Side view expandable frames and devices for manipulating interventional devices

Abstract

A side-looking manipulation device for positioning an interventional device within a patient. The side-looking manipulation device includes an angled inner catheter, a side-looking expandable frame, and a sheath. The angled inner catheter is made of a tubular flexible material and includes a distal portion that, when unconstrained, is biased to bend toward one side. The side-looking expandable frame includes a tubular base and a plurality of leaflets. The tubular base has a proximal end and a distal end, and the angled inner catheter extends through the tubular base. The plurality of leaflets each have a different length and width. When unconstrained, each leaflet extends from the distal end of the tubular base and is shaped biased such that it extends outwardly and to one side in the direction of curvature to peripherally surround the distal tip of the angled inner catheter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 438,187, filed on January 10, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to the manipulation of interventional devices (e.g., guidewires, catheters, and needles). More specifically, the present disclosure relates to devices with side-viewing expandable frames for guiding interventional procedures and related methods. Additionally, the present disclosure relates to the manipulation and tracking of interventional devices for medical procedures.

[0004] background

[0005] Catheters and guidewires are the primary interventional tools used in minimally invasive surgery. They are long, flexible devices that can be inserted into anatomical structures and remotely controlled from outside the body. Guidewires are typically used to navigate through anatomical structures, while catheters extend along the guidewire to provide support and allow for the delivery of other interventional devices, such as balloons, stents, guidewires, needles, and implants. Due to the limitations of remote control of these devices, most surgical time is dedicated to manipulating the catheter and guidewire.

[0006] Many cardiovascular procedures are performed using minimally invasive techniques using catheters and guidewires. Example applications may include therapeutic or diagnostic procedures, all of which require accurate manipulation of interventional devices to the intended anatomical target.

[0007] To address the limitations in guidewire navigation, catheter tips are pre-shaped into various curvatures to help guide the guidewire in a specific direction. However, these are still subject to the same navigation and support limitations as straight catheters and may require looping through multiple devices to reach the destination. Another approach uses a cable fixed to one side of the catheter tip that extends back to the handle and can be actuated to deflect the catheter. The catheter tip has a portion made of a softer material than the rest of the catheter to maximize the amount of deflection that occurs at the tip.

[0008] Another approach uses an external magnetic field to directly manipulate the catheter tip. This can be achieved by integrating a magnet at the catheter tip and adjusting the external magnetic field to control the position of the device. The field can be remotely controlled from outside the operating room, reducing the user's exposure to the ionizing radiation of X-ray image guidance. These magnetically actuated catheters typically require a dedicated operating room with equipment to generate the magnetic field, and the catheters are customized to be compatible with the technology. The 2D guidance of X-ray fluoroscopy exacerbates the mechanical limitations of the catheter device. In addition, X-rays do not provide great resolution or contrast when imaging soft tissues. Alternative imaging modalities can be used to supplement the image guidance provided by X-rays and provide additional detailed information about tissue structure, composition, and function for diagnostic purposes.

[0009] Other attempts to address some of these limitations include robotically manipulated catheters. Robotic catheters use motorized pull wires to mechanically advance, retract, and rotate the catheter away from the body. Therefore, robotic tendon-based devices are still subject to the same limitations of navigation and manipulation as conventional devices.

[0010] Therefore, there is a need for devices, systems, and methods that can provide improved visualization, navigation, and device support in a desired orientation for surgery, particularly at the acute angles that are challenging in many minimally invasive procedures.

[0011] Overview

[0012] The present disclosure addresses limitations in accurate manipulation and precise handling of interventional devices within the vascular system, particularly for applications where sharp deflection angles are required. The disclosed embodiments provide a more stable handling system that can reduce the incidence of vascular injury and the number of catheter changes / manipulations, as well as allow interventional devices to enter tortuous vasculature and hard-to-reach locations. The disclosed system includes a side-view expandable frame that can be deployed or anchored within a vascular lumen, a cardiac chamber, a stent graft, or any anatomical site of interest.

[0013] Embodiments include a side-viewing manipulator for positioning an interventional device within a patient's body. The side-viewing manipulator includes an angled inner catheter, a side-viewing expandable frame, and a sheath. The angled inner catheter is made of a tubular flexible material and includes a distal portion that, when unconstrained, is biased to bend to one side. The distal portion begins in a first, unbent position and terminates at a distal tip. The side-viewing expandable frame includes a tubular base and a plurality of leaflets. The tubular base has a proximal end and a distal end, and the angled inner catheter extends through the tubular base. The plurality of leaflets have different lengths and widths. When unconstrained, each leaflet extends from the distal end of the tubular base and is biased in shape so that it extends outward and to one side in the direction of the bend to peripherally surround the distal tip of the angled inner catheter. The sheath has an elongated tubular shape, and the angled inner catheter and the side-viewing expandable frame are sized to be axially retracted into the sheath and folded into a compressed state within the sheath.

[0014] Embodiments include a side-view manipulator for positioning an interventional device in a patient's body. The side-view manipulator includes a side-view expandable frame, a set of strings anchored on the distal end of the side-view expandable frame, and an angled inner catheter. The side-view expandable frame is shaped to expand outward within a cavity (e.g., a vascular lumen, a stent graft, or a cardiac chamber). The side-view expandable frame also has a plurality of elongated leaflet members having a common bending direction and a distal end. A set of strings is anchored on the distal end of the side-view expandable frame. The angled inner catheter can be fixed inside the side-view expandable frame and supported by a set of strings connected to the distal end of the angled inner catheter. The angled inner catheter is operated by controlling the position of the interventional device using a set of strings having at least one degree of freedom.

[0015] Embodiments include a side-view expandable frame for positioning an interventional device within a patient. The side-view expandable 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 inner conduit to extend therethrough. The plurality of leaflets have different 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 for a first portion and is biased to expand outwardly in a configuration that is angled to one side for a second portion.

[0016] In an embodiment, the side-view expandable frame houses a flexible, angled inner catheter designed to allow passage of an interventional device (e.g., a guidewire, catheter, microcatheter, energy source, laser, needle, intravascular ultrasound, or angioscope).

[0017] In another embodiment, the side-view expandable frame can manipulate the inner catheter using magnetic or electric field generators that can be connected to branches of the frame. In another embodiment, the side-view expandable frame can be mounted on a multi-lumen inner catheter to allow multiple interventional devices to pass through simultaneously. In another embodiment, the distal end of the expandable frame can be used as an anchor for multiple ropes or cables that are fixed to the distal tip of the inner catheter at one end and connected to a handle at the other end. By actuating the ropes from the handle end, the inner catheter can be manipulated with multiple degrees of freedom to allow control and accurate positioning of the catheter tip in a plane facing the target area or vascular system. The present disclosure provides a more stable mechanical system for deploying stents, microcoils, balloon-expandable stents or any other interventional devices in a less invasive manner.

[0018] In another embodiment, the side-viewing expandable frame can have radiopaque markers at its distal end to allow for better visualization and orientation of the frame relative to the anatomy under fluoroscopy. The side-viewing expandable frame branches can 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 area of ​​interest as it moves.

[0019] In another embodiment, the side-view expandable frame can form an eyelet at the distal tip to allow actuation of multiple ropes or cables with minimal friction for cable-based control and using the frame as an anchor for cables in a parallel cable drive mechanism.

[0020] In another embodiment, the present disclosure can be used for interventional, diagnostic or drug infusion procedures, such as regenerative stem cell therapy, clot dissolving drugs, chemotherapeutic agents, injection of contrast agents, or for biopsy in oncology applications. The present disclosure can also be used for imaging purposes.

[0021] In another embodiment, the inner conduit may be flexible, but not so flexible as to prevent a user from being able to transmit meaningful forces through the device unless supported by a portion of the anatomy (eg, a vessel wall).

[0022] Applicants have recognized the need for the present disclosure in various areas of interventional devices. In one example, the surgery can involve a fenestrated endovascular aortic repair procedure, a minimally invasive method for placing an expandable fenestrated stent graft within a dilated aorta. An important step in this surgery is gaining access from within the stent graft to important arteries that provide blood supply to other organs. Typically, J-tip catheters are used to guide guide wires to a target location for vascular cannulation and catheterization. However, due to the extreme take-off angles of the target vessel and its parent artery, the maneuverability and torquability levels of these catheters and guide wires are quite low. Therefore, a side-view expandable frame can reduce the possibility of an increase in operative time, radiation exposure, contrast volume, and risk of renal failure.

[0023] Another example is endovascular aortic arch repair surgery, in which a guidewire is used to facilitate the placement of a stent graft in the supplying artery. After the main graft is deployed, branch grafts need to be placed to allow continued perfusion of the supra-aortic vessels. Although 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 large pulsatile blood flow, accessing the target vessel ostium using a conventional catheter requires a high degree of dexterity and precise device manipulation. The use of a side-view expandable frame allows the clinician to access the target vessel ostium without the need for extensive manipulation or repositioning of the catheter to accommodate the curvature of the arch.

[0024] In another example, catheter-based renal denervation is used to treat patients with uncontrolled hypertension. Using an endovascular approach, a catheter is inserted into the renal artery to destroy the renal sympathetic nerves using radiofrequency ablation. The use of a side-viewing expandable frame allows for adequate arterial wall contact in the tortuous and angled renal arteries requiring ablation, resulting in better, improved outcomes.

[0025] As another example, mesenteric angioplasty and stenting are minimally invasive procedures used to treat patients with chronic mesenteric ischemia. A hollow catheter is used to advance a guidewire through the plaque blocking the mesenteric artery. Excessive guidewire and catheter manipulation can increase the risk of branch perforation. Therefore, a side-viewing expandable frame using an angled catheter can allow for better placement and fewer catheter-guidewire manipulations.

[0026] As another example, cardiac resynchronization therapy is used to treat patients with chronic heart failure. Using a transvenous approach, the coronary sinus is cannulated to allow the delivery of a pacing lead into the coronary venous system. However, in most patients, access to the coronary sinus remains a challenge due to difficulties caused by the anatomy of the coronary sinus and the orientation of its ostium. In addition to this, positioning and orienting conventional non-steerable catheters in a dynamic cardiovascular environment is very challenging due to the limitations mentioned previously. Therefore, due to the enhanced maneuverability, it may be possible to allow for easier positioning of the side-viewing expandable frame. Rotating the catheter and sheath within the vasculature or multiple catheter changes may lead to arrhythmias and vascular damage, so avoiding excessive manipulation by using a reliable steering device is preferred.

[0027] In another example, transseptal puncture is a method used by electrophysiologists and interventional cardiologists to perform procedures that require access to the left atrium of the heart. To treat various cardiac conditions in 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 could increase the risk of cardiac perforation, thrombosis, and air embolism, a side-view expandable frame can be used to position the needle.

[0028] In another example, following a successful transseptal puncture, a minimally invasive mitral valve repair procedure 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 flexure to be able to navigate the transseptal puncture and then be positioned to face the mitral valve. Due to the limitations mentioned previously, another technical challenge is the ability to manipulate and control the device in a dynamic environment. Providing a side-viewing expandable frame as mentioned can allow for increased maneuverability and control to navigate the transseptal puncture.

[0029] In another example, transjugular intrahepatic portosystemic shunt is a procedure used to treat patients with cirrhosis. As scar tissue blocks blood flow in the liver, pressure in the portal vein may increase and 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 the stent is placed, the portal vein must be punctured. Due to poor visualization and catheter limitations, portal vein positioning can be challenging, and multiple puncture attempts may increase the risk of bleeding.

[0030] In another example, to treat intracranial aneurysms, endovascular coiling procedures use catheters and microcatheters to release platinum coils into the aneurysm area to block blood flow. However, due to the limited level of control and restriction of microcatheter movement within the aneurysm, the risk of perforation may increase. Coil placement requires precise positioning, and the use of a side-viewing expandable frame can allow access to the aneurysm area at the appropriate angle without excessive manipulation.

[0031] Many minimally invasive imaging methods are limited by the small space within the surgical catheter and have a reduced field of view (FOV) or resolution. Images are also obtained relative to a floating reference frame within the anatomical structure, making it difficult to know the absolute position of the target of interest. In addition, it is difficult to align a separate interventional tool to the obtained image for guidance, especially if the imaging catheter functions independently of the interventional tool, such as most commercial ultrasound catheters do not have an internal lumen that supports guidewire insertion. The present disclosure addresses these limitations by providing a side-view expandable frame with a sheath capable of delivering an angled internal catheter. Imaging can be improved by the enhanced manipulation capabilities of the disclosed device.

[0032] Ultrasound as an imaging modality can be used for tissue characterization by measuring acoustic impedance and reflection coefficient, elastic imaging of tissue to determine mechanical properties, visualization of tissue to determine shape, location of targets for image guidance, and measurement of blood flow using Doppler. In addition to the mechanical properties measured by ultrasound, electrical probes can also be used to measure electrical properties of tissue, such as impedance, conductivity, and dielectric constant, by using electrodes.

[0033] Optical imaging techniques can also be implemented into imaging probes. Possible applications are spectroscopy at various wavelengths, miniaturized 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 from tissue regions with high nuclear activity.

[0034] The above summary is not intended to describe each illustrated embodiment or every implementation of the present subject matter.The following figures and detailed description more particularly exemplify various embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The subject matter of the present invention may be more fully understood upon consideration of the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which: Figure 1A is a perspective view of a side-view manipulator with a side-view expandable frame and an angled inner catheter, according to an embodiment.

[0037] Figure 1Bis a perspective view of a side-view manipulator having a side-view expandable frame allowing one degree of freedom, according to an embodiment.

[0038] Figure 1C is a perspective view of a side view manipulator having a side view expandable frame as a manipulator allowing two degrees of freedom, according to an embodiment.

[0039] Figure 1D is a perspective view of a side-view manipulator with a side-view expandable frame and an angled inner catheter, according to an embodiment.

[0040] Figure 1E is a perspective view of a side-view manipulator with a side-view expandable frame and an angled inner catheter, according to an embodiment.

[0041] Figure 2 is a perspective view of a side-view steering device having a side-view expandable frame with an attached handle, according to an embodiment.

[0042] Figure 3 is a perspective view of a side-view steering device with a side-view expandable frame, according to an embodiment.

[0043] Figure 4 is a perspective view of a side-view steering device having a side-view expandable frame with a mesh structure, according to an embodiment.

[0044] Figure 5 is a perspective view of a side-view steering device having a side-view expandable frame sewn, stitched, or glued to fabric, according to an embodiment.

[0045] Figure 6 is a schematic diagram of the use and deployment of a side-view expandable frame for cannulation of a target vessel in a FEVAR (Fenestrated Endovascular Aortic Aneurysm Repair) procedure, according to an embodiment.

[0046] Figure 7 is a schematic diagram illustrating the use and deployment of a side-view expandable frame for aortic arch repair surgery to facilitate guidewire navigation from within a stent graft, according to an embodiment.

[0047] Figure 8 is a schematic diagram of a side-view expandable frame used and deployed for renal denervation surgery to facilitate ablation of nerves in a renal artery, according to an embodiment.

[0048] Figure 9is a schematic diagram of the use and deployment of a side-view expandable frame for a superior mesenteric artery angioplasty and stenting procedure to facilitate guidewire navigation through a plaque and allow for expansion of a stent graft, according to an embodiment.

[0049] Figure 10 is a schematic diagram of the use and deployment of a side-view expandable frame for a coronary angioplasty procedure to facilitate guidewire navigation for coronary artery cannulation, according to an embodiment.

[0050] Figure 11 is a schematic diagram of a side view of the use and deployment of an expandable frame for cardiac resynchronization therapy to facilitate lead placement through the coronary sinus, according to an embodiment.

[0051] Figure 12 is a schematic diagram of the use and deployment of a side-view steering device for needle navigation in a transseptal puncture, according to an embodiment.

[0052] Figure 13 is a schematic diagram of a side view of an expandable frame for use and deployment for guidewire navigation in a transcatheter mitral valve repair procedure, according to an embodiment.

[0053] Figure 14 is a schematic diagram from a side view of an expandable frame for use and deployment for guidewire navigation in a transcatheter tricuspid valve repair procedure, according to an embodiment.

[0054] Figure 15 is a schematic diagram of a side view of an expandable frame for use and deployment for venipuncture and stent graft deployment in a transjugular intrahepatic portosystemic shunt procedure, according to an embodiment.

[0055] Figure 16 is a schematic diagram of a side view of an expandable frame for use and deployment for delivering coils in a brain or cardiac aneurysm during an endovascular coil embolization procedure, in accordance with an embodiment.

[0056] Figure 17A A and B are perspective views of a side view expandable frame according to an embodiment, depicting stages of the manufacturing process before and after expansion of the side view expandable frame.

[0057] Figure 18 is a perspective view of a side view of a sequence of expansion of an expandable frame, according to an embodiment.

[0058] Although the various embodiments are susceptible to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the present invention is not intended to limit the claimed invention to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter defined by the claims.

[0059] Detailed Description of the Figures

[0060] Disclosed herein are devices, systems, and methods for manipulating side-view devices (including guidewires or catheters) in various medical interventional procedures. Disclosed examples propose more stable manipulation systems that can reduce the incidence of vascular damage and the number of catheter replacement / operations. The disclosed embodiments of the devices can also allow interventional devices to enter tortuous vascular systems and difficult-to-reach locations. The disclosed devices can include a side-view expandable framework that can be deployed or anchored in a vascular lumen, a cardiac chamber, a stent graft, or any intended anatomical location, such as a heart chamber, a stent graft, or any intended anatomical location. The side-view expandable framework can accommodate flexible, curved, or angled internal conduits designed to allow interventional devices (such as guidewires, catheters, microcatheters, energy sources, lasers, needles, intravascular ultrasound, or angioscopes) to pass through.

[0061] Figures 1A-1E A side-looking manipulator 100 for positioning an interventional device within a patient is disclosed. The side-looking manipulator 100 shown includes a side-looking expandable frame 1, an angled inner catheter 2, and a sheath 3. Some embodiments of the side-looking manipulator 100 also depict a tether or cable 4 for guiding a guidewire 5 or other interventional device.

[0062] Centrally located Figures 1A-1E Inside is the angled inner catheter 2. The angled inner catheter 2 is made of a tubular flexible material and includes a distal portion 102 that is biased to bend to one side when unconstrained. The distal portion 102 begins at an unbent first position 104 and ends at a distal tip 106. Thus, the distal portion 102 is a portion of the angled inner catheter 2 that can be used, for example, Figures 1A-1E Seen in.

[0063] The expandable frame 1 shown in side view comprises a tubular base 110 and a plurality of leaflets 112. Figure 1A Eight leaflets 112 can be seen in the figure. The leaflets 112 are each shown as an elongated member having a common bending direction and a distal end 116. This common bending direction refers to a similar overall, general direction and arrangement of the bending positions, as shown. Leaflets having a common bending direction should not be so narrowly interpreted as limiting the leaflets to structures of exactly the same shape, contour 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 Figures 1A-1E It cannot be seen well in the , but see for example Figure 18 .exist Figures 1A-1E, the angled inner catheter 2 is shown as extending through the tubular base 110. A plurality of leaflets 112 have different lengths and widths. When unconstrained as shown, each leaflet 112 extends from the distal end 116 of the tubular base 110. Each of the leaflets 112 is biased in shape so that it extends outward and to one side in the direction of the bend to peripherally surround the distal tip 106 of the angled inner catheter 2 with the distal end 118 of the leaflet 112. In certain embodiments, the side view expandable frame 1 and its leaflets 112 can be formed from a tube. In some embodiments, the side view expandable frame 1 is formed by laser cutting, photolithography, electrical discharge machining (EDM), or by water jet abrasion. In some embodiments, the side view expandable frame 1 comprises a shape memory metal. For example, such a shape memory metal can comprise a nickel titanium alloy.

[0064] In some embodiments, the leaflets 112 are connected by at least one strut 119. In some embodiments, the structure of at least one strut 119 varies along its length. In some embodiments, at least one strut 119 has multiple connection points 121 that allow for connection of multiple leaflets 112.

[0065] In some embodiments, a set of tethers 4 are anchored to the distal ends 118 of the leaflets 112 of the expandable frame 1. See, for example, Figure 1B and 1C In some embodiments, the leaflet 112 can extend to a distal end 118 where there are holes 10 forming an eyelet configuration (e.g., see Figure 3 In some cases, the leaflet 112 can extend to a distal end 118 having a radiopaque marker 16 (e.g., see Figure 6 ).

[0066] Although only partially shown Figures 1A-1E In the embodiment of the present invention, the sheath 3 can be generally in the form of an elongated tubular shape. In this tubular shape, the angled inner conduit 2 and the side view extendable frame 1 are designed to be axially retracted. Specifically, they are retracted and folded into a compressed state.

[0067] The side view, curved and angled nature of the device 100 and frame 1 can be understood in various ways. Figure 1DAn example is shown in which the distal portion 102 of the angled inner catheter 2 has a first tubular axis 120 at an unbent first position 104 and a second tubular axis 122 at a 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 degrees 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.

[0068] In some embodiments, for example, Figure 1C , the side-view manipulator 100 can be understood to include a side-view expandable frame 1, a set of strings 4 anchored at the distal end of the side-view expandable frame 1, and an angled internal catheter 2. The side-view expandable frame 1 is shaped to expand outward within a cavity (e.g., a vascular lumen, a stent graft, or a heart chamber) and has a distal end. The angled internal catheter 2 can be fixed inside the side-view expandable 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 by using a set of strings 4 having at least one degree of freedom to control the position of the interventional device.

[0069] The side-view expandable frame 1 can be retracted into the sheath 3 and redeployed while maintaining its maximum expanded diameter. The side-view expandable frame 1 can maintain its rigidity when the angled inner catheter 2 is manipulated. In some embodiments, the angled inner catheter 2 is bent at a 90-degree angle. The side-view expandable frame 1 can include a plurality of leaflets 112, and the leaflets 112 are connected by a plurality of struts 119.

[0070] In some embodiments, the side-view expandable frame 1 can include a tubular base 110 and a plurality of leaflets 112. The tubular base 110 has a proximal end 114 and a distal end 116. The tubular base 110 can be sized to allow the angled inner catheter 2 to extend therethrough. The plurality of leaflets 112 have different lengths and extend from the distal end 116 of the tubular base 110.

[0071] like Figure 1E As shown, each of the plurality of leaflets 112 can be biased to expand outwardly in a straight configuration with a first portion 130 and biased to expand outwardly in a configuration that is angled to one side with a second portion 132. 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. Figure 1E As can be seen, the widths of the plurality of leaflets 112 are different.

[0072] Additionally, the distal ends 118 of the plurality of leaflets 112 can form an aperture 10 having an eyelet configuration. In some embodiments, the plurality of leaflets 112 have distal ends 118 with radiopaque markers 16. In some embodiments, the plurality of leaflets 112 have at least one strut 119 and can include a plurality of connection points 121 that allow for connection of the plurality of leaflets 112.

[0073] Now specific reference Figure 1A , the side-view expandable frame 1 can be mounted on an angled inner catheter 2. The angled inner catheter 2 can be designed to allow the passage of an interventional device (e.g., a guidewire, catheter, microcatheter, energy source, laser, needle, intravascular ultrasound, or an angioscope). The side-view expandable frame 1 can be collapsed into a hollow cylindrical tube or sheath 3. The length and width of the hollow cylindrical tube or sheath 3 can vary, depending on the interventional procedure being performed.

[0074] In one example, the angled inner catheter 2 can be used to facilitate cardiac resynchronization therapy and treatment of patients with chronic heart failure. Using a transvenous approach, the coronary sinus is cannulated to allow delivery of a pacing lead into the coronary venous system. The side-viewing expandable frame 1 facilitates access to the coronary sinus and improves orientation in terms of accessing its ostium. In addition, positioning the angled inner catheter 2 becomes less challenging. Thus, the side-viewing expandable frame 1 allows for easier positioning and additional manipulation due to its curved orientation.

[0075] Now refer to Figure 1B and 1C , a perspective view of a side-view expandable frame 1 allowing one or two degrees of freedom, respectively, which houses an angled inner catheter 2 that can allow passage of an interventional device, such as a guidewire 5. The side-view expandable frame 1 can also serve as an anchor for a plurality of strings or cables 4 and can be retracted into a cylindrical tube or sheath 3.

[0076] Now refer to Figure 2 In the embodiment of FIG, the steering device 9 may include a side-view expandable frame 1 positioned inside the sheath 3. The sheath 3 may be used to steer the angled inner catheter 2 by moving a joystick 7 located on the handle side 6. The joystick 7 may be configured to actuate a plurality of strings or cables 4 to allow steering the angled inner catheter 2 in two degrees of freedom. Optionally, and as Figure 1B As can be seen, the angled inner catheter 2 can be manipulated in one degree of freedom. A guidewire 5 can then be passed through the lumen of the angled inner catheter 2. The handle side 6 can have a sliding button 8 that allows the tension on the multiple strings or cables 4 to be released.

[0077] In an example, the angled inner catheter 2 can be manipulated with multiple degrees of freedom by actuating multiple strings or cables from the handle side 6 to allow controlled and accurate positioning of the catheter tip in a plane facing the target area or vasculature. The present disclosure provides a more stable mechanical system for deploying stents, microcoils, balloon expandable stents, or any other interventional devices in a less invasive manner.

[0078] Now refer to Figure 3 , according to one example, a perspective view of an alternative design of a side-view expandable frame 1 that can be mounted on a sheath 3 and used as a steering device 9. The side-view expandable frame 1 can have one or more apertures 10 comprising holes on the distal tip for passing a plurality of strings or cables 4 through and anchored to the holes. In another example, the side-view expandable frame can also have an extension 11 on the distal end to prevent the angled inner catheter 2 from interacting with the anatomical structure in which the side-view expandable frame 1 is deployed or anchored.

[0079] In various embodiments, the side view expandable frame 1 can be formed from a tube. In alternative or additional embodiments, the side view expandable frame 1 can be formed by laser cutting, photolithography, EDM, or by water jet abrasives. In various embodiments, the side view expandable frame can include a shape memory metal. For example, the shape memory metal can include a nickel titanium alloy. Figure 18 As shown, a portion of the expandable frame 1 from a side view which has been cut out of the tube can be understood from the first depiction of its compressed state. Furthermore, the continuous one-piece structure of the expandable frame 1 from a side view is shown.

[0080] Now refer to Figure 4 , side view, the expandable frame can have a basket 1B that sets the shape to the side. A plurality of ropes or cables 4 anchored to the basket 1B are used to manipulate the angled inner catheter 2. The angled inner catheter 2 can be deployed from or retracted into the sheath 3. The length and design of the sheath 3 can vary based on the intended interventional medical procedure.

[0081] Now refer to Figure 5 , an example of a side-view expandable frame 1 has a fabric 12 sutured, sewn, or glued to the outer or inner surface of the side-view expandable frame 1 to add additional mechanical support or to connect multiple branches together. The fabric 12 allows the frame 1 to maintain its rigidity when multiple strings or cables 4 are actuated to manipulate the angled inner catheter 2 during an interventional procedure.

[0082] Now refer to Figure 6According to one example, a side-view expandable frame can be used for a target vessel cannulation procedure. The side-view expandable frame 1 can be deployed from within a sheath 3 to be placed within a stent graft 13 having fenestrations or openings 14. A radiopaque marker 16 can be used and placed at the distal end of the side-view expandable frame 1 and the angled inner catheter 2.

[0083] In one example, after confirming that the side-viewing expandable frame 1 is facing the ostia of the renal artery 15, the plurality of strings or cables 4 can then be operated to steer the angled inner catheter 2 to a position facing the fenestration or opening 14. A guidewire 5 can then be passed through the lumen of the angled inner catheter 2 to perform cannulation and catheterization of the renal artery 15.

[0084] Now refer to Figure 7 , shows a side-view expandable frame 1 used in an aortic arch repair procedure. The side-view feature of the expandable frame 1 gives it an additional mechanical advantage when cannulating a target vessel from within a stent graft 13 using a guidewire 5. When the guidewire is deployed from within the sheath 3, the guidewire 5 is configured to orient itself in the same plane as the ostium to be treated.

[0085] Now refer to Figure 8 , the side-view expandable frame 1 can be positioned facing the ostium of the renal artery 15 to allow the ablation catheter 16 to pass through the lumen of the angled inner catheter 2. Manipulation of the multiple strings or cables 4 can steer the angled inner catheter 2, and thereby steer the ablation catheter 16 to different positions to ensure that the radiopaque marker 17 on the ablation catheter 16 contacts the nerve 18 to be ablated.

[0086] Now refer to Figure 9 , exploded view of a side-view expandable frame 1 positioned within a 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 can be deployed at an angle to properly access the superior mesenteric artery 19. The side-view expandable frame 1 allows the guidewire 5 to pass through the plaque 20 and into the superior mesenteric artery 19 without the need to reposition a steering device.

[0087] Now refer to Figure 10, the side-view expandable frame 1 can be deployed within the heart 21 and facing the coronary artery 22. As part of an angioplasty and stenting procedure, the angle of the side-view expandable frame 1 can facilitate precise navigation of a guidewire 5 through a plaque 20. Mesenteric angioplasty and stenting is a minimally invasive method for treating patients with chronic mesenteric ischemia. The angled internal catheter 2 can be used to advance the guidewire 5 through a plaque 20 that blocks a mesenteric artery. Excessive guidewire and catheter manipulation can increase the risk of branch perforation. Therefore, the side-view expandable frame 1 using an angled catheter 2 can allow for better placement and fewer catheter-guidewire manipulations. In another example, the side-view expandable frame 1 can be entered through additional blood vessels to access different chambers and vessels of the heart.

[0088] Now refer to Figure 11 , another example of a side-view expandable frame 1 deployed in the heart 21, facing the coronary sinus 23, to facilitate accurate placement of a pacing lead in the coronary venous system. Cardiac resynchronization therapy is used to treat patients with chronic heart failure. Using a transvenous approach, the coronary sinus 23 is cannulated to allow delivery of a pacing lead into the coronary venous system. However, in most patients, accessing the coronary sinus remains a challenge due to difficulties caused by the anatomy of the coronary sinus and the orientation of its ostium. Therefore, the side-view expandable frame 1 may allow for easier positioning due to its curved shape. Rotation of the catheter and sheath within the vasculature or multiple catheter exchanges may lead to arrhythmias and vascular damage, so the use of an angled inner catheter 2 delivered through the sheath 3 may lead to improved surgical outcomes.

[0089] Now refer to Figure 12 , side view, expandable frame 1 can be positioned in the right atrium 24 when pushed out of sheath 3. Multiple strings or cables 4 can be actuated to precisely steer the angled inner catheter 2 toward the fossa ovalis 25 and allow the passage of a needle 26 to preform a transseptal puncture. The angled inner catheter 2 can be deployed from sheath 3, which can be provided in multiple lengths to accommodate different anatomies of different users.

[0090] In another example, Figure 13 As seen, the side viewing expandable frame 1 can be deployed in the left atrium 27 to facilitate navigation of the guidewire 5 through the mitral valve 28. As part of a mitral valve repair procedure, the guidewire 5 can be inserted into the mitral valve 28 in the left atrium 27. Following a successful transseptal puncture, a mitral valve 28 repair is often required to treat mitral regurgitation or stenosis. Due to the location of the mitral valve 28 and its large size, the side viewing expandable frame 1 can allow for increased flexion to navigate the mitral valve. Additionally, the expandable nature of the side viewing expandable frame 1 allows for increased precision and manipulation by the clinician to address different anatomies in different patients.

[0091] In another example, Figure 14 Shown is a side view of the use and deployment of the expandable frame 1 in a tricuspid valve repair procedure. The sheath 3 can be inserted into the right atrium of the heart to reach the tricuspid valve.

[0092] Now refer to Figure 15 , an example of an application of the side-viewing expandable frame 1, wherein the side-viewing expandable frame 1 is deployed within the liver 29. Once deployed, the side-viewing expandable frame 1 can deliver a needle 26 for hepatic artery puncture. The stent graft 13 can then be placed through the puncture site as part of a transjugular intrahepatic portosystemic shunt procedure. In another example, a guidewire 5 instead of the needle 26 can be used for an interventional procedure within the liver. Depending on clinical needs, the side-viewing expandable frame 1 can deploy various tools and objects through the sheath 3 for different medical purposes.

[0093] Now refer to Figure 16 , the side-view expandable frame 1 can be deployed within a cerebral artery 30. Once deployed, the side-view expandable frame 1 can facilitate delivery of a coil 31 within an aneurysm 32 as part of an endovascular coil embolization procedure. The side-view expandable frame 1 is configured to deploy at an angle adjusted to precisely deliver the coil 31.

[0094] Figure 17A 、 17B 18 depict aspects of a manufacturing process that can be used to produce a side-view expandable frame 1, as described in embodiments throughout the present disclosure. The side-view expandable frame 1 can be made from a tubular body (cylindrical tube) made from a superelastic or shape memory alloy (e.g., Nitinol). Methods of making the side-view expandable frame 1 can include selectively removing material to form stent cuts or patterns by laser cutting, water jet cutting, chemical milling, or electrospark machining.

[0095] After the removal process, the cut tube can be asymmetrical, with one side longer than the other, to allow the material to deform and achieve the desired side-view shape. The shape-setting process begins with a series of incremental steps that expand the cut Nitinol tube from its initial diameter to its fixed diameter by heating it at elevated temperatures using custom-made dies of varying sizes. Once solidified and cooled, it is reheated for a second shape-setting process that deforms it sideways using a jig of a different shape and bend angle.

[0096] Figure 17A and 17BThe illustrated embodiment depicts, respectively, certain early stages, in which the side-view expandable frame 1 is cut or machined into a collapsed configuration, and a second stage of expanding the side-view expandable frame 1 using an incrementally customized mold 140. The manufacturing process involves expanding the initially tubular cut tube using various heating, cooling, reheating, and deformation steps. Figure 18 Also depicted is the stage of flexure and expansion of the leaflets 112 that must be engineered for reliable deformation when the side-view expandable frame is unconstrained within the patient.

[0097] According to an example, Figure 17A and 17B Also provided are example views of the side view expandable frame 1 before and after expansion. The side view expandable frame 1 can be started from a closed or collapsed position to allow access to smaller anatomical structures. The length and width of the sheath 2 can be quite large, depending on the procedure to be performed and what tools can be delivered or positioned through the sheath. After being inserted or manipulated into the target anatomical structure, the side view expandable frame 1 can be expanded or deployed, such as Figure 17B Expansion can allow for easier anchoring of the device, more precise placement, and ease of delivery.

[0098] In an embodiment, a side-view expandable frame 1 can have a tubular body having a proximal end and a distal end, and a plurality of leaflets. Each leaflet can be secured to the distal end of the tubular body of the shaft 2. Furthermore, the leaflets can have a first portion and a second portion, each portion expanding in a different configuration. For example, the first portion of the leaflet can expand gradually in a straight configuration, while the second portion of the leaflet can be deformed to expand at an angle to the side, with the distal tip of the leaflet curving inward. In alternative examples, the leaflets can expand in the opposite configuration, or in other configurations as deemed appropriate or necessary for the procedure being performed.

[0099] In an embodiment, the length and width of the leaflet can vary depending on the minimally invasive procedure being performed. The distal end of the leaflet can also be formed with an eyelet configuration and / or have radiopaque markers. The leaflet has at least one strut, and the width of the strut can vary along the length of the strut. At least one strut can have multiple connection points that allow for the connection of multiple leaflets.

[0100] Now refer to Figure 18 , according to an example, the expansion sequence of the expandable frame. The expandable frame 1 can be expanded to different degrees, such as Figure 18At each expansion level, the growth or extension of the side-viewing expandable frame 1 can be stopped or paused to allow for increased availability and precise placement of delivered devices and treatments. Furthermore, the side-viewing expandable frame 1 can be controlled to gradually extend and deploy within a human vessel or organ. For example, if the target anatomical structure is located in a small or difficult-to-reach area, the side-viewing expandable frame 1 can be only partially expanded, thereby allowing for increased access and better delivery of treatments and devices.

[0101] The proposed disclosure describes a self-expanding side-view frame 1 that, when assembled, can be folded into a compressed configuration by a delivery sheath 3 and then radially expanded at the treatment site when the sheath or delivery device is retracted.

[0102] In operation, the side-view expandable frame 1 can be retracted into the interior of the sheath 3 and redeployed while maintaining its maximum expanded diameter. The side-view expandable frame can include a cable-driven 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 an angled inner catheter 2. Once the side-view expandable frame 1 has been deployed in a cavity (e.g., a vascular lumen, a stent graft, or a cardiac chamber), a plurality of ropes or cables 4 can be anchored on the distal end of the side-view expandable frame 1. Then, the curved or angled inner catheter 2 is fixed inside the side-view expandable frame 1 and supported by a plurality of ropes or cables 4 connected to the distal end of the angled inner catheter 2.

[0103] In an example, the curved inner catheter 2 can be manipulated with at least one degree of freedom to control the position of an interventional device within a vessel lumen, stent graft, or heart chamber using a plurality of ties or cables 4. The side-view expandable frame 1 can maintain its rigidity as the curved inner catheter 2 is manipulated. The curved inner catheter 2 can be bent or angled at various angles, including 90 degrees. The plurality of ties or cables 4 can include a set of any number of ties or cables.

[0104] Various embodiments of the systems, devices, and methods have been 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 the various features of the embodiments described can be combined in various ways to produce many additional embodiments. Furthermore, while various materials, sizes, shapes, configurations, and positions, etc., have been described for use with the disclosed embodiments, other materials, sizes, shapes, configurations, and positions, etc., other than those disclosed, may be used without exceeding the scope of the claimed invention.

[0105] Those skilled in the relevant art will recognize that the subject matter of the present invention may include fewer features than shown in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter of the present invention may be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments may include combinations of different individual features selected from different individual embodiments, as understood by those skilled in the art. Furthermore, elements described with respect to one embodiment may be implemented in other embodiments even if not described in such embodiments, unless otherwise indicated.

[0106] Although dependent claims may refer to specific combinations with one or more other claims in a claim, other embodiments may include combinations of dependent claims with the subject matter of other dependent claims, or combinations of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0107] Any incorporation by reference of the above-mentioned documents is limited such that no subject matter is incorporated that is inconsistent with the explicit disclosure herein. Any incorporation by reference of the above-mentioned documents is further limited such that no claims contained in such documents are incorporated herein by reference. Any incorporation by reference of the above-mentioned documents is further limited such that any definitions provided in such documents are not incorporated herein by reference unless expressly included herein.

[0108] For purposes of claim interpretation, it is expressly intended that the provisions of 35 USC § 112(f) not be invoked unless a claim recites the specific terms "means for" or "step for."

Claims

1. A side-view manipulator for positioning an interventional device within a patient's body, comprising: an angled inner conduit of tubular flexible material including a distal portion biased to bend to one side when unconstrained, the distal portion commencing in an unbent first position and terminating at a distal tip; Side view of the expandable frame, which includes: a tubular base having a proximal end and a distal end, the angled inner conduit 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 and biased in shape to extend outwardly and to one side in a curved direction to peripherally surround the distal tip of the angled inner conduit when unconstrained; and The elongated tubular shaped sheath, the angled inner conduit and the side view expandable frame are sized for axial retraction into the sheath and folding into a compressed state within the sheath.

2. A side-view manipulation device according to claim 1, wherein the side-view expandable frame including the plurality of leaflets of different lengths and widths has been cut from a tube.

3. The side looking manipulator of claim 2, wherein the side looking expandable frame is a continuous structure.

4. The side looking manipulator of claim 1 , wherein the side looking expandable frame is formed by laser cutting, photolithography, EDM or by water jet abrasives.

5. The side-looking manipulator of claim 1 , wherein the distal portion has a first tubular axis in the unbent first position and a second tubular axis at the distal tip when unconstrained.

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

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

8. The side looking manipulator of claim 5, wherein the angle between the first tubular axial orientation and the second tubular axial orientation is approximately perpendicular.

9. The side-view steering device according to claim 1, wherein the distal end of the leaflet forms an eyelet structure.

10. The side-looking manipulator of claim 1, wherein the leaflet has a distal end with a radiopaque marker.

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

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

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

14. The side-view manipulator of claim 1 further comprising a set of strings anchored at the distal end of the side-view expandable frame, the strings providing a portion of a cable drive mechanism for positioning an interventional device at the distal tip of the angled inner catheter.

15. The side looking manipulator of claim 14, wherein the distal tip of the angled inner catheter is aligned with the plane of anchor locations of a set of tethers on the distal end of the side looking expandable frame.

16. A side-view manipulator for positioning an interventional device within a patient, comprising: a side-view expandable frame shaped to expand outwardly within a lumen, such as a vessel lumen, a stent graft, or a heart chamber, the side-view expandable frame having a plurality of elongated leaflet members having a common direction of curvature and a distal end; a set of tethers anchored to the distal end of the side-view expandable frame; an angled inner catheter secured within said side-view expandable frame and supported by said set of tethers connected to a distal end of said angled inner catheter; wherein the angled inner catheter is manipulated in at least one degree of freedom to control the position of the interventional device using the set of strings.

17. The side looking manipulator of claim 16, wherein the side looking expandable frame is capable of being retracted into a sheath and redeployed while maintaining its maximum expanded diameter.

18. The side looking maneuvering device of claim 16, wherein the side looking expandable frame is capable of maintaining its rigidity when the angled inner catheter is manipulated.

19. The side-looking manipulator of claim 16, wherein the angled inner conduit bends at a 90 degree angle.

20. The side looking steering device of claim 16, wherein the side looking expandable frame comprises a plurality of leaflets, and the leaflets are connected by a plurality of struts.

21. A side-view expandable 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 extend the angled inner conduit therethrough; a plurality of leaflets of varying lengths extending from a distal end of the tubular base; as well as Each of the plurality of leaflets is biased to flare a first portion outwardly in a straight configuration and a second portion outwardly in a sideways angled configuration.

22. The side-view expandable 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. The side-view expandable frame of claim 21, wherein the plurality of leaflets have different widths.

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

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

26. The side-view expandable frame of claim 21, wherein the plurality of leaflets have at least one strut.

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

28. The side view expandable frame of claim 21, wherein the side view expandable frame is formed from a tube.

29. The side view expandable frame of claim 21, wherein the side view expandable frame is formed by laser cutting, photolithography, EDM, or by water jet abrasion.

30. The side view expandable frame of claim 21, wherein the side view expandable frame comprises a shape memory metal.

31. The side view expandable frame of claim 28, wherein the tubes forming the side view expandable frame are asymmetrical, wherein the length of one side is greater than the length of the other side.

32. The side view expandable frame of claim 28, wherein the tube is expanded to different diameters during a first shape setting and once cooled, is reheated to undergo a second shape setting to produce a plurality of shapes and angles.

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