the transparent reservoir (30), thus alerting the medical staff to the presence of CSF in the spinal needle (10).

[0085] Once the medical staff is certain that they have located the subarachnoid space by detecting the presence of CSF in the transparent reservoir (30), the medical fluid device (not illustrated) can be attached to the connection port (24) at the distal end (22) of the hub (20) for subsequent administration of an anesthetic or medication through the spinal needle (10). The transparent reservoir (30) does not affect the administration of the anesthetic or medication.

[0086] The Tuohy, Whitacre, Quinckle, or Sprotte needles of the prior art can be configured according to the principles of the present invention, i.e., the spinal needle reservoir of the present invention can be provided in such known types of needles.

[0087] The combination of these elements forms a spinal needle with a transparent reservoir, which is used to detect the presence of CSF using an expandable detector during anesthesia and analgesia procedures required in surgical or invasive procedures.

[0088] In accordance with the foregoing, it will be observed that the spinal needle with expandable CSF detector has been designed to facilitate the detection of CSF within the needle and thus dispense a drug or anesthetic in the correct direction and location of the meninges without losing an excessive amount of the patient's CSF. It will be evident to any person skilled in the art that the spinal needle modalities with expandable CSF detector, as described above and illustrated in the accompanying drawings, are merely illustrative and not limiting to the present invention, since numerous significant changes in their details are possible without departing from the scope of the invention.

[0089] Therefore, the present invention shall not be considered restricted except as required by prior art and within the scope of the appended claims. List of references

[0090] 10 Spinal needle

[0091] Pavilion 20

[0092] 21 Proximal end of the auricle

[0093] 22 Distal end of the auricle

[0094] 23 First transition region

[0095] 24 Connection port

[0096] 25 Anti-rotation protruding section

[0097] 26 Second transition region

[0098] 27 First tactile brand

[0099] 28 Second tactile mark

[0100] 30 Transparent LCR reservoir

[0101] 31 Proximal wall of the clear CSF reservoir

[0102] 32 Distal wall of the clear CSF reservoir

[0103] 33 Left side wall of the transparent LCR tank

[0104] 34 Right side wall of the transparent LCR tank

[0105] 35 Base of the transparent LCR tank

[0106] 36 Top wall of the transparent LCR tank

[0107] 37 Docking region

[0108] 38 Opening of the coupling region

[0109] 40 LCR Detector

[0110] 50 Cannula

[0111] 51 Cannula protector

[0112] 52 Cannula tip

[0113] 53 UV Adhesive

[0114] 60 Chuck base

[0115] 61 Chuck Guide

Claims

Claims

1. i A spinal needle (10) characterized in that it comprises: a) a hub (20) having a proximal end (21) and a distal end (22), which comprises: i) a transparent reservoir (30) disposed in the proximal end (21) of the hub (20) and configured to receive CSF, i) an expandable CSF detector (40) disposed within the transparent reservoir (30), and iii) a connection port (24) disposed at the distal end (22) of the hub (20) and configured to couple with a medical fluid device; and b) a cannula (50) comprising a tip (52) and fluidically attached to the proximal end (21) of the hub (20).

2. The spinal needle (10) according to claim 1, further characterized in that the transparent reservoir (30) protrudes perpendicularly from the longitudinal axis of the pavilion (20) and is formed by a proximal wall (31), a distal wall (32), left (33) and right (34) side walls, a base (35) and a top wall (36).

3. The spinal needle (10) according to claim 2, further characterized in that the upper wall (36) of the transparent reservoir (30) comprises a convex geometry and its proximal (31), distal (32), lateral (33, 34) walls and base (35) comprise a flat geometry.

4. The spinal needle (10) according to claim 3, further characterized in that the edges of the walls of the transparent reservoir (30) are rounded.

5. The spinal needle (10) according to any of the preceding claims, further characterized in that the transparent reservoir (30) has an internal volume capacity of between 0.05 mL and 5 mL, preferably between 0.05 mL and 0.1 mL.

6. The spinal needle (10) according to any of the preceding claims, further characterized in that the expandable CSF detector (40) is a material capable of increasing its volume upon contact with CSF, preferably hydrophilic cellulose.

7. The spinal needle (10) according to claim 6, further characterized in that the CSF expandable detector (40) comprises a rounded flat geometry that expands longitudinally upon contact with the CSF, particularly preferably the detector geometry is selected from circular, oval and elliptical.

8. The spinal needle (10) according to claim 7, further characterized in that the CSF expander detector (40) is arranged in the lower region of the distal wall (32) of the transparent reservoir (30), on an axis parallel to the longitudinal axis of the cannula (50).

9. The spinal needle (10) according to claim 8, further characterized in that the CSF detector (40) is disposed within the transparent reservoir (30) by means of a contact film adhesive.

10. The spinal needle (10) according to any of the preceding claims, further characterized in that the pail (20) additionally comprises an anti-rotation protruding section (25) disposed between the transparent reservoir (30) and the connection port (24).

11. The spinal needle (10) according to claim 10, further characterized in that the protruding anti-rotation section (25) consists of a plate projecting around the perimeter of the pavilion (20), comprising a fin with a flat base oriented towards the lower part of the pavilion (20) configured to prevent the spinal needle (10) from rotating when placed on a surface and a flat-based fin facing upwards of the pavilion (20).

12. The spinal needle (10) according to claim 11, further characterized in that the pavilion (20) additionally comprises a first tactile mark (27) disposed on the top of the flat-based fin facing the top of the pavilion (20) of the anti-rotation protruding section (25).

13. The spinal needle (10) according to claim 12, further characterized in that the first tactile mark (27) consists of a groove oriented in the same direction with respect to the tip of the cannula (52).

14. The spinal needle (10) according to any of the preceding claims, further characterized in that the connection port (24) is a Luer-type connector.

15. The spinal needle (10) according to any of the preceding claims, further characterized in that the cannula (50) has a pencil-tip configuration.

16. The spinal needle (10) according to claim 15, further characterized in that the cannula (50) has a tip (52) selected from the group consisting of a Whitacre pencil-type tip, a Quincke-type tip, or a Sprotte-type tip.

17. The spinal needle (10) according to any of the preceding claims, further characterized in that the hub (20) comprises a coupling region (37) disposed at its most proximal end (21) and configured to join the cannula (50).

18. The spinal needle (10) according to claim 17, further characterized in that the union between the cannula (50) and the coupling region (37) of the hub (20) is carried out by means of an adhesive material, preferably by means of a UV adhesive (53).

19. The spinal needle (10) according to claim 17 or 18, further characterized in that it additionally It comprises a protector (51) for the cannula (50) capable of coupling with the coupling region (37) of the pavilion (20).

20. The spinal needle (10) according to any of claims 10 to 19, further characterized in that the hub (20) is configured with a first cylindrical transition section (23) located between the connection port (24) and the anti-rotation protruding section (25) and a second conical transition section (26) located between the anti-rotation protruding section (25) and the transparent reservoir (30).

21. The spinal needle (10) according to claim 20, further characterized in that the first transition section (23) comprises a second tactile mark (28) oriented in the same direction with respect to the tip of the cannula (52).

22. The spinal needle (10) according to claim 21, further characterized in that the second tactile mark (28) is a relief that can have a shape selected from letters, numbers and geometric figures.

23. The spinal needle (10) according to any of the preceding claims, further characterized in that it additionally comprises a mandrel guide (61) within the cannula (50).

24. The spinal needle (10) according to claim 23, further characterized in that the mandrel guide (61) runs along the entire longitudinal axis of the hub (20) to engage with a mandrel base (60), which in turn engages with the connection port (24).

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