Heat removal loop in a mechanical arm of a surgical device

Abstract

The surgical apparatus comprises a flexible arm and / or arms, a capsule assembly connected distally to the arms (comprising a liquid-tight shell defining a capsule assembly interior and having one or more heat-generating imaging and / or electronic components disposed therein), and a conduit array (the conduit array and a portion of the capsule assembly interior exterior to the conduit array collectively form a liquid-tight closed flow loop for convective removal of heat from the capsule assembly interior, the closed flow loop comprising one or more arm-disposed sections of the conduit array, the conduit array being disposed at least partially along and / or within the arms and collectively spanning at least a majority of the longitudinal direction of the arms twice and in parallel).

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 037018, filed June 10, 2020, which is incorporated herein by reference in its entirety.

[0003] The present invention relates generally to the field of minimally invasive surgery, and more particularly to thermal management of heat-generating surgical devices, such as imaging systems, and methods for their use. [Background technology]

[0004] The advantages of minimally invasive surgery are well established. Such surgical instruments typically have a surgical end effector located at the distal end of an articulated surgical arm (preferably having a minimal diameter), which is inserted through a small opening (e.g., a body wall incision, a natural orifice) to reach the surgical site. In some instances, an endoscope can be used to provide an image of the surgical site. In some instances, the surgical arm has one or more bends controlled by a mechanical cable. Longitudinal movement of the mechanical cable affects the bend, ultimately controlling the position and orientation of the end effector relative to the longitudinal axis of the surgical arm. In some instances, the surgical arm can be bent and / or rotated to reciprocate relative to the longitudinal axis of the surgical arm.

[0005] Surgical arms have been developed using a chip-on-tip approach, in which a tip with an image sensor and associated illumination is placed in the distal region of the endoscope shaft to acquire high-resolution in-situ images. The images are obtained using miniaturized electronics and / or imaging components. In recent years, more advanced image sensors with high light sensitivity and resolution, such as complementary metal-oxide semiconductor (CMOS) image sensors, have been developed. Furthermore, the use of powerful light-emitting diodes and laser diodes has recently become desirable to significantly improve illumination and contrast. However, these light-emitting diodes and / or high-resolution image sensors generate high temperatures and require sufficient cooling to meet regulatory standards for maximum heat output. Cooling or heat dissipation is particularly challenging given the limited size constraints of MIS surgical tools, the flexibility requirements of flexible (and / or articulated) surgical arms, and the need to maintain sterility in the surgical environment. Summary of the Invention

[0006] According to embodiments disclosed herein, a system for removing heat from a heat-generating component of a mechanical arm includes: (a) an inner shell surrounding a distal heat-generating component and defining a capsule; (b) an outer shell surrounding the inner shell and forming an annular gap between the inner shell and the outer shell; (c) a conduit array having first and second distal openings, each of the conduits fluidly communicating with the annular gap and communicating with each other therethrough; and (d) a circulation mechanism configured to introduce a fluid into the annular gap through the first distal opening and discharge the fluid from the annular gap through the second distal opening, the circulation mechanism absorbing heat generated by the heat-generating component by the fluid passing through the annular gap.

[0007] In some embodiments, a longitudinal portion of the conduit array may be positioned at least partially within and / or along the mechanical arm so as to span at least one flexible arm section.

[0008] In some embodiments, the heat generating component may form part of an imaging device.

[0009] In some embodiments, the heat generating component may form part of a chip-on-chip device that places a chip on the tip.

[0010] In some embodiments, the circulation device can include a pump positioned proximally from the at least one flexible arm section and mechanically coupled to the fluid.

[0011] In some embodiments, a longitudinal majority of the conduit array may be disposed within the arm.

[0012] In some embodiments, the system can further include an inner casing disposed within the capsule and in at least indirect thermal communication between the heat-generating component and the inner shell. In some embodiments, the inner casing can comprise a metal characterized by a thermal conductivity of at least 200 W / mK. In some embodiments, the system can further include a thermal gel or thermal paste disposed within the capsule and / or configured to provide at least indirect thermal communication between the inner shell and the heat-generating component or the inner casing. In some embodiments, the system can further include a thermal gel or thermal paste disposed within the capsule and / or configured to provide at least indirect thermal communication between the inner shell and the heat-generating component or the inner casing.

[0013] In some embodiments, the conduit array may comprise one or more arm arrangement sections of the conduit array that collectively span two longitudinal times and parallel across at least a majority of the length of at least one flexible arm section.

[0014] In some embodiments, the pumps may be selected and the conduit array may be configured to provide a fluid flow through the interior of the outer shell of between 10 and 200 ml / sec.

[0015] In some embodiments, during operation of the heat generating component, the heat transfer coefficient of convective heat transfer from the surface of the capsule to the flowing fluid is 10 to 200 W / m 2 The pumps can be selected and the conduit array can be configured to induce fluid flow that maintains k.

[0016] According to embodiments disclosed herein, a surgical instrument includes: (a) an articulated arm, the articulated arm having a bendable portion configured to bend (i) through an angle of at least 120° and (ii) such that the radius of curvature after bending is at most three times the diameter of the bendable portion; (b) a capsule assembly connected distally to the mechanical arm, the capsule assembly including a fluid-tight shell defining an interior of the capsule assembly, a heat-generating component disposed within the capsule assembly; and (c) a forced heat convection system, the forced heat convection system including (i) one or more conduit sections in fluid communication with the interior of the capsule assembly, and (ii) a pump mechanically coupled to a fluid disposed within the one or more conduit sections.

[0017] In some embodiments, the heat generating component can include a chip-on-chip imaging device with a chip disposed at its tip.

[0018] In some embodiments, the capsule assembly can include a capsule disposed within a shell to form an air gap between the capsule and the shell, and heat is removed through the air gap formed between an inner wall of the capsule assembly and a conduit array.

[0019] According to embodiments disclosed herein, a surgical apparatus includes: (a) a flexible arm; (b) a capsule assembly distally connected to the arm, the capsule assembly including a fluid-tight shell defining a capsule assembly interior, with one or more heat-generating components disposed within the capsule assembly interior; and (c) a conduit array, the conduit array and a portion of the capsule assembly interior external to the conduit array collectively forming a fluid-tight closed flow loop for convective removal of heat from the capsule assembly interior, the fluid-tight closed flow loop including one or more arm-disposed sections of the conduit array that (i) are disposed at least partially along and / or within the arm and (ii) collectively span two times in parallel longitudinal directions across at least a majority of the longitudinal length of the flexible arm.

[0020] In some embodiments, the surgical apparatus may further include a positive displacement pump for flowing fluid through the liquid-tight closed flow loop to remove heat generated by the one or more heat-generating components from within the capsule assembly by forced convection.

[0021] In some embodiments, the arm-disposed section may comprise at least 75% of the liquid-tight closed flow loop.

[0022] In some embodiments, the portion of the liquid-tight closed flow loop inside the capsule assembly inner wall and outside the conduit array can have a length of at least 5 mm.

[0023] In some embodiments, the portion of the liquid-tight closed flow loop inside the capsule assembly inner wall and outside the conduit array can have a length equal to at least 50% of the diameter of the capsule assembly inner wall.

[0024] In some embodiments, the pump can be selected and / or the liquid-tight closed flow loop can be formed to provide a fluid flow rate through the interior of the capsule assembly of between 10 and 200 ml / sec.

[0025] In some embodiments, (i) a capsule may be fixedly positioned within the capsule assembly so as to define an annular region outside the capsule and within the shell, and / or (ii) one or more of the imaging components and / or electronic components may be positioned within the capsule so as to seal the one or more imaging components and / or electronic components from the annular region.

[0026] In some embodiments, the capsule can be repeatedly autoclavable.

[0027] In some embodiments, an annular region gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 1 cm of the capsule's length. In some embodiments, an annular region gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 50% of the capsule's length.

[0028] In some embodiments, when fluid is flowed through the conduit array into the annular region, a portion of the flowing fluid can pass longitudinally through the annular region for at least 50% of the length of the capsule assembly.

[0029] In some embodiments, during operation of the surgical device, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid is between 10 and 200 W / m 2 The pump can be selected and / or form the liquid-tight closed flow loop to cause fluid flow that maintains k.

[0030] In some embodiments, a thermal gel and / or thermal paste may be disposed within the capsule to provide at least indirect thermal communication between the one or more heat generating components and an encapsulation of the capsule.

[0031] In some embodiments, the surgical device can further comprise an inner casing disposed within the capsule and in at least indirect thermal communication between the one or more heat-generating components and an encapsulation coating of the capsule. In some embodiments, the inner casing can comprise a metal characterized by a thermal conductivity of at least 200 W / mK.

[0032] According to embodiments disclosed herein, a surgical apparatus includes: (a) a flexible arm; (b) a capsule assembly distally connected to the arm, the capsule assembly including a fluid-tight shell defining a capsule assembly interior, with one or more heat-generating components disposed within the capsule assembly interior; (c) one or more conduit sections (i) disposed at least partially along and / or within the arm; (ii) collectively spanning at least a majority of a longitudinal length of the arm twice in a parallel manner; and (iii) reaching the capsule assembly; and (d) a pump for forced thermal convection cooling of the capsule assembly interior, the pump mechanically coupled to a fluid disposed within the one or more conduit sections; the surgical apparatus configured such that the one or more conduit sections are part of a liquid-tight closed fluid flow loop thermally coupled to the capsule assembly.

[0033] In some embodiments, the pump can be selected to provide a fluid flow of 10-200 ml / sec through the interior of the capsule assembly, forming the liquid-tight closed flow loop.

[0034] In some embodiments, the liquid-tight closed fluid loop can comprise a portion of the capsule assembly interior that is external to the one or more conduit sections.

[0035] In some embodiments, a capsule can be fixedly positioned within the capsule assembly to define an annular region outside the capsule and within the shell.

[0036] In some embodiments, during operation of the surgical device, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid is between 10 and 200 W / m 2 The pump can be selected and / or form the liquid-tight closed flow loop to cause fluid flow that maintains k.

[0037] According to embodiments disclosed herein, a surgical apparatus includes: (a) a flexible arm; (b) a capsule assembly distally connected to the arm, the capsule assembly including an outer shell and a capsule disposed within the outer shell to form an annular gap between the outer shell and the capsule, the capsule including a heat-generating component sealed therein; and (c) first and second conduit sections having first and second distal openings in direct fluid communication with the capsule assembly, respectively, and indirect fluid communication with each other through the annular gap, such that when fluid is discharged from the first distal opening into the interior of the capsule assembly, the fluid traverses the annular gap and is discharged therefrom to the second distal opening.

[0038] In some embodiments, an annular gap thickness of between 0.05 mm and 0.3 mm can be maintained over at least 180 degrees of the capsule assembly circumference for at least 1 cm of the capsule length. In some embodiments, the annular gap can have a thickness of at least 0.05 mm and up to 0.3 mm over at least 75% of the capsule circumference for at least 20% of the capsule length.

[0039] In some embodiments, the first and second distal openings can be at least 5 mm from each other.

[0040] In some embodiments, the first and second distal openings can be at a distance from each other that is at least equal to 50% of a diameter of the capsule assembly inner wall.

[0041] In some embodiments, the capsule can be repeatedly autoclavable.

[0042] Some embodiments may further comprise a thermal gel and / or a thermal paste disposed within the capsule such that the one or more heat generating components are in at least indirect thermal communication with an encapsulation of the capsule.

[0043] In some embodiments, the surgical device can further comprise an inner casing disposed within the capsule and in at least indirect thermal communication between the one or more heat-generating components and an encapsulation of the capsule, hi some embodiments, the inner casing can comprise a metal characterized by a thermal conductivity of at least 200 W / mK.

[0044] According to embodiments disclosed herein, a surgical apparatus includes: (a) a flexible arm having an arm section configured to bend at least 90 degrees; (b) a capsule assembly distally connected to the arm, the capsule assembly including a heat-generating component that generates heat during operation of the surgical apparatus; and (c) a fluid transport system for removing heat from the capsule assembly, the fluid transport system including: (i) a pump disposed proximally from the arm section configured to bend; and (ii) a conduit array disposed at least partially within and / or along the arm so as to span at least the arm section configured to bend.

[0045] In some embodiments, the conduit array can form a flow path from the capsule assembly, through the pump, distally, and back to the capsule assembly, which is continuous proximally and discontinuous within the capsule assembly.

[0046] In some embodiments, the arm section configured to bend may be configured to bend at least 120 degrees.

[0047] In some embodiments, the arm section configured to flex can include a cambered section configured to transition into and out of a cambered configuration.

[0048] In some embodiments, the fluid transport system may be selected and / or the conduit array may be configured to provide a fluid flow rate through the interior volume of the capsule assembly of between 10 and 200 ml / sec.

[0049] In some embodiments, when the arm configured to bend is bent, the flow path can remain continuous from the capsule assembly proximally through the pump and back to the capsule assembly distally.

[0050] In some embodiments, when the arm configured to bend is bent, the fluid capacity of the flow path may not decrease by more than 30%.

[0051] In some embodiments, the capsule assembly can comprise a capsule containing the heat-generating component, and heat removal from the capsule assembly occurs by convectively absorbing heat from the capsule in fluid being pumped through the fluid transport system.

[0052] In some embodiments, the fluid transport system can be configured such that at least 70% of the absorbed heat is lost by the pumped fluid as it traverses the conduit array.

[0053] In some embodiments, the fluid transport system can be configured such that a first portion of the absorbed heat is lost when traversing proximally from the capsule assembly through the pump, and a second portion of the absorbed heat is lost when traversing distally from the pump to the capsule assembly.

[0054] According to an embodiment, a method of removing heat from a flexible surgical arm is disclosed, the arm having a heat-generating component disposed within a capsule assembly distally connected to the arm. The method includes (a) thermally coupling a forced convection heat dissipation system to the capsule assembly, the forced convection heat dissipation system including (i) a conduit array disposed at least partially within the arm, and (ii) the pump mechanically coupled to the fluid to induce said flow, the conduit array having a heat-removing fluid disposed therein; and (b) operating the pump to cause the fluid to (i) flow distally through a first conduit of the conduit array to the capsule assembly, (ii) remove at least a portion of the heat generated from the illumination and / or imaging components from the capsule assembly by forced convection, and (iii) flow proximally from the capsule assembly through a second conduit of the conduit array, whereby at least a portion of the heat removed from the capsule assembly is dissipated therein.

[0055] In some embodiments, at least 75% of the length of the conduit array is disposed within the arm.

[0056] In some embodiments, removing at least a portion of the heat from the capsule assembly with the fluid can include flowing the fluid through an interior volume of the capsule assembly exterior to the conduit array along a flow path having a length of at least 5 mm.

[0057] In some embodiments, the flow path through the interior volume of the capsule assembly and exterior of the conduit array can have a length equal to at least 50% of the diameter of the inner wall capsule assembly.

[0058] In some embodiments, the fluid can flow through the interior of the capsule assembly at a flow rate of 10 to 200 ml / sec.

[0059] In some embodiments, a capsule containing the heat generating component can be fixedly positioned within the capsule assembly to define an annular region outside the capsule and within the capsule assembly through which the fluid flows.

[0060] In some embodiments, an annular region gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 1 cm of the capsule's length, and in some embodiments, an annular region gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 50% of the capsule's length.

[0061] In some embodiments, a portion of the flowing fluid can pass longitudinally through the annular region for at least 50% of the length of the capsule assembly.

[0062] In some embodiments, removing at least a portion of the thermal fluid flow from the capsule assembly comprises maintaining a heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid between 10 and 200 W / m during movement of the surgical arm. 2 k.

[0063] According to embodiments disclosed herein, a surgical apparatus includes: (a) a flexible arm having an arm section configured to bend at least 90 degrees; (b) a capsule assembly distally connected to the arm, the capsule assembly including an outer shell and a capsule disposed within the outer shell such that an annular gap is formed between the outer shell and the capsule, the capsule including heat-generating electronic components and / or imaging components that generate heat during operation of the surgical apparatus; and (c) a forced convection heat removal system for removing heat from the capsule assembly, the heat removal system comprising: (i) a conduit array, the longitudinal portion of the conduit array being at least 100 mm in diameter; and (ii) a pump (located proximally from the arm section configured to bend and mechanically coupled to the fluid) disposed at least partially within and / or along the arm so as to at least straddle the arm section configured to bend, the conduit arrays each having first and second distal openings in direct fluid communication with the capsule assembly and in indirect fluid communication with each other through the annular gap, such that when fluid disposed within the conduit array is discharged from the first distal opening into the interior of the capsule assembly, the fluid traverses the annular gap and is discharged therefrom to the second distal opening.

[0064] In some embodiments, the pump may be selected and / or the conduit array may be configured to provide a fluid flow rate through the annular gap of between 10 and 200 ml / sec.

[0065] In some embodiments, the capsule can be repeatedly autoclavable.

[0066] In some embodiments, an annular gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule assembly circumference for at least 1 cm of the capsule's length. In some embodiments, an annular gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule's circumference for at least 50% of the capsule's length.

[0067] In some embodiments, when the fluid is flowed through the conduit array into the annular gap, a portion of the flowing fluid can pass longitudinally through the annular gap for at least 50% of the length of the capsule assembly.

[0068] In some embodiments, during operation of the surgical device, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid is between 10 and 200 W / m 2 The pumps can be selected to create a fluid flow that maintains k, forming the conduit array. [Brief explanation of the drawings]

[0069] The invention will now be further described, by way of example only, with reference to the accompanying drawings, in which: Dimensions of parts and features shown in the figures have been chosen for convenience and clarity of presentation and are not necessarily to scale; furthermore, in some of the figures, the relative sizes of objects and relative distances between objects may be exaggerated for convenience or clarity of presentation.

[0070] [Figure 1] FIG. 1 is a diagram showing a surgical arm unit according to an embodiment of the present invention. [Figure 2A] FIG. 2A shows a mechanical arm with a bendable section according to an embodiment of the present invention. [Figure 2B] Figure 2B is a diagram showing a mechanical arm having a bendable section according to an embodiment of the present invention, and is a diagram showing the bending angle of the bendable section of the mechanical arm of Figure 2A relative to the central axis. [Figure 3] FIG. 3 is a schematic diagram showing the central axis of a mechanical arm, the diameter of the cross section of the mechanical arm, and the radius of curvature of the bendable portion of the mechanical arm used in the present disclosure. [Figure 4] FIG. 4 is a schematic perspective view of a capsule including one or more electronic and / or imaging components, according to an embodiment of the present invention. [Figure 5] FIG. 5 is a schematic illustration of a distal portion of surgical arms each including a capsule assembly according to an embodiment of the present invention. [Figure 6] FIG. 6 is a schematic illustration of a distal portion of surgical arms each including a capsule assembly according to an embodiment of the present invention. [Figure 7] FIG. 7 illustrates a distal portion of an exemplary surgical arm with a capsule assembly that does not include a distal covering, according to an embodiment of the present invention. [Figure 8] FIG. 8 illustrates a distal portion of the surgical arm and capsule assembly of FIG. 6 showing fluid flow, according to an embodiment of the present invention. [Figure 9] FIG. 9 is a schematic cross-sectional view of a proximal portion of a capsule assembly, according to an embodiment of the present invention. [Figure 10] FIG. 10 is a schematic cross-sectional view of a capsule assembly according to an embodiment of the present invention. [Figure 11] FIG. 11 is a schematic cross-sectional view of a capsule assembly according to an embodiment of the present invention. [Figure 12A] FIG. 12A shows the distal portion of the surgical arm of FIG. 7 with the outer shell and capsule covering removed. [Figure 12B] FIG. 12B shows "Detail A" of FIG. 12A with the distal cap removed. [Figure 13] FIG. 13 is a schematic perspective view of a conduit array for fluid transport in a surgical arm. [Figure 14] FIG. 14 is a schematic perspective view of a conduit array for fluid transport in a surgical arm for removing heat from a capsule assembly, according to an embodiment of the present invention. [Figure 15] FIG. 15 is a schematic perspective view of a conduit array for fluid transport in a surgical arm for removing heat from a capsule assembly, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0071] The present invention will now be described, by way of example only, with reference to the accompanying drawings. Referring now in detail and specifically to the drawings, it is emphasized that the illustrated features are presented by way of example only for the purpose of illustrative discussion of preferred embodiments of the invention, and to provide what is believed to be the most useful and readily understandable explanation of the principles and conceptual aspects of the invention. In this regard, no attempt has been made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, and the description taken together with the drawings will make apparent to those skilled in the art how several forms of the invention may be embodied in practice. Like reference characters are typically used throughout the drawings to designate like elements.

[0072] NOTE: Throughout this disclosure, subscripted reference numbers (e.g., 101) or letter-modified reference numbers (e.g., 100a) may be used to designate multiple separate appearances of an element in a single drawing. For example, 101 is one appearance (of multiple appearances) of element 10, and similarly, 100a is one appearance (of multiple appearances) of element 100.

[0073] According to embodiments, a mechanical surgical arm can have a surgical device attached or otherwise connected to its distal end. The surgical device can be permanently attached or removably (i.e., detachably) attached. In some embodiments, a surgical device can be detached from the arm after surgical use and replaced with another device at the distal end of the arm, and / or the detached device can be reused on the same or a different arm after sterilization. Alternatively, or additionally, the surgical device can be detached after surgical use and separately sterilized. For example, it can be autoclaved and then returned to the distal end of the arm for repeated use. Alternatively, or additionally, the surgical device can be permanently attached to the surgical arm, and the entire arm can be sterilized for repeated use.

[0074] The "distal" end of an arm is used herein to mean the end to which a surgical device is connected, i.e., the end that is furthest from the operator or user of the surgical apparatus that comprises the arm in a typical surgical procedure. During a surgical procedure, the distal end is the end of the arm that first enters the patient's body. The term "distal" is also used herein to indicate a direction toward the distal end. "Proximal," as used herein, clearly refers to an end or direction that is opposite the distal end or distal direction.

[0075] The term "mechanical arm" is used herein to indicate that the arm comprises mechanically controllable parts and can generally be remotely controlled using a control unit or input device mechanically and / or electronically connected to the arm. It may be desirable for a surgical arm to be sized and / or shaped to be suitable for insertion into the human body. For example, the arm can be sized and / or shaped to be suitable for insertion through a laparoscopic port and / or for performing laparoscopic surgery. For example, the arm can be sized and / or shaped to be suitable for insertion through a natural body orifice, such as the vagina, anus, trachea, esophagus, or ear canal. The arm can be flexible and / or articulated. The arm can be mechanical. The term "flexible arm" is used herein to mean that at least a portion (or portions) of the arm can bend, i.e., bend and / or pivot, to a desired angle or direction. Bending includes multiple bends to form an "S" shape or other shape, and arching, i.e., bending back more than 180°. The term "articulated arm" is used to mean that the arm includes one or more "joints," i.e., mechanical assemblies that are capable of bending and / or pivoting. Thus, there is much overlap between the use of the terms "flexible arm" and "articulated arm," and for most or all purposes, both flexible and articulated arms are suitable for practicing the present invention.

[0076] Use of the term "disposed within" throughout this disclosure and the appended claims should be understood to interchangeably include either "disposed completely within" or "disposed partially within."

[0077] One example of a surgical device for use with a surgical arm is an endoscopic capsule that can be inserted into the body to provide medical personnel with images of internal organs. The endoscopic capsule can include, but is not limited to, an imaging device (e.g., an imaging sensor), illumination and / or imaging components, and / or other electronic components. Non-limiting examples of imaging components or devices are “chip-on-tip” cameras or “chip-on-tip” devices (e.g., sensors and / or other components) that can incorporate an imaging sensor. Chip-on-tip devices are particularly suitable for incorporation into endoscopic capsules located at the distal tip of a surgical arm. The capsule can also include a light source, such as a light-emitting diode (LED), to illuminate the internal organs imaged by one or more imaging components. Some or all of these components can generate heat during surgery and during pre- and / or post-surgical use, which can result in the need to remove excess heat from the capsule to allow surgery or other uses of the capsule to continue without risk from “hot spots.” It may be desirable to provide such mechanical arms with a heat removal system to prevent hot spots. Hot spots may form at the distal end of the arm where heat-generating components may be present, or elsewhere along the arm's length (e.g., too much heat may be transferred too quickly during heat removal, which may manifest as localized hot spots elsewhere in the arm itself or on the surface of the arm). Undesirable hot spots are, for example, locations where the arm or components of the arm may reach high localized temperatures, e.g., 41°C or higher, or 50°C or higher. Thus, the heat removal system is designed to maintain temperatures below either or both of these thresholds.

[0078] Referring now to the figures, and particularly to FIG. 1 , arm unit 204 includes a proximal end at which support unit 223 is attached to arm 102 and a distal end at which a surgical device, such as endoscopic capsule assembly 305, is attached to arm 102. The example of an endoscopic capsule assembly is intended to be non-limiting, as any suitable heat generating device may be used in practicing embodiments of the present invention. Bendable section 200 of arm 102 is located along the arm's length closer to the distal end. In embodiments, arm 102 can be at least 50 cm long, or at least 100 cm long, or at least 120 cm long, or at least 150 cm long. In embodiments, bendable section 200 can be at least 50 cm long, or at least 100 cm long, or at least 120 cm long, or at least 150 cm long.

[0079] 2A and 2B, the bendable portion 200 of the arm 102 can include a series of laminated links 199 that provide external flexibility to the arm 102. In one example of the plurality of laminated links 199 in the bendable portion 200 of the arm 102, one or more segments of the arm 102 or bendable portion 200 can bend at an angle θ of at least 90° relative to the central axis centerline CL. In some embodiments, the bendable arm section can be configured to bend at least 120°, or at least 150°, or at least 180°, at least 210°, at least 240°, or at least 270°. In some embodiments, the bendable arm section can be configured to bend (i) through an angle of at least 90°, or at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, or at least 170°, or at least 180°, or at least 190°, or at least 200°, or at least 210°, or at least 220°, or at least 230°, or at least 240°, or at least 250°, or at least 260°, or at least 270°. In some embodiments, the bendable portion 200 of the arm 102 can comprise non-contiguous segments. In other words, the bendable portion 200 can comprise multiple bendable portions with or without intervening non-bendable segments. NOTE: Angle of bend or deflection, throughout this specification and the claims appended hereto, means the angle measured between the centerline of the non-bendable portion of an arm proximal to one or more bent flexible elements and / or bendable sections, and the centerline of the non-bendable portion of the same arm distal to the same bent flexible element(s) and / or bendable sections, as illustrated in FIG. 2B.

[0080] To maintain the bending capacity of the arm, it is important that the components of the heat removal system installed in the arm have a similar bending capacity. It may be desirable for the heat removal system and its components to be configured for use with the arm 102, such as the example arm of FIGS. 2A and 2B. For example, when employing conduits (e.g., tubing, pipes, etc.) to carry heat removal fluid, it may be desirable for the conduits to be sufficiently flexible to maintain serviceability when the arm 102 is bent to its fullest extent. In embodiments of the present invention, the conduits used to carry the heat removal fluid retain their fluid carrying capacity throughout their respective sections. In some embodiments, these capacities may decrease by 30% or less, or 20% or less, or 10% or less when the flexible / articulated arm is bent to its fullest extent. In embodiments, the conduits may be fabricated from multi-layer tubing. The multi-layer tubing may include additional reinforcing / support layers between layers of flexible material. The support layers may include, by way of non-limiting example, polymer-based wire, e.g., nylon wire.

[0081] The mechanical properties, e.g., flexibility, of the arm 102 and the conduits running longitudinally therethrough can be evaluated in terms of the minimum radius of curvature of the arm 102. Any portion or segment of the bendable section 200 of the arm 102 can be bent to a radius of curvature R, which, for purposes of this disclosure, is calculated as the radius of curvature about a central axis, or centerline CL, as shown in FIG. 3 for clarity. In embodiments, the lower limit of the radius of curvature R can be defined by the size and particular design of the bendable section and its constituent links, as well as by the diameter D of the arm 102. For example, the radius of curvature R can be limited to be at most three times the diameter of the arm 102, or at most two times the diameter of the arm 102, or at most 1.5 times the diameter of the arm 102, or at most 1.25 times the diameter of the arm 102.

[0082] The diameter D of the bendable section 200 (or any segment thereof) of a mechanical surgical arm 102 suitable for surgical procedures, particularly minimally invasive surgical procedures, can range from 6 to 12 mm, or 7 to 11 mm, or 8 to 10 mm, or 8 to 9 mm. Different segments can be designed to have different D values. The "length" of the link 199, i.e., the length when assembled into the unbent bendable section 200, can range from 1.5 to 4 mm, or 2.0 to 3.25 mm, or 2.25 to 2.75 mm. Each link 199 can accommodate an arc of 5° to 15°, or 6° to 13°, or 7° to 11°, or 8° to 10° when the corresponding bendable section 200 (or segment thereof) is maximally flexed or bent. The resulting radius of curvature R can be in the range of 10-20 mm, or 11-16 mm, or 12-15 mm, or 13-14 mm. In some embodiments, the bending of the arms can be limited by the flexibility of the conduit of the heat removal system, in which case the resulting radius of curvature R can be in the range of 10-30 mm, or 15-20 mm.

[0083] Referring now to FIG. 4 , capsule 320 includes a circumferential outer surface 321 and an encapsulation 323 (not shown in FIG. 4 ) having a distal outer surface 322. The periphery is illustrated as cylindrical for convenience, but as previously mentioned, the cross-sectional shape is not critical. Furthermore, the ratio of length to width or thickness and the regularity of the outer surface are all non-limiting examples for ease of illustration. Distal outer surface 322 includes at least an outer portion of each of one or more electronic and / or imaging components 325. In embodiments, the capsule can use “chip-on-tip” imaging and / or illumination technology for endoscopic applications. Those skilled in the art will understand that capsules with electronic and / or imaging components can be used for other purposes and are within the scope of the present invention. Capsule 320 is preferably sealed to be fluid-tight, and in preferred embodiments, is fluid-tight against, for example, cooling fluids for removing heat from the capsule or water vapor at temperatures and pressures used in autoclave sterilization. Non-limiting examples of temperatures and pressures used for autoclave sterilization include 115°C at 690 mbar (millibar gauge), 121°C at 1034 mbar, and 132°C at 1862 mbar. Accordingly, capsule 320 is preferably autoclavable in that it remains fluid-tight against water vapor at one or more of the aforementioned examples of temperatures and pressures used for autoclave sterilization. Furthermore, capsule 320 is preferably repeatedly autoclavable in that it remains fluid-tight against water vapor at one or more of the aforementioned examples of temperatures and pressures used for autoclave sterilization for at least 10 cycles, or at least 25 cycles, or at least 50 cycles, or at least 100 cycles.

[0084] Reference is now made to FIGS. 5 and 6. FIG. 5 illustrates a capsule assembly 305 mounted on the distal end of the mechanical arm 102. The endoscopic capsule assembly 305 can have any practical cross-section, with the capsule shape being merely a design choice. Examples of elliptical and circular cross-sections are shown in the various figures, and no particular significance should be attached to the application of either design choice in any of the examples described herein. While FIG. 5 illustrates a capsule assembly 305 with a length that appears much longer than its width or thickness, and FIG. 6 illustrates a capsule assembly 305 with a length that appears much smaller compared to that of FIG. 5, both figures are merely schematic, and the respective dimensions shown are not intended to be meaningful. In both FIGS. 5 and 6, the exterior of the arm 102 is transparent for illustrative purposes, revealing the first and second fluid conduits 340A, 340B, and the central core 380. The central core 380 illustrated herein is a simplified representation of the various elements installed in the surgical arm 102 and does not represent an actual single delivery device. Thus, the central core 380 can include one or more individual longitudinal elements along with other arm components. In embodiments, the central core 380 is disposed within the mechanical surgical arm and generally runs along a portion, most, or all of the arm's length. The central core 380 can include, for example, but is not limited to, a power carrier for powering the surgical device (e.g., the power components of the distally attached capsule assembly 305), an electronic transmission medium for issuing control commands to the capsule assembly 305 and / or transmitting data (e.g., images) from the capsule assembly 305, and mechanical elements for flexing the arm 102. The first conduit 340A is provided for transporting a heat removal fluid to the capsule assembly 305. In embodiments, the fluid (not shown) can include, for example, but not exclusively, a heat transfer gas such as air, nitrogen, or helium, or a liquid such as, for example, an oil-based or water-based liquid. The second conduit 340B is provided for transporting the heat removal fluid away from the capsule assembly 305.

[0085] The capsule assembly 305 can include a capsule 320 disposed therein, such as capsule 320 in FIG. 4 , which is shown in a cutaway view in FIG. 6 . As can be seen in FIG. 6 , the outer shell 310 surrounds the capsule 320 to form an annular gap between the capsule 320 and the outer shell 310. The term “annular” as used in this disclosure and the appended claims is intended to be broader than the strict literal meaning of “circular” and should be interpreted as meaning “surrounding,” as in “annular gap 311 surrounds capsule 320” in FIG. 6 . In FIG. 6 , the capsule 320 is illustratively depicted as elliptical, and the capsule 320 is not necessarily circular in cross section. Furthermore, the annular gap 311 may, in some designs, have a non-uniform thickness along the circumference, i.e., the perimeter, of the capsule 320 and / or the (longitudinal) length of the capsule 320 or capsule assembly 305. Structurally, the outer shell 310 as shown has three particular design features: The annular gap 311 between the shell 310 and the capsule 320 serves to hold the capsule 320 in a desired position within the shell 310 while maintaining the gap 311 as needed, and seals the annular gap 311 from the environment, at least circumferentially and at the distal end. The function of the gap 311 is described below in connection with FIGS. 8-10. Still referring to FIGS. 5 and 6, the shell 310 may, in some designs, be formed to include a distal covering 318. The openings 316 in the distal covering 318 may be formed to provide a seal around each of the electronic and / or imaging components 325 on the distal outer surface 322 of the capsule 320, thus sealing the capsule's annular gap 311 from the environment. Such a seal is preferably liquid-tight. In some embodiments, the seal is also air-tight. In other designs, including the design shown in FIG. 7, the shell may not have a distal covering 318. In such a design (not shown), the distal outer surface 322 of the capsule 320 may be exposed to the environment, and the capsule is instead sealed around the capsule periphery (e.g., at or near the distal end of the capsule 320).In some designs, the capsule may be suitably seated within annular "rings" at the distal and proximal ends, respectively, of the shell 310. In an embodiment (not shown), the rings are formed as part of the shell 310 and serve to hold the capsule 320 in a desired position within the outer shell 310 while maintaining a gap 311 around the capsule 320 for most of its length (e.g., except where the circumferential surface 321 of the capsule engages the "ring"). In the example of FIG. 7, the capsule 320 is sealed at its distal end to a distal outer surface 322 and to a connector element 327 that connects the capsule 320 to the arm 102.

[0086] Reference is now made to FIGS. 8 and 9. FIG. 8 incorporates the fluid flow scheme on the cutaway view of FIG. 6, and FIG. 9 is a schematic cross-sectional view of the proximal portion of capsule assembly 305. Inflow arrow 140A indicates fluid flow into the interior of capsule assembly 305, specifically, into annular gap 311 surrounding capsule covering 323. As shown in FIG. 8, fluid enters the interior of capsule assembly 305 through distal opening 345A of first fluid conduit 340A. As indicated by through-flow arrow 150 in both FIGS. 8 and 9, fluid flows around capsule 320 and exits the interior of capsule assembly 305 through distal opening 345B of second fluid conduit 340B. The direction of fluid flow out of the interior of capsule assembly 305 is indicated by outflow arrow 140B. As is apparent from FIGS. 8 and 9, the illustrated elements can be used to provide and maintain flow paths for fluid. Here, the flow path includes (i) distal flow through first fluid conduit 340A to its distal opening 345A, (ii) "annular" (as defined herein) flow through the portion of the interior of capsule assembly 305 not occupied by capsule 320, and (iii) proximal flow through second fluid conduit 340B and out its distal opening 345B. Fluid flow can be maintained by positive pressure applied to or within first fluid conduit 340A. The portion of the fluid flow path inside the capsule assembly inner wall and external to any of the conduits, i.e., the portion indicated by arrow 150, has a length of at least 5 mm or at least 1 cm. This length can be selected to ensure that the fluid flow is adequately distributed through capsule assembly 305 and contacts as much of outer surface 321 of capsule covering 323 as possible. In some embodiments, as shown in Figures 11 and 12A, the flow path 348 can be shaped to route fluid flow from the distal opening 345A of the first fluid conduit 340A to the gap 311 and from the gap 311 to the distal opening 345B of the second fluid conduit 340B.

[0087] It should be noted that the conventions used in these figures, e.g., the "first" and "second" conduits or openings, and the particular left-to-right direction of flow through the annular gap, are merely for convenience and are not critical, and in other instances the left-right orientation and flow direction are switched.

[0088] FIG. 10 is a cross-sectional view of another example of a capsule assembly 305 according to an embodiment. An annular gap 311 surrounds the capsule 320 so as to be interposed between the capsule 320 and the outer shell 310. The outer shell is preferably made of a thermally insulating material, such as a thermoplastic characterized by a thermal conductivity of less than 1 W / mK or less than 0.5 W / mK. This characteristic includes, but is not limited to, thermoplastic polymers such as polypropylene, acrylonitrile butadiene styrene (ABS), polysulfone, or polyethylene. The capsule 320 includes an outer covering 323 having an outer surface 321. From another perspective, it will be apparent to one skilled in the art that the "outer covering 323" of the capsule 320 is the "inner shell" of the capsule assembly 305 in that it is surrounded by the outer shell 310. Therefore, the term "internal shell" as used in this disclosure or the appended claims can be understood to mean an encapsulation or "external encapsulation" when the capsule is installed in a capsule assembly as used herein, which can refer to an outer encapsulation of the capsule that is surrounded by or configured to be surrounded by an outer shell. The outer encapsulation 323 is preferably made of a material characterized by a thermal conductivity of at least 200 W / mK, such as aluminum, copper, silver, or gold. The arrangement of the high thermal conductivity outer encapsulation 323 and the low thermal conductivity outer shell 310 is useful for transferring heat from within the capsule 320 into the annular gap 311 while preventing transferred heat from passing through the outer shell 310 and leaving the capsule 320. The arrangement of the electronic component 330 of the capsule 320 containing the electronic component in contact with the inner capsule casing 329 is useful for transferring heat from the component 330 to the encapsulation casing 323 and / or for providing internal structural support for the encapsulation casing 323. The inner capsule casing 329 is preferably made from a material characterized by a thermal conductivity of at least 200 W / mK, such as aluminum, copper, silver, or gold.

[0089] Figure 11 is another cross-sectional view of capsule assembly 305 of Figure 10 , orthogonal to the cross-sectional view of Figure 10 , to better illustrate fluid flow into, through, and out of capsule assembly 305. Figure 11 shows an example configuration of flow channel 348. Flow channel 348 routes fluid inflow 140A from distal opening 345A of first fluid conduit 340A to gap 311, and fluid outflow 140B from gap 311 to distal opening 345B of second fluid conduit 340B on the opposite side of capsule assembly 305. As discussed above, through-flow 150 arrows represent the circumferential movement of fluid through annular gap 311.

[0090] 12A shows capsule 320 of the arm of FIG. 7 with both outer shell 310 and capsule covering 323 of capsule assembly 305 removed, revealing inner capsule casing 329, proximally disposed connector element 327 connecting capsule 320 to arm 102, and distal cap 349. The distal cap includes a structural feature that encloses at least a portion of each of electronic and / or imaging components 325 while leaving distal surfaces of electronic and / or imaging components 325 exposed. For clarity, it is noted that distal cap 349 is a component of capsule 320, while distal covering 318 is an optional structural feature of outer shell 310. Capsule 320 generally includes distal cap 349 regardless of whether parent capsule assembly 305 includes outer shell 310 shaped to have distal covering 318. In some embodiments, as shown in FIG. 12A , the outward-facing surface of the inner capsule casing 329 includes grooves 341, striations, or other equivalent channels or troughs. Thermal paste (not shown) can be applied within these to improve heat conduction from the inner capsule casing 329 to the encapsulation 323 (not shown in FIG. 12A ). Thermal paste, such as an alumina-based thermal paste or any other thermal gel with a thermal conductivity greater than 5 W / mK or greater than 7 W / mK, can be spread in a thin layer on the outer surface of the inner capsule casing 329, in addition to the amount applied within the grooves. Heat-generating components (including electronic and / or optical components 325 or other electronic components 330 within the capsule, as particularly shown in FIGS. 10 and 11 ) are in contact with the inner capsule casing 329, which is in contact with the encapsulation 323, optionally via thermal paste, to improve overall heat removal from the capsule 320. As described herein above, both the inner capsule casing 329 and the encapsulation 323 are made from a metallic material characterized by high thermal conductivity, and therefore, according to embodiments, heat is efficiently transferred from the various components 325, 330 to the outer surface 321 of the encapsulation 323, from where it is removed by convection as described herein. Figure 12B shows a detail (Detail A) of Figure 12A with the distal cap 349 removed for illustrative purposes.The inner capsule casing 329 can be formed to be in direct contact with one or more of the distally located electronic and / or optical components 325, as clearly shown with respect to components 325A, 325D in FIG. 12B.

[0091] Reference is now made to Figures 13-15, which show schematic illustrations of examples of components of a surgical device.

[0092] FIG. 13 shows a conduit array comprising first and second conduits 340A, 340B. The conduits have distal openings 345A, 345B, respectively. While the conduits 340A, 340B are shown as being positioned alongside and facing each other across the central core 380, the relative spacing of the two conduits 340A, 340B can vary according to design needs. In embodiments, the conduit array can be positioned within the surgical arm 102, for example alongside an element of the central core 380, and run along some, most, or all of the section of the arm 102. In embodiments, the conduit array can be positioned within the bendable section 200 of the surgical arm 102 and run along some, most, or all of the section of the bendable section 200. As shown, the portion of the conduit array within the arm can comprise two (or more) conduits 340 such that the conduit array straddles the arm or a portion thereof at least twice. The conduit array is preferably formed to have suitable longitudinal flexibility using materials that provide adequate resistance to "choking off" or "choking off" of fluid transport within one or more of the constituent conduits when bent in accordance with the arm flexibility requirements as described herein above. For example, bendable section 200 can be bent at least 90°, or at least 135°, or at least 180°, at least 210°, at least 240°, or at least 270°. In other words, any conduit 340 of the conduit array can be bent to any of the radii of curvature discussed herein while still being able to maintain fluid flow therethrough.

[0093] 13, the first and second conduits 340A, 340B comprise a single continuous conduit (e.g., a single flexible tube), although in other embodiments, the conduits 340A, 340B may comprise multiple tubes joined together. The conduit array is in mechanical communication with a pump 390. The pump 390 is preferably a positive displacement pump. An example of a suitable pump is a peristaltic pump, which can be deployed to create fluid flow through the conduit array without direct physical contact with the fluid itself. In some embodiments, the pump 390 can be a centrifugal pump, such as, for example, an impeller pump.

[0094] 14, a conduit array comprising first and second conduits 340A, 340B is used to facilitate the flow of fluid that removes heat from capsule 320 disposed within outer shell 310 and collectively form capsule assembly 305. Capsule assembly 305 is shown schematically without a sealing element at its distal end, e.g., distal coating 318. The fluid flow path from distal openings 345A, 345B of first and second conduits 340A, 340B through annular gap 311 within capsule assembly 305 is not shown but may follow flow paths 140A, 140B, 150 illustrated in FIGS. 8, 9 and / or 11.

[0095] FIG. 15 shows a conduit array including first and second conduits 340A, 340B, which are also used to convey a fluid flow to remove heat from the capsule 320 disposed within the outer shell 310 to form the capsule assembly 305. In FIG. 15, the closed (e.g., liquid-tight and / or fluid-tight) loop for fluid flow includes the first conduit 340A, the annular gap 311 within the capsule assembly (and around the capsule 320), and the second conduit 340B. The fluid flow path is continuous throughout the conduit assembly and is discontinuous with respect to the capsule assembly 305 as it traverses the interior of the capsule assembly 305. The portion of the flow path within the capsule assembly 305 preferably equals at least 50%, or at least 75%, or at least 90% of the diameter of the inner wall of the capsule assembly 305.

[0096] As previously disclosed herein, the conduit array traverses some, most, or all of the section of the arm 102. The intra-arm portion of the closed flow loop can have a length that is at least 75%, or at least 85%, or at least 95%, or at least 99% of the length of the closed flow loop.

[0097] The pump 390 maintains a positive pressure in the first conduit 340A to maintain flow throughout the loop. In embodiments, the portion of the conduit array in contact with the pump 390 is external to the arm. For example, the pump can be within the support unit 223. The actual location of the pump is a function of design choice. In a non-limiting example of a surgical apparatus design, the pump itself can be located within the support unit 223 and can be externally powered. Or, the pump can be external to both the arm 102 and the support unit 223, but powered from within the support unit 223 or elsewhere.

[0098] 15, and generally from within capsule assembly 305, is accomplished as follows: Fluid flows through first conduit 340A of the conduit array (by pumping action of pump 390) and out a distal outlet 345A of conduit 340A into annular gap 311 within the capsule assembly between capsule 320 and outer shell 310. Pump 390 is thus part of a circulation mechanism configured to introduce fluid into annular gap 311 via first distal opening 345A of conduit 340A and to expel the fluid from annular gap 311 via second distal opening 345B of conduit 340B, such that the fluid passes through annular gap 311 to absorb heat generated by heat-generating components (e.g., electronic components and / or imaging components 325). Fluid flows through narrow annular gap 311. The annular gap preferably has a thickness of between 0.05 mm and 0.3 mm, or optionally between 0.05 mm and 0.4 mm, or between 0.1 mm and 0.3 mm, or between 0.1 mm and 0.4 mm, or between 0.2 mm and 0.3 mm, or between 0.2 mm and 0.4 mm, over at least half the circumference of capsule 320, or for at least half the length of the capsule, or for at least 1 cm, at least 2 cm, at least 3 cm, at least 4 cm, or at least 5 cm of the length of capsule 320. In embodiments, the fluid flow through the interior of capsule assembly 305 in terms of fluid volumes per second is between 10 and 200 ml / sec, or between 30 and 150 ml / sec, or between 50 and 100 ml / sec.

[0099] In embodiments, elements of the fluid transport regime (components and pump design as well as fluid volume and flow rate) are selected such that the fluid "passes" longitudinally through the annular gap 311 (i.e., from the distal outlet 345A of the first conduit 340A in the proximal portion of the capsule assembly 305) for a distance equal to at least 50%, or at least 70%, or at least 90% of the section of the capsule assembly 305, flowing around and removing heat from the capsule before exiting via the second distal outlet 345B of the second conduit 340B. Heat removal is achieved primarily via forced convection heat transfer from the capsule to the flowing fluid. During operation of the heat removal system while the arm is in motion, the fluid flow preferably provides a heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid of 10 to 200 W / m during operation of the arm unit 204. 2 k, or 50-100 W / m 2 k, where the area component means the surface area of ​​the capsule 320.

[0100] The heated fluid traverses the second conduit 340B, which, like the first conduit 340A, spans some, most, or all of the section of the arm 102 and loses heat to the conduit walls. The conduit wall material is selected for its heat transfer / heat absorption characteristics, in addition to the flexibility criteria mentioned above. For example, if the heat transfer coefficient of the conduit material is too high, the heated flowing fluid may lose heat too quickly, potentially creating hot spots in the second conduit 340B proximal to the capsule assembly. If the heat transfer coefficient of the conduit material is too low, the heated flowing fluid may lose heat too slowly, potentially resulting in incomplete cooling of the fluid by the conduit walls even after passing through the entire conduit assembly to the pump 390 and back to the distal capsule assembly 305. In some designs, all of the heat removed from the capsule is absorbed by the walls of the second conduit 340B as the fluid flows proximally from the capsule assembly 305 to the pump 390. In some designs, heat is absorbed in the walls of both the second conduit 340B (as the fluid flows proximally from the capsule assembly 305 to the pump 390) and the first conduit 340A (as the fluid flows distally from the pump 390 back to the capsule assembly 305). In embodiments, at least 70%, or at least 80%, or at least 90%, or at least 95%, or at least 99% of the heat absorbed by the fluid in the capsule assembly 305 is lost as the heated fluid traverses the conduit array.

[0101] It will be apparent to one skilled in the art that any of the features described in connection with any of the figures may be combined with one another within the scope of the present invention, even if not explicitly combined in this disclosure.

[0102] First Additional Consideration of the Embodiment

[0103] According to an embodiment, the surgical instrument comprises: (a) A flexible and / or articulated arm having (i) a bendable portion configured to bend through an angle of at least 90°, or at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, or at least 170°, or at least 180°, or at least 190°, or at least 200°, or at least 210°, or at least 220°, or at least 230°, or at least 240°, or at least 250°, or at least 260°, or at least 270°, and / or (ii) a radius of curvature after bending that is at most 3 times the diameter of the bendable portion, or at most 2 times the diameter of the bendable portion, or at most 1.5 times the diameter of the bendable portion, or at most 1.25 times the diameter of the bendable portion. (b) a capsule assembly connected distally to the mechanical arm, the capsule assembly including a fluid-tight shell defining an interior of the capsule assembly, the heat-generating components being disposed within the capsule assembly; (c) A forced thermal convection system comprising: (i) one or more conduit sections in fluid communication with the capsule assembly interior; and (ii) a pump mechanically coupled to a fluid disposed within the one or more conduit sections.

[0104] In some embodiments, the flexible arm may comprise a mechanical arm. In some embodiments, the flexible arm may be articulated.

[0105] In some embodiments, the surgical instrument can be an imaging instrument. In some embodiments, the surgical instrument can comprise a tip-on-chip imaging instrument having a tip disposed at its distal end. In some such embodiments, the surgical instrument can further comprise a light emitting diode.

[0106] In some embodiments, the heat-generating component can be selected from the group consisting of an image sensor, an image processor, an electrode, an illumination source, a laser diode, an ultrasonic transducer, and a data processing element. In some such embodiments, the image sensor can be a CMOS image sensor. In some such embodiments, the lighting device can include at least one light-emitting diode.

[0107] In some embodiments, the capsule assembly can include a capsule disposed in the capsule assembly to form an air gap between the capsule and the shell, and heat is removed through the air gap formed between the capsule assembly inner wall and the conduit array.

[0108] In some embodiments, the pump can be a positive displacement pump. In some embodiments, the pump can be a centrifugal pump.

[0109] Second Additional Consideration of the Embodiment

[0110] According to an embodiment, a surgical apparatus is disclosed, the surgical apparatus comprising: a surgical instrument; (a) Flexible arm. (b) a capsule assembly connected distally to the arm, the capsule assembly including a fluid-tight shell defining an interior of the capsule assembly, the heat-generating component being disposed within the capsule assembly; (c) a conduit array (the conduit array and a portion of the interior of the capsule assembly external to the conduit array collectively form a liquid-tight closed flow loop for convective removal of heat from the interior of the capsule assembly, the liquid-tight closed flow loop comprising one or more arm-positioned sections of the conduit array, the one or more arm-positioned sections (i) disposed at least partially along and / or within the arms, and (ii) collectively longitudinally spanning at least a majority of the longitudinal length of the flexible arms twice and in parallel);

[0111] In some embodiments, the surgical apparatus may further include a positive displacement pump for flowing fluid through the liquid-tight closed loop to remove heat generated by one or more imaging and / or electronic components from within the capsule assembly by forced convection.

[0112] In some embodiments, the arm placement section can have a length that is at least 75%, or at least 85%, or at least 95%, or at least 99% of the length of the liquid-tight closed flow loop.

[0113] In some embodiments, the portion of the liquid-tight closed flow loop inside the capsule assembly and external to the conduit array can have a length of at least 5 mm or at least 1 cm. In some embodiments, the portion of the liquid-tight closed flow loop inside the capsule assembly and external to the conduit array can have a length equal to at least 50%, or at least 75%, or at least 90% of the diameter of the capsule assembly inner wall.

[0114] In some embodiments, the pump can be selected to provide a fluid flow rate of 10-200 ml / sec, or 30-150 ml / sec, or 50-100 ml / sec through the interior of the capsule assembly, forming a liquid-tight closed flow loop.

[0115] In some embodiments, the capsule can be fixedly positioned within the capsule assembly to define an annular region outside the capsule and within the shell.

[0116] In some embodiments, one or more imaging and / or electronic components can be disposed within the capsule such that the imaging and / or electronic components are sealed from the annular region, hi some embodiments, the capsule is repeatedly autoclavable.

[0117] In some embodiments, an annular region gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 5 cm of the capsule assembly length, and / or for at least 50% of the capsule assembly length. In some embodiments, an annular region gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 5 mm of the capsule assembly length, or at least 10 mm, or at least 15 mm, or at least 25 mm, and / or for at least 50% of the capsule assembly length, and / or for at least 180 degrees of the capsule circumference.

[0118] In some embodiments, the fluid can be caused to flow through the conduit array into the annular region, with a portion of the flowing fluid passing longitudinally through the annular region for at least 50% of the length of the capsule assembly.

[0119] In some embodiments, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid during operation of the surgical device is between 10 and 200 W / m 2 k or 50-100W / m 2 A pump can be selected to create a fluid flow that maintains a fluid flow between k and 100 kJ, forming a liquid-tight closed flow loop.

[0120] In some embodiments, the pumps can be selected to form a liquid-tight closed flow loop during operation of the surgical apparatus to maintain a maximum external surface temperature of the capsule assembly below 50° C. In some embodiments, the pumps can be selected to form a liquid-tight closed flow loop during operation of the surgical apparatus to maintain a maximum external surface temperature of the capsule assembly below 41° C.

[0121] In some embodiments, the arm can have a length of at least 50 cm. In some such embodiments, the arm can include a remotely controllable portion having a length of at least 50 cm.

[0122] In some embodiments, the conduit array may comprise a single conduit.

[0123] In some embodiments, the pump can be a peristaltic pump.

[0124] In some embodiments, the heat generating component may include at least one of an imaging component and an electronic component.

[0125] In some embodiments, the arm may be mechanical and / or articulated.

[0126] Third Additional Consideration of the Embodiment

[0127] According to an embodiment, a surgical apparatus is disclosed, the surgical apparatus comprising: (a) Flexible arm. (b) a capsule assembly connected distally to the arm, the capsule assembly comprising a fluid-tight shell defining an interior of the capsule assembly, with one or more heat-generating imaging and / or electronic components disposed within the capsule assembly; (c) one or more conduit sections (i) disposed at least partially along and / or within the arms, (ii) collectively spanning longitudinally at least a majority of the longitudinal length of the arms twice and in parallel, and (iii) reaching into the capsule assembly. The surgical apparatus further comprises: (d) A pump for forced thermal convection cooling of the interior of the capsule assembly, the pump being mechanically coupled to a fluid disposed within one or more conduit sections. The surgical device is configured such that the one or more conduit sections are part of a liquid-tight closed fluid flow loop that is thermally coupled to the capsule assembly.

[0128] In some embodiments, the pump can be selected to provide a fluid flow rate of 10-200 ml / sec, or 30-150 ml / sec, or 50-100 ml / sec through the interior of the capsule assembly, forming a liquid-tight closed flow loop.

[0129] In some embodiments, the liquid-tight closed fluid loop can comprise a portion of the capsule assembly interior that is external to one or more conduit sections.

[0130] In some embodiments, the capsule can be fixedly positioned within the capsule assembly to define an annular region outside the capsule and within the shell.

[0131] In some embodiments, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid during operation of the surgical device is between 10 and 200 W / m 2 k or 50-100W / m 2 A pump can be selected to create a fluid flow that maintains a fluid flow between k and 100 kJ, forming a liquid-tight closed flow loop.

[0132] In some embodiments, the pumps can be selected to maintain a maximum external surface temperature of the capsule assembly below 50° C. during operation of the surgical apparatus, forming a liquid-tight closed flow loop. In some embodiments, the pumps can be selected to maintain a maximum external surface temperature of the capsule assembly below 41° C. during operation of the surgical apparatus, forming a liquid-tight closed flow loop.

[0133] In some embodiments, the arms can have a length of at least 50 cm.

[0134] In some embodiments, the arm can include an arm section configured to bend at least 90°, or at least 135°, or at least 180°, or at least 210°.

[0135] In some embodiments, the arm section can have a length of at least 50 cm.

[0136] In some embodiments, one or more of the conduit sections may comprise a single continuous conduit.

[0137] In some embodiments, the pump can be a peristaltic pump or an impeller pump.

[0138] Fourth Additional Consideration of the Embodiment

[0139] According to an embodiment, a surgical apparatus is disclosed, the surgical apparatus comprising: (a) Flexible arm. (b) a capsule assembly connected distally to the arm (the capsule assembly comprises an outer shell and a capsule disposed within the outer shell to form an annular gap between the outer shell and the capsule, the capsule including heat-generating electronic components and / or imaging components sealed therein from the annular gap); (c) first and second conduit sections, each having a first and second distal opening in direct fluid communication with the capsule assembly and in indirect fluid communication with each other through the annular gap, such that when fluid is discharged from the first distal opening into the interior of the capsule assembly, the fluid traverses the annular gap and is discharged from there to the second distal opening;

[0140] In some embodiments, an annular region gap thickness of between 0.05 mm and 0.3 mm can be maintained over at least 180 degrees of the capsule circumference for at least 5 cm of the length of the capsule assembly and / or for at least 50% of the length of the capsule assembly.

[0141] In some embodiments, the annular gap can have a thickness of at least 0.05 mm and up to 0.3 mm over at least 75%, or at least 90%, or at least 99% of the capsule circumference for at least 2 cm of the length of the capsule assembly, and / or for at least 20% of the length of the capsule assembly.

[0142] In some embodiments, the first and second distal openings can be at a distance of at least 5 mm or at least 1 cm from each other, hi some embodiments, the first and second distal openings can be at a distance from each other equal to at least 50%, or at least 75%, or at least 90% of the diameter of the capsule assembly inner wall.

[0143] In some embodiments, the capsule is repeatedly autoclavable.

[0144] In some embodiments, the arm can comprise an arm section configured to bend at least 90°, or at least 120°, or at least 150°, or at least 180°, or at least 210°, or at least 240°, or at least 270°.

[0145] In some embodiments, the first and second conduits can both be part of a single continuous conduit.

[0146] Fifth Additional Consideration of the Embodiment

[0147] According to an embodiment, a surgical apparatus is disclosed, the surgical apparatus comprising: (a) A flexible arm comprising an arm section configured to bend at least 90°. (b) A capsule assembly connected distally to the arm (the capsule assembly includes heat generating components that generate heat during operation of the surgical device). (c) a fluid transport system for removing heat from the capsule assembly (the fluid transport system comprising: (i) a pump positioned proximal to the arm section configured to bend; and (ii) a conduit array positioned at least partially within and / or along the arm so as to span at least the arm section configured to bend).

[0148] In some embodiments, the conduit array can form a flow path from the capsule assembly, through the pump distally, back to the capsule assembly, that is continuous proximally, and discontinuous within the capsule assembly.

[0149] In some embodiments, the arm section configured to bend can be configured to bend at least 120°, or at least 150°, or at least 180°, or at least 210°, or at least 240°, or at least 270°.

[0150] In some embodiments, the arm section configured to bend can include a cambered section configured to transition into and out of a cambered configuration.

[0151] In some embodiments, the pump can be a peristaltic pump.

[0152] In some embodiments, the fluid transport system can be selected to form a conduit array such that the fluid flow through the internal volume of the capsule assembly is between 10 and 200 ml / sec, or between 30 and 150 ml / sec, or between 50 and 100 ml / sec.

[0153] In some embodiments, when the arm configured to bend is bent, the flow path can remain continuous from the capsule assembly proximally, through the pump, and back to the capsule assembly distally.

[0154] In some embodiments, when an arm configured to bend bends, the fluid capacity of the flow path can be reduced by no more than 30%, no more than 20%, or no more than 10%.

[0155] In some embodiments, the capsule assembly can include a capsule containing a heat-generating component, and heat is removed from the capsule assembly by pumping fluid through a fluid transport system, which convectively absorbs heat from the capsule.

[0156] In some embodiments, the fluid transport system can be configured such that at least 70%, or at least 80%, or at least 90%, or at least 95% of the absorbed heat is lost by the pumped fluid as it traverses the conduit array.

[0157] In some embodiments, the fluid transport system can be configured such that a first portion of the absorbed heat is lost as the pumped fluid traverses proximally from the capsule assembly through the pump, and a second portion of the absorbed heat is lost as the pumped fluid traverses distally from the pump to the capsule assembly.

[0158] Sixth Additional Consideration of the Embodiment

[0159] According to an embodiment, a method for removing heat from a flexible surgical arm having a heat-generating illumination component and / or an imaging component disposed within a capsule assembly distally connected to the arm is disclosed, the method comprising the steps of: (a) thermally coupling a forced convection heat dissipation system to the capsule assembly, the forced convection heat dissipation system comprising: (i) a conduit array disposed at least partially within the arm, the conduit array having a heat removal fluid disposed therein; and (ii) a pump mechanically coupled to the fluid to induce said flow. (b) operating the pump to cause the fluid to flow (i) distally through a first conduit of the conduit array to the capsule assembly, (ii) by forced convection remove at least a portion of the heat generated by the illumination and / or imaging components from the capsule assembly, and (iii) proximally from the capsule assembly through a second conduit of the conduit array to dissipate at least a portion of the heat removed from the capsule assembly.

[0160] In some embodiments, the pump can be a peristaltic pump.

[0161] In some embodiments, at least 75%, or at least 85%, or at least 95%, or at least 99% of the length of the conduit array can be disposed within the arms.

[0162] In some embodiments, causing the fluid to remove at least a portion of the heat from the capsule assembly can include flowing the fluid through an interior volume of the capsule assembly that is external to the conduit array along a flow path having a length of at least 5 mm or at least 1 cm.

[0163] In some embodiments, the flow path through the interior volume of the capsule assembly and the exterior of the conduit array can have a length equal to at least 50%, or at least 75%, or at least 90% of the diameter of the inner wall capsule assembly.

[0164] In some embodiments, the fluid may be flowed through the interior of the capsule assembly at a flow rate of 10 to 200 ml / sec, or 30 to 150 ml / sec, or 50 to 100 ml / sec.

[0165] In some embodiments, a capsule comprising a heat-generating illumination component and / or an imaging component can be fixedly positioned within the capsule assembly to define an annular region outside the capsule and within the capsule assembly through which fluid flows.

[0166] In some embodiments, the heat-generating illumination and / or imaging components can be disposed within an encapsulation such that the heat-generating illumination and / or imaging components are sealed from the annular region.

[0167] In some embodiments, the capsule is repeatedly autoclavable.

[0168] In some embodiments, an annular region gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 5 cm of the capsule assembly length, and / or for at least 50% of the capsule assembly length. In some embodiments, an annular region gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 5 mm of the capsule assembly length, or at least 10 mm, or at least 15 mm, or at least 25 mm, and / or for at least 50% of the capsule assembly length, and / or for at least 180 degrees of the capsule circumference.

[0169] In some embodiments, a portion of the flowing fluid can pass longitudinally through the annular region for at least 50% of the length of the capsule assembly.

[0170] In some embodiments, the step of removing at least a portion of the thermal fluid flow from the capsule assembly comprises maintaining a heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid between 10 and 200 W / m during movement of the surgical arm. 2 k or 50-100W / m 2 k.

[0171] In some embodiments, removing at least a portion of the thermal fluid flow from the capsule assembly can include maintaining a maximum exterior surface temperature of the capsule assembly during operation of the surgical apparatus below 50° C. In some embodiments, removing at least a portion of the thermal fluid flow from the capsule assembly can include maintaining a maximum exterior surface temperature of the capsule assembly during operation of the surgical apparatus below 41° C.

[0172] In some embodiments, the arm can have a length of at least 50 cm. In some such embodiments, the arm can include a remotely controllable portion having a length of at least 50 cm. In some embodiments, the conduit array can comprise a single conduit.

[0173] Seventh Additional Consideration of the Embodiment

[0174] According to an embodiment, a surgical apparatus is disclosed, the surgical apparatus comprising: a surgical instrument; (a) A flexible arm comprising an arm section configured to bend at least 90°. (b) a capsule assembly connected distally to the arm (the capsule assembly includes an outer shell and a capsule disposed within the outer shell to form an annular gap between the outer shell and the capsule, the capsule including heat-generating electronic components and / or heat-generating imaging components that generate heat during operation of the surgical apparatus); (c) a forced convection heat removal system for removing heat from the capsule assembly, the heat removal system comprising: (i) a conduit array disposed at least partially within and / or along the arm so as to span at least the arm section configured to bend, the conduit arrays each having first and second distal openings in direct fluid communication with the capsule assembly and indirect fluid communication with each other through the annular gap, wherein when fluid disposed within the conduit array exits the first distal opening into the interior of the capsule assembly, the fluid traverses the annular gap and exits therefrom at the second distal opening; and (ii) a pump displaced proximally from the arm section configured to bend and mechanically coupled to the fluid.

[0175] In some embodiments, at least 85%, or at least 95%, or at least 99% of the length of the conduit array is disposed within the arms.

[0176] In some embodiments, the fluid flow path across the annular gap can have a length of at least 5 mm or at least 1 cm, hi some such embodiments, the fluid flow path across the annular gap can have a length equal to at least 50%, or at least 75%, or at least 90% of the inner diameter of the capsule assembly.

[0177] In some embodiments, the pumps can be selected and the conduit array can be configured to provide a fluid flow rate through the annular gap of 10-200 ml / sec, or 30-150 ml / sec, or 50-100 ml / sec.

[0178] In some embodiments, the capsule is repeatedly autoclavable.

[0179] In some embodiments, an annular gap thickness of between 0.05 mm and 0.6 mm can be maintained over at least 180 degrees of the capsule circumference for at least 5 cm of the capsule assembly length and / or at least 50% of the capsule assembly length. In some embodiments, an annular gap thickness of between 0.1 mm and 0.6 mm can be maintained over at least 5 mm of the capsule assembly length, or at least 10 mm, or at least 15 mm, or at least 25 mm, and / or at least 180 degrees of the capsule circumference for at least 50% of the capsule assembly length.

[0180] In some embodiments, when fluid is forced to flow through the conduit array into the annular gap, a portion of the flowing fluid passes longitudinally through the annular gap for at least 50% of the length of the capsule assembly.

[0181] In some embodiments, the heat transfer coefficient for convective heat transfer from the capsule surface to the flowing fluid during operation of the surgical device is between 10 and 200 W / m 2 k or 50-100W / m 2 The pumps can be selected and the conduit array can be configured to induce fluid flow that maintains a constant flow between k.

[0182] In some embodiments, the pumps can be selected and the conduit array configured to maintain a maximum exterior surface temperature of the capsule assembly below 50° C. during operation of the surgical apparatus.

[0183] In some embodiments, the pumps can be selected and the conduit array configured to maintain a maximum exterior surface temperature of the capsule assembly below 41° C. during operation of the surgical apparatus.

[0184] The present invention has been described using detailed descriptions, which are provided by way of example only and are not intended to limit the scope of the invention. The described embodiments have different features, not all of which are required in all embodiments of the invention. Some embodiments of the invention utilize only some of the features or possible combinations of the features. Those skilled in the art to which the present invention pertains will recognize variations of the described embodiments of the invention and embodiments of the invention comprising various combinations of the features noted in the described embodiments.

[0185] Any feature or combination of features described herein may be combined with any feature and combination described in U.S. Patent Application No. 15 / 915,237, filed March 8, 2018, published as U.S. Patent Application Publication No. 20180256246; U.S. Patent Application No. 15 / 454,123, filed March 9, 2017, published as U.S. Patent Application Publication No. 20170258539; and U.S. Patent Application No. 15 / 501,862, filed February 6, 2017, published as U.S. Patent Application Publication No. 20170239005, all of which are incorporated by reference herein as if fully set forth in their entireties.

[0186] In the specification and claims of this disclosure, the verbs "comprise," "include," and "have," and their conjugations, are used to indicate that the object or objects of the verb are not necessarily an exhaustive list of parts, components, elements, or portions of the subject or subjects of the verb. As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the terms "marking" or "at least one marking" can include a plurality of markings.

Claims

1. 1. A system for removing heat from a heat generating component of a mechanical arm, the system comprising: a. an inner shell surrounding the distal heat generating component and defining a capsule; b. an outer shell surrounding the inner shell and defining an annular gap between the outer shell and the inner shell; c. a conduit array, each having a first distal opening and a second distal opening in fluid communication with the annular gap and in fluid communication therethrough; a circulation mechanism configured to introduce a fluid into the annular gap through the first distal opening and to discharge the fluid from the annular gap through the second distal opening, the fluid passing through the annular gap absorbing heat generated by the heat-generating component; The first distal opening and the second distal opening are disposed on opposite sides of the annular gap.

2. 1. A system for removing heat from a heat generating component of a mechanical arm, the system comprising: a. an inner shell surrounding the distal heat generating component and defining a capsule; b. an outer shell surrounding the inner shell and defining an annular gap between the outer shell and the inner shell; c. a conduit array, each having first and second distal openings in fluid communication with the annular gap and in fluid communication therethrough; d. a circulation mechanism configured to introduce a fluid into the annular gap through the first distal opening and to expel the fluid from the annular gap through the second distal opening, the fluid passing through the annular gap absorbing heat generated by the heat-generating component; an inner casing disposed within the capsule and in at least indirect thermal communication between the heat generating component and the inner shell; and A system comprising a thermal gel or thermal paste disposed within the capsule and configured to provide at least indirect thermal communication between the inner shell and the heat-generating component or the inner casing.

3. 3. The system according to claim 1 or claim 2, The heat-generating component forms part of an imaging device.

4. 3. The system according to claim 1 or claim 2, The system, wherein the circulation mechanism comprises a pump positioned proximally from at least one flexible arm section and mechanically coupled to the fluid.

5. 3. The system according to claim 1 or claim 2, A system wherein a longitudinal majority of the conduit array is disposed within the arm.

6. 10. The system of claim 1, The system further comprises an inner casing disposed within the capsule and in at least indirect thermal communication between the heat generating component and the inner shell.

7. 7. The system of claim 6, The system further comprises a thermal gel or paste disposed within the capsule and configured to provide at least indirect thermal communication between the inner shell and the heat-generating component or the inner casing.

8. A system according to claim 2 or claim 6, The system wherein the outer surface of the inner casing comprises grooves and / or troughs.

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