System and method for target size estimation

Abstract

A medical device may include a handle assembly having an actuator and a sheath. The sheath may extend between a proximal end and a distal end. The proximal end of the sheath may be coupled with an actuator. The medical device may also include an end effector movable relative to the sheath between an extended configuration and a retracted configuration. The end effector may include a plurality of expandable legs. Each of the plurality of expandable legs may include a plurality of first indicia and a plurality of second indicia. The color of each of the first plurality of indicia may be different than the color of each of the second plurality of indicia.

Description

[0001] This application is a divisional application of an application with an application date of April 29, 2019, application number 201980028935.1 (international application number PCT / IB2019 / 053495), and invention name “System and method for target size estimation”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This patent application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 664,793, filed on April 30, 2018, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present disclosure generally relates to medical systems, devices and related methods. More specifically, the present disclosure relates to medical systems and / or devices for treating tissue and / or removing objects in a patient's body. Background Art

[0005] Medical retrieval devices are often used to remove organic matter (e.g., blood clots, tissue, and biological coagulants such as urinary stones, bile duct stones, and pancreatic stones) and inorganic matter (e.g., parts of medical devices or other foreign matter) that may obstruct or otherwise reside within a patient's body cavity. For example, coagulants can grow in certain parts of the body, such as the kidneys, pancreas, and gallbladder. Minimally invasive medical procedures, such as during percutaneous nephrolithotomy (PNCL), are used to remove these coagulants through natural orifices or through incisions.

[0006] In order to remove such coagulation (e.g., kidney stones), a medical device, such as a retrieval device (e.g., an expandable basket) can be delivered through the working channel of the insertion device. The shaft of such a medical device can be selectively extended and retracted relative to the working channel of the insertion device or the sheath of the medical device to expand or retract the end effector (e.g., a basket) to perform one or more therapies, treatments, or diagnostic assessments on the subject. For example, the end effector can be expanded to capture stones or other such materials therein to be removed through the working channel. However, if the stone is too large to pass through the working channel, a medical professional may be required to manipulate the medical device so that the stone is removed from the end effector if possible, or one or more additional procedures may be required to break the stone (e.g., lithotripsy, etc.) so that it can pass through the working channel. However, typically, the only way to measure the size of the stone is through a trial and error process, in which the captured stone is withdrawn to the working channel of the insertion device to see if the stone can physically pass through it. This trial and error process increases the operation time and may cause damage to the patient's surrounding tissues, the end effector, and / or the insertion device itself.

[0007] The systems, devices, and methods of the present disclosure may remedy some of the above-mentioned deficiencies or address other aspects of the prior art. Summary of the invention

[0008] Examples of the present disclosure relate particularly to medical devices.Each example disclosed herein may include one or more features described in conjunction with any other disclosed example.

[0009] In one example, a medical device may include a handle assembly having an actuator and a sheath. The sheath may extend between a proximal end and a distal end. The proximal end of the sheath may be coupled to the actuator. The medical device may also include an end actuator that is movable between an extended configuration and a retracted configuration relative to the sheath. The end actuator may include a plurality of expandable legs. Each of the plurality of expandable legs may include a plurality of first markings and a plurality of second markings. The color of each of the first plurality of markings may be different from the color of each of the second plurality of markings.

[0010] Examples of medical devices may include one or more of the following features. The color of each of the second plurality of markings may be darker than the color of each of the first plurality of markings. The color of each of the first markings may be white or the color of each of the first markings may be blue. The color of each of the second markings may be black. The first plurality of markings and the second plurality of markings may alternate along the length of each of the plurality of legs. Each of the first plurality of markings may include a first coefficient of friction, and each of the second plurality of markings may include a second coefficient of friction greater than the first coefficient of friction. Each of the first plurality of markings may include a physical property, and each of the second plurality of markings may not have the physical property. The physical property of each of the first plurality of markings may include one or more of a protrusion, a bump, an extension, a tine, a groove, a cutout, a notch, or a depression. The length of each of the first markings may be the same. The length of each of the second markings may be the same. The length of each of the first plurality of markings may be the same as the length of each of the second plurality of markings. The length of each of the first plurality of markings and the second plurality of markings may be between about 0.5 mm and about 3.0 mm. The length of each of the first plurality of markings and the second plurality of markings may be 2.0 mm. The length of each of the first plurality of markings may be different from the length of each of the second plurality of markings. The plurality of legs may include 3 to 8 legs.

[0011] In another example, a method may include inserting a medical device into a location within a subject. Additionally, the method may include moving an end effector of the medical device to an extended and expanded configuration, wherein the end effector may include a plurality of legs. Additionally, the method may include capturing an object with the plurality of legs of the end effector and measuring a size of the object using a plurality of first markings and a plurality of second markings alternately disposed along at least one of the plurality of legs. The color of each of the first plurality of markings may be different from the color of each of the second plurality of markings.

[0012] Examples of the method may include one or more of the following features. Measuring the size of the target may include measuring a first dimension of the target, and the method may further include measuring a second dimension of the target. The second dimension may be substantially orthogonal to the first dimension. The method may include manipulating the orientation of the target relative to the end effector. Manipulation may include applying a distally directed force on the guidewire to impact or contact the target.

[0013] In another example, a medical device may include a handle assembly that includes an actuator. The medical device may also include a sheath extending between a proximal end and a distal end. The proximal end of the sheath may be coupled to the actuator. The medical device may also include an end actuator that can move between an extended configuration and a retracted configuration relative to the sheath. The end actuator may include a plurality of expandable legs. At least one of the plurality of expandable legs may include a plurality of first markings. The length of each of the first markings may be the same. At least one of the plurality of expandable legs may include a plurality of second markings. The length of each of the second markings may be the same. The length of each of the first plurality of markings may be the same as the length of each of the second plurality of markings. The first plurality of markings and the second plurality of markings may alternate along the length of each leg of the plurality of legs. The color of each of the first plurality of markings may be different from the color of each of the second plurality of markings.

[0014] Examples of medical devices may also include one or more of the following features. Each of the plurality of legs may include a first plurality of markings and a second plurality of markings. The color of each of the second plurality of markings may be darker than the color of each of the first plurality of markings. The length of each of the first plurality of markings and the second plurality of markings may be between about 0.5 mm and about 3.0 mm. The length of each of the first plurality of markings and the second plurality of markings may be 2.0 mm. The color of each of the first plurality of markings may be white, or the color of each of the plurality of first markings may be blue, and the color of each of the second markings may be black.

[0015] The foregoing general description and the following detailed description are exemplary and illustrative only, and are not limitations on the claimed features. As used herein, the terms "comprises," "including," "having," "comprising," or other variations thereof are intended to encompass non-exclusive inclusions, such that a process, method, article, or device comprising a series of elements includes not only those elements, but may include other elements that are not explicitly listed or inherent to such a process, method, article, or device. In addition, the term "exemplary" is used herein in the sense of "example," rather than "ideal." As used herein, unless otherwise specified, the terms "approximately," "substantially," and "roughly" represent values ​​within a range of + / - 5% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0017] Figure 1 An exemplary medical device is shown in an extended and expanded configuration;

[0018] Figure 2A The device is shown in a retracted and collapsed configuration within a working channel of an insertion device. Figure 1 medical devices;

[0019] Figure 2B Shown is a graph of a target of interest in an extended and expanded configuration. Figure 1 medical devices; and

[0020] Figure 2C The device is shown in an extended and expanded configuration after capturing an object of interest therein. Figure 1 medical device. DETAILED DESCRIPTION

[0021] Examples of the present disclosure relate to a medical device for treating an internal region of a patient's body. The medical device may include an end effector including a plurality of markers.

[0022] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

[0023] The terms "proximal" and "distal" as used herein are used to refer to the relative positions of components of an exemplary medical device or insertion device. When used herein, "proximal" refers to a position relatively closer to the outside of a patient or closer to a medical professional using the medical device or insertion device. Conversely, "distal" refers to a position relatively farther away from a medical professional using the medical device or insertion device, or a position closer to the inside of a patient.

[0024] Figure 1 An exemplary medical device 10 is shown. The medical device 10 includes a sheath 12, which includes a distal end 14 and a proximal end 16. The sheath 12 can be, for example, a hollow tube and includes a longitudinally extending lumen 26. The sheath 12 can be made of a polymer material, a metal, or a combination of materials. The medical device 10 can also include a shaft 18, which is connected to (e.g., by any suitable connection mechanism, such as, for example, laser welding, adhesives and / or mechanical fasteners, etc.) an end effector 20 at its distal end or is formed integrally with the end effector (e.g., integrally formed). The shaft 18 can be elongated and can include, for example, a wire, a braid, a shaft and / or any other suitable drive member configured to transmit a translational force and / or a rotational force from its proximal end to its distal end.

[0025] As shown, the end effector 20 may include a device configured to capture and / or retrieve material (e.g., stone S, Figures 2A-2C ) cage or basket-like member. The end effector 20 can be laser cut and / or chemically etched from a tube and can be constructed of any suitable material, such as, for example, shape memory materials, including synthetic plastics, stainless steel, and superelastic metal alloys of nickel / titanium (e.g., nitinol), copper, cobalt, vanadium, chromium, iron, etc.; or alternative materials, including, for example, other metal alloys, powdered metals, ceramics, thermoplastic composites, ceramic composites, and polymers. Likewise, combinations of these and other materials may be used.

[0026] The end effector 20 and the shaft 18 can be in an extended and expanded state ( Figure 1 ) and the retracted and collapsed states ( Figure 2A ) between the proximal end 16 of the sheath 12. For example, the medical device 10 may include a handle assembly 22 located at the proximal end 16 of the sheath 12. The handle assembly 22 may include an actuating member 24 for moving the sheath 12 relative to the end effector 20 so as to convert the end effector 20 between the extended state and the retracted state. For example, the proximal end 16 of the sheath 12 may be fixed to the actuator 24, and the proximal end of the shaft 18 may be fixed to the handle assembly 22 by a locking member 28 in any suitable manner (e.g., by clamping, friction, adhesive, welding and / or heat riveting, etc.). The locking member 28 may be threadedly coupled to the proximal end of the handle assembly 22. When so coupled, the locking member 28 maintains the axial position of the shaft 18 relative to the handle 30 of the handle assembly 22. That is, the locking member 28 prevents the axial translation of the shaft 18 relative to the handle 30 of the handle assembly 22.

[0027] In use, a medical professional can push the actuator 24 distally relative to the handle 30 to move the actuator 24 in the extended state ( Figure 1 ) and retracted state ( Figure 2A ), the end effector 20 can be moved between the extended state and the retracted state. For example, the medical professional can hold the handle 30 in the palm of their hand with their thumb or finger on the actuator 24. To move the end effector 20 from the extended state to the retracted state, the medical professional can push, slide, or advance the actuator 24 relative to the handle 30. Because the sheath 12 is coupled to the actuator 24, moving the actuator 24 distally causes the sheath 12 to move distally toward or past the end effector 20. As the sheath 12 is advanced past the end effector 20, the end effector 20 transitions (e.g., collapses, compresses, etc.) to its retracted state within the lumen 26 of the sheath 12.

[0028] As described above, the end effector 20 may be a basket or retrieval device including a plurality of legs 50. For example, Figure 1 As shown, the end effector 20 may include four legs 50. However, in other arrangements, the end effector 20 may include more or less than four legs 50. For example, the end effector 20 may include about 3 to about 8 legs. Each such leg 50 may include a plurality of scales, logos or markings thereon. For example, each leg 50 may include a plurality of first markings 52A and a plurality of second markings 52B. The first markings 52A and the second markings 52B may be arranged alternately along the length of each leg 50. For example, each leg may include a marking pattern starting with a first marking 52A followed by a second marking 52B, and thereafter repeating along the length of each leg 50. Each first marking 52A may have a first color, and each second marking 52B may have a second color. The second color of the second marking 52B is generally darker in the visible spectrum (e.g., may have a higher wavelength) than the first color of the first marking 52A. For example, the second marking 52B may be black, and the first marking 52A may be white or blue. While these colors enable sufficient contrast to be easily distinguished by medical professionals, it should be understood that specific references to colors are merely descriptive and the present disclosure is not limited thereto. Instead, the second color of the second marking 52B can be any color that is sufficiently different from the first marking 52A so that a medical professional can visually distinguish the first marking 52A from the second marking 52B during use. Optionally, one of the first marking 52A or the second marking 52B can include a colored coating, while the other of the first marking 52A or the second marking 52B can be uncoated so as to have a different color (e.g., the color of a bare wire or the like).

[0029] In some arrangements, each of the first mark 52A and the second mark 52B comprises a common length, such as 2 mm. Although described and depicted herein (e.g. Figure 2B) has a length of 2 mm, but the present disclosure is not limited to this. Instead, the length of the mark, such as the first mark 52A and / or the second mark 52B, can be any suitable length (e.g., 0.5 mm, 1 mm, 1.5 mm, 2.5 mm, 3 mm, or fractions therebetween, etc.) to facilitate the medical professional to estimate the size of the stone S, which will be described in further detail below. Optionally, each first mark 52A can have a first length (e.g., 2 mm) and each second mark 52B can have a second length (e.g., 1 mm). In either arrangement, the length of each of the first mark 52A and the second mark 52B, whether the same or different, can be provided to the medical professional to facilitate the medical professional to estimate the size of the stone S, which will be described in further detail below.

[0030] In some arrangements, the first mark 52A may include a different coefficient of friction than the second mark 52B. For example, the coefficient of friction of the first mark 52A may be greater than the coefficient of friction of the second mark 52B, or vice versa. Such different coefficients of friction may allow different lengths of marks to alternately grip and slide on the uneven surface of the stone, thereby manipulating and capturing the stone in an optimal orientation for removal. In addition, the first mark 52A may optionally include one or more additional physical attributes that are different from the second mark 52B, or vice versa. For example, the first mark 52A may include one or more protrusions, bumps, extensions, or tines extending radially outward from the leg 50 relative to the longitudinal axis of the leg 50, while the second mark 52B may not include or have such physical attributes, or vice versa. Alternatively, the first mark 52A may include one or more grooves, cutouts, notches, depressions, etc. extending radially inward toward the leg 50 relative to the longitudinal axis of the leg 50, while the second mark 52B may not include or have such physical attributes, or vice versa. In either manner, varying gripping profiles along each leg 50 of the end effector 20 may be achieved.

[0031] In some arrangements, the end effector 20 can be formed from a tube. For example, the method of forming the end effector 20 can include starting from a hollow tube or sleeve. In this case, the shaft 18 can include such a hollow tube or sleeve. At least a portion of the hollow tube or sleeve can then be cut (e.g., laser cut), and thus, the end effector 20 can be integrally formed from a single piece of material. Alternatively, the end effector 20 can be formed from a plurality of separate and distinct legs 50 coupled to each other in any suitable manner.

[0032] The medical device 10 can be delivered into the body of a subject by any suitable insertion device 70 having a working channel 72 extending therethrough. The insertion device 70 can include any device configured to allow a user to access and view an internal area of ​​a subject's body, such as a ureteroscope, a hysteroscope, a hysteroscope, a bronchoscope, a cystoscope, and the like.

[0033] In use, a medical professional may position the insertion device 70 at a desired location within a subject's body (e.g., a location within a subject's urethra). Such a location may be proximal to a stone S or other such material to be captured by the end effector 20. Next, the medical professional may deliver the medical device 10 into the subject's body through the working channel 72 of the insertion device 70. For example, the distal end 14 of the sheath 12 may be advanced through the working channel 72, such as Figure 2A shown.

[0034] Next, as described above, by manipulating one or both of the actuator 24 and the handle 30 relative to the other of the actuator 24 and the handle 30, the end effector 20 can be moved to a position such as Figure 2B Once so arranged, the end effector 20 can be manipulated to capture the stone S therein, such as Figure 2C Once received therein, the medical professional can estimate the size of the stone S by the first marker 52A and the second marker 52B. For example, when observing the internal area of ​​the subject's body by any suitable imaging method (e.g., by a camera associated with the insertion device 70), the medical professional can easily calculate how much of the first marker 52A and the second marker 52B need to extend along a first dimension of the stone S (e.g., a dimension that is generally coaxial or parallel to the longitudinal axis of the sheath 12) to measure the size of the stone S along the first dimension. For example, as Figure 2C As shown, where each of the first mark 52A and the second mark 52B has a common length of 2 mm, the stone S has a dimension extending along approximately 3 marks (e.g., one first mark 52A and two second marks 52B) in the first direction, indicating a total size of 6 mm (e.g., 3×2 mm=6 mm).

[0035] Next, the medical professional can visually inspect the general shape of the stone S to determine whether a second dimension of the stone S that is generally orthogonal to the first dimension is approximately the same. For example, if the stone S is generally spherical, such as Figures 2A-2CAs shown, the medical professional can determine that a second dimension of the stone S that is generally orthogonal to the first dimension (e.g., generally orthogonal to the longitudinal axis of the sheath 12) is also approximately 6 mm. However, if the stone S is elliptical and / or is not generally spherical in shape, the medical professional can estimate the second dimension of the stone S based on an estimate of the first dimension of the stone S. For example, if the first dimension of the stone S appears to be approximately twice the second dimension of the stone S, the medical professional can determine that the second dimension of the stone S is approximately 3 mm (e.g., 6 mm / 2=3 mm). However, optionally, the medical professional can manipulate the stone S relative to the end effector 20 to rotate or adjust the orientation of the stone S within the end effector 20, and then directly observe the size of the stone S along the longitudinal axis of the sheath 12. For example, the medical professional can manipulate the actuator 24 and the handle 30 to adjust the orientation of the stone S. Optionally, one or more additional medical devices, such as a guide wire 80 ( Figure 2C ) etc. to push, stab or adjust the stone S relative to the end effector 20. For example, the medical professional can apply a distally directed force on the guide wire 80 to contact or impact the stone S, thereby manipulating the orientation of the stone S.

[0036] In estimating the size of the stone S, the medical professional can quickly and efficiently determine whether one or more procedures are needed to fragment or otherwise reduce the size of the stone S prior to removal. For example, if the estimated size of the stone is larger than the known size (e.g., diameter) of the working channel 72, the medical professional does not need to withdraw the stone S toward the insertion device 70, only to find out by trial and error that it is too large to pass through the working channel 72, thereby avoiding potential damage to the end effector 20 or the insertion device 70. That is, the markings 52A and 52B provide an easily accessible in vivo size estimate of the stone S captured by the end effector 20. In this way, surgical time and costs can be reduced because trial and error removal of stones S that are too large to pass through the working channel 72 of the insertion device 70 is reduced.

[0037] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those who receive the teachings provided herein will recognize that other modifications, applications, embodiments, and alternatives of equivalents all fall within the scope of the features described herein. Therefore, the features claimed should not be considered to be limited by the foregoing description.

Claims

1. A medical device comprising: a handle assembly including an actuator; a sheath extending between a proximal end and a distal end, the proximal end of the sheath being coupled to the actuator; as well as an end effector movable relative to the sheath between an extended configuration and a retracted configuration, the end effector comprising a plurality of expandable legs, at least one expandable leg of the plurality of expandable legs comprising a plurality of first markings and a plurality of second markings; wherein each of the first plurality of markings and / or each of the second plurality of markings comprises a physical attribute extending radially outward or inward relative to a longitudinal axis of the corresponding leg, and Wherein, a length of each of the first plurality of marks and a length of each of the second plurality of marks are substantially the same.

2. The medical device according to claim 1, wherein: The first plurality of markings and the second plurality of markings alternate along a length of at least one expandable leg of the plurality of expandable legs.

3. A medical device according to any one of the preceding claims, wherein: The physical properties include one or more of extensions or depressions.

4. The medical device according to any one of the preceding claims, wherein: Each of the plurality of expandable legs includes the plurality of first markings and the plurality of second markings.

5. The medical device according to any one of the preceding claims, wherein: Each of the first plurality of indicia and each of the second plurality of indicia include the physical attribute.

6. The medical device according to any one of the preceding claims, wherein: A physical property of each of the first plurality of markings is different from a physical property of each of the second plurality of markings.

7. A medical device according to any one of the preceding claims, wherein: The end effector is formed from a shape memory material.

8. The medical device according to any one of the preceding claims, wherein: The end effector is unitary.

9. The medical device according to claim 7, wherein: The end effector is integrally formed from a hollow tube.

10. The medical device according to any one of the preceding claims, wherein The color of each of the second plurality of indicia is different from the color of each of the first plurality of indicia.

11. The medical device according to claim 10, wherein: Each of the second plurality of markings is darker in color than each of the first plurality of markings.

12. The medical device according to any one of the preceding claims, wherein: A length of each of the first plurality of marks and a length of each of the second plurality of marks are between 0.5 mm and 3.0 mm.

13. The medical device according to claim 12, wherein: Each of the first plurality of marks and the second plurality of marks has a length of 2.0 mm.

14. The medical device according to any one of the preceding claims, wherein: Each of the first plurality of markings includes a first coefficient of friction, and each of the second plurality of markings includes a second coefficient of friction, and the second coefficient of friction is different from the first coefficient of friction.

15. The medical device according to claim 14, wherein: The second friction coefficient is greater than the first friction coefficient.

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