Delivery systems and methods for delivering prostheses

Abstract

A delivery system and method for delivering a prosthesis are disclosed. The delivery system includes a mandrel for securing a stent to an axis. The mandrel includes at least one recess for receiving a paddle-shaped member of the stent. The delivery system also includes at least one sensor positioned within the at least one recess and configured to detect the presence of the paddle-shaped member relative to the at least one recess.

Description

Technical Field

[0001] This technology generally relates to delivery catheters for percutaneous delivery of medical devices. Background Technology

[0002] Medical catheters, or delivery catheters, are typically used to access blood vessels and target sites within the body and perform various functions at those sites. These devices are suitable for delivering and deploying medical devices such as prosthetic heart valves, stent grafts, and stents to target sites within the body. When the catheter is navigated to and positioned at the target site, the medical device is typically delivered in a radially compressed state or releasably carried within the distal region of the delivery catheter. In many cases, such as those involving the cardiovascular system, the path to the target site may be tortuous, and there may be conflicting design considerations requiring trade-offs between size, flexibility, material selection, and operational control.

[0003] Typically, the advancement of the delivery catheter within the patient is monitored via fluoroscopy, enabling clinicians to manipulate the catheter to control and guide its distal end through the patient's vascular system to the target site. This tracking requires the distal end of the delivery catheter to be safely navigated to the target site through the clinician's manipulation of the proximal end. Ideally, the delivery catheter will have a low profile or small outer diameter to facilitate navigation through the tortuous vascular system. Additionally, the medical device must be loaded onto the delivery catheter before implantation. Currently, the loading process requires extensive user training to identify misloading of the medical device. Due to the complex steps involved in the loading process, current procedures may misidentify misloading of the medical device, leading to surgical complications. To identify misloading, a fluoroscopic misloading check is required during each procedure to verify that the medical device is correctly loaded onto the delivery catheter. This unnecessarily delays the procedure and exposes physicians and patients to unnecessary radiation. Summary of the Invention

[0004] This disclosure generally relates to a prosthesis delivery system that provides feedback indicating correct loading of an implantable medical device and feedback indicating release of the implantable medical device. The prosthesis delivery system includes one or more sensors positioned and configured to detect correct loading of the implantable medical device. The prosthesis delivery system includes one or more sensors in communication with the one or more indicators. The one or more indicators output an indication of correct loading of the implantable medical device.

[0005] In one aspect, this disclosure provides a delivery system for delivering an implantable medical device (e.g., a prosthesis). The delivery system includes a prosthesis retaining member or mandrel for securing the prosthesis to an axis. The mandrel includes at least one recess for receiving the retaining member (e.g., a paddle-like element of a prosthesis stent or frame). The delivery system also includes at least one sensor positioned within the at least one recess and configured to detect the presence of the prosthesis paddle-like element relative to the at least one recess.

[0006] In another aspect, this disclosure provides a delivery system for delivering a prosthesis. The delivery system includes an axis for delivering the prosthesis to a target site. The delivery system also includes a prosthesis retaining member or mandrel coupled to the axis for securing a portion of an implantable medical device to the axis. The mandrel includes at least one recess for receiving the retaining member (e.g., a paddle-like component of a prosthesis stent or frame). Further, the delivery system includes a sheath covering the retaining member or paddle-like component and the mandrel. The sheath is configured to move relative to the axis. The delivery system includes at least one sensor positioned within the at least one recess and configured to detect the presence of the retaining member or paddle-like component relative to the at least one recess.

[0007] In another aspect, the present invention provides a method for determining the correct loading of an implantable medical device, such as a prosthesis retention member or a mandrel, coupled to a delivery system. The method includes activating one or more of at least one sensor or at least one indicator. The at least one sensor is positioned within a recess in the mandrel and configured to detect the presence of a paddle-shaped element of the implantable medical device relative to the recess. The method further includes, in response to the activation, outputting an indication of the relative position of the paddle-shaped element to the recess via the at least one indicator.

[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] The foregoing and other features and advantages of this disclosure will become apparent from the following description of the embodiments shown in the accompanying drawings. The drawings, which are incorporated herein and form part of this specification, are further used to explain the principles of this disclosure and to enable those skilled in the art to make and use the embodiments of this disclosure. The drawings are not drawn to scale.

[0010] Figures 1A to 1E Different views of a prosthesis delivery system according to an embodiment of the present invention are depicted.

[0011] Figures 2A to 2D The embodiments of the present invention are described. Figures 1A to 1EDifferent views of the alignment of the paddle-shaped component of the stent in the prosthesis delivery system.

[0012] Figure 3 The embodiments of the present invention are described. Figures 1A to 1E An example of sensor positioning in a prosthesis delivery system.

[0013] Figure 4A and Figure 4B The embodiments of the present invention are described. Figures 1A to 1E Another example of sensor positioning in a prosthesis delivery system.

[0014] Figure 5A and Figure 5B The embodiments of the present invention are described. Figures 1A to 1E Another example of sensor positioning in a prosthesis delivery system.

[0015] Figure 6 The embodiments of the present invention are described. Figures 1A to 1E The operation process of the prosthesis delivery system. Detailed Implementation

[0016] 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 following detailed description illustrates examples of embodiments and is not intended to limit the technology or its application and use. Although the description of embodiments of the invention is made in the context of implantable medical devices, the technology can also be used with other devices. Furthermore, it is not intended to be construed as being bound by any express or implied theory presented in the foregoing technical field, background art, summary of the invention, or the following detailed description.

[0017] The terms “distal” and “proximal”, when used in the following description to refer to a delivery system or catheter, relate to position or direction relative to the treating clinician. Therefore, “distal” and “distal” refer to a position away from or in a direction away from the treating clinician, while the terms “proximal” and “proximal” refer to a position close to or towards the clinician. The terms “distal” and “proximal” are used in the following description to refer to devices to be implanted in a blood vessel, such as artificial heart valves, with reference to the direction of blood flow. Therefore, “distal” and “distal” refer to a position in a downstream direction relative to the direction of blood flow, and the terms “proximal” and “proximal” refer to a position in a upstream direction relative to the direction of blood flow.

[0018] The embodiments disclosed herein relate to a prosthesis delivery system for delivering implantable medical devices (e.g., prostheses including stents and replacement heart valves) to an implantation or target site (e.g., a natural heart valve). To ensure proper loading of the implantable medical device onto the prosthesis delivery system, the delivery catheter of the prosthesis delivery system includes one or more sensors. These one or more sensors are positioned and configured to assist in loading the implantable medical device and provide confirmation that the implantable medical device is correctly loaded. For example, the one or more sensors may be positioned and configured to detect and output the positioning, location, and alignment of an attachment component (e.g., a paddle) of the implantable medical device relative to a connecting component (e.g., a spool) of the delivery catheter. The one or more sensors provide positioning, location, and alignment to an indicator that provides visual, auditory, or physical feedback indicating correct loading.

[0019] Figures 1A to 1E Several views of a prosthesis delivery system 100 according to an embodiment of the present invention are shown. Those skilled in the art will recognize that... Figures 1A to 1E An example of a delivery system is shown, and Figures 1A to 1E Existing components shown may be removed, and / or additional components may be added to the prosthesis delivery system 100.

[0020] like Figure 1A As shown, this figure is a cross-sectional view of a prosthesis delivery system 100, which includes a delivery catheter 102, also referred to herein as a delivery device. The prosthesis delivery system 100 also includes a handle 104 for controlling the operation of the delivery catheter 102. An implantable medical device 150 is mounted in a radially compressed configuration at the distal portion 103 of the delivery catheter 102. By manipulating the delivery catheter 102 using the handle 104, the prosthesis delivery system 100 is configured to deliver, release, or deploy the implantable medical device 150 at a desired treatment location or target site. Therefore, the prosthesis delivery system 100 is sized and configured for minimally invasive advancement through the vascular system.

[0021] like Figure 1A As shown in the diagram and the unfolded diagram of the distal portion 103 Figure 1BAs further shown, the delivery catheter 102 includes an outer sheath 106, an intermediate shaft 108, and an inner shaft 110. The outer sheath 106 may include a proximal portion 107 extending from the handle 104 to the distal portion 103. The outer sheath 106 forms an inner lumen 111 in which the intermediate shaft 108 extends from the handle 104 to a spindle 118 located in the distal portion 103. When in a compressed configuration, the outer sheath 106 may also include a distal portion 114 extending over the spindle 118 and the implantable medical device 150. In embodiments, the outer sheath 106 may be formed as a tubular structure with a circular cross-section. In some embodiments, the distal portion 114 of the outer sheath 106 may be formed to have the same diameter as the proximal portion 107. In some embodiments, the distal portion 114 of the outer sheath 106 may be formed to have a diameter larger than that of the proximal portion 107. In one embodiment, the distal portion 114 of the outer sheath 106 may be used with the delivery catheter 102 to minimize endovascular trauma during the introduction, tracking, and delivery of the delivery catheter 102 to the desired treatment site. As described in further detail below, during operation, the distal portion 114 of the outer sheath 106 may be retracted (or advanced) by the operating handle 104, thereby exposing the implantable medical device 150.

[0022] In one embodiment, the intermediate shaft 108 has a proximal end 109 disposed within the handle 104. The intermediate shaft 108 extends from the handle 104 through the lumen 111 to a distal end 113. When the outer sheath 106 is disposed on the implantable medical device 150, the distal end 113 of the intermediate shaft 108 is disposed within the outer sheath 106. The intermediate shaft 108 can be coupled to the spindle 118 at the distal end 113. Figure 1B As shown, the intermediate shaft 108 forms an inner cavity 117 in which the inner shaft 110 extends from the handle 104 to the head end 127 located in the distal portion 103. In an embodiment, the intermediate shaft 108 may be formed as a tubular structure with a circular cross-section. The intermediate shaft 108 is slidably disposed within the outer sheath 106 and operatively coupled to the handle 104. As used herein, "slidably" means reciprocating in the longitudinal direction along or substantially parallel to the central longitudinal axis LA of the prosthesis delivery system 100.

[0023] In one embodiment, the inner shaft 110 may extend distally from within the handle 104 through the lumen 117 of the intermediate shaft to a tip 127 located in the distal portion 103. The inner shaft 110 may form a lumen 125 through which a guidewire 126 may pass. In one embodiment, the guidewire 126 may function as a guide for delivering the catheter 102 to a target site (e.g., a natural heart valve). The guidewire 126 may be loaded into a distal opening of the lumen 125 (e.g., the proximal end of the guidewire 126 is loaded into the distal end of the lumen 125 formed by the inner shaft 110). The delivery catheter 102 may be tracked along the guidewire 126 to the treatment site. Although not shown, the delivery catheter 102 may include additional shafts or sheaths positioned within the lumen 111 of the outer sheath 106, the lumen 117 formed by the intermediate shaft 108, and / or the lumen 125 formed by the inner shaft 110.

[0024] like Figure 1B and perspective view of the distal portion 103 Figure 1C (The outer sheath 106 has been removed for illustrative purposes only) As shown, the distal end 113 of the intermediate shaft 108 is coupled to the spindle 118. In an embodiment, the implantable medical device 150 may be releasably coupled to the spindle 118. Figure 1C As shown, the implantable medical device 150 may include a frame or stent 151 configured to support a medical device to be implanted (e.g., a heart valve replacement). The stent 151 may include one or more paddle-shaped members 152 extending proximally from a first end of the stent 151 located in the delivery system 100. Figure 1C A paddle-shaped member 152 is shown in the figure. For example, as shown, the paddle-shaped member 152 may extend from one or more structural supports or pillars 154 of the support 151.

[0025] The spindle 118 may be a tubular component having at least one recess 120 formed on its outer surface. In some embodiments, the spindle 118 may be formed as a cylinder. The recess 120 is configured to receive a paddle-shaped member 152 extending from the implantable medical device 150. The paddle-shaped member 152 is fitted within or engages with the recess 120 of the spindle 118 such that the implantable medical device 150 is releasably coupled to the spindle 118 and thereby coupled to the intermediate shaft 108. When the paddle-shaped member 152 is properly engaged with the recess 120, the paddle-shaped member 152 may be contained within the recess 120 such that the paddle-shaped member 152 does not extend beyond the outer periphery of the spindle 118, thereby allowing the distal portion 114 of the outer sheath 106 to cover the spindle 106 without forming a "protrusion" or incongruity in the surface of the outer sheath 118. Figure 1BOnly one recess 120 is visible, but those skilled in the art will understand that the spindle 118 may include two or more recesses 120 for receiving corresponding mating paddle-shaped elements of the implantable medical device 150. For example, in an embodiment, such as Figure 1A and Figure 1C As shown, the mandrel 118 may include two recesses 120 formed at relatively circumferential positions on the mandrel 118.

[0026] In some embodiments, the recess 120 may be formed to a size and shape that mates with or fits the paddle-shaped member 152. For example, as Figure 1B As shown, the recess 120 can be formed as a hemispherical or "bell-shaped" recess within the mandrel 118. The shape of the recess 120 can reflect the shape of the paddle 152, such that the paddle 152 is fitted within the recess 120. Figure 1D (It is along line A) Figure 1C As shown in the radial cross-sectional view, the recess 152 can be formed to a certain depth, such that the paddle 152 is fitted into the recess 120 without extending beyond the outer circumferential surface 119 of the mandrel 118. Although Figures 1A to 1E One configuration of recess 120 and paddle 152 is shown, but those skilled in the art will recognize that recess 120 and paddle 152 can be formed in any complementary design, shape, and / or size. In some embodiments, recess 120 and paddle 152 can be configured to interlock.

[0027] During delivery to the target site (e.g., the location of a natural heart valve), the outer sheath 106 may cover the implantable medical device 150 and retain the paddle-shaped member 152 within the recess 120, as shown in an axial cross-sectional view of the axis 118. Figure 2A and Figure 2B As shown. Figure 2A As shown, when the implantable medical device 150 is correctly loaded (e.g., the paddle 152 is contained within the recess 120), the distal portion 114 of the outer sheath 106 contacts the outer surface 119 of the mandrel 118, thereby forming a continuous surface. To release the implantable medical device 150, the distal portion 114 of the outer sheath 106 can be retracted (or advanced) by operating the handle 104, thereby exposing at least a portion of the implantable medical device 150 and the mandrel 118. The implantable medical device 150 can then be deployed by extending the stent 151 to a partially or fully uncompressed state.

[0028] During the loading of the implantable medical device 152 onto the delivery catheter 102, it is important that the paddle 152 properly mates with the recess 120. For example... Figure 2A and Figure 2CAs shown, these two figures are perspective views of the mandrel 118, with the distal portion 114 of the outer sheath 106 removed. If the implantable medical device 150 is properly loaded, the paddle-shaped member 152 can be positioned within the recess 120, for example, completely contained within the recess formed by the recess 120. That is, the paddle-shaped member 152 rests within the recess 120 such that it does not extend beyond the outer surface 119 of the mandrel 118. This allows the distal portion 114 of the outer sheath 106 to cover the implantable medical device 150 and retain the paddle-shaped member 152 within the recess 120 without interfering with the implantable medical device 150.

[0029] like Figure 2B and Figure 2D As shown, these two figures are perspective views of the mandrel 118, with the distal portion 114 of the outer sheath 106 removed. If the implantable medical device 150 is not properly loaded, one or more of the paddles 152 may not be fully positioned within the recess 120. If one of the paddles 152 is not properly positioned within one of the recesses 120, the outer sheath 106 may interfere with and constrict the paddle 152. For example, when not positioned within the recess 120, the distal portion 114 of the outer sheath 106 may press a portion of the paddle 152 against the outer surface 119 of the mandrel 118, potentially causing the paddle 152 or the support 151 to bend or warp. Such improper loading may damage the implantable medical device 150. Additionally, because the paddle 152 is not fully contained within the recess 120, the paddle 152 can create a "protrusion" 200 in the outer sheath 106, which can affect the delivery of the implantable medical device 150 to the target site.

[0030] Typically, to ensure that the implantable medical device 150 is correctly loaded onto the delivery catheter 102, the user of the prosthesis delivery system 100 uses an imaging device (e.g., a fluoroscope) to examine the delivery catheter 102 and the implantable medical device 150 after the implantable medical device 150 has been loaded. However, this process can be difficult and may expose technicians to radiation. Moreover, because the examination is performed after the implantable medical device 150 has been loaded, the implantable medical device may be unnecessarily damaged. Furthermore, if the implantable medical device 150 has been previously loaded, the process may need to be repeated by a physician or other technician at the time of implantation, who may not be properly trained to identify incorrect loading.

[0031] In an implementation, to ensure proper loading of the implantable medical device 150, the delivery catheter 102 may include one or more sensors 122 configured to provide indication of proper loading of the implantable medical device 150. Figure 1A and Figure 1BAs shown, the spindle 118 includes one or more sensors 122 for detecting the positioning, location, and alignment of the paddle 152 relative to the recess 120. The sensors 122 are configured to detect the presence, location, and alignment of the paddle 152 relative to the recess 120. The sensors 122 are coupled to an indicator 124 positionable on the handle 104. The indicator 124 can be configured to output data collected by the sensors 122, such as data representing the positioning, location, and alignment of the paddle 152 relative to the recess 120. In an embodiment, the indicator 124 can be configured to output feedback to the user of the prosthesis delivery system 100, including the positioning, location, and alignment of the paddle 152 relative to the recess 120. The indicator 124 can output feedback based on the data collected by the sensors 122 in any type of format perceptible to the user of the prosthesis delivery system 100 (e.g., visual, auditory, tactile, etc.).

[0032] like Figure 1A and Figure 1B As shown, sensor 122 can be coupled to indicator 124 via one or more wires 129. Wires 129 can be configured to transmit data collected by the sensor to indicator 124. Similarly, wires 129 can be configured to supply power to sensor 122 from a power source (not shown). In embodiments, wires 129 may be positioned within a cavity 117 defined by intermediate shaft 108. In some embodiments, the power source may be located in handle 104. The power source can be any type of device that supplies power to sensor 122, indicator 124, and / or any other component of prosthetic delivery system 100. While sensor 122 is described as being connected to indicator 124 via one or more wires 129, those skilled in the art will recognize that data can be transmitted between sensor 122 and indicator 124 via any type of data communication device or process (e.g., wireless communication). Similarly, while sensor 122 is described as being connected to a power source via one or more wires 129, those skilled in the art will recognize that sensor 122 can receive power from other sources such as an internal power source (e.g., a battery) within sensor 122, wireless power transmission, etc. Furthermore, although the indicator 124 is shown as being mounted on the handle 104, the indicator 124 can be separated from the handle 104, especially in the case of wireless communication, such as on mobile devices, medical monitors, etc.

[0033] The handle 104 may also have one or more actuation devices to activate the sensor 122 and the indicator 124. The actuation device may be any type of mechanical, electrical and / or electromechanical device for activating the sensor 122 and / or the indicator 124. For example, the actuation device may include a button, switch, knob, etc.

[0034] In one embodiment, sensor 122 may be positioned on and / or within the mandrel 118 at a location capable of detecting whether the paddle 152 properly mates with the recess 120. In another embodiment, such as Figure 1A , Figure 1C and Figure 1D As shown, each recess 120 may include a single sensor 122. For each recess 120, the sensor 122 may be formed within the bottom surface 130 of the recess 120, such as... Figure 1D As shown. Sensor 122 can be configured to detect the presence of paddle 152 in the recess 120 and relay the signal back to indicator 124.

[0035] For example, such as Figure 1A As shown, indicator 124 can be a visual indicator including red and green lights. When sensor 122 and indicator 124 are activated, indicator 124 can display a red light indicating misalignment or a green light indicating correct alignment (e.g., paddle 152 is within recess 120). In operation, as further described below, sensor 122 can be configured to detect the presence of paddle 152. When one or both paddles 152 are not within the corresponding recess 120, the corresponding sensor 122 provides a signal to indicator 124 indicating the absence of paddle 152, and in response, indicator 124 displays a red light. If both paddles 152 are within recess 120, sensor 122 provides a signal to indicator 124 indicating the presence of paddles, and in response, indicator 124 displays a green light. Although indicator 124 is described as providing a red or green light indicating correct alignment, those skilled in the art will recognize that indicator 124 can output any type of feedback perceptible to a user. For example, indicator 124 may include a display showing text such as “Misaligned” and “Aligned”. Similarly, indicator 124 may output auditory feedback indicating alignment, such as a beep, a voice such as “Aligned”, etc. Indicator 124 may alternatively or additionally provide tactile feedback, such as vibration, indicating correct or incorrect alignment.

[0036] In another implementation, such as Figure 4A and Figure 4B As shown, these two figures are respectively along Figure 1C The radial cross-sectional view taken from line A and the enlarged perspective view of the mandrel 118 show that each recess 120 may include multiple sensors 122. For each recess 120, the sensor 122 may be formed in a pattern surrounding the bottom surface 130 of the recess 120, such as... Figure 4BAs shown. For example, as illustrated, each recess 120 may include four sensors arranged in a square pattern around the bottom surface 130 of each recess 120. Multiple sensors 122 in each recess 120 may be configured to operate together to detect the presence of the paddle 152 in the recess 120 and relay the signal back to the indicator 124. Although Figure 4A and Figure 4B Four sensors 122 are shown in a square pattern in each recess 120, but those skilled in the art will recognize that this is an example and each recess 120 may include any number of sensors 122 in any pattern.

[0037] exist Figure 4A and Figure 4B During operation of the illustrated embodiment, indicator 124 may be a visual indicator including red and green lights. When sensor 122 and indicator 124 are activated, indicator 124 may display a red light indicating misalignment or a green light indicating correct alignment (e.g., paddle 152 is within recess 120). In operation, as further described below, sensor 122 may be configured to detect the presence of paddle 152. In this embodiment, multiple sensors 122 may operate together to detect the presence of 152. For example, when a threshold number of sensors 122 indicate the presence of paddle 152, indicator 124 may only display a green light.

[0038] That is, when the paddle 152 is not within the recess 120, all of the plurality of sensors 122 provide a signal to the indicator 124 indicating that the paddle 152 is not present, and in response, the indicator 124 displays a red light. If one of the paddles 152 is partially within one recess of the recess 120, a portion of the plurality of sensors 122 (e.g., three of the sensors 122) provide a signal to the indicator 124 indicating that the paddle 152 is not present, and a portion of the plurality of sensors 122 (e.g., one of the sensors 122) provide a signal to the indicator 124 indicating that the paddle 152 is present. If the number of sensors 122 that detect the presence of the paddle 152 is higher than a threshold, the indicator 124 displays a green light. In some embodiments, the threshold number of sensors 122 may be all of the sensors 122. In other embodiments, the threshold number of sensors 122 may be less than all of the sensors 122, for example, three of the four sensors 122. Although indicator 124 is described as providing a red or green light indicating correct alignment, those skilled in the art will recognize that indicator 124 may output any type of feedback perceptible to a user. For example, indicator 124 may include a display showing text such as “not aligned” and “aligned”. Similarly, indicator 124 may output auditory feedback indicating alignment, such as a beep, a voice such as “aligned”, etc. Indicator 124 may alternatively or additionally provide tactile feedback indicating correct or incorrect alignment, such as vibration.

[0039] In another implementation, such as Figure 5A As shown, these two figures are respectively along Figure 1C The radial cross-sectional view taken from line A and the enlarged perspective view of the mandrel 118, in addition to including the recess 120 of the sensor 122 as described above, show that one or more sensors in the sensor 122 can be positioned around the outer surface 119 of the mandrel 118. For example, as... Figure 5A As shown, sensors 122 may be formed at equal intervals within the outer surface 119 around the spindle 118. As also shown, the spindle 118 may include eight sensors 122 spaced apart around its outer periphery. The sensors 122 in each recess 120 and those around the outer surface 119 of the spindle 118 may be configured to operate together to detect the presence of the paddle 152 in the recess 120 and relay the signal back to the indicator 124. Although Figure 5A and Figure 5BEight sensors 122 formed around the outer periphery of the mandrel 118 are shown, but those skilled in the art will recognize this as an example, and the mandrel 118 may include any number of sensors 122 formed in any pattern on the outer surface 119 of the mandrel 118. For example, the mandrel 118 may include one or more of the sensors 122 formed around a recess 120 within the outer surface 119.

[0040] exist Figure 5A and Figure 5B During operation of the illustrated embodiment, indicator 124 may be a visual indicator including red and green lights. When sensor 122 and indicator 124 are activated, indicator 124 may display a red light indicating misalignment or a green light indicating correct alignment (e.g., paddle 152 is within recess 120). In operation, as further described below, sensor 122 may be configured to detect the presence of paddle 152 and relay a signal to indicator 124. In this embodiment, sensor 122 in each recess 120 and sensor 122 surrounding the outer surface 119 of mandrel 118 may operate together to detect the presence of paddle 152. For example, when sensor 122 located within the outer surface 119 of mandrel 118 indicates that paddle 152 is not present, and when sensor 122 located within recess 152 indicates that paddle 152 or a combination thereof is present within recess 120, indicator 124 may only display a green light.

[0041] That is, when the paddle 152 is not within the recess 120 or is only partially within the recess 120, one or more sensors 122 located within the outer surface 119 can detect the paddle 152 and provide an indicator 124 with a signal indicating that the paddle 152 is present on the outer surface 119. In response, the indicator 124 displays a red light. If none of the sensors 122 located within the outer surface 119 detect the paddle 152 (and the sensors 122 within the recess 120 detect the paddle), the indicator 124 displays a green light. Although the indicator 124 is described as providing a red or green light indicating correct alignment, those skilled in the art will recognize that the indicator 124 may output any type of feedback that can be perceived by a user. For example, the indicator 124 may include a display showing text such as “Misaligned” and “Aligned”. Similarly, for example, the indicator 124 may output auditory feedback indicating alignment, such as a beep, a voice such as “Aligned”, etc. Indicator 124 may alternatively or additionally provide tactile feedback, such as vibration, to indicate correct or incorrect alignment.

[0042] In the above description, the mandrel 118 is described as including a sensor 122 within the recess 120 and the outer surface 119. Those skilled in the art will recognize that the mandrel 118 may include any number of sensors 122 of any of the above configurations. For example, the sensor 122 may be included only in the recess 120. Similarly, for example, the sensor 122 may be included only within the surface 119 of the mandrel 118. Likewise, for example, the sensor 122 may be included in both the recess 120 and the outer surface 119. Those skilled in the art will also recognize that the sensor 122 may be positioned relative to the mandrel 118 in any manner. For example, as described above, the sensor 122 may be located within the outer surface 119 and positioned at any depth from the outer surface 119. Similarly, for example, the sensor 122 may be positioned on the outer surface 119.

[0043] In any of the above embodiments, sensor 122 can be any type of sensing device that detects the presence of paddle 152. In some embodiments, sensor 122 can be a capacitive sensor. As disclosed herein, a capacitive sensor can be configured to detect and measure anything conductive or having a dielectric material different from air or the surrounding material. For example, a capacitive sensor can operate using mutual capacitance, wherein paddle 152 alters the mutual coupling between row and column electrodes formed in sensor 122, which are scanned sequentially. Sensor 122 can output a signal representing self-capacitance or absolute capacitance, wherein paddle 152 loads or adds parasitic capacitance to sensor 122 relative to ground. In both cases, the difference between the previous absolute position and the current absolute position produces relative motion of paddle 152 during that time. The capacitive sensor can be made of materials such as copper, indium tin oxide (ITO), or printed conductive ink.

[0044] When sensor 122 includes a capacitance sensor, indicator 124 can be configured to read the signal provided by sensor 122 to determine capacitance. Indicator 124 can be configured to compare the capacitance of sensor 122 with a capacitance threshold. If the capacitance read from sensor 122 exceeds the capacitance threshold, indicator 124 can determine that sensor 122 has detected the presence of paddle 152 and output appropriate feedback. In an embodiment, for example, indicator 124 can be configured to read (or receive) a voltage value representing the capacitance of sensor 122 from sensor 122. Indicator 124 can be configured to include circuitry or logic that determines capacitance based on the voltage value of the sensor and compares that capacitance with a capacitance threshold to determine the presence of paddle 152 within recess 120.

[0045] In another embodiment, sensor 122 may include a mechanical, electrical, and / or electromechanical device that causes circuit activation. In this embodiment, sensor 122 may be part of a circuit formed by sensor 122, indicator 124, and wire 129. When paddle 152 contacts sensor 122, the circuit is completed, and a signal indicating the presence of paddle 152 is transmitted to indicator 124. In some embodiments, sensor 122 may include a mechanical, electrical, and / or electromechanical switch activated by the presence of paddle 152. In some embodiments, sensor 122 may include corresponding contacts that complete the circuit when the conductive material of paddle 152 contacts sensor 122.

[0046] In another embodiment, sensor 122 may include a force sensor. The force sensor may be configured to detect a force applied to sensor 122 by paddle 152. Indicator 124 may be configured to include circuitry or logic that determines the force based on a signal from the sensor and compares that force to a force threshold to determine the presence of paddle 152 within recess 120. When sensor 122 includes a force sensor, indicator 124 may be configured to read the signal provided by sensor 122 to determine the force measured by sensor 122. Indicator 124 may be configured to compare the force detected by sensor 122 to a force threshold. If the force read from sensor 122 exceeds the force threshold, indicator 124 may determine that sensor 122 has detected the presence of paddle 152 and output appropriate feedback.

[0047] In another embodiment, sensor 122 may include a pressure sensor. The pressure sensor may be configured to detect pressure applied to sensor 122 by paddle 152. Indicator 124 may be configured to include circuitry or logic that determines the pressure based on a signal received from sensor 122 and compares that pressure to a pressure threshold to determine the presence of paddle 152 within recess 120. When sensor 122 includes a pressure sensor, indicator 124 may be configured to read the signal provided by sensor 122 to determine the pressure measured by sensor 122. Indicator 124 may be configured to compare the pressure detected by sensor 122 to a pressure threshold. If the pressure read from sensor 122 exceeds the pressure threshold, indicator 124 may determine that sensor 122 has detected the presence of paddle 152 and output appropriate feedback.

[0048] Back Figure 1AThe handle 104 may include a housing and one or more actuating mechanisms. The handle 104 may be configured to have the one or more actuating mechanisms, each extending through the housing of the prosthesis delivery system 100 for handover by the user. The one or more actuating mechanisms may be configured to retract / pull or push / advance the outer sheath 106 proximally relative to the intermediate axis 108. The handle 104 provides a surface conducive to user operation and gripping and may have various shapes, including but not limited to cylindrical shapes. In embodiments, the handle 104 may include various other actuating mechanisms, such as, but not limited to, axially sliding levers, rotary racks and pinions, or other suitable actuating mechanisms. For example, the actuating mechanisms may employ any construction capable of providing the desired sheath actuation function, such as those described in U.S. Patent No. 8,579,963 to Tabor, which is incorporated herein by reference in its entirety.

[0049] In the embodiments, the outer sheath 106, intermediate shaft 108, and / or inner shaft 110 may be made of materials such as, but not limited to, polyurethane, polyether block amide (PEBA), polyamide-polyether block copolymer, polyethylene, or other materials suitable for the purposes of this disclosure. The outer sheath 106 may be coupled to the actuation mechanism of the handle 104 by adhesives, welding, clamping, and other suitable coupling means. The distal end 111 of the intermediate shaft 108 may be removably coupled to the spindle 118 by a threaded connection, or permanently coupled to the spindle 118 by adhesives, welding, clamping, and other suitable coupling means.

[0050] In some embodiments, the implantable medical device 150 includes a stent 151 that supports a prosthetic valve component within the stent 151. In some embodiments, the stent 151 self-expands to return from a radially compressed or contracted delivery configuration to a radially expanded configuration. In some embodiments, the stent 151 can be expanded by a balloon or other inflation device. In any embodiment, portions of the stent 151 may be designed to have a variety of different configurations and sizes to meet different requirements for the location where the stent can be implanted. For example, the implantable medical device 150 may be configured as a replacement for an aortic valve. Similarly, for example, the implantable medical device 150 may be configured as a replacement for a mitral valve, as disclosed in U.S. Patent Application Publication No. 2012 / 0101572 to Kovalsky et al. and U.S. Patent Application Publication No. 2012 / 0035722 to Tuval, each of which is incorporated herein by reference in its entirety. In any embodiment, each portion of stent 151 may have the same or different cross-sections, such as circular, elliptical, rectangular, hexagonal, square, or other polygonal shapes, but it is currently considered that a circular or elliptical shape may be preferred when providing a valve prosthesis to replace the aortic or mitral valve. In any embodiment, stent 151 may have a symmetrical hourglass configuration, a generally tubular configuration, or other stent configurations or shapes known in the art for valve replacement.

[0051] In any implementation, the prosthetic valve component of the implantable medical device 150 may be able to block flow in one direction to regulate flow passing through it via valve leaflets, which may form a mitral or tricuspid replacement valve. Figure 1E An example of an implantable medical device 150 including a prosthetic valve component 160 is shown. Figure 1E As shown, the prosthetic valve component 160 may include a tricuspid valve having three leaflets 162, but a bicuspid leaflet configuration may alternatively be used in embodiments of the invention. As known to those skilled in the art of prosthetic tissue valve construction, the leaflets 162 are sutured or otherwise securely and sealingly attached to the inner surface of the stent 151. The leaflets 162 may be made of pericardial material; however, the leaflets may alternatively be made of another material. Natural tissues used for replacing valve leaflets can be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissues such as pericardial patches, bypass grafts, blood vessels, submucosal intestinal tissue, umbilical tissue, and human or animal analogs. Suitable synthetic materials for use as leaflets 162 include those commercially available from Invista North America SARLof Wilmington, DE. Materials can be made from polyester, other fabrics, nylon blends, polymeric materials, and vacuum-deposited nickel-titanium alloys. One polymeric material that can be used to make Leaf 162 is ultra-high molecular weight polyethylene (UHMWPE), commercially available from Royal DSM of the Netherlands under the trademark DYNEEMA. For some leaf materials, it may be desirable to coat one or both sides of Leaf 162 with a material that will prevent or minimize overgrowth. It is further desirable that the leaf material be durable and resistant to stretching, deformation, or fatigue.

[0052] Leaflet 162 may also include graft material. The graft material may be a natural or biological material, such as the pericardium or another membranous tissue, such as the submucosa of the intestine. Alternatively, the graft material may be a low-porosity woven fabric, such as polyester, polyester fabric, or PTFE, which forms a unidirectional fluid channel when attached to the stent. In one embodiment, the graft material may be a knitted or woven polyester, such as a polyester or PTFE knitted fabric, which can be used when it is necessary to provide a medium for tissue ingrowth and to allow the fabric to stretch to conform to a curved surface. Alternatively, polyester velvet fabric may be used, for example, when it is necessary to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other suitable cardiovascular fabrics are commercially available, for example, from Bard Peripheral Vascular, Inc. of Tempe, Arizona.

[0053] Figure 6 A method 600 for operating a prosthesis delivery system 100 including sensor 122 according to an embodiment of the present invention is illustrated. Those skilled in the art will recognize that... Figure 6 An example of the steps that can be performed is shown, and Figure 6 The existing steps shown can be removed, and / or additional steps can be added to method 600.

[0054] In step 602, when the implantable medical device 150 is loaded, the sensors 122 and indicators 124 of the prosthesis delivery system 100 can be activated. In an embodiment, the user of the prosthesis delivery system 100 can activate the sensors 122 and indicators 124 using an activation device on the handle 104.

[0055] In step 604, the implantable medical device 150 can be loaded onto the delivery catheter 102. During loading, in step 606, an indicator 124 can be monitored to determine if the implantable medical device 150 is correctly aligned. For example, as Figure 1AAs shown, indicator 124 may be a visual indicator that includes red and green lights. When sensor 122 and indicator 124 are activated, indicator 124 may display a red light indicating misalignment or a green light indicating correct alignment (e.g., paddle 152 is within recess 120).

[0056] During loading, when the paddle 152 is not within the recess 120, the sensor 122 provides a signal to the indicator 124 indicating the absence of the paddle 152, and in response, the indicator 124 displays a red light. If the paddle 152 is within the recess 120, the sensor 122 provides a signal to the indicator 124 indicating the presence of the paddle, and in response, the indicator 124 displays a green light. When the indicator 124 displays a green light, the user can confirm that the implantable medical device has been correctly loaded.

[0057] In step 608, the prosthesis delivery system 100 may be secured for transport, delivery, and / or use. In step 610, the alignment of the implantable medical device 150 may optionally be checked prior to surgery. As described above, the sensors 122 and indicators 124 of the prosthesis delivery system 100 may be activated. The user of the prosthesis delivery system 100 (e.g., a physician) may activate the sensors 122 and indicators 124 using the activation device on the handle 104. The indicators 124 may be monitored to determine whether the implantable medical device 150 is correctly aligned.

[0058] In step 612, surgery can be performed using the prosthesis delivery system 100. In step 614, the release of the implantable medical device 150 can be checked. Similar to checking alignment, sensors 122 and indicators 124 of the prosthesis delivery system 100 can be activated. The user of the prosthesis delivery system 100 (e.g., a physician) can activate sensors 122 and indicators 124 using an activation device on the handle 104. Indicators 124 can be monitored to determine that the implantable medical device 150 has been released.

[0059] To indicate release, the user can monitor indicator 124 to determine when the paddle 154 is no longer present in the recess 120, thus indicating the release of the implantable medical device 150. For example, when the paddle 152 is no longer in the recess 120, sensor 122 provides a signal to indicator 124 indicating the absence of the paddle 152, and in response, indicator 124 displays a red light. The user can use the red light to signal that the implantable medical device has been released.

[0060] Sensor 120 and indicator 124 allow confirmation of the loading of the implantable medical device 150 without the need for imaging equipment (e.g., a fluoroscope) to view the delivery catheter 102 and the implantable medical device 150 at their location during loading or before surgery. Therefore, during loading or surgery (e.g., at implantation), a physician or other technician can confirm the correct loading of the implantable medical device 150 and / or identify incorrect loading without requiring specialized training. Similarly, a physician or other technician can use sensor 120 and indicator 124 to confirm the correct release of the implantable medical device 150.

[0061] It should be understood that the various embodiments disclosed herein can be combined with combinations different from those specifically presented in the specification and drawings. 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 completely added, combined, or omitted (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 device or component, it should be understood that the techniques of this disclosure can be performed by a combination of devices or components associated with, for example, a medical device.

Claims

1. A delivery system for delivering a prosthesis, the delivery system comprising: a mandrel for securing a stent to a shaft, the mandrel including at least one pocket for receiving a paddle of the stent; and at least one sensor positioned within the at least one pocket and configured to detect a presence of the paddle relative to the at least one pocket.

2. The delivery system of claim 1, further comprising: at least one indicator coupled to the at least one sensor, wherein the at least one indicator outputs an indication of a relative position of the paddle to the at least one pocket.

3. The delivery system of claim 2, wherein the indication output by the at least one indicator confirms that the paddle is properly positioned within the at least one pocket.

4. The delivery system of claim 3, wherein the indication is at least one of a visual indication or an audio indication.

5. The delivery system of claim 1, wherein the at least one sensor includes a capacitive sensor, wherein proximity of the paddle to the sensor causes a change in capacitance in the capacitive sensor.

6. The delivery system of claim 1, wherein the at least one sensor includes a force sensor that detects a force exerted by the paddle to the at least one pocket.

7. The delivery system of claim 1, wherein the at least one sensor includes an electrical circuit, wherein contact between the paddle and completes the electrical circuit.

8. The delivery system of claim 1, further comprising: at least one additional sensor positioned within an outer surface of the mandrel and configured to detect a presence of the paddle relative to the outer surface.

9. The delivery system of claim 1, further comprising: at least one additional sensor positioned on an outer surface of the mandrel and configured to detect a presence of the paddle relative to the outer surface.

10. A delivery system for delivering a prosthesis, the delivery system comprising: a shaft for delivering the prosthesis to a target site; a mandrel coupled to the shaft for securing a stent of an implantable medical device to the shaft, the mandrel including at least one pocket for receiving a paddle of the stent; a sheath covering the stent and the mandrel, wherein the sheath is configured to move relative to the shaft; and at least one sensor positioned within the at least one pocket and configured to detect a presence of the paddle relative to the at least one pocket.

11. The delivery system of claim 10, further comprising: at least one indicator coupled to the at least one sensor, wherein the at least one indicator outputs an indication of a relative position of the paddle to the at least one pocket.

12. The delivery system of claim 11, wherein the indication output by the at least one indicator confirms that the paddles are properly positioned within the at least one pocket.

13. The delivery system of claim 12, wherein the indication is at least one of a visual indication or an audio indication.

14. The delivery system of claim 10, wherein the at least one sensor comprises a capacitive sensor, wherein proximity of the paddles causes a change in capacitance in the capacitive sensor.

15. The delivery system of claim 10, wherein the at least one sensor comprises a force sensor that detects a force applied to the at least one pocket by the paddles.

16. The delivery system of claim 10, wherein the at least one sensor comprises an electrical circuit, wherein contact between the paddles completes the electrical circuit.

17. The delivery system of claim 10, further comprising: at least one additional sensor positioned within an outer surface of the mandrel and configured to detect a presence of the paddles relative to the outer surface.

18. The delivery system of claim 10, further comprising: at least one additional sensor positioned on an outer surface of the mandrel and configured to detect a presence of the paddles relative to the outer surface.

19. A method for determining proper loading of an implantable medical device coupled to a mandrel of a delivery system, the method comprising: activating one or more of at least one sensor or at least one indicator, wherein the at least one sensor is positioned within a pocket of the mandrel and is configured to detect a presence of paddles of the implantable medical device relative to the pocket; and in response to the activating, outputting, via the at least one indicator, an indication of a relative position of the paddles to the pocket.

20. The method of claim 19, wherein the indication output by the at least one indicator confirms that the paddles are properly positioned within the pocket.

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