Surgical consoles, sample receivers, and insertable endoscopic instruments for tissue removal
Through the improved endoscopic instrument, the combination of the power-driven instrument head and the suction channel is used to achieve efficient cutting and sampling of polyps in colonoscopy, solving the problems of inaccurate and time-consuming polyps removal in the prior art, and improving the efficiency of colon cancer screening.
Patent Information
- Application Number
- CN202111457049.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2016-03-15
- Filing Date
- 2017-03-15
- Publication Date
- 2025-08-19
- Estimated Expiration
- 2037-03-15
AI Technical Summary
In existing colonoscopy, polyp removal technology lacks accuracy and time-consuming, resulting in smaller polyps not being detected, leaving behind a risk of colon cancer, and the sampling process is cumbersome.
An improved endoscopic instrument is provided that enables the simultaneous cutting and removal of polyps during colonoscopy by means of a power-driven instrument head and suction channel within a single instrument channel, reducing the sampling steps.
It improves the accuracy and speed of polyp removal, reduces the sampling steps, and enhances the effectiveness of colon cancer screening.
Smart Images

Figure CN114159013B_ABST
Abstract
Description
[0001] This application is a divisional application of the Chinese patent application with application number 201780028827.5 and invention name “Surgical console, sample receiver and insertable endoscopic instrument for tissue removal”.
[0002] Related applications
[0003] This application claims the benefit of and priority to U.S. Provisional Application No. 62 / 308,829, filed on March 15, 2016, entitled “Surgical Console, Specimen Receiver, and Insertable Endoscopic Instrument for Tissue Removal.” This application is a continuation-in-part of and claims priority to U.S. Application No. 14 / 792,369, filed on July 6, 2015, entitled “Insertable Endoscopic Instrument for Tissue Removal,” which is a continuation-in-part of and claims priority to U.S. Patent Application No. 14 / 537,362 (now U.S. Patent No. 9,072,505), filed on November 10, 2014, entitled “Insertable Endoscopic Instrument for Tissue Removal,” which is a continuation-in-part of and claims priority to U.S. Patent Application No. 14 / 537,362, filed on May 16, 2014, entitled “Insertable Endoscopic Instrument for Tissue Removal.” No. 8,882,680, filed on May 17, 2013, and entitled “Insertable Endoscopic Instrument for Tissue Removal,” which claims the benefit of and priority to U.S. Provisional Patent Application No. 61 / 824,760, filed on May 17, 2013, and entitled “Insertable Endoscopic Instrument for Tissue Removal.” U.S. Patent Application No. 14 / 280,202 is also a continuation-in-part of U.S. Patent Application No. 13 / 336,491, filed on December 23, 2011, and entitled “Endoscopic Tool For Debriding and Removing Polyps,” which claims the benefit of and priority to U.S. Provisional Patent Application No. 61 / 566,472, filed on December 2, 2011, and entitled “Endoscopic Tool For Debriding and Removing Polyps.” Each of these applications is incorporated herein by reference in its entirety for all purposes. Background Art
[0004] In the United States, colon cancer is the third leading cause of cancer and the second leading cause of cancer-related deaths. Colon cancer originates from pre-existing colon polyps (adenomas), which occur in up to 35% of the American population. Colon polyps can be benign, precancerous, or cancerous. Colonoscopy is widely recognized worldwide as an excellent screening tool for colon cancer, which is increasing in incidence. According to the literature, a 1% increase in colonoscopy screening results in a 3% decrease in colon cancer incidence. The demand for colonoscopies currently exceeds the ability of the healthcare system to provide adequate screening. Despite increases in colon cancer screening over the past few decades, only 55% of eligible people receive screening, far below the recommended 80%, leaving millions of patients at risk.
[0005] Due to a lack of adequate resources, operators performing colonoscopies typically sample only the largest polyps, exposing patients to sampling bias by leaving behind smaller, less detectable polyps that may progress to colon cancer prior to future colonoscopies. Due to sampling bias, a negative result from a sampled polyp does not ensure that the patient is truly cancer-free. Existing polyp removal techniques lack precision and are cumbersome and time-consuming.
[0006] Currently, colon polyps are removed using a snare that is introduced into the patient through a working channel defined within an endoscope. The snare's tip is passed around the stem of the polyp, cutting it from the colon wall. Once cut, the cut polyp remains on the patient's intestinal wall until it can be retrieved as a sample by an operator. To retrieve the sample, the snare is first removed from the endoscope, and biopsy forceps or suction are applied through the same channel of the endoscope to retrieve the sample.
[0007] Therefore, there is a need for an improved endoscopic instrument that increases the accuracy and speed of polyp removal for biopsy. Summary of the Invention
[0008] An improved endoscopic instrument is provided that can accurately remove sessile polyps and efficiently obtain samples of multiple polyps from a patient. In particular, the improved endoscopic instrument is capable of removing one or more polyps and retrieving the removed polyps without having to alternate between using a separate cutting tool and a separate sample retrieval tool. Sampling can be used in conjunction with a colonoscopy. In some embodiments, the endoscopic instrument can cut and remove tissue from a patient. In some such embodiments, the endoscopic instrument can cut and remove tissue substantially simultaneously from a patient accessed through a flexible endoscope.
[0009] In one aspect, an endoscopic instrument insertable into a single instrument channel of an endoscope includes a powered instrument head configured to remove material at a site within a subject accessible by a flexible endoscope having a working channel. The powered instrument head has a first distal end and a first proximal end. The first distal end of the powered instrument head defines a material entry port through which removed material can enter the flexible endoscopic instrument. A body is coupled to the first proximal end of the powered instrument head and configured to drive the powered instrument head. The body includes a flexible portion having a second distal end and a second proximal end. The second proximal end of the flexible portion defines a material exit port. A suction channel extends from the material entry port of the powered instrument head to the material exit port of the flexible portion. The second proximal end of the flexible portion is configured to couple to a vacuum source so that removed material entering the suction channel via the material entry port is removed from the suction channel at the material exit port while the endoscopic instrument is positioned within the instrument channel of the flexible endoscope.
[0010] In some embodiments, the main body further comprises a power actuator. The power actuator is coupled to the first proximal end of the power-driven instrument head and is configured to drive the power-driven instrument head. In some embodiments, the power actuator is one of a hydraulic power actuator, a pneumatic power actuator, or an electric power actuator. In some embodiments, the power actuator comprises at least one of a motor, a Tesla rotor, and a vane rotor. In some embodiments, the endoscopic instrument comprises an energy storage component configured to provide power to the power actuator. In some embodiments, the suction channel is defined by the power-driven instrument head, the power actuator, and the flexible portion.
[0011] In some embodiments, the powered actuator is a hydraulic powered actuator or a pneumatic powered actuator. In some such embodiments, the flexible portion includes a fluid inlet tubular member configured to supply irrigation to actuate the powered actuator and a fluid outlet tubular member configured to remove fluid supplied to actuate the actuator. In some embodiments, the flexible portion includes a suction tubular member that defines a proximal portion of the suction channel.
[0012] In some embodiments, the powered actuator includes a hollow portion that fluidly couples a material entry port of the powered instrument head and a material exit port of the flexible portion.
[0013] In some embodiments, the instrument includes an engagement assembly configured to contact a wall of an instrument channel of the endoscope upon actuation. In some embodiments, the engagement assembly includes a compliant ring structure configured to deform.
[0014] In some embodiments, a powered instrument head includes an outer structure and a cutting shaft disposed within the outer structure, the cutting shaft coupled to a powered actuator and configured to rotate relative to the outer structure when the powered actuator is actuated. In some embodiments, the cutting shaft includes a hollow portion and a material entry port.
[0015] In some embodiments, the flexible portion comprises a hollow flexible torque cable. The flexible torque cable has a distal region configured to couple to a first proximal end of a powered instrument head and a proximal region configured to couple to a powered actuator. In some embodiments, the flexible torque cable defines a portion of a suction channel. The distal region of the flexible torque cable is fluidically coupled to a material entry port of the powered instrument head, and the proximal region of the flexible torque cable comprises a material exit port.
[0016] In some embodiments, the instrument has an outer diameter of less than about 5 mm. In some embodiments, the flexible portion is at least 40 times the length of the powered instrument head. In some embodiments, the outer diameter of the powered actuator is less than about 4 mm.
[0017] According to another aspect, an endoscopic instrument includes a powered instrument head configured to remove material from a site within a subject's body. The powered instrument head includes a cutting tip and a material entry port configured to allow material to enter the distal end of the endoscopic instrument. A body is coupled to the powered instrument head. The body includes an elongated, hollow, flexible tubular member including a material exit port configured to allow material to exit the proximal end of the endoscopic instrument. A suction channel extends from the material entry port of the powered instrument head to the material exit port of the elongated, hollow, flexible tubular member. A second proximal end of the flexible portion is configured to be fluidically coupled to a vacuum source such that removed material entering the suction channel via the material entry port of the powered instrument head is removed from the endoscopic instrument via the material exit port. The endoscopic instrument is configured to travel through a tortuous instrument channel of an endoscope. In some embodiments, the instrument has an outer diameter of less than approximately 5 mm, and wherein the flexible tubular member is at least 72 inches long.
[0018] In some embodiments, the body further comprises a powered actuator coupled to the first proximal end of the powered instrument head and configured to drive the powered instrument head. In some embodiments, the powered actuator is an electric actuator and further comprises a conductive wire configured to be coupled to a power source. In some embodiments, the suction channel is defined by the powered instrument head, the powered actuator, and the flexible portion. In some embodiments, the flexible tubular member defines a proximal portion of the suction channel.
[0019] In some embodiments, the powered actuator is one of a hydraulic powered actuator or a pneumatic powered actuator and further includes a fluid inlet tubular member configured to supply fluid to actuate the powered actuator and a fluid outlet tubular member configured to remove the fluid supplied to actuate the actuator.
[0020] In some embodiments, the instrument includes an engagement assembly configured to contact a wall of an instrument channel of the endoscope when actuated. In some embodiments, the engagement assembly includes a vacuum actuated structure configured to move to an engaged position, wherein the vacuum actuated structure is not in contact with the instrument channel when the vacuum is actuated, and to move to a retracted position, wherein the vacuum actuated structure is not in contact with the instrument channel when the vacuum is not actuated.
[0021] In some embodiments, a powered instrument head includes an outer structure and a cutting shaft disposed within the outer structure, the cutting shaft coupled to a powered actuator and configured to rotate relative to the outer structure when the powered actuator is actuated.
[0022] In some embodiments, the flexible tubular member comprises a hollow flexible torque cable. The flexible torque cable has a distal region configured to couple to a first proximal end of a powered instrument head and a proximal region configured to couple to a powered actuator located external to the endoscopic instrument. In some embodiments, the flexible torque cable further defines a portion of a suction channel, wherein the distal region of the flexible torque cable is fluidly coupled to a material entry port of the powered instrument head, and the proximal region of the flexible torque cable comprises a material exit port. In some embodiments, the instrument comprises a sheath surrounding the flexible torque cable.
[0023] According to another aspect, a flexible endoscopic biopsy retrieval tool adapted for use with an endoscope includes a housing, a clearing component coupled to the housing, and a sample retrieval conduit disposed within the housing for retrieving cleared material removed by the clearing component. In various embodiments, the improved flexible endoscope can be configured with an integrated endoscopic biopsy retrieval tool including the clearing component and the sample retrieval conduit for retrieving cleared material removed by the clearing component.
[0024] According to another aspect, a method of retrieving a polyp from a patient includes placing an endoscopic instrument within an instrument channel of an endoscope, inserting the endoscope into the patient, actuating a removal component of the endoscopic instrument to cut a polyp in the patient, and actuating a sample retrieval component of the endoscopic instrument to remove the cut polyp from the patient.
[0025] According to yet another aspect, an endoscope includes a first end and a second end separated by a flexible housing. An instrument channel extends from the first end to the second end, and an endoscopic instrument is coupled to the instrument channel at the first end of the endoscope. The endoscopic instrument includes a clearing component and a sample retrieval conduit partially disposed within the instrument channel.
[0026] According to yet another aspect, an endoscopic instrument insertable into a single instrument channel of an endoscope includes a cutting assembly configured to remove material at a site within a subject. The cutting assembly includes an outer cannula and an inner cannula disposed within the outer cannula. The outer cannula defines an opening through which material to be removed enters the cutting assembly. The endoscopic instrument also includes a flexible outer tube coupled to the outer cannula and configured to rotate the outer cannula relative to the inner cannula. The flexible outer tube may have an outer diameter smaller than that of the instrument channel into which the endoscopic instrument is insertable. The endoscopic instrument also includes a flexible torque coil having a portion disposed within the flexible outer tube. The flexible torque coil has a distal end coupled to the inner cannula. The flexible torque coil is configured to rotate the inner cannula relative to the outer cannula. The endoscopic instrument also includes a proximal connector coupled to the proximal end of the flexible torque coil and configured to engage a drive assembly configured to rotate the proximal connector, the flexible torque coil, and the inner cannula upon actuation. The endoscopic instrument also includes a suction channel having a suction port configured to engage a vacuum source. The suction channel is partially defined by the inner wall of the flexible torque coil and the inner wall of the inner cannula and extends from an opening defined in the inner cannula to the suction port. The endoscopic instrument also includes an irrigation channel having a first portion defined between the outer wall of the flexible torque coil and the inner wall of the flexible outer tube and configured to deliver irrigation fluid to the suction channel.
[0027] In some embodiments, the proximal connector is hollow, and the inner wall of the proximal connector defines a portion of the suction channel. In some embodiments, the proximal connector is a rigid cylindrical structure and is configured to be positioned within a drive socket of a drive assembly. The proximal connector may include a connector configured to engage with the drive assembly and a tensioning spring configured to bias the inner sleeve toward the distal end of the outer sleeve. In some embodiments, the size and bias of the tensioning spring are such that the tensioning spring positions the cutting portion of the inner sleeve near the opening of the outer sleeve. In some embodiments, the proximal connector is rotationally and fluidically coupled to a flexible torque coil.
[0028] In some embodiments, the endoscopic instrument further comprises an irrigation connector comprising an irrigation access port and a tubular member coupled to the irrigation connector and the flexible outer tube. The inner wall of the tubular member and the outer wall of the flexible torque coil can define a second portion of the irrigation channel, which is fluidically coupled to the first portion of the irrigation channel. In some embodiments, the endoscopic instrument further comprises a rotational coupler that couples the flexible outer tube to the tubular member and is configured to rotate the flexible outer tube relative to the tubular member and rotate the opening defined in the outer cannula relative to the inner cannula. In some embodiments, the irrigation connector defines an inner bore, and the flexible torque coil is disposed in the inner bore.
[0029] In some embodiments, the endoscopic instrument further comprises a liner, the flexible torque coil being disposed within the liner, the outer wall of the liner being configured to define a portion of the irrigation channel. In some embodiments, the inner cannula is configured to rotate axially relative to the outer cannula, and the suction channel is configured to provide suction at an opening of the inner cannula.
[0030] In some embodiments, the flexible torque coil includes a plurality of threads. Each thread in the plurality of threads can be wound in a direction opposite to the direction in which one or more adjacent threads in the plurality of threads are wound. In some embodiments, the flexible torque coil includes a plurality of layers. Each layer in the plurality of layers can be wound in a direction opposite to the direction in which one or more adjacent layers in the plurality of layers are wound. In some embodiments, each layer can include one or more threads.
[0031] In some embodiments, the flexible outer tube has a length that exceeds the length of the endoscope into which the endoscopic instrument can be inserted. In some embodiments, the flexible outer tube has a length that is at least 100 times greater than the outer diameter of the flexible outer tube. In some embodiments, the flexible portion is at least 40 times the length of the cutting assembly.
[0032] According to another aspect, a sample receiver includes a first receiver member, a sample capture member, and a second receiver member. The first receiver member includes a first receiver port configured to receive a fluid flow including a material, the first receiver member defining a first portion of an interior of the sample receiver. The sample capture member is in fluid communication with the first portion of the interior. The sample capture member is configured to obtain a material sample from the fluid flow. The sample capture member is disposed between the first portion of the interior and the second portion of the interior. The sample capture member is configured to filter the fluid flow to obtain the material sample. The second receiver member is configured to couple to the first receiver member. The second receiver member defines a second portion of the interior of the sample receiver. The second portion is located downstream of the first portion. The second receiver member includes a second receiver port configured to couple to a vacuum source.
[0033] According to yet another aspect, a method for obtaining a material sample from an endoscopic tool in a sample receptacle includes positioning a sample capture member between a first receptacle member and a second receptacle member. The method includes receiving a fluid flow including a material at a first receptacle port of the first receptacle member, the first receptacle member defining a first portion of an interior of the sample receptacle, the sample capture member being positioned in the first portion. The method includes coupling a second receptacle member to the first receptacle member, the second receptacle member defining a second portion of the interior of the sample receptacle. The method includes coupling a vacuum source to a second receptacle port of the second receptacle member to cause the fluid to flow through the sample receptacle. The method includes obtaining the material sample by filtering the fluid flow using the sample capture member.
[0034] According to yet another aspect, a surgical console includes a drive assembly, a vacuum interface, a fluid transfer device, a user interface, and control circuitry. The drive assembly is configured to be coupled to an endoscopic tool. The drive assembly is configured to be rotated by a motor. The motor is configured to rotate the drive assembly at a speed associated with the rotation of the endoscopic tool. The vacuum interface is configured to be coupled to the endoscopic tool to apply a vacuum to the endoscopic tool. The fluid transfer device is configured to be coupled to the endoscopic tool to cause a fluid to flow through the endoscopic tool. The user interface is configured to receive user input indicating at least one of an instruction to rotate the endoscopic tool while applying a vacuum to the endoscopic tool or an instruction to cause a fluid to flow through the endoscopic tool. The control circuitry is configured to extract instructions from the user input and control the operation of at least one of the drive assembly, the vacuum interface, or the fluid transfer device based on the instructions. In response to the user input indicating an instruction to rotate the endoscopic tool, the control circuitry is configured to cause the drive assembly to rotate the endoscopic tool while the vacuum interface applies a vacuum to the endoscopic tool.
[0035] According to yet another aspect, a method for operating a surgical console includes receiving user input at a user interface. The user input indicates at least one of the following instructions: (1) an instruction to rotate an endoscopic tool using a drive assembly while applying vacuum to the endoscopic tool using a vacuum interface, the drive assembly being configured to be coupled to the endoscopic tool, the drive assembly being configured to be rotated by a motor, the motor being configured to rotate a drive element at a speed associated with the rotation of the endoscopic tool; the vacuum interface being configured to be coupled to the endoscopic tool to apply vacuum to the endoscopic tool; or (2) an instruction to flow a fluid through the endoscopic tool using a fluid transfer device configured to be coupled to the endoscopic tool. The method includes extracting instructions from the user input. The method includes controlling the operation of at least one of the drive assembly, the vacuum interface, or the fluid transfer device based on the instructions. The controlling operation includes causing the drive assembly to rotate the endoscopic tool while causing the vacuum interface to apply vacuum in response to the user input indicating the instruction to rotate the endoscopic tool.
[0036] According to yet another aspect, a method for operating an endoscopic tool includes coupling a drive element of the endoscopic tool to a drive assembly of a surgical console. The method includes fluidically coupling a vacuum port of the endoscopic tool to a first end of a sample receptacle. The method includes fluidically coupling a second end of the sample receptacle to a vacuum interface. The method includes fluidically coupling a flush port of the endoscopic tool to a fluid transfer device. The method includes inserting the endoscopic tool into an instrument channel of an endoscope. The method includes identifying material to be resected at a location within a subject. The method includes cutting the material by rotating the endoscopic tool while flowing a fluid through the endoscopic tool using the fluid transfer device. The method includes obtaining a sample of the material in the sample receptacle by applying a vacuum to the endoscopic tool using the vacuum interface.
[0037] According to yet another aspect, a connector assembly for an endoscopic tool includes a first connector end, a second connector end, a drive transmission assembly, an irrigation channel, and a suction channel. The first connector end defines a first opening configured to receive the drive assembly. The second connector end is opposite the first connector end and defines a second opening and a third opening. The drive transmission assembly extends between the first connector end and the second connector end. The drive transmission assembly is configured to couple to the drive assembly via the first opening so as to be rotated by the drive assembly. The drive transmission assembly is configured to couple to a flexible torque transmission assembly at the second connector end so as to rotate the flexible torque transmission assembly in response to rotation of the drive assembly. The irrigation channel includes an irrigation port and a first channel portion fluidically coupled to the irrigation port and the second opening. The irrigation port is configured to receive fluid and cause the received fluid to flow through the irrigation channel. The suction channel includes a vacuum port and a second channel portion fluidically coupled to the vacuum port and the third opening. The vacuum port is configured to transmit a suction force applied to the vacuum port to the second channel portion.
[0038] According to yet another aspect, a method for operating an endoscopic tool includes receiving a drive assembly at a first opening defined by a first connector end of a connector assembly of the endoscopic tool. The method includes coupling the drive assembly to a drive transmission assembly of the connector assembly. The drive transmission assembly extends between the first connector end and a second connector end of the connector assembly. The second connector end defines a second opening and a third opening. The method includes coupling the drive transmission assembly to a flexible torque transmission assembly at the second connector end. The method includes rotating the flexible torque transmission assembly in response to rotation of the drive transmission assembly. The method includes receiving a fluid at a flush port of the connector assembly. The method includes flowing the fluid through a flush channel, the flush channel including a flush port and a first channel portion fluidly coupled to the flush port and the second opening. The method includes applying a suction force to a vacuum port of the connector assembly. The method includes transmitting the suction force through a suction channel, the suction channel including the vacuum port and a second channel portion fluidly coupled to the vacuum port and the third opening to obtain a sample of material removed by the endoscopic tool.
[0039] This summary is provided to introduce some concepts in a simplified form that are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended that this summary be used to limit the scope of the claimed subject matter. Furthermore, the claimed subject matter is not limited to implementations that provide any or all advantages or solve any or all problems of the prior art. BRIEF DESCRIPTION OF THE DRAWINGS
[0040] The present disclosure is illustratively shown and described with reference to the accompanying drawings, in which:
[0041] Figure 1A Shown are the various types of polyps that can form in the body.
[0042] Figure 1B Shown is a perspective partial view of an endoscope according to an embodiment of the present disclosure.
[0043] Figure 1C A perspective view of an endoscopic instrument according to an embodiment of the present disclosure is shown.
[0044] Figure 2A and 2B A side perspective view of an endoscopic instrument coupled to the endoscope shown in FIG. 1 is shown in accordance with an embodiment of the present disclosure.
[0045] Figure 3A and 3B Shown is a side perspective view of an exemplary endoscopic instrument coupled with the endoscope shown in FIG. 1 , according to an embodiment of the present disclosure.
[0046] Figure 4AAn exploded view of an endoscopic instrument that may be coupled to an endoscope is shown according to an embodiment of the present disclosure.
[0047] Figure 4B A perspective view of an endoscopic instrument coupled to an endoscope is shown, illustrating various conduits associated with the endoscopic instrument.
[0048] Figure 5 Shown is a side perspective view of another exemplary endoscopic instrument coupled with the endoscope shown in FIG. 1 , according to an embodiment of the present disclosure.
[0049] Figure 6 Shown is an enlarged view of an exemplary endoscopic instrument according to an embodiment of the present disclosure.
[0050] Figure 7 The embodiment according to the present disclosure is shown Figure 6 A perspective view of the outer blades of the cutting tool of the endoscopic instrument is shown in FIG.
[0051] Figure 8 The embodiment according to the present disclosure is shown Figure 6 A perspective view of the inner blade of the cutting tool of the endoscopic instrument is shown in FIG.
[0052] Figure 9 The embodiment according to the present disclosure is shown Figure 6 A perspective view of the rotor of an endoscopic instrument is shown in FIG.
[0053] Figure 10 The embodiment according to the present disclosure is shown Figure 6 A perspective view of the housing of the endoscopic instrument is shown in FIG.
[0054] Figure 11 The embodiment according to the present disclosure is shown Figure 6 A perspective view of a cap of an endoscopic instrument is shown in FIG.
[0055] Figure 12 The embodiment according to the present disclosure is shown Figure 6 A perspective view of a coupling member of an endoscopic instrument is shown in FIG.
[0056] Figure 13 A perspective view of an endoscopic instrument coupled to an endoscope is shown, illustrating various conduits associated with the endoscopic instrument.
[0057] Figure 14 Another perspective view of an endoscopic instrument coupled to an endoscope is shown, illustrating various conduits associated with the endoscopic instrument.
[0058] Figure 15 is a conceptual system architecture diagram illustrating various components for operating an endoscopic instrument according to an embodiment of the present disclosure.
[0059] Figure 16A An exploded view of an exemplary endoscopic instrument according to an embodiment of the present disclosure is shown.
[0060] Figure 16B The embodiment according to the present disclosure is shown Figure 16A A cross-sectional view of an endoscopic instrument is shown in FIG.
[0061] Figure 16C A schematic diagram of an exemplary engagement assembly of an exemplary endoscopic instrument according to an embodiment of the present disclosure is shown.
[0062] Figure 16D FIG. 1 shows an embodiment of the present disclosure when the engagement assembly is disengaged. Figure 16C A cross-sectional view of the engagement assembly shown in FIG.
[0063] Figure 16E FIG. 1 shows an embodiment of an endoscope in which the engagement assembly is configured to engage with an instrument channel of the endoscope according to an embodiment of the present disclosure. Figure 16A A cross-sectional view of the engagement assembly shown in FIG.
[0064] Figure 17A An exploded view of an exemplary endoscopic instrument according to an embodiment of the present disclosure is shown.
[0065] Figure 17B The embodiment according to the present disclosure is shown Figure 17A A cross-sectional view of the endoscopic instrument shown in .
[0066] Figure 18A An exploded view of an exemplary endoscopic instrument utilizing a Tesla rotor according to an embodiment of the present disclosure is shown.
[0067] Figure 18B The embodiment according to the present disclosure is shown Figure 18A A cross-sectional view of an endoscopic instrument is shown in FIG.
[0068] Figure 19A An exemplary endoscopic instrument coupled to a powered actuation and vacuum system is shown in accordance with an embodiment of the present disclosure.
[0069] Figure 19B The embodiment according to the present disclosure is shown Figure 19A A cross-sectional view of the powered actuation and vacuum system is shown in FIG.
[0070] Figure 19C The embodiment according to the present disclosure is shown Figure 19A An exploded view of an exemplary head of an endoscopic instrument is shown in FIG.
[0071] Figure 19DA cross-sectional view of a portion of an endoscopic instrument having an engagement assembly according to an embodiment of the present disclosure is shown.
[0072] Figure 19E Shown is a disengaged position according to an embodiment of the present disclosure Figure 19D A cross-sectional view of the engagement assembly shown in FIG.
[0073] Figure 19F Shown in an engaged position according to an embodiment of the present disclosure Figure 19D A cross-sectional view of the engagement assembly shown in FIG.
[0074] Figure 20 is a conceptual system architecture diagram illustrating various components for operating an endoscopic instrument according to an embodiment of the present disclosure.
[0075] Figures 21AA-21F Aspects of an endoscope assembly according to embodiments of the present disclosure are shown.
[0076] Figures 22A-22H Various implementations of exemplary flexible cables according to embodiments of the present disclosure are shown.
[0077] Figure 23AA-23BB An exemplary implementation of a cutting tool according to an embodiment of the present disclosure is shown.
[0078] Figures 24A-24C Various aspects of a drive shaft of a coupling component according to embodiments of the present disclosure are shown.
[0079] Figure 25 Exemplary housing components according to embodiments of the present disclosure are shown.
[0080] Figures 26A-26E An exemplary sleeve bearing according to an embodiment of the present disclosure is shown.
[0081] Figures 27A-27C An exemplary substrate forming a portion of a housing according to an embodiment of the present disclosure is shown.
[0082] Figures 28A-28D An exemplary side panel forming a portion of a housing according to an embodiment of the present disclosure is shown.
[0083] Figures 29AA-29EE Various aspects of a ferrule according to an embodiment of the present disclosure are shown.
[0084] Figures 30AA-30C Aspects of an endoscope assembly according to an embodiment of the present disclosure are shown wherein the tip is press fit.
[0085] Figures 31AA-31ABand 31B-31C illustrate aspects of an endoscope assembly in which the tip is press-fitted according to an embodiment of the present disclosure.
[0086] Figure 32 A top view of an exemplary flexible portion of an endoscopic tool according to an embodiment of the present disclosure is shown.
[0087] Figure 33 is a cross-sectional view of an exemplary cutting assembly of an endoscopic tool using a torque cord according to an embodiment of the present disclosure.
[0088] Figures 34A-34C are cross-sectional views of different configurations of the flexible portion region of one embodiment of an endoscopic tool described herein.
[0089] 35 shows various views of a portion of an endoscopic tool according to an embodiment of the present disclosure.
[0090] Figure 36 A cross-sectional view of a flexible portion region of one implementation of an endoscopic tool according to an embodiment of the present disclosure is shown.
[0091] Figure 37 A cross-sectional view of one implementation of an endoscopic tool is shown in accordance with an embodiment of the present disclosure.
[0092] Figure 38A and 38B Various views of a distal portion of one implementation of an endoscopic tool are shown, according to an embodiment of the present disclosure.
[0093] Figure 39A and 39B BB and CC according to an embodiment of the present disclosure. Figure 38A and 38B A cross-sectional view of the distal portion of the endoscopic tool is shown in FIG.
[0094] Figures 40A-40B A perspective view of an endoscopic tool and a portion of a drive assembly configured to drive the endoscopic tool is shown according to an embodiment of the present disclosure.
[0095] Figure 40B An endoscope tool and a drive assembly according to an embodiment of the present disclosure are shown. Figure 40A A perspective view of a portion of an endoscopic tool is shown.
[0096] Figure 41 Shows a top view and a bottom view of an endoscope tool according to an embodiment of the present disclosure Figures 40A-40B A top exposed view of a portion of the drive assembly is shown in FIG.
[0097] Figure 42The cross section of the endoscope tool and the drive assembly according to an embodiment of the present disclosure is shown. Figures 40A-40B A cross-sectional view of a portion of section AA is shown in FIG.
[0098] Figure 43 The drive connector and the endoscope according to the embodiment of the present disclosure are shown. Figures 40A-40B An enlarged view of a portion of the drive assembly is shown in FIG.
[0099] Figure 44 An endoscope tool and an endoscope according to an embodiment of the present disclosure are shown. Figures 40A-40B A perspective view of a portion of the drive assembly is shown in FIG.
[0100] Figure 45 A cross-sectional view of a portion across section BB of an endoscopic tool and drive assembly according to an embodiment of the present disclosure is shown.
[0101] Figure 46 An enlarged cross-sectional view of a rotational coupler portion of an endoscopic tool is shown in accordance with an embodiment of the present disclosure.
[0102] Figure 47A and Figure 47B Shown are top and cross-sectional views of a rotational coupler of an endoscopic tool according to an embodiment of the present disclosure.
[0103] Figure 48 is a perspective view of a portion of an endoscopic tool inserted for operation within a drive assembly according to an embodiment of the present disclosure.
[0104] Figure 49 Another embodiment of an endoscopic tool and a drive assembly configured to drive the endoscopic tool according to an embodiment of the present disclosure is shown.
[0105] Figure 50A According to an embodiment of the present disclosure Figure 49 Side view of the endoscopic tool and drive assembly shown in .
[0106] Figure 50B According to an embodiment of the present disclosure, the Figure 49 A cross-sectional view of the endoscopic tool and drive assembly is shown in FIG.
[0107] Figure 51A is an exploded perspective view of an improved endoscope tool according to an embodiment of the present disclosure.
[0108] Figure 51B According to an embodiment of the present disclosure Figure 51A An end view of the improved endoscopic tool is shown in FIG.
[0109] Figure 51CAccording to an embodiment of the present disclosure, the Figure 51B A cross-sectional view of the improved endoscopic tool is shown in FIG.
[0110] Figures 52A-52F Aspects of a console configured for operation with endoscopic tools are shown according to embodiments of the present disclosure.
[0111] Figure 53A is a rear perspective view of components of a console configured for operation with endoscopic tools according to an embodiment of the present disclosure.
[0112] Figure 53B According to an embodiment of the present disclosure Figure 53A An exploded perspective view of the components of the console shown in FIG.
[0113] Figure 54A is a perspective view of components of a console configured for operation with endoscopic tools according to an embodiment of the present disclosure.
[0114] Figure 54B According to an embodiment of the present disclosure Figure 54A An exploded perspective view of the components of the console shown in FIG.
[0115] Figure 54C According to an embodiment of the present disclosure Figure 54A A detailed view of the console's interface is shown in .
[0116] Figure 55A is a perspective view of components of a console configured for operation with endoscopic tools according to an embodiment of the present disclosure.
[0117] Figure 55B According to an embodiment of the present disclosure Figure 55A An exploded perspective view of the components of the console shown in FIG.
[0118] Figure 55C According to an embodiment of the present disclosure Figure 55A A side view of the components of the console is shown in FIG.
[0119] Figure 55D According to an embodiment of the present disclosure Figure 55A A top view of the components of the console is shown in FIG.
[0120] Figure 56A is an exploded perspective view of an interface of a console configured for operation with an endoscopic tool according to an embodiment of the present disclosure.
[0121] Figure 56B According to an embodiment of the present disclosure Figure 56A End view of the interface shown in .
[0122] Figure 56C According to the embodiment of the present disclosure Figures 56A-56B A cross-sectional view of the interface shown in FIG. 1 is taken at section AA.
[0123] Figure 57A is a perspective view of a console drive assembly for a console configured to operate with an endoscopic tool according to an embodiment of the present disclosure.
[0124] Figure 57B According to an embodiment of the present disclosure Figure 57A An exploded perspective view of the console drive assembly is shown in .
[0125] Figure 57C According to an embodiment of the present disclosure Figure 57A A side view of the console drive assembly is shown in FIG.
[0126] Figure 58A According to an embodiment of the present disclosure Figure 57A A perspective view of the torque coil of the console drive assembly is shown in FIG.
[0127] Figure 58B According to an embodiment of the present disclosure Figure 57A An exploded perspective view of the torque coil of the console drive assembly is shown in FIG.
[0128] Figure 58C According to an embodiment of the present disclosure Figure 57A Side view of the torque coil of the console drive assembly shown in .
[0129] Figures 59A-59C Aspects of a rack assembly for holding a sample receiver for a console configured to operate with endoscopic tools are shown in accordance with embodiments of the present disclosure.
[0130] Figures 60A-60B Aspects of the engagement of an endoscopic tool with a console are shown according to embodiments of the present disclosure.
[0131] Figure 61 An aspect of coupling a tube to an inlet of a sample receptacle is shown according to an embodiment of the present disclosure.
[0132] Figure 62 An aspect of coupling a tube to an outlet of a sample receiver is shown according to an embodiment of the present disclosure.
[0133] Figures 63A-63B Aspects of coupling a fluid transfer device to an endoscopic tool are shown according to embodiments of the present disclosure.
[0134] Figure 64is an exploded view of a sample receiver configured for operation with a console and endoscopic tools according to an embodiment of the present disclosure.
[0135] Figure 65 A flowchart of a method for operating an endoscope tool using a console according to an embodiment of the present disclosure is shown. DETAILED DESCRIPTION
[0136] The technology provided herein relates to improved flexible endoscopic instruments that can accurately and efficiently obtain samples of single and multiple polyps and tumors from a patient. In particular, the improved endoscopic instruments can remove samples from one or more polyps and retrieve the removed samples without having to remove the endoscopic instrument from the treatment site in the patient's body.
[0137] Figure 1A The various types of polyps that can form in the body are shown. Although particularly large polyps and / or sessile or flat polyps must be removed individually using biopsy forceps or en bloc using endoscopic mucosal resection (EMR), most polyps can be removed via snare polypectomy. A recent study concluded that depressed sessile polyps had the highest malignancy rate at 33%. The same study also found that non-polypoid neoplastic lesions (sessile polyps) accounted for 22% of patients with polyps or 10% of all patients undergoing colonoscopy. There are multiple barriers to the removal of colon polyps, namely the difficulty in removing sessile polyps, the time taken to remove multiple polyps, and the lack of cost differentiation when multiple polyps are removed. Due to the challenges of removing less accessible sessile polyps and the fact that multiple polyps require more time per patient, most polyps are removed individually, leaving tissue behind as the size of the polyp increases, resulting in sampling bias where the pathology of the remaining tissue is unknown, leading to an increased false negative rate.
[0138] Colonoscopy is not a perfect screening tool. With current colonoscopy practices, endoscopists expose patients to sample bias by removing the largest polyps (stalked polyps), leaving behind less detectable and less accessible sessile / flat polyps. Sessile polyps are very difficult or impossible to remove endoscopically using existing technology and are often left alone. Under current practice, an estimated 28% of stalked polyps and 60% of sessile (flat) polyps are not detected, biopsied or removed, which leads to sample bias and a 6% false negative rate for colonoscopic screening. Current colonoscopy instruments for polypectomy are limited by their inability to adequately remove sessile polyps and their low efficiency in completely removing multiple polyps. According to clinical literature, sessile polyps larger than 10 mm carry a greater risk of malignancy. Fragments of sessile polyps left behind after incomplete resection can grow into new polyps and carry the risk of malignancy.
[0139] In the recent past, endoscopic mucosal resection (EMR) has been used to remove sessile polyps. EMR involves using an injection to lift the surrounding mucosa, then opening a snare to cut the polyp, and finally using biopsy forceps or a retrieval device to remove the polyp. For forceps, the injection needle and snare must be repeatedly introduced and removed through the length of the colonoscope, which is approximately 5.2 feet.
[0140] The present disclosure relates to an endoscopic tool that can provide an innovative alternative to existing polyp removal tools, including snares, thermal biopsies, and EMR, by introducing a flexible, powered instrument that works with current-generation colonoscopes and can cut and remove any polyp. The endoscopic tool described herein can be designed to enable physicians to better address sessile or large polyps and remove multiple polyps in significantly less time. By employing the endoscopic tool described herein, physicians can become more effective in the early diagnosis of colorectal cancer.
[0141] The present disclosure will be more fully understood through the following description, which should be read in conjunction with the accompanying drawings. In this specification, like numbers represent similar elements in various embodiments of the present disclosure. In this specification, the claims will be interpreted with respect to the embodiments. Those skilled in the art will readily appreciate that the methods, devices, and systems described herein are merely exemplary and may be varied without departing from the spirit and scope of the present disclosure.
[0142] Referring back to the accompanying drawings, Figure 1B A perspective partial view of an endoscope according to an embodiment of the present disclosure is shown. Although the present disclosure relates to endoscopic instruments suitable for use with any type of endoscope, for convenience, the teachings of the present disclosure relate to endoscopic instruments for use with lower gastrointestinal scopes (e.g., colonoscopes). However, it should be understood that the scope of the present disclosure is not limited to endoscopic instruments for use with gastrointestinal scopes, but extends to any type of flexible endoscope, including but not limited to bronchoscopes, gastroscopes, and laryngoscopes, or other medical devices that can be used to treat patients.
[0143] According to various embodiments, a typical lower gastroenteroscope 100 includes a substantially flexible member extending from a first end or head 102 to a second end or handle. The head 102 can be configured to rotate so that the tip 104 of the head 102 can be oriented in any direction within a hemispherical space. The handle has controls that allow the operator of the endoscope 100 to steer the colonoscope toward an area of interest within the colon and to turn corners between colon segments using two steering wheels.
[0144] A series of instruments reside on the face 106 of the tip 104 of the scope, including, but not limited to, one or more water channels 108A-108N (commonly referred to as water channels 108, for flushing the area with water), one or more additional light sources 110A-110N (commonly referred to as light sources 110), a camera lens 112, and an instrument channel 120 through which endoscopic instruments can be passed for various operations. The instrument channel 120 can vary in size based on the type of endoscope 100 being used. In various embodiments, the diameter of the instrument channel 120 can range from approximately 2 mm to 6 mm, or more specifically, from approximately 3.2 mm to 4.3 mm. Some larger scopes can have two instrument channels 120, allowing two tools to be delivered into the patient's body simultaneously. However, larger scopes can cause discomfort to the patient and may be too large to pass through some smaller lumens into the patient's body.
[0145] Figure 1C FIG2 shows a perspective view of an endoscopic instrument 150 according to an embodiment of the present disclosure. The endoscopic instrument 150 is configured to Figure 1B The endoscopic instrument 150 is configured to be inserted into the instrument channel 120 of the endoscope 100, for example Figure 1B FIG. 1 depicts the instrument channel 120 of endoscope 100. In some embodiments, the portion of endoscopic instrument 150 configured to be inserted into instrument channel 120 can be sized to have an outer diameter that is smaller than the inner diameter of the endoscope's instrument channel 120. In some such embodiments, endoscopic instrument 150 can be sized to have an outer diameter small enough to be slidably inserted into the instrument channel when the endoscope is coiled or bent. When the endoscope is coiled or bent, the instrument channel can form a tortuous path including one or more curves and bends. In one exemplary embodiment, an endoscope includes an instrument channel having an inner diameter of approximately 4.3 mm when the endoscope is straightened. However, when the endoscope is coiled or bent, portions of the endoscope near the bent portion can have clearance less than the inner diameter of approximately 4.3 mm. In some embodiments, the endoscope can have a clearance of approximately 3.8 mm, rather than the 4.3 mm achieved when the endoscope is straightened. In some embodiments, the endoscope can have a clearance of approximately 3.2 mm. Thus, in some embodiments, the endoscopic instrument 150 can be sized so that it can be slidably inserted into an instrument channel of an endoscope, and the instrument channel can be used even when the endoscope is coiled or bent.
[0146] In some embodiments, the endoscopic instrument 150 includes a powered instrument head 160 configured to remove material from a site within a subject's body. The powered instrument head 160 has a distal end 162 and a proximal end 161. The distal end 162 of the powered instrument head 160 defines a material entry port 170 through which material to be removed can enter the endoscopic instrument 150. The powered instrument head 160 can include a cutting portion at the distal end 162 that is configured to cut tissue and other materials. As used herein, a port can include any opening, hole, or gap through which material can enter or exit. In some embodiments, the material entry port can be an opening through which material to be removed can enter the endoscopic instrument 150. In some embodiments, material to be removed can be drawn into the material entry port, whereupon the instrument head can then remove the material.
[0147] The body 152 includes a head 155 and a flexible portion 165. A distal end 156 of the head 155 of the body 152 is coupled to a proximal end 161 of a powered instrument head 160. In some embodiments, the head 155 of the body 152 is configured to drive the powered instrument head 160. A proximal end 158 of the head 155 can be coupled to a distal end 166 of the flexible portion 165. A proximal end 176 of the flexible portion 165 defines a material exit port 175. The flexible portion 165 can include a hollow, flexible tubular member.
[0148] The endoscopic instrument also includes a suction channel that extends from a material entry port 170 of the powered instrument head 160 to a material exit port 175 of the flexible portion 165. In some embodiments, the suction channel is defined by the powered instrument head 160, the head portion 155 of the body 152, and the flexible portion 165 of the body. A proximal end 176 of the flexible portion 165 is configured to be coupled to a vacuum source so that resected material that enters the suction channel via the material entry port 170 is removed from the suction channel at the material exit port 175 while the endoscopic instrument 150 is disposed within the instrument channel of the endoscope.
[0149] The head 155 includes a housing having an outer diameter configured such that the endoscopic instrument 150 can be slidably inserted into an instrument channel of an endoscope. In some embodiments, the head 155 can include a powered actuator configured to drive the powered instrument head 160. In some embodiments, the powered actuator is disposed within the head 155. In some embodiments, the powered actuator is located external to the portion of the endoscopic instrument 150 that can be inserted into the instrument channel of an endoscope. In some embodiments, the powered actuator can drive the powered instrument head via a shaft that can transfer motion generated by the powered actuator to the powered instrument head. In some embodiments, the powered actuator is not part of the endoscopic instrument 150, but is coupled to the powered instrument head 160. In some embodiments, the shaft can be a flexible shaft. In some such embodiments, the flexible shaft can be a flexible torque coil, additional details of which are described below with reference to Figures 19A-19C supply.
[0150] The endoscopic instrument 150 can be sized to be inserted into an instrument channel of an endoscope. In some embodiments, the endoscopic instrument 150 can be sized so that the endoscopic instrument can be inserted into the instrument channel of an endoscope while the endoscope is being inserted into a subject. In some such embodiments, an endoscope (e.g., a colonoscope) can be curved or bent, thereby requiring the endoscopic instrument 150 to be sized so that it can be inserted into the curved or bent endoscope.
[0151] In some embodiments, the head 155 and powered instrument head 160 of the endoscopic instrument 150 can be substantially rigid or stiff, while the flexible portion 165 can be relatively flexible or compliant. The head 155 and powered instrument head 160 can be substantially rigid. Thus, in some such embodiments, the head 155 and powered instrument head 160 can be sized, at least in thickness and length, to enable the endoscopic instrument 150 to maneuver through sharp turns and curves during insertion of the endoscopic instrument 150 into the instrument channel of an endoscope. In some embodiments, the length of the powered instrument head 160 can be between approximately 0.2" and 2", between approximately 0.2" and 1", or in some embodiments, between 0.4" and 0.8". In some embodiments, the outer diameter of the powered instrument head 160 can be between approximately 0.4" and 1.5", between 0.6" and 1.2", and between 0.8" and 1". In some embodiments, the length of the head portion 155 of the body may be between about 0.5"-3", between about 0.8" and 2", and between 1" and 1.5".
[0152] The length of the flexible portion 165 can be substantially and / or relatively longer than the length of the head and powered instrument head 160. In some embodiments, the flexible portion 165 can be sufficiently long such that the combined length of the endoscopic instrument exceeds the length of the instrument channel of an endoscope into which the instrument can be inserted. Thus, the length of the flexible portion 165 can have a length exceeding approximately 36", approximately 45", or approximately 60". For endoscopic instruments configured for use with other types of endoscopes, the length of the flexible portion can be shorter than 36", but still long enough to allow the body of the endoscopic instrument to have a length that is approximately the same as or greater than the length of the endoscope with which the instrument is to be used.
[0153] The outer diameter of the flexible portion 165 can also be configured to allow endoscopic instruments to be inserted into the instrument channel of the endoscope. In some embodiments, the outer diameter of the flexible portion 165 can be smaller than the corresponding inner diameter of the instrument channel of the endoscope. In some such embodiments, the endoscopic instrument can be sized to have an outer diameter small enough to be slidably positioned within the endoscope when the endoscope is coiled or bent. For example, an endoscope can include an instrument channel that has an inner diameter of approximately 4.3 mm when the endoscope is straightened. However, when the endoscope is coiled or bent, the portion of the endoscope near the bend can have a clearance less than the inner diameter of approximately 4.3 mm. In some embodiments, the clearance can be as low as 3.2 mm. Thus, in some embodiments, the endoscopic instrument can be sized to allow endoscopic instruments to be slidably inserted into the instrument channel of the endoscope even when the endoscope is coiled or bent.
[0154] Figure 2A and 2B as well as Figure 3A and 3B The embodiment according to the present disclosure is shown Figure 1B 100. Figure 2A and 2B As shown, the endoscopic instrument 220 can extend outside the tip 104 of the endoscope 100, and Figure 3A and 3B The endoscopic tool 220 is shown retractable within the endoscope so that no portion of the endoscopic instrument 220 extends beyond the tip 104 of the endoscope 100. As will be described in further detail with reference to FIG4 , the endoscopic instrument 220 is capable of cutting or removing polyps and obtaining the removed polyps from the treatment site without having to remove the endoscopic instrument 220 from the endoscope 100.
[0155] Figure 4AAn exploded view of an endoscopic instrument 220 suitable for use with an endoscope 100 according to an embodiment of the present disclosure is shown. The endoscopic instrument 220 includes a removal component for removing polyps growing in a patient's body and a sample retrieval component for retrieving the removed polyps from a surgical site. The endoscopic instrument 220 includes a tube 410 coupled to a cap 420. In various embodiments, the cap 420 can be sealingly engaged with the tube 410. The cap can be aligned with the main shaft 430 at a first portion of the main shaft 430. In various embodiments, the main shaft 430 can be substantially hollow. The main shaft 430 can be coupled to a rotor 440 configured to rotate the main shaft 430. A second portion of the main shaft 430 includes inner blades 450, which can be configured to interact with outer blades 460. In some embodiments, the outer blades 460 can be separated from the inner blades by a gap that forms an irrigation channel (not shown). The housing 470 is configured to surround the cap 420 and the rotor 440, as described above with reference to FIG. Figure 2A and 3A It should be understood that the endoscopic instrument 220 may include other components, such as gaskets, bearings, seals, etc.
[0156] Figure 4B is a schematic diagram of an endoscopic instrument partially inserted into an instrument channel of an endoscope. In various embodiments, the cap, connector, rotor, and housing may be made of injection-molded plastic. The spindle and cannula may be made of surgical-grade steel, and the tube may be made of silicone. However, it should be understood that these materials are merely examples of materials that may be used. Those skilled in the art will appreciate that other materials may be used in place of the aforementioned materials.
[0157] Figure 4A The tube 410 can be sized to pass through Figure 4A and 4BThe instrument channel 120 of the endoscope 100 is shown in FIG. The tube 410 may include one or more pneumatic fluid inlet conduits 412, one or more pneumatic fluid outlet conduits 414, one or more irrigation conduits 416, and one or more aspiration conduits 418. The pneumatic fluid inlet conduit 412 is configured to supply pressurized air to pneumatically drive the rotor 440, while the pneumatic fluid outlet conduit 414 removes the air supplied by the pneumatic fluid inlet conduit 412 to prevent the entry of large amounts of air into the patient. The irrigation conduit 416 supplies irrigation fluid, such as water, between the inner blade 450 and the outer blade 460 to help lubricate the area between the inner blade 450 and the outer blade 460. Furthermore, the irrigation fluid then flows from the exterior of the inner blade 450 to the interior of the inner blade 450. It should be understood that the interior of the inner blade 450 can be aligned with the aspiration conduit 418 of the tube 410 via the cap 420, so that any fluid entering the inner blade 450 can pass through the inner blade 450 and enter the aspiration conduit 418 of the tube 410. The irrigation fluid flowing through the interior of the inner blade 450 and the suction conduit 418 helps lubricate the suction conduit 418, through which the polyps and other waste products removed from the patient's body are removed. As described above, the tube 410 is coupled to the cap 420 at a first end, but is coupled to one or more components at a second end (not shown). For example, at the second end, the pneumatic air inlet conduit 412 can be coupled to a compressed air source, while the irrigation fluid conduit 416 can be coupled to a water supply. Additionally, the pneumatic fluid outlet conduit 414 can be coupled to a compressed air source or simply exposed to the outside of the patient's body for ventilation.
[0158] In various embodiments, the suction conduit 418 can be coupled to a disposable cartridge configured to capture resected polyps and store them for later examination. In various embodiments, the disposable cartridge can include multiple collection bins. The operator can select a collection bin in which to collect samples of a specific resected polyp. Upon selecting a collection bin, the suction conduit 418 delivers the collected material from the patient to the specific collection bin. Thus, the operator can collect samples from each polyp in a respective collection bin. In this manner, the cancerous nature of a single polyp can be determined.
[0159] Cap 420 can be sized to fit within the first end of tube 410. In various embodiments, the first end of tube 410 can include a connector configured to couple with cap 420. In various embodiments, cap 420 can be press-fitted into the connector of tube 410. Thus, cap 420 can include corresponding conduits that mate with the conduits of tube 410. Thus, compressed air from a compressed air source can be supplied toward rotor 440 via pneumatic air inlet conduit 412 of tube 410 and corresponding pneumatic air inlet conduits of cap 420. Rotor 440 can include one or more rotor blades 442 against which compressed air strikes, thereby causing rotor 440 to rotate. The air striking rotor blades 442 can then exit through corresponding pneumatic air exit conduits of the cap and pneumatic air inlet conduit 414 of tube 410. The speed at which rotor 440 can rotate depends on the amount of air and the pressure at which the air is supplied to rotor 440. In various embodiments, the speed at which rotor 440 rotates can be controlled by an operator of endoscope 100. Although the present disclosure discloses a pneumatic device for operating the rotor, some embodiments may include a hydraulic device for operating the rotor. In such an embodiment, a fluid such as water may be supplied in the pneumatic air inlet pipe 412 instead of compressed air.
[0160] As described above, the main shaft 430 is coupled to the rotor 440 such that when the rotor 440 rotates, the main shaft 430 also rotates. In various embodiments, the first end of the main shaft 430 includes an inner blade 450, which in turn rotates with the rotor 440. The inner blade 450 can be sized to fit within the diameter of the outer blade 460. In various embodiments, irrigation fluid supplied from an irrigation fluid source can be supplied through the irrigation fluid conduit 416 of the tube 410 and corresponding conduits of the cap 420, along the space between the inner blade 450 and the outer blade 460, and into the aspiration conduit 418 defined by the inner diameter of the inner blade 450. It should be understood that because the aspiration conduit 418 is coupled to a vacuum source, fluids and other materials can be drawn through the aspiration conduit. In this manner, the irrigation fluid can lubricate at least a substantial portion of the length of the aspiration conduit 418, from the tip 452 of the inner blade 450, through the main shaft 430, the cap 420, and the tube 410, and into the disposable cartridge.
[0161] The inner blade 450 is rotatable relative to the outer blade 460 such that the interaction between the inner blade 450 and the outer blade 460 causes the polyp to be cut upon contact with the inner blade 450. In various embodiments, other mechanisms for cutting the polyp may be used, which may or may not include the use of the rotor 440, the inner blade 450, or the outer blade 460.
[0162] The removal component can generally be configured to remove polyps. For example, removal can, for example, include any action involving separating a polyp or a part of a polyp from the patient's body surface. Therefore, actions including but not limited to cutting, snaring, chopping, slicing, and crushing are also examples of removal in whole or in part. Therefore, the removal component can be a component that can cut, snare, chop, slice, or crush a polyp from the patient's body surface. Therefore, the removal component can be embodied as tweezers, scissors, a knife, a snare, a pulverizer, or any other component that can remove polyps. In some embodiments, the removal component can be manually actuated so that the removal component can be operated by the conversion of a mechanical force applied by the operator, or a turbine, a motor, or any other force-generating component can be used to automatically actuate to actuate the removal component. For example, the removal component can be hydraulically, pneumatically, or electrically actuated. In various embodiments, a separate conduit passing through the tube or channel of the endoscope can be configured to carry wires to provide power to an electric actuator (e.g., a motor).
[0163] According to various embodiments, the removal component may include a turbine assembly comprised of a rotor 440, rotor blades 442, and a main shaft 430. An operator can activate the removal component of the endoscopic instrument by supplying compressed air to the turbine assembly. When the operator is ready to begin polyp removal, the operator activates the turbine assembly, causing the removal component to be activated. In embodiments, such as the embodiment disclosed in FIG. 4 , actuating the removal component may be configured to rotate the inner blades 450 relative to the outer blades 460. Upon activation, the operator can move the endoscopic instrument 220 toward the polyp to be removed, causing the inner blades 450 to remove the polyp, leaving the removed portion of the polyp adjacent to the area surrounding the polyp's growth. The operator can then deactivate the turbine assembly and activate suction through the suction conduit 418. The operator can then position the inner blades toward the removed polyp, causing the removed polyp to be retrieved through the suction conduit 418. In various embodiments, when the clearing component is actuated, the suction component of the endoscopic instrument can be actuated, thereby allowing any cleared material to be retrieved by the suction component.
[0164] Although the above-described embodiments incorporate a removal component utilizing a turbine assembly, the scope of the present disclosure is not limited to these embodiments. Rather, it will be understood by those skilled in the art that the removal component may be manually operated, or any other means of removing the polyp may be utilized such that the removed polyp can be retrieved from the surgical site via the aforementioned suction conduit. Thus, examples of a removal component may include, but are not limited to, scissors, blades, saws, or any other sharp tool that may or may not be driven by a turbine assembly. It will be appreciated that it may be desirable to use a removal component that is capable of cutting the polyp into sufficiently small pieces so that the cut pieces can be retrieved via the suction conduit without having to remove the endoscopic instrument from the endoscope.
[0165] The geometry and assembly of the turbine assembly for rotating at least one cutting tool blade can be based on fluid dynamics. Bernoulli's equation can be used to explain the conversion between fluid pressure and fluid velocity. According to this equation, fluid velocity is related to the initial fluid pressure as follows:
[0166]
[0167] Where V is velocity, P is pressure, and D is mass density.
[0168] To achieve the calculated velocity of the fluid, the flow may be generated at the outlet such that the channel through which the fluid flows satisfies an empirically determined L / D ratio of 2, where 'D' is the wetted diameter of the stream and 'L' is the length of the channel.
[0169] To further understand the interaction of the rotor blade and the fluid, assume that the rotor blade is manufactured so that the air jet hits the rotor blade on a flat surface. The linear momentum equation can be applied to find the resulting force:
[0170]
[0171] in: is the mass flow rate of the impinging air jet, and V is the volume.
[0172] Assuming the control volume remains constant (the volume between the blades), the force generated on the blades can be solved as:
[0173]
[0174] In an impulse turbine, the quantity V out and V in are the same, the change in momentum is caused only by the change in direction of the fluid. is defined by the pump being specified. The actual value also needs to take into account the speed of the rotor. Finally, the force generated by the single blade-air jet interaction is:
[0175]
[0176]
[0177] Where 'θ' is the difference in angle between the incident air jet and the outgoing air jet. Theoretically, the maximum amount of torque can be generated with a 'θ' value of 180°, but doing so will actually send the incident jet to the back of the next blade. Therefore, this angle is best designed to be 15° to 20° below 180° to allow the fluid to exit cleanly. Finally, the force can be defined as the rotational torque:
[0178]
[0179] The second force that can be considered comes from redirecting the air jet from the nozzle into the turbine wheel. To power the turbine, the air jet can be turned 90° from the direction of the air jet to the direction of the blades. This rotation of the air jet will generate a force on the fixed housing that is a function of the jet velocity, which in turn is proportional to the applied pressure:
[0180]
[0181] This force may be reacted through the connection between the housing and the endoscope, failure to do so may result in ejection of the turbine assembly during operation.
[0182] Computational analysis based on the finite element method (FEM) showed that the area of greatest stress is located near the root of the blade, where the sharp corner is located. Existing air nozzle channels in endoscopes can simplify the design of the air input channel. Air nozzles in existing endoscopes direct pressurized air through the objective lens to remove moisture, and also provide expansion of the cavity being inspected or direct pressurized water through the objective lens to clear debris.
[0183] Now refer to Figure 4B , a perspective view of an endoscopic instrument coupled to an endoscope is shown illustrating various conduits associated with the endoscopic instrument. In particular, a pneumatic air inlet conduit 412 is shown supplying pressurized air to the rotor assembly, while a pneumatic air outlet conduit 412 (not shown in this view) removes air from the rotor assembly to the exterior of the endoscope 100. An irrigation channel 416 is shown carrying irrigation fluid into the endoscopic instrument 220, wherein the irrigation fluid enters an aspiration conduit 418 which carries material from the patient to a collection component external to the endoscope. Figure 4B As shown, irrigation fluid can enter the suction conduit 418 at the irrigation fluid inlet opening 419. It should be understood that the placement of the irrigation fluid inlet opening 419 can be placed at any location along the suction conduit. As suction is applied to the suction conduit, irrigation fluid can be forced into the suction conduit without the risk of material flowing in the suction conduit flowing outside the suction conduit through the irrigation fluid inlet opening 419. Furthermore, in some embodiments, the irrigation channel can only supply irrigation fluid to the endoscopic instrument while suction is applied to the suction conduit.
[0184] Figure 5A side perspective view of another endoscopic instrument coupled to the endoscope shown in FIG1 is shown in accordance with an embodiment of the present disclosure. The additional endoscopic instrument 500 is sized to couple with the wall of the instrument channel 120 defining the tip 104 of the endoscope 100. In various embodiments, the additional endoscopic instrument 500 can be removably coupled to the instrument channel 120 of the endoscope 100 at the tip 104 of the endoscope 104 by an interference fit or a press fit. In other embodiments, the additional endoscopic instrument 500 can be coupled to the endoscope 100 using other attachment means known to those skilled in the art.
[0185] Now refer to Figure 6 , shows an enlarged view of an additional endoscopic instrument 500. The additional endoscopic instrument includes an outer blade or support member 510, an inner blade 520 disposed within the outer blade 510, and a rotor 530 coupled to the inner blade 520 and enclosed by a housing 540. The housing is coupled to a cap 550, which is further coupled to a connector 560. In some embodiments, the connector 560 can be sized to engage with the inner diameter of the instrument channel 120 of the endoscope 100. In some embodiments, any other component of the endoscopic instrument can be configured to engage with the endoscope 100 in a manner that secures the endoscopic instrument to the instrument channel 120.
[0186] Figure 7-12 The embodiment according to the present disclosure is shown Figure 6 1-4 , the additional endoscopic instrument 500 may be adapted to fit within the first end of the instrument channel 120 of the endoscope 100 .
[0187] In various embodiments, the second end of the instrument channel 120 can be coupled to a vacuum source that allows material to be aspirated through the instrument channel 120. An aspiration conduit extends from the vacuum source, through the instrument channel of the endoscope, and further through the connector 560, cap 550, and rotor 530, to a first end of the inner blade 520, which has an opening defined by the inner diameter of the inner blade 520. It should be understood that the connector 560, cap 550, housing 540, and rotor 530 have corresponding central apertures 566, 556, 546, and 536 that are aligned so that material is allowed to flow from the opening of the inner blade 520 to the vacuum source via the second end of the instrument channel 120.
[0188] Additionally, the housing 540 of the additional endoscopic instrument 500 includes a pneumatic air inlet port 542 and a pneumatic air outlet port 544, as shown. Figure 10As shown. The pneumatic air inlet port 542 can be adapted to receive compressed air from a compressed air source through a pneumatic air inlet conduit that extends along the length of the endoscope 100 and out of the patient's body, while the pneumatic air outlet port 544 can be adapted to exhaust air impinging on the rotor 530 through a pneumatic air outlet conduit that extends along the length of the endoscope 100 and out of the patient's body. In this manner, the rotor can be actuated by supplying compressed air from a compressed air source, as described above with reference to Figures 1-4. It should be understood that although the rotor and related components disclosed herein describe the use of pneumatic air, the rotor can be driven hydraulically. In such an embodiment, the pneumatic air conduit can be configured to transport a liquid, such as water, to and from the area surrounding the rotor.
[0189] Now also refer to Figure 13 It should be understood that the pneumatic air inlet and outlet conduits can extend from the additional endoscopic instrument to the pneumatic air source through the instrument channel 120 of the endoscope 100. In such an embodiment, a tube including separate conduits for the pneumatic air inlet and outlet conduits and the suction conduit can extend from the exterior of the endoscope to the additional endoscopic instrument within the endoscope. The tube can be capable of being fed through the instrument channel of the endoscope and coupled to the additional endoscopic instrument 500. In such an embodiment, the additional endoscopic instrument 500 can be configured with an additional component having predefined channels that couple the corresponding channels of the tube to the pneumatic air inlet and outlet openings of the additional endoscopic instrument and the suction conduit formed within the additional endoscopic instrument. Additionally, an irrigation fluid channel can be defined within the tube to allow irrigation fluid to be supplied to the additional endoscopic instrument 500, from where it is transferred to the suction conduit.
[0190] In various embodiments, the tip of the outer blade 510 can be sharp and can cause discomfort to the patient when entering a cavity of the patient's body. Thus, before inserting an additional endoscopic instrument into the patient's body, a protective structure (not shown), such as a gel cap or other similar structure, can be attached to the outer blade to prevent the outer blade from contacting the surface of the patient's body and causing injury. Once the endoscopic instrument is inserted into the patient's body, the protective structure can be released from the outer blade 510. In various embodiments, the protective structure can dissolve upon entry into the patient's body.
[0191] Now refer to Figure 14, an improved endoscope with a built-in polyp removal assembly is shown according to an embodiment of the present disclosure. The improved endoscope 1400 can be similar to a conventional endoscope in many respects, but can be distinguished in that the improved endoscope can include a built-in polyp removal assembly 1440 within an instrument channel of the endoscope 1400. The polyp removal assembly 1440 can include a turbine assembly having a rotor 1442 with rotor blades sealed in a housing 1444 having one or more inlet and outlet ports for admitting pneumatic or hydraulic fluid to actuate the rotor 1442. The inlet ports can be designed so that the fluid can interact with the rotor blades at a suitable angle to ensure that the rotor can be driven at a desired speed.
[0192] Additionally, the polyp removal assembly 1440 can be coupled to a connector 1420 that is configured to couple the polyp removal assembly 1440 to a tube 1470. The tube 1470 can include a pneumatic air inlet conduit 1412, a pneumatic air outlet conduit (not shown), an irrigation fluid conduit 1416, and a suction conduit 1418 that passes through the center of the turbine assembly. The tube 1440 can be sized such that the tube 1440 can be securely coupled to the connector 1420 such that one or more conduits of the tube 1440 couple to corresponding conduits within the connector 1440. The connector 1420 can be designed to include an irrigation fluid inlet opening 419 that allows irrigation fluid to enter the suction conduit 1418 of the tube 1440 when the tube is coupled to the connector.
[0193] The turbine assembly of endoscope 1400 can be configured to couple with a removable clearing assembly 1460, which includes a spindle and a cannula, in a manner such that the clearing assembly is operable while the turbine assembly is in operation.
[0194] In other embodiments of the present disclosure, an endoscope can be designed to facilitate the removal of one or more polyps and the removal of the associated removal material in a single procedure. In various embodiments, the endoscope can include one or more separate channels for removing removal material, supplying irrigation fluid, and supplying and removing at least one of pneumatic or hydraulic fluid. Furthermore, the endoscope can include a removal component that can be fixedly or removably coupled to one end of the endoscope. In various embodiments, separate removal component channels can be designed for the removal component based on its operation. Furthermore, the endoscope can include a light and a camera. In one embodiment, the endoscope can utilize existing channels to supply pneumatic or hydraulic fluid to an actuator of the endoscopic instrument to actuate the removal component. For example, in the endoscope shown in FIG. 1 , water channels 108A-N can be modified to pneumatically or hydraulically supply fluid to the actuator. In such an embodiment, the endoscopic instrument can include a connector having a first end that can be coupled to an opening associated with an existing channel 108 of the endoscope, with the other end of the connector exposed to an opening at the actuator.
[0195] In various embodiments of the present disclosure, the endoscopic instrument can also be configured to detect the presence of certain tissue layers. This may be useful for physicians to take additional precautions to prevent intestinal perforation when removing polyps. In some embodiments, the endoscopic instrument can be equipped with a sensor that can communicate with a sensor processing unit external to the endoscope to determine the type of tissue. The sensor can collect temperature information as well as density information and provide a signal corresponding to this information to the sensor processing unit, which can identify the type of tissue being sensed. In some embodiments, the sensor can be an electrical sensor.
[0196] Additionally, the endoscopic instrument may be equipped with an injectable dye component that allows the doctor to mark specific areas within the patient's body. In other embodiments, the doctor may utilize a clearing component to mark specific areas without the use of an injectable dye.
[0197] While the present disclosure discloses various embodiments of endoscopic instruments, including but not limited to tools that can be attached to the tip of an endoscope and tools that can be fed through the length of an endoscope, the scope of the present disclosure is not intended to be limited to these embodiments or endoscopic instruments generally. Rather, the scope of the present disclosure extends to any device that can be used to clear and remove polyps from a patient using a single tool. Thus, the scope of the present disclosure extends to improved endoscopes that can be constructed with some or all of the components of the endoscopic instruments described herein. For example, an improved endoscope having an integrated turbine assembly and configured to couple to a clearing component is also disclosed. Furthermore, the endoscope may include a predefined conduit extending through the length of the endoscope, such that only the suction conduit may be defined by a disposable tube, while the air inlet and outlet conduits and the irrigation conduit are permanently defined within the improved endoscope. In other embodiments, the suction conduit is also predefined but is manufactured so that it can be cleaned and decontaminated for use on multiple patients. Similarly, the clearing component may be integral to the endoscope but also capable of being cleaned and decontaminated for use on multiple patients. Furthermore, it will be understood by those skilled in the art that any or all of the components comprising the endoscopic instrument may be built into an existing endoscope or into a newly designed endoscope for use in debridement and removal of polyps from a patient.
[0198] Now refer to Figure 15 , shows a conceptual system architecture diagram illustrating various components for operating an endoscopic instrument according to an embodiment of the present disclosure. Endoscopic system 1500 includes endoscope 100 equipped with endoscopic instrument 220, and endoscope 100 can be coupled to an air supply measurement system 1510, an irrigation system 1530, and a polyp removal system 1540. As described above, the tubes extending within endoscope 100 can include one or more pneumatic air inlet conduits 412 and one or more pneumatic air outlet conduits 414. Pneumatic air inlet conduits 412 are coupled to air supply measurement system 1510, which includes one or more sensors, meters, valves, and other components that control the amount of gas (e.g., air) supplied to endoscope 100 to drive rotor 440. In some embodiments, air supply measurement system 1510 can be used to control the amount of air supplied to rotor 440. Furthermore, the delivery of air used to actuate rotor 440 can be manually controlled by a physician using endoscope 100. In one embodiment, the physician can use a foot pedal or a manual lever to supply air to rotor 440.
[0199] However, the pneumatic air exit conduit 414 may not be coupled to any components. As a result, air exiting the rotor 440 may simply exit the endoscope and enter the atmosphere via the pneumatic air exit conduit 414. In some embodiments, the pneumatic air exit conduit 414 may be coupled to an air supply metering system 1510 so that air exiting the pneumatic air exit conduit 414 is supplied back to the rotor via the pneumatic air inlet conduit 412. It will be appreciated that a similar arrangement may be used for a hydraulically driven turbine system.
[0200] The endoscope 100 can also be coupled to an irrigation system 1530 via the irrigation fluid conduit 416. The irrigation system 1530 can include a flow meter 1534 coupled to an irrigation source 1532 for controlling the amount of fluid flowing from the irrigation source 1532 to the endoscope 100.
[0201] As described above, the endoscope 100 may also include a suction conduit 418 for removing polyps from the patient. The suction conduit 418 may be coupled to a polyp removal system 1540, which may be configured to store polyps. In various embodiments, a physician may be able to collect samples in one or more cartridges 1542 within the polyp removal system 1540 so that the removed polyps can be individually tested.
[0202] In various embodiments of the present disclosure, an endoscope includes a first end and a second end separated by a flexible housing, an instrument channel extending from the first end to the second end, and an endoscopic instrument including a scavenging component and a sample retrieval conduit disposed within the instrument channel. The endoscopic instrument may further include a flexible tube, the sample retrieval conduit partially disposed within the flexible tube, and the flexible tube extending from the first end to the second end of the endoscope. The flexible tube may further include a pneumatic air inlet conduit and a fluid flushing conduit. In various embodiments, the scavenging component may include a turbine assembly and a cutting tool. In various embodiments, the endoscope is configured to have a built-in endoscopic instrument, the instrument channel may have a diameter that is larger than the instrument channel of existing endoscopes. In this way, a larger portion of scavenging material can be aspirated from the patient without clogging the aspiration conduit.
[0203] In other embodiments, the endoscope may include a first end and a second end separated by a flexible housing; an instrument channel extending from the first end to the second end; and an endoscopic instrument coupled to the instrument channel at the first end of the endoscope, the endoscopic instrument including a clearing component and a sample retrieval tubing partially disposed within the instrument channel. In some embodiments, the endoscopic instrument may be removably attached to the endoscopic instrument.
[0204] In other embodiments of the present disclosure, an endoscope system includes an endoscope comprising a first end and a second end separated by a flexible housing, an instrument channel extending from the first end to the second end, and an endoscopic instrument coupled to the instrument channel at the first end of the endoscope. The endoscopic instrument may include a scavenging component and a flexible tube, the flexible tube having a length greater than the length of the endoscope. Furthermore, the flexible tube may include a sample retrieval line, a pneumatic air inlet line, and a fluid flush line, a disposable cartridge configured to couple to the sample retrieval line near the second end of the endoscope, a pressurized air source configured to couple to the pneumatic air inlet line near the second end of the endoscope, and a fluid flush source configured to couple to the fluid flush line near the second end of the endoscope. In various embodiments, the endoscope may also include at least one camera source and at least one light source. In some embodiments of the present disclosure, the pneumatic air inlet line supplies pressurized air to a turbine assembly of the scavenging component near the first end of the endoscope, and the fluid flush line supplies flushing fluid to the sample retrieval line near the first end of the endoscope.
[0205] Figure 16A An exploded partial view of an endoscopic instrument 1600 is shown, which is similar to Figure 1C The endoscopic instrument 150 is depicted in FIG, wherein the endoscopic instrument 1600 is configured to be inserted into an instrument channel of an endoscope, e.g. Figure 1B Endoscope 100 depicted in FIG. Figure 16B Shown Figure 16A A partial cross-sectional view of the endoscopic instrument shown in FIG. Figure 16A and 16B As shown, the head of the endoscopic instrument 1600 may include a powered actuator 1605, a powered instrument head 1680 including a cutting shaft 1610 and an outer structure 1615, and a feed-through connector 1620 coupled to the distal end of a flexible tubular member 1630. The flexible tubular member 1630 forms the tail of the endoscopic instrument 1600. Thus, Figure 16A and 16B The head of an endoscopic instrument 1600 is shown.
[0206] Endoscopic instrument 1600 is configured to define a suction channel 1660 that extends from the proximal end of flexible tubular member 1630 to the distal tip 1614 of powered instrument head 1680. In some embodiments, the proximal end of flexible tubular member 1630 can be configured to be fluidically coupled to a vacuum source. In this manner, when suction is applied at the proximal end of flexible tubular member 1630, material at or around the distal tip 1614 of powered instrument head 1680 can enter endoscopic instrument 1600 at the distal tip and flow through suction channel 1660 all the way to the proximal end of flexible tubular member 1630.
[0207] Powered actuator 1605 can be configured to drive a powered instrument head 1680, which includes a cutting shaft 1610 disposed within an outer structure 1615. In some embodiments, powered actuator 1605 can include a drive shaft 1608 mechanically coupled to cutting shaft 1610. In some embodiments, one or more coupling elements can be used to couple drive shaft 1608 to a proximal end 1611 of cutting shaft 1610, such that cutting shaft 1610 is driven by drive shaft 1608. Powered actuator 1605 can be an electric actuator. In some embodiments, electric actuator can include electrical terminals 1606 configured to receive conductive wires for supplying current to electric actuator 1605. In some embodiments, electric actuator can include a motor. In some embodiments, the motor can be a micromotor, such that the motor has an outer diameter of less than a few millimeters. In some embodiments, powered actuator 1605 has an outer diameter of less than approximately 3.8 mm. In addition to having a small footprint, the powered actuator 1605 can be configured to meet specific torque and rotational speed parameters. In some embodiments, the powered actuator 1605 can be configured to generate sufficient torque and / or rotate at a sufficient speed to be able to cut tissue from a subject. Examples of motors that meet these requirements include micromotors manufactured by Maxon Precision Motors, Inc., located in Fall River, Massachusetts, USA. Other examples of motors include any type of motor, including AC motors, DC motors, piezoelectric motors, etc.
[0208] The powered instrument head 1680 is configured to be coupled to the powered actuator 1605 so that the powered actuator 1605 can drive the powered instrument head. As described above, the proximal end 1611 of the cutting shaft 1610 can be configured to be coupled to the drive shaft 1608 of the powered actuator 1605. The distal end 1614 of the cutting shaft 1610, opposite the proximal end 1611, can include a cutting tip 1612. The cutting tip 1612 can include one or more sharp surfaces capable of cutting tissue. In some embodiments, the cutting shaft 1610 can be hollow and can define a material entry port 1613 at or around the cutting tip 1612 through which cut material can enter the endoscopic instrument 1610. In some embodiments, the proximal end 1611 of the cutting shaft 1610 can include one or more exit holes 1614 sized to allow material to flow from the material entry port 1613 to exit the cutting shaft 1610. Figure 16A and 16BAs shown, exit holes 1614 are defined in the wall of the cutting shaft 1610. In some embodiments, these exit holes 1614 can be sized such that material that enters the cutting shaft 1610 via the material entry port 1613 can exit the cutting shaft 1610 via the exit holes 1614. In some embodiments, the portion of the cutting shaft 1610 proximate the drive shaft 1608 can be solid such that all material that enters the cutting shaft 1610 exits the cutting shaft 1610 via the exit holes 1614.
[0209] The outer structure 1615 can be hollow and configured such that the cutting shaft can be disposed within the outer structure 1615. Thus, the outer structure 1615 has an inner diameter that is larger than the outer diameter of the cutting shaft 1610. In some embodiments, the outer structure 1615 is sized such that the cutting shaft 1610 can freely rotate within the outer structure 1615 without contacting the inner wall of the outer structure 1615. The outer structure 1615 can include an opening 1616 at a distal end 1617 of the outer structure 1615 such that the cutting tip 1612 and a material entry port 1613 defined in the cutting shaft 1610 are exposed when the cutting shaft 1610 is disposed within the outer structure 1615. In some embodiments, the outer surface of the cutting shaft 1610 and the inner surface of the outer structure 1615 can be coated with a heat-resistant coating to help reduce heat generation when the cutting shaft 1610 rotates within the outer structure 1615. The proximal end of outer structure 1615 is configured to attach to a housing that houses powered actuator 1605 .
[0210] The feed-through connector 1620 can be concentrically positioned around the portion of the cutting shaft 1610 that defines the exit aperture 1614. In some embodiments, the feed-through connector 1620 can be hollow and configured to enclose an area surrounding the exit aperture 1614 of the cutting shaft 1610 such that material exiting the exit aperture 1614 of the cutting shaft 1610 is contained within the feed-through connector 1620. The feed-through connector 1620 can include an exit port 1622 that can be configured to receive the distal end of the tubular member 1630. In this manner, any material within the feed-through connector 1620 can flow into the distal end of the flexible tubular member 1630. The feed-through connector 1620 can function as a fluid coupler that allows fluid communication between the cutting shaft 1610 and the tubular member 1630.
[0211] The tubular member 1630 can be configured to couple to the outlet port 1622 of the feed-through connector 1620. A suction channel 1660 extends from the material entry port 1613 of the cutting shaft 1610 to the proximal end of the tubular member 1630 through the cutting shaft 160, the feed-through connector 1620, and the flexible tubular member 1630. In some embodiments, the tubular member 1630 can be configured to couple to a vacuum source at the proximal end of the tubular member 1630. Thus, when the vacuum source applies suction to the proximal end of the tubular member 1630, material can enter the suction channel via the material entry port 1613 of the cutting shaft 1610 and flow through the suction channel 1660 toward the vacuum source and out of the endoscopic instrument 1600. In this manner, the suction channel 1660 extends from one end of the endoscopic instrument 1600 to the other end of the endoscopic instrument 1600. In some embodiments, a vacuum source can be applied to the tubular member 1630 so that material at the treatment site can be drawn from the treatment site, through the suction channel 1660, and out of the endoscopic instrument 1600 while the endoscopic instrument 1600 remains positioned within the instrument channel of the endoscope and within the subject being treated. In some embodiments, one or more surfaces of the cutting shaft 1610, feed-through connector 1620, or tubular member 1630 can be treated to improve the flow of fluids. For example, the inner surface of the cutting shaft 1610, feed-through connector 1620, or tubular member 1630 can be coated with a superhydrophobic material to reduce the risk of material being removed from the patient clogging the suction line.
[0212] Examples of various types of instrument heads that can be coupled to powered actuator 1605 are disclosed in, among others, U.S. Patent No. 4,368,734, U.S. Patent No. 3,618,611, U.S. Patent No. 5,217,479, U.S. Patent No. 5,931,848, and U.S. Patent Publication No. 2011 / 0087260. In some other embodiments, the instrument head can include any type of cutting tip that can be driven by a powered actuator (e.g., powered actuator 1650) and can cut tissue into pieces small enough to allow the tissue to be removed from the treatment site via a suction channel defined within endoscopic instrument 1600. In some embodiments, powered instrument head 1680 can be configured to include a portion that can remove material from the treatment site. In some embodiments, the suction channel can have a circumference on the order of a few microns to a few millimeters.
[0213] In some embodiments, where the powered actuator 1620 operates using electric current, the current can be supplied via one or more wires electrically coupling the powered actuator to a current source. In some embodiments, the current source can be external to the endoscopic instrument 1600. In some embodiments, the endoscopic instrument 1600 can include an energy storage component, such as a battery, configured to supply electrical energy to the powered actuator. In some embodiments, the energy storage component can be located within the endoscopic instrument. In some embodiments, the energy storage component or other power source can be configured to provide sufficient current to the powered actuator so that the powered actuator generates a desired amount of torque and / or speed to enable the cutting shaft 1610 to cut tissue material. In some embodiments, the amount of torque sufficient to cut tissue can be greater than or equal to approximately 2.5 Nmm. In some embodiments, the rotational speed of the cutting shaft can be between 1000 and 5000 rpm. However, these torque and speed ranges are examples and are not intended to be limiting in any way.
[0214] The endoscopic instrument 1600 may include other components or elements, such as the seals 1640 and bearings 1625 shown. In some embodiments, the endoscopic instrument 1600 may include other components not shown herein but that may be included in the endoscopic instrument 1600. Examples of such components may include sensors, cables, wires, and other components, such as components for engaging with the inner wall of an instrument channel of an endoscope into which the endoscopic instrument may be inserted. Additionally, the endoscopic instrument may include a housing that surrounds one or more of the powered actuator, the feed-through connector 1620, and any other components of the endoscopic instrument 1600. In some embodiments, the tail portion of the endoscopic instrument 1600 may also include a flexible housing, similar to Figure 1C , which may carry one or more flexible tubular members, such as flexible tubular member 1630, as well as any other wires, cables, or other components.
[0215] In some embodiments, the endoscopic instrument can be configured to engage with an instrument channel of an endoscope into which the instrument is inserted. In some embodiments, the outer surface of the head of the endoscopic instrument can engage with the inner wall of the instrument channel of the endoscope, so that the endoscopic instrument does not undergo any unnecessary or undesirable movement that may occur when the instrument channel does not support the endoscopic instrument. In some embodiments, the head of the body of the endoscopic instrument can include a securing mechanism for securing the head of the body to the inner wall of the instrument channel. In some embodiments, the securing mechanism can include a friction element that deploys to engage with the inner wall. The friction element can be a seal, an O-ring, a clamp, etc.
[0216] Figure 16C A schematic diagram of an engagement assembly of an exemplary endoscopic instrument is shown. Figure 16DA cross-sectional view of the engagement assembly is shown when the engagement assembly is disengaged. Figure 16E A cross-sectional view of the engagement assembly is shown when the engagement assembly is configured to engage with an instrument channel of an endoscope. Figure 16C and 16D As shown, engagement assembly 1650 includes a housing portion 1652 defining a cylindrical recess 1654 surrounding an outer surface 1656 of the housing portion. Recess 1654 is sized such that a flexible sealing member 1670 can be partially seated within recess 1654. A cylindrical actuating member 1660 is configured to surround housing portion 1652. Cylindrical actuating member 1660 is slidably movable along the length of housing portion 1652. Cylindrical actuating member 1660 is configured to engage fixation member 1670 by pressing against a surface of fixation member 1670. Actuating member 1660 can exert a force on fixation member 1670, causing fixation member 1670 to deform, resulting in fixation member 1670 becoming flatter and wider. Fixation member 1670 is configured such that, as fixation member 1670 widens, its outer surface can engage the inner surface of an instrument channel of an endoscope into which an endoscopic instrument is inserted. In this manner, when the cylindrical actuation member 1660 is actuated, the endoscopic instrument 1600 can engage the instrument channel, thereby preventing the endoscopic instrument 1600 from moving relative to the instrument channel. This can help provide stability for the operator while treating a subject. In some embodiments, more than one engagement assembly 1650 can be positioned along various portions of the endoscopic instrument 1600.
[0217] Figure 17A An exploded view of an exemplary endoscopic instrument 1700 is shown in accordance with an embodiment of the present disclosure. Figure 17B A cross-sectional view of an endoscopic instrument 1700 is shown. The endoscopic instrument 1700, similar to Figure 16A and 16B The endoscopic instrument 1600 shown in FIG can also be configured to be inserted into an instrument channel of an endoscope, such as Figure 1B 1700. However, endoscopic instrument 1700 differs from endoscopic instrument 1600 in that endoscopic instrument 1700 defines a suction channel 1760 extending through powered actuator 1705. Thus, material entering material inlet port 1713 of endoscopic instrument 1700 can flow through endoscopic instrument 1700 and out of the endoscopic instrument in a straight line.
[0218] like Figure 17A and 17B As shown, endoscopic instrument 1700 is similar to endoscopic instrument 1600, except that the endoscopic instrument includes a different powered actuator 1705, a different cutting shaft 1710, and a different feed-through connector 1720. Powered actuator 1705 is similar to Figure 16A 1605, but differs in that powered actuator 1705 includes a hollow drive shaft 1708 extending through the length of powered actuator 1705. Because some components are different, the manner in which the endoscope is assembled is also different.
[0219] In some embodiments, the powered actuator 1605 can be any actuator that can have a hollow shaft extending through the length of the motor. The distal end 1708a of the drive shaft 1708 includes a first opening and is coupled to the proximal end 1711 of the cutting shaft 1705. Unlike the cutting shaft 1610, the cutting shaft 1710 includes a fluid outlet hole 1714 located at the bottom of the cutting shaft 1710. As a result, the entire length of the cutting shaft 1710 is hollow. The proximal end 1708b of the drive shaft 1708 is configured to be coupled to a feed-through connector 1720, which differs from the feed-through connector 1620 in that the feed-through connector 1720 includes a hollow bore 1722 that defines a channel aligned with the proximal end of the drive shaft, such that the drive shaft 1708 and the hollow bore 1722 are fluidically coupled. Hollow bore 1722 can be configured to connect to a flexible tubular member 1730 , which, like flexible tubular member 1630 , extends from a feed-through connector at a distal end to a proximal end that is configured to be coupled to a vacuum source.
[0220] like Figure 17A and 17B As shown, the drive shaft 1708 can be hollow, such that the drive shaft 1708 defines a first opening at the distal end 1708a and a second opening at the proximal end 1708b of the drive shaft 1708. The cutting shaft 1710 is also hollow and defines an opening 1714 at the bottom end 1710a of the cutting shaft 1710. The distal end 1708a of the drive shaft 1708 is configured to couple to the bottom end 1710a of the cutting shaft 1710 such that the first opening of the drive shaft 1708 is aligned with the opening at the bottom end 1710a of the cutting shaft 1710. In this way, the drive shaft 1708 can be fluidically coupled to the cutting shaft 1710. The distal end 1710b of the cutting shaft 1710 includes a cutting tip 1712 and a material entry port 1713.
[0221] The proximal end 1708a of the drive shaft 1708 is fluidly coupled to the distal end of the flexible tubular member 1730 via a feed-through connector 1720. In some embodiments, the feed-through connector 1720 couples the drive shaft and the flexible tubular member so that the flexible tubular member does not rotate with the drive shaft. The proximal end of the flexible tubular member can be configured to be coupled to a vacuum source.
[0222] like Figure 17BAs shown, the endoscopic instrument 1700 defines an aspiration channel 1760 that extends from the material entry port 1713 through the cutting shaft, the drive shaft, the feed-through connector 1720, and to the second end of the flexible tubular member 1730. In this manner, material entering the material entry port 1713 can flow through the length of the endoscopic instrument and exit the endoscopic instrument at the second end of the endoscopic instrument.
[0223] The other components of the endoscopic instrument 1700 are similar to Figure 16A and 16B 16. For example, the outer structure 1715, the coded component 1606, the seals, and the bearings can be substantially similar to the outer structure 1615, the coded component 1606, the seals 1640, and the bearings 1625 shown in FIG16. Other components, some of which are shown, can be included to construct the endoscopic instrument and enable the instrument to function properly.
[0224] Figure 18A An exploded view of an exemplary endoscopic instrument 1800 is shown in accordance with an embodiment of the present disclosure. Figure 18B A cross-sectional view of an endoscopic instrument 1800 is shown. The endoscopic instrument 1800, similar to Figure 17A and 17B The endoscopic instrument 1700 shown in FIG can also be configured to be inserted into an instrument channel of an endoscope, such as Figure 1B However, endoscopic instrument 1800 differs from endoscopic instrument 1700 in that endoscopic instrument 1800 includes a pneumatically or hydraulically powered actuator 1805.
[0225] In some embodiments, powered actuator 1802 comprises a Tesla turbine, comprising a Tesla rotor 1805, a housing 1806, and a connector 1830. The connector 1830, together with the housing 1806, encloses the Tesla rotor 1805. The Tesla rotor 1805 may include a plurality of disks 1807, spaced apart and sized to fit within the housing. In some embodiments, the Tesla rotor may include 7 to 13 disks having a diameter between approximately 2.5 mm and 3.5 mm and a thickness between 0.5 mm and 1.5 mm. In some embodiments, the disks are separated by gaps ranging from 0.2 mm to 1 mm. The Tesla turbine 1802 may also include a hollow drive shaft 1808 extending along the center of the Tesla rotor 1805. In some embodiments, the distal end 1808a of the drive shaft 1808 is configured to couple to a cutting shaft 1810, such that the cutting shaft 1810 is driven by the Tesla rotor. That is, in some embodiments, the cutting shaft 1810 rotates as the drive shaft 1808 of the Tesla rotor 1805 rotates. In some embodiments, the cutting shaft 1810 may include a Figure 16A In some such embodiments, the feed-through connector fluidly couples the cutting shaft and the flexible portion, similar to Figure 16A Feed-through connector 1630 shown in .
[0226] The connector 1830 of the Tesla turbine 1802 can include at least one fluid inlet port 1832 and at least one fluid outlet port 1834. In some embodiments, the fluid inlet port 1832 and the fluid outlet port 1834 are configured such that fluid can enter the Tesla turbine 1802 via the fluid inlet port 1832, causing the Tesla rotor 1805 to rotate, and exit the Tesla turbine 1802 via the fluid outlet port 1834. In some embodiments, the fluid inlet port 1832 is fluidically coupled to a fluid inlet tubular member 1842, which is configured to supply fluid to the Tesla rotor via the fluid inlet port 1832. The fluid outlet port 1834 is fluidically coupled to a fluid outlet tubular member 1844 and configured to remove fluid supplied to the Tesla turbine 1802. The amount of fluid supplied and removed from the Tesla turbine 1802 can be configured such that the Tesla rotor 1805 can generate sufficient torque while rotating at a sufficient speed to cause the cutting shaft 1810 to cut tissue at the treatment site. In some embodiments, the fluid can be air or any other suitable gas. In some other embodiments, the fluid may be any suitable liquid, such as water. Further details on how to supply or remove fluid from a pneumatic or hydraulic actuator (e.g., Tesla turbine 1802) are provided above. Figure 4A-15 Described.
[0227] The connector 1830 also includes a suction port 1836 that is configured to couple to an opening defined at the proximal end 1808b of the hollow drive shaft 1808. The suction port 1836 is also configured to couple to a distal end of a flexible tubular member 1846, similar to Figure 17A , the flexible tubular member 1730 shown in FIG, , is configured to be coupled to a vacuum source at a proximal end. In some embodiments, the flexible tubular housing can include one or more of the fluid inlet tubular member 184, the fluid outlet tubular member 1844, and the flexible tubular member 1846. In some embodiments, the flexible tubular housing can include other tubular members and components extending from the head of the endoscopic instrument to the proximal end of the tail of the endoscopic instrument 1800.
[0228] Cutting shaft 1810 and outer structure 1815 are similar to Figure 17A 1800 and the outer structure 1715 of the endoscopic instrument 1700 are depicted in FIG. The cutting shaft 1810 is hollow and defines an opening at a proximal end 1810b of the cutting shaft 1810. The proximal end 1810b of the cutting shaft 1810 is configured to couple to the distal end 1808a of the drive shaft 1808 such that the opening at the distal end 1808a of the drive shaft 1808 is aligned with the opening defined at the proximal end 1808b of the cutting shaft 1810. In this manner, the drive shaft 1808 can be fluidly coupled to the cutting shaft 1810. The distal end 1810b of the cutting shaft 1810 includes a cutting tip 1812 and a material entry port 1813, similar to FIG. Figure 16A and 17A Cutting shafts 1610 and 1710 are shown in FIG.
[0229] In some embodiments, an irrigation opening 1852 can be formed in the housing 1806. The irrigation opening 1852 is configured to be fluidically coupled to the suction channel 1860. In some such embodiments, the irrigation opening 1852 is configured to be fluidically coupled to a gap (not clearly visible) separating the wall of the outer structure 1815 and the cutting shaft 1810. Thus, fluid supplied to the Tesla turbine 1802 can enter the gap through the irrigation opening 1852. The fluid can flow toward the material inlet port 1813 of the cutting shaft 1810, through which the fluid can enter the suction channel 1860. In some embodiments, because the suction channel 1860 is fluidically coupled to a vacuum source, fluid from the Tesla turbine 1802 can be directed to flow through the suction channel 1860 as irrigation fluid along with any other material near the material inlet port 1813. Thus, the irrigation fluid can flush the suction channel 1860, reducing the risk of clogging.
[0230] Additionally, when the irrigation fluid flows in the gap separating the outer structure 1815 and the cutting shaft 1810, the irrigation fluid can be used to reduce the generation of heat. In some embodiments, one or both of the cutting shaft 1810 and the outer structure 1815 can be coated with a heat-resistant layer to prevent the cutting shaft and the outer structure from heating up. In some embodiments, one or both of the cutting shaft 1810 and the outer structure 1815 can be surrounded by a heat-resistant sleeve to prevent the cutting shaft 1810 and the outer structure 1815 from heating up.
[0231] In some embodiments, other types of hydraulic or pneumatic powered actuators may be utilized in place of the Tesla turbine. In some embodiments, a multi-bladed rotor may be used. In some such embodiments, the powered actuator may be configured to be fluidically coupled to the fluid inlet tubular member and the fluid outlet tubular member, similar to Figure 18B Tubular members 1842 and 1844 are shown in FIG.
[0232] As mentioned above about Figure 16A 、 17A As described with respect to endoscopic instruments 1600, 1700, and 1800 depicted in FIG18A, endoscopic instruments can be configured to meet specific size requirements. Specifically, the endoscopic instrument can be sufficiently long such that, when the endoscopic instrument is fully inserted into an endoscope, the powered instrument head can extend beyond the face of the endoscope at one end, exposing the cutting tip, while the tail of the endoscopic instrument can extend beyond the other end of the endoscope, allowing the tail to be coupled to a vacuum source. Thus, in some embodiments, the endoscopic instrument can be configured to be longer than the endoscope into which the endoscopic instrument will be inserted. Furthermore, because endoscopes have instrument channels having different diameters, the endoscopic instrument can also be configured to have a sufficiently small outer diameter so that the endoscopic instrument can be inserted into the instrument channel of the endoscope into which the endoscopic instrument will be inserted.
[0233] Some endoscopes, such as colonoscopes, may have instrument channels with inner diameters as small as a few millimeters. In some embodiments, the outer diameter of the endoscopic instrument may be less than about 3.2 mm. Thus, a powered actuator as part of the endoscopic instrument may be configured to have an outer diameter that is smaller than the outer diameter of the endoscopic instrument. At the same time, the powered actuator may be configured to generate a sufficient amount of torque while rotating at a speed sufficient to cut tissue at a treatment site within a subject.
[0234] In some other embodiments, the endoscopic instrument can be configured such that the powered actuator is not housed within the endoscopic instrument at all or at least within a portion of the endoscopic instrument that can be inserted into the instrument channel of the endoscope. Instead, the endoscopic instrument includes a flexible cable configured to couple the powered instrument head of the endoscopic instrument to the powered actuator located external to the endoscope.
[0235] Figure 19A An example endoscopic instrument 1900 is shown coupled to a powered actuation and vacuum system 1980. The endoscopic instrument includes a head 1902 and a tail. The tail includes a flexible cable 1920 that can provide torque to the head 1902. The powered actuation and vacuum system 1980 includes a powered actuator 1925, a coupler 1935, and a vacuum tube 1930 that is configured to couple to the coupler 1935 at a first end 1932 and to a vacuum source at a second end 1934. In some embodiments, the flexible cable 1920 can be hollow and configured to carry fluid from the head 1902 to the coupler 1935.
[0236] Figure 19B Shown Figure 19A 1980 is a cross-sectional view of a powered actuator and vacuum system 1980. A powered actuator 1925 includes a drive shaft 1926 mechanically coupled to a proximal end 1922 of a flexible cable 1920. In some embodiments, the drive shaft 1926 and flexible cable 1920 are mechanically coupled via a coupler 1935. The coupler 1935 includes a vacuum port 1936 to which a first end 1932 of a vacuum tube 1930 can be fluidically coupled. The coupler 1935 can be closed, fluidically coupling the vacuum tube 1930 and the flexible cable. In this manner, suction applied to the vacuum tube 1930 can be applied continuously through the flexible cable 1920 to the head 1902 of the endoscopic instrument 1900. Furthermore, any material in the flexible cable 1920 can flow through the flexible cable, through the coupler 1935, and to the vacuum tube 1930. In some embodiments, the coupling between the flexible cable and the vacuum tube can occur within the head 1902. In such an embodiment, coupler 1935 can be configured to be small enough to be positioned within head 1902.
[0237] Figure 19C Shown Figure 19A19. An exploded view of an example head of an endoscopic instrument 1900 is shown in FIG. The head includes a housing cap 1952, a collet 1954, a cutting shaft 1956, a shaft coupler 1958, and a head housing 1960. In some embodiments, the collet 1954 is slightly tapered toward the distal end so that the collet 1954 can couple with the cutting shaft 1956 disposed within the collet 1954. The shaft coupler 1958 is configured to couple the cutting shaft to the distal end of the flexible cable 1920. The head 1960 and the housing cap 1952 are configured to accommodate the shaft coupler 1958.
[0238] Figure 19D A cross-sectional view of a portion of an endoscopic instrument 1900 having an engagement assembly is shown. In some embodiments, the head housing 1960 can include an engagement assembly for engaging with the inner wall of the instrument channel. The engagement assembly can be similar to Figure 16C Engagement assembly 1650 is shown in FIG. In some embodiments, the engagement assembly can be actuated via a vacuum source. Figure 19E Shown in disengaged position Figure 19D A cross-sectional view of the engagement assembly shown in FIG. Figure 19F Shown in the engaged position Figure 19D A cross-sectional view of the engagement assembly shown in FIG.
[0239] The engagement assembly can include a pair of vacuum actuated members 1962 configured to rotate between an extended position, in which the members 1962 extend outward to engage the walls of the instrument channel 1990, and a retracted position, in which the members 1962 are positioned such that they are substantially parallel to the walls of the instrument channel 1990. The groove 1964 is fluidly coupled to a suction channel 1970 defined within the flexible cable 1920. In some embodiments, a fluid channel 1966 fluidly couples the groove 1964 to the suction channel 1970. When a vacuum source is applied to the suction channel 1970, a suction force is applied to the members 1962, causing them to move from the retracted position (e.g., Figure 19E as shown) to the extended position (as Figure 19F In some embodiments, the engagement assembly may further include an outer ring supported by vacuum actuated member 1964. Outer ring 1966 may be configured to help guide the endoscopic instrument through the instrument channel of the endoscope. In particular, the outer ring may prevent the endoscopic instrument from tilting to one side, which could cause the powered instrument tip to strike the instrument channel.
[0240] Endoscopic instruments 1900 are similar to Figures 16A-18A1900, but differs in that the endoscopic instrument 1900 does not include a powered actuator within the head 1902 of the endoscopic instrument 1900. Instead, the endoscopic instrument 1900 includes a flexible cable 1920 for providing torque to a powered instrument head 1904 of the endoscopic instrument 1900. In some embodiments, the powered instrument head 1904 may be similar to Figures 16A-18A 1904 . In some embodiments, the flexible cable 1920 can be hollow so that fluid can flow through the flexible cable 1920. In some such embodiments, the proximal end 1922 of the flexible cable 1920 can be configured to be coupled to a vacuum source, while the distal end 1921 of the flexible cable 1920 can be coupled to the powered instrument head 1904. In this manner, fluid entering the material inlet port 1907 can flow through the powered instrument head 1904 and into the flexible cable 1920, the fluid can flow through the flexible cable 1920, and can be removed from the endoscopic instrument 1900 at the proximal end 1922 of the flexible cable 1920.
[0241] In some embodiments, a flexible cable, such as flexible cable 1920, can replace a powered actuator and drive shaft housed within an endoscopic instrument. For example, Figure 16A 、 17A Endoscopic instruments 1600, 1700, and 1800 depicted in FIG18A can be configured to utilize a flexible cable that is coupled at its distal end to a cutting shaft of a powered instrument head and at its proximal end to a powered actuator located external to the endoscopic instrument. The powered actuator located external to the endoscopic instrument can be significantly larger than powered actuators 1605, 1705, or 1805. When the powered actuator is actuated, the torque generated by the powered actuator can be transferred from the powered actuator to the powered instrument head via the flexible cable. Flexible cable 1920 is configured to transfer the torque from the powered actuator to the cutting shaft. In some embodiments, flexible cable 1920 is or includes a finely wound coil having multiple threads and multiple layers that can transmit rotation of one end of the flexible cable to the opposite end of the flexible cable. The cable's flexibility enables the coil to maintain performance even when the coil portion is bent. Examples of flexible cable 1920 include torque coils manufactured by ASAHI INTECC USA, INC., located in Santa Ana, California, USA. In some embodiments, the flexible cable 1920 may be surrounded by a sheath to avoid frictional contact between the outer surface of the flexible cable and other surfaces. In some embodiments, the flexible cable 1920 may be coated with polytetrafluoroethylene (PFTE) to reduce frictional contact between the outer surface of the flexible cable and other surfaces.
[0242] Figure 20is a conceptual system architecture diagram illustrating various components for operating an endoscopic instrument according to an embodiment of the present disclosure. The endoscopic system 2000 includes an endoscope 100 equipped with an endoscopic instrument 2002, which includes a flexible tail 2004. The endoscopic instrument may be, for example, Figure 4A-14 、 Figure 16A 、 17A , 18A and 19A. The system further includes an endoscope control unit 2005 that controls the operation of the endoscope 100 and an instrument control unit 2010 that controls the operation of the endoscopic instrument 2002.
[0243] In addition, the endoscopic instrument also includes a vacuum source 1990, a sample collection unit 2030, and a tissue sensing module 2040. The vacuum source 1990 is configured to be fluidically coupled to a flexible tubular member that forms a portion of the suction channel. In this manner, material flowing from the endoscopic instrument through the suction channel to the vacuum source 1990 can be collected at the sample collection unit 2030. The tissue sensing module can be communicatively coupled to a tissue sensor disposed at the distal tip of the endoscopic instrument 2000. In some such embodiments, the tissue sensing module can also be configured to be communicatively coupled to the instrument control unit 2010, such that the tissue sensing module can send one or more signals instructing the control unit 2010 to cease actuation of the powered actuator.
[0244] In some embodiments where the powered actuator is electrically actuated and disposed within the endoscopic instrument, the powered actuator can be electrically coupled to the instrument control unit 2010. In some such embodiments, the powered actuator is coupled to the control unit via one or more cables. In some embodiments, the powered actuator can be battery operated, in which case the tube can include a cable extending from the control unit to the powered actuator or a battery for actuating the powered actuator.
[0245] In some embodiments, where a powered instrument head is coupled to a flexible torque coil that couples the powered instrument head to a powered actuator residing external to the endoscope, the powered actuator can be part of the instrument control unit.
[0246] In various embodiments of the present disclosure, an endoscope includes a first end and a second end separated by a flexible housing, an instrument channel extending from the first end to the second end, and an endoscopic instrument including a scavenging component and a sample retrieval conduit disposed within the instrument channel. The endoscopic instrument may further include a flexible tube, with the sample retrieval conduit partially disposed within the flexible tube, the flexible tube extending from the first end to the second end of the endoscope. The flexible tube may further include a pneumatic air inlet conduit and a fluid flushing conduit. In various embodiments, the scavenging component may include a turbine assembly and a cutting tool. In various embodiments, in which the endoscope is configured to have a built-in endoscopic instrument, the instrument channel may have a diameter that is larger than that of an instrument channel of existing endoscopes. In this manner, a larger portion of scavenging material can be aspirated from a patient without clogging the aspiration conduit.
[0247] In other embodiments, the endoscope may include a first end and a second end separated by a flexible housing; an instrument channel extending from the first end to the second end; an endoscopic instrument coupled to the instrument channel at the first end of the endoscope, the endoscopic instrument including a clearing component and a sample retrieval tubing partially disposed within the instrument channel. In some embodiments, the endoscopic instrument may be removably attached to the endoscopic instrument.
[0248] In other embodiments of the present disclosure, an endoscope system includes an endoscope comprising a first end and a second end separated by a flexible housing, an instrument channel extending from the first end to the second end, and an endoscopic instrument coupled to the instrument channel at the first end of the endoscope. The endoscopic instrument may include a scavenging component and a flexible tube having a length greater than the length of the endoscope. Furthermore, the flexible tube may include a sample retrieval line, a pneumatic air inlet line, and a fluid flush line, a disposable cartridge configured to couple to the sample retrieval line near the second end of the endoscope, a pressurized air source configured to couple to the pneumatic air inlet line near the second end of the endoscope, and a fluid flush source configured to couple to the fluid flush line near the second end of the endoscope. In various embodiments, the endoscope may also include at least one camera source and at least one light source. In some embodiments of the present disclosure, the pneumatic air inlet line supplies pressurized air to a turbine assembly of the scavenging component near the first end of the endoscope, and the fluid flush line supplies flushing fluid to the sample retrieval line near the first end of the endoscope.
[0249] As mentioned above Figures 19A-19C As described, the endoscopic tool may include a flexible cable that may be configured to be driven by a powered actuator located external to the endoscopic tool itself. The flexible cable may be a torque coil or a rope.
[0250] Figures 21AA-21F Various aspects of an endoscope assembly are shown. In particular, Figures 21AA-21FVarious views of an endoscopic tool 2110 are shown that is coupled to a powered actuator 2120 enclosed in a housing 2150. As shown in FIG21 , the powered actuator 2120 can be a motor operably coupled to a flexible cable via a pulley system. The housing 2150, including one or more structures such as a base plate 2152, one or more side panels 2154, and a top panel 2156, can surround the motor 2120. The coupling component 2130 can be configured to couple the flexible cable 2114 to the motor 2120 while providing a suction mechanism to remove any fluid that passes through the endoscopic tool 2110. The coupling component 2130 can include a suction port 2170 through which fluid within the endoscopic tool 2110 can be removed and collected. Figure 21B In the embodiment, a pair of pulleys 2160 and 2162 coupled to a timing belt 2164 are configured such that rotational energy from the motor is transferred to one end of a flexible cable 2114. The other end of the flexible cable 2114 can be coupled to a cutting member 2112. Figures 22A-22H Additional details regarding flexible cable 2114 are described.
[0251] Figures 22A-22H Various embodiments of example flexible cables are shown. In some embodiments, the flexible cable can be made from three separate wires or conductors. The inner conductor can have a left-handed winding, the middle conductor can have a right-handed winding, and the outer conductor can have a left-handed winding. In some embodiments, the inner conductor can have a right-handed winding, the middle conductor can have a left-handed winding, and the outer conductor can have a right-handed winding. In some embodiments, the flexible cable can be made from two separate wires or conductors. In some such embodiments, the inner conductor can have a left-handed winding and the outer conductor can have a right-handed winding. In some other embodiments, the inner conductor can have a right-handed winding and the outer conductor can have a left-handed winding. In some embodiments, the conductor strands can be twisted with a right-hand lay or a left-hand lay. Examples of flexible cables include conductor cords and torque coils manufactured by ASAHI INTECC. In some embodiments, the outer diameter of the torque cord or coil is limited by the size of the working channel of the endoscope, with which the endoscopic tools will be used. Other sizing considerations that need to be considered include providing sufficient space for suction channels, irrigation channels, etc. In some embodiments, the outer diameter of the torque coil or torque rope may range between 0.1 mm and 4 mm. In some embodiments, the torque coil or rope may have an outer diameter of 0.5 mm to 2.0 mm.
[0252] Return to reference Figure 21D, shows a cross-sectional view of the coupling assembly 2130. The coupling assembly 2130 couples one end of the endoscopic tool to the powered actuator 2120 and to the suction port 2170 via pulleys 2160 and 2162. The coupling assembly includes a collection chamber 2181 where fluid within the suction tube 2118 of the endoscopic tool 2110 can be collected before being withdrawn from the coupling assembly 2130. The coupling assembly includes the collection chamber 2181, which can also include a drive shaft 2186 configured to engage the pulley 2162. A flexible cable or torque cord 2114 can be coupled to one end of the drive shaft 2186. The opposite end of the drive shaft 2186 is coupled to the pulley 2162 such that the drive shaft is operably coupled to the motor 2120. Thus, when the motor rotates, the pulley and timing belt 2164 are configured to rotate the drive shaft 2186 and, in turn, the torque rope 2114. Figures 24A-24C Various aspects of the drive shaft of the coupling component 2130 are shown. Figures 24A-24C As shown, drive shaft 2186 can be configured to receive one end of a flexible cable via opening 2406. A pair of holes 2402a and 2402b can be configured to receive set screws or other securing members to secure the flexible cable to drive shaft 2186.
[0253] The coupling component 2130 also includes a housing component 2500 that couples the flexible portion of the endoscopic tool to the suction port 2170 via the opening 2502 . Figure 25 An example housing component 2500 is shown.
[0254] Figures 26A-26E An exemplary sleeve bearing is shown.
[0255] Figures 27A-27C An example base plate 2152 is shown forming part of the housing. Figures 28A-28D An example side panel forming part of the housing is shown. The side panel may also serve as a feed-through mount.
[0256] In some embodiments, the coupling component is part of the endoscopic tool.In some embodiments, the coupling component is coupled to the flexible portion of the endoscopic tool via a compression fit component 2182.
[0257] The flexible portion of the endoscopic tool includes an outer tube comprising a suction tube 2118, a torque cord 2114, and a sheath 2116 surrounding the outer circumference of the torque cord 2114. The sheath can help reduce friction or kink formation. The suction tube 2118 is configured to be coupled to the cutting tool 2190 so that material entering the cutting tool 2190 via the opening 2193 can pass through the length of the endoscopic tool 2110 via the suction tube 2118.
[0258] like Figures 21E-21FAs shown, the torque rope is configured to be coupled to an inner sleeve 2192 that forms part of a cutting tool. The inner sleeve 2192 may be surrounded by or disposed within an outer sleeve 2191. An opening 2193 is formed within the outer sleeve 2191 at one end of the cutting tool 2190. Details of the cutting tool 2190 are provided herein. Figure 23AA-23BB An example embodiment of a cutting tool is shown. The cutting tool may be any type of cutting tool used in existing medical devices. Figure 23AA-23BB The cutting tools shown in the drawings are shown for illustrative purposes only, and the present disclosure is not intended to be limited to such sizes, shapes, or dimensions. Commercially available cutting tools can be used. In some embodiments, the length of the cutting tool can be modified. In some embodiments, the inner cannula can be coupled to the collar, and the outer cannula can be coupled to the outer suction tube. In some embodiments, the connection between the outer cannula and the suction channel can be sealed to prevent material from leaking through the connection.
[0259] In some embodiments, the torque cord 2114 is coupled to the inner sleeve 2192 via a ferrule 2194. The ferrule can be a component that couples the torque cord to the inner sleeve so that the rotational energy within the torque cord is transferred to the inner sleeve. Additional details regarding the shape, size, and dimensions of the ferrule are provided in FIG. Figures 29AA-29EE Depending on the size of the torque cord or flexible cable used in the endoscopic tool 2110, the shape and size of the ferrule may vary. In addition, Figures 29AA-29EE The ferrules shown in the drawings are shown for illustrative purposes only and are not intended to be limited to the specific dimensions, shapes, or sizes shown. In some embodiments, the end of the torque cord can be inserted into and coupled to a short length of hypodermic tubing. Doing so can make it easier to attach the ferrule to the distal end and clamp it to the proximal end (toward the drive shaft). In some embodiments, a graphite-filled cyanoacrylate, such as Loctite Black Max, can be used. Other similar types of materials can also be used instead.
[0260] Figures 30AA-30C Aspects of an endoscope assembly are shown wherein the tip is press fit. In some embodiments, the flexible portion of the endoscopic tool can include a balloon structure that can be deployed such that the balloon structure can engage the inner wall of the endoscope. The balloon structure can be coupled to an air supply line 3006 that is coupled to an air supply source such that when air is supplied, the balloon can expand and engage the inner wall of the endoscope. In some embodiments, the balloon structure can expand asymmetrically, such as Figures 30AA-30ABAs shown. In some embodiments, the air supply source can be activated via a foot pedal. The irrigation line 3002 can be configured to supply irrigation fluid. The irrigation fluid can flow toward the cutting tool, where the irrigation fluid can then flow through the suction channel 3004. The irrigation fluid can prevent the suction channel from clogging. Figure 30C As shown, a flexible cable or torque cord can be press-fit into a button on one end of the cutting tool.
[0261] Figures 31AA-31AB 31B-31C show aspects of an endoscope assembly in which the tip is press-fit. In some embodiments, the flexible portion of the endoscopic tool can include a balloon structure that can be deployed so that the balloon structure can engage the inner wall of the endoscope. The balloon structure can be coupled to an air supply source so that when air is supplied, the balloon can expand and engage the inner wall of the endoscope. In some embodiments, the balloon structure can expand symmetrically, such as Figure 31AA and 31AB As shown. The irrigation line can be configured to supply irrigation fluid. The irrigation fluid can flow to the cutting tool, and then the irrigation fluid can flow through the suction channel. The irrigation fluid can prevent the suction channel from being blocked. Figure 31C As shown, a flexible cable or torque cord may be welded to one end of the cutting tool.
[0262] Figure 32 A top view of an example flexible portion of an endoscopic tool is shown. In some embodiments, Figure 32 The flexible portion shown in FIG can be used with Figures 30AA-30C For use with the embodiments shown in Figures 31AA-31AB and 31B-31C. The flexible portion 3202 includes a central channel 3204 through which the flexible cable passes. The flexible portion 3202 also includes two suction channels 3406a and 3406b, an irrigation channel 3408, and an air supply channel 3410.
[0263] In some embodiments, the operating speed of the torque rope can vary. In some exemplary embodiments, the torque rope can have an operating speed within the range of 0.5k RPM to 20k RPM. In some embodiments, the torque rope can have an operating speed within the range of 1kRPM and 4k RPM. In some embodiments, the operating speed of the torque rope can vary. In some exemplary embodiments, the torque rope can operate with a torque of 5 to 100mN*m (millinewton meters). In some embodiments, the torque rope can operate with a torque of 20 to 50mN*m (millinewton meters). However, it will be understood by those skilled in the art that the torque and operating speed of the flexible cable can be varied based on the performance of the endoscopic tool. In some embodiments, various factors contribute to the performance of the endoscopic tool, including the amount of suction, the type of cutter, the size of the opening in the cutter, etc. Thus, the torque and operating speed of the operating flexible cable can depend on multiple factors.
[0264] Figure 33 33 is a cross-sectional view of an example cutting assembly of an endoscopic tool using a torque cord. Cutting assembly 3300 includes an outer cannula 3302, an inner cannula 3304 (which includes an inner cutter 3306 disposed within outer cannula 3302), a PTFE bearing 3308, a semi-compliant balloon 3310, and a multi-lumen extrusion 3312. A torque cord 3314 can be coupled to inner cutter 3306. The outer cannula can have a diameter between 0.05 inches and a size suitable for passing through an instrument channel of an endoscope.
[0265] Figures 35AA-35AC Cross-sectional views of different configurations of the flexible portion region of one embodiment of the endoscopic tool described herein are shown.The flexible portion region may include a suction lumen 3402, an inflation lumen 3404, an irrigation or flushing lumen 3406, and a torque cord.
[0266] Figure 35 shows various views of portions of an endoscopic tool. The endoscopic tool may include an outer cannula 1, an inner cutter 2, an inner cannula 3, a torque cord 4, a tri-lumen extrusion 5, a balloon 6, a PTFE spacer 7, two side arms 8, a proximal plug 9, a PTFE washer 10, and a washer cap 11.
[0267] Figure 36 A cross-sectional view of the flexible portion region of one embodiment of an endoscopic tool described herein is shown. The flexible portion region may include an outer expansion sheath 3602, an outer coil 3604, a torque coil 3606, and a multi-lumen extrusion 3608 disposed within the torque coil. The multi-lumen extrusion 3608 may include an irrigation lumen 3610 and a suction lumen 3612.
[0268] Figure 37A cross-sectional view of one embodiment of an endoscopic tool described herein is shown. The endoscopic tool includes an outer cannula 3702, an inner cutter 3704, an inner torque coil 3706, an outer coil 3708, an outer inflation sheath and balloon 3710, and a multi-lumen extrusion 3712. A gear 3714 (e.g., a worm gear) can engage the torque coil to drive the inner cutter.
[0269] Figure 38A and 38B Various views of a distal portion of one embodiment of an endoscopic tool described herein are shown. The endoscopic tool includes an outer cutter 3802 defining an opening 3804. The endoscopic tool also includes an inner cutter 3806 disposed within the outer cutter. The inner cutter is coupled to a torque coil 3808. The torque coil is disposed within a PET heat shrink 3810 or other type of tube. The outer cutter is coupled to a braided shaft 3812 to allow the outer cutter 3802 to rotate relative to the inner cutter 3806.
[0270] Figure 39A and 39B Shown along section BB and section CC Figure 38A and 38B A cross-sectional view of the distal portion of the endoscopic tool is shown in FIG.
[0271] In some embodiments, an endoscopic instrument insertable into a single instrument channel of an endoscope may include a powered instrument head or cutting assembly configured to remove material from a site within a subject. The cutting assembly includes an outer cannula and an inner cannula disposed within the outer cannula. The outer cannula defines an opening through which material to be removed enters the cutting assembly. The endoscopic instrument also includes a flexible outer tube coupled to the outer cannula and configured to rotate the outer cannula relative to the inner cannula. The outer diameter of the flexible outer tube may be smaller than the instrument channel into which the endoscopic instrument is insertable. The endoscopic instrument also includes a flexible torque coil having a portion disposed within the flexible outer tube. The flexible torque coil has a distal end coupled to the inner cannula. The flexible torque coil is configured to rotate the inner cannula relative to the outer cannula. The endoscopic instrument also includes a proximal connector coupled to the proximal end of the flexible torque coil and configured to engage a drive assembly configured to rotate the proximal connector, the flexible torque coil, and the inner cannula upon actuation. The endoscopic instrument also includes a suction channel having a suction port configured to engage a vacuum source. The suction channel is partially defined by the inner wall of the flexible torque coil and the inner wall of the inner cannula and extends from an opening defined in the inner cannula to the suction port. The endoscopic instrument also includes an irrigation channel having a first portion defined between the outer wall of the flexible torque coil and the inner wall of the flexible outer tube and configured to deliver irrigation fluid to the suction channel.
[0272] In some embodiments, the proximal connector is hollow and the inner wall of the proximal connector defines a portion of the suction channel. In some embodiments, the proximal connector is a rigid cylindrical structure and is configured to be positioned within a drive socket of a drive assembly. The proximal connector may include a coupler configured to engage with the drive assembly and a tensioning spring configured to bias the inner cannula toward the distal end of the outer cannula. In some embodiments, the size and bias of the tensioning spring are such that the tensioning spring positions the cutting portion of the inner cannula near the opening of the outer cannula. In some embodiments, the proximal connector is rotationally and fluidically coupled to the flexible torque coil. In some embodiments, the size and bias of the tensioning spring can be such that the distal tip of the inner cannula can contact the inner distal wall of the outer cannula. This can limit any lateral or undesirable movement caused by whipping at the distal end of the inner cannula due to rotation of the flexible torque coil.
[0273] In some embodiments, the endoscopic instrument further comprises an irrigation connector comprising an irrigation access port and a tubular member coupled to the irrigation connector and the flexible outer tube. The inner wall of the tubular member and the outer wall of the flexible torque coil can define a second portion of the irrigation channel, which is fluidically coupled to the first portion of the irrigation channel. In some embodiments, the endoscopic instrument further comprises a rotational coupler that couples the flexible outer tube to the tubular member and is configured to rotate the flexible outer tube relative to the tubular member and rotate the opening defined in the outer cannula relative to the inner cannula. In some embodiments, the irrigation connector defines an inner bore, and the flexible torque coil is disposed in the inner bore.
[0274] In some embodiments, the endoscopic instrument further comprises a liner, the flexible torque coil being disposed within the liner, the outer wall of the liner being configured to define a portion of the irrigation channel. In some embodiments, the inner cannula is configured to rotate about a longitudinal axis of the inner cannula and relative to the outer cannula, and the suction channel is configured to provide suction at an opening of the inner cannula.
[0275] In some embodiments, the flexible torque coil includes a plurality of threads. Each thread of the plurality of threads can be wound in a direction opposite to the direction in which one or more adjacent threads of the plurality of threads are wound. In some embodiments, the flexible torque coil includes a plurality of layers. Each of the plurality of layers can be wound in a direction opposite to the direction in which one or more adjacent layers of the plurality of layers are wound. In some embodiments, each layer can include one or more threads. Additional details about the flexible torque coil are provided above with respect to at least Figures 22A-22H A discussion of flexible cables is described.
[0276] In some embodiments, the flexible outer tube has a length that exceeds the length of the endoscope into which the endoscopic instrument can be inserted. In some embodiments, the flexible outer tube has a length that is at least 100 times greater than the outer diameter of the flexible outer tube. In some embodiments, the flexible portion is at least 40 times longer than the cutting assembly.
[0277] Figures 40A-40B Shown is a perspective view of an endoscopic tool 4000 and a portion of a drive assembly 4050 configured to drive the endoscopic tool. Figure 40B A perspective view of an endoscope tool and a portion of a drive assembly configured to drive a Figures 40A-40B The endoscopic tool shown in . Now also refer to Figure 41 、 42 and 43, Figure 41 Shows a top view of the endoscope tool 4000 and Figures 40A-40B A top exposed view of a portion of the drive assembly 4050 is shown in FIG. Figure 42 A cross-sectional view of the endoscope tool 4000 and a portion of the drive assembly 4050 across section AA is shown. Figure 43 An enlarged view of a portion of the drive connector and drive assembly 4050 of the endoscope is shown. Figure 44 Endoscopic tool 4000 and Figures 40A-40B A perspective view of a portion of the drive assembly is shown in FIG. Figure 45 Shown is a cross-sectional view of an endoscopic tool and a portion of a drive assembly across section BB. Figure 46 An enlarged cross-sectional view of the rotary coupler portion of an endoscopic tool is shown. Figure 47A and Figure 47B Shown are top and cross-sectional views of a rotary coupler of an endoscopic tool.
[0278] like Figures 40A-47B As shown, endoscopic tool 4000 can be configured to be inserted into an instrument channel of an endoscope. Examples of endoscopes can include gastroscopes, such as colonoscopes, laryngoscopes, or any other flexible endoscopes. The endoscopic tool can include a flexible portion 4002 that is shaped, sized, and configured to be inserted into the instrument channel, while the remainder of the endoscopic tool 4000 can be configured to remain outside the instrument channel of the endoscope. The shape and size of the flexible portion 4002 can fit within the instrument channel and be configured to navigate through the tortuous path defined by the instrument channel when the endoscope is inserted into the patient's body. In the case of a colonoscope, the endoscope can form a series of bends exceeding at least 60 degrees, and in some cases, exceeding 90 degrees.
[0279] Endoscopic tool 4000 may include a cutting assembly 4010 configured to remove material from a site within a subject. Figure 1C and the cutting assembly 160 described elsewhere in the specification and drawings. In some embodiments, the cutting assembly 4010 may include an outer sleeve and an inner sleeve disposed within the outer sleeve. The outer sleeve may define an opening 4012 through which material to be removed can enter the cutting assembly 4010. In some embodiments, the opening 4012 defines a portion of a radial wall extending through the outer sleeve. In some embodiments, the opening can extend only around a portion of the radius of the outer sleeve, for example, up to one-third of the circumference of the radial wall. When the suction channel 4090 extends between the suction port 4092 and the opening 4012, any suction applied at the suction port 4092 causes a suction force to be applied at the opening 4012. The suction force causes material to be drawn into the opening of the outer sleeve, where it can then be cut by the inner sleeve of the cutting assembly.
[0280] The inner cannula may include a cutting portion configured to be positioned adjacent to opening 4012 so that material to be resected that enters the cutting assembly through opening 4012 can be resected by the cutting portion of the inner cannula. The inner cannula may be hollow, and the inner wall of the inner cannula may define a portion of a suction channel that can extend the length of the endoscopic tool. The distal end of the inner cannula may include the cutting portion, while the proximal end of the inner cannula may be open so that material that enters the distal end of the inner cannula through the cutting portion can pass through the proximal end of the inner cannula. In some embodiments, the distal end of the inner cannula may contact the inner surface of the distal end of the outer cannula. In some embodiments, this may allow the inner cannula to rotate relative to the outer cannula along a substantially longitudinal axis, thereby providing greater stability to the inner cannula during rotation. In some embodiments, the size of the opening may determine the size of the material cut or resected by the inner cannula. Thus, the size of the opening may be determined in part based on the size of the suction channel defined by the inner circumference of the flexible torque coil.
[0281] The endoscopic instrument 4000 may include a flexible torque coil 4080 configured to be coupled to the proximal end of the inner cannula at the distal end of the flexible torque coil 4080. The flexible torque coil may include a thin coil having multiple threads and multiple layers, which can transmit the rotation of one end of the flexible torque coil to the opposite end of the flexible torque coil. Each threaded layer of the flexible torque coil can be wound in a direction opposite to the direction in which each threaded layer adjacent to the threaded layer is wound. In some embodiments, the flexible torque coil may include a first threaded layer wound in a clockwise direction, a second threaded layer wound in a counterclockwise direction, and a third threaded layer wound in a clockwise direction. In some embodiments, the first threaded layer is separated from the third threaded layer by the second threaded layer. In some embodiments, each threaded layer may include one or more threads. In some embodiments, the threaded layers may be made of different materials or have different characteristics, such as thickness, length, etc.
[0282] The flexibility of the torque coil 4080 allows the coil to maintain performance even in curved portions of the torque coil 4080. Examples of flexible torque coils 4080 include torque coils manufactured by ASAHI INTECC USA, INC, located in Santa Ana, California, USA. In some embodiments, the flexible torque coil 4080 can be surrounded by a sheath or liner to avoid frictional contact between the outer surface of the flexible torque coil 4080 and other surfaces. In some embodiments, the flexible torque coil 4080 can be coated with polytetrafluoroethylene (PFTE) to reduce frictional contact between the outer surface of the flexible torque coil 4080 and other surfaces. The flexible torque coil 4080 can be sized, shaped, or configured to have an outer diameter that is smaller than the diameter of the instrument channel of the endoscope into which the endoscopic tool will be inserted. For example, in some embodiments, the outer diameter of the flexible torque coil can be in the range of 1-4 mm. The length of the flexible torque coil can be sized to exceed the length of the endoscope. In some embodiments, the inner wall of the flexible torque coil 4080 can be configured to define another portion of the aspiration channel that is fluidly coupled to the portion of the aspiration channel defined by the inner wall of the inner cannula of the cutting assembly 4010. The proximal end of the flexible torque coil 4080 can be coupled to the proximal connector assembly 4070, details of which are provided below.
[0283] Endoscopic instrument 4000 may include a flexible outer tube 4086 that may be coupled to a proximal end of an outer sleeve. In some embodiments, the distal end of flexible outer tube 4086 may be coupled to the proximal end of the outer sleeve using a coupling component. In some embodiments, the outer sleeve may be configured to rotate in response to rotating the flexible outer tube. In some embodiments, flexible outer tube 4086 may be a hollow, braided tube having an outer diameter that is smaller than an instrument channel of an endoscope into which endoscopic instrument 4000 is to be inserted. In some embodiments, the length of flexible outer tube 4086 may be sized to exceed the length of the endoscope. Flexible outer tube 4086 may define a bore through which a portion of flexible outer tube 4086 extends. Flexible outer tube 4086 may include a braid, threads, or other features that facilitate rotation of flexible outer tube 4086 relative to a flexible torque coil that is partially disposed within flexible outer tube 4086.
[0284] Endoscopic instrument 4000 can include a rotation coupler 4030 configured to couple to the proximal end of a flexible outer tube 4086. Rotation coupler 4030 can be configured to allow an operator of the endoscopic tool to rotate flexible outer tube 4086 via a rotation tab 4032 coupled to or integral to rotation coupler 4030. By rotating rotation tab 4032, the operator can rotate the flexible outer tube and the outer cannula along the longitudinal axis of the endoscope and relative to the inner cannula of the endoscope and cutting assembly 4010. In some embodiments, while the endoscope is within a patient, the operator may wish to rotate the outer cannula while the endoscopic instrument is inserted within the endoscope. The operator may wish to rotate the outer cannula to position the opening of the outer cannula to a position where a portion of the outer cannula's radial wall defining the opening can be aligned with a camera of the endoscope, allowing the operator to visualize material entering the endoscopic instrument through the opening for resection. This may be due in part to the fact that the openings are defined along a radial wall extending on one side of the outer sleeve, rather than being openings formed in an axial wall of the outer sleeve.
[0285] In some embodiments, the proximal end 4034 of the rotating coupler 4030 can be coupled to the irrigation connector 4040. In some embodiments, the rotating coupler 4030 can be a rotating Luer component that allows the distal end 4036 of the rotating coupler 4030 to rotate relative to the proximal end 4034 of the rotating coupler 4030. This allows the flexible outer tube 4086 to rotate without causing the component coupled to the proximal end of the rotating coupler 4030 to rotate. In some embodiments, the proximal end 4034 of the rotating coupler 4030 can be coupled to an outer tubular member 4044 configured to couple the proximal end 4034 of the rotating coupler 4030 to the irrigation connector 4040. The rotating coupler 4030 can define a hole along a central portion of the rotating coupler 4030, through which a portion of the flexible torque coil 4080 extends. In some embodiments, the rotating coupler 4030 can be a male-to-male rotating Luer connector. In some embodiments, the rotary coupler can be configured to handle pressures up to 1200 psi.
[0286] The irrigation connector 4040 can be configured to introduce irrigation fluid into the endoscopic tool 4000. The irrigation connector 4040 includes an irrigation port 4042 that is configured to engage an irrigation source (e.g., a container of water). In some embodiments, the irrigation connector 4040 can be a Y-port used in a fluid delivery system that conforms to medical device industry standards and is sized to couple to a flexible outer tube 4086 or outer tubular member 4044 that couples the distal end 4048 of the irrigation connector 4040 to the proximal end 4034 of the rotation coupler 4030. In some embodiments, the irrigation connector can define a hollow passage between the proximal end 4046 and the distal end 4048 of the irrigation connector 4040 that is sized to allow the torque coil 4080 to pass through the hollow passage defined by the irrigation connector 4040.
[0287] As described above, the proximal connector assembly 4070 is configured to be coupled to the proximal end of the flexible torque coil 4080. The proximal connector assembly 4070 can be configured to engage with the drive assembly 4050, which is configured to provide torque to the inner cannula via the proximal connector assembly 4070 and the flexible torque coil 4080. The proximal connector assembly 4070 can further define a portion of the suction channel and be configured to fluidically couple the suction channel to a vacuum source to facilitate removal of material that has entered the suction channel. In some embodiments, the proximal end of the proximal connector assembly 4070 can include a suction port 4092 through which material that has entered the endoscopic tool 4000 can be withdrawn from the endoscopic tool 4000.
[0288] In some embodiments, the endoscopic tool 4000 can be configured to be driven by a drive assembly 4050. The drive assembly 4050 is configured to provide rotational energy from an energy source to the endoscopic tool 4000. The drive assembly 4050 can include a housing 4060 that can house a first bevel gear 4054 and a second bevel gear 4056, the first bevel gear 4054 and the second bevel gear 4056 being positioned such that rotation of the first bevel gear 4054 causes rotation of the second bevel gear 4056. The second bevel gear 4056 can be coupled to a drive receptacle that is sized and shaped to receive and engage a proximal connector assembly 4070 of the endoscopic tool 4000. In some embodiments, the first bevel gear 4054 can be coupled to a motor (not shown) or other rotational source via a rotational input shaft 4052.
[0289] The proximal connector assembly 4070 may include a hollow drive shaft 4072, a coupler 4076 through which the hollow drive shaft 4072 passes, and a tensioning spring 4074 coupled to the hollow drive shaft 4072. The distal end of the drive shaft 4072 may be coupled to the proximal end of the flexible torque coil 4080. In some embodiments, the drive shaft 4072 and the flexible torque coil 4080 may be permanently coupled to each other. In some embodiments, the drive shaft 4072 and the flexible torque coil 4080 may be coupled using a coupler, a press fit, a weld (e.g., a butt weld), or any other attachment means that allows the flexible torque coil 4080 to rotate when the drive shaft 4072 rotates and allows material passing through the flexible torque coil 4080 to flow through the drive shaft 4072. The proximal end of the drive shaft 4072 may define a suction port 4092. In some embodiments, the suction port 4092 can be configured to engage a vacuum source such that material entering the opening 4012 flows through the suction channel 4090 and out of the endoscopic tool through the suction port 4092 .
[0290] A coupler 4076 (e.g., a hexagonal coupler) can be configured to couple to a hollow drive shaft. In some embodiments, the hexagonal coupler is a portion of the hollow drive shaft. The coupler 4076 may include an outer wall configured to engage an inner wall of the drive socket 4058. The drive socket 4058 is coupled to the second bevel gear 4056 and configured to rotate when the second bevel gear 4056 rotates. In some embodiments, the drive socket 4058 may be a hollow cylindrical tube. In some embodiments, the proximal end 4059 of the drive socket 4058 may include an opening defined by the inner wall of the proximal end of the drive socket 4058, the opening having a diameter smaller than the inner diameter of the remainder of the drive socket 4058. In some embodiments, the diameter of the opening through the proximal end 4059 of the drive socket 4058 may be large enough to receive the drive shaft 4072 but small enough to prevent the tension spring 4074 coupled to the drive shaft 4072 from passing through the opening. In some embodiments, the inner diameter of the remainder of the drive socket is sized to engage with coupler 4076 .
[0291] The tensioning spring 4074 can be biased such that, during operation of the endoscopic tool 4000, the tensioning spring 4074 can prevent the drive shaft 4072, the flexible torque coil 4080, and the inner cannula from sliding toward the proximal end of the endoscopic tool 4000. In some embodiments, without the tensioning spring 4074, the inner cannula can slide away from the distal end of the endoscopic tool 4000. This can be due to the force exerted by the material to be resected at the opening 4012. In some embodiments, the tensioning spring 4074 provides a counterforce that prevents the inner cannula from sliding away from the distal end when the inner cannula contacts the material to be resected at the opening 4012. In some embodiments, the tensioning spring 4074 can be configured to bias the distal end of the inner cannula to contact the inner wall of the distal end of the outer cannula. In some embodiments, the size and biasing of the tensioning spring 4074 can cause the distal tip of the inner cannula to contact the inner distal wall of the outer cannula. This can limit any lateral or undesirable movement of the whipping at the distal end of the inner cannula due to rotation of the flexible torque coil.
[0292] The housing 4060 can be configured to engage with a suction end cap 4062 and a locking collar 4064. In some embodiments, the suction end cap 4062 can be configured to allow the vacuum source to maintain a secure connection with the suction port 4092 of the drive shaft 4072. In some embodiments, the suction end cap 4062 can be configured to allow the drive shaft 4072 to rotate while maintaining a secure connection between the vacuum source and the suction port 4092 of the drive shaft 4072. In some embodiments, the suction end cap 4062 can be configured to be fixed to a portion of the housing 4060 such that the suction port of the drive shaft 4072 is accessible via an opening in the suction end cap 4062. In some embodiments, the vacuum source can be coupled to the end cap 4062 such that the vacuum source does not rotate with the proximal end of the drive shaft 4072. In some embodiments, one or more bearings or bushings can be used to facilitate a fluid connection between the suction port 4092 of the drive shaft 4072 and the vacuum source without causing the vacuum source to rotate with the drive shaft 4072.
[0293] The locking collar 4064 can be configured to secure the irrigation connector 4040 to the proximal connector assembly 4070. In some embodiments, the locking collar 4064 can be configured to secure the proximal end 4046 of the irrigation connector 4040 to the housing 4060 of the drive assembly 4050. The locking collar 4064 can further be configured to prevent the proximal connector assembly 4070 from being disengaged from the drive receptacle 4058 and moving toward the distal end of the endoscopic tool 4000. In some embodiments, the locking collar 4064 can be configured to secure a liner 4082 to the flexible torque coil 4080, the drive shaft 4072, or the housing 4060, wherein the flexible torque coil 4080 is disposed within the liner 4082. In some embodiments, the liner 4082 can function as a heat shrink to reduce the dissipation of heat generated in the flexible torque coil to other components of the endoscopic tool. In some embodiments, the outer wall of the liner 4082 can define a portion of the irrigation channel, while the inner wall of the liner 4082 can be used to prevent any material that passes through the suction channel from escaping through the walls of the flexible torque coil. In some embodiments, the liner 4082 can also prevent irrigation fluid that passes through the irrigation channel from flowing through the walls of the flexible torque coil 4080 into the suction channel 4090.
[0294] The distal end 4048 of the irrigation connector 4040 can be configured to engage the inner wall of the outer tube 4044. In some embodiments, the distal end 4048 of the irrigation connector 4040 can be press-fitted to the proximal end of the outer tube 4044. In some embodiments, a connector can be used to connect the distal end 4048 of the irrigation connector 4040 and the outer tube. The inner wall of the outer tube 4044 and the outer wall of the liner 4082 can define a portion of the irrigation channel 4096. The outer tube 4044 can extend from the distal end 4048 of the irrigation connector 4040 to the proximal end 4034 of the rotation coupler 4030. The distal end of the outer tube 4044 can be configured to engage the proximal end 4034 of the rotation coupler 4030.
[0295] In some embodiments, the irrigation channel can extend from the irrigation inlet port to the opening of the outer cannula. The irrigation channel can be defined by the inner wall of the outer tubular member, the rotary coupler, the inner wall of the outer tube, and the inner wall of the outer cannula. In some embodiments, the irrigation channel can also be defined by the outer wall of the inner cannula and the outer wall of the flexible torque coil 4080. In some embodiments, the endoscopic instrument 4000 may further include a hollow liner 4082 sized to fit around the flexible torque coil 4080. In some embodiments, the hollow liner 4082 can serve as a barrier between the irrigation channel 4096 and the suction channel 4090. In some embodiments, the hollow liner 4082 can prevent air or other fluids from penetrating into the threads of the flexible torque coil 4080. In addition, the hollow liner can allow the suction channel to maintain suction force throughout the entire length of the suction channel by preventing air from escaping or entering through the threads of the flexible torque coil 4080.
[0296] As described above, the cutting assembly 4010 includes an outer sleeve. The braided tube 4086 is coupled to the outer sleeve so that rotating the rotating tab 4032 of the rotating coupler 4030 causes the outer sleeve to rotate. The outer sleeve includes an opening 4012 located at the distal end of the outer sleeve. The opening is defined within a portion of the radial wall of the outer sleeve and may extend only around a portion of the radius of the outer sleeve. When the suction channel 4090 extends between the suction port 4092 and the opening 4012, any suction applied at the suction port 4092 causes a suction force to be applied to the opening 4012. The suction force causes material to be drawn into the opening of the outer sleeve, which can then be cut by the inner sleeve of the cutting assembly. In some embodiments, the aspirated material can be collected in a collection box. In some embodiments, the collection box can be fluidically coupled to the proximal end of the suction channel.
[0297] The inner cannula is disposed within the outer cannula and is configured to excise any material drawn into or otherwise introduced into the opening 4012 by the suction force in the suction channel 4090. The inner cannula can cut, excise, remove, clear, or shave material at the opening 4012 based in part on the interaction between the cutting surface and the wall of the outer cannula defining the opening. In some embodiments, rotational movement of the cutting surface relative to the opening 4012 can cause the material to be cut, excised, removed, or shaved. A flexible torque coil is coupled to the inner cannula and causes the inner cannula to rotate along its longitudinal axis. Because the outer cannula is coupled to the outer tube and non-rotationally coupled to the inner cannula or the flexible torque coil, the inner cannula rotates relative to the outer tube. A gap between the outer wall of the inner cannula and the inner wall of the outer tube defines a portion of an irrigation channel through which irrigation fluid can flow from the irrigation connector 4040, through the portion of the irrigation channel partially defined by the outer tube 4044, the rotational coupler 4030, and the flexible outer tube 4086, toward the cutting surface of the inner cannula. The inner cannula may define a portion of the aspiration passageway through which removed or resected material and irrigation fluid may flow from the cutting surface of the inner cannula toward the aspiration port 4092 .
[0298] The length of the cutting assembly 4010 can be sized to allow the endoscopic instrument 4000 to traverse the length of the endoscope when the endoscope is inserted into the patient. In some embodiments, the endoscope can be positioned within the patient and the endoscope can include a bend greater than 60 degrees. Thus, the length of the cutting assembly 4010 can be no more than a few centimeters. In some embodiments, the length of the cutting assembly 4010 can be less than 1% of the length of the endoscopic tool 4000, or less than the length of the flexible portion of the endoscope into which the endoscopic tool can be inserted. As described above, tissue sensing capabilities can be implemented using the cutting assembly as part of a tissue sensor.
[0299] It should be understood that one or more seals, bearings, and other components may be used. Seals may be used to maintain pressure, prevent fluid leakage, or securely couple components to one another. In some embodiments, bearings may be used to allow components to rotate relative to one another without adversely affecting the components or performance of the endoscopic tool.
[0300] Figure 45 A cross-sectional view of a portion of the endoscope tool and drive assembly across section BB is shown. Figure 45As shown, the second bevel gear 4056 can be configured to engage with the drive socket 4058 of the drive assembly 4050. The proximal connector 4070 of the endoscopic tool 4000, including the coupler 4076 and the drive shaft 4072, can be inserted and disposed within the drive socket 4058. The outer wall of the coupler 4076 is sized to engage with the inner wall of the drive socket 4058 so that when the drive socket 4058 rotates, the coupler 4076 also rotates. Because the coupler 4076 is coupled to the drive shaft 4072, when the drive socket 4058 rotates, the drive shaft 4072 can also rotate. The inner wall of the drive shaft defines a portion of the suction channel 4090.
[0301] Figure 46 An enlarged cross-sectional view of the rotary coupler portion of an endoscopic tool is shown. Figure 47A and Figure 47B Shown are top and cross-sectional views of a rotary coupler of an endoscopic tool.
[0302] like Figure 46-47B As shown, the outer tube 4044 is configured to engage with the rotary coupler 4030. The outer tube 4044 surrounds the liner 4082, which in turn surrounds the flexible torque coil 4080. The inner wall of the flexible torque coil 4080 can define a portion of the suction channel 4090. The space between the inner wall of the outer tube 4044 and the outer wall or surface of the liner 4082 defines a portion of the irrigation channel. The tab 4032 can be configured to be rotated by the operator of the endoscopic tool. In some embodiments, the operator can rotate the tab 4032 and rotate the outer cannula relative to the inner cannula and the endoscope while the endoscopic tool is inserted into the instrument channel of the endoscope. In this way, the operator can position the opening defined by the outer cannula by rotating the outer cannula to the desired position. In some embodiments, by providing a mechanism by which the outer sleeve can be rotated relative to the endoscope, the operator does not have to be concerned with the position of the opening when the endoscopic tool is inserted into the instrument channel of the endoscope, because the operator may be able to adjust the position of the opening by rotating the outer sleeve while the endoscopic tool is inserted into the endoscope.
[0303] Figure 48Figure 4800 is a perspective view of a portion of an endoscopic tool inserted for operation within a drive assembly. Drive assembly 4800 includes a drive interface 4810 configured to receive the proximal connector 4070 of endoscopic tool 4000. Proximal connector 4070 can engage with the drive receptacle of drive interface 4810 to transfer rotational energy generated by drive assembly 4800 to the cutting assembly of endoscopic tool 4000. Drive assembly 4800 can include a pump 4820 or other fluid displacement device to control the flow of irrigation fluid to the irrigation port 4042 of endoscopic tool 4000. In some embodiments, pump 4820 can be a peristaltic pump. In some embodiments, the pump can be any positive displacement fluid pump. In some embodiments, a valve can be positioned between pump 4820 and irrigation port 4042 to control the amount of irrigation fluid entering the endoscopic tool. In some embodiments, the speed at which pump 4820 operates can determine the rate at which irrigation fluid enters the endoscopic tool. The drive assembly can also include a pinch valve 4830. In some embodiments, the pinch valve can be configured to control the application of suction force to the suction channel.
[0304] In some embodiments, an actuator, such as a control switch, can be used to actuate drive assembly 4800. In some embodiments, the actuator can be a foot pedal, a manual switch, or any other actuating device for controlling drive assembly 4800. In some embodiments, the actuator can be coupled to a drive device, such as pump 4820, such that when the actuator is actuated, pump 4820 begins to rotate, generating torque that is transferred to the proximal connector of the endoscopic tool via drive interface 4810. The torque applied to the proximal connector can be transferred to the inner cannula via a flexible torque coil, thereby rotating the inner cannula relative to the outer cannula. In some embodiments, the actuator can be coupled to a pinch valve, such as pinch valve 4830, to control the amount of suction applied to the suction channel. In some embodiments, the actuator can be configured to simultaneously actuate the drive device and pinch valve, causing the inner cannula to rotate while suction is applied through the suction channel. In some embodiments, the actuator can also be coupled to an irrigation control switch or valve that controls the flow of irrigation fluid to the endoscopic tool via irrigation inlet port 4042. In some embodiments, the actuator can be configured to actuate the drive device, the pinch valve for suction, and the irrigation control switch for irrigation simultaneously, so that the inner cannula rotates while suction is applied through the suction channel and irrigation fluid is supplied to the endoscopic tool.
[0305] In some embodiments, a separate irrigation control switch can be configured to control the flow of irrigation fluid through an irrigation channel of the endoscope tool.An operator can control the volume of irrigation fluid provided to the irrigation channel via the irrigation control switch.
[0306] Figures 40A-48The drive assembly configuration shown in is an example configuration of a drive assembly. It should be understood that the endoscope tool 4000 can be configured to be driven by other drive assembly configurations. In some embodiments, the proximal connector portion of the endoscope tool 4000 can be modified to engage with other drive assembly configurations. In some embodiments, the endoscope tool 400 can be configured to be packaged as one or more different components that can be assembled prior to inserting the endoscope tool into the instrument channel of the endoscope. In some embodiments, the proximal connector of the endoscope tool 4000 can be assembled together by the operator of the endoscope tool after one or more components of the endoscope tool are engaged with components of the drive assembly.
[0307] Figure 49 Another embodiment of an endoscopic tool and a drive assembly configured to drive the endoscopic tool is shown. Figure 50A yes Figure 49 Side view of the endoscopic tool and drive assembly shown in . Figure 50B It is cut along section AA Figure 49 Endoscopic tool 4910 is similar to endoscopy tool 4000, but differs from endoscopy tool 4000 in that endoscopy tool 4910 has a different proximal connector 4912. In this embodiment, the proximal connector 4912 can be coupled to a flexible torque coil, similar to Figures 40A-43The flexible torque coil 4000 is shown and includes a proximal connector engagement structure 4914 configured to engage with a drive assembly 4950. The proximal connector engagement structure can be sized to engage with the drive assembly 4950 and include one or more engagement surfaces configured to engage the drive assembly 4950. The engagement surfaces can be coupled to a drive shaft included in the proximal connector 4912 such that when the drive assembly 4950 applies a rotational force to the engagement surfaces, the drive shaft rotates, which in turn causes the flexible torque coil and cutting assembly of the endoscopic tool 4900 to rotate. In some embodiments, the engagement surface 4914 can be a cylindrical object having an outer wall configured to engage with the drive assembly 4950 and an inner wall configured to engage with the outer wall of the drive shaft. In some embodiments, the proximal connector 4910 can also include fins 4916 or other structures that prevent the proximal connector 4910 and the endoscopic tool 4910 from rotating relative to the drive assembly 4950. In some embodiments, the sides of fins 4916 can rest on or engage with mounting structures 4936a and 4936b. In this manner, fins 4916 prevent proximal connector 4910 from rotating relative to drive assembly 4950 when the drive assembly applies a rotational force on the engaging surfaces. Mounting structure 4936 can be configured such that various components of drive assembly 4950 can be mounted on or receive support from mounting structure 4936.
[0308] The drive assembly 4950 may include a retractable arm 4922, one or more spring-loaded bearings 4924, a drive belt 4932 and a drive wheel 4936, and one or more fixed bearings 4940. The retractable arm 4922 may be configured to rotate between a first position and a second position. The spring-loaded bearing 4924 may be mounted to the retractable arm 4922 and positioned such that when the retractable arm 4922 is in a position such as Figure 49 and 50AIn the first position shown in FIG-B, the spring-loaded bearing 4924 can exert a force on the proximal connector 4912 so that the proximal connector is held in place when the drive assembly 4950 is actuated. The spring-loaded bearing 4924 can be positioned so that when the proximal connector 4912 of the endoscopic tool 4910 is engaged with the drive assembly 4950, the spring-loaded bearing 4924 engages an engagement member 4916 of a drive shaft (not shown) disposed within the proximal connector 4912. The engagement member 4916 can be strategically positioned on the proximal connector 4912 so that when the retractable arm 4922 is in the first position, the spring-loaded bearing 4924 contacts the engagement member 4916. The engagement member 4916 can be cylindrical and surround the drive shaft disposed within the proximal connector 4912. The engagement member 4916 can form a portion of an outer wall of the proximal connector 4912. In some embodiments, the engagement member 4916 can rotate along the longitudinal axis of the proximal connector 4912 and relative to the proximal connector 4912. In some embodiments, the drive wheel 4936 can be a resilient friction drive wheel.
[0309] A drive device, such as a motor or other drive source, can drive a drive wheel 4936 mounted on the mounting shaft 4930 via a drive belt 4934, which moves when the drive device is actuated. The drive belt 4934 can cause the drive wheel 4936 to rotate. The engagement member 4916 of the proximal connector 4912 can be configured to contact the drive wheel 4936 when the endoscopic tool is positioned within the drive assembly 4950. A fixed bearing 4940 of the drive assembly 4950 can be positioned to hold the proximal connector 4912 in place while rotation of the drive wheel 4936 rotates the engagement member 4916. The fixed bearing 4940 can also provide a force that maintains contact between the drive wheel 4936 and the engagement member 4916.
[0310] like Figure 50B As shown, when the telescopic arm is in the first or engaged position, the spring-loaded bearing 4924 contacts the one or more engagement members 4916 on a first side, and the drive wheel 4936 contacts the engagement member 4916 on a second side. The spring-loaded bearing can allow the engagement member 4916 to rotate when the drive wheel rotates. The fin 4914 rests on the mounting structure of the drive assembly, preventing the endoscopic tool from rotating. When the telescopic arm is in the second or disengaged position, the spring-loaded bearing 4924 does not contact the one or more engagement members 4916. Therefore, the endoscopic tool is not securely positioned within the drive assembly, and therefore, actuating the drive assembly may not rotate the flexible torque coil within the endoscopic tool.
[0311] It should be understood that the outer diameter of the endoscopic instrument can be sized to be inserted into the instrument channel of the endoscope when the endoscope is inserted into the patient. In addition, the size of the endoscopic instrument can be large enough so that the endoscopic tool contacts the inner wall of the instrument channel at various portions of the instrument channel to maintain the stability of the endoscopic instrument. If the outer diameter of the endoscopic instrument is much smaller than the inner diameter of the instrument channel, there may be a large amount of space between the endoscopic instrument and the inner wall of the instrument channel, which may allow the endoscopic instrument to move, vibrate, or otherwise experience some instability during operation.
[0312] Improved endoscopic tool for removing material from a patient's body
[0313] Figures 51A-51C Endoscopic tool 5100 is shown. Endoscopic tool 5100 can be similar to various endoscopy tools described herein, including endoscopy tool 4000 (e.g., Figures 40A-40B , 41 and 42). The endoscopic tool 5100 can be configured to obtain samples of polyps and tumors from a patient. The endoscopic tool 5100 can be configured to be rotated by a torque source (e.g., a motor coupled to a drive assembly or drive shaft of the endoscopic tool 5100). The endoscopic tool 5100 can be configured to cause an irrigation fluid to flow out to a site within the subject (e.g., a site within the colon, esophagus, lungs of the subject). The endoscopic tool 5100 can be configured to remove material at a site within the subject. The endoscopic tool 5100 can be configured to provide suction via a suction channel to obtain a sample of the material removed at the site within the subject. In some embodiments, the endoscopic tool 5100 can be configured to be inserted into an instrument channel, such as an instrument channel of an endoscope (e.g., a gastroscope, such as a colonoscope, a laryngoscope, or any other flexible endoscope).
[0314] The endoscopic tool 5100 includes a proximal connector 5110 and a flexible torque transfer assembly 5200. The proximal connector 5110 is configured to couple a drive assembly 5150 (e.g., a drive assembly including a drive shaft configured to be rotated by a rotational energy source) of the endoscopic tool 5100 to the flexible torque transfer assembly of the endoscopic tool 5100. In some embodiments, the proximal connector 5110 includes a first connector end 5114 at which the drive assembly 5150 is coupled and a second connector end 5118 at which the flexible torque transfer assembly 5200 is coupled. Figure 51A and 51C As shown, the first connector end 5114 includes an inner wall 5116 defining an opening in which the drive assembly 5150 can be received. For example, in some embodiments, the proximal connector 5110 can be used to connect the drive assembly 5150 to a drive shaft of a surgical console (e.g., see FIG. Figures 55A-55D57A-57C , etc.). The proximal connector 5110 includes a drive transfer assembly 5122. The drive transfer assembly 5122 is configured to be operably coupled to the drive assembly 5150, receive torque from the drive assembly 5150 when the drive assembly 5150 rotates, and transfer the torque to the flexible torque transfer assembly 5200 to rotate the flexible torque transfer assembly 5200. In some embodiments, the drive assembly 5150, the drive transfer assembly 5122, and at least a portion of the flexible torque transfer assembly 5200 are coaxial. For example, the drive transfer assembly 5122 can be coupled to the drive assembly 5150 along the drive shaft 5102, and the drive transfer assembly 5122 can also be coupled to the flexible torque transfer assembly 5200 along the drive shaft 5102 at the proximal end 5204 of the flexible torque transfer assembly 5200. It should be understood that rotating the flexible torque transfer assembly can include rotating the flexible torque transfer assembly at one of the flexible torque transfer assembly components (e.g., an inner cannula).
[0315] In some embodiments, the drive transfer assembly 5122 includes gears, belts, or other drive components to control the direction and / or torque transmitted from the drive assembly 5150 to the flexible torque transfer assembly 5200. For example, such drive components can be positioned at an angle relative to each other to change the rotational axis of the flexible torque transfer assembly 5200, or offset relative to each other to move the rotational axis of the flexible torque transfer assembly 5200 relative to the drive shaft 5102.
[0316] In some embodiments, the drive assembly 5150 includes a drive engagement member 5152. The drive engagement member 5152 is configured to engage the drive assembly 5150 to a rotational energy source (e.g., a drive rotated by a motor, such as the console drive assembly 6150 of the console 6000, etc.). The drive engagement member 5152 can be configured to be fixedly and / or rigidly connected to the console drive assembly 6150 such that the drive engagement member 5152 rotates in unison with the console drive assembly 6150. For example, as Figure 51A As shown, the drive engagement member 5152 includes a proximal drive end 5154 that includes a fitting (e.g., a hex fitting, a pin fitting, etc.) that is configured to engage (e.g., lock, mate, fixedly engage, frictionally engage, etc.) an engagement receiver member 6158 of the console drive assembly 6150 of the console 6000. As such, rotation of the console drive assembly 6150 causes rotation of the drive engagement member 5152.
[0317] In some embodiments, the drive assembly 5150 includes one or more shaft components 5154 configured to transmit rotation of the drive engagement member 5150 to the drive transmission assembly 5122. In some embodiments, the drive transmission assembly 5122 includes one or more shaft components 5156. The shaft component 5156 may include an insulating member 5156a (e.g., a heat sleeve, a heat shrink, etc.) configured to insulate components of the drive assembly 5150 from heat generated by rotation of the drive assembly or its components. The shaft component 5156 may include a cutter 5156b. The shaft component 5156 may include a shaft torque coil 5156c, which may be similar to other torque coils described herein. In some embodiments, the shaft component 5156 may include a shaft torque cable. The shaft component 5156 may include a shaft tube 5156d. The shaft tube 5156d can include a radius that is smaller than the relatively larger radius of the drive engagement member 5152 (e.g., a relatively larger radius that can facilitate receiving rotational energy from a drive shaft or other rotational energy source, such as by engaging the drive engagement member 5152 to the engagement receiver member 6158 of the console drive assembly 6150). For example, the shaft tube 5156d can include a relatively smaller radius that is closer to the radius of the drive transmission assembly 5122 and / or the flexible torque transmission assembly 5200. In such an embodiment, the torque received at the drive transmission assembly 5122 and / or the flexible torque transmission assembly 5200 can be modified (e.g., increased) in a manner corresponding to the change in radius between the radius of the drive engagement member 5152 and the radius of the shaft tube 5156d.
[0318] The distal portion of the endoscopic tool 5100 (eg, the distal portion including the cutting assembly 5201) can be similar to other distal portions of the endoscopic tools described herein (eg, Figure 42 ). In some embodiments, the cutting assembly 5201 may include an outer sleeve and an inner sleeve disposed within the outer sleeve. The outer sleeve may define an opening 5208 through which material to be removed can enter the cutting assembly 5201. In some embodiments, the opening 5208 is defined as a portion of the radial wall passing through the outer sleeve. In some embodiments, the opening 5208 may extend only around a portion of the radius of the outer sleeve, for example, to one-third of the circumference of the radial wall. When the suction channel extends between the vacuum port (e.g., vacuum port 5126) and the opening 5208, any suction applied at the vacuum port will apply a suction force at the opening 5208. The suction force causes material to be drawn into the opening or cutting window of the outer sleeve, which can then be cut by the inner sleeve of the cutting assembly 5201.
[0319] The inner cannula may include a cutting portion configured to be positioned adjacent to the opening 5208 so that material to be resected that enters the cutting assembly 5201 through the opening 5208 can be resected by the cutting portion of the inner cannula. The inner cannula may be hollow, and the inner wall of the inner cannula may define a portion of a suction channel that can extend the length of the endoscopic tool. The distal end of the inner cannula may include the cutting portion, while the proximal end of the inner cannula may be open so that material that enters the distal end of the inner cannula through the cutting portion can pass through the proximal end of the inner cannula. In some embodiments, the distal end of the inner cannula may contact the inner surface of the distal end of the outer cannula. In some embodiments, this may allow the inner cannula to rotate relative to the outer cannula along a substantially longitudinal axis, thereby providing greater stability to the inner cannula during rotation. In some embodiments, the size of the opening may determine the size of the material cut or resected by the inner cannula. Thus, the size of the opening may be determined in part based on the size of the suction channel defined by the inner circumference of the flexible torque coil.
[0320] The endoscopic tool 5100 may include a flexible torque coil 5212 configured to be coupled to the proximal end of the inner cannula at the distal end of the flexible torque coil 5212. The flexible torque coil may include a thin coil having multiple threads and multiple layers, which can transmit the rotation of one end of the flexible torque coil to the opposite end of the flexible torque coil. Each threaded layer of the flexible torque coil can be wound in a direction opposite to the direction in which each threaded layer adjacent to the threaded layer is wound. In some embodiments, the flexible torque coil may include a first threaded layer wound in a clockwise direction, a second threaded layer wound in a counterclockwise direction, and a third threaded layer wound in a clockwise direction. In some embodiments, the first threaded layer is separated from the third threaded layer by the second threaded layer. In some embodiments, each threaded layer may include one or more threads. In some embodiments, the threaded layers may be made of different materials or have different characteristics, such as thickness, length, etc.
[0321] The flexibility of the torque coil 5212 allows the coil to maintain performance even in a curved portion of the torque coil 5212. Examples of flexible torque coils 5212 include torque coils manufactured by ASAHI INTECC USA, INC., located in Santa Ana, California, USA. In some embodiments, the flexible torque coil 5212 can be surrounded by a sheath or lining (e.g., sheath 5214) to avoid frictional contact between the outer surface of the flexible torque coil 5212 and other surfaces. In some embodiments, the flexible torque coil 5212 can be coated with polytetrafluoroethylene (PFTE) to reduce frictional contact between the outer surface of the flexible torque coil 5212 and other surfaces. The size, shape, or configuration of the flexible torque coil 5212 can be designed to have an outer diameter that is smaller than the diameter of the instrument channel of the endoscope into which the endoscopic tool will be inserted. For example, in some embodiments, the outer diameter of the flexible torque coil can be in the range of 1-4 mm. The length of the flexible torque coil can be designed to exceed the length of the endoscope. In some embodiments, the inner wall of the flexible torque coil 5212 can be configured to define another portion of the suction channel that is fluidly coupled to the portion of the suction channel defined by the inner wall of the inner cannula of the cutting assembly 5201. The proximal end of the flexible torque coil 5212 can be coupled to the proximal connector 5110 (e.g., coupled to the drive transmission assembly 5122 of the proximal connector 5110, etc.).
[0322] Endoscopic tool 5100 may include a flexible outer tube 5206 that may be coupled to a proximal end of an outer cannula. In some embodiments, the distal end of flexible outer tube 5206 may be coupled to the proximal end of the outer cannula using a coupling component. In some embodiments, the outer cannula may be configured to rotate in response to rotating the flexible outer tube. In some embodiments, flexible outer tube 5206 may be a hollow, braided tube having an outer diameter that is smaller than an instrument channel of an endoscope into which endoscopic tool 5100 is to be inserted. In some embodiments, the length of flexible outer tube 5206 may be sized to exceed the length of the endoscope. Flexible outer tube 5206 may define a bore through which a portion of flexible outer tube 5206 extends. Flexible outer tube 5206 may include a braid, threads, or other features that facilitate rotation of flexible outer tube 5206 relative to a flexible torque coil partially disposed within flexible outer tube 5206. The flexible outer tube may define a portion of an irrigation channel for delivering fluid to a site within a subject.
[0323] Endoscopic tool 5100 can include a rotation coupler 5216 configured to couple to the proximal end of flexible outer tube 5206. Rotation coupler 5216 can be configured to allow an operator of the endoscopic tool to rotate flexible outer tube 5206 via a rotation tab 5218 coupled to or integral to rotation coupler 5216. By rotating rotation tab 5218, the operator can rotate the flexible outer tube and outer cannula along the longitudinal axis of the endoscope and relative to the inner cannula of endoscope and cutting assembly 5201. In some embodiments, while the endoscope is within a patient, the operator may wish to rotate the outer cannula while an endoscopic instrument is inserted within the endoscope. The operator may wish to rotate the outer cannula to position the opening of the outer cannula to a position where the portion of the outer cannula's radial wall defining the opening can be aligned with the endoscope's camera, allowing the operator to visualize material entering the endoscopic instrument through the opening for resection. This may be due in part to the fact that the openings are defined along a radial wall extending on one side of the outer sleeve, rather than being openings formed in an axial wall of the outer sleeve.
[0324] In some embodiments, the proximal end 5220 of the rotating coupler 5216 can be fluidically coupled to the proximal connector 5110, such that an irrigation channel of the endoscopic tool 5100 passes from the irrigation port 5134 through the flexible outer tube 5206 and into the rotating coupler 5216. Thus, irrigation fluid entering the proximal connector 5110 at the irrigation port 5134 can pass through the rotating coupler 5216 for output at a site within the subject's body. In some embodiments, the rotating coupler 5216 can be a rotating Luer component that allows the distal end 5222 of the rotating coupler 5216 to rotate relative to the proximal end 5220 of the rotating coupler 5216. This prevents the components coupled to the proximal end of the rotating coupler 5216 from rotating when the flexible outer tube 5206 rotates. The rotating coupler 5216 can define a hole along a central portion of the rotating coupler 5216, through which a portion of the flexible torque coil 5212 extends. In some embodiments, the rotating coupler 5216 can be a male-to-male rotating Luer connector. In some embodiments, the rotary coupler can be configured to handle pressures up to 1200 psi.
[0325] In some embodiments, the flexible torque transfer assembly 5200 is configured to be fluidically coupled to a vacuum source to apply a suction force to the suction channel. The suction channel allows fluid and material (e.g., a sample to be obtained) to be drawn into the distal end 5204 of the flexible torque transfer assembly 5200 so as to flow to the proximal end 5202 of the flexible torque transfer assembly 5200. For example, after the cutting assembly 5201 is used to remove material from a site within a subject, vacuum pressure can be applied through the suction channel to draw (e.g., transfer by suction, etc.) the fluid and material into the flexible torque transfer assembly 5200.
[0326] In some embodiments, the proximal connector 5110 is configured to couple to a vacuum source to provide suction for aspiration. Figure 51A and 51C As shown, the proximal connector 5110 includes a vacuum port 5126 (e.g., a suction port). The vacuum port / suction port 5126 can be similar to other suction ports disclosed herein. The vacuum port 5126 is configured to fluidically couple the suction channel of the endoscopic tool 5100 to a vacuum source (e.g., to a vacuum source with a sample receiver located between the vacuum source and the endoscopic tool). The vacuum port 5126 is configured to transfer a suction force applied to the vacuum port 5126 to the suction channel so as to draw fluids and materials entering the distal end 5204 of the endoscopic tool 5100 through the suction channel to the vacuum source. In some embodiments, for example Figure 51A and 51C As shown, the vacuum port 5126 includes a vacuum port channel 5130 oriented transversely to the drive shaft 5102 (and thus the suction channel). This can facilitate coupling a tube to the vacuum port 5126 that extends to a sample receiver or vacuum source without interfering with the manipulation of the proximal connector 5110 and the endoscopic tool 5100. In various embodiments, the vacuum port channel 5130 can be oriented at different angles relative to the drive shaft 5102. In some embodiments, a vacuum tube 5132 can be coupled to the vacuum port 5126.
[0327] In some embodiments, the proximal connector 5110 is configured to couple to a fluid source to provide fluid for output by the endoscopic tool 5100 to a site within a subject. Figures 51A-51C As shown, the proximal connector 5110 includes a flush port 5134, which includes a flush port channel 5136 that is configured to receive fluid from a fluid source. The flush port 5134 is configured to be fluidically coupled to a flush channel of the flexible torque transfer assembly 5200 (e.g., a flush channel defined between the flexible outer tube 5206 and the flexible torque coil 5212 and extending to an opening at the distal end 5204 of the flexible torque transfer assembly 5200) so that fluid can flow from the proximal connector 5110 through the flexible torque transfer assembly 5200 to be output at a site within the subject. In some embodiments, a fluid (e.g., a flush fluid) can be used to cool the flexible torque transfer assembly 5200, which can generate heat due to friction caused by rotation or other movement. In some embodiments, the fluid can be used to wash a site within the subject. In some embodiments, the fluid provides lubrication to facilitate rotation or other movement of components of the endoscopic tool 5100 relative to each other. In some embodiments, the flush port 5134 is configured to be coupled to a fluid transfer device or flush pump (e.g., such as Figures 52A-52F6200 shown). The flush port 5134 receives a flow of flush fluid from the flush pump and delivers the fluid to the flush channel. In some embodiments, the flush channel is defined as including the flush port 5134 and / or a tube connecting the flush port 5134 to a fluid source. In some embodiments, the flush port 5134 can be coupled to the fluid source via a fluid tube 5140. The fluid tube 5140 can be coupled to a fitting 5144 (e.g., a vented spike fitting, a non-vented spike fitting, etc.) configured to interface the fluid tube 5140 to the fluid source.
[0328] Consoles for endoscopy tools
[0329] Now refer to Figures 52A-56C , shows a console 6000 for an endoscopic tool. The console 6000 is configured to receive control commands (e.g., user input) for controlling the operation of an endoscopic tool (e.g., endoscopic tool 5100), such as various endoscopic tools disclosed herein, including Figure 51A-51A The console 6000 is configured to be connected to the endoscope tool 5100, the sample receiver (e.g., Figure 64 The console 6000 may interface with devices such as a sample receiver 7000 shown), a vacuum source, a suction source, etc. Thus, the console 6000 is configured to interface devices coupled to the console 5100 with each other. The console 6000 may interface the devices using mechanical connections as well as electronic connections.
[0330] In some embodiments, the console 6000 includes a user interface 6010. The user interface 6010 is configured to receive user input (e.g., user input from an operator of the console 6000, a user performing surgery using the console and / or endoscopic tool 5100, etc.). The console 6000 is configured to perform operations based on the received user input. For example, the console 6000 may include processing electronics (e.g., processing circuitry / processor, memory, etc.) configured to process user input in order to generate an output (e.g., a control signal) that is configured to cause the device to perform operations associated with the user input. The processor may be or may include one or more microprocessors, application specific integrated circuits (ASICs), a circuit comprising one or more processing components, a set of distributed processing components, a circuit for supporting a microprocessor, or other hardware configured for processing. The processor may be configured to execute computer code. The computer code may be stored in a memory to perform and facilitate the activities described herein. In some embodiments, the computer code may be retrieved from a hard disk storage device or a communication interface and provided to the processor (e.g., the computer code may be provided from a source external to the console 6000). The memory can be any volatile or non-volatile computer-readable storage medium capable of storing data or computer code related to the activities described herein. For example, the memory can include a module, which is a computer code module (e.g., executable code, object code, source code, script code, machine code, etc.) configured to be executed by the processor. The memory can include computer executable code related to functions including motor control, processing user input, controlling devices such as the endoscopic tools disclosed herein, receiving and transmitting data, etc. In some embodiments, the processing electronics can represent a collection of multiple processing devices.
[0331] In some embodiments, the user interface 6010 includes a user input device 6014 (e.g., a button, a knob, a switch, a foot pedal, etc.) configured to receive user input for controlling the operation of the console 6000 and for controlling devices operably coupled to the console 6000 (e.g., the endoscope tool 5100, etc.). Figure 52A and 52EAs shown, the user interface 6010 may include a speed controller 6014a (e.g., for controlling the rotational speed of a drive of the console, etc.), a power button 6014b, a vacuum control release 6014c configured to receive user input for controlling the vacuum control device 6040 (e.g., user input indicating an instruction to turn on the vacuum control device 6040 so that the vacuum source, the endoscopic tool 5100, the sample receiver 7000, etc. can be fluidically coupled via the vacuum control device 6040), and an irrigation input 6014d configured to irrigate and / or flush a flush tube (e.g., an irrigation and / or flush tube, etc., which is configured to fluidly couple the fluid transfer device 6200 to the endoscopic tool).
[0332] In some embodiments, the user interface 6010 includes an auxiliary control interface 6018. For example, the auxiliary control interface 6018 can be configured to receive user input for rotating the endoscopic tool 5100 (e.g., inner cannula), for vacuum control, for irrigation control, etc. In some embodiments, the auxiliary control interface 6018 is configured to receive user input or other control signals from a remote input device (e.g., a foot pedal, a manual controller, a portable electronic device, etc.). The auxiliary control interface 6018 can be configured to communicate with the remote input device via a wired connection or a wireless signal (e.g., radio frequency, infrared, Bluetooth, Internet Protocol, WI-FI, etc.). For example, the foot pedal can be configured to receive user input for rotation, vacuum control, and / or irrigation control, and send control signals based on the user input for receipt by the auxiliary control interface 6018. In some embodiments, the auxiliary control interface 6018 is configured to receive control signals from the foot pedal for processing to control the operation of the endoscope tool 5100, including for applying vacuum to the suction channel of the endoscope tool 5100, for rotating components of the endoscope tool 5100, and / or for causing irrigation fluid to flow through the irrigation channel of the endoscope tool 5100 to a site within the subject's body. In some embodiments, the foot pedal includes a pedal input configured to receive input corresponding to each function of the foot pedal (e.g., rotation, vacuum, irrigation, etc.). In some embodiments, the first pedal input is configured to receive input corresponding to activation of multiple functions (e.g., rotation and suction / vacuum), and the second pedal input is configured to receive input corresponding to activation of other functions (e.g., irrigation). In some embodiments, the first pedal input is configured to receive input corresponding to activation of multiple functions (e.g., rotation and irrigation), and the second pedal input is configured to receive input corresponding to activation of other functions (e.g., suction / vacuum). For example, the second pedal input can be configured for vacuum control or irrigation, but only within a predetermined time period (e.g., 5 seconds, 10 seconds, 12 seconds, 15 seconds, etc.) after activating the first pedal input. In some embodiments, the predetermined time period is determined based on preventing heat buildup in the endoscopic tool or ensuring that the vacuum pulls tissue toward the cutting window for resection by rotating the cutting window. In some embodiments, the predetermined time period is determined based on preventing inadvertent activation of the suction force. In some embodiments, when the first foot pedal is actuated, a suction force is applied and after a predetermined time, a drive motor is actuated to cause the inner cannula to rotate. In this way, the material to be resected can be drawn into the cutting window of the outer cannula before the inner cannula rotates. In addition, by applying suction before actuating the cutter, any material captured in the suction channel can be removed before cutting additional material.
[0333] In some embodiments, the console 6000 includes a vacuum control device 6040 (e.g., a vacuum control valve). The vacuum control device 6040 is configured to couple a vacuum source to the endoscopic tool 5100. For example, the vacuum control device 6040 can be configured to fluidically couple a tube to the vacuum port 5126 of the proximal connector 5110 of the endoscopic tool 5100 and also fluidly couple the tube to a sample receptacle (e.g., the sample receptacle 7000) and / or the vacuum source. In some embodiments, the vacuum control device 6040 mechanically engages (e.g., clamps, locks, holds, etc.) a vacuum tube that fluidly couples the endoscopic tool 5100 to the sample receptacle 7000. In some embodiments, the vacuum control device 6040 includes a manifold configured to fluidly couple the endoscopic tool 5100 to multiple sample receptacles 7000. The user interface 6010 may include a manifold / valve controller configured to control the flow of fluid through the exit endoscope tool 5100 to one or more of the plurality of sample receivers 7000 .
[0334] In some embodiments, the vacuum control device 6040 is configured to open in response to user input received at the vacuum control release 6014c. For example, in response to actuation of the vacuum control release 6014c, the processing electronics of the console 6000 can receive a vacuum release signal and cause the vacuum control device 6040 to open, allowing the vacuum tube to be positioned within the vacuum control device 6040. In some embodiments, the vacuum control device 6040 can be configured to be mechanically coupled to the vacuum control release 6014c such that actuation of the vacuum control release 6014c mechanically actuates the vacuum control device 6040 to open the vacuum control device 6040. In some embodiments, the vacuum control device 6040 is configured to open for a predetermined amount of time. For example, the vacuum control device 6040 can be actuated to an open position for a predetermined amount of time in response to input received at the vacuum control release 6014c and then automatically close after the predetermined amount of time.
[0335] In some embodiments, the processing electronics of the console 6000 are configured to receive control signals from the foot pedal and perform at least one of controlling the rotation of the endoscope tool 5100, controlling the fluid source to deliver irrigation fluid through the endoscope tool 5100 (e.g., controlling the operation of the fluid delivery device 6200 to output fluid from the fluid delivery device 6200 into the endoscope tool 5100), or controlling the application of vacuum pressure to the endoscope tool 5100 (e.g., enabling the vacuum source to apply suction to the endoscope tool 5100). For example, the processing electronics can be configured to receive a first signal from a first pedal input and a second signal from a second pedal input, causing the motor 6300 to rotate the endoscope tool 5100 in response to receiving the first signal, thereby causing the fluid delivery device 6200 to output fluid into the endoscope tool 5100 in response to receiving the first signal, and causing the vacuum control device 6040 to apply vacuum pressure to the endoscope tool 5100 in response to receiving the second signal (e.g., in response to receiving the second signal within a predetermined time of receiving the first signal).
[0336] In some embodiments, the console 6000 includes an endoscope tool interface 6100. The endoscope tool interface 6100 is configured to engage the endoscope tool 5100. In some embodiments, the endoscope tool interface 6100 is configured to mechanically engage (e.g., fixedly engage, rigidly engage, etc.) the drive assembly 5150 of the endoscope tool 5100 to rotate the drive assembly 5150. For example, the endoscope tool interface 6100 can serve as an interface between the endoscope tool 5100 and a drive mechanism of the console 6000.
[0337] Figures 56A-56C 6. An embodiment of an endoscope tool interface 6100 is shown in greater detail. The endoscope tool interface is configured to be coaxially attached to the console 6000 with a console drive assembly (e.g., console drive assembly 6150). The endoscope tool interface includes an interface receiver 6104 configured to couple to the proximal connector 5110 of the endoscope tool 5100, facilitating alignment and coupling of the console drive assembly 6150 with the proximal connector 5110 so that the console drive assembly 6150 can rotate the drive assembly 5150 of the endoscope tool 5100.
[0338] Return to reference Figures 52A-54CIn some embodiments, the console 6000 includes a fluid delivery device 6200 (e.g., an irrigation pump). The fluid delivery device 6200 is configured to flow a fluid (e.g., an irrigation fluid) through the endoscopic tool 5100 for output by the endoscopic tool 5100 at the distal end 5104 of the endoscopic tool 5100. In some embodiments, the irrigation fluid is received in the operating room from a fluid source (e.g., a water container, a saline / IV bag, etc.). The fluid delivery device 6200 can be configured to output the fluid at a pressure sufficient to drive the fluid to an outlet at the distal end 5104 of the endoscopic tool 5100.
[0339] In some embodiments, the console 6000 includes a motor 6300. The motor 6300 is configured to provide rotational energy to rotate the endoscopic tool 5100. In some embodiments, the motor 6300 is an electric motor. In some embodiments, the motor 6300 is a variable speed motor. In some embodiments, the motor 6300 is a fixed speed motor; if a variable rotation rate from the fixed speed motor 6300 is required, a speed change device (e.g., gears, etc.) can be used to step from the rotation rate of the motor 6300 to the desired rotation rate. In some embodiments, the speed control 6014a of the console 6000 is configured to receive a speed control input (e.g., a speed control input corresponding to the absolute rotation rate of the motor 6300 or the console drive assembly 6150, a relative rotation rate based on a percentage of the maximum rotation rate of the motor 6300 or the console drive assembly 6150, etc.). In such an embodiment, user input can be received indicating a desired rotational rate of the endoscopic tool 5100, and the motor 6300 and console drive assembly 6150 (including any gears coupled between the output shaft of the motor 6300 and the console drive assembly 6150, etc.) can be configured to output torque to the endoscopic tool 5100 based on the desired rotational rate indicated by the user input.
[0340] Further references Figures 55A-55D , shows the mechanical coupling between the various components of the console 6000, including the endoscope tool interface 6100, the console drive assembly 6150, the vacuum control device 6040, and the motor 6300. In some embodiments, the output shaft of the motor 6300 is coupled to and coaxial with the console drive assembly 6150. In other embodiments, such as Figures 55A-55D As shown in FIG, the output shaft 6304 of the motor 6300 is parallel to and offset from the drive shaft of the console drive assembly 6150. In such an embodiment, the intermediate drive assembly 6350 can be configured to couple to the output shaft 6304 and the console drive assembly 6150 so as to transmit the rotational output of the output shaft 6304 to the drive assembly 6150. For example, as shown in FIG. Figures 55A-55DAs shown, the intermediate drive assembly 6350 includes a first rotational member (e.g., a pulley) 6354 configured to engage the output shaft 6304, a second rotational member (e.g., a pulley) 6358 configured to engage with the console drive assembly 6150, and a rotation transfer device (e.g., a belt) 6362 configured to transfer rotation from the first rotational member 6354 to the second rotational member 6358. For example, the rotation transfer device 6362 can frictionally engage both the first rotational member 6354 and the second rotational member 6358 such that when the output shaft 6304 of the motor 6300 rotates the first rotational member 6354, the rotation transfer device 6362, and thereby the console drive assembly 6150, also rotates.
[0341] Figures 57A-57C An embodiment of a console drive assembly 6150 is shown in greater detail. The console drive assembly 6150 is configured to transfer rotation of a rotational energy source (e.g., motor 6300) into rotation of an endoscopic tool (e.g., endoscopic tool 5100). In some embodiments, the console drive assembly 6150 includes an input shaft 6154. The input shaft 6154 can be configured to couple to the output shaft 6304 of the motor 6300. For example, the input shaft 6154 can be coupled to the output shaft 6304 via an intermediate shaft, a gear, or a double-sided coupling member (e.g., a coupling member having a first receiving surface configured to engage the input shaft 6154 and a second receiving surface configured to engage the output shaft 6304). In some embodiments, the input shaft 6154 is configured to couple to the intermediate drive assembly 6350. For example, the input shaft 6154 can be configured to engage the second rotational member 6358 such that rotation of the second rotational member 6358 caused by rotation of the output shaft 6304 causes rotation of the input shaft 6154 .
[0342] In some embodiments, the console drive assembly 6150 includes an engagement receiver member 6158. The engagement receiver member 6158 is configured to engage the console drive assembly 6150 to the endoscopic tool 5100 so as to engage the drive engagement member 5152. For example, the engagement receiver member 6158 can include a receiving surface 6162 shaped to engage (e.g., frictionally engage) the drive engagement member 5152 (e.g., a hexagonal fitting shaped to match the hexagonal head of the drive engagement member 5152, etc.). When the console drive assembly 6150 is rotated by the motor 6300, rotational energy is transferred to the drive engagement member 5152 via the input shaft 6154 of the engagement receiver member 6158, thereby rotating the endoscopic tool 5100.
[0343] In some embodiments, the console drive assembly 6150 includes a drive torque coil 6400 . Figures 58A-58CAn embodiment of the drive torque coil 6400 is shown in greater detail. The drive torque coil 6400 is configured to be positioned within the console drive assembly 6150 between the engagement receiver member 6158 and the input shaft 6154. The drive torque coil 6400 can be similar to other torque coils disclosed herein. The drive torque coil 6400 can be configured to compensate for torque forces that could disrupt the orientation of the endoscopic tool 5100, and this compensation can be supplemented by the flexible torque coil 5212. The drive torque coil 6400 can include a friction reducing member 6404 positioned at the end of the drive torque coil 6400, which is configured to reduce friction and wear between the drive torque coil 6400 and other components of the console drive assembly 6150. The drive torque coil 6400 can complement the action of the flexible torque coil 5212. The drive torque coil 6400 can be configured to freely rotate within the console drive assembly 6150 using the friction reducing member 6404, while compressing or expanding to compensate for compressive or extensive forces applied to the console drive assembly 6150.
[0344] In some embodiments, the console 6000 includes one or more stand assemblies 6500 . Figures 59A-59C An embodiment of the support assembly 6500 is shown in greater detail. The support assembly 6500 can be configured to hold (e.g., support, engage) a device configured to be fluidly coupled to the console 6000 and / or the endoscopic tool 5100. For example, the support assembly 6500 can be configured to hold a sample receiver (e.g., Figure 64 In some embodiments, the rack assembly 6500 includes a rack receiver surface 6504. The rack receiver surface 6504 can be configured to receive and engage the sample receiver 7000. For example, the rack receiver surface 6504 can include features configured to frictionally and / or mechanically engage the sample receiver 7000. Figures 59A-59CAs shown, the support assembly 6500 may include one or more sample engagement receiver members 6508 extending into the support body 6514 of the support assembly 6500. The sample engagement receiver members 6508 are configured to reciprocally engage engagement features of the sample receiver 7000. In some embodiments, the sample engagement receiver member 6508 includes a first receiving portion 6510 that is continuous with and offset from a second receiving portion 6512. As such, an engagement feature of the sample receiver 7000 can be positioned within the first receiving portion 6510. When the sample receiver 7000 is rotated, the engagement feature can translate (e.g., slide) along the first receiving portion 6510 and then reposition vertically to the second receiving portion 6512. Thus, the sample engagement receiver member 6508 is configured to prevent rotation of the sample receiver 7000 unless the sample receiver 7000 is also translated in a direction perpendicular to the plane of rotation. In other words, while a user can insert or remove the sample receiver 7000 by rotating and moving the sample receiver 7000, unintentional force applied to the sample receiver 7000 (e.g., during surgery) will not cause the sample receiver 7000 to be removed from the bracket assembly 6500. In some embodiments, the bracket assembly 6500 is configured to be fluidically coupled to the sample receiver 7000. For example, if the console 6000 includes a fluid connector for coupling to the sample receiver 7000 (e.g., for coupling a vacuum source to the sample receiver 7000), the fluid connector can be fluidically coupled to the sample receiver 7000 via the bracket assembly 6500.
[0345] Return to reference Figures 52A-52F In some embodiments, the console 6000 includes a holder assembly 6600. The holder assembly 6600 may include a holder receiver 6604 configured to hold (e.g., support) a component configured for use with the console 6000. For example, the holder receiver 6604 may be configured to hold a control device for controlling the operation of an endoscopic tool. The holder assembly 6600 may include a fastening member (e.g., a screw, bolt, etc.) 6608 configured to fasten the component to the holder receiver 6604.
[0346] Further references Figures 53A-53BIn some embodiments, the console 6000 includes a power input assembly 6650. The power input assembly 6650 may include a power cable receiver 6660 that is configured to receive power from a remote power source. The power input assembly 6650 may include an input (e.g., a switch, button, etc.) 6664 that is configured to turn the power of the console 6000 on / off. The power input assembly 6650 may be configured to deliver energy to components of the console 6000 (e.g., the motor 6300, the user interface 6010, processing electronics, etc.). In some embodiments, the power input assembly 6650 may include a local power source (e.g., a battery). The local power source may be configured to provide all power to the console 6000, provide backup power to the console 6000, and / or provide local power to certain components of the console 6000. For example, the battery may be configured to power the processing electronics, while the remote power source may be configured to provide power to the motor 6300.
[0347] Figure 60A-6 3 shows various views of operating and connecting the console 6000 with the endoscopic tools 5100 and other components described herein. Figures 60A-60B , showing the endoscope tool 5100 coupled to the console 6000 at the endoscope tool 6100. The proximal connector 5110 is configured to be positioned adjacent the endoscope tool interface 6100 to engage the endoscope tool 5100 to the console drive assembly 6150. In some embodiments, the endoscope tool interface 6100 includes an engagement actuator 6104 configured to engage the endoscope tool 5100 to the console 6000. In some embodiments, the engagement actuator 6104 can be configured to be positioned in a first unlocked position ( Figure 60A ) and a second locked position ( Figure 60B ), such that movement of the engagement actuator 6104 moves the engagement actuator 6104 between the first and second positions. For example, an operator of the console 6000 can move the engagement actuator 6104 between these positions to lock or unlock the endoscopic tool 5100 from the console 6000.
[0348] Now refer to Figure 61 , sample receiver (e.g., Figure 64) can be fluidically coupled to a vacuum source. For example, a tube (e.g., a vacuum tube, a suction tube, etc.) can be fluidically coupled to an outlet of the sample receiver (e.g., a second receiver port 7018). The tube can be used to apply a suction force to the sample receiver 7000 so as to draw the fluid from the endoscopic tool 5100 through the sample receiver 7000 toward the vacuum source (e.g., via a suction channel). In some embodiments, the tube can be configured to remove excess fluid that leaves the sample receiver 7000. In some embodiments, the tube is transparent, allowing an operator to observe the fluid leaving the sample receiver 7000 to determine the content of the fluid. In some embodiments, the console 6000 is positioned on the fluid path between the vacuum source and the sample receiver.
[0349] In some embodiments, the irrigation channel includes an irrigation port 5134, an irrigation port channel 5136, a portion defined between the flexible outer tube 5206 and the flexible torque coil 5212 (e.g., a portion defined between the inner wall of the flexible outer tube 5206 and the exterior of the flexible torque coil 5212), and extends to an opening at the distal end 5204 of the torque transfer assembly 5200. In some embodiments, the irrigation channel includes a portion defined between the rotational coupler 5216 and the flexible torque coil 5212. In some embodiments, the irrigation channel includes a portion defined by the interface of the proximal connector 5110 between the irrigation port channel 5136 and the portion defined between the flexible outer tube 5206 and the flexible torque coil 5212. In some embodiments, the irrigation channel extends from the irrigation port 5134 to the opening at the distal end 5204 of the torque transfer assembly 5200. In some embodiments, the irrigation channel extends from the endoscopic tool 5100 to the fluid source. For example, the flush channel can extend through a tube that fluidly couples the flush port 5134 to a fluid source (eg, to the fluid delivery device 6200). In some embodiments, the flush channel includes a fluid source.
[0350] Now refer to Figure 62 and Figures 51A-51C , a sample receiver (e.g., sample receiver 7000) can be fluidly coupled to the endoscope tool 5100. For example, a tube 6702 (e.g., a vacuum tube, a suction tube, etc.) can be fluidly coupled between the vacuum port 5126 of the proximal connector 5110 and an inlet (e.g., the first receiver port 7014) of the sample receiver 7000. The tube can be used to apply a suction force to the endoscope tool 5100 to draw fluid out of the endoscope tool 5100 (e.g., via a suction channel), for example, to obtain a sample in the sample receiver 7000.
[0351] In some embodiments, the suction channel includes a vacuum port 5126, a vacuum port channel 5130, and a portion defined by the inner wall of the flexible torque coil 5212. The suction channel is partially defined by the portion defined by the inner wall of the inner cannula of the cutting assembly 5201, which extends to the opening 5208. In some embodiments, the suction channel includes (or is partially defined by) the interface of the proximal connector 5110 between the vacuum port channel 5130 and the portion defined by the flexible torque coil 5212. In some embodiments, the suction channel extends from the vacuum port 5126 to the opening 5208.
[0352] In some embodiments, the suction channel extends from the endoscopic tool 5100 to the vacuum source. For example, the suction channel can be defined in part by a tube that fluidly couples the vacuum port 5126 to the vacuum source. In some embodiments, the suction channel includes a sample receptacle (e.g., the sample receptacle 7000). The suction channel can include a tube that fluidly couples the endoscopic tool 5100 to the sample receptacle (e.g., the sample receptacle 7000). Figure 62 ), a channel extending through the sample receiver, and a tube fluidly coupling the sample receiver to a vacuum source (e.g., Figure 61 In some embodiments, a suction channel extends from a vacuum source through the endoscopic tool 5100 through the sample receptacle to the opening 5208, such as when the distal end 5204 of the torque transfer assembly 5200 is positioned at a site within a subject.
[0353] Now refer to Figures 63A-63B 51A-51C, a fluid transfer device 6200 (e.g., an irrigation pump) can be fluidically coupled to the irrigation port 5134 of the proximal connector 5110. In some embodiments, the fluid transfer device 6200 includes an actuation member 6204 configured to open the fluid transfer device 6200 to expose an outlet of the fluid transfer device 6200. An operator of the console 6000 can couple a tube to the outlet of the fluid transfer device 6200 and to the irrigation port to fluidically couple the fluid transfer device 6200 to an irrigation channel of the endoscopic tool 5100. In some embodiments, the actuation member 6204 is configured to be positioned in a first closed position (see Figure 64 ) and shifts to the second open position (see Figure 64 In some embodiments, the console 6000 includes a user input configured to receive a fluid transfer device control command. The processing electronics of the console 6000 can be configured to receive the fluid transfer device control command and cause the fluid transfer device 6200 to open or close (e.g., actuate the actuation member 6204) based on the fluid transfer device control command.
[0354] Sample receiver
[0355] Figure 64 An exploded perspective view of a sample receptacle 7000 is shown. The sample receptacle 7000 is configured to receive a fluid stream and obtain a sample of material from the fluid stream (e.g., tissue from a patient, a polyp removed from a patient's colon, etc.). The sample receptacle 7000 can be fluidically coupled to the endoscopic tool 5100. The sample receptacle 7000 can be fluidically coupled to a vacuum source. The vacuum source can be used to provide a suction force through the sample receptacle 7000 to draw the fluid stream from the endoscopic tool 5100 through the sample receptacle 7000 and out of the sample receptacle 7000. Thus, the fluid stream can be drawn through a sample capture member for capturing a sample from the fluid stream.
[0356] The sample receiver 7000 includes a first receiver member 7010, a second receiver member 7050, and a sample capture member 7100. The first receiver member 7010 is configured to be positioned upstream relative to the flow of fluid through the sample receiver 7000. The second receiver member 7050 is configured to be positioned downstream relative to the flow of fluid through the sample receiver 7000. The first receiver member 7010 and the second receiver member 7050 are configured to engage with each other, with the sample capture member 7100 positioned within the first receiver member 7010 and the second receiver member 7050.
[0357] For example, Figure 64 As shown, the first receiver member 7010 includes a first receiver port 7014 configured to receive a fluid flow and pass the fluid flow to the interior of the sample receiver 7000 via a first receiver channel 7018 fluidly coupled to the first receiver port 7014. The second receiver member 7050 includes a second receiver port 7054 configured to receive a fluid flow via a second receiver channel 7058 fluidly coupled to the second receiver port 7054. The second receiver port 7054 is configured to be coupled to a vacuum source (e.g., a vacuum source located downstream of the sample receiver 7000) to provide a suction force to draw the fluid flow out of the sample receiver 7000.
[0358] In some embodiments, the first receiver member 7010 is configured to engage the second receiver member 7050. For example, the first receiver member 7010 may include features configured to mate and engage (e.g., lock, attach to, couple, connect, etc.) with features of the second receiver member 7050. Figure 64As shown, the first receiver member 7010 includes an outer edge 7022 having a receiver engagement member 7026 extending therefrom. The receiver engagement member 7026 is configured to be positioned within a corresponding receiver engagement member 7066 located on the inner edge 7062 of the second receiver member 7050. For example, the receiver engagement member 7066 can include a track configured to receive the receiver engagement member 7026 such that when the first receiver member 7010 is rotated relative to the second receiver member 7050, the receiver engagement member 7026 slides within the track of the receiver engagement member 7066. In various embodiments, components including such an engagement member can be interchangeable between the first receiver member 7010 and the second receiver member 7050.
[0359] In some embodiments, the first receiver port 7014 (and / or the first receiver channel 7018) comprises an inner diameter that is smaller than the inner diameter of the second receiver port 7054 (and / or the second receiver channel 7058). This can facilitate fluid flow through the sample receiver 7100 by facilitating a reduced pressure gradient in the direction of fluid flow.
[0360] In some embodiments, the sample receiver 7000 is configured to be coupled to the console 6000. For example, the sample receiver 7000 can be coupled to the bracket assembly 6500 of the console 6000. Figure 64 And return to Figures 59A-59C In some embodiments, the sample receiver 7000 includes a console engagement member 7200 configured to engage the sample receiver engagement member 6508 of the rack assembly 6500. For example, the sample receiver engagement member 6508 can include a track configured to receive the console engagement member 7200 when the sample receiver 7000 is positioned in the rack assembly 6500. In some embodiments, the first receiving portion 6510 is offset from the second receiving portion 6512 to facilitate locking the sample receiver 7000 in the rack assembly 6500. This can help maintain the sample receiver 7000 in place if an angular force is applied to the sample receiver 7000, such as due to fluid flowing through the sample receiver 7000, action of the motor 6300, or an angular force generated from an object contacting the sample receiver 7000.
[0361] The sample capture member 7100 is configured to obtain a sample of material from a fluid stream passing through the sample receptacle 7000. In some embodiments, the sample capture member 7100 is configured to filter the fluid stream to obtain a sample of material. For example, the sample capture member 7100 can be a size filter (e.g., a mesh filter, a paper filter, etc.) configured to separate materials in the fluid stream by size. The sample capture member 7100 can be selected based on the known or expected size of the material obtained from the fluid stream in order to separate the sample to be obtained from other materials of similar size (e.g., a size within the order of magnitude of the sample to be captured). For example, before a procedure to be performed, an operator can select the sample capture member 7100 to have a filter size (e.g., a mesh size, etc.) configured based on the known or expected size of the material. The sample capture member 7100 can include a volume size (e.g., a surface area, a circumference, etc.) configured to fit within the receiving surface of the first receptacle member 7010 and / or the second receptacle member 7050.
[0362] For example, Figure 64 As shown, the sample capture member 7100 includes a first sample capture surface (e.g., upstream surface) 7104, a second sample capture surface (e.g., downstream surface) 7108, a sample capture body 7112 extending between the first sample capture surface 7104 and the second sample capture surface 7108, and a sample capture edge 7112. A fluid stream having entered the sample receiver 7000 via the first receiver port 7014 flows through the first receiver channel 7018, contacts the first sample capture surface 7104, flows through the sample capture body 7112, and exits the sample capture member 7100 via the second sample capture surface 7108 to flow into the second receiver channel 7058. The sample capture member 7100 selectively passes fluid through the sample capture body 7112, for example, by blocking material that is too large to pass through the sample capture body 7112. For example, if the sample capture member 7100 includes a mesh filter, the size of the mesh can be designed so that the sample to be obtained is too large to pass through the mesh, while blood and other fluids in the fluid stream pass through the gaps in the mesh.
[0363] In some embodiments, after the procedure is complete (e.g., after the sample is obtained), the sample receiver 7000 can be opened to remove the sample. For example, the first receiver member 7010 can be rotated relative to the second receiver member 7050 to open the sample receiver 7000, thereby exposing the sample capture member 7100 and the sample.
[0364] In some embodiments, if the size of the material to be captured is not known or anticipated, a sample capture member 7100 can be selected intraoperatively. For example, based on information acquired by the endoscopic tool 5100 regarding the sample to be obtained, the operator can determine the expected size of the sample and select the sample capture member 7100. In some embodiments, the sample receptacle 7000 can be decoupled from the endoscopic tool 5100 to allow replacement of the sample capture member 7100 and / or the sample receptacle 7000. In some embodiments, if the sample receptacle 7000 is fluidically coupled to the endoscopic tool 5100 via the console 6000, the sample receptacle 7000 can be decoupled from the console 6000. In some embodiments, if the console 6000 is fluidically coupled to multiple sample receptacles 7000, a fluid output control can be used to redirect the flow of fluid exiting the endoscopic tool 5100 to a sample receptacle 7000 having a sample capture member 7100 of the appropriate size.
[0365] In some embodiments, the sample receiver 7000 includes a fluid-tight seal member 7150. The fluid-tight seal member is configured to be positioned within the sample receiver 7000 and abut against a surface of the first receiver member 7010 and / or the second receiver member 7050 to prevent fluid flow from exiting the sample receiver 7000 at the interface between the first receiver member 7010 and the second receiver member 7050. In some embodiments, the fluid-tight seal member 7150 is configured to surround the sample capture member 7100 to support the sample capture member 7100. In some embodiments, one or more surfaces of the first receiver member 7010 and / or the second receiver member 7050 are configured to support the sample capture member 7100, for example, by applying tension and / or compression to the sample capture member 7100 to support the sample capture member 7100 against differential pressures caused by fluid flow through the sample capture member 7100.
[0366] In some embodiments, the sample receptacle 7000 includes an indicator configured to provide a visual indication of whether the sample receptacle 7000 has acquired material. The indicator can include a transparent or translucent portion configured to allow an operator to see into the interior of the sample receptacle 7000. The indicator can be coupled to a pressure sensor disposed within the sample receptacle 7000 and provide an output indicating the pressure within the sample receptacle 7000. In some embodiments, fluid exiting the sample receptacle 7000 to the vacuum source can provide an indication of whether the sample receptacle 7000 has acquired material.
[0367] In some embodiments, the sample receiver 7000 is directly coupled to the vacuum port 5126 of the endoscope tool 5100, for example, by connecting the vacuum port 5126 to the first receiver port 7014 of the sample receiver 7000 using a tube. In some embodiments, the sample receiver 7000 is fluidically coupled to the endoscope tool 5100 via the console 6000. For example, the console 6000 may include a valve and / or manifold system configured to fluidically couple to and transfer fluid into or out of the endoscope tool 5100, including a manifold configured to fluidically couple the sample receiver to the endoscope tool 5100. In some embodiments, the sample receiver 7000 defines a length from an opening of the first receiver port 7014 (e.g., an opening where fluid is received) to an opening of the second receiver port 7054 (e.g., an opening where a vacuum source can be coupled; an opening where fluid exits the second receiver port 7054). The length can be greater than or equal to 1 inch and less than or equal to 5 inches. The length can be greater than or equal to 2 inches and less than or equal to 4 inches. The length can be 2 inches. In some embodiments, the sample receptacle 7000 defines a diameter or width of the outer rim 7022. The diameter can be greater than or equal to 0.5 inches and less than or equal to 4 inches. The diameter can be greater than or equal to 1 inch and less than or equal to 3 inches. The diameter can be 1.5 inches. The dimensions of the sample receptacle 7000, such as the length of the sample receptacle 7000 and / or the diameter of the outer rim 7022, can be configured to facilitate a pressure gradient through the sample receptacle 7000 such that the sample capture member 7100 can effectively capture a sample. For example, given a known vacuum pressure or range of vacuum pressures applied via the second receptacle port 7054, the dimensions of the sample receptacle 7000 can be configured to facilitate a pressure gradient through the sample receptacle 7000 that is greater than a first threshold sufficient to extract fluid through the sample capture member 7100 and less than a second threshold above which the sample capture member 7100 is expected to collapse into the second receptacle channel 7058.
[0368] Figure 65A flow chart of a method 7300 for operating a console configured to operate with an endoscopic tool is shown. The method 7300 can be performed using various systems and devices disclosed herein, including the endoscopic tool 5100, the console 6000, and the sample receiver 7000. The method 7300 can be performed by a surgeon, a medical assistant, or other operator, for example, in an operating room. The method 7300 can include or be performed as part of a procedure for obtaining polyp and tumor samples from a patient; a procedure using a gastroscope, such as a colonoscope, a laryngoscope, or any other flexible endoscope; a minimally invasive surgical procedure, etc. In some embodiments, the method 7300 includes positioning an instrument channel at a site within the patient's body. In some embodiments, the method 7300 can begin by identifying material to be removed (e.g., as discussed with respect to step 7350).
[0369] At 7310, the endoscopic tool is coupled to the console. For example, the endoscopic tool may include a proximal connector including an engagement member configured to engage an engagement receiver member of an interface of the console. The proximal connector may be positioned proximal to the interface such that the engagement member is aligned with the engagement receiver member and the engagement member is engaged with the engagement receiver member. In some embodiments, the console includes an actuation member configured to be actuated to lock or unlock the engagement between the endoscopic tool and the console. In some embodiments, engaging the engagement member to the engagement receiver member operably couples a motor of the console to the endoscopic tool such that rotation of the motor causes rotation of the endoscopic tool. In some embodiments, a surgeon or other operator couples the endoscopic tool to the console.
[0370] In some embodiments, at 7315, the endoscopic tool is fluidically coupled to a sample receptacle (e.g., a sample receptacle configured to filter fluid from the endoscopic tool to separate the material sample from the fluid). For example, the endoscopic tool can include a vacuum port (e.g., a vacuum port of a proximal connector of the endoscopic tool) that is fluidically coupled to an inlet of the sample receptacle via a tube. In some embodiments, a surgeon or other operator can fluidically couple the endoscopic tool to the sample receptacle.
[0371] In some embodiments, at 7320, the endoscopic tool is fluidly coupled to a vacuum source. For example, the endoscopic tool may include a vacuum port (e.g., a vacuum port positioned on a proximal connector of the endoscopic tool) that is configured to be fluidly coupled to the vacuum source via a tube. The tube can be coupled to the vacuum port, for example, by sliding the tube around the vacuum port to form a fluid seal, or by positioning the tube near the vacuum port and coupling the tube to the vacuum port using a coupling fitting or other device. In some embodiments, coupling the endoscopic tool to the vacuum source at the vacuum port fluidly couples a suction channel of the endoscopic tool (e.g., a suction channel extending from the vacuum port to an opening at the distal end of the endoscopic tool) to the vacuum source. In some embodiments, the endoscopic tool is fluidly coupled to the vacuum source via a sample receptacle that is configured to obtain a sample of material drawn through the suction channel from the opening at the distal end of the endoscopic tool to the vacuum port. For example, a tube can be fluidly coupled to a vacuum port and an inlet of a sample receiver (e.g., a first receiver port), and the tube can also be fluidly coupled between an outlet of the sample receiver (e.g., a second receiver port) and a vacuum source, such that a vacuum applied to the outlet of the sample receiver is applied through a suction channel that extends through the interior of the sample receiver through the endoscopic tool to an opening at the distal end of the endoscopic tool so as to draw a material sample through the opening into the sample receiver through the endoscopic tool. In some embodiments, the tube between the endoscopic tool and the sample receiver is coupled via a vacuum control device. The console can receive a vacuum control release command at a user interface, process the vacuum control release command, and actuate, release, or open the vacuum control device to allow the tube to be coupled via the vacuum control device. In some embodiments, a surgeon or other operator can fluidly couple the endoscopic tool to the vacuum source, for example, by fluidly coupling the tube from the vacuum port of the endoscopic tool to the sample receiver and fluidly coupling the tube from the sample receiver to the vacuum source.
[0372] In some embodiments, at 7330, the endoscopic tool is fluidically coupled to a fluid source. For example, the endoscopic tool can be fluidically coupled to a fluid transfer device, such as an irrigation pump, including a fluid transfer device included in the console. In some embodiments, a tube can be fluidically coupled between an irrigation port of the endoscopic tool (e.g., an irrigation port located on a proximal connector of the endoscopic tool) and the fluid transfer device. In some embodiments, fluidically coupling the fluid transfer device to the endoscopic tool fluidically couples the fluid transfer device to an irrigation channel that extends through the endoscopic tool from the irrigation port through the tube of the endoscopic tool to an opening at a distal end of the endoscopic tool so that irrigation fluid can be output at the distal end (e.g., at a site within a subject) by action of the fluid transfer device. In some embodiments, the console can receive a priming or flushing instruction at a user interface, process the instruction, and cause the fluid transfer device to prime or flush the fluid transfer device and / or prime or flush the irrigation channel. In some embodiments, a surgeon or other operator can fluidly couple the endoscopic tool to a fluid source such that fluid from the fluid source can pass through an irrigation channel defined by the endoscopic tool to the distal end of the cutting assembly.
[0373] In some embodiments, at 7340, an endoscopic tool is inserted into an instrument channel of the endoscope. For example, the endoscopic tool can be inserted into the instrument channel such that the distal end of the endoscopic tool is positioned at a site within the subject in order to interact with the site (e.g., to remove material, obtain a sample of the material, etc.). In other embodiments, the endoscopic tool is inserted into the instrument channel before coupling the endoscopic tool to the console. In some embodiments, a surgeon or other operator can insert the endoscopic tool into the instrument channel.
[0374] In some embodiments, at 7350, material to be resected is identified at a location within the subject. For example, image information (e.g., image information received from an image capture device of an instrument channel, etc.) can be used to determine the location of the material and / or the properties of the material. In some embodiments, the surgeon or operator can identify the material to be resected. In some embodiments, the surgeon or operator can move or orient a cutting window defined within an outer cannula of the endoscopic tool by rotating a rotary coupler located external to the subject. As described herein, the rotary coupler is configured to control the direction of the cutting window. In some embodiments, upon identifying the material to be resected, the surgeon or operator can orient the cutting window adjacent to the material to be resected such that when suction is applied to the endoscopic tool, the material is resected.
[0375] In some embodiments, at 7360, the operation of the endoscopic tool can be controlled. For example, commands can be received at the console for processing to control the endoscopic tool or other components operably coupled to the console. In some embodiments, the commands are received as user input at a user interface of the console. In some embodiments, the processing electronics of the console receive the user input from the user interface and process the input to determine how to control the operation of the endoscopic tool or other components. For example, one or more user inputs can be received (e.g., at a foot pedal) indicating instructions to perform an operation such as rotating the endoscopic tool, applying vacuum to the endoscopic tool (e.g., a suction channel of the endoscopic tool), and / or flowing irrigation fluid through the endoscopic tool for output by the endoscopic tool (e.g., flowing irrigation fluid through an irrigation channel of the endoscopic tool). The processing electronics can receive the user input and process the user input to determine the operation indicated by the input, so as to cause the operation to occur. For example, in response to receiving input indicating an instruction to rotate the endoscopic tool, the processing electronics can rotate a motor of the console to rotate the endoscopic tool. In some embodiments, the processing electronics can receive multiple user inputs and process the multiple user inputs to coordinate the operation of an endoscopic tool or other device. For example, the processing electronics can receive a first input indicating an instruction to rotate the endoscopic tool and a second input indicating an instruction to apply vacuum to the endoscopic tool (e.g., by controlling the operation of a vacuum control device), and control the operation of the vacuum control device based on whether the second input is received within a predetermined time of the first input. In some embodiments, controlling the operation of the endoscopic tool includes using the endoscopic tool to remove material from a site within a subject, including by rotating a cutting window at a distal end of the endoscopic tool relative to the material. In some embodiments, the operation of the endoscopic tool can be controlled by a surgeon or other operator, for example, by providing user input to a user interface.
[0376] In some embodiments, at 7370, a sample of the material is obtained. For example, after the material is removed, suction can be applied to the material via a suction channel of the endoscopic tool (e.g., by controlling the operation of a vacuum control device to apply suction from a vacuum source to the endoscopic tool) so that suction is applied at the opening of the endoscopic tool to draw the sample through the suction channel of the endoscopic tool. The sample can be drawn into a sample receptacle fluidically coupled to the suction channel, such as a sample receptacle configured to filter fluid exiting the endoscopic tool and entering the sample receptacle, so as to separate the sample from the remainder of the fluid. In some embodiments, the surgeon or other operator obtains the sample of the material by controlling the operation of a console to apply suction.
[0377] In some embodiments, at 7380, the sample is removed from the sample receiver. For example, the sample can be captured in the sample receiver and removed from the sample receiver. In some embodiments, removing the sample includes separating the sample receiver from the endoscopic tool. In some embodiments, removing the sample includes opening the sample receiver to access the sample. In some embodiments, the sample receiver is a disposable sample receiver, such that the entire sample receiver is removed as part of removing the sample. In some embodiments, the sample capture device (e.g., a filter) of the sample receiver is a disposable filter, such that the filter can be replaced when the sample receiver is reused. In some embodiments, a surgeon or other operator removes the sample.
[0378] In some embodiments, at 7390, the samples are cataloged. For example, the samples can be cataloged based on properties of the samples (e.g., chemical properties, medical properties, etc.) and / or based on the location of the site within the subject from which the samples were obtained. For example, the samples can be associated with different locations within the subject, such as different locations within the colon, larynx, lungs, or other areas of the subject. In some embodiments, the samples can be cataloged by a surgeon or other operator. In some embodiments, the samples are stored for transport and sent to a remote facility (e.g., a testing laboratory away from the operating room where the surgery to obtain the samples was performed) for cataloging or other analysis.
[0379] In some embodiments, at 7400, a determination is made as to whether more samples should be obtained. For example, more samples may be obtained based on whether more polyps, tumors, or other material has been identified for resection and / or analysis. More samples may be obtained based on preoperative planning or an intraoperative decision. In some embodiments, a surgeon or other operator may determine whether more samples should be obtained.
[0380] In some embodiments, if it is determined that more samples are to be obtained, then at step 7410, the sample receptacle is fluidly coupled to the endoscopic tool and the vacuum source so that the endoscopic tool can be controlled to obtain additional samples in the sample receptacle. In some embodiments, if the previous sample receptacle was a disposable sample receptacle, a new sample receptacle can be used. In some embodiments, if the previous sample receptacle included a disposable filter, the filter can be replaced. In some embodiments, the surgeon or other operator can fluidly couple the sample receptacle to the endoscopic tool and the vacuum source. The method can then return to step 7350, for example, to identify additional material to be removed. The endoscopic tool can be controlled to obtain additional samples as disclosed herein. For example, the endoscopic tool can be repositioned, rotated, or otherwise controlled to enable the acquisition of additional samples. In some embodiments, the surgeon or other operator can repeat the steps of the method, for example, by repeatedly controlling the endoscopic tool, etc.
[0381] In some embodiments, if it is determined that no further samples are to be obtained, the procedure can be ended at 7420. In some embodiments, ending the procedure includes decoupling the endoscopic tool from the console and / or from other components coupled to the endoscopic tool (e.g., a vacuum source, a sample receptacle, and / or a fluid transfer device). In some embodiments, the sample is not removed from the sample receptacle until the endoscopic tool is decoupled from the sample receptacle.
[0382] It should be understood that Figure 65 One or more steps of the method shown in do not have to be performed in the order shown. For example, step 7340 may be performed before steps 7310 to 7330.
Claims
1. A surgical console comprising: a drive assembly configured to be coupled to an endoscopic tool, the drive assembly configured to be rotated by a motor configured to rotate a drive element at a speed associated with rotation of the endoscopic tool; a vacuum interface configured to couple to the endoscopic tool to apply a vacuum to the endoscopic tool; a user interface configured to receive user input indicating an instruction to rotate the endoscopic tool while applying a vacuum to the endoscopic tool; as well as a control circuit configured to extract the instruction from the user input to control at least one of the drive assembly or the vacuum interface, the control circuit configured to cause the drive assembly to rotate the endoscopic tool while the vacuum interface applies a vacuum to the endoscopic tool in response to the user input indicating an instruction to rotate the endoscopic tool; Wherein the user interface includes a speed controller configured to receive an indication of a rotational speed of the endoscopic tool, and the control circuit is configured to cause the drive assembly to output a torque to the endoscopic tool corresponding to the rotational speed.
2. The surgical console of claim 1 , wherein the vacuum interface comprises a vacuum control configured to fluidly couple a tube to a vacuum port of the endoscopic tool and to at least one of a sample receiver or a vacuum source.
3. The surgical console of claim 2 , wherein the user interface comprises a vacuum control release configured to receive a vacuum control instruction, the vacuum control instruction configured to cause the vacuum control device to be actuated to one of an open position or a closed position, the vacuum control device configured to receive the tube in the open position, and the vacuum control device configured to engage with the tube in the closed position. 4 . The surgical console of claim 3 , wherein the vacuum control device is configured to be actuated to the open position for a predetermined amount of time and to automatically close after the predetermined amount of time.
5. The surgical console of claim 1 , wherein the user input is a first user input, wherein the instruction is a first instruction, and wherein the user interface is configured to receive a second user input indicating a second instruction to flow fluid through the endoscopic tool, and further comprising: a fluid delivery device configured to be coupled to the endoscopic tool to cause fluid to flow through the endoscopic tool, wherein the control circuit is further configured to extract the second instruction from the user input to control the fluid delivery device; as well as Wherein the user interface includes an irrigation input configured to cause at least one of irrigation or flushing of a tube coupled to the fluid transfer device and a flush port of the endoscopic tool. 6 . The surgical console of claim 1 , the drive assembly comprising a drive torque coil, wherein the drive torque coil is configured to expand or compress to compensate for an expansion force or a compression force associated with the torque.
7. The surgical console of claim 1, wherein the drive assembly includes an engagement receiver member configured to engage a drive shaft of the endoscopic tool.
8. The surgical console of claim 1, further comprising a bracket assembly configured to removably engage the sample receiver, the bracket assembly comprising a first receiving portion continuous with and offset from a second receiving portion.
9. The surgical console of claim 1 , further comprising an endoscope tool interface configured to receive a proximal connector of the endoscope tool, the endoscope tool interface comprising an engagement actuator configured to be in a first position and a second position, wherein The endoscope tool interface is configured to engage a proximal connector of the endoscope tool in the first position and to disengage from the proximal connector of the endoscope tool in the second position.
10. The surgical console of claim 5 , wherein the user interface is communicatively coupled to a first remote input device associated with control of the drive assembly and the fluid transfer device, and a second remote input device associated with control of the vacuum interface, and the control circuit is configured to control the vacuum interface based on receiving the second control instruction from the second remote input device if the second control instruction is received within a predetermined time after receiving the first control instruction from the first remote input device.
11. A method for operating a surgical console, comprising: receiving a user input at a user interface, the user input indicating an instruction to rotate an endoscopic tool using a drive assembly while applying a vacuum to the endoscopic tool using a vacuum interface, the drive assembly configured to be coupled to the endoscopic tool, the drive assembly configured to be rotated by a motor configured to rotate a drive element at a speed associated with rotation of the endoscopic tool, the vacuum interface configured to be coupled to the endoscopic tool to apply the vacuum to the endoscopic tool; extracting the instruction from the user input; as well as controlling at least one of the drive assembly or the vacuum interface based on the instructions, wherein controlling includes causing the drive assembly to rotate the endoscopic tool while causing the vacuum interface to apply a vacuum in response to user input indicating an instruction to rotate the endoscopic tool; Also included is receiving an indication of a rotational speed of the endoscopic tool at a speed controller of the user interface; The drive assembly is caused to output a torque to the endoscopic tool based on the speed.
12. The method of claim 11, further comprising fluidly coupling a vacuum control of the vacuum interface to a vacuum port of the endoscopic tool and to at least one of a sample receptacle or a vacuum source.
13. The method of claim 12, further comprising receiving a vacuum control command at a vacuum control release of the user interface and causing the vacuum control device to be actuated to one of an open position or a closed position, wherein The vacuum control device is configured to receive a tube in the open position and is configured to engage the tube in the closed position.
14. The method of claim 13, wherein actuating the vacuum control device to the open position comprises actuating the vacuum control device to the open position for a predetermined amount of time and automatically closing the vacuum control device after the predetermined amount of time.
15. The method of claim 11, wherein the user input is a first user input, wherein the instruction is a first instruction, and further comprising: receiving, at the user interface, a second user input indicating a second instruction to flow a fluid through the endoscopic tool using a fluid delivery device configured to be coupled to the endoscopic tool; controlling the fluid transfer device based on the second instruction, wherein controlling includes causing the drive assembly to rotate the endoscopic tool while causing the vacuum interface to apply a vacuum in response to user input of the second instruction instructing to rotate the endoscopic tool; as well as A priming instruction is received at a priming input of the user interface, and based on the priming instruction, at least one of priming or flushing a tubing coupled to the fluid transfer device and a flush port of the endoscopic tool is enabled.
16. The method according to claim 11, further comprising: A drive torque coil of the drive assembly is expanded or compressed to compensate for an expansion force or a compression force associated with the torque.
17. The method of claim 11, further comprising engaging a drive shaft of the endoscopic tool via an engagement receiver member of the drive assembly.
18. The method according to claim 11, further comprising: receiving a proximal connector of the endoscopic tool at an endoscopic tool interface; positioning an engagement actuator of the endoscope tool interface in a first position to engage the endoscope tool interface to a proximal connector of the endoscope tool; as well as Positioning the engagement actuator in a second position disengages the endoscope tool interface from the proximal connector of the endoscope tool.
19. The method of claim 15 further comprising receiving a first control instruction from a first remote input device associated with control of the drive assembly and the fluid transfer device, receiving a second control instruction from a second remote input device associated with control of the vacuum interface, and causing the vacuum interface to apply vacuum to the endoscopic tool if the second control instruction is received within a predetermined time after the first control instruction.
Citation Information
Patent Citations
Insertable endoscopic instrument for tissue removal
US10265055B2
Surgical cutting device and method for performing surgery
US20110087260A1
Endoscopic tool for debriding and removing polyps
US20130144186A1
Insertable Endoscopic Instrument For Tissue Removal
US20140249448A1
Vacuum rotary dissector
US3618611A