Delivery device with guidewire control

Abstract

The present disclosure relates generally to delivery devices for transcatheter delivery of prostheses. The delivery devices include a hollow shaft that supports a prosthesis thereon. A handle assembly holds the shaft. The delivery device further includes a guidewire that is selectively guided through the handle assembly and the shaft. The guidewire guides the shaft to a target site where the prosthesis is to be deployed. In practice, an operator managing the inner catheter controls positioning of the prosthesis. The delivery devices disclosed herein are configured to also allow the operator to control the position of the guidewire ergonomically, as the position of the guidewire affects the deployed position of the prosthesis. In this way, a second operator for positioning the guidewire can be dispensed with. Embodiments of the present disclosure are believed to improve predictability and ease of use of positioning.

Description

Technical Field

[0001] This technology as a whole relates to a method for transcatheter prosthesis delivery devices and guidewires for controlling the delivery device. Background Technology

[0002] Implanted artificial heart valves can be used to repair or replace diseased or otherwise defective heart valves. Typically, heart valve replacement surgery is an open-heart surgery performed under general anesthesia, during which the heart is stopped and blood flow is controlled by a cardiopulmonary bypass machine. Traditional open surgery can cause significant trauma and discomfort to patients and exposes them to many potential risks, such as infection, stroke, kidney failure, and side effects associated with the use of a cardiopulmonary bypass machine.

[0003] Due to these drawbacks of open-heart surgery, there is growing interest in minimally invasive and percutaneous heart valve replacement. Using percutaneous transcatheter (or transluminal) techniques, an artificial heart valve is compacted for delivery in a catheter, then advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart. In the heart, the artificial heart valve is then deployed in the valve ring to be restored (e.g., the aortic valve ring). While transcatheter techniques have gained widespread acceptance for delivering conventional stents to restore vascular patency, percutaneous delivery of more complex artificial heart valves has yielded mixed results.

[0004] This disclosure provides improvements related to transcatheter delivery devices. Summary of the Invention

[0005] The present disclosure relates generally to a delivery device for transcatheter delivery of a prosthesis. The delivery device includes a hollow shaft supporting the prosthesis thereon. A handle assembly holds the shaft. The delivery device further includes a guidewire selectively guided through the handle assembly and the shaft. The guidewire guides the shaft to a target site where the prosthesis will be deployed. In practice, an operator managing the shaft or the internal catheter controls the positioning of the prosthesis. The delivery device disclosed herein is configured to ergonomically also allow the operator to control the position of the guidewire, as the position of the guidewire affects the deployment position of the prosthesis. In this way, a second operator for positioning the guidewire can be eliminated. Embodiments of this disclosure are believed to improve the predictability and ease of use of positioning.

[0006] In one aspect, this disclosure provides a delivery device including a handle assembly having a distal end and a proximal end. The handle assembly further includes a body defining a lumen extending from the distal end to the proximal end. The delivery device further includes a hollow shaft extending from the distal end of the handle assembly and a guidewire extending through the lumen. The delivery device also includes a guidewire control having an actuator positioned at the distal end of the handle assembly and a lock positioned at the proximal end of the handle assembly. The actuator is interconnected with the lock via a connector located within the lumen. The guidewire control has an unlocked state, wherein movement of the actuator slides accordingly to advance the guidewire. The guidewire control also has a locked state, in which longitudinal movement of the guidewire relative to the body is prevented.

[0007] In another aspect, this disclosure provides a method for controlling a guidewire. The method may include providing a delivery device having a handle assembly having a distal end and a proximal end. The handle assembly further includes a body defining a lumen extending from the distal end to the proximal end. The delivery device further includes a hollow shaft extending from the distal end of the handle assembly and a guidewire control. The guidewire control includes an actuator positioned at the distal end of the handle assembly and a lock positioned at the proximal end of the handle assembly. The actuator is interconnected with the lock via a connector located within the lumen. In this example, the guidewire control is set to an unlocked state. The method further includes positioning the guidewire through the lumen and guiding the guidewire through the lumen and into the patient's vascular system near a target site by movement of the actuator. The method also includes changing the lock to a locked state.

[0008] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims. Attached Figure Description

[0009] Figure 1 Three clinicians operating the delivery device are shown.

[0010] Figure 2 This is a partial top view of the delivery device with guidewire control disclosed herein.

[0011] Figure 3 yes Figure 2 An enlarged top view of the actuator of the guidewire control.

[0012] Figure 4 yes Figure 2 A magnified top view of the lock of the guide wire control.

[0013] Figure 5 yes Figure 2 A cross-sectional view of the delivery device.

[0014] Figure 6 yes Figures 2 to 3 An enlarged cross-sectional view of the actuator.

[0015] Figure 7 yes Figure 2 and Figure 4 An enlarged cross-sectional view of the lock.

[0016] Figure 8 It shows how to use Figure 2 The device's actuator has an optional hand placement. Detailed Implementation

[0017] Specific embodiments of this disclosure are now described with reference to the accompanying drawings, wherein like reference numerals denote like or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to position or orientation relative to the treating clinician. “Distal” or “distal” means a position away from or away from the clinician. “Proximal” and “proximal” mean a position close to or towards the clinician. Although this disclosure has been described with reference to preferred embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of this disclosure.

[0018] Figure 1 Two clinicians, C1 and C2, are shown delivering a prosthesis via transcatheter surgery using a delivery device 10. The delivery device 10 can be any delivery device known in the art, and includes a handle assembly 12 connected to a hollow shaft 14 (not visible) supporting the prosthesis. A guidewire 16 is provided and can extend through the handle assembly 12 and the shaft 14. In one example, the prosthesis is supported on the shaft 14, and an external catheter (not shown) is provided to selectively cover the shaft 14 and the prosthesis. For example, the prosthesis can be one of a variety of prostheses, such as, for example, a stent or an artificial heart valve. In this procedure, the first clinician, C1, manages and controls the shaft 14 and the external catheter. For example, the first operator, C1, controls the depth of the shaft (and optionally the external catheter) during prosthesis deployment. The second operator, C2, guides the guidewire 16 through the proximal end of the handle assembly 12 of the device to the distal end of the device 10, through the patient's vascular system to the target site. The second clinician, C2, uses the guidewire to fine-tune and adjust the tension of the shaft / optionally the external catheter. It has been observed that, when using such delivery devices, the first operator C1 typically holds the shaft 14 or the external catheter with one hand and grasps the guidewire 16 with the other hand. The first operator C1 then moves the guidewire 16 past the second clinician C2, which is ergonomically inconvenient. Optionally, a third clinician C3 (if present) is provided to retract the external catheter.

[0019] Figures 2 to 8A delivery device 110 for transcatheter delivery of prosthesis 111 is shown together. Delivery device 110 includes a hollow shaft 112 supporting the prosthesis 111 thereon. It should be noted that... Figure 5 In this illustration, shaft 112 is not shown to scale and is shown shortened for illustrative purposes. In practice, shaft 112 can be significantly longer. The delivery device 110 may further include an external catheter (not shown) that selectively covers shaft 112 and prosthesis 111 during delivery. Handle assembly 114 holds shaft 112 and external catheter. In some embodiments, handle assembly 114 is configured to allow an operator to control movement of the external catheter relative to shaft 112. Handle assembly 114 includes a body 116 having a distal end 118 and a proximal end 120. Body 116 defines an internal lumen 122 extending through the proximal end 120 and through the distal end 118. Delivery device 110 further includes a guidewire 124 that is selectively guided through the internal lumen 122 of handle assembly 114 and through shaft 112. It is conceivable that guidewire 124 may be disposed separately from delivery device 110. Guide wire 124 passes through hollow shaft 112 to guide prosthesis 111 to the target site for deployment of prosthesis 111. In practice, the operator managing shaft 112 controls the positioning of prosthesis 111. The delivery device disclosed herein is configured to also allow the operator to control the position of the guide wire, as the position of the guide wire affects the deployment position of the prosthesis. In this way, a second operator for positioning the guide wire can be eliminated. Embodiments of this disclosure are believed to improve the predictability and ease of use of positioning.

[0020] The delivery device 1110 includes a guide wire control 130, which includes an actuator 132 located at the distal end 118 of the body 116 of the handle assembly 114. In some embodiments, the actuator 132 is positioned on a shaft 112. The actuator 132 is configured to control the advance of the guide wire 124. In one example, the actuator 132 has a thumbwheel 134 (schematically shown) fixed to a slider 138, which engages and advances the guide wire 124, guiding it through an opening or lumen 139 in the slider 138. One embodiment of this would utilize a rack and pinion mechanism, where the thumbwheel 134 is the driving pinion and the rack is attached to the guide wire 124. Any other actuator capable of advancing the guide wire 124 and connecting it to the connector 140 is suitable.

[0021] The guidewire control 130 further includes a connector 140 that extends through a lumen 122 of the body 116 and interconnects the actuator 132 to a lock 142 located at the proximal end 120 of the body 116. The connector 140 may be soldered or otherwise secured to both the actuator 132 and the lock 142. In one embodiment, the lock 142 is mounted to one or more support rods 143 extending from the proximal end 120. In various embodiments, the connector 140 includes a lumen 144 through which the guidewire 124 is guided. In such embodiments, the lumen 144 of the connector 140 is coaxial with the lumen 139 of the actuator / slider 138. In one embodiment, the connector 140 is not hollow but a rod (i.e., a rigid wire or shaft), and the guidewire 124 is routed parallel to and spaced apart from the connector 140. When the lock 142 is in the unlocked state, the actuator 132, which moves back and forth via the thumb wheel 134, pulls and pushes the lock 142 and the connector 140 relative to the body 116 of the handle assembly 114.

[0022] Lock 142 includes a lumen or opening 146 through which guidewire 124 is guided, and the lock is configured to have an unlocked state in which guidewire 124 can move longitudinally through both the lumen 146 of lock 142, the lumen 122 of body 116, and the lumen 139 of slider 138. Lock 142 is further configured to have a locked state in which guidewire 124 is locked and held in a longitudinal position relative to both handle assembly 114 and shaft 112. In one usage example, lock 142 remains in its unlocked state until shaft 112 is tracked and in its initial position, near the target site. Guidewire 124 is then locked by lock 142, thereby allowing the operator to take over from the patient side (i.e., the distal end 118 of handle assembly 114), thus allowing a single operator to position controls during prosthesis deployment. In one example, lock 142 may be a Tuohy Borst type connector.

[0023] The apparatus disclosed herein (e.g., delivery device 110) can be used in a method of controlling guidewire 124. This method may include providing delivery device 110. A prosthesis 111 (such as, for example, a stent or artificial heart valve) may be positioned on or collapsed on shaft 112. In this example, guidewire control 130 is in an unlocked state. The method further includes positioning guidewire 124 through lumen 146 of lock 142, lumen 122 of handle assembly 114, and lumen 139 of actuator 132, and guiding guidewire 124 into the patient's vascular system, near a target site, by movement of actuator 132 or other actuation. In an example where connector 140 includes lumen 146, guidewire 124 may also be guided through connector 140. Shaft 112 is advanced along guidewire 124 until prosthesis 111 is guided to the target site for deployment. The method also includes changing the lock 142 to a locked state, such that the guide wire 124 is maintained in a longitudinal position relative to the handle assembly 114 and the shaft 112 during the positioning of the shaft 112 / prosthesis 111 and the deployment of the prosthesis 111.

[0024] It should be understood that the various aspects disclosed herein can be combined in different combinations than those specifically presented in the specification and figures. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, and may be added, combined, or omitted entirely (e.g., performing the described technique may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

Claims

1. A delivery device, the delivery device comprising: A handle assembly having a distal end and a proximal end, the handle assembly further including a body defining a lumen extending from the distal end to the proximal end; A hollow shaft extending from the distal end of the handle assembly; A guidewire that extends through the lumen; and A guidewire control; the guidewire control includes an actuator positioned at the distal end of the handle assembly and a lock positioned at the proximal end of the handle assembly, the actuator being interconnected with the lock via a connector located within the lumen; wherein the guidewire control has an unlocked state, wherein movement of the actuator slides accordingly to advance the guidewire, and the guidewire control further has a locked state, in which longitudinal movement of the guidewire relative to the body is prevented.

2. The delivery device according to claim 1, wherein the actuator comprises a thumb wheel.

3. The delivery device of claim 1, wherein the actuator includes a slider mounted above the shaft.

4. The delivery device according to claim 1, wherein the connector is a rigid shaft.

5. The delivery device according to claim 1, wherein the connector is a tube.

6. The delivery device according to claim 5, wherein the tube is a sodium hypochlorite tube.

7. The delivery device of claim 5, wherein the guidewire is guided through the tube.

8. The delivery device of claim 5, wherein the tube extends from the distal end of the body of the handle assembly to the proximal end.

9. The delivery device according to claim 1, wherein, In the unlocked state, the lock is configured to move toward and away from the body.

10. The delivery device according to claim 9, wherein, In the unlocked state, the movement of the actuator pulls and pushes the connector and the lock.

11. The delivery device according to claim 9, wherein, In the locked state, the lock maintains its longitudinal position relative to the body.

12. The delivery device of claim 1, wherein the lock comprises a Tuohy Borst connector.

13. The delivery device of claim 1, wherein the actuator is positioned on the shaft.

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