Driving handle for delivering implant, and delivery system

A drive handle and system for delivering an implant are disclosed. The drive handle includes a manual control unit, an electrical control unit and a transmission mechanism. The manual control unit is connected to the transmission mechanism to actuate the transmission mechanism to drive a delivery catheter for delivering the implant. The electrical control unit is connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter. The drive handle is switchable between a manual drive/control mode and an electrical drive/control mode to drive the delivery catheter to deliver the implant. The operation is simple, and the operating physician can take full advantage of the two modes to perform the surgical procedure based on his/her own operational preferences. This can result in higher surgical accuracy. Further, by providing these two modes, the apparatus has an increased the security and a reduced surgical risk.

TECHNICAL FIELD

The present invention relates to the field of medical devices and, in particular, to a drive handle and system for delivering an implant.

BACKGROUND

Heart valve diseases are some of most frequently diagnosed cardiac diseases in China, and most of them are valve damage caused by rheumatic fever. In recent years, the aging population has led to an increasing incidence of valve degeneration (including calcification, mucoid degeneration, etc.) and valve damage caused by metabolic disorders in China.

Conventionally, heart valve surgery is an open-heart procedure conducted under general anesthesia, during which, following an incision made along the patient's sternum (sternotomy), the heart is stopped and blood flow is guided through a “heart-lung” bypass machine (extracorporeal circulation machine). Therefore, traditional heart valve surgery is a high injuries operation accompanied with obvious risks and may bring to the patient transient disturbances caused by emboli and other issues associated with the use of the extracorporeal circulation machine, such that a complete recovery typically requires a couple of months. In addition, for the elders and some special population groups, the trauma of the surgery is unbearable and the recovery needs more time and is sometime even impossible.

Minimally invasive intervention surgery offers a variety of advantages, including needlessness of sternotomy, minimal trauma and quick recovery for the patients. In the recent ten years, interventional therapies have shown a tendency to be able to cope with not only all diseases curable by internal and external treatments but also some diseases that the surgical treatments could not handle. After entering the twenty-first century, researches on interventional therapies for heart valve diseases such as percutaneous valve replacement technologies, have been experiencing a notable acceleration, and have evolved from experimental researches to small-scale clinical trials. And the interventional therapies for heart valve diseases are likely to have breakthroughs in technical “bottlenecks” to achieve large-scale clinical applications. This makes the technologies again a focus of research efforts in the field of interventional cardiology.

Valve implantation relies on a catheter for delivery of the stent. Currently, many manual delivery systems for a valve sent have been developed. Examples of such manual delivery systems include those disclosed in Chinese Patent Pub. No. CN101961269A assigned to Hangzhou Venus Medical Instrument Co., Ltd., Chinese Patent Pub. No. CN1961847A assigned to Wen Ning, Chinese Patent Pub. No. CN102573703A assigned to Medtronic, Inc. (the U.S.) and Chinese Patent Pub. No. CN101553190A assigned to Edwards Lifesciences Corp. (the U.S.). Such a manual delivery catheter generally comprises an inner shaft, an outer shaft, a valve stent and a push-pull mechanism. The inner shaft includes a guide tip and a connector for a valve stent. The valve stent is loaded on an intermediate section between the guide tip and the connector for the valve stent of the inner shaft and securely attached to the connector. The outer shaft shields over the inner shaft in order to cover the valve stent and is movable along the outer surface of the inner shaft. The push-pull mechanism is in operative connection with the inner shaft as well as with the outer shaft so as to deploy the valve stent.

However, these existing delivery catheters are operated with mechanical motions including rotating, advancing and retracting by manual means, which are tedious and laborious and prone to cause hand fatigue of the operating physicians. Additionally, the manual delivery operations impose high requirements on the operating physician and raise a considerable amount of risk in terms of faulty operations and inaccuracy of the operation which lead to deterioration in surgical performance.

U.S. Patent Pub. No. US20120239142A1 discloses an electric power-driven delivery system comprising a handle on which operator buttons are arranged for electrically controlling the advancement and retraction of the catheter for loading or deploying of the valve. This allows simple operation and reduces the operational burden on the physicians. However, the electric power-driven delivery of the catheter is associated with a great unknown risk for accidents which may lead to surgery failure and even patient deaths in severe cases.

SUMMARY OF THE INVENTION

It is an objective of the present invention to address the issues of operational complexity and a low security, arising from use of the conventional drive handles, by presenting a drive handle and system for delivering an implant, freely switchable between a manual drive mode and an electric drive mode for controlling and driving a catheter.

In order to address the above issues, the present invention provides a drive handle for delivering an implant, comprising a manual control unit, an electrical control unit and a transmission mechanism, the manual control unit being connected to the transmission mechanism to actuate the transmission mechanism to drive a delivery catheter for delivering the implant, the electrical control unit being connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter.

Optionally, in the drive handle, the transmission mechanism may comprise a motion conversion member, a lead screw and a motion transmission member, the lead screw having a first end connected to the motion conversion member and a second end connected to the motion transmission member, the motion conversion member being configured to receive a motion signal from the manual control unit for actuating the lead screw, the motion transmission member being configured to receive a motion signal from electrical control unit for actuating the lead screw.

Optionally, in the drive handle, the transmission mechanism may further comprise a support member, a displacement member disposed around the lead screw, and a connecting member disposed on the displacement member, the support member being configured to support and fix the lead screw, the lead screw being provided with an external thread for engaging with an internal thread of displacement member, the connecting member being configured to establish a connection between the lead screw and the delivery catheter.

Optionally, in the drive handle, the manual control unit may comprise a manual control member and a manual drive shaft connected to the manual control member.

Optionally, in the drive handle, electrical control unit may comprise a power supply, control buttons and a motor, the control buttons being configured to control a rotational direction of the motor, the power supply being configured to supply power to the control buttons and to the motor.

Optionally, in the drive handle, electrical control unit may further comprise a controller in electrical connection with the control buttons and the motor, the controller being configured to receive a direction command and a speed command from the control buttons and, control a rotational direction and a speed of the motor based on the direction command and the speed command.

The present invention also provides system for delivering an implant, comprising a delivery catheter and the drive handle for delivering an implant as defined above connected to the delivery catheter, the drive handle being configured to drive the delivery catheter so as to load or deploy the implant.

Optionally, in the system, the manual control unit, the electrical control unit, the transmission mechanism may be arranged within a first shell and a proximal end of the delivery catheter may be arranged within the first shell.

Optionally, in the system, the manual control unit, the electrical control unit and the transmission mechanism may be arranged within the first shell and the proximal end of the delivery catheter may be arranged within a second shell, wherein the first shell is detachably connected to the second shell, and wherein opposite sides of the first shell and the second shell are provided with displacement grooves, through which the connecting member for establishing the connection between the lead screw and the delivery catheter is detachably connected to the delivery catheter.

Optionally, in the system, the delivery catheter may comprise an inner shaft and an outer shaft disposed over a portion of the inner shaft, wherein the implant is loaded in a space between the outer shaft and the inner shaft.

Optionally, in the system, the delivery catheter may further comprise a stability shaft disposed over a portion of the outer shaft and a stability shaft mounting configured to fix the stability shaft.

Optionally, in the system, the inner shaft may comprise a guide tip and an a connector for the implant, wherein the implant is loaded over a section of the inner shaft between the guide tip and the connector for the implant, and wherein the implant has one end attached to the connector for the implant.

Optionally, in the system, the delivery catheter may further comprise an inner shaft mounting and an outer shaft mounting, the inner shaft mounting being configured to fix the inner shaft, the outer shaft mounting being configured to fix the outer shaft.

As noted above, the present invention provides the drive handle and delivery system for delivering an implant, the drive handle for delivering an implant comprising the manual control unit, the electrical control unit and the transmission mechanism, wherein the manual control unit is connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter, and the electrical control unit is connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter. Thus, the drive handle for delivering an implant is switchable between the manual and electrical drive/control modes to drive the delivery catheter to deliver the implant and improve security of the apparatus. The operation is simple, and the operating physician can perform the surgical procedure based on his/her own operational preferences, resulting in a reduced surgical risk.

In the figures,1denotes a drive handle for delivering an implant;2, an inner shaft;20, an inner shaft mounting;21, an inner flush shaft;210, an inner flush shaft mounting;2b, a connector for implant;2c, an implant loading section;2d, a proximal end section of the inner shaft;2a, a guide tip;3, an outer shaft;30, an outer shaft mounting;4, a stability shaft;40, a stability shaft mounting;5, a delivery catheter;6, a valve stent;7, a first shell;8, a second shell;9, a hasp;10, a manual control unit;101, manual control member;102, a manual drive shaft;11, a electrical control unit;110, a power supply;111, a power supply contact;112, a power supply switch;113, a motor;114, control buttons;115, a controller;12, a transmission mechanism;120, a motion conversion member;122, a motion transmission member;123, a displacement member;121, a lead screw;124, a support member; and125, connecting member.

DETAILED DESCRIPTION

The drive handle and delivery system proposed in this invention will be described in greater detail below with reference to the accompanying drawings and specific embodiments. Features and advantages of the invention will be more apparent from the following detailed description, and from the appended claims. Note that the figures are provided in a very simplified form not necessarily presented to scale, with the only intention of facilitating convenience and clarity in explaining the embodiments.

Reference is now made toFIGS. 1 and 5, the implant delivery system of the present invention comprises a delivery catheter5and a drive handle1connected thereto for delivering an implant. The drive handle1drives the delivery catheter so that the implant is loaded or deployed. In some embodiments of the present invention, the delivery catheter5includes an inner shaft2, an outer shaft3and a stability shaft4.

According to the present invention, the delivery catheter5and the drive handle1may be disposed in two arrangements. In the first arrangement, the delivery catheter5and the drive handle1form an undetachable entity. In the second arrangement, the delivery catheter5and the drive handle1are separate parts coupled together in a detachable manner.

According to the arrangements of the delivery catheter5and drive handle1, the implant delivery system of the present invention has the following two embodiments.

Reference is now made toFIG. 1, an elevation view of the implant delivery system according to a first embodiment of the present invention. As shown inFIG. 1, the system comprises: the delivery catheter5and the drive handle1that is connected to a proximal end of the delivery catheter5. The drive handle1drives the delivery catheter5so as to allow loading and deploying of the implant.

Reference is now made toFIG. 2, a partial cross-sectional view of the implant delivery system according to the first embodiment of the present invention.FIG. 2clearly shows a positional relationship between the drive handle1and the delivery catheter5with respect to each other and their constructions. The drive handle1includes a manual control unit10, an electrical control unit11and a transmission mechanism12. The manual control unit10is connected to the transmission mechanism12so as to allow the transmission mechanism12to drive the delivery catheter5. The electrical control unit11is also connected to the transmission mechanism12so as to enable the transmission mechanism12to drive the delivery catheter5. Additionally, the manual control unit10, the electrical control unit11and the transmission mechanism12are all disposed in a first shell. The proximal end of the delivery catheter5is arranged within the first shell (note that, as used herein, the term “proximal end” refers to an end far away from a guide tip2aof the inner shaft, while the “distal end” refers to an end close to the guide tip2aof the inner shaft. Therefore, the proximal end of the delivery catheter refers to an end thereof located far away from the guide tip2aof the inner shaft. Reference can be made toFIG. 1for more details in this regard). Preferably, the delivery catheter5is connected to the drive handle1by connecting member125. When a manual drive/control mode is selected, the manual control unit10actuates the transmission mechanism12so that the latter drives the delivery catheter5. In case an electrical drive/control mode is selected, the electrical control unit11drives the transmission mechanism12, thereby enabling the delivery of the implant by the delivery catheter5. Thus, with the drive handle1of the present invention, the physician is allowed to select different modes for various practical needs. The operation is simple, and the physician can perform the surgical procedure based on his/her own operational preferences. In addition, since the drive handle1of the present invention can operate in two modes (i.e., the manual and electrical drive/control modes), in the event of one of the modes failing during an ongoing surgical procedure, it can be switched to the other mode to enable continuation of the procedure, thereby lowering the risk arising from driving the delivery catheter5in a single mode and hence increasing the security of the device.

Further, the transmission mechanism12includes a motion conversion member120, a lead screw121, a motion transmission member122, a support member124and a displacement member123fitted around the lead screw121. The lead screw121is connected to the motion conversion member120at one end and to the motion transmission member122at the other end. The motion conversion member120is configured to receive a motion signal for actuating the lead screw121from the manual control unit10. The motion transmission member122is configured to receive another motion signal for actuating the lead screw121from the electrical control unit11. The support member124is configured to support and mount the lead screw121and to limit the length of travel of the displacement member123. The lead screw121is provided with an external thread that mates with an internal thread in the displacement member123. The connecting member125is configured to establish a connection between the lead screw121and the delivery catheter5. Preferably, the lead screw121is a screw rod. Here, the connection between the lead screw121and the proximal end of the delivery catheter5is established by means of the connecting member125that is disposed on the displacement member123. More specifically, the connecting member125is connected to the outer shaft3. Preferably, the displacement member is a nut. It is a matter of course that the displacement member may also be selected other than a nut in other specific embodiments. The connection between the lead screw121and the delivery catheter5includes, but is not limited to, to that established by the connecting member125, and any otherwise established connection is also possible as long as it makes it possible that during axial movement of the displacement member123along the lead screw121, there is a medium enabling the outer shaft3of the delivery catheter5to axially move relative to the inner shaft2and the stability shaft4.

Further, the manual control unit10includes manual control member101and a manual drive shaft102connected to the manual control member101.

Further, the electrical control unit11includes a power supply110, control buttons114and a motor113. The control buttons114control a rotational direction of the motor113and hence a transitional direction of the displacement member123. The control buttons114and the motor113are powered by the power supply110. Preferably, the motor is a direct current (DC) motor. More preferably, the electrical control unit11further includes a controller115. The controller115receives direction and speed commands from the control buttons114and, based thereon, control the rotational direction and speed of the motor113and hence the transitional direction and speed of the displacement member123. The power supply110supplies power to the controller115and the control buttons114via wires. Preferably, the motor113is a stepping motor. It will be readily appreciated that the electrical control unit11may be powered by a built-in power supply (e.g., the power supply110) and corresponding supporting accessories (e.g., a power supply contact111and a power supply switch112). The built-in power supply may be arranged in a power compartment (not shown) on the first shell7and is electrically connected to the power supply contact111which is also disposed within the compartment, with the power supply switch112being in electrical connection with the power supply contact111and the control buttons114. Preferably, the built-in power supply is a disposable or rechargeable power supply. The present invention is not limited to any particular power supply, and a lithium, zinc-manganese, nickel-cadmium or other battery is possible. The electrical control unit11may also be powered by an external power supply and corresponding supporting accessories (e.g., the power supply switch112). The power supply switch112is electrically connected to a power supply plug (not shown) and to the control buttons114.

In this embodiment, the manual control unit10, the automatic1land transmission mechanism12are all arranged in the first shell7. Specifically, the power supply contact111, control buttons114and controller115of the electrical control unit11are fixed on the first shell7by fitted and fixed into slots, while each of the power supply switch112, the manual control unit10and the transmission mechanism12is fixed to the first shell7by screws.

Referring toFIGS. 1, 2 and 3a-3d, the delivery catheter5includes the inner shaft2, the outer shaft3disposed over part of the inner shaft2and the stability shaft disposed over part of the outer shaft3. The implant is loaded in a space between distal ends of the outer shaft3and the inner shaft2. Specifically, the inner shaft2includes the guide tip2aand a connector for the implant2b. The implant is loaded around an implant loading section2cbetween the guide tip2aand the connector for the implant2b, with its one end secured to the connector for the implant2b. The “outer shaft3disposed over part of the inner shaft2” is desired to be configured to allow a distal end of the outer shaft3to be close to the guide tip2aduring the delivery of the implant. The stability shaft4is provided mainly to prevent unwanted contact between the outer shaft3and the treated tissue when it is moved before the deployment of the implant. To this end, the stability shaft4covers as large part of the outer shaft3as possible. Meanwhile, during the delivery of the implant, the catheter5is required to pass through the aortic arch. This requires the delivery catheter5to have low bending stiffness and high flexibility. During the deployment of the implant, in order to fully release the implant, it is needed to move the outer shaft3toward the proximal end. This requires the outer shaft3not to be completely covered by the stability shaft4. The length of the outer shaft3covered by the stability shaft4may be determined by those skilled in the art based on the geometry of the tissue and the type of the implant, in order to meet all of the foregoing requirements.

Furthermore, as shown inFIG. 2, the delivery catheter5further comprises an inner shaft mounting20, an outer shaft mounting30and a stability shaft mounting40. The inner shaft mounting20is disposed at a proximal end of the inner shaft2(i.e., the end thereof far away from the guide tip2a) and is configured to secure the inner shaft2. The outer shaft mounting30is disposed at a proximal end of the outer shaft3(i.e., the end thereof far away from the guide tip2a) and is configured to secure the outer shaft3. The outer shaft mounting30is provided with a lumen for passing through the inner shaft2. The stability shaft mounting40is disposed at a proximal end of the stability shaft4(i.e., the end thereof far away from the guide tip2a) and is configured to secure the stability shaft4. The stability shaft mounting40is provided with a lumen for the passage of the outer shaft3therethrough. The inner shaft2is fixed to the first shell7by the inner shaft mounting20. The outer shaft3is connected to the displacement member123by the outer shaft mounting30and the connecting member125. The outer shaft mounting30is moveable relative to the first shell7. The stability shaft4is fixed to the first shell7by the stability shaft mounting40. Specifically, the proximal end of the inner shaft2is secured to the inner shaft mounting20which is, in turn, fitted and fixed into an inner shaft slot at a proximal end of the first shell7. The proximal end of the stability shaft4is secured to the stability shaft mounting40which is, in turn, fitted and fixed into a stability shaft slot at a distal end of the first shell7(i.e., the end thereof close to the guide tip2a).

The process to deploy the implant by the delivery catheter5driven by the drive handle1will be better understood from the description set forth below in the context of a valve stent6being implemented as the implant, which is to be read in conjunction withFIGS. 3a-3d.FIG. 3ashows the valve stent6that has not been deployed. As clearly shown fromFIG. 3a, the valve stent6is loaded around the section of the inner shaft2between the guide tip2aand the connector for the implant2b(i.e., the implant loading section2cof the inner shaft2), with a proximal end section2dof the inner shaft connected at one end to the connector for the implant2band fixedly connected at the other end to the inner shaft mounting20by means of a threaded fit or an adhesive. The inner shaft mounting20is fitted and fixed into the inner shaft slot at the proximal end of the first shell7so that the inner shaft2is fixed as a whole relative to the drive handle1. By doing this, it is also ensured that the valve stent6loaded on the connector for the implant2bis fixed relative to the drive handle1. The distal end of the outer shaft3is disposed over the valve stent6on the implant loading section2c. Preferably, the distal end of the outer shaft3comes into contact with a proximal end face of the guide tip2aat the distal end of the inner shaft2, and the proximal end of the outer shaft3is fixed to the outer shaft mounting30. In order to release the valve stent, regardless of whether in the manual or electrical drive/control mode, the outer shaft3is moved with the outer shaft mounting30relative to the drive handle1, with the inner shaft2and the stability shaft4being fixed relative to the drive handle1. Specifically, the lead screw121of the transmission mechanism12is connected at one end to the motor113in the electrical control unit11via the motion transmission member122, so that when in the electrical drive/control mode, if the motor113rotates under the control of direction and speed parameters set by the control buttons114, the rotation will be converted by the motion transmission member122and the lead screw121into axial movement of the displacement member123. Under the action of the connecting member125that connects the displacement member123with the outer shaft mounting30, the outer shaft3will then move along with the outer shaft mounting30axially relative to the inner shaft2and the stability shaft4. When in the manual drive/control mode, rotation of the manual control member101can be transmitted to the lead screw121via both the manual drive shaft102and the motion conversion member120in the transmission mechanism12, such that the lead screw121drives the displacement member123to move axially. As a result, the outer shaft3moves axially relative to the inner shaft2and the stability shaft4. Reference can be made toFIGS. 3a-3dfor the deployment of the valve stent6in both the manual and electrical drive/control modes.FIGS. 3b-3dshow successive configurations of the valve stent6during the process in which the outer shaft3shown inFIG. 3amoves toward the proximal end of the drive handle, and the valve stent6is then accordingly deployed gradually from the delivery catheter5. And states of the valve stent6are presented successively inFIGS. 3b-3d.

Obviously, loading of the valve stent in vitro may be achieved by choosing a direction opposite to that for deploying the valve stent by the control buttons114, such that the outer shaft3and inner shaft2to move relative to each other in directions opposite to those for deploying the valve stent, or through manually rotating the manual control member in a direction opposite to that for deploying the valve stent.

While the embodiments herein are described in the context of the valve stent6(e.g., a heart valve stent) being implemented as the implant, those skilled in the art will appreciate that the delivery apparatus disclosed in the present invention may also be used to place other implants (e.g., vascular stents) than valve stents at their target sites in the body.

FIG. 4shows control buttons114each indicating a direction combined with a speed. The buttons in the first row are high-gear buttons (corresponding to higher speeds), while those in the second row are low-gear buttons (corresponding to lower speeds). Pressing a button marked with an arrow pointing to the right will cause the outer shaft3to retract to allow the release of the implant. When a button marked with an arrow pointing to the left is pressed, the outer shaft3will move in the opposite direction to allow the loading of the implant.

With combined reference toFIGS. 1 and 5, this second embodiment differs from Embodiment 1 in that a second shell8is further provided, wherein the manual control unit10, the electrical control unit11and the transmission mechanism12are all disposed in the first shell7, and the proximal end of the delivery catheter5is arranged in the second shell8. The first shell7is connected to the second shell8in a detachable manner. Opposite sides of the first shell7and the second shell8are provided with displacement grooves, through which the connecting member125is detachably connected to the delivery catheter5. The delivery catheter5includes the inner shaft2and the outer shaft3disposed over part of the inner shaft2. The implant is loaded in a space between distal portions of the outer shaft3and the inner shaft2. The delivery catheter5further comprises the inner shaft mounting20and the outer shaft mounting30. The inner shaft mounting20is moveable relative to the second shell8. The outer shaft mounting30is fixed at a distal end of the second shell8. Preferably, the connecting member125is detachably connected to the inner shaft mounting20by means of a snap or other means. Preferably, the second shell8and the first shell7are connected together with a hasp9.

Specifically, the inner shaft mounting20is disposed at the proximal end of the inner shaft2and is moveable relative to the second shell8. More preferably, an inner flush shaft21is provided in the inner shaft and its proximal end is fixed into an inner flush shaft slot at a proximal end of the second shell8by means of an inner flush shaft mounting210. The outer shaft mounting30at the proximal end of the outer shaft3is fixed into an outer shaft slot at the distal end of the second shell8and is provided with a lumen for the passage of the inner shaft2therethrough. In order to deploy the valve stent in the manual or electrical drive/control mode, the inner shaft mounting20is driven to move toward the distal end of the drive handle1such that the inner shaft2moves towards its distal end. In this embodiment, the drive handle1can be detached from the delivery catheter5as desired and to be reused, leading to lower surgical cost. In order to load the valve stent, the inner shaft2and the outer shaft3may be driven to move in opposite directions to those for deployment of the valve stent either by the manual control member101in an opposite direction or by the control buttons114with suitable direction parameters.

The embodiments herein are described in a progressive manner in which differences between the embodiments are emphasized. Reference may be made between the embodiments for details in their same or similar features.

In summary, the drive handle and system are provided in the present invention, the drive handle comprising the manual control unit, the electrical control unit and the transmission mechanism, the manual control unit being connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter, the electrical control unit being connected to the transmission mechanism to actuate the transmission mechanism to drive the delivery catheter. Thus, the drive handle of the present invention is switchable between the manual and electrical drive/control modes to drive the delivery catheter to deliver the implant. The operation is simple, and the operating physician can take full advantage of the two modes to perform the surgical procedure based on his/her own operational preferences. This can result in higher surgical accuracy. Further, by providing the two modes, the apparatus has an increased security and the surgical risk can be reduced.

The foregoing description presents merely some preferred embodiments of the present invention and is not intended to limit the scope of the invention in any sense. Any changes and modifications made by those skilled in the art in light of the disclosure herein are considered to fall within the scope defined by the appended claims.