Delivery Device

Abstract

The medical device is delivered percutaneously to a deployment location within a subject's body, such as an atrioventricular valve. Apparatus and methods for use with a medical device (21) are described. A delivery device (20) delivers the medical device (21) to the mitral valve and / or left ventricle of a subject. The delivery device (20) includes a steerable catheter (22) with two or more deflection cables. At least one of the deflection cables is a steering deflection cable (26) configured to steer a distal portion of the steerable catheter through a first steerable catheter deflection plane. At least one of the deflection cables is a height adjustable deflection cable (28) configured to deflect a tip of the steerable catheter by steering the tip of the steerable catheter through a second steerable catheter deflection plane such that the tip is deflected from within the left atrium towards the roof of the left atrium. Other applications are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS The present application, No. 63 / 184,403 to Shimel, entitled "Delivery Devices," filed May 5, 2021, which is incorporated herein by reference; and This application claims priority to U.S. Provisional Patent Application No. 63 / 184,427 to Shimel, entitled "Percutaneous Introducer Sheath," filed May 5, 2021, which is incorporated by reference herein.

[0002] The present invention relates to medical devices and methods, and more particularly to devices and methods for percutaneously delivering medical devices to a deployment location within a subject's body, such as an atrioventricular valve. [Background technology]

[0003] The human heart is a muscular organ that, by contraction of four chambers, pumps deoxygenated blood through the lungs for oxygenation, as well as oxygenated blood to the rest of the body.

[0004] After circulating through the body, deoxygenated blood from the body enters the right atrium through one or more vena cava. In a healthy subject, the right atrium contracts and pumps blood into the right ventricle through the tricuspid valve. The right ventricle contracts and pumps blood through the pulmonary semilunar valve into the pulmonary artery, which splits into two branches, one for each lung. The blood becomes oxygenated while passing through the lungs and re-enters the heart through the left atrium. The left atrium contracts and pumps oxygenated blood into the left ventricle through the mitral valve. The left ventricle contracts and pumps oxygenated blood through the aortic valve into the aorta to be distributed to the rest of the body. The tricuspid valve closes during right ventricular contraction, thereby preventing blood from flowing back into the right atrium. Similarly, the mitral valve closes during left ventricular contraction, thereby preventing blood from flowing back into the left atrium. The mitral and tricuspid valves are known as atrioventricular valves, and each of these valves controls the flow of blood between the atria and the ventricles.

[0005] In the mitral valve, the mitral annulus defines the mitral orifice. Anterior and posterior leaflets extend from the mitral annulus. The leaflets are connected to the papillary muscles in the left ventricle by chordae tendineae. During ventricular diastole, in a healthy subject, the left atrium contracts, forcing blood into the left ventricle through the mitral orifice. Blood flows through the mitral orifice, pushing the leaflets apart and into the left ventricle with little resistance. In a healthy subject, the leaflets of the aortic valve are held closed by blood pressure in the aorta.

[0006] During ventricular systole, the left ventricle contracts to pump blood through the aortic valve into the aorta, and the leaflets of the aortic valve are pushed open by the blood flow. In healthy subjects, the mitral annulus contracts, pushing the leaflets inward and reducing the area of ​​the mitral orifice by approximately 20%-30%. The leaflets coapt to absorb the excess leaflet surface area, creating a coaptation surface that constitutes a seal. The pressure of blood in the left ventricle pushes against the ventricular surfaces of the leaflets, forcing them tightly together at their coaptation surfaces, thereby forming a tight, leak-proof seal.

[0007] Effective sealing of the mitral valve during ventricular systole depends on adequate coaptation. Inadequate coaptation can be caused by any number of physical abnormalities that allow leaflet prolapse (e.g., stretched or torn chordae or weak papillary muscles) or prevent coaptation (e.g., short chordae or small leaflets). There are also pathologies that result in mitral valve insufficiency, including collagen vascular disease, ischemic mitral regurgitation (e.g., resulting from myocardial infarction, chronic heart failure, or failed / unsuccessful surgical or catheter revascularization), myxomatous degeneration of the leaflets, and rheumatic heart disease. Mitral regurgitation leads to many complications, including arrhythmias, atrial fibrillation, palpitations, chest pain, congestive heart failure, syncope, fatigue, low cardiac output, orthopnea, paroxysmal nocturnal dyspnea, pulmonary edema, shortness of breath, and sudden death.

[0008] There are various medical devices configured to be delivered in minimally invasive procedures, in which a delivery device is used to deliver the device percutaneously (through a puncture in the skin) to a deployment location where the device is to be deployed. Many such medical devices are deployed within the subject's vasculature and / or within the subject's heart. For example, such medical devices may include prosthetic valves (e.g., prosthetic mitral valves, prosthetic aortic valves, and / or prosthetic tricuspid valves), valve repair devices (e.g., edge-to-edge devices such as annuloplasty rings or mitral leaflet clips), stents, hole closure devices, and / or endovascular simulation devices. Typically, larger medical devices are inserted into the subject's vasculature via the femoral vein or femoral artery, while smaller devices may also be inserted via the radial vein or artery, or another vein or artery, depending on the deployment location. During delivery of the medical device to the deployment location, the medical device is typically maintained in a radially constrained (i.e., crimped) configuration within the delivery device. When disposed at a deployed position, the medical device radially expands to the deployed configuration, in some cases the medical device is configured to self-expand, while in other cases the medical device radially expands in an active manner, for example via balloon inflation.

[0009] There are various medical devices configured to be implanted in atrioventricular valves (such as the mitral valve) and / or in the left ventricle. For example, a prosthetic mitral valve may be deployed to replace the native mitral valve. Alternatively, a mitral valve repair device, such as an annuloplasty ring or a mitral leaflet clip, may be deployed to repair an unhealthy mitral valve. Some such devices are implanted in an open surgical procedure. Others are implanted in a minimally invasive procedure, in which a delivery device is used to deliver the device percutaneously to the mitral valve and / or left ventricle. One approach for percutaneous delivery of a device to the mitral valve and / or left ventricle is the transseptal approach. Using the transseptal approach, a delivery device is typically inserted into the femoral vein and then advanced through the subject's vena cava and thence through the right atrium to the atrial septum. The delivery device is then pierced through the atrial septum and directed from within the left atrium toward the mitral valve. Summary of the Invention

[0010] According to some applications of the invention, a delivery device is advanced through the atrial septum from the subject's vena cava into the subject's right atrium and from there into the subject's left atrium. The distal end of the delivery device is advanced toward the native mitral valve, typically through the leaflets of the native mitral valve and into the left ventricle. Typically, the delivery device is used to deliver a percutaneously implantable medical device, such as a prosthetic mitral valve, a mitral valve repair device (an edge-to-edge device such as an annuloplasty ring or mitral leaflet clip), an artificial chordae tendineae, and / or another percutaneously implantable medical device.

[0011] For some applications, the delivery device includes an outer steerable catheter and an inner steerable catheter, the inner steerable catheter being axially slidable relative to the outer steerable catheter. Typically, upon advancement of the delivery device through the atrial septum from the subject's vena cava into the subject's left atrium, the distal end of the inner steerable catheter is disposed inside the outer steerable catheter. More typically, once the distal end of the outer steerable catheter is disposed inside the left atrium, the inner steerable catheter is advanced from the distal end of the outer steerable catheter and then steered toward the subject's mitral valve and / or left ventricle. For some applications, the inner steerable catheter is configured to be steered independently of the outer steerable catheter once the inner steerable catheter is advanced from the distal end of the outer steerable catheter.

[0012] For some applications, the outer steerable catheter includes first and second steering deflection cables that are configured to be manipulated by a user to steer the distal end of the outer catheter through the first outer steerable catheter deflection plane toward the atrial septum of the subject. Alternatively, the outer catheter includes only a single steering deflection cable that is configured to be manipulated by a user to steer the distal end of the outer steerable catheter through the first outer steerable catheter deflection plane toward the atrial septum of the subject. For some applications, in addition to one or more steering deflection cables, the outer catheter includes a height adjustment deflection cable. Typically, the height adjustment deflection cable is configured to be manipulated by a user to steer the tip of the outer steerable catheter through the second outer steerable catheter deflection plane, thereby deflecting the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium. More typically, the second outer steerable catheter deflection plane is perpendicular to the first outer steerable catheter deflection plane. Thus, the height adjustment deflection cable is typically disposed at a 90 degree angle to the steering deflection cable or cables.

[0013] Typically, the delivery device includes a capsule at its distal end. More typically, the percutaneously implantable medical device is held in a crimped (i.e., radially constrained) configuration inside the capsule during delivery of the medical device to the mitral valve and / or left ventricle of the subject. To deploy the device in the mitral valve and / or left ventricle of the subject, the medical device is released from the capsule, as described in more detail below. For some applications, the medical device is a self-expandable medical device configured to radially self-expand upon release from the capsule. For example, the medical device may include a shape memory alloy (such as Nitinol) that is shape-set to a desired radially expanded configuration. Alternatively or additionally, the device may be actively radially expanded (e.g., via balloon expansion) after release from the capsule.

[0014] For some applications, the capsule includes a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location, and a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location. Typically, the proximal and distal portions are reversibly coupleable to one another. More typically, once the medical device is released from within the capsule, the proximal and distal portions of the capsule are recoupled to one another before being retracted from within the subject's body.

[0015] For some applications, the capsule includes a guide portion defined by at least one of the distal capsule portion and the proximal capsule portion. The guide portion is configured to guide the distal and proximal capsule portions back to their coupled configuration after the medical device is deployed. For example, for some applications, the proximal capsule portion defines a lip at its distal end and the distal capsule portion defines a corresponding lip at its proximal end, which lips are shaped to slide into place relative to one another. Alternatively, only one of the capsule portions defines a lip, which lip is configured to receive the other capsule portion. Typically, the proximal and distal portions are shaped to define a substantially smooth outer surface when properly coupled to one another. In this manner, upon advancement of the capsule to the medical device deployment position, the capsule is atraumatic and does not cause damage to the target tissue. Similarly, upon retraction of the capsule from the medical device deployment position, the capsule is atraumatic and does not cause damage to the target tissue or to the deployed medical device. For some applications, the lip is formed as a complete ring. For some applications, the lip, generally as described above, is divided into a number of separate arc-shaped segments. For example, the lip may be formed from four arc-shaped segments spaced 90 degrees apart from one another, each covering a 30 degree arc. In this way, the medical device may be released before the entire capsule is removed, thus saving on the height required to release the medical device.

[0016] For some applications, a handle of the delivery device includes a rotational control component configured to transmit a rotational motion to the capsule. A nut is disposed within the capsule and configured to translate the rotational motion into axial motion of a portion of the capsule, thereby releasing at least a portion of the medical device from within the capsule.

[0017] According to some applications, a delivery device is used to deliver a medical device in a minimally invasive procedure, in which the medical device is inserted percutaneously (through a puncture in the skin) to a deployment location where the device is to be deployed. Typically, the delivery device is inserted through a percutaneous introducer sheath and through a puncture in the patient's skin. For some applications, the delivery device includes a capsule (e.g., a capsule as described herein) at its distal end, which is configured to house the medical device in its radially constrained (i.e., crimped) configuration upon delivery of the medical device to the deployment location. For some such applications, the capsule is larger in diameter than a portion of the delivery device proximal to the capsule (e.g., a steerable catheter as described herein). In some cases, the difference in diameter between the capsule and a portion of the delivery device proximal to the capsule may cause bleeding after the capsule is advanced through the vascular puncture. This is because the insertion of the capsule widens the vascular puncture, so that the vascular wall surrounding the puncture does not seal against the portion of the delivery device proximal to the capsule that is narrower than the capsule. Such problems may also occur with other forms of delivery devices having a widened distal portion and a proximal portion that is narrower than the widened distal portion, and the scope of this application is applicable mutatis mutandis to all such delivery devices.

[0018] According to some applications of the invention, the percutaneous introducer sheath is made of a stretchable material (e.g., an elastomer such as silicone or polyurethane). As described in more detail below, the percutaneous introducer sheath defines a lumen that is sized to accommodate a portion of the delivery device proximal to the capsule in a non-stretched state of the percutaneous introducer sheath. More typically, in a non-stretched state of the percutaneous introducer sheath, the outer diameter of the sheath is about equal to or greater than the outer diameter of the capsule. For some applications, the difference, if any, between the outer diameter of the percutaneous introducer sheath and the outer diameter of the capsule is less than 20 percent (e.g., less than 5 percent, or less than 2 percent) of the outer diameter of the capsule. Prior to inserting the percutaneous introducer sheath into the subject's body, the capsule is typically advanced through the lumen defined by the percutaneous introducer sheath by stretching the percutaneous introducer sheath such that the entire capsule is disposed distal to the distal end of the percutaneous introducer sheath. The capsule is then advanced through the subject's skin and into the subject's vasculature, followed by the percutaneous introducer sheath. Typically, even after the vascular puncture is widened by the capsule, the vessel wall surrounding the puncture seals against the outside of the percutaneous introducer sheath, since the outer diameter of the sheath is about equal to or greater than the outer diameter of the capsule. For some applications, during advancement of the delivery device through the subject's vasculature, the percutaneous introducer sheath is disposed to remain within the subject's skin and the puncture in the vasculature, and the portion of the delivery device proximal to the capsule is advanced through a lumen defined by the percutaneous introducer sheath.

[0019] It should be noted that the introducer sheath being stretchable allows the introducer sheath to be mounted on the delivery device in the environment in which the procedure will be performed (e.g., a catheter lab). As mentioned above, in this environment and prior to inserting the percutaneous introducer sheath into the subject's body, the capsule is typically advanced through the lumen of the percutaneous introducer sheath by stretching the percutaneous introducer sheath so that the entire capsule is disposed distal to the distal end of the percutaneous introducer sheath. In contrast, if the introducer sheath was not sufficiently stretchable, it would have to be placed around the portion of the delivery device proximal to the capsule (or a capsule having a smaller diameter would be required) in a clean room prior to the procedure as part of the delivery device assembly process.

[0020] In general, in the specification and claims of this application, the term "proximal" and related terms, when used with reference to a device or portion thereof, should be interpreted to mean an end of the device or portion of the device that is closer to the location through which the device would typically be inserted into the subject's body when inserted into the subject's body. The term "distal" and related terms, when used with reference to a device or portion thereof, should be interpreted to mean an end of the device or portion of the device that is farther from the location through which the device would typically be inserted into the subject's body when inserted into the subject's body.

[0021] Thus, according to some embodiments of the present invention, An apparatus for use with a medical device is provided that includes a delivery device configured to deliver the medical device to the mitral valve and / or left ventricle of a subject, the delivery device comprising: a steerable catheter including two or more deflection cables; at least one of the deflection cables is a steering deflection cable configured to steer a distal portion of the steerable catheter through a first steerable catheter deflection plane to steer a distal portion of the steerable catheter from the subject's vena cava, through the subject's right atrium and interatrial septum, and into the subject's left atrium; At least one of the deflection cables is a height adjustable deflection cable configured to deflect the tip of the steerable catheter relative to a portion of the steerable catheter proximal to the tip, such that steering the tip of the steerable catheter through the second steerable catheter deflection plane causes the tip to be deflected from within the left atrium toward the roof of the left atrium.

[0022] In some applications, the height adjustment deflection cables are disposed at a 90 degree angle to the steering deflection cables.

[0023] In some applications, the steering deflection cable is configured to steer a distal portion of the steerable catheter through a first steerable catheter deflection plane through an angle greater than 0 degrees to 60 degrees to steer a distal portion of the steerable catheter from a subject's vena cava, through the right atrium and the atrial septum, and into the subject's left atrium.

[0024] In some applications, the height adjustment deflection cable is configured to steer the tip of the steerable catheter through a second steerable catheter deflection plane from 0 degrees to an angle greater than 30 degrees to deflect the tip of the steerable catheter relative to a portion of the steerable catheter proximal to the tip.

[0025] In some applications, the steerable catheter includes an outer steerable catheter and the delivery device further includes an inner steerable catheter disposed within the outer steerable catheter, a distal portion of the inner steerable catheter configured to be advanceable from a distal end of the outer steerable catheter and to be steerable independently of the outer steerable catheter.

[0026] In some applications, the inner steerable catheter includes a first set of one or more steering deflection cables configured to steer a distal end of the inner steerable catheter through a first inner steerable catheter deflection plane toward a target mitral valve, and a second set of one or more steering deflection cables configured to steer the distal end of the inner steerable catheter through a second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the target mitral valve.

[0027] In some applications, the first set of one or more steering deflection cables is configured to steer the distal end of the inner steerable catheter through a first inner steerable catheter deflection plane through an angle greater than 0 degrees to 80 degrees to steer the distal end of the inner steerable catheter toward a target mitral valve.

[0028] In some applications, the second set of one or more steering deflection cables is configured to steer the distal end of the inner steerable catheter through an angle of at least -45 degrees to +45 degrees through a second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with a target mitral valve.

[0029] In some applications, a first set of one or more steering bias cables are disposed at a 90 degree angle relative to a second set of one or more steering bias cables.

[0030] In some applications, the delivery device further includes a capsule configured to house the medical device during delivery of the medical device to the mitral valve and / or left ventricle and configured to maintain the medical device in a radially constrained configuration during delivery of the medical device to the mitral valve and / or left ventricle.

[0031] In some applications, the capsule comprises: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration during delivery of the medical device to the mitral valve and / or left ventricle; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration during delivery of the medical device to the mitral valve and / or left ventricle; Includes.

[0032] For some applications, the proximal end of the proximal capsule portion defines a recess such that the proximal end of the proximal capsule portion is configured to be retracted to overlap the distal end of the inner steerable catheter.

[0033] According to some applications of the present invention, there is further provided a method of delivering a medical device to a mitral valve and / or left ventricle of a subject, the method comprising: inserting a delivery device including at least one steerable catheter into a vena cava of a subject; steering a distal portion of the steerable catheter through a first steerable catheter deflection plane to steer a distal portion of the steerable catheter from the subject's vena cava, through the subject's atrial septum and into the subject's left atrium; deflecting the steerable catheter tip from within the left atrium toward the roof of the left atrium by steering the steerable catheter tip through a second outer steerable catheter deflection plane; advancing a medical device beyond the tip of the outer steerable catheter; steering a medical device from a tip of the steerable catheter toward a target mitral valve; Includes.

[0034] According to some applications of the present invention, There is further provided an apparatus for use with a medical device, the apparatus including a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: a capsule configured to house the medical device upon delivery of the medical device to the deployment location and configured to maintain the medical device in a radially constrained configuration upon delivery of the medical device to the deployment location; a handle including a rotational control component configured to transmit a rotational motion to the capsule; a motion conversion mechanism disposed within the capsule, the motion conversion mechanism configured to convert rotational motion into axial motion of a portion of the capsule, thereby releasing at least a portion of the medical device; Includes.

[0035] In some applications, the motion conversion mechanism includes a screw-and-nut mechanism.

[0036] In some applications, the capsule comprises: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; Includes.

[0037] In some applications, the delivery device further includes a delivery catheter, and the proximal end of the proximal capsule portion defines a recess such that the proximal end of the proximal capsule portion is configured to be retracted to overlap a distal end of the delivery catheter.

[0038] In some applications, the distal capsule portion is coupled to the first shaft; The delivery device further includes a distal device interface configured to secure a distal portion of the medical device, the distal device interface coupled to the second shaft; The motion conversion mechanism is configured to cause rotational motion of the first shaft relative to the second shaft resulting in axial motion of the first shaft relative to the second shaft, thereby moving the distal capsule portion axially relative to the distal portion of the medical device.

[0039] For some applications, the delivery device further includes a bearing mechanism configured to decouple rotational motion of the distal capsule portion from rotational motion of the first shaft.

[0040] In some applications, the motion conversion mechanism includes a screw-nut mechanism.

[0041] In some applications, the first shaft has a threaded surface and the second shaft has a threaded surface such that rotational movement of the first shaft relative to the second shaft results in axial movement of the first shaft relative to the second shaft.

[0042] In some applications, the first shaft has a threaded surface and the distal device interface has a threaded surface such that rotational movement of the first shaft relative to the second shaft results in axial movement of the first shaft relative to the second shaft.

[0043] According to some applications of the present invention, There is further provided an apparatus for use with a medical device, the apparatus including a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: A capsule configured to contain a medical device upon delivery of the medical device to a deployment location, a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment position, the distal capsule portion coupled to the first shaft; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; A capsule comprising: a distal device interface configured to secure a distal portion of a medical device, the distal device interface coupled to the second shaft; a handle including a rotational control component configured to transmit rotational motion to the first shaft; a motion translating mechanism disposed within the distal capsule portion, the motion translating mechanism configured to cause rotational motion of the first shaft relative to the second shaft resulting in axial motion of the first shaft relative to the second shaft, thereby moving the distal capsule portion axially relative to a distal portion of the medical device; Includes.

[0044] According to some applications of the present invention, There is further provided an apparatus for use with a medical device, the apparatus including a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; a distal capsule portion and a proximal capsule portion configured to be reversibly connectable to one another such that (a) the distal capsule portion and the proximal capsule portion define a connected configuration in which the distal capsule portion and the proximal capsule portion define a substantially smooth outer surface, the distal capsule portion and the proximal capsule portion configured to be disposed in the connected configuration upon delivery of the medical device to a deployment location, and (b) the distal capsule portion and the proximal capsule portion are separable from one another to deploy the medical device by releasing the distal and proximal portions of the medical device from their radially constrained configuration; a guide portion defined by at least one of the distal capsule portion and the proximal capsule portion, the guide portion configured to guide the distal capsule portion and the proximal capsule portion back to their coupled configuration after the medical device is deployed; Includes.

[0045] In some applications, the guide portion includes lips disposed at the ends of the distal and proximal capsule portions, the lips being configured to overlap one another in a coupled configuration of the distal and proximal capsule portions.

[0046] In some applications, the delivery device further includes a delivery catheter, and the proximal end of the proximal capsule portion defines a recess such that the proximal end of the proximal capsule portion is configured to be retracted to overlap a distal end of the delivery catheter.

[0047] According to some applications of the present invention, there is further provided an apparatus for use with a delivery device including a widened distal portion and a proximal portion narrower than the widened distal portion, the apparatus comprising: an introducer sheath defining an internal lumen therethrough and configured to facilitate introduction of the delivery device through the vascular puncture; The introducer sheath comprises an expandable material. The introducer sheath is The introducer sheath is stretched such that the widened distal portion of the delivery device is insertable through a lumen defined by the introducer sheath. In a non-extended state, the lumen can accommodate a proximal portion of a delivery device; and such that in a non-stretched state, the outer diameter at the distal end of the introducer sheath is approximately equal to or greater than the outer diameter of the widened distal portion of the delivery device; The size is determined.

[0048] In some applications, the apparatus is used in conjunction with a delivery device that includes a capsule configured to house the medical device upon delivery of the medical device to a deployment location, and a delivery catheter disposed proximally to the capsule and narrower than the capsule.

[0049] In some applications, the introducer sheath is configured such that, prior to inserting the introducer sheath into the subject's body, the widened distal portion of the delivery device is advanced through the lumen of the introducer sheath by stretching the introducer sheath such that the entire widened distal portion is disposed distal to the distal end of the introducer sheath.

[0050] In some applications, the introducer sheath includes a femoral introducer sheath configured to be inserted into a femoral vessel of a subject, the overall length of the introducer sheath being between 60 mm and 120 mm. In some applications, the diameter of a lumen defined by the introducer sheath is between 7 mm and 10 mm. In some applications, the outer diameter at the distal end of the introducer sheath is between 8 mm and 12 mm. In some applications, the diameter of a lumen defined by the introducer sheath is between 7 mm and 10 mm.

[0051] In some applications, in the unstretched state of the introducer sheath, the difference between the outer diameter of the introducer sheath at its distal end and the outer diameter of the widened distal portion of the delivery device is less than 20 percent of the outer diameter of the widened distal portion of the delivery device. In some applications, in the unstretched state of the introducer sheath, the difference between the outer diameter of the introducer sheath at its distal end and the outer diameter of the widened distal portion of the delivery device is less than 5 percent of the outer diameter of the widened distal portion of the delivery device. In some applications, in the unstretched state of the introducer sheath, the difference, if any, between the outer diameter of the introducer sheath at its distal end and the outer diameter of the widened distal portion of the delivery device is less than 2 percent of the outer diameter of the widened distal portion of the delivery device.

[0052] According to some applications of the present invention, There is further provided an apparatus for use with a medical device, the apparatus including a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: A delivery catheter; a capsule disposed at a distal end of the delivery catheter, the capsule configured to contain the medical device during delivery of the medical device to the deployment location and to maintain the medical device in a radially constrained configuration during delivery of the medical device to the deployment location; a proximal end of the capsule defining a recess such that the proximal end of the capsule is configured to be retracted to overlap the distal end of the delivery catheter; Includes.

[0053] In some applications, The capsules are a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location; The proximal end of the proximal capsule portion defines a recess.

[0054] The present invention will be more fully understood from the following detailed description of its application, taken together with the drawings in which: [Brief description of the drawings]

[0055] [Figure 1A] 1 is a schematic diagram illustrating a delivery device being advanced toward the left ventricle of a subject, in accordance with some applications of the present invention. [Figure 1B] 1 is a schematic diagram illustrating a delivery device being advanced toward the left ventricle of a subject, in accordance with some applications of the present invention. [Figure 1C]1 is a schematic diagram illustrating a percutaneously implantable medical device being released from a capsule in a delivery device, according to some applications of the present invention. [Figure 1D] 1 is a schematic diagram illustrating a percutaneously implantable medical device being released from a capsule in a delivery device, according to some applications of the present invention. [Figure 2A] 1 is a schematic diagram of an inner steerable catheter and an outer steerable catheter of a delivery device according to some applications of the present invention. [Figure 2B] 1 is a schematic diagram of an inner steerable catheter and an outer steerable catheter of a delivery device according to some applications of the present invention. [Figure 2C] 1 is a schematic diagram of an inner steerable catheter and an outer steerable catheter of a delivery device according to some applications of the present invention. [Figure 3A] FIG. 2 is a schematic diagram showing a capsule of a delivery device according to some applications of the present invention. [Figure 3B] FIG. 2 is a schematic diagram showing a capsule of a delivery device according to some applications of the present invention. [Figure 4A] 1 is a schematic diagram of a proximal capsule portion and a distal capsule portion of a delivery device according to some applications of the present invention. [Figure 4B] 1 is a schematic diagram of a proximal capsule portion and a distal capsule portion of a delivery device according to some applications of the present invention. [Figure 4C] 1 is a schematic diagram of a proximal capsule portion and a distal capsule portion of a delivery device according to some applications of the present invention. [Diagram 5] 1 is a schematic diagram of a stage and handle portion of a delivery device according to some applications of the present invention. [Figure 6A] 1 is a schematic diagram of a delivery device according to some applications of the present invention. [Figure 6B] 1 is a schematic diagram of a delivery device according to some applications of the present invention. [Figure 7] 1 is a schematic diagram of a delivery device being percutaneously inserted into a subject's body through a percutaneous introducer sheath, in accordance with some applications of the present invention. [Figure 8] 1 is a schematic diagram of a percutaneous introducer sheath according to some applications of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056] Reference is now made to Figures 1A and 1B, which are schematic diagrams illustrating the advancement of a delivery device 20 toward a subject's native mitral valve 46 and / or left ventricle 54 via a transseptal delivery approach, according to some applications of the present invention. Reference is also made to Figures 1C and 1D, which are schematic diagrams illustrating a percutaneously implantable medical device 21 being released from a delivery device capsule 40, according to some applications of the present invention. As shown in Figure 1A, the distal end of the delivery device 20 is typically advanced through the atrial septum 52 from the subject's vena cava 42 into the subject's right atrium 43, and from there into the subject's left atrium 50. The distal end of the delivery device is advanced toward the native mitral valve, typically through the leaflets 58 of the native mitral valve into the left ventricle 54, as shown in Figure 1B. For some applications, the delivery device 20 is guided over a guidewire 48 toward the subject's native mitral valve 46. Typically, the delivery device is used to deliver a percutaneously implantable medical device 21, such as a prosthetic mitral valve (as shown diagrammatically in Figures 1C and 1D), a mitral valve repair device (such as an annuloplasty ring or mitral valve leaflet clip), an artificial chordae tendineae, and / or another percutaneously implantable medical device.

[0057] For some applications, the delivery device includes a capsule 40 at its distal end. Typically, the percutaneously implantable medical device is held in a crimped (i.e., radially constrained) configuration inside the capsule during delivery of the medical device to the mitral valve and / or left ventricle of the subject. More typically, the medical device is released from the capsule, as described in more detail below, to deploy the device in the mitral valve and / or left ventricle of the subject. For some applications, the medical device is a self-expandable medical device configured to radially self-expand upon release from the capsule. For example, the medical device may include a shape memory alloy (such as Nitinol) that is shape-set to a desired radially expanded configuration. Alternatively or additionally, the device may be actively radially expanded (e.g., via balloon expansion) after release from the capsule. For some applications, the distal portion 23 of the medical device 21 is first released from the capsule (as illustrated diagrammatically in FIG. 1C), and then the proximal portion 25 of the medical device is released from the capsule (as illustrated diagrammatically in FIG. 1D), as described in more detail below.

[0058] Reference is now made to Figures 2A, 2B, and 2C, which are schematic diagrams of the outer steerable catheter 22 and the inner steerable catheter 24 of the delivery device 20 according to some applications of the present invention. Figures 2A and 2B show side views of the outer steerable catheter and the inner steerable catheter, and Figure 2C shows a cross-sectional view. As shown in the transition from Figure 2A to Figure 2B, typically the inner steerable catheter is axially slidable relative to the outer steerable catheter. Typically, during advancement of the delivery device 20 from the subject's vena cava 42 into the subject's left atrium 50 through the atrial septum 52 (anatomy shown in Figures 1A-1B), the distal end of the inner steerable catheter is disposed inside the outer steerable catheter, as shown in Figure 2A. More typically, once the distal end of the outer steerable catheter is disposed inside the left atrium, the inner steerable catheter is advanced from the distal end of the outer steerable catheter (i.e., the configuration shown in FIG. 2B) and then steered toward the mitral valve and / or left ventricle of the subject. For some applications, the inner steerable catheter is configured to be steered independently of the outer steerable catheter once the inner steerable catheter is advanced from the distal end of the outer steerable catheter.

[0059] For some applications, the outer steerable catheter includes first and second steering deflection cables 26 that are configured to be manipulated by a user to steer the distal end of the outer catheter through the first outer steerable catheter deflection plane toward the atrial septum of the subject. Alternatively (embodiment not shown), the outer catheter includes only a single steering deflection cable 26 that is configured to be manipulated by a user to steer the distal end of the outer steerable catheter through the first outer steerable catheter deflection plane toward the atrial septum of the subject. Typically, in addition to the one or more steering deflection cables 26, the outer catheter includes a height adjustment deflection cable 28. Typically, the height adjustment deflection cable 28 is configured to be manipulated by a user to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium by steering the tip of the outer steerable catheter through the second outer steerable catheter deflection plane. Typically, the second outer steerable catheter deflection plane is perpendicular to the first outer steerable catheter deflection plane, and thus the height adjustment deflection cable 28 is typically disposed at a 90 degree angle to the steering deflection cable or cables 26, as shown in FIG.

[0060] For some applications, the steering deflection cable 26 is configured to steer the distal end of the outer steerable catheter through a first outer steerable catheter deflection plane through an angle greater than 0 degrees to 60 degrees or greater than 75 degrees (e.g., 0-90 degrees). For some applications, the height adjustment deflection cable 28 is configured to steer the distal end of the outer steerable catheter through a second outer steerable catheter deflection plane through an angle greater than 0 degrees to 30 degrees or greater than 40 degrees (e.g., 0-45 degrees) to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium.

[0061] Note that in Figure 2C, each steering deflection cable is shown as dual because typically each steering deflection cable follows a first path from the proximal end of the catheter to the distal end of the catheter, and then follows a return path from the distal end of the catheter to the proximal end of the catheter.

[0062] It should be noted that within the left atrium, the inner steerable catheter typically needs to be steered through approximately a 90 degree bend because the inner steerable catheter is advanced from the distal end of the outer steerable catheter after the outer steerable catheter has penetrated the atrial septum. Thus, the tip of the inner steerable catheter typically advances from the outer steerable catheter in a short direction and must be steered to point in an inferior-anterior direction in order to advance toward the mitral valve. Typically, the outer steerable catheter is made to penetrate the atrial septum below the roof of the atrium (e.g., in a postero-inferior or postero-superior position) as shown in Figures 1A-1B because the septum is thinner and more easily penetrated in this position. As mentioned above, the height adjustment deflection cable 28 is configured to be manipulated by the user to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium. Typically, this provides the inner steerable catheter with more height to steer through the curve described above, resulting in a less acute curve, and also provides height for the capsule to deploy above the mitral valve annulus.

[0063] Typically, the inner steerable catheter 22 includes one or more steering deflection cables 30. For some applications, the inner steerable catheter includes (a) a first set 32 ​​of one or more (e.g., a pair) steering deflection cables configured to be manipulated by a user to steer the distal end of the inner steerable catheter through a first inner steerable catheter deflection plane toward a target mitral valve, and (b) a second set 34 of one or more (e.g., a pair) steering deflection cables configured to be manipulated by a user to steer the distal end of the inner steerable catheter through a second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the target mitral valve.

[0064] For some applications, the first set of steering deflection cables 32 is configured to steer the distal end of the inner steerable catheter through an angle of 0 degrees to greater than 80 degrees, or greater than 100 degrees (e.g., 120 degrees) through the first inner steerable catheter deflection plane. For some applications, the second set of steering deflection cables 34 is configured to steer the distal end of the inner steerable catheter through an angle of at least -45 degrees to +45 degrees through the second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the target mitral valve. Typically, the set 32 ​​of steering deflection cables 28 is disposed at a 90 degree angle relative to the second set 34 of steering deflection cables, as shown in FIG. 2C.

[0065] 2A-2C show the use of the inner steerable catheter 24 within the outer steerable catheter 22, it is noted that for some applications, a steerable catheter configured like the outer steerable catheter 22 is used without an inner steerable catheter. For example, a medical device may be steered directly toward the mitral valve and / or left ventricle of a subject from within a steerable catheter configured like the outer steerable catheter 22. Similarly, while the outer steerable catheter 22 is shown as including two steering deflection cables 26, the scope of the invention includes outer steerable catheters that include only a single steering deflection cable 26 in combination with a height adjustment deflection cable 28. Also, while the inner steerable catheter 24 is shown as including two sets 32 and 34 of steering deflection cables 30, the scope of the invention includes inner steerable catheters that include only a single set of steering deflection cables 30 or only a single steering deflection cable 30.

[0066] Reference is now made to Figures 3A and 3B, which are schematic diagrams illustrating a capsule 40 of a delivery device 20 according to some applications of the present invention. Typically, the medical device is held in a crimped (i.e., radially constrained) configuration inside the capsule during delivery of the medical device to a deployment location (such as the mitral valve and / or left ventricle of a subject). More typically, the medical device is released from the capsule to deploy the device at the deployment location. It should be noted that the capsules illustrated in Figures 3A-3B (as well as Figures 4A-4C) may be used with any medical device delivered in a crimped configuration to a deployment location within a subject's body, and are not limited to being used with devices deployed within the mitral valve and / or left ventricle. For example, the capsules illustrated in Figures 3A-3B (as well as Figures 4A-4C) may be used with medical devices delivered to the aorta, vena cava, tricuspid valve, right ventricle, right atrium, right ventricle, pulmonary veins, pulmonary arteries, etc. of a subject.

[0067] For some applications, the capsule includes a distal capsule portion 60 configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location, and a proximal capsule portion 62 configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to a deployment location. Typically, the proximal and distal portions are reversibly connectable to one another, as described in more detail below. For some applications, the capsule additionally includes a tapered distal tip 70 configured to facilitate advancement of the capsule into the vasculature of a subject, and thereafter acts as a dilator for advancement through the atrial septum. Typically, the distal tip is made of a soft material, such that the tip is atraumatic and does not damage the subject's tissue upon advancement of the delivery device to a deployment location. The distal tip typically allows advancement of the system over a guidewire, with the soft material following the guidewire direction.

[0068] For some applications, the outer shaft 64, the mid shaft 66, and the inner shaft 68 are all disposed within the inner steerable catheter 24 (shown in FIGS. 2B-2C). The outer shaft is typically coupled to the proximal capsule portion 62, such that axial motion of the outer shaft relative to the mid and inner shafts transmits axial motion relative to the mid and inner shafts to the proximal capsule portion. To release the proximal portion of the medical device from within the proximal capsule portion, the outer shaft is typically retracted axially proximally relative to the mid and inner shafts, thereby retracting the proximal capsule portion from over the proximal portion of the medical device. (Note that relative proximal motion of the outer shaft relative to the mid and inner shafts may be accomplished by advancing the mid and inner shafts distally relative to the outer shaft, rather than retracting the outer shaft.)

[0069] The inner shaft 68 is typically coupled to the distal capsule portion 60 such that axial motion of the inner shaft transfers axial motion to the distal capsule portion. (Note that the rotational motion of the distal capsule portion is typically decoupled from the rotational motion of the inner shaft via a bearing mechanism 72, as described in more detail below with reference to FIGS. 4A-4C.) For some applications, the delivery device includes a distal device interface 74, which is configured to fix the distal portion of the medical device in a fixed axial position relative to the midshaft as long as the distal portion is retained within the distal capsule portion. For some applications, the distal device interface is a flange extending radially from the midshaft, as shown. To release the distal portion of the medical device from within the distal capsule portion, the inner shaft is typically advanced axially distally relative to the midshaft (typically using the techniques described below with reference to FIGS. 4A-4C). This causes the distal capsule portion to be advanced distally relative to the distal device interface. When the proximal end of the distal capsule portion is advanced beyond the distal device interface, the distal portion of the medical device is typically released from the distal device interface (typically via radial self-expansion of the distal portion of the medical device and / or by another mechanism as described herein above).

[0070] Reference is now made to Figures 4A, 4B, and 4C, which are schematic illustrations of the proximal and distal capsule portions 62, 60 of a delivery device at various stages of advancement of the distal capsule portion 60 relative to the proximal capsule portion 62, in accordance with some applications of the present invention. In some cases, it may be desirable to advance the distal capsule portion 60 relative to the proximal capsule portion 62 in a precisely controlled manner. For example, when used with the prosthetic mitral valve frame described in U.S. Patent Application Publication No. 2022 / 0015896 to Agian (herein incorporated by reference), it may be desirable to first release a middle portion of the valve frame (e.g., the radially expandable arms of the valve frame) from being covered by the distal capsule portion, without completely releasing the entire distal portion of the valve frame. Typically, to allow the physician to maintain precise control of the advancement of the distal capsule portion 60 relative to the proximal capsule portion 62, the physician uses a rotational control mechanism (e.g., mechanism 108 shown in FIG. 5 ) whose rotational motion is converted into axial motion of the inner shaft 68 (which is coupled to the distal capsule portion). For some such applications, the conversion from rotational motion to axial motion of the inner shaft 68 occurs at the distal end of the inner shaft, and typically within the capsule. It is noted that if the conversion from rotational motion to axial motion of the inner shaft 68 occurs at the proximal end of the inner shaft, the axial motion of the inner shaft would need to be transmitted along the entire length of the inner shaft before being transmitted to the distal capsule portion, which may result in inaccurate transmission of the axial motion to the distal capsule portion. In contrast, by converting the rotational motion to axial motion of the inner shaft 68 at the distal end of the inner shaft (in accordance with some applications of the present invention), the axial motion does not need to be transmitted along the entire length of the inner shaft before being transmitted to the distal capsule portion. Rather, the axial motion is transmitted from within the capsule to the distal capsule portion.

[0071] For some applications, the inner shaft 68 defines a threaded outer surface 76 at its distal end, and the inner surface of the distal device interface 74 (described hereinabove as typically a flange) and / or the intermediate shaft 66 are correspondingly threaded. The distal device interface 74 and / or the threaded inner surface of the intermediate shaft 66 act as a nut, such that rotation of the distal end of the inner shaft advances the inner shaft distally relative to the distal device interface 74. As described hereinabove, typically, the distal device interface 74 secures the distal end of the medical device, and more typically, axial motion of the inner shaft is transferred to the distal capsule portion. Thus, advancement of the inner shaft relative to the distal device interface 74 advances the distal capsule portion relative to the distal end of the medical device. As described hereinabove, for some applications, the distal capsule portion includes a bearing mechanism 72. The bearing mechanism is configured to isolate rotational motion of the distal capsule portion from rotational motion of the inner shaft. Thus, rotation of the inner shaft advances the distal capsule portion distally relative to the distal end of the medical device, but does not rotate the distal capsule portion.

[0072] It should be noted that the scope of the present application generally includes any capsule configured to contain a medical device upon delivery of the medical device to a deployed position and configured to maintain the medical device in a radially constrained configuration upon delivery of the medical device to a deployed position. The handle includes a rotation control mechanism (e.g., mechanism 108) configured to transmit a rotational motion to the capsule. A nut (e.g., the distal device interface 74 and / or the threaded inner surface of the intermediate shaft 66) that comprises a portion of the screw-nut mechanism is disposed within the capsule and configured to convert the rotational motion into an axial motion of a portion of the capsule, thereby releasing at least a portion of the medical device from within the capsule. For example, the capsule may include a single-piece capsule having a nut (e.g., the distal device interface 74 and / or the threaded inner surface of the intermediate shaft 66) disposed at one end of the capsule (e.g., the proximal or distal end), such that the entire capsule moves axially in response to a rotational motion.

[0073] Typically, once the medical device is released from within the capsule 40, the proximal and distal portions of the capsule are reconnected to one another before being retracted from the subject's body. For some applications, the capsule includes a guide portion defined by at least one of the distal and proximal capsule portions. The guide portion is configured to guide the distal and proximal capsule portions back to their connected configuration after the medical device is deployed. For example, as shown in Figures 4B-4C, for some applications, the proximal capsule portion defines a lip 80 at its distal end and the distal capsule portion defines a corresponding lip 82 at its proximal end, the lips 80 and 82 being shaped to slide into place relative to one another. Alternatively, only one of the capsule portions defines a lip, which lip is configured to receive the other capsule portion (not shown embodiment). Typically, the proximal and distal portions are shaped to define a substantially smooth exterior when properly connected to one another. In this manner, the capsule is atraumatic and does not damage the subject's tissue during advancement of the capsule to the medical device deployment position. Similarly, upon retraction of the capsule from the medical device deployment location, the capsule is atraumatic and does not damage the target tissue or the deployed medical device. For some applications, the lip described above is formed as a complete ring (as shown). For some applications (not shown), the lip, generally as described above, is divided into multiple separate arc-shaped segments. For example, the lip may be formed from four arc-shaped segments spaced 90 degrees apart from each other and each covering a 30 degree arc. In this manner, the medical device may be released before the entire capsule is removed, thus saving the height required to release the medical device.

[0074] 5 is a schematic diagram of a stage 90 and handle portion 92 of a delivery device according to some applications of the present invention. For some applications, the handle portion includes a first handle 94 configured to control steering of the outer steerable catheter 22, a second handle 96 configured to control steering of the inner steerable catheter 24, and a deployment handle 98 configured to control release of the medical device from the capsule 40.

[0075] Typically, the first handle 94 includes a first rotation control mechanism 100 for controlling the steering deflection cable 26 (configured to be manipulated by a user to steer the distal end of the outer steerable catheter through a first outer steerable catheter deflection plane toward the atrial septum of the subject). More typically, the first handle 94 includes a second rotation control mechanism 102 for controlling the height adjustment deflection cable 28 (configured to be manipulated by a user to deflect the distal end of the outer steerable catheter from within the left atrium toward the roof of the left atrium by steering the tip of the outer steerable catheter through a second outer steerable catheter deflection plane).

[0076] Typically, the second handle 96 includes a first rotational control mechanism 104 for controlling the first set of steering deflection cables 32 (configured to be manipulated by a user to steer the distal end of the inner steerable catheter through a first inner steerable catheter deflection plane toward the target mitral valve). More typically, the second handle 96 includes a second rotational control mechanism 106 for controlling the second set of steering deflection cables 34 (configured to be manipulated by a user to steer the distal end of the inner steerable catheter through a second inner steerable catheter deflection plane to align the distal end of the inner steerable catheter with the target mitral valve).

[0077] As described herein above, the deployment handle typically includes a rotational control mechanism 108 for controlling the axial movement of the distal capsule portion 60. More typically, the deployment handle includes a second rotational control mechanism 110 for controlling the axial movement of the proximal capsule portion 62. Typically, the handle portion includes a number of flushing ports through which the respective catheters and shafts are flushed.

[0078] Typically, the stage 90 is configured to position the handle portion 92 and allows for adjustment of the position of the handle portion. For some applications, the stage is configured to facilitate quick attachment of the handle portion to the stage, for example via a snap lock mechanism, without the need for any screws. For some applications, the stage is configured to facilitate modification of the orientation of the handle portion during a procedure to allow for realignment of the handle portion relative to the percutaneous access point.

[0079] Reference is now made to Figures 6A and 6B, which are schematic diagrams of a delivery device 20 according to some applications of the present invention. In general, the delivery device 20 shown in Figures 6A and 6B is similar to that shown in Figures 1A to 5, except for the differences described below. For some applications, the proximal end of the proximal capsule portion 62 defines a recess 118. Typically, the recess is sized to allow the proximal capsule portion to overlap with the distal end of the delivery catheter (e.g., the inner steerable catheter 24 of the delivery device 20 described herein above with reference to Figures 2A to 2C) as the proximal capsule portion is retracted. Typically, without this recess, there would need to be a gap between the distal end of the delivery catheter and the proximal capsule portion to allow the proximal capsule portion to be retracted relative to the delivery catheter (e.g., to release the proximal end of the implantable device). In contrast, when the proximal capsule portion includes the recess 118, the proximal capsule portion is typically disposed adjacent to the distal end of the delivery catheter even before the proximal capsule portion is retracted (as shown in Figure 6A). Alternatively, the proximal capsule portion partially overlaps the distal end of the delivery catheter even before the proximal capsule portion is retracted (embodiment not shown). Thereafter, when the proximal capsule portion 62 is retracted, the proximal end of the proximal capsule portion is overlapped (or further overlapped) with the distal end of the delivery catheter by the recess that slides over the distal end of the delivery catheter. Typically, the recess 118 allows the device to occupy less space (e.g., less height) within the left atrium than would otherwise be required by eliminating the need for a gap to exist between the distal end of the delivery catheter and the proximal capsule portion.

[0080] Reference is now made to FIG. 7, which is a schematic diagram of a delivery device 120 being percutaneously inserted into a subject's body through a puncture in the patient's skin 122 via a percutaneous introducer sheath 124, according to some applications of the present invention. Typically, the delivery device is used to deliver a medical device (e.g., medical device 21 shown in FIGS. 1C-1D) in a minimally invasive procedure in which the medical device is percutaneously inserted (through a puncture in the skin) to a deployment location where the device is to be deployed. Many such medical devices are deployed in the subject's vascular system and / or in the subject's heart via a puncture in the subject's vascular system. For example, such medical devices may include prosthetic valves (e.g., prosthetic mitral valves, prosthetic aortic valves, and / or prosthetic tricuspid valves), valve repair devices (e.g., edge-to-edge devices such as annuloplasty rings or mitral leaflet clips), stents, hole closure devices, and / or endovascular simulation devices. Typically, larger medical devices are inserted into the subject's vascular system via the femoral vein or femoral artery, while smaller devices are inserted via the radial vein or artery, or another vein or artery, depending on the deployment location. Typically, the delivery device is inserted through a percutaneous introducer sheath, through a puncture of the patient's skin and into the patient's vascular system. For some applications, delivery device 20 (described herein above with reference to Figures 1A-6B) is used as delivery device 120.

[0081] During delivery of the medical device to the deployment location, the medical device is typically maintained in a radially constrained (i.e., crimped) configuration within the delivery device. Once disposed at the deployment location, the medical device radially expands to the deployed configuration. In some cases, the medical device is configured to self-expand, while in other cases, the medical device radially expands in an active manner, for example via balloon inflation.

[0082] For some applications, the delivery device includes a capsule 126 at its distal end, which is configured to house the medical device in its radially constrained (i.e., crimped) configuration upon delivery of the medical device to the deployed position. For some such applications, the capsule is larger in diameter than a portion 128 of the delivery device proximal to the capsule. (As noted above, for some applications, delivery device 20 (described herein above with reference to FIGS. 1A-6B ) is used as the delivery device 120, in which case capsule 126 typically corresponds to capsule 40 and portion 128 typically corresponds to steerable outer catheter 22.) In some cases, the difference in width between the capsule and the portion of the delivery device proximal to the capsule can cause bleeding after the capsule is advanced through the vascular puncture. This is because insertion of the capsule widens the vascular puncture, so that the vascular wall surrounding the puncture does not seal against the portion of the delivery device proximal to the capsule and narrower than the capsule. Such problems can also occur with other forms of delivery devices having a widened distal portion and a proximal portion narrower than the widened distal portion. The scope of the present application is applicable mutatis mutandis to all such delivery devices.

[0083] According to some applications of the invention, the percutaneous introducer sheath is made of a stretchable material (e.g., an elastomer such as silicone or polyurethane). As described in more detail below, the percutaneous introducer sheath defines a lumen 130 that is sized to accommodate the portion of the delivery device proximal to the capsule in the unstretched state of the percutaneous introducer sheath. More typically, in the unstretched state of the percutaneous introducer sheath, the outer diameter of the sheath is approximately equal (or equal to) or greater than the outer diameter of the capsule. For some applications, the difference, if any, between the outer diameter of the percutaneous introducer sheath and the outer diameter of the capsule is less than 20 percent (e.g., less than 5 percent, or less than 2 percent) of the outer diameter of the capsule. Prior to inserting the percutaneous introducer sheath into the subject's body, the capsule is typically advanced through the lumen 130 by stretching the percutaneous introducer sheath so that the entire capsule is disposed distal to the distal end of the percutaneous introducer sheath (e.g., as shown in FIG. 7 ). The capsule is then advanced through the subject's skin and into the subject's vasculature, followed by the percutaneous introducer sheath. Typically, even after the vascular puncture has been widened by the capsule, the vessel wall surrounding the puncture seals against the outside of the percutaneous introducer sheath, since the outer diameter of the sheath is approximately equal to the outer diameter of the capsule. For some applications, during advancement of the delivery device through the subject's vasculature, the percutaneous introducer sheath is disposed to remain within the subject's skin and the puncture in the vasculature, and the portion 128 of the delivery device proximal to the capsule is advanced through the lumen 130.

[0084] It should be noted that the introducer sheath's stretchability allows it to be loaded onto the delivery device in the environment in which the procedure will be performed (e.g., a catheter lab). As noted above, in this environment and prior to inserting the percutaneous introducer sheath into the subject's body, the capsule is typically advanced through lumen 130 by stretching the percutaneous introducer sheath so that the entire capsule is disposed distal to the distal end of the percutaneous introducer sheath. In contrast, if the introducer sheath was not sufficiently stretchable, it would have to be placed around portion 128 of the delivery device in a clean room prior to the procedure as part of the delivery device assembly process (or a capsule having a smaller diameter would be required).

[0085] Reference is now made to FIG. 8, which is a schematic diagram of a percutaneous introducer sheath 124 according to some applications of the present invention. For some applications, the introducer sheath is a femoral introducer sheath and has an overall length L between 60 mm and 120 mm, for example between 70 mm and 110 mm. Typically, the femoral introducer sheath has an outer diameter D1 at its distal end between 8 mm and 12 mm, for example approximately 10 mm. For some applications, the diameter D2 of the lumen 130 defined by the introducer sheath is between 7 mm and 10 mm, for example approximately 8 mm, or approximately 9 mm. Typically, the smaller the lumen diameter, the more difficult it is to insert a capsule through the lumen and then advance a delivery device through the lumen. For some applications, the lumen is lubricated with a lubricant (e.g., a solid oil) before and / or during the procedure. For some applications (not shown), the introducer sheath includes a flushing port to facilitate flushing of the introducer sheath with a lubricant.

[0086] For some applications, the distal portion 132 of the introducer sheath is tapered, typically with both the outer diameter of the sheath and the diameter of the lumen narrowing within the distal portion. The tapering of the distal portion of the introducer sheath typically enhances the seal between the introducer sheath and the delivery device. In particular, the narrowing of the lumen within the distal portion typically forms a seal between the introducer sheath and the delivery device. For some applications, as a result of the formation of this seal, it is not necessary to provide forward flushing of the space between the introducer sheath and the delivery device. Typically, the proximal end of the introducer sheath includes a widened portion 134 to facilitate holding the introducer sheath in place by the medical professional. For some applications, the widened portion allows the medical professional to pull or push the introducer sheath during the procedure.

[0087] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove, but rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art and that would occur to one skilled in the art upon reading the foregoing description.

Claims

1. 1. An apparatus for use with a medical device, comprising: a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: a capsule configured to contain the medical device upon delivery of the medical device to the deployed position and configured to maintain the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; a handle comprising a rotational control component configured to transmit a rotational motion to the capsule; a motion conversion mechanism disposed within the capsule, the motion conversion mechanism configured to convert rotational motion into axial motion of a portion of the capsule, thereby releasing at least a portion of the medical device; An apparatus comprising:

2. The apparatus of claim 1 , wherein the motion conversion mechanism comprises a screw and nut mechanism.

3. The capsule comprises: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; 3. The apparatus according to claim 1 or claim 2, comprising:

4. 4. The apparatus of claim 3, wherein the delivery device further comprises a delivery catheter, and wherein a proximal end of the proximal capsule portion defines a recess such that the proximal end of the proximal capsule portion is configured to be retracted to overlap a distal end of the delivery catheter.

5. the distal capsule portion is coupled to a first shaft; The delivery device further comprises a distal device interface configured to secure a distal portion of the medical device, the distal device interface coupled to a second shaft; the motion conversion mechanism is configured to cause rotational motion of the first shaft relative to the second shaft to result in axial motion of the first shaft relative to the second shaft, thereby moving the distal capsule portion axially relative to the distal portion of the medical device.

4. The apparatus of claim 3.

6. The apparatus of claim 5 , wherein the delivery device further comprises a bearing mechanism configured to decouple rotational movement of the distal capsule portion from rotational movement of the first shaft.

7. The apparatus of claim 5 , wherein the motion conversion mechanism comprises a screw and nut mechanism.

8. 8. The apparatus of claim 7, wherein a surface of the first shaft is threaded and a surface of the second shaft is threaded such that rotational movement of the first shaft relative to the second shaft results in axial movement of the first shaft relative to the second shaft.

9. 8. The apparatus of claim 7, wherein a surface of the first shaft is threaded and a surface of the distal device interface is threaded such that rotational movement of the first shaft relative to the second shaft results in axial movement of the first shaft relative to the second shaft.

10. 1. An apparatus for use with a medical device, comprising: a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; a distal capsule portion and a proximal capsule portion configured to be reversibly connectable to one another such that (a) the distal capsule portion and the proximal capsule portion define a connected configuration in which the distal capsule portion and the proximal capsule portion define a substantially smooth outer surface, the distal capsule portion and the proximal capsule portion configured to be disposed in the connected configuration upon delivery of the medical device to the deployment location, and (b) the distal capsule portion and the proximal capsule portion are separable from one another to deploy the medical device by releasing the distal and proximal portions of the medical device from their radially constrained configuration; a guide portion defined by at least one of the distal capsule portion and the proximal capsule portion, the guide portion configured to guide the distal capsule portion and the proximal capsule portion back to their coupled configuration after the medical device is deployed; An apparatus comprising:

11. 11. The device of claim 10, wherein the guide portion comprises lips disposed at ends of the distal and proximal capsule portions, the lips being configured to overlap one another in the coupled configuration of the distal and proximal capsule portions.

12. 12. The apparatus of claim 10 or claim 11, wherein the delivery device further comprises a delivery catheter, and wherein a proximal end of the proximal capsule portion defines a recess such that the proximal end of the proximal capsule portion is configured to be retracted to overlap a distal end of the delivery catheter.

13. 1. An apparatus for use with a medical device, comprising: a delivery device configured to deliver the medical device to a deployment location within a subject's body, the delivery device comprising: A delivery catheter; a capsule disposed at a distal end of the delivery catheter, the capsule configured to contain the medical device during delivery of the medical device to the deployment location and to maintain the medical device in a radially constrained configuration during delivery of the medical device to the deployment location; a proximal end of the capsule defining a recess such that the proximal end of the capsule is configured to be retracted to overlap the distal end of the delivery catheter; An apparatus comprising:

14. The capsule comprises: a distal capsule portion configured to maintain a distal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; a proximal capsule portion configured to maintain a proximal portion of the medical device in a radially constrained configuration upon delivery of the medical device to the deployed position; Equipped with The device of claim 13 , wherein a proximal end of the proximal capsule portion defines the recess.

Images