Ergonomically designed steering wheel

Abstract

To provide catheter steering handles that are ergonomically designed to enable an operator to reduce hand fatigue.SOLUTION: Various ergonomic aspects of the catheter steering handles more naturally conform to the palm of the hand and can be held by the hand in a natural, low-stress posture during operation of the catheter steering handle. In another aspect, the catheter steering handle is configured such that the operator can release or partially release the grip on the handle. Thereby, the operator can relax and loosen the hand, thereby reducing fatigue.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] This application claims priority based on U.S. Provisional Application No. 62 / 794,328 and U.S. Provisional Application No. 62 / 868,105. The entire disclosure content of these applications is incorporated herein by reference.

[0002] This application relates to a steering handle for a flexible catheter, and more specifically to a steering handle shape that ergonomically improves the gripping of the handle.

Background Art

[0003] A steering handle is used to direct a flexible catheter while passing through an organ of the body, to bend the distal end of the flexible catheter, and to control the function of the catheter when the catheter is placed in a predetermined position. Examples include vascular access to the heart and ureteral access to the kidney. A common problem with steering handles is operator hand fatigue. The operator may have to hold the steering handle with one hand for a certain period of time during the operation. There is a long-felt need for a steering handle that solves the problem of hand fatigue.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0005] Various embodiments of this specification disclose catheter handling handles that are ergonomically configured to reduce operator hand fatigue. Various ergonomic embodiments of the handling handles in the present invention include external shapes that are more naturally adapted to the palm of the hand and that can be held in the hand in a natural and low-stress posture when operating the handling handle. In other embodiments of this specification, the catheter handling handle is configured so that the operator can release or partially release their grip on the catheter handling handle. This reduces fatigue as the operator can relax and bend their hand.

[0006] Structurally, various embodiments of the present invention include a steering handle for a catheter, comprising a housing that includes a main body portion defining a handle axis, a head portion, and a base portion separated by the main body portion along the handle axis, wherein the housing includes a central plane encompassing the handle axis and penetrating the front and rear surfaces of the housing, the steering handle comprising a thumb lever coupled to the head portion, the thumb lever being rotatable about a transverse axis perpendicular to the central plane. The thumb lever extends rearward and parallel to the central plane and is rotatable about a transverse axis perpendicular to the central plane.

[0007] In some embodiments, the housing forms a transition portion at the connection between the main body portion and the head portion, and the housing has a cross-section centered on the handle axis at the transition portion, which forms a joint portion that is coplanar with the central plane, and the joint portion is reduced in size relative to the head portion and the main body portion at the central plane immediately adjacent to the transition portion. The minimum opening dimension is set to be between 20 millimeters and 30 millimeters.

[0008] In some embodiments, the handle axis is curved, the rear surface of the main body has a convex contour at the center, and the front surface of the main body has a concave contour at the center. The convex and concave contours have radii of 300 mm to 1000 mm.

[0009] The head portion and the transition portion form a catch on the front of the housing at the central plane. The front of the head portion includes a projection that extends forward to form the catch. In some embodiments, at least a portion of the projection forms a finger rest. In some embodiments, the head portion and the transition portion have a hook-shaped contour on the front of the housing at the central plane. The front of the head portion includes a projection that extends forward, defining the forward length of the hook-shaped contour. At least a portion of the projection forms a finger rest. In some embodiments, at least one push-button actuator is positioned near the finger rest.

[0010] In some embodiments, the catch has a hook-shaped contour on its central surface. The catch forms an opening on its central surface, and the opening has a minimum opening dimension from the front surface of the main body portion of the steering handle to the reference point and the distal end portion of the projection. In some embodiments, the catch has a predetermined depth on its central surface, and the depth is defined as the maximum depth dimension from the reference line to the hook-shaped contour perpendicular to the reference line. In some embodiments, the minimum opening dimension is 20 mm or more and 30 mm or less, and in some embodiments, the minimum opening dimension is 24 mm or more and 27 mm or less. In some embodiments, the maximum depth dimension is 13 mm or more and 28 mm or less, and in some embodiments, the maximum depth dimension is 18 mm or more and 23 mm or less. In some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is 0.7 or more and 1.7 or less, in some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is 0.9 or more and 1.5 or less, and in some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is 1.1 or more and 1.4 or less.

[0011] The base portion includes a bulkhead. The outer surface of the bulkhead is positioned at the center of the bulkhead plane, and the bulkhead plane intersects the main body portion of the handle at the front surface of the housing such that it defines a connection point with the central plane, and the bulkhead plane defines an acute inclination angle that extends distally from a reference vector perpendicular to the plane of the housing at the connection point. In some embodiments, the acute inclination angle is 10° to 60°, in some embodiments, the acute inclination angle is 15° to 50°, and in some embodiments, the acute inclination angle is 20° to 40°.

[0012] In various embodiments of the present invention, the catheter assembly comprises a housing including a head portion located at the proximal end of the housing, a base portion located at the distal end of the housing, and a body portion separating the head portion from the base portion, the body portion having a handle axis, and the housing having a central surface that encompasses the handle axis and penetrates the front and rear surfaces of the housing, a catheter port, and an electrical port. The handle axis is curved. The catheter is coupled to the catheter port and extends distally from the catheter port. The catheter is a flexible catheter. The housing forms a transition portion at the joint between the body portion and the head portion, and the head portion and the transition portion form a catch on the front surface of the ugling on the central surface. In some embodiments, the catheter port extends from the distal outer edge of the base portion. The electrical port extends from the base portion. In some embodiments, the front surface of the head portion includes a projection extending forward to form a catch. At least a portion of the projection forms a finger rest. In some embodiments, at least one push-button actuator is located near the protruding portion.

[0013] In some embodiments, the housing has a cross-section centered on the handle axis at a transition portion that forms a joint located coplanar with the central plane, and the joint portion is smaller than the head portion and body portion immediately adjacent to the transition portion. The dimensions of the transition portion are 20 mm to 30 mm. In some embodiments, the rear surface of the body portion has a convex contour on the central plane. The front surface of the body portion has a concave contour on the central plane. In some embodiments, the thumb lever is coupled to the head portion and is rotatable about a lateral axis perpendicular to the central plane. The thumb lever extends in the rearward direction and parallel to the central plane.

[0014] Various embodiments of the present invention provide a method for alleviating hand fatigue when operating a catheter handling handle, comprising the steps of: grasping the main body of the catheter handling handle between the palm and fingers with a first finger positioned inside a catch formed by the catheter handling handle; rotating the thumb lever of the catheter handling handle to manipulate the catheter; and opening the hand to release the main body of the catheter handling handle with the catch of the catheter handling handle passing over the first finger so that the catheter handling handle is suspended from the first finger. In some embodiments, the main body of the catheter handling handle is curved in the step of preparing the catheter handling handle, with the fingers grasping the concave surface of the curved main body during the grasping step, and the palm resting on the convex surface of the curved main body during the grasping step, with the convex surface located opposite the concave surface. In some embodiments, the base of the catheter handling handle is positioned vertically below the first finger during the step of opening the hand. The center of gravity of the catheter manipulating handle is positioned vertically below the first finger during the hand-opening step. In some embodiments, the method includes the steps of preparing a catheter manipulating handle functionally coupled to a catheter, and providing a tangible persistent medium with the various steps of the method as operating commands. [Additional note 1] A control handle for a catheter, A steering wheel comprising a housing that includes a main body portion defining a steering axis, a head portion, and a base portion separated by the main body portion along the steering axis, wherein the housing includes a central surface that encompasses the steering axis and penetrates the front and rear surfaces of the housing, A steering handle characterized in that the housing has a transition portion formed at the joint between the main body portion and the head portion, and the transition portion forms a catch on the front surface of the housing at the central surface. [Additional note 2] The steering handle according to Appendix 1, characterized in that the front surface of the head portion includes a projection that extends forward to form the catch. [Additional note 3] The steering handle according to Appendix 2, characterized in that a finger rest is provided on at least a portion of the protruding part. [Additional note 4] The steering handle according to Appendix 3, characterized in that at least one push-button actuator is located on the distal portion of the protrusion. [Additional note 5] The steering handle according to Appendix 2, characterized in that the catch forms a hook-shaped contour on the central surface. [Additional note 6] The catch has an opening in the central surface, and the opening is formed along a reference line that defines the minimum opening dimension from the front surface of the main body portion of the control handle to the reference point and the distal end portion of the protrusion. The steering handle according to Appendix 5, characterized in that the catch defines a depth on the central surface, and the depth is defined as the maximum depth dimension from the reference line to the hook-shaped contour perpendicular to the reference line. [Additional note 7] The steering handle according to Appendix 6, characterized in that the minimum opening dimension is 20 millimeters or more and 30 millimeters or less. [Additional note 8] The steering handle according to Appendix 7, characterized in that the minimum opening dimension is 24 millimeters or more and 27 millimeters or less. [Additional note 9] The steering handle according to any one of the appendices 6 to 8, characterized in that the maximum depth dimension is 13 millimeters or more and 28 millimeters or less. [Additional Item 10] The steering handle according to any one of Additional Items 6 to 8, wherein the maximum depth dimension is 18 millimeters or more and 23 millimeters or less. [Additional Item 11] The steering handle according to Additional Item 6, wherein the ratio of the minimum opening dimension to the maximum depth dimension is 0.7 or more and 1.7 or less. [Additional Item 12] The steering handle according to Additional Item 6, wherein the ratio of the minimum opening dimension to the maximum depth dimension is 0.9 or more and 1.5 or less. [Additional Item 13] The steering handle according to Additional Item 6, wherein the ratio of the minimum opening dimension to the maximum depth dimension is 1.1 or more and 1.4 or less. [Additional Item 14] The housing defines a cross-section centered on the handle axis at the transition portion, The steering handle according to Additional Item 1, wherein the transition portion has a coupling dimension smaller than the head portion and the body portion on the central surface directly adjacent to the transition portion, and the coupling dimension on the central surface is defined. [Additional Item 15] The steering handle according to Additional Item 14, wherein the coupling dimension is 20 millimeters or more and 30 millimeters or less. [Additional Item 16] The steering handle according to Additional Item 1, wherein the handle axis is supported in a cantilever manner. [Additional Item 17] The steering handle according to Additional Item 16, wherein the rear surface of the body portion has a convex contour on the central surface. [Additional Item 18] The steering handle according to Additional Item 17, wherein the front surface of the body portion has a concave contour on the central surface. [Additional Item 19] The steering handle includes a thumb lever coupled to the head portion, The steering handle according to Appendix 1, characterized in that the thumb lever is rotatable about a horizontal axis perpendicular to the central surface. [Additional Note 20] The steering handle according to appendix 19, characterized in that the thumb lever extends in a rearward direction parallel to the central surface. [Additional Note 21] The steering handle according to Appendix 1, characterized in that the base portion includes a bulkhead. [Additional note 22] The outer surface of the bulkhead is located at the center of the bulkhead plane, The bulkhead plane intersects with the main body portion of the handle on the front surface of the housing such that it forms a connection point with the central surface. The steering handle according to appendix 21, characterized in that the bulkhead plane defines an acute angle of inclination that extends distally from a reference vector perpendicular to the front surface of the housing at the connection point. [Additional Note 23] The steering handle according to Appendix 22, characterized in that the aforementioned acute angle of inclination is 10° or more and 60° or less. [Additional note 24] The steering wheel according to Appendix 23, characterized in that the aforementioned acute angle of inclination is 15° or more and 50° or less. [Additional note 25] The steering handle according to Appendix 24, characterized in that the aforementioned acute angle of inclination is 20° or more and 40° or less. [Additional note 26] A catheter assembly, It is a housing, A head portion located at the proximal end of the housing, A base portion located at the distal end of the housing, A main body portion that separates the head portion from the base portion, wherein the main body portion defines the handle axis, and the housing is a central surface that encompasses the handle axis, and the central surface penetrates the front and rear surfaces of the housing. Catheter port and, Electrical port, The housing includes, A catheter connected to the catheter port and extending distally from the catheter port, An electrical cable connected to and extending from the electrical port, In the catheter assembly comprising, A catheter assembly characterized in that the housing has a transition portion formed at the connection between the main body portion, the head portion, and the transition portion, and the head portion and the transition portion have a catch formed on the front surface of the housing in the concave surface. [Additional note 27] The catheter assembly according to appendix 26, characterized in that the catheter port extends from the distal outer edge of the base portion. [Additional note 28] The catheter assembly according to Appendix 27, characterized in that the electrical port extends from the base portion. [Additional note 29] The catheter assembly according to appendix 26, characterized in that the front surface of the head portion includes a projection that extends forward to form the catch. [Additional note 30] The catheter assembly according to Appendix 29, characterized in that a finger rest is provided on at least a portion of the protruding part. [Additional note 31] The catheter assembly according to appendix 30, characterized in that at least one push-button actuator is located on the distal portion of the protrusion. [Additional note 32] The housing defines a cross-section centered on the handle axis in the transition portion. The catheter assembly according to appendix 31, characterized in that the transition portion has a coupling dimension smaller than the head portion and the main body portion on the central surface directly adjacent to the transition portion, and the coupling dimension on the central surface is defined accordingly. [Additional note 33] The catheter assembly according to Appendix 32, characterized in that the aforementioned coupling dimension is 20 millimeters or more and 30 millimeters or less. [Additional note 34] The steering handle according to appendix 26, characterized in that the steering shaft axis is cantilevered. [Additional note 35] The catheter assembly according to appendix 34, characterized in that the rear surface of the main body portion has a convex contour on the central surface. [Additional note 36] The catheter assembly according to appendix 34 or 35, characterized in that the front surface of the main body portion has a concave contour on the central surface. [Additional note 37] The aforementioned control handle is equipped with a thumb lever connected to the head portion, The catheter assembly according to Appendix 26, characterized in that the thumb lever is rotatable about a lateral axis perpendicular to the central plane. [Additional note 38] The catheter assembly according to appendix 37, characterized in that the thumb lever extends in a rearward direction parallel to the central surface. [Additional note 39] The catheter assembly according to Appendix 26, characterized in that the catheter is flexible. [Additional note 40] A control handle for a catheter, A steering wheel comprising a housing that includes a main body portion defining a steering axis, a head portion, and a base portion separated by the main body portion along the steering axis, wherein the housing includes a central surface that encompasses the steering axis and penetrates the front and rear surfaces of the housing, A steering wheel characterized in that the housing defines a transition portion at the joint between the main body portion and the head portion, the housing has a cross section centered on the steering wheel axis at the transition portion, and the transition portion has a joint dimension smaller than that of the head portion and the main body portion on the central surface directly adjacent to the transition portion, thereby defining the joint dimension on the central surface. [Additional note 41] The steering handle according to appendix 40, characterized in that the steering shaft axis is cantilevered. [Additional note 42] The steering handle according to appendix 40, characterized in that the rear surface of the main body portion has a convex contour on the central surface. [Additional note 43] The steering handle according to appendix 41 or 42, characterized in that the front surface of the main body portion has a concave contour on the central surface. [Additional note 44] The steering wheel according to Appendix 43, characterized in that the convex contour and at least one of the convex contours have a radius of 100 mm or more and 500 mm or less. [Additional note 45] The steering wheel according to Appendix 43, characterized in that the convex contour and at least one of the convex contours have a radius of 125 mm or more and 400 mm or less. [Additional note 46] The steering wheel according to Appendix 43, characterized in that the convex contour and at least one of the convex contours have a radius of 150 mm or more and 300 mm or less. [Additional note 47] The steering handle according to appendix 40, characterized in that the head portion and the transition portion form a catch on the front surface of the housing at the central surface. [Additional note 48] The steering handle according to appendix 47, characterized in that the catch has a hook-shaped contour. [Additional note 49] The steering handle according to appendix 48, characterized in that the front surface of the head portion extends in the forward direction and includes a projection that defines the forward length of the hook-shaped contour. [Additional Note 50] The steering handle according to appendix 47, characterized in that a finger rest is provided on at least a portion of the protruding part. [Additional note 51] The steering wheel according to appendix 50, characterized in that at least one push-button actuator is located near the finger rest. [Additional note 52] The aforementioned control handle is equipped with a thumb lever connected to the head portion, The steering handle according to appendix 40, characterized in that the thumb lever is rotatable about a lateral axis perpendicular to the central surface. [Additional note 53] The steering handle according to appendix 52, characterized in that the thumb lever extends in a rearward direction parallel to the central surface. [Additional note 54] A control handle for a catheter, A steering wheel comprising a housing including a main body portion defining a curved steering axis, a head portion, and a base portion separated along the curved steering curve formed by the main body portion, wherein the housing includes a central surface that encompasses the curved reading axis and penetrates the front and rear surfaces of the housing, A steering wheel characterized in that the rear surface of the main body portion forms a convex contour on the central surface, and the front surface of the main body portion forms a concave contour on the central surface. [Additional note 55] The steering handle according to Appendix 54, characterized in that the housing defines a transition portion at the joint between the main body portion and the head portion, the housing has a cross section centered on the handle axis at the transition portion, and the transition portion has a joint dimension smaller than that of the head portion and the main body portion on the central surface directly adjacent to the transition portion, defining the joint dimension on the central surface. [Additional note 56] The steering handle according to Appendix 55, characterized in that the aforementioned coupling dimension is 20 millimeters or more and 30 millimeters or less. [Additional note 57] The steering handle according to appendix 54, characterized in that the head portion and the transition portion form a catch on the front surface of the housing at the central surface. [Additional note 58] The steering handle according to appendix 57, characterized in that the front surface of the head portion extends in the forward direction and includes a projection that defines the forward length of the hook-shaped contour. [Additional note 59] The steering handle according to appendix 58, characterized in that the protruding portion includes a finger rest adjacent to at least one push-button actuator. [Additional note 60] The steering handle according to appendix 59, characterized in that at least one of the push-button actuators is located near the protrusion and on the head portion. [Additional note 61] The aforementioned control handle is equipped with a thumb lever connected to the head portion, The steering handle according to appendix 58, characterized in that the thumb lever is rotatable about a lateral axis perpendicular to the central surface. [Additional note 62] A method for reducing hand fatigue when operating a catheter manipulator handle, The steps include preparing the catheter manipulator handle which is functionally connected to the catheter, A step of recording an operation command in a tangible persistent medium, In the method comprising, The aforementioned operation command, With the first finger of the hand positioned inside the catch formed by the catheter handling handle, the main body of the catheter handling handle is grasped between the palm of the hand and the finger, To operate the catheter, the thumb lever of the catheter operating handle is rotated with the thumb of the hand, and With the catch of the catheter handling handle passing over the first finger so that the catheter handling handle is suspended from the first finger, the hand is opened to release the main body portion of the catheter handling handle. A method characterized by containing the following. [Additional note 63] The method according to appendix 62, characterized in that the operation command includes placing a second finger on the finger rest portion of the protruding head portion that extends in the forward direction. [Additional note 64] The method according to Appendix 62, characterized in that the first finger among the aforementioned fingers is the middle finger. [Additional note 65] The method according to any one of appendices 62 to 64, wherein the operation command includes pressing a push button located near the finger rest portion of the protruding portion. [Additional note 66] In the step of preparing the catheter handling handle, the main body portion of the catheter handling handle is made into an arched main body portion. When the aforementioned finger grasps the object, it grasps the concave surface of the arch-shaped main body portion. The palm is placed on the convex surface of the arch-shaped main body portion during the grasping step. The method according to Appendix 62, characterized in that the convex surface is located on the opposite side of the concave surface. [Additional note 67] The method according to Appendix 65, characterized in that the second finger among the aforementioned fingers is the index finger. [Additional note 68] The main body portion of the catheter manipulator is an arched main body portion, When the aforementioned finger grasps the object, it grasps the concave surface of the arch-shaped main body portion. The palm is placed on the convex surface of the arch-shaped main body portion during the grasping step. The method according to Appendix 65, characterized in that the convex surface is located on the opposite side of the concave surface. [Additional note 69] The method according to Appendix 62, characterized in that the base portion of the catheter manipulating handle is positioned vertically below the first finger among the fingers when the hand is opened. [Additional note 70] The method according to Appendix 69, characterized in that the center of gravity of the catheter manipulating handle is positioned vertically below the first finger among the fingers when the hand is opened. [Brief explanation of the drawing]

[0015] [Figure 1A] This is a perspective view of a catheter assembly having a catheter control handle connected to a controllable catheter in an embodiment of the present invention. [Figure 1B] This is a perspective view of a catheter assembly having a catheter control handle connected to a controllable catheter in an embodiment of the present invention. [Figure 2] This is a left side view of the catheter handling handle shown in Figure 1 in an embodiment of the present invention. [Figure 3] This is a front view of the catheter handling handle shown in Figure 1 in an embodiment of the present invention. [Figure 4] This is a right side view of the catheter handling handle shown in Figure 1 in an embodiment of the present invention. [Figure 5] This is a rear view of the catheter handling handle shown in Figure 1 in an embodiment of the present invention. [Figure 6A] This is a partial cross-sectional view along the central plane VI-VI shown in Figure 5 of an embodiment of the present invention. [Figure 6B] This is a cross-sectional view along the central plane of the catheter assembly shown in Figure 1B in an embodiment of the present invention. [Figure 7A] This is a partial enlarged view of region VIIA in Figure 6A in an embodiment of the present invention. [Figure 7B] This is a partial enlarged view of region VIIB in Figure 6B in an embodiment of the present invention. [Figure 8] This is a perspective view of a catheter manipulator handle held in a gripping position according to an embodiment of the present invention. [Figure 9] This is a perspective view of the catheter handling handle shown in Figure 8, which is held in a relaxed position in an embodiment of the present invention. [Figure 10] This is a perspective view of the catheter handling handle shown in Figure 8, which is held in a relaxed position in an embodiment of the present invention. [Modes for carrying out the invention]

[0016] Figures 1A to 7B show catheter assemblies 30a and 30b, including control handles 32a and 32b, in embodiments of the present invention. In the present invention, the catheter assemblies 30a and 30b and the control handles 32a and 32b are collectively and collectively referred to as one or more catheter assemblies 30 and one or more control handles 32, respectively. The catheter assembly 30 includes a controllable catheter 34 having a proximal end portion 36 and a distal end portion 38. The catheter control handle 32 includes a housing 42. The housing 42 has a head portion 44 and a base portion 46 separated via a body portion 48. The body portion 48 defines the handle axis 50, and the head portion 44, body portion 48, and base portion 46 are arranged along the handle axis 50. The housing 42 defines a central surface 52 that is coplanar with the handle axis 50 and penetrates the front surface 54 and rear surface 56 of the housing 42. The front surface 54 of the housing 42 faces forward 62, and the rear surface 56 of the housing 42 faces backward 64.

[0017] In this invention, in relation to the control handle 32 and the catheter 34, the terms “proximal” and “to the proximal” refer to a direction 66 along the handle axis 50 toward the head portion 44, and the terms “distal” and “to the distal” refer to a direction 67 along the handle axis 50 toward the opposite side of the head portion 44. Accordingly, the head portion 44 is located proximal to the body portion 48 of the control handle 32, and the base portion 46 is located distal to the body portion 48 of the control handle 32.

[0018] In some embodiments, the housing 42 is branched at the central surface 52 to form two housing portions 42a and 42b (see Figures 4 and 5). The housing portions 42a and 42b are fastened together by a fastener 68. In some embodiments, the fastener 68 is mounted with its head housed in a central bore 69. The central bore 69 is located in the same housing portions 42a and 42b (Figure 4 shows housing portion 42b). It should be noted that the housing portions 42a and 42b may be joined without fasteners by, for example, a press-fit structure extending between the housing portions 42a and 42b themselves.

[0019] The main body portion 48 is curved such that the front surface 54 of the central surface 52 has a concave contour, and the rear surface 56 has a convex contour. In such embodiments, the convex contour 74 has a radius 76 of 100 mm to 500 mm (see Figures 4 and 6B). In some embodiments, the convex contour 74 has a radius 76 of 125 mm to 400 mm. In some embodiments, the convex contour 74 has a radius 76 of 100 mm to 300 mm. In the present invention, the range indicated by "greater than or equal to" or "less than or equal to" includes not only all values ​​from endpoint to endpoint, but also the values ​​at the endpoints.

[0020] The housing 42 has a transition portion 82 at the joint 84 between the head portion 44 and the main body portion 48. The housing 42 has a cross section 86 centered on the handle axis 50 at the transition portion 82. A minimum point 88 is formed at the transition portion 82 on the rear surface 56 and central surface 52 of the handle 42 (Figures 7A and 7B). The joint dimension 90 is defined as the minimum dimension between the minimum point 88 and the front surface 54 of the steering handle 32 on the central surface 52. The joint dimension 90 is smaller than the central surface dimension of the head portion 44 and the main body portion 48 that are directly adjacent to the transition portion 82. In some embodiments, the joint dimension 90 is 20 millimeters or more and 30 millimeters or less.

[0021] The front surface 54 of the head portion 44 includes a projection 98 that partially extends beyond the main body portion 48 in the forward direction 62. The projection 98 includes a distal end portion 100. The main body portion 48 and the projection 98 of the head portion 44 are combined to form a catch 102 into which the phalanges P of the hand are inserted. In some embodiments, the catch 102 forms a hook shape 104 (traced in Figure 7) on the front surface 54 of the housing 42 at the central surface 52 of the transition portion 82. The projection 98 determines the forward length 106 of the hook shape 104. The head portion 44 forms the front surface, or front contour 110, of the projection 98. In some embodiments, at least a portion of the projection 98 also forms a finger rest 108.

[0022] Furthermore, the catch 102 is characterized by having an opening 112 and a depth 114 on its central surface 52. The opening 112 is defined along a reference line 115 and has a minimum opening dimension 116 from the front surface 54 of the main body portion 48 of the handle 32 to a reference point 118 of the distal end portion 100. The reference line 115 is tangent to the reference point 118. The depth 114 is defined as the maximum depth dimension 119 from the hook shape 104 of the catch 102 to the reference line 115, and the maximum depth dimension 119 is perpendicular to the reference line 115.

[0023] In some embodiments, the ratio of the minimum opening dimension 116 to the maximum depth dimension 119 is between 0.7 and 1.7. In some embodiments, the ratio of the minimum opening dimension 116 to the maximum depth dimension 119 is between 0.9 and 1.5. In some embodiments, the ratio of the minimum opening dimension 116 to the maximum depth dimension 119 is between 1.1 and 1.4. In some embodiments, the minimum opening dimension 116 is between 20 millimeters and 30 millimeters. In some embodiments, the minimum opening dimension 116 is between 24 millimeters and 27 millimeters. In some embodiments, the maximum depth dimension 119 is between 13 millimeters and 28 millimeters. In some embodiments, the maximum depth dimension 119 is between 18 millimeters and 23 millimeters.

[0024] In some embodiments, the head portion 44 includes a thumb lever 122. The thumb lever 122 extends parallel to the central plane 52 in the rearward direction 64 and is used to connect to the distal end portion 38 of the maneuverable catheter 34. The thumb lever 122 is rotatable in two directions about a transverse axis 124 which is perpendicular to the central plane 52. The head portion 44 also includes one or more push-button actuators 126 on the opposite side of the thumb lever 122. The one or more push-button actuators 126 are positioned on the head portion 44 in close proximity to the finger rest 108.

[0025] In some embodiments, the catheter handling handle 32 includes an electrical port 128, and a cable or wiring 120 is inserted into and routed through the electrical port 128. The cable 120 is used, for example, to control the illumination of an LED, to receive signals from an imaging device, to provide control commands from one or more push-button actuators 126, and to supply power to the catheter assembly 30. In some embodiments, both the catheter 34 and the cable 120 extend in close proximity to the catheter handling handle 32.

[0026] The base portion 46 includes a bulkhead 132, and one or more input ports 134 are configured to interact with external systems (e.g., perfusion systems, suction systems, and fiber optic systems) via the bulkhead 132. Some or all of the input ports 134 are fitted with external valves (not shown), such as three-way valves. The base portion 46 includes a catheter port 136, to which the proximal end portion 36 of the maneuverable catheter 34 is coupled. At least one of the electrical port 128 and the catheter port 136 is fitted with a tension-relieving structure 142.

[0027] The bulkhead 132 intersects with the front surface 54 of the main body portion 48 at a connection point 139 located on the central surface 52 of the handle 32. The outer surface of the bulkhead 132 is centered on a bulkhead plane 140 that extends in the forward direction 62 and the distal direction 67 with respect to a reference vector 141 that extends in the forward direction 62 perpendicular to the connection point 139. The reference vector 141 is coplanetized with the central plane 52. As a result, the bulkhead plane 140 has an inclination angle θ with respect to the reference vector 141. The inclination angle θ is defined in the distal direction with respect to the reference vector 141. In some embodiments, the inclination angle θ is 10° or more and 60° or less. In some embodiments, the inclination angle θ is 15° or more and 50° or less. In some embodiments, the inclination angle θ is 20° or more and 40° or less.

[0028] In some embodiments, one or more valve actuators 138 extend through a base portion 46 to allow flow to enter and exit the catheter assembly 30 and to block an input port 134 into which a device is inserted. When multiple valve actuators 138 are implemented, the valve actuators 138 are configured to rotate in the same linear direction (opposite to the rotational direction). For example, multiple valve actuators 138 include levers 144 or other indicators that are oriented in the same direction in the flowable configuration, regardless of whether the valve actuators 138 extend from either housing portion 42a or housing portion 42b. In the illustrated embodiment, all levers 144 of the valve actuator 138 are oriented in the rearward direction 64 in the flowable configuration, i.e., the open configuration (see Figures 2 and 4). Similarly, all levers 144 are oriented, for example, downward when the valve actuator 138 is in a flow-insulated configuration, i.e., the closed configuration (not shown). The corresponding rotation direction is indicated in Figures 2 and 4 by arrow 146 near the valve actuator 138, showing the rotation direction from closed to open configuration. The rotation direction of the valve actuator 138 extending through housing portion 42a is in the opposite direction to the rotation direction of the valve actuator 138 extending through housing portion 42b, so as shown in the illustrated line direction. In the illustrated embodiment, the valve actuator 138 in housing portion 42a rotates clockwise (see Figure 2), while the valve actuator 138 in housing portion 42b rotates counterclockwise (see Figure 4).

[0029] Figures 2 and 3 represent a human hand 160 with a dashed line. The hand 160 has a thumb T and other fingers P identified as the index finger I, middle finger M, ring finger R, and little finger L. In Figure 2, the grasping finger 162 is positioned on the catch 102, and the acting finger 164 is positioned on the finger rest 108. In Figures 2 and 3, the grasping finger 162 is the index finger I and the acting finger 164 is the middle finger M, but any other finger P may be selected as the grasping finger 162. The reason for the name acting finger 164 is that it is the finger that operates the push button actuator 126. In Figure 2, the acting finger 164 is the index finger I, but the middle finger M or ring finger R can also be selected for activation, so it is not limited to the index finger I. Furthermore, multiple fingers (for example, the index finger I and the middle finger M) may be positioned as acting fingers 164 simultaneously.

[0030] Functionally, the curved main body portion 48 of the housing 42 is ergonomically shaped to conform to the curvature of the palm. The housing 42 can perform all functions of operation without requiring a change in the hand's gripping posture. By reducing the coupling dimension 90 of the catheter manipulator handle 32 in the transition portion 82, the thumb T positioned inside the catch 102 and the gripping fingers 162 are brought closer together compared to conventional manipulator handles. This reduces hand fatigue when gripping the main body portion 48 with the gripping fingers 162 positioned in the catch 102. Furthermore, fatigue is reduced when the thumb T is operating the thumb lever 122, as the thumb T is even closer to the gripping fingers 162 when gripping the main body portion 48. The inclination angle θ of the bulkhead 132 avoids or reduces interference between tubes (not shown) extending from the input port 134 on which the hand 160 is placed.

[0031] The minimum opening dimension 116 and maximum depth dimension 119 of the catch 102, and their ratio, are configured to complement the gripping fingers 162. That is, the catch 102 is configured so that the catheter manipulator handle 32 covers or suspends the gripping fingers 162. In some embodiments, the center of gravity of the handle 32 is located near or inside the base portion 46 so that the base portion 46 is aligned below the gripping fingers 162 in the hydraulic direction when the handle 32 is not being gripped (see Figure 9). In some embodiments, the catheter manipulator handle 32 is balanced by the distal extension of the catheter 34 and cable 120 so that the handle 32 can balance with the gripping fingers 162 without the need to grip the catheter manipulator handle 32. Therefore, as shown in Figures 8 to 10, by positioning the gripping fingers 162 inside the catch 102, the operator can rest or relax their hand (for example, by loosening their grip or bending their hand) while the catheter manipulating handle 32 is suspended from the gripping fingers 162.

[0032] Figures 1B, 6B, and 7B show the control handle 32b. Figures 2 to 5 show only the control handle 32, but the ergonomic configuration described above applies equally to the control handle 32b. One difference between the control handles 32a and 32b is the shape of the projection 98 and the front surface 110. The projection 98 of the control handle 32b extends further forward 62 compared to the projection 98 of the control handle 32a. Also, the front surface 110 of the control handle 32b defines a linear tangential slope 152, while the front surface 110 of the control handle 32a defines a concave surface 154.

[0033] Functionally, the shapes of the front surfaces 110 of the control handles 32a and 32b each offer unique advantages. The concave surface 154 of the front surface 110 of the control handle 32a provides the operator with a tactilely perceptible reference point regarding the area on the front surface 110 where the button 126 is located. The linear tangential slope 152 of the front surface 110 of the control handle 32b provides operators who prefer to use a longer length of a pair of fingers P on the front surface 110 when operating the button 126.

[0034] Referring to Figures 8 to 10, the skillful operation of the catheter control handle 32 is shown based on one embodiment of the present invention. As shown in Figures 2 and 8, the catheter control handle 32 is grasped with all fingers (thumb T and other fingers P). When grasping the catheter control handle 32, the grasping fingers 162 are positioned inside the catch 102. When performing the control function, the operator grasps the catheter control handle 32 between the thumb T and the other fingers P (see Figure 8). The selected grasping finger 162 is inserted inside the catch 102, and the thumb T is positioned on the thumb lever 122. The middle finger M is shown as the grasping finger 162 in Figures 8 to 10, but any of the other fingers P can be used as the grasping finger 162. The selected operating finger 164 is positioned on the finger rest 108. The distal end portion 38 of the controllable catheter 34 can be bent by rotating (articulating) the thumb lever 122 back and forth with the thumb T. By sliding the operating finger 164 upward and reaching the push-button actuator 126, the operating finger 164 can be positioned to activate the push-button actuator 126.

[0035] To relax the hand 160, the operator can release their grip on the catheter manipulator handle 32 while keeping the gripping fingers 162 inside the catch 102. In this way, the catheter manipulator handle 32 is suspended from the gripping fingers 162 while bending, i.e., relaxing, the hand 160 (see Figures 9 and 10). By releasing the grip, the thumb T can be separated from the thumb lever 124 (see Figure 9). Alternatively, the thumb T can remain in contact with the thumb lever 124 (see Figure 10). In the latter configuration, the operator can continue to manipulate or maintain the orientation of the distal end portion 38 of the manipulable catheter 34 while releasing the hand 160. It should be noted that although the illustrated hand 160 is a right hand, the illustrated catheter manipulator handle 32 can be used with either the left or right hand.

[0036] Figure 9 shows the center of gravity 166 of the handle 32 located near the base portion 56. The center of gravity 166 is located below the catch 102 and the gripping fingers 162, along a vertical axis 168 aligned with the direction of gravity. The catheter handling handle 32 is balanced because the catheter 34 and cable 120 extend distally. This allows the handle 32 to balance with the gripping fingers 162 without the need to grasp the handle 32 itself. The handle 32 itself is suspended from the gripping fingers 162 when the hand is bent or relaxed, thus eliminating the need for the operator to apply force to maintain the orientation of the handle 32 during rest.

[0037] The finger rest 108 of the projection 98 provides a region on the head portion 44 where the finger used to operate the push button can be safely rested when the push button is not in operation. The operator does not need to keep the finger used to operate the push button in a position that extends away from the head portion 44 during operation; that is, the finger used to operate the push button does not need to be placed distal to the head portion 44. The finger rest 108 is also located on the head portion 44 in a known position close to the push button actuator 126 when the finger used to operate the push button is resting on it.

[0038] In some embodiments, the above-described method for alleviating hand fatigue while operating a catheter manipulator handle is provided as instructions in a tangible, persistent medium. Non-limiting examples of tangible, persistent media include paper documents and computer-readable media, including compact disks and magnetic storage devices (e.g., hard disks, flash disks, cartridges, floppy disks). The computer-readable media may be local or accessible via the Internet. Instructions may be self-contained in a single medium or divided across two or more media. For example, some instructions are written in paper documents and instruct the user to access one or more steps of the method via the Internet. Steps accessible via the Internet are stored in one or more computer-readable media. Instructions may be in the form of handwritten text, diagrams, and / or video presentations.

[0039] This specification incorporates, by reference, the preambles of Patent Documents 1, 2, and 3. In this specification, the incorporation of any patent documents is limited so as not to include anything that contradicts the express disclosures of those documents.

[0040] Each of the additional drawings and methods disclosed herein can be used separately or in conjunction with other features and methods to provide improved apparatus and methods for establishing and utilizing the features and methods. Therefore, combinations of features and methods disclosed herein may not necessarily require the implementation of the disclosures herein in a broad sense, and are instead disclosed solely to illustrate particularly representative and preferred embodiments.

[0041] Various modifications of the embodiments described herein will be obvious to those skilled in the art. For example, various features described in different embodiments can be appropriately combined, separated, and recombined with other features, used individually or in various combinations, as will be understandable to those skilled in the art. Similarly, the various features described above should be considered illustrative examples and not limit the technical scope or technical idea of ​​the present invention.

[0042] As will be understandable to those skilled in the art, various embodiments may have fewer features than any of the embodiments described herein. The embodiments described herein are not intended to represent a comprehensive set of features combined in any one way. Therefore, the embodiments are not mutually exclusive combinations of features, but rather, as will be understandable to those skilled in the art, the claims comprise different embodiments and different combinations of features selected therefrom.

[0043] Unless otherwise specified, “embodiment(s),” “disclosure,” “present disclosure,” “embodiment(s) of the disclosure,” and “disclosed embodiment(s),” as well as similar examples included herein, refer to the specification of this application (the description and drawings relating to the claims) which are not considered prior art.

[0044] For the purpose of interpreting the claims, it is explicitly intended that the provisions of 35 U.S. SC 112(f) should not be applied unless the specific terms “means for” or “step for” are explicitly stated in each claim. [Explanation of Symbols]

[0045] 30 Catheter Assembly 30a Catheter Assembly 30b Catheter Assembly 32 Control handle 32a Control handle 32b Control handle 34 Catheter 36 Proximal end portion (of catheter 34) 38 (Distal end portion of catheter 34) 42 (Housing of the control handle 32) 42a Housing section 42b Housing section 44 (Head portion of housing 42) 46 (Base part of housing 42) 48 Main body (of housing 42) 50 Handle axis 52 Central plane 54 (Front of housing 42) 56 Rear (of housing 42) 62 Forward direction 64 backward direction 66 Proximal direction 67 Distal direction 68 Fixtures 74 Convex contour (of the rear surface 56) 82 Transition Section 84 (Joint between head portion 44 and main body portion 48) 86 Cross section (of housing 42 in transition section 82) 88 Minimum point 90 Joint dimensions 98 Protrusion 100 (Distal end portion of projection 98) 102 Catch 104 Hook Shape 106 (forward length of hook shape 104) 108 Finger rest (of the protruding part 98) 110 Front (front contour) of (protruding portion 98) 114 (depth of catch 102) 115 Reference Line 116 (Minimum opening dimension of opening 112) 118 Reference point 119 Maximum depth dimension 120 Cables (Wiring) 122 (Head section 44) Thumb lever 124 Lateral axis 126 Push Button Actuator 128 Electrical Ports 132 (Base section 46) Bulkhead 134 input ports 136 Catheter Port 138 Valve Actuator 139 Connection point 140 Bulkhead Plane 141 Reference Vector 142 Strain Relief Structure 144 Lever 152 Tangential gradient 154 Concave surface 160 (human) hands 162 Fingers for grasping 164 Fingers to activate

Claims

1. A control handle for a catheter, A steering wheel comprising a housing that includes a main body portion defining a steering axis, a head portion, and a base portion separated by the main body portion along the steering axis, wherein the housing is arranged on the same plane as the steering axis and defines a central surface that penetrates the front and rear surfaces of the housing, A steering wheel characterized in that the housing has a transition portion between the main body portion and the head portion, the head portion and the transition portion have a catch formed on the front surface of the housing at the central surface, the catch is configured so that fingers can be inserted into it and is formed by a projection extending forward from the head portion, and at least a portion of the projection forms a finger rest.

2. The steering handle according to claim 1, characterized in that at least one push-button actuator is located near the finger rest.

3. The steering handle according to claim 1, characterized in that at least one push-button actuator is located in the head portion near the protruding portion.

4. The steering handle according to claim 1, wherein the housing has a cross-section centered on the handle axis in the transition portion that forms a joint dimension arranged on the same plane as the central surface, and the joint dimension is reduced in the central surface immediately adjacent to the transition portion compared to the head portion and the main body portion.

5. The steering wheel according to claim 1, characterized in that the steering wheel axis is curved.

6. The rear surface of the main body portion has a convex contour on the central surface, The steering handle according to claim 5, characterized in that the front surface of the main body portion has a concave contour on the central surface.

7. The steering wheel according to claim 6, characterized in that at least one of the convex contour and the concave contour has a radius of 100 mm or more and 500 mm or less.

8. The aforementioned control handle is equipped with a thumb lever connected to the head portion, The steering wheel according to claim 1, characterized in that the thumb lever is rotatable about a lateral axis perpendicular to the central surface.

9. The steering wheel according to claim 8, characterized in that the thumb lever extends in the rearward direction and parallel to the central surface.

10. The steering wheel according to claim 1, characterized in that the base portion includes two or more input ports that are configured to work in conjunction with an external system.

11. The control handle according to claim 1, characterized in that the center of gravity of the control handle is located near the base portion and below the catch along the vertical axis, and the vertical axis is aligned with the direction of gravity.

12. A catheter assembly comprising a control handle as described in claim 1, The catheter assembly is characterized by comprising a controllable catheter and an electrical cable connected to the base portion of the control handle and configured to maintain the balance of the control handle.

13. The control handle according to claim 10, characterized in that the external system includes at least one of a perfusion system, a suction system, and an optical fiber system.

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