DESC:FIELD

The present disclosure relates to spinal needles used in various medical procedures. In particular, it relates to a spinal needle apparatus having a hollow spinal needle that incorporates a central stylet. The spinal needle apparatus can be inserted into the subarachnoid space of the vertebral canal with minimal stretching or disturbance of the surrounding tissues. The apparatus is configured to enhance precision, safety, and user control during procedures such as lumbar punctures, spinal anesthesia, and intrathecal drug administration, and is adaptable for use with needles of varying gauge sizes. The apparatus includes features to facilitate accurate needle placement, reliable verification of cerebrospinal fluid (CSF) flow, and ergonomic handling, making it suitable for diverse clinical applications.

BACKGROUND

One of the primary applications of a spinal needle is to perform a lumbar puncture, also known as a spinal tap. During such medical procedure, the healthcare provider inserts the spinal needle between the vertebrae in the lower back to collect a sample of cerebrospinal fluid (CSF) for diagnostic testing. The collected CSF can be analyzed to help diagnose various neurological conditions, such as meningitis, encephalitis, multiple sclerosis and other neurological conditions.

By collecting and analyzing the CSF, healthcare providers can gain important insights into the patient's neurological health and facilitate the accurate diagnosis and management of various neurological conditions.

Spinal needles are also used to administer medications directly into the spinal canal. This may include anesthetics for regional anesthesia or pain management, as well as chemotherapy drugs for certain types of cancer. In surgical settings, spinal needles are used to deliver local anesthetics into the spinal canal to induce spinal anesthesia. This numbs the lower half of the body, allowing for pain-free surgery on the abdomen, pelvis, or lower extremities.

Spinal needles are sometimes used in conjunction with imaging techniques such as fluoroscopy to inject contrast dye into the spinal canal for myelography. Such procedure can help diagnose spinal cord injuries, tumors, or other abnormalities.

Overall, spinal needles are versatile medical devices that play a crucial role in various diagnostic and therapeutic procedures involving the spinal canal. The use of spinal needles require skill and precision to minimize the risk of complications such as nerve damage or infection. Therefore, they are typically employed by trained healthcare professionals in clinical settings. However, their use can be challenging due to the need for precise needle placement to avoid complications such as nerve damage, infection, or post-dural puncture headache. Conventional spinal needles may lack features to verify correct needle orientation or CSF return, and their designs may not adequately accommodate varying needle gauges or provide ergonomic handling for healthcare providers.

Conventional spinal needles often lack mechanisms for verifying needle orientation or CSF return, leading to potential misalignment or repeated insertion attempts. Additionally, many existing designs are limited to specific needle gauges, reducing their versatility. Ergonomic handling is often inadequate, increasing the risk of slippage or fatigue during delicate procedures. The present disclosure overcomes these limitations by providing a spinal needle apparatus with integrated verification features, adaptable gauge compatibility, and ergonomic design optimized for user control and patient safety. For example, prior art needles may rely on operator skill alone for orientation, lacking tactile or visual cues, and may not provide clear visualization of CSF flow, increasing the risk of procedural errors. In contrast, the present apparatus includes a modular tube insert for gauge adaptability, a pressure-fit stylet hub connection for stability, and enhanced visualization features to ensure accurate placement and flow confirmation.

The spinal cord and nerve roots are situated within the vertebral canal, which is surrounded by three membrane layers: the dura mater, arachnoid, and pia mater. The dura mater and arachnoid line in close proximity at the periphery of the canal, while the pia mater directly overlays the spinal cord. The space separating the dura mater and arachnoid from the pia mater is known as subarachnoid space. The subarachnoid space is the fluid-filled area between the arachnoid membrane and the pia mater, the innermost layer of the meninges that surround the spinal cord. This space is filled with cerebrospinal fluid (CSF) and contains the nerve roots as they exit the spinal cord. Accessing this space is crucial for performing procedures such as lumbar punctures, spinal anesthesia, and intrathecal drug administration. Further, accessing the subarachnoid space is a critical step in above stated procedures, as it allows healthcare providers to collect samples, administer medications, or perform diagnostic tests directly within the fluid-filled space surrounding the spinal cord and nerve roots.

The present disclosure addresses these limitations by providing a spinal needle apparatus with enhanced precision, safety, and adaptability. The apparatus incorporates features such as a secure stylet-needle connection, adaptable gauge compatibility, and visual/tactile feedback mechanisms to overcome the shortcomings of prior art devices. By incorporating an optimized design and the use of a central stylet, the present disclosure aims to enhance the safety, precision, and patient comfort during the insertion of the spinal needle into the subarachnoid space. The improved needle design may help minimize the risk of complications and improve the overall effectiveness of spinal procedures.

SUMMARY

Certain examples of the present disclosure are provided below. It should be understood that these examples are presented merely to provide the reader with a brief summary of certain forms the disclosure might take and that these examples are not intended to limit the scope of the disclosure. Indeed, the disclosure may encompass a variety of examples that may not be set forth below.

One of the objectives of this disclosure is to provide a spinal needle apparatus that enhances their functionality, safety, and ease of use for healthcare providers performing various spinal procedures.

Another objective is to provide a spinal needle apparatus that minimizes tissue trauma and improves patient outcomes through precise needle placement and reliable verification of cerebrospinal fluid (CSF) return.

Another objective is to provide a spinal needle apparatus being compatible with a range of needle gauges and adaptable to various clinical scenarios, including pediatric and adult patients, as well as patients with spinal deformities. The spinal needle apparatus 10 offers several clinical advantages, including reduced risk of post-dural puncture headache due to precise needle placement, minimized tissue trauma from the stylet’s occlusion of the needle lumen, and improved patient comfort during procedures. The apparatus’s adaptability to various needle gauges enables its use in diverse patient populations, including pediatric and adult patients, enhancing its utility in clinical settings. Additionally, the apparatus’s ergonomic design reduces operator fatigue, while its verification features improve procedural efficiency and reduce the likelihood of repeated insertion attempts, potentially lowering complication rates.

Another objective is to incorporate means for visually and tactually verifying the orientation of the needle side port. This feature aims to assist healthcare providers in accurately positioning the side port during the insertion of the spinal needle into the subarachnoid space. The means may include visual markers, tactile indicators, or alignment features integrated into the needle hub or stylet hub to ensure correct orientation during insertion.

Another objective of the present disclosure is to provide a spinal needle apparatus with a mechanism that facilitates visual verification of cerebrospinal fluid (CSF) return. This feature can help confirm the successful placement of the needle tip within the subarachnoid space, allowing for accurate sample collection or medication administration. The mechanism may include a transparent or translucent portion of the needle hub or a dedicated CSF visualization chamber to enhance visibility of CSF flow.

The present disclosure provides a spinal needle apparatus designed to enhance precision, safety, and ease of use in medical procedures such as lumbar punctures, spinal anesthesia, and intrathecal drug administration. The apparatus comprises a stylet assembly including a stylet hub and a stylet, and a needle assembly including a needle hub, a housing, and a hollow needle. The stylet is configured to occlude the hollow needle’s internal lumen during insertion to minimize tissue trauma, while the stylet hub features an engaging element that forms a secure, releasable pressure-fit connection with the needle hub, ensuring stability and precise manipulation during procedures.

The apparatus comprises a modular tube insert within the needle hub’s housing, which includes a through channel and conical openings to accommodate hollow needles of varying gauge sizes, enhancing versatility across diverse patient populations, including pediatric and adult patients. The stylet hub incorporates raised portions, flat portions, and visual or tactile indicators, such as color-coded markers or raised ridges, to facilitate ergonomic handling and verify needle orientation. The needle hub includes a finger grip with concave surfaces for precise control and a mechanism, such as a transparent portion or CSF visualization chamber, to confirm cerebrospinal fluid (CSF) return, ensuring accurate placement in the subarachnoid space.

The spinal needle apparatus and its method of use reduce complication risks, improve procedural efficiency, and support single-pass insertion, benefiting healthcare providers and patients.

In some examples, the present disclosure provides a modular tube insert that is interchangeable to accommodate hollow needles of varying gauge sizes, while the housing of the needle hub remains consistent, enhancing the apparatus’s versatility and cost-efficiency across diverse clinical applications.

In some examples, the present disclosure provides a spinal needle apparatus with a stylet that is easily inserted and manipulated with a focus on enhancing the user-friendliness and control during the insertion and withdrawal of the stylet, which is an integral component of the spinal needle assembly.

In some examples, the stylet of the present disclosure is securely attached to the stylet hub through a robust and reliable bonding process using a suitable adhesive material.

In some examples, an insert with its adaptable channel profile allows the needle assembly to accommodate needles of different gauge sizes, enhancing the flexibility and utility of the spinal needle system. In an example, the insert is tubular. The insert may be of any other shape, for example, tapered, half cylindrical, square, helical, multi-lumen and/or any other geometrical shape or a combination thereof.

In some examples, the unique design of the stylet hub enhances the user’s ability to precisely control and manipulate the stylet during critical stages of spinal procedures, ultimately contributing to improved safety and effectiveness.

In some examples, the needle closer to the sharp distal tip may include one or more openings. In some examples, the needle may include a sharp distal tip. In some examples, the needle may include a rounded tip. In some examples, the needle may include a tapered tip.

Other examples, features and advantages of the present disclosure will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the present disclosure or may be apparent by the practice of the examples of the disclosure as set forth hereinafter.

These and other objects and features of the present disclosure will become more readily apparent from the following description which strives to improve the overall performance, safety, and efficiency of spinal needle apparatus, ultimately benefiting both healthcare providers and patients undergoing spinal procedures.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The above and other objects and advantages of the disclosure will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:

Fig. 1 illustrates a perspective view of the spinal needle apparatus in accordance with some examples of the present disclosure;

Figs. 2A & 2B illustrate a side view of the spinal needle apparatus in accordance with some examples of the present disclosure;

Fig. 3 illustrates a perspective view of the stylet hub and stylet partially inserted in alignment with the needle hub in accordance with some examples of the present disclosure;

Fig. 4A illustrates a cross-sectional view of the spinal needle apparatus in accordance with some examples of the present disclosure;

Fig. 4B illustrates the detail “A” of Fig. 4A;

DETAILED DESCRIPTION

Those skilled in the art will appreciate that the disclosed aspects and features of the present disclosure are not limited to any particular embodiment of a spinal needle apparatus. It will be readily understood that the parts/components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. The spinal needle apparatus incorporating the innovative aspects and features herein described, can be tailored for use with a variety of medical articles.

The present disclosure relates to a spinal needle apparatus 10. As shown in Figs. 1, 2A, 2B & 3, a spinal needle apparatus 10 comprising: a stylet assembly 12 including a stylet hub 14 and a stylet 16; a needle assembly 18 including a needle hub 20, a housing 22 (as shown in Fig. 4A) and a hollow needle 24 defining a lumen. The spinal needle apparatus 10 is configured to provide enhanced precision and safety during insertion into the subarachnoid space, with features that facilitate ergonomic handling, reliable connection between components, and compatibility with the intended clinical processes.

As shown in Figs. 2A, 2B, 3 & 4B, the stylet assembly 12 comprising the stylet 16 has a proximal end 26 connected to the stylet hub 14 and a distal end 28, likewise the hollow needle 24 has a proximal end 26a connected to the needle hub 20 and a distal end 28a. The stylet 16 has a length and a diameter.

The length and diameter of the stylet 16 are specifically designed to effectively occlude the hollow spinal needle 24 when the stylet 16 is inserted into the needle 24. This design feature serves to prevent the entry of unwanted materials, such as tissue or other substances, into the lumen of the spinal needle 24 during the insertion process.

By ensuring that the stylet 16 fully occupies the internal volume of the hollow needle 24, the present disclosure minimizes the risk of contamination or obstruction of the needle's lumen. This, in turn, helps maintain the integrity of the spinal needle 24 and facilitates the successful completion of the intended medical procedure, whether it involves the collection of cerebrospinal fluid, the administration of medications, or other diagnostic or therapeutic applications.

The precise dimensions of the stylet 16 are carefully selected to achieve this occlusion function, providing a secure and reliable fit within the hollow spinal needle 24 during the insertion and withdrawal of the stylet 16. The stylet 16 is manufactured from a biocompatible material, such as stainless steel or a rigid polymer, selected for its strength, flexibility, and compatibility with sterilization processes. The stylet 16 may include a polished or coated surface to reduce friction during insertion and withdrawal, enhancing user control and minimizing tissue trauma.

The stylet hub 14 is configured to provide a secure handling and precise manipulation, and may have a shape selected from the group consisting of rectangular, cylindrical, spherical, or combinations thereof. The stylet hub 14 includes a combination of raised portions 30 and flat areas/portions 32 distributed across its surface, as shown in Fig. 1, to enhance grip, even under wet or gloved conditions. The stylet hub 14 may further include visual or tactile indicators to assist in verifying the orientation of the needle side port during insertion. The illustrated shape of the stylet hub 14 allows the stylet hub 14 to be held and gripped comfortably from almost any angle using a conventional and uniform grip. The raised areas 30 and flat portions 32 of the stylet hub 14 enhances the user’s ability to manipulate the stylet 16, even when wearing surgical gloves during medical procedures. The varied surface texture and contours provide a secure and controlled grip, minimizing the risk of slippage or loss of control during the insertion and withdrawal of the stylet 16.

While the illustrated embodiment shows a rectangular shape for the stylet hub 14, it is important to note that the disclosure is not limited to this specific shape. The stylet hub 14 may also be designed in other shapes, such as square or spherical or any other geometrical shape or a combination thereof, as long as the chosen shape prioritizes user comfort, grip and ease of handling and manipulation during spinal procedures.

As shown in Figs. 2A, 2B & 3, the needle hub 20 comprises a finger grip 66 component at its outer surface, which facilitates easy handling and manipulation by a healthcare provider. The finger grip 66 has a plurality of sides, including raised portions and flat portions, which provide a comfortable and secure grip for the user. The length and width of the finger grip 66 are carefully selected to allow it to be easily held and manipulated between the thumb and forefingers of a healthcare provider, thereby enabling precise control and manipulation of the needle hub 20.

Furthermore, the sides of the finger grip 66 are slightly concave, which facilitates handling and reduces the risk of accidental dropping or misplacement of the needle hub 20 and also helps to distribute the weight of the needle hub 20 evenly, making it more comfortable to hold and use for extended periods. The finger grip 66 ensures that the needle hub 20 can be easily maneuvered and controlled, even in tight spaces or during delicate procedures, thereby enhancing the overall usability and effectiveness of the medical device.

The finger grip 66 is designed to provide a secure and comfortable grip for the user, allowing for precise control and manipulation of the needle hub 20. The raised and flat portions on the sides of the finger grip 66 provide a textured surface that helps to prevent the needle hub 20 from slipping out of the user's hand, even when handling it in wet or slippery conditions. The concave design of the sides also helps to reduce fatigue and discomfort during extended use, making it easier for healthcare providers to perform procedures with precision and accuracy.

As shown in Fig. 3, the stylet hub 14 has an engaging element 34 disposed around stylet 16 at the point where the stylet communicates and joins the stylet hub 14. The engaging element 34, may have a shape configured to ensure a secure connection, such as frustoconical, cylindrical, or tapered, with the broader base adjacent to the stylet hub 14 in some embodiments. The engaging element 34, thus, has a specific shape having length and width that allow it to slide into and securely fit within the hollow needle hub 20 as shown in Fig. 4A. The engaging element 34 slides into and contacts the interior walls of the needle hub 20 creating a pressure fit that ensures a stable and reliable connection. The precise fit ensures a stable and reliable connection between the stylet hub 14 and the needle hub 20. Additionally, the stylet hub 14 has a position element 36 which keeps the stylet hub 14 in correct position relative to the needle hub 20 as shown in Fig. 3. When engaged together, the stylet hub 14 and the needle hub 20 create a pressure fit that enables the stylet 16 to be rotated around its axis while still being securely held in place by the pressure fit with the needle hub 20. The stylet 16 slides into hollow needle 24 through needle hub 20. This arrangement ensures a stable and adjustable connection between the stylet hub 14 and the needle hub 20, allowing healthcare provides to manipulate the stylet 16 as needed during spinal procedures without compromising the integrity of the assembly.

The stylet 16 of the present disclosure is securely attached to the stylet hub 14 through a robust and reliable bonding process. As depicted in Figure 4A, the proximal end of the stylet 16 is glued to the stylet hub 14 using a suitable adhesive material. The glued connection 44a ensures that the stylet 16 remains firmly connected to the stylet hub 14 throughout the entire procedure, preventing any accidental detachment or misalignment. The suitable adhesive material may include epoxies, UV-curable adhesives or the like. The glue used for this purpose is chosen for its high bonding strength, durability, and resistance to the various environmental conditions and substances encountered during medical procedures.

The attachment of the stylet 16 to the stylet hub 14 is critical for maintaining the integrity and functionality of the spinal needle assembly 18. It allows the healthcare provider to confidently manipulate the stylet 16 and needle 24 during the procedure, ensuring precise control and minimizing the risk of complications. By securely attaching the stylet 16 to the stylet hub 14 through a reliable bonding process, the present disclosure provides a robust and user-friendly spinal needle assembly 18 that is well-suited for a wide range of medical applications.

The stylet hub 14, thus, makes it easier for the healthcare provider, such as an anesthesiologist, to visually identify and manipulate the stylet 16 during medical procedures, and thereby reducing tissue trauma and enhancing the healthcare provider’s ability to respond quickly and accurately once the cerebrospinal fluid flow is observed.

The spinal needle assembly 18 of the present disclosure comprises a hollow needle 24 with specific dimensions suitable for spinal injection procedures. As shown in Figures 3 and 4A, the needle 24 has a length and diameter that allow for safe and effective administration of medications or collection of cerebrospinal fluid during spinal procedures. The needle 24 has a sharp tip 38 on its distal end 28a, which is the end that is inserted into the patient's body during the procedure. The proximal end 26a of the hollow needle 24 is designed to receive the stylet 16 and has an intake opening 46 (as shown in Fig. 4B) that allows the stylet to be inserted and moved through the length of the needle 24. The intake opening 46 is positioned at the proximal end 26a of the hollow needle 24 to facilitate the insertion and movement of the stylet 16 through the needle 24 which allows the healthcare provider to easily and precisely control the movement of the stylet 16 during the procedure ensuring accurate placement and minimizing the risk of complications.

A needle hub 20 is securely disposed around the proximal end 26a of the hollow needle 24. The needle hub 20 serves as a connection point between the needle 24 and the stylet assembly 12, as well as a hub for the healthcare provider to manipulate the needle 24 during the procedure. The needle hub 20 comprises a proximal portion 40 and a distal portion 42 as shown in Figs. 4A and 4B. When the stylet assembly 12 and the needle assembly 18 are engaged together as shown in Fig. 4A, the proximal portion 40 of the needle hub 20 is securely received within the stylet assembly 12, ensuring a stable and reliable connection between the two components. This interlocking mechanism between the needle hub 20 and the stylet assembly 12 is a crucial feature of the present disclosure, as it allows for seamless integration of the needle and stylet components, facilitating smooth and controlled insertion of the needle 24 into the patient's body during spinal procedures.

The distal portion 42 of the needle hub 20 comprises a housing 22 that accommodates a tube insert 48. The tube insert 48 comprises a body 50 with a proximal end 26b and a distal end 28b and a through channel 52 running therethrough as shown in Fig. 4B. The tube insert 48 is received within the housing 22 from the end at the distal portion 42 of the needle hub 20. The hollow needle 24 is received partially within the channel 52 through the distal end 28b portion of the tube insert 48. The very end of such partially received hollow needle 24 within the channel 52 forms an intake opening 46 as shown in Fig. 4B. The channel 52 has a profile including a diameter being slightly larger than the outer diameter of the needle 24. The profile of the channel 52 may vary depending on the different gauge sizes of the needle 24. Thus, the needle 24 of different gauge size can be received within the tube insert 48 and be used as per need.

The tube insert 48 has openings 54 having a conical profile at both the proximal end 26b and the distal end 28b thereof. The profile of the conical opening 54 at the proximal end 26b is larger in dimension than the profile of the conical opening 54 at the distal end 28b of the tube insert 48 as shown in Fig. 4B. The conical opening 54 at the proximal end 26b of the tube insert 48 facilitates the insertion and alignment of the stylet 16 within the needle assembly 18. The conical opening 54 at the proximal end 26b serves to guide the stylet 16 accurately towards the intake opening 46 of the needle 24, ensuring precise positioning and alignment, providing healthcare providers with a reliable and user-friendly tool for spinal procedures. Thus, the larger conical opening 54 at the proximal end 26b facilitates the insertion and alignment of the stylet 16, while the smaller conical opening 54 at the distal end 28b helps direct the needle 24 into the correct position within the tube insert 48. The conical openings 54 are designed with precise angles and dimensions to minimize insertion resistance and ensure smooth stylet and needle alignment.

The tube insert 48 in the distal portion 42 of the needle hub 20 is configured to accommodate needles of different gauge sizes by varying the profile of the channel 52. The profile of the channel 52 including its diameter is designed to be slightly larger than the outer diameter of the hollow needle 24. This allows the channel 52 to accommodate needles of different gauge sizes, ensuring a secure and precise fit. Thus, the tube inserts 48 can accommodate needles 24 of varying gauge sizes, as the channel 52 can adapt to fit needles with different outer diameters. The choice of needle 24 size depends on the specific procedure, patient characteristics, and clinician preferences. As such, smaller size spinal needles 24, typically ranging from 22 to 27 gauge, are often used for procedures requiring more precision or when there is a need to minimize trauma to tissues. These smaller needles 24 are commonly used in pediatric patients or in adults where a finer gauge needle is deemed appropriate, such as for diagnostic purposes or in patients with spinal pathologies. Larger size spinal needles 24, usually ranging from 16 to 20 gauge, are utilized when a faster flow rate of cerebrospinal fluid (CSF) is needed, such as during spinal anesthesia for surgery. Such larger sized spinal needles 24 are also preferred when a clinician anticipates difficulties in needle placement due to factors like obesity or spinal deformities. Larger needles 24 allow for quicker CSF extraction or injection, which is advantageous in certain clinical scenarios.

The tube insert 48 may be color-coded to correspond to specific needle gauge sizes of the hollow needle 24, enabling medical professionals to quickly and accurately select the appropriate tube insert 48 and needle 24 combination, thereby preventing mismatching errors during assembly or use. Such color-coding feature enhances procedural efficiency and safety by ensuring compatibility between the tube insert 48 and the hollow needle 24. In contrast to prior art designs, where entire needle hubs were replaced without color differentiation due to the need for a transparent needle hub 20 to visualize cerebrospinal fluid (CSF) flow, the present disclosure’s modular tube insert 48 allows color-coding without compromising the transparency of the needle hub 20. For example, during assembly, a color-coded tube insert 48 can be paired with a stylet 16 having a matching color indicator, facilitating error-free assembly and precise gauge selection in clinical settings.

The needle 24 is securely attached to the tube insert 48 and the housing 22 of the needle hub 20 through a robust and reliable bonding process. As depicted in Figs. 4A & 4B, the proximal end portion of the needle 24 being received within the channel 52 of the tube insert 48 is glued to the housing 22 of the needle hub 20 using a suitable adhesive material. The glued connection 44b ensures that the needle 24 remains firmly connected to the tube insert 48 and the housing 22 of the needle hub 20 throughout the entire procedure, preventing any accidental detachment or misalignment. The suitable adhesive material may include epoxies, UV-curable adhesives or the like. The glue used for this purpose is chosen for its high bonding strength, durability, and resistance to the various environmental conditions and substances encountered during medical procedures.

The tube insert 48 can be manufactured from a range of materials including biocompatible plastic materials such as polypropylene (PP), polycarbonate (PC), silicone, polyurethane, polytetrafluroethylene (PTFE), polyether ether ketone (PEEK), or any other plastic material or any combination thereof. The material is selected to provide flexibility, durability, and compatibility with sterilization processes, and may include additives to enhance radiopacity for use with imaging techniques such as fluoroscopy. The tube insert 48 is manufactured to precise tolerances to ensure consistent fit and performance across different needle gauges.

The tube insert 48 is the sole component within the needle hub 20 that requires replacement to accommodate hollow needles 24 of varying gauge sizes, enabling the housing 22 to remain unchanged and thereby simplifying inventory and assembly processes. The mold for manufacturing the tube insert 48 is designed to be significantly simpler and more cost-effective to modify compared to tooling for the entire needle hub 20, facilitating rapid adaptation to different gauge requirements. Furthermore, the simplified design of the tube insert 48 mold allows for higher precision in manufacturing, ensuring tight tolerances for the through channel 52 and conical openings 54, which enhance the accuracy and reliability of needle 24 and stylet 16 alignment during spinal procedures.

The tube insert 48 has an outer profile configured to complement the inner geometry of the housing 22 of the needle hub 20, enabling the tube insert 48 to slide securely and smoothly into the needle hub 20 during assembly. The outer profile may be shaped in various forms, such as cylindrical, hexagonal, or other polygonal configurations, to ensure a precise and stable fit within the housing 22, minimizing movement and enhancing reliability during spinal procedures. Such design facilitates easy insertion and removal of the tube insert 48, supporting efficient adaptation to different gauge sizes of the hollow needle 24 while maintaining structural integrity and alignment with the stylet 16.

As shown in Fig. 4A & 4B, the hollow needle hub 20 is disposed around the proximal end 26a of the needle 24. The hollow needle hub 20 defines a funnel shaped opening 56 with two distinct openings as shown in Fig. 4B. The first opening is narrow opening 58 that communicates directly with the needle intake opening 46. The second opening is a wide opening 60 located at the proximal end of the needle hub 20. The engaging element 34 of the stylet hub 14 is received into wide opening 60 in a slide fit connection between the two components. The wide opening 60 has a shape that corresponds to the shape of engaging element 34 of the stylet hub 14 to allow such a slide fit connection between the two components. In some examples, wide opening 60 is substantially tubular or cylindrical allowing a corresponding shaped engaging element 34 to form a slide fit connection with the wide opening 60. Such a slide fit connection ensures a secure and stable attachment between the parts or components preventing accidental separation during use. The needle hub 20 also includes an extended opening 62 having an engaging/locking feature 64 as shown in Fig. 3. The extended opening 62 and engaging/locking feature 64 serve to further secure and stabilize the connection between the needle hub 20 and the stylet hub 14. The engaging/locking feature 64 may include a snap-fit mechanism, a threaded connection, or a bayonet lock to ensure a reliable and releasable connection.

The spinal needle apparatus 10 is used by inserting the hollow needle 24, with the stylet 16 in place, into the patient’s vertebral canal until the subarachnoid space is reached. The healthcare provider uses the finger grip 66 on the needle hub 20 and the ergonomic stylet hub 14 to control insertion. Visual or tactile indicators on the stylet hub 14 assist in verifying needle orientation. Upon reaching the subarachnoid space, the stylet 16 is withdrawn, and CSF return is observed through the needle hub 20, confirming correct placement. The apparatus may then be used for CSF collection, medication administration, or other spinal procedures. The apparatus’s design ensures minimal tissue trauma and supports efficient, single-pass insertion, enhancing patient safety and procedural success.

As used herein, the term “proximal”, “bottom”, “down” or “lower” refers to a location on the device that is closest to the medical practitioner using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term “distal”, “top”, “up” or “upper” refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. For example, the distal region of a needle will be the region of the needle containing the needle tip which is to be inserted e.g. into a patient's vein.

The terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and/or" includes any and all combinations of one or more of the associated' listed items.

It will be further understood that the terms "comprises" "comprising," "includes" and/or "including" when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present disclosure belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

While this disclosure is susceptible of example in many different forms, the description provided above includes specific examples with the understanding that the present disclosure is to be considered as an exemplification of the principles of the disclosure and is not intended to limit the disclosure to the examples detailed herein.

The foregoing summary and description are, thus, illustrative only and is not intended to be in any way limiting. In addition to the illustrative examples, aspects, embodiments, and features described above, further examples, aspects, embodiments, and features will become apparent from the appended claims.
,CLAIMS:1. A spinal needle apparatus (10) comprising:
a stylet assembly (12) including a stylet hub (14) and a stylet (16), the stylet (16) having a proximal end (26) connected to the stylet hub (14) and a distal end (28);
a needle assembly (18) including a needle hub (20), a housing (22), and a hollow needle (24), the hollow needle (24) having a proximal end (26a) connected to the needle hub (20) and a distal end (28a);
wherein the stylet (16) is configured to be inserted into the hollow needle (24) to occlude an internal lumen of the hollow needle (24) during insertion,
wherein the stylet hub (14) includes an engaging element (34) configured to form a pressure-fit connection with the needle hub (20) to securely and releasably couple the stylet assembly (12) to the needle assembly (18), and
wherein the needle assembly (18) includes a tube insert (48) disposed within the housing (22), the tube insert (48) having a through channel (52) configured to accommodate hollow needles (24) of varying gauge sizes.

2. The spinal needle apparatus (10) as claimed in claim 1, wherein the stylet hub (14) comprises a combination of raised portions (30) and flat portions (32) distributed across its surface to enhance grip and reduce slippage during manipulation, even under wet or gloved conditions.

3. The spinal needle apparatus (10) as claimed in claim 1, wherein the stylet hub (14) further includes visual or tactile indicators selected from the group consisting of color-coded markers, raised ridges, and indexed alignment notches, configured to verify orientation of a needle side port during insertion.

4. The spinal needle apparatus (10) as claimed in claim 1, wherein the needle hub (20) comprises a finger grip (66) having a plurality of sides with raised portions, flat portions, and concave surfaces configured to provide ergonomic handling and precise control during spinal procedures.

5. The spinal needle apparatus (10) as claimed in claim 1, wherein the engaging element (34) of the stylet hub (14) has a shape selected from the group consisting of frustoconical, cylindrical, and tapered, configured to slide into and contact interior walls of the needle hub (20) to form the pressure-fit connection.

6. The spinal needle apparatus (10) as claimed in claim 1, wherein the needle hub (20) includes an engaging/locking feature (64) selected from the group consisting of a snap-fit mechanism, a threaded connection, and a bayonet lock, configured to further secure the connection between the needle hub (20) and the stylet hub (14).

7. The spinal needle apparatus (10) as claimed in claim 1, wherein the stylet (16) is securely attached to the stylet hub (14) by a glued connection (44a) using an adhesive material selected from the group consisting of epoxies and UV-curable adhesives, the glued connection (44a) being resistant to environmental conditions encountered during medical procedures.

8. The spinal needle apparatus (10) as claimed in claim 1, wherein the tube insert (48) comprises conical openings (54) at a proximal end (26b) and a distal end (28b), the conical opening (54) at the proximal end (26b) having a larger dimension than the conical opening (54) at the distal end (28b) to guide the stylet (16) toward an intake opening (46) of the hollow needle (24).

9. The spinal needle apparatus (10) as claimed in claim 1, wherein the through channel (52) of the tube insert (48) has a diameter slightly larger than an outer diameter of the hollow needle (24), enabling a secure fit for needles ranging from 16 to 27 gauge.

10. The spinal needle apparatus (10) as claimed in claim 1, wherein the tube insert (48) is manufactured from a biocompatible material selected from the group consisting of polypropylene, polycarbonate, silicone, polyurethane, polytetrafluoroethylene, polyether ether ketone, and combinations thereof, the material including additives to enhance radiopacity for imaging-guided procedures.

11. The spinal needle apparatus (10) as claimed in claim 1, wherein the hollow needle (24) is securely attached to the tube insert (48) and the housing (22) by a glued connection (44b) using an adhesive material selected from the group consisting of epoxies and UV-curable adhesives.

12. The spinal needle apparatus (10) as claimed in claim 1, wherein the needle hub (20) defines a funnel-shaped opening (56) comprising a narrow opening (58) communicating with an intake opening (46) of the hollow needle (24) and a wide opening (60) configured to receive the engaging element (34) of the stylet hub (14) in a slide-fit connection.

13. The spinal needle apparatus (10) as claimed in claim 1, wherein the needle hub (20) includes a mechanism for visual verification of cerebrospinal fluid (CSF) return, the mechanism comprising a transparent or translucent portion, a dedicated CSF visualization chamber, or a flow indicator.

14. The spinal needle apparatus (10) as claimed in claim 1, wherein the stylet (16) is manufactured from a biocompatible material selected from the group consisting of stainless steel and rigid polymers, the stylet (16) having a polished or coated surface to reduce friction during insertion and withdrawal.

15. The spinal needle apparatus (10) as claimed in claim 1, wherein the hollow needle (24) comprises a tip (38) at the distal end (28a) selected from the group consisting of a sharp tip, a rounded tip, and a tapered tip, configured to facilitate insertion into a patient’s subarachnoid space with minimal tissue trauma.

16. The spinal needle apparatus (10) as claimed in claim 1, wherein the stylet hub (14) further comprises a position element (36) configured to maintain alignment of the stylet hub (14) relative to the needle hub (20) during insertion and manipulation.