Devices, systems and methods for epicardial imaging and injection

Abstract

The present application relates to devices, systems and methods for epicardial imaging and injection. Systems and methods for injecting one or more medicaments into tissue within a patient's body are provided, the system comprising a catheter. A needle guide extends from the distal end of the catheter and terminates at a distal tip, for example, the distal tip includes a foot with a contact surface that prevents damage, the needle guide has a smaller cross-section than the distal end and is biased into a curved shape. The needle guide includes a channel connecting from the lumen of the catheter to an outlet at the distal tip, and a needle device is disposed in the channel, the needle device can be deployed from the outlet to inject one or more medicaments into the tissue. The catheter also includes an imaging assembly on the distal end, which is configured to capture images of tissue adjacent to the distal tip of the needle guide.

Description

[0001] This application is a divisional application of Chinese patent application 2014800731414 (PCT / US2014 / 065846) filed on November 14, 2014 and entitled “DEVICES, SYSTEMS AND METHODS FOR EPICARDIAL IMAGING AND INJECTION”. Technical Field

[0002] The present invention relates generally to devices, systems and methods for imaging and / or performing medical procedures, and more particularly to devices, systems and methods for injecting one or more agents into tissue (eg, epicardially into a patient's heart). Background Art

[0003] The pericardial space provides an advantageous access for many medical procedures. For some procedures, for example, an epicardial approach can provide a more direct access with fewer risks, such as the risk of clots or other embolic events (e.g., release of device fragments, air, etc.), compared to an intravascular approach. Recently, there has been a significant increase in the number of treatments designed to enter and treat the heart via an epicardial approach, via a subxiphoid portal as well as a surgical portal. Many of these treatments require careful positioning, for example, to target specific areas and avoid other specific areas. These areas can include the auricles, coronary arteries, coronary veins, fat pads, separate / individual chambers of the heart and / or their walls, etc. In general, these anatomical structures are difficult to visualize using standard imaging modalities (such as fluoroscopy or ultrasound), where poor resolution and / or the ability to deliver and contain contrast agents is difficult, which presents practical and significant challenges to the development of practical treatment devices and procedures.

[0004] Therefore, devices and methods that facilitate medical procedures via epicardial approaches would be beneficial. Summary of the invention

[0005] The present invention relates to devices, systems and methods for performing medical procedures, for example, within the pericardial space of a patient's body. More specifically, the present invention relates to devices, systems and methods for imaging and / or injecting one or more agents into tissue (e.g., epicardially into the wall of a patient's heart).

[0006] Devices with the ability to easily navigate and deliver a range of treatments to a range of anatomical structures via direct epicardial visualization are highly desirable. For example, injection catheters need to avoid the major coronary arteries and veins. Ablation systems need to be reliably positioned and ensure good proximity to tissue in addition to avoiding certain anatomical structures. Atrial appendage closure devices need to ensure proper positioning and secure closure. All of these objectives can be more easily achieved using devices and systems that provide direct visualization.

[0007] According to one embodiment, a device for imaging tissue during a medical procedure is provided, the device comprising a tubular member including a proximal end, a distal end sized to be introduced into a patient's body, and one or more lumens extending between the proximal and distal ends. A tubular extension extends distally beyond the distal end to a distal tip, the tubular extension having a smaller cross-section than the distal end and being biased into a curved shape, the tubular extension including a passageway connecting from a first lumen of the tubular member to an outlet at the distal tip. The device may also include a foot on the distal tip including a substantially atraumatic contact surface for contacting tissue having an area greater than the cross-section of the tubular extension; and an imaging assembly on the distal end configured to acquire images of tissue adjacent to the foot.

[0008] According to another embodiment, a device for imaging tissue during a medical procedure is provided, the device comprising a tubular member including a proximal end, a distal end sized to be introduced into a patient's body, and one or more lumens extending between the proximal and distal ends. A tubular extension extends distally beyond the distal end to a distal tip, the tubular extension having a smaller cross-section than the distal end and being biased into a curved shape, the tubular extension comprising a passageway communicating from a first lumen of the tubular member to an outlet at the distal tip. The device may also include a foot on the distal tip, which includes a sufficiently atraumatic contact surface for contacting tissue having an area larger than the cross-section of the tubular extension; a sufficiently transparent expandable member, the expandable member including a proximal end and a distal end, the proximal end of the expandable member being attached to the distal end of the tubular member, and the distal end of the expandable member being attached to one of the distal tip and the foot; and an imaging assembly on the distal end, which is within the interior of the expandable member and is configured to capture images of tissue adjacent to the foot and the expandable member surface surrounding the foot.

[0009] According to yet another embodiment, a system for injecting one or more medicaments into tissue within a patient's body is provided, the system comprising a catheter, the catheter comprising: a tubular member comprising a proximal end, a distal end sized to be introduced into the patient's body, and one or more lumens extending between the proximal and distal ends; a needle guide extending distally beyond the distal end to a distal tip, the needle guide having a smaller cross-section than the distal end and biased into a curved shape, the needle guide comprising a passageway communicating from a first lumen of the tubular member to an outlet at the distal tip; and an imaging assembly on the distal end configured to acquire an image of tissue adjacent to the distal tip of the needle guide. The system also comprises a needle device comprising a needle tip within the passageway of the needle guide and movable from a retracted position in which the needle tip is disposed within the passageway and an advanced position in which the needle tip is deployed from the outlet.

[0010] According to another embodiment, a method for imaging tissue structures within a patient's body is provided, the method comprising: introducing a distal end of a catheter into a pericardial space adjacent to the patient's heart; unfolding a curved delivery guide extending from the distal end of the catheter so that a foot on the delivery guide is oriented laterally relative to the distal end; maneuvering the catheter so that the foot contacts the heart wall; and acquiring one or more images of the foot and adjacent tissue to identify a target location on the heart wall.

[0011] According to yet another embodiment, a method for imaging tissue structures within a patient's body is provided, the method comprising: introducing a distal end of a catheter into the patient's body; expanding a balloon on the distal end, wherein a curved delivery guide extends from the distal end of the catheter through the interior of the balloon, the delivery guide comprising a foot, the foot being coupled to a distal surface of the balloon such that the foot is oriented laterally relative to the distal end; manipulating the catheter so that the foot and balloon contact tissue within the patient's body; and acquiring one or more images of the foot and adjacent tissue to identify a target location within the patient's body.

[0012] According to yet another embodiment, a method for injecting one or more medicaments into a patient's heart is provided. The method includes: introducing a distal end of a catheter into a pericardial space adjacent to the patient's heart; deploying a curved needle guide extending from the distal end of the catheter so that a foot on the needle guide is oriented laterally relative to the distal end; manipulating the catheter so that the foot contacts the heart wall; acquiring one or more images of the foot and adjacent tissue to identify a target location on the heart wall; and deploying a needle device from the needle guide into the target location to deliver one or more medicaments.

[0013] Other aspects and features of the present invention will become more apparent from the following description considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The accompanying drawings illustrate exemplary embodiments of the present invention, in which:

[0015] Figure 1 is a side view of an exemplary embodiment of a system for performing an injection including a catheter having a curved delivery guide and an imaging assembly, and a needle device deployable from the delivery guide.

[0016] Figure 1A and Figure 1B is obtained along line 1A-1A Figure 1 0014] A cross-sectional view of a catheter of FIG. 1 is shown showing an alternative exemplary lumen configuration for a proximal section of the catheter.

[0017] Figure 1C and Figure 1D is obtained along line 1C-1C Figure 1 0014] A cross-sectional view of a catheter of FIG. 1 is shown, illustrating an alternative exemplary lumen configuration for a distal section of the catheter.

[0018] Figure 2 can be included in Figure 1 A partial cross-sectional side view of an exemplary embodiment of a needle device in a system of FIG.

[0019] Figure 3 yes Figure 1 0026] A side view of the distal end of a catheter showing an exemplary embodiment of a delivery guide and an imaging assembly within a balloon on the distal end.

[0020] Figure 3A and Figure 3B yes Figure 3 Details of the imaging components.

[0021] Figure 3C and Figure 3D yes Figure 3 Details of alternative embodiments of the imaging assembly.

[0022] Figure 4A and Figure 4B yes Figure 3 Detail of the distal end of the catheter showing an exemplary field of view of the imaging assembly relative to the delivery guide and foot.

[0023] Figure 5A and Figure 5B can be provided in a catheter (such as in Figure 1 Detail of an exemplary embodiment of a foot on a delivery guide of a catheter shown in FIG.

[0024] Figure 5C yes Figure 1 Detail of an exemplary embodiment of the foot and balloon of a catheter.

[0025] Figure 5D-Figure 5K can be provided in a catheter (such as in Figure 1 Side view of an alternative embodiment of a foot on a delivery guide of a catheter shown in FIG.

[0026] Figure 6A-6C is shown for making Figure 1 Details of an exemplary method of catheterization of the balloon.

[0027] Figure 7 is a cross-sectional view of a patient's body showing the use of Figure 1 An exemplary method of injecting one or more medicaments into the epicardium of a patient's heart using a system.

[0028] Figure 8 is to use Figure 7 Example images acquired by the imaging component of the system.

[0029] Fig.9A and Fig. 9B is a side view of a distal portion of a needle device including a vascular reentry lumen and an imaging assembly.

[0030] Fig.10 is a side view of a distal region of another embodiment of an imaging catheter.

[0031] Fig.11 is a side view of a distal region of yet another embodiment of an imaging catheter. DETAILED DESCRIPTION

[0032] Turning to the attached figure, Figure 1 An exemplary embodiment of a system 8 for performing a medical procedure within a patient's body is shown, such as for imaging and / or injecting one or more agents into one or more tissues or lumens within the patient's body (e.g., into the wall of the patient's heart (not shown, see, for example, Figure 7)) is an exemplary embodiment of a system 8. As shown, the system 8 generally includes an imaging and / or delivery catheter 10 and a needle device 60, wherein the imaging and / or delivery catheter 10 carries a needle or delivery guide 20, a balloon 30 and an imaging assembly 40, and the needle device 60 can be deployed from the delivery guide 20. Optionally, the system 8 may include one or more additional components or devices, for example, an access or delivery sheath, one or more stylets, one or more additional needle devices, and / or one or more guidewires or rails (all not shown). Additionally or alternatively, as an alternative to or in addition to introducing the needle device 60, the catheter 10 can also be used to introduce other devices, for example, laser devices, electrical ablation devices, etc. (not shown), as described elsewhere in this document.

[0033] Generally speaking, the catheter 10 is an elongated tubular member that includes a proximal end 12, a distal end 14 sized for insertion into a patient's body, a central longitudinal axis 16 extending between the proximal and distal ends 12, 14, and one or more lumens 18 extending between the proximal and distal ends 12, 14. A needle or delivery guide 20, a balloon 30, and an imaging assembly 40 may be provided on the distal end 14, for example, to facilitate imaging of the patient's body, and / or to deploy a tip 65 of a needle device 60 to inject one or more medicaments and / or otherwise perform a medical procedure, as described elsewhere herein.

[0034] In an exemplary embodiment, as in Figure 1A-Figure 1D As shown in FIG. 1 , the catheter 10 may include a central or primary lumen 18a and one or more secondary lumens 18b-18c extending at least partially between the proximal end 12 and the distal end 14, for example, within different sections of the catheter 10, as further described elsewhere herein. In one embodiment, as shown in FIG. Figure 1A As shown, the proximal section of the catheter 10 may include a single relatively large central lumen 18a that may extend from the proximal end 12 to a position adjacent the distal end 14. The central lumen 18a may include one or more tubes, wires, and / or other components extending between the proximal end 12 and the distal end 14 of the catheter 10. For example, as shown, the central lumen 18a may include an inflation lumen 39 that communicates with the interior of the balloon 30, a delivery lumen 69 for receiving a needle device 60, and one or more cables 49 for providing power to the imaging assembly 40 and / or for providing imaging output from the imaging assembly 40. Optionally, for example, if the distal end 14 of the catheter 10 is steerable and / or otherwise deflectable, one or more pull wires (one pull wire 19 is shown) and / or a stylet (not shown) may be provided within the central lumen 18a.

[0035] As in Figure 1C and Figure 1D As shown in , within the distal section of the catheter 10 adjacent the distal end 14, the configuration of the lumen 18 may be optionally varied to provide the distal section with different mechanical properties and / or other characteristics, such as providing one or more auxiliary lumens 18b-18d for receiving one or more of the components within the central lumen 18a within the proximal section. For example, one or more inflation lumens 18b (two are shown) may be provided in the wall of the catheter 10 that communicates with (one or more) inflation lumens 39 in the proximal section, and / or a delivery lumen 18c may be provided in the wall of the catheter 10 that communicates with the delivery lumen 69 of the receiving needle device 60. Alternatively, as in Figure 1D As shown in FIG. 1 , a single auxiliary lumen 18b′ may be provided in the distal section, the auxiliary lumen 18b′ being dimensioned to receive the needle device 60 and to allow an inflation medium to be introduced around the needle device 60 and / or removed from around the needle device 60. In a further alternative, as in Figure 1B As shown in FIG. 1 , auxiliary lumens 18 b - 18 c may extend from the proximal end 12 of the catheter 10 to the distal end 14 .

[0036] Optionally, as in Figure 1C and Figure 1D , one or more additional lumens 18d (one shown in phantom) may be provided for receiving a stylet and / or a traction wire (not shown). Additionally or alternatively, if desired, an infusion / aspiration lumen may be provided, such as an infusion / aspiration lumen communicating with one or more ports (not shown) on the distal end 14 adjacent the balloon 30. Such lumens and port(s) may allow infusion of saline or other clear fluids to clear the area surrounding the balloon 30 of blood or other obstructive material, and / or may allow aspiration to remove such material, blood, and / or other material that has accumulated in the pericardial space, for example.

[0037] Optionally, the distal end 14 may include one or more features to improve visibility under ultrasound, MRI, or other imaging modalities, for example by providing one or more radiopaque markers on one or more regions in the distal end 14, delivery guide 20, foot 28, and / or balloon 30 and / or adding dopants to one or more regions in the distal end 14, delivery guide 20, foot 28, and / or balloon 30, as is known in the art.

[0038] The catheter 10 can be fully flexible, semi-rigid, and / or rigid along its length, and can be made of a variety of materials including plastics, metals, and / or composite materials, as is well known to those skilled in the art. For example, the catheter 10 can be fully flexible at the distal end 14 to facilitate advancement through tortuous anatomical structures, and / or can be semi-rigid or rigid at the proximal end 11 to improve the pushability and / or torquability of the catheter 10 without a substantial risk of buckling or compression. In an exemplary embodiment, specific reference is made to the Figure 1A-Figure 1D , the catheter 10 may include, for example, an inner liner 11A that at least partially or completely surrounds or otherwise defines a central lumen 18a, a reinforcement layer 11B surrounding the inner liner 40, and an outer jacket 11C surrounding the reinforcement layer 42, each of which may extend at least partially between the proximal end 12 and the distal end 14 of the catheter 10. The reinforcement layer 11B and / or the outer jacket 11C may be attached to the inner liner 11A, for example, by lamination, adhesion, adhesive bonding, ultrasonic welding, reflow or other heating, etc. In an exemplary embodiment, one or more of the central lumen 18a and / or the auxiliary lumens 18b-18d may include a smooth material, or may be made of one or more layers of thermoplastic or other polymeric material, including one or more coatings on the inner surface 41a having desired properties, for example, a hydrophilic coating and / or a smooth coating, for example, similar to the liners disclosed in U.S. Patent Nos. 7,550,053 and 7,553,387 and U.S. Application No. 2009 / 0126862, the disclosures of which are expressly incorporated herein by reference.

[0039] Optionally, any or all of the inner liner 11A, reinforcement layer 11B, and / or outer jacket 11C may be made of multiple layers of the same or different materials (not shown), e.g., to provide desired material properties in different sections of the catheter 10. In an exemplary embodiment, outer jacket 1C may be made of PEBAX, nylon, polyurethane, and / or other thermoplastic materials, e.g., so that the material of outer jacket 11C may be heated and reflowed and / or otherwise formed around the components.

[0040] Optionally, the distal section of the catheter 10 may be pre-shaped, steerable or deflectable, i.e., may be bent, curved or otherwise deflected. Figure 1 In the embodiment shown in FIG. 1 , the distal end 14 can be biased into a curved shape, for example, having a greater radius of curvature than the delivery guide 20. Optionally, a stylet (not shown) can be inserted into the catheter 10 (e.g., inserted into the Figure 1C and Figure 1D The catheter 10 may include one or more traction wires 19, such as in the catheter 10, for example, to straighten the distal end 14 and / or otherwise support the distal end 14 during introduction into the patient's body. Figure 1A As shown in FIG. 1 , the one or more pull wires 19 may be actuated to guide the distal end 14 between straight and curved shapes as desired during use.

[0041] Return to Figure 1 , a handle or hub 50 can be provided on the proximal end 12 of the catheter 10, for example, configured and / or dimensioned for gripping and / or manipulating the system 8 from the proximal end 12. In addition, the handle 50 can include one or more ports 52 that communicate with corresponding lumens within the catheter 10. For example, the port 52a can be in communication with the delivery lumen 69, 18c, or 18b', for example, for removably receiving the needle device 60 therein, as further described elsewhere herein. Optionally, the port 52a includes one or more valves, for example, a hemostatic valve (also not shown), which can provide a substantially fluid-tight seal while accommodating the insertion of the needle device 60 (or other device) into the delivery lumen 69, 18c, or 18b'. Alternatively, the needle device 60 can be integrally formed as part of the catheter 10, i.e., non-removable, and the port 52a can be omitted.

[0042] In addition, a side port 52b in communication with the inflation lumen(s) 39, 18b may be provided, for example, for delivering fluid into and / or withdrawing fluid from the interior 36 of the balloon 30, as described elsewhere herein. Figure 1 As shown in FIG, a syringe or other source of inflation medium 70 can be coupled to side port 52b for introducing fluid (e.g., saline, nitrogen, etc.) into the interior 36 of the balloon 30 and / or removing fluid (e.g., saline, nitrogen, etc.) from the interior 36 of the balloon 30.

[0043] The handle 50 and / or the proximal end 12 may also include one or more connectors, such as electrical connectors, etc. (not shown), for connecting the imaging assembly 40 to a controller 48 via one or more cables 56, such as a power supply, processor, display, etc. (not shown).

[0044] Finally, the handle 50 may also include one or more actuators, such as a slide, a button, a switch, a rotary actuator, a lock, etc., for example, for activating and / or manipulating components on the distal end 14 or otherwise operating the device 10. For example, an actuator 54 coupled to the needle device 60 may be provided for deploying and retracting the needle tip 65 during injection, and / or a locking mechanism (not shown) for locking the needle device 60 in one or more predetermined positions may be included, as further described elsewhere in this article. In addition, one or more switches 49 may be provided on the controller 48 and / or on the handle 50 for operating the imaging assembly 40, as further described elsewhere in this article. If the catheter 10 is manipulable or deflectable, one or more slides or other actuators (not shown) may also be provided for guiding corresponding (one or more) traction wires to deflect the distal end 14, or a port (not shown) for receiving a stylet may be provided, for example, to straighten or otherwise deflect the distal end 14, as described elsewhere in this article.

[0045] Steering Figure 3 , showing the distal end 14 of the catheter 10, providing additional details of the components carried thereon. For example, as shown, the delivery guide 20 can include a tubular member that is biased into a curved shape, but is sufficiently flexible to be guided into a substantially straight shape (not shown), for example, to facilitate introduction into a patient's body, as described elsewhere herein.

[0046] The delivery guide 20 generally includes a proximal end 22 attached to the distal end 14 of the catheter 10, a distal end 24 terminating in a foot 28, and a lumen or passage 26 extending between the proximal end 22 and the distal end 24. The passage 26 can communicate between the delivery lumen 18c, 69 in the catheter 10 and the outlet 29 in the foot 28, and / or can be sized to receive at least the tip 65 of the needle device 60. As shown, the delivery guide 20 has a smaller outer diameter or other maximum cross-section than the distal end 14 of the catheter 10 and is mounted offset from the central axis 16 of the catheter 10. For example, attaching the delivery guide 20 to the catheter 10 eccentrically relative to the imaging assembly 40 can minimize the extent to which the delivery guide 20 obscures the field of view of the imaging assembly 40, as described elsewhere herein.

[0047] The proximal end 22 of the delivery guide 20 can be attached to the distal end 14 of the catheter 10 using known methods. In an exemplary embodiment, the proximal end 22 of the delivery guide 20 can be docked on the distal end 14, at least partially received in a recess (not shown) in the distal end 14, received on a fitting (also not shown) on the distal end 14, and / or attached using other methods to substantially permanently mount the delivery guide 20 on the distal end 14 so that the channel 26 is aligned with the delivery lumen 18c, 69 of the catheter 10. Additionally or alternatively, the delivery guide 20 can be bonded to the catheter 10, for example, using an adhesive, heating, sonic welding, etc.

[0048] The delivery guide 20 can be biased into a curved shape defining a simple consistent radius curve, or can be biased into a more complex curved shape as desired, for example, to place the foot 28 and outlet 29 at a desired location relative to the distal end 14 of the catheter 10. For example, it may be desirable to orient the outlet 29 substantially perpendicular to the longitudinal axis 16 of the catheter 10, for example, to deploy the tip 65 of the needle 60 into the epicardium or other tissue structure along which the distal end 14 of the catheter 10 is disposed. In an exemplary embodiment, the delivery guide 20 can be made of an elastic material (e.g., nitinol) to allow the delivery guide 20 to straighten, for example, to pass through an introducer or sheath, but elastically return to its curved shape while deflecting as needed to reduce the risk of damage to tissue contacted by the foot 28. In an alternative embodiment, the delivery guide 20 can be actuatable between a curved shape and a substantially straight shape, for example, by utilizing a stylet or pull wire (not shown) similar to the stylet or pull wire described for the distal end 14 of the catheter 10.

[0049] Steering Figure 5A-Figure 5C , a foot 28 can be attached to the distal end 24 of the delivery guide 20, for example, to provide an enlarged and / or substantially atraumatic tip for the delivery guide 20. For example, as shown, the foot 28 can include a substantially atraumatic contact surface 28a having an area larger than the cross-section of the delivery guide 20, which can reduce the risk of puncturing, scratching, or otherwise damaging tissue contacted by the delivery guide 20. In an exemplary embodiment, the foot 28 can be molded or otherwise formed separately from the delivery guide and attached to the distal end 24, for example, by one or more of an interference fit, fusion, sonic welding, bonding with an adhesive, etc. Figure 5AOptional relief cuts are shown that may be provided in the distal end 24 or foot 28 of the delivery guide 20 to enhance attachment. Alternatively, the foot 28 may be molded or otherwise formed directly on the distal end 24. The foot 28 may be made of a variety of materials, for example, an elastomeric material such as silicone, a thermoplastic material such as polyurethane, polyether block amide, nylon, fluoropolymer, or thermoset material, metal, etc.

[0050] Optionally, as in Figure 5B 29, a window 28b may be provided on the foot 28 and the delivery guide 20 that may allow viewing of the lumen 26 of the delivery guide 20 directly adjacent to the outlet 29. For example, the window 28b may allow a user to view the tip (not shown) of the needle device 60, for example, to confirm that the tip is positioned directly adjacent to the outlet 29 prior to deployment (or when the needle device 60 is first loaded into the catheter 10), as described elsewhere herein. Alternatively, the foot 28 may be made of a sufficiently transparent or translucent material to allow visual identification of the tip 65 of the needle device 60 adjacent to the outlet 29. Additionally or alternatively, the foot 28 may include one or more features (not shown) that facilitate identification of the foot 28 in images acquired by the imaging assembly 40 and / or using external imaging. Additionally or alternatively, the foot 28 and / or the delivery guide 20 may include markings that facilitate identification of variables (such as needle depth) during deployment of the tip 65.

[0051] Steering Figure 5D-Figure 5K , showing that it is possible to replace Figure 5A-Figure 5C An alternative embodiment of a foot is provided by way of the foot 28 shown in FIG. Figure 5D Foot 28D is shown which may include, for example, a depression 28D-b in distal surface 28D-a surrounding an outlet 29D which may provide a working space into which one or more devices may be introduced to perform a procedure. Figure 5E Another embodiment of a foot 28E comprising a loop 28E-c extending from the distal end 24 of the delivery guide 20 is shown. Fig. 5F Yet another embodiment of a foot 28F is shown that includes a loop 28F-C that is bent to define a distal contact surface 28F-a that surrounds an opening 28F-d that is aligned with the outlet 29 of the passage 26. Figure 5G-Figure 5I End views of alternative shapes for the contact surfaces 28G-a, 28H-a, 28I-a of the feet 28G, 28H, 28I are shown, for example, including a recess 28G-e, 28H-e, 28I-e adjacent the outlet 29 of the passage 26.

[0052] Steering Figure 5J, shows another exemplary embodiment of a foot 28J, which includes a substantially planar distal contact surface 28J-a having a plurality of engagement features 28J-f (e.g., barbs, treads, etc.), which may enhance engagement between the foot 28J and tissue against which the foot 28J is placed. Figure 5K Another exemplary embodiment of a foot 28K is shown, which also includes a substantially planar distal contact surface 28K-a that may optionally include one or more engagement features (not shown). In addition, the foot 28K includes a recess 28K-e in the contact surface 28K-a, which is in communication with a vacuum line 28K-g that extends, for example, along the delivery guide 20. A vacuum can be applied to the vacuum line to create suction in the distal surface 28K-a, thereby enhancing engagement with the contacted tissue. Such vacuum features and / or engagement features can enhance the fixation of the feet 28J, 28K relative to the tissue such that any movement of the tissue (e.g., due to the beating of the patient's heart) causes corresponding movement of the feet 28J, 28K, the delivery guide 20, and possibly the balloon 30 and the distal end 14 of the catheter 10 (not shown, see Figure 1 ), which can stabilize the field of view of the imaging assembly 40. Because the distal end 14 moves synchronously with the tissue, the field of view can be relatively stationary, thereby stabilizing the image and facilitating identification of desired tissue structures. In a further alternative, one or more magnets can be provided on the foot (not shown), and a mating magnet can be positioned at a desired location adjacent to the foot within a chamber of the heart, which can stabilize the foot relative to the heart. In a further alternative, a stabilizing element (e.g., a tip 65 of the needle device 60) can extend from the delivery guide 20 to engage and / or pierce adjacent tissue, thereby eliminating or reducing relative motion between the imaging assembly 40 and the tissue being imaged, and thereby providing image stabilization.

[0053] Additional References Figure 6A-6C , balloon 30 may include a proximal end 32 attached to distal end 14 of catheter 10 and a distal end 34 attached to distal end 24 of delivery guide 20 and / or foot 28 . Fig. 6A Exemplary shapes of balloon 30 that may be provided, for example, after being dipped or otherwise formed are shown.

[0054] As in Figure 6C As shown in FIG. 1 , the proximal end 32 of the balloon 30 can be secured to the outer surface of the catheter 10 using, for example, adhesive, heating, interference fit, an outer collar (not shown), etc. Figure 5C , Figure 6B and Figure 6C, the distal end 34 of the balloon 30 can be attached to the distal end 24 and / or the foot 28 of the delivery guide 20, for example, such that the distal end 34 of the balloon 30 is at least partially inverted on itself. This can facilitate close contact between the distal surface 38 of the balloon 30 and the tissue surface being viewed (not shown), and / or minimize gaps around the foot 28, which can reduce optical distortion and / or facilitate fluid removal from between the balloon 30 and the contacted tissue surface. In addition, this arrangement can prevent the foot 28 from extending substantially beyond the distal surface 38 of the balloon 30, for example, such that the contact surface 28a of the foot 28 is substantially coextensive with the distal surface 38 of the balloon.

[0055] When fluid is introduced into the interior 36 of the balloon 30, the balloon 30 may be expandable from a retracted condition or a delivery condition (not shown) to an expanded condition, e.g., Figure 1 and Figure 7 Optionally, the balloon 30 can be shaped such that, in the expanded condition, the balloon 30 can define a substantially flat distal surface 38 , which can facilitate imaging of tissue structures through the balloon 30 using the imaging assembly 40 .

[0056] In an exemplary embodiment, balloon 30 can be made of a compliant and / or elastic material, for example, an elastomeric material such as silicone, latex, rubber matrix / isoprene, and Chronoprene. The compliance of balloon 30 can facilitate the removal of fluid between distal surfaces 38, and / or can offset the bias of delivery guide 20 during introduction, as described elsewhere herein. Alternatively, balloon 30 can be made of a substantially non-compliant material, for example, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), fluorinated ethylene propylene (FEP), polyethylene terephthalate (PET), polyurethane, olefin, and polyethylene (PE), so that when balloon 30 is fully inflated to an expanded configuration, balloon 30 expands to a predetermined shape.

[0057] The material can be sufficiently flexible and / or elastic so that the distal surface 38 can sufficiently conform to the shape of the contacted tissue structure (e.g., the epicardium of the patient's heart), which can move blood or other fluids from between the distal surface 38 and the contacted tissue to facilitate imaging by the balloon 30. Additionally or alternatively, the balloon 30 can act as a tissue spacer by utilizing the distal surface 38 to guide easily deformable soft tissue (e.g., cardiac tissue and / or epicardium) away from the imaging assembly 40. Moreover, the combination of the balloon 30, delivery guide 20, and foot 28 can provide a substantially fixed imaging depth, angle of view, and / or field of view in images acquired using the imaging assembly 40, for example, because the foot 28 stabilizes the distal end 14 relative to the contacted tissue, as described elsewhere herein.

[0058] The balloon 30 can also counteract undesired rotation of the delivery guide 20 during use. For example, the curved shape of the delivery guide 20 defines a plane that can cause a bias in the catheter 10 to orient itself when the delivery guide 20 is positioned between tissue structures (e.g., between the outer wall and the epicardium of the heart). However, in order to properly image the desired anatomical structures and deliver therapy to a target location (e.g., with a needle), it is desirable that the delivery guide 20 be oriented partially or substantially orthogonal to the surface of the heart. The bias in the curved shape can prevent stable positioning of the delivery guide 20 relative to the heart, but when the balloon 30 is inflated, the balloon 30 can counteract such a bias because the balloon 30 can create a substantially spherical or cylindrical shape for the distal end 14 that is substantially neutral in the axis of rotation.

[0059] The material may also be sufficiently transparent, i.e., to allow light from the imaging assembly 40 to pass therethrough and / or to be reflected from tissue or other structures back to the imaging assembly 40 across the distal surface 38 of the balloon 30, as described elsewhere herein. As used herein, "transparent" refers to any material and / or fluid that can allow sufficient light to pass therethrough so as to identify or otherwise visualize an object through the material and / or fluid. As used herein, "light" may refer to optical radiation within the visible spectrum, but may also include other spectrums, such as infrared ("IR") light or ultraviolet ("UV") light.

[0060] Return to Figure 3 And additional reference Figure 3A-3D , the imaging assembly 40 generally includes, for example, one or more cameras or other imaging elements 42 and one or more light sources 44 mounted on the distal surface 15 of the catheter 10. Figure 3 As best seen in FIG. 1 , the distal end 14 of the catheter 10 may terminate in an angled distal surface 15, i.e., the distal surface 15 is not perpendicular to the central axis 16 of the catheter, such that when guided along a path as in FIG. Figure 3A The distal surface 15 has a substantially circular shape when viewed from the central axis 16 shown in FIG. Figure 3B When viewed from directly above the distal surface 15 shown in FIG. 1 , the distal surface 15 has an elliptical shape.

[0061] Figure 4A and Figure 4BAn exemplary field of view that may be provided by imaging element 42 and an illumination field that may be provided by light source 44 are shown. As shown, imaging element 42 may have a field of view 43 that is angled relative to distal end 14 of catheter 10, i.e., such that a central axis 43a of field of view 43 defines an angle, such as an acute angle, relative to longitudinal axis 16 of catheter 10. For example, with delivery guide 20 in a relaxed, curved shape, field of view 43 may be centered on foot 28, which may facilitate imaging of tissue contacted by foot 28 (and distal surface 38 of balloon 30, not shown for clarity).

[0062] Similarly, the illumination field 45 of the light source 44 can also be angled relative to the distal end 14 of the catheter 10, for example, to enhance illumination of tissue structures that are offset from the distal end 14. The illumination field 45 of the light source 44 can be substantially parallel to the field of view 43, or can be offset relative to each other if desired. In addition, the illumination field 45 can have a wider angle than the field of view 43, which can facilitate illumination and / or imaging of tissue and / or other features across the balloon 30.

[0063] In an exemplary embodiment, the imaging element 42 may include a CMOS (complementary metal oxide semiconductor) or CCD (charge coupled device) sensor exposed within the interior 36 of the balloon 30 for capturing images of light passing through the balloon 30. Alternatively, the imaging element 42 may include a bundle of optical fibers, such as a coherent imaging bundle, extending between the proximal end 12 and the distal end 14 of the catheter 10 and terminating adjacent the distal surface 15.

[0064] Optionally, one or more lenses, filters, etc. (not shown) can be coupled to imaging element 42, for example, to focus light from beyond distal surface 38 of balloon 30 onto an active area of ​​imaging element 42, direct the field of view of imaging element 42, and / or filter light of undesirable wavelengths, as known to those skilled in the art. Optionally, imaging element 42 can be covered with a transparent protective coating, for example, to prevent the inflation medium within interior 36 from contacting imaging element 42.

[0065] The one or more light sources 44 may include one or more LEDs (light emitting diodes) and / or other light sources mounted on the distal surface 15 adjacent to the imaging element 42, for example, the one or more LEDs and / or other light sources sufficiently surrounding the imaging element 42 to deliver light into the interior 36 and / or through the distal surface 38 of the balloon 30. Alternatively, one or more optical fibers may be provided extending from the proximal end 12 of the catheter 10 to the distal surface 15, for example, to be transmitted from the controller 48 (at Figure 1The expansion medium within the interior 36 may provide a heat sink, for example, to dissipate any heat generated by the light source 44 and / or other chips or components mounted on the distal surface 15 during operation.

[0066] Figure 3C and Figure 3D An exemplary configuration of a light source 44 that may be provided on the distal surface 15 is shown. For example, the light source 44 may include a plurality of LEDs that emit visible white light and a plurality of LEDs that emit visible red light. Including light sources other than white light may increase the bandwidth of light received by the imaging element 42 (e.g., red light may make red tissue appear more natural in the image). Additionally or alternatively, the light source 44 may be doped to increase the bandwidth emitted. Optionally, other sources of non-visible light may be included, such as infrared or ultraviolet light, for example, emitting longer wavelengths that may allow penetration into tissue to identify blood vessels below the tissue contact surface (such as blood vessels within the myocardium of the heart). The arrangement of light sources of different colors may also adjust the depth of the field of view by placing different LEDs at different locations around the imaging element 42. For example, as in Figure 3D As shown in FIG. 1 , red LED 44b may be provided on distal surface 15 closer to foot 28 than white LED 44a to place the red LED closer to tissue when foot 28 is placed in contact with tissue.

[0067] As in Figure 1 As shown in FIG. 1 , the controller 48 may provide power to the imaging element 42 and / or the light source 44, and / or ... for example, via the catheter 10 (in FIG. Figure 1A 4 and 56). The controller 48 may include one or more processors, displays, memories, etc. (not shown) to process, display, and / or store images acquired from the imaging element 42. For example, the imaging element 42 may acquire digital images and may convert the onboard image data into analog signals, which may be transmitted to the controller 48 via the cables 49b, 56, which may convert the images back into digital images and / or further process the images for display. Additional information about imaging components and / or balloons that may be provided on the catheter 10 is disclosed in U.S. Pat. No. 6,979,290, the entire disclosure of which is expressly incorporated herein by reference.

[0068] Steering Figure 2 , shows an exemplary embodiment of a needle device 60 that can be loaded into a catheter 10, for example, such that a tip 65 of the needle 60 can be deployed from and retracted into a delivery guide 20 (not shown, see Figure 1 ), as described elsewhere herein. In general, the needle device 60 includes a main portion 62, a tip portion 64, and a lumen 66 therebetween, extending, for example, from a hub 68 on the main portion 62 to a tip 65. The tip 65 may include an angled, multi-faceted, or other sharp shape, as desired to facilitate penetration into tissue. The hub 68 may include one or more connectors and / or seals (not shown), for example, for coupling a source of one or more medicaments (also not shown) to the main portion 62, such that the medicament(s) may be delivered through the lumen 66 to the outside of the tip 65, for example, to be delivered into tissue into which the tip 65 is inserted.

[0069] Generally, the main portion 62 has a first outer diameter and length, and the tip portion 64 has a second outer diameter and length, for example, such that the main portion 62 can be received within the delivery lumen 69, 18c of the catheter 10, and the tip portion 64 can be received within the channel 26 of the delivery guide 20. In one embodiment, as in Figure 2 , the second outer diameter can be less than the first outer diameter, and the second length can be shorter than the first length. The first length can be sufficiently long so that the main portion 62 extends from the proximal end 12 of the catheter 10 into a distal section of the catheter 10 adjacent to the distal end 14, and the second length can be sufficient to extend the tip portion 64 into the passage 26 and place the tip 65 adjacent to the outlet 29. Thus, the transition section 63 can be provided between the main portion 62 and the tip portion 64, for example, in a distal section of the catheter 10 adjacent to the distal end 14.

[0070] Similarly, the delivery lumen 69, 18c of the catheter 10 may include a first region and a second region, wherein the first region defines a first inner diameter and extends from the proximal end 12 to a position within the distal end 14 of the catheter, and the second region defines a second inner diameter that is smaller than the first inner diameter and is connected to the channel 26 in the delivery guide 20, thereby providing a gradually decreasing transition section (not shown) between the first region and the second region.

[0071] The relative dimensions of the needle device 60 and the delivery lumen can be configured such that the main portion 64 can be slidably received in a first region of the delivery lumen 69, 18c, and the tip portion 64 can be slidably received in a second region of the delivery lumen 69, 18c and the channel 26. In the retracted position, for example, when the needle device 60 is initially loaded into the catheter 10, the transition segment 63 on the needle device 60 can be proximally offset a predetermined distance from the tapered transition segment within the delivery lumen 69, 18c. When the needle device 60 is actuated to deploy the tip 65, the tapered transition segment can provide a stop to limit advancement of the needle tip 65 in the advanced position, for example, allowing only a predetermined length of the tip 65 to be pushed out of the outlet 29 of the delivery guide 20. Additionally or alternatively, the actuator 54 on the catheter 10 (in Figure 1 ) can limit the length of the tip 65 that is pushed out from the outlet 29.

[0072] Such depth control may be particularly useful when injecting (one or more) medicaments into some tissue structures (e.g., into the epicardium, myocardium, etc.) without completely penetrating into a chamber of the heart. Providing a stopper near the distal end 14 of the catheter 10 may provide improved depth control over the actuator 54, particularly if the catheter 10 (or needle device 60) is capable of some axial compression or extension between the proximal end 12 and the distal end 14.

[0073] Another potential advantage of having a main portion 62 that is larger than the tip portion 64 is that the lumen 66 of the needle device 60 can have a relatively larger diameter along a majority of the length of the needle device 60. If a viscous fluid is being delivered using the needle device 60, the resistance to flow can be lower in the main region 66a than in the tip region 66b of the lumen, thereby reducing the overall force required to deliver the fluid compared to a lumen sized to a uniform diameter similar to the passageway 26.

[0074] The needle device 60 can be made of a material such that the needle shaft has a fixed length and sufficient column strength to prevent buckling, but can be sufficiently flexible when bent, for example, to facilitate navigation along a tortuous path when the catheter 10 is positioned along a tortuous anatomical structure, without causing excessive friction and / or affecting the flexibility and torquability of the catheter 10 for optimal navigability. In an exemplary embodiment, the tip portion 64 can have a relatively thin wall, for example, no greater than 27 gauge, or no greater than 32 gauge, to reduce the stiffness of the tip portion 64, particularly within the channel 26 of the curved delivery guide 20. The main portion 62 can be made of a sufficiently flexible material or alternatively a semi-rigid or rigid material, such as a braid-reinforced polymeric shaft, a single-material polymer like polyimide, nitinol, stainless steel, etc., which can be selectively treated to reduce its stiffness in selected areas while maintaining general resistance to compression and extension. For example, the major portion may be formed by laser cutting a generally rigid tube with an optimized release cut to impart the desired flexibility (while maintaining the fluid-tight lumen 66).

[0075] Return to Figure 2 Optionally, the needle device 60 may include, for example, a blocker wire 80 that is slidably received in the lumen 66. The blocker wire 80 may be of sufficient length so that when fully advanced into the lumen 66, its tip 84 extends a short distance beyond the needle tip 65, as shown. In this way, the blocker wire 80 may provide a sufficiently atraumatic guide to facilitate advancement of the needle device 60 into the catheter 10, e.g., minimizing the risk of the needle tip 65 snagging the walls of the delivery lumen 69, 18c, and / or passage 26, which would otherwise remove material from the walls and / or blunt the needle tip 65 or otherwise damage the needle tip 65. Once the needle device 60 is fully inserted into the catheter 10, the blocker wire 80 may be removed at any time prior to delivery of the medicament(s) via the lumen 66. In alternative embodiments, the needle device 60 may be provided as a user pre-loaded device or the needle device 60 and / or may be provided integrally within the catheter 10, in which case the swage wire 80 may be omitted if desired.

[0076] Steering Figure 7, an exemplary method for performing a medical procedure within the pericardial space 94 (i.e., between the patient's heart 90 and the pericardial sac 92) is shown. Initially, the distal end 14 of the catheter 10 can be introduced into the patient's body, for example, through the pericardial sac 92 into the pericardial space 94 with the balloon 30 deflated. For example, the distal end 7 of the introducer sheath 6 can be introduced into the patient's chest cavity, for example, by utilizing a minimally invasive or open surgical access, and then the distal end 14 of the catheter 10 can be inserted through the sheath 6. The sheath 6 can at least partially straighten the delivery guide 20, and / or otherwise facilitate advancement of the distal end 14 into the pericardial space 94.

[0077] Once distal end 14 is exposed within pericardial space 94, balloon 30 can be inflated and catheter 10 can be manipulated to position foot 28 and balloon 30 against the wall of heart 90. For example, catheter 10 can be rotated to orient foot 28 toward heart 90, e.g., with balloon 30 counteracting any bias created by the curved shape of delivery guide 20, as described elsewhere herein.

[0078] Imaging assembly 40 may be used to acquire images of pericardial space 94 and heart 90, for example, as in Figure 8 . In addition, if desired, external imaging can be used in conjunction with capturing images using imaging assembly 40. Catheter 10 can be further manipulated as needed, for example, to move distal end 14 along the wall of heart 90 until a target location is identified for treatment. For example, as shown, target location 96 can be identified in the image so that an injection can be performed while avoiding undesirable anatomical structures (such as arteries or veins 97). Once foot 28 is positioned at target location 96 (based on verification of the image), needle device 60 can be activated to deploy needle tip 65 from outlet 29 and pierce into target location 97, as in Figure 7 As shown in .

[0079] In one approach, the needle device 60 can be loaded into the catheter 10 directly prior to activating the needle device 60 (i.e., after positioning the foot 28 and the outlet 29 at the target location 96). Alternatively, the needle device 60 can be loaded into the catheter 10 before the catheter 10 is inserted into the sheath 6 and maintained in a retracted position during manipulation of the catheter 10. In either case, once the needle device 60 is fully received within the catheter 10, the tip 65 can be disposed within the delivery guide 20 adjacent to the outlet 29. Optionally, if the foot 28 and / or the delivery guide 20 include a window that can be seen in an image of the imaging assembly 40, the position of the tip 65 can be verified, or the position of the tip 65 can be verified directly outside the patient's body (if the needle device 60 is loaded prior to introduction). After the tip 65 is deployed and pierced into the tissue at the target location 97, one or more medicaments can then be delivered into the tissue through the needle device 60.

[0080] As described elsewhere herein, the depth of penetration of the needle tip 65 may be controlled by a mating stop in the distal section of the catheter 10 and / or by an actuator on the handle 50. For example, it may be desirable to inject one or more medicaments into the myocardium of the heart 90 while avoiding exposure of the medicament(s) to the underlying chamber 98 of the heart 90. Thus, a needle device 60 having a predetermined length may be selected to ensure that the tip 65 extends a predetermined distance from the outlet 29 of the foot 28.

[0081] After the desired amount of (one or more) medicaments is delivered, the needle tip 65 can then be retracted into the delivery guide 20. Optionally, the catheter 10 can be further manipulated, for example, to inject additional (one or more) medicaments into the epicardium / myocardium in a similar manner at one or more additional locations. If desired, the needle device 60 can be removed from the catheter 10 and replaced with a different needle device, for example, having a different length, tip diameter and / or other desired characteristics. Once the desired injection is completed, the balloon 30 can be deflated and the catheter 10 is removed from the patient's body (together with the sheath 6 and / or any other device).

[0082] Although particularly useful for performing injections through pericardial space 94, catheter 10 may be used to perform other procedures. For example, in place of needle device 60, other devices may be introduced into catheter 10 to deliver other treatments through channel 26 of delivery guide 20. For example, a laser device, an ablation device, and / or other device (not shown) may be positioned so that the device may be deployed from outlet 29 and / or otherwise placed against tissue adjacent outlet 29 so that energy or other treatment may be delivered.

[0083] Steering Fig.9A and Fig. 9B , shows another embodiment of a needle device 160 that includes an elongated shaft terminating in a tip portion 164 that includes an imaging assembly 140 thereon that can be similar to any of the embodiments described elsewhere herein. As shown, the tip portion 164 terminates in an angled tip 165 that defines an outlet 166. A relatively small recurrent lumen 170 can extend from the outlet 166 to a port 172 that is proximally offset from the outlet 166 within the field of view of the imaging assembly 140, for example.

[0084] Alternatively, the return vessel lumen 170 may be replaced with a groove or other feature that may cause blood to travel upward from the outlet 166 to the port 172, for example due to capillary action and / or blood pressure encountered at the outlet 166. In a further alternative, the port 172 may be replaced with a window (not shown) that may close the return vessel lumen 170 but allow blood passing through the window to be identified in an image from the imaging assembly 140. In yet another alternative, a wicking material may be provided in place of the lumen 170 to draw blood along the tip 165 to the window to provide a visual indication when the tip 165 is positioned in a vessel.

[0085] For example, during use, the tip portion 164 of the needle device 160 can be positioned adjacent to a tissue structure 190 (e.g., a wall of the heart) into which an injection is to be made, such as in Fig.9A In an exemplary embodiment, the needle device 160 can be loaded into a similar Figure 1 1 and described elsewhere herein, in a catheter, or other delivery sheath (not shown). Once positioned at the target location, the needle device 160 can be advanced to insert the tip 165 into the tissue at the target location, such as in Fig. 9B If the tip 165 enters the blood vessel 192, blood can travel along the blood vessel lumen 170 and exit the port 172. The imaging assembly 40 can be used to capture images during insertion and identify whether such blood flashback occurs, thereby confirming whether the user has inserted the tip 165 into the blood vessel 192.

[0086] For example, it may be desirable to perform a subcutaneous injection and avoid any blood vessels that may transport the injected medicament away from the target location. Alternatively, it may be desirable to deliver the medicament into the target blood vessel. Either way, once the image is used to confirm the desired location of the tip 165, one or more medicaments may be delivered via the outlet 166.

[0087] Steering Fig.10, another embodiment of an imaging catheter including a large central lumen for delivering one or more additional devices (not shown) is shown. The catheter includes a balloon positioned adjacent to the distal end, for example, for creating a space within a body cavity or possible space. The wall of the catheter includes an imaging element and one or more lighting elements. The imaging element may include a coherent fiber bundle with a distal objective lens, or may be manufactured as described elsewhere in this article. The lighting element may include one or more fiber optic elements or LEDs, as described elsewhere in this article.

[0088] Fig.11 A similar catheter including a large central lumen and a balloon is shown, wherein the imaging element may be carried on a member extending away from the central axis of the catheter, for example, to create a distance and thereby a field of view for imaging a device (not shown) introduced through the central lumen. The illumination element is not shown, but may be provided as in Fig.10 are included as illustrated in or elsewhere in this document.

[0089] The above disclosure of exemplary embodiments has been presented for the purpose of illustration and description. This is not intended to be exhaustive, nor is it intended to limit the invention to the precise form disclosed. Based on the above disclosure, many changes and modifications of the embodiments described herein will be apparent to those skilled in the art.

[0090] In addition, when describing representative embodiments, the specification has presented methods and / or processes in a particular order of steps. However, in this sense, these methods or processes should not rely on the specific order of steps described, but to the extent that the methods or processes do not rely on the specific order of steps set forth herein. Those skilled in the art will appreciate that other orders of steps are possible. Therefore, the specific order of steps set forth in the specification should not be construed as limiting the claims.

[0091] Although the present invention is susceptible to various modifications and alternative forms, specific examples of the present invention have been shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to the specific form or method disclosed, on the contrary, the present invention will cover all modifications, equivalents and alternative forms falling within the scope of the appended claims.

Claims

1. An apparatus for imaging tissue during a medical procedure, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a body of a patient, a longitudinal axis extending between the proximal and distal ends of the tubular member, and one or more lumens extending between the proximal and distal ends; a tubular extension extending distally beyond the distal end to a distal tip, the tubular extension having a proximal end permanently attached to the distal end, the tubular extension having a smaller cross-section than the distal end and being biased into a curved shape, the tubular extension being formed of a resilient material to allow the tubular extension to straighten but resiliently return to the curved shape, the tubular extension including a passageway communicating from the first lumen of the tubular member to an outlet at the distal tip; a foot on said distal tip comprising a substantially atraumatic contact surface for contacting tissue having an area greater than said cross-section of said tubular extension; as well as An imaging assembly including an imaging element mounted on the distal end, the imaging assembly being configured to acquire images of tissue adjacent to the foot, the imaging element having a field of view offset from the longitudinal axis such that the field of view is focused on the foot when the tubular extension is in the curved shape.

2. The apparatus of claim 1 , wherein the tubular member includes a central longitudinal axis extending between the proximal end and the distal end, and wherein the tubular extension is biased into the curved shape, wherein the foot deviates from the longitudinal axis and is flexibly movable into a substantially straightened shape to facilitate introduction into the patient's body.

3. The device of claim 2, wherein the distal end terminates at a distal surface defining a non-perpendicular angle relative to the longitudinal axis, and the imaging element is mounted on the distal surface such that the field of view of the imaging element is offset from the longitudinal axis.

4. The device according to claim 1 further comprises a substantially transparent expandable member, the expandable member comprising a proximal end and a distal end, the proximal end of the expandable member being attached to the distal end of the tubular member, the distal end of the expandable member being attached to one of the distal tip and the foot, such that the imaging component is disposed within the interior of the expandable member.

5. The apparatus of claim 4, wherein the expandable member is capable of expanding from a contracted condition to an expanded condition when a fluid is introduced into the interior of the expandable member through an inflation lumen of the tubular member.

6. The apparatus of claim 1, further comprising: a needle device disposed within said passageway of said tubular extension; and An actuator on the proximal end of the tubular member for directing the needle device from a retracted position in which the tip of the needle device is disposed within the passageway and an advanced position in which the tip is deployed from the outlet.

7. An apparatus according to claim 6, wherein the needle device comprises a tubular body and a tip portion, wherein the tubular body extends from the proximal end of the tubular member through the first tubular cavity in the tubular member and extends into the distal end of the tubular member, and the tip portion extends from the tubular body into the channel and terminates in the tip.

8. The apparatus of claim 7, wherein the needle device is completely removable from the tubular member from the proximal end of the tubular member.

9. The apparatus of claim 7, wherein: the first lumen having a first region defining a first inner diameter and extending from the proximal end of the tubular member to a position within the distal end of the tubular member, and a second region defining a second inner diameter that is smaller than the first inner diameter and communicating with the passageway in the tubular extension; as well as The tubular body has a first portion and a second portion, the first portion extending from the proximal end of the tubular member into the distal end of the tubular member and sized to be slidably received in the first region of the first lumen, and the second portion sized to be slidably received in the second region of the first lumen and in the passageway, Wherein a transition from the first region to the second region provides a stopper, the stopper engaging a transition from the first portion to the second portion to limit advancement of the tip of the needle device in the advanced position.

10. An apparatus for imaging tissue during a medical procedure, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, a longitudinal axis extending between the proximal and distal ends of the tubular member, and one or more lumens extending between the proximal and distal ends; a tubular extension extending distally beyond the distal end to a distal tip, the tubular extension having a proximal end permanently attached to the distal end, the tubular extension having a smaller cross-section than the distal end and being biased into a curved shape, the tubular extension being formed of a resilient material to allow the tubular extension to straighten but resiliently return to its curved shape, the tubular extension including a passageway communicating from the first lumen of the tubular member to an outlet at the distal tip; a foot on said distal tip comprising a substantially atraumatic contact surface for contacting tissue having an area greater than said cross-section of said tubular extension; a substantially transparent expandable member, the expandable member comprising a proximal end and a distal end, the proximal end of the expandable member being attached to the distal end of the tubular member, the distal end of the expandable member being attached to one of the distal tip and the foot; as well as An imaging assembly comprising an imaging element mounted on the distal end of the tubular member, the imaging assembly being within the interior of the expandable member and configured to acquire images of tissue adjacent to the foot, the field of view of the imaging element being offset from the longitudinal axis such that the field of view is focused on the foot when the tubular extension is in the bent shape.

11. A system for injecting one or more medicaments into tissue within a patient's body, comprising: a. A device according to any one of claims 1-5; and b. A needle device disposed within the passageway of the tubular extension and movable from a retracted position in which the needle tip of the needle device is disposed within the passageway and an advanced position in which the needle tip is deployed from the outlet.

12. A system for injecting one or more medicaments into tissue within a patient's body, comprising: a. The device according to claim 10; and b. A needle device disposed within the passageway of the tubular extension and movable from a retracted position in which the needle tip of the needle device is disposed within the passageway and an advanced position in which the needle tip is deployed from the outlet.

13. The system of claim 11, wherein the tubular extension is biased into the curved shape and flexibly moves into a substantially straightened shape to facilitate introduction into a patient's body.

14. The system of claim 13, wherein the field of view of the imaging element is offset from the longitudinal axis such that the field of view is substantially centered on the distal tip of the tubular extension in the curved shape.

15. The system of claim 13, wherein the distal end terminates at a distal surface that defines a non-perpendicular angle relative to the longitudinal axis, and wherein the imaging element is mounted on the distal surface such that a field of view of the imaging element is offset from the longitudinal axis.

16. The system of claim 11 or 12, further comprising a substantially transparent expandable member, the expandable member comprising a proximal end and a distal end, the proximal end of the expandable member being attached to the distal end of the tubular member, the distal end of the expandable member being attached to the distal tip, such that the imaging assembly is disposed within the interior of the expandable member.

17. The system of claim 11 or 12, wherein the needle device comprises a tubular body extending from the proximal end of the tubular member, through the first lumen in the tubular member, and into the distal end of the tubular member.

18. The system of claim 17, wherein the needle device is completely removable from the tubular member from the proximal end of the tubular member.

19. The system of claim 17, wherein: the first lumen having a first region defining a first inner diameter and extending from the proximal end of the tubular member to a position within the distal end of the tubular member, and a second region defining a second inner diameter that is smaller than the first inner diameter and communicating with the passageway in the tubular extension; as well as The tubular body has a first portion and a second portion, the first portion extending from the proximal end of the tubular member into the distal end of the tubular member and sized to be slidably received in the first region of the first lumen, and the second portion sized to be slidably received in the second region of the first lumen and in the passageway, Wherein a transition from the first region to the second region provides a stopper, the stopper engaging a transition from the first portion to the second portion to limit advancement of the needle tip in the advanced position.

Images