Laser fiber with varying lateral position and intensity

Abstract

To solve the problem in which pieces resulting from conventional laser lithotripsy can be too large to dissolve or to naturally pass through the body.SOLUTION: A lithotripsy or other medical laser treatment system can include a lateral actuator to laterally displace a distal portion of a laser fiber, where the distal portion of the laser fiber can be scanned or otherwise controlled to generate a spatial or spatiotemporal sub-targeting pattern without requiring laterally moving an endoscope carrying the laser fiber in a longitudinal passage such as a working channel. A targeted stone can be selectively weakened along the pattern, e.g., using lower energy pulses, before being fragmented, e.g., by a higher energy shock pulse.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Claim of Priority This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 882,837, filed Aug. 5, 2019; U.S. Provisional Patent Application No. 63 / 000,570, filed Mar. 27, 2020; and U.S. Provisional Patent Application No. 63 / 027,007, filed May 19, 2020, which are hereby incorporated by reference in their entireties.

[0002] This specification generally relates to endoscopic laser systems, and more particularly to systems and methods for varying the lateral position of a laser fiber and the intensity of laser pulses.

Background Art

[0003] In laser lithotripsy, pulses of laser energy can be applied endoscopically through a laser fiber to a target such as a kidney, bile duct, gallbladder, or other stone to fragment the stone into various pieces.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, the resulting fragments can scatter throughout the body. These fragments may be too large to dissolve or pass through the body naturally, potentially requiring retrieval by a physician using a suction device, forceps, basket, or other retrieval device. Retrieving stone fragments can be extremely time-consuming and difficult. The presence and nature of any resulting stone fragments may present further challenges for the patient. [Means for solving the problem]

[0006] This specification describes laser therapy systems, such as lithotomy systems or other medical treatment systems, that include a laser fiber which can be configured to provide one or both of the following: lateral position variation and / or variation of laser pulse intensity. The distal end of the laser fiber can be actuated by scanning or other means to vary the lateral position of the laser fiber with respect to the center of a working lumen or other longitudinal passage or other reference longitudinal axis of a rigid or flexible endoscope or other elongated medical device. In this way, the position of the laser fiber can be changed at one or more of various lateral positions without the need to move or change the position of the endoscope. Laser pulses can be emitted at such different lateral positions. The intensity of such laser pulses can also be controlled to allow the emission of laser pulses of different intensities at different lateral positions. Lateral positioning or modification of the laser fiber, variation of laser pulse intensity, or both may be useful for delivering sequences or patterns of laser energy to kidney stones or other stones or targets. The patterns can be selected to help improve or optimize the way the target is treated, such as how the stones are broken up. This can help reduce the size or movement of fragments resulting from the fracture of kidney stones or other stones or targets. This can help reduce or avoid the need for any fragment retrieval or the complexity of the procedure by a physician.

[0007] Example 1 is a laser therapy system that enables the delivery of laser energy through an endoscope from different lateral positions without the need to change the lateral position of the endoscope. The laser therapy system comprises a laser fiber including a distal portion configured to be inserted into a patient through the longitudinal passage of the endoscope, the distal portion of the laser fiber being actuated to be at least laterally adjustable with respect to the longitudinal passage within the longitudinal passage at a selected position among a plurality of available positions that are laterally displaced within the longitudinal passage of the endoscope.

[0008] In Example 2, the subject of Example 1 optionally includes the fact that the distal portion of the laser fiber includes a bent portion.

[0009] In Example 3, the subject of Example 2 optionally includes the fact that the distal portion of the laser fiber is rotatable around the longitudinal path.

[0010] In Example 4, one or more of the themes from Examples 1-3 are optionally configured such that a laser fiber is coupled to a laser source controlled by a controller circuit to provide first and second laser pulses through the laser fiber, the second laser pulse containing higher energy than the first laser pulse, and the second pulse is delivered laterally closer to the center of the target than the first laser pulse is delivered, without requiring a change in the lateral position of the endoscope.

[0011] In Example 5, one or more subjects from Examples 1-4 optionally include at least one actuator configured to actuate a lateral displacement of the distal portion of a laser fiber in a specified pattern according to a control signal provided by a controller circuit.

[0012] In Example 6, the subject of Example 5 optionally includes the further actuation capability such that the distal portion of the laser fiber is longitudinally translatable with respect to at least one actuator.

[0013] In Example 7, one or more of the themes from Examples 5-6 optionally include at least one actuator comprising a first actuator configured to actuate the lateral displacement of the distal portion of the laser fiber and a different second actuator configured to actuate the longitudinal translation of the laser fiber.

[0014] In Example 8, one or more of the themes from Examples 5-7 are optionally configured such that the controller circuit generates a control signal to activate at least one actuator using a feedback signal in response to electromagnetic radiation from a target.

[0015] In Example 9, the subject of Example 8 optionally includes the fact that the feedback signal includes imaging data or spectral data.

[0016] In Example 10, one or more of the themes from Examples 8–9 are optionally configured such that the controller circuit uses information about the distance between the distal end of the laser fiber and the target to generate a control signal for activating at least one actuator.

[0017] In Example 11, one or more of the themes from Examples 1 to 10 optionally include being actuated by at least one of electromagnetic, electrostatic, or piezoelectric means such that the distal portion of a laser fiber is displaced laterally relative to the longitudinal path within the longitudinal path when actuated according to a control signal provided by a controller circuit.

[0018] In Example 12, one or more subjects from Examples 1 to 11 optionally include being coupled to a laser source controlled by a controller circuit, such that the laser fiber provides a lateral pattern of lower-energy laser pulses toward the periphery of the target and at least one higher-energy laser pulse toward the center of the target, without requiring a change in the lateral position of the endoscope.

[0019] In Example 13, the subject matter of Example 12 optionally includes that the lateral pattern includes at least one of a spiral pattern, a meandering pattern, a star pattern, or a zigzag pattern.

[0020] In Example 14, the subject matter of any one or more of Examples 1 to 13 optionally includes that the distal portion of the laser fiber is operable to be at least laterally positioned adjustably with respect to the central longitudinal axis of the longitudinal passage within the longitudinal passage at a selected position among a plurality of available positions laterally displaced within the longitudinal passage of the endoscope.

[0021] In Example 15, the subject matter of any one or more of Examples 1 to 14 optionally includes that the distal portion of the laser fiber is operable to be at least laterally positioned adjustably with respect to the central longitudinal axis of the laser fiber within the longitudinal passage at a selected position among a plurality of available positions laterally displaced within the longitudinal passage of the endoscope.

[0022] In Example 16, the subject matter of any one or more of Examples 5 to 10 optionally includes that at least one actuator is configured to actuate the distal portion of the laser fiber so as to be at least laterally positioned adjustably with respect to the longitudinal passage within the longitudinal passage at a selected position among a plurality of available positions laterally displaced within the longitudinal passage of the endoscope while maintaining the endoscope in a stationary lateral state.

[0023] In Example 17, the subject matter of Example 16 optionally includes that at least one actuator is located at the distal portion of the laser fiber.

[0024] In Example 18, the subject matter of any one or more of Examples 16 to 17 optionally includes that at least one actuator is located at the proximal portion of the laser fiber.

[0025] Example 19 is a method of endoscopic laser therapy for enabling at least a lateral orientation of a laser beam to be changed with respect to a target area without the need to move the endoscope. This method includes providing a laser fiber configured to extend through a longitudinal passage of the endoscope and transmitting or receiving a control signal to actuate positioning of a distal portion of the laser fiber at least laterally within the longitudinal passage of the endoscope at a selected one of a plurality of available positions displaced laterally within the longitudinal passage of the endoscope.

[0026] In Example 20, the subject matter of Example 19任选地, 包括the laser fiber being actuated by a controller to provide first and second laser pulses via the laser fiber, the second laser pulse including higher energy than the first laser pulse包含.

[0027] In Example 21, the subject matter of Example 20任选地, 包括the second laser pulse being transmitted when the distal portion of the laser fiber is relatively closer to the center of the target area than when the first laser pulse is transmitted without changing the lateral position of the endoscope包含.

[0028] In Example 22, the subject matter of any one or more of Example 20 - 21任选地, 包括the second laser pulse being transmitted after a specified time interval from when the first laser pulse is transmitted and the first laser pulse being repeatedly transmitted to consistently apply the first laser pulse energy to the target area包含.

[0029] In Example 23, the subject matter of Example 22任选地, 包括the first laser pulse being repeatedly transmitted along a pattern boundary toward a lateral periphery of the target area and the second laser pulse being applied closer to the center of the target area laterally包含.

[0030] [[ID=二十]]In Example 24, the subject matter of any one or more of Example 19 - 23任选地, 包括the distal portion of the laser fiber being displaced laterally in a spiral pattern according to a control signal provided by a controller包含. 注:原文中“任意選択で”直译为“任选地 ”,在专利文本语境中可理解为“可任选地”“可选择地”等意思,这里保留原文表述方式以更贴近原文风格。“包含”表示原文中“含む”的意思,在专利文本中常这样翻译。你可根据实际需求进一步调整表述使其更符合专利文本规范。

[0031] In Example 25, one or more of the themes from Examples 19-23 optionally include the distal portion of a laser fiber being displaced laterally in a meandering pattern according to a control signal provided by a controller.

[0032] In Example 26, one or more themes from Examples 19–23 optionally include the distal portion of a laser fiber being displaced laterally in a zigzag pattern according to a control signal provided by a controller.

[0033] In Example 27, one or more of the themes from Examples 19-23 optionally include the distal portion of a laser fiber being displaced laterally in a star pattern according to a control signal provided by a controller.

[0034] In Example 28, one or more of the themes from Examples 19-27 optionally include selecting or controlling a target pattern that includes different target lateral positions using information about at least one of the morphologies or compositions of at least a portion of the target area.

[0035] In Example 29, one or more subjects from Examples 19–28 optionally include sending or receiving control signals to actuate the distal portion of a laser fiber to be displaced laterally in a specified pattern so as to send one or more laser pulses toward the lateral periphery of a target region before sending one or more laser pulses toward the lateral periphery of a target region closer to the center of the target region.

[0036] Example 30 is a laser therapy system for laser therapy via an endoscope that enables the direction of a laser beam toward a target at least laterally without the need to move the endoscope, the system comprising a laser fiber configured to extend through the longitudinal passage of the endoscope, and means for sending or receiving control signals to position the distal portion of the laser fiber at least laterally at a selected position among a plurality of available positions laterally displaced within the longitudinal passage of the endoscope.

[0037] In Example 31, the subject of Example 30 is optionally coupled to a laser source controlled by a controller circuit so as to provide first and second laser pulses through the laser fiber, wherein the second laser pulse contains higher energy than the first laser pulse, and the second pulse is delivered laterally closer to the center of the target than when the first laser pulse is delivered, without the need to change the lateral position of the endoscope.

[0038] This summary is an overview of some of the teachings of this application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details relating to the subject matter are found in the detailed description and the attached claims. Other aspects of this disclosure will be apparent to those skilled in the art by reading and understanding the following detailed description and by viewing the drawings which form part thereof, and the detailed description and drawings should not be constrained. The scope of this disclosure is defined by the attached claims and their legal equivalents.

[0039] In drawings, elements are not always drawn to scale, and similar numbers in different drawings may represent similar components. Similar numbers with different subscripts may represent different similar cases. [Brief explanation of the drawing]

[0040] [Figure 1A] This is a side cross-sectional view of a part of the endoscope system. [Figure 1B] This is an end view of a lateral actuator and a laser fiber. [Figure 1C] This is an end view of a lateral actuator including a stabilizer and a laser fiber. [Figure 1D] This is a side cross-sectional view of a part of the endoscope system. [Figure 1E] This figure shows various examples of side cross-sectional views of parts of an endoscope system. [Figure 1F]This figure shows various examples of side cross-sectional views of parts of an endoscope system. [Figure 1G] This figure shows various examples of side cross-sectional views of parts of an endoscope system. [Figure 1H] This figure shows an example of a system that uses feedback signals reflected from a target to control and adjust the position of a laser fiber relative to the distal end of an endoscope. [Figure 1I] This figure shows an example of a system that uses feedback signals reflected from a target to control and adjust the position of a laser fiber relative to the distal end of an endoscope. [Figure 2] This is a side cross-sectional view of a part of the endoscope system. [Figure 3] This is a graph showing the use of different laser energies. [Figure 4A] This figure shows various examples of fluctuating spatial or spatial-temporal trajectories of a laser beam that can be operated laterally without the need to move the endoscope. [Figure 4B] This figure shows various examples of fluctuating spatial or spatial-temporal trajectories of a laser beam that can be operated laterally without the need to move the endoscope. [Figure 4C] This figure shows various examples of fluctuating spatial or spatial-temporal trajectories of a laser beam that can be operated laterally without the need to move the endoscope. [Figure 4D] This figure shows various examples of fluctuating spatial or spatial-temporal trajectories of a laser beam that can be operated laterally without the need to move the endoscope. [Modes for carrying out the invention]

[0041] This specification describes examples of techniques that can help address the problem of controlling stone fragmentation during lithotomy or other laser surgery or treatment, which may include using a laser fiber that can be operated to position or reposition laterally with respect to any reference longitudinal axis of the working channel or other longitudinal passage of an endoscope or other instrument, without the need to move or reposition the endoscope or other instrument, for example. This makes it possible to first prepare the target stone by cracking it or otherwise at different target locations, intensities, or both, with multiple pulses or patterns of multiple pulses, and then fragment the stone at the desired locations and intensities with subsequently delivered laser pulses. This can help break the stone into fragments small enough to pass naturally from the body, thereby reducing, minimizing, or avoiding the need for physician intervention for fragment removal.

[0042] Figure 1A shows an example of a part of an endoscope or similar medical treatment system, such as an endoscopic laser lithotripsy system 100. In the example of Figure 1A, the lithotripsy system 100 may include or be coupled to at least one laser source 130. The laser source 130 may be mechanically and optically connected to a laser fiber 140, which may include a single optical fiber or a bundle of optical fibers. The laser fiber 140 may be introduced through a proximal access port 142 and extend into a working channel or other longitudinal passage 145 or lumen of an endoscope 110 or similar device. The endoscope 110 may include a proximal handle portion 112 and an elongated distal portion 113, the distal portion 113 may be configured to be inserted into the patient through an opening or incision, etc. The endoscope 110 can provide visual inspection or treatment of soft (e.g., non-calcified) or hard (e.g., calcified) tissue, and may be useful for visualizing, destroying, or otherwise treating kidney stones or other stones or targets.

[0043] In Figure 1A, the laser source 130 may include one or more laser sources, which may include, for example, a diode or diode-pumped thulium fiber laser, a holmium laser, a green light laser, a YAG laser, or other types of lasers. The laser source 130 may be configured to provide a laser output of variable energy intensity. For example, lower energy intensities may be used for providing a “targeting” beam or for treating soft (e.g., non-calcified) tissue, and one or more higher energy intensities may be used to provide a “treatment” beam for hard (e.g., calcified) tissue or stone. Multiple higher energy intensity treatment beam levels may be provided, for example, per pulse or depending on the target location, for establishing, adjusting, or regulating a desired treatment pulse energy intensity to a specified level.

[0044] In Figure 1A, the endoscope 110 may include, or be provided with, visualization and illumination optical systems, such optical systems may include, for example, a visualization optical path 160 and an illumination optical path 150, each of which may extend longitudinally along the elongated body 113 of the endoscope 110, such as from the proximal handle portion 112 of the endoscope 110 to the distal end of the endoscope 110. An eyepiece, camera, or imaging display 115 may be provided or coupled to the visualization optical path 160, such as in or near the proximal handle portion 112 of the endoscope 110, such an eyepiece, camera, or imaging display 115 may enable user or machine visualization of a target region 117, for example, at or near the distal end of the endoscope 110. Such a target region 117 can be illuminated by light 170, which can be provided, for example, by an illumination light source 118 at the proximal end of the illumination light path 150, emitted from the distal end of the illumination light path 150, or emitted from an LED or other illumination source that can be located at or near the distal end of the endoscope, such as by an electrical conductor that extends longitudinally to provide power.

[0045] In Figure 1A, the endoscope 110 may include an elongated distal body portion 113 having a certain length. The endoscope 110 may include a working channel or longitudinal passage 145 or other lumen extending along its length. The endoscope 110 may be rigid (for example, rigid when inserted into a tissue-containing area, or rigid when it has sufficient cylindrical strength for insertion into long, tubular anatomical tissue) or flexible (for example, flexible when following the contours of winding anatomical regions such as ureters or bile ducts). The working channel or longitudinal passage 145 or other lumen may define a reference longitudinal axis, such as a central longitudinal axis extending through the working channel or longitudinal passage 145 or other lumen, which is straight when the distal portion 113 of the endoscope 110 is straight and bent when the distal portion 113 of the endoscope 110 is bent (for example, in a flexible implementation of the endoscope). In the distal portion 113 of the endoscope 110, the central longitudinal axis can be defined to extend longitudinally through the working channel or longitudinal passage 145 or other lumen.

[0046] This method may include providing the ability to determine or change the position of the distal portion of the laser fiber 140 in at least lateral directions relative to a reference longitudinal axis, such as the working channel of the endoscope 110 through which the laser fiber 140 extends, or the central longitudinal axis of the longitudinal channel 145 or other lumen, with respect to the longitudinal passage 145. This allows the user to observe the target region via the visualization optical path 160 with the target stone in the field of view and the laser fiber 140 targeted, and to position the distal portion of the endoscope 110 within the longitudinal passage 145. Then, different lateral locations of the stone can be targeted by determining or changing the position of the distal portion of the laser fiber 140 at different lateral locations within the working channel of the endoscope 110 through which the laser fiber 140 extends, or the longitudinal passage 145 or other lumen. For example, this makes it possible to selectively position the distal portion of the laser fiber 140 at a desired position, such as a grid on the XY plane, which can be defined as extending perpendicular to the central longitudinal axis of the longitudinal passage 145 of the distal portion 113 of the endoscope 110.

[0047] For example, an actuator 185 may be included to operate the lateral positioning or repositioning of the distal portion of a laser fiber 140 relative to the longitudinal passage 145 in the distal portion 113 of the endoscope 110, and the actuator 185 may be located, for example, at or near the distal end of the endoscope. This allows for target scanning or other lateral adjustment of the laser fiber 140 without the need to bend or move the endoscope 110 laterally. The controller circuit 120 can communicate with the actuator 185 via a telecommunications bus 127, etc., to remotely control the actuator 185 to establish the lateral position of the laser fiber 140. The telecommunications bus 127 may include electrical connections extending along the laser fiber 140 or electrical connections extending into the distal portion 113 of the endoscope body 110 to connect to the actuator 185 or to electrical contacts to the actuator 185.

[0048] The actuator 185 can be controlled to position or reposition the distal portion of the laser fiber 140 within the longitudinal passage 145 of the distal portion 113 of the endoscope 110, in order to enable the delivery of laser energy through the endoscope 110 from different lateral positions without the need to change the lateral position of the endoscope 110. In this specification, such positioning or repositioning of the distal portion of the laser fiber 140 is described with respect to a longitudinal reference axis, such as the central longitudinal axis or another reference longitudinal axis, in order to clarify the illustrative and explanatory concepts. However, such lateral positioning or repositioning of the distal portion of the laser fiber 140 by the actuator 185 can also be performed with respect to another preferred fixed reference location, including a lateral internal dimension such as the internal diameter (ID) of the longitudinal passage 145 itself.

[0049] The actuator 185 can operate to actuate the positioning or movement of the distal portion of the laser fiber 140 so that the distal portion of the laser fiber 140 is positioned at a selected lateral position among several available lateral positions. The movement of the distal portion of the laser fiber 140 can be actuated and guided without the need to move the endoscope 110 or the laser source 130. The distal portion of the laser fiber 140 (for example, by moving the distal portion of the laser fiber 140 laterally relative to the longitudinal passage 145 within the longitudinal passage 145) facilitates positioning and targeting by the user, enabling precise targeting, target changing, or both, by allowing the user to maintain visualization of the target region 117 at a given position or location of the endoscope 110 via a stationary visualization path 160.

[0050] The actuator 185 can be connected to or otherwise operably coupled to one or both of the laser fiber 140 and the endoscope 110 to actuate the lateral positioning of the distal portion of the laser fiber 140 within the longitudinal passage 145 or relative to the endoscope 110. For example, the actuator 185 may include one or more electromagnetic, electrostatic, piezoelectric, or other actuating elements to actuate or otherwise enable the lateral positioning of the laser fiber 140 with respect to the working channel of the endoscope 110 or another longitudinal passage 145, or another reference location where the endoscope 110 can actuate as a reference frame.

[0051] For example, Figure 1B shows an end view of an example of a portion of the actuator 185, which can be located, for example, within a longitudinal passage 145 and may have, for example, a circular peripheral inner diameter. As shown in Figure 1B, the actuator 185 may include at least one permanent magnet or electromagnet 190, which may be attached, for example, to the distal portion of the laser fiber 140. One or more permanent magnets or electromagnets 190 may be affected by the magnetic field or electromagnetic field generated by the actuator 185. Such a magnetic field or electromagnetic field may be generated to actuate the lateral positioning or repositioning of the distal portion of the laser fiber 140 at one of several laterally displaced locations (conceptually shown in Figure 1B by a point-like XY grid). Such a magnetic or electromagnetic field can be generated via at least one permanent magnet or electromagnet 191, which can be mounted at a desired location relative to the longitudinal passage 145, for example, within the longitudinal passage 145 or within the body of the endoscope 110, such as in the peripheral inner diameter of the longitudinal passage 145 or near the longitudinal passage 145. Using the influence of such a magnetic or electromagnetic field, the distal portion of the laser fiber 140 can be moved laterally to a specified lateral position relative to a fixed reference frame of the endoscope 110, such as the longitudinal passage 145 of the endoscope 110.

[0052] Figure 1C shows an example of a portion of the actuator 185, which can optionally be combined with a mechanical stabilizer or positioning stage 192 to support such electromagnetic operation of lateral movement or positioning, the mechanical stabilizer or positioning stage 192 may include, for example, grooves or recesses, such grooves or recesses may help provide, for example, a set of clearly defined stable lateral locations, and the laser fiber 140 can "rest" in those locations when not being electromagnetically positioned or repositioned by the actuator 185. For example, a series of linear grooves in a semicircular disc-shaped stabilizer stage 192 separated by a clearly defined specified distance can define a set of available lateral positions, the laser fiber 140 (or secondary engagement mechanism) can be mechanically stabilized in those lateral positions, and from those lateral positions, sub-target laser pulses can be emitted toward a target object. Such linear translation can be actuated by controlling the effect of the permanent magnet or electromagnet 190 (attached to the laser fiber 140) by the linear action of the permanent magnet or electromagnet 191A-B, and the permanent magnet or electromagnet 191A-B can be positioned toward the ends of a linear arrangement of available lateral positions, for example, on the stage 192. By acting the mechanical stabilizer stage 192 in the rotational direction by controlling the effect of one or more permanent magnets or electromagnets 193 attached to the stage 192 by one or more permanent magnets or electromagnets 194 which can be mounted dispersed around the periphery of the longitudinal passage 145, it is possible to further provide lateral positioning of the rotating plane without changing the lateral position of the endoscope 110, and enable sub-targeting by the laser fiber 140 in polar coordinates. The XY arrangement of grooves in the stabilizer separated by a clearly defined specified distance can similarly define the plane matrix of available lateral positions for lateral positioning of the plane and sub-targeting in Cartesian coordinates.Examples of secondary engagement mechanisms or mechanical stabilizers or positioning stages 192 may include, among other things, claw or rack-and-pinion arrangements.

[0053] The actuator 185 may, additionally or alternatively, determine or change the lateral position of the distal portion of the laser fiber 140 relative to a fixed reference frame provided by the endoscope 110 by using attractive, repulsive, or both electrostatic forces between the distal portion of the laser fiber 140 and a fixed reference frame provided by the endoscope 110. Optionally, such electrostatic action of lateral movement may be assisted by combining it with a mechanical stabilizer or positioning stage 192, as described herein.

[0054] The actuator 185 may, additionally or alternatively, use a piezoelectric or ferroelectric material to apply force between the distal portion of the laser fiber 140 and a fixed reference frame provided by the endoscope 110 to determine or alter the lateral position of the distal portion of the laser fiber 140 relative to such fixed reference frame. Optionally, such piezoelectric or ferroelectric action of lateral movement may be combined with a mechanical stabilizer or positioning stage 192 to assist it, as described herein. The mechanical stabilizer or positioning stage 192 may optionally be part of a mechanical lithotripsy device that can be included in or introduced into the endoscope 110 to deliver ultrasound or other mechanical impact energy to kidney stones or other target objects. This may provide additional lithotripsy that can give the user greater flexibility in achieving specific tasks or goals related to the reduction or removal or reshaping of target objects.

[0055] In general, any actuator 185 capable of applying force between the distal portion of the laser fiber 140 and a fixed reference frame provided by the endoscope 110 is intended to be used alone or, optionally, in combination with a mechanical stabilizer or positioning stage. By configuring the actuator 185 to be remotely controlled via a control circuit 120, etc., such lateral positioning or repositioning of the distal portion of the laser fiber 140 can enable sub-targeting at multiple locations on the target object located near the distal end of the endoscope 110 or other instrument, without the need to reposition such endoscope 110 or other instrument. This is useful for the user, who can maintain the target object in the field of view while using such sub-targeting to deliver a desired spatial-temporal series of laser pulses or laser pulse sequences at various desired locations on the target object, including adjusting the energy levels of one or more individual laser pulses. This allows the user to deliver desired energy to desired locations in a desired spatial or spatial-temporal sequence, thereby helping to determine how much the target object will ultimately be fragmented. In doing so, one or more desired fragmentation characteristics can be promoted or obtained. This can reduce the workload or complications that result from fragmentation.

[0056] The actuator 185 can be operated as a scanner to orient the leading edge of the laser fiber 140 at an angle or direction according to an input voltage or other control signal. The actuator 185 can be controlled to orient the leading edge 141 of the laser fiber 140 to emit laser beam pulses along a specified spatial or spatial-temporal pattern (without needing to move the endoscope 110), and may include the ability to adjust the laser pulse energy intensity, for example, pulse by pulse, at one or more such sub-target locations within the spatial or spatial-temporal pattern. In one example, the distance between such available sub-target locations may be greater than or equal to the diameter of the laser fiber 140. In another example, the distance between such sub-target locations may be less than the diameter of the laser fiber 140, for example, to allow for the overlap of pulses delivered from adjacent sub-target locations among multiple available sub-target locations.

[0057] The laser source 130 can be configured to provide a variable laser output toward the target object via the laser fiber 140, such a laser output may include, for example, a low-energy continuous-wave laser output for the target, or a pulsed laser output at a higher, tunably variable energy. In one example, the initial position and target of the endoscope 110 using the laser source 130 can be used alone or together with other information. For example, such other information can be provided by the user via a user interface to establish one or more characteristics of a spatial or spatial-temporal pattern of one or more sub-target locations of the target stone or object. For example, by using the target or aiming laser beam provided by the laser source 130, the user can select the center of the target stone or object. Such target position information can be recorded by the control circuit 120 and can be used to initiate a suitable spatial or spatial-temporal pattern of one or more sub-target locations of the target stone or object, which may, for example, be based, at least in part, on the user's initial targeting of the center of the target stone or object. Similarly, the user can use the target laser beam provided by the laser source 130 to select one or more locations on the target center and the periphery of the target stone or object, and the control circuit 120 can record such information and use such information to establish a suitable spatial or spatial-temporal pattern of one or more sub-target locations on the target stone or object, which can be based, for example, at least in part, on the initial targeting by such user on the center and periphery of the target stone or object. Other user input information or pre-operative or inter-operative imaging information can be provided to the control circuit 120 via one or more user interface devices or sensors, for example, information on one or more characteristics of the target stone or object or its environment. Such information can be used by the control circuit 120 to select a suitable spatial or spatial-temporal pattern of sub-targets based on such one-dimensional or multi-dimensional information.Such selection can be algorithmic, for example, involving weighted or mixed information, or using machine learning or artificial intelligence techniques to select appropriate spatial or spatial-temporal patterns of sub-targets based on training data that includes other target stones or objects or target environments that reveal one or more similar characteristics.

[0058] Figure 1D shows an example in which system 100 may include an optical fiber 140, which may include a distal portion that may include an arcuate portion or other off-axial bend 143 or curved portion that can be oriented obliquely from, for example, the center or other longitudinal axis of the endoscope 110. The bend 143 may be used alone or in conjunction with lateral positioning provided by actuator 185 to target one or more locations within or beyond the range defined by the inner diameter (ID) of the working channel or other longitudinal passage 145 or other lumen of the endoscope 110 through which the laser fiber 140 extends. In addition or alternatively, actuator 185 may optionally include rotational actuation capability to rotate the bent distal portion of the laser fiber 140 for a subtarget. Actuator 185 does not need to be located entirely on the distal portion of the endoscope 110. Instead, a portion of actuator 185 may be located on the proximal handle 112 to rotate or vibrate the laser fiber 140 to obtain a desired orientation of the bent or straight distal portion of the laser fiber 140. Additionally or alternatively, the actuator 185 may optionally include a bending action capability to adjust the bending of the distal portion of the laser fiber 140 for the sub-target by means of electromagnetic, electrostatic, piezoelectric, etc., as described herein. Additionally or alternatively, the sub-target location, the sub-target peripheral boundary, or both can be controlled by one or more of such rotational, bending, or lateral actions. Such various actions are useful during laser targeting (e.g., continuous waves) or laser treatment (e.g., pulses), as described herein, and do not require movement of the endoscope 110 or the laser source 130.

[0059] Figures 1E to 1G show an example of a system 100 that allows a laser fiber 140 to be longitudinally and axially translated to various positions relative to the distal end of the endoscope 110. As shown in Figures 1E and 1F, such axial translation of the laser fiber 140 may include longitudinal axial translation (e.g., sliding) relative to the actuator 185. This allows the actuator 185 to remain within the endoscope 110, providing lateral positioning or repositioning of the laser fiber 140 while still allowing freedom to change the position of the laser fiber 140 axially, which may include, for example, protruding outward from the distal end of the working channel or other lumen of the endoscope 110, or retracting so that it becomes coplanar with the working channel or other longitudinal passage 145 or lumen of the endoscope 110, or is slightly retracted within the working channel or other longitudinal passage 145 or lumen of the endoscope 110. Regardless of the axial translation position of the distal surface 141 of the laser fiber 140, the laser fiber 140 can still be positioned laterally adjustable relative to the longitudinal passage 145 of the endoscope 110 or other fixed reference frame. The lateral positioning of the distal portion of the laser fiber 140 can be selected from a number of available lateral positions (e.g., those shown by the dotted grid in Figure 1B). Lateral movement of the laser fiber 140 can be guided without moving the endoscope 110 or the laser source 130. Figure 1E shows an example in which the distal surface 141 of the laser fiber 140 can be longitudinally translated and positioned to extend from the endoscope 110 into the body, for example, to position the laser fiber 140 to a desired treatment site.

[0060] In some examples, two or more actuators can be used to actuate and control different movements of the laser fiber 140. Figure 1G shows an example of a system 100 having two separate actuators in an endoscope. In the example shown in Figure 1G, the first actuator 185A can control the longitudinal axial translation of the laser fiber 140, and a different second actuator 185B can control the lateral positioning of the laser fiber 140.

[0061] Figures 1H and 1I illustrate an example of a system 100 that controls and adjusts the position of a laser fiber 140 relative to the distal end of an endoscope 110 using a feedback signal reflected from a target. The feedback signal can be generated in response to the electromagnetic radiation of a target (e.g., light 170). In Figure 1H, the target is located within the field of view of an endoscope camera or imaging device 125 through an optical path 160. In response to the electromagnetic radiation of the target, the signal reflected from the target can be collected by the endoscope camera or imaging device 125. The imaging data of the target can be transmitted through the optical path 160 to a feedback analyzer 182. The feedback analyzer 182 may include a spectrometer configured to generate one or more spectral characteristics from the imaging data. A controller circuit 120 can use one or more spectral characteristics to adjust the laser settings of the laser source 130. The feedback analyzer 182 can further calculate the distance between the distal end of the laser fiber 140 and the target. The controller circuit 120 can control the actuator 185 to adjust the position of the distal end of the laser fiber 140 based on a calculated distance between the distal end of the laser fiber 140 and the target. For example, if the calculated distance exceeds a desired laser emission range (within a specified margin), the controller circuit 120 can generate a control signal to control the actuator 185 to slide the laser fiber 140 toward the target until the distal end of the fiber reaches the laser emission range relative to the target. In some examples, spectral information of the target from the feedback analyzer 182 can be used by the controller circuit 120 to determine the movement and position of the laser fiber 140 via the actuator 185.

[0062] In addition to transmitting the imaging signal from optical path 160, or alternatively, in some examples, the signal reflected from the target can be collected and transmitted through a separate optical path. In Figure 1I, a laser fiber 140 can be used to deliver a laser beam to the target and transmit the target's spectral data back to the feedback analyzer 182. An optical splitter 183 can direct the reflected feedback signal to the feedback analyzer 182. The feedback analyzer 182 can generate one or more spectral characteristics from the spectral signal, and the controller circuit 120 can use one or more spectral characteristics to adjust the laser settings of the laser source 130. Similar to the above discussion with reference to Figure 1H, the feedback analyzer 182 can further calculate the distance between the distal end of the laser fiber 140 and the target. Based on the calculated distance, the controller circuit 120 can control the actuator 185 to adjust the position of the distal end of the fiber, along with optionally spectral information of the target from the feedback analyzer 182.

[0063] Figure 2 shows an example of a part of system 200 similar to system 100, where the laser source 130 may include a combination of two laser sources, for example, a therapeutic laser source 210 that can provide a therapeutic laser beam (e.g., pulsed higher energy) and a targeting laser source 220 that can provide a targeting beam (e.g., a continuous wave lower energy). The therapeutic beam 210 may include adjustable or variable energy laser pulses. For example, lower energy pulses can be used to first form cracks on the target surface of a stone or other target according to a desired or specified spatial or spatial-temporal pattern, etc. Then, one or more higher energy pulses can be used to fragment the stone or other target, and can be biased to have a tendency to fragment along the previously established cracks, for example. By doing so, the morphology of the resulting fragments can be better controlled.

[0064] For example, a therapeutic beam may include laser energy that can be delivered with variable peak power, instead of, or in addition to, adjustable or variable energy laser pulses. For instance, instead of delivering laser energy with a specific pulse width and constant amplitude, the pulse width can be increased by a certain coefficient and the amplitude by the same coefficient, resulting in the delivery of the same amount of laser energy at different power levels. Variable energy and variable power can be used together or separately in a sequence of laser pulses, for example, to deliver to a target area according to a desired spatial and temporal pattern. For example, low peak power with a long pulse width can help evaporate organic or inorganic substances within the target stone to accelerate its thermal degradation (for example, in the case of a calcium oxalate monohydrate crystal, delivering laser energy at a lower temperature can help the energy penetrate to a greater depth). After delivery of lower peak power laser energy (e.g., with a long pulse width), if desired, laser energy can be delivered with a shorter pulse width and higher peak power to create a thermal gradient within the target stone.

[0065] Figure 3 shows a spatial-temporal graph 300 of the use of a spatial-temporal sequence of laser pulses having different pulse energies or power levels, which may include, for example, lower-energy pulses 310 and higher-energy laser pulses 320. In Figure 3, the sequence represents time in the X direction of the graph, but is annotated by locations "A" and "B" on the stone or other target. In this example, location "A" is at or near the center of the stone or other target, and location "B" is at or near the periphery of the stone or other target. The laser pulses delivered between location "A" and location "B" represent pulses delivered when the laser fiber 140 is translated from location "A" to location "B" or when the laser fiber 140 is translated from location "B" to location "A", which may include the use of actuator 185. The lower-energy pulse 310 may be selected to cause a crack in the target stone without fragmenting it. Therefore, in Figure 3, a lower energy pulse 310 can be delivered, starting from location "A", moving towards the center of the stone, then towards the periphery of the stone to location "B", then returning to location "A" at the center of the stone, at which point a higher energy pulse 320 can be delivered in the first attempt to fragment the target stone. If such fragmentation with the higher energy pulse 320 is unsuccessful, a further lower energy pulse 310 can be delivered, moving from the location towards the center of the stone to location "B" at the periphery of the stone, then returning to location "A" at the center of the stone, at which point another higher energy pulse 320 can be delivered in the second attempt to fragment the target stone. Further iterations are also possible. The same or different location "B" towards the periphery of the stone can be used for various iterations, and different location "B" in different iterations will cause multiple cracks along such a path from location "A" to such different peripheral location "B". It may be preferable to use the higher energy pulse 320 only when moving towards the center of the stone, for example, to minimize the impact of the higher energy pulse 320 on neighboring tissue.The spatial and temporal pattern shown in Figure 3 is an example of such a pattern that can be acquired using an actuator 185, which can be remotely controlled using the control circuit 120, as described above.

[0066] Figures 4A to 4D show examples of spatial or spatial-temporal patterns that can be obtained using the actuator 185, which can be remotely controlled using the control circuit 120 without requiring the user to change the position of the endoscope 110. As described herein, such lateral positioning operations of the laser fiber 140 can be performed in conjunction with rotational positioning operations to provide sub-targets according to polar coordinates, etc.

[0067] In Figure 4A, starting from peripheral location "B" on the periphery of the target stone, a lower energy laser pulse can be delivered, and such pulses can be applied along the spiral path 410 toward central location "A". After treatment with the lower energy pulse, a higher energy pulse can be delivered at central location "A" to fragment the pre-cracked or pre-weakened target stone. As described herein, multiple iterations are possible, and for example, one or more of the energy or power levels can be varied by choice.

[0068] In Figure 4B, a lower energy laser pulse can be emitted starting from peripheral location "B" and continued along the meandering path 420. A higher energy laser pulse "A" can be applied at or near the center location "A" of the target stone, either on the initial path or after the completion of the meandering path. Further iterations are also possible, as described herein, starting, for example, at the same or different peripheral location "B" or near it, and varying, for example, one or more of the energy or power levels.

[0069] In Figure 4C, starting from peripheral location "B", lower energy laser pulses can be emitted and continued along a "star-shaped" path of linear segments, for example, from peripheral location "B" to peripheral locations "C", "D", "E", "F", and back to peripheral location "B". Then, higher energy laser pulses can be emitted toward the central location "A".

[0070] In Figure 4D, starting from peripheral location "B", a lower energy laser pulse can be emitted and travel across the target stone along the zigzag pattern 440. Then, a higher energy laser pulse can be emitted toward the central location "A". Further iterations are also possible, as described herein, starting, for example, at the same or different peripheral location "B" or nearby, and varying, for example, one or more of the energy or power levels.

[0071] The above description highlights use cases involving lithotripsy via endoscopic equipment. However, this technique can also be applied using other minimally invasive devices (e.g., laparoscopes, arthroscopes, etc.), or even with guides during open surgery. Because this laser sub-target does not require movement of a guide device, it can also be used in medical treatment techniques other than lithotripsy, or in other applications involving laser surgery or targeted delivery of laser energy. The target can include not only kidney stones, gallstones, gallbladder stones, or other stones, but also bone or cartilage or other hard or soft tissue.

[0072] In the case of tissue excision where the target is tissue to be excised or coagulated rather than a target stone, it may be necessary to provide fixed or variable energy, fixed or variable power, or fixed or variable wavelength laser energy from one or more laser sources, such as pulses or continuous waves, in a desired spatial-temporal pattern, in order to facilitate one or more of the cutting or coagulation, or to balance or otherwise coordinate these two or other objects.

[0073] The above detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be carried out. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also intend examples in which only the shown or described elements are provided. Furthermore, the inventors also intend examples (or one or more embodiments thereof) that use any combination or arrangement of the shown or described elements for a particular example (or one or more embodiments thereof) or for other examples (or one or more embodiments thereof) shown or described herein.

[0074] In the event of any inconsistency between the use described herein and any reference incorporated by reference, the use described herein shall prevail.

[0075] In this specification, the terms “a” or “an” are used to mean including one or more, without relying on any other instances or uses of “at least one” or “one or more,” as is commonly found in patent literature. In this specification, the term “or” is used to mean non-exclusive “or,” and therefore “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this specification, the terms “including” and “in which” are used as plain English equivalents of the terms “equipped with” and “wherein.” Furthermore, in the following claims, the terms “including” and “equipped with” are open-ended, meaning that a system, device, article, composition, configuration, or process that includes elements other than those enumerated after such terms in a claim is also considered to fall within the scope of that claim. In addition, in the following claims, terms such as “first,” “second,” and “third” are used solely as labels and are not intended to impose numerical requirements on their subjects.

[0076] The above description is intended to be illustrative, not restrictive. For example, the examples (or one or more embodiments thereof) described above can be used in combination with each other. Those skilled in the art may also use other embodiments by considering the above description. The abstract is provided to enable readers to quickly ascertain the essence of the technical disclosure. The abstract is submitted with the understanding that it is not intended to be used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features may be grouped together in order to simplify the disclosure. This should not be interpreted as meaning that any unclaimed disclosed feature is essential to any claim. Conversely, the subject matter of the invention may be smaller in scope than all the features of a particular disclosed embodiment. Accordingly, the following claims are incorporated herein by reference as examples or embodiments in the detailed description, and each claim stands on its own as a separate embodiment, and such embodiments are intended to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims, along with the full scope of equivalents to which such claims are given.

Claims

1. A medical system that provides therapeutic energy, including laser pulses, to a target within a patient via an endoscope without needing to change the position of the endoscope, An optical fiber configured to deliver the therapeutic energy to the target, the optical fiber including a distal portion that is operable to be inserted into the patient through the longitudinal passage of the endoscope, A medical system comprising a stabilizer stage in the longitudinal passage, which includes a plurality of fixed elements corresponding to different positions in the lateral direction perpendicular to the longitudinal axis of the longitudinal passage, and which mechanically stabilizes the distal portion of the optical fiber to facilitate the delivery of the therapeutic energy, including the laser pulse, from the distal portion at the respective positions of the plurality of fixed elements.

2. A medical system according to claim 1, characterized in that the plurality of fixing elements of the stabilizer stage include grooves or recesses, and the grooves or recesses have a size and shape that fixes and mechanically stabilizes the distal portion of the optical fiber at the corresponding position.

3. A medical system according to claim 1 or 2, characterized in that the plurality of fixed elements are linearly arranged along the lateral direction perpendicular to the longitudinal axis of the longitudinal passage.

4. A medical system according to claim 3, characterized in that the plurality of fixed elements are arranged in a two-dimensional array on a plane perpendicular to the longitudinal axis of the longitudinal passage.

5. A medical system according to any one of claims 1 to 4, further comprising an actuator configured to actuate the lateral displacement of the distal portion of the optical fiber relative to one of the plurality of fixed elements.

6. A medical system according to claim 5, wherein the actuator includes one or more permanent magnets or electromagnets configured to actuate the lateral displacement of the distal portion of the optical fiber magnetically or electromagnetically.

7. A medical system according to claim 6, wherein the distal portion of the optical fiber includes one or more permanent magnets or electromagnets attached to the distal portion, and the one or more permanent magnets or electromagnets of the optical fiber are configured to be affected by the magnetic field generated by the one or more permanent magnets or electromagnets of the actuator, thereby causing the lateral displacement of the distal portion of the optical fiber.

8. A medical system according to claim 6 or 7, characterized in that the one or more permanent magnets or electromagnets of the actuator are arranged in the peripheral inner diameter of the longitudinal passage.

9. A medical system according to any one of claims 5 to 8, wherein the actuator includes one or more electrostatic elements configured to electromagnetically actuate the lateral displacement of the distal portion of the optical fiber relative to one of the plurality of fixed elements.

10. A medical system according to any one of claims 5 to 9, wherein the actuator is further configured to operate the rotation of the stabilizer stage about the longitudinal axis of the longitudinal passage, and the rotation of the stabilizer stage allows for the lateral positioning of the rotation plane of the distal portion of the optical fiber without changing the lateral position of the endoscope.

11. A medical system according to claim 10, wherein the actuator includes one or more permanent magnets or electromagnets configured to actuate the rotation of the stabilizer stage magnetically or electromagnetically.

12. A medical system according to claim 11, wherein the stabilizer stage includes one or more permanent magnets or electromagnets attached to the stabilizer stage, and the one or more magnets or electromagnets of the stabilizer stage are configured to cause the rotation of the stabilizer stage under the influence of a magnetic field generated by the one or more permanent magnets or electromagnets of the actuator.

13. A medical system according to claim 11 or 12, characterized in that the one or more permanent magnets or electromagnets of the actuator are distributed around the peripheral portion of the longitudinal passage.

14. A medical system according to any one of claims 5 to 13, Further including a controller circuit, A medical system characterized in that the actuator is configured to actuate the lateral displacement of the distal portion of the optical fiber relative to one of the plurality of fixed elements in accordance with an actuator control signal provided by the controller circuit.

15. A medical system according to claim 14, wherein the controller circuit measures the distance between the distal end of the optical fiber and the target, and generates the actuator control signal based at least in part on the measured distance.

16. A medical system according to claim 14 or 15, wherein the controller circuit is configured to identify target characteristics based on a feedback signal corresponding to the electromagnetic radiation of the target, and to generate the actuator control signal based at least in part on the identified target characteristics.

17. A medical system according to any one of claims 14 to 16, further comprising a laser source configured to provide a first laser pulse and a second laser pulse to the target via an optical fiber in accordance with a medical control signal generated by the controller circuit, A medical system characterized in that the second laser pulse contains higher energy than the first laser pulse, and the second laser pulse is delivered closer to the target in the lateral direction than when the first laser pulse is delivered, without requiring a change in the lateral position of the endoscope.

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