Steerable and rotatable medical device

Abstract

A medical device and related methods that facilitate rotating a medical device to a plurality of planes are described. The medical device can include a handle including a proximal portion and a distal portion coupled to the proximal portion by a connector configured to be grasped by a user. The distal portion can be rotatable relative to the proximal portion by rotating the connector, and an articulation mechanism can be disposed within the proximal and distal portions of the handle and extending through the connector. The articulation mechanism can be configured to control articulation of a shaft coupled to the handle and include a coupler that is translatable relative to the connector independently of rotation of the connector.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 567,229, filed March 19, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical devices and actuator mechanisms for medical devices. More specifically, this disclosure relates to medical systems and devices for selectively adjusting the orientation of a medical device along various planes. Background Technology

[0004] During a medical procedure, a user can operate a medical device that includes a handle and a shaft extending distally from the handle. Some devices also include a steering mechanism that allows the user to deflect the distal end of the device's shaft. However, in order to change the deflection of the distal end in multiple planes, the user may have to rotate the device's handle in an uncomfortable manner, which can lead to increased fatigue over time and make manipulating the device more difficult.

[0005] For example, medical professionals may experience wrist and hand discomfort from manually manipulating medical devices to reach different planes. Therefore, the procedure may be prolonged and / or pose risks to the patient. Summary of the Invention

[0006] This disclosure includes a medical device that facilitates rotation of the medical device onto multiple planes.

[0007] For example, this disclosure includes a handle comprising a proximal portion and a distal portion, the distal portion being coupled to the proximal portion via a connector configured for gripping by a user. The distal portion can be rotated relative to the proximal portion by rotating the connector, and a hinge mechanism can be disposed within the proximal and distal portions of the handle and extend through the connector. The hinge mechanism can be configured to control the hinge of the axis coupled to the handle and includes a connector capable of translating relative to the connector independently of rotation of the connector.

[0008] According to some aspects, a shaft or its proximal end may be coupled to the distal end of a distal portion of a handle, and the hinge mechanism may include at least one hinge member extending from the handle through the shaft. The proximal portion of the handle includes an actuator that receives user input to control translation of the connector. The connector may include a knob. The connector may include a proximal extension abutting against and rotatable relative to the distal extension. The connector may include a proximal slider and a distal slider, the proximal slider including the proximal extension, and the distal slider including the distal extension. The proximal portion of the handle may include an actuator, and user input received by the actuator may control translation of the connector. The distal slider may be configured to rotate by rotation of the connector but not by rotation of the proximal slider. The connector may be biased toward the proximal portion of the handle. The proximal portion of the handle may include a spring that biases the connector toward the proximal portion of the handle. The proximal portion of the handle may include a locking mechanism to lock the rotatable position of the connector relative to the proximal portion of the handle. Alternatively, the connector may define a plurality of holes, and the locking mechanism may include a pin receivable in each hole. The hinge mechanism may include a cam coupled to at least one hinge member, the cam being contained within the distal portion of the handle. Furthermore, for example, the cam may be coupled to a coupler and configured to rotate via translation of the coupler.

[0009] This disclosure also includes a medical device that may include a handle having a proximal portion and a distal portion, the proximal portion including an actuator, and the distal portion being coupled to the proximal portion via a connector configured for gripping by a user. The distal portion may rotate relative to the proximal portion by rotation of the connector. A shaft may be coupled to the distal portion of the handle, and a hinge mechanism may be configured to control the hinge of the shaft. The hinge mechanism may be disposed within the handle and extend through the connector. The hinge mechanism may include a connector that is translatable relative to the connector independently of rotation of the connector. For example, the connector may include a proximal slider coupled to the actuator and a distal slider coupled to at least one hinge member extending from the handle through the shaft. Furthermore, the connector is translatable relative to the connector independently of rotation of the connector.

[0010] According to some aspects, the distal end of the proximal slider abuts against the proximal end of the distal slider, and the distal slider is rotatable relative to the proximal slider. The connector may include a housing surrounding the distal end of the proximal slider and the proximal end of the distal slider. The handle may include a locking mechanism to restrict rotation of the distal portion of the handle relative to the proximal portion of the handle. In some examples, the locking mechanism may include a pin that can be inserted into a plurality of holes defined by the connector.

[0011] This disclosure also includes a medical device comprising a handle having a proximal portion and a distal portion, the distal portion being coupled to the proximal portion via a connector configured for gripping by a user. The distal portion can be rotated relative to the proximal portion by rotating the connector, and a hinge mechanism can be disposed within the proximal and distal portions of the handle and extend through the connector. The hinge mechanism can be configured to control the hinge of an axis coupled to the handle and can include a connector capable of translating relative to the connector independently of rotation of the connector. According to some aspects, the proximal portion of the handle may include a pin that can be inserted into a plurality of holes defined by the connector to selectively restrict rotation of the distal portion of the handle relative to the proximal portion of the handle. Attached Figure Description

[0012] Exemplary aspects are illustrated in conjunction with the accompanying drawings, which form part of this specification, and serve, together with the written description, to explain the principles of this disclosure. Each drawing depicts one or more exemplary aspects of this disclosure, as follows:

[0013] Figure 1 A front sectional view of an exemplary medical device according to some aspects of this disclosure is depicted.

[0014] Figure 2 Depicting Figure 1 The proximal handle portion of the medical device.

[0015] Figure 3 Depicting Figure 1 The proximal handle portion, connector, and distal portion of the medical device.

[0016] Figure 4 Depicting the rotating handle Figure 1 A frontal cross-sectional view of a medical device.

[0017] Figure 5A Depicting Figure 1 Connectors for medical devices.

[0018] Figure 5B Depicting Figure 1 Features of the distal portion of the handle of a medical device. Detailed Implementation

[0019] The general description above and the detailed description below are merely exemplary and illustrative, and not intended to limit the claimed features. As used herein, the terms “comprising,” “consisting of,” “having,” “including,” or other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. In this disclosure, relative terms such as “about,” “substantially,” “approximately,” and “approximately” are used to indicate a possible variation of 10% in the value or characteristic described.

[0020] Various aspects of this disclosure will now be described with reference to exemplary medical devices, systems, and methods that facilitate ergonomic guidance of the medical device to a user. For example, a medical device may include a handle configured to rotate an axis of the medical device without rotating it entirely within the handle, for example, by rotating a distal portion of the handle relative to a proximal portion of the handle. The proximal and distal portions of the handle may be coupled together via a rotatable connector. The medical device may include an articulation mechanism disposed within the handle and configured to control the axis of the medical device along one or more planes. The articulation mechanism may extend through the proximal portion of the handle, the connector, and the distal portion of the handle. The connector may be configured to be gripped by a user to allow selective rotation of the connector and the distal portion of the handle relative to the proximal portion of the handle. The articulation mechanism may include features that allow a user to deflect a distal end of the axis of the medical device and rotate the axis independently of the deflection.

[0021] Various aspects of this disclosure will now be illustrated with detailed reference to the accompanying drawings. Where possible, the same reference numerals will be used throughout the drawings to denote the same or similar parts.

[0022] Figure 1 An exemplary medical device 100 is shown, including a handle 106 and a shaft 102. The medical device 100 can be any suitable device configured to allow a user to access and observe internal areas of a subject's body and to perform medical diagnosis and / or treatment on the subject. For example, the medical device 100 can be a ureteroscope, endoscope, hysteroscope, bronchoscope, cystoscope, or other endoscope or similar medical device.

[0023] Handle 106 may include a port 107 communicating with a working channel defined by shaft 102. Assistive instruments (e.g., biopsy forceps, grasping forceps, baskets, snares, and / or other devices) may be inserted into port 107 and advanced through the working channel to enter the subject's body through a distal opening at the distal end 105 of shaft 102, thereby performing medical procedures. Shaft 102 may provide access to body cavities (e.g., along a tortuous path, such as via natural body orifices).

[0024] The handle 106 includes a proximal portion 110 and a distal portion 150 coupled together via a connector 140. The connector 140 may be rotatable, allowing the distal portion 150 of the handle to rotate relative to the proximal portion 110. Although the connector 140 is shown as a knob, other shapes are also contemplated here as long as the connector is rotatable. The handle 106 may have any suitable shape that can be gripped by a user's hand. For example, the proximal portion 110 of the handle 106 may include a gripping portion proximal to the connector 140. As discussed further below, the connector 140 may also be configured to be gripped by a user. The distal portion 150 of the handle may be coupled to a proximal end 104 of a shaft 102. The proximal end 104 of the shaft may be detachably or permanently connected to the distal end of the distal portion 150 of the handle 106.

[0025] Handle 106 also includes an actuator 112 operatively coupled to a hinge mechanism to control movement of shaft 102. In this example, port 107 is shown on the distal portion 150 of handle 106, while actuator 112 is shown on the proximal portion 110 of handle 106; however, other arrangements are also considered herein. Actuator 112 is shown as a rotatable lever in the figures, but can be configured as another type of actuator, such as a knob, switch, or wheel. As will be discussed in more detail below, actuator 112 can be operatively coupled (e.g., directly or indirectly) to the hinge mechanism in handle 106 and to one or more hinge members 160 (e.g., traction cables) extending through handle 106 and / or shaft 102.

[0026] The hinge mechanism includes a connector 130 that is translatable relative to the connector 140, for example, along the longitudinal axis of the handle 106. In some examples, the connector 130 includes a proximal extension that abuts against a distal extension, the distal extension being rotatable relative to the proximal extension. For example, the connector 130 may include a proximal slider 136 and a distal slider 138 joined together and rotatable relative to each other.

[0027] Actuator 112 can control the translation of connector 130 to deflect the distal end 105 of shaft 102 using one or more hinge members 160. Actuator 112 can be operatively coupled to connecting rod 116 and cam 118, and further operatively coupled to proximal slider 136, to convert movement of actuator 112 (e.g., in the case of actuator 112 being a lever, the lever being rotated via user input) into translation along the longitudinal axis of medical device 100. Similarly, distal slider 138 can be coupled to connecting rod 154 and cam 156 to drive cam 156 to rotate, thereby controlling the movement applied to one or more hinge members 160 coupled to cam 156. Figure 1 The tension on the two hinge members 160 is shown. The hinge members 160 may extend through the shaft 102 (or be otherwise operably coupled to the hinge members extending through the shaft 102) to deflect the shaft 102 relative to the handle 106 and the longitudinal axis of the medical device 100.

[0028] Once the distal end 105 of shaft 102 is in the desired position relative to the longitudinal axis of medical device 100 (e.g., off-axis), the user can adjust the plane along which shaft 102 extends by rotating shaft 102. To rotate shaft 102 without rotating the grip handle 106 and the hand controlling actuator 112, the user can grip the proximal portion 110 of handle 106 with one hand while rotating connector 140 (e.g., using the other hand) to rotate the distal portion 150 of handle 106 and shaft 102 relative to the proximal portion 110 of handle 106. Because the distal portion 150 is rotatable relative to the proximal portion 110, the user does not need to adjust their grip on the proximal portion 110 to rotate shaft 102.

[0029] Figure 2 An exploded view of the features of the hinge mechanism is shown, including a proximal slider 136 and a distal slider 138 of the connector 130. At least a portion of the proximal slider 136 and the distal slider 138 may be located within the proximal portion 110 of the handle 106. As described above, the proximal slider 136 may be coupled to a cam 118 and a connecting rod 116. This connection may include, for example, mechanical fasteners (e.g., screws, fixing screws, bolts, rivets, etc.) or adhesives. The handle 106 may include features that guide the movement of the proximal slider 136 and the distal slider 138 in a linear direction.

[0030] The connector 130 may include a housing that at least partially or completely surrounds the distal end 122 of the proximal slider 136 and the proximal end 124 of the distal slider 138. In some examples, the proximal slider 136 and the distal slider 138 have surfaces that abut against each other, for example, within the housing, and allow the proximal slider 136 to rotate relative to the distal slider 138. In some examples, as shown, the distal end of the proximal slider 136 and the proximal end of the distal slider 138 are each cylindrical in shape with flat surfaces that abut against each other. Other shapes may also be considered here, provided that the proximal slider 136 is rotatable relative to the distal slider 138. For example, the housing of the connector 130 may define a cavity with sufficient space to allow the distal slider 138 to rotate relative to the proximal slider 136. Although Figure 2 The illustration shows a shell defining a generally cylindrical cavity, but this is merely exemplary and other shapes may be considered in this paper.

[0031] The proximal slider 136 can be a single, integral component, or it can comprise two or more components joined together. For example, the housing of the proximal slider 136 includes an extension comprising the distal end 122 of the proximal slider 136, which is integral with or fixedly coupled to the proximal end of the proximal slider 136 (the proximal end of the proximal slider 136 is coupled to the connecting rod 116, cam 118, and actuator 112). Although Figure 2 A threaded connection is shown to secure the extension to the remainder of the proximal slider 136, but this is merely exemplary. Other types of mating elements or adhesives may be used, or the extension may be integral with the remainder of the proximal slider 136.

[0032] Similarly, the distal slider 138 can be a single, integral component, or it can include two or more components joined together. For example, the distal slider 138 may include an extension that includes a proximal end 124 of the distal slider 138, the extension being integral with or fixedly coupled to the distal end of the distal slider 138 (the distal end of the distal slider 138 is coupled to the connecting rod 154, the cam 156, and the hinge member 160). Although Figure 2 A threaded connection is shown to secure the extension to the remainder of the distal slide 138, but this is merely exemplary. Other types of mating elements or adhesives may be used, or the extension may be integral with the remainder of the distal slide 138.

[0033] The distal slider 138 may have a geometric cross-section that prevents rotation of the distal slider 138 relative to the connector 140 and the distal portion 150 of the handle 106. In this way, rotation of the connector 140 can cause a corresponding rotation of the distal slider 138 and the distal portion 150 of the handle 106. In aspects of this disclosure, at least a portion of the distal slider 138 may have a rectangular (e.g., square) cross-sectional shape, which is slidably received within a corresponding rectangular (e.g., square) aperture of the connector 140. Thus, the distal slider 138 can translate relative to the connector 140 within the handle 106 without rotating relative to the connector 140. This configuration allows the user to rotate the connector 140 to rotate the distal portion 150 of the handle 106 without engaging the hinge member 160 coupled to the distal slider 138. Figure 4 This shows the effect after the distal portion 150 of the handle 106 is rotated. Figure 1 The medical device 100 does not change the deflection of the distal end 105 of the shaft 102.

[0034] As described above, the deflection of shaft 102 can be achieved via user input at actuator 112. The user engages actuator 112, which in turn controls the translation of connector 130 along the longitudinal axis of handle 106 (and along the longitudinal axis of medical device 100). Rotation of actuator 112 engages cam 118 within the proximal portion 110 of handle 106, which transmits motion to proximal slider 136 of connector 130 via connecting rod 116. Because the distal end 122 of proximal slider 136 abuts against the proximal end 124 of distal slider 138, translation of proximal slider 136 causes translation of distal slider 138. Translation of distal slider 138 causes connecting rod 154 to rotate cam 156 and controls the tension of hinge member 160 connected to cam 156, thereby deflecting shaft 102.

[0035] According to some aspects of this disclosure, the handle 106 includes a locking mechanism to limit rotation of the distal portion 150 relative to the proximal portion 110. Figure 3 An exemplary locking mechanism is shown. The locking mechanism may include a pin 147 that can be received in one of a plurality of holes 148. For example, the proximal portion 110 of a handle 106 may include the pin 147, and the connector may include a plurality of holes 148. The holes 148 may be spaced at regular intervals, such as uniformly spaced at 10-degree intervals. The spacing between the holes 148 shown in the figures (and therefore the total number of holes 148) is merely exemplary and not a limitation on other examples (e.g., holes spaced at 45-degree intervals, 30-degree intervals, etc.).

[0036] Connector 140 can be biased in the proximal direction, for example, via spring 142. To rotate connector 140, the user can apply a force in the distal direction to overcome the biasing force of spring 142 and release pin 147 from the corresponding hole 148. Pin 147 can retract from its position within one hole 148 to unlock the locking mechanism, allowing connector 140 to rotate freely with the distal portion 150 of handle 106. Once pin 147 is released, connector 140 can be allowed to rotate relative to the proximal portion 110 of handle 106.

[0037] Figure 5A and Figure 5B The diagram depicts mating elements of connector 140 and the distal portion 150 of handle 106, allowing connector 140 to cause a corresponding rotation of the distal portion 150 of handle 106 (e.g., when a user rotates connector 140). For example, connector 140 includes a slot or cavity 145 receiving a corresponding protrusion 155 of the distal portion 150. The shape of the cavity 145 and the protrusion 155 allows connector 140 to translate relative to the distal portion 150 of handle 106 to facilitate engagement of the locking mechanism as described above.

[0038] Connector 140 may have surface features, such as ribs or bevels, to facilitate user gripping. When the user has rotated shaft 102 to face a desired orientation by rotating the distal portion 150 of handle 106 coupled to shaft 102, pin 147 can be re-inserted into the corresponding hole 148 to lock medical device 100 in the desired position. The user can release connector 140 to move it proximally due to the biasing force of spring 142 and lock handle 106 in position by inserting pin 147 into the corresponding hole 148.

[0039] While this disclosure describes the principles of the disclosure with reference to illustrative aspects of specific medical uses and procedures, it is not limited thereto. Those skilled in the art and those who have received the teachings herein will recognize that alternative modifications, applications, aspects, and equivalents fall within the scope of the aspects described herein. Therefore, this disclosure should not be considered as limited by the foregoing description.

Claims

1. A medical device comprising: A handle having a proximal portion and a distal portion, the distal portion being connected to the proximal portion via a connector configured for gripping by a user, wherein rotation of the connector allows the distal portion to rotate relative to the proximal portion; and A hinge mechanism is disposed within the proximal and distal portions of the handle and extends through the connector, wherein the hinge mechanism is configured to control the hinge of the shaft coupled to the handle, and includes a connector capable of translating relative to the connector independently of rotation of the connector.

2. The medical device of claim 1, further comprising a shaft, wherein a proximal end of the shaft is coupled to a distal end of a distal portion of the handle, and wherein, The hinge mechanism includes at least one hinge member extending from the handle through the shaft.

3. The medical device according to claim 1 or 2, wherein, The proximal portion of the handle includes an actuator, and the translation of the connector is controlled by user input received by the actuator.

4. The medical device according to any one of the preceding claims, wherein, The connector includes a knob.

5. The medical device according to any one of the preceding claims, wherein, The connector includes a proximal extension that abuts against a distal extension and is rotatable relative to the distal extension.

6. The medical device according to any one of the preceding claims, wherein, The connector includes a proximal slider with a proximal extension and a distal slider with a distal extension.

7. The medical device according to any one of the preceding claims, wherein, The proximal portion of the handle includes an actuator, and the translation of the connector is controlled by user input received by the actuator.

8. The medical device according to claim 6 or 7, wherein, The distal slider is configured to rotate by rotation of the connector without rotating the proximal slider.

9. The medical device according to any one of the preceding claims, wherein, The connector is biased in the direction toward the proximal portion of the handle.

10. The medical device according to any one of the preceding claims, wherein, The proximal portion of the handle includes a spring that biases the connector toward the proximal portion of the handle.

11. The medical device according to any one of the preceding claims, wherein, The proximal portion of the handle includes a locking mechanism for locking the rotatable position of the connector relative to the proximal portion of the handle.

12. The medical device according to claim 11, wherein, The connector defines a plurality of holes, and the locking mechanism includes a pin that can receive a pin in each hole.

13. The medical device according to claim 11 or 12, wherein, The locking mechanism restricts the rotation of the distal portion of the handle relative to the proximal portion of the handle.

14. The medical device according to any one of the preceding claims, wherein, The hinge mechanism further includes a cam coupled to at least one hinge member, the cam being contained within the distal portion of the handle.

15. The medical device according to any one of the preceding claims, wherein, The cam is coupled to the connector and configured to rotate by translation of the connector.

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