Patent Application
20210386972
The present disclosure relates generally to apparatus and methods for medical application. More particularly, the subject disclosure is directed to an articulated medical device having a hollow cavity, wherein the device is capable of maneuvering within a patient, and allowing a medical tool to be guided through the hollow cavity for medical procedures, including endoscopes, cameras, and catheters.
Bendable medical instruments such as endoscopic surgical instruments and catheters are well known and continue to gain acceptance in the medical field. The bendable medical instrument generally includes a flexible body commonly referred to as a sleeves or sheaths. One or more tool channels extend along (typically inside) the flexible body to allow access to a target located at a distal end of the body.
The instrument is intended to provide flexible access within a patient, with at least one curve or more leading to the intended target, while retaining torsional and longitudinal rigidity so that a physician can control the tool located at the distal end of the medical instrument by maneuvering the proximal end of the medical instrument.
Recently, to enhance maneuverability of the distal end of the instrument, robotized instruments that control distal portions have emerged. In those robotized instruments, to create curves locally at the distal portion by robotics, different techniques have been disclosed.
By way of example, United States patent publication number 2016/0067450, provides multiple conduits to retain the shape of the proximal part, while the driving tendons are bending the distal part in the medical instruments. The multiple conduits would be controlled selectively in a binary way by constraining or unconstraining the proximal ends of the conduits. By selecting the constrained conduits, the bendable medical device can change the length of bending distal segment by changing the stiffness of the bendable medical device based on the area where the conduits deploy.
However, there remains a need in the industry to further refine and advance bendable medical devices to minimize the outer size (diameter) of the bendable medical instrument, and to maximize the size (diameter) of the tool channel allowing for larger/more effective tools.
Thus, to address such exemplary needs in the industry, the presently disclosed apparatus teaches a medical apparatus comprising: a bendable body comprising: a hollow cavity extending the length of the bendable body; and a wall formed about the hollow cavity; at least one control wire slideably situated in the wall; and an anchor configured at a distal end of the at least one control wire, wherein, the anchor is affixed within the wall.
In various embodiments, the anchor may extend along an axial direction of the control wire with at least one projection element configured for embedding into the wall, thus embedding the anchor into the wall of the apparatus.
In another embodiment, the wall comprises at least one lumen configured to allow the control wire to slideably rest in the wall.
In additional embodiments, a second control wire may be slideably situated in the wall, having its own anchor for affixing the second control wire to the wall, wherein the position of the anchor for the first and the second control wires are different along the axial direction of the bendable body. In addition, additional control wires may be added to the apparatus.
In various other embodiments, the at least one control wire may includes a plurality of anchors, wherein the position of each anchor is different along the axial direction of the bendable body.
In another embodiment, the medical apparatus further comprising a driving unit in communication with the at least one control wire, configured to actuate the at least one control wire in the wall.
In yet another embodiment, the at least one control wire may further comprise of an outer wire and an inner wire, wherein the inner wire is slideably nested within the outer wire. In addition, each of the inner wire and outer wire may have one or more anchors for affixing the outer wire to the wall and the inner wire has an anchor for affixing the inner wire to the wall, wherein the position of the anchor for the outer wire and the inner wires are different along the axial direction of the bendable body.
In further embodiments, the control wire and/or anchor may comprise of a radio opaque material.
In additional embodiments, a functional probe may be selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, anchor, control wire and combinations therefrom.
In other embodiments, the affixing of the anchor to the wall may comprise of heating the wall and anchor to create a fusion.
The subject apparatus may be used in a variety of applications and by a variety of methods, including the steps of: providing a bendable body comprising: a hollow cavity extending the length of the bendable body; a wall formed about the hollow cavity; at least one control wire slideably situated in the wall; and an anchor configured at a distal end of the at least one control wire; heating the anchor configured in the wall to create a fusion between the wall and anchor; and cooling the anchor configured in the wall to set the fusion.
In other embodiments, use of the medical apparatus may involve: providing a medical apparatus comprising: a bendable body having a hollow cavity extending the length of the bendable body, and a wall formed about the hollow cavity; at least one control wire slideably situated in the wall; and an anchor configured at a distal end of the at least one control wire wherein the anchor is affixed to the wall; advancing the medical apparatus into a subject; bending the medical apparatus to accommodate obstacles in the subject; and treating the subject once the medical apparatus advances to a desired target in the subject.
In yet additional embodiments, the medical apparatus may be amended to comprise: a bendable body having a plurality of wire guides spaced a distance from each other and extending the length of the bendable body, where a wall is formed about the plurality of wire guides; wherein at least one control wire slideably situated in at least one wire guide; and an anchor is configured at a distal end of the at least one control wire, with the anchor affixed to the at least one wire guide.
These and other objects, features, and advantages of the present disclosure will become apparent upon reading the following detailed description of exemplary embodiments of the present disclosure, when taken in conjunction with the appended drawings, and provided paragraphs.
Further objects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying figures showing illustrative embodiments of the present invention.
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 numeral(s) including by the designation “′” (e.g. 12′ or 24′) signify secondary elements and/or references of the same nature and/or kind. Moreover, while the subject disclosure will now be described in detail with reference to the Figures, it is done so in connection with the illustrative 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 subject disclosure as defined by the appended paragraphs.
The navigation software 6 and the driving unit 2 are communicatively-coupled via a bus to transmit/receive data between each other. Moreover, the navigation software 6 is connected and may communicate with a CT scanner, a fluoroscope and an image server (not in Figure), which are ancillary components of the bendable medical device system 1. The image server may include, but is not limited to, a DICOM™ server connected to a medical imaging device including but not limited to a CT and/or MRI scanner and a fluoroscope. The navigation software 6 processes data provided by the driving unit 2 and data provided by images stored on the image server, and/or images from the CT scanner and the fluoroscope in order to display images onto the image display.
The images from the CT scanner may be pre-operatively provided to navigation software 6. With navigation software, a clinical user creates an anatomical computer model from the images. In this particular embodiment, the anatomy is that of a lung with associated airways. From the chest images of the CT scanner, the clinical user can segment the lung airways for clinical treatments, such as biopsy. After generating the lung airway map, the user can also create plan to access the lesion for the biopsy. The plan includes the airways to insert and maneuver the bendable medical device 3 leading to the intended target, which in this example is a lesion.
The driving unit 2 comprises actuators and a control circuitry. The control circuitry is communicatively-coupled with operation console 5. The driving unit 2 is connected to the bendable medical device 3 so that the actuators in the driving unit 2 operate the bendable medical device 3. Therefore, a clinical user can control the bendable medical device 3 via the driving unit 2. The driving unit 2 is also physically connected to a positioning cart 4. The positioning cart 4 includes a positioning arm, and locates the driving unit 2 and the bendable medical device 3 in the intended position with respect to the target/patient. The clinical user can insert, maneuver and retreat the bendable medical device 3 to perform medical procedures, here a biopsy in the lungs of the patient.
The bendable medical device 3 can be navigated to the lesion in the airways based on the plan by the clinical user's operation. The bendable medical device 3 includes a hollow cavity for various tools (e.g. a biopsy tool). The bendable medical device 3 can guide the tool to the lesion of the patient. In one example, the clinical user can take a biopsy sample from the lesion with a biopsy tool.
The bendable segments 12, 13, 14, can independently bend and can form a shape with three independent curvatures, as seen in
The bendable body 7 includes a set of first control wires 9a, 9b, 9c, a second set of control wires 10a, 10b, 10c, and a third set of control wires 11a, 11b, 11c. The wall 8 houses the control wires 9a-11c in the lumens 34, which are configured along longitudinal direction of the bendable body 7. The lumens 34 allow for slideable movement of the control wires 9a-11c along an axial direction of the bendable body. The control wires 9a-11c are terminated at the distal end of each bendable segment 12, 13 and 14, to form the three bendable groups, each with three wires each (a, b, c). The first control wires 9a, 9b, 9c are terminated at the distal end of the first bendable segment 12 with anchoring segments 15a, 15b, 15c, and are configured apart from each other by approximately 120 degrees within the wall 8. The first control wires 9a, 9b, 9c are connected to the driving unit 2 at the proximal end of the wires 9a, 9b, 9c. The driving unit 2 induces pushing or pulling forces to move the control wires 9a, 9b, 9c by actuating those wires, and bending the bendable body 7 from the distal end 24.
Similarly, the second set of control wires 10a, 10b, 10C are terminated at the distal end of the second bendable segment 13, using the anchoring segments 16a, 16b, 16c, and are connected to the driving unit 2 at the proximal end. The second set of control wires 10a, 10b, 10c are also housed in 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.
In the same way, the third set of control wires 11a, 11b, 11c are also configured to bend the bendable body 7 at the third bendable segment 14, once again by inducing pushing or pulling, actuated at the distal end 24 of the control wires 11a, 11b, 11c by the driving unit 2.
Accordingly, by pushing and pulling the set of control wires 9, 10, 11, the first, the second and the third bendable segments 12, 13, 14, respectively, individually bend the bendable medical device 3, in three dimensions.
The subject bendable medical device 3 incorporates control wires 9, 10, 11, that can be fixed to the bendable body 7 by using minimal space in the bendable body wall 8. Because the anchoring segment 15-17 is localized within the individual lumens 34, the bendable medical device 3 with the control wires 9, 10, 11, can be effectively miniaturized, especially when using multiple control wires 9, 10, 11. Additionally, the control wires 9, 10, 11, can be fully contained within the bendable body 7 wall 8, not needing to be outside the outer diameter 42 or inside the inner diameter 40; thus not impinging on the tool channel 18 or unnecessarily increasing 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 pushing force, torque as well as pulling force to the bendable body 7. Therefore, the bendable medical device 3 can reduce the number of control wires 9, 10, 11, or force load per the control wire 9, 10, 11, to achieve the target bending maneuver in comparison to the conventional tendon-driven system with pulling forces.
Moreover, because the anchoring segment 15-17 does not need additional abutment parts that cover the cross section of the bendable body 7, the bendable medical device 3 can reduce the number of jointing points between the bendable body 7 and those additional abutment parts at the position of the anchoring segment 15-17. Therefore, the subject bendable medical device 3 can improve continuity of flexibility with reduced influence of motion control and reduce risks of failure in those jointing points. Also, the bendable medical device 3 can have a continuous smooth surface on the outer diameter 42 and the inner diameter 40 of the bendable body 7 to avoid risk of trauma to the patient anatomy and improved tool advancement/retraction in the tool channel 18.
Furthermore, the control wire 9, 10, 11, can be fixed to the bendable body at a wide variety of positions along the length of the bendable body 7, allowing the bendable medical device 3 to be configured to have multiple bending segments, especially a distal bending segment manipulated independently from the proximal part of the bendable body to provide improved flexible access to the intended treatment area of the patient.
With the first, the second and the third bendable segments 12, 13 and 14, respectively, the bendable medical device 3 can orient the distal end 24 without moving the proximal part 19 that goes through all bifurcations to this lesion. By using the three-dimensional bending capability of the first and the second bendable segments 12 and 13, the bendable medical device 3 can perform unique maneuvers to enhance capability of the peri-bronchial targeting (
In a first maneuver in an omni-directional orientation (
The second maneuver is a clustering sampling, as provided in
In
In
Moreover, the first control wire 9 and second control wire 10 can be made of a material visible in the medical imaging modality. In this particular embodiment, the first control wire 9 and second control wire 10 are radio-opaque and visible in X-ray fluoroscopy. Therefore, the clinical user can distinguish the shape of the first control wire 9 and second control wire 10 as the surrogate shape of the bendable body 7 under the X-ray fluoroscopy. Also, with the distal segment only containing the first control wire 9, the clinical user can distinguish the distal segment from the proximal segment in the X-ray fluoroscopy.
In
In another embodiment, the first control wire 9 may contain an electromagnetic position tracking sensor or a shape sensing fiber, such that consistent coordinate management may be implemented, providing an advantage in the registration of the coordinates between the sensor system, the medical images, and the target/patient.
By having the control wire with a plurality of the anchoring segments, the bendable medical device can include the control wire fixed at all degrees of freedom of motions to the bendable body through the axial direction of the bendable body. This special control wire can maintain the geometrical relationship, i.e. a position and an orientation, between the control wire and the bendable body while the bendable body is bending, torsional and/or translational motions. Therefore, the control wire can effectively reflect its mechanical property to the resultant mechanical property of the bendable medical device with those constraints to modify the mechanical property of the bendable medical device. Specifically, an axial mechanical stiffness of the control wire can be reflected ideally while reducing risk of buckling of the control wire.
Moreover, the control wire can be utilized as a sensing element to localize the position and the orientation of the tip of the bendable body by leveraging consistency of the geometrical relationship to the bendable body.
Since the anchoring segments are localized within the space of one lumen 34, the bendable body 7 can have multiple different functional probes at the same time. For example, the bendable body 7 may include the electromagnetic position tracking sensor and the endoscopic camera unit, and can measure position and orientation of the endoscopic view in real-time.
Additional advantages may be recognized when having the first and the second bendable segments arranged a distance from the distal end of the bendable body, thus enhancing distal dexterity. The first and second bendable segments can be adjusted/manipulated independently to change the orientation of the distal end of the catheter as well as the position of the distal end three-dimensionally; both sections do not have to move in the same plane. With these motions, the distal end of the catheter can access a wide range of positions from a variety of orientations with the three bendable segments. Therefore, the bendable medical device provides physicians a wider addressable area and approaches for access of a medical instrument, such as biopsy forceps, a fine aspiration needle or an ablation probe.
Also, the third bendable segment can deform by external forces to follow the shape of tortuous pathways in the anatomy, such as lung airways, blood vessels and brain ventricles, while minimizing exerted force to the anatomy. Therefore, by following the shape of the anatomy, the third bendable segment can be navigated by the first and the second bendable sections when the catheter is inserted, and develop the delivery line for both the medial instruments for medical treatments and the driving force for control.
In addition, the bendable medical device provides consistent and accurate distal maneuvers by having the first and the second bendable segments. The second bendable segment detaches the motions of the first bendable segments from the rest of the proximal part of the bendable medical device. Because the proximal part of the catheter including the second bending bendable segment goes through the tortuous pathways in the anatomy, and interacts with the anatomy with many contacts along the pathways, those contacts interfere with the motion of the catheter and deteriorate control accuracy of the catheter. Moreover, this deterioration in itself is not systematic but random because the contact points and degree of contacts change by patient motion and the bendable medical device maneuvers. Therefore, by detaching the first and the second bendable segments, the bendable medical device can prevent the deterioration of control and achieves consistent and accurate distal maneuvers.
Finally, as the bendable body can avoid the uncontrollable contraction and the expansion in the bending motion by reflecting the axial stiffness of the first control wire, the bendable medical device can improve control accuracy of the bending, and reduce the cross talk among the different bending segments.
In yet another embodiment of the subject innovation, detailed in
With this configuration, since the second control wire 10 shares the same axis and space with the first control wire 9, the second control wire 10 can cancel out the pushing and pulling forces of the first control wire 9 in the interval of the second control wire 10 without passing through other structures of the bendable body 7. For example, when the first control wire 9 is pulled to bend the distal end, the second control wire 10 can be pushed with the same magnitude of force to maintain the shape of the proximal part. Moreover, since the first control wire 9 is nested in the second control wire 10, the axes of those two control wires would keep consistency even when the bendable body 7 is bent along the pathways. Therefore, the bendable medical device 3 can effectively reduce the cross talk between different bendable segments during clinical operation. Especially when the bendable body involves relatively low axial stiffness and can distort its cross sectional plane from a plane without driving forces, the second control wire can compensate for those distortions in the interval of the second control wire by cancelling out the axial driving forces on the first control wire.
In addition, this configuration of discrete sections and continuous outer lining 46 can be tuned to the required flexibility necessary for navigation to accommodate the anatomy of the patient. Furthermore, this embodiment allows the control wires 9 to be affixed to the bendable body 7 at the wire guides 36.
This application claims priority to U.S Provisional Patent Application No. 62/750,641, titled “Medical Apparatus with Reflow Trapped Anchors and Method of Use Thereof” filed on Oct. 25, 2018, the disclosure of which is herein incorporated in its entirety by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US19/57711 | 10/23/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62750641 | Oct 2018 | US |
