The present disclosure relates generally to medical devices and, more particularly to a steerable device applicable to guide interventional tools and instruments, such as endoscopes and catheters, in medical procedures.
United States Patent Application Publication No. 2020/0383670 describes a medical device having a bendable body for insertion into a patient. The medical device includes at least a first driving wire configured in the bendable body, a first break-out wire attached to the first driving wire, and a contracting guide that is movable against the first driving wire. The first break-out wire is connected to an actuator configured to maneuver the bendable body to guide the medical device through passages. The contracting guide may be a contractible coil parallel to the first driving wire, and situated to contact the first driving wire when a motor conveys pushing and pulling forces.
To avoid buckling the driving wire when the contracting guide contacts the driving wire, the contractible coil surrounds the driving wire and the diameter of the driving wire is converted to the diameter of the break-out wire to avoid buckling thin driving wires. U.S. Pub. No. 2020/0383670 does not, however, describe that the contractible coil covers the full stroke of the driving wires. Where the contractible coil does not cover the full stroke of the driving wires, there is a risk of buckling of the driving wires around the boundary of the driving wires with the break-out wires.
Embodiments of the present disclosure provide a medical apparatus comprises a bendable body having a driving wire configured in the bendable body, a break-out wire attached to the driving wire, wherein a distal end of the break-out wire is attached to a proximal end of the driving wire, a distal guide tube guiding the driving wire and ending before the break-out wire with a space; a resilient element abutting the driving wire along at least a portion of a longitudinal direction of the driving wire; and an actuator configured to retract and advance the driving wire via the break-out wire thereby maneuvering the bendable body. The resilient element expands or contracts along the longitudinal direction of the driving wire, and it stays within the space between a proximal end of the distal guide tube and the distal end of the break-out wire. In some embodiments, the length of the resilient element is at least as long as a length of the driving wire from a proximal end of the distal guide tube.
Embodiments of the present disclosure also provide a steerable medical device including a resilient element such as a spring and a driving wire, with a length of the spring being greater than a length of the driving wire. According to various embodiments, the spring is a contractible coil spring which covers the full stroke of the driving wire. The present disclosure thus reduces, or eliminates, the risk of buckling of the driving wire by providing a medical device which reduces uncovered stroke of the driving wire with the spring.
According to embodiments of the present disclosure, a medical apparatus comprises a bendable body having a driving wire configured in the bendable body, a break-out wire attached to the driving wire, wherein a distal end of the break-out wire is attached to a proximal end of the driving wire, a resilient element such as a spring surrounding the driving wire along at least a portion of a longitudinal direction of the driving wire, the spring being movable against the driving wire; and an actuator configured to retract and advance the driving wire via the break-out wire and configured to maneuver the bendable body, wherein the spring contracts along the longitudinal direction of the driving wire, and a length of the spring is at least as long as a length of the driving wire from a proximal end of a distal guide tube that guides the driving wire to the distal end of the break-out wire.
According to some embodiments, a medical apparatus comprises a bendable body, at least one driving wire attached to the bendable body, an actuator, a break-out wire guide, a spring, and at least one break-out wire. The bendable body has a centroid along a longitudinal direction, the centroid including a proximal end and a distal end. The at least one driving wire is attached to the bendable body and extends to the proximal end of the centroid through the bendable body with an offset distance from the centroid. The actuator pushes and pulls one of the driving wires, the break-out wire guide bridging between the proximal end of the driving wires and the actuator to transmit push and pull forces from the actuator to the driving wires. The spring contracts along the longitudinal direction, and the at least one break-out wire has a larger diameter than the driving wire. An eyelet in the break-out wire guide has a proximal area and distal area with different cross sectional sizes along the longitudinal direction, wherein the cross sectional size of the proximal area of the eyelets is larger than the cross sectional size of the distal area of the eyelet, and the driving wire goes through the eyelet from the distal area to the proximal area of the eyelet, and the break-out wire is attached to the proximal end of the driving wire and extends through the proximal area of the eyelet, and is attached to the actuator. Wherein the spring surrounds the driving wire in the proximal area of the eyelet, and is surrounded by the eyelets, and is contracted by the break-out wire while the actuator is pushing the driving wire. The natural length of the spring is longer than a length of the driving wire from the distal guide tube to the distal end of breakout wire at the most proximal operation position of tractor. In some embodiments, the spring is compressed at the operation position of tractor for the straight shape of the bendable body.
According to some embodiments, a medical apparatus comprises an anchored spring without pre-tension or compression. The natural length of the spring is the same as the length of the driving wire from the distal guide tube to the distal end of breakout wire at the operation position of tractor for the straight shape of the bendable body. A distal end of the spring is attached to the boundary of the distal and proximal guide tubes. And a proximal end of the spring is attached to the boundary of the driving and breakout wires.
According to some embodiments, the diameter of the breakout wire is larger than the diameter of the driving wire, thus further aiding in avoiding buckling of the medical apparatus. Further variants may include a tapered breakout wire and/or driving wire to assist in retaining structural integrity.
According to some embodiments, a medical apparatus comprises a bendable body having a compression resistance element to maintain the length of the bendable body against compression force. One or more of the driving wire, the break-out wire guide, the spring, and the break-out wire are detachably attached to actuator.
Further features of the present disclosure will become apparent from the following description of exemplary embodiments with reference to the attached drawings.
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.
Exemplary embodiments are described below with reference to the drawings. The following description and drawings are illustrative of the disclosure and are not to be construed as limiting the disclosure.
In referring to the description, specific details are set forth in order to provide a thorough understanding of the examples disclosed. In other instances, well-known methods, procedures, components and materials have not been described in detail as not to unnecessarily lengthen the present disclosure.
It should be understood that if an element or part is referred herein as being “on”, “against”, “connected to”, or “coupled to” another element or part, then it can be directly on, against, connected or coupled to the other element or part, or intervening elements or parts may be present. In contrast, if an element is referred to as being “directly on”, “directly connected to”, or “directly coupled to” another element or part, then there are no intervening elements or parts present. When used, term “and/or”, includes any and all combinations of one or more of the associated listed items, if so provided.
Spatially relative terms, such as “under” “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description and/or illustration to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the various figures. It should be understood, however, that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, a relative spatial term such as “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein are to be interpreted accordingly.
The terms first, second, third, etc. may be used herein to describe various elements, components, regions, parts and/or sections. It should be understood that these elements, components, regions, parts and/or sections should not be limited by these terms. These terms have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed a second element, component, region, part, or section without departing from the teachings herein.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an”, and “the”, are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms “includes” and/or “including”, when used in the present specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof not explicitly stated. The term “position” or “positioning” should be understood as including both spatial position and angular orientation.
The present disclosure details a medical device capable of being steered for guidance through passages. More specifically, the subject medical device contains a central cavity, extending the length of the medical device, for accepting and advancing medical tools and devices including endoscopes, cameras, and catheters, and the ability to guide or maneuver the medical tool or device through passages.
Returning to
The break-out unit 9 comprises a distal guide tube 6, a proximal guide tube 7, at least two break-out wires 8A and 8B, and a spring 17 (see
The two motors 12 shown in
As depicted in
Position AA in
The spring 17 has a neutral length without any tension and compression at position BB (
When the driving wire 4 is pushed from position BB to AA, the spring 17 is compressed (
When the driving wire 4 is further pushed beyond position AA to CC (
Accordingly, in this embodiment, the spring 17 covers the driving wire 4 from position BB to position CC, which is the full range of the required stroke, and can prevent the buckling of the driving wire 4 whenever the driving wire 4 is pushed.
Specifically, with this embodiment, spring 17 can be assembled in the break-out unit 9 without bonding/attaching to the other part. This embodiment simplifies the manufacturing and structure of break-out unit 9, with miniaturized size and affordable cost. Moreover, no bonding elements results in greater durability of the break-out unit 9.
Also, since the spring 17 is not compressed at position BB, spring 17 is subjected to minimal compressed forces through full range of stroke during operation. This feature has advantages in reducing the driving force by the amount of compressed force for actuator 13.
Moreover, when the actuator 13 measures force on the driving wire 4, the compressed force to the spring 17 would be systematic error factor. By minimizing the compressed force, we can also reduce the systematic error for wire force measurement from the actuator 13.
In yet another embodiment, the spring 17 may have a compressed condition at position BB. With this design, the spring 17 is always compressed from position BB to position CC. This design presents an advantage in keeping spring 17 from rattling by having compressed force everywhere from position BB to position CC.
As described above, according to the exemplary embodiment described with reference to
Another embodiment of the present disclosure has a similar configuration of the steerable medical device 1 in
As seen in
When the driving wire 4 is pushed from position AA and reaches position CC (
Specifically, in this embodiment, the absolute magnitude of compression and tension force to the spring 17 can be minimized. This allows minimizing the additional force required to manipulate the actuator 13.
Moreover, when the actuator 13 will measure force on driving wire 4, those compressed and tension forces to the spring 17 would be systematic error factor. By minimizing the absolute magnitude of those forces with this embodiment, we can also reduce the systematic error for wire force measurement from the actuator 13.
The distal end of spring 17 can be attached to the proximal end of distal guide tube 6. In addition, the proximal end of spring 17 can be attached to the proximal end of the driving wire 4.
As described above, according to the exemplary embodiment described with reference to
A third embodiment of the present disclosure has a similar configuration of the steerable medical device 1 detailed in
While this configuration has aforementioned advantages, this configuration adds a new requirement to maintain length and shape of the bendable body 2 while the break-out unit 9 is detached from actuator 13.
When the bendable body 2 and break-out unit 9 are detached from actuator 13, the bendable body 2 would be subjected to the following two factors to change its length and shape.
The first factor is the force from spring 17 in the break-out unit 9. Since the break-out wire 8 is not connected to the tractor 10, the spring 17 would convey pulling or pushing forces to the bendable body 2 if the spring 17 is compressed or tensioned at position AA. In this case, the bendable body 2 is compressed or tensioned by the compressed or tensioned spring 17, respectively.
The second factor is the force from outside. Since the break-out wire 8 is not connected to the tractor 10, the break-out wire 8 is relatively free to move. In this instance, when the bendable body 2 contacts some object in the environment, the bendable body 2 is bent by the outside force.
According to some embodiments, the following designs are effective to maintain the length and shape of bendable body 2 when detached from actuator 13.
Design 1. Break-Out Unit of First Embodiment with Compression Resistance Element in Bendable Body 2
Break-out unit 9 of the first embodiment has a compressed spring 17 at position AA. In this configuration, when the bendable body 2 is detached from actuator 13, the bendable body 2 is subjected to a compression force by the compressed spring 17. The bendable body 2 has a compression resistance element, which can be backbone 5 in
The compression resistance element needs to cope with the compression force from spring 17, so as to retain the spring 17 within the wanted tolerance values of compression and expansion.
According to some embodiments, a catheter may be the compression resistance element in bendable body 2. The catheter may be designed such that the inner and outer tubes in the bending section can be the compression resistance element. Especially, when the inner tube includes metal braid structure, the inner tube can be reinforced in terms of compression force.
Design 2. Break-Out Unit of Second Embodiment with any Bendable Body 2
Since the break-out unit 9 of the second embodiment doesn't have a compression and tension force on the spring 17 at position AA, the break-out unit 9 of the second embodiment would maintain the length of bendable body 2.
Moreover, when the driving wire 4 moves from position AA toward position BB or position CC, the spring 17 generates a force to return to position AA. Therefore, break-out unit 9 of the second embodiment would also maintain the shape of bendable body 2.
Design 3. Break-Out Unit of Second Embodiment with Compressed or Tensioned Spring 17 with Compression or Tension Resistance Element in Bendable Body 2
Break-out unit 9 of the second embodiment can have a compressed or tensioned spring 17 at position AA by design of spring 17. The degree of compression or tensioning with this configuration would have a wider range than the break-out unit 9 detailed in the first embodiment, since the first embodiment requires that the maximum length of spring without tension should be larger than the length to cover driving wire 4 at position BB. Therefore, the break-out unit 9 of the second embodiment can have optimal compression or tension force for bendable body 2.
In this design, with the compressed spring 17 at position AA, the bendable body 2 has compression resistance element, which is the same as Design 1. Accordingly, when the bendable body 2 is detached from actuator 13, the bendable body 2 would be subjected to tension forces by tensioned spring 17. The bendable body 2 has a tension resistance element, which has a force stronger than tension or compression force of the spring 17, thus resisting the springs 17 force. This tension resistance element can be backbone 5 in
According to some embodiments, a catheter may be the tension resistance element in bendable body 2. The catheter may be designed such that the inner and outer tubes in the bending section can be the tension resistance element.
As described above, the third embodiment provides a configuration which allows exchanging the bendable body 2 from the actuator 13 if it is necessary. For example, when the bendable body 2 is broken, or has different design/trajectory for target anatomy or location. Specifically, when the bendable body 2 is intended for one-time-use, this configuration allows using the actuator 13 as a reusable device. Three design embodiments under the third embodiment maintain the length and shape of the bendable body 2 when it is detached from the actuator 13. This can guarantee the designed function of the bendable body 2 in the actual implementation of the detachably attached bendable body 2 to actuator 13.
While the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the present disclosure is not limited to the exemplary embodiments described.
This application claims priority from U.S. Provisional Patent Application No. 63/132,374 filed on Dec. 30, 2020, as well as U.S. Provisional Patent Application No. 63/149,963 filed on Feb. 16, 2021, both filed in the United States Patent and Trademark Office, the disclosures of which are incorporated herein in their entirety by reference.
Number | Date | Country | |
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63149963 | Feb 2021 | US | |
63132374 | Dec 2020 | US |