Patent Application
20230248556
The present invention relates to the field of medical devices and, in particular, to a control handle, a control wire and an implant delivery device
The heart has four chambers: the left atrium and left ventricle on the left side of the heart; and the right atrium and right ventricle on the right side of the heart. In addition, there are ventricular inflow tracts between the atria and ventricles, the left ventricular outflow tract consisting of the left ventricle and aorta and the right ventricular outflow tract consisting of the right ventricle and pulmonary artery. There are also “one-way valves” in the ventricular inflow and outflow tracts. The human heart has four valves: the aortic valve connecting the left ventricle to the aorta; the pulmonary valve connecting the right ventricle to the pulmonary artery; the mitral valve connecting the left atrium to the left ventricle; and the tricuspid valve connecting the right atrium to the right ventricle. All these valves function like one-way valves which allow blood flow in the forward direction but prevent the backward flow of blood. Defects in any one of these valves can induce hemodynamic changes and functional abnormalities in the heart and are called valvular heart disease.
With the development of social economy and the aging of population, the incidence of valvular heart disease has increased significantly. Studies have shown that this figure has reached up to 13.3% among those 75 years or older. Surgical treatment remains first choice for patients with severe valvular disease. However, for those with advanced ages, complications in multiple organs, a history of thoracotomy or poor heart functions, the surgical approach is associated with high risk and high mortality or even precludes some patients. Transcatheter valve replacement/repair has attracted a lot of attention amongst academics and researchers thanks to its advantages such as no need for thoracotomy, minor trauma and rapid recovery.
Due to the anatomical complexity of the human body, placement accuracy is particularly important for interventional surgery. In order to deliver implants along various vascular paths accurately to target sites, delivery devices with controllable flexibility are usually used.
Typically, controllable flexibility for a catheter relies on a control wire embedded alongside the catheter. The control wire is welded to a pull ring arranged at a distal end of the catheter, and proximally coupled to a handle, as well, a slider is set in handle. In this way, through sliding the slider to move, the control wire can be pulled to bend the flexible catheter in different shape. However, this conventional technique cannot control bending speed, and slider for driving the control wire makes the handle have to be in large size, which leads to unsatisfactory overall structural compactness of the handle.
It is an object of the present invention to overcome the above-described problems with the conventional delivery devices, i.e., a lack of bending speed control and structural incompactness, by presenting a control handle, a control wire and an implant delivery device.
The above object is attained by a control handle for an implant delivery device according to the present invention, which comprises basic part and rotary part.
The basic part is connected to a flexible catheter in a catheter assembly and has an axial direction that is as same as an axial direction of the flexible catheter.
The rotary part is rotatably coupled to the basic part, and a rotational axis of the rotary part is not coplanar with an axis of the basic part. The rotary part is fixedly coupled to a proximal end of the control wire and is configured to rotate to cause the control wire to be wound thereon.
Optionally, in the control handle, the rotary part may comprise a manipulation portion and a winding portion that are sequentially connected along an axial direction of the rotary part, wherein the manipulation portion has a radial outer size greater than a radial outer size of the winding portion, and wherein the winding portion is configured for winding of the control wire thereon.
Optionally, in the control handle, the winding portion may comprise at least two axial shaft sections with different outer diameters.
Optionally, in the control handle, the rotary part may comprise a wire securing member, wherein the rotary part is fixedly coupled to a proximal end of the control wire through the wire securing member.
Optionally, in the control handle, the wire securing member may comprise a wire anchor having a first external thread, wherein the rotary part may comprise an axial blind bore and a radial wire aperture, wherein the blind bore is in communication with the wire aperture, wherein the blind bore has a first internal thread engageable with the first external thread, wherein the blind bore is configured for insertion of the proximal end of the control wire therein through the wire aperture, and wherein the wire anchor is configured to be screwed into the blind bore, and to press and secure the control wire.
Optionally, in the control handle, the rotary part may comprise a self-locking portion, furtherly, the control handle configured with a locking member to apply a resistive torque to the self-locking portion to limit a rotation of the rotary part when a rotating torque is smaller than the resistive torque.
Optionally, in the control handle, the self-locking portion may comprise a plurality of grooves arranged circumferentially about the rotational axis of the rotary part, wherein the locking member comprises a spring plunger comprising a fixation member, an elastic element and a stop ball, wherein the stop ball is coupled to the fixation member by the elastic element, wherein the fixation member is fixedly coupled to the basic part, wherein the stop ball is brought into abutment against a corresponding groove by an elastic force provided by the elastic element, thereby applying the resistive torque to the self-locking portion.
Optionally, in the control handle, the rotary part may comprise a threaded portion having a second external thread, wherein the basic part has a second internal thread engageable with the second external thread, wherein the rotary part is threadedly connected to the basic part by the threaded portion, and wherein a rotation of the rotary part with respect to the basic part is converted into an axial translation of the rotary part with respect to the basic part through the second external thread and the second internal thread.
Optionally, in the control handle, the basic part may comprise a hollow catheter fixture oriented in the axial direction of the basic part, wherein the catheter fixture is configured for insertion of a proximal end of the flexible catheter therein, and wherein the catheter fixture comprises a radial wire slot configured for a passage of the control wire therethrough.
Optionally, the control handle may further comprise a limiting shell , wherein the wire slot extends in an axial direction of the catheter fixture to a distal end of the catheter fixture, wherein the catheter fixture is provided at the distal end thereof with a third external thread, and the limiting shell has a third internal thread engageable with the third external thread, and wherein the limiting shell is threadedly connected to the catheter fixture.
The above object is also attained by a control wire for the control handle as defined above according to the present invention. The control wire comprises a first traction wire segment and a second traction wire segment, wherein the first traction wire segment is fixedly coupled at a distal end thereof to a proximal end of the second traction wire segment, wherein the first traction wire segment is more flexible than the second traction wire segment, wherein the first traction wire segment is fixedly coupled at a proximal end thereof to the rotary part, wherein the first traction wire segment is configured to be wound on the rotary part.
Optionally, in the control wire, the first traction wire segment may be implemented as a polymeric wire segment and the second traction wire segment is implemented as a metallic wire segment.
The above object is also attained by an implant delivery device according to the present invention, which comprises the control handle as defined above and the catheter assembly. The catheter assembly comprises the control wire as defined above and the flexible catheter. The distal end of the control wire is inserted within the catheter and is fixedly coupled to a distal end of the flexible catheter.
In summary, the present invention provides a control handle, a control wire and an implant delivery device. The control handle includes a basic part and a rotary part. The basic part is configured to connect a flexible catheter in a catheter assembly and has an axial direction that is as same as an axial direction of the flexible catheter. The rotary part is rotatably coupled to the basic part along a radial direction of the basic part, and an axis of rotation of the rotary part is not coplanar with an axis of the basic part. The rotary part is fixedly coupled to a proximal end of the control wire and is configured to rotate to cause the control wire to be wound thereon.
In this arrangement, since the axis of rotation of the rotary part is not coplanar with the axis of the basic part, as a result of rotation of the rotary part, the control wire is wound on the rotary part, enabling bending control. In this way, the control handle is allowed to have a shorter length, leading to increased structural compactness. Further, the rotary part on which the control wire is wound can be resized to enable adjustment of transmission ratio and hence bending speed, which can better address the needs of different applications.
Those of ordinary skill in the art would appreciate that the following drawings are presented merely to enable a better understanding of the present invention rather than to limit the scope thereof in any sense. In the drawings:
In these figures,
1, a control handle; 11, a basic part; 110, a base body; 111, a catheter fixture; 112, a wire slot; 113, an adhesive filling aperture; 114, a third external thread; 115, a protrusion; 116, a stop groove; 117, a circlip; 118, an air evacuation aperture; 12, a rotary part; 121, a manipulation portion; 122, a winding portion; 123, a threaded portion; 124, a wire anchor; 125, a wire aperture; 126, a transition section; 127, a self-locking portion; 128, a groove; 129, a limiting member; 13, a shell; 131, a limiting shell; 14, a spring plunger; 141, a fixation member; 142, a stop ball;
2, a catheter assembly; 21, a control wire; 211, a first traction wire segment; 212, a second traction wire segment; 22, a flexible catheter; 221, a balloon; 222, an outer catheter; 223, a catheter holder; 2231, a filling port; 2232, a guidewire exit; 23, a balloon catheter; 231, a tip; 232, a balloon supporter ; 233, an inner catheter; 24, a control wire exit;
3, an implant.
Objects, advantages and features of the present invention will become more apparent upon reading the following more detailed description of the present invention, which is set forth by way of particular embodiments with reference to the accompanying drawings. Note that the figures are provided in a very simplified form not necessarily drawn to exact scale and for the only purpose of facilitating easy and clear description of the embodiments. In addition, the structures shown in the figures are usually partial representations of their actual counterparts. In particular, as the figures would have different emphases, they are sometimes drawn to different scales.
As used herein, the singular forms “a”, “an” and “the” include plural referents, and the term “or” is generally employed in the sense of “and/or”, “several” of “at least one”, and “at least two” of “two or more than two”. Additionally, the use of the terms “first”, “second” and “third” herein is intended for illustration only and is not to be construed as denoting or implying relative importance or as implicitly indicating the numerical number of the referenced item. Accordingly, defining an item with “first”, “second” or “third” is an explicit or implicit indication of the presence of one or at least two of the items. The term “proximal end” usually refers to an end closer to an operator, and the term “distal end” usually refers to an end closer to a patient or lesion. The terms “one end” and “the other end”, or “proximal end” and “distal end”, are generally used to refer to opposite end portions including the opposite endpoints, rather than only to the endpoints. As used herein, the terms “mounting”, “coupling” and “connection” should be interpreted in a broad sense. For example, a connection may be a permanent, detachable or integral connection, or a mechanical or electrical connection, or a direct or indirect connection with one or more intervening media, or an internal communication or interaction between two components. Furthermore, when an element is referred herein to as being disposed on another element, it is typically only meant that the two elements are connected, coupled, mated or geared to each other either directly or indirectly with the presence of intervening element(s). Such reference should not be interpreted as indicating or implying any relative spatial relationship between the two elements. That is, the referenced element may be positioned inside, outside, above, beneath, beside or in any other spatial relationship to the other element, unless the context clearly specifies. Those of ordinary skill in the art can understand the specific meanings of the above-mentioned terms herein, depending on their context.
It is an object of the present invention to overcome the above-described problems with the conventional delivery devices, i.e., a lack of bending speed control and structural incompactness, by presenting a control handle, a control wire and an implant delivery device. The invention will be described below with reference to the accompanying drawings.
Referring to
Optionally, the catheter assembly 2 may further include a balloon catheter 23 disposed within the flexible catheter 22. In an alternative exemplary embodiment, the balloon catheter 23 includes a tip 231, balloon supporters 232 and an inner catheter 233 that are sequentially connected in the direction from a distal end to a proximal end thereof. The flexible catheter 22 includes a balloon 221, an outer catheter 222 and a catheter holder 223 that are sequentially connected in the direction from the distal end to the proximal end thereof. A distal end of the balloon 221 is sealingly connected to a distal end of the balloon supporters 232. The balloon 221 is collapsible or foldable. Moreover, it is dilatable when a fluid (e.g., a contrast fluid) is filled therein. A proximal end of the inner catheter 233 is sealingly connected to the catheter holder 223. The inner catheter 233 comprises a lumen for passage of a guidewire therethrough. At a proximal end of the catheter holder 223, there are provided a filling port 2231 and a guidewire exit 2232. The guidewire exit 2232 is preferably arranged in an axial direction of the inner catheter 233, while the filling port 2231 may be arranged at an angle with respect to the axial direction of the inner catheter 233, thus forming a branch. A clearance formed between the inner catheter 233 and the outer catheter 222 is brought into communication with the filling port 2231 to allow the fluid to be filled into or discharged from the balloon 221 through the clearance between the inner catheter 233 and the outer catheter 222. Before the fluid is filled into the balloon 221, the balloon 221 is in a collapsed or folded configuration, the implant 3 can be crimped over, and move with, the balloon 221. Upon the implant 3 being advanced to a target site, the fluid may be filled into the balloon 221 through the filling port 2231 to expand the balloon 221 and hence the implant 3 to a predetermined size.
In order to address the problem sought to be solved by the present invention, referring to
The rotary part 12 is rotatably coupled to the basic part 11 about a rotational axis which is not coplanar with an axis of the basic part 11. Preferably, the rotational axis of the rotary part 12 is perpendicular to the axis of the basic part 11. The rotary part 12 is fixedly connected to the proximal end of the control wire 21 and configured to rotate to cause the control wire 21 to be wound thereon. With this arrangement, the rotary part 12 is able to convert movement of the control wire 21 in the axial direction thereof to a circumferential movement around the rotary part 12. Accordingly, as a result of rotation of the rotary part 12, the control wire 21 will be wound on the rotary part 12, enabling bending control of the flexible catheter. In this way, the control handle 1 is allowed to have a shorter length, leading to increased structural compactness. Further, the rotary part 12 on which the control wire 21 is wound may be resized to enable adjustment of transmission ratio and hence bending speed, which can better address the needs of different applications.
Preferably, the rotary part 12 includes a manipulation portion 121 and a winding portion 122 that are connected together along the axial direction thereof,. A radial outer size of the manipulation portion 121 is greater than a radial outer size of the winding portion 122. The winding portion 122 is configured for winding of the control wire 21 thereon. It is to be noted that, here, the “radial outer size” of the manipulation portion 121 refers to maximum radial size in a radial direction of the rotary part 12. In an alternative embodiment, the manipulation portion 121 has a circular peripheral circumference. In this case, the radial outer size of the manipulation portion 121 refers to its outer diameter. If the peripheral circumference of the manipulation portion 121 is polygonal, then the radial outer size of the manipulation portion 121 will refer to a diameter of a circle circumscribed around the polygon. The same applies to the radial outer sizes of the components described below. The manipulation portion 121 is configured to be gripped and rotated by an operator. When the operator applies an external force on the manipulation portion 121, a rotating torque will be created to drive the entire rotary part 12 to rotate about its own rotational axis. Therefore, in order to provide a sufficient rotating torque, the manipulation portion 121 is desired to have a large enough radial outer size. In the exemplary embodiment shown in
Referring to
As shown in
Referring to
Preferably, wire slot 112 extends in the axial direction of the catheter fixture 111 to a distal end thereof. Accordingly, a distal end portion of the catheter fixture 111 has an open C-shaped cross-section. Additionally, a third external thread 114 may be provided around the distal end of the catheter fixture 111, and the shell 13 may have a limiting shell 131 having a third internal thread engageable with the third external thread 114. In this way, the limiting shell 131 can be threadedly connected to the catheter fixture 111. When this threaded connection of the limiting shell 131 with the catheter fixture 111 is being established, due to the open C-shaped cross-section, the distal end portion of the catheter fixture 111 will deform inwardly as it is being compressed by the limiting shell 131. As a result, an interior surface of the catheter fixture 111 will tightly abut against an exterior surface of the flexible catheter 22, resulting in more reliable connection between the flexible catheter 22 and the catheter fixture 111.
With continued reference to
Referring to
Preferably, the rotary part 12 further includes two axially spaced limiting members 129, such as circlips, which are raised over the main portion of the rotary part 12. When the rotary part 12 axially translates with respect to the base body 110 to predetermined positions, as a result of its own rotation, the limiting members 129 will come into abutment against the base body 110 and thus the rotary part 12 cannot axially move any more. In this way, axial movement of the rotary part 12 and hence displacement of the control wire 21 is limited within a predetermined range.
Optionally, the rotary part 12 may include a self-locking portion 127, and the control handle 1 may further include a locking member configured to apply a resistive torque to the self-locking portion 127 to prevent the rotary part 12 from rotate when the rotating torque is smaller than the resistive torque. Referring to
As shown in
As shown in
In the exemplary embodiment of
In some implant delivery applications, a varying bending speed may be required. For example, during delivery of a heart valve prosthesis, slow bending may be desirable before the prosthesis reaches the aortic arch. However, in order to advance the prosthesis through the aortic arch, rapid bending may be more favored. After this, a slower bending speed may be again desired. Correspondingly, the winding portion 122 may include three axial shaft sections with outer diameters respectively of 2.5 mm, 4.0 mm and 2.5 mm. Adjacent shaft sections are preferably connected by transition sections 126. Axial lengths of the three shaft sections may be configured as practically required. In use, the heart valve prosthesis may be crimped over a middle section of the balloon 221 using a crimper before the procedure starts, and it is ensured that both ends of the heart valve prosthesis are situated between the two balloon supporters 232. A distal end portion of the catheter assembly 2 may be then advanced within the femoral artery, so as to deliver the heart valve prosthesis to distal end. Immediately before the heart valve prosthesis reaches the aortic arch, the manipulation portion 121 is rotated to commence bending control during advancement. The bending control undergoes the three successive bending phases: slow, rapid and slow. The prosthesis is then advanced to a target site. Then a predetermined amount of a diluted contrast fluid may be filled into the balloon via the filling port 2231 with the aid of a balloon pump to expand the heart valve prosthesis to a predetermined size.
The inventors have found that, although the control handle 1 is allowed to have a reduced overall size by winding the control wire 21 on the rotary part 12, when a metal wire, such as a stainless steel wire, is chosen as the control wire, as is commonly practice in existing delivery devices, the winding may cause fatigue or even breakage of the wire. In view of this, in embodiments of the present invention, there is also provided a control wire 21 including a first traction wire segment 211 and a second traction wire segment 212. A distal end (on the left side of
Optionally, the first traction wire segment 211 may be formed of a polymeric material, which is preferred to be polyethylene. The second traction wire segment 212 may be formed of a metallic material, which is preferred to be austenitic stainless steel, a nickel-titanium alloy or the like.
Optionally, the fixed coupling of the distal end of the first traction wire segment 211 and the proximal end of the second traction wire segment 212 may be accomplished, for example, by gluing, welding or crimping.
In summary, the present invention provides a control handle, a control wire and an implant delivery device. The control handle includes a basic part and a rotary part. The basic part is configured to connect a flexible catheter in a catheter assembly and has an axial direction that is the same as an axial direction of the flexible catheter. The rotary part is rotatably coupled to the basic part along a radial direction of the basic part, and an axis of rotation of the rotary part is not coplanar with an axis of the basic part. The rotary part is fixedly coupled to a proximal end of the control wire and is configured to rotate to cause the control wire to be wound thereon. In this arrangement, since the axis of rotation of the rotary part is not coplanar with the axis of the basic part, as a result of rotation of the rotary part, the control wire is wound on the rotary part, enabling bending control. In this way, the control handle is allowed to have a shorter length, leading to increased structural compactness. Further, the rotary part on which the control wire is wound can be resized to enable adjustment of transmission ratio and hence bending speed, which can better address the needs of different applications.
It is to be noted that the foregoing several embodiments may be combined. The description presented above is merely that of some preferred embodiments of the present invention and is not intended to limit the scope thereof in any sense. Any and all changes and modifications made by those of ordinary skill in the art based on the above teachings fall within the scope as defined in the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202110801252.4 | Jul 2021 | CN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CN2021/113829 | 8/20/2021 | WO |
