Delivery devices for delivering implantable or inserted medical devices

Abstract

A medical delivery device for delivering a medical device includes an elongated member suitable for navigation, a deployment chamber, and a compression mechanism. The deployment chamber can be configured to accommodate the medical device when the medical device is navigated to a target site. The deployment chamber can be located at a distal end of the delivery device and can include a distal opening through which the medical device can be deployed. The compression mechanism is configured to longitudinally compress in response to a predetermined force so that the elongated member and the deployment chamber are relatively closer together along the longitudinal axis of the delivery device.

Description

Technical Field

[0001] The present disclosure generally relates to medical delivery devices configured to deliver implantable and / or insertable medical devices to a target site within the human body. Background Art

[0002] Various medical devices for delivering treatment and / or monitoring physiological conditions have been used clinically or proposed for clinical use in patients. Examples include medical devices that deliver treatment to the heart, muscles, nerves, brain, stomach, or other organs or tissues or patients and / or monitor conditions associated with the heart, muscles, nerves, brain, stomach, or other organs or tissues or patients. Some medical devices may employ one or more electrodes for delivering therapeutic electrical signals to such organs or tissues and / or one or more electrodes for sensing intrinsic electrical signals generated by such organs or tissues in the patient's body. Similarly, some medical devices may additionally or alternatively include one or more other sensors for sensing physiological parameters of the patient.

[0003] For example, some medical devices can be used as a pacemaker or cardioverter-defibrillator that provides therapeutic electrical signals to the heart. The therapeutic electrical signals may include pulses for pacing, or electric shocks for cardioversion or defibrillation. In some examples, the medical device can sense the intrinsic depolarization of the heart, and thereby control the delivery of therapeutic signals to the heart based on the sensed depolarization. When an abnormal rhythm such as bradycardia, tachycardia, or fibrillation is detected, one or more appropriate therapeutic electrical signals can be delivered to restore or maintain a predetermined (e.g., relatively more normal) rhythm. For example, in some cases, an implanted medical device can deliver a pacing stimulus to the patient's heart when bradycardia or tachycardia is detected, and / or deliver a cardioversion shock or a defibrillation shock to the heart when fibrillation is detected.

[0004] In some examples, a medical device can utilize one or more medical leads having one or more electrodes or other sensors for delivering therapeutic electrical signals or sensing. For example, an electrode or sensor can be carried at a distal portion of a lead, wherein a proximal portion of the lead can be coupled to a medical device housing containing a circuit system such as a signal generating circuit system and / or a sensing circuit system. Alternatively, an implanted medical device can function without a lead, such that the implantable medical device includes one or more electrodes on its external housing for delivering therapeutic electrical signals to a patient and / or sensing a patient's intrinsic electrical signals. For example, a leadless cardiac device such as a leadless pacemaker can sense intrinsic depolarization and / or other physiological parameters of the heart, and / or deliver therapeutic electrical signals to the heart. A leadless cardiac device can be positioned inside or outside the heart, and in some examples, can be anchored to the wall of the heart via a fixing mechanism. A leadless cardiac device can be delivered to the heart percutaneously and / or transvascularly using a device including a catheter. Summary of the invention

[0005] Various aspects of the present disclosure relate to the structure of a medical delivery device configured to deliver an insertable or implantable medical device to a target site in a human patient. For example, the delivery device may include a slender member (e.g., a catheter) suitable for navigation with a deployment cabin, and the insertable or implantable medical device may be an implantable leadless pacemaker. The deployment cabin may be configured to accommodate the medical device when the medical device is navigated to the target site. The deployment cabin may be located at the distal end of the delivery device and may include a distal opening, through which the medical device may be deployed. The delivery device may include a compression mechanism, which is configured to axially compress (e.g., compress along the longitudinal axis of the delivery device) a predetermined amount in response to a predetermined force, so that the slender member and the deployment cabin are relatively closer together along the longitudinal axis of the delivery device. In some examples, the compression mechanism is configured to compress in an unbalanced manner so that one longitudinal side of the compression mechanism is relatively more compressed than another longitudinal side (e.g., a longitudinal side on the opposite side of the compression mechanism relative to the longitudinal axis of the delivery device). For example, the compression mechanism may be compressed in an unbalanced manner in response to the deployment cabin contacting the target site at an angle greater than a threshold. Unbalanced compression can cause the deployment module to be angled relative to the compressor so that the distal surface of the deployment module is flush with the target site.

[0006] The present disclosure is intended to provide an overview of the subject matter described in the present disclosure. It is not intended to provide an exclusive or exhaustive explanation of the devices and methods described in detail in the following drawings and descriptions. The details of one or more aspects of the present disclosure are set forth in the following attached drawings and descriptions. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1Ais a conceptual schematic diagram illustrating an example therapy system including a leadless implantable medical device that may be used to monitor one or more physiological parameters of a patient and / or provide therapy to the patient's heart.

[0008] Figure 1B is a conceptual schematic diagram illustrating another example therapeutic system including an implantable medical device coupled to a plurality of leads that can be used to monitor one or more physiological parameters of a patient and / or provide therapy to the patient's heart.

[0009] Figure 2A is a conceptual schematic diagram illustrating an example delivery apparatus including an example compression mechanism and a deployment capsule housing an example implantable medical device.

[0010] Figure 2B is shown along with Figure 2A A deployment mechanism having a main cavity of the elongated member received by the deployment mechanism viewed in a cut-plane intersecting the elongated member Figure 2A A conceptual illustration of a cross-sectional view of a first example of an elongated member of a delivery device.

[0011] Figure 2C is shown along with Figure 2A A deployment mechanism having a deployment mechanism received by a dedicated deployment mechanism cavity of the elongated member as viewed in a cross-section of the elongated member intersecting the elongated member Figure 2A A conceptual illustration of a cross-sectional view of a second example of an elongated member of a delivery device.

[0012] Figure 2D is shown along with Figure 2A An observation of the cross section of the compression mechanism Figure 2A Conceptual schematic of a cross-sectional view of the compression mechanism of a delivery device.

[0013] Figure 3 is shown along with Figure 2A Another observation in the cross section Figure 2A Conceptual schematic of a cross-sectional view of the deployment module and compression mechanism of the delivery device.

[0014] Figures 4A-4C The diagrams respectively show that when the delivery device approaches, contacts and presses against the target site in the patient's body, Figure 2A An observation in the cross section of Figure 2A Conceptual schematic of a cross-sectional view of the delivery device.

[0015] Figure 5A and Figure 5B They are respectively showing that when the delivery device approaches and presses against the target site in the patient's body from a certain angle, Figure 2AAn observation in the cross section of Figure 2A Conceptual schematic of a cross-sectional view of the delivery device.

[0016] Fig. 6A is shown along Figure 2A A cross-section of a device having a distal stop attached to an elongated member Figure 2A Conceptual schematic of a cross-sectional view of the delivery device.

[0017] Figure 6B is shown along Figure 2A A cross-section of a view showing different proximal components Figure 2A Conceptual schematic of a cross-sectional view of the delivery device.

[0018] Fig. 7A and Figure 7B are conceptual schematic diagrams showing cross-sectional views of an uncompressed state and a compressed state, respectively, of an example delivery device including an example compression mechanism having relatively different physical properties with respect to adjacent portions of the delivery device.

[0019] Fig. 8A and Figure 8B 2 are conceptual schematic diagrams showing cross-sectional views of an uncompressed state and a compressed state, respectively, of an example delivery device including an example compression mechanism defining a first circumferential cut-out.

[0020] Fig.9A and Fig. 9B 2 are conceptual schematic diagrams showing cross-sectional views of an uncompressed state and a compressed state, respectively, of an example delivery device including an example compression mechanism defining a second circumferential cutout.

[0021] Fig. 10A and Fig. 10B 2 are conceptual schematic diagrams showing cross-sectional views of an uncompressed state and a compressed state, respectively, of an example delivery device including an example compression mechanism defining an accordion structure.

[0022] Fig.11A and Fig. 11B Conceptual schematic diagrams showing a side view and an exploded view, respectively, of an example delivery device including an example compression mechanism including a set of interlocking components.

[0023] Fig. 12A and FIG12B are respectively showing the Fig.11A and Fig. 11B The cross section taken from the longitudinal axis shows the uncompressed and compressed states. Fig.11A and Fig. 11B Conceptual schematic of a cross-sectional view of the compression mechanism of a delivery device.

[0024] Fig.13A and Fig. 13B 2 are conceptual schematic diagrams showing cross-sectional views of an uncompressed state and a compressed state, respectively, of an example delivery device including an example compression mechanism defining an inner slide.

[0025] Fig.14A and Fig. 14B 2 are conceptual schematic diagrams showing cross-sectional views of an example delivery device in an uncompressed state and a compressed state, respectively, including an example compression mechanism defining a spring structure.

[0026] Fig.15 A flow chart depicts a method of delivering a medical device to a target site within a patient using a delivery device.

[0027] Fig.16 A flow chart depicts a method of manufacturing a delivery device for delivering a medical device to a target site within a patient using the delivery device. DETAILED DESCRIPTION

[0028] Various aspects of the present disclosure relate to methods and systems for delivering an inserted or implanted medical device to a target site in a patient's body. Once the medical device is navigated to the target site, the medical device can be fixed to the target site with a fixing element on or near the distal end of the medical device. The delivery device may include a proximal hub, an elongated member (e.g., a catheter) extending from the hub suitable for navigation, a deployment cabin located at the distal end of the elongated member, and a compression mechanism.

[0029] The compression mechanism may extend around the entire periphery or circumference of the delivery device along the axial length of the delivery device. The compression mechanism may be configured to axially compress relative to other portions of the delivery device (e.g., compress along the longitudinal axis of the delivery device) such that the other portions of the delivery device define a substantially constant axial length in response to a predetermined force, while the overall axial length of the delivery device is compressed by an amount corresponding to the compression of the compression mechanism. In other words, the compression mechanism may define a first axial length as measured between a proximal portion and a distal portion of the compression mechanism along the longitudinal axis of the delivery device, and in response to the compression of the compression mechanism in response to the predetermined force, the first axial length of the compression mechanism is reduced to a second, shorter axial length.

[0030] In some examples, it may be advantageous to verify that a deployment capsule is pressed against a target site with a predetermined amount of force prior to deploying a medical delivery device. For example, deploying a medical device upon initial contact may result in the fixation mechanism of the medical device loosely or otherwise suboptimally securing itself to a tissue layer at the target site. Loosely securing a medical device to a target site may increase the likelihood that an electrode or sensor of the medical device achieves poor contact or position, and thereby provides treatment to and / or monitors a patient with difficulty, or becomes unfixed within the patient's body. Similarly, deploying a medical device after pressing the deployment capsule against a target site with a relatively high force may result in the medical device securing itself to sensitive muscle tissue of a patient that exceeds a target tissue layer at the target site (e.g., beyond a vantage point of the medical device). Various aspects of the present disclosure may improve the ability to provide feedback to a clinician in response to a delivery device pressing the deployment capsule against a target site with a predetermined (e.g., desired) amount of force (or a force within a desired and / or predetermined range of force) by compressing a predetermined amount in response to a predetermined force.

[0031] A delivery device that is navigated to a target site in a patient's body can be introduced (e.g., percutaneously) into the patient's body, into the patient's venous system using an introducer sheath that provides a breechable seal. In some examples, this seal can be constantly pressed radially inward toward the center of the seal to maintain the seal. Breaking through this seal to insert the delivery device through the introducer sheath may require a certain amount of force. The amount of force required to insert the delivery device may be less than the threshold force required to compress the delivery device via a compression mechanism, so that during the insertion of the delivery device, the compression mechanism can avoid causing the delivery device to be compressed or otherwise deformed. It may be advantageous for the delivery device to define a relatively static profile during insertion to provide predictable feedback to the clinician performing the insertion.

[0032] After insertion, the delivery device can be removed by the same introducer sheath, while the medical device is left inserted or implanted in the patient's body when it is fixed to the target site. In some examples, the compression mechanism can be positioned immediately proximal to the deployment cabin. Further, in some examples as discussed and described herein, the compression mechanism can provide a relatively smooth or gradual transition from a relatively small radius of the elongated member to a relatively large radius of the deployment cabin. Providing such a smooth transition can reduce the difficulty of re-breaking the seal of the introducer sheath when the deployment cabin is removed from the patient using the introducer sheath.

[0033] Figure 1A1 is a conceptual diagram illustrating an example therapy system 10A that can be used to monitor one or more physiological parameters of and / or provide therapy to heart 12 of patient 14 using one or more medical devices delivered using a delivery device of the present disclosure. The therapy system 10A includes an implantable medical device (IMD) 16A that is communicatively (e.g., wirelessly) coupled to an external device 18. IMD 16A can be an implantable leadless pacemaker that provides electrical signals to heart 12 via one or more electrodes (not shown in FIG. 1 ) on its external housing. Additionally or alternatively, IMD 16A can sense electrical signals associated with depolarization and repolarization of heart 12 via electrodes on its external housing. In some examples, IMD 16A provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. For example, IMD 16A can be a Micra pacing system (TPS) commercially available from Medtronic plc. TM equipment.

[0034] For example, IMD 16A may include internal circuitry 28. IMD 16A may define a hermetically sealed housing within which IMD 16A contains internal circuitry 28. IMD 16A may also include a power source and / or memory for internal circuitry 28. Internal circuitry 28 may be configured to provide the functionality attributed to an implantable medical device herein. Internal circuitry 28 may include one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combination of such components.

[0035] For example, the internal circuit system 28 may include a processing circuit system, a stimulation circuit system, a telemetry circuit system, a sensing circuit system, and the like. The stimulation circuit system may generate and deliver electrical stimulation under the control of the processing circuit system. For example, in operation, the processing circuit system may access a memory to load a treatment program to the stimulation circuit system, wherein the stimulation parameters of the treatment program may include a voltage amplitude, a current amplitude, a pulse rate, a pulse width, a duty cycle, or a combination of electrodes (e.g., wherein the electrodes are fixed to the IMD 16A). The telemetry circuit may be configured to perform wireless communication using a radio frequency protocol or an inductive communication protocol. For example, the telemetry current may include one or more antennas configured to communicate with an external device 18. The processing circuit may transmit operating information such as sensing information and receive a treatment program or treatment parameter adjustment via the telemetry circuit. Similarly, in some examples, the IMD 16A may communicate with other implanted devices such as a stimulator, a control device, or a sensor via a telemetry circuit. The sensing circuit system may be configured to sense one or more parameters of the patient 14. For example, the sensing circuit system may sense parameters of the heart 12 using electrodes of the IMD 16A. Based on the sensed value by the sensing circuitry, the processing circuitry may use the telemetry circuitry to provide information or use the stimulation circuitry to provide therapy associated with the sensed value.

[0036] The IMD 16A may include a fixation element, such as a set of fixation tines, to secure the IMD 16A to patient tissue. The fixation element of the IMD 16A may be positioned near a distal end of the IMD 16A such that the fixation element is configured to extend substantially immediately out of a distal opening of a deployment bay of the delivery device after the IMD 16A is deployed using a delivery device. In the example of FIG. 1 , the IMD 16A is positioned as a whole within the heart 12, proximate to an inner wall of the right atrium 20, to provide right atrial 20 pacing. Although the IMD 16A is shown as being within the heart 12 and proximate to an inner wall of the right atrium 20 in the example of FIG. 1 , the IMD 16A may be positioned at any other location outside or within the heart 12. For example, the IMD 16A may be positioned outside or inside the right ventricle 22, the left atrium 24, and / or the left ventricle, respectively, for example to provide right ventricular, left atrial, and left ventricular pacing. Further, although Figure 1A A single IMD 16A is shown in FIG. 1 , but system 10A may include additional IMDs that are similar to or different from IMD 16A.

[0037] Depending on the location of implantation, IMD 16A may include other stimulation functions. For example, IMD 16A may provide atrioventricular node stimulation, fat pad stimulation, vagus nerve stimulation, or other types of cardiac stimulation or neural stimulation. In other examples, IMD 16A may be a monitor that senses one or more parameters of heart 12 (e.g., electrical activity, mechanical activity, and / or pressure) and may not provide any stimulation functions. In some examples, system 10A may include multiple leadless IMDs 16A to provide stimulation and / or sensing at various locations. IMD 16A may include a distal fixation element such as a set of fixed tines.

[0038] As described above, IMD 16A may be delivered and deployed to its target site using the delivery device described herein. IMD 16A may be substantially completely contained within a deployment compartment of the delivery device such that a fixation element of IMD 16A is adjacent to a distal opening of the deployment compartment. Figure 1A After IMD 16A is securely attached to the target site (eg, fixation tines depicted), the delivery device can be retracted from patient 14 (eg, including retracting the delivery device over the proximal end of IMD 16A, depending on whether IMD 16A was secured prior to full deployment).

[0039] Figure 1A Further depicted is external device 18, such as a (clinician or patient) programmer that wirelessly communicates with IMD 16A. In some examples, external device 18 comprises a handheld computing device, a computer workstation, or a networked computing device. External device 18 may include a user interface that presents information to a user and receives input from the user. It should be noted that a user may also interact with external device 18 remotely via a networked computing device.

[0040] A user (such as a physician, technician, surgeon, electrophysiologist, other clinician, or patient) interacts with external device 18 to communicate with IMD 16A. For example, a user may interact with external device 18 to retrieve physiological or diagnostic information from IMD 16A. For example, a user may use external device 18 to retrieve information from IMD 16A related to the rhythm of heart 12, heart rhythm trends over time, or arrhythmia episodes. A user may also interact with external device 18 to program IMD 16A.

[0041] In some examples, the user may use external device 18 to retrieve information from IMD 16A related to other sensed physiological parameters of patient 14, or identify information derived from sensed physiological parameters such as intracardiac or intravascular pressure, activity, posture, tissue oxygen level, blood oxygen level, respiration, tissue perfusion, heart sounds, electrocardiac graph (EGM), intracardiac impedance, thoracic impedance, etc. In some examples, the user may use external device 18 to retrieve information from IMD 16A related to the performance or integrity of IMD 16A, or the performance or integrity of corresponding components of system 10A, such as a power supply of IMD 16A. As another example, the user may interact with external device 18 to select values ​​for parameters of a therapy provided by IMD 16A, such as pacing and / or neural stimulation therapy.

[0042] IMD 16A and external device 18 may communicate via wireless communication using any technology known in the art. Examples of communication technology may include, for example, low frequency or radio frequency (RF) telemetry. In some examples, external device 18 may include a programming head that may be placed proximate to the patient's body near the IMD 16A implant site to improve the quality or safety of communication between IMD 16A and external device 18.

[0043] Figure 1B 1 is a conceptual diagram showing another example treatment system 10B that can be used to monitor one or more physiological parameters of a patient 14 and / or provide treatment to a heart 12 of a patient 14 using a medical device inserted or implanted using a delivery device described herein. Treatment system 10B includes an IMD 16B and an external device 18, and IMD 16B is coupled to medical leads 30A, 30B, 30C (collectively referred to as "leads 30"). As mentioned herein, each of IMD 16B and medical leads 30 may be generally referred to as an IMD. In one example, IMD 16B may be an implantable pacemaker that provides electrical signals to heart 12 via electrodes coupled to one or more of leads 30. IMD 16B may include an electrical stimulation generator and may be attached to the proximal end of medical leads 30. In other examples, IMD 16B may deliver neural stimulation signals in addition to or in lieu of pacing therapy. In some examples, IMD 16B may also include cardioversion and / or defibrillation functionality. In other examples, IMD 16B may exclusively or primarily provide monitoring functionality. Patient 14 is typically, but not necessarily, a human patient.

[0044] Leads 30 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and / or deliver electrical stimulation to heart 12. In some examples, a delivery device as described herein may be used to deliver electrical stimulation to heart 12. Figure 1B Each medical lead 30 is delivered to its corresponding target site. Figure 1B , right ventricular (RV) lead 30B extends through one or more veins (not shown), superior vena cava (not shown), and right atrium 20, and into right ventricle 22. RV lead 30B may be used to deliver RV pacing to heart 12. Left ventricular (LV) lead 30A extends through one or more veins, vena cava, right atrium 20, and into coronary sinus 32, to an area adjacent to the free wall of left ventricle 26 of heart 12. Alternatively, LV lead 30A may be implanted "directly" into left ventricle 26, such that LV lead 30A extends through a hole in the ventricular septum or atrial septum, for example. LV lead 30A may be used to deliver LV pacing to heart 12. Right atrium (RA) lead 30C extends through one or more veins and vena cava, and into right atrium 20 of heart 12. RA lead 30C may be used to deliver RA pacing to heart 12.

[0045] In some examples, system 10B may additionally or alternatively include one or more leads or one or more lead segments ( Figure 1B 10B) that deploys one or more electrodes within the vena cava or other veins, or within or near the aorta. Furthermore, in another example, system 10B may additionally or alternatively include one or more additional intravenous or extravascular leads or lead segments that deploy one or more electrodes epicardially, such as near an epicardial fat pad, or near the vagus nerve. In other examples, system 10B may not include one of ventricular leads 30A and 30B.

[0046] One or more of the medical leads 30 may include a fixing element such as a set of fixing tines to fix the distal end of the medical lead to the patient's tissue. For clarity, only a fixing element such as a tines is shown for each medical lead 30. As depicted, the fixing element may include a distal tines that are configured to extend distally from the lead 30 and self-biased when deployed (e.g., deployed to a biased configuration from a deployment module of a delivery device as described herein). In other examples, the fixing element may include other types of tines, such as tines that are not self-biased (but are biased or deformed or actuated by other components), tines of other shapes (e.g., spiral tines), tines that are configured to be manually controlled by a clinician, and the like. Fixing elements such as tines may be made of substantially any biocompatible material. In some examples, one of the medical leads 30 may be fixed by an alternative technique for fixing the corresponding other medical leads 30. For example, although each of the medical leads 30 is shown as being secured using a set of fixation tines (the medical leads extending through one or more veins and the vena cava and into the right atrium 20 of the heart 12), the medical leads may alternatively be secured to the heart 12 using an alternative technique such as "passive fixation" (e.g., such that the LV lead 30A is secured to the target site without the need for a device for holding the end of the LV lead 30A against the target site, but rather is held against the target site by pressure generated by the shape and longitudinal tension of the LV lead 30A).

[0047] As described above, one or more medical leads 30 can be delivered and deployed to the corresponding target site using the delivery device described herein. The medical lead 30 can be deployed to the corresponding target site in or near the heart 12 using one or more delivery devices herein in a subsequent procedure. In this example, the fixed element of the corresponding medical lead 30 can be navigated to the target site in the deployment cabin of the delivery device, so that the other parts of the corresponding medical lead 30 can be accommodated by the cavity of some of the deployment cabin, compression mechanism and / or slender member. When the distal end of the medical lead 30 is deployed to fix the corresponding medical lead 30 to the target site, the delivery device can be withdrawn from the corresponding medical lead 30 to retract the delivery device from the patient 14. In this way, when one of the medical leads 30 is successfully deployed, the clinician can retract the delivery device so that the delivery device moves proximally relative to the corresponding deployed medical lead 30 (for example, when the delivery device is retracted, the corresponding deployed and distally fixed medical lead 30 slides in one or more cavities of the delivery device defined by the deployment cabin, compression mechanism and / or slender member of the delivery device).

[0048] IMD 16B may sense electrical signals accompanying depolarization and repolarization of heart 12 via electrodes coupled to at least one of leads 30. In some examples, IMD 16B provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configuration of electrodes used by IMD 16B for sensing and pacing may be unipolar or bipolar.

[0049] IMD 16B may also provide neurostimulation therapy, defibrillation therapy, and / or cardioversion therapy via electrodes located on at least one of leads 30. For example, when ventricular fibrillation of ventricles 22 and 26 is detected, IMD 16B may deliver defibrillation therapy in the form of electrical pulses to heart 12. In some examples, IMD 16B may be programmed to deliver progressive therapy, such as pulses with increasing energy levels, until the fibrillation of heart 12 ceases. As another example, IMD 16B may deliver cardioversion or anti-tachycardia pacing (ATP) in response to detecting a ventricular tachycardia, such as a tachycardia of ventricles 22 and 26.

[0050] As described above with respect to IMD 16A of FIG1 , external device 18, such as a clinician or patient programmer, may be used to communicate with IMD 16B. In addition to the functionality described with respect to IMD 16A of FIG1 , a user may use external device 18 to retrieve information from IMD 16B regarding the performance and integrity of leads 30, and may interact with external device 18 to select parameters for any additional therapies provided by IMD 16B, such as cardioversion and / or defibrillation.

[0051] Leads 30 may be electrically coupled to signal generation circuitry and sensing circuitry (not shown) of IMD 16B via connector block 34. In some examples, the proximal end of lead 30 may include electrical contacts that are electrically coupled to corresponding electrical contacts within connector block 34 of IMD 16B. Figure 1B Not shown, but similar to IMD 16A, IMD 16B may include circuitry 28. Circuitry 28 may include the processing circuitry, signal generation circuitry, and sensing circuitry described above, as well as any other circuitry, power supplies, antennas, or other hardware or software necessary or useful for configuring IMD 16B to provide therapy and / or monitor the condition of patient 14.

[0052] Figure 1B The configuration of the system 10B shown in FIG. 1 is only an example. In other examples, instead of Figure 1B The transvenous lead 30 shown in FIG. Figure 1BIn addition to the transvenous lead 30 shown in FIG. 1 , the system may include extravascular leads, subcutaneous leads, substernal leads, epicardial leads, and / or patch electrodes. Further, IMD 16B need not be implanted in patient 14. For each of these examples, any number of medical leads may include a set of fixed tines on the distal end of the medical lead that are navigated to their respective target sites using a delivery device according to the techniques described herein.

[0053] Furthermore, in other examples, the system may include any suitable number of leads coupled to IMD 16B, and each of the leads may extend to any location within or near heart 12. For example, other examples of systems may include, for example, Figure 1B 20, and an additional lead positioned in or near left atrium 24. Other examples of systems may include a single lead extending from IMD 16B into right atrium 20 or right ventricle 22, or two leads extending into a respective one of right ventricle 22 and right atrium 20. In each of these examples, any number of medical leads may include a fixation mechanism on the distal end of the medical leads, and any number of medical leads may be delivered using a medical delivery device in accordance with the techniques described herein.

[0054] Figure 2A Depicted is a device for delivering an inserted or implanted medical device (e.g., an IMD 16B, or Figure 2A An example medical delivery device 50 is shown in FIG. 1 , an IMD 16A). Figure 2A Depicted Figure 2B and Figure 2C The cross-sectional view of the cross-sectional section 47 (wherein Figure 2B and Figure 2C Two examples of cross-sectional configurations of delivery device 50 are depicted), Figure 2D A cross-sectional view of section 49, and Figure 3 51 of a cross-sectional view of a delivery device 50. The delivery device 50 may include a deployment module 52 configured to accommodate at least a portion of a medical device and deploy the medical device. In some examples, the deployment module 52 may be configured to accommodate substantially all of an inserted or implanted medical device prior to deploying the medical device.

[0055] The delivery device 50 may further include a compression mechanism 54 that deforms axially (e.g., deforms along the longitudinal axis of the delivery device) in response to an axial force above a threshold force. The delivery device 50 may further include a hub 56 for handling the delivery device 50. In some examples, the hub 56 may be configured to remain outside the patient 14 body while the deployment capsule 52 is navigated to the target site, thereby allowing a clinician to use one or more mechanisms or ports (not shown) of the hub 56 to navigate the intravenous system and deploy the medical device. The deployment capsule 52 may be positioned at or near the distal end 58 of the delivery device 50, and the hub 56 may be positioned at or near the proximal end 60 of the delivery device 50, wherein the elongated member 62 extends between the hub 56 and the deployment capsule 52, each of which will be discussed in detail below.

[0056] The elongated member 62 may be a flexible, elongated cylindrical member, although the member 62 may define one or more other cross-sectional shapes, including multiple cross-sectional shapes along the longitudinal length of the elongated member 62. The elongated member 62 may define multiple internal longitudinal cavities for various purposes. For example, Figure 2B As depicted in the conceptual schematic cross-sectional view of FIG. 8 , the elongated member 62 may define a main cavity 80 that occupies a majority of the cross-sectional width of the elongated member 62 .

[0057] The main cavity 80 can be configured to accommodate a deployment mechanism 86A that can slide axially within the main cavity 80 relative to the delivery device 50 (e.g., slide along the longitudinal axis of the delivery device) (e.g., so that as a result of the actions performed using the deployment mechanism 86A, an inserted or implanted medical device navigated to a target site by the delivery device 50 can be deployed from the deployment compartment 52). For example, the deployment mechanism 86A can be some form of a tether or catch for holding, pushing, or otherwise moving an inserted or implanted medical device so that the medical device can be deployed from the deployment compartment 52. Additionally or alternatively, the main cavity 80 can be configured to accommodate a portion of an inserted or implanted medical device to be deployed by the delivery device 50 as described herein. The elongated member 62 may further define a guidewire cavity 82 configured to accommodate a guidewire that can slide axially within the guidewire cavity relative to the delivery device (e.g., compressed along the longitudinal axis of the delivery device) (e.g., such that the deployment module 52 is navigated to the target site by sliding the delivery device along a guidewire that was previously navigated to the target site). Alternatively or additionally, one or more deflection members 84 may be embedded in the elongated member 62, the one or more deflection members 84 being used to deflect the elongated member 62 in one or more directions. For example, the deflection member 84 may include a wire pulled from a port (not shown) on the hub 56 for deflecting the elongated member 62. The deflection member 84 may be configured to deflect the elongated member 62 configured to navigate the delivery device 50 to the target site in a predetermined manner. In other words, the deflection member 84 longitudinally embedded within the slender member 62 can be configured to deflect the slender member 62 in a predetermined manner when the delivery device 50 is inserted into the body of the patient 14 (e.g., to navigate through a particularly tortuous and predetermined length of the intravenous system).

[0058] In some examples, the elongated member 62 may include different combinations of lumens and / or longitudinal elements, whether used for the same or different purposes. Figure 2C 2 depicts a conceptual schematic diagram of a second example cross-sectional configuration of the elongated member 62. The cross-sectional configuration of the elongated member 62 as depicted in FIG. 2 is substantially similar to the cross-sectional configuration of the elongated member 62, except that Figure 2C The elongated member 62 defines a dedicated deployment lumen 88 configured to accommodate a deployment mechanism 86B. The deployment mechanism 86B can be substantially similar to the deployment mechanism 86A, wherein the deployment mechanism 86B can be configured to slide axially within the deployment lumen 88 relative to the delivery device and deploy the medical device once the deployment capsule 52 is adjacent to the target site.

[0059] Back to Figure 2A, the delivery device 50 can be configured to be inserted into the patient 14 to deliver an insertable or implantable medical device. The delivery device 50 can be configured to be inserted into the patient 14 using an introducer sheath (not depicted). In some examples, the delivery device 50 may include a fully biocompatible material. For example, the delivery device 50 may include a polymer material such as polyether block amide (PEBA), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polybutylene terephthalate (PBT), polyethylene terephthalate (PET), nylon, etc., and / or a metal material such as titanium, nitinol, stainless steel, etc. The delivery device 50 can be configured such that a clinician inserting the deployment capsule 52 into the body of the patient 14 and navigating the deployment capsule 52 to a target site within the body of the patient 14 can do so without causing a force above a threshold force for deforming the compression mechanism 54 to be applied to the compression mechanism 54 (e.g., such that the compression mechanism 54 substantially resists deformation as discussed herein in response to insertion or navigation to the target site).

[0060] In some examples, such as Figure 2A As depicted, the deployment module 52 can accommodate an insertable or implantable medical device to be deployed such that the deployment module 52 is configured to fit most or substantially all of the corresponding insertable or implantable medical device within the recess 64 defined by the deployment module 52. For example, Figure 2A As depicted, deployment module 52 may house IMD 16A within recess 64 as defined by outer wall 66 of deployment module 52 and proximal wall 68 defined by deployment module 52. Outer wall 66 may be configured to radially enclose an axial length of a medical device such as IMD 16A. Further, outer wall 68 may be configured to block proximal movement of a medical device such as IMD 16A relative to deployment module 52. Although not shown for purposes of illustration, the recess 64 may be configured to radially enclose an axial length of a medical device such as IMD 16A. Figure 2A Deployment pod 52 is depicted in FIG. 5 as being transparent (for purposes of depicting IMD 16A), but it should be understood that deployment pod 52 may define a substantially continuous housing for a corresponding medical device to be delivered by delivery device 50 .

[0061] The deployment capsule 52 may further define a distal opening 70 to the recess 64 through which the IMD 16A may be deployed from the recess 64. In some examples, the distal-most surface of the deployment capsule 52 may define the distal opening 70. The deployment capsule 52 may define the recess 64 as a physical space sized to partially or completely contain a medical device such as the IMD 16A when the delivery device 50 is navigated into the patient 14 to deliver the corresponding medical device. The deployment capsule 52 may define the recess 64 such that when the IMD 16A is received within the recess 64, the fixation element 17 is proximal to the distal opening 70. In some examples, one or more fixation elements 17 may engage with the inner circumference of the deployment capsule 52 prior to deployment from the deployment capsule 52. As discussed herein, the compression mechanism 54 may be configured to improve the ability of the fixation element 17 to be fixed to tissue at a target site. For example, the compression mechanism 54 may improve the fixation element 17 in a manner such as to facilitate delivery of the fixation element to the patient 14. Figure 2A 16A is depicted as being able to be deployed and / or provide force in distal direction 92 and / or radial direction 94. Improving the ability of fixation element 17 to be deployed and / or provide force in distal direction 92 may improve the ability of IMD 16A to be secured to right ventricle 22. Alternatively, improving the ability of fixation element 17 to be deployed and / or provide force in radial direction 94 may improve the ability of IMD 16A to be secured to right atrium 20.

[0062] In some examples (not depicted), deployment pod 52 may alternatively or additionally be configured to deploy an inserted or implanted medical device that extends through the length of delivery device 50. For example, delivery device 50 may be configured to deliver one or more leads 30 of IMD 16B.

[0063] like Figure 2D As depicted in the conceptual schematic cross-sectional view of FIG. 5 , the compression mechanism 54 can define an elongated member cavity 81 that occupies a majority of the cross-sectional width of the compression mechanism 54, and the elongated member 62 can extend axially through the elongated member cavity 81. Figure 2D As depicted, the elongated member 62 defines a Figure 2B as depicted (e.g., rather than as Figure 2C The cross-sectional configuration of FIG. 1 is similar to that of FIG. 1 , but in other examples, except that Figure 2D In addition to those cavities and features depicted, the elongated member 62 may define other cavities or include other features. In some examples, the deployment compartment 52 may define an aperture in the inner sidewall 68 (or may not define a proximal wall at all). A deployment mechanism such as the deployment mechanism 86A may extend through such an aperture to initially retain the medical device and subsequently deploy the medical device to be contained within the deployment compartment 52. Alternatively, an insertable or implantable medical device may include, for example, Figure 1BA lead such as lead 30 may extend from elongated member 62 through a hole in proximal wall 68 to deployment compartment 52 such that a distal fixation element of lead 30 may be proximal to a distal opening 70 of deployment compartment 52.

[0064] like Figure 2D As depicted, the elongated member 62 may no longer include an embedded deflection member 84 at a longitudinal position where the elongated member 62 is within the elongated member lumen 81 of the compression mechanism 54. In other words, the compression mechanism 54 may be positioned longitudinally along the delivery device 50 at a position distal to the distal end of the deflection member 84. As discussed herein, the deflection member 84 may be deflected to deform the elongated member 62 in a predetermined manner. In some examples, the elongated member 62 may be configured to be relatively consistent longitudinally along the length of the elongated member 62, such that the elongated member 62 defines a relatively static cross-sectional shape made of a relatively static set of materials. Configuring the elongated member 62 to be relatively consistent longitudinally in this manner may improve the ability of the deflection member 84 to deform the elongated member 62 in this predetermined manner because the longitudinally consistent components may introduce fewer factors to consider. Similarly, positioning the compression mechanism 54 on the delivery device 50 at a location distal to the deflection member 84 can simplify the deflection process of the deflection member 84 and thereby improve the ability of the deflection member 84 to deflect the slender member 62 in a predetermined manner (e.g., because positioning the compression mechanism 54 distal to the deflection member 84 can reduce the number of variables that need to be properly accounted for during the deflection process, as the compression mechanism 54 may have a relatively different response to the deflection / deformation of the deflection member 584 compared to the consistent longitudinal profile of the slender member 62). Improving the ability of the deflection member 84 to deflect in a predetermined (e.g., desired) manner can improve the ability of the delivery device 50 to deliver a medical device to a target site of a patient.

[0065] As described above, the compression mechanism 54 can be configured to respond to an axial force applied to the delivery device 50, for example, greater than a threshold force (e.g., Figures 4A-4C In some examples, the compression mechanism 54 can be configured to deform longitudinally in response to a compressive force, such as a force applied to the compression mechanism 54 from both a proximal direction and a distal direction along or parallel to the longitudinal axis of the delivery device 50. The compression mechanism 54 can be relatively more deformable than other portions of the delivery device 50 in response to an axial force above a threshold force, such that the compression mechanism 54 is substantially the only element of the delivery device 50 that deforms a significant amount in response to the axial force.

[0066] The threshold force may be sufficient to compress the compression mechanism 54 longitudinally, so that the compression mechanism 54 may define the threshold force. The compression mechanism 54 may be configured to define the threshold force as the force applied to the compression mechanism when the clinician presses the deployment capsule 52 (e.g., using the port of the hub 56) against the tissue at the target site. For example, the compression mechanism 54 may define the threshold force as the axial compression force sufficient to compress the compression mechanism 54 when the deployment capsule 52 contacts and presses against the right atrium 20 of the heart 12 of the patient 14 with a force that is not sufficient to perforate the tissue of the right atrium 20. In some examples, the threshold force may be between 1 and 2 Newtons, but in other examples, the threshold force may be smaller or larger and / or may include a wider range. In some examples, the threshold force may be higher than the force expected to be applied to the compression mechanism 54 during the insertion of the delivery device 50 into the patient 14. Similarly, the threshold force may be higher than the force expected to be applied to the compression mechanism 54 when the delivery device 50 is manipulated before insertion or when the deployment capsule 52 is navigated to the target site of the patient 14. In this way, during the normal (e.g., expected or planned) course of action during a medical device deployment procedure using delivery device 50, compression mechanism 54 can be configured to deform substantially solely in response to deployment capsule 52 being pressed against tissue at a target site in order to deploy the medical device.

[0067] The compression mechanism 54 can be configured to deform in a predetermined manner. In some examples, the compression mechanism 54 can be configured to deform a predetermined amount in response to a force greater than or equal to a threshold force. For example, the compression mechanism 54 can be configured to deform by compressing in the longitudinal direction so that the axial length 72 of the compression mechanism 54 as measured along the longitudinal axis of the delivery device 50 is relatively shorter due to the deformation. Therefore, the compression mechanism 54 can be configured so that in response to an applied force of at least the threshold force, the axial length 72 of the compression mechanism 54 is compressed by a predetermined amount to a predetermined shorter length. The compression mechanism 54 can be configured to be relatively flexible so that the compression mechanism 54 can be repeatedly deformed and bent back into an uncompressed state in response to the application of a force of at least the threshold force or the release of a force of at least the threshold force.

[0068] The compression mechanism 54 may have a relatively strong shape memory regarding the shape of the compression mechanism 54 in the uncompressed state, such that the compression mechanism 54 may return to the uncompressed state in response to a lack of force of at least a threshold force applied to the delivery device 50. In other words, the compression mechanism 54 may be configured to bend from the uncompressed shape to a predetermined shape once the force applied to the compression mechanism 54 exceeds the threshold force, and then deform from the predetermined shape back to the uncompressed shape once the force is no longer applied to the compression mechanism 54 or is otherwise reduced to an amount below the threshold force.

[0069] The compression mechanism 54 may include a proximal component 74 and a distal component 76, wherein the proximal component 74 is fixed to the delivery device 50 at a relatively proximal position compared to the distal component 76. In some examples, such as Figure 2A As depicted, both the proximal component 74 and the distal component 76 can be fixed to (e.g., chemically bonded to) the elongated member 62. In some examples, when the compression mechanism 54 is in an uncompressed state, the proximal component 74 and the distal component 76 can define an axial gap 78 therebetween. When the compression mechanism 54 is in an uncompressed state, the gap 78 can be an axial physical space into which neither the proximal component 74 nor the distal component 76 extends longitudinally. The axial length of the gap 78 when in this uncompressed state can be substantially equal to the amount of axial compression that the compression mechanism 54 may experience due to a force exceeding a threshold force. In some examples, the only component of the delivery device 50 that extends longitudinally between the proximal component 74 and the distal component 76 is the elongated member 62.

[0070] The compression mechanism 54 can be deformed by deforming "closing" or otherwise contracting the gap 78, such that at least a portion of the proximal component 74 can be configured to move longitudinally closer to at least a portion of the distal component 76. In this way, one or both of the proximal component 74 and the distal component 76 can be configured to move longitudinally in response to a force to define the gap 78 to be relatively smaller, or such that the gap 78 no longer exists. For example, when the compression mechanism 54 is deformed, at least a portion of the proximal component 74 can contact at least a portion of the distal component 76.

[0071] In some examples, one of the proximal component 74 or the distal component 76 can deform relatively more in response to a force above a threshold force. The distal component 76 and the proximal component 74 can be made of different materials or define different structures, etc., so that one of the two is relatively more stable in the axial direction than the corresponding other. In some examples, the proximal component 74 can be made of a relatively more rigid material than the distal component 76, so that the distal component 76 deforms relatively more in response to a force above a threshold force than the proximal component 74.

[0072] In some examples, the compression mechanism 54 may include radiopaque elements 90A, 90B (collectively, "radiopaque elements 90") that may indicate deformation of the compression mechanism 54. For example, the compression mechanism 54 may include radiopaque elements 90 that allow a clinician monitoring intravenous navigation of the delivery device 50 to determine whether the compression mechanism 54 has been deformed and the degree to which the compression mechanism 54 has been deformed. For example, Figure 2AAs depicted, the compression mechanism 54 may include a first radiopaque element 90A on or in the proximal component 74 and a second radiopaque element 90B on or in the distal component 76, so that a clinician can track the movement of the proximal component 74 relative to the distal component 76 (e.g., moving relatively closer to the distal component 76) by tracking the radiopaque element 90 moving closer together using various fluoroscopic techniques. In other examples, the radiopaque element 90 may alternatively or additionally be positioned at a location on the delivery device proximal or distal to the compression mechanism 54 (e.g., rather than being directly fixed to the compression mechanism 54). For example, the radiopaque element 90A may be fixed to the elongated member 62 at a location proximal to the compression mechanism 54, and / or the radiopaque element 90B may be fixed to the deployment module 52 at a location proximal to the distal side of the compression mechanism 54. The radiopaque element 90 can be a band of radiopaque material embedded within the delivery device 50, a band extending along the periphery of a portion of the delivery device 50, a doped portion of the delivery device 50 (e.g., relative to an adjacent portion), etc. In other examples, the delivery device 50 can alternatively or additionally include an echogenic material in place of or in addition to the radiopaque element 90. For example, the delivery device 50 can include two echogenic elements (e.g., carbide) located proximate to the location where the radiopaque element 90 is located. The echogenic elements can be used to monitor the compression of the compression mechanism 54 in response to a force of at least a threshold force using echocardiography.

[0073] In some examples, such as Figure 2A As depicted, the compression mechanism 54 can be located at a position immediately proximal to the deployment capsule 52. In other examples (not depicted), the compression mechanism 54 can be located along the length of the deployment capsule 52 or along the length of the elongated member 62. Positioning the compression mechanism 54 immediately proximal to the deployment capsule 52 can enable the delivery device 50 to deform asymmetrically about the longitudinal axis (e.g., more on one side of the longitudinal axis than on the other side) to enable the deployment capsule 52 to contact the target site flushly (e.g., as shown in FIG. 1 ). Figure 5A and Figure 5B ). Further, positioning compression mechanism 54 immediately proximal to deployment capsule 52 may enable delivery device 50 to be removed from patient 14 via introducer sheath using relatively little force as a result of proximal component 74 tilting from a radius relatively close to the radius of elongated member 62 to a radius relatively close to the radius of deployment capsule 52.

[0074] Figure 3 Depicted along Figure 2A A conceptual schematic diagram of a cross-sectional view of a deployment module 52 and a compression mechanism 54 taken through cross-sectional section 51 . Figure 3The delivery device 50 is depicted before a force greater than a threshold force has been applied to the compression mechanism 54, such that Figure 3 The compression mechanism 54 is in an uncompressed state. In this uncompressed state, the gap 78 is at a relatively fully maximized length as defined between the proximal component 74 and the distal component 76. Figure 3 As depicted, elongated member 62 includes lumen 100. Lumen 100 may serve any of the purposes described herein, such as a medical device lumen for transporting or housing an inserted or implanted medical device during intravenous navigation (e.g., Figure 2B and Figure 2C The main lumen 80 of the delivery device 50, a guidewire lumen for a guidewire, a deployment lumen for accommodating a deployment mechanism, etc. In some examples, the deployment module 52, the compression mechanism 54, and the elongated member 62 can each be substantially symmetrical about the longitudinal axis 101 of the delivery device 50 as reflected, such that the depicted Figure 3 The cross-sectional view is substantially similar to all views of the deployment module 52, compression mechanism 54, and slender member 62 as taken along a plane parallel to and intersecting the longitudinal axis 101.

[0075] like Figure 3 As depicted, the proximal component 74 can be a relatively solid component such that the proximal component 74 can define a few cavities or recesses or substantially no cavities or recesses between the outer surface 102 of the proximal component 74 and the elongated member 62. The outer surface 102 of the proximal component 74 can be substantially continuous. Further, for example, when compared to the distal component 76, the proximal component 74 can be made of a relatively rigid material (such as a rigid form of PEBA, such as 70D or As a result of the proximal component 74 being relatively solid and / or the proximal component 74 comprising a relatively rigid material, the proximal component 74 may be relatively less likely to deform in response to a force above a threshold force being applied to the compression mechanism 54 when compared to the distal component 76.

[0076] like Figure 3As depicted, the radius of the proximal component 74 can increase as the proximal component 74 extends distally. For example, the proximal-most length 104 of the proximal component 74 can define a first outer diameter 106 that is only slightly larger than the diameter 108 of the elongated member 62 (e.g., 10-20% larger than the diameter 108 of the elongated member 62), while the distal-most length 110 of the elongated member 62 can be inclined or angled outward from the first outer diameter 106 to a second outer diameter 112 that is significantly larger than the outer diameter 108 of the elongated member 62 (e.g., 50-150% larger than the diameter 108 of the elongated member 62). In some examples, the second diameter 112 can be relatively similar to a diameter 114 of the distal component 76 and / or the deployment module 52. Configuring the proximal portion 74 of the compression mechanism 54 to extend radially outward from a diameter 106 similar to the diameter 108 of the elongated member 62 to a diameter 112 similar to the diameter 114 of the deployment capsule 52 can reduce the necessary force for retracting the deployment capsule 52 from the introducer sheath after successful deployment of the medical device as described herein. Further, configuring the proximal portion 74 of the compression mechanism 54 to define an increasing radius as the proximal portion extends distally can reduce the likelihood of kinking of the elongated member 62 during use or navigation of the delivery device 50.

[0077] In some examples, the proximal component 74 can define a substantially constant angle or slope of the outer surface 102 between the first outer diameter 106 and the second outer diameter 112. In other examples, the proximal component 74 can "step" between a plurality of increasing diameters along the second length 110 to transition between the first diameter 106 and the second diameter 112 (e.g., rather than being angled or sloped between the two diameters).

[0078] On the contrary, Figure 3As depicted, the distal member 76 can define a flexible sheet that bends within the compression mechanism 54. The flexible sheet of the distal member 76 can include a first end 116 and a second end 120. A proximal portion 126 of the sheet adjacent to the first end 116 can be attached (e.g., mechanically or chemically secured) to the distal portion 118 of the elongated member 62 such that the first end 116 is radially aligned with the distal end 130 of the elongated member 62. Further, a distal portion 128 of the sheet adjacent to the second end 120 can be attached to the proximal portion 122 of the deployment module 52 such that the distal portion 128 extends distal to the proximal end 132 of the deployment module 52 (e.g., and the second end 120 of the sheet is slightly distal to the proximal end 132). In other words, a first end of the flexible sheet of the distal component 76 may be secured to the elongated member 62 and a second end may be secured to the deployment capsule 52 such that a length of the flexible sheet adjacent to the respective ends of the flexible sheet is secured to the elongated member 62 in a proximal direction of both ends. Both the proximal portion 126 and the distal portion 128 of the sheet of the distal component may be secured to the elongated member 62 and the deployment capsule 52, respectively, mostly or substantially completely around the circumference of the distal component 76.

[0079] Similar to the proximal component 74, the distal component 76 can define a substantially continuous outer surface 124 (e.g., a surface defining the largest radius of the distal component 76 along any plane perpendicular to the longitudinal axis 101), such that the outer surface 124 substantially avoids defining ridges or holes. For example, when compared to the proximal component 74, the distal component 76 can be made of a relatively soft and / or flexible material, such as a material between 25D and 40D. Overmolded or melted thermoplastic elastomer (TPE), or other elastomer applied using an adhesive or mechanical attachment element. As a result of distal component 76 defining a sheet attached to elongated member 62 at first end 116 and to deployment module 52 at second segment 120 and / or distal component 76 being made of a relatively softer and / or more flexible material, distal component 76 can be configured to deform (e.g., axially compress) when exposed to a force above a threshold force.

[0080] Figures 4A-4C FIG. 1 is a diagram showing the delivery device 50 navigating to and engaging with the target site 140 in the patient 14. Figure 2A51 is a conceptual diagram of a cross-sectional view taken through section 51 of the target site 140. As described herein, the target site 140 can be in the right atrium 20 of the heart 12 of the patient 14, but in other examples the delivery device 50 can be used to deliver an insertable or implantable medical device to other areas of the patient 14. The target site 140 may include a tissue layer 142 that the insertable or implantable medical device is configured to pierce during deployment in order to secure the medical device to the target site 140. In other words, in some examples, the insertable or implantable medical device is configured to mechanically attach itself to the tissue layer 142 of the target site. The medical device may be configured to: Figure 2B-2D The deployment mechanism 88 may be configured to secure itself to the tissue layer 142 using distal tines or some other securing element or elements configured to extend distally from the deployment compartment 52 when pushing the medical device distally out of the distal opening 70 of the deployment compartment. Further, in some examples, the target site 140 may include muscle tissue 144 that is below the tissue 142 with respect to the delivery device 50, i.e., further away from the delivery device than the tissue 142.

[0081] like Figure 4A As depicted, the clinician has navigated the delivery module 52 of the delivery device 50 to the target site 140 such that the medical device (not shown for clarity) at least partially contained within the deployment module 52 is positioned within the target site 140. Figure 4A ) is adjacent to the target 140. As depicted, prior to contacting the target site 140, the compression mechanism 54 can be in an uncompressed state 146, wherein the uncompressed state 146 is substantially similar to the configuration of the proximal component 74 and the distal component 76 described herein.

[0082] As a result of the distal force 156 being applied to the delivery device 50, the deployment module 52 can be navigated proximal to the target site 140. The clinician can apply the distal force 156 by, for example, applying a force to one or more proximal components of the delivery device 50. For example, the clinician can apply the distal force 156 to the hub 56 (at Figure 2A ), or otherwise use the hub 56 to apply a distal force 156. The distal force 156 can be less than a threshold force configured to deform the compression mechanism 54.

[0083] Figure 4B The deployment capsule 52 is depicted contacting tissue 142 at the target site 140. As a result of distal force 156 (e.g., as applied by a clinician), the deployment capsule 52 may thus contact tissue at the target site 140. Figure 4B As depicted, when the delivery device 50 first contacts the target site 140 , the compression mechanism 54 can define a gap 78 between the proximal component 74 and the distal component 76 .

[0084] Figure 4C The delivery device 50 is depicted as being pressed into the target site 140, causing the compression mechanism 54 to deform into the compressed state 148. The compression mechanism 54 may deform into the compressed state 148 as a result of a normal force 158 from the target site 140. As a result of the clinician maintaining a distal force 156 on the delivery device 50 while the deployment capsule 52 contacts the target site 140, the target site 140 may apply a normal force 158 to the compression mechanism 54 (e.g., such as through the deployment capsule 52). The normal force 158 and the distal force 156 combined may meet or exceed a threshold force, causing the compression mechanism 54 to deform into the compressed state 148.

[0085] As depicted, when in the compressed state 148, the compression mechanism 54 can substantially cease to define the gap 78. As a result of the deformation of the distal component 76, the compression mechanism 54 can substantially cease to define the gap 78. Figure 4C As depicted, the deformation may include the distal component 76 bending outwardly such that the distal component 76 defines a curved diameter 156 that is larger than the previous diameter 114 of the distal component 76. When deformed into the compressed state 148, the deformation of the compression mechanism 54 may be substantially mirrored (i.e., substantially symmetrical) about the longitudinal axis 101. As a result of both the distal force 156 and the normal force 158 being substantially aligned (e.g., substantially coaxial) with the longitudinal axis 101, the compression mechanism 54 may be deformed into the substantially mirrored compressed state 148. Further, the elongated member 62 may be configured to not compress or deform in response to the combined distal force 156 and the normal force 158. For example, the elongated member 62 may be made of a material that will substantially avoid compression in response to forces similar to the distal force 156 and the normal force 158.

[0086] As a result of the elongated member 62 not being compressed by the combined distal force 156 and normal force 158, once the compression mechanism 54 is deformed, the distal portion 118 of the elongated member 62 can extend distally toward the deployment compartment 52. In some examples, the distal portion 118 of the elongated member 62 can extend distally an amount sufficient to deploy a medical device contained within the deployment compartment 52. For example, the distal portion 118 can extend distally relative to the deployment compartment 52 and contact and push the proximal end of the contained medical device distally. The distal portion 118 can push the medical device therein an amount sufficient to "activate" or otherwise cause the fixation element to fix the medical device against the target site 140.

[0087] As a result of the distal portion 118 of the elongated member 62 being attached to the first end 116 of the distal component 76, the first end 116 can also extend distally toward the deployment module 52 in response to the compression mechanism 54 deforming. Figure 2A ), once the clinician successfully applies distal force 156 and navigates deployment capsule 52 to target site 140 so that the corresponding inserted or implanted medical device is ready to be deployed, the deformation of compression mechanism 54 can provide visual feedback to the clinician (e.g., when using fluoroscopic techniques). Providing feedback to the clinician can improve the ability of the clinician to verify that the inserted or implanted medical device has been navigated to the appropriate location and is at the appropriate axial distance and orientation from the wall of the target site 140, thereby reducing or eliminating the possibility of suboptimal deployment as a result of premature deployment.

[0088] Figure 5A and Figure 5B Describes how it comes from Figure 2A 51 of the delivery device 50 is a conceptual schematic cross-sectional view of navigating to the target site 156 and engaging the target site 156 at an angle 160 relative to the longitudinal axis 101 of the delivery device 50. In other words, Figure 5A The surface of the distal end 164 of the deployment capsule 52 is depicted as defining an angle 160 with the surface of the target site 140 (e.g., rather than the two surfaces being flush or parallel to each other). Depending on the particular geometry of the venous system of the patient 14, in some examples, the target site 140 may be approached at such an angle 160. For example, Figure 5A As depicted, as a result of approaching the target site 140 at the angle 160, only one side 162 of the distal end 164 of the deployment capsule 52 may initially contact the target site 140. If the deployment capsule 52 deploys the inserted or implanted medical device when the distal end 164 of the deployment capsule 52 is at the angle 160 with the target site 140, the tines or fixation elements of the inserted or implanted medical device may have difficulty securing to the target site 140 as intended. For example, the tines or fixation elements of the inserted or implanted medical device proximal to the side 162 contacting the target site 140 may secure to the muscle tissue 144, while the tines or fixation elements opposite the side 162 may not be successfully secured to any layer of the target site 140.

[0089] Figure 5B The compression mechanism 54 is depicted once it has been compressed as a result of contacting the target site 140 at an angle 160. Figure 5BAs depicted, the compression mechanism 54 is deformed into an unbalanced or asymmetric compression state 162. In the unbalanced compression state 162, the compression mechanism 54 may be deformed more on one side than on an opposite side (e.g., a side as viewed across the longitudinal axis 101). For example, in the unbalanced compression state 162, the compression mechanism may define different shapes on different sides of the longitudinal axis 101, such that one side 116A at the first end (and a corresponding side 118A of a distal portion thereof) is relatively distal to a second side 116B at the first end (and a corresponding side 118B of a distal portion thereof).

[0090] When the deployment module 52 contacts the target site 140 (eg Figure 5A 101 ), as a result of the normal force 158 being at an angle 160 to the longitudinal axis 101, the compression mechanism 54 can be compressed into an unbalanced compression state 162. The deformation of the compression mechanism 54 into the unbalanced compression state 162 can substantially align (e.g., create co-linearity) the longitudinal axis 101 and the normal force 158 of the delivery device. In other words, the compression mechanism 54 can be deformed so that the distal end 164 of the deployment module 52 is flush with the target site 140. By deforming so that the distal end 164 of the deployment module 52 is flush with the target site 140, the delivery device can improve the ability of the delivery device 50 to deploy an inserted or implanted medical device so that the fixation element is fixed to the tissue layer 142 without piercing the muscle tissue 144.

[0091] In some examples, the delivery device 50 may include features configured to improve the ability of the deployment capsule 52 and compression mechanism 54 to be retracted from the introducer sheath. Fig. 6A Depicted is a diagram showing how Figure 2A Section 51 of the observation Figure 2A 14, wherein a distal stop 170 is attached to the distal end 118 of the elongated member 62. The distal stop 170 can extend radially outward from the distal end 118 of the elongated member 62 to engage with a ridge 172 of the deployment module 52 as the delivery device 50 is withdrawn. The ridge 172 can extend radially inward from the inner surface of the deployment module 52. When the clinician applies a withdrawal force 176 to the delivery device 50 (e.g., by pulling on the hub 56 or the elongated member 62 located outside the patient 14), the distal stop 170 can press against the ridge 172. The distal stop 170 can improve the ability of the compression mechanism 54 to maintain a stable structure by reducing the amount that the distal component 76 can bend when the delivery device 50 is withdrawn through the introducer sheath.

[0092] In some examples, the elongated member 62 may terminate at the proximal end of the compression mechanism 54. For example, Figure 6B Depicted is a diagram showing a cross-sectional view of the Figure 2A5 is a conceptual diagram of a cross-sectional view of a delivery device 50 in which the elongated member 62 does not extend beyond the proximal end of the compression mechanism 54. The compression mechanism 54 includes a proximal component 174, which can be substantially similar to the proximal component 174 except for any differences described herein. Figure 2A-5B The proximal member 74 of the delivery device 50. The proximal member 174 may include a tube 178 extending axially from the proximal member 174. The tube 178 may have an outer diameter and an inner lumen substantially similar to the slender member 62. The tube 178 may extend from the proximal member 174 aligned with the longitudinal axis 101 of the delivery device 50. The tube 178 may be fixedly attached to the distal member 76. The tube 178 may be fixedly attached to the distal member 76 in a manner substantially similar to the manner in which the slender member 62 is fixedly attached to the distal member 76. In some examples, the compression mechanism 54 is configured so that only the proximal member 174 is directly fixed to the slender member 62 (e.g., so that the proximal member 174 is subsequently fixed to the distal member 76), which can functionally "stiffen" the compression mechanism 54, thereby increasing the threshold force that may compress the compression mechanism 54.

[0093] As discussed herein, in some examples, a compression mechanism can be positioned along the length of the deployment capsule. In this example, the compression mechanism can define a relatively "weaker" element compared to longitudinally adjacent portions of the deployment capsule, for example, less rigid or elastic in one or more directions or along one or more axes (such as along the longitudinal axis of the delivery device). Due to such a weaker element, the length of the deployment capsule itself can be compressed in response to a force above a threshold force. The weaker element may include a relatively softer material, relatively thinner walls, or a structure that is relatively unstable with respect to longitudinal compression, compared to longitudinally adjacent portions of the deployment capsule. Radiopaque elements or other elements visible via imaging can be placed on both longitudinal sides of the compression mechanism so that compression of the deployment capsule as a result of compression of the weaker element can be monitored. Figures 7A-14B Examples of compression mechanisms comprising "weaker" elements relative to adjacent portions of the longitudinal axis of the deployment module are found.

[0094] Fig. 7A and Figure 7B is a conceptual schematic diagram of a side view of an example medical delivery device 250 in an uncompressed state 246 and a compressed state 248. Delivery device 250 can be substantially similar to delivery device 50, except for any differences described herein. Delivery device 250 can define a longitudinal axis 201 and can include a deployment capsule 252. Deployment capsule 252 can be substantially similar to deployment capsule 52, except for any differences described herein.

[0095] Delivery device 250 includes a compression mechanism 254 that can be configured to compress axially as described herein to provide similar utility as described above with respect to compression mechanism 54. Fig. 7A and Figure 7B As depicted, delivery device 250 may include compression mechanism 254 within the length of deployment capsule 252 (e.g., such that deployment capsule 252 is on either axial side of compression mechanism 254). In other examples (not depicted), compression mechanism 254 may be at other locations along delivery device 250, such as immediately proximal to deployment capsule 252 (e.g., similar to Figure 2A-6B ), or at other locations along an elongated member (e.g., an elongated member similar to elongated member 62) of delivery device 250. In some examples, compression mechanism 254 can be located at the distal end of delivery device 250 such that compression mechanism 254 is functionally a distal tip (not depicted) of delivery device 250. In such examples where compression mechanism 254 is located at the distal tip, compression mechanism 254 can deform to indicate a prescribed force, such as by flaring radially outward, while also being configured to ensure a normal angle for optimal deployment as described herein.

[0096] The compression mechanism 254 can be made of a different material than the deployment chamber 252. For example, the compression mechanism 254 can be made of a material that is relatively more axially compressible and / or otherwise deformable than the deployment chamber 252. In some examples, in addition to being constructed of different materials, the compression mechanism 254 can be similar in structure to the deployment chamber 252. For example, the deployment chamber 252 can define a substantially cylindrical shape centered on the longitudinal axis 201, so that the deployment chamber 252 can have a substantially circular cross-section as observed along a section perpendicular to the longitudinal axis 201. In this example, when the compression mechanism 254 is in the uncompressed state 246, the compression mechanism 254 can define a substantially identical cylindrical shape with a substantially similar circular cross-sectional shape. In other words, the deployment chamber 252 can define a substantially constant inner radius 260 and a wall thickness 262 along its length, and the compression mechanism 254 can define a substantially constant inner radius 264 and a wall thickness 266 that are substantially similar to the inner radius 260 and the wall thickness 262 of the deployment chamber 252.

[0097] Deployment module 252 can be navigated to a target site (e.g., similar to Figures 4A-5BOnce the deployment capsule 252 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 258 to the deployment capsule 252 (and thus to the compression mechanism 254) as a result of the continued distal force 256. The compression mechanism 254 may deform from the uncompressed state 246 to the Figure 7B In some examples, the compression state 248 of the compression mechanism 254 may be predetermined. Figure 7B The depicted “crumpled” shape of the compression mechanism 254 can be predetermined, wherein the compression mechanism 254 extends radially outward to a first radius 268 that is larger than the inner radius 264 of the uncompressed state 264, and also extends radially inward to a second radius 270 that is smaller than the inner radius 264, such that the compression mechanism 254 can reliably and / or predictably deform to the shape of the crumpled state 248. Further, in some examples, the compression mechanism 254 can be configured to repeatedly deform to the compressed state 248 in response to the distal force 256 and the normal force 258, and then return to the uncompressed state 246 once the normal force 258 and / or the distal force 256 are reduced or released (e.g., not applied).

[0098] In some examples (not depicted), the delivery device 250 may include one or more radiopaque elements configured to indicate the amount by which the compression mechanism 254 is longitudinally compressed in response to a force above a threshold force. Figure 2A With the depicted radiopaque marking element 90, the delivery device may include a first radiopaque element positioned adjacent a proximal portion of the compression mechanism 254 and include a second radiopaque element adjacent a distal portion of the compression mechanism 254. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 254 from the uncompressed state 246 to the compressed state 248.

[0099] Fig. 8A and Figure 8B 346 and a compressed state 348. Delivery device 350 can be substantially similar to delivery device 50 and delivery device 250, except for any differences described herein. Delivery device 350 can define a longitudinal axis 301 and can include a deployment module 352. Deployment module 352 can be substantially similar to deployment module 52, except for any differences described herein.

[0100] Delivery device 350 includes a compression mechanism 354 that can be configured to axially compress as described herein to provide similar utility as described above with respect to compression mechanism 54 and compression mechanism 254. Fig. 8A and Figure 8B As depicted, delivery device 350 may include compression mechanism 354 within the length of deployment capsule 352 (e.g., such that deployment capsule 352 is on either axial side of compression mechanism 354). In other examples (not depicted), compression mechanism 354 may be at other locations along delivery device 350, such as immediately proximal to deployment capsule 352 (e.g., similar to that shown in FIG. Figure 2A-6B ), or at other locations along an elongated member (e.g., an elongated member similar to elongated member 62) of the delivery device 350. In some examples, the compression mechanism 354 can be located at the distal end of the delivery device 350 such that the compression mechanism 354 is functionally a distal tip (not depicted) of the delivery device 350. In such examples where the compression mechanism 354 is located at the distal tip, the compression mechanism 354 can deform to indicate a prescribed force, such as by flaring radially outward, while also being configured to ensure a normal angle for optimal deployment as described herein.

[0101] At least a portion of the compression mechanism 354 can define a wall that is gradually thinner relative to the wall of the deployment module 352 along the axial length of the compression mechanism 354 (e.g., defining a smaller radius width on a single wall). For example, along the length of the deployment module 352, the deployment module 352 can include a tubular wall 340 that defines a substantially cylindrical shape and is centered on the longitudinal axis 301. The tubular wall 340 can define a substantially constant inner radius 360 (as measured from the longitudinal axis 301) and a substantially constant outer radius 362 along the length of the deployment module 352. Similarly, the compression mechanism 354 can define a tubular wall 342 that is substantially aligned with the longitudinal axis 301. In some examples, the inner surface 344 of the compression mechanism 354 can extend radially outward from the longitudinal axis 301 to define an inner radius 364 that is relatively larger than the inner radius 360 of the deployment module 352. The inner surface 344 of the compression mechanism 354 can be inclined or angled from the inner radius 360 of the deployment chamber 352 to a relatively larger inner radius 364 of the compression mechanism 354 at both axial ends of the compression mechanism 354, so that the inner surface 344 defines a smooth transition from the inner radius 360 to the inner radius 364 and then back to the inner radius 360.

[0102] In some examples, while tubular wall 342 of compression mechanism 354 can define an outer radius 366 that is substantially similar to outer radius 362 of deployment capsule 352, in other examples, an outer surface of compression mechanism 354 can extend radially inward toward longitudinal axis 301 to define an outer radius 366 that is substantially smaller than outer diameter 362 of deployment capsule 352. In these examples, while compression mechanism 354 can be made of substantially the same material as deployment capsule 352, in some examples it can be made of one or more different materials.

[0103] Deployment module 352 can be navigated to a target site (e.g., similar to Figures 4A-5B The distal force 356 may be substantially similar to the distal force 156 and the distal force 256. Once the deployment capsule 352 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 358 to the deployment capsule 352 (and thus to the compression mechanism 354) as a result of the continued distal force 356. The compression mechanism 354 may deform from the uncompressed state 346 to the Figure 8B In some examples, the compression state 348 of the compression mechanism 354 may be predetermined. Figure 8B The depicted “corrugated” shape of the compression mechanism 354 can be predetermined, wherein the compression mechanism 354 extends radially outward to define an inner corrugation radius 368 that is larger than the inner radius 364 of the compression mechanism 354 in the uncompressed state 364. In this manner, the compression mechanism 354 can reliably and / or predictably deform to the shape of the corrugated state 348. Further, in some examples, the compression mechanism 354 can be configured to repeatedly deform to the compressed state 348 in response to the distal force 356 and the normal force 358, and thereafter return to the uncompressed state 346 once the normal force 358 and / or the distal force 356 are reduced or released (e.g., not applied).

[0104] In some examples (not depicted), the delivery device 350 may include one or more radiopaque elements configured to indicate the amount by which the compression mechanism 354 is longitudinally compressed in response to a force above a threshold force. Figure 2A With the depicted radiopaque marker element 90, the delivery device 350 may include a first radiopaque element positioned adjacent a proximal portion of the compression mechanism 354 and include a second radiopaque element adjacent a distal portion of the compression mechanism 354. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 354 from the uncompressed state 346 to the compressed state 348.

[0105] Fig.9A and Fig. 9B 4 is a conceptual diagram of a side view of an example medical delivery device 450 in an uncompressed state 446 and a compressed state 448. Delivery device 450 can be substantially similar to delivery device 50, delivery device 250, and delivery device 350, except for any differences described herein. Delivery device 450 can define a longitudinal axis 401 and can include a deployment capsule 452. Deployment capsule 452 can be substantially similar to deployment capsule 52, deployment capsule 252, and / or deployment capsule 352, except for any differences described herein.

[0106] Delivery device 450 includes compression mechanism 454, which can be axially compressed as described herein to provide similar utility as described above with respect to compression mechanism 54, compression mechanism 254, and compression mechanism 354. Fig.9A and Fig. 9B As depicted, delivery device 450 may include compression mechanism 454 within the length of deployment capsule 452 (e.g., such that deployment capsule 452 is on either axial side of compression mechanism 454). In other examples (not depicted), compression mechanism 454 may be at other locations along delivery device 450, such as immediately proximal to deployment capsule 452 (e.g., similar to that shown in FIG. Figure 2A-6B ), or at other locations along an elongated member (e.g., an elongated member similar to elongated member 62) of delivery device 450. In some examples, compression mechanism 454 can be located at the distal end of delivery device 450 such that compression mechanism 454 is functionally a distal tip (not depicted) of delivery device 450. In such examples where compression mechanism 454 is located at the distal tip, compression mechanism 454 can deform to indicate a prescribed force, such as by flaring radially outward, while also being configured to ensure a normal angle for optimal deployment as described herein.

[0107] Compression mechanism 454 may define an outer wall that is relatively thinner than deployment module 452. For example, along the length of deployment module 452, deployment module 452 may define a tubular wall 440 that defines a substantially cylindrical shape centered about longitudinal axis 401. Tubular wall 440 of deployment module 452 may define a substantially constant inner radius 460 (as measured from longitudinal axis 401) and a substantially constant outer radius 462 along the length of deployment module 452. Similarly, compression mechanism 454 may define tubular wall 442 that is substantially aligned with longitudinal axis 401 and defines a substantially constant radius 464 along the length of compression mechanism 454. Inner radius 464 of compression mechanism 454 may be larger than inner radius 460, such that tubular wall 442 of compression mechanism 454 may be thinner than tubular wall 440 of deployment module 452.

[0108] In some examples, inner surface 444 of compression mechanism 454 may define a smooth angle or curve from inner radius 460 of deployment module 452 to inner radius 464 of compression mechanism 454. Inner surface 444 may define such a curved angle or curve on both axial ends of compression mechanism 454. In some examples, compression mechanism 454 may be made of substantially the same material as deployment module 452.

[0109] Deployment module 452 can be navigated to a target site (e.g., similar to Figures 4A-5BThe distal force 456 may be substantially similar to the distal force 156, the distal force 256, and the distal force 356. Once the deployment capsule 452 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 458 to the deployment capsule 452 (and thus to the compression mechanism 454) as a result of the continued distal force 456. The compression mechanism 454 may deform from the uncompressed state 446 to the Fig. 9B In some examples, the compression state 448 of the compression mechanism 454 may be predetermined. Fig. 9B The depicted “corrugated” shape of the compression mechanism 454 can be predetermined, wherein the compression mechanism 454 extends radially outward to a first radius 468 that is larger than the inner radius 464 of the uncompressed state 464, and also extends radially inward to a second radius 470 that is smaller than the inner radius 464, such that the compression mechanism 454 can reliably and / or predictably deform to the shape of the corrugated state 448. Further, in some examples, the compression mechanism 454 can be configured to repeatedly deform to the compressed state 448 in response to the distal force 456 and the normal force 458, and thereafter return to the uncompressed state 446 once the normal force 458 and / or the distal force 456 are reduced or released (e.g., not applied).

[0110] In some examples (not depicted), the delivery device 450 may include one or more radiopaque elements configured to indicate the amount by which the compression mechanism 454 is longitudinally compressed in response to a force above a threshold force. Figure 2A As depicted radiopaque marking elements 90, the delivery device 450 may include a first radiopaque element positioned adjacent a proximal portion of the compression mechanism 454 and include a second radiopaque element adjacent a distal portion of the compression mechanism 454. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 454 from the uncompressed state 446 to the compressed state 448.

[0111] Fig. 10A and Fig. 10B 5 is a conceptual diagram of a side view of an example medical delivery device 550 in an uncompressed state 546 and a compressed state 548. Delivery device 550 can be substantially similar to delivery device 50, delivery device 250, delivery device 350, and delivery device 450, except for any differences described herein. Delivery device 550 can define a longitudinal axis 501 and can include a deployment capsule 552. Deployment capsule 552 can be substantially similar to deployment capsule 52, deployment capsule 252, deployment capsule 352, and / or deployment capsule 452, except for any differences described herein.

[0112] Delivery device 550 includes compression mechanism 554, which can be axially compressed as described herein to provide similar utility as described above with respect to compression mechanism 54, compression mechanism 254, compression mechanism 354, and compression mechanism 454. Fig. 10A and Fig. 10B As depicted, delivery device 550 may include compression mechanism 554 within the length of deployment capsule 552 (e.g., such that deployment capsule 552 is on either axial side of compression mechanism 554). In other examples (not depicted), compression mechanism 554 may be at other locations along delivery device 550, such as immediately proximal to deployment capsule 552 (e.g., similar to that shown in FIG. Figure 2A-6B ), or at other locations along an elongated member of delivery device 550 (e.g., an elongated member similar to elongated member 62).

[0113] The compression mechanism 554 can define an accordion structure that includes panels that are angled, for example, alternately inwardly and outwardly from the longitudinal axis 501. For example, along the length of the deployment module 552, the deployment module 552 can define a tubular wall 540 that defines a substantially cylindrical shape centered on the longitudinal axis 501 (e.g., coaxial with the longitudinal axis 501). The tubular wall 540 of the deployment module 552 can define a substantially constant inner radius 560 (as measured from the longitudinal axis 501) and a substantially constant outer radius 562 along the length of the deployment module 552. The tubular wall 540 of the deployment module 552 can be attached to the compression mechanism 554. In some examples, the tubular wall 540 of the deployment module 552 and the compression mechanism 554 can define a unitary structure.

[0114] The compression mechanism 554 can define a series of panels 544A-544C (collectively, "panels 544"), wherein adjacent panels 544 are configured to extend radially outward from the longitudinal axis 501 at an angle relative to the longitudinal axis 501, and then extend radially inward toward the longitudinal axis 501 at an angle relative to the longitudinal axis 501. The panels 544 can together define an accordion structure centered on the longitudinal axis 501. The panels 544 can extend between an inner radius 542 and an outer radius 564, wherein the inner radius 542 is less than the inner radius 560 of the deployment module 552 and the outer radius 564 is greater than the outer radius 562 of the deployment module 552. Further, in some examples, the tubular wall 549 can be relatively thicker than the panels 544. In certain examples, the compression mechanism 554 can be made of substantially the same material as the deployment module 552.

[0115] Deployment module 552 can be navigated to a target site (e.g., similar to Figures 4A-5BThe distal force 556 may be substantially similar to the distal force 156, the distal force 256, the distal force 356, and the distal force 456. Once the deployment capsule 552 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 558 to the deployment capsule 552 (and thus to the compression mechanism 554) as a result of the continued distal force 556. The compression mechanism 554 may deform from the uncompressed state 546 to the Fig. 10B Compression state 548 of compression mechanism 554. In some examples, compression state 548 of compression mechanism 554 may be predetermined.

[0116] For example, Fig. 10B The compression state 548 of the compression mechanism 554 depicted may be predetermined, wherein the panels 544 continue to extend radially inwardly between the inner radius 542 and the outer radius 564 between different predetermined axial lengths between the panels 544. Fig. 10A As depicted, in the uncompressed state 546, the panels 544 can define an axial length 566 between the panels 544 extending outward to a larger radius 564. In the compressed state 548, the panels 544 can define an axial length 568 between the panels 544 extending outward to the larger radius 564. Further, in some examples, the compression mechanism 554 can be configured to repeatedly deform to the compressed state 548 in response to the distal force 556 and the normal force 558, and thereafter return to the uncompressed state 546 once the normal force 558 and / or the distal force 556 are reduced or released (e.g., not applied).

[0117] In some examples (not depicted), the delivery device 550 may include one or more radiopaque elements configured to indicate the amount by which the compression mechanism 554 is longitudinally compressed in response to a force above a threshold force. Figure 2A With the depicted radiopaque marking element 90, the delivery device 550 may include a first radiopaque element positioned adjacent a proximal portion of the compression mechanism 554 and include a second radiopaque element adjacent a distal portion of the compression mechanism 554. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 554 from the uncompressed state 546 to the compressed state 548.

[0118] Fig.11A and Fig. 11B 6 and 7. Conceptual schematic diagrams showing a side view and an exploded view, respectively, of an example delivery device 650 including an example compression mechanism 654 including a set of interlocking components. Fig. 11BDelivery device 650 is depicted exploded along longitudinal axis 601. Delivery device 650 can be substantially similar to delivery device 50, delivery device 250, delivery device 350, delivery device 450, and delivery device 650, except for any differences described herein. Delivery device 650 can define longitudinal axis 601 and can include deployment module 652. Deployment module 652 can be substantially similar to deployment module 52, deployment module 252, deployment module 352, deployment module 452, and / or deployment module 552, except for any differences described herein. Delivery device 650 can further include elongated member 662. Elongated member 662 can be substantially similar to elongated member 62, except for any differences described herein.

[0119] Delivery device 650 includes compression mechanism 654, which can be configured to axially compress as described herein to provide similar utility as described above with respect to compression mechanism 54, compression mechanism 254, compression mechanism 354, compression mechanism 454, and compression mechanism 554. Fig.11A and Fig. 11B As depicted, the delivery device 650 may include a compression mechanism 654 at a location immediately proximal to the deployment capsule 652. Thus, the compression mechanism 654 may be between the elongated member 662 and the deployment capsule 652, thereby substantially attaching the elongated member 662 to the deployment capsule 652. In other examples (not depicted), the compression mechanism 654 may be at other locations along the delivery device 650, such as within the length of the deployment capsule 652 (e.g., similar to that shown in FIG. Figures 7A-10B ), or at other locations along the elongated member 662 of the delivery device 650 .

[0120] The compression mechanism 654 can define a set of interlocking components that are configured to be securely attached to both the elongated member 662 and the deployment capsule 652 and enable the deployment capsule 652 to move axially relative to the elongated member 662 in response to a force above a threshold force. For example, the compression mechanism 654 can include interlocking components proximal cover 620, annular member 622, intermediate member 624, and distal cover 626. The proximal cover 620 can be securely attached to the elongated member 662. For example, the intermediate member 624 can be molded directly to the elongated member 662. The annular member 622, the proximal cover 620, the distal cover 626, the distal cover 626, and the deployment capsule 652 can all be configured to interlock / snap together to the intermediate member 624.

[0121] The distal cover 626 can be configured to compress in response to a force above a threshold force. In response to a force above a threshold force, the distal cover 626 can compress longitudinally relatively more than other components of the delivery device 650, such that the distal cover 626 is functionally the only component that compresses longitudinally. As a result of the relative softness of the material of the distal cover 626, the distal cover 626 can compress such that the distal cover 626 can be relatively softer than other components of the compression mechanism 654, as well as softer than the elongated member 662 and the deployment module 652. The compression mechanism 654 can define a plurality of gaps 678A-678D (collectively, "gaps 678") between respective interlocking components.

[0122] In some examples, the compression mechanism 654 can be configured to define a gap 678 into which the deployment capsule 652 can slide axially. The deployment capsule 652 can slide axially in the gap 678 relative to components of the compression mechanism 654 and relative to the elongated member 662. The deployment capsule 652 can slide in the gap 678 in response to the distal cover 626 being compressed.

[0123] In some examples, one component of the compression mechanism 654 can be securely attached to the elongated member 662 in a semi-permanent manner (e.g., such as being overmolded onto the elongated member 662, chemically bonded to the elongated member 662, etc.), while the other components are interlocked / snapped into place to the one component that is securely attached to the elongated member 662. For example, the intermediate member 624 can be configured to be securely attached to the elongated member 662. In some examples, the intermediate member 624 can be secured to the elongated member 662 by being molded directly to the outer distal surface of the elongated member 662, such that the outer diameter 628 of the elongated member 662 is substantially the same as the inner diameter 630 of the intermediate member 624. In some examples, at least a portion of the central barrel 646 of the intermediate member 624 and the proximally extending connecting member 640 of the intermediate member 646 can be molded to the elongated member 662. In other examples, the distal end of the elongated member 662 can be chemically bonded or thermally bonded to the inner surface of the intermediate member 624. The intermediate member 624 can define a cavity substantially centered about the longitudinal axis 601 of the delivery device 650. In some examples, the intermediate member 624 can define a substantially circular "hollow" shape as a result of this cavity.

[0124] The intermediate member 642 can define features to which other features of the compression mechanism 654 can be secured. For example, the proximally extending connecting member 640 of the intermediate member 624 can terminate proximally at an interlocking lip 644 extending radially outward from the longitudinal axis 601 of the delivery device 650. In some examples, the intermediate member 624 can define a plurality of connecting members 640 and a plurality of interlocking lips 644, such as Fig.11A and Fig. 11B. For example, the intermediate member 624 can define four connecting members 640 and four interlocking lips 644 radially spaced apart around the longitudinal axis 601. Further, the intermediate member 624 can define one or more flanges 648 extending radially outward from the barrel 646. The flange 648 can be located on the intermediate member 624 toward the distal end of the barrel 646. The flange 648 can be arranged radially around the intermediate member 624. For example, the intermediate member 624 may include four flanges 648, each of which is a mirror image of each other across the longitudinal axis 601. Each flange 648 can only extend incompletely around the perimeter of the barrel 646, so that a gap is present between radially adjacent flanges 648. In some examples, each flange 648 can be aligned axially with the corresponding connecting member 640, so that each flange 648 is on the distal end of the barrel 646 opposite to the corresponding connecting member 640.

[0125] The intermediate member 624 can define a substantially circular cross-section. Further, the intermediate member 624 can be substantially symmetrical as viewed along a plane intersecting the longitudinal axis 601 of the delivery device 650 and a plane parallel to the longitudinal axis 601 of the delivery device 650. Where the intermediate member 624 includes a plurality of connecting members 640, interlocking lips 644, and / or flanges 648, the plurality of connecting members 640, interlocking lips 644, and / or flanges 648 can be radially arranged around the longitudinal axis 601. In other words, where more than one of any of the connecting members 640, interlocking lips 644, and / or flanges 648 is present, such elements can be mirrored around the longitudinal axis 601 of the delivery device 650 or otherwise evenly spaced around the longitudinal axis 601 of the delivery device 650.

[0126] In some examples, the intermediate member 624 may further include a distally extending deployment member 668. The deployment member 668 may be configured to secure the medical device within the deployment compartment 652 until the compression mechanism 654 is compressed, at which point the deployment member 668 may deploy the medical device. For example, the deployment member 668 may bend in response to the compression mechanism 654 being compressed, thereby deploying the medical device. The distally extending deployment member 668 may extend axially from the barrel 646 of the intermediate member 624 in a distal direction substantially parallel to the longitudinal axis 601. Although in some examples, the intermediate member 624 may define only one distally extending deployment member 668, in other examples, the intermediate member 624 may define a plurality of distally extending deployment members 668. The distally extending connecting member 668 may define a ridge 676 that extends radially outward from a distal portion of the distally extending deployment member 668. The ridge 676 may initially be coupled to a medical device within the deployment module 652 to secure the medical device, and may become decoupled from the medical device in response to compression by the compression mechanism 654 .

[0127] When the intermediate member is fixedly attached to the elongated member 620, the proximal cover 620 can be configured to be securely interlocked to the intermediate member 624. To this end, the proximal cover 620 can define one or more notches 634 that extend radially outward from the inner radius 630 of the proximal cover 620 along the length of the proximal cover in the longitudinal direction. Further, the proximal cover 620 can define one or more grooves 632 that extend radially into the proximal cover 620 along the length of the proximal cover in the longitudinal direction. In some examples, the proximal cover 620 can define a plurality of grooves 632 and a plurality of notches 634, such as Fig.11A and Fig. 11B . For example, the proximal cover 620 may define four slots 632 and four notches 634. In some examples, the slots 632 and notches 634 may be radially adjacent to each other such that the slots 632 and notches 634 do not substantially overlap radially. In some examples, a corresponding portion of the proximal cover 620 defining one or more slots 632 may extend axially in a proximal direction relative to a corresponding portion of the proximal cover 620 defining one or more notches 634. As a result of this relative proximal extension, the notches 634 may terminate proximally at a radial opening 642 at least partially defined by the radially adjacent slots 632.

[0128] The proximal cover 620 can be configured to slide the notch 634 on the interlocking lip 644, after which the interlocking lip 644 can extend radially outward through the corresponding opening 642. After extending radially outward from the corresponding opening, the interlocking lip 644 can be axially engaged with the proximal cover 620, so that the interlocking lip 644 mechanically fixes the proximal cover 620 to prevent the proximal cover 620 from moving proximally relative to the intermediate member 624 (and thereby relative to the elongated member 662 fixedly attached to the intermediate member 624). The proximal cover 620 can define a cavity substantially centered on the longitudinal axis 601 of the delivery device 650. In some examples, the proximal cover 620 can define a substantially circular "hollow" shape as a result of this cavity. When both the proximal cover 620 and the intermediate member 624 are interlocked on the delivery device 650, the cavity of the proximal cover 620 can be substantially coaxial with the cavity of the intermediate member 624.

[0129] The proximal cover 620 can define a substantially circular cross-section. Further, the proximal cover 620 can be substantially symmetrical as viewed along a plane intersecting the longitudinal axis 601 of the delivery device 650 and a plane parallel to the longitudinal axis 601 of the delivery device 650. Where the proximal cover 620 includes a plurality of slots 632 and / or notches 634, the plurality of slots 632 and / or notches 634 can be radially arranged around the longitudinal axis 601. In other words, where more than one of either or both of the slots 632 and / or notches 634 is present, the slots 632 and / or notches 634 can be mirrored around the longitudinal axis 601 of the delivery device 650 or otherwise evenly spaced around the longitudinal axis 601 of the delivery device 650.

[0130] The annular member 622 may include a substantially circular band 655 having a plurality of extension members 658 extending axially proximally from the band 655 in a direction substantially parallel to the longitudinal axis 601. The annular member 622 may be configured to be secured on the barrel 646 of the intermediate member 624 between the flange 648 and the distally facing surface defined by the recess 634. In other words, the inner diameter of the annular member 622 may be substantially similar to the outer diameter of the barrel 646 of the intermediate member 624, such that the annular member 622 may initially slide on the barrel 646 before engaging with and being secured against proximal movement by the distally facing surface of the recess 634 of the proximal cover 620 and secured against distal movement by the proximal facing surface of the recess 634 of the proximal cover 620.

[0131] The annular member 622 can define one or more radial openings 636. The radial openings 636 can be substantially similar to the openings 642. Each respective opening 636 can be defined by a portion of the proximal surface of the band 655 and two radially adjacent extension members 658. In some examples, the extension members 658 (and the openings 636 therein) can be arranged radially around the annular member 62. For example, the annular member 622 can define four extension members 658 (and thereby define four openings 636 between adjacent pairs of extension members 658), wherein each extension member 658 is a mirror image of another extension member 658 across the longitudinal axis 601. In some examples, as the extension members 658 extend axially from the band 655 in the proximal direction, the extension members 658 can curl or deflect radially inward toward the longitudinal axis 601. The annular member 622 can define openings 636 such that each opening 636 can be aligned with a corresponding slot 632 of the proximal cover 620 when the annular member 622 is secured to the intermediate member 624 and the proximal cover 620 .

[0132] The annular member 622 can define one or more notches 638 extending radially outward from an inner radius of the band 655 of the annular member 622. The annular member 622 can define the notches 638 to be axially aligned with the openings 636. For example, each notch 638 can extend axially across the band 655 distal to the corresponding opening 636.

[0133] The annular member 622 can define a cavity substantially centered on the longitudinal axis 601 of the delivery device 650. In some examples, the annular member 622 can define a substantially circular "hollow" shape as a result of this cavity. When the annular member 622, the proximal cover 620, and the intermediate member 624 are interlocked on the delivery device 650 (e.g., when the annular member 622 and the proximal cover 620 are interlocked with the intermediate member 624 fixedly fixed to the slender member 662), the cavity of the annular member 622 can be substantially coaxial with the cavity of the proximal cover 620 and the cavity of the intermediate member 624.

[0134] The distal cap 626 may include a barrel 660 and one or more flanges 664 extending radially outward from the barrel 660 at the proximal end of the barrel 660. The distal cap may be configured to slide over a distally extending connecting member 668. The axial length of the distal cap 626 may be substantially similar to the axial length between the barrel 646 and the ridge 676 of the distally extending connecting member 668, such that when the distal cap 626 is flush with the intermediate member 624, the ridge 676 maintains the distal cap 626 flush with the intermediate member 624.

[0135] The flanges 664 can be substantially similar to the flanges 648 of the intermediate member 624. In some examples, the flanges 664 of the distal cap 626 can be configured to be flush with the flanges 648 of the intermediate member 624 when the distal cap 626 is secured to the intermediate member 624 (e.g., secured via the ridges 676). For example, similar to the flanges 648 of the intermediate member 624, each flange 664 can be mirrored with another corresponding flange 664 across the longitudinal axis 601. Each flange 664 can extend only partially around the circumference of the barrel 660, such that a gap is present between radially adjacent flanges 664.

[0136] As described above, the distal cap 626 can be made of a relatively softer material than the compression mechanism 654 and / or other components of the delivery device 650. In some examples, both the barrel 660 and the flange 664 of the distal cap 626 can be made of a relatively soft material. In other examples, only the barrel 660 (or only the distal portion of the barrel 660) can be made of a relatively soft material.

[0137] The distal cap 626 can define a cavity substantially centered on the longitudinal axis 601 of the delivery device 650. In some examples, the distal cap 626 can define a substantially circular "hollow" shape as a result of this cavity. The cavity of the distal cap 626 can be substantially coaxial with the cavity of the proximal cap 624, the cavity of the annular member 622, and the cavity of the intermediate member 624, as all four are interlocked on the delivery device 650.

[0138] The proximal end of the deployment capsule 652 can be configured to slide on the barrel 660. The deployment capsule 652 can include proximal extension fingers 670 extending axially from the deployment capsule 652 in the proximal direction. Each extension finger 670 can define a depression 672 extending radially inwardly so as to extend the finger at a proximal portion of the extension finger 670 between the proximal lip 674 and the distal lip 686. Once received by the deployment capsule 624 to the distal cover 626, the extension finger 670 can be configured to extend axially within the gap between the flange 664 and the flange 648. Once the extension finger 670 has been axially extended between the flange 664 of the distal cover 626 and the flange 648 of the intermediate member 624, the annular member 622 can be received by the depression 672 of the extension finger 670. Once received, the extension member 658 can extend proximally to curl around the proximal lip 674 of the extension finger 670, thereby engaging the annular member 622 to prevent the deployment capsule 652 from moving distally relative to the annular member 622 when the distal cover 626 is not compressed. When the distal cover 626 is compressed, the deployment capsule 652 can move longitudinally into the gap 678 defined by the compression mechanism 654 until the distal lip 686 engages the distal-facing surface of the annular member 622. In this manner, the elongated member 662 can be securely attached to the intermediate member 624 that interlocks with the proximal cover 620, the distal cover 626, the annular member 622, and the deployment capsule 652, such that substantially only the deployment capsule 652 can move proximally relative to the other components of the delivery device 650 in response to the distal cover 626 compression (which is in response to a force above a threshold force).

[0139] Fig. 12A 12B and 12B are conceptual schematic diagrams of cross-sectional views taken along a plane passing through the longitudinal axis 601 of the delivery device 650 when the distal cap 626 is in an uncompressed state and a compressed state, respectively. Fig. 12A As depicted, when the compression mechanism 654 defines the gap 678, the proximal lip 674 of the extended finger 670 of the deployment module 652 engages the annular member 622. Further, as shown Fig. 12A12B , the distal cover 626 has been compressed to a second axial length 692 that is relatively smaller than the first axial length 690. The distal cover 626 can be compressed in response to a distal force 656 that is greater than a threshold force. The distal force 656 can be substantially similar to the distal force 156, the distal force 256, the distal force 356, the distal force 456, and the distal force 556. In response to the distal force 656 compressing the distal cover 626, the deployment compartment 652 can extend proximally into the gap 678 to substantially occupy / eliminate the gap 678. The deployment compartment 652 can extend proximally into the gap 678 until the proximal lip 686 of the extension finger 670 engages the distal-facing surface of the annular member 622. In this manner, the longitudinal length of the gap 678 can define the amount that the distal cover 626 is compressed, as the distal force 656 can only compress the distal cover 626 by a longitudinal amount equal to the length that the deployment module 652 can move proximally as defined by the gap 678. Although FIG. 12B depicts the distal cover 626 as being compressed without substantially radially buckling inward for purposes of clarity, in other examples, the distal cover 626 can buckle inwardly toward the longitudinal axis 601 of the delivery device 650 in response to the distal force 656.

[0140] Fig. 12A 12B depicts a circular groove 682 defined by the deployment module 652. The circular groove 682 can be a groove cut axially into the inner surface of the deployment module 652. In some examples, when the circular groove 682 is cut axially into the deployment module 652, the circular groove 682 can define a radius 684 that is substantially constant from the longitudinal axis 601. The deployment module 652 can define the groove 682 at an axial position that is substantially aligned with the distal ends of the fingers 670 of the deployment module 652, so that when received by the deployment module 652, the distal cover 626 can extend distally to substantially as far as the distal tip of each of the fingers 670.

[0141] The distal end 680 of the distal cap 626 can be received within the circular groove 682 of the deployment capsule 652, thereby radially and axially securing the distal cap 626 to the deployment capsule 652. The deployment capsule 652 can define the circular groove 682. In some examples, the circular groove 682 can extend 360° around the longitudinal axis 601 of the delivery device 650. In some examples, the circular groove 682 can extend only an amount around the longitudinal axis 601 corresponding to the shape defined by the distal end 680 of the distal cap 626.

[0142] In some examples (not depicted), the delivery device 650 may include one or more radiopaque elements configured to indicate the amount by which the compression mechanism 646 is longitudinally compressed in response to a force above a threshold force. Figure 2A As depicted radiopaque marker elements 90, the delivery device 650 may include a first radiopaque element attached to one or more of the elongated member 662, the proximal cap 620, the annular member 622, the intermediate member 624, and / or the distal cap 626, and include a second radiopaque element attached to the deployment capsule 652. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 654 from an uncompressed state to a compressed state.

[0143] Alternatively or additionally, the delivery device may include an electrical component that can indicate when the compression mechanism is compressed in response to a force greater than a threshold force. For example, the delivery device may include an electronic circuit that is closed or opened in response to a deformation that is in response to a force greater than a threshold force. For example, the delivery device 650 may include electrical components of the electronic circuit on opposite sides of one or more gaps 678 so that when the components of the compression mechanism move into the gap 678, the components may contact each other (and thereby close the circuit) or separate (and thereby open the circuit). The electronic circuit may be configured to provide an indication to a clinician operating the delivery device when the electrical circuit is thereby partially and / or completely closed or opened. For example, the electronic circuit may be configured to turn on or off an indicator such as a light emitting diode (LED), a tactile feedback device, etc. in response to the electronic circuit being turned on or off. The intensity of the indication (e.g., the amount of light provided by the LED or the amount of tactile feedback) can indicate the extent to which the electrical circuit is currently turned on and / or off and / or is about to be turned on or off. The indicator may be positioned near the proximal end of the delivery device 650 (e.g., such as at a position such as Figure 2A 54 (near or on the depicted hub 56), thereby improving the clinician's ability to detect the indication.

[0144] Fig.13A and Fig. 13B746 and compressed state 748, respectively. Delivery device 750 can be substantially similar to delivery device 50, delivery device 250, delivery device 350, delivery device 450, delivery device 550, and delivery device 650, except for any differences described herein. Delivery device 750 can define a longitudinal axis 701 and can include a deployment module 752 and an elongated member 762. Deployment module 752 can be substantially similar to deployment module 52, deployment module 252, deployment module 352, deployment module 452, deployment module 552, and / or deployment module 652, except for any differences described herein. Similarly, elongated member 762 can be substantially similar to elongated member 62 and / or elongated member 662, except for any differences described herein.

[0145] Delivery device 750 includes compression mechanism 754 that can be axially compressed as described herein to provide similar utility as described above with respect to compression mechanism 54, compression mechanism 254, compression mechanism 354, compression mechanism 454, compression mechanism 554, and compression mechanism 654. Fig.13A and Fig. 13B As depicted, delivery device 750 may include compression mechanism 754 at a location immediately proximal to deployment capsule 752 (e.g., such that deployment capsule 752 is immediately distal to compression mechanism 754 and elongated member 762 is immediately proximal to compression mechanism 754). In other examples (not depicted), compression mechanism 754 may be at other locations along delivery device 750, such as within the length of deployment capsule 552 (e.g., similar to that shown in FIG. Figures 7A-10B ), or at other locations along the elongated member 762 of the delivery device 750.

[0146] The compression mechanism 754 can define a tubular slider 760 that is configured to be fixed to the deployment module 752 and configured to slide axially relative to the slender member 760. The tubular slider 760 can be a member that is substantially tubular in shape and attached to the inner periphery of the proximal portion 764 of the deployment module 752. The tubular slider 760 can be aligned (substantially coaxial) with the longitudinal axis 701 of the delivery device 750. The tubular slider 760 can define a relatively constant inner radius 766 along the axial length 744 of the tubular slider 760. The inner radius 766 can be only slightly smaller than the inner radius of the slender member 762.

[0147] The compression mechanism 754 can further include a distal collar 768 fixed to the periphery of the proximal portion 764 of the deployment module 752, a proximal collar 770 fixed to the periphery of the distal portion 772 of the elongated member 762, and a flexible sheath 774 fixed to the periphery of both the proximal and distal collars 770, 768. The flexible sheath 774 can be relatively flexible relative to the other components of the compression mechanism 754 (e.g., the tubular slider 760, the proximal collar 770, and / or the distal collar 768). For example, the flexible sheath 774 can be made of a relatively flexible material, or the flexible sheath 774 can be relatively thinner than the other components of the compression mechanism 754. The flexible sheath 774 can be the only component of the compression mechanism that is fixed to both the deployment module 752 and the elongated member 762. The flexible sheath 774 can couple the deployment capsule 752 to the elongated member 762 such that the deployment capsule 752 and the elongated member 762 define an axial gap 776 therebetween when the compression mechanism 754 is in the uncompressed state 746. In some examples, the axial length 744 can be substantially greater than the axial gap 776 in the uncompressed state 746 and be secured to the deployment capsule 752 such that the tubular slider 760 extends axially far beyond the distal portion 772 of the elongated member 762. For example, the tubular slider 760 can be secured to the deployment capsule 752 and define the axial length 744 such that at least half of the axial length 744 of the tubular slider 760 extends proximally beyond the distal end of the elongated member 762. In some examples, the tubular slider 760 can extend substantially all the way back to the hub of the delivery device 750, and the tubular slider 760 can be locked into a proximal position at the hub to reduce the possibility of premature deployment of the medical device and / or to protect the structural integrity of the compression mechanism 754 when the compression mechanism 754 is inserted through the introducer sheath. In such examples, the compression mechanism 754 can function primarily as a coil spring or the like. Configuring the tubular slider 760 to extend proximally far beyond the distal end of the elongated member 762 can improve the ability of the delivery device 750 to maintain a predetermined shape as it is manipulated and navigated within a vein.

[0148] Deployment module 752 can be navigated to a target site (e.g., similar to Figures 4A-5B The distal force 756 may be substantially similar to the distal force 156, the distal force 256, the distal force 356, the distal force 456, the distal force 556, and the distal force 656. Once the deployment capsule 752 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 758 to the deployment capsule 752 (and thus to the compression mechanism 754) as a result of the continued distal force 756. The compression mechanism 754 may deform from the uncompressed state 746 to the Fig. 13BIn some examples, the compression state 748 of the compression mechanism 754 may be predetermined.

[0149] In some examples, the compression mechanism 754 may include radiopaque elements, such as radiopaque bands 790A, 790B (collectively referred to as "radiopaque bands 790"). The two radiopaque bands 790 may be secured to the periphery of the flexible sheath 774. For example, the compression mechanism 754 may include a proximal radiopaque band 790B radially aligned with the distal portion 772 of the elongated member 762 and a distal radiopaque band 790A radially aligned with the proximal portion 764 of the deployment module 752. The clinician can monitor the axial distance between the radiopaque bands 790 to determine when the compression mechanism defines the compressed state 748, and thereby determine when the contained medical device is ready to be deployed from the deployment module 752.

[0150] Fig.14A and Fig. 14B 846 and compressed state 848, respectively. Delivery device 850 can be substantially similar to delivery device 50, delivery device 250, delivery device 350, delivery device 450, delivery device 550, delivery device 650, and delivery device 750, except for any differences described herein. Delivery device 850 can define a longitudinal axis 801 and can include a deployment capsule 852. Deployment capsule 852 can be substantially similar to deployment capsule 52, deployment capsule 252, deployment capsule 352, deployment capsule 452, deployment capsule 552, deployment capsule 652, and / or deployment capsule 752, except for any differences described herein.

[0151] Delivery device 850 includes compression mechanism 854, which can be configured to compress axially as described herein to provide similar utility as described above with respect to compression mechanism 54, compression mechanism 254, compression mechanism 354, compression mechanism 454, compression mechanism 554, compression mechanism 654, and compression mechanism 754. Fig.14A and Fig. 14B As depicted, delivery device 850 may include compression mechanism 854 within the length of deployment capsule 852 (e.g., such that deployment capsule 852 is on either axial side of compression mechanism 854). In other examples (not depicted), compression mechanism 854 may be at other locations along delivery device 850, such as immediately proximal to deployment capsule 852 (e.g., similar to that shown in FIG. Figure 2A-6B ), or at other locations along an elongated member of delivery device 850 (e.g., an elongated member similar to elongated member 62).

[0152] The compression mechanism 854 can define a spring structure including an outer spring 820 that is fixed to the outer surface 822 of the deployment module 852 on either side of the longitudinal axis of the gap 824 in the deployment module 852. The spring 820 can be wrapped around the deployment module 852 as the spring 820 extends longitudinally across the gap 824. The compression mechanism 854 can include an inner slide 826 extending across the gap 824 within the deployment module 852. The slide 826 can be fixed to only one side of the deployment module 852 relative to the gap 824, so that the slide 826 can move longitudinally relative to the other side of the deployment module 852. The slide 826 can define a length within the deployment module 852 sufficient to keep both sides of the deployment module 852 centered on the longitudinal axis 801 across the gap 824. For example, the slide 826 can define a length that is 75% or more of the length of the deployment module 852. The slide 826 can be made of substantially the same material as the deployment module 852. The spring 820 may be secured (eg, welded) to the deployment module on either side of the gap 824. The spring 820 may be unsecured across the gap 824 such that the spring 820 is free to compress across the gap 824. The spring 820 may be centered about the longitudinal axis 801.

[0153] The deployment module 852 can be navigated to the target site (e.g., similar to Figures 4A-5B The distal force 856 may be substantially similar to the distal force 156, the distal force 256, the distal force 356, the distal force 456, the distal force 556, the distal force 656, and the distal force 756. Once the deployment capsule 852 contacts the tissue layer of the patient 14 at the target site, the tissue layer may apply a normal force 858 to the deployment capsule 852 (and thereby to the compression mechanism 854) as a result of the continued distal force 856. The compression mechanism 854 may deform from the uncompressed state 846 to the Fig. 14B The compression state 848 of the compression mechanism 854 can be predetermined.

[0154] For example, Fig. 14B The compression state 848 of the depicted compression mechanism 854 can be predetermined such that the spring 820 compresses a predetermined amount in response to the distal force 856 and the normal force 858. As a result of the compression of the spring 820, the gap 824 within the deployment module 852 can be compressed by a predetermined amount, thereby reducing the overall length of the deployment module 852. Furthermore, in some examples, the compression mechanism 854 can be configured to repeatedly deform to the compressed state 848 in response to the distal force 856 and the normal force 858, and then return to the uncompressed state 846 once the normal force 858 and / or the distal force 856 are reduced or released (e.g., not applied).

[0155] In some examples (not depicted), the delivery device 850 may include one or more radiopaque or echogenic elements configured to indicate the amount by which the compression mechanism 854 is longitudinally compressed in response to a force above a threshold force. Figure 2A With the depicted radiopaque marking element 90, the delivery device 850 may include a first radiopaque element positioned adjacent a proximal portion of the compression mechanism 854 and include a second radiopaque element adjacent a distal portion of the compression mechanism 854. Using two such radiopaque elements, a clinician may track the compression of the compression mechanism 854 from an uncompressed state 846 to a compressed state 848.

[0156] Fig.15 A flow chart depicting a method of delivering a medical device to a target site in a patient using a delivery device as described herein. Fig.15 It is a reference Figure 2A-6B The delivery device 50 and Figure 1A 16A, but it should be understood that in other examples, Fig.15 The method can be accomplished using other delivery devices described herein to deliver any insertable or implantable medical device. The clinician can insert delivery device 50 into patient 14 (900). When delivery device 50 is inserted into the patient, IMD 16A can be contained in deployment compartment 52 of delivery device 50. The clinician can insert delivery device 50 into patient 14 using an introducer sheath.

[0157] The clinician can navigate the delivery device 50 to the target site 140 in the patient 14 (902). For example, the clinician can navigate the deployment module 52 of the delivery device 50 to the right atrium 20 of the heart 12 of the patient 14 (e.g., Figure 1A ). The clinician can use the hub 56 to navigate the delivery device 50 to the target site using one or more deflection members 86A, 86B. Once the clinician has navigated the deployment capsule 52 to the target site 140, the clinician can press the deployment capsule 53 against the target site 140 (904). The clinician can press the deployment capsule 52 against the target site 140 using a distal force 156 above a threshold value so that the target site 158 exerts a longitudinal normal force 158 on the deployment capsule 52. The distal force 156 applied by the clinician can be less than the force that perforates the tissue layer 142 with the distal end 162 of the deployment capsule 52.

[0158] The clinician can observe that the compression mechanism 54 of the delivery device 50 compresses in response to the clinician applying a distal force 156 above the threshold force (906). The compression mechanism 54 can compress so that the elongated member 62 of the delivery device 50 moves longitudinally toward the deployment compartment 52 of the delivery device 50. The clinician can use fluoroscopic technology to monitor one or more radiopaque bands of the delivery device 50 to observe the compression mechanism 54 compression. In response to observing that the compression mechanism 54 compresses a predetermined amount, the clinician can deploy the IMD 16A (808). The clinician can deploy the IMD 16A so that the fixation element 17 extends distally out of the distal opening 70 of the deployment compartment 52. Once the IMD 16A is deployed, the clinician retracts the delivery device 50 outside the patient's body (910). The clinician can withdraw the delivery device 50 from the introducer sheath through which the delivery device 50 is inserted.

[0159] Fig.16 A flow chart depicting a method of manufacturing a delivery device for delivering a medical device to a target site within a patient's body. Figure 2A-5B Delivery Equipment Discussion Fig.16 It should be understood that Fig.16 The described order of the steps of the method is depicted for purposes of illustration, as in other examples the method may be completed in other orders.

[0160] The proximal component 74 of the compression mechanism 54 can be secured to the elongated member 62 (950). The proximal component 74 can be secured to the elongated member 62. For example, the proximal component 74 can be chemically bonded, overmolded, thermally bonded, or mechanically attached to the elongated member 62. The inner cavity 81 of the proximal component 74 can be secured to the outer surface of the elongated member 62. In some examples, the proximal component 74 can be secured to the elongated member 62 at a location slightly proximal to the distal end 130 of the elongated member 62.

[0161] The distal component 76 can connect the elongated member 62 to the deployment module 52. The distal component 76 can be a flexible sheet having a first end 116 and a second end 120. A first portion 126 of the distal component 76 adjacent to the first end 116 can be secured to the elongated member 62 (952). The first portion 126 of the distal component 76 can be secured to the elongated member 62 such that the first end 116 of the distal component 76 is radially aligned with the distal end 130 of the elongated member 62 and the first portion 126 extends proximally parallel to the elongated member 62. The first portion 126 can be chemically bonded to the elongated member 62. The first portion 126 can be secured to the elongated member 62 at a location distal to the location where the distal component 74 is secured to the elongated member 62.

[0162] A second portion 128 of the distal member 76 adjacent the second end 120 of the distal member is secured to the deployment module 52 (954). The second portion 128 of the distal member 76 is secured to the deployment module 52 such that the second portion 128 extends proximally from the second end 120 in parallel with the deployment module 52. The second portion 128 may be chemically bonded, overmolded, thermally bonded, or mechanically attached to the deployment module 52.

[0163] The radiopaque element 90 may be secured to the proximal component 74 and the distal component 76 (956). For example, a radiopaque element 90 formed of an outer band of radiopaque material may be secured to the periphery of both the proximal component 74 and the distal component 76. In some examples, the radiopaque element 90 may be secured between the proximal interface of the proximal component 74 and the elongated member 62 and / or the distal interface between the distal component 76 and the deployment module 52 to enhance one or both interfaces.

[0164] The present disclosure relates generally to medical delivery devices that include one or more components that deform axially in a predetermined manner in response to an applied force above a predetermined threshold to deliver an implantable medical device to the right atrium of a patient's heart. However, one or more aspects of the present disclosure may also be applicable to delivering other insertable or implantable medical devices to the right atrium or other areas of a patient. For one example, as discussed herein, various aspects of the present disclosure may be applicable to delivering a lead including a distal fixation element to a target site within a patient's body. Other applications of various aspects of the present disclosure will also be understood by those of ordinary skill in the art.

[0165] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. A medical delivery device, comprising: an elongated member configured to navigate an intravenous system of a patient; a deployment capsule coupled to the distal end of the elongated member and configured to receive at least a portion of an insertable or implantable medical device, the deployment capsule defining a distal opening configured for deployment of the insertable or implantable medical device out of the deployment capsule at a target site within a patient; as well as a compression mechanism configured to longitudinally move a distal portion of the deployment capsule and the elongated member toward each other in response to the deployment capsule applying a distal force of at least a threshold force to the target site, wherein: A distal planar surface of the deployment module defines the distal opening; The target site defines a plane; and The compression mechanism is configured to axially deform relatively more on one side of a longitudinal axis of the medical delivery device than on an opposite side of the medical device in response to the distal planar surface contacting the plane at an angle greater than a threshold angle.

2. The medical delivery device of claim 1, wherein: The compression mechanism is configured to compress axially to move the elongated member and the deployment module axially toward each other.

3. The medical delivery device of claim 1, wherein: The angle decreases as a result of the compression mechanism being axially deformed relatively more on one side of the longitudinal axis than on the opposite side.

4. The medical delivery device according to any one of claims 1 to 3, characterized in that The elongated member, compression mechanism, and deployment module are substantially symmetrical about a center plane of the medical delivery device.

5. The medical delivery device according to any one of claims 1 to 4, characterized in that The insertable or implantable medical device is a leadless pacemaker.

6. The medical delivery device according to any one of claims 1 to 5, characterized in that The insertable or implantable medical device is configured to secure itself to the target site using one or more fixation elements located at a distal end of the insertable or implantable medical device.

7. The medical delivery device of claim 6, wherein: The one or more fixation elements include one or more fixation tines.

8. The medical delivery device according to any one of claims 1 to 7, characterized in that Further comprising a proximal radiopaque marker and a distal radiopaque marker, wherein the proximal radiopaque marker and the distal radiopaque marker are configured to longitudinally move the distal portion of the deployment module and the slender member closer to each other in response to the compression mechanism longitudinally moving them longitudinally toward each other.

9. The medical device according to claim 8, characterized in that The proximal radiopaque marker is near a proximal portion of the compression mechanism, and the distal radiopaque marker is near a distal portion of the compression mechanism.

10. The medical delivery device according to any one of claims 1 to 9, characterized in that The threshold force is greater than a force required to insert the delivery device through an introducer sheath to gain access to the patient's intravenous system.

11. The medical delivery device according to any one of claims 1 to 10, characterized in that The compression mechanism defines one or more chambers.

12. The medical delivery device of claim 11, wherein: The one or more lumens of the compression mechanism include a guidewire lumen configured to receive a guidewire.

13. The medical delivery device according to any one of claims 11 or 12, characterized in that The one or more lumens of the compression mechanism include a medical device lumen configured to receive a portion of the medical device.

14. The medical delivery device according to any one of claims 11 to 13, characterized in that Further including: a hub at a proximal end of the elongated member; as well as A deployment mechanism is configured to deploy the insertable or implantable medical device, wherein the one or more lumens of the compression mechanism include a deployment lumen configured to accommodate at least a portion of the deployment mechanism.

Images