Medical fluid delivery

Abstract

The devices, assemblies, systems, and techniques described herein can facilitate the delivery of a medical fluid, such as an adhesive, to a patient. For example, a medical assembly can include a flexible catheter configured to be disposed within an anatomy of a patient, where the flexible catheter defines an inner lumen configured to contain a volume of a medical adhesive. The medical assembly can also include a shaft defining a shaft cross-sectional dimension that is less than an inner lumen cross-sectional dimension of the inner lumen, where advancement of the shaft through at least a portion of the inner lumen forces at least a portion of the volume of the medical adhesive out of a distal opening of the inner lumen of the flexible catheter.

Description

Technical Field

[0001] This disclosure relates to medical components and techniques for delivering fluids via catheters. Background Technology

[0002] Healthy leg veins contain valves that allow blood to move in one direction from the lower limb towards the heart. These valves open as blood flows toward the heart and close to prevent venous reflux or blood backflow. When veins weaken and become dilated, their valves cannot close properly, which can lead to impaired venous return and drainage of venous blood from the leg, a condition known as venous insufficiency. Venous reflux is most common in superficial veins. The largest superficial vein is the great saphenous vein (GSV), which extends from the top of the foot to the groin, where it originates from a deep vein.

[0003] Factors that may contribute to venous reflux disease include female sex, genetics, obesity, lack of physical activity, multiple pregnancies, age, a history of blood clots in the legs, and occupations involving prolonged standing. According to population studies, the prevalence of visible tortuous veins, a common indicator of venous reflux disease, is as high as 15% in adult men and 25% in adult women. Clinical records from over 1000 patients indicate that the average age of patients treated for venous reflux was 48 years, and over 75% of patients were women.

[0004] Venous return can be addressed in the great saphenous vein using non-invasive methods. These methods include radiofrequency (RF) ablation, laser ablation, and sclerotherapy (including foam sclerotherapy). One approach also involves delivering an adhesive into the GSV to close symptomatic veins. In this adhesive treatment, the adhesive is typically removed from a sealed vial and placed into a syringe before being injected into the GSV through a catheter. Summary of the Invention

[0005] In some aspects, this disclosure describes exemplary medical components, devices, systems, and techniques for delivering medical fluids (e.g., medical adhesives) to a patient. In one example, the medical component may be configured to deliver medical adhesive to a hollow anatomical structure (e.g., a structure resembling a blood vessel configured to contain fluid) to reduce blood flow or to completely close the hollow anatomical structure. Such closure of the hollow anatomical structure can be beneficial for treating various conditions, such as venous reflux or venous insufficiency in a patient's superficial or deep veins. The medical component described herein may be configured to deliver one or more clumps of medical adhesive to appropriate locations within the hollow anatomical structure to seal the structure.

[0006] For example, the medical component may include a flexible catheter and a shaft (e.g., a mandrel) configured to be inserted into the lumen of the flexible catheter. The lumen of the flexible catheter may be pre-filled with a volume of medical adhesive. Once the flexible catheter is positioned at a target site within the patient's hollow anatomy, a clinician can insert the shaft into the flexible catheter to force the medical adhesive away from the distal end of the flexible catheter and into the hollow anatomy for closure. In another example, a clinician may insert a pre-filled tube containing medical adhesive into the lumen of the flexible catheter. Inserting the shaft into the flexible catheter may puncture the proximal end of the pre-filled tube and force the medical adhesive away from the distal end of the pre-filled tube and away from the distal opening of the flexible catheter. In some examples, the flexible catheter may include a side opening configured to receive a guidewire, which facilitates navigation of the flexible catheter to a target location within the patient's hollow anatomy.

[0007] In one example, the medical component includes a flexible catheter and a shaft. The flexible catheter is configured to be disposed within a patient's hollow anatomy. The flexible catheter defines an inner lumen having an internal cross-sectional dimension and a distal opening of the inner lumen. The inner lumen is configured to contain a volume of medical adhesive. The shaft defines an axial cross-sectional dimension smaller than the internal cross-sectional dimension of the inner lumen. The shaft is advanced through at least a portion of the inner lumen, forcing at least a portion of the volume of medical adhesive away from the distal opening of the inner lumen.

[0008] In another example, a method includes navigating the distal end of a flexible catheter to a target location within a patient's hollow anatomy, wherein the flexible catheter defines an inner lumen having an inner cross-sectional dimension and a distal opening of the inner lumen, and wherein the inner lumen is configured to accommodate a volume of medical adhesive, and advancing an axis through at least a portion of the inner lumen to force at least a portion of the volume of medical adhesive away from the distal opening of the inner lumen, wherein the axis defines an axial cross-sectional dimension smaller than the inner cross-sectional dimension of the inner lumen.

[0009] In another example, the medical component includes a flexible catheter and a shaft. The flexible catheter is configured to be disposed within a patient's hollow anatomical structure. The flexible catheter defines an inner lumen having an internal cross-sectional dimension and a distal opening of the inner lumen. The internal cross-sectional dimension ranges from about 0.102 cm to about 0.254 cm. The flexible catheter includes a reinforcing portion comprising at least one of a coil or braid within the wall of the flexible catheter. The inner lumen is configured to accommodate a volume of medical adhesive. The shaft defines an axial cross-sectional dimension smaller than the internal cross-sectional dimension. The advancement of the shaft through at least a portion of the inner lumen forces at least a portion of the volume of medical adhesive away from the distal opening of the inner lumen of the flexible catheter. The volume of the medical adhesive ranges from about 1.0 mL to about 4.0 mL.

[0010] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the examples according to this disclosure will be apparent from the specification and drawings and from the claims. Attached Figure Description

[0011] Figure 1A , 1B 1C, 1D, and 1E are schematic diagrams of exemplary procedures for delivering venous occlusion material to a patient.

[0012] Figure 2A , 2B 2C, 2D, and 2E are schematic diagrams of exemplary procedures for delivering venous occlusion material to a patient at multiple target locations.

[0013] Figure 3 This is a conceptual diagram of an exemplary catheter and mandrel configured to deliver venous occlusion material to a patient.

[0014] Figure 4A and 4B These are perspective and sectional views of a catheter designed to deliver venous occlusion material to the proximal end of the patient.

[0015] Figure 5A This is a cross-sectional view of the distal end of an exemplary catheter pre-filled with venous occlusion material and the mandrel located within the catheter.

[0016] Figure 5B It is along Figure 5A A cross-sectional view of the duct taken at point AA. Figure 5C It is along Figure 5A A cross-sectional view of the duct taken at BB.

[0017] Figure 6A This is a cross-sectional view of the distal end and guidewire exit port of another exemplary catheter pre-filled with venous occlusion material.

[0018] Figure 6B It is along Figure 6A A cross-sectional view of the duct taken at CC. Figure 6C It is along Figure 6A A cross-sectional view of the duct taken at DD.

[0019] Figure 7A and 7B yes Figure 6A A cross-sectional view of an exemplary catheter and a guidewire exit port closed by the advance of venous occlusive material.

[0020] Figure 8A This is a cross-sectional view of the distal end of another example catheter configured to receive a pre-filled tube filled with venous occlusion material.

[0021] Figure 8B It is along Figure 8A A cross-sectional view of the duct taken at point AA. Figure 8C It is along Figure 8A A cross-sectional view of the duct taken at BB.

[0022] Figure 9A and 9B yes Figure 8A A cross-sectional view of an exemplary catheter, wherein a mandrel forces venous occlusion material out of a pre-filled tube.

[0023] Figure 10A and 10B This is a cross-sectional view of an exemplary catheter and guidewire exit port, which is closed by the advancement of a pre-filled tube containing venous occlusion material.

[0024] Figure 11 This is a flowchart of an exemplary technique for delivering a volume of venous occlusion material out of a catheter pre-filled with venous occlusion material by advancing a mandrel within the catheter.

[0025] Figure 12 It is a flowchart of an exemplary technique for inserting a pre-filled cylinder containing venous occlusion material and advancing a mandrel to deliver a volume of venous occlusion material away from the pre-filled cylinder and catheter. Detailed Implementation

[0026] This disclosure describes medical components, devices, systems, and techniques relating to the delivery of medical fluids to a patient's hollow anatomical structures, such as veins or arteries. Venous reflux or venous insufficiency is a condition in which venous valves are no longer able to close properly and blood is able to flow back within a vein (e.g., the great saphenous vein or perforating vein). Treatment for venous reflux may include closing or removing one or more veins subject to venous reflux. An exemplary treatment may include delivering a medical adhesive to a vein such that the medical adhesive causes venous closure. Once the medical adhesive has cured, the introduction of the adhesive prevents blood from flowing through the vein. After venous closure, blood may be diverted to other veins without impairing systemic blood flow.

[0027] An exemplary method for delivering medical adhesive into a vein may include using a syringe gun, a syringe, and a catheter. The medical adhesive may be stored in a container (e.g., a vial). A clinician may load some or all of the medical adhesive contained in the vial into the syringe. The clinician may then attach the catheter to the syringe, infuse the catheter with the medical adhesive, insert the distal end of the catheter into the target vein, and attach the syringe to the syringe gun. When the distal end of the catheter is at the target location within the vein, the clinician may actuate the syringe gun, which depresses the plunger of the syringe and delivers a bolus of the medical adhesive away from the distal end of the catheter. The clinician may withdraw the catheter one or more times over short distances and deliver additional corresponding boluses of the medical adhesive to other locations within the vein to achieve complete closure of the vein.

[0028] In some examples, medical adhesives can have a viscosity similar to honey, for example, between approximately 8,000 centipoise (cps) and 12,000 cps. In some commercial adhesives, the viscosity is between 1,000 and 2,500 cps. This viscosity of medical adhesives can provide several advantages when delivered into a vein, such as the ability to displace blood and resistance to flow away from the delivery site within the vein. Due to the relatively high viscosity of medical adhesives, syringe guns are often equipped with force multipliers to make it easier for clinicians to deliver the medical adhesive from the syringe. Therefore, this system requires a higher force than might be needed to dispense viscous medical adhesive from a syringe and through a catheter. While syringes and syringe guns provide an efficient delivery system, the system setup involves several steps prior to the procedure, which prolongs the procedure time and can be tricky. Furthermore, clinicians may attempt to use portions of the system (e.g., syringes and medical adhesives) to treat other patients, portions of which may be ineffective for the second patient and pose a potential hazard.

[0029] In the aforementioned method of delivering adhesive to the GSV to close symptomatic veins, there are several aspects that could require improvement in adhesive delivery. For example, the adhesive is typically removed from a sealed vial into the syringe, which can be time-consuming and / or messy. Furthermore, the entire length of the catheter must be infused with adhesive before it can be delivered for treatment, which can also be time-consuming, potentially wasteful, and may require considerable force depending on the adhesive's viscosity. At least for these reasons, a system that allows the catheter to be pre-loaded with adhesive could be advantageous compared to obtaining the adhesive from a sealed vial used for the procedure.

[0030] The systems, devices, and techniques described herein can reduce the complexity of medical fluid delivery and promote increased patient safety. In some examples, the medical component may include a flexible catheter and a shaft (e.g., a mandrel) configured to be inserted into the lumen of the flexible catheter and force medical fluid (e.g., a medical adhesive) out of the distal opening of the flexible catheter. In one example, the flexible catheter is pre-filled with a volume of medical adhesive. For example, the manufacturer may fill the flexible catheter at the manufacturing plant and store the medical adhesive within the flexible catheter, eliminating the need for clinicians to infuse the flexible catheter or otherwise transfer the medical adhesive from a storage container to the flexible catheter prior to the procedure. Once the flexible catheter is inserted into the patient's desired vein (or other anatomical structure), the physician inserts the shaft into the proximal opening of the flexible catheter and advances the shaft through the lumen of the flexible catheter to force the medical adhesive out of the distal opening of the flexible catheter and into the vein.

[0031] In another example, the system is a tube-based catheter delivery system comprising a pre-filled tube containing a volume of medical adhesive, separate from the flexible catheter. In one specific example, a clinician inserts the pre-filled tube containing the medical adhesive into the lumen of the flexible catheter. In another specific example, during the manufacturing process, the pre-filled tube is pre-loaded into the lumen of the flexible catheter. The clinician can then insert the distal end of a shaft into the lumen of the flexible catheter to pierce the proximal end of the pre-filled tube, forcing the medical adhesive away from the distal end of the pre-filled tube and out of the distal opening of the flexible catheter. In this way, the shaft is advanced through the lumen of the pre-filled tube until the clinician has dispensed the desired amount of medical adhesive. If more medical adhesive is needed than provided in a single pre-filled tube, the pre-filled tube can be removed from the flexible catheter, and another pre-filled tube containing more medical adhesive can be reloaded into the flexible catheter. In one example, the pre-filled tube is filled and sealed during manufacturing. Thus, the pre-filled tube is provided to the clinician in a pre-filled and ready-to-use state. In another example, the tube is filled by a clinician (or other practicing physicians who work with the clinician), so that the tube is pre-filled before the procedure.

[0032] Prefilled catheter delivery systems, or prefilled cartridge-based catheter delivery systems, can therefore be configured to deliver medical adhesives without syringes or injection guns, which can help reduce the time and cost associated with medical procedures. Because the diameter of the flexible catheter is smaller than that of a syringe, dispensing medical adhesive from the flexible catheter may require less force compared to using a syringe. These systems also reduce the likelihood that medical adhesive will be reused for another patient, as the adhesive remains within the catheter already inserted into the patient. For example, the reuse of medical adhesive can be avoided to prevent the spread of disease between patients, or to ensure the adhesive is effective. Prefilled catheter delivery systems can simplify procedure setup because the medical adhesive does not need to be transferred from the clinician to the flexible catheter. Cartridge-based catheter delivery systems may include the step of inserting a prefilled cartridge (containing the medical adhesive) into the flexible catheter prior to the procedure. If a closure procedure needs to be performed on a patient's vein, the clinician may choose to insert another prefilled cartridge containing additional medical adhesive.

[0033] Any of the flexible catheter delivery systems described herein can also be configured to facilitate catheter delivery using a rapid-change guidewire. For example, the flexible catheter may include a side opening configured to receive a guidewire that facilitates navigation of the flexible catheter to a target location within a patient's hollow anatomy (e.g., a vein). Once in place, the guidewire can be removed from the lumen of the flexible catheter via the side opening. In some examples, advance of medical adhesive from a location proximal to the side opening may force a baffle within the flexible catheter to close the side opening leading to the catheter and prevent the medical adhesive from leaving through the side opening. In other examples, advance of a tube filled with medical adhesive distally through the side opening may cause the pre-filled tube to close the side opening in the flexible catheter leading to the lumen defined by the flexible catheter. In other examples, the flexible catheter may have an "over-the-wire" configuration comprising a separate guidewire lumen that extends parallel to the lumen receiving the pre-filled tube along the entire length of the catheter. In this example, the side opening and baffle may not be provided.

[0034] While the catheter delivery systems described herein are primarily referred to as delivering medical adhesives to a patient's veins to manage venous return, these systems may be used to manage other conditions or to deliver medical fluids to other locations within a patient's body. For example, the catheter delivery systems described herein may be configured to deliver wound-closing adhesives to damaged hollow anatomical structures (e.g., blood vessels, or a portion of the gastrointestinal tract) or other tissues. As another example, the catheter delivery systems described herein may be configured to deliver medical fluids, such as medications, to desired tissues in a patient. Other exemplary uses of the catheter delivery systems described herein may include delivering adhesives to specific locations (e.g., arterial embolization) to interrupt blood flow to prevent blood from reaching a tumor. Although human structures are described herein, the medical components and techniques described herein may be used to treat other animal species.

[0035] Figure 1A , 1B Figures 1C, 1D, and 1E are schematic diagrams of exemplary procedures for delivering venous occlusion material to a patient. Figure 1A As shown, the medical component 10 includes a flexible catheter 12 having a proximal end 14A and a distal end 14B, and a shaft 18. The flexible catheter 12 has been inserted into a patient's vein 20. In some examples, the vein 20 may be the great saphenous vein, but in other examples, the vein 20 may be any superficial vein, deep vein, or perforating vein. The vein 20 includes a lower portion 24 and an upper portion 22. The shaft 18 (e.g., a mandrel) is inserted into the proximal end 14A of the flexible catheter 12 to force medical adhesive (e.g., a spindle) into place. Figure 1A-1EA portion of the medical adhesive 26 shown exits from the distal end 14B of the flexible catheter 12. The shaft 18 can be inserted by a clinician or can be inserted during manufacturing and sent to a clinician in a pre-inserted state.

[0036] The flexible catheter 12 is configured to be disposed within a hollow anatomical structure of the patient (e.g., vein 20). The flexible catheter 12 is an elongated structure (e.g., a tubular body) defining at least one lumen with an internal luminal cross-sectional dimension (e.g., diameter in the case of a cylinder), a proximal opening of the lumen, and a distal opening of the lumen. The lumen of the flexible catheter 12 is configured to contain a volume of medical adhesive, either directly or via another structure disposed within the flexible catheter 12 (e.g., a pre-filled tube or other container). A shaft 18 (e.g., a mandrel or other actuating member) defines an axial cross-sectional dimension smaller than the internal luminal cross-sectional dimension of the flexible catheter 12.

[0037] The shaft 18 may be an elongated structure, axially rigid to resist compression and laterally flexible to conform to the curvature of the flexible catheter 12 and the patient's vascular system. In some examples, the shaft 18 may be made of a metal or metal alloy, such as medical-grade stainless steel, titanium alloy (e.g., nitinol), or any other such metal. In other examples, the shaft 18 may be made of a polymer or a combination of polymers. The shaft 18 may have a cross-sectional shape of at least one of circular, elliptical, rounded square, or other shapes. In some examples, the cross-sectional shape of the shaft 18 may be selected to correspond to the cross-sectional shape of the lumen of the flexible catheter 12.

[0038] Advancing shaft 18 through at least a portion of the lumen of flexible catheter 12 can force at least a portion of a volume of medical adhesive out of the distal opening of the lumen of flexible catheter 12. For example, a user can apply a force in a distal direction to shaft 18, and shaft 18 can transmit this force to increase the pressure of a volume of medical adhesive within the lumen of flexible catheter 12. The increased pressure will cause at least a portion of the volume of medical adhesive to flow distally through the lumen and eventually out of the distal end 14B of flexible catheter 12. Shaft 18 may include a handle located at its proximal end, which facilitates manipulation by hand. Furthermore, flexible catheter 12 may include one or more structural features near the proximal end 14A that allow a user to hold flexible catheter 12 when shaft 18 is inserted and / or advanced into flexible catheter 12. In some examples, flexible catheter 12 may be inserted into a lumen defined by a guiding catheter. The guiding catheter may be initially inserted into vein 20 and facilitates navigation of flexible catheter 12 to vein 20.

[0039] In some cases, clinicians may use imaging tools, such as ultrasound transducer 16, to assist in guiding flexible catheter 12 to one or more target sites where medical adhesive will be received. Ultrasound transducer 16 can be multifunctional. For example, ultrasound transducer 16 may include one or more ultrasound sensors for generating images to help clinicians guide catheter 20 (or another device, such as a guide catheter or guidewire) through a patient's vascular system. The ultrasound transducer may also act as a compression element against vein 20 after a clump of medical adhesive has been delivered into vein 20, and / or identify areas within vein 20 that may require further occlusion or closure. In some examples, ultrasound transducer 16 may be positioned to contact the outer surface of the patient's skin before placement of flexible catheter 12 or any other device (e.g., a guide catheter or guidewire through blood vessel 20). Ultrasound transducer 16 can assist in generating images to help guide one or more catheters or guiding devices to one or more target sites where venous occlusion material (e.g., medical adhesive) will be introduced. In some examples, the ultrasound transducer 16 may also serve as a compression element before, during, or after the introduction of medical adhesive to assist in the closure of the vein 20. By serving as a compression element, the ultrasound transducer 16 can help flatten and / or reduce the size of the vein 20. In some examples, the ultrasound transducer 16 may include Doppler flow detection capability and help identify areas within the vein 20 that may require further closure or occlusion and therefore necessitate the application of venous occlusive material.

[0040] In some examples, the flexible catheter 12 may include one or more features that facilitate visualization of one or more portions of the flexible catheter 12 under ultrasound visualization using an ultrasound transducer 16. For example, the flexible catheter 12 may include one or more echogenic portions at a distal portion of the flexible catheter 12. The echogenic portions may include one or more cavities defined within the wall of the flexible catheter 12. These cavities may be arranged circumferentially, axially, and / or radially within the wall of the flexible catheter 12. The cavities may include gases (e.g., air or nitrogen), solid materials (e.g., metallic alloys), or other materials that can be distinguished from other anatomical structures or fluids within the patient.

[0041] like Figure 1BAs shown, advancement of shaft 18 in the (distal) direction of arrow 19 can apply force to a volume of medical adhesive contained within flexible catheter 12, displacing a clump 26 of the medical adhesive out of the distal end 14B of flexible catheter 12. In some examples, shaft 18 may include one or more markings along its length indicating the volume of medical adhesive delivered by advancement of shaft 18. For example, each marking along the length of shaft 18 may specify a single clump or a specified volume, such as 0.2 ml (mL) or some other volume increment. In this way, the user can use the markings along shaft 18 associated with the proximal opening of flexible catheter 12 as a measure of the amount of medical adhesive delivered during advancement of shaft 18.

[0042] exist Figure 1C In the example, the medical adhesive clump 26 has been delivered into the vein 20, and the clinician has withdrawn the flexible catheter 12 proximally from the site of delivery of the clump 26. Once the flexible catheter 12 is removed from the area containing the clump 26, the clinician can apply pressure to that portion of the vein 20 containing the medical adhesive clump 26. For example, as... Figure 1D As shown, optional compression elements (such as the operator's hand 28, a sequential compression device, or an ultrasonic transducer 16) can be used to apply pressure to the outer surface of the patient's body and compress the inner wall of the vein 20. The optional compression elements can be used to compress portions of the blood vessel before, during, or after the introduction of the medical adhesive. When the compression element compresses a portion of the vein 20 during or after the introduction of the cluster 26, the blood vessel is compressed against the cluster 26, as... Figure 1D As shown. This compression facilitates the occlusion and collapse of vein 20 to allow the vessel wall to coapt. In some examples, when additional portions of the vessel are treated with medical adhesive, the target area of ​​vein 20 can be compressed immediately after the injection of medical adhesive, or no more than approximately 5 minutes, 4 minutes, 3 minutes, 2 minutes, 1 minute, 30 seconds, 15 seconds, or less after the injection of medical adhesive.

[0043] After delivering the bolus 26 and applying pressure to the site containing the bolus 26, the clinician can withdraw the flexible catheter 12 back to its new position within the vein 20 and repeat the process. Figure 1B-1DThe steps shown are for delivering another block of medical adhesive to a new location within vein 20. In some examples, the different locations for delivering the medical adhesive may be spaced between approximately 0.5 cm and approximately 5 cm along the length of vein 20. In other examples, for each location to receive the block of medical adhesive, the distal end 14B of the flexible catheter 12 may be moved between approximately 3% and approximately 50% of the total length of vein 20 to be treated. In some examples, each site for treatment may be between approximately 3% and approximately 20% of the total length of the treatment site for vein 20. In some examples, the total treatment site of vein 20 may have a length between approximately 2 cm and approximately 50 cm, or in some examples, a length between approximately 5 cm and approximately 40 cm.

[0044] like Figure 1E As shown, multiple clumps of medical adhesive have been delivered to vein 20 to create an occluded portion 30 of vein 20. The occluded portion 30 may include medical adhesive that has been delivered from catheter 12 into vein 20 and adhered to the wall of vein 20. In some examples, the occluded portion 30 may include a continuous length of medical adhesive caused by multiple delivered clumps. In other examples, the occluded portion 30 may include multiple separated areas of vein 20 that have been joined by medical adhesive. After the medical adhesive has been delivered, a clinician can remove the flexible catheter 12 and shaft 18 from vein 20 and the patient.

[0045] In some examples, for example Figure 5A-7B For example, the lumen of the flexible catheter 12 is pre-filled (e.g., by the manufacturer, not by the clinician) with a certain volume of medical adhesive. The volume of medical adhesive pre-filled in the lumen is sufficient to handle the entire length of the vein 20. By pre-filling the flexible catheter 12 with the volume of medical adhesive, the user will not need to add medical adhesive to the flexible catheter 12 before performing procedures on the patient. In some examples, the proximal end 14A of the flexible catheter 12 may be sealed, or a plug may be inserted proximally into the lumen to seal the lumen of the flexible catheter 12 and prevent the medical adhesive from curing while stored within the flexible catheter 12. Alternatively, a seal, film, or cap may be provided on the distal end 14B of the flexible catheter 12 to keep the medical adhesive in an uncured state while stored within the flexible catheter 12. The user may remove the proximal or distal seal before use, or in some examples, the advancement of the shaft 18 may puncture or displace the proximal seal, while the pressure caused by the advancement of the shaft 18 may rupture the distal seal. In this way, the device or mechanism configured to seal the medical adhesive within the flexible catheter 12 can be removed, displaced, or broken by the advancement of the shaft 18 within the lumen of the catheter 12.

[0046] When the lumen of the flexible catheter 12 is pre-filled with a volume of medical adhesive, the cross-sectional dimensions of the shaft 18 can be configured to correspond to the cross-sectional dimensions of the lumen of the flexible catheter 12. For example, the cross-sectional dimensions of the shaft 18 (e.g., the diameter of a cylindrical shaft) can be slightly smaller than the cross-sectional dimensions of the lumen of the flexible catheter 12 to allow the shaft 18 to move within the lumen, but to prevent excessive (if any) medical adhesive from passing between the shaft 18 and the wall of the flexible catheter 12. Therefore, the diameter of the shaft 18 may not be exactly the same as the diameter of the lumen defined by the flexible catheter 12. In some examples, the distal end of the shaft 18 may include, be attached to, or otherwise contact a movable plug that separates the medical adhesive from the shaft 18. In this way, the shaft 18 can force the movable plug against the medical adhesive to force the medical adhesive away from the distal end 14B of the flexible catheter 12.

[0047] In some examples, the flexible catheter 12 may be configured to be inserted over a guidewire into a vein 20 or other hollow anatomical structure. The guidewire may first be inserted into the vein 20, and then the flexible catheter 12 may be inserted over the guidewire until the distal end 14B is in the desired position. When the flexible catheter 12 is pre-filled with medical adhesive, the guidewire must be able to exit from the lumen of the flexible catheter 12 and pass through the wall of the flexible catheter 12 at a location distal to the location where the medical adhesive is contained within the flexible catheter 12. In some examples, the flexible catheter 12 may define a lateral opening in the wall of the flexible catheter at a location distal to a volume of medical adhesive pre-filled within the lumen, the lateral opening being sized to receive the guidewire. The wall of the flexible catheter 12 may define a circular, oval, square, rectangular, or any other shape of lateral opening configured to receive the guidewire.

[0048] For example, a baffle structure can be arranged within the flexible catheter 12 to hold the medical adhesive proximal to the side opening when the guidewire is inserted into the lumen of the flexible catheter 12. Once the guidewire is removed, the structure can be moved to allow the medical adhesive to be delivered through the lumen of the catheter 12 and located distal to the structure. For example, the flexible catheter 12 may include a baffle configured to move between a first position holding a volume of medical adhesive proximal to the side opening, and a second position closing the side opening relative to the lumen and allowing the adhesive to move through the side opening. In some examples, distal advancement of the medical adhesive within the lumen of the flexible catheter 12 (e.g., via advancement of the shaft 18) forces the baffle from the first position to the second position. In the second position, the baffle allows the medical adhesive to flow through the lumen and is located distal to the side opening.

[0049] In other examples, for example Figure 8A-10BFor example, the lumen of the flexible catheter 12 is configured to receive a pre-filled tube containing a volume of medical adhesive. The pre-filled tube is configured to be at least partially inserted into the lumen of the flexible catheter 12. The pre-filled tube may define an outer diameter corresponding to the cross-sectional dimensions of the lumen of the flexible catheter 12. The outer diameter of the pre-filled tube may be slightly smaller than the diameter of the lumen of the flexible catheter, allowing the pre-filled tube to slide within the lumen. In some examples, the cross-sectional dimensions of the shaft 18 are configured such that the shaft 18 can slide within the lumen defined by the walls of the pre-filled tube. In these examples, advancement of the distal end of the shaft 18 through the proximal portion of the pre-filled tube forces at least a portion of the medical adhesive away from the distal end of the pre-filled tube and away from the distal opening of the lumen of the flexible catheter 12. In other examples, as the shaft 18 is advanced distally within the lumen of the flexible catheter 12, the shaft 18 may contact and compress the sidewalls of the pre-filled tube to expel the medical adhesive from the pre-filled tube and the distal opening of the flexible catheter 12.

[0050] In some examples, the flexible catheter 12, configured to receive a pre-filled cartridge filled with medical adhesive, also defines a side opening sized to receive a guidewire, facilitating navigation of the flexible catheter 12 to a target location within the patient's body. After the flexible catheter 12 is positioned at the target location, the guidewire can be removed from the lumen of the catheter 12. The pre-filled cartridge can then be advanced distally within the lumen of the flexible catheter 12 until the distal end of the pre-filled cartridge is distal to the side opening, such that the pre-filled cartridge covers and closes the side opening. In some examples, the flexible catheter 12 may include a baffle configured to move between a first position allowing the guidewire to enter the side opening defined by the catheter 12, and a second position closing the side opening relative to the lumen of the catheter 12. Distal advancement of the pre-filled cartridge within the lumen of the flexible catheter 12 forces the baffle from the first position to the second position. In some examples, the baffle may be made of a material more elastic than the wall of the pre-filled cartridge. When subjected to pressure applied by shaft 18, the wall of the pre-filled tube may bulge or rupture at the side opening. Therefore, the baffle can provide support for the wall of the pre-filled tube at the side opening and help ensure that the medical adhesive is guided away from the distal opening of the flexible catheter 12.

[0051] The lumen of the flexible catheter 12 can typically have a cross-sectional dimension ranging from approximately 0.040 inches (0.102 cm) to approximately 0.100 inches (0.254 cm). The external dimensions (e.g., outer diameter) of the flexible catheter 12 can range from approximately 0.045 inches (0.114 cm) to approximately 0.115 inches (0.292 cm). These dimensions can correspond to a flexible catheter 12 with a French sizing ranging from 3 French diameter to 9 French diameter. However, smaller or larger diameters may be used in other examples. The flexible catheter 12 can be composed of one or more polymer layers, and in some examples, the polymer can vary along the length of the flexible catheter 12. In some examples, the flexible catheter 12 may include a reinforcing portion comprising at least one of a coil or braid within the wall of the flexible catheter 12 (e.g., embedded within the wall). The coil or braid can be made of a polymer or one or more metals. In some examples, the flexible catheter 12 may include a polytetrafluoroethylene (PTFE) liner defining an inner lumen that contains a medical adhesive or is configured to receive a pre-filled tube containing a medical adhesive.

[0052] In some examples, the medical adhesive described herein may have a viscosity between about 8,000 centipoise (cps) and 12,000 cps. In other examples, the medical adhesive may have a viscosity between 1,000 cps and 2,500 cps. The volume of the medical adhesive pre-filled in the flexible catheter 12 or contained in a single pre-filled cartridge may range from about 1.0 mL to about 4.0 mL. This volume may be selected based on the target vessel to be treated (e.g., the great saphenous vein may require a larger volume of medical adhesive than perforating veins). Each clump of medical adhesive delivered to a single site within the vessel may range from about 0.01 cubic centimeters (cc) to 3 cc. In one example, each clump may range from about 0.01 cc to 1.0 cc of medical adhesive.

[0053] Exemplary medical adhesives may include cyanoacrylates (e.g., 2-octylcyanoacrylate). In some examples, the cyanoacrylate may be aliphatic 2-cyanoacrylates, such as alkyl, cycloalkyl, alkenyl, or alkoxyalkyl 2-cyanoacrylates (e.g., VenaSeal). TM(Medtronic, Minneapolis, MN). In some embodiments, the alkyl group may have 1-16 carbon atoms and may be a C1-C8 alkyl ester or a C1-C4 alkyl ester. Some possible esters include methyl cyanoacrylate, ethyl cyanoacrylate, n-propyl cyanoacrylate, isopropyl cyanoacrylate, n-butyl cyanoacrylate, isobutyl cyanoacrylate, pentyl cyanoacrylate, hexyl cyanoacrylate, cyclohexyl cyanoacrylate, heptyl cyanoacrylate, octyl cyanoacrylate, 2-methoxyethyl cyanoacrylate, and 2-ethoxyethyl cyanoacrylate. Other medical adhesives that may be used include bioadhesives such as bovine serum albumin-glutaraldehyde compositions (e.g., BIOGLUE, Cryolife, Atlanta, GA), PVA, Biogard, collagen, fibrinogen, fibronectin, hydatidine, laminin, thrombin, gelatin, mixtures thereof, or other biocompatible adhesives.

[0054] In other examples, the flexible catheter 12 can deliver other fluids. Materials other than adhesives can be used, including hardeners such as hypertonic salts, sodium tetradecyl sulfate, glycerol chromate, tetracycline, talc, bleomycin, or podocalciferol. For example, foam generated from one or more of the components described above can be used to enhance the ablation and closure of the vein 20. Viscosity and the foam mixture can also be controlled while taking into account the desired clinical outcomes. In some examples, cyanoacrylate formulations contain one or more additives that impart desired properties to the formulation, such as viscosity, color, radiation impermeability, etc. Some examples of additives (e.g., thickeners and polymerization inhibitors) are discussed further below.

[0055] In some examples, the adhesive may also include therapeutic agents, such as anti-inflammatory agents, anti-infective agents, anesthetics, pro-inflammatory agents, cell proliferators, or combinations thereof. In some examples, medical adhesives (e.g., cyanoacrylate adhesives) may have selected properties. In some examples, medical adhesives may have a curing time between about 5 and 60 seconds, or even shorter in some examples. In other examples, the curing time may occur almost simultaneously with blood contact.

[0056] Figure 2A , 2B 2C, 2D, and 2E are conceptual diagrams of exemplary procedures for delivering venous occlusion material (e.g., medical adhesive) to a patient at multiple target locations. Figures 2A-2E The program can be with Figure 1A-1E The procedures are similar. However, Figures 2A-2E A procedure is described for adhering a medical adhesive to an occlusion formed in a vein 44, the procedure being referenced. Figure 1A-1E An example of the described vein 20. The flexible catheter 40 can be similar to... Figure 1A-1E Flexible catheter 12.

[0057] like Figures 2A-2EAs illustrated in the example, the flexible catheter 40 can be percutaneously introduced into the vein 44 at the entry site and advanced distally through the lumen across the treatment area within the vein 44. External compression (e.g., manual compression) is applied to cause the vein 44 distal to the flexible catheter 40 to collapse, forming as shown in the example. Figure 2A The example illustrates a first occlusion 46. After the occlusion 46 is formed in the vein 44, a first volume V1 within the vein 44 can be defined between the distal end 42 of the flexible catheter 40 and the occlusion 46, as shown. Figure 2B As shown. In other examples, when the adhesive may be an embolic agent that blocks blood flow within a blood vessel, external compression may not be necessary.

[0058] Then, a medical adhesive having a second volume V2, for example in the form of a clump, can be injected from the distal end 42 of the flexible catheter 40 into the vein 44 (e.g., by advancing the shaft 18 through the flexible catheter 40 to deliver the medical adhesive from the distal end 42 of the flexible catheter 40). In some examples, the second volume V2 (of the injected medical adhesive) is at least about 100%, 105%, 110%, 120%, 125%, 130%, 140%, 150%, 175%, 200%, 250% or more of the first volume V1 (of the vein 44 located between the occlusion and the distal end 42 of the catheter 40), such that the proximal advancing edge or crescent of the medium V2 proximally passes the distal end 42 of the flexible catheter 40, as... Figure 2C As shown. Figure 2D As shown, the flexible catheter 40 is then withdrawn proximally, and a second occlusion 48 can be formed closer to the proximal side, for example, via external compression. Additional medical adhesive can then be injected to form a volume V2' larger than the vein 44 located between the occlusion 48 and the distal end 42 of the flexible catheter 40, as shown. Figure 2E As shown. Depending on the desired clinical outcome, the procedure may subsequently be repeated for a total of at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more occlusions.

[0059] Figure 3 This is a conceptual diagram of an example system 50 configured to deliver venous occlusion material (e.g., medical adhesive) to a patient. (See diagram 50 for example system 50.) Figure 3As shown, system 50 includes a flexible catheter 52 and a mandrel 62. The flexible catheter 52 may be similar to the flexible catheter 12 described above, and the mandrel 62 may be similar to the shaft 18 described above. The flexible catheter 52 may have an outer wall 54 and an inner wall 56. The inner wall 56 defines a lumen 57 in which a medical adhesive or a pre-filled tube containing a medical adhesive may be disposed. The flexible catheter 52 may also define a proximal opening 58 leading to the lumen 57, into which the body 66 of the mandrel 62 can be inserted. Advancement of the body 66 through the lumen 57 may dispense the medical adhesive or other fluid within the lumen 57 from a distal end 60 defined by the flexible catheter 12, which corresponds to... Figure 3 The distal opening of the cavity 57 in the example shown.

[0060] The mandrel 62 may include a body 66 attached to the handle 64. The mandrel body 66 may be axially rigid and laterally flexible for insertion through the lumen 57 of the flexible catheter 52 and to provide thrust against adhesive or other medical fluid within the lumen 57. A distal end 68 of the body 66 may have a distal surface (e.g., a flat surface) configured to apply pressure to the medical adhesive within the lumen 57 of the flexible catheter 52. In some examples, the distal surface of the distal end 68 may be rounded, dome-shaped, or have a slightly tapered end that facilitates insertion of the distal end 68 into the proximal opening 58 of the flexible catheter 52.

[0061] In some examples, the mandrel body 66 includes a marking 67 along its axial length. When the marking is compared to the proximal opening 58, the marking 67 can indicate the amount of medical adhesive delivered from the flexible catheter 52. The mandrel body 66 may be configured to have a length such that the distal end 68 reaches the distal opening 60 of the flexible catheter 52 while the handle 64 is located proximal to the proximal opening 58. In other examples, the mandrel body 66 may be configured to have a length less than the total length of the flexible catheter 52 to maintain a predetermined length of the flexible catheter 52 distal to the mandrel body 66, and to maintain a flexible end that provides a more injury-resistant tip than the distal end 68 of the mandrel body 66.

[0062] The handle 64 can be sized to fit the human hand and facilitate the operation of the mandrel body 66. The handle 64 can be made of any suitable material, such as, but not limited to, metal, metal alloy, polymer, or composite material. In some examples, the proximal end of the flexible catheter 52 may include a textured outer surface or a different material that facilitates gripping by the user's hand on the proximal end of the flexible catheter 52. In some examples, the proximal end of the flexible catheter 52 may have a larger diameter and / or be made of a harder material that allows for manipulation by the user without collapsing the lumen 57. In some examples, the distal end of the mandrel body 66 may be pre-inserted into the proximal opening 58 of the flexible catheter 52 to seal the medical adhesive from the external environment, for example, during storage of the system 50. In this way, a manufacturer can provide a system comprising a mandrel 62 and a flexible catheter 52 pre-filled with a predetermined volume of medical adhesive while maintaining the integrity of the pre-filled medical adhesive. Figure 4A and 4B An exemplary proximal end of a flexible catheter is shown.

[0063] In other examples, the diameter of the mandrel body 66 may be equal to or greater than the inner diameter of the flexible conduit 52. However, in response to insertion of the mandrel body 66 into the lumen 57, the flexible conduit 52 may expand or stretch radially to increase its inner diameter to the size of the receiving body 66. In this way, stretching of the flexible conduit 52 can provide a tight seal around the mandrel 66. Alternatively, the mandrel body 66 may be covered or attached to a compressible or incompressible end having a larger diameter than the body 66. In this way, both the compressible and incompressible ends can contact the inner wall 56 to prevent proximal movement of the adhesive, similar to a syringe plunger. When inserted into the lumen 57, the diameter of the compressible end may decrease. The incompressible end may be sized just smaller than the diameter of the lumen to allow sliding within the lumen 57 while also preventing most or all of the adhesive from moving proximal over the incompressible end.

[0064] Figure 4A and 4B These are perspective and sectional views, respectively, of the proximal end of a flexible catheter 70 configured to deliver venous occlusion material to a patient. The flexible catheter 70 may be similar to the flexible catheters 12 and 52 described herein. Figure 4AAs shown, the flexible catheter 70 includes an elongated member 71 defining an outer wall 72 and an inner wall 74. The inner wall 74 defines an inner lumen 78 configured to be pre-filled with a medical adhesive (or other medical fluid) or to receive a pre-filled cylinder containing a medical adhesive. A flange 76 is attached to the elongated member 71 and provides a surface that a user can grip to manipulate the position of the flexible catheter 70, for example, to advance the flexible catheter 70 proximally or distally within the patient's vascular system.

[0065] like Figure 4B As shown in the cross-sectional view, flange 76 extends transversely to (e.g., perpendicularly to) the longitudinal axis 73 of elongated member 71. Flange 76 may include a distally facing concave surface to facilitate user finger placement when providing proximal forces to counteract distal forces generated by advancing mandrel 52 through lumen 78. In other examples, the proximal end of flexible conduit 70 may include a handle surrounding the periphery of outer wall 72, for example, allowing the user to wrap their fingers around the handle and then around elongated member 71 when mandrel 52 is inserted into lumen 78. In any case, flexible conduit 70 may include a structure on its distal end that facilitates user operation of flexible conduit 70 and insertion and advancement of mandrel 52 or other devices, such as shaft 18. Figure 1A-1E ).

[0066] Figure 5A This is a cross-sectional view of the distal end of an exemplary flexible catheter 80 pre-filled with a venous occlusion material (e.g., medical adhesive) and an axis 96 located within the lumen defined by the flexible catheter 80. The flexible catheter 80 may be an example of the flexible catheters 12, 52, or 70 described herein. The flexible catheter 80 and axis 96 can provide a system that facilitates the delivery of medical adhesive into a patient for various treatments, such as delivering medical adhesive into a vein for vascular occlusion. Medical adhesive 98 may be stored within the flexible catheter 80 prior to delivery to the patient during a medical procedure. For example, the lumen of the flexible catheter 80 may be filled with medical adhesive 98 by the manufacturer and then stored and / or transported for later use by a clinician. In this way, the flexible catheter 80 can serve as both a storage container and a delivery container for medical adhesive 98. Prefilling the flexible catheter 80 with a certain volume of medical adhesive 98 can reduce the total procedure time, reduce the amount of adhesive required (i.e., it is not necessary to irrigate the entire length of the catheter with adhesive), and reduce the likelihood that a single-use flexible catheter 80 can be reused for a medical procedure performed on another patient.

[0067] Prefilling the flexible catheter 80 with medical adhesive 98 contrasts with alternative methods of dispensing medical adhesive, which may include a separate vial of medical adhesive added to the flexible catheter 80 by a clinician or other user prior to procedure, such as via a syringe or other fluid delivery mechanism. In some examples, the flexible catheter 80 may have an increased volume and / or length to store the entire volume of medical adhesive 98 required to perform the procedure, compared to other catheters that are not prefilled with medical adhesive. This can reduce the time clinicians spend preparing procedures and decrease the likelihood of the medical adhesive being reused for another patient. For example, prefilling the flexible catheter 80 eliminates the need for the flexible catheter 80 to be infused or padded by a clinician to displace air prior to procedure.

[0068] Figure 5A The example shows the distal end 81 of a flexible conduit 80, wherein the distal end of the shaft 96 has been inserted into the lumen of the flexible conduit 80. The flexible conduit 80 can be constructed of any suitable material. For example, the flexible conduit 80 may include an outer wall 82 and an inner liner 86. The outer wall 82 may define a cylindrical shape and, in some examples, include a reinforcing portion comprising a reinforcing member 84. The reinforcing member 84 may be a coil, braid, or other structure that provides structural reinforcement to the outer wall 82, which improves the maneuverability, trackability, and / or crimp resistance of the flexible conduit 80. The outer wall 82 may be made of one or more polymers (e.g., polytetrafluoroethylene (PTFE)) or thermoplastics, such as... The flexible catheter 80 is constructed as follows. Because the flexible catheter 80 is pre-filled with medical adhesive 98, it may not benefit from translucency, which would otherwise be advantageous during perfusion of the catheter 80 with the medical adhesive. The opacity of the flexible catheter 80 allows for a wider range of catheter designs, such as including reinforcing members 84. Furthermore, in some examples, the outer wall 82 may be filled with an echogenic material, such as ZnO2, TiO2, etc. (e.g., as described in U.S. Patent No. 5,921,933 assigned to Medtronic, Inc., which is incorporated herein by reference). This opaque outer wall 82 can be constructed to be thinner than those materials that remain translucent. A thinner outer wall 82 can reduce the outer diameter of the flexible catheter 80, which can increase patient comfort and facilitate insertion of the flexible catheter 80. In some examples, the flexible catheter 80 can be constructed with various rigidity distributions. In one example, the proximal end of the flexible catheter 80 may be more rigid than the distal end of the flexible catheter 80. In another example, the distal end of the flexible catheter 80 may be more rigid than the proximal end of the flexible catheter 80.

[0069] A reinforcing member 84 may be located within the outer wall 82 (e.g., embedded within or sandwiched between two outer walls 82), and may be made of metal, metal alloy, polymer, or composite material. The reinforcing member 84 may be made of a material more rigid than the outer wall 82. A liner 86 may define the lumen of the flexible catheter 80 for receiving the medical adhesive 98. The liner 86 may be formed of or otherwise constructed of a material resistant to the adhesion of the medical adhesive 98. For example, the liner 86 may be made of PTFE, which prevents the medical adhesive 98 from adhering to the inner surface of the flexible catheter 80. In addition to or instead of the liner 86, the surface of the flexible catheter 80 defining the lumen containing the adhesive may include a hydrophilic or hydrophobic material selected to resist formulation interactions with the medical adhesive 98. In some examples, the outer surface of the outer wall 82 may be coated with a hydrophilic, hydrophobic, and / or lubricating material to facilitate insertion into a patient's blood vessel.

[0070] The flexible catheter 80 may also include an echoic portion at its distal end, which facilitates visualization under ultrasound imaging. By confining the echoic portion to the distal end of the flexible catheter 80, the remaining portion of the proximal end of the flexible catheter 80 (e.g., the outer wall 82 and the inner liner 86) can be thinner to facilitate a greater volumetric capacity to hold the medical adhesive 98, while achieving a larger inner diameter (lumen) for a given outer diameter of the flexible catheter 80. In this way, the inner diameter of the flexible catheter 80 can be smaller at the distal end than at a more proximal location to accommodate these echoic materials.

[0071] In some examples, the echogenicity of the flexible catheter 80 may be provided by air channels 92A and 92B disposed at the distal end of the flexible catheter 80 and within a wall material 88 (which may resemble the outer wall 82). A liner 86 may extend to the distal end 81 of the flexible catheter 80 and to the distal opening 94. In some examples, the distal opening 94 may be covered by a flap or a destructible cap that is forced open by increased pressure from the abutting adhesive 98 of the shaft 96. In other examples, a cap may cover the flexible catheter 80 pre-filled with adhesive 98, and this cap may be removed immediately before the flexible catheter 80 is inserted into the patient. Alternatives to or in addition to air channels 92A and 92B, the flexible catheter 80 may include other echogenic materials near the distal opening 94. In some examples, radiopaque markers, such as a metallic band 90, may be positioned at or near the distal end 81 of the flexible catheter 80 to facilitate visualization under ultrasound, X-ray, fluoroscopy, or other imaging modalities. In some examples, the metal strip 90 may be coated with a polymer such as PTFE, the metal strip 90 may be disposed on the radially outward surface of the flexible conduit 80, and / or the metal strip 90 may be forged to the distal end of the flexible conduit 80.

[0072] The cross-sectional dimensions (e.g., diameter or cross-sectional area) of the shaft 96 are configured to correspond to the cross-sectional dimensions of the lumen defined by the liner 86. Therefore, the dimensions of the shaft 96 can be slightly smaller than the dimensions of the liner 86 to allow the shaft 96 to advance through the lumen defined by the liner 86, while preventing or reducing any backflow of medical adhesive 98 between the shaft 96 and the liner 86. The user can access the flexible catheter 80 from its proximal end ( Figure 5A (Not shown) The shaft 96 is manually advanced. In some examples, the shaft 96 can be delivered from a coiled carrier tube located proximal to the proximal opening of the flexible catheter 80. Because the shaft 96 can be coiled until inserted into the lumen of the flexible catheter 80, a longer length of the shaft 96 extending posteriorly from the flexible catheter 80 can avoid complicating the manipulation of the flexible catheter 80 or requiring additional space near the patient. The shaft 96 can be about Figure 3 An example of the body 66 of the described spindle 62.

[0073] Delivery of pre-filled material into the lumen of the flexible catheter 80 (in) Figure 5A In the example, the medical adhesive 98 (filled with medical adhesive 98 and shaft 96) can provide advantages over systems where the medical adhesive is delivered from a syringe or syringe attached to the proximal end of the catheter. For example, a pre-filled flexible catheter 80 can reduce preparation time before delivering the medical adhesive 98 into the patient, such as the time required to infuse the syringe and catheter with the medical adhesive stored in a vial. Additionally, delivering the medical adhesive 98 from the flexible catheter 80 via force provided from shaft 96 can reduce the force required to deliver the medical adhesive 98 away from the distal opening 94.

[0074] As an example, a 3 cubic centimeter (cc) syringe filled with medical adhesive can have a diameter of 0.38 inches (0.97 cm). However, the diameter of the lumen within the flexible catheter 80 can be significantly smaller, which reduces the force required to displace the medical adhesive 98 from the flexible catheter 80. This reduction in force can improve the user's delivery capacity.

[0075] Examples of pressure reduction for various sizes of flexible catheters 80 compared to a 3cc syringe with a diameter of 0.38 inches are described in Table 1 below.

[0076] Table 1:

[0077]

[0078] As shown in Table 1, “Vol” is the volume of the flexible catheter 80, “ID” is the inner diameter of the defined lumen of the catheter 80, “OD” is the outer diameter of the catheter 80, “wall” is the wall thickness from the lumen to the outer surface of the catheter 80, “length” is the total length of the flexible catheter 80 from its proximal end to its distal end, and “pressure reduction” is the estimated pressure reduction compared to a system using a 3cc syringe attached to a catheter having the dimensions of the catheter in Example A.

[0079] Table 1 shows that, compared to a syringe, the reduction in the inner diameter of the flexible catheter 80, and consequently the reduction in its cross-sectional area, generally reduces pressure. To increase the volume of the flexible catheter 80 while maintaining a lower delivery pressure, a longer flexible catheter 80 can be used. These dimensions of the flexible catheter 80 can be adjusted for certain applications. For example, when dealing with smaller vessels (e.g., perforating veins or spider veins), the length, inner diameter, and / or outer diameter of the flexible catheter 80 can be reduced to maintain a smaller volume of medical adhesive 98. In these examples, a smaller shaft can be used to correspond to a flexible catheter with a smaller inner diameter (e.g., flexible catheter 80).

[0080] In addition to reducing the pressure required for delivery compared to using a syringe, delivering the medical adhesive 98 by advancing the shaft 96 through the catheter lumen also reduces compliance in the adhesive delivery system and allows for more controlled delivery of the medical adhesive 98. This reduced compliance also reduces the amount of medical adhesive that continues to flow from the distal opening 94 after the user stops applying pressure to the shaft 96. However, the flexible catheter 80 can be configured to provide the desired amount of dripping that a clinician might expect to deliver a clump of medical adhesive 98.

[0081] In some examples, the shaft 96 and / or the handle portion attached to the proximal portion of the shaft 96 may include a notch or pawl that engages with the flexible catheter 80 to provide the user with tactile feedback regarding the amount of medical adhesive delivered from the distal opening 94. Alternatively, the shaft 96 may include visual markings on the proximal portion that become covered by the flexible catheter 80 as the shaft 96 is advanced distally into the catheter lumen to indicate how much volume of medical adhesive 98 is delivered from the distal opening 94 along with the distance the shaft 96 is advanced distally relative to the flexible catheter 80. For example, the visual markings of the shaft 96 may be substantially similar to... Figure 3 The mark 67 is on the body 66 of the mandrel 62 shown.

[0082] Figure 5B and 5C They are along Figure 5A Cross-sectional views of the conduit at different axial positions A and B. (See attached image.) Figure 5BAs shown, the liner 86 of the conduit 80 is located radially inside the outer wall 82. The liner 86 can define the conduit lumen configured as a receiving shaft 96. Figure 5C As shown, the distal end of the flexible catheter 80 includes a metal strip 90 defining an outer surface surrounding a wall 88. The wall 88 may be made of the same or similar material as the outer wall 82. A liner 86 is radially disposed within the wall 88 and defines an inner lumen therein for a medical adhesive 98. The wall 88 also defines two air passages 92A and 92B, which provide echo characteristics for the catheter 80. In other examples, a single air passage or three or more air passages may be defined by the wall 88.

[0083] like Figure 5A and 5C As shown, the diameter of the catheter lumen in axial position B is smaller than the diameter in axial position A of the flexible catheter 100. This smaller lumen diameter, compared to the proximal portion of the flexible catheter 80, can be achieved by the addition of echo-reflecting material (e.g., air channels 92A and 92B) and / or metal strip 90. The smaller diameter at axial position B can also be smaller than the diameter of the shaft 96 to help retain the shaft 96 within the catheter 80 during medical procedures and to prevent the shaft 96 from leaving the distal opening 94 and adversely impacting the patient's tissues.

[0084] Figure 6A This is a cross-sectional view of the distal end of an exemplary flexible catheter 100, which is pre-filled with medical adhesive 98 and defines a guidewire at an outlet port 116. Figure 6A The shaft 120 within the lumen 114 of the catheter 100 is also shown. (As shown) Figure 6A As shown in the example, the flexible conduit 100 includes an outer wall 102, a reinforcing member 104, and an inner liner 106. The flexible conduit 100 and the shaft 120 can be respectively coupled to… Figure 5A The flexible catheter 80 and shaft 96 are substantially similar. For example, the outer wall 102 of catheter 100 may be similar to outer wall 82, the reinforcing member 104 may be similar to reinforcing member 84, the liner 106 may be similar to liner 86, and the shaft 120 may be similar to shaft 96. However, the flexible catheter 100 defines a guidewire exit port 116 configured to receive a guidewire 118, which can be used to facilitate navigation of the flexible catheter 100 to a target site within a patient's blood vessel (or other hollow anatomical structure). The shaft 120 is configured to be disposed within a lumen 114 defined by the liner 106 and located proximal to a medical adhesive 98 contained within the lumen 114.

[0085] The outer wall 102 defines an outlet port 116, which is an opening from the lumen 114 to the outside of the flexible catheter 100. One end of a baffle 108 is attached to the outer wall 102, and the remainder of the baffle 108 is sized to extend across the lumen 114 to prevent flow through the lumen 114. For example, the dimensions and configuration of the remainder of the baffle 108 may be configured to match the cross-sectional area of ​​the lumen 114 and to seal against a medical adhesive 98 located proximal to the baffle 108 and the outlet port 116. In this way, the flexible catheter 100 can be pre-filled with the medical adhesive 98, while also enabling the use of a guidewire 118. The guidewire 118 can be navigated to a target treatment site within the blood vessel, and the flexible catheter 100 can then be navigated to the target treatment site while inserted onto the guidewire 118. In this way, the guidewire 118 can extend through the outlet port 116 and protrude from the distal opening 122. Therefore, in some examples, the flexible catheter 100 may be referred to as a rapid exchange catheter.

[0086] The baffle 108 may be configured as one or more layers of material forming a movable membrane (e.g., a polymer of polyurethane, a metal or metal alloy, or a composite material). In some examples, the baffle 108 may be constructed of collagen or some other bio-based material configured to occlude the outlet port 116, and when the baffle 108 is “open,” the baffle opens the lumen 114 and allows fluid to flow through the lumen 114 and to the distal side of the outlet port 116. The baffle 108 may be configured to remain in place to hold the medical adhesive 98 proximal to the outlet port 116 until sufficient force is applied from the medical adhesive 98 to the baffle 108. Advancement of the shaft 120 as the guidewire 118 is removed from the flexible catheter 100 may increase the pressure applied to the medical adhesive 98 until the pressure forces the medical adhesive 98 to move distally, causing the baffle 108 to move distally to cover the outlet port 116 (e.g., as shown in the image). Figure 7A (As shown).

[0087] Once the baffle 108 covers the outlet port 116, the medical adhesive 98 can flow toward the distal opening 122 without flowing out through the outlet port 116. In some examples, the baffle 108 may be glued to the inner surface of the outer wall 102 and / or the inner surface of the liner 106. For example, the proximal portion 110 of the baffle 108 may adhere to either the inner or outer surface of the outer wall 102. In other examples, the proximal portion 110 of the baffle 108 may be formed from or otherwise attached to the outer wall 102 and / or the liner 106. The distal portion 112 of the baffle 108 may also adhere to, frictionally engage with, or otherwise abut against the liner 106 to seal the medical adhesive 98 proximal to the cavity 114 within the cavity 114. However, in some examples, when the baffle 108 is circular, the distal portion 112 may refer to the outer edge of the baffle 108. In any case, the distal portion 112 may be less firmly adhered to or attached to the flexible catheter 100, such that pressure from the medical adhesive 98 causes the distal portion 112 to release, while the proximal portion 110 remains attached to prevent the baffle 108 from detaching. In other examples, the baffle 108 may define a perforated, thinned, or pre-cut portion that ruptures in response to higher pressure from the medical adhesive 98. The remaining portion of the baffle 108 may still be sized to fold over the inner wall of the liner 106 and cover the outlet port 116.

[0088] The outlet port 116 may be a lateral opening defined by the outer wall 116 and the inner liner 106. The outlet port 116 may be disposed distal to the medical adhesive 98 pre-filled within the lumen 114 of the flexible catheter 100. The outlet port 116 may be sized to receive one or more guidewires 118 of different sizes. The outlet port 116 may be defined by a surface perpendicular to the longitudinal axis of the flexible catheter 100, such that the longitudinal axis defined by the outlet port 116 is perpendicular to the longitudinal axis of the flexible catheter 100. In other examples, the outlet port 116 may be defined by an inclined surface within the outer wall 102 and / or the inner liner 106, such that the longitudinal axis of the outlet port 116 is neither parallel to nor perpendicular to the longitudinal axis of the flexible catheter 100. The inclined surface may aid in guiding the guidewire 118 into the lumen 114 located distal to the adhesive 98.

[0089] Figure 6B and 6C They are along Figure 6A Cross-sectional views of the flexible conduit 100 at different axial positions C and D. (See attached images.) Figure 6B As shown, the flexible conduit 100 includes an inner liner 106 located radially inside the outer wall 102. The inner liner 106 may define an inner lumen 114, within which the shaft 120 is disposed. Figure 6CAs shown, the distal end of the flexible catheter 100 includes an outer wall 102 located radially outside the liner 106. The liner 106 defines an inner lumen 114, and a guidewire 118 is disposed within the inner lumen 114.

[0090] Figure 7A and 7B It is parallel to Figure 6A A cross-sectional view of the longitudinal axis of the flexible catheter 100, wherein the guidewire 118 is removed from the outlet port 116. Figure 6A In the example, the baffle 108 is in a first position, which occludes the lumen 114 and holds a certain volume of medical adhesive 98 proximal to the baffle 108 and the outlet port 116. However, as Figure 7A As shown, the baffle 108 is configured to move from a first position to a second position in which the baffle 108 closes the outlet port 116 relative to the lumen 114 (e.g., a side opening in the flexible conduit 100).

[0091] Once the flexible catheter 100 is positioned at the target location within the patient's body, the clinician can withdraw the guidewire 118 proximally from the lumen 114 via the outlet port 116. At this point, the flap 108 can remain in the first position to hold the medical adhesive 98 proximally to the outlet port 116. When the clinician wishes to deliver the medical adhesive 98 from the distal opening in the flexible catheter 100, the clinician can advance the shaft 120 distally (as indicated by arrow 124), which increases the pressure on the medical adhesive 98 and propels it distally within the lumen 114, forcing the flap 108 to move from the first position to the second position. The proximal portion 110 of the flap 108 can serve as a hinge to allow the remainder of the flap 108 to move within the lumen 114.

[0092] exist Figure 7A The diagram shows a second position of the baffle 108, wherein the distal portion 112 of the baffle 108 contacts the portion of the liner 106 and / or the outer wall 102 located distal to the outlet port 116, in order to close the lumen 114 relative to the outlet port 116. In the second position, the baffle 108 allows medical adhesive 98 to flow along the radially inward-facing surface of the baffle 108 and into the distal portion of the lumen 114 until at least a portion of the medical adhesive 98 exits the flexible catheter 100 through the distal opening.

[0093] In some examples, some or all of the baffles 108 may be configured to contact the inward-facing portion of the outer wall 102 in areas where the inner liner 106 is not disposed. In this way, when the baffle is in a position such as Figure 7AIn the second position shown, the baffle 108 may be substantially flush with the liner 106. In other examples, the baffle 108 may be attached to and / or in contact with the liner 106 in the second position. Because the baffle 108 may be relatively thin, the resulting reduction in the lumen diameter may not significantly affect the advancement of the medical adhesive 98 or the shaft 120 within the catheter lumen 114. However, the baffle 108 may be made of a material with stiffness and / or thickness to resist pressure from the medical adhesive 98 generated by the advancement of the shaft 100, to prevent the medical adhesive 98 from flowing out of the outlet port 116.

[0094] like Figure 7B As shown, the baffle 108 in the second position allows the distal end of the shaft 120 to pass through the baffle 108 and the outlet port 116 distally. For example, the distal portion 112 of the baffle 108 can rest against the liner 106 and / or the outer wall 102 without inhibiting the advancement of the shaft 120. Thus, the baffle 108 can move the shaft 120 distally to the outlet port 112 without interfering with the continued dispensing of medical adhesive 98 from the distal opening of the catheter 100 until the procedure is completed or all medical adhesive 98 has been delivered from the flexible catheter 100.

[0095] Figure 8A This is a cross-sectional view of the distal end of an exemplary flexible catheter 130 configured to receive a pre-filled tube 144 filled with a venous occlusion material (e.g., medical adhesive 98). The flexible catheter 130 may be an example of the flexible catheters 12, 52, or 70 described herein, facilitating the delivery of medical adhesive 98 for various procedures, such as delivering medical adhesive 98 to a vein for vascular occlusion. Furthermore, the flexible catheter 130 may be similar to the flexible catheter 80 and configured to receive a shaft similar to a shaft 96 (e.g., [missing information]). Figure 9A (See shaft 152). For example, outer wall 132 can be similar to outer wall 82, reinforcing member 134 can be similar to reinforcing member 84, liner 136 can be similar to liner 86, outer wall 138 can be similar to outer wall 88, metal strip 140 can be similar to metal strip 90, and air cavities 142A and 142B can be similar to air cavities 92A and 92B. However, flexible catheter 130 can be configured to receive a pre-filled cylinder 144, which is a separate structure from catheter 130 and contains a predetermined volume of medical adhesive 98.

[0096] The pre-filled tube 144 may be a sealed tube or other container defined by at least a sidewall 148C, a proximal sidewall 148A, and a distal sidewall 148B. The outer diameter (or other cross-sectional dimension) of the pre-filled tube 144 may correspond to the cross-sectional dimension of the lumen 133 of the catheter 130. In this way, the outer diameter of the pre-filled tube 144 may be smaller than the diameter of the lumen 133 to facilitate insertion of the pre-filled tube 144 into the lumen 133. The pre-filled tube 144 may be filled with a predetermined volume of medical adhesive 98 by the manufacturer, and the pre-filled tube 144 may be stored and delivered to the user for insertion into the flexible catheter 130 prior to performing procedures on the patient. In this way, when the flexible catheter 130 is completely outside the patient or after the flexible catheter 130 has been positioned within the target blood vessel, the user may insert the pre-filled tube 144 into the lumen 133 defined by the liner 136.

[0097] The proximal sidewall 148A and distal sidewall 148B of the pre-filled cylinder 144 can be configured to respond to a shaft (e.g., Figure 9A The shaft 152 may rupture due to pressure applied directly or indirectly to the walls 148A, 148B. Therefore, advancement of the shaft 152 can cause medical adhesive 98 to flow out of the distal opening 150 defined by the distal tube 146 of the pre-filled tube 144. Although the distal tube 146 is shown as protruding distally from the distal end of the flexible catheter 130, in other examples, the distal tube 146 may terminate at the same location as the distal end of the flexible catheter or terminate proximally from the distal end of the flexible catheter 130.

[0098] In other examples, the flexible catheter 130 may be pre-loaded with a pre-filled cartridge 144 by the manufacturer. However, the benefit of the pre-filled cartridge 144 is that if additional medical adhesive 98 is needed during the procedure, an additional pre-filled cartridge can be inserted into the flexible catheter 130. The used (e.g., empty or otherwise used) pre-filled cartridge 144 can be removed from the lumen 133 of the flexible catheter 130 by withdrawing the shaft 152 used to push the medical adhesive 98 out of the distal opening 150. For example, the pre-filled cartridge 144 may be friction-fitted to or otherwise contacted with the shaft 152 sufficiently to be withdrawn proximally from the proximal end of the flexible catheter 130 in response to the proximal withdrawal of the shaft 152 from the lumen 133. Alternatively, the used pre-filled cartridge 144 can remain within the catheter lumen 133, and subsequent pre-filled cartridges can be "stacked" proximally from cartridge 144, allowing additional medical adhesive to flow through the used cartridge 144 as it exits from another pre-filled cartridge and before delivery to the patient. In yet another example, the outer wall 138 at the distal end of the flexible catheter 130 can be removably attached, for example, by screwing the outer wall 138 to the distal end of the flexible catheter 130. In such an example, the outer wall 138 can be removed from the flexible catheter 130, the used cartridge 144 is removed, a new pre-filled cartridge 144 is inserted, and the outer wall 138 is reattached.

[0099] The pre-filled tube 144 (e.g., proximal sidewall 148A, distal sidewall 148B, and sidewall 148C) can be formed of any suitable material, such as, but not limited to, polymers, such as polypropylene, high-density polyethylene (HDPE), or PTFE. These materials, for example, can exhibit a low coefficient of friction, allowing the pre-filled tube 144 to be inserted through the lumen 133 of the flexible conduit 130. In some examples, the pre-filled tube 144 may include an echogenic region, making its location visible under ultrasound imaging.

[0100] The proximal wall 148A of the pre-filled cartridge 144 can be configured to be removed, punctured, or ruptured by the shaft 152. In some examples, the distal end of the shaft 152 may be tapered to facilitate puncture of the proximal wall 148A. In some examples, the proximal wall 148A may be configured as a cap that can be removed or punctured before or during use. The distal wall 148B of the pre-filled cartridge 144 can also be configured to be removed, punctured, or ruptured by increased pressure generated in the medical adhesive 98 by distal advancement of the shaft 152 within the catheter lumen 133. In other examples, the distal wall 148B may be a cap or lid configured to be removed or punctured before the user inserts the pre-filled cartridge 144 into the catheter lumen 133.

[0101] In some examples, the outer wall 138 at the distal end of the flexible catheter 130 may have a greater thickness than the outer wall 132, resulting in a smaller diameter of the lumen 133 at the distal portion of the catheter. For example, the outer wall 132 may define a shoulder 141. This shoulder 141 prevents the pre-filled cartridge 144 from being pushed out of the distal end of the flexible catheter 130. In other words, the shoulder 141 allows the shaft 152 to advance to increase the pressure within the pre-filled cartridge 144, allowing medical adhesive 98 to be dispensed from the distal opening 150 without the pre-filled cartridge 144 itself being pushed out of the distal end of the catheter 130.

[0102] Providing medical adhesive 98 via one or more pre-filled cartridges 144 can offer one or more advantages over syringe-based delivery of medical adhesive. For example, using pre-filled cartridges can reduce the risk of reusing the adhesive and / or device in another patient. Since the pre-filled cartridge 144 is already in the patient, clinicians are unlikely to attempt to deliver any remaining medical adhesive 98 to a different patient. Additionally, even if some medical adhesive 98 remains after treating one patient, this relatively small amount may not be of much value for use on another patient. Delivery of medical adhesive 98 via pre-filled cartridges (e.g., pre-filled cartridge 144) also facilitates adding more medical adhesive to the procedure as needed and reduces potential waste of medical adhesive from patients who require only a small volume. In some examples, the pre-filled cartridges may be configured with different volumes of medical adhesive 98 for certain types of vessels or procedures, allowing clinicians to use pre-filled cartridges with the appropriate volume of medical adhesive. For example, the length and / or diameter of the prefilled tube 144 can be specified to maintain a certain volume of medical adhesive 98.

[0103] Figure 8B and 8C They are along Figure 8A Cross-sectional views of the flexible conduit 130 at different axial positions B and C. (See attached images.) Figure 8B As shown, the liner 136 of the catheter 130 is located radially inside the outer wall 132. The liner 136 defines an inner lumen 133 in which the sidewall 148C of the pre-filled cartridge 144 is disposed. Additionally, the pre-filled cartridge 144 contains a medical adhesive 98. Figure 8CAs shown, the distal end of the flexible catheter 130 includes a metal strip 140 defining an outer surface surrounding a wall 138. The wall 138 may be made of the same or similar material as the outer wall 132. The wall 138 also defines two air channels 142A and 142B, which are echogenic features that make the distal portion of the catheter 130 visible via ultrasound imaging. In other examples, the wall 138 may define a single air channel or three or more air channels. A liner 136 is radially disposed within the wall 138 to define an inner lumen 133 within which the distal tube 146 of a pre-filled tube 144 is disposed. Medical adhesive 98 can be dispensed through a distal opening 150 defined by the distal tube 146 of the pre-filled tube 144.

[0104] Figure 9A and 9B yes Figure 8A A cross-sectional view of an exemplary flexible catheter 130 is shown, illustrating the state in which the mandrel shaft 152 has been advanced distally through the catheter lumen 133 to force the medical adhesive 98 out of the pre-filled tube 144. Figure 9A As shown, the cross-sectional dimensions of the shaft 152 are configured to correspond to the cross-sectional dimensions of the cavity 133 defined by the inner surface of the cylinder sidewall 148C, and are disposed within said cavity. Therefore, the advancement of the distal end of the shaft 152 through the proximal portion of the pre-filled cylinder 144 forces at least a portion of the medical adhesive 98 away from the distal end of the pre-filled cylinder 144, and away from the distal opening 150 of the pre-filled cylinder 144 and the distal opening of the flexible catheter 130.

[0105] like Figure 9B As shown, advancement of shaft 152 in the direction of arrow 154 causes the proximal wall 148A of the tube to disengage from its position and move together with the distal end of shaft 152 through the lumen of the pre-filled tube 144. In other examples, the proximal wall 148A of the tube may be punctured or ruptured, such that the proximal wall 148A remains attached to the sidewall 148C, but shaft 152 may pass through the proximal wall 148A and contact the proximal edge of a volume of medical adhesive 98 stored within the pre-filled tube 144. The increased pressure within the medical adhesive 98 caused by the advancement of shaft 152 may cause the distal wall 148B of the tube to rupture, allowing the medical adhesive to flow out of the pre-filled tube 144, for example, through the distal wall 148B, through the distal tube 146, and out of the distal opening 150. In other examples, the distal wall 148B of the tube may be removed by the user before the pre-filled tube 144 is inserted into the flexible catheter 130.

[0106] In other examples, shaft 152 may be configured with a diameter larger than the diameter of the lumen of the pre-filled tube 144 and smaller than the diameter defined by the catheter liner 136. Thus, the advancement of shaft 152 can cause the sidewall 148C of the tube to collapse as the medical adhesive 98 is advanced away from the distal opening 150. If necessary, additional pre-filled tubes can still be inserted into the flexible catheter 130, as pressure from shaft 152 can still cause additional medical adhesive from one or more subsequent pre-filled tubes to flow through the first pre-filled tube 144 and out of the distal opening 150. Then, once the procedure for the patient is complete, the collapsed, used tubes (one or more) can remain within the flexible catheter 130 and be discarded.

[0107] In some examples, the catheter configured to receive a pre-filled tube of medical adhesive can be a quick-exchange catheter. Figure 10A and 10B This is an example of such a catheter 170 and a cross-sectional view of an exemplary guidewire 182 configured for insertion through a guidewire outlet port 176 defined by the catheter 170. Figure 10A As shown in the example, the flexible catheter 170 includes an outer wall 172, a reinforcing member 174, and an inner liner 174. The flexible catheter 170 can be substantially similar to... Figure 8A The flexible catheter 130. For example, the outer wall 172 may be similar to the outer wall 132, the reinforcing member 174 may be similar to the reinforcing member 134, and the inner liner 174 may be similar to the inner liner 136. The pre-filled cylinder 184 is similar to the pre-filled cylinder 144 and contains a volume of medical adhesive 186 similar to medical adhesive 98. However, the flexible catheter 170 may define a guidewire exit port 176 to allow the flexible catheter 170 to be navigated through the patient's vascular system to a desired location within the patient's blood vessels.

[0108] The outer wall 172 defines an outlet port 176, which is an opening from the catheter lumen 178 to the outside of the flexible catheter 170. The outlet port 176 may be a side opening defined by the outer wall 172 and the liner 174. The outlet port 176 may be sized to receive one or more guidewires 182 of different sizes. The outlet port 176 may be defined by a surface perpendicular to the longitudinal axis of the flexible catheter 170, such that the longitudinal axis defined by the outlet port 176 is perpendicular to the longitudinal axis of the flexible catheter 170. In other examples, the outlet port 176 may be defined by an inclined surface within the outer wall 172 and / or the liner 174, such that the longitudinal axis of the outlet port 176 is neither parallel to nor perpendicular to the longitudinal axis of the flexible catheter 170.

[0109] Guidewire 182 can be navigated to a target location within the patient's vascular system, and then flexible catheter 170 can be navigated along guidewire 182 to the target location. In this way, guidewire 182 can extend through outlet port 176 and exit from distal opening 180. Therefore, in some examples, flexible catheter 170 may be referred to as a rapid exchange catheter.

[0110] exist Figure 10A In the example, the pre-filled tube 184 has not yet been inserted into the catheter lumen 178, or it has been inserted but remains proximal to the outlet port 176. When the guidewire 182 is removed from the flexible catheter 170, as... Figure 10B As shown, the distal advancement of the pre-filled cylinder 184 in the direction of arrow 188 can position the pre-filled cylinder 184 adjacent to the outlet port 176. In this way, a portion of the pre-filled cylinder 184 covers and closes the outlet port 176 to prevent the medical adhesive 186 from being discharged through the outlet port 176 in response to the advancement of the shaft 152 against the pre-filled cylinder 184.

[0111] In some examples, the flexible catheter 170 may include... Figure 6A The flexible catheter 100 has a similar baffle 108. The baffle can be configured to move between a first position allowing the guidewire 182 to enter the outlet port 176, and a second position closing the outlet port 176 relative to the lumen 178. Distal advancement of the pre-filled tube 184 within the catheter lumen 178 in the direction of arrow 188 can force the baffle from the first position to the second position, closing the outlet port 176, to help prevent the medical adhesive 186 from exiting the outlet port 176. The pre-filled tube 184 can then slide past the baffle and hold the baffle against the outlet port 176 in the second position.

[0112] Figure 11 This is a flowchart of an exemplary technique for delivering a volume of venous occlusive material (e.g., medical adhesive) out of a catheter pre-filled with venous occlusive material by advancing a shaft within the catheter. For illustrative purposes, see [link to illustrative diagram]. Figure 5A Description of various aspects of the flexible conduit 80 and shaft 96 Figure 11 The technology. However, this description is not intended to be limiting. Figure 11 The technology can be used with other devices or systems, such as flexible conduits 12, 40, 54, 100, shafts 18 or 120 and / or mandrels 62.

[0113] like Figure 11As illustrated in the examples, a user can insert or deliver the distal end of the flexible catheter 80 to a target location within a patient's hollow anatomy, such as a vein (200). In some examples, the user can use an ultrasound transducer to visualize the target location and the distal end of the flexible catheter 80. The flexible catheter 80 may be pre-filled with medical adhesive 98 to be delivered to the patient. In some examples, the user can insert the flexible catheter 80 without the assistance of other devices. For example, the catheter 80 may include a reinforcing member 84 or other structural features that increase the structural integrity and maneuverability of the catheter 80, allowing it to be navigated through the vascular system without the assistance of a guiding device (e.g., a guidewire or guiding catheter). In other examples, the user can use a guiding catheter within which the flexible catheter 80 can be inserted to the target location. Alternatively or additionally, the user can use a guidewire (e.g., guidewire 118) to navigate the flexible catheter 100 to the target location within the patient and remove the guidewire from the catheter 100 before delivering the medical adhesive 98.

[0114] Once the flexible catheter 80 is positioned at the target location, the user can advance the shaft 96 through at least a portion of the lumen of the flexible catheter 80 to force at least a first portion of a volume of medical adhesive 98 (e.g., a clump) away from the distal opening 94 of the lumen of the flexible catheter 80 (202). The user can then apply pressure to the tissue above the target location where the first portion of the medical adhesive has been received to cause the vein to collapse and the medical adhesive to solidify (204). If another target location exists within the vein (the “yes” branch of box 206), the user can withdraw the flexible catheter 80 proximally and position the distal end of the flexible catheter 80 at the new target location (208). The user can then advance the shaft 96 further through the lumen of the flexible catheter 80 to deliver a second portion of a volume of medical adhesive 98 to a portion of the target location in the vessel (202). This process can be repeated until the entire length of the vessel has been engaged with the medical adhesive 98. If there are no other target areas to be treated with medical adhesive 98 (the "No" branch of box 206), then the user can remove the flexible catheter 80 and shaft 96 (e.g., a portion of the mandrel) from the patient (210).

[0115] In some examples, the volume of medical adhesive 98 delivered from the flexible catheter 80 can range from approximately 1.0 mL to approximately 4.0 mL. This volume can vary depending on the type of vessel being treated. For example, treating the great saphenous vein may require a larger volume of medical adhesive than treating perforating veins. Therefore, different flexible catheters can be pre-filled with different volumes of medical adhesive, allowing some pre-filled flexible catheters to be designated for the treatment of certain vessels. These different available volumes can reduce waste of medical adhesive used for smaller vessels or smaller treatment areas.

[0116] Figure 12 This is a flowchart of an exemplary technique for inserting a pre-filled cylinder containing venous occlusion material into the lumen of a catheter and advancing a shaft through the lumen to deliver a volume of venous occlusion material away from the pre-filled cylinder and the catheter. For illustrative purposes, see the attached diagram. Figure 8A , 9A Description of various aspects of the flexible conduit 130 and shaft 152 of 9B Figure 12 The technology. However, this description is not intended to be limiting. Figure 12 The technology can be used with other devices or systems, such as flexible conduits 12, 40, 54, 170, shaft 18 and / or mandrel 62.

[0117] like Figure 12 As illustrated in the examples, a user can insert or deliver the distal end of the flexible catheter 130 to a target location within a patient's hollow anatomical structure, such as a vein (220). In some examples, the user can use an ultrasound transducer to visualize the target location and the distal end of the flexible catheter 130. In some examples, the user can insert the flexible catheter 130 without the assistance of other devices. For example, reinforcing member 134 or other structural features of the flexible catheter 130 can increase the structural integrity and maneuverability of the catheter 130, allowing it to be navigated through the vascular system without the assistance of a guiding device (e.g., a guidewire or guiding catheter). In other examples, the user can use a guide catheter, guiding catheter, or needle within which the flexible catheter 130 can be inserted to the target location. Alternatively or additionally, the user can insert a guidewire (e.g., guidewire 182) to navigate the flexible catheter 170 to the target location, then slide the flexible catheter 170 over the guidewire and remove the guidewire before delivering medical adhesive 186, as per [reference to...]. Figure 10A and 10B The subject of discussion.

[0118] Once the flexible catheter 130 is positioned at the target location, the user can insert a pre-filled tube 144 containing medical adhesive 98 into the flexible catheter 130 (222). The user can then advance a shaft 152 through at least a portion of the lumen 133 of the flexible catheter 130 and the pre-filled tube 144 to force at least a first portion of a volume of medical adhesive 98 (e.g., a clump) away from the distal opening 150 of the pre-filled tube 144 and the distal end of the flexible catheter 130 (224). The user can then apply pressure to the tissue above the target location where the first portion of the medical adhesive has been received to cause the vein to collapse and the medical adhesive to solidify (226). If another target location exists within the vein (the "yes" branch of box 228), the user can withdraw the flexible catheter 130 and position the distal end of the flexible catheter 130 at the new target location (230). The user can then advance shaft 152 further through lumen 133 and pre-filled tube 144 to deliver a second portion of a volume of medical adhesive 98 to a partial target location in the vessel (224). This process can be repeated until the entire length of the vessel has been engaged with medical adhesive 98. If there are no other target areas to be treated by medical adhesive 98 (the "No" branch of box 228), the user can remove flexible catheter 130 and shaft 152 (e.g., a portion of the mandrel) from the patient (232).

[0119] In some examples, the volume of medical adhesive 98 delivered from the pre-filled cartridge 144 can range from approximately 1.0 mL to approximately 4.0 mL. This volume can vary depending on the vessel being treated. For example, treating the great saphenous vein may require a larger volume of medical adhesive than treating a perforating vein. Therefore, pre-filled cartridges with different volumes of medical adhesive can be used for the treatment of certain vessels. These different available volumes of pre-filled cartridge 144 can reduce waste of medical adhesive used for smaller vessels or smaller treatment areas. Furthermore, in some examples where all the medical adhesive 98 has been delivered but more target locations still need to be treated, the user can remove the shaft 152 from the lumen 133 and insert a new pre-filled cartridge 144 with medical adhesive into the flexible catheter 130 (223) before advancing the shaft 152 again.

[0120] Various examples have been described. These and other examples are within the scope of the appended claims.

Claims

1. A medical component, the medical component comprising: A flexible catheter configured to be disposed within a patient’s hollow anatomical structure, wherein the inner wall of the flexible catheter defines an inner lumen having an inner cross-sectional dimension and a distal opening of the inner lumen, and wherein the inner lumen is configured to accommodate a volume of medical adhesive. as well as A shaft, the shaft defining a cross-sectional dimension smaller than the cross-sectional dimension of at least a portion of the lumen, wherein the distal surface defined by the shaft is configured to contact a medical adhesive within the lumen of the flexible catheter, wherein the shaft is advanced through at least a portion of the lumen and at least a portion of the shaft contacts the inner wall to cause the distal surface of the shaft to apply pressure to the medical adhesive, thereby forcing at least a portion of the volume of medical adhesive away from the distal opening of the lumen, and wherein: The portion of the cavity is the first portion of the cavity. The cross-sectional dimension of the inner cavity is the first cross-sectional dimension of the first portion of the inner cavity. The flexible catheter includes a proximal end that defines a first portion of the lumen, and The flexible catheter includes a distal end that defines a distal opening and a second portion of the lumen, the second portion of the lumen having a second lumen cross-sectional dimension that is smaller than the first lumen cross-sectional dimension and smaller than the axial cross-sectional dimension.

2. The medical component of claim 1 further includes the medical adhesive pre-filled within the lumen of the flexible catheter in a predetermined volume.

3. The medical component according to claim 1, wherein, The cross-sectional size of the shaft is set to be smaller than the cross-sectional size of the inner cavity, and to prevent the medical adhesive of a certain volume from flowing between the shaft and the wall of the flexible catheter.

4. The medical component according to claim 1, wherein, The flexible catheter defines a side opening configured to be disposed distal to a predetermined volume of medical adhesive pre-filled within the lumen, the side opening being configured to receive a guidewire.

5. The medical component according to claim 4, wherein, The flexible catheter includes a baffle configured to move between a first position and a second position, the first position holding a volume of medical adhesive proximal to the side opening, and the second position closing the side opening relative to the lumen, wherein distal advancement of the medical adhesive within the lumen forces the baffle to move from the first position to the second position.

6. The medical component of claim 1, further comprising a pre-filled tube filled with the stated volume of medical adhesive, wherein the pre-filled tube is configured to be inserted into the inner cavity.

7. The medical component according to claim 6, wherein, The pre-filled cylinder is defined with an outer diameter smaller than the cross-sectional dimension of the inner cavity.

8. The medical component according to claim 6, wherein, The flexible catheter is configured to have a side opening for receiving a guidewire.

9. The medical component according to claim 8, wherein, The advance of the pre-filled cylinder toward the distal side of the side opening closes the side opening.

10. The medical component according to claim 8, wherein, The flexible catheter includes a baffle configured to move between a first position and a second position, the first position allowing the guidewire to enter the side opening, and the second position closing the side opening relative to the lumen, wherein distal advancement of the pre-filled tube within the lumen forces the baffle to move from the first position to the second position.

11. The medical component according to claim 1, wherein, The cross-sectional dimensions of the inner cavity include a diameter ranging from 0.102 cm to 0.254 cm.

12. The medical component according to claim 1, wherein, The outer diameter of the flexible catheter is in the range of 0.114 cm to 0.292 cm.

13. The medical component according to claim 1, wherein, The flexible conduit includes a reinforcing portion, which comprises at least one of a coil or a braid within the wall of the flexible conduit.

14. The medical component according to claim 1, wherein, The flexible catheter includes an echo portion at the distal portion of the flexible catheter.

15. The medical component according to claim 1, wherein, The flexible catheter includes a polytetrafluoroethylene liner defining the lumen.

16. The medical component according to claim 2, wherein, The medical adhesive has a viscosity between 8000 cps and 12000 cps.

17. The medical component of claim 1, wherein, The volume of the medical adhesive is in the range of 1.0 mL to 4.0 mL.

18. A medical component, the medical component comprising: A flexible catheter, configured to be placed within a patient's hollow anatomical structure, wherein: The inner wall of the flexible catheter defines an inner lumen with an internal cross-sectional dimension and a distal opening of the lumen, the internal cross-sectional dimension ranging from 0.102 cm to 0.254 cm. The flexible catheter includes a reinforcing portion, the reinforcing portion comprising at least one of a coil or braid within the wall of the flexible catheter, and The inner cavity is configured to accommodate a certain volume of medical adhesive pre-filled within it; and The flexible catheter defines a side opening configured to be disposed distal to the volume of medical adhesive pre-filled within the lumen, the side opening being configured to receive a guidewire; and A shaft, the shaft defining a cross-sectional dimension smaller than the cross-sectional dimension of at least a portion of the lumen, wherein the distal surface defined by the shaft is configured to contact a medical adhesive within the lumen of the flexible catheter, and wherein the shaft is advanced through at least a portion of the lumen and at least a portion of the shaft contacts the inner wall to cause the distal surface of the shaft to apply pressure to the medical adhesive, thereby forcing at least a portion of a certain volume of the medical adhesive to exit the distal opening of the lumen of the flexible catheter, wherein the volume of the medical adhesive is in the range of 1.0 mL to 4.0 mL.

Images