Medical device delivery system with internal ribs and vents

Abstract

In some instances, a medical device delivery system includes a device cup configured to hold a medical device at the distal end of a catheter, the cup having a cylindrical body defining at least one vent extending from an outer surface of the body to an inner surface of the body, and at least one internal rib extending inward from the inner surface, the rib being configured to contact the medical device.

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 medical devices, such as pacemakers or implantable cardioverter-defibrillator systems, can be used to provide cardiac sensing and therapy to patients via one or more electrodes. As an example, some intracardiac devices (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 cavity of the patient's heart. IMDs with a pulse generator configured for implantation within a cavity 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 The delivery catheter can then be withdrawn from the patient.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 apparatuses and systems for delivering implantable medical devices (IMDs) within a patient's vascular system. In some instances, the delivery apparatus includes a cup configured to hold the IMD, the cup defining one or more internal ribs configured to secure the IMD within the cup. In some instances, the cup additionally or alternatively defines one or more vents and channels to allow fluid to enter and / or exit the cup.

[0004] In one example, an implantable medical device delivery system includes: an elongated shaft extending from a proximal end to a distal end of the elongated shaft, the elongated shaft being configured to extend through a patient's vascular system; and a device cup attached to the distal end of the elongated shaft, the device cup including a cylindrical body configured to receive an implantable medical device, wherein the cylindrical body extends from a proximal end to a distal end of the cylindrical body, and wherein the cylindrical body includes: an inner surface; an outer surface; a distal opening at the distal end of the cylindrical body, the distal opening being configured for passage of the implantable medical device; and at least one internal rib extending inwardly from the inner surface, the rib being configured to contact the implantable medical device to frictionally retain the implantable medical device within the device cup.

[0005] Another example is a method using a medical device delivery system. The system includes: an elongated shaft comprising a proximal end and a distal end; and a device cup attached to the distal end of the elongated shaft, the device cup comprising a cylindrical body configured to receive an implantable medical device, the cylindrical body comprising at least one vent located proximally at the distal end of the device cup. The method includes introducing the distal end of the elongated shaft toward a tissue implantation site into a patient's vascular system; injecting a radioactive dye distally through the elongated shaft; observing the radioactive dye exiting the at least one vent; and, based on the observation of the radioactive dye exiting the at least one vent, implanting the implantable medical device at the tissue implantation site.

[0006] 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

[0007] Figure 1 This is a side view showing a system for delivering an implantable medical device (IMD) within a patient's vascular system.

[0008] Figure 2 This is a conceptual diagram illustrating the delivery of an instance IMD from an instance delivery system to the implantation site within a patient.

[0009] Figure 3 This is a plan view of an IMD based on some of the techniques disclosed herein.

[0010] Figure 4 This is a perspective view of a cup-shaped object containing an IMD according to some techniques of this disclosure.

[0011] Figure 5 yes Figure 4 The cup-shaped object and the close-up perspective view of the IMD depicted in the painting.

[0012] Figure 6 yes Figure 4 and 5 A perspective view of the cup and IMD within the instance introducer device, with portions of the introducer device and cup omitted.

[0013] Figure 7 yes Figure 1 A cross-sectional side view of the IMD delivery system depicted in the figure.

[0014] Figure 8 yes Figure 7 Another cross-sectional side view of the system depicted in the figure shows an instance of fluid flowing through a vent defined by a cup-shaped structure.

[0015] Figure 9 This is a perspective view of another example system for delivering IMD within a patient's vascular system, based on some examples of this disclosure.

[0016] Figures 10A-10C yes Figure 9 The example device is a plan view of a cup-shaped object, which illustrates example techniques for using a cup-shaped object according to some examples of the present disclosure.

[0017] Figure 11A-11E This is a perspective view of another example system for delivering IMD within a patient's vascular system, based on some examples of this disclosure.

[0018] Figures 12A-12C yes Figure 11A-11E A plan view of an example cup-shaped device, illustrating example techniques for using a cup-shaped device according to some examples of the present disclosure.

[0019] Figure 13 This is a flowchart illustrating an example method of delivering an IMD within a patient's vascular system according to some techniques of this disclosure. Detailed Implementation

[0020] Generally, this disclosure describes devices and systems for delivering implantable medical devices (IMDs) within a patient's vascular system or other anatomical structures. Figure 1 This shows the method used for delivering IMD ( Figure 1 A conceptual diagram of an example delivery system 10 (not shown). 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 (e.g., the heart), the devices, systems, and techniques of this disclosure can be used to deliver an IMD to any anatomical location.

[0021] The external member 16 (also referred to as the “introducer”) is an elongated member that defines 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.

[0022] 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 includes an elongated shaft 12, a handle 14, and a device cup 18. The handle 14 is located at the proximal end of the shaft 12 and may include one or more elements 52 (such as buttons, switches, etc.) configured to control movement at the distal end of the shaft 12. In some instances, the handle 14 includes a side port 46 for connection to a flushing assembly, thereby enabling the delivery of fluid through the lumen defined by the shaft 12 to the device cup 18.

[0023] The device cup 18 is positioned at the distal end of the shaft 12. The device cup 18 includes components configured to receive and support the IMD when it is implanted within the patient's vascular system (e.g., as described below regarding...). Figure 3 The IMD (20) described herein has a hollow cylindrical body. The distal end of the tether 40 can be attached to the IMD and extends through a lumen defined by the shaft 12 of the inner member 48. A physician can insert the distal end of the inner member 48, including the device cup 18, through the lumen of the outer member 16 placed within the patient's vascular system. After the device cup 18 has extended through the distal end 50 of the outer member 16 and reached the implantation site in the patient's body, the physician can release the IMD from the device cup 18, for example, by releasing the IMD from the tether 40 and retracting the shaft 12 and the cup 18 proximally through the outer member 16.

[0024] Due to various design considerations, the outer diameter of the cup 18 may be only slightly smaller than the inner diameter of the outer member 16. Due to the movement of these closely matched diameters, retraction of the cup 18 proximally through the outer member 16 may cause fluid (e.g., the patient's bodily fluids) to be ejected proximally from the proximal end 32 of the outer member 16, which may produce a piston-like or syringe-like aspiration, forcing the fluid within the outer member 16 to flow out through the proximal end 32.

[0025] In some embodiments according to this disclosure, the device cup 18 includes or defines one or more vents 28 configured to relieve fluid pressure within the external member 16, reducing or preventing such fluid from being ejected from the proximal end 32. The vents 28 can relieve fluid pressure by providing an alternative path, for example, through a distal opening 44 of the device cup 18, for fluid to exit the space between the shaft 12 and the external member 16.

[0026] Figure 2 This is a conceptual diagram illustrating the delivery of the IMD 20 from the medical device delivery system 10 to the implantation site within the patient's vascular system. Figure 2The example illustrates an IMD 20 that has been delivered through external component 16, which the operator has manipulated upwards through the inferior vena cava (IVC) and right atrium into the right ventricle of the patient's heart 42. The IMD 20 and external component 16 may be similar to the device and tool described in commonly assigned U.S. Patent No. 9,526,522, assigned to Medtronic plc of Dublin, Ireland.

[0027] In some cases, the IMD 20 may be a pacemaker device with a housing containing electronic components suitable for performing various pacing functions. For example, the IMD 20 may include application-specific integrated circuits (ASICs), electronic circuitry, processors (shared, dedicated, or grouped), and memory, combinational logic circuitry, state machines, or other suitable components or combinations of components that provide pacing functionality, executing one or more software or firmware programs. The specific form of the software, hardware, and / or firmware used to implement the functions disclosed herein will be determined primarily by the specific system architecture employed in the pacemaker and the specific detection and therapy delivery methods employed by the pacemaker.

[0028] The IMD 20 is shown secured at the implantation site by the fixation member 24, but still held within the shaft 12 of the inner member 48 by the tether 40. The inner member 48 extends from the distal opening 50 of the outer member 16. The shaft 12 engages with the device cup 18. Thus, the operator can test the fixation of the IMD 20 at the implantation site via the tether 40 and / or, if necessary, remove the IMD 20 from the implantation site for repositioning at a more suitable site. While the IMD 20 is shown with the fixation member 24 comprising a plurality of toothed structures, it should be understood that the technology disclosed herein is not limited to any particular device fixation structure. For example, as described in more detail herein, the disclosed device can be used to rotate a screw-shaped fixation structure (helix) into the tissue at the implantation site.

[0029] Once the implantation of IMD 20 is satisfactory, the operator can separate IMD 20 from internal component 48, for example, by actuating the mechanism at the proximal end of tether 40 to release the distal end of tether 40 from IMD 20, and then pull handle 14 proximally to retract the entire internal component 48 via external component 16.

[0030] In some IMD delivery systems, one or more bodily fluids may accumulate between the shaft 12 and the outer member 16 after the operator has extended the device cup 18 beyond the distal end 50 of the outer member 16 within the patient's vascular system. Without a vent 28, this fluid could be pulled or compressed proximally by the device cup 18 when the physician withdraws the inner member 48 from the outer member 16, and fluid could be ejected from the proximal end 32 of the outer member 16 toward the physician. However, in some embodiments according to this disclosure, the device cup 18 defines a vent 28 configured to drain fluid distally toward the patient's vascular system through the interior of the device cup 18. The vent 28 can be configured, for example, in size and shape designed to provide an alternative, and in some cases preferred, path relative to the distal end 32 of the outer member 16, for the fluid to exit the space between the shaft 12 and the outer member 16 at the distal end 50 of the outer member 16.

[0031] Figure 3 This is a plan view of the IMD 20 instance configuration. Figure 3 An IMD 20 including a housing 22 is shown. In some instances, the housing 22 may be hermetically sealed. In some instances, the housing 22 may contain an electronic controller (not shown), such as a pulse generator and an associated power supply. Regarding... Figure 4-13 Describe the features of example cup-shaped devices such as device cup 18, and their interaction with IMD 20 within the device cup.

[0032] The IMD 20 includes an electrode 54 and a fixation member 24. The electrode 54 can be electrically connected to a controller via a hermetically sealed feedthrough assembly (not shown). The housing 22 may be formed of a biocompatible and biostable metal, such as titanium, and laminated with an insulating layer such as medical-grade polyurethane, parylene, or silicone. In some instances, the device 20 may include another electrode 62 (not shown), formed, for example, by removing a portion of the insulating layer to expose the metal surface of the housing 22. When the fixation member 24 secures the electrode 54 to the target implantation site in close tissue contact, the electrode 62 can be used in conjunction with the electrode 54 for bipolar pacing and sensing. Figure 3 The IMD 20 is further illustrated, including an optional attachment structure 56 that engages with the housing 22. The tether attachment structure 56 can be configured to attach to the tether 40 ( Figure 1 and 2 And, for example, by retracting a component (not shown), it can be tightened.

[0033] Further reference Figure 3 Device fixation members 24 are spaced apart from each other around the periphery of device housing 22, wherein the fixation members 24 are configured to fix device 20 to tissue at the implantation site. Although in Figure 3Only two fixing members 24 are shown, but the IMD 20 may include four, up to eight, or more than eight fixing members 24. According to one example, the fixing members 24 are integrally formed from a nickel-titanium alloy tubing or other biocompatible tubing. After cutting the nickel-titanium alloy tubing, the members 24 can be formed by bending and holding them at the indicated curvature while undergoing heat treatment. The fixing members 24 can be mounted to the distal end of the device housing 22, for example, in a manner similar to that described for fixing assembly 102 in U.S. Patent No. 10,112,045, the entire description of which is incorporated herein by reference. The hyperelastic properties of the nickel-titanium alloy allow the fixing members 24 to elastically deform between a relaxed state and an extended state, in which the free end of each fixing member 24 extends distally away from the device housing 22.

[0034] Figure 4 It contains Figure 2 and 3 IMD 20 Figure 1 and 2 A transparent perspective view of an example configuration of the device cup 18. The device cup 18 includes a hollow cylindrical member attached to the distal end of the shaft 12 of the inner member 48. In some examples, the device cup 18 may have an outer diameter of about 0.308 inches, an inner diameter of about 0.275 inches, and a thickness of about 0.016 inches (the difference between the outer and inner diameters).

[0035] The cup-shaped device 18 is configured to receive and support the IMD 20. The internal component 48 may include an elongated tether 40 passing through the internal cavity of the shaft 12. The distal end of the tether 40 may be configured to be removably connected to the distal end of the IMD 20, such as to the attachment structure 56.

[0036] like Figure 4 As shown, the cup-shaped device 18 includes a vent 28. The vent 28 may include an opening extending from an outer surface or outer surface of the cup-shaped device 18 to an inner surface or inner surface, configured to allow fluid to drain from the outer surface to the inner surface, from the inner surface to the outer surface, or both. Figure 4 In one example, the device cup 18 includes a plurality (three in this example) of vent holes 28 longitudinally distributed along the cylindrical body of the device cup 18. In other examples, the device cup may include any number of one or more vent holes 28, which may be distributed on the device cup in any manner, for example, longitudinally and / or circumferentially. In some examples, such as Figure 4In the example shown, the vent 28 can be positioned closer to the proximal end of the device cup 18 than the distal end, for example to avoid interaction with the serration 24 of the IMD 20 and / or to place one or more vents above the electrode 62 of the IMD 20.

[0037] like Figure 4 As shown, the device cup 18 may also include one or more external channels 26. The external channels 26 may include elongated recesses entering the outer surface of the device cup 18, configured to guide fluid downwards from the outer surface of the device cup 18 into a vent 28. The external channels 26 may extend from or near the proximal end of the device cup 18 to the location of the vent 28 to provide a preferred path for fluid accumulating between the shaft 12 and the external member 16 proximal to the device cup 18 to flow to the vent 28. Figure 4 As shown, the vent 28 may be located within the external channel 26, and in some cases, closer to the distal end, and then to the proximal end of the channel.

[0038] Despite Figure 4 Not shown, but the device cup 18 may additionally or alternatively include one or more internal channels 78 (FIG. 11). Internal channels 78 may include defined fluid paths along the inner surface of the device cup 18, configured to guide fluid upward from the inner surface of the device cup 18 into the vent 28. The direction of fluid from the inside to the outside of the device cup 18, for example, a radioactive dye, is described in more detail below to visually determine the alignment of the distal opening 44 of the cup 18 with tissue. The dimensions, shapes, and numbers of the vent 28, external channels 26, and internal channels 78 (such as the diameter of the vent 28, and the length, width, and depth of channels 26 and 78) may be configured based on the characteristics of the fluids they will interact with, the desired level of fluid flow, and other conditions of use of the system 10.

[0039] although Figure 4 Not shown, but the cup-shaped device 18 may include one or more internal ribs 30. Figure 6 and 7The internal rib 30 may include an elongated projection extending inwardly from the inner surface of the device cup 18. In some instances, the internal rib 30 may be configured to define an internal channel, such as internal channel 78. The length dimensions of the outer channel 26, the internal channel 78, and the internal rib 30 may, but are not necessarily, in the direction of the longitudinal axis of the device cup 18. In some instances, the internal rib 30 may contact the outer surface 22 of the IMD 20 to generate more friction between the device cup 18 and the IMD 20, providing better control over the IMD 20 (e.g., holding the IMD 20 more firmly in place within the device cup 18). In this way, the internal rib 30 may contact the outer surface 22 of the IMD 20 to frictionally retain the IMD 20 within the device cup 18.

[0040] In embodiments according to this disclosure, various numbers, combinations, configurations, and arrangements of the external channel 26, internal channel 78, internal ribs 30, and / or vents 28 can provide their respective advantages to the physician or other operator of the system 10. Figure 1 As discussed above, such advantages may include, but are not limited to, improved control (e.g., retention) of IMD 20, relief of fluid pressure, and / or visual alignment of system 10 relative to the patient’s vascular system and the target implant tissue.

[0041] Figure 5 This is a close-up perspective view of the cup-shaped device 18 and IMD 20 within the external component 16. Figure 5 In the example depicted, the device cup 18 defines an external channel 26 and three vents 28. The external channel 26 includes an elongated recess entering the outer surface of the device cup 18, the elongated recess not extending through the surface. The external channel 26 may extend from a proximal end of the device cup 18 to a distal end. In some examples, the device cup 18 may define a plurality of external channels 26 arranged circumferentially around a cylindrical body of the device cup 18.

[0042] The device cup 18 defines a vent 28 within the external channel 26. The vent 28 includes one or more openings extending from the outer surface of the device cup 18 to the inner surface of the device cup 18, i.e., extending through the device cup 18. In some instances, the vent 28 may be substantially circular and have a diameter of about 0.025-0.050 inches. For example, the vent 28 may have a diameter of 0.036 inches. In other instances, the vent 28 may have other shapes, such as rectangular or elliptical shapes. In some instances, the vent 28 may be an elongated and circular "slot," for example, shaped like a hockey rink. In some instances, the vent 28 has an elongated shape, for example, where the dimension of the hole along one axis is larger than the dimension along another orthogonal axis, the larger dimension of which may be oriented substantially parallel to the longitudinal axis defined by the cup 18. The elongated vent 28 can increase the likelihood that the electrodes 62 of the IMD 22 are exposed to blood, thereby facilitating electrical measurements using the electrodes when the IMD is inside the cup, for example, because the IMD 22 can move longitudinally within the cup 18.

[0043] When the IMD 20 is housed within the device cup 18, the vent 28 can initially be “plugged” by the IMD 20. After a physician or other operator releases the IMD 20 into the patient’s vascular system, fluid may accumulate between the axis 12 and the external member 16, for example, in region 58. Without the external channel 26 and the vent 28, the fluid could be pulled or compressed proximally by the device cup 18 when the physician withdraws the internal member 48 from the external member 16, and the fluid might be jetted toward the physician. However, because the device cup 18 defines the external channel 26 and the vent 28, the fluid will instead be compressed into the external channel 26 and into the vent 28. The fluid can then exit distally (e.g., through the interior of the device cup 18 toward the patient’s internal vascular system).

[0044] In some instances, the vent 28 can be arranged circumferentially around the cylindrical body of the cup-shaped part 18 of the device. In some instances, like... Figure 5 In the examples depicted, the vent 28 may additionally or alternatively be arranged longitudinally along the cup-shaped part 18 of the device. In some examples, the vent 28 may be closer to the proximal end of the cup-shaped part 18 than to the distal end 44. Figure 7 ).

[0045] In some instances, one or more of the vents 28 may be positioned near or directly above the ring electrode 62 of the IMD 20. In these instances, the vents 28 allow bodily fluids from within the patient to contact the ring electrode 62. When conductive fluid contacts both the electrode 54 and the ring electrode 62 of the IMD 20, a circuit can be completed, allowing the user to activate the IMD 20 while it is still contained within the device cup 18. Some instances are configured with internal ribs, such as internal rib 30, that allow fluid to reach the ring electrode 62, even though the vents 28 are not directly above the electrodes.

[0046] In some instances, the user can determine whether the cup 18 and IMD 20 are correctly positioned relative to cardiac tissue based on the impedance or other electrical parameters of the signals delivered via electrical paths including electrodes 54 and 62 or other electrodes included in the delivery system 10. In some instances, a relatively high impedance can indicate that the cup 18 is positioned flush with and at sufficient depth within the cardiac tissue, which may be the desired correct fixation. Some instances may employ any of the techniques described in U.S. Patent Application Serial No. 16 / 146,391, filed September 28, 2018, entitled "Impedance-Based Verification of Delivery of Implantable Medical Devices," by Medtronic Corporation, entitled "Impedance-Based Verification of Delivery of Implantable Medical Devices," which is incorporated herein by reference in its entirety.

[0047] Figure 6 This is a perspective view of the device cup 18 and IMD 20, where portions of the outer member 16 and the device cup 18 are removed to show an example longitudinal cross-sectional profile of the device cup 18. Figure 6 In the example depicted, the device cup 18 defines at least two internal ribs 30A and 30B (collectively referred to as internal ribs 30) that are evenly spaced around the inner circumference of the device cup 18. For example, the device cup 18 may define two ribs 30 spaced 180 degrees apart from each other. In other examples, the device cup 18 may define three internal ribs 30 spaced 120 degrees apart from each other around the inner circumference of the device cup 18. The internal ribs 30 include elongated projections extending inward from the inner surface of the device cup 18. For example, the internal ribs 30 may extend inward (e.g., radially) from the inner surface of the device cup 18 toward the central axis of the device cup 18. The internal ribs 30 may extend inward, for example, about 0.075 inches.

[0048] In some instances, the inner ribs 30 may contact the outer surface 22 of the IMD 20, generating more friction between the device cup 18 and the IMD 20, providing better control over the IMD 20 (e.g., holding the IMD 20 more securely in place within the device cup 18). In some instances, the device cup 18 may define more than two inner ribs 30 circumferentially distributed around its inner surface. For example, the device cup 18 may define three inner ribs 30, each spaced 120 degrees from the other two. In this example configuration, when the IMD 20 is inserted and held in place by the inner ribs at its three locations, the flexible material of the device cup 18 may slightly deform from a perfectly circular cross-section to a slightly triangular cross-section. In some instances, the device cup 18 may be biased, for example, like a spring, to its undeformed state, providing the force exerted by the inner ribs 30 on the IMD 20 to hold the IMD 20 within the device cup 18.

[0049] In some instances, internal ribs (e.g., internal rib 30A) may be formed along the (inner) surface of the device cup 18 opposite to the corresponding outer channel (e.g., outer channel 26), such that the wall thickness of the device cup 18 is uniform throughout the device cup 18. In other instances, internal ribs (e.g., internal rib 30B) do not have corresponding outer channels (e.g., the ribs are disposed on the opposite surface of the uniform outer surface of the device cup 18), such that the device cup 18 along internal rib 30B is thicker than the rest of the cup. In these instances, internal rib 30B may be configured to retain and hold the IMD 20, but not necessarily to drain the fluid.

[0050] Figure 7 This is a cross-sectional side view of the IMD delivery system 10. Figure 7 In the example depicted, the cup-shaped device 18 defines a pair of external channels 26A and 26B (collectively referred to as external channels 26). Each of the external channels 26 corresponds to a corresponding internal rib 30A and 30B defined by the inner surface of the cup-shaped device 18. Furthermore, each pair of external channels 26 and internal ribs 30 defines three vent holes 28. Figure 8 As shown, when the physician retracts the inner component 48 proximally via the outer component 16 (indicated by the thick black arrow 34), the fluid 60 is forced distally from region 58 (i.e., in the opposite direction to arrow 34), through the vent 28, into the internal region of the device cup 18 previously occupied by the IMD 20, and outward through the distal end 44 of the device cup 18 (…). Figure 7 ).

[0051] In addition to guiding fluid during the withdrawal of the internal component 48 via the external component 16 after IMD implantation, the vent 28 can be used to indicate the alignment of the IMD delivery system, and more specifically the cup-shaped device, relative to the patient's target tissue prior to IMD implantation. Figure 9 and 10A -C illustrates another example, IMD delivery system 60, which, unless otherwise stated, may be similar to IMD delivery system 10. Figure 1-8 The IMD delivery system 60 includes an instance arrangement of vents 28, which allows physicians to determine the alignment of the IMD delivery system 60 with respect to the patient's tissue at the implantation site.

[0052] For example, a physician can inject a radioactive dye into the IMD delivery system 60. Depending on the placement of the system 60 relative to the patient's vascular system, the radioactive dye can exit the system 60 through the distal end 44 of the device cup 64 (indicating incorrect placement of the system 60) or through a vent 28 (indicating correct placement of the system 60), which can be positioned closer to the proximal end of the device cup 64 than the distal end 44. The location where the dye exits the device cup 64 is highly visually apparent on fluoroscopic or other images of the tissue implantation site, indicating the alignment of the IMD delivery system 60.

[0053] Figure 9 This is a perspective view of a system 60 according to some embodiments of the present disclosure, the system including a device cup 64 attached to the distal end of an elongated shaft 12 of an internal member 66. Figure 9 In the example depicted, the cup-shaped device 64 defines three vents 28; however, it should be understood that the cup-shaped device 64 can define any number of vents. Although in Figure 9-10C Not shown, but the cup-shaped device 64 may include one or more internal ribs and / or internal channels that define a path for the flow of the radioactive dye 38. Figure 10B ).exist Figure 9 In this example, the vent 28 is not configured to drain the patient's fluid into the device cup 64 during retraction of the device cup 64 via the external member 16, because the vent would be "blocked" by the inner surface of the external member 16 and there is no corresponding external channel to guide the fluid into the vent. However, if the vent 28 is positioned along a narrower circumference of the proximal conical portion of the device cup 64 (e.g., Figures 10A-10C As shown), the vent 28 will not be "blocked" by the external component 16 and the patient's fluid will not require an external channel to enter the device cup 64 through the vent 28.

[0054] Figures 10A-10C The text describes the patient tissue 36 at the implantation site during procedures such as implantation of IMD 20. Figure 9 Example device: cup-shaped object 64. For example... Figure 10A As shown, a physician or other operator can navigate the distal end 44 of the device cup 64 toward the tissue implantation site 36 within the patient's vascular system. Once the physician has aligned the distal end 44 with the tissue 36, the physician can inject the radioactive dye 38 distally through the internal lumen of the shaft 12.

[0055] like Figure 10B As described, in some cases, the physician may not have properly aligned the distal end 44 of the device cup 64 with the tissue 36. For example, as... Figure 10B As shown, the distal end 44 can be positioned at an angle to the tissue 36. In these examples, a larger portion of the radioactive dye 38 can escape from the device cup 18 through the gap formed between the distal end 44 and the tissue 36. The plume of radioactive dye 38 generated near the implantation site can vividly appear on fluoroscopic imaging of the surrounding area, informing the physician or operator that the device cup 64 is misaligned. In this configuration, a small amount of radioactive dye 38 can also escape through the vent 28.

[0056] like Figure 10C As depicted, in some cases, the physician may have successfully aligned the distal end 44 of the device cup 64 with the tissue 36 at the implantation site of the IMD 20. For example, the entire distal end 44 may be covered or concealed by the tissue 36. In these instances, a larger portion of the radioactive dye 38 may escape from the device cup 64 through the vent 28 compared to when the distal end 44 is misaligned with the tissue 36. The resulting plume of radioactive dye 38, positioned at a significant distance from the implantation site 36, can vividly appear on a fluorescence microscope image of the surrounding area, informing the physician or operator that the device cup 64 is correctly aligned and that the IMD 20 can be implanted at site 36. In some instances, sufficient pressure from the distal end 44 against the tissue 36 and a “bulge” in the tissue 36 may increase the amount of dye 38 leaving the vent 28.

[0057] Various parameter values ​​can be selected based on the degree of contact between the distal end 44 and the tissue 36 to promote different flows of dye 38 through the vents 28. In some instances, the combined diameter of the vents 28 can be selected to be smaller than the difference between the diameters of the cup 64 and the IMD 20, for example, a certain amount, fraction, or percentage smaller than the diameter difference. The diameter of each vent 28 can be selected based on the density of dye 38. The shape and radial position of the vents 28 can be selected to achieve the desired shape of the dye 38 plume.

[0058] The vent 28 can be positioned along the longitudinal axis of the cup 64 closer to the proximal end 68 of the cup 64 than to the distal end 44 to avoid interference with the fixing members of the IMD 20 and to allow dye 38 exiting the vent 28 to be distinct from dye 38 exiting the distal end 44 of the cup 64. On the other hand, a shorter longitudinal distance between the distal end 44 and the vent 28 can facilitate the intentional covering of one or more vents 28 in response to pressure applied by the cup 64 and / or bulges exceeding a certain predefined level.

[0059] Figure 11A-11E Another example of a cup-shaped device 74, which is attached to the distal end of an elongated shaft 12 of an internal member 76 according to some embodiments of the present disclosure, is depicted. Figure 11A It is a transparent perspective view of the cup-shaped object 74 containing IMD 20. Figure 11B It is an opaque perspective view of the inner surface of the cup-shaped part 74 of the device with IMD 20 removed. Figure 11C It is an opaque perspective view of the outer surface of the cup-shaped object 74. Figure 11D It is a transparent perspective view of the device cup 74 with IMD 20 removed. Figure 11E It is an opaque perspective view of the cup-shaped object 74 of the device with a portion of the cup-shaped object 74 removed.

[0060] like Figure 11A-11E As depicted, the outer surface defined by the cup-shaped part 74 of the device has three external channels 26A-26C (collectively referred to as external channels 26). Each external channel 26 contains a vent 28A-28C (collectively referred to as vent 28). However, it should be understood that the cup-shaped part 74 of the device can define any number of external channels, and each external channel 26 can contain any number or shape of vent 28. Figure 11A-11E The cup-shaped device 74 depicted in the illustration also defines three internal ribs 72A-72C (collectively referred to as internal ribs 72), each internal rib 72 corresponding to an external channel 26 and a vent 28. These internal ribs 72 can contact and retain the IMD 20, separating the outer circumference of the IMD 20 from the inner circumference of the device cup-shaped device 74, and allowing the vent 28 to drain fluid from the patient regardless of whether the IMD 20 is present within the device cup-shaped device 74.

[0061] exist Figure 11A-11E In the example configuration depicted, each internal rib 72 includes a distal bifurcated structure defining a pair of parallel elongated extensions, the shape of which is similar to the two forks of a tuning fork.

[0062] Each of these double extensions further defines a corresponding side of the internal channels 78A-78C (collectively referred to as internal channels 78). It should be understood that although the internal channels 78 are referred to as “channels”, unlike the external channels 26, the internal channels 78 may be flush with or at the same level as the corresponding surface of the device cup 74, except for the corresponding internal ribs 72 that define their boundaries.

[0063] exist Figure 11A-11E In the examples depicted, the internal ribs 72 are portrayed as paired, straight, parallel extensions. In other examples, the internal ribs 72 may be formed in a helical shape, as by rotating the cup-shaped device 74 during the molding process. (See also: Regarding...) Figures 12A-12C As further described, the internal channel 78 can improve the visual alignment of the device cup 74 within the patient's vascular system by guiding the flow of radioactive dye away from or toward the vent 28. The size, shape, and / or material of the internal rib 72 and the internal channel can be selected to facilitate the desired flow of dye. In some instances, porous media and / or valves may be used within the channel 78 or otherwise within the device cup 74 to facilitate the desired flow of dye. In some instances, in addition to or in place of the rib / channel, porous media may be included within the device cup 74 and may be configured to provide the desired flow of dye or other fluids within the cup.

[0064] Figures 12A-12C Depicting Figure 11A-11E Example device: cup-shaped object 74. For example... Figure 12A As shown, a physician or other operator can navigate the distal end 44 of the device cup 74 toward the tissue implantation site 36 within the patient's vascular system. Once the physician has aligned the distal end 44 with the tissue 36, the physician can inject the radioactive dye 38 distally through the internal lumen of the shaft 12.

[0065] like Figure 12B As described, in some cases, the physician may not have properly aligned the distal end 44 of the device cup 74 with the tissue 36. For example, as... Figure 12BAs shown, the distal end 44 can be positioned at an angle to the tissue 36 (e.g., the longitudinal axis of the device cup 74 is not perpendicular to the tissue 36). In these examples, the radioactive dye 38 will travel from the axis 12 toward the distal end 44 of the device cup 74. The radioactive dye 38 will be largely prevented from escaping through the vent 28, as the vent 28 is bordered on both sides by the bifurcations of the internal rib 72 and the IMD 20, which can physically contact the internal rib 72. Therefore, a significant portion of the radioactive dye 38 can escape from the device cup 74 through the gap formed between the distal end 44 and the tissue 36. The resulting plume of radioactive dye 38 near the tissue implantation site 36 can vividly appear on fluoroscopic imaging of the surrounding area, informing the physician or operator that the device cup 74 is misaligned with the tissue.

[0066] like Figure 12C As depicted, in some cases, the physician may have successfully aligned the distal end 44 of the device cup 74 with the tissue 36 at the implantation site of the IMD 20. For example, the entire distal end 44 may be covered or occluded by the tissue 36. In these instances, the radioactive dye 38 will travel distally from the axis 12 toward the distal end 44, where it will be captured by the tissue 36 and redirected downward into the internal channel 78 defined by the tuning fork-shaped internal rib 72, and exit through the vent 28. Thus, compared to when the distal end 44 is not aligned with the tissue 36, a larger portion of the radioactive dye 38 can escape from the device cup 18 through the vent 28 (as in...). Figure 12B (In the middle). The resulting plume of radioactive dye 38, placed at a significant distance from the implantation site 36, can vividly appear on fluoroscopic imaging of the surrounding area, informing the physician or operator that the device cup 74 is correctly aligned with the tissue 36 and that the IMD 20 can be implanted at the tissue site 36. In some instances, the amount of dye 38 leaving the vent 28 can be increased in response to sufficient pressure from the distal end 44 against 36 and the “bulge” of the tissue 36.

[0067] Values ​​of various parameters can be selected based on the degree of contact between the distal end 44 and the tissue 36 to promote different flows of dye 38 through the vents 28. In some instances, the combined diameter of the vents 28 can be selected to be smaller than the difference between the diameters of the cup 74 and the IMD 20, for example, a certain amount, fraction, or percentage smaller than the diameter difference. The diameter of each vent 28 can be selected based on the density of dye 38. The shape and radial position of the vents 28 can be selected to achieve the desired shape of the dye 38 plume.

[0068] The vent 28 can be positioned along the longitudinal axis of the cup 74 closer to the proximal end 80 of the cup 74 than to the distal end 44 to avoid interference with the fixing member 24 of the IMD 20 and to allow dye 38 exiting the vent 28 to be distinct from dye 38 exiting the distal end 44 of the cup 74. On the other hand, a shorter longitudinal distance between the distal end 44 and the vent 28 can facilitate the intentional covering of one or more vents 28 in response to pressure applied by the cup 74 and / or bulges exceeding a certain predefined level.

[0069] Figure 13 This is a flowchart illustrating a method of implanting an IMD within a patient's vascular system according to some techniques of this disclosure. A physician or other qualified operator inserts an external component 16 (such as an introducer) into the patient's vascular system (130). For example, a physician may insert the external component 16 into the femoral vein in the patient's leg and navigate the external component 16 upward through the patient's vascular system into the patient's heart. The lumen of the external component 16 then defines a rigid path through the patient's vascular system.

[0070] The physician can then insert the shaft 12 of the inner component 48 (such as a delivery catheter) into the lumen of the outer component 16 (132). Using one or more controls 52 on the proximal handle 14, the physician can navigate the distal end 44 of the inner component 48 through the lumen of the outer component 16 toward the tissue implantation site 36.

[0071] Once the physician has determined that the distal end 44 is at or near the implantation site 36, for example via a screen depicting an X-ray image of the implantation site 36, the physician can inject the radioactive dye distally toward the implantation site 36 via the axis 12 of the internal member 48. In some cases, the distal end 44 of the internal member 48 may not yet be fully aligned with the implantation site 36. In these cases, the physician can observe the radioactive dye 38 escaping as a plume through the gap between the distal end 44 and the tissue 36 (136).

[0072] If misalignment is observed, the physician can realign the distal end 44 with the tissue 36 via the control 52 on the handle 14 (138). Once the distal end 44 has been successfully realigned with the tissue implantation site 36, the physician can inject the radioactive dye 38 again through the axis 12 of the internal member 48 (140). In this case, because the distal end 44 is completely covered by the tissue 36, the radioactive dye 38 escapes instead through one or more vents 28 defined by the device cup 18, which the physician can observe on the screen (142). After confirming successful alignment of the device cup 18 by observing the plume of radioactive dye 38, the physician inserts the medical device 20 into the tissue implantation site 36.

[0073] The following clauses provide some examples of this disclosure.

[0074] Clause 1: In some instances, an implantable medical device delivery system includes: an elongated shaft extending from a proximal end of the elongated shaft to a distal end of the elongated shaft, the elongated shaft being configured to extend through a patient's vascular system; and a device cup attached to the distal end of the elongated shaft, the device cup comprising a cylindrical body configured to receive an implantable medical device, wherein the cylindrical body extends from a proximal end of the cylindrical body to a distal end of the cylindrical body, and wherein the cylindrical body includes: an inner surface; an outer surface; a distal opening at the distal end of the cylindrical body, the distal opening being configured for passage of the implantable medical device; and at least one internal rib extending inwardly from the inner surface of the cylindrical body, the rib being configured to contact the implantable medical device to frictionally retain the implantable medical device within the device cup.

[0075] Clause 2: In some instances of the system of Clause 1, the cylindrical body further includes at least one vent extending from the outer surface of the cylindrical body to the inner surface of the cylindrical body, said at least one vent being configured to allow fluid to pass through the cylindrical body.

[0076] Clause 3: In some instances of the system described in Clause 2, at least one vent contains multiple vents.

[0077] Clause 4: In some instances of the system described in Clause 3, multiple vents include at least three vents.

[0078] Clause 5: In some instances of systems in Clause 3 or Clause 4, multiple vents are distributed around the circumference of the cylindrical body.

[0079] Clause 6: In some instances of the system of any one of Clauses 3 to 5, multiple vents are distributed longitudinally along the cylindrical body.

[0080] Clause 7: In some instances of the system of any one of Clauses 2 to 6, at least one vent is closer to the proximal end of the cylindrical body than to the distal end of the cylindrical body.

[0081] Clause 8: In some instances of the systems of any one of Clauses 2 to 7, at least one vent is configured to allow increased flow of fluid from inside the cylindrical body in response to the covering of the distal opening.

[0082] Clause 9: In some instances of the systems of any one of Clauses 2 to 8, at least one vent is configured to guide radioactive dye when the distal end of the cylindrical body is positioned against the patient’s tissue such that the distal opening is covered by the tissue.

[0083] Clause 10: In some instances of the systems of any one of Clauses 2 to 9, at least one vent is located above the electrode of the implantable medical device and is configured to allow bodily fluids to come into contact with the electrode when the implantable medical device is held within the device cup.

[0084] Clause 11: In some instances of the system of any one of Clauses 2 to 10, the cylindrical body further includes at least one external channel.

[0085] Clause 12: In some instances of the system described in Clause 11, at least one external channel includes multiple external channels.

[0086] Clause 13: In some instances of the systems described in Clause 11 or Clause 12, multiple external channels are distributed around the circumference of the cylindrical body.

[0087] Clause 14: In some instances of the system of any one of Clauses 11 to 13, at least one external channel extends longitudinally from the proximal end of the cylindrical body.

[0088] Clause 15: In some instances of the system of any one of Clauses 11 to 14, at least one vent extends through at least one external passage.

[0089] Clause 16: In some instances of the system of Clause 15, at least one external channel is configured to direct fluid outside the cylindrical body to at least one vent.

[0090] Clause 17: In some instances of the systems of Clause 15 or Clause 16, the system further includes an external member defining a lumen; and an internal member configured to be fitted inside the lumen, the internal member including an elongated shaft and a device cup, wherein the external channel is configured to guide bodily fluid through at least one vent and exit from the distal end of the cylindrical body as the internal member moves through the lumen of the external member.

[0091] Clause 18: In some instances of the system of any one of Clauses 1 to 17, at least one internal rib comprises a plurality of internal ribs.

[0092] Clause 19: In some instances of the system described in Clause 18, multiple internal ribs are distributed around the circumference of the cylindrical body.

[0093] Clause 20: In some instances of the system of Clause 18 or Clause 19, multiple ribs include at least three ribs.

[0094] Clause 21: In some instances of the system of any one of Clauses 1 to 20, at least one internal rib extends longitudinally from the proximal end of the cylindrical body.

[0095] Clause 22: In some instances of the system of any one of Clauses 2 to 21, at least one vent extends through at least one internal rib.

[0096] Clause 23: In some instances of the system of any one of Clauses 1 to 22, at least one internal rib includes a distal bifurcation structure.

[0097] Clause 24: In some instances of the system of Clause 23, the distal bifurcation structure includes a tuning fork shape extending distally.

[0098] Clause 25: In some instances of the systems of Clause 23 or Clause 24, the cylindrical body further includes at least one vent extending from an outer surface of the cylindrical body to an inner surface of the cylindrical body, the at least one vent being configured to allow fluid to pass through the cylindrical body, and wherein a distal bifurcation defines an internal channel, the at least one vent being located within the internal channel, and the internal channel being configured to guide fluid inside the cylindrical body to the at least one vent.

[0099] Clause 26: In some instances of the systems in any of Clauses 1 to 25, the implantable medical device is a pacemaker.

[0100] Clause 27: In some instances, a method includes using a medical device delivery system comprising: an elongated shaft including a proximal end and a distal end; and a device cup attached to the distal end of the elongated shaft, the device cup including a cylindrical body configured to receive an implantable medical device, the cylindrical body including at least one vent located proximally at the distal end of the device cup; and the method comprising: introducing the distal end of the elongated shaft toward a tissue implantation site into a patient's vascular system; injecting a radioactive dye distally through the elongated shaft; observing the radioactive dye exiting at least one vent; and, based on the observation of the radioactive dye exiting at least one vent, implanting the implantable medical device at the tissue implantation site.

[0101] Clause 28: In some instances of the method of Clause 27, distal injection of radioactive dye includes a second distal injection of radioactive dye, the method further comprising, prior to the second distal injection of radioactive dye: a first distal injection of radioactive dye via an elongated axis; observation of the radioactive dye exiting the distal end of the device cup; and realigning the distal end of the device cup with the tissue implantation site.

[0102] Clause 29: In some instances of the method of Clause 27 or Clause 28, the method further includes retracting the elongated shaft proximally from the patient's vascular system via an external member, wherein during the proximal retraction of the elongated shaft, fluid flow within the external member passes through at least one vent and exits from the distal opening of the device cup.

[0103] 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 system, comprising: An elongated shaft extending from a proximal end of the elongated shaft to a distal end of the elongated shaft, the elongated shaft being configured to extend through the patient's vascular system; as well as A cup-shaped device attached to the distal end of the elongated shaft, the cup-shaped device comprising a cylindrical body configured to receive an implantable medical device, wherein the cylindrical body extends from a proximal end to a distal end, and wherein the cylindrical body comprises: Inner surface; Outer surface; A distal opening at the distal end of the cylindrical body, the distal opening being configured for passage of the implantable medical device; and At least one internal rib extending inwardly from the inner surface of the cylindrical body, the rib being configured to contact the implantable medical device to frictionally retain the implantable medical device within the device cup, wherein the at least one internal rib includes a distal bifurcation structure, wherein the length dimension of the distal bifurcation structure is substantially parallel to the longitudinal axis of the device cup, wherein the cylindrical body further includes at least one vent extending from the outer surface of the cylindrical body to the inner surface of the cylindrical body, the at least one vent being configured to allow fluid to pass through the cylindrical body, and wherein the distal bifurcation structure defines an internal channel, the at least one vent being located within the internal channel, and the internal channel being configured to guide fluid within the cylindrical body to the at least one vent.

2. The system according to claim 1, wherein the at least one vent comprises a plurality of vents.

3. The system according to claim 2, wherein the plurality of vents comprises at least three vents.

4. The system according to claim 2 or 3, wherein the plurality of vent holes are distributed around the circumference of the cylindrical body.

5. The system according to claim 2 or 3, wherein the plurality of vent holes are distributed longitudinally along the cylindrical body.

6. The system of claim 1, wherein the at least one vent is closer to the proximal end of the cylindrical body than to the distal end of the cylindrical body.

7. The system of claim 1 or 6, wherein the at least one vent is configured to allow increased flow of fluid from inside the cylindrical body in response to the distal opening being covered.

8. The system of claim 1 or 6, wherein the at least one vent is configured to guide radioactive dye when the distal end of the cylindrical body is positioned against the patient's tissue such that the distal opening is covered by the tissue.

9. The system of claim 1 or 6, wherein the at least one vent is located above the electrode of the implantable medical device and is configured to allow bodily fluids to contact the electrode when the implantable medical device is held within the device cup.

10. The system according to claim 1 or 6, wherein the cylindrical body further comprises at least one external channel.

11. The system of claim 10, wherein the at least one external channel comprises a plurality of external channels.

12. The system of claim 10, wherein a plurality of external channels are distributed around the circumference of the cylindrical body.

13. The system of claim 10, wherein the at least one external channel extends longitudinally from the proximal end of the cylindrical body.

14. The system of claim 10, wherein the at least one vent extends through the at least one external channel.

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