Capture basket for laser lithotripsy

Abstract

Devices, systems, and methods for a retrieval device for treating kidney stones. A retrieval device includes a deployable basket having a deployed cover. The basket is deployed and manipulated around a kidney stone. The cover is then deployed around the basket to receive kidney stones for laser lithotripsy. Debris at or below a target size is allowed to escape through an aperture in the cover, or removed via a suction tube.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 512,258, filed July 6, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to medical devices, and more specifically to devices for capturing and / or removing objects (such as stones, other calculi, or foreign bodies) from within the body. Background Technology

[0003] Removal devices have been used to remove stones and other stone-like deposits from patients. One type of removal device includes a sheath, an elongated member extending within the sheath and movable relative to the sheath, and a basket-like component attached to the distal end of the elongated member. The basket-like component may have multiple legs and may have a collapsed position within the sheath and an extended position beyond the distal end of the sheath. When the basket-like component is in the extended position, the target stone can be captured within the basket-like component and removed from the body. However, some stones may become too large to be removed from the body after being captured within the basket-like component. In such cases, a device such as a laser fiber or other laser lithotripsy device can be used to break up the stone (referred to herein as "stone communition") before extraction. The stone fragments can then be removed from the body without damaging surrounding body tissue.

[0004] If laser treatment is attempted when the stone is located within the basket of supports, smaller stone fragments generated during laser treatment may escape from the basket and between the supports. These fragments may be larger than acceptable and may migrate beyond the immediate work area, often remaining elsewhere in the urinary tract. If left behind, these larger fragments can cause problems for the patient; on the other hand, locating and recaptured them can significantly prolong the duration of the surgical procedure.

[0005] This disclosure provides a removal device and a method of using the removal device, which avoids the aforementioned disadvantages of existing devices. Summary of the Invention

[0006] This disclosure provides alternatives for the design, materials, manufacturing methods, and uses of medical devices and medical systems. In a first example, a removal device for treating kidney stones may include: an elongated member; a basket-like member connected to a distal end of the elongated member, the basket-like member being movable between a constricted position having a first diameter and an expanded position having a second diameter greater than the first diameter; and a cover member connected to the basket-like member, the cover member being deployable to form a barrier around the basket-like member after the basket-like member has been moved to the expanded position and surrounds the kidney stone.

[0007] As an alternative or additional option to any of the above examples, the basket may include a sheath sized to enclose the basket in a contracted position, wherein the basket retracts from the sheath when moved to an expanded position.

[0008] As an alternative or additional option to any of the above examples, the basket-like member may include a plurality of legs that engage at the proximal end with an elongated member and at the distal end with an atraumatic tip.

[0009] As an alternative or additional option to any of the above examples, the device may further include: a plurality of ropes connected to the cover, the ropes being threaded between the cover and the non-traumatic tip of the basket-like member, such that pulling the ropes deploys the cover.

[0010] As an alternative or additional option to any of the above examples, the cover can be moved from the proximal end of the basket to a non-traumatic tip to form a barrier around the basket.

[0011] As an alternative or additional embodiment to any of the above examples, the device may further include: a plurality of ropes connected to the cover, wherein the cover is deployed in front of the basket-like member, such that pulling the ropes moves the cover from the distal end of the basket-like member to the proximal end of the basket-like member to form a barrier around the basket-like member.

[0012] As an alternative or supplement to any of the above examples, the cover may be permeable.

[0013] As an alternative or additional option to any of the above examples, the cover may include at least one piece of biocompatible material.

[0014] As an alternative or additional option to any of the above examples, the biocompatible material may be a thermoplastic, plant fiber, or animal tissue.

[0015] As an alternative or additional option to any of the above examples, the cover may have multiple holes of pre-selected sizes.

[0016] As an alternative or additional solution to any of the above examples, the diameter of the hole can be between 1 mm and 5 mm.

[0017] As an alternative or additional option to any of the above examples, the cover may be a wire mesh, the holes including the spaces between the wires of the mesh.

[0018] In another example, an endoscopic surgical device includes: an endoscope having an instrument channel; a retrieval device according to any one of the above examples, wherein the first diameter of the basket-like part of the retrieval device in a retracted position is smaller than the inner diameter of the instrument channel, such that the retrieval device can be deployed into a patient through the instrument channel of the endoscope; and a laser fiber adapted to be deployed through the endoscope and inserted into the workspace formed by the unfolded basket-like part and the deployed cover of the retrieval device.

[0019] As an alternative or additional option to any of the above examples, the endoscopic surgical device may further include a suction tube adapted to be deployed through the endoscope and inserted into the workspace, the suction tube being in fluid communication with a suction source.

[0020] In another example, a method for operating an endoscopic surgical device according to any one of the above examples includes: deploying a basket-like part of the extraction device; manipulating the basket-like part around a target object; deploying a cover to surround the basket-like part with the target object inside, the covered basket-like part defining a workspace; inserting a laser fiber into the workspace; and applying laser energy through the laser fiber to reduce the target object to one or more fragments.

[0021] In another example, an endoscopic surgical device includes: an endoscope having an instrument channel; a retrieval device including an elongated member; a basket-like member connected to the distal end of the elongated member, the basket-like member being movable between a constricted position having a first diameter smaller than the inner diameter of the instrument channel and an expanded position having a second diameter larger than the inner diameter of the instrument channel; and a cover connected to the basket-like member, the cover being deployable to form a barrier around the basket-like member after the basket-like member has been removed from the instrument channel and moved to the expanded position and surrounds the kidney stone; and a laser fiber adapted to be deployed through the endoscope and inserted into the workspace formed by the expanded basket-like member and the deployed cover of the retrieval device.

[0022] These and other features and advantages of this disclosure will become apparent from the following detailed description, the scope of which is set forth in the appended claims. Attached Figure Description

[0023] The accompanying drawings, which are incorporated in and form part of this specification, illustrate various embodiments and, together with the description, serve to explain the principles of this disclosure.

[0024] Figure 1 A removal device located within a body cavity is described;

[0025] Figure 2 Depicting the unfolded position Figure 1 The extraction device;

[0026] Figure 3 Depicting the captured kidney stones Figure 1 and Figure 2 The extraction device;

[0027] Figure 4 It depicts the deployment of overlays. Figures 1 to 3 The extraction device.

[0028] Figure 5 A laser fiber with a function for treating kidney stones is depicted. Figures 1 to 4 The extraction device;

[0029] Figure 6 A suction tube with a function for removing stone fragments is depicted. Figures 1 to 5 The extraction device;

[0030] Figure 7 An extraction device with an alternative cover is described;

[0031] Figure 8A and Figure 8B The deployment of the cover around the basket-like part of the retrieval device is depicted;

[0032] Figures 9A to 9E An alternative deployment of the cover around the basket-like part of the retrieval device is depicted.

[0033] While this disclosure is open to various modifications and alternatives, its specific content has been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the invention is not intended to be limited to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0034] This disclosure is now described with reference to illustrative medical systems that can be used in endoscopic medical procedures. However, it should be noted that reference to this specific procedure is provided for convenience only and is not intended to limit the disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed apparatus and related methods of use can be used in any suitable procedure, whether medical or otherwise. This disclosure can be understood with reference to the following description and accompanying drawings, wherein like elements are referred to by like reference numerals.

[0035] All numerical values ​​herein are assumed to be modified by the term "approximately," whether explicitly indicated or not. In the context of numerical values, the term "approximately" generally refers to a series of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many instances, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their common and customary definition, as understood from and consistent with the context of the specification.

[0036] The description of a numerical range by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that desired dimensions, ranges, and / or values ​​may deviate from those explicitly disclosed.

[0037] As used in this specification and the appended claims, unless expressly stated otherwise, the singular forms “a,” “an,” and “the” include plural references. As used in this specification and the appended claims, unless expressly stated otherwise, the term “or” is generally used in its meaning, including “and / or.” It should be noted that, for the purpose of facilitating understanding, certain features of this disclosure may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Unless expressly stated otherwise, each instance of a feature may include and / or be covered by the singular disclosure. For the purpose of brevity and clarity, not all elements of this disclosure need to be shown in every figure or discussed in detail below. However, it will be understood that, unless expressly stated otherwise, the following discussion can equally apply to any and / or all components that exist in more than one form. Additionally, for clarity, not all instances of certain elements or features may be shown in every figure.

[0038] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Further, when a specific feature, structure, or characteristic is described in connection with an embodiment, unless otherwise expressly stated to the contrary, implementing that specific feature, structure, or characteristic in conjunction with other embodiments will be within the knowledge of those skilled in the art, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arrangeable to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0039] For clarity, certain identifying numerical designations (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designations are not intended to be restrictive but merely illustrative. In some embodiments, for the sake of brevity and clarity, previously used numerical designations may be modified and deviated from. That is, a feature identified as a “first” element may subsequently be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or designation in each instance will be apparent to those skilled in the art.

[0040] The detailed description is intended to illustrate and not limit this disclosure. Those skilled in the art will recognize that the various elements described can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description illustrates exemplary embodiments of this disclosure.

[0041] Figure 1 and Figure 2 A retrieval device 100 according to an exemplary embodiment of the present disclosure is shown. The retrieval device 100 includes a basket-like member 102 connected to an elongated member 104. The device 100 also includes a sheath 106, and the elongated member 104 is disposed within the sheath 106. Relative movement between the elongated member 104 and the sheath 106 assists the basket-like member 102 in forming an unfolded position (e.g., Figure 2 (as shown) and the location of contraction (as shown) Figure 1 As shown), in the unfolded position, the basket 102 is substantially completely disposed outside the distal end of the sheath 106, and in the retracted position, the basket 102 is substantially completely disposed inside the sheath 106.

[0042] In some embodiments, the device 100 may not include the sheath 106. Instead, the component designated as sheath 106 in the figures may instead be the instrument channel 106 associated with the endoscope probe. Those skilled in the art will recognize that moving the elongated member 104 relative to the channel 106 of the endoscope probe will allow for the retracted and extended positions of the basket 102 as described herein.

[0043] The basket 102 may include a plurality of legs 108. The legs 108, and thus the proximal end of the basket 102, may be connected to the distal end of the elongated member 104 in any conventional manner. For example, the legs 108 may be made of separate pieces of material welded, bonded, brazed, brazed, and / or otherwise connected to the distal end of the elongated member 104. Alternatively, in another exemplary embodiment, the legs 108 may be formed of one or more pieces of material identical to the elongated member 104. While the figures show a basket 102 with three legs 108, other exemplary embodiments of the basket 102 may include more or fewer than three legs 108 to facilitate the removal of stones 120, stone-like deposits, or other foreign objects.

[0044] In an exemplary embodiment, the legs 108 may be looped, knotted, fastened, braided, braided, welded, glued, and / or otherwise joined at the distal end of the basket 102, and the distal end may define a non-traumatic tip 110. The non-traumatic tip 110 may be blunt, round, flat, smooth, knotted, looped, or any other non-traumatic shape known in the art. The non-traumatic tip 110 may be sized to assist in the capture and removal of the stone 102 within the body. For example, the non-traumatic tip 110 may be as small as possible to avoid interfering with the capture and removal of the target stone 120. In an exemplary embodiment, the legs 108 of the basket 102 may form the non-traumatic tip 110. In an alternative embodiment, the non-traumatic tip 110 may include, for example, a cap.

[0045] The elongated member 104 can be formed from, for example, wires, rods, tubes, hypotubes, cannulas, stents, or other biocompatible materials or combinations thereof known in the art. Such materials can include, but are not limited to, polyamides, PEBAX, silver, stainless steels (such as the 300 and 400 series), cobalt-chromium, nickel, titanium, nitinol, thermoformed plastics, polytetrafluoroethylene (“PTFE”), and expanded polytetrafluoroethylene (“ePTFE”). The elongated member 104 can also be a polymer-coated metal and can have one or more layers of material. The elongated member 104 can be solid or hollow and can be generally cylindrical. Alternatively, the elongated member 104 can be formed from a flat sheet of material. If formed from a flat sheet, the elongated member 104 can be formed into a generally cylindrical shape.

[0046] The overall length and diameter of the elongated member 104 can vary depending on the application. For example, a relatively long elongated member 104 may be advantageous for removing stones 120 or other stone-like deposits deep within a patient's body. Furthermore, an elongated member 104 with a relatively small diameter may be advantageous for removing stones 120 from restricted passages within the human urinary tract. The elongated member 104 may be relatively flexible to facilitate the removal of stones 120 located in complex body structures.

[0047] The sheath 106 can be formed from any of the materials discussed above with respect to the elongated member 104. The sheath 106 can be sized to accommodate the basket 102 in place. Figure 1 In the retracted position, the elongated member 104 and the basket-like member 102 are completely enclosed. In the absence of the sheath 106, the elongated member 104 and the basket-like member 102 can be sized such that they fit within the instrument channel 106 of the endoscope probe in the retracted position. Endoscope probes are known to include instrument channels with a standard diameter, which can be used as a design constraint on the diameter of the device 100 in the retracted position.

[0048] Each leg 108 may be a discrete line, fiber, strand, filament, or similar elongated structure, which are joined together to form a basket-like element 102. Alternatively, the legs 108 may be formed from a single piece of material by cutting, etching, removing, stamping, and / or otherwise shaping.

[0049] refer to Figure 1 The removal device 100 can be initially inserted into the body cavity 130 in the retracted position, such that the basket 102 is completely within the sheath 106 or the endoscopic instrument channel 106. The removal device 100 can be deployed within any suitable class of endoscopes known in the art, which may include imaging and guidance capabilities to locate the stone 120 to be removed.

[0050] The removal device 100 is moved to the vicinity of the stone 120 and then unfolded, as shown. Figure 2 As shown. By keeping the elongated member 104 and the basket 102 stationary while retracting the sheath 106, or by moving the device 100 past the endoscope instrument channel 106, the basket 102 is allowed to open to its biased position. In some embodiments, mechanical or electric components may further assist in the deployment of the basket 102.

[0051] Once the removal device 100 is deployed, the basket-like component 102 is manipulated to surround the target stone 120, as... Figure 3 As shown. Manipulating the basket-like device can be accomplished using an imager, guidewire, or other endoscopic tool known in the art.

[0052] Cover 112 is then deployed above basket 102, as Figure 4 As shown. The cover 112 can be made of fabric, plastic, or any other biocompatible material known in the art. In cases where the removal device 100 is for single use, relatively inexpensive materials such as polyethylene terephthalate or polytetrafluoroethylene (PTFE) can be used. In some procedures, plant fibers (such as cotton or hemp) or degenerated animal tissue (such as mammalian pericardium) may also be used. The basket-like cover can be water-permeable, but it is noteworthy that it is impermeable to stone fragments during laser fragmentation, as further described herein. In some embodiments, a mesh material such as stainless steel can be used for the cover; the pore size of the mesh can act as a size-filtering barrier for stone fragments, as further described below.

[0053] like Figure 5 As shown, once the cover 112 is deployed around the basket 102, the laser fiber 502 is inserted. The laser fiber 502 conducts energy from a laser source suitable for lithotripsy. Any of a variety of solid-state pulsed lasers, such as holmium:YAG lasers or thulium fiber lasers, can be used to treat the stones 120.

[0054] Various techniques for laser lithotripsy are known. Stone 120 is reduced to fragments 122 through ablation, fragmentation, and / or dusting. During the pulverization process, a basket-shaped cover 112 contains the fragments 122. Stone pulverization can continue until the fragments 122 are below a target size (e.g., 5 mm). Once the fragments have reached the permissible size, they can then be released or removed.

[0055] In some embodiments, alternative to laser fragmentation or other methods of fragmentation, such as those known in lithotripsy, may be used. For example, hydraulic and ultrasonic methods of lithotripsy are known in the art. The device 100 may be shaped and designed to withstand the application of these energies to break up the stones 120 and / or fragments 122.

[0056] exist Figure 6 In one embodiment shown, the stone fragment is removed via a suction tube 602 communicating with a suction source 604. The suction tube 602 can be delivered via an endoscope, as described above regarding the delivery of the removal device 100. The target size of the fragment 122 may depend on the size of the suction tube 302, which in turn may be limited by the size of the instrument channel in the endoscope. In some embodiments, suction may be applied intermittently during laser use, thereby removing fragments 122 that are small enough for the suction tube 602, leaving larger fragments for further targeting.

[0057] Figure 7 A basket cover 712 with an aperture 714 is shown. The aperture 714 is intentionally sized to match the size of the fragmented stone, such as 2 mm. Fragments 122 larger than the target size are contained within the basket 102 by the basket cover 712. Fragments 122 smaller than the target size can exit the basket 102 through the aperture 714. During laser targeting of the stone 120 and subsequently fragments 122, the extraction device 100 can be moved to facilitate the escape of smaller fragments 122. For example, partially retracting the basket 102 into the sheath or channel 106 will cause the basket 102 to partially collapse, thereby facilitating the discharge of debris. Similarly, moving or rotating the basket 102 may cause small fragments 122 to escape from the basket 102. Instead of a basic solid cover with apertures, a mesh cover can also have the apertures between the lines of the mesh spaced to match the target size of the fragments.

[0058] Figure 8A and Figure 8B An implementation method for deploying the cover 812 is shown. Figure 8A The basket 102 is shown detached from the sheath or instrument channel 106 and in the deployed position, while the cover 812 remains fully within the sheath or channel 106. A rope 802 runs along the legs 108 of the basket 102 from the tether point 804 to the non-traumatic wound tip 110, then returns upwards to the center of the basket 102 and passes through the sheath or channel 106. The rope 802 may extend further into the sheath or channel 106 and return upwards to the instrument channel for direct manipulation by a medical practitioner, or it may be secured to a device for automated manipulation. The cover 812 is also secured to each tether point 804. Figure 8B As shown, pulling the portion of the rope at the center of the basket 102 causes the outer portion of the rope 802 to move toward the tip 110 of the basket. This, in turn, pulls the tie point 804 and the cover 812 distally along the outrigger 108. The rope 802 is pulled until the tie point 804 reaches the tip 110, thereby deploying the cover 812 along the entire outer side of the basket 102.

[0059] Figures 9A to 9E An implementation method for deploying the cover element 912 is shown. Figure 9A A cover 912 is shown positioned in front of the basket-like member 102 within the sheath or channel 106. When the extraction device is moved to the open position, the cover 912 first extends from the sheath or channel 106, as shown. Figure 9B As shown. Once both the cover 912 and the basket 102 are extended, the basket can be opened and manipulated to capture the stone 120, as... Figure 9CAs shown. Rope 902 is attached to cover 912 at knot 904 at its distal end. Figure 9D and Figure 9E As shown, pulling the rope 902 toward the proximal side of the sheath 106 causes the cover 912 to move to its deployment position above the basket 102.

[0060] It should be understood that this disclosure is illustrative in many respects. Changes may be made in details, particularly in shape, size, and arrangement of steps, without departing from the scope of this disclosure. This may include, to the extent appropriate, using any feature of one example embodiment in other embodiments. Of course, the scope of the invention is defined by the language expressed in the appended claims.

Claims

1. An extraction device for treating kidney stones, comprising: an elongated member; a basket connected to a distal end of the elongated member, the basket being movable between a collapsed position having a first diameter and a deployed position having a second diameter larger than the first diameter; and a cover connected to the basket, the cover being deployable to form a barrier around the basket after the basket has been moved to the deployed position and encloses a kidney stone.

2. The extraction device of claim 1, further comprising: a sheath sized to enclose the basket in the collapsed position, wherein the basket exits the sheath when moved to the deployed position.

3. The extraction device of claim 1, the basket comprising: a plurality of legs joined to the elongated member at a proximal end and joined to a non-traumatic tip at a distal end.

4. The extraction device of claim 3, further comprising: a plurality of cords connected to the cover, the cords threaded between the cover and the non-traumatic tip of the basket such that pulling the cords deploys the cover.

5. The extraction device of claim 4, wherein, the cover moves from the proximal end of the basket to the non-traumatic tip to form a barrier around the basket.

6. The extraction device of claim 1, further comprising: a plurality of cords connected to the cover, wherein the cover is deployed in front of the basket such that pulling the cords moves the cover from the distal end of the basket to the proximal end of the basket to form a barrier around the basket.

7. The retrieval device of any of claims 1-6, wherein, the cover is water permeable.

8. The retrieval device of any of claims 1-7, wherein, the cover comprises at least one sheet of biocompatible material.

9. The extraction device of claim 8, wherein, the biocompatible material is a thermoplastic, a plant fiber, or an animal tissue.

10. The retrieval device of any of claims 1-9, wherein, the cover has a plurality of preselected sized holes.

11. The extraction device of claim 10, wherein, the holes have a diameter between 1 mm and 5 mm.

12. The extraction device of claim 10 or 11, wherein, the cover is a wire mesh, the holes comprising spaces between the wires of the mesh.

13. An endoscopic surgical device, comprising: an endoscope having an instrument channel; the extraction device of any one of claims 1-12, wherein the first diameter of the basket of the extraction device in the collapsed position is smaller than an inner diameter of the instrument channel of the endoscope such that the extraction device can be deployed into a patient through the instrument channel of the endoscope; and a laser fiber adapted to be deployed through the endoscope and inserted into a working space formed by the deployed basket and the deployed cover of the extraction device.

14. The endoscopic surgical device of claim 13, further comprising: a suction tube adapted to be deployed through the endoscope and inserted into the working space, the suction tube being in fluid communication with a suction source.

15. A method for operating the endoscopic surgical device of claim 13 or 14, comprising: deploying the basket of the extraction device; manipulating the basket around a target object; deploying the cover to enclose the basket if the target object is located inside, the covered basket defining a working space; inserting a laser fiber into the workspace; and applying laser energy through the laser fiber to reduce the target object to one or more fragments.

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