Medical scopes for delivering therapeutic agents

Abstract

To provide systems and methods suitable for delivering a therapeutic agent to a target site.SOLUTION: The system comprises a container for holding the therapeutic agent, and a pressure source having pressurized fluid, where the pressure source is in selective fluid communication with at least a portion of the container. A catheter is placed in fluid communication with the container, and has a lumen sized for delivery of the therapeutic agent to a target site. A housing is configured to securely retain the container. The system further comprises a camera having a camera head coupled to the catheter, where the camera provides a visual image of the target site during the delivery of the therapeutic agent.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 035,270, entitled "Medical Scopes for Delivering Therapeutic Agents," filed June 5, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present embodiments relate generally to medical devices, and more particularly to a medical scope for delivering therapeutic agents to a target site. [Background technology]

[0003] There are several instances where it may be desirable to introduce therapeutic agents into the human or animal body. For example, therapeutic drugs or bioactive materials can be introduced to achieve a biological effect. The biological effect may include a number of desired outcomes, such as inducing hemostasis, sealing a perforation, reducing the likelihood of restenosis, or treating a cancerous tumor or other disease.

[0004] Many of these therapeutic agents are injected using intravenous (IV) techniques and via oral administration. While such techniques allow for general introduction of the agent, in many instances it may be desirable to provide localized or targeted delivery of the therapeutic agent, which may allow for guided and precise delivery of the therapeutic agent to a selected target site. For example, localized delivery of the therapeutic agent to a tumor may reduce exposure of the therapeutic agent to normal healthy tissue, thereby reducing potentially harmful side effects. Summary of the Invention [Problem to be solved by the invention]

[0005] Localized delivery of therapeutic agents is performed using catheters and similar introduction devices. By way of example, a catheter can be advanced toward a target site within a patient, and then the therapeutic agent can be injected through the lumen of the catheter to the target site. Typically, a syringe or similar device can be used to inject the therapeutic agent into the lumen of the catheter. However, such delivery techniques may result in a relatively weak flow of the injected therapeutic agent.

[0006] Furthermore, in certain forms, such as powder forms, it may be difficult or impossible to deliver the therapeutic agent to a desired site in a targeted manner. For example, a therapeutic powder, when held in a syringe or other container, cannot be easily delivered through a catheter to a target site in a localized manner that may reduce potentially harmful side effects.

[0007] Additionally, some therapeutic agents are delivered using a catheter advanced through the lumen of a separate medical scope that allows imaging of the target site, such as an endoscope, although the use of separate catheters and medical scopes can involve limitations such as the size of instruments that can fit through the lumen of the scope, transporting the patient to a specific room with the capacity to accommodate endoscopic procedures, etc. [Means for solving the problem]

[0008] The present embodiments provide a system and method suitable for delivery of a therapeutic agent to a target site. In one example, the system includes a container for holding a therapeutic agent and a pressure source having a pressurized fluid, the pressure source being in selective fluid communication with at least a portion of the container. A catheter is disposed in fluid communication with the container and has a lumen sized for delivery of the therapeutic agent to the target site. A housing is configured to securely hold the container. The system further includes a camera having a camera head coupled to the catheter, the camera providing a visual image of the target site during delivery of the therapeutic agent.

[0009] In one embodiment, the system includes a catheter adapter having a main body, a proximal end, and a distal end, the catheter adapter fixed relative to the housing and the distal end of the catheter adapter coupled to the proximal end of the catheter, the proximal end of the catheter adapter having a first diameter and the distal end of the catheter adapter having a second diameter, the first diameter being greater than the second diameter.

[0010] In one embodiment, the system includes a valve assembly having an inlet port and at least first and second outlet ports. Pressurized fluid enters through the inlet port, and in a first state, the pressurized fluid is directed through the first outlet port to provide venting with a lack of delivery of therapeutic agent. In a second state, the pressurized fluid is directed through the second outlet port and into a container holding therapeutic agent to provide delivery of therapeutic agent.

[0011] In one embodiment, a method for delivering a therapeutic agent to a target site includes actuating a pressure source having a pressurized fluid, the pressure source being in selective fluid communication with at least a portion of a container holding the therapeutic agent, and a housing configured to rigidly hold the container. The therapeutic agent is delivered through a catheter in fluid communication between the container and the target site via the pressurized fluid. The method further includes visualizing the target site during delivery of the therapeutic agent using a camera having a camera head coupled to the catheter.

[0012] Other systems, methods, features, and advantages of the invention will be or become apparent to one with skill in the art upon review of the following figures and detailed description, and it is intended that all such additional systems, methods, features, and advantages be included within the scope of the invention and be encompassed by the appended claims.

[0013] The present invention may be more fully understood with reference to the following drawings and description. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the drawings, like reference numbers represent corresponding parts throughout the different views. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a perspective view of a system for delivering a therapeutic agent according to a first embodiment. [Diagram 2] FIG. 2 is a schematic side view of the system of FIG. 1 with a portion of the housing removed. [Diagram 3] FIG. 3 is a perspective view of the system of FIGS. 1-2 with a portion of the housing removed. [Figure 4A] FIG. 4 is a schematic side view of the system of FIGS. 1-3 showing the opposite side of the housing relative to FIG. [Figure 4B] 3 is a schematic side view of the system of FIG. 1 with a portion of the housing removed viewed from the opposite direction relative to FIG. 2. [Figure 5-7] 1A-1C are a side view, a rotated side view, and a close-up perspective view, respectively, of a valve assembly used with the present system, with selected external components shown in phantom to aid in illustrating internal features. [Figure 8] FIG. 1 is a perspective view of a catheter adapter coupled to a catheter, with the outer portion of the catheter shown in phantom to aid in illustrating internal features. [Figure 9] FIG. 9 is a perspective view of a portion of the catheter adapter and catheter of FIG. 8, with external portions shown in phantom to aid in illustrating internal features. [Figure 10] 9 is a cross-sectional view of the catheter and selected internal components taken along line AA of FIG. 8. [Figure 11] FIG. 2 is a top perspective view of the system of FIG. 1 with a portion of the housing removed to show features of the deflection wire assembly. [Figure 12] FIG. 13 is a perspective view of a deflection actuator and wire follower according to one embodiment. [Figure 13] 13 is a perspective view of the deflection actuators and wire followers of FIG. 12 viewed from an opposite angle relative to FIG. 12 and with one of the deflection actuators omitted for purposes of illustration. FIG. [Figure 14] FIG. 13 is a perspective view showing the coupling of one of the deflection actuators and one of the wire followers of FIGS. 11-12. [Figure 15] FIG. 1 is a schematic side view illustrating a distal region of a catheter's therapeutic agent lumen disposed at a non-parallel angle relative to a distal region of the catheter's aspiration lumen. [Figure 16] 1 is a cross-sectional schematic diagram of an alternative embodiment depicting one exemplary configuration in which multiple catheters, each with an associated lumen, are used instead of a single catheter. [Figure 17] FIG. 13 is a side view of a system for delivering a therapeutic agent according to an alternative embodiment with a portion of the housing and the deflection actuator removed for purposes of illustration. [Figure 18] FIG. 18 is a partial perspective view of the system of FIG. 17. [Figure 19] FIG. 19 is a perspective view of the system of FIGS. 17-18 with deflection wires included and selected tubing removed for illustrative purposes. [Figure 20] FIG. 20 is a side view of the system of FIGS. 17 to 19. [Figure 21] FIG. 21 is a perspective view illustrating the features of selected tubing-to-catheter adapters that may be used with the systems of FIGS. 17-20. [Figure 22] FIG. 8 is a side view of a system incorporating an alternative actuated valve assembly in which the location of the outlet port and compression spring are modified relative to the system of FIGS. 5-7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] In this application, the term "proximal" refers to a direction generally toward a physician during a medical procedure, while the term "distal" refers to a direction generally toward a target site within a patient's anatomy during a medical procedure.

[0016] 1-4B, a first embodiment of a system 20 suitable for delivering one or more therapeutic agents is shown. In this embodiment, the system 20 includes a container 30 configured to hold a therapeutic agent 38 for delivery of the therapeutic agent 38 to a target site within a patient through a catheter 90, as described more fully below, and further includes at least one pressure source 68 configured to be disposed in selective fluid communication with at least a portion of the container 30.

[0017] System 20 further includes a housing suitable for securely holding, engaging, and / or covering container 30, pressure source 68, catheter 90, and other components described below. Preferably, housing 22 has an upright section 24 that may be grasped by a user and a section 25 that engages container 30. Actuator 26 is engageable by a user and selectively operable to perform functions described below.

[0018] Container 30 can have any suitable size and shape for holding therapeutic agent 38. In Figures 1-4B, container 30 has a generally tubular configuration having a first region 31, a second region 32, and a reservoir 33 defined by an interior of container 30.

[0019] The container 30 may further include an inlet tube 40, an outlet tube 50, and a cap 60, with the cap 60 configured to be secured to the first region 31 of the container 30, as best seen in Figures 2-3. The inlet tube 40 has first and second ends 41 and 42 with a lumen extending therebetween, while the outlet tube 50 has first and second ends 51 and 52 with a lumen extending therebetween. As shown in Figure 2, the first end 41 of the inlet tube 40 is disposed in fluid communication with an inlet port 62 formed in the cap 60, while the first end 51 of the outlet tube 50 is disposed in fluid communication with an outlet port 63 formed in the cap 60.

[0020] In operation, fluid passing through the inlet port 62 of the cap 60 is directed through the inlet tube 40 and into the reservoir 33. In particular, the u-shaped bend near the second region 32 of the container 30 effectively changes the direction of fluid flow by approximately 180 degrees, such that the fluid originally flows in a direction from the first region 31 of the container 30 towards the second region 32, and then flows from the second region 32 back towards the first region 31. Although in the embodiment of Figures 1-4B, the first region 31 of the container 30 is disposed vertically above the second region 32 of the container 30 in use, it is also possible to have a different arrangement of the first and second regions 31 and 32 in relation to each other, such that they are disposed at least partially horizontally adjacent to each other.

[0021] The second end 52 of the outlet tube 50 can terminate a predetermined distance above the second region 32 of the container 20, as shown in Figures 1-2 and 4A-4B. Thus, as described further below, when fluid from the pressure source 68 is redirected from the second region 32 toward the first region 31, the fluid and therapeutic agent 38 in the reservoir 33 can be directed through the outlet tube 50, through the outlet port 63, and toward the target site. Alternatively, the outlet tube 50 can be omitted, and the therapeutic agent 38 can flow directly from the reservoir 33 into the outlet port 63. Other variations regarding the container 30 and outlet port 63 can be found in U.S. Patent No. 8,118,777, which is incorporated herein by reference in its entirety.

[0022] Moreover, in some embodiments, the platform may be positioned within the container 30 over the curved portion associated with the second region 32, as further described in U.S. Patent No. 8,118,777, and the platform forms a substantially fluid-tight seal with the inner surface of the container 30, thereby preventing therapeutic agent 38 disposed within the reservoir 33 from reaching the curve in the second region 32. In such embodiments, the platform may have an opening through which fluid from the pressure source 68 is directed via a u-shaped tube disposed in the second region 32, as further described in U.S. Patent No. 8,118,777.

[0023] The cap 60 may have any suitable configuration for sealingly engaging the first region 31 of the container 30. In one example, an O-ring is held in place around the periphery of the cap 60 to retain the therapeutic agent 38 within the reservoir 33. The inlet and outlet tubes 40 and 50 may be held in place within the container 30 by one or more support members, such as those further described in U.S. Pat. No. 8,118,777.

[0024] 2, the cap 60 may have one or more flanges 60a that permit a secure, releasable engagement with a complementary interior region of the section 25 of the housing 22. For example, the flanges 60a of the cap 60 may be locked in place within the section 25 by rotating the container 30.

[0025] Advantageously, this allows a first container holding a first therapeutic agent to be coupled to the housing 22 for use with the system 20, and thereafter a second container holding a second composition or substance to be coupled to the housing 22 for use with the system 20. By way of example and without limitation, in one embodiment, the system 20 may be "pre-loaded" with a first container 30 holding a therapeutic agent in the form of a powdered hemostatic agent. At a later point in time, it may be deemed beneficial to deliver a mucoadhesive composition, in which case the first container 30 may be rotated to disengage its flange 60a from the section 25 of the housing, and then the second container 30 may be inserted into the section 25 of the housing 22 for delivery of the mucoadhesive composition. For purposes of simplicity, the formulation within the container 30 will be referred to as a "therapeutic agent 38," although, as described herein, the particular formulation within a container coupled to the housing 22 may be interchanged or changed, and may or may not provide a therapeutic effect in itself.

[0026] The pressure source 68 can include one or more components capable of generating or providing a fluid having a desired pressure. In one embodiment, the pressure source 68 can include a pressurized fluid, such as a liquid or a gas. For example, as shown in FIGS. 2-3, the pressure source 68 can include a pressurized fluid cartridge of a selected gas or liquid, such as carbon dioxide, nitrogen, or any other suitable gas or liquid that may be compatible with the human body. The pressurized fluid cartridge can contain a gas or liquid at a relatively large first predetermined pressure, such as, for example, about 1,800 psi inside the cartridge. The pressure source 68 can optionally include one or more commercially available components.

[0027] Fluid can flow through a pressure regulator, such as a regulator valve 70 having a pressure outlet 72 that can reduce pressure from a pressure source 68 to a relatively small second predetermined pressure, as depicted in FIG. 2. The actuator 26 can be actuated to release fluid from the pressure source 68. For example, a user may rotate the actuator 26, which is converted to linear motion via a threaded engagement between the actuator 26 and the housing 22. When a linear advance is applied to the pressure source 68, the regulator valve 70 can pierce a seal of the pressure cartridge to release high pressure fluid. After the regulator valve 70 reduces the pressure, fluid can flow from the pressure outlet 72 through tubing 75 toward the actuation valve assembly 80.

[0028] 5-7 in conjunction with FIGS. 1-4B, an actuation valve assembly 80 includes a housing 81 having a proximal region 81a and a distal region 81b, as best seen in FIGS. 5-6. A piston 82 having proximal and distal regions 82a and 82b is at least partially disposed within the housing 81. The proximal region 82a of the piston 82 may be coupled to an actuator button 88, as depicted in FIGS. 2-3, thereby allowing a user to perform certain functions, as described further below. The proximal region 82a of the piston 82 may extend a predetermined distance outside the housing 81, as depicted in FIG. 2, to facilitate coupling to the actuator button 88. The distal region 82b of the piston 82 may be positioned adjacent a proximal end of a compression spring 87, as depicted in FIGS. 2 and 5-6. This can provide a default position to which piston 82 can be tilted to be disposed more proximally for purposes described below, but which can be moved distally against the force of spring 87 if a user applies sufficient force to actuator button 88. In particular, actuator button 88 can bear against stop member 27 of housing 22 in a pressing manner, as best seen in FIG. 3, to limit proximal movement of actuator button 88 so that piston 82 does not disengage from actuator valve assembly 80.

[0029] Various inlet and outlet ports are associated with the actuated valve assembly 80. In one embodiment, an inlet port 92 and three different outlet ports 93-95 are associated with the actuated valve assembly 80.

[0030] The inlet port 92 of the actuated valve assembly 80 may be coupled to tubing 75 extending from the pressure outlet 72 of the regulator valve 70, as depicted in FIG. 2, thereby providing pressurized fluid at a predetermined pressure into the actuated valve assembly 80.

[0031] In one embodiment, piston 82 has a generally tubular body 83 with a lumen 84 extending between proximal and distal regions 82a and 82b, as best seen in Figures 6-7. Additionally, first and second slots 85 and 86 extend through different regions of tubular body 83 of piston 82, as seen in Figures 5-7.

[0032] A first slot 85 of the piston 82 is axially aligned with the inlet port 92 in at least one operating state. A second slot 86 of the piston 82 may be axially aligned with the outlet port 93 in the first state, and may also be axially aligned with the outlet port 94 in the second state, thereby selectively providing fluid communication between the piston 82 and the outlet port 93 or the outlet port 94, as described further below.

[0033] When the activation button 88 is not engaged by the user, the force provided by the compression spring 87 biases the piston 82 to a first condition, as depicted in Figures 5-7, in which the first slot 85 of the piston 82 is axially aligned with the inlet port 92 and further in which the second slot 86 of the piston is axially aligned with the outlet port 93. As a result, pressurized fluid from the pressure source 68 (regulated by the regulator valve 70) is directed into the outlet port 93 and into the vent tubing 101, at which point the user has the option to selectively provide vent fluid, for example, by actuating a stop cock or button valve without limitation valve 102, as will be further described below.

[0034] When the actuator button 88 is depressed by a user in a manner that overcomes the force provided by the compression spring 87, the piston 82 is advanced distally to a second state in which the first slot 85 of the piston 82 remains axially aligned with the inlet port 92 while the second slot 86 of the piston 82 is axially aligned with the outlet port 94. As a result, pressurized fluid from the pressure source 68 (regulated by the regulator valve 70) is directed into the outlet port 94 and into the tubing 61, from which it is then directed into the inlet port 62 of the cap 60 and into the container 30 holding the therapeutic agent 38. Notably, one or more sealing members, such as O-rings 96a-c, may be used to provide a fluid-tight seal as the pressurized fluid traverses through the housing 81.

[0035] In one embodiment, the first slot 85 has a length L1 and the second slot 86 has a length L2, where the length L1 is greater than the length L2, as depicted in Figures 5-7. Due to its relatively long length L1, the first slot 85 can remain in fluid communication with the inlet port 92 in both the first and second states, i.e., before and after a user presses the activation button 88. In contrast, due to its relatively short length L2, the second slot 86 moves from fluid communication with the outlet port 93 to the outlet port 94 when a user presses the activation button 88.

[0036] The distal region 82b of the piston 82 can be secured to the proximal end of the compression spring 87 as depicted in Figures 5-7. Alternatively, the piston 82 can be in pressing contact with the compression spring 87 directly without a securing mechanism or can be indirectly coupled to the compression spring 87 as long as the spring force is transferred to the piston 82. In either case, it is preferred that the distal end of the compression spring 87 remains fixed in position relative to the housing 81 of the actuation valve assembly 80. In one embodiment, the compression spring 87 can be in pressing contact with a non-movable internal flange 89 of the actuation valve assembly 80 that holds the distal end of the compression spring 87 in position as depicted in Figures 5-7.

[0037] The lumen 84 of the piston 82 is also in fluid communication with the outlet port 95 of the actuation valve assembly 80 such that pressurized fluid from the pressure source 68 is delivered through the outlet port 95. Specifically, a certain amount of pressurized fluid entering through the inlet port 92 flows distally over the first and second slots 85 and 86 in the piston 82 and through the distal region 82b of the piston 82, at which point the pressurized fluid then passes through the space inside the compression spring 87 within the flange 89 that houses the compression spring 87, as shown in FIGS. 5-7, and then flows into the lumen 97 located distal to the flange 89. The pressurized fluid from the lumen 97 can then escape through the outlet port 95. The pressurized fluid escaping through the outlet port 95 can travel distally into the tubing 111 and toward the fluid reservoir 110, as best seen in FIGS. 2-3.

[0038] Fluid reservoir 110 can have irrigation fluid disposed within container 118. Pressurized fluid traveling from outlet port 95 and through tubing 111 can pass through valve 112 (when in an open state), as best seen in FIG. 2, and then through inlet port 113 associated with container 118. At this point, pressurized fluid (from pressure source 68) is propelling irrigation fluid within reservoir 110 through outlet tube 114 and outlet port 115 associated with container 118, and through tubing 116 that ultimately connects to catheter adapter 120, as described further below.

[0039] In particular, valve 112 is operable by a user to selectively inhibit the flow of pressurized fluid into fluid reservoir 110, and this action then selectively stops or resumes the delivery of irrigation fluid to the target site. In one embodiment, the irrigation fluid in fluid reservoir 110 may comprise water or another suitable fluid, which may be used to clean a camera lens associated with system 20, as described further below.

[0040] Although Figures 1-7 depict example ports 92-95 and associated tubing (such as tubing 75, 101, 61, and 111), it should be understood that other suitable coupling mechanisms can be utilized to secure the various portions of tubing to the various valves and ports.

[0041] 8-10, the system 20 can include a catheter adapter 120 for use with the catheter 90 to facilitate orientation and routing of the components of the system 20 toward the catheter 90. In particular, FIGS. 8-9 provide two views of the catheter adapter 120 and the proximal end 98 of the catheter 90 (in a proximal-to-distal facing direction), while FIG. 10 shows a cross-sectional view of the catheter 90 taken along line AA in FIG. 8 (in a distal-to-proximal facing direction).

[0042] The catheter adapter 120 has a main body 121 having a proximal end 122 and a distal end 123, where the proximal end 122 has a diameter D1 that is greater than a diameter D2 at the distal end 123. At least one taper can be disposed between the proximal end 122 and the distal end 123 to transition from the relatively larger diameter D1 to the relatively smaller diameter D2. In the embodiment of Figures 8-10, two distinct tapers 124 and 125 are provided between the proximal end 122 and the distal end 123 of the main body 121.

[0043] Advantageously, the relatively large diameter D1 at the proximal end 122 allows for the accommodation of numerous tubing and other components as described herein, while the taper thereby facilitates a transition to a relatively small diameter D2 that is relatively closer to the diameter of the catheter 90.

[0044] 8-9, catheter adapter 120 has lumens 131-140, which are described further below, in fluid communication with corresponding lumens 131a-140a of catheter 90. As an example, therapeutic agent lumen 131 of catheter adapter 120 of FIGS. 8-9 is in fluid communication with therapeutic agent lumen 131a of catheter 90 of FIG. 10. As a result, there is a direct correspondence between the lumens of catheter adapter 120 and the lumens of catheter 90.

[0045] The tapering of the main body 121 of the catheter adapter 120 provides for reducing the diameter of the various lumens by a particular amount when comparing the relatively larger inner diameters of the lumens 131-140 at the proximal end 122 of the catheter adapter 120 to the relatively smaller inner diameters of the corresponding lumens of the catheter 90. For example, in one embodiment, the therapeutic agent lumen 131 may have a first inner diameter at the proximal end 122 of the catheter adapter 120 and a second relatively smaller inner diameter in the lumen 131a of the catheter 90, with the inner diameter transition occurring along the catheter adapter 120 as depicted in FIG.

[0046] The reduction in the inner diameter of the various lumens 131-140 is preferably at least 5% for one or more lumens, and in some embodiments 10-90% for a given lumen, depending on the lumen and its purpose. It may be clinically important that a particular lumen, such as the therapeutic agent lumen 131, not be reduced too much from its first diameter at the proximal end 122 of the catheter adapter 120 relative to its corresponding smaller lumen 131a in the catheter, because a catheter lumen that is too small may become clogged. However, the other lumens 131a-140a of the catheter 90 may achieve a significantly smaller diameter if there is no significant drawback to the smaller lumens.

[0047] As seen in Figures 8-10, the catheter adapter 120 has a therapeutic agent lumen 131 that is in fluid communication with the container 30 of Figures 1-4B that holds the therapeutic agent 38. Referring again to Figure 2, the outlet port 63 in the cap 60 in the container 30 may be disposed in fluid communication with a tubing 64 that extends distally, for example, toward a first inlet port 66a of a coupler 65 and a y-shaped or t-shaped coupler without limitation. The exhaust port 67 of the coupler 65 is secured to an outlet tubing 69 that extends distally into engagement with a first, larger diameter of the therapeutic agent lumen 131 of the catheter adapter 120. In particular, the second inlet port 66b of the coupler 65 is in fluid communication with a vent tubing 101 that extends from the outlet port 93 of the valve assembly 80, as described above.

[0048] Advantageously, as a result, the therapeutic agent lumen 131 of the catheter adapter 120 and the corresponding lumen 131a of the catheter 90 provide for selective delivery of therapeutic agent 38 and pressurized fluid from the pressure source 68, or alternatively only pressurized fluid from the pressure source 68, depending on whether the second slot 86 of the piston 82 is axially aligned with the outlet port 93 in the first state, or alternatively, is axially aligned with the outlet port 94 in the second state. This provides a simple and efficient ability for a user to switch between a therapeutic agent delivery mode or alternatively a vent mode (lacking delivery of therapeutic agent).

[0049] 8-10, the catheter adapter 120 further includes an aspiration lumen 132 that is in fluid communication with a suction source (not shown) via an aspiration aperture 145 provided in the housing 22. In some embodiments, the aspiration source can include an external suction pump in fluid communication with the aspiration lumen 132 via tubing (not shown) extending through the aspiration aperture 145. Alternatively, the aspiration source can include a turbine or fan that is passively powered and turns on from the respective actuation of delivery of the therapeutic agent 38 and the pressurized fluid 68 such that air is drawn through the aspiration lumen 132a of the catheter 90 at the same time that the therapeutic agent 38 and the pressurized fluid 68 are expelled from the catheter 90.

[0050] Advantageously, the suction lumen 132a can provide wicking capability at or near the distal end of the catheter 90 and the target site, allowing for continuous or intermittent wicking of pressurized fluid into the catheter 90. This can be beneficial to reduce excess gas expansion from the therapeutic agent delivery mechanism, while maintaining volume and pressure in vivo. Additionally, wicking capability from a suction source delivered via the suction lumen 132a is advantageous to facilitate clearing of excess aerosolized therapeutic agent 38 to restore visibility to the user.

[0051] If an external pump is used, continuous infusion of propellant and suction can be performed. Such continuous infusion may include the benefit of reducing clogging of the passages for delivery of therapeutic agent 38. Furthermore, continuous suction can help maintain a stable ventilation volume within the patient and can be used to draw blood from the target site.

[0052] Optionally, system 20 may incorporate a valve (not shown) to close the provision of suction to suction lumen 132a, which would facilitate venting of the affected body area. Such a valve may be useful in a system having a constant positive pressure, i.e., where there is a continuous delivery of pressurized fluid 68 toward the target site, which may be beneficial to prevent backflow of fluid that may clog therapeutic agent lumen 131a of catheter 90. In such a constant positive pressure system, such a valve to selectively allow suction would aid in the transition between a general suction mode when in the open position or a vent mode when in the closed position.

[0053] 8-10, the catheter adapter 120 further includes an irrigation lumen 133 that is in fluid communication with the reservoir 110 of the container 118 of FIGS. 1-4B that holds irrigation fluid. Referring again to FIG. 2, an outlet port 115 in the cap of the container 118 may be placed in fluid communication with tubing 116 that extends distally to the irrigation lumen 131 of the catheter adapter 120, and which is in turn placed in fluid communication with the irrigation lumen 131a of the catheter 90. As a result, the irrigation lumen 131a provides for delivery of irrigation fluid driven by pressurized fluid from the pressure source 68 when the valve 112 is in the open position.

[0054] 8-10, the catheter adapter 120 further includes a camera lumen 134 and first and second light transmitting lumens 135 and 136. The camera lumen 134 of the catheter adapter 120 and the corresponding camera lumen 134a of the catheter 90 are sized to receive at least some equipment associated with the camera 150. In one non-limiting embodiment, the camera is wired as depicted in the schematic diagram of FIG. 15 and includes a camera cord 152 and a camera head 154 (note that in FIG. 15, some of the lumens of the catheter 90 are omitted for illustrative purposes only). It should be understood that in another embodiment, the camera can be wirelessly connected and thus the camera cord 152 can be omitted. In this example, the camera head 154 can transmit information to an image processing or analysis component over a WiFi or other suitable network.

[0055] The camera 150 has a portion held within a camera container 156 that is coupled to the housing 22 of the system. Referring again briefly to FIG. 4A, in one embodiment, the camera container 156 has a generally box-like configuration that is attached or otherwise secured to the first side surface 28 of the housing 22. In this example, a proximal region 152a of the camera cord 152 may extend proximally from the camera lumen 134 and may be routed through an aperture 157 in the first side surface 28 of the housing 22 and into the camera container 156. The proximal region 152a of the camera cord 152 may be coupled to other camera-related equipment housed within the camera container 156, such as image processing equipment or an adapter for external coupling. In one example, an appropriate cable, such as an HDMI® cable, may be connected to a port on the camera container 156, and the HDMI® cable may then be connected to further image processing or analysis equipment.

[0056] In one embodiment, the camera 150 comprises a CMOS camera that facilitates visual imaging of the target site T (pictured in FIG. 15) during delivery of therapeutic agent 38 and other devices and fluids described herein. The catheter's first and second light transmitting lumens 135a and 136a provide illumination suitable for high resolution imaging using the camera head 154. The light transmitting lumens can allow for the provision of light transmitting components, which in one example and without limitation can include one or more LEDs. In one example, wires operably coupled to two LEDs (one for each lumen 135a and 136a) can be provided, with the wires extending proximally back toward a power source. In various non-limiting embodiments, the power source can include a battery, or alternatively, power can be drawn from devices within or coupled to the camera container 156. In one non-limiting example, power may be provided through an HDMI® cable coupled to camera container 156, in which case a wire may be operatively coupled to circuitry within camera container 156 and may receive power from the HDMI® cable. Preferably, first and second light transmitting lumens 135a and 135a are generally positioned on opposite sides of camera lumen 134a, as depicted in FIG. 10, because providing illumination on only one side of camera 150 may provide insufficient illumination or contrast on the image.

[0057] 11-14 in conjunction with FIGS. 8-10, system 20 further includes at least one deflection wire having proximal and distal regions, the proximal region coupled to the deflection actuator in the housing and the distal region extending through the deflection wire lumen of the catheter to provide the ability to manipulate the distal region of the catheter upon actuation of the deflection actuator.

[0058] 10, four different deflection wires 161-164 are disposed through respective deflection wire lumens 137a-140a of the catheter 90. The deflection wires 161-164 extend in a distal-to-proximal direction from spaced apart engagement points at the distal end 99 of the catheter 90, through respective deflection wire lumens 137a-140a of the catheter 90, through respective deflection wire lumens 137-140 of the catheter adapter 120, and then through the interior space of the housing 22 until the proximal regions of the deflection wires 161-164 approach deflection actuators 171 and 172 that can be engaged by a user to selectively manipulate the deflection wires.

[0059] 11-14, first and second wire followers 181 and 182 are coupled between deflection actuators 171 and 172 and deflection wires 161-164. While first and second wire followers 181 and 182 may be disposed inside housing 22, as best seen in FIG. 4B and depicted in FIG. 11, deflection actuators 171 and 172 may be disposed outside housing 22. In the embodiment shown herein, deflection actuators 171 and 172 are disposed on second side surface 29 of housing 22, i.e., the side surface opposite first side surface 28 to which camera container 156 is secured, it should be understood that deflection actuators 171 and 172 may be disposed on the same surface 28 as camera container 156 or elsewhere on or near housing 22.

[0060] 12-13, the first wire follower 181 can have a main body 181a and can further have a first coupling region 161a to which a proximal end of the first deflection wire 161 can be secured. The first wire follower 181 also has a second coupling region 162a to which a proximal end of the second deflection wire 162 can be secured. In this example, the first coupling region 161a is disposed on the main body 181a at about 180 degrees with respect to the second coupling region 162a as depicted in FIGS. 12-13.

[0061] The first deflection actuator 171 is operatively coupled to the first wire follower 181 such that when the first deflection actuator 171 is rotated in a particular circumferential direction, it produces a corresponding circumferential rotation of the first wire follower 181. In one example, as shown in FIG. 14, a torque shaft 175 extends laterally between the first deflection actuator 171 and the first wire follower 181. The torque shaft 175 may be integrally formed with the first deflection actuator 171 and the first wire follower 181, or may include one or more linkages or other mechanical components that transfer the circumferential motion applied to the first deflection actuator 171 on the first wire follower 181.

[0062] Similarly, the second wire follower 182 can have a main body 182a and can further have a third bonding region 163a to which a proximal end of the third deflection wire 163 can be secured. The second wire follower 182 also has a fourth bonding region 164a to which a proximal end of the fourth deflection wire 164 can be secured. In this example, the third bonding region 163a is disposed approximately 180 degrees apart on the main body 182a relative to the fourth bonding region 162b, as depicted in Figures 12-13.

[0063] The second deflection actuator 172 is operatively coupled to the second wire follower 182 such that when the second deflection actuator 172 is rotated in a particular circumferential direction, a corresponding circumferential rotation of the second wire follower 182 is achieved. In one example, as depicted in FIGS. 12-13, the second deflection actuator 172 may be provided with a plurality of pin holes 176 formed in an inwardly facing surface 177, and the second wire follower 182 may be provided with a plurality of pin holes 186 on an inwardly facing surface 187. A plurality of pins, such as dowel pins (not shown), may extend between the plurality of pin holes 176 and 186 in the respective portions. Thus, a circumferential motion applied to the second deflection actuator 172 is imparted to the second wire follower 182. Note that in this embodiment, the second deflection actuator 172 and the second wire follower 182 each have a central aperture 178 and 188 each disposed around the outer surface of the torque shaft 175 connecting the first deflection actuator 171 and the second wire follower 181, as depicted in Figures 12-13.

[0064] In one example, rotation of the first deflection actuator 171 in a first direction can generate corresponding circumferential motion of the first wire follower 181, thereby applying tension to the first deflection wire 161 to move the distal end 99 of the catheter 90 in an upward direction. Conversely, rotation of the first deflection actuator 171 in an opposite second direction can generate circumferential motion of the first wire follower 181 in the second direction, thereby applying tension to the second deflection wire 162 to move the distal end 99 of the catheter 90 in a downward direction.

[0065] Moreover, rotation of the second deflection actuator 172 in a first direction generates a corresponding circumferential movement of the second wire follower 182, which can impart tension to the third deflection wire 163 to move the distal end 99 of the catheter 90 in a left-to-right direction. Conversely, rotation of the second deflection actuator 172 in an opposite second direction generates a circumferential movement of the second wire follower 182 in a second direction, which can impart tension to the fourth deflection wire 164 to move the distal end 99 of the catheter 90 in a right-to-left direction.

[0066] As a result, the four deflection wires 161-164 are capable of moving the distal end of the catheter 90 in four separate directions, facilitating imaging at the target site T by the camera head 154.

[0067] 15, in this embodiment, the distal region 131a' of the therapeutic agent lumen 131a of the catheter 90 may be disposed at a non-parallel angle relative to the distal region 132a' of the aspiration lumen 132a of the catheter 90. Advantageously, such a technique may reduce the likelihood of the therapeutic agent 38 becoming bounced away from the target site T towards the camera 150 in a manner that may obscure the camera's field of view or otherwise render it inoperable.

[0068] 15, distal region 131a' of therapeutic agent lumen 131a is disposed at an angle α relative to the primary longitudinal axis L of catheter 90. Angle α may range from about 5 degrees to about 75 degrees, and more preferably ranges from about 20 degrees to about 60 degrees. Distal region 132a' of aspiration lumen 132a may be disposed at the same angle α relative to the primary longitudinal axis L, or alternatively may be disposed at a different angle, but in either case, the non-parallel alignment of distal regions 131a' and 132a' of these particular lumens may improve visualization by the camera.

[0069] In operation, the distal end 99 of the catheter 90 can be positioned relatively near a target site. The catheter 90 can be advanced to the target site using open techniques, endoluminal techniques, through the mouth, colon, nostrils, or any other suitable technique, and the camera 150 can facilitate positioning at the target site.

[0070] When the catheter 90 is positioned at the desired target site, the pressure source 68 can be actuated by engaging the actuator 26. As described above, pressurized fluid can flow from the pressure source 68 through the regulator valve 70 and can be set at a desired pressure and rate. It should be understood that any passive type of flow regulator can be used to set the pressurized fluid to the desired parameters. The fluid then flows through the tubing 75 and into the actuated valve assembly 80 via the inlet port 91.

[0071] Pressurized fluid then flows through outlet ports 93 and 95 when actuator button 88 is in its relaxed state. At this point, the user has the option to selectively provide ventilation fluid by actuating valve 102 if pressurized fluid is available through outlet port 93.

[0072] When the user desires to deliver the therapeutic agent 38, the user presses the actuator button, thereby overcoming the force from the compression spring 87 and aligning the second slot 86 of the plunger 82 with the outlet port 94. At this point, regulated pressurized fluid flows through the outlet port 94 and through the tubing 61 toward the container 30. The fluid is then directed through the inlet tube 40 in the container 30 through the inlet port 62, and the direction of the pressurized fluid is then redirected upward at the bottom of the container 30. The regulated fluid then urges the therapeutic agent 38 through the outlet tube 50. The fluid and therapeutic agent 38 then exit through the first end 51 of the outlet tube 50, through the outlet port 63 of the cap 60, then through the coupler 65, the catheter adapter 120, and finally through the catheter 90, as described in detail above, thereby delivering the therapeutic agent 38 to the target site at the desired pressure.

[0073] The system 20 can be used to deliver a therapeutic agent 38 in a variety of procedures, and the therapeutic agent 38 can be selected to perform a desired function upon injection from the distal end of the catheter 90. By way of example only, and without limitation, delivery of the therapeutic agent 38 can be used to provide hemostasis, close perforations, perform lithotripsy, treat tumors and cancers, treat renal dialysis fistula stenosis, vascular graft stenosis, and the like. The therapeutic agent 38 can be delivered during procedures such as coronary angioplasty, renal artery angioplasty, and carotid artery surgery, or generally used to treat a variety of other cardiovascular, respiratory, gastrointestinal, or other conditions. The above-described system can also be used in transvaginal, umbilical, nasal, and bronchial / pulmonary applications.

[0074] For example, when used for hemostasis purposes, thrombin, epinephrine, or sclerosing agents can be provided to reduce localized bleeding. Similarly, when used to close a perforation, a fibrin sealant can be delivered to the localized injury. It should be noted that in addition to the hemostatic properties of the therapeutic agent 38, the relatively high pressure of the fluid and therapeutic agent may act as a mechanical tamponade by providing a compressive force in itself, thereby reducing the time required to achieve hemostasis.

[0075] The therapeutic agent 38 may be selected to perform one or more desirable biological functions, such as, for example, promoting tissue ingrowth from the interior wall of a body vessel, or alternatively, to reduce or prevent an undesirable condition within the vessel wall, such as restenosis. Many other types of therapeutic agents 38 may be used in connection with the system 20.

[0076] The therapeutic agent 38 may be delivered in any suitable form. For example, the therapeutic agent 38 may comprise a powder, liquid, gel, aerosol, or other substance. Advantageously, the pressure source 68 may facilitate the delivery of the therapeutic agent 38 in any of these forms.

[0077] The therapeutic agent 38 utilized may also include an antithrombotic bioactive agent, such as any bioactive agent that inhibits or prevents thrombus formation in a body vessel. Types of antithrombotic bioactive agents include anticoagulants, antiplatelet agents, and fibrinolytic agents. Anticoagulants are bioactive materials that act on any of the factors, cofactors, activated factors, or activated cofactors in the biochemical cascade and inhibit the synthesis of fibrin. Antiplatelet bioactive agents inhibit the adhesion, activation, and aggregation of platelets, which are major components of thrombin and play an important role in thrombosis. Fibrinolytic bioactive agents improve the fibrinolytic cascade or otherwise aid in the dissolution of thrombus. Examples of antithrombotic agents include, without limitation, anticoagulants such as thrombin, factor Xa, factor VIIa, and tissue factor inhibitors; antiplatelet agents such as glycoprotein IIb / IIIa, thromboxane A2, ADP-induced glycoprotein IIb / IIIa, and phosphodiesterase inhibitors; and fibrinolytic agents such as plasminogen activators, thrombin activatable fibrinolysis inhibitor (TAFI) inhibitors, and other enzymes that cleave fibrin.

[0078] Additionally or alternatively, the therapeutic agent 38 may include a thrombolytic agent used to break down blood clots that may adversely affect blood flow in the body's vessels. A thrombolytic agent is any therapeutic agent that directly digests fibrin fibers or activates the natural mechanisms to do so. Examples of commercially available thrombolytic agents include, without limitation, abokinase (urokinase), abokinase open cas (urokinase), activase (alteplase, recombinant), eminase (anitostreplase), retabase (reteplase, recombinant), and streptase (streptokinase), with the corresponding activator in parentheses. Other commonly used names are anisoylated plasminogen-streprotokinase activator complex, APSAC, tissue-type plasminogen activator (recombinant), t-PA, rt-PA. The therapeutic agent 38 may have a coating forming agent to protect or aid in the healing of injuries and / or wounds.

[0079] However, although several exemplary therapeutic agents 38 are described above, it will be apparent that numerous other suitable therapeutic agents may be used in connection with the system 20 and delivered through the catheter 90.

[0080] Advantageously, system 20 allows for localized delivery of a desired amount of therapeutic agent 38 at a desired regulated pressure. System 20 offers significant advantages over therapeutic agents delivered orally or through IV systems because the distal end of catheter 90 can be positioned relatively close to the target site and can reduce accumulation of therapeutic agent in healthy tissue, thereby reducing side effects. Furthermore, delivery of therapeutic agent 38 to the target site is performed in a relatively fast manner due to the relatively high fluid pressure, thereby providing rapid delivery to the target site compared to conventional devices.

[0081] The therapeutic agent 38 may have a certain range of properties that make it suitable for delivery through the catheter 90. Specifically, the mass of the individual particles of the therapeutic agent 38 must be within a certain range. If the particles of the therapeutic agent 38 are too heavy, they will require too much pressure to travel the length of the catheter 90 and may result in clogging of the catheter 90. If the particles are too light, they will aerosolize within the patient's body, such as within the gastrointestinal space, instead of being propelled to the target site. In addition to the mass of the individual particles of the therapeutic agent 38, the size of the particles is also important to ensure proper delivery through the catheter 90. If the particles of the therapeutic agent 38 are too large, they will have a tendency to clog within the delivery catheter 90. If the particles are too small, they may have a relatively large likelihood of being aerosolized instead of being propelled to the target site. Details of suitable properties of therapeutic agent 30 in relation to catheter 90 that are expected to reduce the likelihood of events such as particle aerosolization and catheter clogging are described in U.S. Pat. No. 9,867,931, the contents of which are incorporated herein by reference in their entirety.

[0082] The foregoing describes further operational steps of system 20. For example, a user can optionally provide suction via suction lumen 132a, selectively provide irrigation fluid via irrigation lumen 133a (when irrigation valve 112 is in the open position) to assist in cleaning of camera 150, and engage deflection actuators 171 and 172 to selectively manipulate deflection wires 161-164, thereby moving the distal end of catheter 90 in at least four distinct directions, as described above.

[0083] Advantageously, no separate visualization system, such as an endoscope, is required in system 20 because camera 150 is provided as part of the system including a dedicated lumen in catheter 90. As a result, system 20 can be used as a stand-alone therapeutic agent delivery system with its own imaging capabilities and does not need to be delivered through the lumen of a separate scope, such as an endoscope.

[0084] As a related advantage, system 20 is therefore not constrained by the size of instruments that can fit through the lumen of a conventional scope, and further, since delivery of catheter 90 through a conventional scope is not required, transport of the patient to a specialized room capable of handling endoscopic procedures can be avoided.

[0085] 16, in an alternative embodiment, catheter 90 can be replaced by multiple catheters 190a and 190b. Note that in FIG. 16, the general components and operation are identical to those of system 20, with selected differences described below.

[0086] 16, instead of catheter 90 carrying all of lumens 131-140 associated with system 20, as described above, catheters 190a and 190b can each have a relatively fewer number of selected lumens. By way of example, and without limitation, catheter 190a can have therapeutic agent lumen 191, camera lumen 192, light delivery lumen 193, and at least one deflection wire lumen 194. Catheter 190b can have aspiration lumen 195 and at least one deflection wire lumen 196.

[0087] The system of FIG. 16 may be particularly advantageous in transnasal delivery applications. In this example, each catheter 190a and 190b may pass through one nostril, effectively resulting in a two-nostril delivery system. The catheters 190a and 190b may be joined together by a manifold or holder on the outside of the nose for stabilization. The specific lumens within each of the catheters 190a and 190b may be reconfigured without departing from the spirit of the present embodiment, such as each catheter 190a and 190b having a greater or lesser number of lumens, including the different types of lumens described above. For example, to maximize suction capacity, it may be beneficial to provide the suction lumen 195 in a catheter having a greater or lesser number of lumens (as shown in FIG. 16), although in alternative embodiments, the camera lumen (or other lumen) may be present in the same catheter as the suction lumen.

[0088] Advantageously, the system of FIG. 16 provides a ready-to-use delivery system in an emergency setting, and the patient does not need to be intubated because this is not an endoscopic procedure. Such a system may be stored in a hospital emergency room or non-hospital environment, and may expedite treatment and prevent potential complications associated with intubation and conscious sedation. Note that any of the above-described embodiments may also be delivered orally, and may avoid the need for intubation in scenarios where the catheter is small enough in diameter, e.g., about 6 mm or less, without limitation.

[0089] 17-21, an alternative embodiment of a system 220 for delivering a therapeutic agent is shown and described. The alternative system 220 is similar to system 20, detailed above, with notable exceptions referenced below. It should be noted that Figures 17-18 are side and perspective views of the alternative system 220 with a portion of the housing 22' and the deflection actuators 171 and 172 removed for purposes of illustration, although these components are also shown in Figures 19-20.

[0090] In the embodiment of Figures 17-21, a first valve 202 is provided to selectively permit the flow of an insufflation fluid, a second valve 212 is provided to selectively permit the flow of an irrigation fluid, and a third valve 246 is provided to selectively permit the flow of an aspiration fluid. The first and second valves 202 and 212 generally correspond to the valves 102 and 112 described above, which regulate the insufflation fluid and the irrigation fluid, respectively. In Figures 17-21, the valves 202, 212, and 246 may, for example and without limitation, comprise stop cock or button valves, or other valve types suitable for regulating the fluids flowing therethrough, as generally described above.

[0091] 17, pressurized fluid from pressure source 68 (regulated by regulator valve 70) is directed through inlet port 92 and selectively directed into outlet port 93 (as described in detail above) and then into vent tubing 101a, at which point the user has the option to selectively provide vent fluid by actuating valve 202. As with the above embodiment using valve 102, upon actuation of valve 202, vent fluid flows through outlet tubing 101b and toward catheter 90, as described further below.

[0092] 17-21, pressurized fluid from pressure source 68 is also in fluid communication with outlet port 95 of actuation valve assembly 80 via lumen 84 of piston 82 in the manner described above in FIGS. 2-3 and 5-7. However, in the embodiment of FIGS. 17-18, fluid leaving outlet port 95 is directed into alternative irrigation tubing 211, which is placed directly in communication between reservoir 110, which holds irrigation fluid, and associated inlet port 213, without an intervening valve. Fluid leaving reservoir 110 is then directed via tubing 216, through outlet port 215, and into valve 212, which allows selective flow of irrigation fluid therethrough, as described above. When irrigation fluid is allowed to pass past valve 212, irrigation fluid flows into outlet tubing 217 and toward catheter 90, as described further below.

[0093] 17-21, irrigation valve 212 is disposed downstream relative to reservoir 110, in contrast to the embodiment of FIGS. 1-3, in which irrigation valve 112 is disposed upstream relative to reservoir 110. It should be understood that a user may switch the position of valves such as valves 202, 212, and 246 to be upstream or downstream of a particular reservoir, tubing, or other component without departing from the spirit of the present embodiment.

[0094] 17-21, aspiration fluid provided by a suction source (not shown) may be directed through tubing 245, which passes through aspiration aperture 145 provided in housing 22', as viewed in FIG 17. Tubing 245 is coupled to an inlet port of valve 246, as depicted in FIG 17, such that valve 246 allows selective flow of aspiration fluid therethrough. When aspiration fluid is allowed to pass past valve 246, the aspiration fluid flows into inlet tubing 247 and toward catheter 90, as described further below.

[0095] 21 in conjunction with FIGURES 17-19, system 220 further includes an adapter system 320 that allows various sections of tubing carrying insufflation or therapeutic agents, as well as irrigation and aspiration fluids, to be placed in fluid communication with catheter 90. Notably, adapter system 320 of FIGURES 17-21 is an alternative to catheter adapter 120 described above, although the purpose of adapter system 320 is similar in that it allows larger sections of tubing to transition into smaller sections of tubing (or cannula) that may better match the space constraints within catheter 90.

[0096] As best seen in Figures 17 and 21, the adapter system 320 uses multiple adapters 322, 332, and 342 between selected tubing and the catheter 90. Specifically, a first adapter 322 is coupled between the outlet tubing 69 (extending from the outlet port 67 of the coupler 65 as described above) and the catheter 90. The first adapter 322 has a proximal coupling port 323 that may have a barb element (similar to the coupler 333 of the second adapter 332, which is easier to visualize in Figure 21) that receives the distal end of the outlet tubing 69. A first cannula 325, having relatively small inner and outer diameters compared to the outlet tubing 69, is secured between the first adapter 322 and the catheter 90. Specifically, the proximal end of the first cannula 325 is secured in relationship to the outlet region 324 of the first adapter 322 using, for example, a press fit or other mechanical or adhesive fastening. Moreover, the distal end of first cannula 325 is secured within therapeutic agent lumen 131a of catheter 90 using a press fit or other securement technique (as viewed in cross section in FIG. 10 ). As a result, first adapter 322 provides a transition zone that allows therapeutic agent or vent fluid that originally left coupler 65 via larger diameter outlet tubing 69 to be guided into smaller diameter cannula 325 and then received within therapeutic agent lumen 131a of catheter 90.

[0097] 21, a second adapter 332 is coupled between the outlet tubing 217 (extending from the valve 212 associated with the irrigation fluid, as described above) and the catheter 90. The second adapter 332 has a proximal coupling port 333 (which may have a barb element) that receives the distal end of the outlet tubing 217, as shown in FIG. 21. A second cannula 335, having a relatively small inner and outer diameter compared to the outlet tubing 217, is secured between the second adapter 332 and the catheter 90. Specifically, the proximal end of the second cannula 335 is secured in relation to the outlet region 334 of the second adapter 322, for example, using a press fit or other mechanical or adhesive fastening. The distal end of the second cannula 335 is secured within the irrigation lumen 133a of the catheter 90 (as viewed in cross section in FIG. 10) using a press fit or other fastening technique. As a result, the second adapter 332 provides a transition zone that allows irrigation fluid that originally left the valve 212 via the relatively larger diameter outlet tubing 217 to be guided into the relatively smaller diameter cannula 335 and then received into the irrigation lumen 133a of the catheter 90.

[0098] A third adapter 342, best seen in FIGS. 17 and 21, is coupled between the outlet tubing 247 (extending from the valve 246 associated with the aspiration fluid, as described above) and the catheter 90. The third adapter 342 has a proximal coupling port 343 (which may have a barb element) that receives the distal end of the outlet tubing 247. A third cannula 345, having a relatively small inner and outer diameter compared to the outlet tubing 247, is secured between the third adapter 342 and the catheter 90. Specifically, the proximal end of the third cannula 345 is secured in relation to the outlet region 344 of the third adapter 342, for example, using a press fit or other mechanical or adhesive fastening. The distal end of the third cannula 345 is secured within the aspiration lumen 132a of the catheter 90 (as seen in cross section in FIG. 10) using a press fit or other fastening technique. As a result, the third adapter 342 provides a transition zone that allows aspiration fluid that originally left the valve 246 via the relatively larger diameter outlet tubing 247 to be guided into the relatively smaller diameter cannula 345 and then received into the aspiration lumen 132a of the catheter 90.

[0099] Note that in Figure 21, deflection wires 161-164 are shown in a partially disassembled state, with their proximal ends, for illustrative purposes only, unfixed (although in use they would be coupled to deflection actuators 171 and 172, as detailed above), and their distal ends extending within their respective deflection wire lumens 137a-140a of the catheter, as described above in Figure 10. Note further that in Figures 17-21, camera cord 152 for the camera and light transmitting elements have been omitted for illustrative purposes only, although these components may be routed within their respective lumens 134a, 135a, 136a of catheter 90 in the manner described in Figure 10 above.

[0100] In the embodiment of Figures 17-21, the proximal end 98 of the catheter 90 can be secured relative to the housing 22' using a catheter holder 291, as best seen in Figures 17 and 21. In one example, the catheter holder 291 has a generally cylindrical guide 292 having a lumen 293 extending axially therethrough. The guide 292 can have an outer diameter that approximates the size of the discharge opening 23' of the housing 22', as shown in Figure 21, such that the guide 292 is held relative to the housing 22' by a friction fit and / or using an adhesive or mechanical bond. The catheter 90 can have an outer diameter that approximates the size of the lumen 293 of the catheter holder 291, as depicted in Figure 21, such that the proximal end 98 of the catheter 90 is held relative to the catheter holder 291 by a friction fit and / or using an adhesive or mechanical bond.

[0101] 22, an alternative system 220' is shown having a modified actuation valve assembly 80'. In this embodiment, the location of the alternative outlet port 95' and compression spring 87' is modified relative to its location in the actuation valve assembly 80 of FIGS. 5-7. Specifically, the distal region 81b' of the actuation valve assembly 80' has the outlet port 95' disposed proximally (or upstream) relative to the compression spring 87' as shown in FIG. 22. With such a design, it may be easier for a user to press the actuation button 88 because significant pressure may not build up with the piston 82. Note that the other elements of FIG. 22 generally correspond to the same parts described above, and that tubing (not shown) would be coupled to the outlet port 95' and routed to the inlet port 113 or 213 associated with the reservoir 110 that holds the irrigation fluid, as detailed above.

[0102] While various embodiments of the present invention have been described above, the present invention should not be limited except in light of the appended claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the present invention, and it is not necessarily expected that all embodiments of the present invention will achieve all of the advantages described.

Claims

1. 1. A system suitable for delivering a therapeutic agent to a target site, comprising: a container for holding the therapeutic agent; a housing configured to securely hold the container; a pressure source having a pressurized fluid, the pressure source being in selective fluid communication with at least a portion of the container; a catheter having a therapeutic agent lumen, a camera lumen, and a light delivery lumen in fluid communication with the container; a camera having a camera head coupled to the camera lumen of the catheter; a light delivery component coupled to the light delivery lumen of the catheter; A system having

2. 2. The system of claim 1, further comprising a camera container coupled to the housing, the camera having a camera cord coupled to the camera head, at least a portion of the camera cord extending from the camera container through at least a portion of the camera lumen of the catheter.

3. The system of claim 2 , wherein the light transmitting component comprises an LED coupled to a wire, at least a portion of the wire extending from the camera container through at least a portion of the light transmitting lumen.

4. 2. The system of claim 1, further comprising a reservoir for holding irrigation fluid, the catheter further comprising an irrigation lumen, the irrigation lumen enabling the irrigation fluid to pass through the irrigation lumen to clean the camera.

5. 5. The system of claim 4, further comprising a valve assembly for routing the pressurized fluid to provide pressure for irrigation through the irrigation lumen of the catheter, for venting through the therapeutic agent lumen of the catheter, and for therapeutic agent delivery through the therapeutic agent lumen of the catheter.

6. The system of claim 1 , wherein the catheter has an aspiration lumen configured to allow suction in a distal-to-proximal direction from the target site toward the housing.

7. 10. The system of claim 1, further comprising at least one deflection wire having a proximal region and a distal region, the catheter further comprising at least one deflection wire lumen, the distal region of the at least one deflection wire extending through at least a portion of the at least one deflection wire lumen of the catheter to provide the ability to manipulate the distal region of the catheter.

8. 1. A system suitable for delivering a therapeutic agent to a target site, comprising: a container for holding the therapeutic agent; a housing configured to securely hold the container; a pressure source having a pressurized fluid, the pressure source being in selective fluid communication with at least a portion of the container; a catheter having a therapeutic agent lumen, a camera lumen, and at least one deflection wire lumen in fluid communication with the container; a camera having a camera head coupled to the camera lumen of the catheter; at least one deflection wire having a proximal region and a distal region, the distal region of the at least one deflection wire extending through at least a portion of the at least one deflection wire lumen of the catheter to provide the ability to steer the distal region of the catheter; A system having

9. 10. The system of claim 8, further comprising at least one deflection actuator, the proximal region of the at least one deflection wire being coupled to the at least one deflection actuator such that the distal region of the catheter is manipulated upon operation of the at least one deflection actuator.

10. the at least one deflection wire includes a first deflection wire, a second deflection wire, a third deflection wire, and a fourth deflection wire; and the at least one deflection actuator includes a first deflection actuator and a second deflection actuator; the first deflection actuator is coupled to the first deflection wire and the second deflection wire to enable movement of the catheter in a first direction and a second direction based on a direction in which the first deflection actuator is rotated; 10. The system of claim 9, wherein the second deflection actuator is coupled to the third deflection wire and the fourth deflection wire to enable movement of the catheter in a third direction and a fourth direction based on the direction in which the second deflection actuator is rotated.

11. The system of claim 10 , wherein the at least one deflection wire lumen comprises four deflection wire lumens, each of the four deflection wire lumens adapted to receive one deflection wire.

12. 10. The system of claim 8, further comprising a reservoir for holding irrigation fluid, the catheter further comprising an irrigation lumen, the irrigation lumen enabling the irrigation fluid to pass through the irrigation lumen to clean the camera.

13. The system of claim 12 , wherein the catheter further comprises an aspiration lumen configured to allow suction in a distal-to-proximal direction from the target site toward the housing.

14. 14. The system of claim 13, further comprising a first valve configured to selectively allow a flow of an insufflation fluid through the therapeutic agent lumen of the catheter, a second valve configured to selectively allow a flow of an irrigation fluid through the irrigation lumen of the catheter, and a third valve configured to selectively allow aspiration fluid through the aspiration lumen of the catheter.

15. 1. A system suitable for delivering a therapeutic agent to a target site, comprising: a container for holding the therapeutic agent; a housing configured to securely hold the container; a pressure source having a pressurized fluid, the pressure source being in selective fluid communication with at least a portion of the container; a catheter having a therapeutic agent lumen in fluid communication with the container and a camera lumen; a camera having a camera head coupled to the camera lumen of the catheter; a valve assembly that routes the pressurized fluid to provide pressure for venting through the therapeutic agent lumen of the catheter and for therapeutic agent delivery through the therapeutic agent lumen of the catheter; A system having

16. 16. The system of claim 15, wherein the catheter further comprises an irrigation lumen, the camera providing a visual image of the target site during delivery of the therapeutic agent, and the irrigation lumen allowing irrigation fluid to pass through the irrigation lumen to clean the camera.

17. 16. The system of claim 15, wherein the catheter further comprises an aspiration lumen, a distal region of the aspiration lumen being disposed at a non-parallel angle relative to a distal region of the therapeutic agent lumen.

18. 16. The system of claim 15, further comprising a first valve configured to selectively allow flow of a ventilation fluid through the therapeutic agent lumen of the catheter.

19. 16. The system of claim 15, wherein the catheter further comprises an irrigation lumen, the system further comprising a second valve configured to selectively allow flow of irrigation fluid through the irrigation lumen of the catheter.

20. 16. The system of claim 15, wherein the catheter further comprises an aspiration lumen, the system further comprising a third valve configured to selectively allow flow of aspiration fluid through the aspiration lumen of the catheter.

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