EFFICIENT MULTI-FUNCTIONAL ENDOSCOPIC INSTRUMENT
20230248434 · 2023-08-10
Assignee
Inventors
- Gregory Altshuler (Lincoln, MA, US)
- Ilya Yaroslavsky (N. Andover, MA, US)
- Dmitri Boutoussov (Southborough, MA, US)
- Viktoriya Andreeva (Moscow Region, RU)
- Anastasiya Kovalenko (Moscow Region, RU)
- Olivier Traxer (Paris, FR)
- Michael Barenboym (Boston, MA, US)
- Isaac Ostrovsky (Wellesley, MA, US)
Cpc classification
A61B1/05
HUMAN NECESSITIES
A61B18/26
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
A61B1/07
HUMAN NECESSITIES
A61B1/307
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61B2018/263
HUMAN NECESSITIES
A61B1/00137
HUMAN NECESSITIES
A61B1/0057
HUMAN NECESSITIES
International classification
A61B18/26
HUMAN NECESSITIES
A61B1/00
HUMAN NECESSITIES
A61B1/07
HUMAN NECESSITIES
Abstract
An instrument for endoscopic applications, including urology. The instrument may include both irrigation and aspiration channels, effective attraction and suction of tissue and body stone fragments, enhanced viewing clarity of the operational area, illumination fibers with steering function for flexible version of the scopes. In some embodiments, a distal head is configured to locate a mouth of the working channel within a viewing angle of the visualization system. In some embodiments, a transparent cap is disposed at the distal end of endoscope to provide an enhanced view of the operational area. Irrigation and aspiration channels may be arranged so that consistent water flow will attract tissue and body stone particles and remove heated liquid. Illumination fibers may be utilized as pull linkages or push-pull linkages for deflection and steering of flexible embodiments of the scope.
Claims
1-108. (canceled)
109. An endoscopic surgical instrument for accessing internal organs of a human body, comprising: a catheter shaft that defines and extends along a central axis and having a proximal portion coupled to a handle; a distal tip portion coupled to a distal portion of the catheter shaft; a transparent medium coupled to the distal tip portion and including a distal face; a working channel extending through the catheter shaft and the transparent medium from the proximal portion of the catheter shaft through the distal face of the transparent medium; an illuminator disposed at the distal tip portion; and an imaging receiver disposed at the distal tip portion and proximal to the transparent medium, wherein the distal face of the transparent medium defines a mouth of the working channel and is positioned from the imaging receiver at an axial distance that is in a range of 1 millimeter to 10 millimeters inclusive.
110. The endoscopic surgical instrument of claim 109, wherein the mouth is at least partially within a viewing angle of the imaging receiver.
111. The endoscopic surgical instrument of claim 110, wherein the mouth and a target zone are visible via the imaging receiver.
112. The endoscopic surgical instrument of claim 109, wherein the working channel is an aspiration channel.
113. The endoscopic surgical instrument of claim 112, comprising an internal hollow of the catheter shaft exclusive of the aspiration channel, the internal hollow extending from the proximal portion to the distal portion of the catheter shaft and defining an irrigation channel.
114. The endoscopic surgical instrument of claim 113, wherein the irrigation channel defines at least one outlet at the distal tip portion for directing irrigation flow at an angle relative to the central axis that is within a range of 0 degrees to 170 degrees inclusive.
115. The endoscopic instrument of claim 114, wherein a distance from the distal face to an edge of a first outlet of the at least one outlet of the irrigation channel is within a range of 2 mm to 5 mm inclusive and has a size that is within a range of 0.5 mm×1.0 mm to 3.0 mm×3.0 mm.
116. The endoscopic instrument of claim 114, wherein an edge of the at least one outlet is positioned adjacent a proximal face of the transparent medium.
117. The endoscopic surgical instrument of claim 113, wherein a pressure sensor is operatively coupled to at least one of the aspiration channel and the irrigation channel.
118. The endoscopic surgical instrument of claim 109, further comprising a laser fiber, a portion of which extends through the catheter shaft.
119. The endoscopic surgical instrument of claim 118, wherein the laser fiber is supported by a laser fiber optic port.
120. The endoscopic surgical instrument of claim 118, wherein the laser fiber is inserted into the working channel, or the laser fiber is permanently integrated within the catheter shaft.
121. The endoscopic surgical instrument of claim 118, wherein a working port of the working channel has an inner dimension within a range of 0.5 millimeters to 1.5 millimeters inclusive.
122. The endoscopic surgical instrument of claim 118, wherein a distal end of the laser fiber is selectively positionable at axial positions ranging from +5 millimeter to −5 millimeter inclusive relative to the distal face.
123. The endoscopic surgical instrument of claim 122, wherein a distal end of the laser fiber is selectively positionable at axial positions ranging from 0 millimeter to −3.0 millimeter inclusive relative to the distal face.
124. The endoscopic surgical instrument of claim 123, wherein a distal end of the laser fiber is selectively positionable at axial positions ranging from −0.05 millimeter to −1.00 millimeter inclusive relative to the distal face.
125. The endoscopic surgical instrument of claim 109, wherein a cross-sectional area of the mouth of the working channel is in a range of 5% to 50% smaller than a cross-sectional area of the working channel proximal to the mouth.
126. The endoscopic surgical instrument of claim 109, wherein the transparent medium defines a pressure relief that extends from the mouth.
127. The endoscopic surgical instrument of claim 109, wherein the transparent medium is configured to provide a clear visual path between the imaging receiver and the distal face of the transparent medium.
128. The endoscopic surgical instrument of claim 109, wherein a proximal face of the transparent medium is planar and seats with a distal face of the distal tip portion.
129. The endoscopic surgical instrument of claim 109, wherein the distal face of the transparent medium is a contoured surface.
130. The endoscopic surgical instrument of claim 129, wherein a recess for holding the imaging receiver is located on a base platform of the distal tip portion and is arranged to face in distally.
131. A method, comprising: providing an endoscopic surgical instrument as described in claim 109.
132. The method of claim 131, further comprising positioning a distal end of a laser fiber inside the transparent medium.
133. The method of claim 131, further comprising: positioning a distal end of a laser fiber inside the distal head portion; positioning the distal head portion proximate a body stone material contained within an internal organ; providing irrigation and aspiration flows through irrigation ports and a working channel, respectively; recessing the distal end of the laser fiber relative to a mouth forming a distal face of a transparent medium; drawing the body stone material toward the distal end of the laser fiber; ablating the body stone material using laser energy delivered through the laser fiber; removing products of ablation through the working channel; and removing heated irrigation fluid from the treatment area through the working channel.
134. The method of claim 133, wherein an average laser power delivered with the laser fiber is in a range of 120 Watts to 200 Watts inclusive for kidney applications.
135. The method of claim 133, further comprising balancing the irrigation and aspiration flows such that a net positive irrigation flow is maintained, wherein the irrigation flow exceeds the aspiration flow by up to 50 milliliters per minute, or a negative pressure within the internal organ generated by the aspiration flow does not deviate from a surrounding environmental pressure by more than 20%.
136. The method of claim 135, wherein a pressure sensor is operatively coupled to the working channel, and the method further includes: detecting a pressure drop in the working channel using the pressure sensor, and triggering the laser fiber to ablate a body stone material that is causing a blockage at the mouth.
137. The method claim 135, wherein removing the products of ablation through the working channel at least partially overcomes a retropulsion effect when a laser system comprising the laser fiber, irrigation ports and working channel is operated in a contact mode, and accelerates treatment of small products of ablation when the laser system is operated in non-contact mode.
138. The method claim 133, wherein the laser energy delivered through the laser fiber is configured to operate in a dusting mode such that ablated particles that are smaller than an inner dimension of the working channel are removed through the working channel by the aspiration flow.
139. The method claim of claim 138, wherein the laser energy has a laser pulse energy in a range 0.02 Joules to 1 Joule inclusive.
140. A method for removing body stone material from an internal organ, comprising: providing an endoscopic surgical instrument, the endoscopic surgical instrument comprising: a catheter shaft including a distal head portion disposed at a distal portion of the catheter shaft, the distal head portion including a distal face and defining a mouth at the distal face, and the catheter shaft configured such that a portion of a laser fiber can extend through the catheter shaft, a working channel extending within the catheter shaft from a proximal portion of the catheter shaft through the distal head portion of the catheter shaft, the working channel comprising an internal hollow of the catheter shaft, the internal hollow extending from the proximal portion to the distal portion of the catheter shaft and defining an irrigation channel; positioning a distal end of a laser fiber inside the distal head portion; positioning the distal head portion proximate a body stone material contained within an internal organ; ablating the body stone material using the laser fiber; and removing products of ablation through the working channel.
141. The method of claim 140, further comprising delivering an irrigation fluid through a distal tip of the distal head portion such that a flow of the irrigation fluid is directed at an angle that is within a range of 0 degrees to 170 degrees inclusive relative to a central axis of the distal tip.
142. The method of claim 141, wherein the flow of irrigation fluid is directed in a radial direction r to create a flow field such that the irrigation fluid flows in a vector radially outward and an aspiration flow draws flow into the mouth.
143. The method of claim 133, further comprising operating the working channel as an aspiration channel such that an aspiration flow is activated, pulsing the irrigation flow and the aspiration flow, and synchronizing the pulsed irrigation and aspiration flows with the laser radiation from the laser fiber.
144. The method of claim 140, wherein the distal end of the laser fiber is positioned inside the distal head portion such that ablative laser energy is emitted from within the distal head portion.
145. The method of claim 140, further comprising positioning the distal end of the laser fiber at an axial position ranging from +5 millimeter to −5 millimeter inclusive relative to the distal face.
146. The method of claim 145, further comprising positioning the distal end of the laser fiber at axial positions ranging from 0 millimeter to −3.0 millimeter inclusive relative to the distal face.
147. The method of claim 146, further comprising positioning the distal end of the laser fiber at axial positions ranging from −0.05 millimeter to −1.00 millimeter inclusive relative to the distal face.
148. The method of claim 140, further comprising positioning the distal head portion such that the distal head portion is in contact or quasi contact with the body stone material or fragment of the body stone material.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0074] Referring to
[0075] Functionally, the steering mechanism 39 enables articulation of the distal portion 35 of the catheter 32, particularly for embodiments incorporating a catheter shaft 33 that is flexible or semi-flexible, for routing through body vessels of the patient to a target zone 56 and for alignment of the distal head portion 34 to hone in on individual body stones 58 within the target zone 56. The illumination system 52 generates visible light that is delivered to the target zone 56 for illumination of the body stones 58 and surrounding tissue, for example stones within a kidney, ureter or bladder. The ablation laser system 46 includes, for example, a Thulium or Holmium fiber or solid state laser, for delivering laser energy to the target zone 56 for ablation and break up of body stones 58. Delivery of the laser energy may be accomplished using a laser fiber, for example, silica or other optical fiber material. The irrigation system 42 provides pressurized irrigation fluid for cooling of the target zone 56 and for moving fragments of body stones 58 within the target zone 56. The aspiration system 44 draws liquid medium away from the target zone 56, including particles from the body stones 58 that may be suspended in the medium. In some embodiments, the aspiration system 44 includes a pressure sensor 48 that monitors the aspiration pressure. Pressure sensors may also be utilized to monitor the irrigation pressure.
[0076] Herein, “body stones” encompass any stone that is produced by the human body, including kidney stones and ureteral stones, as well as species thereof including calcium stones, uric acid stones, struvite stones, and cysteine stones. “Body stones” may also include stones found in or formed by other organs of the body, for example, bladder stones, gallbladder stones, prostate stones, pancreas stones, saliva gland stones, and belly stones. The present disclosure describes, but in general is not limited to, systems and techniques for breakup of kidney and ureteral stones. In view of this disclosure, those of skill in body stone therapies will recognize the application of various aspects disclosed herein for the remediation of body stones other than kidney and ureteral stones as well as for treatment of hard and soft tissues.
[0077] Referring to
[0078] In some embodiments, the distal head portion 34a contains one or more illuminators 130. The illuminators 130 may be the distal end of an illumination or lighting fiber optic 132 for transmitting light in the visible spectrum and is operatively coupled to the illumination system 52 at the handle 38. The illumination fiber optic 132 pass through an illumination fiber optic port 134 formed in the distal tip portion 96 and may extend into the transparent cap 100. Optionally, the illuminator 130 may be light emitting diodes (LEDs) (not depicted) that are proximate the proximal face 104 of the transparent cap 100 and are sourced by an electrical lead that extends through the catheter 32. The illumination fiber optics 132 act as optical waveguides and may extend through the catheter 32 and be coupled to the illumination system 52 at the handle 38.
[0079] In some embodiments, one or more illumination fiber optics 132 are mechanically affixed to the distal head portion 34a (e.g., with an adhesive), for example, to the illumination fiber optic port 134 or the transparent cap 100 or both. The fiber optic(s) 132 may extend through and remain free to slide within lumens 107 (
[0080] The distal head portion 34a defines a working channel 102 that passes through the distal tip portion 96 and through the proximal face 104 and the distal face 106 of the transparent cap portion 100. The working channel 102 defines a mouth 108 at the distal face 106. The working channel 102 may serve, for example, as an aspiration port, in which case the mouth 108 and working channel define an aspiration inlet. The working channel 102 extends through the catheter 32 and may be coupled, for example, to the aspiration system 44 at the handle 38. The distal head portion 34a may define, for example, a round or oblong cross-section that defines and is concentric about a central axis 110. The working channel 102 includes a working port 103 that is formed in and passes through the distal head portion 34a and defines the mouth 108. In some embodiments, the working port 103 includes a cap working port 103a and a distal tip working port 103b that are in fluid communication with each other. The cap working port 103a passes through the transparent cap 100, defining a cap working port axis 111. In some embodiments, the distal tip working port 103b passes through the distal tip portion 96 to transition between the catheter shaft 33 and the transparent cap 100. Alternatively, embodiments where the transparent cap 100 is coupled directly to the catheter shaft 33 are also contemplated (e.g., without a transitioning of the distal tip portion), such that the working port 103 comprises only the cap working port 103a. Embodiments where the distal head 34 includes a distal tip portion 96 without a transparent cap are also disclosed herein. (See
[0081] A laser fiber optic 112 for transmitting ablative laser energy is disposed in the working channel 102, a distal end 114 of the laser fiber optic 112 being positioned proximate the distal face 106 of the transparent cap portion 100, and a proximal end of the laser fiber optic 112 being coupled to the ablation laser system 46 via the handle 38. A core diameter of the laser fiber optic 112 may be in a range of 0.05 to 0.4 millimeters for a catheter having a flexible shaft and up to 1.5 millimeters a catheter having a rigid shaft. In some embodiments, the laser fiber optic 112 is substantially concentric with the cap working port axis 111 or otherwise extends through a center portion of cap working port 103a to define an annular region 116 between the laser fiber optic 112 and the cap working port 103a. In some embodiments, the position of the distal end 114 of the laser fiber optic 112 can be controlled within a range of +/−5 millimeter inclusive relative to the distal face 106 of the transparent cap portion 100, where “+” and “−” refer respectively to the distal and proximal directions 50 and 51 along the working port axis 111. In some embodiments, the position of the distal end 114 can be controlled within a range of +/−3 millimeter inclusive relative to the distal face 106. In some embodiments, the position of the distal end 114 be controlled within a range of +1 to −3 millimeter inclusive relative to the distal face 106. In some embodiments, the position of the distal end 114 can be controlled within a range of −0 to −3 millimeter inclusive relative to the distal face 106. In some embodiments, the position of the distal end 114 can be controlled within a range of −0.05 to −1 millimeter inclusive relative to the distal face 106. Herein, a range that is said to be “inclusive” includes the endpoint values of the range as well as all values between the endpoint values.
[0082] In some embodiments, one or more working ports 122 are defined that extend through the transparent distal head portion 34. The working port 103 and the working port 122 may be plumbed to a common working channel 109, as depicted in
[0083] Akin to the working port 103, each of the working ports 122 may comprise a cap working port 122a and a distal tip working port 122b that are in fluid communication with each other. The cap working port(s) 122a passes through the transparent cap 100. In some embodiments, the distal tip working port(s) 122b passes through the distal tip portion 96 to transition between the catheter shaft 33 and the transparent cap 100. Alternatively, embodiments where the transparent cap 100 is coupled directly to the catheter shaft 33 are also contemplated (e.g., without a transitioning of the distal tip portion), such that the working port(s) 122 comprises only the cap working port(s) 122a.
[0084] In some embodiments, the distal head portion 34a includes an imaging receiver 142, which may include image-forming optics defining a field of view 148 of the endoscopic system 30, characterized by a viewing angle β. In some embodiments, the imaging receiver 142 defines a viewing angle β that is within a range of 90 to 120 degrees inclusive (±45 to 60 degrees inclusive from the viewing axis of the imaging receiver). The imaging receiver 142 may be an imaging device 144 (depicted), such as a complementary metal oxide semiconductor (CMOS) sensor (including a semiconductor chip, imaging optics, and supporting electronics) or a charge-coupled device (CCD) camera sensor. In some embodiments, the imaging face the imaging receiver 142 is from 0.5×0.5 millimeter to 1.5.×1.5 millimeter. An example of the described CMOS image sensor is the NANEYE 2D supplied by AWAIBA CMOS Image Sensors of Argau, Switzerland. See https://ams.com/naneye, last visited Jan. 16, 2020.
[0085] The imaging device 144 may include a cable 146 that extends through the catheter 32 and may be coupled to the visualization system 54 at the handle 38. The cable 146 may be routed through a cable port 145 defined by the distal tip 96. In some embodiments, the imaging device 144 is disposed in a recess 147 at the distal face 98 of the distal tip portion 96. Imaging devices 144 may define a viewing angle β that is ±45 degrees of normal. Optionally, the imaging receiver 142 is a distal end of an optical system and imaging fiber optic (not depicted) which extends through the catheter 32 and is coupled to the visualization system 54 at the handle 38. The distal face 106 of the transparent cap 100 may be flat (depicted) or, alternatively, shaped as a lens (not depicted) for imaging onto the imaging receiver 142.
[0086] Referring to
[0087] Referring to
[0088] By this arrangement, the working channel 102 is disposed within and is effectively surrounded by the single working channel 124. The irrigation system 42 may be coupled to the catheter shaft 33 so that irrigation fluid can flow through the balance of the hollow 129 that is not occupied by the components. The tubular shaft 120 may be implemented with any of the distal head portions 34 depicted at
[0089] For the various disclosed endoscopic systems 30 that implement aspiration and irrigation simultaneously, the total treatment time can be reduced while the safety of the procedure is enhanced. A method according to an embodiment of the disclosure may include some or all of the following: [0090] (1) Identifying a stone in the internal organ of the patient using ultrasound, fluoroscopy or other diagnostic methods available to the artisan; [0091] (2) Inserting the catheter 32 into the body of the patient and bringing the distal end of the catheter into the proximity of the target zone 56; [0092] (3) Obtaining an image of a targeted body stone 58 or stone fragment; [0093] (4) Bringing the distal end 114 of the laser fiber optic 112 into contact or quasi contact with the targeted body stone or fragment; [0094] (5) Activating an irrigation flow and an aspiration flow; and [0095] (6) Delivering laser energy from the ablation laser system 46 through the laser fiber 112 to ablate stone 58 into the large fragments (greater than 1 millimeter), small fragments (less than 1 millimeter) or particles (less than 0.25 millimeter).
The method above may be used for contact as well as non-contact treatment of body stones 58.
[0096] Referring to
[0097] Functionally, positioning the distal end 114 of the laser fiber 112 inside the distal head 34 protects the distal end 114 of the fiber from damage by stone ablation products, and can also increase the laser ablation efficiency while decreasing the total laser treatment time. Such placement minimizes or excludes fiber burn back and eliminates the need to reposition the fiber distal end 114 during the laser procedure. The transparent cap 100 provides a clear visual path between the imaging receiver 142 and the distal face 106 of the transparent cap 100, thus eliminating or substantially reducing the debris (e.g., ablation particles) within the near field of view 148 that would otherwise be present between the imaging receiver 142 and the laser fiber optic 112. The reduction of debris in the near field of view 148 enables the operator to better visualize the mouth 108, the distal end 114 of the laser fiber optic 112, and a given targeted body stone 58, and also reduces the attenuation of the light emitted by the illuminator(s) 130 for better illumination of the target zone 56. Also, the distal face 106 of the transparent cap 100, which can be more readily visualized than the smaller distal end 114 of the laser fiber optic 112, can assist the operator with positioning of the distal head portion 34a for better control of the distance between the distal end 114 of the laser fiber optic 112 and the targeted body stone 58. The improved control leads to increased ablation efficiency, as there is little or no gap between the distal end 114 and the targeted body stone 58 or fragment (said gap typically not exceeding 1 millimeter). The reduction of debris in the near field of view 148 also reduces the attenuation of the light from the illuminator(s) 130 for better illumination of the target zone 56 and a clearer view of the image of the target zone 56. Disposing the imaging device 144 in the recess 147 enables the proximal face 104 of the transparent cap to be planar to seat with the distal face 98 of the distal tip portion 96. The inclined surface 101 reduces the trauma of passing the distal head portion 34a through bodily vessels en route to the target zone 56.
[0098] Coupling to the steering mechanism 39 of the handle 38 via the illumination fiber optics 132 enables the illumination fiber optics 132 to also serve as the pull linkage and, in some embodiments, as a push-pull linkage for steering catheters 32 having shafts 33 that are flexible or semi-rigid. The need for separate pull wires and the connectors associated with coupling them to the distal head portion 34d is thereby negated, enabling more cross-section to be devoted to working channels, or reducing the cross-sectional profile of the catheter 32, or a combination thereof. Arranging the illumination fiber 132 so as to encroach on the boundary of the working ports 122 provides more cross-sectional area for irrigation flow.
[0099] By disposing the laser fiber optic 112 in the working channel 102, the distal end 114 can be recessed relative to the distal face 106 of the transparent cap 100 because the suction of the solution into the working channel 102 tends to draw the body stone 58 toward the laser fiber optic 112. Recessing the distal end 114 mechanically protects the laser fiber optic 112 during insertion and operation. In some embodiments, the distal end 114 of the laser fiber 112 can oscillate laterally during the laser treatment due to forces of irrigation or aspiration flow as well as laser-induced bubbling and streaming in the liquid. Such oscillations may be desirable and can be controlled through controlling parameters of the laser as well as the irrigation and/or aspiration flow (e.g., by modulating the flow rate).
[0100] Also, drawing the body stones 58 toward the laser fiber optic 112 can reduce or overcome “retropulsion” effects that develop when the heat of ablation forms vapor pockets on the ablated face of the body stone 58. Retropulsion effects are described in greater detail at International Application No. PCT/US19/42491 to Altshuler, et al., filed Jul. 18, 2019 and owned by the owner of the present application, the disclosure of which is hereby incorporated by reference herein in its entirety except for express definitions and patent claims contained therein. Furthermore, because distal end 114 can be viewed through the transparent cap 100, visualization and control of the distance between the distal end 114 of the laser fiber optic 112 and the targeted body stone 58 is not compromised. In addition, collateral heat created by the process of laser ablation may be efficiently dissipated by the irrigation fluid and removed by the aspiration of the heated irrigation fluid through the working channel 102, thereby reducing the risk of accidental thermal damage to surrounding tissues.
[0101] Referring to
[0102] In some embodiments, the major dimension 166 of the oblong cross section 164 extends tangentially (i.e., substantially parallel to a tangential direction θ relative to the central axis 110 of the distal head portion 34d) and the minor dimension 168 extends radially (i.e., parallel to a radial direction r relative to the central axis 110 of the distal head portion 34d). In the depicted embodiment, working ports 122a may be disposed at an outer tangential perimeter 170 of the transparent cap 100, the working ports 122a passing through the proximal face 104 and the distal face 106 of the transparent cap 100 and being open at the distal face 106 and along the outer tangential perimeter 170 of the transparent cap 100 (e.g., along the inclined surface 101).
[0103] Referring to
[0104] Functionally, when the working channel 102 is utilized for aspiration, the proximity of the working ports 122 surrounding the mouth 108 creates a flow field 256 that flows outward from the working ports 122 and folds inward toward the mouth 108. The flow field concept is discussed further attendant to
[0105] Referring to
[0106] The oblong cross-section 167b is achieved by locating the working ports 122 and illumination fiber optics 132 closer to the central axis 110, so that the oblong cross-section 167b has a reduced profile (i.e., has less cross-sectional area) relative to the circular cross-section 167a. The oblong cross-section 167b defines a major axis 171 that passes through a maximum outer dimension OD1 of the oblong cross-section 167b and a minor axis 169 that is perpendicular to the major axis 171. The minor axis 169 may define a minimum outer dimension OD2 of the oblong cross-section 167b. In some embodiments, the outer dimensions OD, OD1 of the cross-sections 167a, 167b are in a range of 2 to 3.2 millimeter inclusive; in some embodiments, the outer dimensions OD, OD1 are in a range of 1.7 millimeters to 2.6 inclusive; in some embodiments, the outer dimensions OD, OD1 are in a range of 2.2 to 2.5 millimeters inclusive. In some embodiments, the outer dimension OD2 of the cross-section 167b is in a range of 1.7 to 2.5 millimeters inclusive; in some embodiments, the outer dimension OD2 is in a range of 1.7 to 2.0 millimeters.
[0107] Referring to
[0108] For the distal head portion 34i, the distal tip working port(s) 122b defined by the distal tip portion % extends through a respective beveled face 214 formed at the distal tip portion 96 of the catheter 32. Alternatively, the distal tip portion 96 may be chamfered (not depicted) around a tangential perimeter 216 of the outer tangential surface 97 to define the beveled face(s) 214. In some embodiments, the proximal face 104 of the transparent cap 100 extends radially over the beveled face 214 to define an outlet 218 of the distal tip working port(s) 122b. Accordingly, for the distal head portion 34i as depicted, there is no cap irrigation port that passes through the transparent cap 100. Instead, irrigation ports 122b terminate the working channel 124 proximal to the transparent cap 100 and are configured to direct flow onto the proximal face 104 of the transparent cap 100.
[0109] In some embodiments, each of the illumination fiber optics 132 is disposed within a corresponding one of the distal tip working ports 122b, with the illumination fiber optic(s) extending into the transparent cap 100 of the distal head portion 34i. Each illumination fiber optic 132 may be configured to diffuse, refract, scatter, or otherwise redirect visible light 222 radially into the transparent cap 100. The transparent cap may also be configured to diffuse or scatter the visible light 222. The transparent cap 100 may contact a distal end portion 224 of the at least one illumination fiber optic 132, for example to effect the anchoring of the illumination fiber optic(s) 132 to the distal head portion 34. In some embodiments, an interface 226 between the distal end portion 224 of the illumination fiber optic 132 and the transparent cap 100 is configured to direct the visible light 222 radially away from the illumination fiber optic. For example, to augment redirecting the visible light 222, the distal end portion 224 of the illumination fiber optic(s) 132 may be uncladded. The redirection of the visible light 222 may occur along the entire length of the interface 226. In another example, the interface 226 includes a transparent or semi-transparent adhesive that scatters or refracts the visible light 222 away from the illumination fiber optic 132. In another example, the illumination fiber optic(s) 132 defines a relatively large numerical aperture (e.g., in a range of 0.35 to 0.65 inclusive). The example aspects above promote the redirection of the visible light 222 through the transparent cap 100.
[0110] Referring to
[0111] Referring to
[0112] Functionally, the redirection of the visible light 222 away from the illumination fiber optic(s) 132 and into the transparent cap 100 can provide a more uniform irradiation of the target zone 56. The pressure relief(s) 192 of distal head portions 34i through 34k help stabilize the captured and targeted body stone 58 at the mouth 108 of the cap working port 103a in the aspiration mode. In the absence of the pressure relief(s) 192, the targeted body stone 58 can effectively plug the working port 103, creating a larger pressure differential across the body stone 58. The high pressure differential creates large forces that act on the targeted body stone 58. These large forces can cause, for example, the capture of the targeted body stone 58 to be unstable, such that the body stone 58 becomes dislodged from the working port 103. In another example, the large forces can cause the excessively large fragments of the targeted body stone 58 to become lodged in the working port 103 or to jam between the laser fiber optic 112 and the working port 103, thereby fouling the distal head portion 34 and damaging the laser fiber optic 112. The pressure relief(s) 192 enables aspiration flow around the captured body stone 58, thereby moderating the pressure differential across the body stone 58 and the attendant forces exerted on the body stone 58. The moderated pressures and forces mitigate capture instabilities and reduce the occurrence of excessively large fragments becoming lodged in the working port 103.
[0113] Arranging the transparent cap 100 to extend radially over the beveled portions 214 (
[0114] In operation, the radially outward facing outlets 218 create the flow field 256 that flows outward from the distal head portion 34k and folds inward toward the mouth 108. Flow for distal head portions 34i and 34j may behave in a similar manner. When the working channel 102 is used for aspiration, fragments of body stones 58 that are small enough (e.g., less than 0.5 millimeters) become entrained in the flow field 256 and evacuated through the mouth 108 and working channel 102. Other body stones 58 or fragments thereof that are too large to pass (e.g., 1 to 3 millimeters) are drawn into targeting proximity of the distal end 114 of the laser fiber optic 112 by the flow field 256. As these larger stones are brought into range of the laser fiber optic 112, the ablation laser system 46 may be energized to ablate the body stones 58. The ablation breaks the body stones 58 into smaller fragments that are then drawn into the working channel 102 through the mouth 108.
[0115] When a large body stone 58 enters or approaches the mouth 108 during aspiration, the working channel 102 may experience a drop in pressure as the stone obstructs the mouth 108. As such, in some embodiments, the ablation laser system 46 (
[0116] Functionally, establishing the flow field 256 to draw the body stone 58 toward the laser fiber optic 112 speeds up the process of laser lithotripsy. For example, when operating in the non-contact mode with peak outflow angles α that are within the 10 to 60 degree range, the irrigation flow 252 sweeps the small stones and stone fragments toward the mouth 108 of the aspiration channel 103 for more efficient operation. The irrigation flows 252 and the aspiration flow 254 may be continuous or pulsed, either individually or for both. In some embodiments, pulsed flows are synchronized with the laser pulses to enhance the ablation and removal of ablation particles. The need for hunting and chasing body stone 58 is reduced because the flow field draws the body stone 58 into an effective range (typically 0 to 3 millimeter) of the laser fiber optic 112. Also, having been drawn into the effective range of the fiber optic 112, the body stone 58 is more efficiently fragmented by the ablation process. Navigation within the target zone 56 is improved because the redirection of some of the visible light 222 provides a more uniform lighting of the target zone 56. The amount of attenuation by the smaller fragments and particles from the body stones 58 in the field of view 148 is reduced by the aspiration and by the presence of the transparent cap 100 in the near field of view 148.
[0117] Referring to
[0118] The single illumination fiber optic 132 may be configured to exert both a pulling force and a pushing force on the distal head portion 34l. In some embodiments, the cross-section of the single illumination fiber optic 132 measures 0.2 millimeter×0.5 millimeter.
[0119] Functionally, the single illumination fiber optic 132 may occupy less cross-section of the distal head portion 34l than do a pair of illumination fiber optics 112 of, for example, the distal head portion 34d of
[0120] The domed profile 262 of the transparent cap 100 may be generally hemispherical and define the cap working port 103a therethrough. In some embodiments, the distal head portion 34l is oblong, defining the major and minor axes 171 and 169 and attendant outer dimensions OD1 and OD2, akin to distal head portion 34h (
[0121] Functionally, the domed profile 262 of the transparent cap can provide smooth and easy passage of the distal head portion 34l through body vessels such as the ureter and calyces, particularly when steering the distal head portion 34l through a turn. Arranging the maximum axial dimension Z of the transparent cap 100 to be in line with the imaging receiver 142 increases the length (and therefore the clarity) of the path normal to the imaging receiver relative to the flat distal face 106 of other transparent caps 100 (e.g.,
[0122] The asymmetric flow cross-section 264 of the distal tip working ports 122b may be configured to occupy a greater fraction of the cross-sectional area of the distal head portion 34l than for axisymmetric working ports such as the circular working ports 122 of the distal head portion 34b or the oblong working ports 122 of distal head portions 34c, 34g, 34h. Effectively, structure is provided in the distal tip portion 96 for bounding the working port 103 and for mounting the laser fiber optic 112, the illumination fiber optic 132, and the imaging receiver 142. The balance of the oblong cross-section 167b of the distal head portion 34l is structured to provide the asymmetric flow cross-sections 264.
[0123] The laser fiber optic port 266 protrudes radially into the working port 103 and may be dimensioned to provide a close sliding fit with the laser fiber optic 112. The working port 103 defines a maximum inner radius R. The protrusion of the fiber optic port 266 encroaches on the maximum inner radius R to define a minimum inner dimension 268 of the working port 103. The laser fiber 112 may be mounted within the port 266 during manufacturing and sterilized together with the catheter 32. Various methods of mounting the laser fiber can be used, including (but not limited to) friction-controlled mechanical attachment, over-molding, adhesive bonding, or other suitable techniques. Such pre-integration of the laser fiber into the scope reduces the preparation time for surgery, as the surgeon does not need to insert the fiber into a scope.
[0124] The distal end 114 of the fiber 112 may be recessed within the working port 103 proximal to the surface distal 106 to mitigate fiber burn back effects.
[0125] Functionally, the asymmetric flow cross-sections 264 act to increase the flow cross-sections of the distal tip working ports 122b relative to a circular, oblong, or other axisymmetric cross-section, providing, for example, greater cross-section for irrigation flow or passage of catheter tools. Likewise, the offset of the laser fiber optic port 266 and laser fiber optic 112 provides a greater unimpeded flow cross-section for the working port 103. That is, for a working port 103 having a given cross-sectional flow area, a minimum inner dimension 265 (
[0126] The distal head portion 34l depicts the transparent cap 100 as extending radially over the beveled portions 214 of the distal tip portion 96, akin to
[0127] Referring to
[0128] The reducing flange 290 may also be implemented with distal head portions 34 where the mouth 108 is defined by the transparent cap 100. A transparent cap 100 with the reducing flange 290 is depicted at
[0129] A maximum axial offset A of the imaging receiver is defined as a distance from a distal extremity 291 of the extension portion 286 to the imaging receiver 142, the distance being parallel to the working port axis 111. For embodiments where the distal face 98 defines a plane 292 that is normal to the working port axis 111 (depicted in
[0130] The distal end 114 of the laser fiber optic 112 is positioned proximate the mouth 108. An axial location δ of the distal end 114 of the laser fiber 112 is defined relative to a distal-most location 292 of the mouth 108. For embodiments where the mouth 108 defines the plane 292 normal to the working port axis 111 (depicted in
[0131] In some embodiments, the positioning of the distal end 114 of the laser fiber optic 112 is selective over a range of axial locations δ. In some embodiments, the distal end 114 of the laser fiber 112 can be selectively positioned (i.e., is “selectively positionable”) at axial distances ranging from 1 millimeter distal to the distal-most location 292 to 3 millimeters proximal to the distal-most location 292 (inclusive). In some embodiments, the axial locations S range from flush with the distal-most location 292 to 1 millimeter proximal to the distal-most location 292 (inclusive). In some embodiments, the axial locations δ range from 0.05 millimeter to 0.6 millimeter inclusive proximal to the distal-most location 292.
[0132] The recess 147 for holding the imaging receiver 142 is formed on the base platform 288 and is arranged to face in distally. In some embodiments, the distal face 98 and the base platform 288 define substantially parallel planes (depicted). In some embodiments, a shoulder 294 transitions between the outer tangential surface 97 of the distal tip portion 96 and the base platform 288 at the tangential perimeter 216. Likewise, a shoulder 296 transitions between a tangential surface 298 of the extension portion 286 and the distal face 98. The shoulders 294, 296 may be, for example, arcuate (depicted), radiused, or beveled.
[0133] The pressure relief(s) 192 extend axially from the distal face 98 and radially through the extension portion 286 and outer tangential surface 97. The pressure relief(s) 192 may be a notch or notches. The cross-sectional size of the notches can be from 0.1 to 1 millimeters inclusive in axial depth and 0.2 to 0.5 millimeters inclusive in tangential width. The function of the pressure relief(s) 192 is described above attendant to
[0134] Referring to
[0135] In some embodiments, the laser parameters for treatment with the various disclosed embodiments herein are be selected in accordance with the following guidelines: [0136] (1) A wavelength in the range of 1.9-2.1 micrometers to match peak of water absorption which is a major initial chromophore for body stone ablation. [0137] (2) Limiting pulse energy to prevent stone retropusion effects so as not to overcome the effects of aspiration and propel the treatment stone away from the opening of the aspiration working port 103. The laser pulse energy for stone dusting may be minimal as low as 0.001 Joules to 0.2 Joules for this purpose. For stone fragmentation, the laser pulse energy may be in the range 0.2 Joules to 2 Joules inclusive. [0138] (3) For simultaneous aspiration and irrigation applications, the heat energy absorbed by the liquid medium within a body organ may be partially or completely evacuated due to the aspiration. For aspiration flows 254 in a range of 50 to 100 milliliters per minute inclusive and irrigation flows 252 in a range of 10 to 150 milliliters per minute inclusive, the average laser power delivered to the target zone 56 by the ablation laser system 46 may be increased over conventional laser lithotripsy techniques without adverse effects. The maximum average power for ureteral applications can be as high as 30 to 50 Watts inclusive; for kidney applications, 60 to 120 Watts inclusive; for bladder applications, up to 200 Watts inclusive. These average powers represent an increase that is several times greater than with the conventional laser lithotripsy techniques, and without increasing temperature of the liquid medium beyond critical levels for the ureter, kidney or bladder. For example, conventional laser lithotripsy is typically limed to 10 to 30 Watts in for ureteral applications and 30 to 50 Watts in kidney application. The proposed average laser power increases thus represent an increase that is 1.5 to 2.5 times greater than conventional systems. The increase in the average laser power (or in the pulse repetition rate for fixed laser pulse energy systems) increases the speed of ablation proportionally.
[0139] Functionally, endoscopic systems 30 implementing the distal head portion 34n operate in similar manner to endoscopic systems 30 utilizing the distal head portion 34a (i.e., where the aspiration and irrigation occur sequentially using the working channel 102 as a common working channel 109). Endoscopic systems 30 implementing the distal head portion 34o operate in similar manner to endoscopic systems 30 that implement simultaneous aspiration and irrigation (e.g., with distal head 34b). For both the distal heads 34n and 34o, the maximum axial offset A between the imaging receiver 142 and the distal extremity 291 of the extension portion 286 enables the mouth 108 to be disposed within the viewing angle β of the imaging receiver 142. Being within the viewing angle β does not necessarily mean that the mouth can be visualized by the visualization system 54, but only that at least a portion of the mouth 108 falls within the viewing angle β of the imaging receiver 142. For embodiments where the mouth 108 is supported by an opaque structure (e.g., the extension portion 286 is made of an opaque polymer or rubber), the mouth 108 may not be visible. Where the mouth 108 is obscured by an opaque structure, the target zone 56 is still mostly visible, and the reaction of the body stones 58 or fragments thereof to the ablation process and the flow field 256 can be monitored. For embodiments where the mouth 108 is supported by a transparent or semi-transparent medium (e.g., the transparent cap 100 of distal head portions 34a through 34m), the mouth will be visible through the medium, which enables complete visualization of the ablation process.
[0140] In contrast with conventional ureteroscopes, the distal face 98 of the disclosed distal head portions 34 is designed to be in contact or quasi contact with the targeted stone 58 or fragment. For axial locations δ greater than about 0.2 millimeters proximal to the mouth 108, the distal end 114 of the laser fiber optic 112 is not always in direct contact with the body stone 58 or stone fragment, even during active aspiration. Despite instances of a lack of direct contact, laser energy can be effectively delivered to the stone 58 in the liquid medium environment through a distance of up to about 3 millimeters. By operating the laser at wavelengths that are at or near peak absorption for water, the water initially absorbs the laser energy to quickly form a vapor channel between the distal end 114 of the laser fiber 112 and the stone material, greatly reducing the attenuation of the laser energy. Also, the stone 58 or fragment may oscillate or rotate at the mouth 108 so that the surface of the stone 58 or fragment moves perpendicular to the axis of the laser fiber 112. Such oscillation and rotation increases the speed of ablation. The phenomena and effects of vapor channeling and laser fiber oscillation are described in further detail at International Patent Application No. PCT/US19/42491 to Altshuler, et al., incorporated by reference above.
[0141] The reducing flange 290 acts to prevent blockage of the working channel 102 and working port 103. During aspiration, some fragments generated during ablation will have a dimension that is equal to or larger than the inner diameter of the working channel 102. The presence of the laser fiber 112 reduces the flow cross-section of the working channel 102, such that the fragment becomes lodged between the laser fiber 112 and the working channel 102. The reduced area of the mouth 108 when defined by the reducing flange 290 acts to reduce the size of the fragments that can pass into the working channel 102, thereby reducing the incidence of blockage.
[0142] The different outlet angles ϕ of distal head portion 34o are suitable for different operating modes. In contact mode operation, used to ablate large stones or stone fragments, irrigation flows 252 should be directed so as not to impinge on the larger stones or fragments. Accordingly, distal tips 96 defining outlet angles ϕ in a range of 20 degrees to 170 degrees inclusive may be utilized. In non-contact mode, the irrigation flows 252 maintain churning of small fragments within the target zone 56. Accordingly, distal tips 96 defining outlet angles ϕ in a range 20 degrees to 45 degrees inclusive may be utilized.
[0143] When operating the working channel 102 in aspiration, the suctioning of the fragments towards the working channel may partially or completely overcome the retropulsion effect in contact mode and accelerate treatment of small fragments in non-contact mode. The disclosed endoscopic systems 30 operate efficiently when laser operates in dusting mode, where the ablated particles that are smaller than the inner dimension of the working channel 102 can be evacuated from human body by aspiration to provide a stone-free treatment result. For example, a SUPERPULSE Thulium fiber laser with pulse energy from 0.02 to 1 J can provide fragmentation and dusting ablation for particle sizes below 0.5 millimeters. If the laser fiber 112 has core diameter in a range of 0.05 to 0.2 millimeters and an outer diameter below 0.4 millimeters, and the inner diameter of the working channel 102 is greater than 1 millimeter, the particles having dimensions less than 0.5 millimeters can be evacuated through the working channel 102.
[0144] When performing a laser lithotripsy procedure, aspiration flows 254 of approximately 200 milliliters per minute may be utilized. The aspiration generally produces a negative pressure within a kidney. Such negative pressure should not deviate from the surrounding environmental pressure by more than 20%.
[0145] Operationally, the aspiration flow 254 and irrigation flows 252 may be balanced to maintain a net positive irrigation flow. In some embodiments, the irrigation flow 252 exceeds the aspiration flow 254 by up to 50 milliliters per minute. In some embodiments, the net positive irrigation flow is in a range of 10 to 30 milliliters per minute inclusive.
[0146] Referring to
[0147] The illumination fiber optics 132 may also include a buffer layer 282 and an overcoat layer 284 (
[0148] Functionally, the oblong cross sections 164 of the illumination fiber optics 132 enable the sectional dimensions of the catheter 32 and distal head portion 34d to be reduced relative to the distal head portion 34a. The oblong cross sections 164 can be arranged to provide a lower profile in the radial direction while increasing the dimension (and stiffness) in the tangential direction. The overcoat layer 284 provides protection for the cladding layer 282 as well as lubricity for ease of sliding the illumination fiber optic 132 within the lumen 107 during steering operations. In some embodiments, the overcoat layer extends proximate to but not through the distal head portion 34. For the illumination fiber optic 132d, the overcoat layer 284 may also hold the individual circular fiber optics together to bind together and stabilize the oblong cross-section 164d of the ribbon.
[0149] In addition to acting as an optical waveguide that transmits visible light, each oblong cross-section 164 provides enhanced rigidity along the major dimension 166 of the illumination fiber optic 132 (i.e., along the tangential direction θ), while enabling and facilitating flexing of the oblong cross-section 164 along the minor dimension 168 (i.e., along the radial coordinate r perpendicular to the major dimension 166). Accordingly, the oblong cross-sections 164 of the illumination fiber optics 132 provide torsional rigidity for catheter 32 having a flexible shaft, partially or totally negating the need for a separate torsion sleeve that is customary in conventional flexible catheters.
[0150] Accordingly, utilizing illumination fiber optics 132 that define oblong cross sections 164 enables the elimination of a torsion sleeve and pull wires and associated connectors. As a result, the radial profile of the distal head portion 34d can be diminished for reducing the invasiveness and enhancing the safety of the laser lithotripsy procedure.
[0151] Referring to
[0152] The illumination fiber optics 132 may be affixed to the rotating cam 310, for example, with a bonding adhesive 312 (depicted). The steering mechanism 39 may also include a shaft 316 about which the rotating cam 310 rotates. In some embodiments, the steering mechanism 39 includes a thumb lever 318 coupled to the rotating cam 310. In some embodiments, the illumination fiber optics 132 are routed from the illumination system 52 to the rotating cam 310, from the rotating cam 310 to routing sheaths 320, and from the routing sheaths 320 to the distal head portion 34 via the catheter shaft 33. In some embodiments, the illumination system 52 includes a light emitting diode 322 as the visible light source. In some embodiments, the illumination system 52 is housed within the steering handle 38, being powered by one or more batteries 324 (depicted).
[0153] Referring to
[0154] For termination 325b (
[0155] For termination 325c (
[0156] Functionally, the effect of stripping the buffer 282 is to enhance redirection of the visible light 222, as discussed above. The refraction of the visible light 222 through the rounded surfaces of the termination head 329 provides greater divergence of the beam where mismatch of the refractive indices between the illumination fiber optic 132 and the bonding adhesive 327 may be present. The larger dimension of the termination head 329 relative to the dimension of the shaft of the illumination fiber optic 132 also provides structural integrity to the anchoring at the terminations 325b and 325c.
[0157] In operation, a first of the illumination fiber optics 132 is pulled in tension when the rotating cam 310 is actuated in a first rotational direction 326 to articulate the distal head portion 34 in a first lateral direction. A second of the illumination fiber optics 132 is pulled in tension when the rotating cam 310 is actuated in a second rotational direction 328 to articulate the distal head portion 34 in a second lateral direction.
[0158] Referring to
[0159] Image 340b (
[0160] Images 340 demonstrate that as the axial cap thickness 99 increases, the illumination light is spread out to more uniformly irradiate the targeted zone 56 as viewed by the visualization system 54. At some point, for still greater axial cap thicknesses 99, as well as for greater maximum axial offsets A of distal head portions 34o and 34p (
[0161] For the images 340b, 340c, and 340d, the mouth 108 of the distal head portion 34j is in the field of view 148. Surprisingly, the presence of the mouth 108 and the working port 103 leading to the mouth 108 introduce little or no distortion to the images 340b, 340c, and 340d, despite the presence of the extensive structure of the extension 182 and the pressure reliefs 192 (
[0162] In some embodiments, the foregoing methods of operation are provided as instructions on a tangible, non-transitory medium that are supplied with the catheter 32. Non-limiting examples of a tangible, non-transitory medium include a paper document and computer-readable media including compact disc and magnetic storage devices (e.g., hard disk, flash drive, cartridge, floppy drive). The computer-readable media may be local or accessible over the internet. The instructions may be complete on a single medium, or divided among two or more media. For example, some instructions may be written on a paper document that instruct the user to access one or more of the steps of the method over the internet, the internet-accessible steps being stored on a computer-readable medium or media. The instructions may be in the form of written words, figures, and/or video presentations.
Example 1
[0163] The distal portion 35 of a prototype for the catheter 32 was constructed using a transparent cap 100 fabricated from quartz according to the embodiment depicted at
[0164] A SUPERPULSE Thulium fiber laser (FiberLase U2, with wavelength 1940 nm and peak power 500 Watts, manufactured by IPG Photonics of Oxford, Mass., U.S.A.) operating at a pulse energy of 0.1 Joules, a pulse repetition rate 300 Hz, and an average power of 30 Watts was used for ablation of stones in all experiments. As a model of body stones, phantoms made out of BEGOSTONE material (universally accepted model of body stones) were utilized. Treatment simulation was conducted in a cuvette filled with water. Five phantom stones of about 1.5 millimeter diameter each were used for the simulation; weights and times were precisely measured, but dimensions of the phantom stones were approximate.
[0165] Comparison was made between the Example 1 configuration and a conventional configuration operating with the working channel 102 delivering irrigation fluid. For the conventional configuration, the cap was removed so that the end of the catheter shaft was exposed. The laser fiber was positioned so that the distal tip extended 3.5 millimeters beyond the end of the shaft. For the Example 1 configuration, completion of treatment was defined as ablation of the stone samples to particles that completely evacuated through the aspiration channel. For the conventional configuration, the treatment completion was defined as breakage of stone samples to particles smaller than 0.5 millimeter (which were removed with an aspiration flow of 10 milliliters/minute at a distance of about 40 centimeters). The results are summarized in Table 1.
TABLE-US-00001 TABLE 1 Efficiency of stone breaking for conventional vs. disclosed configuration Initial Total Irrigation Aspiration stone laser Stone flow, flow, weight, time ON, breakage Mode of treament Configuration ml/min ml/min mg $ rate, mg/s Contact Conventional 10 0 223 960 0.23 Example 1 100 100 260 250 1.04 Non- Conventional 10 0 28 47 0.6 contact Example 1 100 100 27 12 2.3
[0166] As can be seen from Table 1, the Example 1 configuration provides more than a four-fold increase in the efficiency of stone breaking in the contact mode and more than a 3.5-fold increase in non-contact mode compared to the conventional configuration without increase in laser power required.
[0167] Each of the additional figures and methods disclosed herein can be used separately, or in conjunction with other features and methods, to provide improved devices and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense and are instead disclosed merely to particularly describe representative and preferred embodiments.
[0168] Various modifications to the embodiments may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant arts will recognize that the various features described for the different embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the disclosure.
[0169] Persons of ordinary skill in the relevant arts will recognize that various embodiments can comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the claims can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.
[0170] The following references are hereby incorporated by reference herein in their entirety except for patent claims and express definitions contained therein: International Application No. PCT/US19/42491 to Altshuler, et al., filed Jul. 18, 2019 and owned by the owner of the present application; U.S. Pat. No. 9,775,675 to Irby, Ill. Any incorporation by reference of documents herein is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein.
[0171] Unless indicated otherwise, references to “embodiment(s)”, “disclosure”, “present disclosure”, “embodiment(s) of the disclosure”, “disclosed embodiment(s)”, and the like contained herein refer to the specification (text, including the claims, and figures) of this patent application that are not admitted prior art.
[0172] For purposes of interpreting the claims, it is expressly intended that the provisions of U.S.C. 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in the respective claim.