Isolation and attachment catheter and method of use thereof

Abstract

The present invention provides a system and method for navigating within the heart and attaching to the heart wall to perform injection of one or more agents into tissue. The system includes an outer catheter, an intermediate catheter slidably disposed within the lumen of the outer catheter, and a needle catheter slidably disposed within the lumen of the intermediate catheter. The intermediate catheter includes a vacuum hood attached to the distal end of the intermediate catheter so that the radiopaque distal tip of the intermediate catheter extends into the vacuum hood. The vacuum hood includes at least two radiopaque features, and the spatial relationship of the radiopaque features is visually changed under fluoroscopy when the vacuum hood is under a sealed vacuum.

Description

Technical Field

[0001] The present invention generally relates to devices, systems and methods for performing medical procedures, and more particularly, to catheters adapted to attach to and / or isolate a portion of a heart wall during a procedure (e.g., during injection of one or more agents into the myocardium). Background Art

[0002] Minimally invasive devices are often used to perform procedures in body cavities and chambers (including the heart). Such procedures include injecting cells, reagents, filler materials, and / or other substances into the myocardium by minimally invasive (e.g., catheter-based) methods. During such procedures, it is important to identify the correct anatomical location for each injection, navigate to the location, and maintain the selected location when the needle or other injection device is introduced into the tissue, perform the injection, and then remove the injection device. For example, heart movement can make accurate needle positioning difficult. In addition, accidental or excessive movement of the exposed needle can cause trauma, such as lacerations or perforations. In addition, unintentional or premature movement of the needle outward from the tissue can result in the risk of loss of injected material and / or embolic complications.

[0003] Therefore, devices and methods to enhance the stability of a catheter or other device and / or isolate the treatment site during such procedures would be beneficial. Summary of the invention

[0004] The present invention relates to devices, systems and methods for performing minimally invasive medical procedures, such as within the heart of a patient. More specifically, the present invention relates to catheters that include attachment, stabilization and / or isolation elements that employ a vacuum source and that can be used during the injection of agents, cells and / or other materials into tissue, including myocardium or other tissue of the heart.

[0005] The catheter used to perform the injection may include attachment, stabilization and / or isolation elements, for example, using suction / vacuum to attach to the heart wall. For example, an expandable tip, cover, cup or other element may be provided at the distal end of the catheter to achieve attachment or increased stability relative to the heart wall during the procedure. In the case of injections into the heart wall, many unique challenges and risks arise, which may be addressed by one or more of the devices, systems and methods described herein.

[0006] In one embodiment, the catheter may include a vacuum shield including one or more radiopaque features suitable for clearly identifying the heart wall, illustrating needle penetration into tissue, and / or demonstrating secure attachment of the vacuum shield to tissue. In another embodiment, the catheter may include a vacuum shield suitable for enabling needle penetration into tissue while preventing perforation of the heart wall. In yet another embodiment, the catheter may include a vacuum shield suitable for generally reducing trauma to the vasculature, heart chambers, valves, and / or other tissue structures.

[0007] According to another embodiment, a telescoping catheter system adapted to enable clear identification of attachment to a heart wall may be provided.

[0008] In another embodiment, the catheter may include a vacuum shield adapted to enable the beveled needle to be introduced and secured into the heart wall.

[0009] In another embodiment, the catheter may include a vacuum hood adapted to capture stray material before, during, or after injection into tissue.

[0010] In yet another embodiment, a catheter system may be provided that includes a vacuum hood adapted to minimize the potential for clotting and embolism of aspirated blood, a vacuum lumen, and a vacuum source.

[0011] Other aspects and features of the present invention will become apparent from the following description considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings illustrate exemplary embodiments of the present invention, in which:

[0013] Figure 1 is a side view of an exemplary embodiment of a catheter system comprising an outer catheter that is all slidable relative to each other, an intermediate catheter having a distally attached vacuum hood, and an inner injection catheter, the system also comprising a vacuum source and a source of one or more agents in communication with the inner cavity of the intermediate catheter.

[0014] Figure 2 is a cross-sectional side view of an exemplary embodiment of a vacuum shield having a radiopaque feature that may be provided between the shield and an associated catheter such as Figure 1 on the intermediate conduit).

[0015] Figure 3A and Figure 3B are fluoroscopic images showing Figure 2 Appearance of the radiopaque feature of the vacuum hood before and after attaching the vacuum hood to the tissue wall.

[0016] Figure 4A and Figure 4B A side view of another embodiment of a vacuum hood including a fluoroscopic feature is shown, showing the vacuum hood before and after attachment to a tissue wall, respectively.

[0017] Figure 5 is a cross-sectional view of the heart showing the catheter system having an outer catheter, an intermediate catheter, a vacuum hood, and an injection catheter being manipulated within a chamber of the heart.

[0018] Figures 6A-6CThe use of a vacuum hood to allow safe tilting of the needle into the tissue wall (e.g., using Figure 1 and Figure 5 system shown).

[0019] Figure 7 is a side view of another exemplary embodiment of an intermediate conduit including a vacuum hood and a peripheral lumen for infusion / circulation of fluid within an interior chamber of the vacuum hood.

[0020] Fig. 7A It is taken along plane 7A-7A Figure 7 Cross-sectional view of the intermediate duct. DETAILED DESCRIPTION

[0021] Go to the attached picture, Figure 1 An exemplary embodiment of a catheter delivery system 8 is shown, which includes a first or outer catheter or sheath 10, a second or intermediate catheter 20 carrying a vacuum cover 30, and a third or injection catheter or needle device 40, which can be used to perform a procedure within a patient's body, for example, to perform one or more injections into a tissue, such as within the myocardium of a patient's heart (not shown). In addition to the catheters 10, 20, 30, the system 8 may include one or more additional components, for example, a vacuum source 52 (such as a syringe or vacuum pump) and a source 54 of one or more reagents (e.g., including one or more therapeutic and / or diagnostic materials, such as cells, filler materials, gels, etc.). Optionally, the system 8 may include one or more additional devices, for example, a fluid source, and / or one or more guidewires, sheaths, etc. (not shown) for facilitating the introduction of the catheter into the patient's body.

[0022] The outer catheter 10 generally includes a proximal end 12 including a hub or handle 13, a distal end 14 sized for introduction into a patient's body and terminating in a distal tip 15, and one or more lumens (e.g., lumen 16) extending between the proximal end 12 and the distal end 14, thereby defining a longitudinal axis 18 of the catheter 10 and the system 8. Optionally, the distal portion 10 of the outer catheter can be pre-formed, deflectable, and / or otherwise orientable to manipulate the distal end 14, e.g., to facilitate navigation within the patient's vasculature and / or chambers of the heart. For example, the outer catheter 10 can include one or more pull wires or other steering elements (not shown) coupled between the distal tip 15 and an actuator 13a on the handle 13, e.g., for switching between a substantially straight shape and one or more curved shapes (e.g., Figure 5 The distal end 14 is guided between the shapes shown).

[0023] The outer catheter 10 can be constructed using known materials and methods, for example, including a liner surrounding the inner cavity 16, an intermediate reinforcement layer (e.g., a braid, a coil, etc.), and one or more outer sheaths (all not shown for simplicity). In an exemplary embodiment, the liner may include one or more coatings (e.g., a hydrophobic, hydrophilic, or other lubricious coating), and / or may be formed of a lubricious material to facilitate the introduction and / or movement of the intermediate catheter 20 or other instrument within the inner cavity 16. Optionally, the outer catheter 10 may include one or more radiopaque markers (e.g., rings, bands, etc.) at desired locations along its length, such as at and / or adjacent to the distal tip 15, spaced apart from each other (not shown).

[0024] In addition, the external catheter 10 may include one or more additional components on the handle 13, for example, a port 13b that communicates with the lumen 16 and includes one or more valves (e.g., a hemostatic valve (not shown)) to provide a fluid-tight seal but also accommodate insertion of the intermediate catheter 20 and / or other devices into the lumen 16. Optionally, the handle 13 may also include a side port that includes a Luer connector or other fitting (not shown) for coupling a fluid source to the handle 13 and delivering the fluid to the lumen 16 (or additional lumen, not shown) of the catheter 10. Exemplary embodiments of catheters that may be used as the external catheter 10 are disclosed in U.S. Publication No. 2016 / 0082226.

[0025] Continue to refer Figure 1, similar to the outer catheter 10, the intermediate catheter 20 generally includes a proximal end 22, a distal end 24, and one or more lumens (e.g., lumen 26) extending between the proximal end 22 and the distal end 24. In addition, the intermediate catheter 20 includes an expandable vacuum hood 30 carried on the distal end 24 adjacent its distal tip 25, as further described elsewhere herein. The intermediate catheter 20 can be sized to be at least partially received within the outer catheter 10, for example, having a diameter between about six and ten French (2.0-3.3 mm) or between about six and eight French (2.0-2.7 mm), so that the distal end 24 can be inserted into the lumen 16 of the outer catheter 10 through the port 13b in the handle 13 at any time during use, for example, to deploy the vacuum hood 30, as further described elsewhere herein. Alternatively, the intermediate catheter 20 may be preloaded within the outer catheter 10 and / or may not be removed from the outer catheter, for example, with the distal end 24 and the vacuum hood 30 initially positioned within the lumen 16 (e.g., proximal to the distal end 14 of the outer catheter 10). In another alternative, the hood 30 may initially be configured to extend from the distal end 14 of the outer catheter 10, for example, abutting against the distal tip 15, which may provide an atraumatic buffer during advancement of the outer catheter 10 (e.g., through a valve or other tissue structure (not shown)). In either case, the intermediate catheter 20 is configured to slide axially and / or rotationally relative to the outer catheter 10, for example, to provide additional degrees of freedom when navigating within the vascular system or heart, and / or to deploy and withdraw the vacuum hood 30 from the outer catheter distal end 14 when needed, as also described elsewhere herein.

[0026] The intermediate catheter 20 can be constructed using materials and methods similar to those of the outer catheter 10, for example, including a lubricating lining and / or coating, an intermediate reinforcement layer, and one or more outer sheaths (not shown). In addition, the intermediate catheter 20 can include a relatively flexible distal section, for example, offset a predetermined distance proximal to the distal tip 25 and the vacuum cover 30 to facilitate tracking and / or atraumatic navigation. For example, the flexible section can be sufficiently flexible to stabilize the intermediate catheter 20, inhibit movement, and / or prevent cover separation, for example, when the cover 30 is attached to a moving structure (such as a wall of a beating heart (not shown)), as described elsewhere herein.

[0027] The intermediate catheter 20 also includes a handle or hub 28 on the proximal end 24, which includes one or more ports, for example, a port 29a including one or more valves (e.g., a hemostatic valve (not shown)) to provide a fluid-tight seal but also accommodate the insertion of an injection catheter 40 into the lumen 26. In addition, the handle 28 may also include a first side port 29b in communication with the lumen 26 of the intermediate catheter 20, which may include a Luer fitting or other connector (not shown) for coupling a vacuum source 52 to the side port 29b. Optionally, the handle 28 may include one or more additional side ports (not shown), for example, a second side port in communication with a secondary lumen within the intermediate catheter 20, to which a fluid source (e.g., a syringe (also not shown)) may be coupled for delivering heparin, heparinized saline, and / or other anticoagulants or diluents to the secondary lumen, as described elsewhere herein. Alternatively or in addition, the intermediate catheter proximal end 24 may be equipped with a valve or a hub including a valve, for example, to seal against the body of a needle (e.g., the body of an injection catheter 40) that passes through the lumen 26 of the intermediate catheter 20 (not shown). A hole or channel (also not shown) may be provided in the side wall of the intermediate catheter 20, for example, in communication with a lumen (e.g., the primary lumen 26 of the intermediate catheter 20) (e.g., fluid may be infused or aspirated therethrough), for example, to transmit negative pressure or vacuum to the vacuum hood 30.

[0028] Additional references Figure 2 , a vacuum cover 30 is disposed on the distal end 24 of the intermediate catheter 20, which includes an expandable element (e.g., a cover, a cup, a suction cup, etc.) that can be expanded between a collapsed configuration and an expanded configuration, for example, having a diameter or other cross-sectional dimension that is larger than the outer diameter of the intermediate catheter 20 in the expanded configuration. Figure 2 In the illustrated embodiment, the vacuum hood 30 includes a first or proximal end 32 that can be attached to the intermediate conduit 20 and a distal end or face 34 that is sized and / or shaped to be placed against a tissue surface (not shown), as described elsewhere herein. The vacuum hood 30 at least partially encloses an interior region or chamber 36 that communicates with the primary lumen 26 of the intermediate conduit 20 and the distal face 34, for example, so that a vacuum can be generated from a vacuum source 52 coupled to the side port 29b via the primary lumen 26 within the chamber 36 and thus at the distal face 34. For example, the vacuum hood 30 can have a generally conical or frustoconical shape, a hemispherical or other bulbous shape, for example, with a size that increases from the proximal end 32 to the distal face 34, for example, generally symmetrical about the longitudinal axis 18.

[0029] In the collapsed configuration, the vacuum cover 30 may be rolled, folded, or otherwise compressed to a size sufficient to pass through the primary lumen 26, but may also be elastically biased to assume an expanded configuration when deployed from the lumen 26. Optionally, the cover 30 may include one or more supports or features (not shown) formed into or attached to the cover material to bias the cover toward the expanded configuration and / or bias the distal side 34 to open to a desired size and / or shape. For example, the folded portion or other features and / or markings may also provide support to the cover 30, for example to prevent the cover 30 from collapsing radially inward.

[0030] The vacuum hood 30 can be constructed of a generally flexible or compliant material (such as silicone, urethane, or polyether block amide) so that the vacuum hood 30 can pass through and / or contact tissue structures (e.g., within the vasculature and / or heart of a patient) without causing trauma, but has sufficient rigidity so that the vacuum hood 30 does not completely collapse when a vacuum is applied. Specifically, the vacuum hood 30 can be configured with features that enable at least the distal surface 34 to maintain a generally open shape with a relatively consistent cross-sectional area, for example, as further described elsewhere herein. It should be understood that the force by which the vacuum hood 20 can be attached to tissue (e.g., to the heart wall) can be a function of the vacuum applied and the cross-sectional area of ​​the distal surface 34 that engages the tissue. Therefore, the attachment force can be modulated by adjusting these two parameters.

[0031] Figure 2 A side view of an exemplary embodiment of a vacuum hood 30 attached to the distal end 24 of the intermediate catheter 20 is shown. In the illustrated embodiment, the proximal end 32 of the vacuum hood 30 can be attached to the distal end 24 proximal to the distal tip 25 of the intermediate catheter 20, i.e., such that the intermediate catheter distal tip 25 extends a predetermined distance into the chamber 36 of the vacuum hood 30. The vacuum hood 30 can be substantially permanently attached to the intermediate catheter distal end 24, for example, by one or more of bonding with an adhesive, interference fit, sonic welding, fusion, etc.

[0032] Optionally, the vacuum shield 30 may include one or more annular gussets, folds, thin areas, thick areas, or other features 38 that support the shield 30 but also allow axial movement of the distal face 34 toward and / or away from the proximal end 32, for example, to enable the shield 30 to shorten when a vacuum is present within the chamber 36 of the shield 30, such as when attached to the wall of a heart or other tissue structure, as further described elsewhere herein. For example, the feature 38 may simply be a thinning portion, a more compliant material, a pleat, a fold, a bellows, or other mechanical feature in the wall of the shield 30, for example, extending circumferentially around one or more locations along the length of the shield 30.

[0033] For example, in Figure 2In the illustrated embodiment, the cover 30 may include an annular outward fold 38a and an annular inward fold 38b, thereby defining a bellows that allows the cover 30 to expand and contract axially, which may facilitate placement against tissue structures (e.g., a heart wall that is not oriented perpendicular to the longitudinal axis 18), as further described elsewhere herein. For example, the fold 38 may compress or extend symmetrically, or may accommodate one side of the cover 30 to extend while the opposite side is compressed. Alternatively, if desired, multiple annular outward and / or inward folds may be provided, for example, to increase the axial compression and / or extension distance that the distal surface 34 may deflect relative to the intermediate catheter distal end 24.

[0034] Additionally or alternatively, the cover 30 may include a flexible proximal region (not shown), e.g., spaced a predetermined distance from the proximal end 32, which may allow the distal surface 34 of the cover 30 to pivot or gimbal relative to the longitudinal axis 18 and the proximal end 32. Such annular folds 38, features, and / or flexible regions may be molded or otherwise formed directly into the cover material, or may be constructed by forming the cover 30 from multiple segments (e.g., annular segments) formed from different materials attached together.

[0035] The intermediate catheter distal tip 25 may include one or more outlet ports in communication with the primary lumen 26 of the intermediate catheter 20. For example, Figure 2 As shown, the distal tip 25 includes an axial outlet 45a through which the needle tip 45 can extend during injection. Optionally, the distal tip 25 can include one or more side ports (not shown) proximal to the outlet 45a, for example, to facilitate application of a vacuum to the chamber 36 when the needle tip 45 is positioned through the outlet 45a.

[0036] In addition, the intermediate catheter 20 and / or the vacuum hood 30 may include one or more radiopaque markers to facilitate placement and / or positioning of the distal end 24 and / or the vacuum hood 30 using fluoroscopy or other imaging methods during a procedure (e.g., during introduction into and / or manipulation within a body lumen, placement of the hood distal side 34 against a tissue structure, and / or deployment of the injection catheter 40). For example, Figure 2As shown, the entire intermediate catheter distal tip 25 may be made of a radiopaque material, or may include one or more radiopaque rings, bands, or other discrete markers. Various methods may be used to make the distal tip 25 radiopaque, including doping the outer sheath material of the distal end 24 within the chamber 36 with barium, bismuth, tungsten, or other radiopaque materials known in the art. Alternatively, a separate annular tip may be formed of a radiopaque material and attached to the intermediate catheter distal end 24. In another alternative, a radiopaque band or element made of platinum, platinum / iridium, gold, tungsten, or other radiopaque metal may be provided on the distal tip 25, which may simply be an extension of the distal end 24, as also known. Optionally, if desired, one or more radiopaque markers may be provided on the distal end 24 of the intermediate catheter body 20 proximal to the distal tip 25, for example using a similar method.

[0037] The extension of the intermediate catheter distal tip 25 into the chamber 36 of the vacuum hood 30 can provide structural support to prevent the hood 30 from collapsing under vacuum, and / or can provide a fluoroscopically visible marker in a known relationship to the position of the vacuum hood 30 for navigation. For example, when a vacuum is applied to the vacuum hood 30, the proximal section adjacent the proximal end 32 may have a tendency to collapse; in fact, the hood 30 can be specifically designed to cause the proximal section to collapse, for example, so that the entire hood 30 is more easily wrapped, pulled into the intermediate catheter lumen 26 and / or otherwise constrained, such as for introduction into the body. If the proximal section were to collapse completely under vacuum, fluid communication with the distal side 34 of the hood 30 could be interrupted and no attachment to tissue would be achieved. Extending the distal tip 25 of the intermediate catheter 20 at least partially through the chamber 36 of the hood 30 can ensure that the distal side 34 of the hood 30 remains in fluid communication with the vacuum source 52 when a vacuum is applied via the lumen 26. Additionally or alternatively, extension of intermediate catheter distal tip 25 into chamber 36 of vacuum hood 30 may prevent vacuum hood 30 from crossing the path of needle tip 45 and being penetrated by needle tip 45, for example, when vacuum hood 30 is pressed against or encounters an anatomical structure (e.g., a heart wall).

[0038] Additionally or alternatively, the vacuum cover 30 may include one or more radiopaque markers 39 that may be used independently or in conjunction with one or more radiopaque markers on the intermediate catheter 20, such as the distal tip 25. For example, Figure 2As shown, the vacuum cover 30 may include two annular radiopaque rings or markers 39a, 39b axially spaced from each other. The annular markers 39 may extend continuously around the circumference of the cover 30 or may extend discontinuously around the circumference, for example, defined by a plurality of lines, points, etc. spaced from each other but defining a circumferential line. As shown, the first annular marker 39a may be located at or near the distal side 34, and the second annular marker 39b may be spaced a predetermined distance proximally from the first marker 39a (e.g., adjacent to the outward fold 38a). The markers 39 may be produced similarly to the materials and methods described elsewhere herein, for example, by doping and / or embedding or applying various radiopaque materials to the cover material. In addition or alternatively, the entire cover 30 may be made at least partially radiopaque. In an exemplary embodiment, the vacuum cover 30 may be formed of silicone doped with about 20% barium sulfate, and the markers 39 may be formed of silicone doped with tungsten and applied to the cover 30, for example, to distinguish between the base material and the markers 39 under fluoroscopic imaging.

[0039] The markings 39 may facilitate positioning the vacuum cover 30 and / or confirming when the distal surface 34 is positioned and / or attached to a tissue structure (eg, attached to a heart wall). Figure 3A and Figure 3B Shows Figure 2 0 is an exemplary fluoroscopic view of the vacuum cover 30 showing the relative position of the marker 39 before and after attaching the distal surface 34 to the wall 94 of the heart 90. Figure 3A The vacuum enclosure 30 is shown when it is in an expanded configuration (eg, when freely deployed within the chamber 92 of the heart 90 (eg, as shown in FIG. Fig. 6A )) A representative image that can be obtained. In this configuration, the markings 39a, 39b can be spaced apart from each other by a distance "X" that corresponds to the distance between the markings 39a, 39b when the cover 30 is in a relaxed configuration. Figure 3A As shown, during manipulation of the system 8 within the chamber 92, the distal side 34 of the vacuum hood 30 may initially contact a tissue surface (e.g., a wall 94 of the heart 90). Figure 3B As shown, as the face 34 of the mask 30 is pressed against the wall 94 and a vacuum is applied within the chamber 36, the mask 30 may become attached and / or otherwise secured to the wall 94 due to the vacuum, thereby axially compressing the mask 30 and guiding the markings 39a, 39b closer together, e.g., to a smaller distance "X". This new spacing may provide visual confirmation that the mask 30 is secured to the wall 94, thereby allowing injections and / or other procedures to be performed, as further described elsewhere herein.

[0040] Alternatively, other configurations of markings may be provided on the vacuum hood to facilitate positioning and / or confirm when the hood is attached to the tissue structure. For example, Figure 4A and Figure 4BAnother embodiment of an intermediate conduit 120 carrying a vacuum shield 130 is shown, which can be constructed generally similarly to other embodiments herein. However, in this embodiment, the shield 130 includes a first annular marker (e.g., a radiopaque ring 139a) disposed at the distal face and two or more radiopaque bands or strips 139b extending at least partially along the length of the shield 130 (i.e., partially between the proximal end 132 and the distal face 134). Figure 4A The cover 130 is shown in a relaxed or expanded configuration, such as when the cover 130 is deployed from an external catheter (not shown), and the marker 139b extends generally axially toward the distal face 132 . Figure 4B The cover 130 is shown in a compressed configuration, for example, when pressed against the wall 94 within the chamber 92 of the heart and when a vacuum is applied to attach the cover 130 to the wall 94. As shown, the radiopaque ring 139a can provide visual confirmation when the distal surface 134 is pressed against the wall 93. In addition, when the vacuum is applied, the cover 130 can partially collapse radially inward, thereby causing the markers 139b to move closer together, i.e., reducing the circumferential distance between adjacent markers 139b, all of which can be viewed using fluoroscopy or other imaging methods to confirm that the cover 130 has been successfully sealed and attached to the wall 94.

[0041] Back to Figure 1 The injection catheter 40 also includes a proximal end 42, a distal end 44, and at least one lumen 46 extending between the proximal end 42 and the distal end 44, such as extending from a port in the handle or hub 43 to an outlet 45a in the distal tip 45, such as Figure 2 As shown. The injection catheter 40 can be sufficiently flexible along its length, for example, to enable advancement through the primary lumen 26 of the intermediate catheter 20 along a tortuous path created by the primary lumen 26, for example, through the patient's vasculature from a percutaneous access site into a chamber of the heart (not shown), as described elsewhere herein. The distal end 44 of the injection catheter 40 can terminate in a needle tip 45, for example, having a size between 22 and 28 gauge or between 26 and 28 gauge, and having a bevel, multi-faceted grind, trocar grind, or other sharp shape (as desired) to facilitate penetration into tissue.

[0042] Optionally, the distal end 44 of the injection catheter 40 may include a step-down (eg, a blunt surface from which the needle tip 45 extends), for example, similar to Figures 6A-6C The needle device shown in FIG. 4 can reduce the risk of inserting the needle tip 45 too far into the tissue. Figure 1As shown, the handle 43 may include a port having one or more connectors (e.g., a Luer connector) for connecting a syringe or other injectable material source 54 to the handle 43 for delivery into the needle lumen 46 and out of the outlet 45a. An exemplary embodiment of a needle device that can be used for an injection catheter is disclosed in U.S. Publication No. 2017 / 0119156.

[0043] generally, Figure 1 The system 8 can be used to navigate through the patient's body, for example, through the patient's vascular system into the chamber of the patient's heart to perform one or more injections using the injection catheter 40. For example, the system 8 can be used to enter the left ventricle, for example, using a retroaortic approach or an approach via the atrial septum (not shown). Once in the heart, the vacuum hood 30 can be used to provide stability / attachment to the endocardial surface, thereby facilitating the introduction and maintenance of the needle tip 45 into the heart wall 94 to perform the injection. The size of the vacuum hood 30 can be set to accommodate typical topological features of the heart wall, such as trabeculae in the ventricle, while maintaining the desired seal with the wall. In an exemplary embodiment, in an extended configuration, the distal surface 34 of the vacuum hood 30 may have a diameter between about four millimeters and fifteen millimeters (4-15mm) or between about five millimeters and ten millimeters (5-10mm). The combination of cross-section, material selection, mechanical design, and applied vacuum pressure can be adapted to provide sufficient attachment force to enable needle penetration, for example, even in the absence of significant back support from the injection catheter 40.

[0044] For example, the attachment created by the cover 30 and the vacuum source 54 can be between about 25-125 grams of force or between about 50-100 grams of force. Ideally, the attachment force can be high enough to enable the needle tip 45 to penetrate into the tissue, but low enough to prevent the distal end 44 of the injection device 40 (proximal to the needle tip 45) from passing through the heart wall, which can cause perforation. Optionally, the injection catheter 40 can include a gradual increase in diameter from the needle tip 45 to the distal end 45 of the injection catheter 40 (e.g., as shown in FIG. 1 ). Figures 6A-6C ), such that a lower force (e.g., <75 grams-force) is required to introduce needle tip 45 into wall 94, but a higher force (e.g., >125 grams-force) is required to penetrate wall 94 using the catheter body.

[0045] Now go to Figure 5 , showing basic navigation of the system 8 within a chamber 92 (e.g., the left ventricle) of a heart 90. The distal end 14 of the outer catheter 10 can be navigated into the chamber 92, for example, from a percutaneous access site (not shown) through any intervening body lumen. As previously described, optionally, the distal section of the outer catheter 10 can have a predetermined or variable curve, for example, be biased to a predetermined curve shape and / or be steerable or otherwise deflectable from the proximal end 12 ( Figure 5 Not shown; see Figure 1 ). As desired, the outer catheter 10 may be advanced, retracted, rotated, and / or deflected, for example, to provide alignment of its distal end 14 with a target location in the heart 90.

[0046] Once alignment is achieved, the intermediate catheter 20 can be advanced to guide the distal end 24 and the cover 30 out of the lumen 16, for example, until contact is made between the cover 30 and the heart wall 94 at the target location. For example, if the intermediate catheter 20 is preloaded into the lumen 16 and the cover 30 is disposed adjacent to the distal end 14, the intermediate catheter 20 can be advanced sufficiently to deploy the cover 30, which can elastically expand to an expanded state, for example, as Fig. 6A Alternatively, if the intermediate catheter 20 is initially outside of the outer catheter 10, the cover 30 can be directed to the collapsed configuration, and the cover 30 and intermediate catheter 20 can be loaded into the outer catheter 10, for example, into the lumen 16 through the port 29a (not shown; see Figure 1 ) and then deployed from the outer catheter distal end 14 within the chamber 92. Alternatively, the cover 30 may begin and remain deployed (e.g., positioned proximate to the distal end 14 of the outer catheter 10), for example, to provide a substantially atraumatic buffer that may facilitate advancement of the outer catheter 10, for example, along an introduction path through the aortic valve or other tissue structure (not shown).

[0047] The contact of the distal face 34 of the mask with the wall 94 can be identified by fluoroscopy, for example, using markings 39, 25 on the mask 30 and / or the intermediate conduit 20, as described elsewhere herein. With the mask 30 in close proximity to and / or in direct contact with the wall 94, a vacuum can be applied to the primary lumen 26 of the intermediate conduit 20 (by activating the Figure 1 The vacuum source 52 is shown and is thereby transmitted to the chamber 36 of the mask 30, thereby promoting attachment of the mask 30 to the heart wall 94.

[0048] For example, as the face 34 of the cover 30 comes into contact with the wall 94, the cover 30 may shift, bend, or otherwise move relative to the distal tip 25 of the catheter 20, which may facilitate identification of the surface of the wall 94 under fluoroscopy. Additionally, the relative position of the cover marker 39 and the intermediate catheter distal tip 25 may change as the tissue surface is encountered. Fig. 6A , the distal tip 25 and the cover marker 39 are shown in a generally straight alignment, e.g., concentric alignment with the central axis 18 of the system 8. However, when encountering a surface, the markers 25, 39 may become misaligned due to the flexible connection between the cover 30 and the intermediate catheter 20, e.g., if the cover 30 is laterally deflected relative to the distal end 24 of the cover (e.g., as shown in FIG. Figure 6B and Figure 6C shown).

[0049] Optionally, the cover 30 may include one or more features that allow the cover 30 to conform to a tissue surface that is not orthogonal to the longitudinal axis 18 of the system 8. For example, the cover 30 may include one or more features that enable the cover 30 to bend relative to the longitudinal axis 18. In an exemplary embodiment, the cover 30 may include a mid-section fold, bend, bellows, or other features that enable the cover 30 to compress on one side when encountering tissue obliquely, such as Figure 6B and Figure 6C Alternatively, the proximal narrowing portion of the hood 30 may simply be flexible enough to allow the distal side 34 of the hood 30 to turn toward the tissue when encountering the tissue wall 94. As previously described, the distal tip 25 of the intermediate catheter 20 may extend at least partially into the chamber 34 of the hood 30 to ensure that the vacuum is delivered to the distal side 34, for example, even in the event of a partial collapse of the proximal region of the hood 30. Thus, the vacuum hood 30 may be attached to the tissue wall 94 to enable the needle tip 45 to be stably entered and maintained into the tissue despite encountering the wall 94 at a certain angle or tilt.

[0050] Additionally or alternatively, in another option, the distal section of the intermediate catheter 20 (eg, a section extending beyond the outer catheter distal end 14 and the intermediate catheter distal tip 25, such as Figure 5 The distal flexible section 45 may be formed of a substantially flexible material so that during or after attachment, heart wall motion may be accommodated without causing the cover 30 to become detached from the wall 94. Thus, in addition to transmitting a vacuum and providing an extension for navigation, the distal flexible section may also act as a suspension system or shock absorber between the outer catheter 10 and the cover 30, thereby facilitating a stable attachment. Once the cover 30 is substantially attached to the heart wall 94, the needle tip 45 may be advanced into the wall 94 to inject one or more agents into the underlying tissue, such as Figure 6B shown.

[0051] It should be appreciated that when a vacuum is applied to the chamber 36 of the cover 30 and a seal is formed between the distal side 34 of the cover 30 and the wall 94, a reduction in pressure within the chamber 34 may result in at least a partial collapse of the cover 30, or more specifically, at least a partial axial shortening of the cover 34, e.g. Figure 6B and Figure 6C In conjunction with this shortening, the radiopaque markers 39a, 39b may be moved closer together, as shown. Figure 3B A change in the special relationship represented in the fluoroscopic image of, or otherwise represented in a manner that is easily understood through fluoroscopy, thereby providing a visual indication of the attachment of the cover 30 to the wall 94.

[0052] Thus, the radiopaque features 39, 25 of the cover 30 and / or the intermediate catheter 20 can be used to identify the position of the heart wall 94 and / or the secure attachment of the cover 30 to the heart wall 94. In addition, periodic changes in the relative positions of the markers 25, 39 can be identified, for example, due to contraction of the heart wall 94. In a similar manner, if the needle tip 45 is made at least partially radiopaque, the needle tip 45 can be visualized relative to other fluoroscopic markers (e.g., markers 39 and / or 25) of the system 8. Thus, the user can be able to verify that the needle tip 45 is extending beyond, for example, the distal radiopaque marker 39a of the cover 30 by a predetermined distance. In the attached state, the distal marker 39a can substantially delineate the wall 94 of the heart 90, so that the penetration depth of the needle tip 45 into the wall 94 can be estimated based on the distance beyond the distal marker 39a. Then, the injection device 40 can be used to deliver one or more therapeutic and / or diagnostic materials (e.g., cells, reagents, filler materials, gels and / or other substances) beyond the wall 94 into the myocardium.

[0053] It should be appreciated that the hood 30 can provide a substantially isolated working area for performing injections and / or other procedures. This can be particularly important in situations where the material to be injected provides a degree of embolic risk. For example, if an injection is performed without the needle tip being fully engaged in the target tissue, and / or if the injection material leaks from the injection site, and / or if the injection material otherwise becomes free in the chamber 34, the hood 30 can isolate the free injection material and the vacuum source 52 can cause the free material to be drawn through the lumen 26 of the intermediate catheter 20 rather than released into the chamber 92 of the heart 90.

[0054] Go to Figure 7 , another embodiment of an intermediate catheter 220 is shown, which includes a vacuum cover 230 carried on the distal end 224 of the intermediate catheter 220. Similar to the previous embodiment, the intermediate catheter 220 includes a primary lumen 226a that communicates with the chamber 234 of the cover 230, for example, to apply a vacuum within the chamber 234 and the distal end 234 to attach the cover 230 to a tissue structure (not shown). In addition, the intermediate catheter 220 includes a secondary or peripheral lumen 226b suitable for fluid infusion, for example, offset from the primary lumen (such as Fig. 7AAs vacuum is applied to the intermediate catheter primary lumen 226a, blood may be drawn into the primary lumen 226a, for example, before the distal side 234 is attached to the tissue structure, in the case of partial attachment, and / or at a point of detachment from the tissue. If left static, the blood drawn into the primary lumen 226a may potentially coagulate and provide a possible source of embolic debris, for example, when the injection device 40 is translated within the primary lumen 226a, or in the case where the lumen 226a is flushed. In addition or alternatively, a vacuum source may be coupled to the secondary lumen 226b, for example, to provide a vacuum to the chamber 234 and / or to enhance the vacuum applied via the primary lumen 226a.

[0055] To avoid this, the peripheral lumen 226b can be used to infuse fluid (e.g., heparin, heparinized saline, and / or other anticoagulants or diluents) into the chamber 236. The fluid can be drawn back into the primary lumen 226a of the intermediate conduit 220 under vacuum and thereby dilute, clear, and / or reduce the clotting potential of the blood introduced into that lumen.

[0056] The foregoing disclosure of exemplary embodiments has been given for the purpose of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Based on the above disclosure, many variations and modifications of the embodiments described herein will be apparent to those of ordinary skill in the art.

[0057] In addition, in describing representative embodiments, this specification may present the method and / or process as a specific sequence of steps. However, insofar as the method or process does not rely on the specific sequence of steps described herein, the method or process should not be limited to the specific sequence of steps described. As will be appreciated by those of ordinary skill in the art, other sequences of steps may be possible. Therefore, the specific sequence of steps set forth in this specification should not be interpreted as a limitation to the claims.

[0058] Although the present invention is susceptible to various modifications and alternative forms, specific examples thereof 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 forms or methods disclosed, but rather, the present invention encompasses all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. A system for injecting one or more agents into a tissue within a patient's body, comprising: a first tubular member including a proximal end, a distal end sized for introduction into a patient, and a lumen extending between the first tubular member proximal end and the first tubular member distal end; a second tubular member including a proximal end, a distal end sized for introduction into a patient, and a lumen extending between the second tubular member proximal end and the second tubular member distal end, the second tubular member being slidably disposed within the lumen of the first tubular member; a needle catheter slidably disposed within the lumen of the second tubular member; as well as a vacuum shield including a proximal end attached to the distal end of the second tubular member, the second tubular member including a radiopaque distal tip attached to the distal end of the second tubular member and extending at least partially into the vacuum shield, and the vacuum shield having an annular first radiopaque marker and an annular second radiopaque marker extending circumferentially around the shield and axially spaced from each other such that a distance between at least two radiopaque markers provides a spatial relationship that is visually altered under fluoroscopy when the vacuum shield is under a sealed vacuum, The vacuum hood includes a distal surface shaped to contact a tissue surface within a patient's body; and the vacuum hood includes one or more annular features between the proximal end of the vacuum hood and the distal surface to accommodate axial shortening and / or elongation of the vacuum hood. 2 . The system of claim 1 , wherein the proximal end of the vacuum hood is attached to the distal end of the second tubular member proximal of the distal tip.

3. The system of claim 1 , wherein the distal tip of the second tubular member is configured to provide structural support to prevent collapse of the vacuum hood under vacuum, and / or to provide a fluoroscopically visible marker in a known relationship to the position of the vacuum hood for navigation. 4 . The system of claim 3 , wherein one of the one or more annular features is doped with a radiopaque material to define the first radiopaque marker.

5. The system of claim 4 wherein the second radiopaque marker extends circumferentially around the vacuum enclosure at the distal surface such that a distance between the first radiopaque marker and the second radiopaque marker provides the spatial relationship that changes visually under fluoroscopy when the vacuum enclosure is under a sealed vacuum.

6. The system of any one of claims 2-4, wherein the vacuum hood includes one or more annular folds defining a bellows that are offset a predetermined distance proximal of the distal face to accommodate axial shortening and lengthening of the vacuum hood.

7. A system according to any one of claims 2-4, wherein the vacuum cover includes an annular region offset a predetermined distance proximal to the distal side, the annular region including a material that is more flexible than the material adjacent to the annular region proximally and distally to provide a bendable region of the vacuum cover.

8. The system of any one of claims 2-4, wherein the first radiopaque marker extends circumferentially around the vacuum hood at the distal face and the second radiopaque marker extends circumferentially around the vacuum hood proximal to the distal face.

9. The system of claim 8 further comprising a plurality of markings extending axially at least partially between the proximal end of the vacuum hood and the distal face, such that a circumferential distance between adjacent ones of the plurality of markings provides the spatial relationship that is visually altered under fluoroscopy when the vacuum hood is under a sealed vacuum.

10. The system of claim 1, further comprising a vacuum source coupled to the proximal end of the second tubular member for applying a vacuum through the second tubular member lumen to create a vacuum within the vacuum enclosure.

11. The system of claim 1 , wherein the distal tip of the second tubular member is disposed at least partially through a chamber of the vacuum hood to ensure that the distal face of the vacuum hood remains in fluid communication with a vacuum source when a vacuum is applied through the lumen of the second tubular member.

12. A system according to any one of claims 1-5 and 11, wherein the vacuum cover is configured so that the attachment force applied to the contacting tissue is high enough to enable the needle tip to penetrate into the tissue, but low enough to prevent the distal end of the needle device from passing through the tissue and causing perforation.

13. The system of any one of claims 1-5 and 11, wherein the radiopaque distal tip is secured to the second tubular member distal end such that the distal tip is proximally spaced from the distal side of the vacuum enclosure.

14. A catheter for performing a procedure in a patient's body, comprising: a tubular member comprising a proximal end, a distal end sized for introduction into a patient, and a lumen extending between the proximal and distal ends; a vacuum hood including a proximal end attached to the distal end of the tubular member and a distal side disposed distally beyond the distal end of the tubular member, the vacuum hood defining a chamber in communication with the lumen of the tubular member; a radiopaque distal tip attached to the distal end of the tubular member and extending a predetermined distance into the vacuum enclosure; one or more annular features between the proximal end of the vacuum hood and the distal face to accommodate axial shortening and / or lengthening of the vacuum hood; an annular first radiopaque marker extending circumferentially around the vacuum enclosure at the distal surface; as well as one or more additional radiopaque markers on the enclosure, the one or more additional radiopaque markers being spaced apart from the first radiopaque marker so as to be configured to provide a spatial relationship that is visually altered under fluoroscopy when the vacuum enclosure is under a sealing vacuum, wherein the one or more additional radiopaque markers include an annular second radiopaque marker extending circumferentially around the vacuum hood at a location proximal to the distal surface such that a distance between the first radiopaque marker and the second radiopaque marker provides a spatial relationship that is visibly altered under fluoroscopy when the vacuum hood is under a sealed vacuum.

15. A catheter according to claim 14, wherein the second radiopaque marker is located at a first annular feature of the one or more annular features, so that when the vacuum cover is under a sealed vacuum, the distance between the first radiopaque marker and the second radiopaque marker is shortened when the first annular feature is shortened.

16. The catheter of claim 14, wherein the one or more annular features include one or more annular folds defining a bellows that are offset a predetermined distance proximal of the distal face to accommodate axial shortening and / or elongation of the vacuum hood.

17. A catheter according to claim 14, wherein the one or more annular features include an annular region offset a predetermined distance proximal to the distal side, the annular region including a flexible region comprising a material that is more flexible than the material adjacent to the annular region proximally and distally to provide a bendable region of the vacuum cover.

18. The catheter of claim 17, wherein the material of the flexible region is doped to provide the second radiopaque marker.

19. The catheter of claim 17, wherein the second radiopaque marker is applied at or proximal to the flexible region.

20. A catheter according to claim 14, wherein the one or more additional radiopaque markers also include a plurality of markers extending at least partially axially between the proximal end of the vacuum hood and the distal surface, such that the circumferential distance between adjacent markers in the plurality of markers provides the spatial relationship that is visually changed under fluoroscopy when the vacuum hood is under a sealed vacuum.

21. The catheter of claim 14, wherein the distal tip extends into the chamber such that the distal tip is proximally spaced from the distal side of the vacuum hood, the distal tip comprising a radiopaque material to identify the position of the distal tip relative to the radiopaque marking on the vacuum hood.

22. The catheter of claim 21, wherein the entire distal tip is radiopaque.

23. The catheter of claim 21, wherein the distal tip includes one or more annular radiopaque markers defining the radiopaque material.

24. The catheter of claim 14, further comprising a vacuum source coupled to the proximal end of the tubular member for applying a vacuum through the tubular member lumen to generate a vacuum within the chamber and distal face of the vacuum enclosure.

25. The catheter of claim 14, further comprising an infusion lumen extending between the tubular member proximal end and the tubular member distal end and communicating with the chamber of the vacuum enclosure.

26. The catheter of claim 25, further comprising a fluid source coupled proximally to the tubular member and in communication with the infusion lumen for delivering fluid into the chamber of the vacuum enclosure.

27. The catheter of claim 14, wherein the tubular member further comprises a flexible section proximal to the distal end of the tubular member, the flexible section being sufficiently flexible to stabilize the distal end of the tubular member, inhibit movement, and / or prevent hood detachment.

28. A system for injecting one or more agents into tissue within a patient's body, comprising: A catheter according to any one of claims 14 to 27; as well as A needle device includes a distal end disposed within the tubular member lumen, the needle device being axially slidable relative to the tubular member so as to deploy a needle tip from the tubular member lumen through the chamber of the vacuum cover onto the needle device distal tip to perform an injection.

29. The system of claim 28, further comprising a reagent source of one or more reagents, the reagent source coupled to the needle device, the needle device comprising a delivery lumen, the delivery lumen being connected to an outlet in the needle tip to deliver the one or more reagents from the reagent source to outside the outlet.

30. The system of claim 29, wherein the vacuum hood is configured such that the attachment force applied to the contacting tissue is high enough to enable the needle tip to penetrate into the tissue, but low enough to prevent the distal end of the needle device from passing through the tissue and causing a perforation.

31. The system of claim 29, wherein the distal tip extends into the vacuum enclosure to identify an orientation of the enclosure based on a spatial relationship of the first and second radiopaque markers relative to the distal tip.

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