Side-viewing telescopic frame and device for steering an interventional device - Patent Application 20070122997

Abstract

A side-viewing steering device for positioning an interventional device within a patient includes a tilted internal catheter, a side-viewing telescopic frame, and a sheath. The tilted internal catheter is made of a tubular flexible material and includes a distal end portion that is biased to bend to one side when unconstrained. The side-viewing telescopic frame includes a tubular base and multiple leaflets. The tubular base has a proximal end and a distal end, with the tilted internal catheter extending therethrough. Each of the multiple leaflets has a varying length and width. When unconstrained, each leaflet extends from the distal end of the tubular base and is biased in shape to extend outward and in a bent orientation to one side and circumferentially surround the distal tip of the tilted internal catheter.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 438,187, filed January 10, 2023, which is incorporated by reference herein in its entirety.

[0002] The present disclosure relates to steering interventional devices such as guidewires, catheters, and needles. More particularly, the present disclosure relates to devices and related methods involving side-viewing telescoping frames for guiding interventional procedures. Furthermore, the present disclosure relates to steering and tracking interventional devices for medical procedures. [Background technology]

[0003] Catheters and guidewires are the primary interventional instruments for minimally invasive procedures. They are long, flexible devices that can be inserted into anatomical structures and controlled remotely from outside the body. Guidewires are typically used to navigate through the anatomical structures while catheters advance along them to provide support for and enable the delivery of other interventional devices, such as balloons, stents, leads, needles, and implants. Due to limitations in remote control of these devices, the majority of the procedure time is devoted to manipulating the catheters and guidewires.

[0004] Many cardiovascular procedures are performed using minimally invasive techniques using catheters and guidewires. Exemplary applications may include therapeutic or diagnostic procedures, all of which require precise manipulation of interventional devices to desired anatomical targets.

[0005] To address the limitations in guidewire navigation, catheter tips are pre-shaped into various curvatures to help orient the guidewire in a specific direction. However, these still suffer from the same navigation and support limitations as straight catheters and may require repeated passes through multiple devices to reach the desired point. Another method uses cables secured to the side of the catheter tip that return to the handle and can be actuated to deflect the catheter. The catheter tip has a section made of a softer material than the rest of the catheter to maximize the amount of deflection that occurs at the tip.

[0006] An additional method uses an external magnetic field to directly manipulate the catheter tip. This can be achieved by integrating a magnet into the catheter tip and adjusting the external magnetic field to control the device position. The magnetic field can be remotely controlled from outside the operating room, reducing user exposure to ionizing radiation from X-ray image guidance. These magnetically driven catheters typically require a dedicated operating room for the equipment to generate the magnetic field and a custom catheter adapted for this technology. The mechanical limitations of the catheter device are exacerbated by the 2D guidance of X-ray fluoroscopy. Additionally, X-rays offer less resolution and contrast when imaging soft tissue. Alternative imaging modalities can be used to supplement the image guidance provided by X-rays and to provide other detailed information about tissue structure, composition, and function for diagnostic purposes.

[0007] Other attempts at addressing some of these limitations include robotically controlled steerable catheters, which use motor-driven pull wires to mechanically advance, retract, and rotate the catheter remotely from outside the body. Thus, robotic tendon-based devices still suffer from the same navigation and steering limitations as traditional devices. Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, there is a need for devices, systems, and methods that can provide improved visualization, navigation, and device support in desired directions in many minimally invasive procedures, especially for procedures that challenge acute angles. [Means for solving the problem]

[0009] The present disclosure addresses limitations in accurate manipulation and precise steering of interventional devices within the vasculature, especially for applications requiring sharp deflection angles. The disclosed embodiments propose a more stable steering system that may reduce the incidence of vascular trauma and the number of catheter exchanges / manipulations, as well as enable interventional device access in tortuous vasculature and difficult-to-reach sites. The disclosed system includes a side-viewing telescoping frame that can be deployed or tethered within a lumen, a ventricular cavity, a stent graft, or any anatomical site of interest.

[0010] One embodiment includes a side-viewing steering device for positioning an interventional device within a patient. The side-viewing steering device includes a tilted internal catheter, a side-viewing telescopic frame, and a sheath. The tilted internal catheter is made of a tubular flexible material and includes a distal end portion that is biased to bend to one side when unconstrained. The distal end portion begins at a first, unbent location and terminates at a distal tip. The side-viewing telescopic frame includes a tubular base and multiple leaflets. The tubular base has a proximal end and a distal end with the tilted internal catheter extending therethrough. The multiple leaflets have various lengths and widths. Each leaflet extends from the distal end of the tubular base when unconstrained and is biased in shape to extend outward and in a bent orientation to one side and circumferentially surround the distal tip of the tilted internal catheter. The sheath has an elongated tubular shape within which the angled inner catheter and side-viewing telescoping frame are sized for axial retraction and collapse to a compressed state.

[0011] One embodiment includes a side-viewing steering device for positioning an interventional device within a patient. The side-viewing steering device includes a side-viewing telescopic frame, a set of strings tethered to a distal end of the side-viewing telescopic frame, and an angled internal catheter. The side-viewing telescopic frame is shaped to be deployed outwardly within a cavity, such as a lumen, a stent graft, or a ventricular cavity. The side-viewing telescopic frame further includes a plurality of elongated leaflet members having a common bending direction and distal ends. The set of strings are tethered to the distal end of the side-viewing telescopic frame. The angled internal catheter may be secured inside the side-viewing telescopic frame and may be supported by the set of strings connected to the distal end of the angled internal catheter. The angled internal catheter is manipulated using the set of strings having at least one degree of freedom to control the position of the interventional device.

[0012] One embodiment includes a side-viewing telescoping frame for positioning an interventional device within a patient. The side-viewing telescoping frame can include a tubular base and a plurality of leaflets. The tubular base has a proximal end and a distal end. The tubular base can be sized to allow an angled internal catheter to extend therethrough. The plurality of leaflets are of various lengths and extend from the distal end of the tubular base. Each of the plurality of leaflets is biased to expand outwardly in a straight configuration with a first portion and to expand outwardly laterally in an angled configuration with a second portion.

[0013] In one embodiment, the side-viewing telescoping frame houses a flexible, angled inner catheter designed to allow the passage of an interventional device such as a guidewire, catheter, microcatheter, energy source, laser, needle, intravascular ultrasound, or angioscope.

[0014] In another embodiment, the side-looking telescopic frame can steer the inner catheter using magnetic or electric field generators that can be connected to the branches of the frame. In another embodiment, the side-looking telescopic frame can be attached to a multi-lumen inner catheter to allow the passage of multiple interventional devices simultaneously. In another embodiment, the distal end of the telescopic frame can act as an anchor to multiple strings or cables that are affixed to the distal tip of the inner catheter on the one hand and connected to the handle on the other. By actuating the strings from the handle end, the inner catheter can be steered with multiple degrees of freedom to enable controlled and precise positioning of the catheter tip in a plane opposite the target region or vasculature. The present disclosure provides a more stable mechanical system for deploying stents, microcoils, balloon-expandable stents, or any other interventional device in a less traumatic manner.

[0015] In another embodiment, the side-looking telescoping frame may have radiopaque markers at its distal end to allow for better visualization and orientation of the frame's position relative to the anatomy under fluoroscopy. The side-looking telescoping frame branches may extend beyond the distal end of the inner catheter to create an offset from the anatomy and prevent the catheter tip from interacting with the region of interest as it is being moved.

[0016] In another embodiment, the side-viewing telescoping frame may be formed with eyelets at its distal tip to allow for actuation of multiple strings or cables with minimal friction, cable-based control, and use of the frame as an anchor for cables in parallel cable drive mechanisms.

[0017] In yet another embodiment, the present disclosure may be used in interventional, diagnostic, or drug perfusion procedures such as regenerative stem cell therapy, thrombolytic drugs, chemotherapeutic agents, injected contrast agents, or for biopsies in oncology applications. The present disclosure may also be used for imaging purposes.

[0018] In another embodiment, the inner catheter may be flexible, but not so flexible as to prevent the user from being able to transmit significant force to the device unless supported by a portion of the anatomy, such as a blood vessel wall.

[0019] The present applicant has recognized a need for the present disclosure in various fields of interventional devices. In one example, a procedure may involve fenestrated endovascular aortic repair, a minimally invasive technique used to place a telescoping stent graft within a dilated aorta. A key step in this procedure is gaining access from within the stent graft to the aorta, which provides blood supply to other organs. Often, J-tip catheters are used to direct a guidewire to the target site and facilitate vascular cannulation and catheterization. However, due to the extreme takeoff angle of the target vessel from its parent artery, these catheters and guidewires have rather low levels of maneuverability and torqueability. Therefore, a side-viewing telescoping frame may reduce procedure time, radiation exposure, contrast volume, and the potential for increased risk of renal failure.

[0020] Another example in which a guidewire is used to facilitate the placement of a stent graft within a supplying artery is endovascular aortic arch repair. After the main graft is deployed, placement of a branch graft is required to allow continuous perfusion of the supra-aortic vessels. While this treatment has become the standard of care, the risk of stroke remains a major concern. Due to the curvature of the arch, the distance from the femoral access vessel, and the high pulsatile blood flow, accessing the target vessel orifice using a conventional catheter requires a high degree of dexterity and precise device manipulation. The use of a side-viewing telescopic frame allows clinicians to access the target vessel orifice without extensive manipulation or repositioning of the catheter to accommodate the curvature of the arch.

[0021] In yet another example, catheter-based renal denervation procedures are used to treat patients with uncontrolled hypertension. Using an endovascular approach, a catheter is inserted into the renal artery to block the renal sympathetic nerves using radiofrequency ablation. The use of a side-viewing telescopic frame allows for proper arterial wall contact to be achieved within the tortuous and angled renal arteries where ablation is required, resulting in better and improved outcomes.

[0022] As another example, mesenteric angioplasty and stent placement is a minimally invasive procedure used to treat patients with chronic mesenteric ischemia. A hollow catheter is used to advance a guidewire through plaque occluding the mesenteric artery. Excessive guidewire and catheter manipulation can increase the risk of bifurcation perforation. Therefore, a side-viewing telescopic frame using a beveled catheter can allow for better placement and less catheter-guidewire manipulation.

[0023] As another example, cardiac resynchronization therapy is used to treat patients suffering from chronic heart failure. Using a transvenous approach, the coronary sinus is cannulated to enable delivery of a pacing lead to the coronary venous system. However, in most patients, accessing the coronary sinus remains challenging due to difficulties arising from its anatomy and the orientation of its ostium. In addition, positioning and orienting a conventional, non-steerable catheter in a dynamic cardiovascular environment is very difficult due to the limitations mentioned above. Therefore, a side-viewing telescopic frame may enable easier positioning due to enhanced maneuverability. Because rotation of the catheter and sheath within the vasculature or multiple catheter exchanges can result in arrhythmias and vascular injury, it is preferable to avoid excessive manipulation by using a reliable steering device.

[0024] In yet another example, transseptal needle placement is a technique used by electrophysiologists and interventional cardiologists to perform procedures requiring access to the left atrium of the heart. To treat different cardiac disorders within the left atrium, a needle must be inserted from the right atrium through the fossa ovalis into the left atrium. To avoid any sudden or uncontrolled forward movement of the needle, which may increase the risk of cardiac perforation, thrombus formation, and air embolism, a side-viewing telescopic frame can be used to position the needle.

[0025] In another example, after a successful transseptal puncture, a minimally invasive mitral valve repair is performed to treat mitral regurgitation or stenosis. However, due to the location of the mitral valve and its large size, the delivery device must have a high degree of flexion so that it can navigate the transseptal puncture and then be positioned against the mitral valve. Another technical challenge due to the previously mentioned limitations is the ability to manipulate and steer the device in a dynamic environment. Providing a side-viewing telescopic frame as described may allow for navigating the transseptal puncture with increased maneuverability and manipulation.

[0026] In yet another example, transjugular intrahepatic portosystemic shunting is a procedure performed to treat patients with cirrhosis. Due to scar tissue obstructing blood flow within the liver, portal vein pressure increases and can cause the vein to rupture. Using imaging guidance, a catheter is used to place a stent between the portal vein and the hepatic vein to relieve pressure and restore blood flow. However, before placing the stent, the portal vein must be punctured. Due to poor visualization and catheter restrictions, locating the portal vein can be difficult, and multiple puncture attempts can increase the risk of bleeding.

[0027] In another example, for the treatment of intracranial aneurysms, endovascular coiling procedures use catheters and microcatheters to release platinum coils into the aneurysmal region to prevent blood flow. However, due to the limited level of control and constraints on microcatheter movement within the aneurysm, the risk of perforation may be increased. Placing the coil requires precise positioning, and the use of a side-viewing telescopic frame may allow entry into the aneurysmal region at the appropriate angle and without excessive manipulation.

[0028] Many minimally invasive imaging modalities suffer from small spatial constraints within surgical catheters, resulting in a reduced field of view (FOV) or resolution. Images are also acquired relative to a floating reference frame within the anatomy, making it difficult to know the absolute location of the target of interest. Additionally, registering a separate, interrogating instrument for guidance to the acquired image is challenging, especially when the imaging catheter operates independently of the interventional instrument; for example, most commercially available ultrasound catheters lack an internal lumen to support the insertion of a guidewire. The present disclosure remedies these limitations by providing a side-viewing, telescoping frame with a sheath capable of delivering a tilting internal catheter. Imaging can be improved through the enhanced maneuverability of the disclosed device.

[0029] Ultrasound as an imaging modality can be used for tissue characterization through measurement of acoustic impedance and reflection coefficient, tissue elastography to determine mechanical properties, tissue visualization to determine shape, location of targets of interest for image guidance, and measurement of blood flow using Doppler. Similar to mechanical properties measured by ultrasound, electrical probes can be used to measure electrical properties of tissue such as impedance, conductivity, and permittivity through the use of electrodes.

[0030] Optical imaging techniques can also be implemented in imaging probes. Potential applications include spectroscopy at various wavelengths, miniature endoscopy, and optical coherence tomography (OCT). Laser sources can also be used for ablation or combined with acoustic receivers for photoacoustic imaging. Another imaging probe, a nuclear activity detector, can be used to measure high-energy radiation originating from areas of tissue with high nuclear activity.

[0031] The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter herein. The figures and detailed description that follow more particularly exemplify various embodiments.

[0032] The subject matter herein may be more fully understood upon consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0033] [Figure 1A] FIG. 1 is a perspective view of a side-looking steering device with a side-looking telescoping frame and a tilted internal catheter, according to one embodiment. [Figure 1B] FIG. 1 is a perspective view of a side-looking steering device with a side-looking telescoping frame that allows one degree of freedom, according to one embodiment. [Figure 1C] FIG. 1 is a perspective view of a side-viewing steering device with a side-viewing telescoping frame as the steering device allowing two degrees of freedom, according to one embodiment. [Figure 1D] FIG. 1 is a perspective view of a side-looking steering device with a side-looking telescoping frame and a tilted internal catheter, according to one embodiment. [Figure 1E] FIG. 1 is a perspective view of a side-looking steering device with a side-looking telescoping frame and a tilted internal catheter, according to one embodiment. [Figure 2] FIG. 1 is a perspective view of a side-viewing steering device with a side-viewing telescoping frame with a handle attached, according to one embodiment. [Figure 3] FIG. 1 is a perspective view of a side-viewing steering device with a side-viewing telescoping frame, according to one embodiment. [Figure 4] FIG. 1 is a perspective view of a side-viewing steering device with a side-viewing telescoping frame having a mesh-like structure, according to one embodiment. [Figure 5] FIG. 1 is a perspective view of a side-viewing steering device in which a side-viewing telescoping frame is stitched, sewn, or glued to fabric, according to one embodiment. [Figure 6] 1 is a schematic illustration of the use and deployment of a side-view telescoping frame in a FEVAR (fenestrated endovascular aortic aneurysm repair) procedure to cannulate a target vessel, according to one embodiment. [Figure 7] 1 is a schematic illustration of the use and deployment of a side-viewing telescoping frame for aortic arch repair to facilitate guidewire navigation within a stent graft, according to one embodiment. [Figure 8] 1 is a schematic illustration of the use and deployment of a side-viewing telescoping frame for a renal denervation procedure to facilitate ablation of nerves within the renal arteries, according to one embodiment. [Figure 9] FIG. 1 is a schematic illustration of the use and deployment of a side-viewing telescoping frame for superior mesenteric artery angioplasty and stenting to facilitate guidewire navigation through the plaque and allow stent graft balloon expansion, according to one embodiment. [Figure 10] 1A-1C are schematic illustrations of the use and deployment of a side-viewing telescoping frame for coronary angioplasty to facilitate guidewire navigation for coronary artery cannulation, according to one embodiment. [Figure 11] 1A-1C are schematic illustrations of the use and deployment of a side-viewing telescoping frame for cardiac resynchronization therapy to facilitate lead placement through the coronary sinus, according to one embodiment. [Figure 12] 1A-1C are schematic illustrations of the use and deployment of a side-looking steering device for needle navigation within a transseptal puncture, according to one embodiment. [Figure 13] 1A-1C are schematic diagrams of the use and deployment of a side-viewing telescoping frame for guidewire navigation in transcatheter mitral valve repair, according to one embodiment. [Figure 14] 1A-1C are schematic illustrations of the use and deployment of a side-viewing telescoping frame for guidewire navigation in transcatheter tricuspid valve repair, according to one embodiment. [Figure 15] 1 is a schematic illustration of the use and deployment of a side-view telescoping frame for venipuncture and stent-graft deployment in a transjugular intrahepatic portosystemic shunt, according to one embodiment. FIG. [Figure 16] 1 is a schematic illustration of the use and deployment of a side-view telescopic frame for delivery of a coil within a cerebral or cardiac aneurysm during an endovascular coiling procedure, according to one embodiment. [Figure 17A] 1A-1C are perspective views of a side-viewing telescoping frame depicting stages in the manufacturing process before and after expanding the side-viewing telescoping frame, according to one embodiment. [Figure 17B] 1A-1C are perspective views of a side-viewing telescoping frame depicting stages in the manufacturing process before and after expanding the side-viewing telescoping frame, according to one embodiment. [Figure 18] 10A-10C are perspective views of a sequence of expansion of a side-viewing telescoping frame according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0034] While various embodiments are susceptible to various modifications and alternative forms, details of which have been shown by way of example in the drawings and will be described in detail, it is to be understood, however, that there is no intention to limit the claimed invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

[0035] Disclosed herein are devices, systems, and methods for steering side-viewing devices, including guidewires or catheters, during various medical interventional procedures. The disclosed examples propose a more stable steering system that may reduce the incidence of vascular trauma and the number of catheter exchanges / manipulations. Embodiments of the disclosed devices may also enable interventional device access in tortuous vasculature and difficult-to-reach sites. The disclosed devices may include a side-viewing telescoping frame that can be deployed or anchored within a lumen, ventricular cavity, stent graft, or any anatomical site of interest. The side-viewing telescoping frame may house a flexible, curved, or angled internal catheter designed to allow passage of an interventional device, such as a guidewire, catheter, microcatheter, energy source, laser, needle, intravascular ultrasound, or an angioscope.

[0036] 1A-1E disclose a side-viewing steering device 100 for positioning an interventional device within a patient. The side-viewing steering device 100 shown includes a side-viewing telescoping frame 1, an angled inner catheter 2, and a sheath 3. Some embodiments of the side-viewing steering device 100 further depict a string or cable 4 for directing a guidewire 5 or other interventional device.

[0037] Centrally located in Figures 1A-1E is the angled internal catheter 2. The angled internal catheter 2 is made of a tubular flexible material and includes a distal end portion 102 that is biased to bend to one side when unconstrained. The distal end portion 102 begins at an unbent first location 104 and terminates at a distal tip 106. Thus, the distal end portion 102 is the portion of the angled internal catheter 2 that is seen, for example, in Figures 1A-1E.

[0038] The side-view telescopic frame 1 includes a tubular base 110 and multiple leaflets 112. Specifically, eight leaflets 112 are visible in FIG. 1A. Each of the illustrated leaflets 112 is an elongated member having a common bending direction and a distal end 116. This common bending direction refers to a tendency toward a similar overall general direction and bending location, as shown in the figure. The leaflets having a common bending direction should not be interpreted so narrowly as to limit the leaflets to structures of precisely the same shape, configuration, and orientation. The tubular base 110 has a proximal end 114 and a distal end 116. The proximal end 114 and the tubular base 110 are not clearly visible in FIGS. 1A-1E; see, for example, FIG. 18. In FIGS. 1A-1E, the angled internal catheter 2 is shown extending through the tubular base 110. The multiple leaflets 112 have various lengths and widths. Each leaflet 112 extends from the distal end 116 of the tubular base 110 when unconstrained, as shown. Each leaflet 112 is biased in shape so that it extends outward and in a curved orientation to one side, circumferentially surrounding the distal tip 106 of the angled inner catheter 2 at the distal end 118 of the leaflet 112. The side-viewing telescopic frame 1 and its leaflets 112 can be formed from tubing in certain embodiments. In some embodiments, the side-viewing telescopic frame 1 is formed by laser cutting, photoetching, electrical discharge machining (EDM), or water jet ablation. In some embodiments, the side-viewing telescopic frame 1 comprises a shape memory metal. Such a shape memory metal can include, for example, a nickel-titanium alloy.

[0039] In some embodiments, the leaflets 112 are joined by at least one strut 119. In some embodiments, the configuration of the at least one strut 119 varies along its length. In some embodiments, the at least one strut 119 has multiple connection points 121 that allow multiple leaflets 112 to be joined.

[0040] In some embodiments, the set of strings 4 is tethered to the distal ends 118 of the leaflets 112 of the side-viewing telescopic frame 1. See, for example, FIGS. 1B and 1C. In some embodiments, the leaflets 112 may extend to the distal ends 118 with openings 10 that form an eyelet configuration (see, for example, FIG. 3). In some cases, the leaflets 112 may extend to the distal ends 118 with radiopaque markers 16 (see, for example, FIG. 6).

[0041] Although only partially shown in Figures 1A-1E, the sheath 3 can be generally of an elongated tubular shape within which the angled inner catheter 2 and the side-viewing telescopic frame 1 are sized for axial retraction. Specifically, they are retracted and collapsed into a compressed state.

[0042] The side-viewing curved and tilted nature of the device 100 and frame 1 can be understood in various ways. FIG. 1D illustrates one example in which the distal end portion 102 of the tilted internal catheter 2 has a first tubular axis 120 at a first unbent location 104 and a second tubular axis 122 at the distal tip 106. In some side-viewing device embodiments, the angle θ between the first tubular axis 120 and the second tubular axis 122 is at least 50 degrees. In some side-viewing device embodiments, the angle θ between the first tubular axis 120 and the second tubular axis 122 is between 70 and 110 degrees. In some side-viewing device embodiments, the angle θ between the first tubular axis 120 and the second tubular axis 122 is approximately perpendicular.

[0043] In some embodiments, such as in FIG. 1C , the side-viewing steering device 100 can be understood to include a side-viewing telescopic frame 1, a set of strings 4 tethered to the distal end of the side-viewing telescopic frame 1, and an angled internal catheter 2. The side-viewing telescopic frame 1 is shaped to be deployed outwardly within a cavity, such as a lumen, a stent graft, or a ventricular cavity, and the side-viewing telescopic frame has a distal end. The angled internal catheter 2 can be secured inside the side-viewing telescopic frame 1 and supported by a set of strings 4 connected to the distal end 102 of the angled internal catheter 2. The angled internal catheter 2 is manipulated using the set of strings 4, which has at least one degree of freedom, to control the position of the interventional device.

[0044] The side-viewing telescopic frame 1 can be retracted inside the sheath 3 and redeployed while maintaining its maximum expanded diameter. The side-viewing telescopic frame 1 can maintain its rigidity when the angled internal catheter 2 is steered. In some embodiments, the angled internal catheter 2 is bent at a 90-degree angle. The side-viewing telescopic frame 1 can include multiple leaflets 112 joined by multiple struts 119.

[0045] In some embodiments, the side-viewing telescopic frame 1 may include a tubular base 110 and multiple leaflets 112. The tubular base 110 has a proximal end 114 and a distal end 116. The tubular base 110 may be sized to allow the angled inner catheter 2 to extend therethrough. The multiple leaflets 112 are of various lengths and extend from the distal end 116 of the tubular base 110.

[0046] As shown in Figure 1E, each of the plurality of leaflets 112 may be biased to expand outwardly with the first portion 130 in a straight configuration and to expand laterally outward with the second portion 132 in an angled configuration. In some embodiments, the angled configuration of the second portion 132 differs from the straight configuration of the first portion 130 by at least 50 degrees. As seen in Figure 1E, each of the plurality of leaflets 112 varies in width.

[0047] Additionally, the distal ends 118 of the leaflets 112 may form apertures 10 having an eyelet configuration. In some embodiments, the leaflets 112 have distal ends 118 with radiopaque markers 16. In some embodiments, the leaflets 112 may have at least one strut 119 and include a plurality of connection points 121 that allow for joining of the leaflets 112.

[0048] 1A, side-viewing telescoping frame 1 may be attached to an angled internal catheter 2. The angled internal catheter 2 may be designed to allow the passage of an interventional device such as a guidewire, catheter, microcatheter, energy source, laser, needle, intravascular ultrasound, or angioscope. Side-viewing telescoping frame 1 may be folded inside a hollow cylindrical tube or sheath 3. The hollow cylindrical tube or sheath 3 may vary in length and width depending on the interventional procedure being performed.

[0049] In one example, the tilted internal catheter 2 can be used to facilitate cardiac resynchronization therapy and treat patients suffering from chronic heart failure. Using a transvenous approach, the coronary sinus is cannulated to allow delivery of a pacing lead to the coronary venous system. The side-viewing telescopic frame 1 facilitates access to the coronary sinus and improves orientation for accessing its ostium. Additionally, positioning the tilted internal catheter 2 becomes less difficult. Thus, the side-viewing telescopic frame 1 allows for easier positioning and greater maneuverability due to the curved orientation of the side-viewing telescopic frame.

[0050] Reference is now made to Figures 1B and 1C, which are perspective views of a side-viewing telescoping frame 1, respectfully allowing one or two degrees of freedom, housing an angled internal catheter 2 that may allow the passage of an interventional device such as a guidewire 5. The side-viewing telescoping frame 1 may also act as an anchor for multiple strings or cables 4, which may be retracted inside a cylindrical tube or sheath 3.

[0051] Referring now to the embodiment in FIG. 2 , the steering device 9 may include a side-viewing telescopic frame 1 positioned inside the sheath 3. The sheath 3 may be used to steer the tilted internal catheter 2 by moving a joystick 7 seen on the handle side 6. The joystick 7 may be configured to actuate multiple strings or cables 4 to enable steering of the tilted internal catheter 2 in two degrees of freedom. Alternatively, and as seen in FIG. 1B , the tilted internal catheter 2 may be steered in one degree of freedom. A guidewire 5 may then be threaded through the lumen of the tilted internal catheter 2. The handle side 6 may have a slide button 8 that allows tension on the multiple strings or cables 4 to be released.

[0052] In examples, by actuating multiple strings or cables from the handle side 6, the angled internal catheter 2 can be steered with multiple degrees of freedom to allow controlled and precise positioning of the catheter tip in a plane opposite the region or vasculature of interest. The present disclosure provides a more stable mechanical system for deploying stents, microcoils, balloon expandable stents, or any other interventional device in a less traumatic manner.

[0053] Reference is now made to Figure 3, which is a perspective view of an alternative design of a side-viewing telescoping frame 1 that may be attached to a sheath 3 and used as a steering device 9, according to one example. The side-viewing telescoping frame 1 may have one or more openings 10, including holes, at its distal tip for multiple strings or cables 4 to pass through and be tethered thereto. In another example, the side-viewing telescoping frame may also have an extension 11 on its distal end to prevent the angled inner catheter 2 from interacting with the anatomical structure to which the side-viewing telescoping frame 1 is deployed or tethered.

[0054] In various embodiments, the side viewing telescoping frame 1 can be formed from a tube. In alternative or additional embodiments, the side viewing telescoping frame 1 can be formed by laser cutting, photoetching, EDM, or by water jet ablation. In various embodiments, the side viewing telescoping frame can include a shape memory metal. The shape memory metal can include, for example, a nickel-titanium alloy. As shown in FIG. 18 , a portion of the side viewing telescoping frame 1 cut from a tube can be seen from a first depiction of its compressed state. Additionally, the continuous, one-piece construction of the side viewing telescoping frame 1 is shown.

[0055] 4, a side-viewing telescoping frame can have a laterally configured mesh basket 1B. A number of strings or cables 4 tethered to the basket 1B are used to steer an angled internal catheter 2. The angled internal catheter 2 can be deployed from or retracted into a sheath 3. The sheath 3 can vary in length and design based on the intended interventional medical procedure.

[0056] Reference is now made to Figure 5, which is an example of a side-viewing telescopic frame 1 with fabric 12 sewn, stitched, or glued to the exterior or interior surface of the side-viewing telescopic frame 1 to add further mechanical support or to hold multiple branches together. The fabric 12 allows the frame 1 to maintain its rigidity when multiple strings or cables 4 are actuated to steer the angled internal catheter 2 during an interventional procedure.

[0057] 6, the side-viewing telescoping frame, according to one example, may be used for procedures for target vessel cannulation. The side-viewing telescoping frame 1 may be deployed from inside the sheath 3 to be placed within a stent graft 13 having a fenestration or opening 14. Radiopaque markers 16 may be used and placed on the distal end of the side-viewing telescoping frame 1 and the angled inner catheter 2.

[0058] In one example, after confirming that the side-viewing telescopic frame 1 is facing the orifice of the renal artery 15, the multiple strings or cables 4 can then be manipulated to steer the angled internal catheter 2 into a position facing the fenestration or opening 14. A guidewire 5 can then be threaded through the lumen of the angled internal catheter 2 to perform cannulation and catheterization of the renal artery 15.

[0059] Reference is now made to Figure 7, which is an example of a side-viewing telescopic frame 1 being used in an aortic arch repair procedure. The side-viewing feature of the side-viewing telescopic frame 1 provides an additional mechanical advantage when performing target vessel cannulation from inside the stent graft 13 using a guidewire 5. When the guidewire is deployed from within the sheath 3, the guidewire 5 is configured to orient in the same plane as the ostium to be treated.

[0060] 8, the side-viewing telescopic frame 1 can be positioned opposite the orifice of the renal artery 15 to pass the ablation catheter 16 through the lumen of the angled internal catheter 2. Manipulation of the multiple strings or cables 4 can be manipulated to steer the angled internal catheter 2 and in turn, steer the ablation catheter 16 to different positions to ensure that the radiopaque marker 17 on the ablation catheter 16 is in contact with the nerve 18 to be ablated.

[0061] Reference is now made to Figure 9, which is a deployment view of a side-viewing telescoping frame 1 positioned inside the superior mesenteric artery 19 to facilitate navigation of a guidewire 5 through a plaque 20 for the purpose of performing an angioplasty procedure. The guidewire 5 may be deployed obliquely to properly enter the superior mesenteric artery 19. The side-viewing telescoping frame 1 allows the guidewire 5 to pass through the plaque 20 and enter the superior mesenteric artery 19 without having to reposition the steering device.

[0062] Referring now to FIG. 10 , a side-viewing telescopic frame 1 can be deployed inside a heart 21, facing a coronary artery 22. The angle of the side-viewing telescopic frame 1 can facilitate precise navigation of a guidewire 5 through a plaque 20 as part of an angioplasty and stent placement procedure. Mesenteric angioplasty and stent placement is a minimally invasive procedure used to treat patients with chronic mesenteric ischemia. An angled internal catheter 2 can be used to advance a guidewire 5 through a plaque 20 occluding a mesenteric artery. Excessive guidewire and catheter manipulation can increase the risk of bifurcation perforation. Therefore, a side-viewing telescopic frame 1 using an angled catheter 2 can enable better placement and less catheter-guidewire manipulation. In another example, the side-viewing telescopic frame 1 can enter through additional vessels to access different cavities and vessels of the heart.

[0063] Reference is now made to FIG. 11 , which illustrates another example in which a side-viewing telescopic frame 1 is deployed within a heart 21 against the coronary sinus 23 to facilitate accurate placement of a pacing lead within the coronary venous system. Cardiac resynchronization therapy is used to treat patients suffering from chronic heart failure. Using a transvenous approach, the coronary sinus 23 is cannulated to enable delivery of a pacing lead into the coronary venous system. However, in most patients, accessing the coronary sinus remains challenging due to difficulties arising from its anatomy and the orientation of its ostium. Therefore, the side-viewing telescopic frame 1 may enable easier positioning due to its curved shape. Because rotation of the catheter and sheath inside the vasculature or multiple catheter exchanges can result in arrhythmias and vascular injury, the use of an angled internal catheter 2 delivered through a sheath 3 may lead to improved procedural outcomes.

[0064] 12, the side-viewing telescoping frame 1, when advanced out of the sheath 3, can be positioned within the right atrium 24. Multiple strings or cables 4 can be actuated to precisely steer the angled internal catheter 2 to face the fossa ovalis 25 and allow passage of a needle 26 to perform a transseptal puncture. The angled internal catheter 2 can be deployed from the sheath 3, which can be provided in multiple lengths to facilitate different anatomies in different users.

[0065] In another example, and as seen in FIG. 13 , a side-viewing telescopic frame 1 can be deployed within the left atrium 27 to facilitate navigation of a guidewire 5 through the mitral valve 28. The guidewire 5 can be inserted into the mitral valve 28 of the left atrium 27 as part of a mitral valve repair procedure. Mitral valve 28 repair is often required after a successful transseptal puncture to treat mitral regurgitation or stenosis. Due to the location of the mitral valve 28 and its large size, the side-viewing telescopic frame 1 allows for increased flexion to navigate the mitral valve. Additionally, the telescopic nature of the side-viewing telescopic frame 1 allows for increased precision and manipulation by the clinician to address different anatomies in different patients.

[0066] 14 illustrates the use and deployment of a side-viewing telescoping frame 1 in a tricuspid valve repair procedure. A sheath 3 can be inserted into the right atrium of the heart to reach the tricuspid valve.

[0067] Reference is now made to FIG. 15 , which is an example of an application of the side-viewing telescopic frame 1, in which the side-viewing telescopic frame 1 is deployed inside the liver 29. Once deployed, the side-viewing telescopic frame 1 can deliver a needle 26 to perform a coronary artery puncture. A stent graft 13 can then be placed through the puncture site as part of a transjugular intrahepatic portosystemic shunt. In another example, a guidewire 5, rather than a needle 26, can be used for interventional procedures within the liver. Depending on clinical needs, the side-viewing telescopic frame 1 can deploy various instruments and objects through the sheath 3 for different medical purposes.

[0068] 16 , a side-viewing telescopic frame 1 may be deployed inside a cerebral artery 30. Once deployed, the side-viewing telescopic frame 1 may facilitate delivery of a coil 31 inside an aneurysm 32 as part of an endovascular coiling procedure. The side-viewing telescopic frame 1 is configured to be deployed at a controlled angle to precisely deliver the coil 31.

[0069] 17A, 17B, and 18 depict aspects of a manufacturing process that may be used to produce a side-viewing telescoping frame 1 as described throughout the embodiments of the present disclosure. The side-viewing telescoping frame 1 may be fabricated from a tubular body (cylindrical tube) made of a superelastic or shape-memory alloy such as Nitinol. Methods for creating the side-viewing telescoping frame 1 may include forming a stent cut or pattern by selective removal of material using laser cutting, water jet cutting, chemical milling, or electrical discharge machining.

[0070] After the removal process, the shape of the cut tube can be asymmetrical, with one side longer than the other, to allow for material deformation and achieving the desired side-view shape. The initiation of the shape-setting process involves a series of incremental steps utilizing custom-designed molds of different sizes to expand the cut Nitinol tube from its initial diameter to its fixed diameter by heating it at an elevated temperature. Once solidified and cooled, it is reheated to undergo a second shape-setting process that laterally deforms it using a different shape and bend angle fixation.

[0071] The embodiments shown in Figures 17A and 17B each depict a specific initial stage in which the side viewing telescoping frame 1 is cut or fabricated into a collapsed configuration, and a second stage in which the side viewing telescoping frame 1 is expanded using a progressive custom mold 140. This manufacturing process involves expanding an initially tubular cut tube through various heating, cooling, reheating, and deformation steps. Figure 18 further depicts the stages of leaflet 112 bending and expansion that must be performed in order for the side viewing telescoping frame to deform reliably when unconstrained within a patient's body.

[0072] 17A and 17B further provide exemplary views of the side-viewing telescoping frame 1 before and after expansion, according to one example. The side-viewing telescoping frame 1 may start in a closed or constricted position to allow access to smaller anatomical structures. The sheath 2 may vary in length and width depending on the procedure to be performed and what instruments may be delivered or positioned through the sheath. After insertion or manipulation into the targeted anatomical structure, the side-viewing telescoping frame 1 may be expanded or unfolded, as seen in FIG. 17B. Expansion may allow for easier anchoring of the device, more precise placement, and easier delivery.

[0073] In embodiments, the side-viewing telescopic frame 1 may have a tubular body with proximal and distal ends and a plurality of leaflets. Each leaflet may be secured to the distal end of the tubular body of the shaft 2. Furthermore, the leaflets may have first and second portions, each of which expands in a different configuration. For example, the first portion of the leaflets may gradually expand in a straight configuration, while the second portion of the leaflets may be deformed to expand obliquely laterally with the distal tips of the leaflets bent inward. In alternative examples, the leaflets may expand in an inverted configuration or in additional configurations as deemed appropriate or necessary depending on the procedure being performed.

[0074] In embodiments, the leaflets may vary in length and width depending on the minimally invasive procedure being performed. The distal ends of the leaflets may also form eyelet configurations and / or have radiopaque markers. The leaflets have at least one strut, which may vary in width along the length of the strut. The at least one strut may have multiple connection points to allow for the attachment of multiple leaflets.

[0075] Reference is now made to FIG. 18 , which illustrates an example sequence of expansion of a telescopic frame. The side-viewing telescopic frame 1 can be expanded to various degrees, as seen in FIG. 18 . At each level of expansion, the stretching or unfolding of the side-viewing telescopic frame 1 can be halted or stopped to allow for increased usability and precise placement of the device and therapy being delivered. Furthermore, the side-viewing telescopic frame 1 can be configured to be controlled and deployed to unfold progressively within a human vessel or organ. For example, if the targeted anatomical structure is in a small, hard-to-reach area, the side-viewing telescopic frame 1 can only partially expand, allowing for increased access to and better delivery of therapies and devices.

[0076] In assembly, the proposed disclosure describes a self-expanding side-viewing frame 1 that can be folded into a compressed configuration with a delivery sheath 3 and then easily expanded at the treatment site when the sheath or delivery device is retracted.

[0077] During operation, the side-viewing telescopic frame 1 can be retracted inside the sheath 3 and redeployed while maintaining its maximum expanded diameter. The side-viewing telescopic frame can include a cable drive mechanism for positioning an interventional device. As depicted in the various figures, such an interventional device can be located at the distal tip 106 of the angled internal catheter 2. After the side-viewing telescopic frame 1 is deployed within a cavity, such as a lumen, a stent graft, or a ventricular cavity, multiple strings or cables 4 can be tethered to the distal end of the side-viewing telescopic frame 1. The curved or angled internal catheter 2 is then supported by the multiple strings or cables 4 secured inside the side-viewing telescopic frame 1 and connected to the distal end of the angled internal catheter 2.

[0078] In examples, by using multiple strings or cables 4, the bending internal catheter 2 can be manipulated with at least one degree of freedom to control the position of an interventional device within a lumen, stent graft, or ventricular chamber. The side-viewing telescopic frame 1 can maintain its rigidity as the bending internal catheter 2 is manipulated. The bending internal catheter 2 can be bent or tilted at various angles, including 90-degree angles. The multiple strings or cables 4 can include any number of sets of strings or cables.

[0079] Various embodiments of systems, devices, and methods are described herein. These embodiments are provided by way of example only and are not intended to limit the scope of the claimed invention. Furthermore, it should be understood that various features of the described embodiments can be combined in various ways to produce numerous additional embodiments. Furthermore, while various materials, dimensions, shapes, configurations, locations, etc. are described for use with the disclosed embodiments, others than those disclosed may be utilized without departing from the scope of the claimed invention.

[0080] Those skilled in the art will understand that the inventive subject matter may include fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not intended to be an exhaustive representation of ways in which various features of the inventive subject matter can be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, various embodiments may include combinations of different individual features selected from different individual embodiments, as will be understood by those skilled in the art. Furthermore, elements described in connection with one embodiment may be implemented in other embodiments, even when not described in such embodiments, unless otherwise noted.

[0081] Although a dependent claim may refer to a specific combination with one or more other claims within the claim, other embodiments may also include combinations of the dependent claim with the subject matter of each other dependent claim, or combinations of one or more features with other dependent or independent claims. Such combinations are suggested herein unless it is stated that a particular combination is not intended.

[0082] Any incorporation by reference of the above documents is limited so that no subject matter contrary to the express disclosure herein is incorporated. Any incorporation by reference of the above documents is further limited so that no claims contained in such documents are incorporated by reference herein. Any incorporation by reference of the above documents is still further limited so that any definitions provided in such documents are not incorporated by reference herein, unless expressly included herein.

[0083] For purposes of claim interpretation, the provisions of 35 U.S.C. § 112(f) are expressly intended not to be infringed unless the specific terms "means for" or "steps for" are recited in a claim.

Claims

1. 1. A side-looking steering device for positioning an interventional device within a patient, comprising: a beveled inner catheter of tubular flexible material including a distal end portion biased to bend to one side when unconstrained, said distal end portion beginning at a non-bending first location and terminating at a distal tip; A side-view telescopic frame, a tubular base having a proximal end and a distal end, the angled inner catheter extending through the tubular base; a plurality of leaflets of varying lengths and widths, each leaflet extending from the distal end of the tubular base when unconstrained and biased in shape to extend outwardly and to one side in a curved orientation to circumferentially surround the distal tip of the tapered inner catheter; A side-view telescopic frame including: a sheath of elongated tubular shape, within which the angled internal catheter and the side-viewing telescopic frame are sized for axial retraction and collapse into a compressed state; A side-viewing steering device comprising:

2. 10. The side-viewing steering device of claim 1, wherein the side-viewing telescoping frame including the plurality of leaflets of varying lengths and widths is cut from a tube.

3. 3. The side-viewing steering device of claim 2, wherein the side-viewing telescoping frame is a continuous structure.

4. 10. The side-viewing steering device of claim 1, wherein the side-viewing telescoping frame is formed by laser cutting, photoetching, EDM, or by water jet ablation.

5. 2. The side-viewing steering device of claim 1, wherein the distal end portion, when unconstrained, has a first tubular axis at the unbent first location and a second tubular axis at the distal tip.

6. 6. The side-looking steering device of claim 5, wherein the angle between the first tubular axis orientation and the second tubular axis orientation is at least 50 degrees.

7. 6. The side-looking steering device of claim 5, wherein the angle between the first tubular axis orientation and the second tubular axis orientation is between 70 and 110 degrees.

8. 6. The side-looking steering device of claim 5, wherein the angle between the first tubular axis orientation and the second tubular axis orientation is approximately perpendicular.

9. The side-looking steering device of claim 1 , wherein the distal ends of the leaflets form an eyelet configuration.

10. The side-viewing steering device of claim 1 , wherein the leaflets have distal ends with radiopaque markers.

11. 10. The side-viewing steering device of claim 1, wherein the leaflets are joined by at least one strut.

12. 12. The side-looking steering device of claim 11, wherein the width of the at least one strut varies along the length of the strut.

13. 12. The side-viewing steering device of claim 11, wherein the at least one strut has a plurality of connection points that allow for joining of the plurality of leaflets.

14. The side-viewing steering device of claim 1, further comprising a set of strings tethered to the distal end of the side-viewing telescopic frame, which provide part of a cable drive mechanism for positioning an interventional device at the distal tip of the angled internal catheter.

15. 15. The side-viewing steering device of claim 14, wherein the distal tip of the angled internal catheter is in planar alignment with the anchoring location of the set of strings on the distal end of the side-viewing telescopic frame.

16. 1. A side-looking steering device for positioning an interventional device within a patient, comprising: a side-viewing telescoping frame configured to be deployed outwardly within a cavity such as a lumen, a stent graft, or a ventricular cavity, the side-viewing telescoping frame having a plurality of elongated leaflet members having a common bending direction and distal ends; a set of strings tethered to the distal end of the side-viewing telescopic frame; a tilted internal catheter fixed inside the side-viewing telescopic frame, the tilted internal catheter being supported by the set of strings connected to a distal end of the tilted internal catheter; Equipped with A side-looking steering device, wherein by using the set of strings, the angled internal catheter is manipulated in at least one degree of freedom to control the position of the interventional device.

17. 17. The side-viewing steering device of claim 16, wherein the side-viewing telescoping frame is retracted inside a sheath and redeployed while maintaining its maximum expanded diameter.

18. 17. The side-viewing steering device of claim 16, wherein the side-viewing telescoping frame can maintain its rigidity when the angled internal catheter is steered.

19. 17. The side-looking steering device of claim 16, wherein the angled internal catheter is bent at a 90 degree angle.

20. 17. The side-viewing steering device of claim 16, wherein the side-viewing telescoping frame comprises a plurality of leaflets joined by a plurality of struts.

21. 1. A side-viewing telescoping frame for positioning an interventional device within a patient, comprising: a tubular base having a proximal end and a distal end, the tubular base being sized to allow the angled inner catheter to extend therethrough; a plurality of leaflets of varying lengths extending from the distal end of the tubular base; Equipped with A side-viewing telescoping frame, wherein each of the plurality of leaflets is biased to expand outwardly in a straight configuration with a first portion and biased to expand outwardly laterally in a tilted configuration with a second portion.

22. 22. The side-viewing telescoping frame of claim 21, wherein the angled configuration of the second portion differs from the straight configuration of the first portion by at least 50 degrees.

23. 22. The side-viewing telescoping frame of claim 21, wherein each of said plurality of leaflets has a varying width.

24. 22. The side-viewing telescoping frame of claim 21, wherein the distal ends of the plurality of leaflets form an eyelet configuration.

25. 22. The side-viewing telescoping frame of claim 21, wherein the plurality of leaflets have distal ends with radiopaque markers.

26. 22. The side-viewing telescopic frame of claim 21, wherein each of the plurality of leaflets has at least one strut.

27. 27. The side-viewing telescoping frame of claim 26, wherein the at least one strut has a plurality of connection points that allow for joining of the plurality of leaflets.

28. 22. The side viewing telescoping frame of claim 21, wherein the side viewing telescoping frame is formed from a tube.

29. 22. The side viewing telescoping frame of claim 21, wherein the side viewing telescoping frame is formed by laser cutting, photoetching, EDM, or by water jet ablation.

30. 22. The side viewing telescoping frame of claim 21, wherein the side viewing telescoping frame comprises a shape memory metal.

31. 30. The side viewing telescoping frame of claim 28, wherein the tubes forming the side viewing telescoping frame are asymmetric with one side having a greater length than the other.

32. 29. The side-viewing telescopic frame of claim 28, wherein the tube is expanded to different diameters during a first shape setting, cooled, and reheated to create multiple shapes and angles through a second shape setting.

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