Endoscope assembly, and operation-assisting device for tool for treatment or surgery

Abstract

An endoscope assembly (10) is for assisting the operation of a tool for treatment or surgery, and comprises: an imaging element (11); and a shaft (13) that accommodates the imaging element (11) or is connected to the imaging element (11). The endoscope assembly also comprises: a handle (14) that extends by expanding from the shaft (13); and an attachment piece (15) for the tool for treatment or surgery which is attached to the shaft (13).

Description

Endoscope assembly and device for assisting in the operation of treatment or surgical instruments

[0001] The present invention relates to an endoscope assembly for assisting in the manipulation of procedural or surgical instruments.

[0002] Conventional ear surgery involves creating a bone resection site 102 in the ear bone 101 so that the affected area 100 can be seen, and then performing surgery while observing the affected area 100 through a microscope 103 by irradiating it with light 104 (reference numeral 105 denotes the auricle) under a microscope (Fig. 1(A), 1953-Wullstein). This method is invasive because it requires the creation of the bone resection site 102, and there is a problem in that blind spots are easily created when the bone resection site 102 is made smaller to reduce invasiveness.

[0003] Endoscopic surgery, which has the major advantage of being minimally invasive, has been developing dramatically in recent years. Transcanal endoscopic ear surgery (Fig. 1(B), 1998 - Tarabichi), in which an endoscope 107 is inserted into the ear canal 106, an affected area 109 is irradiated from the tip 108 of the endoscope 107, and surgery is performed while observing through the endoscope 107, has only recently become possible.

[0004] Recently, Yamauchi et al., the inventors of the present application, have developed underwater endoscopic ear surgery, in which the area around the affected area is filled with water or an aqueous solution 110 and surgery is performed underwater while observing the area through an endoscope 111 (Fig. 1(C), 2014-Yamauchi, Patent Document 1).

[0005] However, because the access space required for endoscopic surgery is extremely narrow, one-handed surgery is typically performed, in which the surgeon holds the endoscope 112 in one hand and performs the surgical procedure with the dominant hand (Figure 2(A)). While one-handed surgery provides a good field of view, it requires training in surgical procedures, resulting in a steep learning curve. Furthermore, otologic surgery involves suction, grasping, traction, dissection, resection, facial nerve stimulation, and electrocoagulation to remove lesions. These procedures are used to reconstruct the eardrum and conduction, but performing all of these procedures with one hand is not easy.

[0006] It is possible to fix the endoscope 112 with a commercially available endoscope fixator 114 and perform two-handed surgery (Fig. 2B), but fixing the endoscope 112 fixes the field of view and prevents free movement, making it difficult to grasp the three-dimensional effect. Furthermore, there are problems such as the surgical field becoming blurred when the patient moves, making observation difficult, and the fixator being expensive.

[0007] There is also a three-handed surgery method in which the assistant holds the endoscope 112 and the surgeon performs the surgery using both hands (Fig. 2(C)), but this method is difficult to master, requires teamwork, and is not always easy to perform. Furthermore, three-handed surgery cannot be performed in all surgical steps because the hands get in the way in the narrow parts of the ear canal.

[0008] WO2017 / 171085

[0009] An object of the present invention is to provide an endoscope that allows a long working instrument, such as a treatment or surgical instrument, to be operated by the hand holding the endoscope.

[0010] The present invention encompasses the following embodiments. Item 1. An endoscope assembly for assisting in the operation of a treatment or surgical instrument comprising an imaging element and a shaft that houses the imaging element or is connected to the imaging element, the endoscope assembly comprising: a handle portion that extends and expands from the shaft; and an attachment for the treatment or surgical instrument attached to the shaft. Item 2. The endoscope assembly according to item 1, wherein the attachment is located closer to the tip of the shaft than the handle portion. Item 3. The endoscope assembly according to item 1, in which a treatment or surgical instrument is attached to the attachment. Item 4. The endoscope assembly according to item 3, in which the treatment or surgical instrument is a stick-shaped instrument having an operating handle.

[0011] Item 5. The endoscope assembly according to any one of items 1 to 4, wherein the shaft comprises a distal shaft portion and a proximal shaft portion, the distal shaft portion being rotatable relative to the proximal shaft portion. Item 6. The endoscope assembly according to item 5, wherein the distal shaft portion and the proximal shaft portion are connected by a flexible connecting member. Item 7. The endoscope assembly according to item 5, further comprising a traction member having a proximal end fixed to the distal shaft portion and a distal end extending outward from the proximal shaft portion, wherein the distal shaft portion is bent by pulling back the traction member toward the proximal end. Item 8. The endoscope assembly according to any one of items 1 to 4, wherein the shaft comprises a distal shaft portion, a proximal shaft portion, and a substantially tubular member attached to the outer circumferential surface of the proximal shaft portion and rotatable relative to the proximal shaft portion, and wherein the attachment for the treatment or surgical instrument is attached to the substantially tubular member.

[0012] Item 9. The endoscope assembly according to any one of Items 1 to 4, wherein the shaft comprises a distal shaft portion and a proximal shaft portion, the handle portion being attached to the outer periphery of the proximal shaft portion along a portion of the longitudinal direction of the proximal shaft portion, and the endoscope assembly comprises: a traction member having a proximal end fixed to the distal shaft portion, extending through the outside or inner cavity of each of the distal shaft portion and the proximal shaft portion and terminating on the proximal side of the proximal shaft portion, and a mechanism extending through the handle portion from the outside of the handle portion to the inside of the handle portion for selectively advancing or retracting the traction member. Item 10. The endoscope assembly according to any one of Items 1 to 4, wherein the imaging element is housed inside the shaft. Item 11. The endoscope assembly according to any one of Items 1 to 4, wherein the imaging element is connected to the proximal end of the shaft. Item 12. An operation support device for a treatment or surgical instrument that is used by connecting to an endoscope having an imaging device, the operation support device for a treatment or surgical instrument comprising: a shaft that allows the imaging device to capture an image of a subject through the tip, the shaft comprising: a handle portion that extends from the shaft; and an attachment for the treatment or surgical instrument attached to the shaft.

[0013] According to the present invention, the surgeon can perform surgical operations with both hands while obtaining a good field of view in accordance with the patient's movements, thereby improving the operability of the surgery.

[0014] (A) Explanatory diagram of microsurgical surgery, (B) transcanal endoscopic ear surgery, and (C) underwater endoscopic ear surgery. (Quoted from URL: http: / / kompas.hosp.keio.ac.jp / sp / contents / medical_info_presentation_201708.html) Explanatory diagram of (A) one-hand surgery, (B) two-hand surgery, and (C) three-hand surgery. (Quoted from URL: http: / / kompas.hosp.keio.ac.jp / sp / contents / medical_info_presentation_201708.html) Perspective view of the endoscope assembly of the first embodiment. Application of the endoscope assembly of Figure 3 in transcanal endoscopic ear surgery (TEES). Perspective view of the endoscope assembly of the second embodiment. Schematic diagram of the endoscope assembly of Figure 5 held in the left hand. Explanatory diagram of an attachment. Perspective view of the endoscope assembly of the third embodiment. 12. (A) and (B) Transmastoid superior semicircular canal closure, one-handed operation in FIG. 2(A). (A) and (B) Transmastoid superior semicircular canal closure, two-handed operation when using the endoscope assembly of the fourth embodiment.

[0015]

[0023] Hereinafter, specific embodiments of the present invention will be described with reference to the drawings. (First Embodiment) Fig. 3 is a perspective view of an endoscope assembly 10 for assisting the operation of a treatment or surgical instrument according to the first embodiment. The endoscope assembly 10 includes a CMOS (Complementary Metal Oxide Semiconductor) image sensor 11 constituting an imaging element, and a substantially cylindrical shaft 13 that houses the CMOS image sensor 11.

[0016] An optical fiber (not shown) extends longitudinally inside the shaft 13, and illumination light from a light source (not shown) such as an LED is guided from the proximal end to the distal end by the optical fiber (not shown) optically connected to the light source (not shown), thereby illuminating the subject. The configuration of such an endoscope optical system is known.

[0017] An objective lens (not shown) is built into the tip of the shaft 13, and light from the subject passes through the objective lens (not shown) at the optically transparent tip 13a of the shaft 13 and forms an image on the CMOS image sensor 11. The image of the subject captured by the CMOS image sensor 11 is transmitted to a signal cable 12 connected to the CMOS image sensor 11 and subjected to signal processing. The signal cable 12 is connected to a computer, and the image of the subject can be observed on a display device connected to the computer. The signal cable 12 can protrude outside the shaft 13 at the side of the shaft 13.

[0018] The endoscope assembly 10 further includes a handle portion 14 extending from the shaft 13. The handle portion 14 extending from the shaft 13 refers to the handle portion 14 extending beyond the diameter and / or length of the shaft 13. The handle portion 14 may be detachable from the shaft 13 using a screw or the like, thereby allowing the handle portion 14 to be changed depending on the type of surgery, the surgeon's hand size, and preferences. Specifically, in FIG. 3 , the distal end of the handle portion 14 is attached to the proximal end of the substantially cylindrical side surface of the shaft 13, and the handle portion 14 extends from the distal end to the proximal end at an angle relative to the axis of the shaft 13. The handle portion 14 extends radially outward from the shaft 13 beyond the diameter of the shaft 13 and extends further proximally than the proximal end of the shaft 13. Since the handle portion 14 extends radially outward beyond the diameter of the shaft 13, there is space on the proximal side of the shaft 13, which makes it less likely to interfere with the second treatment or surgical instrument 18 operated by the operator with the other hand.

[0019] The material constituting the shaft 13 and the handle portion 14 is not limited, and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resin includes thermoplastic resin, thermosetting resin, elastomer, and rubber. For example, it is preferable from the standpoint of ease of manufacture and operability if the shaft 13 and the handle portion 14 are integrally molded from synthetic resin.

[0020] The endoscope assembly 10 further includes a mounting fixture 15 for a treatment or surgical instrument 16 attached to the shaft 13. The mounting fixture 15 includes a holding portion 15a for holding or gripping the treatment or surgical instrument 16, a fixing portion 15b for fixedly attaching the mounting fixture 15 to the side surface of the shaft 13, and a connecting portion 15c for connecting the holding portion 15a and the fixing portion 15b.

[0021] In this embodiment, the holding portion 15a is an elongated member having a generally U-shaped cross section, and holds or clamps the first elongated portion 16b of the treatment or surgical instrument 16 so that the first elongated portion 16b can move back and forth in its longitudinal direction and can be attached to or detached from the holding portion 15a. The material constituting the holding portion 15a is not limited, and may be metal, synthetic resin, a composite material containing at least one of these, or the like. For example, the holding portion 15a may be formed from synthetic resin, and the first elongated portion 16b may be snap-fit ​​into the holding portion 15a using the elasticity of the holding portion 15a.

[0022] In this embodiment, the fixing portion 15b has a substantially frustum shape, but is not particularly limited to this shape as long as it can be fixed to the side surface of the shaft 13. Fixing the fixing portion 15b to the side surface of the shaft 13 can be performed by any fixing joining method, such as bonding with an adhesive or welding. The material constituting the fixing portion 15b is not limited, and may be metal, synthetic resin, or a composite material containing at least one of them. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubbers.

[0023] To improve the mobility and operability of the treatment or surgical instrument 16 attached to the holding portion 15a, the connecting portion 15c is preferably an elastic member such as a spring, particularly a metal leaf spring, or a flexible member. The method of connecting the holding portion 15a and the fixing portion 15b to the connecting portion 15c is not particularly limited and may be any known method. The material constituting the fixing portion 15c is not limited and may be metal, synthetic resin, a composite material containing at least one of these, or the like. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubbers.

[0024] The treatment or surgical instrument 16 includes a distal end 16a, a first elongated portion 16b extending continuously from the distal end 16a at an angle to the distal end 16a, a second elongated portion 16c extending continuously from the distal end 16a at an angle to the first elongated portion 16b, and an operating handle 16d attached to the proximal end of the second elongated portion 16c. The operating handle 16d has a larger diameter than the first and second elongated portions 16a and 16b to facilitate gripping by an operator (also referred to as a surgeon). In this embodiment, the operating handle 16d is generally spherical, but may have any other shape that is easy for the operator to grip. The operating handle 16d may be made of any material, including metal, synthetic resin, or a composite material containing at least one of these. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber.

[0025] In this embodiment, a dissector is used as an example of the treatment or surgical instrument 16. However, other treatment or surgical instruments capable of performing treatments such as dissection, extraction, cutting, crushing, and hemostasis may also be used. The treatment or surgical instrument is preferably a rod- or stick-shaped instrument having a long portion that can be attached to the attachment 15. Examples of such treatment or surgical instruments include, but are not limited to, biopsy forceps, snares, hemostatic clips, knives, ultrasonic instruments (used for tissue incision, tissue dissection, tissue crushing, and / or emulsification of biological samples), high-frequency energy supply instruments, laser devices, and irrigation devices that supply irrigation fluid during underwater endoscopic otological surgery. Note that the distal end 16 a of the treatment or surgical instrument 16 may be detachable from the first long portion 16 b. However, even when the attachment 15 holds a portion of the treatment or surgical instrument 16, the attachment 15 is still considered to hold the treatment or surgical instrument 16.

[0026] The attachment 15 is located closer to the distal end of the shaft 13 than the handle portion 14. Preferably, the range of motion of the handle portion 14 does not overlap with the range of motion of the treatment or surgical instrument 16 so that the handle portion 14 does not interfere with the operation of the treatment or surgical instrument 16 by the operator.

[0027] Next, the operation of the endoscope assembly 10 will be described. First, the treatment or surgical instrument 16 is attached to the holding portion 15a of the attachment 15. Next, the operator grasps the distal end of the shaft 13 of the endoscope assembly 10 and the operating handle 16d of the treatment or surgical instrument 16, and inserts the treatment or surgical instrument 16 and shaft 13, tip first, into the body cavity of the subject. Figure 4 is a schematic diagram of the endoscope assembly 10 of this embodiment inserted into the ear canal 1 during transcanal endoscopic ear surgery (TEES), as an example. The tympanic membrane 3, semicircular canals 4, and cochlea 5 are shown. A light source (not shown) within the endoscope assembly 10 illuminates the affected area around the tympanic membrane 3, and an image of the affected area is captured by the CMOS image sensor 11. If the operator wishes to change the position of the affected area to be imaged, the operator can change the position of the affected area by manipulating the handle portion 14 with the fingers of the left hand (index finger, middle finger, ring finger, etc.) and changing the position of the shaft 13. Furthermore, the operator can grasp and operate the operating handle 16d of the treatment or surgical instrument 16, separately from operating the handle portion 14, to perform treatments such as incision, dissection, and suction on the eardrum 3 or its vicinity using the distal end 16a of the treatment or surgical instrument 16. Furthermore, the operator can operate another treatment or surgical instrument 18 with their right hand to perform treatment, separate from the operation with their left hand. When the treatment on the patient is finished, the operator grasps the distal end of the shaft 13 of the endoscope assembly 10 and the operating handle 16d of the treatment or surgical instrument 16, pulls back the shaft 13 and the treatment or surgical instrument 16, and removes the endoscope assembly 10 from the subject's body cavity.

[0028] The effects of the endoscope assembly 10 for assisting in the operation of a treatment or surgical instrument according to the first embodiment will now be described. The surgeon can operate the endoscope and the treatment or surgical instrument with the same hand. The surgeon can operate a treatment or surgical instrument with the hand holding the endoscope, and can operate another treatment or surgical instrument with the other hand, enabling two-handed operation by the surgeon. Suction, grasping, traction, dissection, and other procedures can be performed with both hands. Alternatively, other operations can be performed with both hands. (For example, in stapedial hand surgery, when inserting a piston while holding down the incus to prevent dislocation at the malleus-incus joint.)

[0029] The endoscope assembly 10 for assisting in the operation of a treatment or surgical instrument according to the first embodiment can be modified as follows: In the first embodiment, a CMOS image sensor 11 is used as the imaging element, but other imaging elements may be used. While FIG. 4 illustrates the application of the endoscope assembly 10 to transcanal endoscopic ear surgery (TEES), the endoscope assembly 10 can also be applied to underwater endoscopic ear surgery (UWEES), as described in Patent Document 1. In the above description, a right-handed operator uses the endoscope assembly 10 with his left hand, but the endoscope assembly 10 can also be used with his right hand by rotating the endoscope assembly 10 180 degrees around the axis of the shaft 13.

[0030] Second Embodiment Next, an endoscope assembly 20 for assisting the operation of a treatment or surgical instrument according to a second embodiment of the present invention will be described. Descriptions of members corresponding to those in the first embodiment of the present invention will be omitted.

[0031] 5 is a perspective view of an endoscope assembly 20 for assisting in the operation of a treatment or surgical instrument according to a second embodiment. The endoscope assembly 20 includes a CCD camera 21 equipped with a CCD (Charged Coupled Device) that serves as an imaging element, and a substantially cylindrical shaft 23 connected to the CCD camera 21. The shaft 23 is connected to the CCD camera 21 at its proximal end. In this embodiment, the shaft 23 includes a hollow, substantially cylindrical distal shaft portion 23a and a hollow, substantially cylindrical proximal shaft portion 23b, and the distal shaft portion 23a is rotatable relative to the proximal shaft portion 23b.

[0032] An optical fiber (not shown) extends longitudinally inside the shaft 23, and the optical fiber (not shown) guides illumination light from a light source (not shown), such as an LED, connected to the base end of the optical fiber (not shown) from the base end to the tip, illuminating the subject.

[0033] A lens (not shown) is built into the tip of the shaft 23, and light from the subject passes through the optically transparent tip of the shaft 23, an objective lens (not shown), an optical fiber, a GRIN (gradient refractive index) lens or other eyepiece, and forms an image on the CCD camera 21. The image of the subject captured by the CCD 21 is transmitted to a signal cable 22 and processed as a signal. The signal cable 22 is connected to a computer, and the image of the subject can be observed on a display device connected to the computer. The field of view is preferably 4K or more.

[0034] The endoscope assembly 20 further includes a handle portion 24 extending from the shaft 23. Specifically, the handle portion 24 extends radially outward along the longitudinal direction of the shaft 23 from a single circumferential point on the side surface of the shaft 23 beyond the diameter of the shaft 23. The handle portion 24 includes two curved protrusions 24a and 24b, and a recess 24c is formed between the two protrusions 24a and 24b. In this embodiment, the protrusion 24b protrudes more in a direction perpendicular to the longitudinal axis of the shaft 23 than the protrusion 24a. The handle portion 24 has a continuous curved surface except for the joint with the shaft 23, and has an ergonomic shape that fits the surgeon's hand better and reduces surgeon fatigue. Specifically, as shown in Figure 6, when using the endoscope assembly 20, the handle portion 24 is held between the thumb and index finger of the surgeon's hand 6, and the protrusions 24a and 24b are placed on both sides of the interdigital web between the thumb and index finger, and the handle portion 24 is grasped so that the surface defining the recess 24c between the two protrusions 24a and 24b comes into contact with the interdigital web.

[0035] The material constituting the shaft 23 and the handle portion 24 is not limited, and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resin includes thermoplastic resin, thermosetting resin, elastomer, and rubber. For example, the shaft 23 and the handle portion 24 may each be molded from a synthetic resin. The shaft 23 and the handle portion 24 can be joined by any fixed joining method, such as bonding with an adhesive or welding.

[0036] The endoscope assembly 20 further includes a mounting fixture 25 for a treatment or surgical instrument 26 attached to the distal shaft portion 23a of the shaft 23. In this embodiment, the mounting fixture 25 is a fastener, and as shown in Fig. 7, is a single member having two substantially parallel flat plate portions 25a, 25b and a vertical flat plate portion 25c that is continuous with the two substantially parallel flat plate portions 25a, 25b and extends substantially perpendicular to the two substantially parallel flat plate portions 25a, 25b. Two parallel wide surfaces 25d, 25e on the opposite sides of the two substantially parallel flat plate portions 25a, 25b from the surfaces that face each other constitute the outer surface of the mounting fixture 25, and the treatment or surgical instrument 26 is attached to one of the wide surfaces 25d, 25e, and the other wide surface 25d, 25e is attached to the substantially cylindrical side surface of the shaft. In other words, one of the wide surfaces 25d, 25e of the attachment 25 holds the treatment or surgical instrument 26, and the other of the wide surfaces 25d, 25e is fixedly attached to the substantially cylindrical side surface of the shaft. The material constituting the attachment 25 is not limited, and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubbers.

[0037] The treatment or surgical instrument 26 has a distal end 26a, a main elongated portion 26b extending continuously from the distal end 26a at an angle to the distal end 26a, and an operating handle 26c attached to the proximal end of the elongated portion 26b. The operating handle 26c has a larger diameter than the elongated portion 26b to make it easier for the operator (also referred to as a surgeon) to grasp. In this embodiment, the operating handle 26c is formed in the shape of an inverted triangular plate with rounded corners on the wide surface so that the operator can easily grasp it with three fingers. However, the operating handle 26c may have any other shape that is easy for the operator to grasp with three fingers, such as a plate with a substantially semicircular wide surface. The material of the operating handle 26c is not limited and may be metal, synthetic resin, a composite material containing at least one of these, or the like. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber.

[0038] The attachment 25 is located closer to the distal end of the shaft 23 than the handle portion 24. Preferably, the handle portion 24 extends radially outward from a position different from the attachment 25 in the circumferential direction of the shaft 23, specifically from a position approximately 180° circumferentially from the attachment 25, so as not to interfere with the range of motion of the treatment or surgical instrument 26 when the operator operates the treatment or surgical instrument 26.

[0039] The size of each component of the endoscope assembly 20 can be selected appropriately depending on the application. For example, when used in transcanal endoscopic otological surgery, the smaller the inner diameter of the shaft, the better, e.g., 2.7 mm or less. The length L1 of the portion of the treatment or surgical instrument 26 distal to the attachment tool 25 is preferably approximately 5 mm to approximately 15 mm. The length L2 of the portion of the treatment or surgical instrument 26 proximal to the attachment tool 25 is preferably approximately 70 mm to approximately 100 mm. The length from the tip of the distal shaft portion 23a to the position of the proximal shaft 23b where the handle portion 24 is attached is preferably approximately 50 mm to approximately 60 mm. The length of the handle portion 24 is preferably approximately 40 mm to 50 mm. Length L2 is set longer than length L1, which facilitates fine manipulation of the tip of the treatment or surgical instrument 26 using the "leverage principle." The dimensions of each part of the endoscope assembly 20 when used for transcanal endoscopic ear surgery have been described above, but it goes without saying that the operator can change the dimensions as appropriate when applying the endoscope assembly 20 for purposes other than ear surgery (such as surgery on other organs).

[0040] Next, the operation of the endoscope assembly 20 will be described. First, the treatment or surgical instrument 26 is fixedly attached to the attachment 25 in advance. Next, the operator grasps the proximal end of the shaft 23 of the endoscope assembly 20 and the operating handle 26c of the treatment or surgical instrument 26, and inserts the treatment or surgical instrument 26 and the shaft 23, tip first, into the body cavity of the subject. If the operator wishes to change the position of the affected area to be imaged, the operator can change the position of the affected area to be imaged by manipulating the handle portion 24 with the fingers of the left hand (index finger, middle finger, ring finger, etc.) and changing the position of the shaft 23. In this embodiment, the distal shaft portion 23a of the shaft 23 is rotatable relative to the proximal shaft portion 23b, and the treatment or surgical instrument 26 is fixed to the attachment 25. Therefore, when the surgeon rotates the operating handle 26c of the treatment or surgical instrument 26 in the circumferential direction of the distal shaft portion 23a, only the distal shaft portion 23a rotates in the circumferential direction independently of the proximal shaft portion 23b, allowing the treatment or surgical instrument 26 to be freely moved to any position in the circumferential direction of the longitudinal axis of the distal shaft portion 23a (and the shaft 23). Furthermore, the operator can operate the treatment or surgical instrument 26 separately from operating the handle portion 24. For example, the distal end 26a of the treatment or surgical instrument 26 can be used to perform treatments such as suction, grasping, traction, dissection, and cutting by gripping and operating the operating handle 26c with the thumb, index finger, and middle finger like chopsticks, or by moving it with only the index finger. Furthermore, in addition to the operation with the left hand, the operator can operate a second treatment or surgical instrument other than the treatment or surgical instrument 26 with the right hand to perform treatment. When treatment on the patient is completed, the operator pulls the endoscope assembly 20 back in the proximal direction while still holding the handle portion 24 between the thumb and index finger, and removes the endoscope assembly 20 from the body cavity of the subject.

[0041] The effects of the endoscope assembly 20 for assisting in the operation of a treatment or surgical instrument of the second embodiment will be described below. The surgeon can operate the endoscope and the treatment or surgical instrument with the same hand. The surgeon can operate a treatment or surgical instrument with the hand holding the endoscope, and can operate another treatment or surgical instrument with the other hand, allowing for two-handed operation by the surgeon. Procedures such as suction, grasping, traction, dissection, and cutting can be performed with both hands. Alternatively, other operations can be performed with both hands.

[0042] The shaft 23 is made up of two members, a distal shaft portion 23a and a proximal shaft portion 23b, and the attachment 25 is fixed to the distal shaft portion 23. Therefore, when the surgeon rotates the operating handle 26c of the treatment or surgical instrument 26 in the circumferential direction of the distal shaft portion 23a, the treatment or surgical instrument 26 can be freely moved to any position in the circumferential direction of the longitudinal axis of the distal shaft portion 23a (and the shaft 23). The treatment or surgical instrument 26 is designed to facilitate delicate surgical operations by manipulating the operating handle portion 26c at hand and by using a leverage ratio at the tip of the treatment or surgical instrument 26.

[0043] The endoscope assembly 20 for assisting in the operation of a surgical instrument according to the second embodiment can be modified as follows: A water flow mechanism that causes water to flow from the base end of the distal shaft portion 23a to the tip may be provided in the annular cross-sectional area between the distal shaft portion 23a and the cylindrical region inside the distal shaft portion 23a that houses the lens and optical fiber.

[0044] Third Embodiment Next, an endoscope assembly 30 for assisting the operation of a treatment or surgical instrument according to a third embodiment of the present invention will be described. Descriptions of members corresponding to those in the first embodiment of the present invention will be omitted.

[0045] 8 is a perspective view of an endoscope assembly 30 for assisting in the operation of a treatment or surgical instrument according to a third embodiment. The endoscope assembly 30 includes a CMOS image sensor 31 constituting an imaging element and a substantially cylindrical shaft 33. The shaft 33 includes a hollow, substantially cylindrical distal shaft portion 33a that houses the CMOS image sensor 31, and a proximal shaft portion 33b. The distal shaft portion 33a and the proximal shaft portion 33b are connected by a flexible connecting member 33c, and the distal shaft portion 33a is rotatable relative to the proximal shaft portion 33b. The proximal and distal ends of the distal shaft portion 33a and the proximal shaft portion 33b are sealed to prevent water from entering the interiors of the distal shaft portion 33a and the proximal shaft portion 33b.

[0046] An optical fiber (not shown) extends longitudinally inside the shaft 33, and illumination light from a light source (not shown) such as an LED is guided from the proximal end to the distal end by the optical fiber (not shown) optically connected to the light source (not shown), thereby illuminating the subject. The configuration of such an endoscope optical system is known.

[0047] An objective lens (not shown) is built into the tip of the shaft 33, and light from the subject passes through the objective lens (not shown) at the light-transmitting tip of the distal shaft portion 33a of the shaft 33, and forms an image on the CMOS image sensor 31. The image of the subject captured by the CMOS image sensor 31 is transmitted to a signal cable 32 and processed as a signal. The signal cable 32 is connected to a computer, and the image of the subject can be observed on a display device connected to the computer.

[0048] The endoscope assembly 30 further includes a handle portion 34 extending from the shaft 33 (and the proximal shaft portion 33b). Specifically, the handle portion 34 extends radially outward from the shaft 33 (and the proximal shaft portion 33b) beyond the diameter of the shaft 33 (and the proximal shaft portion 33b), and also extends beyond the proximal end of the shaft 33 (and the proximal shaft portion 33b). The handle portion 34 includes two protruding portions 34a, 34b having curved surfaces, and a recess 34c is formed between the two protruding portions 34a, 34b. In addition, a substantially cylindrical hole 34d is provided at the tip of the handle portion 34, and the proximal end of the proximal shaft portion 33b is fitted into the hole 34d. The handle portion 34 has a continuous curved surface except for the joint with the shaft 33, and is ergonomically designed to fit the surgeon's hand better and reduce fatigue. Specifically, as shown in Fig. 9, when using the endoscope assembly 30, the surgeon holds the handle portion 34 between the thumb and index finger of the surgeon's hand 6, with the protrusions 34a and 34b positioned on either side of the interdigital web between the thumb and index finger, and grips the handle portion 34 so that the surface defining the recess 34c between the two protrusions 34a and 34b comes into contact with the interdigital web.

[0049] The materials constituting the shaft 33 (i.e., the distal shaft portion 33a, the proximal shaft portion 33b, and the connecting member 33c) and the handle portion 34 are not limited, and may be metal, synthetic resin, a composite material containing at least one of them, or the like. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber. For example, the shaft 33 and the handle portion 34 may each be molded products of synthetic resin. The shaft 33 and the handle portion 34 can be joined by any fixed joining method, such as bonding with an adhesive or welding.

[0050] The endoscope assembly 30 further includes a mounting fixture 35 for a treatment or surgical instrument 36 attached to the distal shaft portion 33a of the shaft 33. In this embodiment, the mounting fixture 35 includes a first loop 35a that surrounds the periphery of the elongated portion 36a of the treatment or surgical instrument 36 at a predetermined position along the longitudinal direction of the elongated portion 36a, and a second loop 35b that is connected to the first loop 35a and surrounds the periphery of the distal shaft portion 33a at a predetermined position along the longitudinal direction of the distal shaft portion 33a. The first loop 35a of the mounting fixture 35 holds the treatment or surgical instrument 36, and the second loop 35b is fixedly attached to the distal shaft 33a of the shaft 33.

[0051] Even when constrained by the first loop 35a, the treatment or surgical instrument 36 has a small range of motion that allows the tip of the treatment or surgical instrument 36 to draw a circle. The material constituting the attachment 35 is not limited and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubbers.

[0052] The treatment or surgical instrument 36 has a long portion 36a and an operating handle 36b attached to the proximal end of the long portion 36a. The long portion 36a is made of a flexible material and is bendable. The operating handle 36b has a larger diameter than the long portion 36b to make it easier for the operator to grip. In this embodiment, the operating handle 36b is formed in the shape of an inverted triangular plate with rounded corners on the wide surface so that the operator can easily grip it with three fingers. However, the operating handle 36b may have any other shape that is easy for the operator to grip with three fingers, such as a plate with a substantially semicircular wide surface. The material of the operating handle 36b is not limited and may be metal, synthetic resin, a composite material containing at least one of these, or the like. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber.

[0053] The attachment tool 35 is located closer to the distal end of the shaft 33 (and distal shaft portion 33a) than the handle portion 34. Preferably, the handle portion 34 extends radially outward from a position different from the attachment tool 35 in the circumferential direction of the shaft 33, specifically from a position approximately 180° circumferentially from the attachment tool 35, so as not to interfere with the range of motion of the treatment or surgical instrument 36 when the operator operates the treatment or surgical instrument 36.

[0054] As shown in FIG. 9 , the endoscope assembly 30 also includes a string-like traction member 38. The distal end of the traction member 38 is fixed to the distal shaft portion 33a, and the proximal end extends outward from the proximal shaft portion 33b and terminates proximally relative to the proximal end of the proximal shaft portion 33b. The traction member 38 is, for example, a wire. A portion of the traction member 38 passes through the exterior or inner cavity of each of the distal shaft portion 33a and the proximal shaft portion 33b. The traction member 38 may extend through the outside of the distal shaft portion 33a and the outside of the proximal shaft portion 33b, or through the inner cavity of the distal shaft portion 33a and the outside of the proximal shaft portion 33b, or through the outside of the distal shaft portion 33a and the inner cavity of the proximal shaft portion 33b, or through the inner cavity of the distal shaft portion 33a and the inner cavity of the proximal shaft portion 33b.

[0055] The size of each component of the endoscope assembly 30 can be selected appropriately depending on the application. For example, when used in transcanal endoscopic surgery, the smaller the inner diameter of the shaft, the better, for example, 2.7 mm or less. The length of the portion of the treatment or surgical instrument 36 distal to the point where it is attached to the attachment tool 35 is preferably about 5 mm to about 15 mm. The distance L3 from the tip of the distal shaft portion 33a to the tip of the treatment or surgical instrument 36 is preferably about 5 mm to about 15 mm.

[0056] The length of the portion of the treatment or surgical instrument 36 on the proximal side from the point where it is attached to the attachment tool 35 is preferably about 70 to about 100 mm. The length from the tip of the distal shaft portion 33a to the position on the proximal shaft 33b where the handle portion 34 is attached is preferably about 50 to about 60 mm. The length of the handle portion 34 is preferably about 40 to 50 mm.

[0057] 9, the ear canal length L4 is approximately 25 to 30 mm, the ear canal diameter L5 is 5 to 9 mm, the length L6 is 5 to 8 mm, and the length L7 is 5 to 10 mm. When the endoscope assembly 30 is used for endoscopic ear canal surgery, the endoscope assembly 30 may be designed to fit this anatomical structure.

[0058] Next, the operation of the endoscope assembly 30 will be described. First, the treatment or surgical instrument 36 is fixedly attached to the attachment 35. Next, the operator grasps the proximal end of the shaft 33 of the endoscope assembly 30 and the operating handle 36b of the treatment or surgical instrument 36, and inserts the treatment or surgical instrument 36 and the shaft 33, distal end first, into the body cavity of the subject. If the operator wishes to change the position of the affected area to be imaged, the operator can change the position of the affected area by manipulating the handle 34 with the fingers of the left hand (index finger, middle finger, ring finger, etc.). Because the treatment or surgical instrument 36 is fixed to the attachment 35, when the operator rotates the operating handle 36b of the treatment or surgical instrument 36 in the circumferential direction of the longitudinal axis of the distal shaft portion 33a, the treatment or surgical instrument 36 can be moved in the circumferential direction of the longitudinal axis of the distal shaft portion 33a (and the shaft 33). Furthermore, by pulling the traction member 38 back toward the base end in the direction of the arrow, the distal shaft portion 33a is bent at an angle θ relative to the base shaft portion 33b. If the angle θ is 0° when the distal shaft portion 33a is in a straight line with the base shaft portion 33b and is not bent, then θ can be in the range of 0° to 120°.

[0059] Furthermore, the operator can operate the treatment or surgical instrument 36 separately from operating the handle portion 34. For example, by gripping and operating the operating handle 36b with the thumb, index finger, and middle finger like holding chopsticks, or by moving it with only the index finger, the operator can perform treatments such as suction, grasping, retraction, dissection, and cutting at the distal end of the treatment or surgical instrument 33. Furthermore, the operator can operate a treatment or surgical instrument other than the treatment or surgical instrument 36 with his right hand, separately from operating it with his left hand. When treatment on the patient is completed, the operator pulls the endoscope assembly 30 back toward the proximal end while still holding the handle portion 34 between the thumb and index finger, and removes the endoscope assembly 30 from the subject's body cavity.

[0060] The following describes the advantages of the endoscope assembly 30 for assisting in the operation of a medical or surgical instrument according to the third embodiment. The surgeon can operate both the endoscope and the medical or surgical instrument with the same hand. The surgeon can operate a medical or surgical instrument with the hand holding the endoscope and another medical or surgical instrument with the other hand, enabling two-handed operation. Procedures such as suction, grasping, traction, dissection, and cutting can be performed with both hands. Alternatively, other operations can be performed with both hands. The shaft 33 is composed of three members: a distal shaft portion 33a, a proximal shaft portion 33b, and a flexible connecting member 33c. The attachment 35 is fixed to the distal shaft portion 33a. Therefore, when the surgeon rotates the operating handle 36b of the medical or surgical instrument 36 in the circumferential direction of the distal shaft portion 33a, the medical or surgical instrument 36 can be freely moved in the circumferential direction of the longitudinal axis of the distal shaft portion 33a (and the shaft 33). The endoscope assembly 30 includes a traction member 38, the base end of which is fixed to the distal shaft portion 33a and the distal end of which extends outward from the proximal shaft portion 33b. Therefore, by pulling the traction member 38 back toward the proximal end in the direction of the arrow, the distal shaft portion 33a can be bent at an angle θ relative to the proximal shaft portion 33b. The treatment or surgical instrument 36 is designed to facilitate delicate surgical operations by manipulating the operating handle portion 36b at hand and leveraging the tip of the treatment or surgical instrument 36.

[0061] The endoscope assembly 30 for assisting in the operation of a treatment or surgical instrument according to the third embodiment can be modified as follows: As shown in FIG. 10 , the hole 34d extends deeply into the handle portion 34, allowing the proximal end of the proximal shaft portion 33b to move back and forth within the hole 34d along the axial direction of the hole 34d. This configuration allows the length of the proximal shaft portion 33b protruding from the handle portion 34, and therefore the length of the shaft 33, to be adjusted, and also allows the shaft 33 to be rotated relative to the handle portion 34 to adjust the relative rotation angle between the handle and the shaft. Furthermore, by providing a fixing member 39 on the handle portion 34 that fixes the position of the proximal shaft portion 33b, the position of the proximal shaft portion 33b relative to the handle portion 34 can be fixed at a desired position. In FIG. 10 , the fixing member 39 is provided on the distal end of the handle portion 34 and can move back and forth (i.e., toward the distal end and the proximal end) along the axial direction of the hole 34d. More specifically, as shown in FIG. 11 , the fixing member 39 has an operating portion 39a exposed above the handle portion 34, a restricting portion 39b extending into the hole 34d, and a connecting portion 39c that passes through a hole (not shown) provided in the handle portion 34 and connects the operating portion 39a and the restricting portion 39b. The cross section of the restricting portion 39b is larger at the distal end than at the proximal end of the restricting portion 39b. Therefore, when the fixing member 39 is moved distally, the restricting portion 39b of the fixing member 39 contacts the proximal shaft portion 33b, restricting movement of the proximal shaft portion 33b along the axial direction of the hole 34d. This fixes the position of the proximal shaft portion 33b relative to the handle portion 34. When the fixing member 39 is moved proximally, the restricting portion 39b of the fixing member 39 separates from the proximal shaft portion 33b, releasing the proximal shaft portion 33b from the restriction.

[0062] 10 and 11 , one or more protrusions may be provided on the portion of the handle portion 34 that contacts the proximal shaft portion 33b (e.g., the wall surface defining the hole 34d), and one or more recesses may be provided on the outer peripheral surface of the proximal shaft portion 33b along the proximal shaft portion 33b, so that the proximal shaft portion 33b is fixed at a desired position relative to the handle portion 34 by fitting the protrusions and the recesses. The configuration of the fixing member is not limited as long as it can restrict movement of the proximal shaft portion 33b along the axial direction of the hole 34d. In the third embodiment, the treatment or surgical instrument 36 is exemplified as the treatment or surgical instrument, but other treatment or surgical instruments such as those described in the first embodiment may also be used.

[0063] Fourth Embodiment Next, an endoscope assembly 40 for assisting the operation of a treatment or surgical instrument according to a fourth embodiment of the present invention will be described. Descriptions of components corresponding to those of the second or third embodiment of the present invention will be omitted.

[0064] FIG. 12 is a perspective view of an endoscope assembly 40 for assisting in the operation of a treatment or surgical instrument according to a fourth embodiment. The endoscope assembly 40 includes a CMOS image sensor 41 constituting an imaging element and a substantially cylindrical shaft 43. The shaft 43 includes a hollow, substantially cylindrical distal shaft portion 43a that houses the CMOS image sensor 41 and a proximal shaft portion 43b. The distal shaft portion 43a and the proximal shaft portion 43b are connected by a flexible connecting member 43c, allowing the distal shaft portion 33a and the proximal shaft portion 33b to rotate relative to each other. In this embodiment, the flexible connecting member 43c is a silicone tube. An image of a subject captured by the CMOS image sensor 41 is transmitted to a signal cable 42 connected to the CMOS image sensor 41 and processed as a signal. The signal cable 42 is connected to a computer, allowing the image of the subject to be observed on a display device connected to the computer.

[0065] The endoscope assembly 40 further includes a handle portion 44 extending from the shaft 43. Specifically, the handle portion 44 extends radially outward from the proximal shaft portion 43b of the shaft 43, exceeding the diameter of the proximal shaft portion 43b. As shown in FIG. 13 , a substantially cylindrical member 47 is provided on a portion of the longitudinal outer circumferential surface of the proximal shaft portion 43b, which is provided around the CMOS image sensor 41, and the handle portion 44 is provided on a portion of the longitudinal outer circumferential surface of the substantially cylindrical member 47. The length of the handle portion 44 is shorter than that of the proximal shaft portion 43b, and the handle portion 44 is located between both longitudinal ends of the proximal shaft portion 43b. The substantially cylindrical member 47 is rotatable in the circumferential direction around its axis and can rotate relative to the proximal shaft portion 43b. The proximal shaft portion 43b and the handle portion 44 are fixed to each other. 12, the distance L8 from the distal shaft portion 43a to the approximately tubular member 47 can be varied depending on the application, but is, for example, about 40 to 80 mm when used in transcanal endoscopic otological surgery. The length L9 of the handle can also be varied depending on the application, but is, for example, about 100 to 200 mm when used in transcanal endoscopic otological surgery.

[0066] In this embodiment, the handle portion 44 is substantially cylindrical, with a substantially constant cross-sectional area from end to end in the longitudinal direction, resulting in a compact shape that does not interfere with treatment. The material from which the shaft 43 and the handle portion 44 are made is not limited, and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber. For example, the shaft 43 and the handle portion 44 may each be molded from a synthetic resin. The shaft 43 and the handle portion 44 can be joined by any suitable method for fixing, such as by adhesive bonding or welding.

[0067] The endoscope assembly 40 further includes a mounting fixture 45 for mounting a treatment or surgical instrument 46. The mounting fixture 45 is indirectly attached to the distal shaft portion 43a of the shaft 43 via a generally tubular member 47. The mounting fixture 45 includes a first fixing portion 45a for fixing the mounting fixture 45 to the treatment or surgical instrument 46, a second fixing portion 45b for fixing the mounting fixture 45 to the side surface of the generally tubular member 47, and a connecting portion 45c connecting the first fixing portion 45a and the second fixing portion 45b. While the connecting portion 45c is shown as a torsion spring in this embodiment, it may be a leaf spring or any elastic member that can be deformed by biasing. One end of the connecting portion 45c is sandwiched between the first fixing portion 45a and the elongated portion 46b of the treatment or surgical instrument 46, and the other end of the connecting portion 45c is sandwiched between the second fixing portion 45b and the generally tubular member 47, forming a generally V-shape. The angle Θ of the V can be changed by moving the position of the medical or surgical instrument 46 relative to the handle portion 44. For example, in an unbiased state, Θ is approximately 30 degrees, but this angle can be reduced by moving the medical or surgical instrument 46 closer to the handle portion 44. The attachment tool 45 is located closer to the distal end of the shaft 43 than the handle portion 44. A tubular member 50 for fixing the medical or surgical instrument 46 on the proximal side of the attachment tool 45 is provided on the medical or surgical instrument 46 proximal to the attachment tool 45. The tubular member 50 is fixed to the long portion 46b or the first fixing portion 45a of the medical or surgical instrument 46 so that the medical or surgical instrument 46 can be inserted into the opening of the tubular member 50. When the tubular member 50 is fixed to the elongated portion 46b of the treatment or surgical instrument 46, the tubular member 50 may be detachable or slidable relative to the elongated portion 46b so that it can be fixed at any position in the longitudinal direction of the elongated portion 46b.

[0068] The treatment or surgical instrument 46 has a distal end 46a, a long portion 46b extending continuously from the distal end 46a at an angle to the distal end 46a, and an operating handle 46c attached to the proximal end of the long portion 46b. The operating handle 46c has a larger diameter than the long portion 46b to make it easier for the operator to grip. The material of the operating handle 46c is not limited and may be metal, synthetic resin, or a composite material containing at least one of these. Synthetic resins include thermoplastic resins, thermosetting resins, elastomers, and rubber. In this embodiment, the treatment or surgical instrument 46 is connected to the approximately tubular member 47 via the attachment 45. Therefore, by rotating the approximately tubular member 47, the position of the treatment or surgical instrument 46 can be rotated around the axis of the approximately tubular member 47 (which is also the axis of the shaft 43) without rotating the proximal shaft portion 43b of the shaft 43.

[0069] 13 , the endoscope assembly 40 also includes a string-like traction member 48. In this embodiment, the distal end of the traction member 48 is fixed to the distal shaft portion 43a, passes between the CMOS image sensor 41 and the distal shaft portion 43a, and between the CMOS image sensor 41 and the proximal shaft portion 43b, and extends from the proximal shaft portion 43b through a hole or slit provided in the side surface of the proximal shaft portion 43b, proximal to the proximal end of the approximately cylindrical member 47. The traction member 48 is, for example, a wire. The distal end of the traction member 48 is fixed to the distal shaft portion 43a, and the traction member 48 extends through the inner cavities of the distal shaft portion 43a and the proximal shaft portion 43b, and the proximal end of the traction member 48 terminates inside the handle portion 44. Note that the traction member 48 may also extend outside the distal shaft portion 43a, the proximal shaft portion 43b, and the approximately cylindrical member 47. It may extend through the inner cavity of the distal shaft portion 43a, the outside of the proximal shaft portion 43b, and the inner cavity or outside of the approximately cylindrical member 47, or it may extend through the outside of the distal shaft portion 43a and the inner cavity of the proximal shaft portion 43b.

[0070] A slidable grip 49 extends through the handle portion 44 from the exterior of the handle portion 44 to the interior of the handle portion 44 to selectively advance or retract the traction member 48. The grip 49 may also be referred to as a tab or knob and may have any shape, such as a post or disk. The grip 49 is movable in the longitudinal direction of the handle portion 44 (the direction indicated by the arrow in FIG. 13 ). The proximal end of the traction member 48 is fixed to the grip 49. Moving the grip 49 toward the distal end of the handle portion 44 advances the traction member 48 out of the handle portion 44 and moves the distal shaft portion 43a further distally. Moving the grip 49 toward the proximal end of the handle portion 44 retracts the traction member 48 into the handle portion 44 and retracts the distal shaft portion 43a further proximally. In addition, the mechanism for selectively sending out or retracting the towing member 48 by operating from outside the handle portion 44 is not limited to the sliding grip portion 49, and can take various configurations, such as a member or device for winding up the towing member 48.

[0071] Next, the operation of the endoscope assembly 40 will be described. First, a treatment or surgical instrument 46 is fixedly attached to the attachment tool 45 in advance. In this embodiment, since the first fixing portion 45a is substantially cylindrical, the treatment or surgical instrument 46 can be inserted and / or removed through the opening of the first fixing portion 45a. This makes it possible to replace the treatment or surgical instrument 46 attached to the attachment tool 45.

[0072] Next, the operator grasps the handle 44 of the endoscope assembly 40 and the operating handle 46c of the treatment or surgical instrument 46 and inserts the treatment or surgical instrument 46 and shaft 43 distally into the subject's body cavity. If the operator wishes to change the location of the affected area to be imaged, the operator grasps the gripping portion 49 with the fingers (index finger, middle finger, ring finger, etc.) of one hand like holding chopsticks and changes the position of the shaft 43, thereby changing the location of the affected area to be imaged. The treatment or surgical instrument 46 and the approximately tubular member 47 are fixed to the mounting fixture 45, and the surgeon can rotate the operating handle 46c of the treatment or surgical instrument 46 in the circumferential direction of the longitudinal axis of the approximately tubular member 47 to move the treatment or surgical instrument 46 in the circumferential direction of the longitudinal axis of the approximately tubular member 47. Furthermore, by pulling back the traction member 48 using the winding mechanism 49, the distal shaft portion 43a can be bent at an angle relative to the proximal shaft portion 43b.

[0073] Furthermore, the operator can operate the treatment or surgical instrument 46 separately from operating the handle portion 44. For example, by operating the operating handle 46c, treatments such as suction, grasping, retraction, dissection, and cutting can be performed at the distal end of the treatment or surgical instrument 46. Furthermore, the operator can operate a treatment or surgical instrument other than the treatment or surgical instrument 46 with his or her right hand and perform treatment, separately from operating the treatment or surgical instrument 46 with his or her left hand. When treatment on the patient is completed, the operator pulls the endoscope assembly 40 back toward the proximal end while still holding the handle portion 44 between the thumb and index finger, and removes the endoscope assembly 40 from the body cavity of the subject.

[0074] The following describes the advantages of the endoscope assembly 40 for assisting in the operation of a medical or surgical instrument according to the fourth embodiment. The surgeon can operate the endoscope and the medical or surgical instrument with the same hand. The surgeon can operate the medical or surgical instrument with the hand holding the endoscope and operate another medical or surgical instrument with the other hand, enabling two-handed operation by the surgeon. Procedures such as suction, grasping, traction, dissection, and cutting can be performed with both hands. Alternatively, different operations can be performed with both hands. Because an elastic member is used in the attachment 45, the position of the medical or surgical instrument 46 relative to the handle portion 44 can be changed by operating the medical or surgical instrument 46 and biasing the elastic member.

[0075] The attachment tool 45 is fixed to the substantially tubular member 47. Therefore, when the surgeon rotates the operating handle 46c of the treatment or surgical instrument 46 in the circumferential direction of the substantially tubular member 47, the treatment or surgical instrument 46 can be freely moved in the circumferential direction of the longitudinal axis of the substantially tubular member 47 (and the shaft 43) without rotating the proximal shaft portion 43b of the shaft 43. The endoscope assembly 40 includes a traction member 48, the distal end of which is fixed to the distal shaft portion 43a, and the proximal end of which terminates in a slidable grip portion 49. Therefore, by moving the grip portion 49 and pulling the traction member 48 back toward the proximal end, the distal shaft portion 43a can be bent at an angle relative to the proximal shaft portion 43b.

[0076] Although the present invention has been described with reference to the first to fourth embodiments, for example, members in one embodiment can also be applied to other embodiments.

[0077] For example, the attachment 35 having the first loop 35a and the second loop 35b of the third embodiment may be used in the second embodiment to surround the elongated portion 26b and the distal shaft portion 23a of the treatment or surgical instrument 26.

[0078] 10 , the hole 34a of the handle portion 34, the proximal shaft portion 33b movable through the hole 34a, and the fixing member 39 may be applied to the endoscope assembly 20 of the second embodiment. In other words, by making the proximal shaft 23b movable within the hole provided in the handle portion 24 and sliding the proximal shaft 23b and therefore the shaft 23 relative to the handle portion 24, the distance between the handle portion 24 and the distal end of the shaft 23 can be adjusted.

[0079] Example 1: Transmastoid Superior Semicircular Canal Closure To assess whether an endoscopic assembly for treatment or surgical instrument manipulation effectively improves surgical operability, a model surgery similar to transmastoid superior semicircular canal closure was performed using a temporal bone model. Autologous tissue (simulated with blue silicone putty) was introduced into one-hand surgery (Fig. 2(A), Fig. 14(A), (B)) and a surgical procedure using a prototype endoscope according to the fourth embodiment of the present invention, and the time required for superior semicircular canal closure was measured and compared (Tables 1 and 2). The temporal bone model used in this experiment was a Schmidt left ear (NB503) model from PHACON GmbH, manufactured by PHACON GmbH.

[0080] Experimental Method: A mastoidectomy was performed on a temporal bone model in advance, opening the superior semicircular canal from the medial surface and filling the mastoid sinus with water. Model surgeries were performed under the following two conditions to evaluate the endoscope assembly for treatment or for assisting in the manipulation of surgical instruments. (1) One-hand surgery. The endoscope was held in the left hand, and a weak needle was held in the right hand. A small piece of silicone putty was attached to the tip, and the needle was guided into the superior semicircular canal, closing the anterior and posterior ends of the open cavity ( Figures 2(A) and 14(A) and (B)). (2) The prototype endoscope of the fourth embodiment of the present invention was held in the left hand, and the surgical instrument 46 was manipulated with the left fingers, and together with the weak needle held in the right hand, a small piece of silicone putty was attached and the needle was guided into the superior semicircular canal, closing the anterior and posterior ends of the open cavity ( Figures 15(A) and (B)).

[0081] The results are shown in Tables 1 and 2. In method (2) using the prototype endoscope of the fourth embodiment, the surgical instrument 46 holds down the small pieces of silicone putty to prevent them from adhering to the weakly curved needle and hindering guidance, facilitating guidance in cooperation and significantly shortening the operation time. When using the endoscope assembly of the example, the average time was 56.542 seconds (standard deviation 8.59), and when operating with one hand, the average time was 84.164 seconds (standard deviation 15.0). (P=0.007, Student's t-test)

[0082]

[0083] The endoscope assembly of the present invention can be used in various surgical procedures using an endoscope. It is primarily intended for transcanal endoscopic ear surgery (including transmastoid underwater endoscopic ear surgery), but can also be used for transcanal endoscopic ear surgery if certain conditions, such as a sufficient ear canal diameter, are met. For example, it facilitates piston and columella placement in stapes surgery and tympanoplasty. Furthermore, the endoscope assemblies of the second and third embodiments have variably bendable shafts 23 and 33, which allow for the removal of cholesteatoma that has progressed toward the epitympanum or mastoid sinus. Furthermore, the endoscope assemblies are applicable to all types of underwater endoscopic inner ear surgery (e.g., semicircular canal fistula, superior semicircular canal dehiscence syndrome, cochlear implants, and DDS).

[0084] In addition, the endoscopic assembly of the present invention can be applied not only to otological surgery, but also to endoscopic sinus surgery, transnasal endoscopic anterior skull base surgery, endoscopic hypopharyngeal and laryngeal surgery, endoscopic neurosurgery, endoscopic gynecological surgery, arthroscopic surgery, cystoscopic surgery, and so-called keyhole endoscopic surgery in veterinary medicine, and is expected to improve operability and safety.

[0085] Reference Signs 10, 20, 30, 40... Endoscope assembly, 11... CMOS image sensor as an imaging element, 13, 23, 33, 43... Shaft, 14, 24, 34, 44... Handle portion, 15, 25, 35, 45... Mounting fixture, 16, 26, 36, 46... Treatment or surgical instrument, 21... CCD camera as an imaging element, 16d, 26c, 36b... Operating handle, 23a, 33a, 43a... Distal side shaft portion, 23b, 33b, 43b... Base side shaft portion, 33c, 43b... Connecting member, 38, 48... Pulling member, 39... Fixing member, 47... Approximately cylindrical member, 49... Grip portion.

Claims

1. An endoscope assembly for assisting in the operation of a treatment or surgical instrument, comprising an imaging element and a shaft that houses the imaging element or is connected to the imaging element, a handle portion extending from the shaft; a treatment or surgical instrument attachment attached to the shaft; An endoscope assembly, wherein the procedural or surgical instrument attachment is secured to the side of the shaft.

2. The endoscope assembly according to claim 1 , wherein the attachment is located distal to the shaft relative to the handle portion.

3. 2. The endoscope assembly according to claim 1, wherein the treatment or surgical instrument is a stick-like instrument having an operating handle.

4. An endoscope assembly according to any one of claims 1 to 3, wherein the shaft comprises a distal shaft portion and a proximal shaft portion, and the distal shaft portion is rotatable relative to the proximal shaft portion.

5. 5. The endoscope assembly according to claim 4, wherein the distal shaft portion and the proximal shaft portion are connected by a flexible connecting member.

6. The endoscope assembly of claim 4, further comprising a traction member having a base end fixed to the distal shaft portion and a distal end extending outward from the proximal shaft portion, wherein the distal shaft portion can be bent by pulling the traction member back toward the proximal end.

7. 4. The endoscope assembly according to claim 1, wherein the shaft comprises a distal shaft portion, a proximal shaft portion, and a generally tubular member attached to the outer peripheral surface of the proximal shaft portion and rotatable relative to the proximal shaft portion, and the attachment for the treatment or surgical instrument is attached to the generally tubular member.

8. the shaft comprises a distal shaft portion and a proximal shaft portion; the handle portion is attached to the outer periphery of the proximal shaft portion along a portion of the longitudinal direction of the proximal shaft portion, The endoscope assembly includes: a traction member having a proximal end fixed to the distal shaft portion, extending through the exterior or inner cavity of each of the distal shaft portion and the proximal shaft portion, and terminating proximally of the proximal shaft portion; a mechanism extending through the handle portion from an exterior of the handle portion to an interior of the handle portion for selectively delivering or retracting the towing member; An endoscope assembly according to any one of claims 1 to 3, comprising:

9. The endoscope assembly according to any one of claims 1 to 3, wherein the imaging element is housed inside the shaft.

10. The endoscope assembly according to any one of claims 1 to 3, wherein the imaging element is connected to the proximal end of the shaft.

11. An operation support device for a treatment or surgical instrument used in connection with an endoscope having an imaging device, a shaft that allows the imaging device to capture an image of a subject through a tip thereof, the shaft comprising: a handle portion extending from the shaft; and a treatment or surgical instrument attachment fixed to the side of the shaft.