Patent Application
20200168360
The present invention relates to flexible sheath assemblies configured to withstand high amounts of temperature during endoscopic energy delivery procedures, and related systems and methods of use. In particular, the present invention provides a sheath assembly having a flexible elongate tubular body designed with a temperature resistant polymer and/or a temperature resistant braided material. Such sheath assemblies are configured for use in any kind of endoscopic energy delivery procedure (e.g., tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc.).
Flexible sheaths are used in therapeutic endoscopy 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 polymer material (e.g., polyether block amide (Pebax)) and a metal braiding (e.g., a stainless steel metal braiding)) must be retracted in such endoscopic ablation procedures as such sheaths are incapable of handling high temperatures associated with ablation energy (e.g., microwave ablation energy). Indeed, such sheaths must be retracted prior to delivery of ablation energy to prevent damage to the sheath from the energy delivery (e.g., microwave field resulting from microwave energy delivery). Such necessary flexible sheath retraction, however, often compromises the endoscopic ablation procedure through, for example, misadjusting the target location and/or misadjusting the positioning of the energy delivery device.
New flexible sheaths capable of withstanding high temperatures associated with ablation energy (e.g., microwave ablation energy) are needed.
The present invention addresses this need.
The present invention relates to flexible sheath assemblies configured to withstand high amounts of temperature during endoscopic energy delivery procedures, and related systems and methods of use. In particular, the present invention provides a sheath assembly having a flexible elongate tubular body designed with a temperature resistant polymer and/or a temperature resistant braided material. Such sheath assemblies are configured for use in any kind of endoscopic energy delivery procedure (e.g., tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc.).
In certain embodiments, the present invention provides flexible sheaths for use in endoscopic procedures. In some embodiments, the flexible sheaths comprise an elongate tubular body having an elongate tubular body proximal end and an elongate tubular body distal end, and a braided body portion, wherein the braided body portion extends from the elongate tubular body distal end to the elongate tubular body proximal end, wherein the composition of the braided body portion is a heat-resistant synthetic fiber, wherein the diameter of the flexible sheath is less than 5 mm.
In some embodiments, the flexible sheath is able to withstand high amounts of temperature (e.g., from approximately 50 C to 150 C) during endoscopic energy delivery procedures without sustaining damage (e.g., structural damage). The flexile sheaths are designed to be operational within a microwave field or microwave zone (e.g., the flexible sheaths are microwave compatible) without sustaining microwave field or microwave zone related damage. The flexile sheaths are designed to be operational within a tissue region experiencing high temperatures (e.g., the flexible sheaths are thermal resistant) without sustaining high temperature related damage.
In some embodiments, the heat-resistant synthetic fiber is polyether ether ketone (PEEK), Kevlar, Aramid fibers, Nomex, and/or Technora.
In some embodiments, 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 a mixture of the interior and exterior of the elongate tubular body. In some embodiments, the flexible sheath has sufficient flexibility to access a circuitous route through a subject (e.g., through a branched structure, through the bronchial tree, through any region of the body to reach a desired location) while retaining the ability to withstand high amounts of temperature during endoscopic energy delivery procedures without sustaining damage (e.g., structural damage).
In some embodiments, the composition of the elongate tubular body is a higher temperature rated polymer material. In some embodiments, the composition of the elongate tubular body is fluorinated ethylene propylene (FEP). In some embodiments, the higher temperature rated polymer material is a thermoplastic copolyester. In some embodiments, the thermoplastic copolyester is Amitel. In some embodiments, the composition of the elongate tubular body is a fluoropolymer. In some embodiments, the fluoropolymer is perfluoromethylalkoxy alkane (MFA) or perfluoroalkoxy alkane (PFA).
In some embodiments, the flexible sheaths further comprise 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 resistant plastic substrate. In some embodiments, the composition of the marker region is a high temperature resistant plastic substrate with a high density ceramic coating.
In some embodiments, the flexible sheaths further comprise a steerable pull ring configured to permit a user to steer the flexible sheath in any desired manner.
In certain embodiments, the present invention provides systems 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.
In certain embodiments, the present invention provides methods 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 a tissue region, inserting the flexible sheath through the primary catheter to a desired tissue region to be treated, inserting the energy delivery device through the flexible sheath to 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.
Additional embodiments are described herein.
Therapeutic endoscopy or interventional endoscopy pertains to an endoscopic procedure during which a treatment (e.g., tissue ablation) (e.g., tissue collection) is carried out via the endoscope. This contrasts with diagnostic endoscopy, where the aim of the procedure is purely to visualize an internal part of a body (e.g., gastrointestinal region, respiratory region, urinary tract region, etc.) in order to aid diagnosis. In practice, a procedure which starts as a diagnostic endoscopy may become a therapeutic endoscopy depending on the findings.
Generally, therapeutic endoscopy involves the administration of an endoscope (“primary catheter”) into a body region until a natural stopping positioning is reached (e.g., until the circumference of the body region inhibits further advancement of the endoscope). Next, a flexible sheath having a circumference smaller than the circumference of the endoscope is advanced through the endoscope and to a desired body region location. Next, a therapeutic tool (e.g., an ablation energy delivery tool) (e.g., a tissue collection tool) having a circumference smaller than the diameter of the flexible sheath is advanced through the flexible sheath to the desired body region location. Next, in ablation energy delivery procedures, the flexible sheath is withdrawn so as to avoid potential high temperature exposure from the ablation energy delivery tool. Next, ablation energy is delivered to the desired body region location. Upon completion of the therapeutic endoscopy, the ablation energy delivery tool is withdrawn through the flexible sheath, the flexible sheath is withdrawn through the endoscope, and the endoscope is withdrawn from the subject.
Current or typical flexible sheaths are constructed with a polymer material (e.g., polyether block amide (Pebax)) and a metal braiding (e.g., a stainless steel metal braiding). Such a polymer material as Pebax is used due to its biocompatibility and flexibility. In addition, such a polymer material as Pebax is used due to its lower melting temperature which is beneficial during manufacturing. Such a metal braiding as a stainless steel metal braiding provides the flexible sheath with torsional stiffness and permits a user (e.g., a clinician) to freely turn and rotate the flexible sheath without it collapsing upon itself
As noted, such flexible sheaths are used in therapeutic endoscopy 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 polymer material (e.g., polyether block amide (Pebax)) and a metal braiding (e.g., a stainless steel metal braiding)) must be retracted in such endoscopic ablation procedures as such sheaths are incapable of handling high temperatures associated with ablation energy (e.g., microwave ablation energy). Indeed, such sheaths must be retracted prior to delivery of ablation energy to prevent damage to the sheath from the energy delivery (e.g., microwave field resulting from microwave energy delivery).
New flexible sheaths capable of withstanding high temperatures associated with ablation energy (e.g., microwave ablation energy) are needed.
The present invention addresses this need through providing flexible sheaths able to withstand high amounts of temperature (e.g., from approximately 50 C to 150 C) during endoscopic energy delivery procedures without sustaining damage (e.g., structural damage). The flexile sheaths are designed to be operational within a microwave field or microwave zone (e.g., the flexible sheaths are microwave compatible) without sustaining microwave field or microwave zone related damage. The flexile sheaths are designed to be operational within a tissue region experiencing high temperatures (e.g., the flexible sheaths are thermal resistant) without sustaining high temperature related damage.
Indeed, the present invention relates to flexible sheath assemblies configured to withstand high amounts of temperature during endoscopic energy delivery procedures, and related systems and methods of use. In particular, the present invention provides a sheath assembly having a flexible elongate tubular body designed with a temperature resistant polymer and/or a temperature resistant braided material. Such sheath assemblies are configured for use in any kind of endoscopic energy delivery procedure (e.g., tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc.).
Accordingly, provided herein are flexible sheaths designed to withstand high amounts of temperature during endoscopic energy delivery procedures.
The flexible sheaths of the present invention are not limited to particular size dimensions. Indeed, in some embodiments, the size dimension of the flexible sheath is such that it is able to fit within and pass through the lumen of a primary catheter (e.g., an 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 within and through its interior one or more suitable tools (e.g., energy delivery device, steerable navigation catheter). In some embodiments, the flexible sheath is of sufficient length to extend from an insertion site (e.g. mouth, incision into body of subject, etc.) to a desired target region within a living body (e.g. 50 cm . . . 75 cm . . . 1 m . . . 1.5 m . . . 2 m . . . 10 m . . . 25 m, etc.). In some embodiments, the flexible sheath is of sufficient length to extend through and beyond the reach of a primary catheter (e.g., endoscope) to reach a treatment site (e.g. peripheral lung tissue, heart tissue, gastrointestinal tissue, etc.) (e.g., any desired location within a living body). In some embodiments, the size dimension of the flexible sheath is such that it is able to fit within and pass through the lumen of a primary catheter (e.g., an endoscope) while retaining the ability to withstand high amounts of temperature during endoscopic energy delivery procedures without sustaining damage (e.g., structural damage).
The flexible sheaths of the present invention are not limited to a particular manner of navigation through a primary catheter and/or through a body region. In some embodiments, the flexible sheath comprises a navigation and/or steering mechanism. In some embodiments, the flexible sheath is without an independent means of navigation, position recognition, or maneuvering. In some embodiments, the flexible sheath relies upon the primary catheter (e.g., endoscope) or a steerable navigation catheter for placement.
In certain embodiments, as shown in
Still referring to
Still referring to
Still referring to
Still referring to
Still referring to
Referring again to
Referring again to
Still referring to
Still referring to
Referring to
Referring to
Referring to
In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered in any desired manner or direction. For example, in some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired curve angle (e.g., from 1 to 180 degrees). In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired bend angle (e.g., from 1 to 360 degrees). In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired bend radius (e.g., from 1 to 360 degrees). In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired curve diameter. In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired reach (e.g., from 0.1 to 100 mm). In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired curl. In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired sweep. In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired curve (e.g., symmetrical or asymmetrical) (e.g., multi-curve or compound curve). In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired loop. In some embodiments, the steerable pull ring 7 permits the flexible sheath 1 to be steered at any desired deflection (e.g., on-plane deflection, off plane deflection).
Still referring to
In some embodiments, the present invention provides systems for therapeutic endoscopic procedures wherein flexible sheaths as described herein, primary catheters, and one or more suitable tools (e.g., energy delivery device, steerable navigation catheter) are provided.
Such embodiments are not limited to a particular type or kind of primary catheter. In some embodiments, the present invention primary catheter is an endoscope. In some embodiments, any suitable endoscope known to those in the art finds use as a primary catheter in the present invention. In some embodiments, a primary catheter adopts characteristics of one or more endoscopes and/or bronchoscopes known in the art, as well as characteristics described herein. One type of conventional flexible bronchoscope is described in U.S. Pat. No. 4,880,015, herein incorporated by reference in its entirety. The bronchoscope measures 790 mm in length and has two main parts, a working head and an insertion tube. The working head contains an eyepiece; an ocular lens with a diopter adjusting ring; attachments for suction tubing, a suction valve, and light source; and an access port or biopsy inlet, through which various devices and fluids can be passed into the working channel and out the distal end of the bronchoscope. The working head is attached to the insertion tube, which typically measures 580 mm in length and 6.3 mm in diameter. The insertion tube contains fiberoptic bundles, which terminate in the objective lens at the distal tip, light guides, and a working channel. Other endoscopes and bronchoscopes which may find use in embodiments of the present invention, or portions of which may find use with the present invention, are described in U.S. Pat. Nos. 7,473,219; 6,086,529; 4,586,491; 7,263,997; 7,233,820; and 6,174,307.
Such embodiments are not limited to a particular type or kind of steerable navigation catheter. In some embodiments, a steerable navigation catheter is configured to fit within the lumen of a primary catheter (e.g., endoscope) and a flexible sheath. In some embodiments, a steerable navigation catheter is of sufficient length to extend from an insertion site (e.g. mouth, incision into body of subject, etc.) to a treatment site (e.g. 50 cm . . . 75 cm . . . 1 m . . . 1.5 m . . . 2 m . . . 5 m . . . 15 m). In some embodiments, a channel catheter is of sufficient length to extend beyond the reach of a primary catheter (e.g., endoscope) to reach a treatment site (e.g. peripheral lung tissue). In some embodiments, a steerable navigation catheter engages a flexible sheath such that movement of the steerable navigation catheter results in synchronous movement of the flexible sheath. In some embodiments, as a steerable navigation catheter is inserted along a path in a subject, the flexible sheath surrounding the steerable navigation catheter moves with it. In some embodiments, a flexible sheath is placed within a subject by a steerable navigation catheter. In some embodiments, a steerable navigation catheter can be disengaged from a flexible sheath. In some embodiments, disengagement of a steerable navigation catheter and flexible sheath allows movement of the steerable navigation catheter further along a pathway without movement of the flexible sheath. In some embodiments, disengagement of a steerable navigation catheter and flexible sheath allows retraction of the steerable navigation catheter through the flexible sheath without movement of the flexible sheath.
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, 6,471,696, 6,383,182, 6,312,427, 6,287,302, 6,277,113, 6,251,128, 6,245,062, 6,026,331, 6,016,811, 5,810,803, 5,800,494, 5,788,692, 5,405,346, 4,494,539, U.S. patent application Ser. Nos. 11/728,460, 11/728,457, 11/728,428, 11/237,136, 11/236,985, 10/980,699, 10/961,994, 10/961,761, 10/834,802, 10/370,179, 09/847,181; Great Britain Patent Application Nos. 2,406,521, 2,388,039; European Patent No. 1395190; and International Patent Application Nos. WO 06/008481, WO 06/002943, WO 05/034783, WO 04/112628, WO 04/033039, WO 04/026122, WO 03/088858, WO 03/039385 WO 95/04385; each herein incorporated by reference in their entireties). Such energy delivery devices are not limited to emitting a particular kind of energy. In some embodiments, the energy delivery devices are capable of emitting radiofrequency energy. In some embodiments, the energy delivery devices are capable of emitting microwave energy. Such devices include any and all medical, veterinary, and research applications devices configured for energy emission, as well as devices used in agricultural settings, manufacturing settings, mechanical settings, or any other application where energy is to be delivered.
The systems for therapeutic endoscopic procedures of the present invention are not limited to particular uses. Indeed, such systems of the present invention are designed for use in any setting wherein 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 to be delivered.
In some embodiments, the systems are configured any type of procedure wherein the flexible sheath described herein can find use. For example, the systems find use for open surgery, percutaneous, intravascular, intracardiac, intraluminal, endoscopic, laparoscopic, or surgical delivery of energy.
The present invention is not limited by the nature of the target tissue or region. Uses include, but are not limited to, treatment of heart arrhythmia, tumor ablation (benign and malignant), control of bleeding during surgery, after trauma, for any other control of bleeding, removal of soft tissue, tissue resection and harvest, treatment of varicose veins, intraluminal tissue ablation (e.g., to treat esophageal pathologies such as Barrett's Esophagus and esophageal adenocarcinoma), treatment of bony tumors, normal bone, and benign bony conditions, intraocular uses, uses in cosmetic surgery, treatment of pathologies of the central nervous system including brain tumors and electrical disturbances, sterilization procedures (e.g., ablation of the fallopian tubes) and cauterization of blood vessels or tissue for any purposes. In some embodiments, the surgical application comprises ablation therapy (e.g., to achieve coagulative necrosis). In some embodiments, the surgical application comprises tumor ablation to target, for example, metastatic tumors. In some embodiments, the systems including the flexible sheath described herein are configured for movement and positioning, with minimal damage to the tissue or organism, at any desired location, including but not limited to, the lungs, brain, neck, chest, abdomen, and pelvis. In some embodiments, the systems are configured for guided delivery, for example, by computerized tomography, ultrasound, magnetic resonance imaging, fluoroscopy, and the like. Indeed, in some embodiments, all inserted components of such a system are configured for movement along a narrow and circuitous path through a subject (e.g. through a branched structure, through the bronchial tree, etc.).
In certain embodiments, the present invention provides methods of treating a tissue region, comprising providing a tissue region and a system 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 supply, a temperature monitor, an imager, a tuning system, a temperature reduction system, and/or a device placement system); positioning a portion of the energy delivery device in the vicinity of the tissue region, and delivering an amount of energy with the device to the tissue region. In some embodiments, the tissue region is a tumor. In some embodiments, the delivering of the energy results in, for example, the ablation of the tissue region and/or thrombosis of a blood vessel, and/or electroporation of a tissue region. In some embodiments, the tissue region is a tumor. In some embodiments, the tissue region comprises one or more of the lung, heart, liver, genitalia, stomach, lung, large intestine, small intestine, brain, neck, bone, kidney, muscle, tendon, blood vessel, prostate, bladder, and spinal cord.
All publications and patents mentioned in the above specification are herein incorporated by reference in their entirety for all purposes. Various modifications and variations of the described compositions, methods, and uses of the technology will be apparent to those skilled in the art without departing from the scope and spirit of the technology as described. Although the technology has been described in connection with specific exemplary embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in the art are intended to be within the scope of the following claims.
The present application claims priority to U.S. Provisional Patent Application No. 62/771,825, filed Nov. 27, 2018, hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62771825 | Nov 2018 | US |
