Valve clamp for device delivery catheter handle

Abstract

The implantable medical device delivery catheter includes a handle (14) and an elongated member disposed within the handle. The elongated member includes an elongated member cavity configured to receive an internal tool (40) configured to extend through a cavity of the delivery catheter including the elongated member cavity and to interface with the implantable medical device. The handle also includes a clamping assembly (38) including a button (26) configured to be actuated toward the longitudinal axis of the elongated member in a direction transverse to the longitudinal axis to compress the elongated member against the internal tool, thereby restricting movement of the internal tool through the elongated member cavity.

Description

Technical Field

[0001] This disclosure relates generally to medical devices, and more specifically to systems for delivering medical devices. Background Technology

[0002] Some types of implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillator systems, can be used to provide cardiac sensing and therapy to a patient via one or more electrodes. As an example, some IMDs include an implantable pulse generator comprising a housing enclosing electronic components, which can be configured for subcutaneous implantation in a patient's chest or within a chamber of the patient's heart. IMDs with a pulse generator configured for implantation within a chamber of the heart can be referred to as intracardiac devices or leadless implantable medical devices. A delivery catheter can be used to deliver the intracardiac device intravenously to the implantation site within the patient's heart and to release the device after it has been secured at the implantation site. The delivery catheter can then be withdrawn from the patient. Summary of the Invention

[0003] Generally, this disclosure relates to delivery catheters and delivery systems for delivering an IMD within a patient's vascular system. In some instances, the delivery system includes a delivery catheter containing a delivery catheter lumen and an internal tool slidably extending through the delivery catheter lumen. The delivery catheter includes a handle in which an elongated member is disposed. The elongated member defines an elongated member lumen, which is a portion of the delivery catheter lumen through which the internal tool slidably extends. The handle also includes a clamping assembly configured to be actuated to selectively press or clamp the elongated member against or hold the internal tool to, for example, restrict movement of the internal tool through the elongated member lumen (and thus through the delivery catheter lumen) or otherwise secure the internal tool in place within the delivery catheter lumen.

[0004] In one example, the implantable medical device delivery catheter includes a shaft configured to extend through a patient's vascular system, wherein the shaft includes a shaft lumen extending from a proximal end of the shaft to a distal end of the shaft, and a handle connected to the proximal end of the shaft. The handle includes an elongated member disposed within the handle, the elongated member including an elongated member cavity in fluid communication with the shaft lumen, wherein the elongated member cavity and the shaft lumen are configured to receive an internal tool, the internal tool being configured to extend through the elongated member cavity and the shaft lumen and interface with the implantable medical device. The handle also includes a clamping assembly including a button configured to be actuated in a direction transverse to the longitudinal axis toward the longitudinal axis of the elongated member to compress the elongated member against the internal tool, thereby restricting movement of the internal tool through the elongated member cavity.

[0005] In another example, the method includes first engaging a clamping assembly of a handle of a medical device delivery catheter to restrict movement of an internal tool through an elongated member cavity disposed within the handle, wherein engaging the clamping assembly includes actuating a button on the clamping assembly in a direction transverse to the longitudinal axis of the elongated member to compress the elongated member against the internal tool. The method further includes, upon first engagement of the clamping assembly, introducing the distal end of a shaft of the delivery catheter toward a tissue site into the patient's vascular system, wherein the shaft includes a shaft cavity extending from a proximal end of the shaft to a distal end of the shaft, wherein the handle is connected to the proximal end of the shaft, wherein the shaft cavity is in fluid communication with the elongated member cavity, wherein the shaft cavity and the elongated member cavity are configured to receive the internal tool, and wherein the internal tool is configured to interface with an implantable medical device. The method further includes releasing the clamping assembly, wherein releasing the clamping assembly includes actuating a button on the clamping assembly remote from the longitudinal axis of the elongated member, and upon release of the clamping assembly, actuating the internal tool, wherein actuating the internal tool includes moving the internal tool through the shaft cavity and the elongated member cavity. The method also includes, after actuating the internal tool, a second engagement of the clamping assembly to restrict movement of the internal tool through the elongated member cavity, and, upon the second engagement of the clamping assembly, a retraction axis from the patient proximally.

[0006] In another instance, the system includes an implantable medical device, as described herein, for delivering catheters and internal tools.

[0007] The present invention is intended to provide an overview of the subject matter described herein. It is not intended to provide an exclusive or exhaustive interpretation of the apparatuses and methods described in detail in the following drawings and description. Further details of one or more examples are set forth in the drawings and the following description. Attached Figure Description

[0008] Figure 1 A side view illustrating a medical device delivery system, including an example delivery catheter, for delivering an implantable medical device (IMD) within a patient's vascular system.

[0009] Figure 2A and 2B for Figure 1 A perspective view of the proximal portion of an example delivery catheter.

[0010] Figures 3A-3D For removing a portion of the outer shell Figure 1 A perspective view of the proximal portion of a delivery catheter in an example medical device.

[0011] Figure 3E and 3F For removing a portion of the outer casing and the clamping button Figure 1 A perspective view of the proximal portion of a delivery catheter in an example medical device.

[0012] Figure 4A and 4B for Figure 1 A cross-sectional side view of an example delivery catheter.

[0013] Figure 4C To explain Figure 1 A perspective cross-sectional view of an instance of a delivery conduit.

[0014] Figure 5A A perspective view of a delivery catheter according to another example of the technology disclosed herein.

[0015] Figure 5B for Figure 5A An exploded view of the instance delivery conduit.

[0016] Figure 5C for Figure 5A A longitudinal cross-sectional side view of a portion of an instance of a delivery conduit.

[0017] Figure 5D For along Figure 5C The line BB in the middle is cut off Figure 5A A cross-sectional end view of a portion of the delivery catheter.

[0018] Figure 6A and 6B for Figure 5A A plan view of an example component of a delivery conduit.

[0019] Figure 7A and 7B A perspective view illustrating an example of an internal tool that can be used with a delivery conduit configured according to the technology of this disclosure.

[0020] Figure 8 A flowchart illustrating an example method of delivering an IMD within a patient's vascular system using a delivery catheter configured according to some of the techniques disclosed herein. Detailed Implementation

[0021] Generally, this disclosure describes devices and systems for introducing implantable medical devices (IMDs) into a patient's vascular system or other anatomical structures. Figure 1 A side view illustrating an example delivery system 10 for introducing an IMD, such as a pacemaker, into a patient's vascular system or other anatomical structure. System 10 includes an internal component 48 and an external component 16. Although described herein in the context of delivering an IMD to a vascular system such as the heart, the devices, systems, and techniques disclosed herein can be used to deliver an IMD to any anatomical location.

[0022] The external member 16 (also referred to as the “introducer”) is an elongated tubular member defining an internal lumen. The external member 16 includes a proximal end 32 and a distal end 50. The external member 16 is configured to provide a rigid channel (lumen) through which a medical device, apparatus, or other therapy is inserted, as if inserted by a physician into a patient’s vascular system.

[0023] The internal component 48 (also referred to as a “delivery catheter”) is configured to be inserted through the lumen of the external component 16 to deliver a medical device within a vascular system. The internal component 48 includes an elongated shaft 12, a handle 14, and a device cup 18. The handle 14 is connected to the proximal end of the shaft 12 and may include one or more elements 52 configured to control movement of the distal end of the shaft 12. In some instances, the handle 14 includes a side port 46 for connection to a flushing assembly.

[0024] A device cup 18 is positioned at the distal end of shaft 12. The device cup 18 includes a hollow cylindrical body configured to receive and support the IMD when it is implanted within a patient's vascular system. For example, a physician may insert the distal end of an internal member 48, including the device cup 18, through a cavity of an external member 16 positioned within the patient's vascular system. Once the device cup 18 has a distal end 50 extending through the external member 16 and reaches the implantation site within the patient, the physician may release the IMD from a distal opening 44 of the device cup 18, for example, by actuating an internal tool 40, such as moving the internal tool 40 (e.g., a mechanical tether) through the shaft cavity 56 of shaft 12. Figure 2A The IMD is advanced through the distal opening 44 and released from the distal end of the internal tool 40. The physician can then retract the shaft 12 and the cup 18 proximally through the external member 16.

[0025] Internal tool 40 extends slidably through the delivery catheter lumen of delivery catheter 48. Figure 1 (Not shown in the image). It should be understood that although this disclosure primarily describes an example of an internal tool 40 configured as a mechanical tether to release an IMD into a patient's anatomy, the disclosed techniques are similar to those of other internal tools configured to advance / retract through a lumen defined by a delivery catheter 48, such as a snare configured to retrieve an IMD from within a patient's anatomy. Therefore, internal tools generally refer to various mechanical components configured to interact with an IMD.

[0026] In some instances, the delivery catheter lumen is composed of a shaft lumen 56 ( Figure 2A The hub 20 (1) and handle 14 are defined by one or more cavities, such as those defined by the hub 20. Figure 3A The hub cavity 58 is defined by valve 28 and is bounded by the valve 28. Figure 3D-3FThe valve cavity 62 is defined by 4B and 4C. The valve 28 or its components described herein are examples of elongated members within the handle 14, and the valve cavity 62 or the cavity of a component of the valve are examples of elongated member cavities configured to slidably receive the internal tool 40. The handle cavity (e.g., including the valve cavity 62 or another elongated member cavity) may be in fluid communication with the shaft cavity 56 to define a continuous conduit cavity configured to slidably receive the internal tool 40. Generally, the elongated member may be a deformable (e.g., elastically deformable) structure defining the cavity, such as a tube, which may be formed of an elastically deformable material.

[0027] As will be described herein, the handle 14 may include a clamping assembly 38 configured to be actuated against an internal tool 40 (e.g., valve 28 and valve cavity 62) within the elongated member cavity to compress or clamp the elongated member within the handle. In this manner, the clamp can prevent or otherwise restrict longitudinal movement of the internal tool 40 or another internal tool through the delivery catheter lumen. Features of the clamping assembly 38 described herein facilitate intuitive, single-handed user actuation in the longitudinal axis direction toward the elongated member to engage the clamping assembly, lock the clamping assembly in an engaged position, and unlock and release the clamping assembly. In this way, the clamping assembly 38 provides better control over the device delivery system and, in some instances, allows a physician to implant or retrieve the IMD without the need for an assistant to operate the handle 14 or tool 40.

[0028] Figure 2A and 2B A perspective view of the proximal portion of the delivery catheter 48, depicting the handle 14 connected to the proximal end of the shaft 12. Figure 2A and 2B An orthogonal xyz coordinate system is included to serve as a reference frame. In some instances, according to the technology of this disclosure, the handle 14 includes a clamping assembly 38 configured to secure and retain an internal tool 40 (such as a mechanical tether or snare) in place relative to the handle 14, for example, selectively preventing or allowing movement of the internal tool 40 in the y-axis direction through the lumen of the delivery catheter 48. In the illustrated example, the clamping assembly 38 is located at the proximal end of the handle 14, but in other instances, it may be located at other locations along the handle 14. The clamping assembly 38 may also form an additional hemostatic seal for the system 10. The clamping assembly 38 may be positioned in an "open" or unlocked position, such as... Figure 2A As shown, either "closed" or locked, such as Figure 2B As shown.

[0029] The clamping assembly 38 includes a clamping button 26. The clamping button 26 can be positioned, for example, from an open position in the negative z-axis direction ( Figure 2A Move to the closed position. Figure 2BThis allows the button 26 to compress or clamp the valve 28 (e.g., the clamping tube 60 of valve 28) closed around the internal tool 40. In other words, the button 26 is configured to be actuated toward the central longitudinal axis of the delivery conduit 48 (e.g., valve 28 and / or clamping tube 60) in a direction substantially transverse (perpendicular) to the central longitudinal axis. When the clamping button 26 is in the closed position and deforms the valve 28, friction between the valve 28 (e.g., made of a polymer, such as rubber) and the internal tool 40 reduces or prevents any movement of the internal tool 40 relative to the valve 28, such as proximal or distal movement along the y-axis. The clamping button 26 can also be actuated, for example, in the positive z-axis direction from the closed position ( Figure 2B Move to the open position ( Figure 2A The internal tool 40 is released. In other words, button 26 is configured to be actuated away from the central longitudinal axis of the delivery catheter 48 in a direction substantially transverse (perpendicular) to the central longitudinal axis. More specifically, as further described below, button 26 is configured to be actuated away from the central longitudinal axis of the delivery catheter 48 in response to applied pressure parallel to the central longitudinal axis in the direction of the distal end of the delivery catheter 48. In this arrangement, the physician can easily actuate button 26 with the same hand holding handle 14, freeing their other hand to hold the position of the axis of the delivery catheter 48 relative to the proximal end 32 of the external member 16 (thus maintaining forward pressure on the delivery cup 18) without an assistant. Once button 26 is unlocked, the tool 40 is then in control.

[0030] Figures 3A-3D To remove a portion of the outer casing to illustrate one or more internal components Figure 1 A perspective view of the proximal portion of the medical device delivery catheter 48. Specifically, Figures 3A-3D The handle 14 has a clamping assembly 38. Figure 3A and 3B Depicts clamping assembly 38 in an "open", "unlocked", or "first" configuration. Figure 3C and 3D Depicts clamping assembly 38 in a “closed,” “locked,” or “second” configuration.

[0031] The clamping assembly 38 includes a hub 20, valve cover portions 30A-30C (collectively referred to as "valve cover 30"), and a button 26. In some embodiments, the shaft 12 may extend proximally through the handle 14 and connect to the hub 20. The hub 20 may be a relatively rigid (e.g., plastic) material configured to connect the shaft 12 to the valve 28. In some embodiments, the hub 20 may define a single internal hub cavity 58 extending through the handle 14. In other embodiments, the hub 20 may include a more complex shape, defining multiple branch cavities. For example, as described by... Figure 3A As illustrated in the example, hub 20 may define a side opening 46 for connection to a second cavity 64 of the flushing assembly.

[0032] Valve 28 is an elongated tubular member disposed within the proximal portion of handle 14. Valve 28 (also referred to as "elongated member 28") defines an inner cavity (e.g., in) that is in fluid communication with cavity 58 of hub 20. Figure 4B and 4C The valve chamber 62 shown in the figure may also be referred to as an elongated member chamber. In some examples, the valve 28 extends from the proximal end of the handle 14 to the shaft 12 at the distal end of the handle 14. In other examples, the valve 28 is positioned near the proximal end of the handle 14 and is connected to another different elongated member, such as a hub 20, which extends the remainder of the passage through the handle 14.

[0033] Valve 28 is made of a relatively soft and / or elastic material, such as an elastomeric material that tends to elastically return to its original shape or configuration after the compression or deformation force has been removed. In some instances, valve 28 contains polymers, such as rubber.

[0034] In at least some instances, the cavity 62 of valve 28 is configured to slidably receive an elongated internal tool 40. The internal tool 40 may include a rope or cable-like element and is configured to attach at its distal end to an IMD located distal to the distal end of shaft 12, for example, within or outside the distal opening of delivery cup 18. The internal tool 40 may be configured to move proximally or distally through the cavity of valve 28. The internal tool 40 may include, for example, a mechanical tether configured to implant the IMD into a patient's vascular system. In other instances, the internal tool 40 may include a snare configured to retrieve the IMD from the patient's vascular system. In these instances, actuating the internal tool 40 involves grasping the IMD with the distal end of the snare.

[0035] The proximal end of valve 28 defines a clamping tube 60, which in some instances may be an elongated member. The clamping tube 60 is an elongated extension of valve 28, configured to be compressed as described for valve 28, such that it is clamped or retracted around an internal tool 40 by a cavity 62 defined by valve 28 and clamping tube 60, thereby frictionally securing the internal tool 40 in place. The clamping tube 60 may partially extend beyond the proximal end of handle 14.

[0036] The valve cover 30 is a relatively rigid and / or durable (e.g., containing plastic) element configured to support and align various other components of the clamping mechanism 38. The valve cover 30 comprises at least three sub-components 30A-30C, however, these three components may be molded or formed from a single unit, or molded or formed from separate units, and subsequently welded or otherwise joined together. Further details are provided below. Figure 3E and 3F Description of valve cover 30.

[0037] The clamping button 26 is an element formed of one or more relatively hard or durable materials (such as plastic) configured to clamp and hold the clamping tube 60 closed around the internal tool 40. The clamping button 26 includes a spade 36, proximal teeth 22, and a handle 54.

[0038] 36 shovels (in) Figure 3B and 4A (Shown in -4C) is a radially extending (e.g., in the negative z-axis direction) or transverse to the longitudinal axis of the handle 14 and toward the clamping tube portion 60 of the valve 28. The spade 36 is configured to contact and compress (or clamp) the outer surface of the clamping tube portion 60 of the valve 28. In some embodiments, the spade 36 may be shaped similarly to the head of a shovel, as it is relatively thin along an axis (e.g., along the longitudinal axis of the handle 14) to reduce the surface area of ​​the spade 36 in contact with the outer surface of the clamping tube 60, and thus increase the pressure applied to the clamping tube 60. For similar reasons, the spade 36 may define a rounded tip configured to contact the outer surface of the clamping tube 60. In other embodiments, the spade 36 may define a substantially flat tip that may be oriented perpendicular to the longitudinal axis of the handle 14.

[0039] The clamping button 26 defines a set of proximal-facing teeth 22, one set disposed on one side of the clamping button 26 (e.g., along the x-axis). The proximal-facing teeth are configured to secure the clamping button 26 in a "locked" position, for example, by engaging with a corresponding set of distal-facing teeth 24 defined by the housing of the handle 14. When placed in the "locked" position ( Figure 3C and 3D When the clamping tube 60 is in use, the soft (e.g., elastic) composition of the clamping tube 60 can press against the distal tooth 24 towards the proximal side and hold the proximal tooth 22, engaging the teeth of the set together.

[0040] In order to place the clamping assembly 38 Figure 3C and 3D In the "locked" position shown, the user can apply downward pressure (e.g., in the negative z-axis direction) to the top of the clamping button 26. This downward pressure will cause the spade 36 extending from the button 26 to press downward into the material of the clamping tube 60, causing the material of the tube to elastically deform and its internal cavity to contract. In some instances, the outer surface of the clamping tube 60 may define an inclined or ramp-like geometry, such as tapering or descending in the proximal direction. Thus, in such instances, in response to the downward compressive force, the material of the clamping tube 60 can elastically apply a restoring force against the spade 36 in the proximal (negative y-axis) and upward (z-axis) directions. The proximal and upward restoring forces will press the distally facing tooth 24 against the proximal facing tooth 22, securing the clamping button 26 in place, holding the clamping tube 60 closed below the spade 36, and securing the mechanical tether 40 in place.

[0041] In order to release the clamping button 26 back to the "unlocked" position ( Figure 3A and 3B The user can apply distal pressure (e.g., along the y-axis, toward the distal end of shaft 12) to the clamping button 26 to release the two sets of teeth. In this way, button 26 is configured to be actuated from a second “locked” position to a first “unlocked” position in response to a longitudinal force in the direction of the distal end of the conduit. The rubber or elastic composition of the clamping tube 60 will tend to press the clamping button 26 upward (e.g., in the z-axis direction) and return it to the “unlocked” position. In some instances, the user can advantageously actuate the button between the locked and unlocked positions with one hand.

[0042] Figure 3E and 3F To illustrate one or more internal components, a portion of the housing and the clamping button 26 are removed. Figure 1 A perspective view of the proximal portion of a medical device delivery catheter. Specifically, Figure 3E and 3F The valve cover components 30A-30C are described. The valve cover 30 is a relatively rigid or durable (e.g., made of plastic) element configured to support various other components of the clamping mechanism 38 and be aligned relative to each other. During assembly, the valve cover 30 is fitted within the valve 28 and snaps onto the hub 20. The valve cover 30 comprises at least three structural components 30A-30C, however, the three components may be molded or formed from a single unit, or molded or formed from separate units and subsequently welded or otherwise joined together. In the illustrated example, the valve cover 30 includes a ring 30A, a lock 30B, and a half-pipeline 30C.

[0043] Ring 30A includes one or more circular or annular structures. For example... Figure 3E As shown, ring 30A may include two annular structures of different diameters configured to engage (and / or hermetically seal) valve 28 with hub 20. For example, ring 30A may include a larger diameter annular structure configured to match the diameter of the proximal end of hub 20 and a second smaller diameter annular structure configured to match or accommodate the distal end of valve 28.

[0044] Lock 30B is a U-shaped or horseshoe-shaped structure extending distally from ring 30A (e.g., in the y-axis direction). Lock 30B is configured to receive and surround locking protrusion 42. Locking protrusion 42 is a projection extending radially from hub 20 (e.g., in the x-axis direction). By surrounding locking protrusion 42, lock 30B secures hub 20 in place relative to valve cover 30, for example, preventing separation between the two components in the y-axis direction. In some instances, lock 30B defines a rectangular central opening configured to receive locking protrusion 42, which may also be generally rectangular.

[0045] The semi-cylindrical element 30C is a semi-cylindrical element extending proximally (e.g., in the negative y-axis direction) from the ring 30A. The semi-cylindrical element 30C is configured to house and support the lower side of the clamping tube 60. For example, when the clamping assembly 38 is engaged (e.g., in the “locked” position), the clamping tube 60 can be compressed between the semi-cylindrical element 30C on the lower side and the spade 36 on the top side.

[0046] Figure 3F The lower side of the semi-pipeline 30C is further depicted. In some instances, the semi-pipeline 30C defines a clamping window 34. The clamping window 34 is an opening, such as a rectangular opening, configured to receive a portion of the clamping tube 60 when the clamping assembly 38 is in the "locked" position. For example, the clamping window 34 may be positioned directly opposite the spade 36, such that the spade 36 forces or presses a portion of the clamping tube 60 downward (on the negative z-axis) into the clamping window 34. Figures 4A-4C As shown, the clamping tube 60 deforms into the clamping window 34 to provide a more tortuous path for the internal tool 40 through the cavity of the clamping tube 60. The more tortuous path provides a larger contact area and contact force between the internal tool 40 and the clamping tube 60, increases the amount of friction between the components, and more firmly secures the mechanical tether 40 in place.

[0047] Figures 4A-4C for Figure 1 A cross-sectional view of the handle 14 of the delivery conduit 48. Specifically, Figures 4A-4C The clamping mechanism 38 of the handle 14 is described in the "locked" configuration. In the "locked" configuration, the clamping button 26 has been pressed in the negative z-axis direction, forcing the spade 36 downwards to the outer surface of the clamping tube 60, which may be the proximal end of the valve 28. In response, the flexible material of the clamping tube 60 compresses or deforms, contracting or clamping its internal cavity around the internal tool 40. A portion of the clamping tube 60 deforms into the clamping window 34 of the semi-pipeline 30C, further deforming the internal cavity of the clamping tube 60. Thus, the internal tool 40 is forced to bend or flex in the area between the spade 36 and the clamping window 34. This bending of the internal tool 40 further reduces or prevents any proximal or distal movement of the internal tool 40 through the internal cavity of the clamping tube 60.

[0048] Figures 5A-5D This describes another example of a medical device delivery catheter 66 according to the technology of this disclosure. The delivery catheter 66 may be... Figure 1-4C An example of an internal component or delivery conduit 48. In Figures 5A-5D Similar numbered elements in can be used with those for Figure 1-4C They are configured and function in essentially the same way as described in this article, except as mentioned in the text. Figure 5A A perspective view of delivery catheter 66. Figure 5B This is an exploded view of catheter 66. Figure 5C This is a longitudinal cross-sectional side view of conduit 66, and Figure 5D For as from Figure 5C The cross-sectional end view of the conduit 66 observed along the axis BB.

[0049] like Figure 5A As shown, the delivery catheter 66 includes a handle 14 (e.g., Figure 1-4C The handle 14 has an additional rotating mechanism 68 to assist the user in turning the button 76. Figure 5B Press radially inward into valve 28 to clamp valve 28 around internal tool 40. Figure 1 (Close) (e.g.) Figure 5B As shown in the exploded view, the rotating mechanism 68 includes an internal cam lock ring 70, an external cam lock 72, and a button 76. The handle 14 also includes a tip button 52, housing portions 74A and 74B, and a pull block 78. Housing portions 74A and 74B contain internal components of the handle 14, such as a valve 28, a button 76, and an internal cam lock ring 70. The pull block 78 is used to slidably connect the tip button 52 to the distal end of a conduit 66, such as via a pull wire 84.

[0050] During use, a user, such as a physician, can apply rotational pressure to the rotating mechanism 68 via an external cam lock 72 rigidly connected to the internal cam lock ring 70. Figure 6A and 6B As shown in more detail, the inner cam locking ring 70 includes a curved inner edge 80 configured to contact the button 76. The curved inner edge 80 defines a portion of a spiral pattern, such that from... Figure 6A As shown in the angle, the radius of curvature of the inner edge 80 of the curve decreases counterclockwise from a first radius "R" to a second radius "r". Therefore, when the user rotates the outer cam lock 72 clockwise, the radius of curvature of the portion of the inner edge 80 contacting the button 76 decreases, causing the button 76 to press the valve 28 radially inward, causing the valve 28 to contract around the inner tool 40, thereby securing the inner tool 40 in place. To unlock or release the inner tool 40, the physician can apply counterclockwise rotational pressure to the outer cam lock 72 to rotate the inner cam lock ring 70, allowing the material of the valve 28 to naturally expand back into the expanded configuration.

[0051] Figure 7A and 7B A perspective view illustrating an example of an internal tool 40 that can be used with a delivery catheter configured according to the technology of this disclosure. Specifically, Figure 7A This describes an instance configuration that can be configured to implant the IMD 210 into a patient's vascular system via a mechanical tether 200. Figure 7BThis describes an example configuration of the snare 220, which can be configured to retrieve the IMD 210 from a patient's vascular system. The mechanical tether 200 and the snare 220 can be configured to be housed within various lumens of the delivery catheter 48 described herein and slidably extend through said lumen, and are engaged by the clamping assembly 38 of the delivery catheter, as described herein for internal tool 40 ( Figure 1 As described in ).

[0052] like Figure 7A As shown, the mechanical tether 200 may include an elongated shaft 206, a handle 202 at the proximal end of the elongated shaft 206, and a tether head assembly 204 at the distal end of the elongated shaft 206. The elongated shaft 206 may be long enough for a clinician to manipulate the handle 202 to advance the tether head assembly 204 beyond the distal opening of the device cup 18 for delivering the catheter 48. The handle 202 may include a button, slider, or other actuable element to allow the clinician to manipulate the mechanical tether 200, such as deflecting or otherwise manipulating the elongated shaft 206, and / or selectively engaging and disengaging the tether head assembly 204 from the IMD 210.

[0053] exist Figure 7A In one example, the proximal end of the IMD 210 includes an attachment member 212 comprising an internal attachment element 214 and a neck portion 216. The tether head assembly 204 may have one or more features actuated via a handle 202 and configured to selectively store, hold, grip, capture, or otherwise attach to the attachment member 212, such as to the internal attachment element 214 or the neck portion 216. Example configurations of the mechanical tether and attachment member of the IMD, along with the technology using them, are described in U.S. Provisional Patent Application No. 62 / 844,674, filed May 7, 2019, and is incorporated herein by reference in its entirety.

[0054] like Figure 7BAs described, snare 220 may include an elongated shaft 226, a handle 222 at the proximal end of the elongated shaft 226, and a snare assembly 224 at the distal end of the elongated shaft 226. The elongated shaft 226 may be long enough for a clinician to manipulate the handle 222 to advance the snare assembly 224 beyond the distal end of the delivery catheter 48. The handle 222 may include a button, slider, or other actuable element to allow a clinician to manipulate the snare 220, such as deflecting or otherwise manipulating the elongated shaft 226, and / or selectively advancing, retracting, or manipulating the snare assembly 224 to retrieve the IMD 210. The snare assembly 224 may be slidably engaged within the elongated shaft 226 to expand (e.g., open) and retract (e.g., close) one or more of its loops. In some instances, the snare assembly 224 may include one or more loops, such as wire loops. In other instances, the snare assembly 224 may additionally or alternatively include one or more net or support-like elements configured to expand or retract. In these and other instances, the snare assembly 224 may include elements configured to extend over the attachment member 212 and then actuated to be configured to capture a reduced size of the attachment member 212, such as gripping the attachment member at the neck portion 216. Instance configurations of IMD snares and attachment members, and techniques for using them, are described in commonly assigned U.S. Provisional Patent Application No. 62 / 743,939, filed October 10, 2018, and are incorporated herein by reference in their entirety.

[0055] Figure 8 A flowchart illustrating a method for delivering an IMD within a patient's vascular system according to some of the techniques disclosed herein. Figure 8 The method for Figure 1 The system and components described herein may be performed using other similar systems and components. A physician or other qualified user or operator may engage the clamping assembly 38 (130) by radially compressing the clamping button 26 on the handle 14 at the proximal end of the IMD delivery catheter 48. Radial compression of the clamping button 26 engages a set of button teeth 22 with a set of body teeth 24, holding the clamping button 26 in a locked position. In this locked position, the spade 36 engages with the outer surface of the clamping tube 60, deforming the clamping tube 60 and causing its internal lumen to contract around the elongated internal tool 40 through which the lumen is delivered. Furthermore, a portion of the outer surface of the clamping tube 60 opposite the spade 36 may wedge into the clamping window 34, further deforming the internal lumen of the clamping tube 60 against the internal tool, securely holding the internal tool in place. In some instances, the internal tool 40 may include an elongated tether configured to deliver the IMD to the implantation site within the patient's vascular system. In other instances, the internal tool 40 may include a snare configured to retrieve the IMD from the patient's vascular system.

[0056] Once the internal tool 40 is locked in place by the clamping assembly 38, the physician can insert and advance the delivery catheter 48 distally toward the tissue implantation site within the patient's vascular system through the lumen (132) of the introducer or external member 16. In some instances, the physician can manipulate elements such as the tip button 52 on the handle 14 to bend or flex the distal end of the delivery catheter 48 to navigate beyond the distal end of the introducer 16.

[0057] Once the distal end of the delivery catheter 48 is close to the tissue implantation site, the physician can press the distal clamping button 26 to release the clamping tube 60 from the internal tool 40 and disengage the clamping assembly 38 (134). Pressing the distal clamping button 26 disengages the button teeth 22 from the body teeth 24, and the expansion of the clamping tube 60 radially forces the clamping button 26 back to its original "unlocked" position.

[0058] Once the internal tool 40 has been released from the clamping tube 60, the physician can actuate the internal tool 40, for example, by advancing it distally beyond the device cup 18, or otherwise moving it through the valve lumen 62 and other lumens of the delivery catheter 48 described herein, to implant one or more fixation components of the IMD into the tissue at the tissue implantation site (136). The physician can then further actuate the internal tool 50 by activating a mechanism such as a button or switch on the proximal end of the internal tool 40 to release the IMD from its distal end (138). In some, but not all, instances, the physician can then radially compress the button 26 to clamp the clamping tube 60 again around the internal tool 40 (140). Finally, the physician can retract the delivery catheter 48 proximally via the external member 16 (142).

[0059] In some instances, the physician can partially press button 26 to apply a holding force to tool 40 without fully closing clamp valve 28. For example, the physician can use partially pressed button 26 to apply resistance to tool 40 to hold it substantially in place, and if necessary, allow tool 40 to move again by applying greater force. This allows the physician to implant or retrieve the IMD without an assistant manipulating handle 14 or tool 40. This is particularly useful when using tool 40 as a snare to retrieve IMD 210.

[0060] The following terms provide some examples of this disclosure.

[0061] Clause 1: In some instances, an implantable medical device delivery catheter includes: a shaft configured to extend through a patient's vascular system, wherein the shaft includes a shaft lumen extending from a proximal end of the shaft to a distal end of the shaft; and a handle connected to the proximal end of the shaft, the handle including: an elongated member disposed within the handle, the elongated member including an elongated member cavity in fluid communication with the shaft lumen, wherein the elongated member cavity and the shaft lumen are configured to receive an internal tool, the internal tool being configured to extend through the elongated member cavity and the shaft lumen and to interface with the implantable medical device; and a clamping assembly including a button configured to be actuated in a direction transverse to the longitudinal axis toward the longitudinal axis of the elongated member to compress the elongated member against the internal tool to restrict movement of the internal tool through the elongated member cavity.

[0062] Clause 2: In some instances of the delivery conduit as described in Clause 1, the button is configured to be actuated from a first position to a second position in which the button abuts against an internal tool to compress the elongated member.

[0063] Clause 3: In some instances of the delivery catheter as described in Clause 2, the clamping assembly includes a set of distally facing teeth, and the button includes a set of proximally facing teeth configured to engage with the distally facing teeth and hold the button in a second position.

[0064] Clause 4: In some instances of the delivery catheter as described in Clause 2, the button is also configured to be actuated from the second position to the first position in response to a longitudinal force in the direction of the distal end of the catheter.

[0065] Clause 5: In some instances of the delivery conduit according to any one of Clauses 2 to 4, the button further includes a spatula configured to engage with the outer surface of the elongated member.

[0066] Clause 6: In some instances of the delivery catheter pursuant to any one of Clauses 1 to 5, the elongated member comprises a flexible polymer.

[0067] Clause 7: In some instances of the delivery catheters described in Clause 6, the flexible polymer comprises rubber.

[0068] Clause 8: In some instances of the delivery conduit pursuant to any one of Clauses 1 to 7, the clamping assembly includes a valve cover.

[0069] Clause 9: In some instances of the delivery conduit as described in Clause 8, the valve cover includes a semi-cylindrical member configured to support the underside of an elongated member.

[0070] Clause 10: In some instances of the delivery catheter described in Clause 9, a semi-cylindrical member defines a clamping window configured to receive a portion of an elongated member to deform the cavity of the elongated member when the clamping assembly engages with the elongated member.

[0071] Clause 11: In some instances of the delivery conduit as described in Clause 9 or Clause 10, the clamping assembly is configured to compress the elongated member between a button and a semi-cylindrical member, the button being configured to actuate toward the longitudinal axis of the elongated member in a direction transverse to the longitudinal axis of the elongated member.

[0072] Clause 12: In some instances of the delivery conduit as described in Clause 8, the valve cover also includes a locking mechanism configured to secure the valve cover to the elongated member.

[0073] Clause 13: In some instances of the delivery catheter pursuant to any one of Clauses 1 to 12, the clamping assembly is positioned at the proximal end of the handle.

[0074] Clause 14: In some instances, the method includes: first engaging a clamping assembly of the handle of a medical device delivery catheter to restrict movement of an internal tool through an elongated member cavity disposed within the handle, wherein engaging the clamping assembly includes actuating a button of the clamping assembly toward the longitudinal axis of the elongated member in a direction transverse to the longitudinal axis to compress the elongated member against the internal tool; in the case of the first engagement of the clamping assembly, introducing the distal end of the shaft of the delivery catheter toward the tissue site into the patient's vascular system, wherein the shaft includes a shaft cavity extending from the proximal end of the shaft to the distal end of the shaft, wherein the handle is connected to the proximal end of the shaft, wherein The shaft cavity is in fluid communication with the elongated member cavity, wherein the shaft cavity and the elongated member cavity are configured to receive an internal tool, and wherein the internal tool is configured to interface with an implantable medical device; a release clamping assembly is provided, wherein the release clamping assembly includes a button actuating the clamping assembly remotely from the longitudinal axis of the elongated member; upon release of the clamping assembly, the internal tool is actuated, wherein actuation of the internal tool includes moving the internal tool through the shaft cavity and the elongated member cavity; after actuation of the internal tool, the clamping assembly is engaged a second time to restrict movement of the internal tool through the elongated member cavity; and upon the second engagement of the clamping assembly, the shaft is withdrawn proximally from the patient.

[0075] Clause 15: In some instances of the method described in accordance with Clause 14, the engagement clamping assembly includes actuating the button from a first position to a second position in which the button abuts against an internal tool to compress the elongated member.

[0076] Clause 16: In some instances of the method described in accordance with Clause 15, the clamping assembly locks the button in a second position, and releasing the clamping assembly includes unlocking the clamping assembly.

[0077] Clause 17: In some instances of the method described in accordance with Clause 15, engaging the clamping assembly includes manually holding the clamping assembly in a second position.

[0078] Clause 18: In some instances of the method pursuant to any one of Clauses 14 to 17, the internal tool is a mechanical tether, and actuating the internal tool includes releasing the implanted medical device from the tether.

[0079] Clause 19: In some instances of the method pursuant to any one of Clauses 14 to 17, the internal tool is a snare, and actuating the internal tool includes grasping the implanted medical device with the distal end of the snare.

[0080] Clause 20: In some instances, the system includes delivery conduits and internal tools as described in Clause 1.

[0081] Clause 21: In some instances of the system described in Clause 20, the internal tool includes a mechanical tether configured to implant the IMD within the patient's vascular system.

[0082] Clause 22: In some instances of the system described in Clause 20, the internal tool includes a snare configured to retrieve the IMD from within the patient's vascular system.

[0083] Clause 23: In some instances of the system pursuant to any one of Clauses 20 to 22, the system further includes an implantable medical device, wherein the implantable medical device includes a pacemaker.

[0084] Various aspects of this disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

1. An implantable medical device delivery catheter, comprising: A shaft configured to extend through a patient’s vascular system, wherein the shaft includes a shaft cavity extending from the proximal end of the shaft to the distal end of the shaft; and A handle connected to the proximal end of the shaft, the handle comprising: An elongated member disposed within the handle, the elongated member comprising an elongated member cavity in fluid communication with the shaft cavity, wherein the elongated member cavity and the shaft cavity are configured to receive an internal tool, the internal tool being configured to extend through the elongated member cavity and the shaft cavity and interface with the implantable medical device; and A clamping assembly comprising a button configured to be actuated toward the longitudinal axis of the elongated member in a direction transverse to the longitudinal axis to compress the elongated member against the internal tool, thereby restricting movement of the internal tool through the cavity of the elongated member; The button is configured to actuate from a first position to a second position, in which the button abuts against the internal tool to compress the elongated member, and the button is also configured to actuate from the second position to the first position in response to a longitudinal force applied to the button toward the distal end of the shaft in the direction of the distal end of the delivery conduit.

2. The delivery catheter of claim 1, wherein the clamping assembly includes a set of distally facing teeth, and the button includes a set of proximally facing teeth configured to engage with the set of distally facing teeth and hold the button in the second position.

3. The delivery conduit according to any one of claims 1 to 2, wherein the button further comprises a spatula configured to engage with the outer surface of the elongated member.

4. The delivery catheter according to any one of claims 1 to 2, wherein the elongated member comprises a flexible polymer.

5. The delivery catheter of claim 4, wherein the flexible polymer comprises rubber.

6. The delivery catheter according to any one of claims 1 to 2, wherein the clamping assembly comprises a valve cap.

7. The delivery conduit of claim 6, wherein the valve cover includes a semi-cylindrical member configured to support the lower side of the elongated member.

8. The delivery catheter of claim 7, wherein the semi-cylindrical member defines a clamping window configured to receive a portion of the elongated member to deform the elongated member cavity when the clamping assembly engages with the elongated member.

9. The delivery conduit of claim 7 or 8, wherein the clamping assembly is configured to compress the elongated member between the button and the semi-cylindrical member.

10. The delivery conduit of claim 8, wherein the valve cover further comprises a locking mechanism configured to secure the valve cover to the elongated member.

11. The delivery catheter according to any one of claims 1 to 2, wherein the clamping assembly is disposed at the proximal end of the handle.

12. The delivery conduit according to any one of claims 1 to 2, further comprising a rotation mechanism configured to actuate the button toward the longitudinal axis of the elongated member.

13. The delivery conduit of claim 12, wherein the rotation mechanism comprises a cam locking ring having an inner edge of a curve defining a variable radius of curvature, the inner edge of the curve being configured to actuate the button toward the longitudinal axis of the elongated member.

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