Lithotripsy device

Abstract

A lithotripsy device configured for breaking and extracting stones from a lumen, the device comprising a hollow delivery shaft formed with a distal opening; the device also comprises a foldable basket configured for being transposed between a first, folded position, in which it is configured for being at least partially accommodated within the hollow delivery shaft, and a second, expanded position, in which it is configured for containing at least one of the stones; the foldable basket comprises a proximal aperture configured for allowing, at least in the second, expanded position, the introduction of a dedicated tool from the hollow delivery shaft into the foldable basket; the foldable basket further comprises at least one alignment mechanism configured, while the foldable basket is in its second, expanded position, to transpose between a first, loose position, and a second, aligned position, in which it is configured for aligning the at least one stone with the proximal aperture, and an actuator configured at least for pushing the foldable basket out of the hollow delivery shaft.

Description

[0001] - 1 -

[0002] LITHOTRIPSY DEVICE

[0003] TECHNOLOGICAL FIELD

[0004] The present invention is in the field of lithotripsy, in particular, devices configured for breaking and removing foreign bodies from a cavity.

[0005] BACKGROUND OF THE INVENTION

[0006] 5 Various energy-delivering techniques fire employed by lithotripsy devices to fragment or dust stones in situ. Consequently, in many cases, stone fragments are typically expulsed from the body spontaneously. Unfortunately, in some cases, stone fragments may not be expelled as quickly or as completely as desired.

[0007] Alternatively, stones or stone fragments are pulled out from various biological

[0008] 10 systems with endoscopic forceps, or by stone extraction baskets, which are ribbed baskets connected to an end of a wire that is received within a lumen of a. sheath. The opposite end of the wire is attached to a handle that is used to slide the sheath over the wire, thereby moving the basket into and out of the lumen of the sheath. When the basket is out of the sheath, it expands to receive its target (a stone / foreign body / tissue). The sheath is then

[0009] 15 moved back toward the basket to reduce the size of the basket openings, and the basket and the enclosed target tire removed from the body.

[0010] However, stone fragments are usually scattered away from the device during stone fragmenting procedures and remain in the organ’s cavity to be naturally excreted. Such fragments may not be sufficiently small to be excreted spontaneously, thus they become

[0011] 20 as a nidus for future stones and pain episodes, and necessitate accessory procedures. Furthermore, when pulled out from the body cavity with a basket / forceps, the stone may cause trauma to the wall of the organ which may result in strictures.

[0012] One example of a lithotripsy device may be found in US20210401499, which discloses a laser lithotripsy system to deliver laser energy from one or more laser sources

[0013] 25 to a stone (e.g., mobile calculus), die system including a capture portion, a first laser node and a second laser node. The capture portion configured to be movable from a stored state to a deployed state. In the deployed state, the capture portion is configured to at least partially surround the stone. The first laser node and the second laser node are coupled to the capture portion and are configured to deliver the laser energy to the stone, and the first laser node is spaced apart from the second laser node

[0014] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0015] GENERAL DESCRIPTION

[0016] In accordance with one aspect of the subject matter of the present application, there is provided a lithotripsy device configured for breaking and extracting stones from a lumen, said device comprising: a hollow delivery shaft formed with a distal opening; a foldable basket configured for being transposed between a first, folded position, in which it is configured for being at least partially accommodated within said hollow delivery shaft, and a second, expanded position, in which it is configured for containing at least one of said stones; said foldable basket comprising a proximal aperture configured for allowing, at least in the second, expanded position, the introduction of a dedicated tool from said hollow delivery shaft into said foldable basket; wherein said foldable basket further comprises at least one alignment mechanism configured, while the foldable basket is in its second, expanded position, to transpose between a first, loose position, and a second, aligned position, in which it is configured for aligning said at least one stone with said proximal aperture; and an actuator configured at least for pushing said foldable basket out of said hollow delivery shaft.

[0017] The foldable basket may be formed with a closable distal end configured for assuming an open state, allowing the introduction of said at least one stone into the basket, and a closed state, preventing the exit of said at least one stone through the closable end.

[0018] In operation, the lithotripsy device may be configured for introduction of the hollow delivery shaft into the lumen containing said at least one stone in order to deliver the foldable basket, in its first, folded position, to the site of the stone, Thereafter, the device may be configured to deploy the foldable basket by pushing it out of the hollow shaft and allowing it to transpose into the second, expanded position. The foldable basket may be biased into its second, expanded position, such that when the actuator is used to push tire basket out of the hollow delivery shaft, it naturally expands from its first, foldable position.

[0019] In its second, expanded position, the foldable basket may be configured for exerting a certain amount of pressure on the walls of the lumen in order to expand the latter, thereby distancing it from the energy used to break the stone, and loosening the position of the stone. More particularly, while in its second, expanded position, the foldable basket may be configured for being further pushed along the lumen towards the stone, up to a position in which said at least one stone is located between the closable distal end of the basket and its proximal aperture.

[0020] The foldable basket may be provided with a closure mechanism configured for selectively closing the closable distal end, thereby preventing egress of the stone therethrough. In accordance with one embodiment, the closure mechanism may be constituted by one or more wires extending along the closable distal end, and configured for pulling it closed. The closure mechanism may also be controlled by the actuator.

[0021] Thus, the device of the present invention may assume at least the following discrete states, and may fluidly transition therebetween: i. Basket in second, expanded position, distal end opened, alignment mechanism in loose position; ii. Basket in second, expanded position, distal end closed, alignment mechanism in loose position; and iii. Basket in second, expanded position, distal end closed, alignment mechanism in aligned position.

[0022] In operation, the basket may be pushed forward within the lumen until the closable distal end of tire basket has passed the stone in state (i). Simultaneously, a suction procedure may also be implemented via the delivery shaft in order to further pull the stone into the basket, This suction procedure may also stick in small fragments of stone which tire already sufficiently small for being evacuated through the delivery shaft.

[0023] Once the distal end has passed the stone, the actuator may be configured for closing the distal end, capturing the stone within the basket in state (ii). In this state, the stone is captured within the basket, but is loose within the space defined by the basket (i.e. free to move). From this state, the alignment mechanism may be actuated in order to transpose from its loose position to its aligned position of state ( i i i ), aligning the stone with the proximal aperture and fixating its position.

[0024] It should be noted that in state (iii), the basket is still in its expanded position, exerting pressure on the walls of the lumen, while the stone is aligned, by virtue of the alignment mechanism, with the proximal aperture, and is remote as possible from the walls of the basket and, consequently, from the walls of the lumen as well.

[0025] The introduction of the basket into the lumen may be performed under basic imaging techniques (e.g. x-ray). However, once the basket encapsulates the stone, the rest of the procedure (i.e. fragmentation of the stone) may be performed without said imaging, owing to the exact alignment between the stone and the energy delivery device.

[0026] In order to facilitate proper imaging, the majority of the basket may be radiolucent, but it may include at least one component which is radiopaque, in order to provide indication that the stone has been encapsulated by the basket. Preferably, the radiopaque component may either extend along a portion of the basket or be located at a distal end of the basket, such that under radiology, the comparative location of the component and the stone may indicate proper encapsulation of the stone within the basket, For example, the radiopaque component may be a frame or ribs of the basket, or it may be a dedicated radiopaque component located at the distal end of the basket.

[0027] In accordance with a specific design variation, the alignment mechanism and the closure mechanism may be constituted by the same arrangement. In particular, the alignment mechanism may have a portion associated with the closable distal end, such that transposing the alignment mechanism from the loose position to the aligned position also closes the distal end of the basket. More specifically, the arrangement may be such that actuating the alignment mechanism first closes the distal end of the basket and thereafter completes the alignment of the stone with the proximal aperture.

[0028] According to one example, the alignment and closure mechanisms are constructed by one or more wires connected at one end to the closable distal end, and at another end to the actuator. More specifically, the one or more wires may extend across the foldable basket, but may be detached from the walls of the basket. In this manner, actuating the wires by pulling on them tightens the wires across a center of the basket, such that, one the one hand, the wires are spaced from the walls of the basket and, on the other hand, anything caught between the wires (e.g. said at least one stone), is automatically aligned with the proximal aperture. - 3 -

[0029] The lithotripsy device may be configured, at least when in state (iii) above, for introduction of a dedicated tool configured for fragmenting the stone captured by the alignment mechanism by providing directional energy thereto, The tool may be configured for being introduced through the hollow delivery shaft all the way to the distal end thereof, so as to enter the basket through the proximal end thereof. Owing to the operation of the alignment mechanism, when the dedicated tool is introduced into the basket, it is inevitably aligned with the captured stone. In accordance with one specific example, the energy may be in the form of a laser or electrohydraulic pulses.

[0030] One of the advantages of the device of the present application is that this alignment considerably reduces the risk of the directional energy emitted from the dedicate tool missing the stone and damaging the walls of the lumen. Another advantage is that in state (iii), the walls of the basket, and subsequently of tire lumen are as far away as possible from the source of the directional energy. It should again be noted that in state (iii), the lumen is still expanded by virtue of the basket, but the stone is fully aligned with the energy delivering device.

[0031] It should also be noted that the equipment required for generating electrohydraulic pulses may be significantly less expensive, more mobile, and simpler to maintain than alternative laser solutions. Furthermore, laser solutions require more accurate visual guidance for avoiding lateral damage to surrounding tissue when fragmenting the stone, a problem which is subverted using the alignment mechanism of the present application.

[0032] In accordance with the present application, the hollow delivery shaft may also be configured for introducing therethrough a secondary tube for providing a desired medium into the basket prior to the application of the energy. In particular, the secondary tube may fill the basket with water or saline, allowing the energy delivery tool to operate in a liquid environment.

[0033] The basket itself may be made of a semi-permeable material and may comprise a support frame, to which a flexible and semi-permeable film is attached. The support frame may comprise support ribs and / or semi-rigid wire-mesh and may be made of Nickel- Titanium (Nitinol) alloy. Thus, when the fluid is provided into the basket, it fills the basket but can permeate outside the basket into the lumen,

[0034] In accordance with a particular design solution, the basket may have two or more different regions, each with a different degree of permeability. For example, the basket may be formed with a proximal region having a first degree of permeability and a distal region, having a second degree of permeability, lower than the first degree. In accordance with a specific design variation, the change in the permeability level may be gradual, continuously becoming less and less permeable towards the distal end of the basket.

[0035] Application of the directional energy to the at least one stone is configured for fragmenting the stone into smaller fragments. Once the stone is sufficiently fragmented into pieces which have a smaller nominal size than that of the hollow delivery tube, the dedicated tool is extracted, and the actuator may be configured for pulling back the basket, trapping inside all of the fragments and securely removing them from the lumen.

[0036] In accordance with another aspect of tire subject matter of the present application, there is provided a basket for a lithotripsy device of the previous aspect, said basket being configured for being transposed between a first, folded position, in which it is configured for being at least partially accommodated within a hollow delivery shaft, and a second, expanded position, in which it is configured for containing at least one item; said foldable basket comprising a proximal aperture configured for allowing, at least in the second, expanded position, the introduction of a dedicated tool into said foldable basket; wherein said foldable basket further comprises at least one alignment mechanism configured, while the foldable basket is in its second, expanded position, to transpose between a first, loose position, and a second, aligned position, in which it is configured for aligning said at least one item with said proximal aperture.

[0037] In accordance with yet another aspect of the subject matter of the present application, there is provided a method for performing a lithotripsy procedure using the lithotripsy device of the previous aspects, said method including at least the steps of:

[0038] (a) introducing a delivery shaft into a lumen containing at least one stone;

[0039] (b) deploying a foldable basket within the lumen for capturing the stone therein;

[0040] (c) while the basket is in its second, expanded position, aligning said stone with a proximal aperture of the basket;

[0041] (d) introducing an energy delivery device into said basket via said proximal opening; and

[0042] (e) fragmenting said stone by delivering directional energy thereto.

[0043] The method may further comprise the step of:

[0044] (f) removing the energy delivery device;

[0045] (g) transposing said foldable basket into its first, folded position; and (h) extracting said foldable basket along with any captured stone fragments, from the lumen.

[0046] BRIEF DESCRIPTION OF THE DRAWINGS

[0047] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0048] Fig. 1A is a schematic isometric view of a lithotripsy device according to one example of the present application;

[0049] Fig. IB is a schematic enlarged view of detail A shown in Fig. 1A;

[0050] Figs. 2A to 2D are schematic side views of a basket of the device shown in Figs. 1 A and IB, shown in four different states thereof, with the delivery shaft being longitudinally cross-sectioned;

[0051] Fig. 2£ is a schematic enlarged view of detail B shown in Fig. 2D;

[0052] Figs. 3A to 3C are schematic side views of an actuator of the device shown in Figs. 1A and IB, shown in three different stages of actuation thereof, during a medical procedure;

[0053] Figs. 4A to 4C are schematic side views of the basket of the device within the lumen, longitudinally cross-sectioned, partially corresponding to the three different stages shown in Figs. 3 A to 3C:

[0054] Fig. 5A is a schematic isometric view of a portion of the actuator of the device shown in Figs. 1A and IB, during introduction of an energy delivery tool therein;

[0055] Fig. 5B is a schematic isometric view of the energy delivery tool shown in Fig. 5Aa, during application of energy to a stone;

[0056] Fig. 5C is a schematic enlarged view of the interface between the stone and the energy delivery tool shown in Figs. 5 A and 5B;

[0057] Fig. 5D is a schematic isometric view of the basket shown in Figs. 5A to 5C, shown after partial fragmentation of the stone;

[0058] Fig. 5E is a schematic isometric longitudinal cross-section view of retraction of the basket shown in Figs. 5 A to 5D, with the fragments of the stone therein; Fig. 6 is a schematic isometric view of a lithotripsy device according to another example of the present application;

[0059] Figs. 7A and 7B are schematic cross-section views of a tip of the lithotripsy device shown in Fig. 6;

[0060] Fig. 8 is a schematic isometric view of the basket of the lithotripsy device shown in Figs. 6 to 7B, shown in the expanded position of the basket;

[0061] Figs. 9A to 9E are schematic illustrations of various stages of operation of the lithotripsy device shown in Figs. 6 to 8; and

[0062] Fig. 10 is a schematic illustration of another example of a basket of a lithotripsy device of the present application.

[0063] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity, or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

[0064] DET .AILED DESCRIPTION OF EMBODIMENTS

[0065] The present invention relates to a device for enabling safe lithotripsy and extraction of stone fragments. The proposed device utilizes a semi-permeable basket, a fragmentation probe, and a fluid transmitting tube, which are threaded within a narrow delivery shaft, in a predetermined respective geometry, to capture a target stone in a safe confined space, in which an isolated fragmentation of the stone is performed, while preventing scatter of stone fragments back to the corresponding organ.

[0066] In the following description, references are made to several embodiments of the present invention, examples of which are illustrated in the accompanying figures. The figures depict an embodiment of the present invention for purposes of illustration only. One skilled in the art will readily recognize from the following description that the described embodiments may be combined, alternative embodiments may be utilized, and other changes may be made without departing from the spirit or scope of tire present invention.

[0067] The terms "for example", "e.g.," "for instance", and "optionally", as used herein, are intended to be used to introduce non-limiting examples. While certain references are made to certain example components, other components can be used and / or the example components can be combined into fewer components and / or divided into additional components.

[0068] Attention is first drawn to Figs. 1 A and 1 B, in which a lithotripsy device is shown, generally designated 1, and comprising an actuator assembly 10 configured for being operated by a user, and a delivery shaft 30 configured for introduction into a lumen in order to extract objects therefrom (e.g. stones). The actuator assembly 10 is configured for operating and controlling a basket (40, shown Figs. 2A to 2E), which is accommodated within the delivery shaft 30.

[0069] The actuator assembly comprises a main housing 12 fitted with a telescopic arrangement of elongated shafts 14, 16, configured for displacement of the basket 40 along the longitudinal axis of the delivery shaft 30, each elongated shaft being fitted with a corresponding stopper 24, 26. The actuator assembly 10 is further provided with two proximal ports 19, 29, configured for any one of the following: operating the basket, performing suction, and insertion of an energy -emitting device. The actuator assembly 10 is also formed with two distal ports 13, 15, which are configured for any one of the following: introduction of fluid into the basket, introduction of a guide-wire, and suction.

[0070] Turning now to Figs. 2A to 2E, the lithotripsy device comprises a basket 40 neatly accommodated within the delivery shaft 30, in a folded position as shown in Fig. 2A. The basket 40 comprises wall made of a semi -permeable mesh 42 and has a distal opening 44, which is naturally open. The basket 40 is biased to be naturally opened, and is prevented from transitioning to its open position by virtue of the wall 32 of the delivery shaft 30.

[0071] The basket 40 is configured for being pushed by the actuator assembly 10 out of the delivery shaft 30, as shown in Fig. 2B. In this position, the basket 40 can expand, becoming considerably wider than the diameter of the delivery shaft 30. In this state, the distal end 44 is wide open and is configured for receiving therein a desired object, The basket 40 is designed with a proximal opening located closer to the opening 34 of the delivery shaft 30, and configured for introduction therethrough of an energy delivery tool 60 (as will be discussed with respect to Figs. 5A to 5E). In addition, the basket 40 is provided with an alignment mechanism constituted by a set of wires 48 extending along the basket from the proximal opening 46 to the distal opening 44.

[0072] With particular reference being made to Fig. 2C, the actuator assembly 10 may be activated to pull on tire wires 48, thereby closing the distal opening 44. However, it should be noted that the wires 48 are connected to the distal opening 44. but not along the length of the basket 40. Thus, when activated, the wires 48 are forced towards a central axis of the basket 40, pulling away from the mesh 42. As shown in Fig. 2C, the distal opening 44 is closed, but the basket 40 is still expanded, with the wires 48 located half way between the mesh 42 and the central axis.

[0073] With reference to Figs. 2D and 2.E, further pulling on the wires 48 causes them to displace even closer towards the central axis of the basket 40, while the basket 40 is still in its expanded position. In this state, the distance between the wires 48 and tire mesh 42 is maximal, and denoted herein as D. As will be shown with regard to Figs. 4A to 4C, this centering of the wires 48 constitutes and alignment mechanism allowing to align anything caught between the wires 48 with the proximal opening 46.

[0074] Turning now to Figs. 3 A to 4C, the lithotripsy device 1 is shown in three different stages of operation thereof. For the sake of simplicity and clarity, Figs. 3A to 3C show the state of the actuator assembly 10, while Figs. 4A to 4C show partially corresponding state of the basket 40.

[0075] With particular reference being made to Fig. 3A, the actuator assembly is shown in its initial state, in which the basket 40 is accommodated within the delivery shaft 30, similar to the state shown in Fig. 2A.

[0076] During a first stage of actuation of the lithotripsy device 1, both shafts 14, 16 are pushed using knobs 24, 26, until the forward knob 24 abuts the housing 12, as shown in Fig. 3B. In this position, the basket 40 is pushed out of the delivery shaft 30 and causes an expansion of the lumen L in which the stone S is trapped, as shown in Figs. 4A and 4B.

[0077] In the position shown in Fig. 4A, a suction procedure is performed in order to such in smaller fragments F within the lumen L into the delivery shaft, and well as bringing the stone S closer into the basket 40. This procedure is performed while advancing the basket 40 forward within the lumen L, until it reaches the state shown in Fig. 2B. In this state, the stone is fully received within the basket 40, and the open distal end 44 is located distally to the stone S.

[0078] Once at this state, the actuator assembly 10 may be activated by pulling back the shaft 14 as shown in Fig. 3C, thereby pulling on the wires 48 and closing the distal end 44 of the basket 40, as shown in Fig. 4C. It should be noted that in this state, since the wires 48 are pulled towards the center of the basket 40, they also center the stone S with - I l - respect to the basket 40, achieving two effects simultaneously : (a) centering and aligning the stone S with the proximal opening 46; and (b) creating a space between tire stone S and the mesh 42 of the basket 40.

[0079] Turning now to Figs. 5 A to 5E, once the stone S is aligned and centered, an energy delivery device 60 may be inserted into the delivery shaft 30 via an opening 28 in the actuator assembly 10. The device may be brought in close proximity to stone S under imaging guidance (e.g., fluoroscopic guidance).

[0080] The energy delivery device 60 has a working end 64 configured for delivering focused directional energy. Once inserted, as shown in Figs. 5B and 5C, the working end 64 is configured for protruding through proximal opening 46 in order to deliver energy to the stone S. Owing to the alignment mechanism, the working end 64 of the energy delivery device 60 will inevitably point directly to the stone S. In the state shown in Fig. 5B, the working end 64 is able to deliver energy E to the stone S in order to cause fragmentation thereof.

[0081] It should be noted that while applying the energy E, the basket 40 is still in an expanded position, expanding the walls of the lumen L. Simultaneously, the wires 48 align the working end 64 and the stone S, and also keep the stone S as far as possible from the mesh 42 of the basket 40, and subsequently from the walls of the lumen L. Thus, the alignment mechanism provides and additional layer of safety making sure that the focused energy isn’t accidentally applied to the lumen or an organ, and only to the stone S requiring fragmentation.

[0082] Application of energy E to tire stone S causes fragments F to break off from the stone S. These fragments can then be sucked into the delivery shaft 30, but are still retained within the basket 40 as shown in Fig. 5D. After complete fragmentation, as shown in Fig. 5E, when the fragments F are of sufficiently small size, the entire basket 40 can be retracted back into the delivery shaft 30, along with any and all fragments, leaving the lumen L completely unscathed.

[0083] Fig. 6 illustrates a perspective view of tut other example of a lithotripsy and extraction device 100, according to an embodiment of the present invention. Device 100 comprises an actuator 110 and a delivery shaft 120 (i.e., a catheter suitable for deployment and operation within a biological body). A proximal end 120a of the delivery shaft 120 is connected to the actuator 110, which is configured to enable maneuvering of delivery shaft 120 towards a target stone (i.e., a stone to be fragmented and extracted), and to remotely control fragmentation and extraction components threaded therein, to fragment and to extract target stones through a distal end 120b of delivery shaft 120, as will be descri bed here inafter .

[0084] Fig. 7 A and 7B illustrate a partial section view of the distal end 120b, in which delivery shaft 120 is sectioned, thus exposing a semi-permeable basket 220, which is connected at the end of a basket guiding tube 210 (e.g., using a designated glue or another suitable mechanical attachment means), according to an embodiment of the present invention. Guiding tube 210 is controlled by actuator 110 to extract / retract basket 220 out from / into distal end 120b.

[0085] With additional reference being made to Fig. 8, a basic configuration of basket 220 is illustrated, according to an embodiment of the present invention. Basket 220 comprises a support frame comprised of support ribs 221, to which a flexible and semi- permeable film 222 is attached (i.e., at a folded state, as shown in Fig. 7A, at a fully deployed state as shown in Fig. 8, or in a transition state therebetween). Film 222 is permeable to irrigation fluid, thereby enabling fluid transmittal therethrough to the environment surrounding basket 2.20, thus providing lubrication between delivery shaft 120 or basket 220 and the surrounding tissue (e.g., of an organ within a biological body).

[0086] The support frame of basket 220 is manufactured with ribs 221 shaped at a preliminary extended state as shown in Fig. 8, suitable to confine typical target stones having a diameter of up to 10 millimeters (before fragmentation). Basket 220 is sufficiently flexible so as to enable its threading (in a pressed state) into delivery shaft 120 (e.g., a 2mm-3mm catheter), whereas basket 220 is pushed out from delivery shaft 120 (i.e., by a controlled axial sliding of guiding tube 210 within delivery shaft 120, performed through actuator 110), it gradually opens to its preliminary extended state.

[0087] According to an embodiment of tire present invention, the frame of basket 120 may be made of a Nickel-Titanium (Nitinol) alloy, with support ribs 121 having a preliminary extended state as shown in Fig. 8, at an ambient body temperature. This way, the effort required for threading basket 120 into delivery shaft 120, and the residual stress in the narrowed basket 120 are reduced, when performed at predetermined lower temperatures (i.e., with respect to the ambient body temperature),

[0088] Reverting to Fig. 713, in which both delivery shaft 120 and guiding tube 210 are illustrated at a section view / , according to an embodiment of the present invention. A fluid transmission tube 211 is threaded for transmitting fluid into / out from tire operating site of device 100, and a probe guiding tube 212 is threaded for guiding an energy-emitting probe 213 (i.e. a flexible probe transmitting energy such as but not limited to laser / thermal / electrohydraulic energy) towards a target stone.

[0089] Further shown in Figs. 7 A to 8 are tightening holes 221 a, to which a tightening wire can be attached (not shown for tire sake of clarity), for enabling remote tightening of the distal end of ribs 221 by pulling the tightening wire, thereby closing basket 220 and forming a confined safe space. In Fig. 8, it can be noted that fluid transmission tube 211 and probe guiding tube 212 are directed to the center of the space within basket 220 for efficiently fragmenting and extracting the fragments of a target stone captured therein, as further illustrated in Figs. 9A to 9C.

[0090] The operation of device 100 including the components described in Figs. 7 A to 8 is performed through actuator 110. Therefore, handle 110 comprises suitable mechanical and / or electro-mechanical control operators which are connected to fragmentation and extraction components threaded in delivery shaft 120 (e.g., for axially maneuvering guiding tube 210 and energy emitting probe 213, for activating probe 213, and for operating irrigation / suction pump(s) transmitting liquid through fluid transmission tube), as described hereinafter.

[0091] In Figs. 9A to 9C, an exemplary process of fragmenting and extracting a target stone with device 100 is carried out according to the following steps: initially, delivery shaft 120 of device 100 is introduced into a natural tube endoscopically, percutaneously, or directly into an organ containing a target stone 301 (Fig. 9A). Delivery shaft 120 is brought in close proximity to stone 301 under imaging guidance (e.g., fluoroscopic guidance).

[0092] Whereas basket 220 reaches near stone 301 , the user of device 100 operates handle 110 to push guiding tube 210, thereby basket 220 is extracted and further advanced to surround stone 301 (Fig. 9B). Optionally, at this stage, a suction means is triggered by handle 110 to extract a small amount of (e.g., previously streamed) irrigation fluid through transmission tube 211, thereby attracting stone 301 towards the cavity of basket 220.

[0093] Subsequently, the distal end of basket 220 is tightened by either pulling a tightening wire connected to tightening holes 221a (i.e., threaded into basket guiding tube 210 and pulled by a corresponding mechanism in actuator 110), or by an initial retraction of basket 220 into shaft 120, thereby pressing convex sections 321a of ribs 221 and bending the ends thereof inwardly. As a result, stone 301 is captured within the confined space of basket 220. Furthermore, it is substantially centered with respect to guiding tube 212 and energy emitting probe 213 threaded therein.

[0094] Before fragmenting energy is emitted toward stone 301, irrigation fluid is transmitted through fluid transmission tube 211, and exits through film 222 (Fig. 9D), thereby providing a medium between basket 220 and residing tissues, providing a medium for energy delivery toward the stone, and a means to reduce the lateral heating induced by the fragmenting energy to be emitted towards stone 301.

[0095] At this stage, probe 213 is being extracted towards stone 301 (Fig. 9E), and then being triggered (e.g., by a corresponding button of actuator 110, or a foot pedal that is engage therewith), to emit fragmenting energy towards the center of the space and the stone 301. The geometrical structure of basket 220, and the concentric arrangement of probe 213 therein in close proximity to stone 301 and aiming towards its center, enables efficient fragmentation of stone 301, with reduced stone fragments scattering, when using focused energy pulses, such as electrohydraulic, or LASER technology.

[0096] According to an embodiment of the present invention, the external diameter of catheter 120 is 2mm-3mm. Such dimensions enable, for instance, to perform a direct entry to a patient’s kidney percutaneously or retrogradely, to fragment an obstructing stone, and extract its fragments in a prompt and short procedure, facilitating a short patient recovery.

[0097] With further reference to Fig. 9E, small fragments 302 of stone 301 remain in the device. It can be noted in Figs. 9C to 9E that the confined space of basket 220, prevents fragments 302 of stone 301 from escaping out of the basket 220, particularly during the fragmentation.

[0098] Finally, basket 220 is pulled back into delivery shaft 120, and extracted from the corresponding organ, along with the stone fragments captured therein. According to an embodiment of the present invention, film 222 (Fig. 8) comprises a hydrophillic coating (for example, a microthin polymer) , for enabling a smooth atraumatic retraction of basket 220 into delivery shaft 120, or for enabling a smooth atraumatic retraction of basket 220 behind shaft 120 (e.g., where the stone fragments are too large to fit into shaft 120), and out from the body, wherein the closed smooth- surfaced basket can widen the body cavity as it is gently being pulled out. Although embodiments of the invention have been described by way of illustration, it will be understood that tire invention may be carried out with many variations, modifications, and adaptations, without exceeding the scope of the claims,

[0099] For example, alternate designs of basket 220 can be used as more advanced materials and structures are developed, such as a basket 401 comprising a semi-rigid wire mesh in li eu of ribs 221 of Fig. 10 shown in a retracted state.

[0100] Furthermore, the different components of the proposed device may be provided in alternate dimensions suitable for specific applications of the present invention.

[0101] It should be readily understood by a person skilled in the art, that the proposed device and components thereof that are intended to interface with a biological body, are fabricated from biocompatible materials and with sufficient strength, durability, and flexibility for being maneuvered safely inside a biological environment.

[0102] Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations, and modifications can be made without departing from the scope of the invention, mutatis mutandis.

Claims

CLAIMS:

1. A lithotripsy device configured for breaking and extracting stones from a lumen, said device comprising: a hollow delivery shaft formed with a distal opening: a foldable basket configured for being transposed between a first, folded position, in which it is configured for being at least partially accommodated within said hollow delivery shaft, and a second, expanded position, in which it is configured for containing at least one of said stones; said foldable basket comprising a proximal aperture configured for allowing, at least in the second, expanded position, the introduction of a dedicated tool from said hollow delivery shaft into said foldable basket; wherein said foldable basket further comprises at least one alignment mechanism configured, while the foldable basket is in its second, expanded position, to transpose between a first, loose position, and a second, aligned position, in which it is configured for aligning said at least one stone with said proximal aperture; and an actuator configured at least for pushing said foldable basket out of said hollow delivery shaft.

2. A lithotripsy device according to Claim 1 , wherein the foldable basket is formed with a closable distal end configured for assuming an open state, allowing the introduction of said at least one stone into the basket, and a closed state, preventing the exit of said at least one stone through the closable end.

3. A lithotripsy device according to Claim 1 or 2, wherein the foldable basket is biased into its second, expanded position, such that when the actuator is used to push the basket out of the hollow delivery shaft, it naturally expands from its first, foldable position.

4. A lithotripsy device according to Claim 1 , 2 or 3, wherein in its second, expanded position, the foldable basket is configured for exerting a certain amount of outwards pressure.

5. A lithotripsy device according to any one of Claims 1 to 4, wherein the foldable basket is provided with a closure mechanism configured for selectively closing the closable distal end.

6. A lithotripsy device according to Claim 5, wherein the closure mechanism is constituted by one or more wires extending along the closable distal end. and configured for pulling it closed,7. A lithotripsy device according to Claim 6, wherein the closure mechanism is controlled by the actuator.

8. A lithotripsy device according to any one of Claims 1 to 7, wherein the device is configured for assuming at least the following discrete states: i. Basket in second, expanded position, distal end opened, alignment mechanism in loose position; ii. Basket in second, expanded position, distal end closed, alignment mechanism In loose position; and iii. Basket in second, expanded position, distal end closed, alignment mechanism in aligned position.

9. A lithotripsy device according to Claim 8, wherein the alignment mechanism and the closure mechanism are constituted by the same arrangement.

10. A lithotripsy device according to Claim 9, wherein the alignment mechanism has a portion associated with the closable distal end, such that transposing the alignment mechanism from the loose position to the aligned position also closes the distal end of the basket.

11. A lithotripsy device according to Claim 10, wherein the arrangement is such that actuating the alignment mechanism first closes the distal end of the basket and thereafter completes the alignment of the stone with the proximal aperture.

12. A lithotripsy device according to any one of Claims 8 to 11 , wherein the alignment and closure mechanisms are constructed by one or more wires connected at one end to the closable distal end, and at another end to the actuator.

13. A lithotripsy device according to Claim 12, wherein the one or more wires extend across the foldable basket, but are detached from the walls of the basket.

14. A lithotripsy device according to Claim 13, wherein actuating the wires by pulling on them tightens the wires across a center of the basket, but retains the basket in its expanded position.

15. A lithotripsy device according to any one of Claims 1 to 14, w'herein the lithotripsy device is configured for introduction of a dedicated tool therethrough configured for fragmenting the stone captured by the alignment mechanism.

16. A lithotripsy device according to Claim 15, wherein fragmentation is performed by delivering directional energy to the stone.

17. A lithotripsy device according to Claim 15 or 16, wherein the tool is configured for being introduced through the hollow delivery shaft all the way to the distal end thereof, so as to enter the basket through the proximal end thereof.

18. A lithotripsy device according to Claim 17, wherein the alignment mechanism ensures that the energy delivery tool is aligned with the captured stone.

19. A lithotripsy device according to any one of Claims 15 to 18, wherein the energy is in the form of at least one of the following: electrohydraulic pulses, laser and ultrasonic lythotrips.

20. A lithotripsy device according to any one of Claims 1 to 19, wherein the hollow delivery shaft is configured for introducing therethrough a secondary tube for providing a desired medium into the basket prior to the application of the energy,21. A lithotripsy device according to Claim 20, wherein the secondary tube is configured to fill the basket with water or saline, allowing the energy delivery tool to operate in a liquid environment.

22. A lithotripsy device according to any one of Claims 1 to 21, wherein the basket itself is made of a semi -permeable material.

23. A lithotripsy device according to Claim 22 or 23, wherein said basket comprises a support frame, to which a flexible and semi -permeable film is attached.

24. A lithotripsy device according to Claim 22, 23 or 24, wherein the basket has two or more different regions, each with a different degree of permeability.

25. A lithotripsy device according to Claim 24, wherein the basket is formed with a proximal region having a first degree of permeability and a distal region, having a second degree of permeability, lower than the first degree.

26. A lithotripsy device according to Claim 24 or 25, wherein the change in the permeability level is gradual, continuously becoming less and less permeable towards the distal end of the basket.

27. A lithotripsy device according to any one of Claims 23 to 26, wherein the support frame comprises support ribs and / or semi-rigid wire-mesh,28. A lithotripsy device according to any one of Claims 23 to 27 , wherein the frame is made of Nickel-Titanium (Nitinol) alloy.

29. A lithotripsy device according to any one of Claims 1 to 27, wherein the majority of the basket is radiolucent.

30. A lithotripsy device according to Claim 29, wherein the basket comprises at least one component which is radiopaque.

31. A lithotripsy device according to Claim 30, wherein the radiopaque component extends along a portion of the basket and / or is located at a distal end of the basket.

32. A lithotripsy device according to Claim 31, wherein the radiopaque component is any one of the following : a support frame, ribs extending along the basket, and a dedicated radiopaque component located at the distal end of the basket.

33. A basket for the lithotripsy device of any one of Claims 1 to 32, said basket being configured for being transposed between a first, folded position, in which it is configured for being at least partially accommodated within a hollow delivery shaft, and a second, expanded position, in which it is configured for containing at least one item; said foldable basket comprising a proximal aperture configured for allowing, at least in the second, expanded position, the introduction of a dedicated tool into said foldable basket; wherein said foldable basket further comprises at least one alignment mechanism configured, while the foldable basket is in its second, expanded position, to transpose between a first, loose position, and a second, aligned position, in which it is configured for aligning said at least one item with said proximal aperture.

34. A method for performing a lithotripsy procedure using the lithotripsy device of any one of Claims 1 to 33, said method including at least the steps of:(a) introducing a delivery shaft into a lumen containing at least one stone;(b) deploying a foldable basket within the lumen for capturing the stone therein;(c) while the basket is in its second, expanded position, aligning said stone with a proximal aperture of the basket;(d) introducing an energy delivery device into said basket via said proximal opening; and(e) fragmenting said stone by delivering directional energy thereto.

35. A method according to Claim 34, wherein the method comprises at least one of the following steps:(f) removing the energy delivery device;(g) transposing said foldable basket into its first, folded position; and(h) extracting said foldable basket along with any captured stone fragments, from the lumen.

36. A method according to Claim 34 or 35, wherein in its second, expanded position, the foldable basket is configured for exerting a certain amount of outwards pressure on the walls of the lumen in order to expand the latter, thereby loosening the position of the stone.

37. A method according to Claim 34, 35 or 36, wherein the basket is configured for being pushed forward within the lumen until the closable distal end of the basket has passed the stone.

38. A method according to any one of Claims 34 to 37, wherein a suction procedure is implemented via the delivery shaft in order to further pull the stone into the basket.

39. A method according to Claim 31, wherein the suction procedure sucks in small fragments of stone from within the lumen which are already sufficiently small for being evacuated through the delivery shaft.

40. A method according to any one of Claims 34 to 38, wherein, once the distal end has passed the stone, the actuator is configured for closing the distal end, capturing the stone within the basket.

41. A method according to Claim 40, wherein the alignment mechanism is actuated in order to transpose from its loose position to its aligned position, aligning the stone with the proximal aperture and fixating its position.

42. A method according to any one of Claims 34 to 41, wherein step (e) is performed while the basket is still in its expanded position.

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