Ergonomic steering handle

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 to U.S. Provisional Application No. 62 / 794,328 and U.S. Provisional Application No. 62 / 868,105, the disclosures of which are incorporated herein by reference in their entireties.

[0002] This application relates to steering handles for flexible catheters, and more particularly to steering handle configurations that provide improved ergonomic grip of the handle. [Background technology]

[0003] Steering handles are used to bend the distal end of a flexible catheter while directing the catheter through a body organ, and to control the catheter's functions once it is in place. Examples include vascular access to the heart and ureteral access to the kidney. A common problem with steering handles is hand fatigue for the operator. The operator may have to hold the steering handle with one hand for more or less periods of time during surgery. A steering handle that solves the hand fatigue problem is desirable. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Provisional Patent Application No. 62 / 868271 [Patent Document 2] International Application No. PCT / US19 / 42491 [Patent Document 3] U.S. Patent No. 9,775,675 Summary of the Invention [Problem to be solved by the invention]

[0005] Various embodiments herein disclose catheter steering handles that are ergonomically configured to reduce fatigue in the operator's hand. Various ergonomic embodiments of steering handles of the present invention include a profile that more naturally fits the palm of the hand and allows the hand to be held in a natural, less stressful position when manipulating the steering handle. In other embodiments herein, the catheter steering handle is configured to allow the operator to release or partially release their grip on the catheter steering handle, which allows the operator to relax and flex their hand, thereby reducing fatigue.

[0006] Structurally, various embodiments of the present invention include a steering handle for a catheter comprising a housing including a body portion defining a handle axis, a head portion, and a base portion separated along the handle axis by the body portion, the housing defining a central plane containing the handle axis and passing through a front and a rear face of the housing, a thumb lever coupled to the head portion and rotatable about a lateral axis perpendicular to the central plane, the thumb lever extending rearwardly and parallel to the central plane and rotatable about a lateral axis perpendicular to the central plane.

[0007] In some embodiments, the housing forms a transition portion at the junction between the body portion and the head portion, the housing has a cross section centered about the handle axis at the transition portion forming a joint disposed flush with the midplane, the joint being reduced relative to the head portion and the body portion at the midplane immediately adjacent the transition portion, and the minimum opening dimension is greater than or equal to 20 millimeters and less than or equal to 30 millimeters.

[0008] In some embodiments, the handle axis is curvilinear, the rear surface of the body portion has a convex contour at the central plane, and the front surface of the body portion has a concave contour at the central plane, the convex contour and the concave contour having a radius between 300 millimeters and 1000 millimeters.

[0009] The head portion and the transition portion form a catch on a front surface of the housing at the central plane. The front surface of the head portion includes a protrusion extending in a forward direction to form the catch. In some embodiments, at least a portion of the protrusion forms a finger hook. In some embodiments, the head portion and the transition portion have a hook-shaped profile on a front surface of the housing at the central plane. The front surface of the head portion includes a protrusion extending in a forward direction to define a forward length of the hook-shaped profile. At least a portion of the protrusion forms the finger hook. In some embodiments, at least one push button actuator is disposed proximate the finger hook.

[0010] In some embodiments, the catch has a hook-shaped profile at the central surface. The catch defines an opening at the central surface, the opening having a minimum opening dimension from a front surface of the steering handle body portion to a datum point and a distal end portion of the protrusion. In some embodiments, the catch has a depth at the central surface, the depth being defined as a maximum depth dimension from a datum line to a hook-shaped profile perpendicular to the datum line. In some embodiments, the minimum opening dimension is between 20 and 30 millimeters, and in some embodiments, the minimum opening dimension is between 24 and 27 millimeters. In some embodiments, the maximum depth dimension is between 13 and 28 millimeters, and in some embodiments, the maximum depth dimension is between 18 and 23 millimeters. In some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is between 0.7 and 1.7, in some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is between 0.9 and 1.5, and in some embodiments, the ratio of the minimum opening dimension to the maximum depth dimension is between 1.1 and 1.4.

[0011] The base portion includes a bulkhead, an outer surface of the bulkhead being centered in the bulkhead plane, the bulkhead plane intersecting the body portion of the handle at the front surface of the housing to define a juncture at the central plane, the bulkhead plane defining an acute bevel angle extending distally from a reference vector that is perpendicular to the plane of the housing at the juncture point. In some embodiments, the acute bevel angle is greater than or equal to 10° and less than or equal to 60°, in some embodiments, the acute bevel angle is greater than or equal to 15° and less than or equal to 50°, and in some embodiments, the acute bevel angle is greater than or equal to 20° and less than or equal to 40°.

[0012] In various embodiments of the present invention, the catheter assembly includes a housing including a head portion disposed at a proximal end of the housing, a base portion disposed at a distal end of the housing, a body portion separating the head portion from the base portion, the body portion having a handle axis, the housing having a central plane that includes the handle axis and that passes through a front and rear face of the housing, a catheter port, and an electrical port. The handle axis is curvilinear. 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 junction between the body portion and the head portion, and the head portion and the transition portion form a catch on the front face of the housing at the central plane. In some embodiments, the catheter port extends from a distal outer edge of the base portion. The electrical port extends from the base portion. In some embodiments, the front face of the head portion includes a protrusion extending forwardly to form a catch. At least a portion of the protrusion forms a finger hook. In some embodiments, at least one push button actuator is disposed on a proximal portion of the projection.

[0013] In some embodiments, the housing has a cross section about the handle axis at a transition portion forming a joint that is flush with the central plane and is reduced in size from the head portion and the body portion immediately adjacent the transition portion. The transition portion dimension is between 20 millimeters and 30 millimeters. In some embodiments, the rear surface of the body portion has a convex contour at the central plane. The front surface of the body portion has a concave contour at the central plane. In some embodiments, a thumb lever is coupled to the head portion and the thumb lever is rotatable about a lateral axis that is perpendicular to the central plane. The thumb lever extends in a rearward direction and parallel to the central plane.

[0014] Various embodiments of the present invention provide a method for reducing hand fatigue when manipulating a catheter steering handle, comprising the steps of gripping a body portion of the catheter steering handle between the palm of the hand and the fingers with a first finger of the hand positioned inside a catch formed by the catheter steering handle, rotating a thumb lever of the catheter steering handle to steer the catheter, and opening the hand to release the body portion of the catheter steering handle with the catch of the catheter steering handle passing the first finger such that the catheter steering handle is suspended from the first finger. In some embodiments, the body portion of the catheter steering handle is an arcuate body portion in the step of preparing the catheter steering handle, the fingers grip a concave surface of the arcuate body portion during the gripping step, the palm rests on a convex surface of the arcuate body portion during the gripping step, and the convex surface is located opposite the concave surface. In some embodiments, the base portion of the catheter steering handle is vertically aligned below the first finger during the step of opening the hand. The center of gravity of the catheter steering handle is vertically aligned below a first one of the fingers during the opening hand step. In some embodiments, the method includes providing a catheter steering handle operatively coupled to the catheter and providing various steps of the method as operational instructions in a tangible, non-transmissible medium. [Additional note 1] A steering handle for a catheter, comprising: 1. A steering handle comprising a housing including a body portion defining a handle axis, a head portion, and a base portion separated along the handle axis by the body portion, the housing defining a midplane that contains the handle axis and that passes through front and rear faces of the housing, A steering handle as claimed in any one of claims 1 to 5, wherein the housing defines a transition portion at the juncture of the body portion and the head portion, the transition portion defining a catch on a front surface of the housing at the central surface. [Additional note 2] A steering handle as described in claim 1, characterized in that the front surface of the head portion includes a protrusion extending in a forward direction to form the catch. [Additional note 3] 3. The steering handle of claim 2, wherein a finger hook is provided on at least a portion of the protrusion. [Additional note 4] 4. The steering wheel of claim 3, wherein at least one push button actuator is disposed at a distal portion of the protrusion. [Additional note 5] The steering handle of claim 2, wherein the catch forms a hook-shaped profile at the central surface. [Additional note 6] the catch has an opening at the central surface, the opening being formed along a reference line defining a minimum opening dimension from the front surface of the body portion of the steering handle to a reference point and a distal end portion of the projection; The steering handle described in appended claim 5, characterized in that the catch defines a depth in the central plane, the depth being defined as a maximum depth dimension from the reference line to the hook-shaped contour perpendicular to the reference line. [Additional note 7] A steering handle as described in appended claim 6, characterized in that the minimum opening dimension is greater than or equal to 20 millimeters and less than or equal to 30 millimeters. [Additional note 8] The steering wheel described in appended claim 7, characterized in that the minimum opening dimension is greater than or equal to 24 millimeters and less than or equal to 27 millimeters. [Additional note 9] 9. The steering handle according to any one of claims 6 to 8, wherein the maximum depth dimension is 13 mm or more and 28 mm or less. [Additional Note 10] 9. The steering handle according to any one of claims 6 to 8, wherein the maximum depth dimension is 18 mm or more and 23 mm or less. [Additional Note 11] The steering handle described in appended claim 6, characterized in that the ratio of the minimum opening dimension to the maximum depth dimension is 0.7 or more and 1.7 or less. [Additional Note 12] A steering handle as described in appended claim 6, characterized in that the ratio of the minimum opening dimension to the maximum depth dimension is 0.9 or more and 1.5 or less. [Additional Note 13] A steering handle as described in appended claim 6, characterized in that the ratio of the minimum opening dimension to the maximum depth dimension is 1.1 or more and 1.4 or less. [Additional Note 14] the housing defines a cross section about the handle axis at the transition portion; 2. The steering handle of claim 1, wherein the transition portion has a smaller combined dimension at the central plane than the head portion and the body portion immediately adjacent the transition portion, defining the combined dimension at the central plane. [Additional Note 15] A steering handle as described in claim 14, characterized in that the connection dimension is greater than or equal to 20 millimeters and less than or equal to 30 millimeters. [Additional Note 16] 2. The steering handle according to claim 1, wherein the handle axis is supported by a cantilever. [Additional Note 17] 17. The steering handle of claim 16, wherein the rear surface of the body portion has a convex contour at the central plane. [Additional Note 18] 18. The steering wheel of claim 17, wherein the front surface of the body portion has a concave contour at the central plane. [Additional Note 19] the steering handle includes a thumb lever coupled to the head portion; 2. The steering wheel of claim 1, wherein the thumb lever is rotatable about a lateral axis perpendicular to the central plane. [Additional Note 20] 20. The steering handle of claim 19, wherein the thumb lever extends rearwardly parallel to the central plane. [Additional Note 21] The steering handle of claim 1, wherein the base portion includes a bulkhead. [Additional note 22] the bulkhead outer surface is centered in a bulkhead plane; the bulkhead plane intersects the body portion of the handle at the front surface of the housing to form a joint at the central plane; 22. The steering handle of claim 21, wherein the bulkhead plane defines an acute inclination angle extending distally from a reference vector that is perpendicular to the front surface of the housing at the attachment point. [Additional Note 23] 23. The steering handle of claim 22, wherein the acute angle of inclination is greater than or equal to 10° and less than or equal to 60°. [Additional note 24] 24. The steering handle of claim 23, wherein the acute angle of inclination is greater than or equal to 15° and less than or equal to 50°. [Additional note 25] The steering handle described in claim 24, wherein the acute angle of inclination is greater than or equal to 20° and less than or equal to 40°. [Additional note 26] A catheter assembly comprising: A housing, a head portion disposed at a proximal end of the housing; a base portion disposed at a distal end of the housing; a body portion dividing the head portion from the base portion, the body portion defining a handle axis, the housing having a midplane that contains the handle axis, the midplane passing through a front and a rear surface of the housing; A catheter port; An electrical port; the housing including a catheter coupled to and extending distally from the catheter port; an electrical cable coupled to and extending from the electrical port; In the catheter assembly, A catheter assembly, characterized in that the housing forms a transition portion at the junction of the body portion, the head portion, and the transition portion, and the head portion and the transition portion form a catch on the front surface of the housing at the central concave surface. [Additional note 27] 27. The catheter assembly of claim 26, wherein the catheter port extends from a distal outer edge of the base portion. [Additional note 28] 28. The catheter assembly of claim 27, wherein the electrical port extends from the base portion. [Additional note 29] 27. The catheter assembly of claim 26, wherein the front surface of the head portion includes a protrusion extending forward to form the catch. [Additional note 30] 30. The catheter assembly described in claim 29, wherein at least a portion of the protrusion is provided with a finger hook. [Additional Note 31] 31. The catheter assembly of claim 30, wherein at least one push button actuator is disposed at a distal portion of the projection. [Additional note 32] the housing defines a cross section about the handle axis at the transition portion; 32. The catheter assembly of claim 31, wherein the transition section has a smaller combined dimension than the head section and the body section at the midplane immediately adjacent the transition section, defining the combined dimension at the midplane. [Additional note 33] 33. The catheter assembly described in claim 32, wherein the joint dimension is greater than or equal to 20 mm and less than or equal to 30 mm. [Additional note 34] 27. The steering handle described in claim 26, wherein the handle axis is supported by a cantilever. [Additional note 35] 35. The catheter assembly of claim 34, wherein the rear surface of the body portion has a convex contour at the median plane. [Additional note 36] 36. The catheter assembly of claim 34 or 35, wherein the front surface of the body portion has a concave contour at the central plane. [Additional note 37] the steering handle includes a thumb lever coupled to the head portion; 27. The catheter assembly of claim 26, wherein the thumb lever is rotatable about a lateral axis perpendicular to the central plane. [Additional note 38] 38. The catheter assembly of claim 37, wherein the thumb lever extends rearwardly parallel to the central plane. [Additional note 39] 27. The catheter assembly according to claim 26, wherein the catheter is flexible. [Additional note 40] A steering handle for a catheter, comprising: 1. A steering handle comprising a housing including a body portion defining a handle axis, a head portion, and a base portion separated along the handle axis by the body portion, the housing defining a midplane that contains the handle axis and that passes through front and rear faces of the housing, 1. A steering handle comprising: a housing defining a transition portion at a junction of the body portion and the head portion, the housing having a cross-section centered about the handle axis at the transition portion, the transition portion defining a smaller joint dimension than the head portion and the body portion at the midplane immediately adjacent the transition portion, the joint dimension at the midplane being smaller than the head portion and the body portion. [Additional note 41] The steering handle described in claim 40, characterized in that the handle axis is supported by a cantilever. [Additional note 42] 41. The steering handle of claim 40, wherein the rear surface of the body portion has a convex contour at the central plane. [Additional note 43] 43. A steering wheel as described in claim 41 or 42, characterized in that the front surface of the body portion has a concave contour at the central plane. [Additional note 44] The steering handle of claim 43, wherein the convex contour and at least one of the convex contours have a radius of greater than or equal to 100 millimeters and less than or equal to 500 millimeters. [Additional note 45] 44. The steering handle of claim 43, wherein the convex contour and at least one of the convex contours have a radius of 125 millimeters or more and 400 millimeters or less. [Additional note 46] A steering handle as described in claim 43, characterized in that the convex contour and at least one of the convex contours have a radius of greater than or equal to 150 millimeters and less than or equal to 300 millimeters. [Additional note 47] 41. The steering handle of claim 40, wherein the head portion and the transition portion form a catch on the front surface of the housing at the central surface. [Additional note 48] 48. The steering handle of claim 47, wherein the catch has a hook-shaped profile. [Additional note 49] 49. The steering handle of claim 48, wherein the front surface of the head portion includes a protrusion extending in a forward direction and defining a forward length of the hook-shaped profile. [Additional Note 50] A steering handle as described in appended claim 47, characterized in that a finger hook is provided on at least a portion of the protrusion. [Additional note 51] 51. The steering wheel described in claim 50, wherein at least one push button actuator is disposed adjacent to the finger rest. [Additional note 52] the steering handle includes a thumb lever coupled to the head portion; 41. The steering wheel of claim 40, wherein the thumb lever is rotatable about a lateral axis perpendicular to the central plane. [Additional note 53] 53. The steering handle of claim 52, wherein the thumb lever extends rearwardly parallel to the central plane. [Additional note 54] A steering handle for a catheter, comprising: 1. A steering handle comprising a housing including a body portion defining a curved handle axis, a head portion, and a base portion separated by the body portion along the curved handle curve, the housing defining a central plane that contains the curved read axis and that passes through front and rear faces of the housing, A steering wheel, wherein the rear surface of the body portion defines a convex contour at the central plane and the front surface of the body portion defines a concave contour at the central plane. [Additional note 55] 55. The steering handle of claim 54, wherein the housing defines a transition portion at a junction of the body portion and the head portion, the housing having a cross-section centered about the handle axis at the transition portion, the transition portion defining a smaller joint dimension than the head portion and the body portion at the midplane immediately adjacent the transition portion, the joint dimension on the midplane. [Additional note 56] A steering handle as described in claim 55, characterized in that the connection dimension is greater than or equal to 20 millimeters and less than or equal to 30 millimeters. [Additional note 57] 55. The steering handle of claim 54, wherein the head portion and the transition portion form a catch on the front surface of the housing at the central surface. [Additional note 58] 58. The steering handle of claim 57, wherein the front surface of the head portion includes a protrusion extending in a forward direction and defining a forward length of the hook-shaped profile. [Additional note 59] 59. The steering wheel of claim 58, wherein the protrusion includes a finger rest adjacent to at least one push button actuator. [Additional note 60] 60. The steering handle of claim 59, wherein at least one of the push button actuators is disposed adjacent the protrusion and in the head portion. [Additional note 61] the steering handle includes a thumb lever coupled to the head portion; 59. The steering handle of claim 58, wherein the thumb lever is rotatable about a lateral axis perpendicular to the central plane. [Additional note 62] 1. A method for reducing hand fatigue while manipulating a catheter steering handle, comprising: providing a catheter steering handle operatively coupled to a catheter; recording operating instructions on a tangible, non-transitory medium; The method comprising: The operation command is grasping a body portion of the catheter steering handle between the palm of the hand and the fingers of the hand with a first finger disposed inside a catch formed by the catheter steering handle; rotating a thumb lever of the catheter steering handle with the thumb of the hand to steer the catheter; and opening the hand to release the body portion of the catheter steering handle with the catch of the catheter steering handle passing through the first one of the fingers such that the catheter steering handle is suspended from the first one of the fingers. The method according to claim 1, further comprising: [Additional note 63] The method described in claim 62, characterized in that the operation command includes placing a second of the fingers on a finger hook portion of a protruding portion of the head portion extending in a forward direction. [Additional note 64] 63. The method according to claim 62, wherein the first finger is a middle finger. [Additional note 65] The method according to any one of claims 62 to 64, wherein the operation command includes pressing a push button located near the finger hook of the protruding portion. [Additional note 66] the body portion of the catheter steering handle is an arcuate body portion in the step of preparing the catheter steering handle; the fingers gripping a concave surface of the arcuate body portion during the gripping step; the palm rests on a convex surface of the arcuate body portion during the gripping step; 63. The method of claim 62, wherein the convex surface is located opposite the concave surface. [Additional note 67] 66. The method according to claim 65, wherein the second finger is an index finger. [Additional note 68] the body portion of the catheter steering handle is an arcuate body portion; the fingers gripping a concave surface of the arcuate body portion during the gripping step; the palm rests on a convex surface of the arcuate body portion during the gripping step; 66. The method of claim 65, wherein the convex surface is located opposite the concave surface. [Additional note 69] 63. The method of claim 62, wherein a base portion of the catheter steering handle is vertically aligned below the first of the fingers during the hand opening step. [Additional note 70] 70. The method of claim 69, wherein the center of gravity of the catheter steering handle is aligned vertically below the first of the fingers during the hand opening step. [Brief description of the drawings]

[0015] [Figure 1A] FIG. 1 is a perspective view of a catheter assembly having a catheter steering handle coupled to a steerable catheter in an embodiment of the present invention. [Figure 1B] FIG. 1 is a perspective view of a catheter assembly having a catheter steering handle coupled to a steerable catheter in an embodiment of the present invention. [Diagram 2] FIG. 2 is a left side view of the catheter steering handle shown in FIG. 1 in the embodiment of the present invention. [Diagram 3] FIG. 2 is a front view of the catheter steering handle shown in FIG. 1 in an embodiment of the present invention. [Figure 4] FIG. 2 is a right side view of the catheter steering handle shown in FIG. 1 in the embodiment of the present invention. [Diagram 5] FIG. 2 is a rear view of the catheter steering handle shown in FIG. 1 in an embodiment of the present invention. [Figure 6A] FIG. 6 is a partial cross-sectional view taken along the central plane VI-VI shown in FIG. 5 in the embodiment of the present invention. [Figure 6B] FIG. 2 is a cross-sectional view taken along the midplane of the catheter assembly shown in FIG. 1B in accordance with an embodiment of the present invention. [Figure 7A] FIG. 6B is a partial enlarged view of region VIIA of FIG. 6A in an embodiment of the present invention. [Figure 7B] FIG. 6B is a partial enlarged view of region VIIB in FIG. 6B according to an embodiment of the present invention. [Figure 8] FIG. 2 is a perspective view of a catheter steering handle held in a gripping position in an embodiment of the present invention. [Figure 9] FIG. 9 is a perspective view of the catheter steering handle shown in FIG. 8 held in a relaxed position in an embodiment of the present invention. [Figure 10] FIG. 9 is a perspective view of the catheter steering handle shown in FIG. 8 held in a relaxed position in an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] 1A-7B depict catheter assemblies 30a, 30b including steering handles 32a, 32b according to an embodiment of the present invention. In the present invention, the catheter assemblies 30a, 30b and steering handles 32a, 32b are collectively and generally referred to as one or more catheter assemblies 30 and one or more steering handles 32, respectively. The catheter assembly 30 includes a steerable catheter 34 having a proximal end portion 36 and a distal end portion 38. The catheter steering handle 32 includes a housing 42. The housing 42 includes a head portion 44 and a base portion 46 separated by a body portion 48. The body portion 48 defines a handle axis 50 along which the head portion 44, body portion 48, and base portion 46 are disposed. The housing 42 defines a central plane 52 that is coplanar with the handle axis 50 and passes through a front face 54 and a rear face 56 of the housing 42. The front face 54 of the housing 42 faces in a forward direction 62 and the rear face 56 of the housing 42 faces in a rearward direction 64 .

[0017] In the present invention, with respect to steering handle 32 and catheter 34, the terms “proximal” and “proximally” refer to a direction 66 along handle axis 50 toward head portion 44, and the terms “distal” and “distally” refer to a direction 67 along handle axis 50 toward the opposite side of head portion 44. Thus, head portion 44 is located proximal to body portion 48 of steering handle 32, and base portion 46 is located distal to body portion 48 of steering handle 32.

[0018] In some embodiments, the housing 42 diverges at a central plane 52 to form two housing portions 42a, 42b (see FIGS. 4 and 5). The housing portions 42a, 42b are secured together by a fastener 68. In some embodiments, the fastener 68 is attached with a head received in a central bore 69 located in the same housing portion 42a, 42b (FIG. 4 shows housing portion 42b). It should be noted that the housing portions 42a, 42b may be joined without a fastener, for example by a press fit structure extending between the housing portions 42a, 42b.

[0019] At the mid-surface 52, the body portion 48 is curved such that the anterior surface 54 is contoured concavely and the posterior surface 56 is contoured convexly. In such embodiments, the convex contour 74 has a radius 76 that is greater than or equal to 100 millimeters and less than or equal to 500 millimeters (see FIGS. 4 and 6B). In some embodiments, the convex contour 74 has a radius 76 that is greater than or equal to 125 millimeters and less than or equal to 400 millimeters. In some embodiments, the convex contour 74 has a radius 76 that is greater than or equal to 100 millimeters and less than or equal to 300 millimeters. For purposes of the present invention, ranges indicated with "greater than or equal to" or "less than or equal to" are inclusive of the endpoint values, as well as all values ​​between the endpoints.

[0020] The housing 42 defines a transition section 82 at a junction 84 between the head portion 44 and the body portion 48. The housing 42 defines a cross section 86 at the transition section 82 that is centered about the handle axis 50. A minimum point 88 is defined at the transition section 82 on the rear surface 56 and on the central plane 52 of the handle 42 (FIGS. 7A and 7B). A junction dimension 90 is defined as the smallest dimension at the central plane 52 between the minimum point 88 and the front surface 54 of the steering handle 32. The junction dimension 90 is less than the central plane dimension of the head portion 44 and the body portion 48 immediately adjacent the transition section 82. In some embodiments, the junction dimension 90 is greater than or equal to 20 millimeters and less than or equal to 30 millimeters.

[0021] The front surface 54 of the head portion 44 includes a projection 98 that extends partially beyond the body portion 48 in the forward direction 62. The projection 98 includes a distal end portion 100. The body portion 48 and the projection 98 of the head portion 44 combine to form a catch 102 configured for insertion of a phalange P of the hand. In some embodiments, the catch 102 forms a hook shape 104 (traced in FIG. 7 ) on the front surface 54 of the housing 42 at the central surface 52 of the transition portion 82. The projection 98 determines a forward length 106 of the hook shape 104. The head portion 44 forms a 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] The catch 102 is also characterized by having an opening 112 at the central surface 52 and a depth 114. The opening 112 is defined along a reference line 115 and has a minimum opening dimension 116 from the front surface 54 of the body portion 48 of the handle 32 to a reference point 118 on the distal end portion 100. The reference line 115 is tangent to the reference point 118. The depth 114 is defined as a maximum depth dimension 119 from the hook shape 104 of the catch 102 to the reference line 115, where 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 greater than or equal to 0.7 and less than or equal to 1.7. In some embodiments, the ratio of the minimum opening dimension 116 to the maximum depth dimension 119 is greater than or equal to 0.9 and less than or equal to 1.5. In some embodiments, the ratio of the minimum opening dimension 116 to the maximum depth dimension 119 is greater than or equal to 1.1 and less than or equal to 1.4. In some embodiments, the minimum opening dimension 116 is greater than or equal to 20 millimeters and less than or equal to 30 millimeters. In some embodiments, the minimum opening dimension 116 is greater than or equal to 24 millimeters and less than or equal to 27 millimeters. In some embodiments, the maximum depth dimension 119 is greater than or equal to 13 millimeters and less than or equal to 28 millimeters. In some embodiments, the maximum depth dimension 119 is greater than or equal to 18 millimeters and less than or equal to 23 millimeters.

[0024] In some embodiments, the head portion 44 includes a thumb lever 122 that extends parallel to the central plane 52 in the rearward direction 64 and is utilized to couple to the distal end portion 38 of the steerable catheter 34. The thumb lever 122 is bidirectionally rotatable about a lateral axis 124 that is perpendicular to the central plane 52. The head portion 44 also includes one or more push button actuators 126 opposite the thumb lever 122. The one or more push button actuators 126 are disposed on the head portion 44 adjacent the finger rest 108.

[0025] In some embodiments, the catheter steering handle 32 includes an electrical port 128 into which the cable or wire 120 is inserted. 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 provide power to the catheter assembly 30. In some embodiments, both the catheter 34 and the cable 120 extend proximate to the catheter steering handle 32.

[0026] The base portion 46 includes a bulkhead 132 through which one or more input ports 134 interface with an external system (e.g., an irrigation system, a suction system, or a fiber optic system). Some or all of the input ports 134 are fitted with external valves (not shown), such as, for example, three-way valves. The base portion 46 includes a catheter port 136 to which the proximal end portion 36 of the steerable catheter 34 is coupled. At least one of the electrical port 128 and the catheter port 136 is fitted with a strain relief structure 142.

[0027] The bulkhead 132 intersects with the front surface 54 of the body portion 48 at a juncture 139 located on the midplane 52 of the handle 32. The exterior surface of the bulkhead 132 is centered about a bulkhead plane 140 that extends in the forward direction 62 and distal direction 67 relative to a reference vector 141 that extends in the forward direction 62 perpendicular to the juncture 139. The reference vector 141 is coplanar with the midplane 52. The bulkhead plane 140 thereby has an inclination angle θ relative to the reference vector 141. The inclination angle θ is defined in the distal direction relative to the reference vector 141. In some embodiments, the inclination angle θ is greater than or equal to 10° and less than or equal to 60°. In some embodiments, the inclination angle θ is greater than or equal to 15° and less than or equal to 50°. In some embodiments, the inclination angle θ is greater than or equal to 20° and less than or equal to 40°.

[0028] In some embodiments, one or more valve actuators 138 extend through the base portion 46 to allow flow into and out of the catheter assembly 30 and to block the input port 134 into which the device is inserted. When multiple valve actuators 138 are implemented, the valve actuators 138 are configured to rotate in the same linear (as opposed to rotational) sense. For example, the multiple valve actuators 138 include levers 144 or other indicators that face the same direction in a flow-enabled configuration, regardless of whether the valve actuator 138 extends from the housing portion 42a or the housing portion 42b. In the illustrated embodiment, all levers 144 of the valve actuators 138 face in the rearward direction 64 in a flow-enabled or open configuration (see FIGS. 2 and 4). Similarly, all levers 144 are oriented to face, for example, downwardly, when the valve actuators 138 are in a flow-isolated or closed configuration (not shown). The corresponding direction of rotation is indicated in Figures 2 and 4 by arrow 146 adjacent valve actuator 138, which indicates the direction of rotation from the closed configuration to the open configuration. As oriented in the illustrated lines, the direction of rotation of valve actuator 138 extending through housing portion 42a rotates in the opposite direction to the direction of rotation of valve actuator 138 extending through housing portion 42b. In the illustrated embodiment, valve actuator 138 in housing portion 42a rotates clockwise (see Figure 2), while valve actuator 138 in housing portion 42b rotates counterclockwise (see Figure 4).

[0029] 2 and 3 show a human hand 160 in dashed lines. The hand 160 has a thumb T and other fingers P identified as index finger I, middle finger M, ring finger R, and pinky finger L. In FIG. 2, a grasping finger 162 is placed on the catch 102 and an actuating finger 164 is positioned on the finger rest 108. In FIG. 2 and 3, the grasping finger 162 is the index finger I and the actuating 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 actuating finger 164 is that it is a finger for actuating the push button actuator 126. In FIG. 2, the actuating finger 164 is the index finger I, but is not limited to the index finger I, as the middle finger M or ring finger R can also be selected for actuation. Furthermore, multiple fingers (e.g., index finger I and middle finger M) may be placed as the actuating finger 164 at the same time.

[0030] In function, the curved body portion 48 of the housing 42 is ergonomically shaped to fit the curvature of the palm. The housing 42 allows all of the functions of operation to be achieved without the need to change the gripping position of the hand. By reducing the joint dimension 90 of the catheter steering handle 32 at the transition section 82, the thumb T and the gripping fingers 162 located inside the catch 102 are closer together than in the case of the prior art steering handle. This reduces hand fatigue when gripping the body portion 48 with the gripping fingers 162 positioned on the catch 102. Also, when the thumb T is operating the thumb lever 122, the thumb T is closer to the gripping fingers 162 when gripping the body portion 48, so fatigue is reduced. The inclination angle θ of the bulkhead 132 avoids or reduces interference between the tubes (not shown) extending from the input port 134 where 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 grasping fingers 162. That is, the catch 102 is configured so that the catheter steering handle 32 covers or is suspended over the grasping fingers 162. In some embodiments, the center of gravity of the handle 32 is located near or within the base portion 46 so that the base portion 46 is hydraulically aligned below the grasping fingers 162 when the handle 32 is not being gripped (see FIG. 9 ). In some embodiments, the catheter steering handle 32 is balanced by the distal extension of the catheter 34 and cable 120, allowing the handle 32 to balance the grasping fingers 162 without the need to grip the catheter steering handle 32. Thus, by positioning the grasping fingers 162 inside the catch 102, as shown in Figures 8-10, the operator can rest or relax their hand (e.g., by loosening their grip or flexing their hand) when the catheter steering handle 32 is suspended from the grasping fingers 162.

[0032] 1B, 6B, and 7B show the steering wheel 32b. Although FIGS. 2-5 show only the steering wheel 32, the ergonomic configurations described above apply equally to the steering wheel 32b. One difference between the steering wheels 32a and 32b is the shape of the protrusion 98 and the front surface 110. The protrusion 98 of the steering wheel 32b extends further in the forward direction 62 compared to the protrusion 98 of the steering wheel 32a. Additionally, the front surface 110 of the steering wheel 32b defines a linear tangential slope 152, and the front surface 110 of the steering wheel 32a defines a concave surface 154.

[0033] Functionally, the shape of the front surface 110 of the steering handle 32a, 32b each offers its own advantages. The concave surface 154 of the front surface 110 of the steering handle 32a provides the operator with a tactile reference as to where the buttons 126 are located on the front surface 110. The linear tangential slope 152 of the front surface 110 of the steering handle 32b provides greater length for operators who prefer to utilize a set of fingers P on the front surface 110 when operating the buttons 126.

[0034] 8-10, dexterous manipulation of the catheter steering handle 32 is shown in accordance with one embodiment of the present invention. As shown in FIGS. 2 and 8, the catheter steering handle 32 is grasped with all fingers (thumb T and fingers P). When grasping the catheter steering handle 32, the grasping fingers 162 are positioned inside the catch 102. To perform the steering function, the operator grasps the catheter steering handle 32 between the thumb T and fingers P (see FIG. 8). The selected grasping finger 162 is inserted inside the catch 102, and the thumb T is positioned on the thumb lever 122. Although the middle finger M is shown in FIGS. 8-10 as the grasping finger 162, any of the fingers P can be utilized as the grasping finger 162. The selected actuating finger 164 is positioned on the finger rest 108. The distal end portion 38 of the steerable catheter 34 is bent by articulating the thumb lever 122 back and forth with the thumb T. The actuation finger 164 can be slid upward to reach the push button actuator 126, positioning the actuation finger 164 in a position to actuate the push button actuator 126.

[0035] To relax the hand 160, the operator can loosen his grip on the catheter steering handle 32 while keeping the gripping fingers 162 inside the catch 102. In this manner, the catheter steering handle 32 is suspended from the gripping fingers 162 while the hand 160 is flexed or relaxed (see FIGS. 9 and 10). By loosening his grip, the thumb T can be released from the thumb lever 124 (see FIG. 9). Alternatively, the thumb T can be left in contact with the thumb lever 124 (see FIG. 10). In the latter configuration, the operator can continue to manipulate or maintain the orientation of the distal end portion 38 of the steerable catheter 34 while relaxing the hand 160. It should be noted that while the hand 160 shown is a right hand, the catheter steering handle 32 shown can be utilized with either a left or right hand.

[0036] 9 depicts 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 grasping fingers 162 along a vertical axis 168 that is aligned with the direction of gravity. As the catheter 34 and cable 120 extend distally, the catheter steering handle 32 remains balanced. This allows the handle 32 to balance the grasping fingers 162 without the need to grasp the handle 32. This eliminates the need for force on the operator's part to maintain the orientation of the handle 32 at rest, since the handle 32 itself is suspended from the grasping fingers 162 when the hand is flexed or relaxed.

[0037] The finger rest 108 of the projection 98 provides an area on the head portion 44 where an actuating finger can safely rest while the push button is not being actuated. The operator does not need to maintain the actuating finger extending away from the head portion 44 during actuation. That is, the actuating finger does not need to be placed in a location distal to the head portion 44. The finger rest 108 is also located on the head portion 44 in a known position proximate to the push button actuator 126 when the actuating finger is placed thereon.

[0038] In some embodiments, the methods for reducing hand fatigue while manipulating a catheter steering handle are provided as instructions on a tangible, non-transitory medium. Non-limiting examples of tangible, non-transitory medium include paper documents and computer readable media, including compact discs 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. The instructions may be contained in a single medium or may be split across two or more media. For example, some instructions may be written on a paper document and instruct a user to access one or more of the method steps via the Internet. The steps accessible via the Internet may be stored on one or more computer readable media. The instructions may be in the form of handwritten text, drawings, and / or video presentations.

[0039] The entire contents of U.S. Patent Nos. 5,393,633, 5,491,621, 5,592,713, and 5,633,722 are incorporated herein by reference. The incorporation of patent documents herein is limited in any way so that no matter contrary to the express disclosure is incorporated herein.

[0040] Each of the additional features 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. Thus, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense, but are instead disclosed only to specifically illustrate exemplary and preferred embodiments.

[0041] Various modifications of the embodiments will be apparent to those skilled in the art upon reading this specification. For example, as can be understood by those skilled in the art, various features described in different embodiments can be combined, separated, and recombined with other features as appropriate, and can be used alone or in various combinations. Similarly, the various features described above should be considered as exemplary embodiments, rather than limiting the technical scope or spirit of the present invention.

[0042] As will be appreciated by those skilled in the art, various embodiments may include fewer features than any of the above-described embodiments. The embodiments described herein are not intended to represent an exhaustive list of combinations of various features. Thus, the embodiments are not mutually exclusive combinations of features, but rather, the claims include different combinations of features selected from different embodiments, as will be appreciated by those skilled in the art.

[0043] Unless expressly stated otherwise, the terms "embodiment(s)," "disclosure," "present disclosure," "disclosed embodiment(s) of the disclosure," and "disclosed embodiment(s)," and similar examples contained herein, refer to the specification (the description and drawings of the claims) of this application which are not admitted to be prior art.

[0044] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) not be invoked unless the specific words "means for" or "step for" appear in each claim. [Explanation of symbols]

[0045] 30 Catheter assembly 30a Catheter assembly 30b Catheter assembly 32 Steering wheel 32a Steering wheel 32b Steering wheel 34 Catheter 36 (of the catheter 34) proximal end portion 38 (of catheter 34) distal end portion 42 (operating handle 32) housing 42a Housing part 42b Housing part 44 (head portion of housing 42) 46 (of housing 42) base portion 48 (of housing 42) main body portion 50 Handle axis 52 Central plane 54 (of housing 42) front 56 (of housing 42) rear surface 62 Forward direction 64 backward direction 66 Proximal 67 Distal 68 Fixtures 74 (rear surface 56) convex contour 82 Transition 84 (Head portion 44 and body portion 48) joint 86 (of the housing 42 at the transition portion 82) 88 Minimum point 90 Joint dimensions 98 Protrusion 100 (of protrusion 98) distal end portion 102 Catch 104 Hook Shape 106 (hook shape 104) forward length 108 (protruding portion 98) finger hook portion 110 (of protrusion 98) front surface (front contour) 114 (Catch 102) Depth 115 Reference Line 116 (of opening 112) minimum opening dimension 118 Reference point 119 Maximum depth dimension 120 Cable (wiring) 122 (Head part 44) Thumb lever 124 Lateral axis 126 Push Button Actuator 128 Electrical Ports 132 (base part 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 Grasping Fingers 164 Finger for Activation

Claims

1. A steering handle for a catheter, comprising:

1. A steering handle comprising a housing including a body portion defining a handle axis, a head portion, and a base portion separated along the handle axis by the body portion, the housing defining a midplane that contains the handle axis and that passes through front and rear faces of the housing, A steering handle as claimed in any one of claims 1 to 5, wherein the housing defines a transition portion at the juncture of the body portion and the head portion, the transition portion defining a catch on a front surface of the housing at the central surface.

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