Intervention handles and intervention systems

Abstract

An interventional handle and an interventional system are disclosed. The interventional handle includes a screw shaft (10), a ball nut (20), and a drive assembly (30). The screw shaft (10) defines a through hole (12) that penetrates the screw shaft (10) along its axis and is fitted for coaxial insertion of a catheter assembly (40). The screw shaft (10) is fitted to be coaxially connected to the catheter assembly (40). The ball nut (20) engages with the screw shaft (10) and is circumferentially rotatable around the screw shaft (10), limiting the displacement of the screw shaft (10) along its axis. The drive assembly (30) is fitted to drive the ball nut (20) to rotate the screw shaft (10) circumferentially, causing axial movement of the screw shaft (10). In this configuration, the catheter assembly (40) is coaxially inserted into the through-hole (12) of the screw shaft (10) and is coaxially coupled to the screw shaft (10), so that only axial force acts on the screw shaft (10). This effectively overcomes the problems associated with conventional eccentric catheters (03).

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to handles and systems for intervention applications.

Background Art

[0002] Interventional therapy is a new treatment technology that has emerged in recent years as a minimally invasive alternative treatment based on state-of-the-art technology. This includes inserting dedicated precision instruments for diagnosing and locally treating lesions present in a patient's body into the patient's body under the guidance of a medical imaging device. This technology is minimally invasive, has a rapid recovery, provides good treatment results, and can avoid potential hazards that conventional surgery can bring to patients.

[0003] Delivery systems used in interventional procedures generally consist of a catheter and a handle. The handle, which functions as the power source for the entire procedure, needs to have sufficient safety and effectiveness. Conventional manual handles transmit power by screw fitting, while electric handles transmit power using a motor, shaft coupling, gears, screws, and other components. Depending on the application, the use of a delivery system with improved performance such as improved accuracy, ease of operation, and improvements in performance aspects such as increased efficiency of power transmission, improved coaxiality of components involved in power transmission to the catheter, and improved steerability of the catheter is required.

[0004] Some conventional handles use a screw and nut as a conversion mechanism for power transmission, with the catheter eccentrically arranged on one side of the screw. This configuration not only occupies a large space but also generates a bending moment on the screw-nut mechanism due to the eccentrically arranged catheter, causing the power transmission by the screw-nut to become stuck and further risking malfunctions and damage.

Summary of the Invention

[0005] The object of the present invention is to provide an interventional handle and system that overcomes the problems associated with conventional handles arising from the use of eccentric catheters.

[0006] For this purpose, the present invention provides an interventional handle comprising a screw shaft, a ball nut, and a drive assembly. The screw shaft defines a through hole that penetrates along its axis, and is fitted so that a catheter assembly is inserted coaxially into it, and the screw shaft is fitted so that it is coaxially connected to the catheter assembly, The ball nut engages with the screw shaft, is rotatable around the screw shaft, and restricts the displacement of the screw shaft along its axis. The drive assembly is adapted to drive the ball nut to rotate around the screw shaft, thereby causing axial movement of the screw shaft.

[0007] Optionally, the screw shaft may have a connecting portion adapted to be coaxially connected to the catheter assembly at a joint portion that is rotationally symmetric with respect to the axis of the screw shaft.

[0008] Optionally, the connecting portion may be continuous around the entire circumference of the inner wall of the through hole, or it may be attached to the catheter assembly along the entire outer periphery of the catheter assembly.

[0009] Optionally, the handle may further include a stop assembly. The stop assembly is switchable between a locked configuration and an unlocked configuration. When the stop assembly is in the lock configuration, it limits the axial movement distance of the screw shaft to a predetermined movement distance range. When the stop assembly is in the unlocked configuration, it no longer restricts the axial travel distance of the screw shaft, allowing it to exceed the predetermined travel distance range.

[0010] Optionally, the stop assembly may have a protruding member and a locking member, the protruding member protruding from the outer wall of the screw shaft, and the locking member being movable between a first position and a second position in a direction perpendicular to the axis of the screw shaft. When the locking member is in the first position, the projection of the locking member and the projection of the protruding member overlap along the axis of the screw shaft, and the stop assembly becomes a locked configuration. In the locked configuration, when the axial movement distance of the screw shaft reaches the limit of the predetermined movement distance range, the protruding member comes into contact with the locking member. When the locking member is in the second position, there is no overlap between the projection of the locking member along the axis of the screw shaft and the projection of the protruding member, and the stop assembly is in the unlocked configuration.

[0011] Optionally, the stop assembly may further include a biasing member adapted to bias the locking member from a first position to a second position, thereby holding the locking member in the second position when not subjected to stress or restriction.

[0012] Optionally, the stop assembly may further include a removable or movable operating member for biasing the locking member from the second position to the first position.

[0013] The operating member may optionally be movably arranged between a third position and a fourth position along the axis of the screw shaft, and may have a push / pull portion, an inclined portion and a contact portion that are sequentially joined along the axis of the screw shaft. When the operating member is in the third position, the push-pull portion coincides with the locking member in the axial direction, and the locking member is in the second position. While the operating member is moved from the third position to the fourth position, the inclined portion gradually biases the locking member from the second position to the first position. When the operating member is in the fourth position, the contact portion contacts the locking member axially, thereby holding the locking member in the first position.

[0014] Optionally, the intervention handle may further comprise a housing, and the operating member may have a removable cover. When the cover is assembled to the housing, the cover comes into contact with the locking member, thereby holding the locking member in the first position. When the cover is removed and separated from the housing, the locking member is in the second position.

[0015] To the above objective, the present invention also provides an interventional system comprising the handle defined above and a catheter assembly inserted into the through-hole and coupled to the screw shaft.

[0016] As described above, the present invention provides a handle and system for interventional applications. The handle comprises a screw shaft, a ball nut, and a drive assembly. The screw shaft defines a through hole, which is formed through the screw shaft in the axial direction and is fitted so that a catheter assembly is coaxially inserted into the through hole. The screw shaft is fitted to be coaxially connected to the catheter assembly. The ball nut engages with the screw shaft and is rotatable in the circumferential direction of the screw shaft, with its displacement along the axial direction of the screw shaft restricted. The drive assembly is fitted to rotate the ball nut around the screw shaft, thereby moving the screw shaft axially.

[0017] With this configuration, the catheter assembly is coaxially inserted into the through-hole of the screw shaft and coaxially coupled to the screw shaft, so only axial forces act on the screw shaft, effectively overcoming the problems associated with conventional eccentric catheters. [Brief explanation of the drawing]

[0018] Those skilled in the art will understand that the following drawings are provided to better understand the present invention and are not intended to limit the scope of the present invention in any way. [Figure 1] Figure 1 shows a schematic axial cross-sectional view of a handle for intervention according to the present invention. [Figure 2] Figure 2 shows a schematic view of an axial cross-section of a handle for intervention according to an embodiment of the present invention. [Figure 3] Figure 3 schematically shows the state in which the screw shaft has translated in the proximal direction in the handle shown in Figure 2. [Figure 4] Figure 4 is a schematic partial view of a handle for intervention according to an embodiment of the present invention, which includes a power transmission member configured as a gear set. [Figure 5] Figure 5 is a schematic partial view of a handle for intervention according to an embodiment of the present invention, which includes a power transmission member implemented as a belt transmission mechanism. [Figure 6] Figure 6 is a schematic partial view of a handle for intervention according to an embodiment of the present invention, which includes a motor implemented as a coreless motor. [Figure 7] Figure 7 is a schematic view of a screw shaft that engages with a ball nut according to an embodiment of the present invention. [Figure 8] Figure 8 shows a schematic view of a handle for intervention according to an embodiment of the present invention. [Figure 9] Figure 9 is a schematic partial view of a handle for intervention according to an embodiment of the present invention, which includes a stop assembly. [Figure 10] Figure 10 shows a schematic axial cross-sectional view of a handle for intervention according to an embodiment of the present invention, which includes a stop assembly. [Figure 11] Figure 11 is a schematic view showing a stop assembly with a locking configuration and a screw shaft located within a predetermined movement distance range according to an embodiment of the present invention. [Figure 12]Figure 12 is a schematic diagram showing a locking stop assembly and a screw shaft located at one end of a predetermined travel distance range, according to one embodiment of the present invention. [Figure 13] Figure 13 is a schematic diagram showing a stop assembly in an unlock configuration according to one embodiment of the present invention. [Figure 14] Figure 14 is a schematic diagram showing a cover assembled to a housing according to an embodiment of the present invention. [Figure 15] Figure 15 is a schematic diagram showing a cover separated from the housing according to an embodiment of the present invention. [Modes for carrying out the invention]

[0019] The object, advantages, and features of the present invention will become even clearer by reading the following more detailed description with reference to the accompanying drawings illustrating specific embodiments. Note that the drawings are significantly simplified for the sole purpose of making the description of the disclosed embodiments easier and clearer, and are not necessarily to exact scale. Furthermore, the illustrated structures typically constitute parts of their real-world counterparts. In particular, they may be illustrated at different scales, as each figure tends to emphasize different aspects.

[0020] In this specification, the singular forms "a," "an," and "the" are used to include plural nouns. The term "or" is generally used to mean "and / or." Similarly, quantitative expressions such as "a number of," "at least one," "at least two," and "two or more" are used in a similarly comprehensive sense. Furthermore, the use of the terms "first," "second," and "third" in this specification is for illustrative purposes only and should not be interpreted as indicating or suggesting relative importance, nor does it implicitly indicate the number of items being referred to. Therefore, specifying an item with an ordinal number such as "first," "second," or "third" explicitly or implicitly indicates that there is one or at least two such items. In this specification, the terms "one end" and "the other end," as well as "proximal end" and "distal end," may be used to refer generally to the corresponding ends, rather than strictly to the endpoints themselves. Furthermore, terms such as “attachment,” “joining,” “connection,” and “positioning,” and their variations, as used herein, shall be interpreted broadly. When an element is described as being “positioned” on another element, this generally means only that a connection, joining, engagement, or transmission relationship exists between them, which may be direct or indirect, including when one or more elements are interposed, and should not be interpreted as indicating or implying a specific spatial positional relationship between them. That is, unless the context clearly indicates otherwise, the element may be positioned inside, outside, above, below, to the side, or in any other position relative to another element. Those skilled in the art will be able to understand the specific meaning of each of the above terms herein in context. Furthermore, terms indicating direction, such as “up,” “down,” “upper side,” “lower side,” “upper,” “downward,” “left,” and “right,” are used in relation to the illustrative embodiments shown, where an upward or upper direction means a direction toward the upper side of the corresponding figure, and a downward or lower direction means a direction toward the lower side of the corresponding figure.

[0021] The object of the present invention is to provide an interventional handle and system that overcomes the problems that arise in conventional handles due to catheter eccentricity, as will be described below with reference to the accompanying drawings.

[0022] As shown in Figure 1, the interventional handle comprises a screw 01, a nut 02, and a catheter 03. The screw 01 is rotatable around its own axis, and its position along its axis is limited. The nut 02 is screwed onto the screw 01, and the movement of the screw 01 is limited to circumferential rotation around its axis. The catheter 03 is attached to one end of the nut 02, so that when the screw 01 is rotated around its axis, the nut 02 can translate along the axis of the screw 01, and therefore the catheter 03 also moves along the axis. As described in the background art, in this configuration, the screw 01 and nut 02 occupy a large space, which is disadvantageous for miniaturizing the handle. Furthermore, when resistance is encountered, the catheter 03 may impart bending torque to the screw 01, and as a result, the screw 01, which is intended to be subjected only to forces along its axis, may bend or deflect to a certain extent. Such deflection torque is extremely undesirable for elongated members such as the screw 01. This is because a large deflection torque could damage the screw 01. As a result, the nut 02 could become jammed into the screw 01, potentially rendering power transmission impossible.

[0023] As shown in Figures 2 and 3, embodiments of the present invention provide an interventional handle comprising a screw shaft 10, a ball nut 20, and a drive assembly 30. The screw shaft 10 defines a through hole 12 that penetrates the screw shaft along its axis, and the through hole 12 is fitted so that a catheter assembly 40 is inserted coaxially into the screw shaft. The screw shaft 10 is fitted to be coaxially connected to the catheter assembly 40. The ball nut 20 engages with the screw shaft 10 so as to be circumferentially rotatable with respect to the screw shaft 10, thereby limiting the axial displacement of the screw shaft 10. The drive assembly 30 is fitted to move the screw shaft 10 axially by rotating the ball nut 20 circumferentially around the screw shaft 10. Since the catheter assembly 40 is coupled to the screw shaft 10, when the screw shaft 10 moves axially, the catheter assembly 40 or a part of it also moves in the same direction.

[0024] Compared to the handle shown in Figure 1, in this embodiment, the catheter assembly 40 is coupled to the screw shaft 10 instead of the ball nut 20. Furthermore, the catheter assembly 40 is directly (partially) inserted into the through hole 12 of the screw shaft 10. In addition, the axial position of the ball nut 20 is restricted, and the rotation of the screw shaft 10 is restricted. As a result, the screw shaft 10 can translate axially as the ball nut 20 rotates, and consequently, the catheter assembly 40 is also driven coaxially and moves accordingly. With this configuration, the catheter assembly 40 applies only axial force to the screw shaft 10, effectively overcoming the problems associated with conventional eccentric catheters.

[0025] As shown in Figure 3, in one exemplary embodiment, the drive assembly 30 includes a manual actuator 31, the manual actuator 31 includes a rotary knob 311, the rotary knob 311 is preferably coaxially and fixedly coupled to the ball nut 20. In this way, the rotation of the rotary knob 311 rotates the ball nut 20. Preferably, as shown in Figure 3, the rotary knob 311 defines a through hole that passes through the rotary knob 311 along the axis of the screw shaft 10, and the screw shaft 10 can be inserted through the through hole.

[0026] As shown in Figures 4 and 5, in other exemplary embodiments, the drive assembly 30 includes an electric actuator 32. The electric actuator 32 includes a motor 321 and a power transmission member 322. The motor 321 is connected to the ball nut 20 via the power transmission member 322. The power transmission member 322 includes, for example, a gear set as shown in Figure 4 or a belt drive mechanism as shown in Figure 5. As shown in Figure 6, in some alternative embodiments, the electric actuator 32 does not include a power transmission member 322. In this case, for example, the motor 321 may be implemented as a coreless motor and may be used to directly drive the ball nut 20. Those skilled in the art will be able to understand the configuration and operation of the electric actuator 32 based on their knowledge of the art.

[0027] The drive assembly 30 may also include both a manual actuator 31 and an electric actuator 32. In manual operation mode, the electric actuator 32 can be rotated without resistance by directly rotating the rotary knob 311. In electric operation mode, the motor 321 can output power to rotate the ball nut 20, and consequently the rotary knob 311.

[0028] As shown in Figure 7, in this embodiment, power may be transmitted between the screw shaft 10 and the ball nut 20 via a ball. This makes it possible to achieve a power transmission efficiency of 90% or more while suppressing power loss. Therefore, under the same load conditions, it is possible to select a motor 321 that has a lower torque output, is smaller, and is less expensive. Optionally, the ball nut 20 may employ an internal or external ball return mechanism without departing from the scope of the present invention. The ball nut 20 can have a configuration known to those skilled in the art, and no further explanation is provided herein.

[0029] Preferably, in this embodiment, the screw shaft 10 is made of a polymer material, which facilitates manufacturing and the formation of the through hole 12. More specifically, since the screw shaft 10 does not experience bending moments during use, forming the screw shaft 10 from a polymer material ensures sufficient tensile and compressive strength, eliminating the need for metal materials. This significantly reduces costs and manufacturing complexity while ensuring strength and reliability.

[0030] Preferably, the screw shaft 10 has a connecting portion 11, which is adapted to be coaxially connected to the catheter assembly 40 along the axis of the screw shaft 10. Optionally, the resultant force transmitted between the connecting portion 11 and the catheter assembly 40 may act along the axis of the screw shaft 10. In one example, the joint between the connecting portion 11 and the catheter assembly 40 is rotationally symmetric about the axis of the screw shaft 10. Here, the "joint" between the connecting portion 11 and the catheter assembly 40 refers to the portion of the connecting portion 11 that is joined to the catheter assembly 40 and receives the force applied by the catheter assembly 40. Furthermore, "rotational symmetry" conventionally refers to the case where, when a shape on a plane is rotated by an angle α (0° < α < 360°) around a fixed point in the plane, the shape after rotation matches the original shape. Such a shape is called a rotationally symmetric shape. However, in this specification, the term is intended to be interpreted more broadly to mean that the joint between the connector 11 and the catheter assembly 40 coincides with the original shape after being rotated by an angle α (0° < α < 360°) around the axis of the screw shaft 10. For example, the connector 11 may be joined to the catheter assembly 40 at multiple points, which may be equally spaced circumferentially around the axis of the screw shaft 10 (for example, the points may define a regular polygon). As understood, the rotational symmetry of the joint between the connector 11 and the catheter assembly 40 around the axis of the screw shaft 10 means that the resultant force transmitted between the connector 11 and the catheter assembly 40 acts along the axis of the screw shaft 10. As a result, the catheter assembly 40, under any resistance or tensile force, applies only forces along the axis of the screw shaft 10 to the screw shaft 10, and does not generate a bending moment in the screw shaft 10.

[0031] If the joint between the connecting portion 11 and the catheter assembly 40 is not rotationally symmetrical about the axis of the screw shaft 10, the catheter assembly 40 will exert a bending moment on the screw shaft 10 to varying degrees. For example, if the catheter assembly 40 is coaxially inserted through the through hole 12 but is joined to the connecting portion 11 at only one point, the joint clearly does not have rotational symmetry with respect to the axis of the screw shaft 10. In this case, when resistance or tensile force is applied, the catheter assembly 40 may exert a bending moment on the screw shaft 10, and such a design is undesirable.

[0032] Preferably, the connecting portion 11 is continuous around the entire circumference of the inner wall of the through hole 12 and is attached around the entire circumference of the outer surface of the catheter assembly 40. This configuration allows the force between the connecting portion 11 and the catheter assembly 40 to be transmitted uniformly in the circumferential direction without generating a bending moment. In another exemplary embodiment, the connecting portion 11 is implemented as a female thread formed in the inner wall of the through hole 12, and correspondingly, a male thread is formed on the outer wall of the catheter assembly 40 to fit. When the catheter assembly 40 is screwed into the connecting portion 11, uniform force transmission in the circumferential direction is possible. Furthermore, the catheter assembly 40 can be easily detached from the connecting portion 11. That is, the catheter assembly 40 is detachably coupled to the connecting portion 11. Therefore, if a different size catheter assembly 40 is required, the catheter assembly 40 can be easily detached and replaced with the other catheter assembly 40. Of course, the present invention is not limited to a specific method for coupling the connecting portion 11 to the catheter assembly 40, and in some embodiments, the coupling may be performed by, for example, snap engagement, adhesive, or interlocking. In this regard, various modifications and substitutions are possible for those skilled in the art.

[0033] Figure 8 shows the use of a prosthetic valve delivery handle in an application example related to interventional treatment of heart valves. Optionally, the handle may further comprise a housing 50, and the catheter assembly 40 may comprise an inner tube (not shown) and an outer tube. The inner tube is movably positioned within the outer tube and fixedly coupled to the housing 50. The outer tube is coupled to a coupling 11. The prosthetic valve is positioned between the inner and outer tubes. During use, the inner and outer tubes, together with the prosthetic valve sandwiched between them, are advanced to the target site. The housing 50, and thus the inner tube, is then held stationary, and the drive assembly 30 is operated to advance or retract the screw shaft 10 in its axial direction, thereby allowing the outer tube to be moved as well. In this way, the outer tube is displaceable relative to the inner tube, thereby enabling loading, releasing, or retrieval of the prosthetic valve. In particular, the catheter assembly 40 may be configured and operated as known in the art, and further description thereof is omitted herein.

[0034] In applications involving interventional treatment of heart valves, it may be necessary to move the outer cannula axially to enable loading, release, or retrieval of the prosthetic valve. In some specific applications, the inner and outer cannulas, along with the prosthetic valve held between them, may be advanced to the target site, and then the outer cannula may be moved proximally (i.e., toward the operator or away from the lesion) to partially release the prosthetic valve. The valve may then be determined, for example, based on radiographic images, to see if it has deployed to the correct position. If not, the outer cannula may be moved distally (i.e., away from the operator or toward the lesion) to retrieve the prosthetic valve, and then an attempt may be made to partially release it again at a different position. This procedure may be repeated until the prosthetic valve is partially released at the desired position. Finally, the prosthetic valve may be fully released by moving the outer cannula proximally.

[0035] In the above application, it is necessary to ensure that each attempt to partially open the artificial valve does not result in the proximal movement of the outer tube leading to complete opening of the artificial valve. For this purpose, as described with reference to Figures 9 to 15, the handle preferably further comprises a stop assembly 60 that can be switched between a locked configuration and an unlocked configuration. When the stop assembly 60 is in the locked configuration, it limits the axial movement distance of the screw shaft 10 to a predetermined range of movement distance. In contrast, when the stop assembly 60 is in the unlocked configuration, it does not further limit the movement distance of the screw shaft 10 along its axis, and allows the movement distance to exceed the predetermined range of movement distance.

[0036] Those skilled in the art will understand that a predetermined travel distance range can be appropriately set as needed to partially release the artificial valve by manipulating the outer tube. In particular, the predetermined travel distance range may depend on factors such as the axial length and expandability of the artificial valve, as well as the initial relative positions of the inner and outer tubes. With this configuration, when the stop assembly 60 is in the locked configuration, the axial travel distance of the screw shaft 10 can be limited to a predetermined travel distance range, so that in any case the movement of the outer tube coupled to the coupling 11 is limited to a partial release of the artificial valve, preventing excessive release of the artificial valve and ensuring reliable retrieval of the artificial valve. After the artificial valve has been partially released in the appropriate position, the stop assembly 60 can be switched to an unlocked configuration in which the axial travel distance of the screw shaft 10 is no longer limited, in which the outer tube coupled to the coupling 11 can be moved proximal by an amount exceeding the predetermined travel distance range to fully release the artificial valve as needed for implantation.

[0037] As shown in Figures 11 to 13, in one exemplary embodiment, the stop assembly 60 includes a protruding member 61 and a locking member 62. The protruding member 61 protrudes from the outer wall of the screw shaft 10, and the locking member 62 is arranged to move between a first position and a second position in a direction perpendicular to the axis of the screw shaft 10. When the locking member 62 is in the first position (see Figures 11 and 12), the projections of the locking member 62 and the protruding member 61 in the axial direction of the screw shaft 10 overlap, and the stop assembly 60 is in a locked configuration. Therefore, when the axial movement distance of the screw shaft 10 reaches the limit of a predetermined movement distance range, the protruding member 61 comes into contact with the locking member 62 (see Figure 12). When the locking member 62 is in the second position (see Figure 13), the projections of the locking member 62 and the protruding member 61 in the axial direction of the screw shaft 10 do not overlap, and the stop assembly 60 is in an unlocked configuration. Here, the projection of the locking member 62 and the protruding member 61 in the axial direction of the screw shaft 10 refers to the projection of their outermost contours on a cross-sectional plane perpendicular to the axis of the screw shaft 10 onto another plane perpendicular to the axis of the screw shaft 10 in the axial direction.

[0038] In the exemplary embodiments shown in Figures 11 to 13, the protruding member 61 protrudes radially outward from the screw shaft 10 and is fixed thereto, while the locking member 62 is movable radially (for example, vertically in the orientation shown in Figures 11 to 13) relative to the screw shaft 10. The locking member 62 is an n-shaped member that defines an opening slightly larger than the outer diameter of the screw shaft 10, within which the screw shaft 10 can move. When the locking member 62 is lowered to a first position (low position shown in Figure 12), the protruding member 61 can come into contact with the locking member 62, preventing the screw shaft 10 from moving further proximally (to the left in the orientation shown in Figure 12). This corresponds to limiting the axial movement of the screw shaft 10 to within a predetermined range of movement. Conversely, when the locking member 62 is raised to a second position (upper position shown in Figure 13), the protruding member 61 is no longer restricted, and the screw shaft 10 can be moved further proximally (to the left in the orientation shown in Figure 12). Preferably, the stop assembly 60 includes two protruding members 61 arranged symmetrically with respect to the axis of the screw shaft 10, thereby enabling more stable and reliable contact with the locking member 62.

[0039] The stop assembly 60 further includes a biasing member that biases the locking member 62 from a first position to a second position. In this way, the locking member 62 remains in the second position when not under stress or restriction. For example, the biasing member may be an elastic member such as a spring or an elastic tab. Alternatively, it may be a magnetic member, for example, consisting of opposing magnets that generate a biasing force through attractive or repulsive forces. The present invention is not limited to any particular structure of the biasing member. The biasing member ensures reliable switching of the locking member 62 and prevents the locking member 62 from becoming stuck in the first position and unable to move when attempting to fully release the artificial valve.

[0040] Optionally, the stop assembly 60 may further have an operating member 64. The operating member 64 is removable or movable. The operating member 64 is used to press the locking member 62 and bias (move) the locking member 62 from a second position to a first position. It will be understood that, under the action of the biasing member, if no stress or restrictions are applied to the locking member 62, the locking member 62 will remain stationary in the second position as a default state. However, in this case, the locking member 62 may be moved to the first position against the biasing force of the biasing member by operating the operating member 64.

[0041] As shown in Figures 9 to 13, in an exemplary embodiment, the operating member 64 is movably positioned between a third position (also referred to as the proximal position, see Figure 13) and a fourth position (also referred to as the distal position, see Figure 12) in the axial direction of the screw shaft 10. The operating member 64 has a push-pull portion 641, an inclined portion 642, and a contact portion 643, which are sequentially joined along the axis of the screw shaft 10. When the operating member 64 is in the third position, the push-pull portion 641 coincides axially with the locking member 62, and the locking member 62 is positioned in the second position. As the operating member 64 is moved from the third position to the fourth position, the inclined portion 642 gradually biases (moves) the locking member 62 from the second position to the first position. When the operating member 64 is in the fourth position, the contact portion 643 is aligned axially with the locking member 62, and the contact portion 643 contacts the locking member 62, holding the locking member 62 in the first position.

[0042] In the exemplary embodiments shown in Figures 9 to 13, the inclined portion 642 is gently inclined toward the first position (downward in the orientation of the figure) along the direction from the fourth position to the third position (leftward in the orientation of the figure). The push-pull portion 641 is joined to the distal end (right end in the orientation of the figure) of the inclined portion 642, and the abutment portion 643 is joined to the proximal end (left end in the orientation of the figure) of the inclined portion 642. With this configuration, as the operating member 64 moves from the third position to the fourth position (rightward in the orientation of the figure), the inclined portion 642, which is inclined toward the first position, gradually biases the locking member 62 toward the first position. When the operating member 64 reaches the fourth position, the abutment portion 643 completely holds the locking member 62 in the first position.

[0043] The exemplary embodiments shown in Figures 9 to 13 are merely non-limiting examples of the operating member 64. In another exemplary embodiment, as shown in Figures 14 and 15, the operating member 64 has a removable cover 644. When the cover 644 is assembled to the housing 50, the cover 644 abuts against the locking member 62, holding the locking member 62 in a first position. After the cover 644 is removed from the housing 50, the locking member 62 is positioned in a second position.

[0044] The cover 644 may be attached to the housing 50, for example, by snap engagement or magnetic attraction. To partially release the artificial valve during use, the cover 644 is held on the housing 50 to prevent excessive release of the artificial valve. Once it is confirmed that the artificial valve is partially deployed in the desired position, the cover 644 may be separated from the housing 50. As a result, the locking member 62 is biased to the second position as it is no longer restrained by the cover 644, and the lock on the screw shaft 10 is released, allowing the screw shaft 10 to move and the artificial valve to be fully released.

[0045] Based on the handle described above, embodiments of the present invention also provide a system for interventional applications. This interventional system comprises a handle and a catheter assembly 40, the catheter assembly 40 being inserted into a through-hole 12 and coupled to a screw shaft 10 (for example, at a coupling portion 11). The system may include other components. These components are configured and can operate in manner well known in the art and therefore do not require further detailed description herein.

[0046] In summary, the present invention provides a handle and system for interventional applications. The handle comprises a screw shaft, a ball nut, and a drive assembly. The screw shaft defines a through-hole extending through the screw shaft along its axis, and the through-hole is fitted to allow a catheter assembly to be inserted coaxially. The screw shaft is fitted to be coaxially coupled to the catheter assembly. The ball nut engages with the screw shaft so as to be rotatable in the circumferential direction of the screw shaft, limiting the axial displacement of the screw shaft. The drive assembly is fitted to rotate the ball nut in the circumferential direction of the screw shaft, thereby allowing the screw shaft to move axially. With this configuration, since the catheter assembly is inserted coaxially into the through-hole of the screw shaft and coaxially coupled to the screw shaft, only axial forces act on the screw shaft, substantially overcoming the problems caused by conventional eccentrically positioned catheters.

[0047] The embodiments described above may be combined as appropriate. The above description merely illustrates some preferred embodiments of the present invention and is not intended to limit the scope of the invention in any way. Any changes or modifications made by those skilled in the art based on the above teachings are also included within the scope of the present invention. [Explanation of symbols]

[0048] 01: Screw 02: Nut 03: Catheter 10: Screw shaft 11:Connection part 12: Through hole 20: Ball nut 30: Drive Assembly 31: Manual Actuator 311: Rotary knob 32: Electric Actuator 321: Motor 322: Power transmission member 40: Catheter Assembly 50: Housing 60: Stop Assembly 61: Protruding member 62: Locking component 64: Operating component 641: Push / Pull Section 642: Inclined part 643: Contact part 644: Cover

Claims

1. It comprises a screw shaft, a ball nut, and a drive assembly, The screw shaft is provided with a through hole that penetrates the screw shaft along its axis, the through hole is fitted so that the catheter assembly passes through it coaxially, and the screw shaft is fitted so that it is connected to the catheter assembly coaxially. The ball nut is fitted and connected to the screw shaft and is rotatable in its circumferential direction around the screw shaft, and the displacement of the ball nut along the axis of the screw shaft is restricted. An interventional handle, wherein the drive assembly is adapted to drive the ball nut to rotate the screw shaft circumferentially, thereby driving the screw shaft to move axially.

2. The interventional handle according to claim 1, wherein the screw shaft has a connecting portion adapted to be coaxially connected to the catheter assembly along the axis of the screw shaft, and the joint portion to which the connecting portion is connected to the catheter assembly is rotationally symmetric with respect to the axis of the screw shaft.

3. The interventional handle according to claim 2, wherein the connecting portion is continuous around the entire circumference of the inner wall of the through hole and is attached to the catheter assembly over the entire outer wall of the catheter assembly.

4. Further equipped with a stop assembly, The stop assembly is switchable between a locked configuration and an unlocked configuration. When the stop assembly is in the locking configuration, the axial movement distance of the screw shaft is limited to a predetermined movement distance range. The intervention handle according to claim 1, wherein when the stop assembly is in the unlock configuration, it no longer restricts the axial travel distance of the screw shaft and allows the axial travel distance of the screw shaft to exceed the predetermined travel distance range.

5. The stop assembly comprises a protruding member and a locking member, the protruding member protruding from the outer wall of the screw shaft, and the locking member being movable between a first position and a second position in a direction perpendicular to the axis of the screw shaft. When the locking member is in the first position, the projection of the locking member and the projection of the protruding member overlap along the axis of the screw shaft, and the stop assembly becomes a locked configuration. In the locked configuration, when the axial movement distance of the screw shaft reaches the limit of the predetermined movement distance range, the protruding member comes into contact with the locking member. The intervention handle according to claim 4, wherein when the locking member is in the second position, there is no overlap between the projection of the locking member and the projection of the protruding member along the axis of the screw shaft, and the stop assembly has the unlock configuration.

6. The intervention handle according to claim 5, further comprising a biasing member adapted to bias the locking member from a first position to a second position, thereby holding the locking member in the second position when not subjected to stress or restriction.

7. The intervention handle according to claim 5 or 6, wherein the stop assembly further comprises an operating member, the operating member being removable or movable, and the operating member being used to apply pressure to the locking member to bias the locking member from a second position to a first position.

8. The operating member is arranged to be movable between a third position and a fourth position along the axis of the screw shaft, and the operating member has a push / pull portion, an inclined portion and a contact portion that are sequentially joined along the axis of the screw shaft. When the operating member is in the third position, the push-pull portion coincides with the locking member in the axial direction, and the locking member is in the second position. While the operating member is moved from the third position to the fourth position, the inclined portion gradually biases the locking member from the second position to the first position. The interventional handle according to claim 7, wherein when the operating member is in the fourth position, the contact portion is aligned axially with the locking member, the contact portion contacts the locking member, and thereby holds the locking member in the first position.

9. The intervention handle further comprises a housing, and the operating member has a removable cover. When the cover is assembled to the housing, the cover comes into contact with the locking member, thereby holding the locking member in the first position. The intervention handle according to claim 7, wherein the locking member is in the second position when the cover is removed and separated from the housing.

10. The intervention handle according to any one of claims 1 to 9, An interventional system comprising: a catheter assembly inserted into the through-hole and coupled to the screw shaft.

Images