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[0001] This application is a continuation-in-part of, and claims the benefit of priority from co-pending U.S. patent application Ser. No. 10/346,709, filed Jan. 15, 2003, and also claims the benefit of prior Provisional Application No. 60/______, filed on May 19, 2003, the full disclosures of which are hereby incorporated herein by reference.
[0002] NOT APPLICABLE
[0003] NOT APPLICABLE
[0004] The present invention relates generally to medical devices, systems and methods. More particularly, the present invention relates to devices, systems and methods for use in endoscopic or laparoscopic procedures.
[0005] Endoscopy is a form of minimally invasive procedure wherein the interior of the body is accessed and visualized through an orifice in the body, such as the esophagus or rectum. Such access allows a surgeon or physician to view and/or treat internal portions of the orifice or internal tissues or organs which are accessible through the orifice. These procedures may be for diagnostic purposes, such as visual inspection or the removal of a tissue sample for biopsy, or the procedure may be used for treatment purposes, such as the removal of a polyp or tumor or the restructuring of tissue. While these procedures can be done using regular open surgery, endoscopy usually involves less pain, less risk, less scarring, and faster recovery of the patient.
[0006] Endoscopy is typically performed with the use of an endoscope, a small circular tube containing optical components. Traditional endoscopes comprise a small diameter “snake-like” insertion tube having a distal end which is inserted into the orifice to the desired internal location. Fiber optics extend through the insertion tube and terminate at the distal end to allow axial viewing from the distal end. Images of the internal location near the distal end of the endoscope are transmitted to a video monitor for the physician to view. A control handle allows the endoscopist to control the direction of the scope and in some cases, permits the actuation of air, water and suction utilities that may be required for the endoscopy procedure.
[0007] Since endoscopes may be used to perform a treatment at an internal location, some endoscopes are equipped with a lumen through which a surgical instrument or tool may be passed. Generally, the lumen extends through the length of the insertion tube to the distal end so that the end effector of the inserted instrument protrudes from the distal end in the axial direction. Thus, the instrument is directed in parallel to the fiber optics so that the end effector is positioned along the line of view.
[0008] Such endoscopes have a number of constraints which limit their usefulness in performing diagnostic and surgical procedures. To begin, surgical instruments and tools are inserted axially through a working lumen in the endoscope. And, most of these endoscopes only allow axial and rotational movement of the tool beyond the distal end. This helps to maintain positioning of the tool within the field of view of the endoscope which is also directed axially. However, this limits the variety and complexity of procedures that may be performed. For example, procedures which involve tissue approximation pose great difficulty since only one portion of tissue may be grasped at a time and lateral, rather than axial, movement may be required. Although steering of an axially inserted tool may be possible near the distal end, such steering typically positions the end effector of the tool out of the field of view of the axially directed scope.
[0009] A similar minimally invasive procedure which overcomes some of these constraints is laparoscopy. In laparoscopy, the interior of the body is accessed and visualized through a small incision. When accessing the abdomen, the incision is usually made in the navel. Laparoscopy was initially used by gynecologists to diagnose and treat conditions relating to the female reproductive organs: uterus, fallopian tubes, and ovaries. It is now used for a wider range of procedures, including operations that in the past required open surgery, such as removal of the appendix (appendectomy) and gallbladder removal (cholecystectomy). Laparoscopy is performed with a device which allows the surgeon or physician to view and/or treat internal tissues or organs which are accessible through the incision. This device is the same or similar to an endoscope, sometimes referred to as a laparoscope. The device comprises a small diameter insertion tube having a distal end which is inserted into the incision to the desired internal location. Fiber optics extend through the insertion tube and terminate at the distal end to allow axial viewing from the distal end. Images of the internal location near the distal end are transmitted to a video monitor for the physician to view. Sometimes, access through an incision creates a shorter, straighter and more direct access path than through an orifice. Therefore, some laparoscopes may have a shorter and stiffer insertion tube than some endoscopes.
[0010] Although laparoscopes suffer from many of the same limitations as endoscopes, laparoscopy allows additional surgical instruments and tools to be inserted through separate incisions to perform procedures. Proper location of the incisions can allow instruments to be positioned in various directions. Therefore, movement and viewing is not limited to the axis of the laparoscope and simultaneous viewing of the tissues and the instruments may be more readily achieved during the procedure. However, these additional benefits are achieved at the cost of increased invasiveness. Access paths must be created for the instruments with the use of trocars requiring general anesthesia, risk of complications and infection, and increased overall recovery time for the access paths to heal. In addition, access may be difficult or contraindicated in some patients, particularly in the morbidly obese.
[0011] Thus, it would be desired to provide an improved methods, devices and systems to perform minimally invasive procedures. Particularly, methods, devices and systems which would provide the benefits of endoscopy, such as lower invasiveness and access to deeply internal locations, with the benefits of laparoscopy, such as the use of multiple instruments with movement and viewing along various axes. The devices and systems would be reliable, convenient and easy to use with improved outcomes for patients due to reduction in invasiveness and therefore risk, cost and recovery time. At least some of these objectives will be met by the invention described hereinafter.
[0012] In addition, it would be desired to provide improved methods, devices and systems which would provide improve passage and manipulation through endovascular passageways. Typical endoscopes have a length in the range of 130 to 190 cm and may be used to traverse a variety of tortuous paths within the body. For example, endoscopes may be used to access the lower gastrointestinal tract from entry through the anus, sometimes reaching as far as the cecum at the distal end of the colon. The upper gastrointestinal tract may be accessed through the esophagus to the stomach and the upper regions of the small intestine. Achieving access to any of these regions, particularly through the colon, involves tedious manipulation of the endoscope. Much of this manipulation involves torqueing of the endoscope. However, once a substantial length of the endoscope has passed into the body, torqueing becomes increasingly difficult. In addition, accessing such regions usually takes place through minimally supported lumens, such as the colon, which do not provide resistive strength or through open cavities, such as the stomach, which do not provide particular pathways for the endoscope. This also limits the use of endoscopic access to desired treatment locations.
[0013] Thus, it would be desired to provide improved methods, devices and systems to access desired treatment locations. Particularly, methods, devices and systems which would improve the ability to access desired treatment locations minimally invasively, particularly endoscopically or laparoscopically. The devices and systems would be reliable, convenient and easy to use with improved outcomes for patients due to reduction in invasiveness and therefore risk, cost and recovery time. At least some of these objectives will be met by the invention described hereinafter.
[0014] The present invention provides systems, devices and methods for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body. And, some embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In these embodiments, the system typically includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form a an angular or boomerang shape. In addition, end effectors extend from the distal ends of each arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon through the scope. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, pulling, tugging, elevation and more complex manipulation of tissue. Thus, the systems and devices of the present invention provide many of the capabilities of open surgery or laparoscopic surgery with an endoscopic approach. In addition, the systems and devices of the present invention provide improvements in manipulation for accessing desired treatment locations.
[0015] In a first aspect of the present invention, the tool arm(s) comprise a shaft having a proximal end and a deflectable or steerable distal end. In some embodiments, the steerable distal end will be laterally stabilized so that the distal end may be steered, i.e. bent or manipulated, within a plane but will resist deflection outside of the plane during use. The steering plane will generally be parallel to a central axis of the scope but may be rotated by rotation of the tool arm. In this way, the arm(s) will maintain stable positioning within the field of view of the scope and will resist accidental deflection outside of the field. It may be appreciated that the tool arm may also be translated axially within the stabilized plane while maintaining viewing within the field.
[0016] A preferred structure for achieving lateral stability comprises a plurality of adjacent links. Usually, the links are pivotally attached by hinged structures. In some embodiments, the hinged structures comprise pivot pins which are disposed parallel to one another and generally transverse to the stabilized plane in which the arm may be steered. In other embodiments, the hinged structures comprise male and female bearing surfaces which define axes, wherein the axes are disposed in parallel to limit deflection of the distal section to within the plane. A variety of other structures are also available to provide lateral stability, such as deployment frames, various shaped linkages connected by reinforcements or pullwires, and slotted tubes, to name a few.
[0017] Typically, the distal end includes at least two steerable sections, wherein a distal-most steerable section includes a tip section which curves in a first direction and wherein an intermediate steerable section includes a base which curves in the opposite direction, where both curves are in the stabilized plane. In some embodiments, the tip section curve has a radius which is greater than that of the curve of the base. To achieved such curvatures, the adjacent links may be shaped to allow substantially continuous deflection. Or, the adjacent links may be shaped so that the steerable distal end is deflectable to form a predetermined curvature wherein the arm is then restricted from further deflection.
[0018] Means for selectively deflecting the distal section of the tool arm(s) often comprise at least one pullwire or one pushwire. Such pull or pushwires may be present in any quantity and arrangement. The means for selectively deflecting the distal section can further include at least one spring which is configured to straighten the distal section in opposition to the pullwire or pushwire.
[0019] In some embodiments, the tool arm includes an end effector disposed at its distal end. A wide variety of end effectors may be used depending on the procedure or tissue manipulations which are desired. For example, end effectors may include but are not limited to knives, needles, sutures, staplers, fasteners, clippers, electrosurgical or hemostatic cutters and coagulators, laser welders, cryosurgery instruments, secondary scopes, forceps, lasers hooks, tongs, graspers, retractors, probes, clamps, scissors, tissue approximation devices and suction applicators. Alternatively, the tool arm may include a tool deployment lumen through which a tool having an end effector may be passed. In these embodiments, the tool arm may include a steering cuff arranged for passage of the tool therethrough so that manipulation of the tool within the steering cuff steers the distal end of the tool arm. Thus, in either case, manipulation of the end effector and the tool arm may be interconnected.
[0020] In another aspect of the present invention, the elongated main body has a distal end, a proximal end, and an arm guide lumen extending through at least a distal section of the elongated main body. In preferred embodiments, the elongated main body has a viewing or scope lumen extending therethrough and terminating in the distal tip. It may be appreciated that the scope lumen may be used for passage of any viewing element or device or the scope lumen may comprise a viewing element or device fixed or integrated within the main body. Herein, it will be assumed that the term “scope lumen” will be used to refer to either of these embodiments.
[0021] The arm guide lumens and the viewing scope lumen may be arranged in any suitable fashion within the main body. For example, when the elongated main body has a second arm guide lumen, the distal terminations of the two arm guide lumens and the one viewing scope lumen may be arranged in a generally triangular pattern on the distal tip of the main body. Alternatively, the lumens may be aligned, wherein the viewing scope lumen is disposed between the arm guide lumens.
[0022] Typically, at least the distal section of the elongated main body is steerable. In some embodiments, the elongated main body comprises a first section and a second section, the first section disposed proximally of the second section, and the first and second sections are independently lockable. Thus, the first section may be lockable while the second section remains steerable. Such steering may be achieved with means for selectively deflecting the second section within at least a single plane. This may include retroflexion wherein the distal end of the main body is directed toward the proximal end. In some embodiments, the distal section of the elongated main body comprises a plurality of adjacent links to allow for such steering.
[0023] Typically, at least the distal section of the elongated main body has a generally cylindrical exterior wherein the arm guide lumen does not extend out of the cylindrical exterior. And, the arm guide lumen terminates at a distal tip of the elongated main body so that the tool arm advances through the distal tip. Likewise, as mentioned previously, the elongated main body typically has a viewing scope lumen extending therethrough and terminating in the distal tip.
[0024] In yet another aspect of the present invention, the tool arms may have a distal end which is steerable by a variety of mechanisms. For example, the distal end may be comprised of a flexible tube having at least one pullwire attached thereto so that manipulation of the at least one pullwire deflects the steerable distal end. Or, the tool arm may have a steerable distal end which comprises a flexible tube having shape memory material so that emergence of the steerable distal end from the distal tip of the main body allows deflection of the steerable distal end to a shape memory position. Or, the tool arm may further comprise a deployment frame extending from the distal tip of the main body, the frame comprising at least two supports each attached to one of the at least two tool arms so that manipulation of the deployment frame deflects the attached tool arms.
[0025] In an additional embodiment of the present invention, the endoluminal tool deployment system may be comprised of an elongated main body having a distal end, a proximal end, and at least two arm guide lumens extending over or through at least a distal section of the elongated main body, wherein said arm guide lumens extend fully to a distal tip of the main body, and at least two tool arms adapted to extend through the arm guide lumens of the elongated main body, said tool arms emerging from the distal tip of the main body.
[0026] In still another aspect of the present invention, the endoluminal tool deployment system comprises an elongated main body having a distal end, a proximal end, and an arm guide lumen extending through at least a distal section of the elongated main body, wherein at least the distal section comprises a plurality of adjacent links. The system further includes a means for selectively deflecting the distal section within at least a single plane, and at least one tool arm adapted to extend through the arm guide lumen of the elongated main body.
[0027] In a further aspect of the present invention, a method is provided for deploying one or more tools in an anatomical space. In a preferred embodiment, the method comprises introducing a distal end of a main body to said anatomical space, advancing a tool arm from a tool deployment lumen in said main body into said anatomical space, deflecting and positioning the tool arm to locate a distal tip thereof adjacent to a target location within the anatomical space, wherein a distal section of the arm is curved and laterally stabilized in a single plane, and advancing a tool through a lumen of the tool arm to the target location.
[0028] In some embodiments, deflecting and positioning comprises tensioning a plurality of adjacent hinged links within the distal section of the tool arm. The adjacent hinged links may be joined by hinge pins which are disposed perpendicularly to the single plane such that the pins stabilize the distal section and inhibit deflection outside of the single plane. The method may further comprise viewing the target location through a viewing scope disposed in the main body, wherein the tool arm extends axially from a distal tip of the main body from a location adjacent to the viewing scope.
[0029] In some embodiments, an endoluminal system is provided comprising an elongated main body having a proximal end, a distal end sized for passage through a body lumen, and at least one lumen extending between the proximal and distal ends. The system further includes a torque transmitting feature which provides torque transmission between the proximal and distal ends while the main body is unlocked and able to form a desired configuration. In addition, the system includes a locking mechanism which locks the main body in the desired configuration. The at least one lumen may be used for passage of any desired device, including, for example, a viewing scope and optionally one or more tool arms. In addition, the system typically includes a steering mechanism which steers the main body to the desired configuration while the main body is unlocked. In most embodiments, the steering mechanism comprises at least one pullwire extending through the plurality of adjacent links.
[0030] In preferred embodiments, at least a portion of the elongated main body comprises a plurality of adjacent links. Torque may be transmitted through the adjacent links by a variety of torque transmitting features. For example, in some embodiments, when the plurality of adjacent links comprises at least a first link and an adjacent second link, the torque transmitting feature comprising at least one protrusion or tooth from the first link slidably engageable with at least one groove in the adjacent second link, the torque transmitting feature providing torque transmission through the portion of the main body while the links are rotateable. In some embodiments, the at least one protrusion comprises a pair of protrusions, each protrusion extending outwardly from an outer surface of the first link in a diametrically opposite position from the other protrusion. Correspondingly, the at least one groove may comprise a pair of grooves, each groove configured to accept one or the pair of protrusions passing therein. When the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring is mateable with the inner surface of the second domed ring along a longitudinal axis, and the rings are rotateable away from the longitudinal axis. In some embodiments, each groove comprises a first groove end and a second groove end, the groove ends substantially aligned with the longitudinal axis to allow sliding of the protrusions along the grooves during rotation of the rings away from the longitudinal axis. It may be appreciated that such protrusions may extend inwardly from an inner surface and the grooves may be disposed on the outer surface of an adjacent link to accept such protrusions. Thus, the protrusions and associated grooves may function in a similar manner in an inverse arrangement.
[0031] In other embodiments, the torque transmitting feature comprises a protrusion or a pin from the first link slidably engageable with a slot in the adjacent second link. This is an example of a torque transmitting feature which provides torque transmission by preventing disengagement of the adjacent links while the main body is unlocked and able to form a desired configuration. In some embodiments, the plurality of adjacent engageable links comprises at least a first link and an adjacent second link and the torque transmitting feature comprising at least one pin from the first link slidably engageable with at least one slot in the adjacent second link. Further, in some embodiments, the at least one pin comprises a pair of pins, each pin extending outwardly from an outer surface of the first link in a diametrically opposite position from the other pin. Similarly, the at least one slot comprises a pair of slots, each slot configured to accept one or the pair of pins passing therethrough.
[0032] In preferred embodiments, the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring being mateable with the inner surface of the second domed rings along a longitudinal axis, and the rings being rotateable away from the longitudinal axis. Typically, each slot comprises an elongate opening between a first slot end and a second slot end, the slot ends substantially aligned with the longitudinal axis to allow sliding of the pins through the slots during rotation of the rings away from the longitudinal axis. It may be appreciated that such pins may extend inwardly from an inner surface and extend through slots on adjacent links. Thus, the pins and associated slots may function in a similar manner in an inverse arrangement.
[0033] In yet other embodiments, the torque transmitting feature comprises a torque transmitting covering over the plurality of adjacent engageable links to prevent disengagement of the adjacent links. In some instances, the torque transmitting covering comprises a snuggly fit sheath including reinforcements, such as a braided material. The reinforcements may comprise nylon, polyurethane, polyethylene, Teflon, metal, or polymer, for example. Optionally, the reinforcements may be coated with a polymer or the reinforcements may be covered with a separate polymer component. Alternatively, the torque transmitting covering may comprise a polymer coating over the links themselves.
[0034] In still further embodiments, an endoluminal device is provided comprising an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising at least a first link and an adjacent second link which are rotateable relative to each other when unlocked, one of the at least one lumen extending through the links having at least one partition. An elongated shaft is present passing through one of the at least one lumen in a manner to transmit torque by contacting the least one partition. In addition, a locking mechanism is provided which locks the links upon actuation by preventing rotation of the links relative to each other.
[0035] In some embodiments, the at least one partition comprises an inward protrusion. And, the at least one lumen extending through the links may have a fluted shape forming the inward protrusions. In other embodiments, the at least one partition comprises a divider spanning across the one of the at least one lumen. The shaft passes through the at least one lumen and is positioned between partitions in each of the links. Torqueing of the plurality of adjacent links is transmitted through the shaft and partitions. For example, by applying torque to a first link, the first link rotates about the longitudinal axis until the shaft contacts a partition. Since the partitions are generally aligned, the shaft will also contact partitions in a second link. Therefore, torque is transmitted from the first link to the second link. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links.
[0036] In additional embodiments, the torque transmitting feature comprises an oval shape of the plurality of adjacent links. And, in other embodiments, the torque transmitting feature comprises a plurality of wires or rods extending through the adjacent links. In preferred embodiments, the plurality of rods comprises approximately 8 to 64 rods. Torque is transmitted from link to link through these torque transmitting features.
[0037] Further, a method of accessing is provided comprising providing an elongated main body having a proximal end, a distal end, a visualizing element and a locking mechanism, wherein the main body is capable of forming a desired configuration in an unlocked state and holding the desired configuration in a locked state. The method further includes introducing the main body through a body passageway in the unlocked state forming the desired configuration so that the distal end reaches a target location, actuating the locking mechanism to hold the main body in the desired configuration, and viewing the target location with the use of the visualizing element.
[0038] Introducing the main body may comprise allowing the main body to assume a shape of the body passageway in the unlocked state forming the desired configuration. Or, introducing the main body may comprise steering the main body through the body passageway in the unlocked state forming the desired configuration. In either situation, in some embodiments, the main body comprises a plurality of adjacent links so that actuating the locking mechanism comprises holding the links in a fixed relation to each other. In particular, the plurality of adjacent links sometimes comprises a plurality of nestable elements so that holding the links comprises wedging the links together to hold them by friction.
[0039] When the main body includes at least one lumen extending between the proximal and distal ends, the method may further comprise introducing an instrument through the at least one lumen. In some embodiments, the instrument comprises a tool arm. When the elongated main body further includes a visualizing lumen and the visualizing element comprises an endoscope, the method may further comprise positioning the endoscope within the visualizing lumen.
[0040] Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.
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[0081] I. Overview
[0082] An embodiment of a system
[0083] The main body
[0084] The system
[0085] In this embodiment, the system
[0086]
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[0088] FIGS.
[0089] FIGS.
[0090]
[0091] As mentioned previously, the endoluminal tool deployment system
[0092] It may be appreciated that the systems, methods and devices of the present invention are applicable to diagnostic and surgical procedures in any location within a body, particularly any natural or artificially created body cavity. Such locations may be disposed within the gastrointestinal tract, urology tract, peritoneal cavity, cardiovascular system, respiratory system, trachea, sinus cavity, female reproductive system and spinal canal, to name a few. Access to these locations may be achieved through any body lumen or through solid tissue. For example, the stomach may be accessed through an esophageal approach, the heart through a port access approach, the rectum through a rectal approach, the uterus through a vaginal approach, the spinal column through a port access approach and the abdomen through a port access approach.
[0093] A variety of procedures may be performed with the systems and devices of the present invention. The following procedures are intended to provide suggestions for use and are by no means considered to limit such usage: Laryngoscopy, Rhinoscopy, Pharyngoscopy, Bronchoscopy, Sigmoidoscopy (examination of the sigmoid colon, the sigmoid colon is the portion that connects the descending colon to the rectum; primarily for diagnostic purposes, however a biopsy procedure and trans anal micro surgery may be performed for removing tumors), Colonoscopy (examination of colon; for the removal of polyps and tumors or for biopsy), and Esophagogastroduodenoscopy (EGD) which enables the physician to look inside the esophagus, stomach, and duodenum (first part of the small intestine). The procedure might be used to discover the reason for swallowing difficulties, nausea, vomiting, reflux, bleeding, indigestion, abdominal pain, or chest pain.
[0094] In addition, endoscopic retrograde cholangiopancreatography (ERCP) may be achieved which enables the surgeon to diagnose disease in the liver, gallbladder, bile ducts, and pancreas. In combination with this process endoscopic sphincterotomy can be done for facilitating ductal stone removal. ERCP may be important for identification of abnormalities in the pancreatic and biliary ductal system. Other treatments include Cholecystectomy (removal of diseased gallbladder), CBD exploration (for common bile duct stones), appendicectomy.(removal of diseased appendix), hernia repair TAP, TEPP and other (all kinds of hernia), fundoplication and HISS procedures (for gastro esophageal reflux disease), repair of duodenal perforation, gastrostomy for palliative management of late stage upper G.I.T. carcinoma), selective vagotomy (for peptic ulcer disease), splenectomy (removal of diseased spleen), gastric restrictive and malabsorbtive procedures (for morbid obesity), upper and lower G.I. endoscopies (diagnostic as well as therapeutic endoscopies), pyloroplastic procedures (for children's congenital deformities), colostomy, colectomy, adrenalectomy (removal of adrenal gland for pheochromocytoma), liver biopsy, gastrojejunostomy, subtotal liver resection, gastrectomy, small intestine partial resections (for infarction or stenosis or obstruction), adhesions removal, treatment of rectum prolaps, Heller's Myotomy, devascularization in portal hypertension, attaching a device to a tissue wall and local drug delivery to name a few.
[0095] II Main Body
[0096] As mentioned previously, the system
[0097] One embodiment of the main body
[0098] Steering and locking may be achieved by any suitable mechanisms. In some embodiments, the shaft
[0099] Generally, the adjacent surfaces
[0100]
[0101] In this embodiment, the wall
[0102] In the embodiment illustrated in
[0103] It may be appreciated that pullwire lumens
[0104] In addition, liners
[0105] As mentioned previously, it may be appreciated that the shaft
[0106] In addition, it may be appreciated that the main body
[0107]
[0108] The visualizing elements
[0109] III Tool Arms
[0110] As mentioned previously, system
[0111] A. Distal End
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[0115]