Endoscopic system for energy delivery - Patents.com

Abstract

The present invention relates to flexible sheath assemblies, and related systems and methods of use, configured to withstand high temperatures during endoscopic energy delivery procedures. Specifically, the present invention provides sheath assemblies having a flexible, elongated tubular body designed with a heat-resistant polymer and / or a heat-resistant braided material. Such sheath assemblies are configured for use in any type of endoscopic energy delivery procedure (e.g., tissue ablation, extraction, cauterization, vascular thrombosis, treatment of cardiac arrhythmias and arrhythmias, electrosurgery, tissue sampling, etc.).

Description

[Technical field]

[0001] The present invention relates to flexible sheath assemblies configured to withstand high temperatures during endoscopic energy delivery procedures, as well as related systems and methods of use. Specifically, the present invention provides a sheath assembly having a flexible, elongated tubular body designed with a heat resistant polymer and / or a heat resistant braided material. Such sheath assemblies are configured for use in any type of endoscopic energy delivery procedure (e.g., tissue resection, extraction, cauterization, vascular thrombosis, treatment of cardiac arrhythmias and arrhythmias, electrosurgery, tissue sampling, etc.). [Background technology]

[0002] Flexible sheaths are used in therapeutic endoscopic procedures (e.g., endoscopic ablation procedures) to provide more precise access to a target location than an endoscope can provide. Current or typical flexible sheaths (e.g., having a polymeric material (e.g., polyether block amide (Pebax)) and a metal braid (e.g., stainless steel metal braid)) must be retracted in such endoscopic ablation procedures because such sheaths cannot handle the high temperatures associated with ablation energy (e.g., microwave ablation energy). In fact, such sheaths must be retracted before transmitting ablation energy to prevent damage to the sheath from energy transmission (e.g., microwave fields resulting from microwave energy transmission). However, such necessary retraction of a flexible sheath often compromises the endoscopic ablation procedure, for example, through misadjusting the target location and / or misadjusting the positioning of the energy delivery device. Summary of the Invention [Problem to be solved by the invention]

[0003] There is a need for new flexible sheaths that can withstand the high temperatures associated with ablation energy (eg, microwave ablation energy).

[0004] The present invention addresses this need. [Means for solving the problem]

[0005] The present invention relates to flexible sheath assemblies configured to withstand high temperatures during endoscopic energy delivery procedures, as well as related systems and methods of use. Specifically, the present invention provides a sheath assembly having a flexible, elongated tubular body designed with a heat resistant polymer and / or a heat resistant braided material. Such sheath assemblies are configured for use in any type of endoscopic energy delivery procedure (e.g., tissue resection, extraction, cauterization, vascular thrombosis, treatment of cardiac arrhythmias and arrhythmias, electrosurgery, tissue sampling, etc.).

[0006] In certain embodiments, the present invention provides a flexible sheath for use in an endoscopic procedure. In some embodiments, the flexible sheath comprises an elongate tubular body having an elongate tubular body proximal end and an elongate tubular body distal end, a braided body portion, the braided body portion extending from the elongate tubular body distal end to the elongate tubular body proximal end, a composition of the braided body portion being a heat resistant synthetic fiber, and a diameter of the flexible sheath being less than 5 mm.

[0007] In some embodiments, the flexible sheath can withstand high temperatures (e.g., about 50° C. to 150° C.) during an endoscopic energy transfer procedure without suffering damage (e.g., structural damage). The flexible sheath is designed to be operable within a microwave field or zone without suffering damage associated with the microwave field or zone (e.g., the flexible sheath is microwave compatible). The flexible sheath is designed to be operable within tissue regions exposed to high temperatures without suffering damage associated with high temperatures (e.g., the flexible sheath is heat resistant).

[0008] In some embodiments, the heat resistant synthetic fibers are polyetheretherketone (PEEK), Kevlar, aramid fibers, Nomex, and / or Technora.

[0009] In some embodiments, the braided body portion extends along the exterior of the elongate tubular body, within the elongate tubular body, along the interior of the elongate tubular body, or along a mixture of the interior and exterior of the elongate tubular body.

[0010] In some embodiments, the flexible sheath has sufficient flexibility to access a circuitous route through the subject (e.g., through branching structures, through the bronchial tree, through any area of ​​the body to reach a desired location) while retaining the ability to withstand high temperatures during an endoscopic energy delivery procedure without incurring damage (e.g., structural damage).

[0011] In some embodiments, the composition of the elongate tubular body is a high temperature rated polymeric material. In some embodiments, the composition of the elongate tubular body is fluorinated ethylene propylene (FEP). In some embodiments, the high temperature rated polymeric material is a thermoplastic copolyester. In some embodiments, the thermoplastic copolyester is Arnitel. In some embodiments, the composition of the elongate tubular body is a fluoropolymer. In some embodiments, the fluoropolymer is a perfluoromethylalkoxyalkane (MFA) or a perfluoroalkoxyalkane (PFA).

[0012] In some embodiments, the flexible sheath further comprises a marker region positioned at the elongate tubular body distal end. In some embodiments, the composition of the marker region is a high density ceramic. In some embodiments, the composition of the marker region is a high temperature heat resistant plastic substrate. In some embodiments, the composition of the marker region is a high temperature heat resistant plastic substrate having a high density ceramic coating.

[0013] In some embodiments, the flexible sheath further comprises a steerable pull ring configured to allow a user to steer the flexible sheath in any desired manner.

[0014] In certain embodiments, the present invention provides a system comprising a primary catheter, a flexible sheath as described herein, and an energy delivery device. In some embodiments, the primary catheter is an endoscope. In some embodiments, the energy delivery device is a microwave energy delivery device.

[0015] In certain embodiments, the present invention provides a method of treating a tissue region, comprising providing a system comprising a primary catheter, a flexible sheath as described herein, and an energy delivery device, inserting the primary catheter into the tissue region, inserting the flexible sheath through the primary catheter into the desired tissue region to be treated, inserting the energy delivery device through the flexible sheath into the desired tissue region to be treated, and treating the tissue region to be treated with the energy delivery device. In some embodiments, the tissue region to be treated is within a subject. In some embodiments, the subject is a human subject.

[0016] Additional embodiments are described herein. [Brief description of the drawings]

[0017] [Figure 1] We show how to separate a standard flexible sheath from an ablation energy device (probe) to avoid exposure to high temperatures during a therapeutic endoscopy procedure. [Diagram 2] 1 illustrates various flexible sheath embodiments. [Diagram 3] 1 illustrates various flexible sheath embodiments. [Figure 4] 1 illustrates various flexible sheath embodiments. [Diagram 5] 1 illustrates various flexible sheath embodiments. [Figure 6] 1 illustrates various flexible sheath embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Therapeutic or interventional endoscopy pertains to endoscopic procedures in which a treatment (e.g., tissue resection) (e.g., tissue collection) is performed via an endoscope. This is in contrast to diagnostic endoscopy, where the purpose of the procedure is purely to visualize the interior of the body (e.g., gastrointestinal area, respiratory area, urinary tract area, etc.) to aid in diagnosis. In fact, a procedure that begins as a diagnostic endoscopy may become a therapeutic endoscopy depending on the findings.

[0019] In general, therapeutic endoscopy involves the administration of an endoscope ("primary catheter") into a body region until a natural stopping position is reached (e.g., until the circumference of the body region prevents further advancement of the endoscope). A flexible sheath having a circumference smaller than that of the endoscope is then advanced through the endoscope to a location in the desired body region. A therapeutic tool (e.g., an ablation energy transmission tool) having a circumference smaller than the diameter of the flexible sheath (e.g., a tissue collection tool) is then advanced through the flexible sheath to a location in the desired body region. Next, in an ablation energy transmission procedure, the flexible sheath is withdrawn to avoid exposure to potential high temperatures from the ablation energy transmission tool. The ablation energy is then transmitted to a location in the desired body region. Once therapeutic endoscopy is completed, the ablation energy transmission tool is withdrawn through the flexible sheath, the flexible sheath is withdrawn through the endoscope, and the endoscope is withdrawn from the subject.

[0020] Current or typical flexible sheaths are constructed using polymeric materials (e.g., polyether block amide (Pebax)) and metal braids (e.g., stainless steel metal braids). Such polymeric materials, such as Pebax, are used for their biocompatibility and flexibility. In addition, such polymeric materials, such as Pebax, are used for their low melting temperature, which is beneficial during manufacturing. Such metal braids, such as stainless steel metal braids, provide a flexible sheath with torsional stiffness, allowing the user (e.g., clinician) to freely turn and rotate the flexible sheath without it collapsing on itself.

[0021] As mentioned above, such flexible sheaths are used in therapeutic endoscopic procedures (e.g., endoscopic ablation procedures) to provide more precise access to a target location than an endoscope can provide. Current or typical flexible sheaths (e.g., having a polymeric material (e.g., polyether block amide (Pebax)) and a metal braid (e.g., stainless steel metal braid)) must be retracted in such endoscopic ablation procedures because such sheaths cannot handle the high temperatures associated with ablation energy (e.g., microwave ablation energy). In fact, such sheaths must be retracted before transmitting ablation energy to prevent damage to the sheath from energy transmission (e.g., microwave fields resulting from microwave energy transmission). FIG. 1 shows how such a standard sheath can be separated from an ablation energy device (probe) to avoid exposure to high temperatures. However, retraction of such a necessary flexible sheath often compromises the endoscopic ablation procedure, for example, through misadjusting the target location and / or misadjusting the positioning of the energy transmission device.

[0022] There is a need for new flexible sheaths that can withstand the high temperatures associated with ablation energy (eg, microwave ablation energy).

[0023] The present invention addresses this need through the provision of a flexible sheath that can withstand high temperatures (e.g., about 50° C. to 150° C.) during an endoscopic energy transfer procedure without suffering damage (e.g., structural damage). The flexible sheath is designed to be operable within a microwave field or zone without suffering damage associated with the microwave field or zone (e.g., the flexible sheath is microwave compatible). The flexible sheath is designed to be operable within tissue regions exposed to high temperatures without suffering damage associated with high temperatures (e.g., the flexible sheath is heat resistant).

[0024] In fact, the present invention relates to flexible sheath assemblies configured to withstand high temperatures during endoscopic energy delivery procedures, as well as related systems and methods of use. Specifically, the present invention provides a sheath assembly having a flexible, elongated tubular body designed with a heat resistant polymer and / or a heat resistant braided material. Such a sheath assembly is configured for use in any type of endoscopic energy delivery procedure (e.g., tissue ablation, extraction, cauterization, vascular thrombosis, treatment of cardiac arrhythmias and arrhythmias, electrosurgery, tissue sampling, etc.).

[0025] Accordingly, provided herein is a flexible sheath designed to withstand high temperatures during endoscopic energy delivery procedures.

[0026] The flexible sheath of the present invention is not limited to a particular size dimension. Indeed, in some embodiments, the size dimension of the flexible sheath is such that it can fit within and pass through the lumen of a primary catheter (e.g., endoscope). In some embodiments, the flexible sheath is of sufficient diameter (e.g., 1 mm...2 mm...3 mm...4 mm...5 mm) to accommodate one or more suitable tools (e.g., energy delivery device, steerable navigation catheter) within and through it. In some embodiments, the flexible sheath is of sufficient length (e.g., 50°C...75°C...1 m....1.5 m...2 m...10 m...25 m, etc.) to extend from an insertion site (e.g., mouth, incision into the subject's body, etc.) to a desired target area within the body. In some embodiments, the flexible sheath is of sufficient length to extend through and beyond the reach of a primary catheter (e.g., endoscope) and reach a treatment site (e.g., peripheral lung tissue, cardiac tissue, gastrointestinal tissue, etc.) (e.g., any desired location within the body). In some embodiments, the size dimensions of the flexible sheath are such that it can fit within and pass through the lumen of a primary catheter (e.g., endoscope) while retaining the ability to withstand high temperatures during an endoscopic energy delivery procedure without suffering damage (e.g., structural damage).

[0027] The flexible sheath of the present invention is not limited to a particular mode of navigation through a primary catheter and / or through a body region. In some embodiments, the flexible sheath includes a navigation and / or steering mechanism. In some embodiments, the flexible sheath does not have an independent means of navigation, position awareness, or steering. In some embodiments, the flexible sheath relies on a primary catheter (e.g., an endoscope) or a steerable navigation catheter for positioning.

[0028] 2 shows an embodiment of the flexible sheath 1 of the present invention. The flexible sheath 1 is not limited to a particular design or configuration. In some embodiments, the design or configuration of the flexible sheath 1 is such that it can withstand high temperatures during an endoscopic energy delivery procedure without suffering damage (e.g., structural damage).

[0029] 2, flexible sheath 1 has an elongate tubular body 2 having an elongate tubular body proximal end 3 and an elongate tubular body distal end 4, a braided body portion 5, and (optionally) a marker region 6. Such embodiments are not limited to any particular positioning of elongate tubular body 2, braided body portion 5, and (optionally) marker region 6 within flexible sheath 1. In some embodiments, elongate tubular body 2, braided body portion 5, and (optionally) marker region 6 are positioned within flexible sheath 1 in any manner that enables the resulting embodiment to be able to withstand high temperatures during an endoscopic energy delivery procedure without suffering damage (e.g., structural damage).

[0030] With continued reference to FIG. 2, the elongated tubular body 2 is not limited to a particular composition. In some embodiments, the composition of the elongated tubular body 2 is any composition that allows the flexible sheath 1 to withstand high temperatures during an endoscopic energy transmission procedure without suffering damage (e.g., structural damage). In some embodiments, the composition of the elongated tubular body 2 is a high temperature rated polymeric material. Such embodiments are not limited to a particular high temperature rated polymeric material. In some embodiments, the high temperature rated polymeric material is fluorinated ethylene propylene (FEP). In some embodiments, the high temperature rated polymeric material is a thermoplastic copolyester. In some embodiments, the thermoplastic copolyester is Arnitel. In some embodiments, the high temperature rated polymeric material is a fluoropolymer. Such embodiments are not limited to a particular fluoropolymer. In some embodiments, the fluoropolymer is a perfluoromethylalkoxyalkane (MFA). In some embodiments, the fluoropolymer is a perfluoroalkoxyalkane (PFA). In some embodiments, only a portion (5%, 10%, 25%, 50%, 75%, 77%, 79%, 85%, 88%, 90%, 94%, 98%, 99%, 99.999%) of the elongate tubular body 2 has a composition of high temperature rated polymeric material. In some embodiments, only a portion (5%, 10%, 25%, 50%, 75%, 77%, 79%, 85%, 88%, 90%, 94%, 98%, 99%, 99.999%) beginning at the elongate tubular body distal end 4 has a composition of high temperature rated polymeric material. In some embodiments, the entire elongate tubular body 2 has a composition of high temperature rated polymeric material.

[0031] 2 , the elongate tubular body 2 has an elongate tubular body proximal end 3 positioned at its proximal end and an elongate tubular body distal end 4 positioned at its distal end. As can be seen, both the elongate tubular body proximal end 3 and the elongate tubular body distal end 4 function as openings in the elongate tubular body 2 and the flexible sheath 1, which represent natural openings through which suitable tools (e.g., energy delivery devices, steerable navigation catheters) can be housed within, passed through, and positioned outside of the flexible sheath 1.

[0032] With continued reference to FIG. 2, the braided body portion 5 is not limited to a particular composition. As mentioned above, current designs of flexible sheaths utilize metal-based braids to provide flexibility to the sheath. However, such metal-based braids, when exposed to a high energy field (e.g., a microwave field), rapidly increase in temperature, thereby damaging the sheath composition (e.g., melting the sheath). As such, the composition of the braided body portion 5 of the flexible sheath 1 of the present invention is any composition that allows the flexible sheath 1 to withstand high temperatures during an endoscopic energy transmission procedure without suffering damage (e.g., structural damage). In some embodiments, the composition of the braided body portion 5 is a heat-resistant synthetic fiber. Such embodiments are not limited to a particular heat-resistant synthetic fiber. In some embodiments, the heat-resistant synthetic fiber is polyetheretherketone (PEEK), Kevlar, aramid fiber, Nomex, and / or Technora.

[0033] 2, the braided body portion 5 is not limited to a particular positioning within the flexible sheath 1. In some embodiments, the braided body portion 5 is positioned along the length of the elongated tubular body 2 from the elongated tubular body proximal end 3 to the elongated tubular body distal end 4. In some embodiments, the braided body portion 5 is positioned within the interior of the elongated tubular body 2 (not visible from the exterior or interior of the flexible sheath 1). In some embodiments, the braided body portion 5 is positioned along the exterior of the elongated tubular body 2 (visible from the exterior but not the interior of the flexible sheath 1). In some embodiments, the braided body portion 5 is positioned within and along the exterior of the elongated tubular body 2 (visible from the exterior but not the interior of the flexible sheath 1). In some embodiments, the braided body portion 5 is positioned along the interior of the elongated tubular body 2 (visible from the interior but not the exterior of the flexible sheath 1). In some embodiments, the braided body portion 5 is positioned within and along the interior of the elongate tubular body 2 (as viewed from the interior but not the exterior of the flexible sheath 1). In some embodiments, the braided body portion 5 is positioned within and along the interior and exterior of the elongate tubular body 2 (as viewed from the interior and exterior of the flexible sheath 1).

[0034] 2, the braided body portion 5 is not limited to a particular braid design. In some embodiments, the design of the braided body portion 5 is capable of withstanding high temperatures during an endoscopic energy delivery procedure without suffering damage (e.g., structural damage).

[0035] 3 shows a standard braided design for the braided body portion 5 of the flexible sheath 1. As can be seen, the braided body portion 5 is positioned within and along the interior of the elongated tubular body 2.

[0036] 2, flexible sheath 1 is not limited to having a particular amount of flexibility provided by braided body portion 5. In some embodiments, flexible sheath 1 has sufficient flexibility to access a circuitous route through a subject (e.g., through branching structures, through the bronchial tree, through any region of the body to reach a desired location) while retaining the ability to withstand high temperatures during an endoscopic energy transfer procedure without incurring damage (e.g., structural damage).

[0037] Referring again to FIG. 2, the flexible sheath 1 has a marker region 6 therein. It is common for flexible sheaths used in endoscopic procedures to have a "marker" at their distal end, which provides the user (e.g., clinician) with the ability to visualize the distal end of the sheath (e.g., via any imaging technique) (e.g., via x-ray) during the procedure. Generally, such sheaths utilize radiopaque materials of high density material for such manufacturers. As with polymeric compositions and braided portions that cannot withstand high temperatures, radiopaque materials of high density material are susceptible to temperature rise when exposed to an energy ablation field (e.g., microwave ablation field). As shown in FIG. 1, the flexible sheath 1 of the present invention overcomes this limitation through providing a marker region 6 that can withstand high temperatures during an endoscopic energy transfer procedure without suffering damage (e.g., structural damage).

[0038] With continued reference to FIG. 2, the marker region 6 is not limited to a particular composition. In some embodiments, the composition of the marker region 6 is one that allows the region to withstand high temperatures during an endoscopic energy delivery procedure without suffering damage (e.g., structural damage). In some embodiments, the composition of the marker region 6 is a ceramic. Such embodiments are not limited to a particular type of ceramic. In some embodiments, the ceramic is a high density ceramic. In some embodiments, the marker region 6 is a high temperature heat resistant plastic substrate. In some embodiments, the marker region 6 is a high temperature heat resistant plastic substrate having a ceramic coating (e.g., a high density ceramic coating).

[0039] 2, the marker region 6 is not limited to a particular location within the flexible sheath 1. In some embodiments, the marker region 6 is positioned at the elongated tubular body distal end 4. In some embodiments, the marker region 6 extends along the entire circumference of the elongated tubular body distal end 4. In some embodiments, the marker region 6 extends along only a portion (e.g., 1%, 2%, 5%, 25%, 50%, 75%, 77%, 78%, 82%, 95%, 99%, 99.9999%) of the entire circumference of the elongated tubular body distal end 4. In some embodiments, the marker region 6 is positioned along the exterior of the elongated tubular body distal end 6 such that it is visible from the exterior but not the interior of the flexible sheath 1. In some embodiments, the marker region 6 is positioned along the interior of the elongated tubular body distal end 6 such that it is visible from the interior but not the exterior of the flexible sheath 1. In some embodiments, the marker region 6 is positioned within the elongate tubular body distal end 6 so as not to be visible from the interior or exterior of the flexible sheath 1 .

[0040] 4, there is shown an embodiment of a flexible sheath 1 viewed through the elongate tubular body distal end 4 of the elongate tubular body 2. As shown, a maker region 6 is positioned along the interior of the elongate tubular body distal end 4. As shown, a braided body portion 5 is positioned within the elongate tubular body 2.

[0041] 5, an embodiment of flexible sheath 1 is shown in a top-down angled perspective view. As can be seen, marker region 6 is positioned along the exterior of elongate tubular body distal end 4. As can be seen, braided body portion 5 is positioned along the exterior of elongate tubular body 2.

[0042] With reference to Figure 6, in some embodiments, the flexible sheath 1 further includes a steerable pull ring 7. As shown in Figure 6, the flexible sheath 1 is shown with a steerable pull ring 7 positioned at the elongated tubular body distal end 4. Such embodiments are not limited to a particular configuration of the steerable pull ring 7. In some embodiments, the steerable pull ring 7 has any configuration that allows a user to manually steer the flexible sheath 1 via manipulation of the steerable pull ring 7 (e.g., manipulation of one or both of the wires results in bending or steering of the sheath).

[0043] In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered in any desired manner or direction. For example, in some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired curve angle (e.g., 1-180 degrees). In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired bend angle (e.g., 1-360 degrees). In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired bend radius (e.g., 1-360 degrees). In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired curve diameter. In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired reach (e.g., .1-100 mm). In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered at any desired curl. In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered in any desired sweep. In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered in any desired curve (e.g., symmetric or asymmetric) (e.g., multi-curve or compound curve). In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered in any desired loop. In some embodiments, the steerable pull ring 7 allows the flexible sheath 1 to be steered in any desired deflection (e.g., in-plane deflection, out-of-plane deflection).

[0044] With continued reference to FIG. 6 , the steerable pull ring 7 has a ring portion 8 and two wires 9. As shown, the ring portion 8 is completely wrapped around the elongated tubular body distal end 4 and serves as a leverage point for the two wires 9. The two wires 9 are positioned to extend along the entire length of the flexible sheath 1 from the elongated tubular body distal end 4 to the elongated tubular body proximal end 4, and the two wires 9 can be manipulated by a user, thereby providing steering of the flexible sheath 1. In some embodiments, the ring portion 8 is resistant to high temperatures (e.g., temperatures resulting from ablation energy). In some embodiments, the composition of the ring portion 8 is polyetheretherketone (PEEK), Kevlar, aramid fiber, Nomex, and / or Technora. In some embodiments, the composition of the ring portion 8 is ceramic. In some embodiments, the composition of the ring portion 8 is non-metallic. In some embodiments, the two wires 9 are attached to the ring portion 8 such that pulling on one or both of the two wires 9 will not dislodge the two wires 9 from the ring portion 8. In some embodiments, the two wires 9 are attached to the exterior of the ring portion 9. In some embodiments, the two wires 9 are attached to the interior of the ring portion 9. In some embodiments, the two wires 9 are positioned in an opposing manner (e.g., directly opposite each other) as shown in FIG. 6. In some embodiments, three or more wires are provided (e.g., 3, 4, 5, 6, 10, 15, 20, etc.). In some embodiments, only one wire is provided (e.g., 3, 4, 5, 6, 10, 15, 20, etc.). In some embodiments, the two wires 9 are resistant to high temperatures (e.g., temperatures resulting from the ablation energy). In some embodiments, the composition of the two wires 9 is polyetheretherketone (PEEK), Kevlar, aramid fiber, Nomex, and / or Technora. In some embodiments, the composition of the two wires 9 is ceramic. In some embodiments, the composition of the two wires 9 is non-metallic.

[0045] In some embodiments, the present invention provides a system for therapeutic endoscopic procedures in which a flexible sheath as described herein, a primary catheter, and one or more suitable tools (e.g., energy delivery device, steerable navigation catheter) are provided.

[0046] Such embodiments are not limited to a particular type or kind of primary catheter. In some embodiments, the primary catheter of the present invention is an endoscope. In some embodiments, any suitable endoscope known to those skilled in the art finds use as a primary catheter in the present invention. In some embodiments, the primary catheter bears one or more of the characteristics of an endoscope and / or bronchoscope known in the art and described herein. One type of conventional flexible bronchoscope is described in U.S. Pat. No. 4,880,015, which is incorporated herein by reference in its entirety. The bronchoscope is 790 mm long and has two main parts: a working head and an insertion tube. The working head includes an eyepiece, an ocular lens with a diopter adjustment ring, attachments for a suction tube, a suction valve, and a light source, and an access port or biopsy inlet that allows various devices and fluids to pass into the working channel and out the distal end of the bronchoscope. The working head is attached to an insertion tube that is typically 580 mm long and 6.3 mm in diameter. The insertion tube contains a bundle of fiber optics terminating in an objective lens at the distal tip, a light guide, and a working channel. Other endoscopes and bronchoscopes that may find use in embodiments of the present invention, or parts that may find use with the present invention, are described in U.S. Patent Nos. 7,473,219, 6,086,529, 4,586,491, 7,263,997, 7,233,820, and 6,174,307.

[0047] Such embodiments are not limited to a particular type or kind of steerable navigation catheter. In some embodiments, the steerable navigation catheter is configured to fit within the lumen of the primary catheter (e.g., endoscope) and the flexible sheath. In some embodiments, the steerable navigation catheter is long enough (e.g., 50 cm...75 cm...1 m...1.5 m...2 m...5 m...15 m) to extend from an insertion site (e.g., mouth, incision into the subject's body, etc.) to a treatment site. In some embodiments, the channel catheter is long enough to extend beyond the reach of the primary catheter (e.g., endoscope) and reach a treatment site (e.g., peripheral lung tissue). In some embodiments, the steerable navigation catheter engages the flexible sheath such that movement of the steerable navigation catheter results in synchronous movement of the flexible sheath. In some embodiments, the flexible sheath surrounding the steerable navigation catheter moves with the steerable navigation catheter as the steerable navigation catheter is inserted along a pathway within the subject. In some embodiments, the flexible sheath is positioned within the subject by the steerable navigation catheter. In some embodiments, the steerable navigation catheter can be disengaged from the flexible sheath. In some embodiments, disengagement of the steerable navigation catheter from the flexible sheath allows movement of the steerable navigation catheter further along the path without movement of the flexible sheath. In some embodiments, disengagement of the steerable navigation catheter from the flexible sheath allows retraction of the steerable navigation catheter through the flexible sheath without movement of the flexible sheath.

[0048] Such embodiments are not limited to a particular type or kind of energy delivery device (e.g., ablation device, surgical device, etc.) (see, e.g., U.S. Pat. Nos. 7,101,369; 7,033,352; 6,893,436; 6,878,147; 6,823,218; 6,817,999; 6,635,055; 6,471,69 No. 6, No. 6,383,182, No. 6,312,427, No. 6,287,302, No. 6,277,113, No. 6,251,128, No. 6,245,062, No. 6, No. 026,331, No. 6,016,811, No. 5,810,803, No. 5,800,494, No. 5,788,692, No. 5,405,346, No. 4,494,539 No. 11 / 728,460, No. 11 / 728,457, No. 11 / 728,428, No. 11 / 237,136, No. 11 / 236,985, No. 10 / 980,699, No. 10 / 961,994, No. 10 / 961,761, No. 10 / 834,802, No. 10 / 370,179, No. 09 / 847,181, UK Patent Application No. 2, See, for example, US Pat. Nos. 406,521, 2,388,039, EP 1395190, and WO 06 / 008481, 06 / 002943, 05 / 034783, 04 / 112628, 04 / 033039, 04 / 026122, 03 / 088858, 03 / 039385, 95 / 04385. Such energy transmission devices are not limited to emitting a particular type of energy. In some embodiments, the energy transmission device can emit radio frequency energy. In some embodiments, the energy transmission device can emit microwave energy. Such devices include any and all medical, veterinary, and research application devices configured for energy emission, as well as devices used in agricultural settings, manufacturing settings, mechanical settings, or any other application in which energy is transmitted.

[0049] The systems for therapeutic endoscopic procedures of the present invention are not limited to a particular application. Indeed, such systems of the present invention are designed for use in any setting where the emission of energy is applicable. Such uses include any and all medical, veterinary, and research applications. In addition, the systems and devices of the present invention may be used in agricultural settings, manufacturing settings, mechanical settings, or any other application where energy is transmitted.

[0050] In some embodiments, the system is configured for any type of procedure in which the flexible sheath described herein may find application, for example, the system finds application for open surgery, percutaneous, intravascular, intracardiac, intraluminal, endoscopic, laparoscopic, or surgical energy delivery.

[0051] The present invention is not limited by the nature of the target tissue or region. Applications include, but are not limited to, treatment of cardiac arrhythmias, tumor resection (benign and malignant), bleeding control during surgery, after trauma, for any other control of bleeding, removal of soft tissue, tissue extraction and harvesting, treatment of varicose veins, intraluminal tissue resection (e.g., to treat esophageal pathologies such as Barrett's esophagus and esophageal adenocarcinoma), treatment of bone tumors, normal bone, and benign bone conditions, intraocular applications, applications in orthopedic surgery, treatment of central nervous system pathologies including brain tumors and electrical disturbances, sterilization surgery (e.g., removal of fallopian tubes), and cauterization of blood vessels or tissues for any purpose. In some embodiments, surgical applications include ablative therapy (e.g., achieving coagulation necrosis). In some embodiments, surgical applications include tumor resection, for example, targeting metastatic tumors. In some embodiments, the system including the flexible sheath described herein is configured for movement and positioning with minimal trauma to tissue or organisms in any desired location, including, but not limited to, the lungs, brain, neck, chest, abdomen, and pelvis. In some embodiments, the system is configured for guided delivery, e.g., by computed tomography, ultrasound, magnetic resonance imaging, fluoroscopy, etc. Indeed, in some embodiments, all inserted components of such a system are configured for travel along narrow and circuitous paths through the subject (e.g., through branching structures, through the bronchial tree, etc.).

[0052] In certain embodiments, the invention provides a method of treating a tissue region, comprising providing a tissue region and a system as described herein (e.g., a primary catheter (e.g., an endoscope), a flexible sheath as described herein, and an energy delivery device (e.g., a microwave ablation catheter), and at least one of the following components: a processor, a power source, a temperature monitor, an imager, a conditioning system, a temperature reduction system, and / or a device placement system), positioning a portion of the energy delivery device near the tissue region, and delivering an amount of energy to the tissue region with the device. In some embodiments, the tissue region is a tumor. In some embodiments, the energy delivery results in, for example, ablation of the tissue region and / or thrombosis of a blood vessel, and / or electroporation of the tissue region. In some embodiments, the tissue region is a tumor. In some embodiments, the tissue region includes one or more of the lung, heart, liver, reproductive organs, stomach, lung, large intestine, small intestine, brain, neck, bone, kidney, muscle, tendon, blood vessel, prostate, bladder, and spinal cord.

[0053] All publications and patents mentioned in the above specification are incorporated herein by reference in their entirety and in their entirety. Various modifications and alterations of the described compositions, methods and uses of the technology will become apparent to those skilled in the art without departing from the scope and spirit of the technology described. Although the technology has been described in connection with certain exemplary embodiments, it should be understood that the claimed invention should not be unduly limited to such specific embodiments. Indeed, various modifications of the described methods for carrying out the invention that are apparent to those skilled in the art are intended to be within the scope of the following "claims."

[0054] [Embodiment] (1) A flexible sheath for use in an endoscopic procedure, the flexible sheath comprising: an elongated tubular body having an elongated tubular body proximal end and an elongated tubular body distal end; and a braided body portion, the braided body portion extending from the elongated tubular body distal end to the elongated tubular body proximal end, the composition of the braided body portion being a heat resistant synthetic fiber, and the diameter of the flexible sheath being less than 5 mm. (2) The flexible sheath of embodiment 1, wherein the heat-resistant synthetic fiber is polyetheretherketone (PEEK), Kevlar, aramid fiber, Nomex, and / or Technora. (3) The flexible sheath of embodiment 1, wherein the braided body portion extends along the exterior of the elongate tubular body exterior, within the elongate tubular body, along the interior of the elongate tubular body, or along a mixture of the interior and exterior of the elongate tubular body. (4) The flexible sheath of embodiment 1, wherein the flexible sheath can withstand high temperatures (e.g., about 50° C. to 150° C.) without suffering damage (e.g., structural damage). (5) The flexible sheath of embodiment 1, wherein the flexible sheath has sufficient flexibility to access a circuitous route through the subject (e.g., through a branching structure, through the bronchial tree, through any region of the body to reach a desired location) while retaining the ability to withstand high temperatures during an endoscopic energy transmission procedure without incurring damage (e.g., structural damage).

[0055] (6) The flexible sheath of embodiment 1, wherein the composition of the elongated tubular body is a high temperature rated polymeric material. (7) The flexible sheath of embodiment 6, wherein the composition of the elongated tubular body is fluorinated ethylene propylene (FEP) or a thermoplastic copolyester (e.g., Arnitel). (8) The flexible sheath of embodiment 6, wherein the composition of the elongated tubular body is a fluoropolymer. (9) The flexible sheath of embodiment 8, wherein the fluoropolymer is a perfluoromethylalkoxyalkane (MFA) or a perfluoroalkoxyalkane (PFA). (10) The flexible sheath of embodiment 1, further comprising a marker region disposed at the distal end of the elongated tubular body.

[0056] (11) The flexible sheath of embodiment 10, wherein the composition of the marker region is a high density ceramic. (12) The flexible sheath described in embodiment 10, wherein the composition of the marker region is a high-temperature heat-resistant plastic substrate (e.g., capable of withstanding temperatures of 50°C to 150°C). (13) The flexible sheath of embodiment 10, wherein the composition of the marker region is a high temperature heat resistant plastic substrate having a high density ceramic coating (e.g., capable of withstanding temperatures of 50°C to 150°C). (14) A system comprising a primary catheter, a flexible sheath as described in embodiment 1, and an energy delivery device. (15) The system of embodiment 14, wherein the primary catheter is an endoscope.

[0057] (16) The system of embodiment 14, wherein the energy transmission device is a microwave energy transmission device. (17) A method of treating a tissue region, comprising providing the system of embodiment 14, inserting the primary catheter into a tissue region, inserting the flexible sheath through the primary catheter into a desired tissue region to be treated, inserting the energy delivery device through the flexible sheath into the desired tissue region to be treated, and treating the tissue region to be treated with the energy delivery device. (18) The method of embodiment 17, wherein the tissue area to be treated is within a subject. (19) The method of embodiment 18, wherein the subject is a human subject. (20) The flexible sheath of embodiment 1, further comprising a steerable pull ring configured to allow a user to steer the flexible sheath in any desired manner.

[0058] (21) The flexible sheath of embodiment 1, wherein the flexible sheath is designed to be operable within a microwave field or zone without suffering damage associated with the microwave field or zone (e.g., the flexible sheath is microwave compatible). (22) The flexible sheath of embodiment 1, wherein the flexible sheath is designed to be operable within tissue regions exposed to high temperatures without suffering from high temperature-related damage (e.g., the flexible sheath is heat resistant).

Claims

1. 1. A flexible sheath for use in an endoscopic procedure, the flexible sheath comprising: an elongate tubular body having an elongate tubular body proximal end and an elongate tubular body distal end; and a braided body portion, the braided body portion extending from the elongate tubular body distal end to the elongate tubular body proximal end, the composition of the braided body portion being a synthetic fiber capable of withstanding 50° C.; and a diameter of the flexible sheath being less than 5 mm. The flexible sheath can be inserted into a subject through a primary catheter, and a treatment tool can be inserted into the subject through the flexible sheath; The braided body portion is positioned along an exterior surface of the elongate tubular body and not on an interior surface of the elongate tubular body.

2. 2. The flexible sheath of claim 1, wherein the synthetic fibers are polyetheretherketone (PEEK), Kevlar, aramid fibers, Nomex, and / or Technora.

3. The flexible sheath of claim 1 , wherein the flexible sheath is sufficiently flexible to access a circuitous route through a subject.

4. The flexible sheath of claim 1 , wherein the composition of the elongate tubular body is a polymeric material.

5. The flexible sheath of claim 4 , wherein the composition of the elongated tubular body is fluorinated ethylene propylene (FEP) or a thermoplastic copolyester.

6. The flexible sheath of claim 4 , wherein the composition of the elongate tubular body is a fluoropolymer.

7. The flexible sheath of claim 6, wherein the fluoropolymer is a perfluoromethylalkoxyalkane (MFA) or a perfluoroalkoxyalkane (PFA).

8. The flexible sheath of claim 1 , further comprising a marker region disposed at the elongate tubular body distal end.

9. The flexible sheath of claim 8 , wherein the composition of the marker region is ceramic.

10. The flexible sheath of claim 8 , wherein the composition of the marker region is a plastic substrate.

11. The flexible sheath of claim 8 , wherein the composition of the marker region is a plastic substrate having a ceramic coating.

12. A system comprising the primary catheter, the flexible sheath of claim 1, and the treatment tool.

13. The system of claim 12 , wherein the primary catheter is an endoscope.

14. The system described in claim 12, wherein the treatment tool is a microwave energy transmission device.

15. The flexible sheath of claim 1 , further comprising a steerable pull ring configured to allow a user to steer the flexible sheath in any desired manner.

16. 16. The flexible sheath of claim 15, wherein the steerable pull ring comprises a ring portion wrapped around an outer periphery of the elongate tubular body distal end and a plurality of wires connected to and extending proximally from the ring portion, the plurality of wires being spaced apart from one another circumferentially about the ring portion.

17. The flexible sheath of claim 1 , wherein the flexible sheath is designed to be operable within a microwave field or zone without suffering damage associated therewith.

18. The flexible sheath of claim 1 , wherein the flexible sheath is designed to be operable within a tissue region of a subject.

19. The flexible sheath of claim 8 , wherein the marker regions are positioned circumferentially about the outer surface of the elongate tubular body.

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