Medical device with wire anchor and method of use thereof

Abstract

An articulated medical device having a hollow core that can be manipulated through a cavity to reach a target in a minimally invasive manner and that allows a medical tool, such as an endoscope, camera, catheter, or the like, to be guided through the cavity to facilitate a medical procedure at the target once the medical device has reached the target.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED PATENT APPLICATIONS This application claims priority from U.S. Provisional Patent Application No. 63 / 308,432, filed in the U.S. Patent and Trademark Office on February 9, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to devices and methods for medical applications. More particularly, the present disclosure is directed to an articulated medical instrument having a cavity that can be steered within a patient and that allows medical tools, such as endoscopes, cameras, catheters, etc., to be guided through the cavity for medical procedures. [Background technology]

[0003] Bendable medical instruments, such as endoscopic surgical instruments and catheters, are well known and continue to gain acceptance in the medical field. Bendable medical instruments generally include a flexible body, commonly referred to as a sleeve or sheath. One or more tool channels extend along (typically internally) the flexible body, allowing access to a target located at the distal end of the flexible body.

[0004] The instrument is intended to provide flexible access within a patient with one or more curves leading to a target of interest while maintaining torsional and longitudinal rigidity, allowing a physician to control tools located at the distal end of the medical instrument by manipulating the proximal end of the medical instrument.

[0005] Recently, robotized instruments have emerged that control the distal portion to increase maneuverability of the distal end of the instrument. In such robotized instruments, various techniques have been disclosed to create localized curves in the distal portion through robotics.

[0006] As an example, U.S. Patent Publication No. 2016 / 0067450 provides multiple conduits to hold the shape of the proximal portion while the driving tendons bend the distal portion of the medical device. The multiple conduits are dually, selectively controlled by constraining or unconstraining the proximal ends of the conduits. By selecting which constrained conduits, the bendable medical device can vary the length to which the distal segment bends by varying the stiffness of the bendable medical device based on the area in which the conduits are deployed.

[0007] However, there remains a need in the industry to further improve and evolve bendable medical devices to minimize the outer dimensions (diameter) of the bendable medical devices and maximize the size (diameter) of the tool channels to allow for the use of larger / more effective tools.

[0008] To maximize the bending output of the medical device, the wire needs some kind of anchoring mechanism to secure the wire to the plastic ring. The strength of the bond between the anchor and the wire as well as the strength of the bond between the anchor and the plastic ring will determine the limit of how hard the wire can be pushed or pulled, and therefore how much deflection will occur. Summary of the Invention

[0009] Thus, to address such exemplary needs in the industry, the present disclosure teaches a medical device comprising: a bendable body having a cavity extending across the bendable body and a wall formed around the cavity; at least one control wire slidably disposed within the wall; and an anchor configured on a distal end of the at least one control wire, the anchor being attached within the wall.

[0010] In other embodiments, the anchors are attached to the control wires by crimping. Alternatively, the anchors are attached to the control wires by welding.

[0011] Additionally, the anchors are attached to the control wires by crimping and welding.

[0012] In another embodiment, the anchor further comprises a feature that provides additional surface area on the outer surface of the anchor to increase the connection strength of the anchor to the wall, and the feature that provides additional surface area on the outer surface of the anchor is selected from the group consisting of notches, holes, grooves, loops, and combinations thereof.

[0013] In other possible embodiments, at least one control wire has multiple anchors, each anchor having a different location along the axial length of the bendable body.

[0014] Additionally, the device may further comprise a driver in communication with the at least one control wire and configured to actuate the at least one control wire within the wall.

[0015] In an additional embodiment, the at least one control wire further comprises an outer wire and an inner wire, the inner wire being slidably nested within the outer wire, the outer wire having anchors for attaching the outer wire to a wall, and the inner wire having anchors for attaching the inner wire to a wall, the locations of the anchors of the outer wire and the inner wire differing along an axial direction of the bendable body.

[0016] In yet another embodiment, the control wires and anchors are made of a radiopaque material.

[0017] Additionally, the device may further comprise a functional probe selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, derivatives thereof, and combinations thereof.

[0018] Additionally, attaching the anchor to the wall involves heating the wall and the anchor to form a heat fusion bond.

[0019] In yet another scenario, the wall has at least two wire guides, the wire guides being positioned at a distance from each other.

[0020] The present invention also teaches a medical device made by a process including the steps of: providing a bendable body comprising a cavity extending from one end of the bendable body to the other end, a wall formed around the cavity, at least one control wire slidably disposed within the wall, and an anchor configured at a distal end of the at least one control wire; heating the anchor configured within the wall to form a melt between the wall and the anchor; and cooling the anchor configured within the wall to solidify the melt.

[0021] The present invention further discloses a method for treating a subject, the method comprising: providing a medical device comprising a bendable body having a cavity extending from one end of the bendable body to the other end and a wall formed around the cavity, at least one control wire slidably disposed within the wall, and an anchor configured at a distal end of the at least one control wire and attached to the wall; advancing the medical device into the subject; bending the medical device to address an obstacle within the subject; and treating the subject when the medical device is advanced to a desired target within the subject.

[0022] The device can be used in a variety of applications and by a variety of methods including the steps of: providing a bendable body comprising a cavity extending from one end of the bendable body to the other end, a wall formed around the cavity, at least one control wire slidably disposed within the wall, and an anchor configured at a distal end of the at least one control wire; heating the anchor configured within the wall to form a melt between the wall and the anchor; and cooling the anchor configured within the wall to solidify the melt.

[0023] These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of exemplary embodiments of the present disclosure, taken in conjunction with the accompanying drawings and the provided paragraphs. [Brief description of the drawings]

[0024] Further objects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings illustrating embodiments of the invention.

[0025] [Figure 1] FIG. 1 is a block diagram of an exemplary bendable medical device including various ancillary components in accordance with one or more embodiments of the present apparatus, methods or systems. [Diagram 2] 2A shows an enlarged perspective view of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method, or system; FIG 2B shows a perspective view of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method, or system; and FIG 2C shows a cross-sectional perspective view of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method, or system. [Diagram 3] FIG. 3 provides a side perspective view of anchors and control wires of an exemplary bendable medical device in accordance with one or more embodiments of the present devices, methods or systems. [Figure 4] FIG. 4 is a side perspective view of an anchor and control wire of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method or system. [Diagram 5] FIG. 5 provides a side perspective view of anchors and control wires of an exemplary bendable medical device in accordance with one or more embodiments of the present devices, methods or systems. [Figure 6] FIG. 6 shows a side perspective view of an anchor and control wire of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method or system. [Figure 7] FIG. 7 illustrates a side perspective view of anchors and control wires of an exemplary bendable medical device in accordance with one or more embodiments of the present apparatus, methods or systems. [Figure 8] FIG. 8 provides a side perspective view of anchors and control wires of an exemplary bendable medical device in accordance with one or more embodiments of the present devices, methods or systems. [Figure 9] FIG. 9 is a side perspective view of an anchor and control wire of an exemplary bendable medical device in accordance with one or more embodiments of the present device, method or system. [Figure 10] FIG. 10 is an illustration of a side perspective view of anchors and control wires of an exemplary bendable medical device in accordance with one or more embodiments of the present devices, methods or systems.

[0026] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. In addition, reference numerals including a designation "'" (e.g., 12' or 24') denote a secondary element and / or reference of the same nature and / or type. Moreover, while the present disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrated embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the present disclosure as defined by the appended paragraphs. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 1 is a system block diagram of an exemplary bendable medical device system 1, including various auxiliary components intended to build a complete medical system. The bendable medical device system 1 includes an actuator or driver 2 (also referred to herein as a "driver") having a base stage 28 for driving wires, a bendable medical device 3, a positioning cart 4, an operator console 5 having push buttons, thumbsticks, and / or joysticks, and navigation software 6. The operator console 5 includes user input devices such as push buttons, thumbsticks, and / or joysticks. The operator console 5 also includes a processor for processing inputs from a user, inputs from sensors, and the like. The processor further processes the mapping between the inputs and the driver and base movements.

[0028] The navigation software 6 and the drive unit 2 are communicatively coupled via a bus to send and receive data to and from each other. Additionally, the navigation software 6 is connected to and can communicate with auxiliary components of the bendable medical device system 1, such as a CT scanner, an X-ray fluoroscope, and an image server (not shown). The image server can include, but is not limited to, a DICOM™ server connected to medical imaging devices such as CT and / or MRI scanners and X-ray fluoroscopes. The navigation software 6 processes data provided by the drive unit 2 and data provided by images stored in the image server and / or images from the CT scanner and the X-ray fluoroscope in order to display images on an image display.

[0029] Images from the CT scanner may be provided to the navigation software 6 preoperatively. Using the navigation software, the clinical user creates an anatomical computer model from the images. In this particular embodiment, the anatomical structures are of the lungs with associated airways. From the CT scanner chest images, the clinical user can segment the lung airways for clinical procedures such as biopsy. After generating the lung airway map, the user can also create a plan for accessing the lesion to be biopsied. The plan includes the airways leading to the target of interest (which is the lesion in this example) for inserting and manipulating the bendable medical device 3.

[0030] The drive unit 2 comprises actuators and control circuitry. The control circuitry is communicatively coupled to an operation console 5. The drive unit 2 is connected to the bendable medical device 3 such that the actuators of the drive unit 2 operate the bendable medical device 3. Thus, a clinical user can control the bendable medical device 3 via the drive unit 2. The drive unit 2 is also physically connected to a positioning cart 4. The positioning cart 4 includes a positioning arm and positions the drive unit 2 and the bendable medical device 3 at an intended position relative to the target / patient. The clinical user can insert, manipulate and withdraw the bendable medical device 3 to perform a medical procedure (here a biopsy on a patient's lung).

[0031] The bendable medical device 3 can navigate to a lesion in the airway based on a plan operated by a clinical user. The bendable medical device 3 includes cavities for various tools (e.g., a biopsy tool). The bendable medical device 3 can guide the tool to the patient's lesion. In one example, the clinical user can use the biopsy tool to take a biopsy sample from the lesion.

[0032] 2A, 2B and 2C are schematic diagrams of a bendable medical device 3, with Fig. 2A detailing an enlarged perspective view of the bendable medical device 3 and Fig. 2B showing a schematic diagram illustrating bendable segments of the bendable medical device 3. The bendable medical device 3 has a distal end 24 and a proximal end (in the direction of arrow A) and comprises a proximal segment 19 and three bendable segments, which are first, second and third bendable segments 12, 13 and 14, respectively (see Fig. 2B).

[0033] As seen in FIG. 2B, the bendable segments 12, 13, 14 can bend independently to form shapes with three independent curvatures. The bendable medical device 3 includes a bendable body 7 having an inner diameter 30 and an outer diameter 32. The outer diameter 32 forms a cylindrical wall 8 of the bendable body 7, and the inner diameter 30 establishes a tool channel 18 (see FIG. 2C). The wall 8 can accommodate several lumens 26 intended to accommodate one or more control wires (described below). The lumens 26 are spaced apart from one another to form at least one cavity 38 that significantly increases the bendable angle of the bendable segments 12, 13, 14. The tool channel 18 is configured to extend from one end of the bendable body 7 to the other end. The proximal portion 19 of the bendable body 7 provides access for a clinical user to insert / remove a medical tool. For example, a clinical user can insert and retrieve a biopsy tool through the tool channel 18 to the distal end 24 of the bendable medical device 3. This can be accomplished after the bendable device 3 has been inserted into the patient, or it can be accomplished simultaneously with the insertion / removal of the bendable device 3.

[0034] The bendable body 7 includes a first set of control wires 9a, 9b, 9c, a second set of control wires 10a, 10b, 10c, and a third set of control wires 11a, 11b, 11c (see FIG. 2A). The wall 8 accommodates the control wires 9a-11c through a lumen 34 arranged along the longitudinal direction of the bendable body 7. The lumen 34 has a groove 36 for each wire, allowing slidable movement of the control wires 9a-11c along the axial direction of the bendable body. The control wires 9a-11c can be terminated at the distal end of each bendable segment 12, 13, 14 to form three bendable groups, each including three wires (a, b, c). The first control wires 9a, 9b, 9c are terminated at the distal end of the first bendable segment 12 by anchor segments 15a, 15b, 15c, and are arranged approximately 120 degrees apart from each other within the wall 8. The first control wires 9a, 9b, 9c are connected at their proximal ends to a driver 2. The driver 2 induces a push or pull force to actuate the control wires 9a, 9b, 9c and move them by bending the bendable body 7 from their distal ends 24.

[0035] Similarly, the second set of control wires 10a, 10b, 10c are terminated with anchor segments 16a, 16b, 16c at the distal end of the second bendable segment 13 and are connected at their proximal ends to the driver 2. The second set of control wires 10a, 10b, 10c are also housed within the wall 8. The second set of control wires 10a, 10b, 10c can bend the bendable body 7 from the distal end of the second bendable segment 13.

[0036] Similarly, the third set of control wires 11a, 11b, 11c are configured to bend the bendable body 7 at the third bendable segment 14, again by inducing a push or pull, and by the anchor segments 17a, 17b, 17c actuated at the distal ends 24 of the control wires 11a, 11b, 11c by the drive unit 2.

[0037] Thus, by pushing or pulling the set of control wires 9, 10, 11, the first, second and third bendable segments 12, 13, 14 each independently bend the bendable medical device 3 in three dimensions.

[0038] The bendable medical device 3 includes control wires 9, 10, 11 that can be secured to the bendable body 7 using minimal space within the wall 8 of the bendable body. Because the anchor segments 15-17 are localized within the individual lumens 34, the bendable medical device 3 including the control wires 9, 10, 11 can be effectively miniaturized, especially when multiple control wires 9, 10, 11 are used. Furthermore, the control wires 9, 10, 11 can be entirely contained within the wall 8 of the bendable body 7 and do not need to be outside the outer diameter 32 or inside the inner diameter 30, so as not to interfere with the tool channel 18 or unnecessarily increase the overall size of the medical device 3. By embedding the anchor segments 15-17 in the wall 8 of the bendable body 7, the control wires 9, 10, 11 can transmit pulling, torque, and pushing forces to the bendable body 7. Therefore, the bendable medical device 3 can reduce the number of control wires 9, 10, 11 and the force applied per control wire 9, 10, 11 to achieve the desired bending operation compared to conventional tendon-driven systems that use pulling forces.

[0039] Furthermore, since the anchor segments 15-17 do not require additional abutment parts to cover the cross section of the bendable body 7, the bendable medical device 3 can reduce the number of junctions between the bendable body 7 and such additional abutment parts at the locations of the anchor segments 15-17. The bendable medical device 3 can therefore increase the continuity of flexibility with reduced impact on motion control, reducing the risk of failure at such junctions. Also, to avoid the risk of trauma to the patient's anatomy and improve advancement / retraction of the tool in the tool channel 18, the bendable medical device 3 can have uninterrupted smooth surfaces on the outer diameter 32 and inner diameter 30 of the bendable body 7.

[0040] Additionally, the control wires 9, 10, 11 may be secured to the bendable body 7 at various locations along the length of the bendable body 7. This allows the bendable medical device 3 to be configured with multiple bend segments, particularly distal bend segments that are operated independently from the proximal portion of the bendable body, to improve flexible access to the target area of ​​the patient.

[0041] Attention is now directed to anchor segments 15-17, and more specifically, to the various anchors implemented in anchor segments 15-17.

[0042] 3 provides the use of a ring 40 that can be welded to the control wire 9. The ring allows for a more regular and predictable weld and a larger weld area, improving tensile strength. Optimally, the ring 40 is made from the same material as the control wire 9.

[0043] Another concept seen in Figure 4 could be to place a tube 42 on the end of the control wire 9. The tube 42 would ideally be made of the same material as the control wire 9 so the two can be welded at the distal end. Notches or holes 44 could be cut into the tube 42 to provide anchoring for the plastic part, or the tube 42 could be crimped or knurled to give it texture.

[0044] 5 is to attach a tube 46 with a notch or hole 48 to the end of the control wire 9, the notch or hole 48 being beyond the end of the control wire 9. The notch or hole 48 provides a purchase in the plastic part to secure the tube 46 to the plastic part.

[0045] Yet another concept shown in Figure 6 could be to connect a ribbon wire 50 to the end of the control wire 9 to form a loop 52. The loop 52 provides a hook in the plastic part to secure the ribbon wire 50 to the plastic part.

[0046] All of these concepts are based on the control wire 9 and the anchor being made of the same material. If the anchor were a different material than the control wire 9, welding would not be a suitable option for connecting the two components. A mechanical attachment such as crimping would be more likely to provide an acceptable joint.

[0047] In the concept shown in Figures 7-10, a tube 54 is provided which is crimped to a control wire 9. The end of the control wire 9 is ball welded to create a mechanical stop. The ball weld prevents the control wire 9 from being pulled out of the tube 54. A crimp 56 works in a similar manner, but also prevents the control wire 9 from being pushed out of the tube. The crimp 56 provides a hook in the plastic part to secure the assembly to the plastic part.

[0048] An alternative configuration of the above concept is to attach a ring 58 made of the same material as the tube 54 but of a larger diameter, as seen in Figure 8. This provides an additional catch for the plastic part.

[0049] Further configurations include multiple crimps 56 as seen in Figure 9. The addition of crimps 56 improves the mechanical connection between the tube 54 and the control wire 9 and also provides additional texture for the plastic parts to hook onto. Additionally, notches or holes 60 can be cut into the tube 54 for added integrity (see Figure 10).

[0050] As can be seen, the present invention provides improved connection strength between the anchors and the control wires and between the anchors and the plastic ring, allowing for greater force to be applied to the ring to cause deflection. Also importantly, the improved connection strength affects the actuation of the control wires as they are pushed and pulled. This is particularly beneficial when multiple control wires are used to cause deflection, as opposing control wires can be pushed and pulled to maximize deflection and provide greater circulation for movement into less visible fissures in the anatomy.

Claims

1. a bendable body having a cavity extending through the bendable body and a wall formed around the cavity; at least one control wire slidably disposed within said wall; an anchor configured on the at least one control wire; A medical device comprising: The anchor is mounted within the wall. Device.

2. The anchor is attached to the control wire by crimping.

2. The apparatus of claim 1.

3. The anchor is attached to the control wire by welding.

2. The apparatus of claim 1.

4. The anchor is attached to the control wire by crimping and welding.

2. The apparatus of claim 1.

5. The anchor further comprises a feature that provides additional surface area on an outer surface of the anchor to increase the strength of the connection of the anchor to the wall.

2. The apparatus of claim 1.

6. the features providing additional surface area on the outer surface of the anchor are selected from the group consisting of notches, holes, grooves, loops, and combinations thereof.

6. The apparatus of claim 5.

7. the at least one control wire has a plurality of anchors, each anchor having a different position along an axial direction of the bendable body; 2. The apparatus of claim 1.

8. a driver in communication with the at least one control wire and configured to actuate the at least one control wire within the wall; The apparatus of claim 1 further comprising:

9. the at least one control wire further comprises an outer wire and an inner wire; The inner wire is slidably disposed within the outer wire in a telescopic manner.

2. The apparatus of claim 1.

10. the outer wire has an anchor for attaching the outer wire to the wall, and the inner wire has an anchor for attaching the inner wire to the wall; The positions of the anchors of the outer wire and the inner wire are different along the axial direction of the bendable body.

10. The apparatus of claim 9.

11. the control wire and the anchor are made of a radiopaque material; 2. The apparatus of claim 1.

12. a functional probe selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, derivatives thereof, and combinations thereof; 2. The apparatus of claim 1.

13. Attaching the anchor to the wall includes heating the wall and the anchor to form a heat seal.

2. The apparatus of claim 1.

14. The wall has at least two wire guides; The wire guides are spaced apart from one another.

2. The apparatus of claim 1.

15. 1. A medical device comprising: Providing a bendable body, the bendable body comprising: a cavity extending through the bendable body; a wall formed around the cavity; at least one control wire slidably disposed within said wall; an anchor configured on a distal end of the at least one control wire; providing a heating the anchor configured in the wall to form a melt between the wall and the anchor; cooling the anchor configured within the wall to solidify the melt; 23. An apparatus made by a process comprising:

16. The anchor is attached to the control wire by crimping.

16. The apparatus of claim 15.

17. The anchor is attached to the control wire by welding.

16. The apparatus of claim 15.

18. The anchor is attached to the control wire by crimping and welding.

16. The apparatus of claim 15.

19. The anchor further comprises a feature that provides additional surface area on an outer surface of the anchor to increase the strength of the connection of the anchor to the wall.

16. The apparatus of claim 15.

20. 1. A method of treating a subject, comprising: Providing a medical device, the medical device comprising: a bendable body having a cavity extending through the bendable body and a wall formed around the cavity; at least one control wire slidably disposed within said wall; an anchor configured on a distal end of the at least one control wire and attached to the wall; providing a advancing the medical device into a subject; bending the medical device to address an obstacle within the object; treating the subject when the medical device is advanced to a desired target within the subject; and The method includes:

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