Medical device

Abstract

Devices, systems, and methods for treating a calculus in an anatomical structure are disclosed. A device can include an elongate member and a tubular member extending distally from the elongate member. The elongate member can define one or more lumens with openings at a distal end of the elongate member. The tubular member can be configured to collapse to a predetermined shape when in a relaxed state and to expand in response to receiving an object. The device can be used with an endoscope, such as a ureteroscope, a lithotripsy device, and / or other medical devices or systems.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 593,099, filed October 25, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to, but is not limited to, medical devices and systems, as well as methods of treatment. More specifically, this disclosure relates to medical devices for use in treatments, such as capturing an object, reducing an object to a smaller object, and removing an object from a subject's body. Background Technology

[0004] Various devices, systems, and methods have been developed to break kidney stones into smaller fragments and remove them from patients. These devices and systems are manufactured using a variety of different methods and can be used in various scenarios depending on the method used. Each known medical device, delivery system, and method has its own advantages and disadvantages. There is always a need for alternative medical devices and delivery methods, as well as alternative methods for manufacturing and using them, such as those instruments that are prone to displacement within anatomical structures. Summary of the Invention

[0005] This disclosure provides designs, materials, manufacturing methods, and alternatives for use in medical devices.

[0006] In a first example, the medical device may include an elongated member defining one or more lumens, having an opening at a distal end of the elongated member; and a tubular member extending distally from the distal end of the elongated member, wherein the tubular member may be configured to constrict to a predetermined shape when in a relaxed state and to expand in response to a receiving object.

[0007] In addition to or as an alternative to any of the examples above, tubular members may have a mesh structure.

[0008] In addition to or as an alternative to any of the examples above, mesh structures can be formed from braided yarns.

[0009] In addition to or as an alternative to any of the examples above, tubular members may have a polymer coating covering at least a portion of the mesh structure.

[0010] In addition to or as an alternative to any of the examples above, a tubular member may have a distal end, a receiving portion extending distally from the elongated member, and a diameter-reducing portion extending between the receiving portion and the distal end.

[0011] In addition to or as an alternative to any of the examples above, when the tubular member is in a predetermined shape, the inner diameter of the tubular member may decrease from the distal end to the diameter-reducing portion in the proximal direction, and then increase from the diameter-reducing portion in the proximal direction.

[0012] In addition to or as an alternative to any of the examples above, the rate of increase of the inner diameter from the diameter-reducing portion in the proximal direction may be greater than the rate of decrease of the inner diameter from the distal end to the diameter-reducing portion in the proximal direction.

[0013] In addition to or as an alternative to any of the examples above, tubular members may include valves that extend across the inner diameter of the tubular member.

[0014] In addition to or as an alternative to any of the examples above, the valve may be located at the distal end of the tubular member.

[0015] In addition to or as an alternative to any of the examples above, the distal end of a tubular member may include a buffer.

[0016] In addition to or as an alternative to any of the examples described above, the medical device may further include a manipulable gripper extending distally from the distal end of the tubular member, the manipulable gripper being configured to adjustably grip an object and position the object within the tubular member.

[0017] In addition to or as an alternative to any of the examples above, the medical device may further include one or more adjustable members communicating with the distal portion of the tubular member, and the one or more adjustable members are configured to be adjusted to close the tubular member around the object.

[0018] In another example, the medical system may include an elongated member defining one or more lumens, having an opening at a distal end of the elongated member; a tubular member extending distally from the distal end of the elongated member; and a stone treatment device configured to extend along a first lumen of one or more lumens of the elongated member, wherein the stone treatment device may be configured to break a stone received in the tubular member into stone fragments, and the tubular member is configured to contain the stone fragments within the tubular member.

[0019] In addition to or as an alternative to any of the examples above, a stone treatment device may be a laser lithotripsy device.

[0020] In addition to or as an alternative to any of the examples above, tubular members may have a mesh structure.

[0021] In addition to or as an alternative to any of the examples above, tubular members may have a polymer coating covering at least a portion of the mesh structure.

[0022] In addition to or as an alternative to any of the examples above, the tubular member can be configured to collapse into a predetermined shape when in a relaxed state and to expand in response to receiving a stone.

[0023] In another example, a method may include delivering a medical device to a subject's renal cavity, the medical device having an elongated member defining one or more lumens and a tubular member extending distally from a distal end of the elongated member; positioning a stone in the tubular member; performing stone treatment on the stone in the tubular member to break the stone into fragments while retaining the stone fragments within the tubular member; and removing the stone fragments from the subject's body.

[0024] In addition to or as an alternative to any of the examples above, stone treatment can be laser lithotripsy.

[0025] In addition to or as an alternative to any of the examples above, positioning a stone in a tubular member may include grasping the stone and moving it to a location within the tubular member.

[0026] In addition to or as an alternative to any of the examples above, retaining stone fragments within a tubular member may include holding a valve extending across the inner diameter of the tubular member in a closed position.

[0027] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. These embodiments are illustrated in more detail by the accompanying drawings and detailed description below. Attached Figure Description

[0028] This disclosure can be more fully understood through the following detailed description, taken in conjunction with the accompanying drawings, wherein:

[0029] Figure 1 This is a schematic diagram of an exemplary medical device that extends into the body of a subject;

[0030] Figure 2 This is a schematic side view of an exemplary medical device;

[0031] Figure 3 yes Figure 2 A schematic partial cross-sectional view of the exemplary medical device shown;

[0032] Figure 4 This is a schematic end view of an exemplary medical device;

[0033] Figure 5 This is a schematic side view of an exemplary medical device;

[0034] Figures 6A-6D A schematic flowchart illustrating the techniques for using medical devices is depicted.

[0035] Figure 7 This is a schematic side view of an exemplary medical device;

[0036] Figure 8A and Figure 8B This is a schematic side view of an exemplary medical device;

[0037] Figure 9 This is a schematic side view of an exemplary medical device; and

[0038] Figure 10 This is a schematic side view of an exemplary medical device.

[0039] While this disclosure is adaptable to various modifications and alternatives, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to limit it to the specific embodiments described. Rather, the invention encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0040] The terms defined below shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0041] All numerical assumptions made herein are modified by the term "approximately," whether explicitly stated or not. The term "approximately" generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent (e.g., having the same function or result) to the listed values. In many cases, the term "approximately" may include numerical values ​​rounded to the nearest significant figure.

[0042] The range of numbers represented by the endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4 and 5).

[0043] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used to include the meaning of “and / or” unless the context clearly indicates otherwise.

[0044] It should be noted that references to "construction," "some constructions," "other constructions," etc., in the specification indicate that the described construction may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with a construction, it should be understood that, unless explicitly stated otherwise, such feature, structure, and / or characteristic may also be used in conjunction with other constructions, whether explicitly described or not.

[0045] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The drawings (not necessarily to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure.

[0046] A variety of systems and procedures can be used to remove kidney stones from a subject (e.g., a patient). One exemplary procedure is flexible ureteroscopy (fURS) and lithotripsy. Other procedures for removing kidney stones from a subject have also been considered.

[0047] Systems and procedures configured to remove kidney stones from a subject may utilize an endoscope (e.g., a flexible ureteroscope and / or other suitable endoscope) inserted through a ureteral sheath that can be inserted through the urethra, bladder, and ureter into the subject's renal cavity to reach the stone location. Once the stone is located, a laser fiber or other suitable lithotripsy device may be inserted through the working channel of the endoscope and / or sheath, and the stone may be fragmented and / or pulverized (e.g., broken into small pieces).

[0048] When a kidney stone fragments, the physician can use a grasper or stone retrieval basket to remove the fragments through an endoscope and / or sheath. The fragments can be removed one by one by removing and reinserting the endoscope and / or grasper until as many stones as possible are removed from the subject. This repetitive grasping and removal of stone fragments can be very time-consuming. Furthermore, when performing fragmentation surgery, care must be taken to ensure that the stone fragments are of appropriate size for removal from the subject, as fragments of 3 mm or larger may be difficult to remove due to the limitations of the ureter's inner diameter.

[0049] When stones are powdered, the stone particles may remain in the patient's body and be naturally excreted from the kidneys over time. When stones are powdered, a ureteral stent can remain in place to facilitate drainage of the stone particles. However, the implanted stent can be uncomfortable for the patient and may require further surgery to remove it after a period of time (e.g., a week or longer). Furthermore, powdering stones may take longer than fragmenting them.

[0050] Figure 1 A schematic diagram of a subject's urinary tract 100 in which a medical device 10 is inserted is shown. The urinary tract 100 may include the urethra 102, bladder 104, ureter 106, and kidney 108, as well as other anatomical structures. In some cases, the target site may be a stone 110 (e.g., a kidney stone and / or other suitable stone) in the kidney 108 (e.g., in the renal cavity) and / or at other locations along the urinary tract 100.

[0051] In operation, a practitioner (e.g., a physician and / or other medical professional) may insert the distal end 12 of the medical device 10 into the urethra 102, wherein the medical device 10 may include an elongated member 14 (e.g., an elongated shaft) and a tubular member 16. At the proximal portion 17 of the medical device 10, the elongated member 14 may extend distally from the handle portion 22, and at the distal portion 18 of the medical device 10, the tubular member 16 may extend distally from the elongated member 14.

[0052] A practitioner can advance the distal portion 18 of the medical device 10 through the urinary tract 100, such that the distal end 12 of the distal portion 18 of the medical device 10 is positioned close to a target area (e.g., close to the stone 110 and / or other suitable target area). In some cases, imaging devices can be used to determine the location of the stone 110 in the subject's body.

[0053] Despite Figure 1 As not shown, a practitioner may position the tubular member 16 around and / or within the stone 110. In some examples, a practitioner may use a grasper or grasping device to pass through the elongated member 14 (e.g., via the lumen of an endoscope and / or the lumen of the elongated member 14) and the distal side of the tubular member 16 to grasp the stone and pull the stone 110 into the tubular member 16. Alternatively or additionally, in some examples, a practitioner may manipulate the tubular member 16 to engage with the stone 110 or otherwise position the tubular member 16 around the stone.

[0054] Once the stone 110 is positioned within the tubular member 16, it can be pulverized or fragmented, such as through lithotripsy. In some examples, the fragmentation or pulverization tool 19 may advance along the elongated member 14 (e.g., via the lumen of an endoscope and / or the lumen of the elongated member 14) and reach the tubular member 16, and be activated to fragment and / or pulverize the stone 110. In some cases, the fragmentation or pulverization tool 19 may be a lithotripsy device, a laser fiber configured to emit a laser beam, an ultrasonic device, and / or other suitable device or system configured to fragment and / or pulverize the stone 110.

[0055] During and / or after fragmentation and / or pulverization, all fragmented portions of the stone 110 can be retained within the tubular member 16 for removal. The fragmented portions of the stone 110 can be removed by removing the medical device 10 from the subject, by applying a vacuum source through the elongated member 14 into the tubular member 16, by flushing, and / or by one or more other suitable methods. Compared to existing fragmentation and pulverization techniques, this stone removal device and / or system can reduce procedure time while achieving complete removal of stone fragments after the stone removal procedure.

[0056] Various additional and / or alternative technologies, devices, or systems may be used to break up stones 110 and / or remove stones from the subject's body. Exemplary suitable technologies, devices, and systems for breaking up stones and / or removing such stones from the subject's body are disclosed in U.S. Patent No. 11,382,693, filed January 31, 2017, entitled "MEDICAL DEVICE AND METHODS OF USE," which is incorporated herein by reference in its entirety for any and all purposes.

[0057] Figure 2 A schematic side view of the distal portion 18 of an exemplary medical device 10 is depicted, wherein an endoscope 13 (e.g., a ureteroscope and / or other suitable endoscope) is inserted through the lumen 23 of the medical device 10. Figure 2 As shown, the medical device 10 may include an elongated member 14 having a distal end 20, and a tubular member 16 extending distally from the distal end 20. A medical device with an endoscope 13 and / or other suitable stone removal devices or systems may be combined and referred to as a medical system.

[0058] The elongated member 14 may be at least partially hollow, with its proximal end connected to the handle portion 22. Figure 1 The distal end 20 is connected to the tubular member 16, such that the tubular member 16 extends distally from the elongated member 14. The elongated member 14 may have any suitable number of lumens. In some examples, and as shown... Figure 2 The elongated member 14 depicted may have a single lumen 23 with an opening at its distal end 20, but other suitable numbers of lumens are also contemplated. The lumen 23 may have any suitable size and / or shape and may be configured to receive an endoscope (e.g., endoscope 13 and / or other suitable endoscope), receive one or more stone treatment devices, receive one or more control wires, and / or be configured for one or more other suitable purposes.

[0059] The elongated member 14 can be any suitable elongated member. For example, the elongated member 14 can be, but is not limited to, a catheter having one or more lumens, a sheath having one or more lumens, an endoscope shaft having one or more lumens, and / or other suitable elongated members. In one example, the elongated member 14 can be a ureteral sheath, but other suitable constructions may also be considered.

[0060] The elongated member 14 can have any suitable shape and / or construction. For example, the elongated member 14 can be circular, oval, irregular, and / or any shape suitable for insertion into the subject's anatomy. The elongated member 14 can have a consistent shape and / or construction along its length, or it can have different shapes and / or constructions along its length. In some examples, the elongated member 14 can have a varying shape along its length, such as a tapering shape at the distal end 20 to facilitate insertion into the body, but other suitable constructions are also considered.

[0061] Depending on the specific implementation and intended use, the length of the elongated member 14 may vary. Similarly, depending on the specific implementation and intended use, the elongated member 14 may be rigid along its entire length, flexible along its entire length, or configured to be bendable only at certain specific locations. In one example, the elongated member 14 may be flexible and adapted for flexible manipulation within the lumen of a subject's anatomical structure. For example, the elongated member 14 may include a manipulation system (not shown) for moving at least a portion of the elongated member (e.g., the distal end) and / or a portion of the tubular member 16 up and down and / or left and right. Additional degrees of freedom may also be provided, for example, via additional hinges to the rotational, translational, or bending segments of the elongated member 14. Examples of such manipulation systems may include at least one of pulleys, control wires, transmissions, or electric actuators.

[0062] The elongated member 14 can be formed of any suitable material having sufficient flexibility to traverse body cavities and tubing. In some examples, the elongated member 14 can be made of any suitable material compatible with living tissue or living systems. That is, the material forming the elongated member can be non-toxic or non-invasive, and it should not cause an immune response or rejection. Exemplary suitable materials that can be used to form the elongated member 14 may include, but are not limited to, polymeric materials, metallic materials, polymeric elastomers, rubber, medically approved polyvinyl chloride, EVA (ethylene vinyl acetate), silicone, polyurethane, C-Flex, and / or other suitable materials.

[0063] As discussed, the elongated member 14 can receive the endoscope 13 and / or other suitable devices or systems. The endoscope 13 may have one or more lumens. For example, as Figure 2As shown by the dashed lines, endoscope 13 may include a first lumen 24 and a second lumen 26, but other suitable numbers of lumens may also be considered. The lumens can be of any suitable size and can be configured to supply fluid to a target area (e.g., flushing), remove material from a target area via negative pressure, receive optical fibers (e.g., laser fibers, etc.), receive a gripper or gripping device, receive wires (e.g., control wires, guide wires, etc.), receive stone fragments, and / or be configured in one or more other suitable ways. The lumen 23 of the elongated member 14 may be configured for similar or different purposes, or may not be configured in this way.

[0064] The tubular member 16 may extend distally from the distal end 20 of the elongated member 14 and may define an expandable and contractile (e.g., collapseable) lumen 28 extending from the proximal end 30 to the distal end 32 of the tubular member 16. In some examples, the tubular member 16 and the lumen 28 may be configured to expand as a stone passes through the lumen 28 and contract and / or collapse around the stone. Thus, the tubular member 16 may be biased to its contractile configuration (e.g., its relaxed state), which may be or have a predetermined shape.

[0065] The tubular member 16 may have a first portion 34 (e.g., a receiving portion), a second portion 36 (e.g., an opening portion), and a third portion 38 (e.g., a diameter-reducing portion). The first portion is configured to receive a stone for performing lithotripsy and / or other suitable fragmentation and / or pulverization procedures on the stone. The second portion is configured to initially receive the stone. The third portion is located between the first portion 34 and the second portion 36 or the distal end 32 of the tubular member 16. In some examples, when the tubular member 16 is in a relaxed state (e.g., in its predetermined shape or configuration), the first portion 34 of the tubular member 16 may extend distally from the elongated member 14, the second portion 36 may define at least a portion of the distal end 32 of the tubular member 16, and the third portion 38 may include a diameter-reducing portion of the tubular member 16, the inner diameter D3 of which is smaller than the inner diameter D1 of the first portion 34 and / or the inner diameter D2 of the second portion 36. For example, the inner diameter of the tubular member 16 may gradually decrease in the proximal direction from the distal end 32 to the third portion 38, and then gradually increase in the proximal direction from the third portion 38 to the first portion 34. Although the figures depict the decreasing diameter D3 as greater than zero, the inner surfaces of the third portion 38 of the tubular member 16 may contact each other such that the decreasing diameter D3 is zero or there is no inner diameter. The decreasing diameter D3 of the third portion 38 of the tubular member 16 (e.g., the necking diameter) may be configured to expand to allow a stone to pass through it in the direction from distal to proximal (e.g., in response to a force pulling a stone into the tubular member 16), and return to the decreasing diameter after the stone has entered the first portion 34 to prevent the stone or a portion of the stone from dislodging in the direction from proximal to distal.

[0066] In some illustrative configurations, when the tubular member 16 is in a relaxed state, one or more of the first portion 34, the second portion 36, and the third portion 38 may have the same diameter as at least one of the first portion 34, the second portion 36, and the third portion 38. In some examples, the second portion 36 and the third portion 38 may have the same or similar reduced diameter relative to the first portion 34, which may or may not facilitate insertion of the device into a body cavity and / or cavities of an anatomical structure of a subject. In some examples, when the tubular member 16 is in a relaxed state, the first, second, and third portions may have the same diameter, which may be configured to prevent the stone or portions of the stone from dislodging from the tubular member 16 after the stone has been positioned within it. Other suitable configurations for the predetermined shape are conceivable.

[0067] The proximal end 30 of the tubular member 16 can be coupled to the distal end 20 of the elongated member 14 in any suitable manner. Exemplary suitable methods for coupling the tubular member 16 to the elongated member 14 include, but are not limited to, reflow techniques, welding, heat shrinking, bonding and / or other suitable joining techniques.

[0068] The tubular member 16 can have any suitable length. In some examples, the tubular member 16 can have a length suitable for receiving stones in the lumen 28, receiving lithotripsy devices via the elongated member 14, and performing lithotripsy on the stones.

[0069] The tubular member 16 can be formed in any suitable manner and is configured to self-contract upon expansion to accommodate an object in the lumen 28 and / or to accommodate a medical component (e.g., a gripper, treatment device, etc.). For example, the tubular member 16 can be formed as a resilient sheath, a laser-cut tube, a knitted tube, a mesh tube, a braided tube, a spiral tube, a woven tube, and / or can be formed in one or more other suitable manners. In one example, the tubular member 16 may have a mesh structure formed by braided threads coupled to the elongated member 14. In some cases, the tubular member 16 may have a support structure.

[0070] The tubular member 16 may be formed of one or more suitable materials. Exemplary suitable materials include, but are not limited to, polymeric materials, metallic materials, woven materials, metal alloys, shape memory alloys, polymers, nickel-titanium alloys, cobalt-chromium-nickel-molybdenum alloys, and / or other suitable materials capable of expanding the tubular member 16 into a shape when positioned at a target site. In some cases, the material may be selected to allow the tubular member 16 to be inserted relatively easily into and / or removed from the subject's anatomy. In some examples, the tubular member 16 may be formed of an alloy, such as, but not limited to, nitinol and / or Elgiloy®. In one example, the tubular member 16 may be braided using one or more threads formed of nitinol.

[0071] Figure 3 Partial sectional and partial side views depict an illustrative configuration of the distal portion 18 of the medical device 10, wherein the elongated member 14 and endoscope 13 are depicted in sectional view, and the tubular member 16 is depicted in side view. In some configurations, the distal end 32 of the tubular member 16 may include a buffer 40 (e.g., a soft tip). The buffer 40 may define the terminating end of the medical device 10 and may be configured to facilitate insertion of the medical device 10 into and / or through the subject's anatomy to reach the target area by reducing or minimizing invasive contact with the anatomy compared to not using the buffer 40.

[0072] The buffer 40 can be configured in any suitable manner to facilitate the insertion of the tubular member 16 into the subject's anatomy. In some examples, the buffer 40 may have a tapered construction with an outer diameter decreasing from proximal to distal, rounded edges or surfaces, and / or other suitable constructions designed to facilitate the insertion of the tubular member 16 into the target site.

[0073] The buffer 40 can be formed of any suitable material configured to achieve non-invasiveness as the tubular member 16 passes through the subject's anatomy. Exemplary materials suitable for the buffer 40 include, but are not limited to, metallic materials, polymeric materials, soft materials, elastic materials, silicone, hydrogels, collagen, elastin, polyurethane, polyethylene, polytetrafluoroethylene (PTFE), polydimethylsiloxane (PDMS), polyglycolic acid (PGA), polylactic acid (PLA), gelatin, chitosan, alginate, polyvinylpyrrolidone (PVP), polycaprolactone (PCL), natural rubber, polyethylene glycol (PEG), and / or other suitable materials. In some examples, the buffer 40 may be formed of silicone and / or other suitable materials.

[0074] In some examples, the material used to form the buffer 40 may have a lower hardness. Exemplary Shore hardness readings for the material suitable for the buffer 40 may include, but are not limited to, 60 A or less, 50 A or less, 40 A or less, 30 A or less, 20 A or less and / or other suitable values.

[0075] Figure 4 Depicting Figure 3 The diagram depicts a schematic distal end view of the distal portion 18 of an exemplary medical device 10. In some cases, a buffer 40 may extend across an opening 42 at the distal end 32 of a tubular member 16 and form a valve 44 extending across the diameter (e.g., inner diameter) of the tubular member 16. Alternatively, the valve 44 may be formed separately from the buffer 40. The valve 44 may have a slit 46 (e.g., as shown in the diagram). Figure 4 The cross slit (and / or other suitable slits) and / or other suitable openings are configured to be normally closed and biased, and selectively opened in response to engagement with a tool (e.g., a gripper, etc.) and / or a stone attached to the tool.

[0076] Although valve 44 is depicted located at the opening 42 of the tubular member 16 (e.g., at the distal end 32), valve 44 may be located at other suitable locations along the length of the tubular member 16, distal to the location where surgery (e.g., lithotripsy) will be performed on the stone contained within the tubular member 16. In some examples, valve 44 may be located at an axial position along the length of the tubular member 16 with its maximum diameter to limit the amount of stretching or expansion required to hold valve 44 in a closed position when the tubular member 16 expands. In other examples, valve 44 may be configured to expand along with the tubular member 16 and may be located at a minimum diameter axial position (e.g., a constricted portion, such as the third portion 38 of the tubular member 16). When valve 44 is located at the minimum diameter axial position, after the stone has passed through the minimum diameter axial position and before surgery is performed on the stone, the tubular member 16 may return to a relaxed contracted state at that minimum diameter axial position, such that valve 44 is in a closed position during surgery.

[0077] During the procedure, the tool can be inserted distally through another opening via slit 46 or valve 44 to engage the stone and remove it through slit 46, and remove the stone from the subject's body and / or perform surgery on the stone as described herein or otherwise, while maintaining valve 44 in a closed configuration. In some examples, valve 44 can automatically close without the application of an opening force sufficient to open it. When the stone is broken into individual fragments, these fragments can remain within tubular member 16 and can be prevented from dislodging from opening 42 by valve 44 maintaining a closed or blocking configuration.

[0078] Figure 5 A schematic side view depicting an illustrative configuration of the distal portion 18 of a medical device 10 having a coating 48 (e.g., an inner covering, an outer covering, and / or other suitable coating). When the coating 48 is provided, it can be applied to and / or cover at least a portion or the entire circumferential surface of a tubular member 16. When the tubular member 16 is formed with a porous configuration (e.g., using woven or braided thread, using cut tubing, etc.), the coating 48 can be configured to prevent stone particles (e.g., fragments, powder, etc.) from escaping through holes and / or other openings in the tubular member 16. In some examples, the coating 48 can form a watertight seal around the tubular member 16.

[0079] Coating 48 can be formed of any suitable material configured to cover the holes or openings along the tubular member 16 and / or configured for other purposes. In some examples, coating 48 may be made of a material selected or configured to mitigate or prevent trauma or damage to the subject's tissues when the tubular member 16 is delivered to the target area. Examples of suitable materials for coating 48 include, but are not limited to, metallic materials, polymeric materials, fabric materials, soft materials, elastic materials, silicone, hydrogels, collagen, elastin, polyurethane, polyethylene, polytetrafluoroethylene (PTFE), polydimethylsiloxane (PDMS), polyglycolic acid (PGA), polylactic acid (PLA), gelatin, chitosan, alginate, polyvinylpyrrolidone (PVP), polycaprolactone (PCL), natural rubber, polyethylene glycol (PEG), and / or other suitable materials. In some examples, coating 48 may be formed of silicone and / or other suitable materials. In some examples, the material used to form coating 48 may have low hardness. Exemplary Shore hardness readings for materials suitable for coating 48 may include, but are not limited to, 60 A or less, 50 A or less, 40 A or less, 30 A or less, 20 A or less and / or other suitable values. Furthermore, although not required, coating 48 may be configured to enhance the elasticity of the tubular member 16 compared to the elasticity of the tubular member 16 without coating 48.

[0080] Figures 6A-6D A schematic flowchart depicts the techniques for capturing stone 110 and performing surgery (e.g., lithotripsy and / or other suitable surgery) on stone 110. Figures 6A-6D The medical device 10 is schematically depicted, with the elongated member 14 in cross-sectional view and the tubular member 16 in side view.

[0081] like Figure 6A As shown, a grasper 50 (e.g., a manipulable grasper) or other suitable stone-removing device can be inserted through the lumen of endoscope 13 to a distal position of the distal end 12 of medical device 10 and adjustably grasp the stone 110. In some cases, the grasper 50 or other suitable device can be inserted through, for example... Figure 6A The endoscope 13 is inserted into its first lumen 24 and / or through other suitable working lumens, including but not limited to the lumen 23 of the elongated member 14, which is independent of the endoscope 13.

[0082] Any suitable gripper 50 or other suitable device can be used, configured to engage the stone 110 and position it within the tubular member 16. In some examples, the gripper 50 may include one or more paddle-like or fork-like members 52 extending distally from an elongated shaft 51 (e.g., a tube and / or other suitable shaft structure) and configured to selectively grip the stone 110. In some examples, in addition to or as an alternative to paddle-like or fork-like members 52, the gripper 50 may include one or more stone retrieval baskets.

[0083] The gripper 50 is controlled by a user (e.g., manually) at or near the proximal end of the medical device 10, or by a robot (e.g., electronically, which may be user-guided or not). In some examples, the paddle or fork 52 may be selectively actuated to accommodate the stone 110 between the paddle or fork 52. Additionally or alternatively, the distal end of the gripper 50 and / or the paddle or fork 52 may be directionally controlled (e.g., manipulated) using traction cables and / or other control mechanisms.

[0084] like Figure 6A As shown, once the stone 110 is grasped, the grasper 50 can be pulled into the tubular member 16. When the diameter of the stone 110 and / or the grasper 50 passing through the tubular member 16 or at its widest point is greater than the inner diameter of the tubular member 16, the tubular member 16 can be in one or more expansion positions 54 (e.g., at the third section 38, as shown). Figure 6A As shown, but other locations may also be considered, dilation occurs at the location to accommodate the stone 110 and / or the grasper 50. Once the stone 110 and / or the grasper 50 has passed through the tubular member 16 at an axial location where the inner diameter is smaller than the diameter of the stone 110 and / or the grasper 50 or the widest portion, the tubular member 16 can be biased to recover and automatically return to a relaxed, contracted configuration. Furthermore, although not shown, the stone 110 can be pulled into the first portion 34 of the tubular member 16, released from the grasper 50 and / or other suitable means, and the grasper 50 and / or other suitable means can be withdrawn from the first lumen 24 of the endoscope 13 and the medical device 10. Alternatively or additionally, the grasper 50 and / or other suitable means may remain in the first lumen 24 when surgery is performed on the stone 110.

[0085] Once the stone 110 is positioned at the desired location within the tubular member 16 (e.g., within the first portion 34 of the tubular member 16), the stone treatment device 56 (e.g., a lithotripsy device and / or other suitable device configured to crush or pulverize the stone 110, such as crushing and / or pulverizing tool 19) can be used as follows Figure 6CThe first lumen 24 or other suitable lumen (including, but not limited to, the lumen 23 of the medical device 10, which is independent of the endoscope 13) is delivered to the tubular member 16. In some cases, the stone treatment device 56 may be a laser lithotripsy device, which includes a laser fiber 58 configured to emit a laser 60, but other suitable stone treatment devices 56 and / or other suitable stone fragmentation or pulverization devices may also be considered.

[0086] Stone treatment device 56 and / or other suitable devices can be positioned adjacent to the stone, and laser 60 or other suitable media can be applied to the stone 110 to break it into fragments (e.g., powder and / or particles). In some cases, endoscope 13 may include one or more imaging components that facilitate observation of the stone 110 and / or the application of laser 60 or other suitable lithotripsy to the stone 110, and facilitate determination of how laser 60 may need to be manipulated to continuously break up the stone 110 within tubular member 16.

[0087] For example, Figure 6D As shown, once the stone 110 has been broken into fragments 62 and / or powder 64 (e.g., fragments of the stone), the stone treatment device 56 and / or other suitable device can be removed from the first lumen 24. The medical device 10, with the fragments 62 and / or powder 64 adhering within the tubular member 16, can then be withdrawn from the subject without leaving any fragments or powder within the subject. Alternatively or additionally, the lithotripsy device and / or other suitable device can be withdrawn from the subject along with the medical device 10 and the fragments 62 and / or powder 64 located within the tubular member 16.

[0088] In some examples, the second lumen 26 of the endoscope 13 and / or other suitable lumen, or the lumen of the medical device 10, may be an aspiration lumen. When an aspiration lumen is included, negative pressure may be applied to the second lumen 26 or other suitable lumen to draw in fragments 62 and / or powder 64 and through the second lumen 26 or other suitable lumen, thereby removing fragments 62 and / or powder 64 from the tubular member 16 and the subject. In some cases, negative pressure may be applied to the second lumen 26 and / or other suitable lumen during stone fragmentation and / or pulverization (e.g., during lithotripsy and / or other suitable procedures).

[0089] In addition to using negative pressure to remove stone fragments 62 and / or powder 64 from the tubular member 16, the lumen 28 of the tubular member 16 can also be flushed through one or more lumens of the elongated member 14 and / or endoscope 13. When flushing is included, the flushing can be applied to the lumen 28 and aspirated from the lumen 28 along with the fragments 62 and / or powder 64 through the suction lumen.

[0090] Compared to Figures 6A-6D The process of removing stones from a subject, as described herein, may include one or more additional and / or alternative steps or features. Utilizing the medical device 10 discussed may advantageously reduce operative time, increase stone clearance rates, reduce the need for postoperative stent implantation, and lower the risk of recurrence due to unremoved stones or stone particles. Furthermore, although... Figures 6A-6D The structure of the tubular member 16 with wide holes or openings is depicted, but these are not necessarily drawn to scale, and any holes and / or openings along the length of the tubular member 16 may be configured to prevent or mitigate the unintentional escape of stone fragments or powder.

[0091] Figure 7 A schematic side view depicting the distal portion 18 of the illustrative configuration of the distal end 18 of the medical device 10, wherein a gripping system 66 (e.g., a manipulable gripping system or gripper) is positioned at or at least partially located at the distal end 32 of the tubular member 16. Although the gripping system 66 is... Figure 7 The gripping system 66 is depicted at least partially located at the distal end 32 of the tubular member 16, but the gripping system 66 may be located at other suitable locations along the length of the tubular member 16.

[0092] The grasping system 66 can be of any suitable construction for engaging stones within a subject's body and pulling the stones into the tubular member 16. When the grasping system 66 is included, it eliminates the need for separate stone grasping devices (e.g., grasper 50 and / or other suitable stone engagement devices). In some examples, the grasping system 66 may include one or more paddle-like members 68 coupled to one or more control lines 70 (e.g., one or more adjustable members) and the distal end of the tubular member 16. In one example, the grasping system 66 may include three paddle-like members 68 and control lines 70 coupled to the paddle-like members to manipulate the paddle-like members 68 between open and closed positions. The control lines 70 may extend from the paddle-like members 68 through one or more lumens of the elongated member 14 (e.g., lumen 23, etc.). Figure 7 (as shown) and / or one or more lumens of endoscope 13.

[0093] During operation, a user or robot can manipulate the control wire 70 at the proximal end of the medical device 10 to adjust the paddle 68 to a closed position for delivery to the target area of ​​the subject. In some cases, the paddle 68, when in the closed position, may have a configuration that facilitates delivery of the medical device to the target area (e.g., a configuration that gradually narrows distally). Furthermore, the paddle 68 may be formed of a soft and / or elastic material to prevent or reduce trauma to the subject's tissues during delivery and / or facilitate stone occlusion at the target area. Once the target area near the stone is reached, the control wire 70 can be manipulated to open the paddle 68, and the tubular member 16 can be adjusted distally such that the stone is positioned adjacent to and / or within the paddle 68. Alternatively or additionally, the paddle may be biased in an open position such that the paddle 68 automatically adjusts to the open position when tension on the control wire 70 is released. The control wire 70 can be manipulated to bring together the paddle-shaped member 68 surrounding the stone and pull the stone to a desired position within the tubular member 16 to perform lithotripsy and / or other procedures on the stone. Other suitable steps or features of the medical device 10, including the use of the paddle-shaped member 68 with its distal end 32 attached to the tubular member 16 and / or other suitable gripping components, are also envisioned.

[0094] Figure 8A and Figure 8B A schematic side view depicting the illustrative configuration of the distal portion 18 of the device 10 is shown, wherein a control wire 72 (e.g., an adjustable member) extends through the medical device 10 and engages the distal end 32 of the tubular member 16. The control wire 72 can be manipulated to close the distal end 32 of the tubular member 16 and pull it into the lumen 28. Although in Figure 8A and Figure 8B Only one control cable 72 is shown, but multiple control cables 72 can be used as needed.

[0095] like Figure 8A As shown, the control wire 72 can be in one or more lumens of the elongated member 14 (e.g., 13, as shown). Figure 8A and Figure 8B (As shown) and / or one or more lumens of the endoscope 13 extending through the medical device 10, extending within the lumen 28 of the tubular member 16, and connected to the distal end 32 of the tubular member 16. A control wire 72 can engage the distal end 32 of the tubular member 16 such that tension can be applied to the control wire 72 to close or at least reduce the diameter of the opening 42 at the distal end 32 of the tubular member 16, and to pull the distal end 32 into the lumen 28 of the tubular member, for example as... Figure 8B As shown. In addition, in some cases, the control wire 72 can be used to control the direction of movement of the tubular member 16 within the subject's body.

[0096] During operation, the user or robot can position the distal end 32 of the tubular member 16 at a target area within the subject (e.g., via manipulation control wire 72 and / or via other suitable control mechanisms). During delivery, the distal end 32 of the tubular member 16 can be in an open or closed position as needed. Furthermore, as described above, the tubular member 16 may include a coating 48 or a buffer 40 formed of soft and / or elastic materials to prevent or mitigate trauma to the subject's tissues during delivery and / or facilitate the engagement of stones at the target area.

[0097] Once the target area near the stone is reached, the control filament 72 can be manipulated to position the distal end 32 of the tubular member 16 at and / or around the stone, such that the stone is positioned near and / or within the opening 42 at the distal end 32 of the tubular member 16. The control filament 72 can be manipulated to close the opening 42 while the stone is located in the lumen 28 of the tubular member 16, and the control filament 72 can be further manipulated to pull the distal end 32 of the tubular member 16 proximally, thereby positioning the stone in an axial position on the tubular member 16 sufficient for lithotripsy and / or other suitable procedures. During the procedure and / or removal from the medical device 10, the distal end 32 of the tubular member 16 can be held in the closed and / or withdrawn position as needed.

[0098] The tubular member 16 can have any suitable construction, such as that discussed herein or others. In some examples, the tubular member 16 may have a shape and / or size configured to facilitate the reception of stones or other objects and to prevent stones or other objects, or a portion thereof, from exiting through the opening at the distal end 32 of the tubular member 16. This is discussed below. Figure 9 and Figure 10 An exemplary configuration of a tubular member 16 is depicted, which is configured to facilitate the reception of stones and prevent stones or portions thereof from dislodging from an opening at the distal end 32 of the tubular member 16.

[0099] Figure 9A schematic side view depicting an illustrative configuration of the distal portion 18 of the medical device 10 is shown, wherein a first transition 74 (e.g., a proximal bend) between the distal end of the first portion 34 of the tubular member 16 and the third portion 38 of the tubular member 16 is sharper than a second transition 76 (e.g., a distal bend) between the second portion 36 and the third portion 38 of the tubular member 16, or the first transition has a greater rate of taper change in the proximal direction than the second transition has in the distal direction. The tapers of the first transition 74 and the second transition 76 may have any suitable rate of taper change in the distal and proximal directions, respectively, as needed. In some examples, the second transition 76 may be a gentle transition or a taper, and a gentle transition or taper between the second portion 36 and the third portion 38 of the tubular member 16 may facilitate the containment of stones within the first portion 34 of the tubular member 16. Additionally or alternatively, the first transition 74 may be a steep transition or taper (e.g., a gentle transition relative to the second transition 76), and the steep transition or taper may impede and / or prevent the stone or its fragments from dislodging from the first portion 34 of the tubular member 16.

[0100] Figure 10 A schematic side view depicting an illustrative configuration of the distal portion 18 of the medical device 10 is shown, wherein the tubular member 16 includes one or more protrusions 78, a first transition portion 74 (e.g., a proximal bend) between the distal end of the first portion 34 of the tubular member 16 and the third portion 38 of the tubular member 16, and a second transition portion 76 (e.g., a distal bend) between the second portion 36 and the third portion 38 of the tubular member 16. In some examples, similar to the above description... Figure 9 The first transition portion 74 may be sharper than the second transition portion 76, such that the second transition portion 76 facilitates the reception of the stone into the first portion 34 of the tubular member 16, and the first transition portion 74 prevents or reduces the possibility that part of the stone will enter the third portion 38 and exit through the distal end of the tubular member 16.

[0101] The protrusion 78 can be configured to receive or capture fragments or portions of the stone contained in the lumen 28 of the tubular member 16 after the stone has been fragmented and / or pulverized. To facilitate the formation of a volumetric space for receiving the fragmented and / or pulverized stone and to prevent fragments and / or powder from leaving the tubular member 16 via the third portion 38, the protrusion 78 can extend distally over one or more suitable portions of the tubular member 16, including the first transition 74, the third portion 38, the second transition 76, and / or other suitable portions. In some examples, the distal extension of the protrusion 78 can facilitate an abrupt transition between the first portion 34 and the third portion 38 of the tubular member 16 and reduce the likelihood of portions of the stone entering the third portion 38.

[0102] The tubular member 16 may include one or more protrusions 78. In some examples, the tubular member 16 may include a single protrusion 78 extending circumferentially around or at least partially around the circumference of the tubular member 16. Alternatively, in some examples, the tubular member 16 may include two or more individual protrusions 78 spaced apart from each other (e.g., circumferentially spaced and / or spaced apart in one or more other suitable ways).

[0103] It should be understood that this disclosure is illustrative in many respects. Changes may be made in details, particularly in the shape, size, and arrangement of steps, without departing from the scope of this disclosure. Where appropriate, this may include using any feature employed in one exemplary embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A medical device comprising: An elongated member defining one or more lumens, having an opening at the distal end of the elongated member; as well as A tubular member extending distally from the distal end of the elongated member, and The tubular member is configured to collapse into a predetermined shape when in a relaxed state and to expand in response to a receiving object.

2. The medical device according to claim 1, wherein, The tubular component includes a mesh structure.

3. The medical device according to claim 2, wherein, The mesh structure is formed from braided yarn.

4. The medical device according to claim 2 or claim 3, wherein, The tubular member has a polymer coating covering at least a portion of the mesh structure.

5. The medical device according to any one of claims 1-4, wherein, The tubular member has a distal end, a receiving portion extending distally from the elongated member, and a diameter-reducing portion extending between the receiving portion and the distal end.

6. The medical device according to claim 5, wherein, When the tubular member is in a predetermined shape, the inner diameter of the tubular member decreases from the distal end to the diameter-reducing portion in the proximal direction, and then increases from the diameter-reducing portion in the proximal direction.

7. The medical device according to claim 6, wherein, The rate of increase of the inner diameter from the diameter reduction portion in the proximal direction is greater than the rate of decrease of the inner diameter from the distal end to the diameter reduction portion in the proximal direction.

8. The medical device according to any one of claims 1-6, wherein, The tubular member includes a valve that extends across the inner diameter of the tubular member.

9. The medical device according to any one of claims 1-8, wherein, The distal end of the tubular member includes a buffer.

10. The medical device according to any one of claims 1 to 9, further comprising: A manipulable gripper extending distally from the distal end of the tubular member is configured to adjustably grip an object and position the object within the tubular member.

11. The medical device according to any one of claims 1 to 10, further comprising: One or more adjustable members communicate with the distal portion of the tubular member, and the one or more adjustable members are configured to be adjusted to close the tubular member around the object.

12. A medical system comprising: An elongated member defining one or more lumens, having an opening at the distal end of the elongated member; A tubular member that extends distally from the distal end of the elongated member; as well as A stone treatment device, configured to extend along a first lumen of one or more lumens of the elongated member, and The stone treatment device is configured to break up stones received in the tubular member into stone fragments, and the tubular member is configured to contain the stone fragments within the tubular member.

13. The medical system according to claim 12, wherein, The stone treatment device is a laser lithotripsy device.

14. The medical system according to claim 12 or claim 13, wherein, The tubular member has a mesh structure and a polymer coating covering at least a portion of the mesh structure.

15. The medical system according to any one of claims 12-14, wherein, The tubular member is configured to collapse into a predetermined shape when in a relaxed state and to expand in response to receiving the stone.

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