DESC:FIELD

The present disclosure relates generally to injection catheters. More particularly, the present disclosure relates to injection catheters designed for delivering one or more fluid agents into a duct within a human body. In particularly, the disclosure pertains to injection catheters configured to administer fluid agents, such as surfactants, in proximity to lung tissues, as well as to methods relating thereto.

BACKGROUND

Surfactant injection catheters are specialized medical devices used to administer exogenous surfactant therapy to newborns including preterm or full-term infants who are at high risk for, or are suffering from, respiratory distress syndrome (RDS) due to surfactant deficiency, commonly referred to as hyaline membrane disease. RDS is especially prevalent among preterm infants, whose immature lungs often lack sufficient endogenous surfactant, a lipoprotein complex essential for reducing surface tension within the alveoli, thereby preventing lung collapse and facilitating effective respiration.

The introduction of surfactant therapy has markedly improved clinical outcomes for neonates with RDS. Conventionally, surfactant is delivered directly into the trachea, either via endotracheal intubation or through a thin catheter. The latter method, commonly referred to as surfactant administration via thin catheter (STC), has gained prominence as a less invasive alternative, enabling surfactant delivery while the infant is on continuous positive airway pressure (CPAP) support. Such approach has the potential to reduce the need for mechanical ventilation and its associated risks.

Despite these advances, the use of surfactant injection catheters is not without complications and limitations. Rapid administration of surfactant can precipitate transient oxygen desaturation and bradycardia in neonates, necessitating vigilant monitoring and prompt intervention. There is also a risk of severe airway obstruction, particularly if the surfactant is not evenly distributed within the lungs, potentially resulting in inadequate treatment or exacerbation of respiratory distress.

More severe complications, such as pulmonary hemorrhage (bleeding in the lungs) and pneumothorax (air leaks into the pleural space), may arise from improper administration techniques or overly rapid instillation of surfactant. Effective and safe surfactant delivery requires skilled personnel who are thoroughly trained in established protocols for administration. Inexperience can increase the likelihood of adverse events. Additionally, current catheter designs may result in suboptimal surfactant distribution, especially if catheter placement is imprecise, leading to insufficient treatment in certain lung regions.

The introduction of any catheter into the trachea also carries a risk of introducing pathogens, which can result in ventilator-associated pneumonia or other infections, a particularly significant concern in neonates with immature immune systems. Furthermore, individual responses to surfactant therapy can vary widely, influenced by factors such as gestational age, underlying health conditions, and timing of administration, thereby complicating treatment protocols and expected outcomes.

Accordingly, there remains a need for improved methods and apparatus for the delivery of surfactant or other medicaments that address the aforementioned shortcomings and problems associated with existing injection catheters.

SUMMARY AND OBJECTS

Certain exemplary aspects of the present disclosure are provided below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the disclosure might take and that these aspects are not intended to limit the scope of the disclosure. Indeed, the invention may encompass a variety of aspects that may not be set forth below. The illustrations and variations described herein are meant to provide examples of the devices and methods of disclosure. It is contemplated that combinations of aspects of specific embodiments or variations or combinations of the specific embodiments or variations are within the scope of this disclosure.

The present invention relates to injection catheter designed for precise and safe delivery of therapeutic agents, such as surfactants or medications, to targeted anatomical sites within a patient. The catheter features a shaft with three distinct sections: a proximal braided tube section for structural support, flexibility, and enhanced fluid flow due to a larger internal diameter; a non-braided tube section made from materials like polyurethane, polyether block amide (PEBA), or silicone for flexibility; and optionally a soft tip section with a lower durometer, rounded or tapered profile, and optional pre-shaped curve to minimize tissue trauma and facilitate navigation through anatomical pathways. A hub at the proximal end connects to external fluid delivery devices, ensuring a secure, leak-proof fluid pathway, while a strain relief molded at the hub-shaft junction enhances flexibility, kink resistance, and durability. The catheter, with an effective length may include radiopaque or graduated markings for accurate placement, and may include a multi-lumen configuration for simultaneous delivery of multiple agents or guidewire use.

In one example, the present disclosure relates to an injection catheter to inject one or more fluid agents or therapeutic agents, for example a fluid agent of surfactant type into a duct of a person, for example in the proximity of lung tissues through the trachea. The injection catheter comprises a shaft/catheter tube that is divided into three distinct sections: a braided tube, a non-braided tube, and a soft tip. Each of these sections plays a crucial role in the overall functionality and performance of the injection catheter, ensuring that it meets the specific needs of medical professionals and patients alike. The shaft of the injection catheter has a proximal end, which is connected to a strain relief, and a distal end, which is inserted into the patient. The strain relief is molded around a junction between the catheter tube and a hub to form a mechanical connection being in a flow communication for fluid administration.

It is to be understood that the present disclosure focuses as an example on the specific case of surfactant delivery to neonatal lung tissue. It should be understood, however, that the device and system may readily be used to deliver any fluid or other medicaments which are deemed appropriate to inject through the injection catheter. The device of the present disclosure is thus not limited solely to surfactant administration in infants and can be used to inject other types of fluids or other medicaments which can be introduced in other conduits, and/or can be used for infants including preterm or full-term newborns, children of various ages as well as for adult patients. Although the current disclosure emphasizes the administration of fluids and medications through the trachea and into the lungs, the injection catheter can be adapted for use in other anatomical locations as well. The device may be suitable for injection into other conduits, such as blood vessels, the gastrointestinal tract, or the urinary tract, specific organs or tissues, depending on the therapeutic need. This broad applicability allows for the seamless integration of the injection catheter into diverse clinical settings, from neonatal intensive care units to adult intensive care units and beyond. One or more fluid agents and/or other medicaments, not being limited to, may include antibiotics, vasopressors, anesthetics, contrast agents for diagnostic imaging procedures, nutritional solutions. The adaptability of the injection catheter allows healthcare professionals to tailor its use to the specific needs and requirements of individual patients, ensuring optimal therapeutic outcomes.

In some examples, the injection catheter comprises a shaft having three distinct sections: a braided tube, a non-braided tube, and a soft tip, all of which are welded together to create a seamless structure. The shaft has a proximal end and a distal end. The shaft is designed with varying durometers along its length, with the distal soft tip constructed from a significantly softer material than that of the braided and/or non-braided tube. Such a design choice ensures that the insertion process is atraumatic, minimizing the risk of injury to the walls of the conduit during catheter placement.

In some examples, not being limited to, the effective overall shaft length is preferably less than 90 cm, and more ideally between 10-50 cm, to facilitate ease of handling and maneuverability during use.

In some examples, the proximal section of the shaft comprises a braided tube, which may be composed of polymeric or metallic materials, providing essential reinforcement to prevent the tube from collapsing or kinking during surfactant delivery. The braided tube, thus, provides critical structural reinforcement to the injection catheter. The braided tube, not being limited to, can be composed of a variety of materials, including high-strength polymeric substances or metallic alloys. The braiding technique may involve intertwining multiple strands of these materials, creating a robust and flexible structure that significantly increases the tensile strength and resistance to deformation. The incorporated reinforcement is essential in preventing the tube from collapsing or kinking during the delivery of surfactant, which is particularly important given the high pressures that may be encountered during administration. The braided design allows for a degree of flexibility, enabling the catheter to navigate through anatomical pathways while maintaining its shape and functionality. Furthermore, the use of polymeric materials can include benefits such as biocompatibility and reduced friction, facilitating smoother insertion and movement within the conduit. In contrast, metallic braids may provide enhanced durability and resistance to wear over time. The combination of these materials in the braided tube not only ensures that the injection catheter can withstand the mechanical stresses associated with surfactant delivery but also contributes to the overall safety and efficacy of the procedure, minimizing the risk of complications associated with catheter collapse or kinking.

In some examples, in addition to braiding, alternative structural reinforcements such as coils or other configurations may be employed between an inner layer and an outer layer of tubing material. Such a design is particularly advantageous, as it allows the physician to securely grip the catheter while applying necessary pressure without compromising the integrity of the tube. Some of the current solutions, utilize a thicker wall in this region to mitigate collapse; however, the incorporation of a braided tube reduces the overall wall thickness required while simultaneously enhancing structural support, thereby improving the catheter's performance and reliability during clinical use. Thus, the integration of these alternative reinforcement techniques not only contributes to the overall durability and performance of the injection catheter but also allows for customization based on specific clinical requirements or patient anatomy. By employing a combination of braiding and these alternative structural reinforcements, the injection catheter can achieve an optimal balance of strength, flexibility, and biocompatibility, thereby enhancing its efficacy in delivering surfactant therapy to neonates at risk of respiratory distress syndrome.

In some examples, the braided shaft of the surfactant delivery catheter is equipped with precise length markings, which serve as critical indicators for healthcare professionals to determine the appropriate depth of insertion into the conduit, specifically targeting the vocal cords during surfactant delivery. These markings enhance the usability of the catheter by providing a clear visual reference, ensuring that the clinician can accurately gauge the insertion depth and avoid unnecessary complications associated with excessive insertion.

In some examples, to further enhance the performance of the braided shaft, an anti-kink collar for example, a strain relief is either glued or insert molded into the design, providing essential support and flexibility that effectively prevents kinking during use. The strain relief is strategically positioned to maintain the integrity of the catheter's shape, allowing for smooth navigation through the anatomical pathways while minimizing the risk of obstruction that could compromise surfactant delivery. Strain relief is a mechanical device used in catheters to protect the connection between the catheter tube and the hub from mechanical stress and strain. It helps prevent kinking or damage to the catheter at the junction between the flexible tube and the more rigid hub. The strain relief is made of a material that is more flexible than the hub. The strain relief is constructed from a thermoplastic elastomer or silicone material to optimize flexibility and durability at the junction between the hub and the shaft. The strain relief is molded around the junction between the catheter tube and hub to form a mechanical connection that does not rely on adhesives or solvent bonding. Alternatively, the strain relief can be joined to the catheter tube and hub by gluing or other adhesives and joining techniques. The strain relief extends along the proximal portion of the catheter tube and secures the entire portion of the tube enclosed within the hub bore. The strain relief grips the catheter tube due to residual hoop stresses in the hub wall and residual contraction forces within the strain relief itself. Thus, the purpose of strain relief is to prevent concentration of bending forces at the catheter hub/tube junction, dissipate these forces, and thereby prevent collapse and kinking of the catheter tube. A small coil of extra catheter tubing is sometimes left at the insertion site to act as an additional strain relief. Thus, the strain relief is a critical component that protects the catheter from damage and kinking at the hub/tube junction, allowing the catheter to be inserted and maneuvered without compromising the integrity of the tubing. It provides a smooth transition between the rigid hub and flexible tube.

In some examples, the non-braided section of the shaft can be manufactured in a contrasting color, such as black, to create a visual cue for the clinician, indicating the optimal stopping point for insertion. In some examples, either the soft tip or medical non braided tube or both are colored. This feature is particularly beneficial as it helps ensure that the catheter is positioned correctly within the conduit, facilitating safe and effective fluid delivery. Moreover, the non-braided tube can be designed to exhibit intermediate stiffness, providing a balance between rigidity and flexibility. Such characteristics allow the non-braided section to withstand the forces exerted during insertion while still accommodating the natural movements of the surrounding tissues. By integrating these thoughtful design elements i.e. length markings, an anti-kink collar, contrasting colors, and variable stiffness, the surfactant delivery injection catheter not only enhances the procedural efficiency but also significantly improves the safety and efficacy of surfactant administration in patients for example in neonates, ultimately contributing to better clinical outcomes.

In some examples, the braided shaft of the injection catheter is constructed from a plastically deformable material, allowing healthcare professionals to manually shape the catheter to conform to the specific anatomy of the patient. This feature is particularly advantageous in clinical settings where anatomical variations can complicate catheter insertion. The ability to plastically deform the material means that when the physician applies pressure or manipulates the catheter with their hands, the shaft can be molded into a desired configuration without the risk of permanent damage or failure. This adaptability is achieved through the selection of materials that exhibit a combination of flexibility and strength, allowing the catheter to retain its new shape during use while still providing the necessary structural integrity to facilitate effective surfactant or other medications delivery. The braiding technique used in the shaft enhances this capability by incorporating multiple strands of material that work together to provide reinforcement while still permitting some degree of deformation. As the physician shapes the catheter, they can create curves, angles, or other configurations that align with the patient's unique anatomical features, such as the contours of the airway. Such a customization not only aids in achieving optimal placement of the catheter but also reduces the likelihood of trauma to surrounding tissues during insertion. Additionally, the ability to modify the catheter's shape can improve the overall maneuverability within complex anatomical pathways, enhancing the ease of use for the clinician. The incorporation of plastically deformable materials in the braided shaft design represents a significant benefit in catheter technology, as it allows for a more personalized approach to patient care. By enabling the physician to adjust the catheter to match the patient's anatomy, the risk of complications associated with improper placement is minimized, ultimately leading to improved outcomes in the administration of, for example surfactant therapy for neonates at risk of respiratory distress syndrome.

In some examples, the braided shaft of the injection catheter is designed to effectively reduce the overall profile of the catheter while maintaining a low effective wall thickness. Such configuration allows for a larger internal diameter without increasing the outer diameter, thus optimizing the catheter's performance characteristics. By utilizing a braided construction, the shaft can achieve necessary stiffness and structural integrity, which are critical for ensuring that the catheter can withstand the pressures associated with fluid injection. The braiding technique enhances the mechanical properties of the catheter by distributing stress evenly along the shaft, which helps prevent kinking or collapsing during use. This is particularly important when delivering surfactant or any other medications, as the catheter may need to navigate through narrow or tortuous anatomical pathways. The ability to maintain a larger internal diameter is advantageous because it facilitates faster rates of fluid injection, allowing for more efficient delivery of surfactant or any other medications. This is crucial in emergency situations where rapid administration can significantly impact patient outcomes. Moreover, the low wall thickness achieved through the braided design contributes to a reduced profile, making the catheter easier to handle and maneuver. A thinner catheter is less likely to cause trauma to surrounding tissues during insertion, enhancing patient comfort and safety. The combination of a larger internal diameter and a reduced external profile allows healthcare providers to use the catheter in a variety of clinical scenarios, including those where access to small or challenging anatomical sites is required. It is to be understood that the low wall thickness achieved through the braided construction is significant because it minimizes the catheter's footprint, making it less intrusive during insertion. This is particularly important in neonatal care, where delicate anatomical structures require careful handling. By maintaining a slim profile, the catheter can navigate through narrow or complex pathways with ease, reducing the risk of trauma to surrounding tissues. Additionally, the braided section of the catheter provides essential support that allows for high-pressure injections. The braiding pattern can be tailored to enhance the catheter's kink resistance and pressure tolerance, ensuring that it can deliver surfactant effectively even under challenging conditions. The use of high-strength materials in the braid contributes to the catheter's ability to handle increased pressure without compromising its structural integrity.

In some examples, the distal portion of the shaft of the surfactant delivery catheter may optionally be pre-shaped at an angle ranging from 15 to 45 degrees, a design feature that enhances the catheter's ability to navigate anatomical structures and facilitates easier entry into the conduit. Such a pre-shaped configuration is particularly beneficial in clinical settings where access to the target site, such as the vocal cords, may be challenging due to the natural curvature of the airway or other anatomical variations. By allowing for a predetermined angle, the catheter can align more naturally with the contours of the anatomy, reducing the risk of trauma during insertion and improving the overall ease of use for healthcare professionals. Moreover, the bend in the distal portion of the shaft is designed with a specific radius that ensures smooth transitions without sharp turns. This thoughtful design consideration is crucial for maintaining an atraumatic insertion process. Sharp turns can create points of high stress on the catheter, potentially leading to kinking or obstruction, which could compromise the delivery of surfactant. By incorporating a gradual curve with a well-defined radius, the catheter minimizes resistance during insertion and allows for a more fluid movement through the conduit. This not only enhances the comfort of the procedure for the patient but also increases the likelihood of successful catheter placement on the first attempt, thereby reducing the time required for the procedure and the associated risks of multiple insertions. Additionally, the pre-shaped distal portion can be tailored to accommodate various patient anatomies, making it a versatile tool in neonatal care. The ability to customize the angle and radius of the bend can be particularly advantageous in situations where standard straight catheters may struggle to provide effective access. Thus, the incorporation of a pre-shaped distal portion with a smooth radius significantly contributes to the catheter's design, ensuring that the surfactant delivery process is efficient, safe, and minimally invasive, ultimately leading to improved outcomes for patients, for example neonates requiring respiratory support.

In some examples, the distal portion of the shaft of the injection catheter is designed to include a small section of the braided shaft, seamlessly transitioning into a non-braided section and culminating in a soft tip. This configuration not only enhances the catheter's structural integrity but also optimizes its functionality during insertion. The inclusion of a braided section at the distal end portion provides additional support and flexibility, ensuring that the catheter can navigate through anatomical pathways without compromising its shape or performance. The non-braided section, which follows the braided portion, can be engineered to have varying degrees of stiffness, allowing for a balance between rigidity and flexibility, which is crucial for effective maneuverability during the insertion process. Furthermore, the soft tip at the end of the injection catheter is specifically designed to minimize trauma upon contact with the tissue, enhancing patient comfort and safety. This soft tip can be made from materials that are both biocompatible and flexible, reducing the risk of injury to delicate structures in the airway or conduit.

In some examples, the tube design comprises two distinct sections: a braided proximal section and a non-braided distal section. The braided section is constructed using an interwoven technique that enhances flexibility and strength, allowing the tube to withstand dynamic movements and distribute stress evenly, thereby reducing the likelihood of mechanical failure. In contrast, the non-braided section is designed for simplicity in manufacturing, utilizing straightforward production techniques that lower costs and streamline the assembly process. This two-section configuration not only minimizes the number of moving parts, thereby enhancing product reliability and longevity, but also allows for optimized performance tailored to specific applications.

In some examples, in addition to the standard configurations, the distal portion of the shaft can be customized into various shapes to facilitate ease of insertion. For instance, the distal end can be designed with curves or angles that align with the natural contours of the anatomical pathways, allowing for smoother navigation and reducing the likelihood of resistance during insertion. These alternative shapes can be tailored to accommodate specific patient anatomies or procedural requirements, making the injection catheter versatile for different clinical scenarios.

In some examples, the injection catheter is designed with a female connection at its proximal end, which serves as the interface for delivering necessary fluids to the patient. In some examples, the female connection takes the form of a female luer fitting, a widely recognized and standardized connector used in medical applications. The female luer provides a secure and reliable means of attaching the injection catheter to various medical devices, such as syringes, tubing sets, or fluid administration systems, enabling the seamless delivery of surfactant or other therapeutic agents or other medicaments. The female luer connection is engineered to ensure a tight and leak-proof seal when coupled with a corresponding male luer fitting. This secure connection minimizes the risk of fluid leakage or accidental disconnection during the administration process, enhancing the overall safety and efficiency of the procedure. The design of the female luer incorporates a tapered internal surface that precisely matches the external taper of the male luer, creating a friction-fit that holds the connection firmly in place. Furthermore, the female luer connection is designed to be compatible with standard luer-lock syringes and tubing sets, ensuring that the injection catheter can be easily integrated into existing medical equipment and workflows. Such compatibility not only simplifies the setup process but also allows for the use of pre-filled syringes or other specialized delivery devices, further streamlining the surfactant administration process.

In some examples, the soft tip at the distal end of the injection catheter is designed with an optional radius around its edges, making it more atraumatic and reducing the risk of trauma to delicate tissues during insertion. Such a design feature is crucial for ensuring patient comfort and safety, particularly when navigating through sensitive anatomical structures such as the vocal cords or trachea. By incorporating a radius around the edges of the soft tip, the catheter's surface becomes smoother and less abrasive. Such a rounded design helps to minimize the potential for tissue irritation or damage that could occur if the tip had sharp edges or a blunt profile. The radius creates a gradual transition from the tip to the shaft, allowing for easier and more gentle insertion while maintaining the necessary rigidity for effective surfactant or other medicaments delivery. The atraumatic nature of the soft tip is further enhanced by the choice of materials used in its construction. These materials are typically soft, flexible, and biocompatible, such as silicone or soft polyurethane, pebax and nylon, which can conform to the shape of the airway without causing undue pressure or trauma. The combination of the radius design and the soft, pliable materials ensures that the catheter can navigate through the anatomy with minimal resistance and discomfort for the patient. Moreover, the atraumatic soft tip with a radius helps to reduce the risk of complications associated with tissue damage, such as bleeding, inflammation, or infection. By minimizing the potential for trauma during insertion, the catheter can be placed more accurately and with greater ease, ultimately contributing to the overall success and safety of the surfactant or other medicaments administration procedure.

In some examples, the catheter shaft is provided with a precisely angled distal end, most preferably set at about 30 degrees, but with other possible angles ranging from 15-45 degrees, which enhances guidance and placement within anatomical conduits such as airways. In some embodiments, the angle formed at the distal end of the shaft is within a range selected from the group consisting of: 15 to 25 degrees, 15 to 30 degrees, 15 to 30 degrees and 15 to 45 degrees. The distal end of the catheter transitions smoothly into a non-braided section and culminates in a soft, atraumatic tip, further minimizing tissue injury during insertion and positioning.

It is an object of the present disclosure to provide a device that allows for the safe and effective administration of surfactant or other medicaments directly into the lungs of neonates suffering from respiratory distress syndrome (RDS). By allowing for timely and effective surfactant delivery, the injection catheter can significantly improve respiratory function and overall outcomes in preterm infants with RDS.

Another object of the present disclosure is to provide an injection catheter designed to minimize trauma during insertion and administration, ensuring comfort and safety for the infant.

Another object of the present disclosure is to provide an injection catheter which can enable surfactant or other medicaments delivery without disrupting ongoing ventilation and/or medical treatment, allowing for continuous respiratory support during the procedure. The injection catheter's design can be utilized in diverse clinical environments, from neonatal intensive care units (NICUs) to emergency care settings, making it a versatile tool for healthcare providers.

Another object of the present disclosure is to provide an injection catheter designed to facilitate straightforward handling and operation by healthcare professionals, improving the efficiency of surfactant or other medicament administration.

Another object of the present disclosure is to provide an injection catheter that combines multiple shaft sections with varying material hardness, including a braided section for strength and kink resistance, a non-braided section for tailored flexibility, and a soft distal tip to minimize trauma during insertion and positioning.

Another object of the present disclosure is to achieve a seamless and robust connection between the different shaft sections through advanced welding or bonding techniques, thereby eliminating gaps or weak points that could lead to leakage or mechanical failure.

Another object of the present disclosure is to enhance patient safety and comfort by incorporating a soft, atraumatic tip at the distal end, which conforms to anatomical contours and reduces the risk of tissue injury, especially in sensitive applications such as pediatric and neonatal care.

Another object of the present disclosure is to ensure reliable and unobstructed fluid delivery by maintaining a continuous and well-aligned lumen throughout the hub, strain relief, and shaft, allowing therapeutic agents to reach the intended anatomical site efficiently.

Another object of the present disclosure is to increase the durability and reliability of the catheter by integrating a strain relief element at the junction between the hub and the shaft, thereby absorbing and distributing mechanical stresses, preventing kinking, and protecting the fluid pathway from obstruction or leakage.

Another object of the present disclosure is to provide an injection catheter adaptable for use with various surfactant formulations or other medicaments and compatible with different delivery systems, such as syringes or infusion pumps. The less invasive nature of the injection catheter may decrease the necessity for intubation, thereby lowering the risks associated with mechanical ventilation.

Another object of the present disclosure is to provide an injection catheter that can be used with a wide range of medical devices. The injection catheter is designed to be compatible with various types of mating connections and/or male or female luer connections and any other types of mating connections between two components.

Another object of the present disclosure is to provide injection catheter incorporating features that allow for easy visualization of the placement and administration process, enhancing procedural accuracy. The design of injection catheter includes safety features to prevent accidental dislodgement or misplacement, ensuring that the medication is delivered precisely where needed.

Yet another object of the present disclosure is to provide an injection catheter which reduces the need for multiple devices minimizing complications, the surfactant injection catheter, thus contributes to lower overall healthcare costs.

A still further object of the present disclosure is to provide an injection catheter having a straightforward design and operation which aids in training healthcare providers, ensuring that they can effectively use the device with confidence.

Yet another object of the present disclosure is to facilitate ease of handling, accurate placement, and maneuverability by optimizing the overall shaft length, preferably within a range that balances sufficient anatomical reach with user-friendly manipulation, and by providing options for customization based on clinical needs.

A further object of the present disclosure is to improve clinical workflow and safety by offering features such as radiopaque markers for imaging guidance, graduated markings for depth assessment, and optional side ports for lateral fluid delivery.

Yet another object of the present disclosure is to reduce the risk of infection and enhance biocompatibility by selecting appropriate medical-grade materials for all components, with the option of incorporating antimicrobial properties.

Another object of the present disclosure is to provide an injection catheter with an elongated shaft constructed from plastically deformable materials, optionally reinforced with a braided structure, allowing manual shaping of the catheter to adapt to the unique anatomical features of individual patients, thereby improving placement accuracy.

A further object of the present disclosure is to incorporate a distal shaft portion featuring an angled formation, preferably about 30 degrees, but within a range of 15 to 45 degrees to facilitate improved guidance, navigation, and atraumatic access to target sites within patient anatomy.

An additional object of the present disclosure is to provide a catheter design combining multiple shaft regions differing in material hardness including braided reinforced sections for structural integrity, non-braided flexible sections for maneuverability, and a soft tip to optimize performance, pushability, and patient comfort.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The above and other objects, examples, features and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout, and wherein:

Fig. 1 illustrates a front and corresponding back view of an injection catheter according to some examples of the present disclosure;

Fig. 2 illustrates a left and corresponding right-side view of the injection catheter shown in Fig. 1;

Fig. 3 illustrates a front cross-sectional view of the injection catheter shown in Fig. 1;

Fig. 4 illustrates a perspective view of the injection catheter shown in Fig. 1;

Figs. 5 illustrate a portion of the shaft of the injection catheter shown in Fig. 1;
Fig. 5A illustrates detail B of Fig. 5A;

Figs. 6A & 6B illustrate an exemplary embodiment of an injection catheter configured for the administration of one or more fluid agents;

DETAILED DESCRIPTION

Referring now to accompanying drawings, those skilled in the art will appreciate that the aspects and features disclosed herein are not limited to any single embodiment or example of the injection catheter. The components and configurations illustrated and described in the figures are provided for exemplary purposes and may be modified, substituted, or arranged in a variety of ways without departing from the scope of the invention.

In general, the injection catheter of the present disclosure is designed to facilitate the administration of fluids, medications, or other therapeutic agents directly into a patient’s body. While one principal application is the delivery of exogenous surfactant for the treatment of respiratory distress syndrome (RDS) in neonates, the catheter may also be employed for a wide range of medical purposes, including but not limited to the administration of other medicaments, diagnostic agents, or supportive fluids.

The injection catheter may be constructed in various forms and sizes to accommodate different patient populations and clinical requirements. For example, the catheter may be adapted for use in neonates, pediatric, or adult patients, and may be configured for compatibility with various respiratory support modalities, such as high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) systems. Such adaptations allow for the administration of therapeutic agents without necessitating invasive procedures like endotracheal intubation, thereby enhancing patient comfort and reducing the risk of complications associated with invasive airway management.

Referring to the accompanying drawings, particularly, Figs. 1, 2, 3 and 4, there is illustrated an exemplary embodiment of an injection catheter 10 according to the present disclosure. The injection catheter 10 comprises an elongated shaft or catheter tube 12 which is functionally divided into three distinct sections: a braided tube section 12a, a non-braided tube section 12b, and a soft tip section 12c. Each of these sections is specifically engineered to optimize the injection catheter’s 10 performance and safety during medical procedures. In some embodiments, the shaft 12 comprises a multi-lumen configuration for simultaneous administration of different therapeutic agents or for use with a guidewire. In some embodiments, wherein the shaft 12 is manufactured from a material selected to provide antimicrobial properties for reducing the risk of infection during use.

The proximal portion of the shaft 12 is formed as a braided tube 12a as illustrated in Figs. 5 & 5A. The braided construction imparts enhanced mechanical strength, flexibility, and resistance to kinking, thereby allowing the injection catheter 10 to be advanced and manipulated with precision while minimizing the risk of collapse or obstruction during use. Distal to the braided section 12a, the shaft transitions to a non-braided tube 12b. The non-braided section 12b provides increased flexibility compared to the braided portion 12a, facilitating easier navigation through anatomical pathways and reducing patient discomfort during insertion and placement. At the distal end of the catheter tube 12, a soft tip 12c is provided as illustrated in Fig. 5. The soft tip 12c is designed to minimize trauma to delicate tissues during advancement and positioning within the patient, thereby enhancing safety and patient comfort.

The shaft 12 of the injection catheter 10 extends from a proximal end 14 to a distal end 16. The proximal end 14 is connected to a strain relief component 18 which is molded around the junction between the catheter tube 12 and a hub 20 forming a secure mechanical and fluid connection for the administration of fluid or medications. The strain relief 18 extends along the proximal portion of the catheter tube 12 and secures the segment of the tube 12 enclosed within the hub bore. The strain relief 18 functions by gripping the catheter tube 12 through residual hoop stresses within the hub wall and contraction forces within the strain relief material itself. Its primary purpose is to prevent the concentration of bending forces at the critical hub/tube junction, dissipate mechanical stresses, and prevent collapse or kinking of the catheter tube 12 during use.

The hub 20 is configured to connect with an external delivery system, such as a syringe or infusion device, to facilitate the administration of fluids, medications, or other therapeutic agents. The hub 20, strain relief 18, and the entire catheter tube 12 including sections 12a, 12b, and 12c are all in fluid communication, forming a continuous conduit from the external delivery apparatus to the internal delivery site within the patient. Collectively, the hub 20, strain relief 18, and catheter tube 12 constitute an integrated system designed to ensure reliable, safe, and efficient delivery of therapeutic agents. This construction not only facilitates effective fluid communication but also enhances the mechanical integrity and user-friendliness of the catheter during clinical use. It is to be understood by those skilled in the art that the specific configuration and materials of each section may be adapted or modified to suit various clinical applications, patient populations, or procedural requirements, without departing from the scope of the present invention.

Referring now to Figs. 5 and 5A of the accompanying drawings, the proximal section of the shaft 12 of the injection catheter 10 incorporates a braided tube 12a, which is designed to provide enhanced structural integrity and flexibility to the catheter 10, addressing common challenges encountered during intraluminal navigation and fluid administration.

The braided tube 12a is constructed from multiple strands of high-strength materials, such as advanced polymers or metallic fibers, which are woven together to from a robust yet pliable structure. The braiding technique imparts significant resistance to kinking and collapsing, enabling the catheter to maintain its intended shape even when subjected to the complex anatomical curves and bends often encountered during clinical procedures. The enhanced flexibility of the braided section 12a allows healthcare providers to maneuver the catheter with precision, facilitating accurate placement at the intended site of fluid delivery.

In addition to its mechanical advantages, the braided tube 12a is designed to withstand the pressures associated with the injection of therapeutic agents or medications. The structural reinforcement provided by the braiding ensures that the catheter can efficiently and reliably deliver fluids, even under elevated pressures, without compromising the integrity of the device which is particularly important in critical care settings where rapid and effective administration of medication is required.

Another notable advantage of the braided section 12a is its ability to maintain a consistent outer diameter while accommodating a larger internal diameter. Such design features allow for higher flow rates, enabling faster delivery of fluids or medications when time is of the essence. The combination of a stable outer profile and increased internal lumen size ensures that the catheter remains easy to handle and compatible with standard medical connectors, while also optimizing the efficiency of fluid administration. By providing a balance of strength, flexibility, and flow capacity, the design of braided section 12a enables healthcare professionals to achieve optimal orientation and accurate delivery of therapeutic agents to the desired anatomical location, thereby improving clinical outcomes and patient care.

Following the braided tube 12a section as illustrated in Fig. 1, the injection catheter 10 transitions into a non-braided tube 12b. This non-braided segment is an important component of the overall catheter design, providing a tailored balance between flexibility and rigidity to optimize both handling and safety during clinical use. The non-braided tube 12b section can be manufactured with varying degrees of stiffness, which may be selected based on the intended application or patient population. For example, a more flexible non-braided section may be desirable for navigating tortuous anatomical pathways, while a stiffer section may provide additional support for advancing the catheter through more resistant tissues or structures. This adaptability allows the catheter to be customized for a variety of clinical scenarios, enhancing its versatility. The non-braided tube 12b is constructed from a material that offers durability and biocompatibility. Suitable materials may include medical grade polymers such as polyurethane, polyether block amide (PEBA), or silicone, all of which are known for their compatibility with bodily tissues and fluids. The use of such materials ensures that the catheter can safely interact with internal anatomical structures without causing irritation, inflammation, or adverse reactions.

In addition to its mechanical and material properties, the non-braided tube 12b may also be designed with features such as radiopaque markers or graduated markings to assist clinicians in accurate placement and depth assessment during procedures. The smooth, non-braided surface of this section further minimizes friction and facilitates atraumatic advancement of the catheter 10 through the patient’s anatomy. Thus, the non-braided tube 12b serves as a critical transitional segment between the reinforced braided section and the softer distal tip, contributing to the overall performance, safety, and ease of use of the injection catheter 10. Its design ensures that the device remains robust and reliable while providing the necessary flexibility for precise and controlled delivery of therapeutic agents.

Referring to Fig. 1 of the accompanying drawings, the distal end 16 of the injection catheter 10 is configured to culminate in a soft tip 12c which is a critical design feature, specifically engineered to minimize trauma during insertion and navigation within the patient’s anatomy. Constructed from a pliable, biocompatible material, the soft tip 12c significantly reduces the risk of injury to delicate tissues, such as those found in the airway, trachea, or other sensitive anatomical structures.

The importance of the soft tip 12c is especially pronounced in pediatric and neonatal applications, where anatomical tissues are particularly sensitive and susceptible to damage. To further enhance its atraumatic properties, the soft tip 12c may be provided with rounded edges or a tapered profile. These features facilitate smoother insertion and advancement, decreasing the likelihood of tissue irritation, perforation, or other complications associated with catheter placement.

In addition to its softness and flexibility, the distal end 16 of the shaft 12 may incorporate further specialized design elements to optimize both safety and performance. For example, the distal end 16 may be shaped with a pre-formed curve or an angled tip, assisting clinicians in navigating complex anatomical pathways and ensuring accurate delivery of therapeutic agents to the intended site of action. Such design variations can be tailored to suit specific clinical requirements or patient populations.

During use, the distal end 16 of the injection catheter 10 is the section that is inserted into the patient’s body. Its design ensures that the catheter 10 can be advanced with minimal resistance and maximum control, allowing healthcare providers to deliver medications or other therapeutic agents precisely where needed. The combination of a soft, atraumatic tip and optional specialized shaping elements makes the distal end 16 highly effective in reducing procedural risks and improving overall patient outcomes.

The three sections of the catheter tube 12 i.e. the braided tube 12a, non-braided tube 12b, and soft tip 12c are meticulously joined together through a precise welding process to form a continuous, seamless structure. The braided tube section 12a, non-braided tube section 12b, and soft tip section 12c are joined by a laser or ultrasonic welding process to form a seamless transition between sections. The welding process is carefully controlled to ensure that each junction between the braided tube 12a, the non-braided tube 12b, and the soft tip 12c is free from gaps, voids or weak points. Such joining is critical in preventing potential leakage or mechanical failure during clinical use, as any discontinuity at the junctions could compromise the integrity of the catheter 10. By creating a uniform and robust bond between the different materials and structural features, the welding process enhances the overall mechanical strength and reliability of the device.

The seamless construction of the catheter tube 12 offers several additional advantages. First, it ensures a smooth internal and external surface along the entire length of the catheter, which reduces the risk of turbulence or obstruction during fluid delivery and minimizes trauma during insertion and navigation through anatomical pathways. Second, the seamless design streamlines the manufacturing process, allowing for greater consistency and quality control across production batches which results in each catheter unit meeting stringent performance and safety standards, thereby providing healthcare professionals with a reliable tool for a variety of medical applications.

Furthermore, the seamless integration of the braided, non-braided, and soft tip sections allows the catheter to maintain the unique functional benefits of each segment namely, the strength and kink resistance of the braided section, the tailored flexibility of the non-braided section, and the atraumatic properties of the soft tip without compromise at the junctions. Such a unified construction contributes to the injection catheter’s superior performance, safety, and ease of use in clinical practice.

The shaft 12 of the injection catheter 10, as illustrated in the accompanying drawings i.e. FIG. 1, is engineered with precisely calibrated variations in material hardness (durometer) along its length. Each segment of the catheter is tailored for its specific functional role and for compatibility with the anatomical structures encountered during use. Higher durometer materials are utilized in the proximal and mid-shaft regions to provide the necessary structural integrity and resistance to kinking, while the distal end is optimized for flexibility and gentleness. This balanced approach ensures that the catheter retains its functional performance maintaining lumen patency and facilitating accurate delivery of therapeutic agents while prioritizing patient comfort and safety.

At the distal end, the soft tip 12c is constructed from a material with a substantially lower durometer than the remainder of the shaft 12. A softer composition at the tip minimizes trauma to sensitive tissues during insertion and navigation, making the catheter particularly suitable for pediatric and neonatal applications, as well as other scenarios where tissue preservation is essential. The pliability of the soft tip 12c enables it to conform to the contours of the surrounding anatomy, significantly reducing the likelihood of abrasion or irritation to patient tissues during advancement and placement.

Proximal to the soft tip 12c, both the non-braided section 12b and the braided section 12a are fabricated from materials with higher durometers. These sections provide the necessary structural support and rigidity, allowing the catheter 10 to maintain its shape and resist kinking or collapsing under the mechanical stresses of insertion and fluid administration. Increased hardness in these regions enables reliable advancement through the patient’s anatomy while maintaining an unobstructed internal lumen for efficient fluid delivery.

The braided section 12a, located at the proximal portion of the shaft, benefits from reinforced construction with high-strength fibers or filaments. Such reinforcement enhances resistance to deformation and imparts a degree of flexibility, enabling the catheter 10 to adapt to anatomical curves without compromising structural integrity. Strength combined with controlled flexibility is essential for navigating complex pathways while ensuring consistent performance.

Careful selection and combination of materials with varying durometers throughout the shaft 12 achieves an optimal balance between patient safety, ease of use, and mechanical reliability. Graduated material hardness along the catheter 10 is a key aspect of the innovative design, contributing to effective performance across a range of clinical applications.

Referring to Figs. 3 and 4 of the accompanying drawings, the hub 20 is positioned at the proximal end 14 of the injection catheter 10 and functions as the primary interface for connecting the catheter 10 to external medical devices. The hub 20 is engineered to facilitate reliable attachment to syringes, fluid administration systems, or other delivery apparatus commonly used in clinical settings.

The design of the hub 20 ensures a secure and leak-proof connection, which is essential for maintaining the integrity of fluid delivery during medical procedures. The hub 20 incorporates features that allow for straightforward attachment and detachment, enabling healthcare professionals to efficiently prepare and execute fluid administration without unnecessary delays or risk of fluid loss.

A central lumen runs through the hub 20 and is precisely aligned with the internal channel of the catheter tube 12. Such alignment creates a continuous, unobstructed pathway for fluids or medications to travel from the external delivery device through the catheter 10 and into the patient. By maintaining a seamless conduit, the hub 20 supports accurate and efficient administration of therapeutic agents. Strategic placement of the hub at the proximal end 14 of the catheter allows for easy access and manipulation by medical personnel during setup and throughout the procedure. The robust construction and precise engineering of the hub 20 contributes to the overall reliability and safety of the injection catheter 10, ensuring consistent performance across a wide range of clinical applications.

Referring to Figs. 3 and 4 of the attached drawings, the injection catheter 10 incorporates a strain relief 18 positioned at the critical junction between the catheter tube 12 and the hub 20. The primary function of the strain relief 18 is to absorb and distribute mechanical stresses that may arise during manipulation of the catheter, particularly when lateral forces are applied or when the device is subjected to repeated flexing during clinical use.

The strain relief 18 is constructed from a flexible, resilient material that provides both kink resistance and enhanced durability at this vulnerable connection point. By allowing controlled flexion, the strain relief 18 prevents excessive bending or kinking of the catheter tube 12 near the hub 20, thereby maintaining an unobstructed fluid pathway and ensuring continuous, reliable delivery of therapeutic agents. This feature is essential for preserving the integrity of the catheter during both insertion and fluid administration, ultimately contributing to the overall safety and performance of the device.

The hub 20, which is also shown in Figs. 3 and 4, serves as the interface between the injection catheter 10 and various external medical devices used for fluid delivery, such as syringes or IV lines. The hub 20 is strategically positioned at the proximal end 14 of the catheter 10 and is designed to facilitate secure and efficient connections with standard medical equipment. The hub 20 features a proximal end 14a and a distal end 16a, each with distinct functions. The proximal end 14a is equipped with an opening 22, which acts as the entry point for fluids or medications. The opening is designed to provide a leak-proof seal when connected to compatible devices, thereby ensuring safe and efficient administration of therapeutic agents. The internal surface of the opening 22 is smooth and precisely finished to minimize turbulence and promote a steady, controlled flow of fluids into the catheter system.

To enhance usability and compatibility, the proximal end 14a of the hub 20 typically incorporates a standardized connector, such as a luer-lock mechanism. This standardized design allows for easy attachment and detachment of syringes, IV lines, or other connectors, making the hub 20 versatile and suitable for a wide range of clinical applications. The secure connection provided by the hub 20 not only improves workflow efficiency for healthcare professionals but also reduces the risk of accidental disconnection or leakage during critical procedures.

Referring to Fig. 3, the distal end 16a of the hub 20 is securely connected to the strain relief 18, which is molded around the junction between the hub 20 and the catheter tube 12. The strain relief 18 serves a critical mechanical function by providing robust support at this connection point, thereby preventing kinking or excessive bending that could compromise the integrity of the catheter system. By absorbing and distributing mechanical stresses encountered during handling and use, the strain relief 18 protects the fluid pathway and maintains the flexibility of the catheter tube 12 without risking obstruction or leakage.

The construction of the strain relief 18 ensures that the transition between the hub 20 and the catheter tube 12 remains both secure and flexible. This design is particularly important during procedures that require repeated manipulation or repositioning of the catheter 10, as it reduces the likelihood of mechanical failure at one of the most vulnerable points in the assembly.

At the proximal end 14a of the hub 20, an opening 22 is provided, which is in direct fluid communication with the lumen of the catheter tube 12. This continuous pathway is essential for the effective administration of fluid agents or medicaments. The precise alignment of the opening 22 with the internal channel of the catheter tube 12 ensures that fluids introduced through the hub 20 flow seamlessly into the catheter and onward to the target site within the patient. Such uninterrupted fluid communication enables healthcare providers to deliver medications or therapeutic agents efficiently and reliably, minimizing the risk of leakage or interruption during administration. The combination of a secure mechanical connection at the distal end 16a and a well-aligned fluid pathway at the proximal end 14a enhances both the safety and functionality of the injection catheter 10, supporting its use in a wide range of clinical applications.

The design of the hub 20, strain relief 18, and catheter tube 12 ensures that all components are in fluid communication with one another ensuring that when a fluid is introduced at the hub 20, it can flow seamlessly through the strain relief 18 and into the catheter tube 12, ultimately reaching the distal end 16 where it is delivered to the patient. The alignment of the lumens within these components maintains a continuous and unobstructed pathway for fluid flow, which is essential for the effective administration of therapeutic agents or other medications. This alignment is critical for preventing turbulence, minimizing the risk of leakage, and ensuring that therapeutic agents reach the distal end 16 of the catheter efficiently and reliably. The unobstructed pathway supports consistent delivery rates and accurate dosing, both of which are essential for effective clinical outcomes.

The integration of these components not only enhances the mechanical durability of the injection catheter 10 but also supports its primary function as a reliable device for the administration of therapeutic agents. By maintaining a continuous, unobstructed fluid channel from the hub 20 to the distal tip, the catheter is well-suited for a wide range of medical applications, including those requiring precise and atraumatic delivery of medications.

In some examples, not being limited to, the effective overall shaft 12 length is preferably less than 90 cm, and more ideally between 10-50 cm, to facilitate ease of handling and maneuverability during use. While the ideal shaft 12 length is between 10-50 cm, it is important to note that this range may need to be adjusted based on the specific patient's anatomy and the requirements of the procedure. In some cases, a slightly longer or shorter shaft 12 may be necessary to ensure optimal positioning and fluid delivery. However, the general principle of minimizing the shaft 12 length to the extent possible, while still maintaining sufficient reach, remains a key design consideration for the injection catheters.

By optimizing the shaft length in accordance with these principles, the injection catheter 10 achieves a high degree of versatility, safety, and user-friendliness, supporting its effectiveness across diverse patient populations and procedural contexts.

Referring now to FIGS. 6A and 6B, illustrated therein is an exemplary embodiment of an injection catheter 10 configured for the administration of one or more fluid agents, such as surfactants, into a duct, for instance, the trachea or another anatomical conduit within a patient. As shown in FIGS. 6A & 6B, the injection catheter 10 comprises an elongated shaft 12 terminating in a soft distal tip 12c. The shaft 12 is, in some embodiments, constructed from a plastically deformable material, optionally featuring a braided reinforcement, to allow manual shaping by the healthcare professional and to accommodate patient-specific anatomical variations, thereby facilitating optimal placement and minimizing patient trauma.

FIG. 6B provides a more detailed side view of the catheter 10. The proximal end of the catheter shaft 12 is attached to a connector port 18, preferably a female luer fitting, providing a secure interface for connection to medical fluid administration devices such as syringes, tubing, or infusion systems. The proximal connector 18 may further incorporate a thumb grip 20 to facilitate secure handling and precise manipulation during advancement and withdrawal of the catheter 10.

The shaft body 12 comprises a selectively deformable construction, which may include a braided section for enhanced kink resistance and strength. The shaft 12 may further comprise at least two distinct regions along its length, such as a reinforced (braided) region followed distally by a non-braided portion, culminating in the soft tip 12c. The non-braided portion may be tailored with variable stiffness to optimize maneuverability and minimize trauma as the catheter traverses through anatomical pathways.

The distal region of the shaft 12 transitions smoothly into a flexible distal tip 12c at the terminal end 16. The soft tip 12c serves to reduce the risk of trauma to delicate tissues upon contact and assists in atraumatic navigation through anatomic structures such as the trachea or bronchial pathways. In some embodiments, the distal tip 12c may be constructed of a biocompatible, soft, elastomeric material. Running coaxially along the shaft 12 is one or more internal lumens, dimensioned to permit smooth passage of therapeutic fluids, such as surfactant, antibiotics, contrast agents, or other medicaments, which are delivered through the catheter and expelled at or near the distal tip 12c to the targeted anatomical site. The catheter's proximal end is terminated with a female luer connector 18, as noted above, which securely mates with standard male luer fittings of syringes or administration lines. The thumb grip 20 provides ergonomic handling during connection, fluid injection, or navigation.

Referring to FIG. 6B, the catheter shaft 12 is functionally divided into three distinct sections: a braided tube section 12a, a non-braided tube section 12b, and a soft tip section 12c. In a preferred embodiment, the part having the distal end portion 12c of the catheter shaft 12 comprises an angled formation that facilitates improved guidance, placement, and atraumatic access to targeted anatomical sites such as the trachea or bronchial airways. Preferably, the catheter terminates in an angled configuration wherein the shaft 12 is bent at an angle of approximately 30 degrees relative to the longitudinal axis of the main shaft portion. Such predetermined angle is engineered to enable more precise navigation around anatomical curves, enhance control during insertion, and allow the user to direct the soft atraumatic distal tip 12c toward desired delivery locations within the patient. In alternative embodiments, the angle of the distal bend may be selected from a range, including but not limited to between 15 to 25 degrees, 15 to 30 degrees, or 15 to 35 degrees or 15 to 45 degrees. In further alternative embodiments, the catheter shaft 12 may be provided without any distal bend, such that the shaft extends linearly with no angled formation at the distal end. The choice of angle may be determined based on user preference, anatomical considerations, or specific procedural requirements. The presence of the angled distal segment not only assists in steering the catheter but also serves to minimize the risk of trauma by providing a more adaptable and responsive interface as the device traverses sensitive tissue pathways. The bend is preferably formed in such a manner that it preserves the catheter’s internal lumen integrity, ensuring uninterrupted fluid delivery through the distal tip 12c during administration of therapeutic agents.

In some embodiments, the injection catheter 10 comprises a non-braided section 12 distal to the braided shaft 18, wherein said non-braided portion 12 is manufactured in a black color or any other dark color. The deliberate selection of a contrasting color for the non-braided section 12 provides several clinical and operational advantages. Specifically, the use of black or another distinctively dark hue enhances visual differentiation between the non-braided distal segment 12, (typically of a darker color) and the proximal braided shaft 18, (typically lighter or neutral in color). Such contrast provides clear visual cues to the clinician during preparation, insertion, and placement of the catheter 10, facilitating identification of the catheter's orientation and position, especially under challenging lighting conditions or in environments requiring rapid intervention. Enhanced visual contrast is particularly beneficial where precise knowledge of the catheter's functional regions is critical, such as distinguishing the flexible, trauma-minimizing distal end portion 16, non-braided 12b + soft tip 12c from the structurally supportive proximal segment 18 during neonatal or pediatric procedures. The coloration of the non-braided section 12 is achieved using biocompatible pigments or additives that do not compromise the mechanical properties, flexibility, or patient safety provided by the catheter 10. In alternative embodiments, other dark or visually contrastive colors may be employed in lieu of black to achieve similar identification and procedural advantages.

In certain alternative embodiments of the injection catheter 10, the distal end 16 of the catheter shaft 12 may be constructed such that a separate soft tip 12c is omitted. Instead, the intermediate tube or non-braided section 12b itself is engineered from a sufficiently soft and atraumatic material, thereby obviating the need for a distinct, dedicated soft tip 12c at the distal extremity. In such configurations, the catheter shaft 12 is designed with only two primary sections: a proximal braided portion 12a, which provides strength, kink resistance, and allows for manual shaping to conform to anatomical pathways, and a distal non-braided portion 12b that possesses both the necessary flexibility for navigation and the softness required to minimize trauma to patient tissue during insertion and placement. By eliminating the separate soft tip 12c, the distal non-braided section 12b is optimized in terms of material composition and wall thickness to ensure atraumatic contact, while also maintaining the functional integrity and fluid delivery capability of the catheter 10. Such a design simplification enhances manufacturing efficiency, reduces the number of material transitions along the shaft, and still maintains a high level of patient safety. The stated embodiment is particularly advantageous where procedural requirements or clinical preferences favor a fully integrated soft distal section over a multi-component distal tip construction.

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 embodiments 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.

The term “coupled”, “connected”, “fitted”, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.

Reference throughout this document to “some embodiments”, “one embodiment”, “certain embodiments”, and “an embodiment” or “some examples” or “one example” or similar terms means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases or in various places throughout this disclosure are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments without limitation.

While aspects of the present disclosure have been described in detail with reference to the illustrated embodiments and/or examples, those skilled in the art will recognize that many modifications may be made thereto without departing from the scope of the present disclosure. The present disclosure is not limited to the precise construction and compositions disclosed herein; any and all modifications, changes, and variations apparent from the foregoing descriptions are within the spirit and scope of the present disclosure. Moreover, the present concepts expressly include any and all combinations and sub combinations of the preceding elements and features. The description is provided for clarification purposes and is not limiting. Words and phrases are to be accorded their ordinary, plain meaning unless indicated otherwise.

The foregoing summary and description are illustrative only and are not intended to be limiting in any way. The scope of the invention is defined by the appended claims, and all variations and equivalents are intended to be embraced therein.
,CLAIMS:1. An injection catheter (10) comprising:
a shaft (12) having a proximal end (14) and a distal end (16), the shaft (12) including:
a braided tube section (12a) positioned at a proximal portion of the shaft (12);
a non-braided tube section (12b) positioned distal to the braided tube section (12a); and
optionally a soft tip section (12c) positioned at the distal end (16) of the shaft (12);
a hub (20) disposed at the proximal end (14) of the shaft (12), the hub (20) having a lumen in fluid communication with the shaft (12) and configured for connection to an external fluid delivery device;
a strain relief (18) molded around a junction between the hub (20) and the shaft (12), the strain relief (18) configured to provide mechanical support, flexibility, and kink resistance at the junction.

2. The injection catheter (10) as claimed in claim 1, wherein the braided tube section (12a) comprises polymeric fibers, metallic fibers, or a combination thereof, braided or woven to form a structure configured to provide structural support, flexibility, and kink resistance, while maintaining a consistent outer diameter and enabling a larger internal diameter relative to the outer diameter, thereby facilitating increased fluid flow rates.

3. The injection catheter (10) as claimed in claim 1, wherein the non-braided tube section (12b) is constructed from a material selected from the group consisting of polyurethane, polyether block amide (PEBA), and silicone, or a combination thereof.

4. The injection catheter (10) as claimed in claim 1, wherein the soft tip section (12c) comprising a biocompatible material with a lower durometer than the braided (12a) and non-braided (12b) tube sections, the soft tip section (12c) being configured to minimize trauma to patient tissues during insertion and positioning.

5. The injection catheter (10) as claimed in claim 1, wherein the soft tip section (12c) has a rounded or tapered profile to further reduce the risk of tissue trauma during insertion.

6. The injection catheter (10) as claimed in claim 1, wherein the shaft (12) has an effective length of less than 90 cm, and preferably between 10 cm and 50 cm.

7. The injection catheter (10) as claimed in claim 1, wherein the hub (20) comprises:
a proximal end (14a) with an opening (22) configured to receive a syringe, IV line, or other fluid delivery system, the opening (22) providing a secure, leak-proof connection;
a distal end (16a) connected to the strain relief (18) and aligned with the lumen of the shaft (12) to provide a continuous, unobstructed fluid pathway.

8. The injection catheter (10) as claimed in claim 1, wherein the strain relief (18) is constructed from a flexible, resilient material and is molded to absorb and distribute mechanical stresses during manipulation of the catheter (10).

9. The injection catheter (10) as claimed in claim 1, wherein the shaft (12), hub (20), and strain relief (18) are joined to form a seamless structure, with welded connections between the braided tube section (12a), non-braided tube section (12b), and soft tip section (12c).

10. The injection catheter (10) as claimed in claim 1, wherein the shaft (12) further comprises radiopaque markers or graduated markings to assist in accurate placement and depth assessment.

11. The injection catheter (10) as claimed in claim 1, wherein the catheter (10) is configured for the administration of surfactants, medications, or other therapeutic agents directly to a target anatomical site within a patient.

12. The injection catheter (10) as claimed in any preceding claim, wherein the soft tip section (12c) is formed with a pre-shaped curve or an angled configuration to facilitate navigation through anatomical pathways.

13. The injection catheter (10) as claimed in any preceding claim, wherein the strain relief (18) is constructed from a thermoplastic elastomer or silicone material to optimize flexibility and durability at the junction between the hub (20) and the shaft (12).

14. The injection catheter (10) as claimed in any preceding claim, wherein the braided tube section (12a), non-braided tube section (12b), and soft tip section (12c) are joined by a laser or ultrasonic welding process to form a seamless transition between sections.

15. The injection catheter (10) as claimed in any preceding claim, wherein the shaft (12) comprises a multi-lumen configuration for simultaneous administration of different therapeutic agents or for use with a guidewire.

16. The injection catheter (10) as claimed in any preceding claim, wherein the shaft (12) is manufactured from a material selected to provide antimicrobial properties for reducing the risk of infection during use.

17. The injection catheter (10) as claimed in any preceding claim, wherein the shaft (12) comprises a plastically deformable braided portion configured to permit manual shaping manual shaping of the shaft to substantially conform to a desired anatomical configuration.

18. The injection catheter (10) as claimed in any preceding claim, wherein the shaft (12) includes a transition from the braided portion to a non-braided portion, and wherein the non-braided portion exhibits a different stiffness profile to enhance maneuverability.

19. The injection catheter (10) as claimed in any preceding claim, wherein the distal end of the shaft (12) forms an angle with respect to the main longitudinal axis of the shaft (12), wherein said angle is approximately 30 degrees.

20. The injection catheter (10) as claimed in claim 19, wherein the angle formed at the distal end of the shaft (12) is within a range selected from the group consisting of: 15 to 25 degrees, 15 to 30 degrees, 15 to 35 degrees and 15 to 45 degrees.

21. The injection catheter (10) as claimed in any preceding claim, wherein the catheter shaft (12) comprises only two primary sections, namely a proximal braided portion (12a) and a distal non-braided portion (12b), the distal non-braided portion (12b) being formed from a sufficiently soft, atraumatic material so as to eliminate the need for a separate soft tip (12c).

22. The injection catheter (10) as claimed in any preceding claim, wherein the non-braided tube section (12b) is colored black or any other dark color to provide visual contrast with the proximal braided tube section (12a).

23. The injection catheter (10) as claimed in any preceding claim, wherein only the distal portion of the shaft (12) including at least a portion of the non-braided section (12b) and/or the soft tip section (12c) is provided with one or more radiopaque elements or markers to facilitate visualization and precise placement under imaging guidance.

24. The injection catheter (10) as claimed in any preceding claim, wherein the distal end of the shaft (12) is configured without any bend or angled formation, such that the longitudinal axis of the distal portion is co-linear with the longitudinal axis of the main shaft.