Devices and methods for loading a transfer sleeve over a capsule of a medical device delivery system

Abstract

Loading devices for loading a transfer sleeve over a capsule of a catheter include a mechanical advantage to overcome the friction force between the transfer sleeve and the capsule.

Description

DEVICES AND METHODS FOR LOADING A TRANSFER SLEEVE OVER A CAPSULE OF A MEDICAL DEVICE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 624,498, filed January 24, 2024, and U.S. Provisional Patent Application Serial No. 63 / 675,554, filed on July 25, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present technology is generally related to medical devices, and, more particularly, to devices and methods for loading transfer sleeves over capsules of delivery systems for stents, prosthetic heart valves and other implantable medical devices.BACKGROUND

[0003] Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of leaflets of a heart valve may be treated with a prosthetic heart valve. A traditional surgical procedure to implant the prosthetic heart valve requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma and discomfort. Traditional surgical procedures may also require extensive recuperation times and may result in life-threatening complications. One alternative to a traditional surgical procedure is delivering implantable medical devices using minimally invasive techniques. For example, a prosthetic heart valve can be percutaneously and transluminally delivered to an implant location. In such methods, the prosthetic heart valve can be compressed or crimped into a delivery catheter for insertion within a patient's vasculature, advanced to the implant location, and re-expanded to be deployed at the implant location.

[0004] During certain procedures, components of a delivery system for the implantable medical device may need to be limited in size and shape due to a patient’s anatomy. For example, a capsule of a delivery system used in a transseptal mitral valve replacement procedure may need to be limited in length due to limited space in the heart chambers for tracking and deployment. Due to the limited length of the capsule, a portion of theimplantable medical device (e.g., a mitral prosthetic heart valve) remains exposed, i.e., is not contained within the capsule. When using implantable medical devices such as a mitral prosthetic heart valve with a tissue valve, the implantable medical device is loaded into the delivery system just prior to the medical procedure at the geographic site of the medical procedure (e.g., a hospital). During a typical loading procedure, the implantable medical device is loaded onto the delivery system under saline. Transfer sleeves and methods of use thereof for maintaining a flushed status of the implant of the system and the implant during transfer from the loading bath to insertion into the patient are disclosed in U.S. Patent Application No. 17 / 490,177 (U.S. Publication No. 2022 / 0104943), assigned to Medtronic Vascular, Inc., which is incorporated by reference herein in its entirety. In some cases, depending on factors such as the length of the capsule and the size of the medical implant, it may be difficult to load the transfer sleeve over the capsule and the medical implant. Thus, there is a need for devices and methods for loading a transfer sleeve over a capsule of a delivery system.SUMMARY

[0005] The techniques and devices of this disclosure generally relate to devices and methods for loading transfer sleeves over a capsule of a delivery system.

[0006] In one example of the present application, a system includes a delivery catheter including a capsule at a distal end thereof, an implantable medical device disposed within the capsule, and a loading device. The capsule includes an open proximal end. A proximal end of the implantable medical device extends proximally from the open proximal end of the capsule. The loading device comprises a funnel having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end. The proximal end of the central lumen has a first diameter and the distal end of the central lumen has a second diameter, wherein the first diameter is larger than the second diameter. The loading device is configured to be advanced proximally over the capsule such that the proximal end of the funnel passes over the implantable medical device and the distal end of the funnel is disposed over the proximal end of the implantable medical device such that the funnel radially compresses the proximal end of the implantable medical device.

[0007] In another example hereof, the system of any of the preceding or following examples further comprises a transfer sleeve, wherein the transfer sleeve is disposed overthe capsule such that a proximal end of the transfer sleeve is disposed adjacent a distal end of the funnel.

[0008] In another example hereof, in the system of any of the preceding or following examples, the transfer sleeve is configured to be advanced proximally over the implantable medical device and push the loading device proximally off of the implantable medical device.

[0009] In another example hereof, in the system of any of the preceding or following examples, the funnel comprises two halves split longitudinally.

[0010] In another example hereof, in the system of any of the preceding or following examples, the loading device further comprises wings extending radially from the funnel.

[0011] In another example hereof, a loading device comprises a first holder configured to hold a transfer sleeve, a second holder configured to hold a catheter having a capsule at a distal end thereof, and means for advancing one of the first holder or the second holder toward the second holder or the first holder such that the transfer sleeve is loaded over the capsule with a mechanical advantage.

[0012] In another example hereof, the loading device of any of the preceding or following examples further comprises: distal clamp; a sliding plate; a loading plate coupled to the sliding plate; a rail; and a screw drive, wherein the second holder is a proximal clamp, wherein the first holder is a space between a shoulder of the sliding plate and the loading plate, wherein the distal clamp is fixedly coupled to the rail, the sliding plate is sliding coupled to the rail, and the proximal clamp is fixedly coupled the rail, and wherein the screw drive is configured to push the sliding plate proximally such that the transfer sleeve is pushed over the capsule.

[0013] In another example hereof, in the loading device of any of the preceding or following examples, the loading device is configured to slide from a first position wherein the sliding plate with the loading plate coupled thereto is disposed adjacent the distal clamp and is spaced from the proximal clamp to a second position wherein the sliding plate with the loading plate coupled thereto is disposed closer to the proximal clamp than in the first position.

[0014] In another example hereof, in the loading device of any of the preceding or following examples, the loading plate defines a passageway extending longitudinally therethrough, the passageway configured to receive a portion of the catheter therein.

[0015] In another example hereof, in the loading device of any of the preceding or following examples, wherein the passageway is tapered in the distal direction.

[0016] In another example hereof, in the loading device of any of the preceding or following examples: the first holder comprises a sleeve holder coupled to a cup; the second holder comprises a connector configured to be coupled to the catheter and a receiver coupled to the connector, the capsule of the catheter configured to be disposed within a conduit of the receiver; the cup is configured to be rotatably advanced relative to the receiver to translate the sleeve holder relative to the catheter such that the transfer sleeve is loaded over the capsule, wherein rotatably advancing the cup provides the mechanical advantage.

[0017] In another example hereof, in the loading device of any of the preceding or following examples, the cup includes an inner thread and the receiver includes an outer thread, wherein the cup is configured to be rotatably advanced over the receiver via the inner thread and the outer thread.

[0018] In another example hereof, in the loading device of any of the preceding or following examples, the connector comprises a proximal cylindrical portion, a flared portion extending distally from the proximal cylindrical portion, and a distal cylindrical portion, wherein the proximal cylindrical portion and the flared portion include longitudinal wall sections and longitudinal gaps disposed between the longitudinal wall sections such that the proximal cylindrical portion is configured to be crimped onto the catheter.

[0019] In another example hereof, the loading device of any of the preceding or following examples further comprises a support configured to be disposed over the catheter and within the receiver, the support configured to reduce or prevent bucking of the catheter during loading of the transfer sleeve over the capsule.

[0020] In another example hereof, in the loading device of any of the preceding or following examples, the support comprises fins configured to extend through the longitudinal gaps in the flared portion of the of the connector.

[0021] In another example hereof, the loading device of any of the preceding or following examples further comprises: a rail; a first jaw fixedly coupled to the rail; a second jaw slidably coupled to the rail; a handle coupled to the second jaw; and a trigger configured to move the second jaw along the rail, thereby providing the mechanical advantage, wherein the first holder is coupled to the first jaw and the second holder is coupled to the second jaw.

[0022] In another example hereof, in the loading device of any of the preceding or following examples, the loading device includes a body and a rotatable knob mounted over the body, wherein the first holder is a portion of the body and the second holder is disposed within the knob rotatable knob.

[0023] In another example hereof, in the loading device of any of the preceding or following examples, the body includes a proximal end, a distal end, and a longitudinal conduit extending from the proximal end to the distal end, wherein the first holder and the second holder are disposed within the conduit.

[0024] In another example hereof, in the loading device of any of the preceding or following examples: a proximal portion of the body includes a threaded shaft and the rotatable knob includes threads configured to engage the threaded shaft such that the rotatable knob translates longitudinally as the know is rotated around the threaded shaft; the second holder is disposed within the rotatable knob and is configured to be translated within the conduit with the rotatable knob, the second holder comprising a catheter conduit configured to fixedly hold the catheter; a distal portion of the body includes arms forming a cavity as the second holder configured to hold the transfer sleeve therein.

[0025] In another example hereof, in the loading device of any of the preceding or following examples: the threaded shaft includes at least one longitudinal opening; and the second holder includes at least one tab extending through the at least one longitudinal opening, wherein the at least one tab extending through the at least one opening prevents rotation of the second holder when the rotatable knob is rotated.

[0026] In another example hereof, in the loading device of any of the preceding or following examples, the body, the rotatable knob, and the second holder are each longitudinally separable.

[0027] In another example of the present application, a transfer sleeve for use with a delivery system for an implantable medical device includes: a body, the body including a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; and an inflation cuff coupled to an inner surface of the body, the inflation cuff forming an inflation cavity, the inflation cuff including an uninflated configuration and an inflated configuration. The inflation cuff in the uninflated configuration has a first inner diameter that enables a distal portion of the delivery system to fit within the lumen. The inflation cuffin the inflated configuration forms a fluid tight cavity engaged with the distal portion of the delivery system.

[0028] In another example hereof, in the transfer sleeve of any of the preceding or following examples, the inflation cuff comprises a first inflation cuff coupled to the inner surface of the body adjacent the proximal end of the body and a second inflation cuff coupled to the body adjacent the distal end of the body, thereby forming two inflation cavities.

[0029] In another example hereof, in the transfer sleeve of any of the preceding or following examples, the inflation cavity is formed between an outer surface of the inflation cuff and the inner surface of the body.

[0030] In another example hereof, in the transfer sleeve of any of the preceding or following examples, the body comprises a flexible body portion configured to longitudinally compress and extend, wherein the flexible body portion stiffens in the inflated configuration to prevent longitudinal compression.

[0031] In another example hereof, in the transfer sleeve of any of the preceding or following examples, the body comprises a flexible body portion configured to longitudinally compress and extend, and the transfer sleeve further comprises a brace assembly removably coupled to the flexible body portion, wherein the brace assembly is configured to prevent longitudinal compression of the flexible body portion when coupled to the flexible body portion and the flexible body portion is configured to longitudinally compress with the brace assembly removed from the flexible body portion.

[0032] In another example of the present application, a method comprises: loading a transfer sleeve in an uninflated configuration onto a distal portion of a delivery system; inflating the transfer sleeve to form a fluid tight cavity surrounding the distal portion of the delivery system and securing the transfer sleeve to the delivery system; placing a distal end the delivery system into a proximal end of an introducer sheath; advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath; and deflating the transfer sleeve.

[0033] In another example hereof, the method of any of the preceding or following examples further comprises, after deflating the transfer sleeve, proximally retracting the transfer sleeve over the delivery system.

[0034] In another example hereof, in the method of any of the preceding or following examples, the transfer sleeve includes an inflation cuff disposed within and secure to a body; the inflation cuff forms an inflation cavity, and inflating the transfer sleeve comprises delivering an inflation fluid to the inflation cavity.

[0035] In another example hereof, in the method of any of the preceding or following examples, the transfer sleeve includes a plurality of inflation cuffs disposed within and secure to a body, the inflation cuffs form inflation cavities, and inflating the transfer sleeve comprises delivering an inflation fluid to the inflation cavities.

[0036] In another example hereof, in the method of any of the preceding or following examples, the transfer sleeve includes a flexible body configured to longitudinally compress and extend, and the method further comprises installing a brace assembly onto the flexible body to prevent the transfer sleeve from longitudinally compressing.

[0037] In another example hereof, the method of any of the preceding or following examples further comprises, after advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath, removing the brace assembly, and longitudinally compressing the transfer sleeve.

[0038] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0039] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings are not to scale.

[0040] FIGS. 1A-1C depict several illustrations of an example delivery system that may be used with transfer sleeves and loading devices disclosed herein.

[0041] FIG. 2A depicts an example of a transfer sleeve that may be used with the loading devices disclosed herein.

[0042] FIG. 2B depicts an illustration of the example transfer sleeve of FIG. 2A being loaded onto a capsule of the delivery system of FIG. 1A.

[0043] FIG. 2C depicts an illustration of the distal end of the delivery system of FIG. 1A with the transfer sleeve of FIG. 2A loaded thereon being loading into an introducer.

[0044] FIG. 3A depicts an illustration of a loading device for loading a transfer sleeve onto aa capsule of a loading system, according to embodiments hereof.

[0045] FIGS. 3B and 3C depict illustrations of the loading device of FIG. 3A being used to load a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0046] FIG. 4 depicts an illustration of a loading device for loading a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0047] FIGS. 5A-5F depict several illustrations of a loading device and a method for loading a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0048] FIGS. 6A-6L depict several illustrations of a loading device and a method for loading a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0049] FIGS. 7A-7E depict several illustrations of a loading device and a method for loading a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0050] FIG. 8A-8E depict several illustrations of a loading device and a method for loading a transfer sleeve onto a capsule of a loading system, according to embodiments hereof.

[0051] FIG. 9 depicts a perspective view of an inflatable transfer sleeve, according to embodiments hereof.

[0052] FIG. 10 depicts a side cross-sectional view of the transfer sleeve of FIG. 9 with an inflation cuff in an uninflated configuration, according to embodiments hereof.

[0053] FIG. 11 depicts a cross-sectional view of the transfer sleeve taken at a line A-A of FIG. 10, according to embodiments hereof.

[0054] FIG. 12 depicts a side cross-sectional view of the transfer sleeve of FIG. 9 with the inflation cuff in an inflated configuration, according to embodiments hereof.

[0055] FIG. 13 depicts a cross-sectional view of the transfer sleeve of FIG. 9 taken at a line B-B, according to embodiments hereof.

[0056] FIG. 14 depicts a method for using a transfer sleeve with a delivery system, according to embodiments hereof.

[0057] FIGS. 15-21 depict several illustrations of the method of FIG. 14 performed using the transfer sleeve of FIG. 9, according to embodiments hereof.

[0058] FIG. 22 depicts a perspective view of a transfer sleeve, according to embodiments hereof.

[0059] FIG. 23 depicts a side cross-sectional view of the transfer sleeve of FIG. 22 with a plurality of inflation cuffs in an uninflated configuration, according to embodiments hereof.

[0060] FIG. 24 depicts a cross-sectional view of the transfer sleeve taken at a line A-A of FIG. 23, according to embodiments hereof.

[0061] FIG. 25 depicts a cross-sectional view of the transfer sleeve taken at a line B-B of FIG. 23, according to embodiments hereof.

[0062] FIG. 26 depicts a side cross-sectional view of the transfer sleeve of FIG. 22 with the plurality of inflation cuffs in an inflated configuration, according to embodiments hereof.

[0063] FIG. 27 depicts a cross-sectional view of the transfer sleeve taken at a line C-C of FIG. 25, according to embodiments hereof.

[0064] FIG. 28 depicts a cross-sectional view of the transfer sleeve taken at a line D-D of FIG. 25, according to embodiments hereof.

[0065] FIGS. 29-35 depict several illustrations of the method of FIG. 14 performed using the transfer sleeve of FIG. 22, according to embodiments hereof.

[0066] FIG. 36 depicts a perspective view of a transfer sleeve, according to embodiments hereof.

[0067] FIG. 37 depicts a side cross-sectional view of the transfer sleeve of FIG. 36 in an uninflated configuration and a longitudinally compressed state, according to embodiments hereof.

[0068] FIG. 38 depicts a side cross-sectional view of the transfer sleeve of FIG. 36 in an uninflated configuration and a longitudinally extended state, according to embodiments hereof.

[0069] FIG. 39 depicts a cross-sectional view of the transfer sleeve taken at a line A-A of FIG. 38, according to embodiments hereof.

[0070] FIG. 40 depicts a side cross-sectional view of the transfer sleeve of FIG. 38 in the longitudinally extended state with an inflation cuff in an inflated configuration, according to embodiments hereof.

[0071] FIG. 41 depicts a cross-sectional view of the transfer sleeve taken at a line B-B of FIG. 40, according to embodiments hereof.

[0072] FIG. 42 depicts a brace assembly of the transfer sleeve of FIG. 38, according to embodiments hereof.

[0073] FIG. 43 depicts a side view of the transfer sleeve with the brace assembly of FIG.42, according to embodiments hereof.

[0074] FIGS. 44-52 depict several illustrations of a method of loading the transfer sleeve of FIG. 36 onto a delivery system and inserting the delivery system into an introducer sheath, according to embodiments hereof.DETAILED DESCRIPTION

[0075] Specific embodiments of the present disclosure are now described with reference to the figures. The following detailed description describes examples of embodiments and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof is in the context of a delivery system that may be used with an implantable medical device, the present technology may also be used in other devices. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0076] The terms “distal” and “proximal”, when used in the following description to refer to a delivery system or catheter are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positions distant from, or in a direction away from the treating clinician, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician.

[0077] Embodiments disclosed herein are directed to devices and methods for loading transfer sleeves onto a delivery system for implantable medical devices. In embodiments, the devices and methods provide a mechanical advantage for the transfer sleeve to be disposed over a capsule and a heart valve prosthesis partially disposed within the capsule.

[0078] FIGS. 1A-1C illustrate an example of a delivery system 100 for which the devices and methods disclosed herein can be used. One skilled in the art will realize that FIGS. 1A-1C illustrate one example of a delivery system, that the devices and methods disclosed herein can be used with other delivery systems, and that existing components illustrated in FIGS. 1A-1C may be removed and / or additional components may be added to the delivery system 100.

[0079] As shown in FIG. 1A, the delivery system 100 generally comprises a catheter portion 102 having a distal portion 104. The catheter portion 102 is coupled to a control handle portion 106 by which the catheter portion 102 is manipulated to deliver an implantable medical device 150, e.g., a prosthetic heart valve including a prosthetic valve structure and a stent, to an implant location and to deploy the implantable medical device 150 at the implant location. The catheter portion 102 is preferably of a length and size so as to permit a controlled delivery of the distal portion 104 to the implant location, e.g., a patient's heart. In embodiments, the catheter portion 102 includes features to enhance maneuverability, steerability and advancement of the distal portion 104 to the implant location. As discussed in further detail below, the distal portion 104 provides the means by which an implantable medical device 150 can be mounted for delivery to the implant location and further enables the expansion of the implantable medical device 150 for effective deployment thereof. The control handle portion 106 preferably controls movements as translated to the distal portion 104 by way of elongate structure of the catheter portion 102. Controlled functionality from the control handle portion 106 is preferably provided in order to permit expansion and deployment of the implantable medical device 150 at a desired location, such as a heart valve annulus, and to provide for ease in the delivery and withdrawal of the delivery system through a patient's vasculature.

[0080] The catheter portion 102 of the delivery system 100 also preferably comprises an outer shaft 108 that is also operatively connected with the control handle portion 106 and that surrounds one or more inner shafts, such as an inner shaft 110, over at least a part of its length. The inner shaft 110 includes a flexible portion 112 that allows maneuverability, steerability and advancement of the distal portion 104 to the implant location. In embodiments, the outer shaft 108 comprises a lubricous inner layer (such as high-density polyethylene HDPE or Polytetrafluoroethylene PTFE), braided stainless steel middle layer with a flexible plastic outer layer, such as comprised of Pebax 7233, or Nylon 12. The outershaft 108 extends from the control handle portion 106 and facilitates the advancement and steering of the delivery system through a patient's vasculature by improving the pushability of the delivery system 100. There may be additional inner shafts within the inner shaft 110.

[0081] The inner shaft 110 is operatively connected with the control handle portion 106 so as to be movable by operation of the control handle portion 106. As illustrated in FIG. IB, which is an enlarged view of the distal portion 104, an implantable medical device 150 is coupled to the inner shaft 110 in a compressed (non-expanded) configuration for delivery to the implant location. A capsule 114 is removably placed over a portion of the implantable medical device 150. The capsule 114 operates to protect the implantable medical device 150 during delivery to the implant location through a patient’s vasculature. In embodiments, the capsule 114 can be reduced in length, e.g., axial length, to allow fortracking and deployment of the implantable medical device 150. For example, during a transseptal mitral valve replacement procedure, the inner shaft 110 can be bent at the flexible portion 112 to steer the implantable medical device 150 (e.g., a mitral prosthetic heart valve) through chambers of a patient’s heart. For example, the control handle portion 106 can include an adjustable handle control 132 that can be manipulated, e.g., rotated, to deflect the flexible portion 112 of the inner shaft 110. As such, the capsule 114 can be limited in length to prevent interference with the flexible portion 112 of the inner shaft 110 when installed over the implantable medical device 150. Due to the reduced length ofthe capsule 114, aportion 152 of the implantable medical device 150 may not be contained within the capsule 114, e.g., a brim of the implantable medical device 150.

[0082] Once the implantable medical device 150 is positioned at the implant location, the capsule 114 can be removed from the implantable medical device 150, and the implantable medical device 150 can be transitioned from a compressed configuration to an uncompressed (expanded) configuration to engage native anatomy at the implant location. For example, the implantable medical device 150 can be loaded over a shaft assembly (not shown) that is coupled to the inner shaft 110. The implantable medical device 150 can be compressively retained within the capsule 114. The shaft assembly can include a retention member (e.g., spindle) which is configured to selectively receive corresponding features of the implantable medical device 150 (e.g., paddles, posts, or eyelets). In some embodiments, as shown, the capsule 114 can be advanced distally to uncover the implantable medicaldevice 150, such as by advancing an inner shaft (not shown) distally relative to the inner shaft 110, with the inner shaft (not shown) coupled to the capsule 114.

[0083] In some embodiments, the implantable medical device 150 can be selfexpanding. For example, the implantable medical device 150 can be constructed of a material that transitions from the compressed configuration to the uncompressed configuration when the capsule 114 is removed and the implantable medical device 150 is decoupled from the inner shaft 110. For example, a stent or frame of the implantable medical device can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol) that is self-expandable from the compressed configuration to the expanded configuration, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). In some embodiments, the implantable medical device 150 can be expanded using expansion devices such as a balloon.

[0084] In order to deliver the implantable medical device 150 to the implant location, e.g., track a prosthetic heart valve to a patient’s heart, a clinician first establishes percutaneous access to a patient's vasculature. In embodiments, as illustrated in FIG. 1C, an introducer 160 can be utilized in combination with the delivery system 100 for establishing access to the patient’s vasculature. As illustrated in FIG. 1C, the introducer 160 includes a sheath portion 164 and a handle or hub portion 162 attached at a proximal end of the sheath portion 164. The sheath portion 164 can be a tubular structure that defines a central or interior lumen from the proximal end to a distal end (not shown) of the sheath portion 164. The hub portion 162 can include a distal portion 165 coupled to the proximal end of the sheath portion 164 and a proximal portion 163 that has an enlarged diameter relative to the distal portion 165. The hub portion 162 can define a central or interior lumen that can decrease, e.g., taper, in diameter from the proximal portion 163 to the distal portion 165, where the interior lumen of the hub portion 162 couples to the interior lumen of the sheath portion 164 at the connection of the hub portion 162 and the sheath portion 164. The hub portion 162 defines an entry port 166 in which the catheter portion 102 of the delivery system 100 can be inserted. In some embodiments, the hub portion 162 can include a flush tube 170 coupled to the interior lumen of the handle portion 162 by a port 168.

[0085] In embodiments, in a method of providing percutaneous access to a patient's vasculature, the introducer 160 can be inserted into a vessel, e.g., a femoral, brachial, or radial artery, using a puncture needle (not shown) inserted through the skin and into thevessel. Once the puncture needle is inserted into the vessel, the introducer sheath can be advanced over the puncture needle and a dilator (not shown) until the distal end of the sheath portion 164 the introducer 160 enters the vessel thereby providing access to the vessel. Once inserted into the vessel and the puncture needle and dilator are removed, the introducer 160 can hold a tract open and protect the vessel from trauma as the catheter portion 102 of the delivery system 100 is introduced into the vessel therethrough. That is, the distal portion 104 of the catheter portion 102 can be inserted into the entry port 166 through the lumens of the hub portion 162 and the sheath portion 164, thereby entering the vessel.

[0086] In embodiments, the implantable medical device 150 needs to be protected and maintained in a sterile environment after being loaded onto the catheter portion 102 and prior to the catheter portion 102 being inserted through the introducer 160 into a patient’s vasculature. To achieve this, a transfer sleeve can be utilized to protect the implantable medical device 150 during the transfer and introduction to a patient’s body through the introducer 160. FIG. 2A illustrates an example of a transfer sleeve 200. The transfer sleeve 200 of FIG. 2A includes a proximal end 202, a distal end 204, and a lumen 206 extending from the proximal end 202 to the distal end 204. The transfer sleeve 200 includes a hub 208 and a shaft 210 extending distally from the hub 208. One skilled in the art will realize that FIG. 2A illustrates one example of a transfer sleeve and that existing components illustrated in FIGS. 2A may be removed and / or additional components may be added to the transfer sleeve 200. Additional details of the example transfer sleeve 200 may be found in U.S. Patent Application No. 17 / 490,177 (U.S. Publication No. 2022 / 0104943), assigned to Medtronic Vascular, Inc., which is incorporated by reference herein in its entirety. Further, the present application is not limited to being used with the transfer sleeve 200, and may be used with other transfer sleeves or modifications of the transfer sleeve 200.

[0087] As explained above, the transfer sleeve 200 is disposed over the capsule 114 and the implantable medical device 150. As shown in FIG. 2B the transfer sleeve 200 and delivery system 100 may be moved towards each other such that the distal end of the capsule 114 is inserted into the proximal end 202 of the transfer sleeve 200. The transfer sleeve 200 and delivery system 100 are moved until the transfer sleeve 200 is disposed capsule 114 and over the portion of the implantable medical device 150 proximal of the capsule 114, as shown in FIGS. 2B and 2C. The delivery system 100 the transfer sleeve 200 disposed overthe capsule 114 and the implantable medical device 150 may then be inserted into the introducer 160, as shown in FIG. 2C.

[0088] As explained above, in some cases, it may be difficult to push the transfer sleeve 200 over the capsule 114 and the portion of the implantable medical device 150 proximal of the capsule 114. Thus, the present disclosure is directed to devices and methods to assist a user in loading the transfer sleeve 200 over the capsule 114 and the portion of the implantable medical device 150 proximal of the capsule.

[0089] FIGS. 3A-3C show a loading device 300 configured to assist in loading a transfer sleeve over a capsule and an implantable medical device. The transfer sleeve may be the transfer sleeve 200 or another transfer sleeve. The capsule may be the capsule 114 of the delivery system 100 or other capsules or parts of a delivery system. The implantable medical device may be the implantable medical device 150 or other implantable medical devices. One skilled in the art will realize that FIGS. 3A-3C illustrate one example of a loading device and that existing components illustrated in FIGS. 3A-3C may be removed and / or additional components may be added to the loading device 300. The loading device 300 shown in FIG. 3A includes a first or proximal end 302, a second or distal end 304, and a central passage or lumen 306 extending from the proximal end 302 to the distal end 304. The central lumen 306 is tapered in the distal direction such that the central lumen 306 has a first diameter DI at the proximal end 302 and a second diameter D2 at the distal end 304, with the first diameter DI being larger than the second diameter D2. Thus, the loading device 300 may be funnel. In a non-limiting example, the first diameter DI may be about 0.683 inch and the second diameter D2 may be in the range of about 0.390 inch. However, this is not meant to be limiting, and other diameters may be used. In particular, the diameters and the length of the loading device 300 may be varied to provide a draft angle 6 in the range of about 2.5 degrees to about 15 degrees. The diameter D2 should be the desired compressed diameter of the implantable medical device 150 disposed on the delivery system. In embodiments, the second diameter D2 is about the same diameter as the capsule 114, only slightly larger.

[0090] In operation, the proximal end 302 with the first (larger) diameter DI is aligned with the distal end of the capsule 114. The delivery system 100 and loading device 300 are moved towards each other (e.g., by moving the loading device 300 proximally while holding the capsule 114 in place, by moving the capsule 114 distally while holding the loadingdevice 300, or by moving the capsule 114 and the loading device 300 in opposite directions towards each other). Because the larger diameter proximal end 302 of the loading device 300 first encounters the portion of the implantable medical device 150 proximal of the capsule 114, the force required to move the loading device 300 of the implantable medical device 150 is reduced. The loading device 300 is loaded over the capsule 114 and the implantable medical device 150 until the distal end 304 of the loading device 300 is proximal of the proximal end of the capsule 114, as shown in FIG. 3B.

[0091] With the loading device 300 in place, the transfer sleeve 200 may be positioned over the distal portion 104 of the delivery system 100. In particular, the distal end of the capsule 114 is located adjacent the proximal end 202 of the transfer sleeve 200. The transfer sleeve 200 and the capsule 114 are translated relative to each other such that the capsule 114 is inserted through the lumen 206 of the transfer sleeve 200, as shown in FIG. 3C (e.g., by moving the transfer sleeve 200 proximally while holding the capsule 114 in place, by moving the capsule 114 distally while holding the transfer sleeve 200 in place, or by moving the capsule 114 and the transfer sleeve 200 in opposite directions towards each other). As the transfer sleeve 200 is moved proximally over the capsule 114, the proximal end 202 of the transfer sleeve 200 extends over the portion of the implantable medical device 150 proximal of the capsule 114. However, due to the loading device 300, the portion of the implantable medical device 150 proximal of the capsule 114 is radially compressed, thus making it easier for the transfer sleeve 200 to be moved over the implantable medical device 150. As the transfer sleeve 200 continues to be moved proximally relative to the capsule 114, the transfer sleeve 200 pushes the loading device 300 proximally, thereby compressing the implantable medical device 150 as the implantable medical device 150 enters the lumen 206 of the transfer sleeve 200. After the transfer sleeve 200 is located over the implantable medical device 150 (as shown in FIG. 2C), the loading device 300 can remain disposed over the shaft 110 of the delivery system 100, or can be removed therefrom, such as by being formed of two separable halves, as described below.

[0092] FIG. 4 shows a loading device 350 similar to the loading device 300 shown in FIGS. 3A-3C. One skilled in the art will realize that FIG. 4 illustrates one example of a loading device and that existing components illustrated in FIG. 4may be removed and / or additional components may be added to the loading device 350. In particular, the loading device 350 includes a first or proximal end 352, a second or distal end 354, and a centralpassage or lumen 356 extending from the proximal end 352 to the distal end 354. The central lumen 356 is tapered in the distal direction such that the central lumen 356 has a first diameter at the proximal end 352 and a second diameter D2 at the distal end 354, with the first diameter being larger than the second diameter. Thus, the loading device 350 may be funnel. The first diameter DI may be about 0.683 inch and the second diameter D2 may be in the range of about 0.390 inch. However, this is not meant to be limiting, and other diameters may be used. In particular, the diameters and the length of the loading device 350 may be varied to provide a draft angle in the range of about 2.5 degrees to about 15 degrees, as described above. The diameter D2 should be the desired compressed diameter of the implantable medical device 150 disposed on the delivery system. In embodiments, the second diameter D2 is about the same diameter as the capsule 114, only slightly larger.

[0093] The loading device 350 includes a first body 358A and a second body 358B that are joined together at a joint line 360. Thus, the loading device 350 is split longitudinally such that the loading device 350 may be removed from the delivery system 100 by separating the first body 358A from the second body 358B. In the embodiment shown in FIG. 4, each of the first body 358A and the second body 358B includes respective proximal wings 362A, 362B and distal wings 364A, 364B. In the embodiment shown, each of the proximal wings 362A, 362B includes two openings 368A, 368B and each of the distal wings 364A, 364B includes two openings 366A, 366B. The openings are generally transverse to the longitudinal axis of the loading device 350. The openings 368A, 368B are aligned and the openings 366A, 366B are aligned such that connectors (not shown) may extend therethrough to couple the first body 358A and the second body 358B together. The connectors (not shown) may be removable such that the loading device 350 may be removed from the delivery system 100 without the loading device 350 having to slide over either end of the delivery system. In a non-limiting example, the connectors (not shown) may be screws, bolts, or similar connectors. In other embodiments, the first and second bodies 358A, 358B may be removably coupled together such a by press-fitting protrusions (not shown) extending transversely from the first body 358A into cavities (not shown) extending transversely into the second body 358B. Other ways to removably couple the first body 358A andthe second body 358B are also contemplated, as would be apparent to those skilled in the art.

[0094] As in the embodiment of FIGS. 3A-3C, the loading device 350 may be used to assist in loading the transfer sleeve 200 over the capsule 114 and the implantable medical device 150. In particular, with the first and second bodies 358A, 358B coupled to each other, the proximal end 352 with the first (larger) diameter is aligned with the distal end of the capsule 114. The delivery system 100 and loading device 350 are moved towards each other (e.g., by moving the loading device 350 proximally while holding the capsule 114 in place, by moving the capsule 114 distally while holding the loading device 350 in place, or by moving the capsule 114 and the loading device 350 in opposite directions towards each other). Because the larger diameter proximal end 352 of the loading device 350 first encounters the portion of the implantable medical device 150 proximal of the capsule 114, the force required to move the loading device 300 of the implantable medical device 150 is reduced. The loading device 350 is loaded over the capsule 114 and the implantable medical device 150 until the distal end 354 of the loading device 350 is proximal of the proximal end of the capsule 114.

[0095] With the loading device 350 in place, the transfer sleeve 200 may be positioned over the distal portion 104 of the delivery system 100. In particular, the distal end of the capsule 114 is located adjacent the proximal end 202 of the transfer sleeve 200. The transfer sleeve 200 and the capsule 114 are translated relative to each other such that the capsule 114 is inserted through the lumen 206 of the transfer sleeve 200 (e.g., by moving the transfer sleeve 200 proximally while holding the capsule 114 in place, by moving the capsule 114 distally while holding the transfer sleeve 200 in place, or by moving the capsule 114 and the transfer sleeve 200 in opposite directions towards each other). As the transfer sleeve 200 is moved proximally over the capsule 114, the proximal end 202 of the transfer sleeve 200 extends over the portion of the implantable medical device 150 proximal of the capsule 114. However, due to the loading device 350, the portion of the implantable medical device 150 proximal of the capsule 114 is radially compressed, thus making it easier for the transfer sleeve 200 to be moved over the implantable medical device 150. As the transfer sleeve 200 continues to be moved proximally relative to the capsule 114, the transfer sleeve 200 pushes the loading device 350 proximally, thereby compressing the implantable medical device 150 as the implantable medical device 150 enters the lumen 206 of the transfer sleeve 200. After the transfer sleeve 200 is located overthe implantable medical device 150 (as shown in FIG.2C), the loading device 350 can remain removed from the delivery system 100 (i.e., the shaft 110) by separating the first and second bodies 358A, 358B from each other.

[0096] FIGS. 5A-5F show a loading device 400 according to embodiments herein. One skilled in the art will realize that FIGS . 5 A-5F illustrate one example of a loading device and that existing components illustrated in FIGS. 5A-5F may be removed and / or additional components may be added to the loading device 400. The loading device 400 includes mechanical assistance for loading the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, as explained below. The loading device 400 includes a distal clamp 410, a sliding plate 420, a loading plate 430, a rail 450, a proximal clamp 460, and a screw drive 470. The loading device 400 includes a first position with the movable plate 420 adjacent the distal clamp 410, shown in FIGS. 5A, 5B, and 5E, and a second position with the sliding plate 420 adjacent the proximal clamp 460, shown in FIGS. 5C, 5D, and 5F.

[0097] As shown in FIGS. 5A-5F, the distal clamp 410 includes a distal base plate 412 and a distal cover plate 413. The distal base plate 412 and the distal cover plate 413 may be coupled together using screws or similar connectors inserted through openings 416 in the distal cover plate 413 and the distal base plate 412 (see FIG. 5C for one of the openings 416 in the base plate 412). Mating surfaces 414 of the distal base plate 412 and the distal cover plate 413 include depressions or grooves 415, 417, respectively, which together form a longitudinal opening through which a threaded shaft 472 of the screw drive 470 is disposed. Further, a washer 476 is disposed in the longitudinal opening defined between the distal base plate 412 and the distal cover plate 413. The washer 476 includes a threaded central opening 477 through which the threaded shaft 472 of the screw drive 470 is disposed. As can be seen in FIGS. 5A and 5B, the groove 415 in the distal base plate 412 continues proximal of the distal cover plate 413, and the threaded shaft 472 of the screw drive 470 is disposed in the groove 415. The distal base plate 412 further includes a groove 419 configured (e.g., shaped) for receiving the rail 450. The distal clamp 410 is configured to remain stationary during operation of the loading device 400, as described below. In particular, the distal clamp 410 is stationary relative to the rail 450.

[0098] As shown in FIGS. 5A-5F, the proximal clamp 460 includes a proximal base plate 462A and a proximal cover plate 462B. The proximal base plate 462A and the proximal cover plate 462B may be coupled together using screws or similar connectorsinserted through openings 464 in the proximal cover plate 462B and the proximal base plate 462A. Mating surfaces 465 of the proximal base plate 462A and the proximal cover plate 462B include depressions or grooves 466A, 466B, respectively, which together form a longitudinal opening through which a shaft of a delivery system may be disposed (see FIG. 5F). The proximal base plate 462A further includes a groove 468 configured (e.g., shaped) for receiving the rail 450. The proximal clamp 460 is configured to remain stationary during operation of the loading device 400, as described below. In particular, the proximal clamp 460 is stationary relative to the rail 450.

[0099] As also shown in FIGS. 5A-5F, the sliding plate 420 is disposed between the proximal clamp 460 and the distal clamp 410. The sliding plate 420 includes a sliding base plate 422 including a groove 426 (See FIG. 5C) configured (e.g. shaped) to slidingly receive the rail 450 therein. The groove 426 enables the sliding plate 420 to slide along the rail 450 between the proximal clamp 460 and the distal clamp 410. The sliding plate 420 further includes a first upper surface 421 for receiving the loading plate 430 thereon, a first shoulder 423 extending upwardly from a distal end of the first upper surface 421, a second upper surface 425 extending distally from an upper end of the first shoulder, and a second shoulder 427 extending upwardly from a distal end of the second upper surface 425. The first upper surface 421 includes openings 424 configured to receive screws or other connectors (not shown) to couple the loading plate 430 to the first upper surface 425. The second upper surface 425 is configured to receive the transfer sleeve 200 between the second shoulder 427 and the loading plate 430, as shown in FIGS. 5E and 5F.

[0100] The loading plate 430 includes a base loading plate 432A and a cover loading plate 432B. The base loading plate 432A and the cover loading plate 432B include aligned openings 434 configured to receive screws or other connectors to couple the base loading plate 432A and the cover loading plate 432B together. Further, the openings 434 are aligned with the openings 424 in the sliding plate 420 to couple the loading plate 430 to the sliding plate 420. When assembled, the loading plate 430 includes a passageway 436 extending from a proximal end to a distal end of the loading plate 430. In the embodiment shown, the passageway 436 includes a proximal cylindrical portion 437A and a tapered portion 437B. The tapered portion 437B includes a proximal end 438 having a first diameter that is larger than a second diameter at a distal end 439 of the tapered portion 437B. Although the passageway 436 is described as having a tapered portion, it need not have a tapered portionbecause the mechanical advantage provided by the screw drive 470, as described below, provides sufficient force to load the transfer sleeve 200 over the capsule 114 and the implantable medical device 150. As shown in FIGS. 5C, 5E, and 5F the distal end 439 of the passageway 436 is aligned with a proximal end of the lumen 206 of the transfer sleeve 200. The passageway 436 is configured to receive the capsule 114 with the implantable medical device 150 leading therein, as shown in FIGS. 5E and 5F.

[0101] The rail 450 extends between and is coupled to the proximal clamp 460 and the distal clamp 410. As explained above, the rail 450 is fixedly coupled to the proximal clamp 460 and the distal clamp 410. A central portion of the rail 450 is configured to slidably receive the sliding plate 420. The rail 450 may include a shape 454 that corresponds to the shape of the groove 426 in the sliding plate 420 such that the sliding plate 420 slides along the rail 450 linearly without moving off-axis.

[0102] The screw drive 470 includes the threaded shaft 472 and a knob 474. As explained above, the threaded shaft 472 extends through the threaded washer 476 disposed within the grooves 415, 417 in the distal base plate 412 and distal cover plate 413, and extends proximally within the groove 415 of the distal base plate 412. A proximal end 478 of the threaded shaft 472 abuts against a distal surface 428 of the sliding plate 420.

[0103] With the parts of the loading device 400 described, its usage to load the transfer sleeve 200 over the capsule 114 of the delivery system 100 with the implantable medical device 150 disposed therein is described with respect to FIGS. 5E and 5F. As shown in FIGSS. 5E, the sliding plate 420 is in a distal position such that the distal surface 428 of the sliding plate abuts a proximal surface of the distal base plate 412. The delivery system 100 is held in place by the proximal clamp 460, with the capsule 114 of the delivery system 100 with the implantable medical device 150 disposed therein distal of the proximal clamp 460. It is understood that although FIG. 5E shows the capsule 114 disposed within the passageway 436 of the loading plate 430, this is not meant to be limiting. The capsule 114 may be disposed just proximal of the loading plate 430 if the mechanical advantage of the screw drive 470 is desired for the entire length of the passageway 436. Such an embodiment would merely entail increasing the distance between the proximal clamp 460 and the distal clamp 410 such that there is a longer travel path of the sliding plate 420 (a longer screw drive 470 may also be required). However, in the embodiment shown, due to the tapered passageway 436, such a mechanical advantage may not be needed for the entire length ofthe capsule 114 and the implantable medical device 150, although such a mechanical advantage may still be used with a tapered passageway 436, if desired.

[0104] In order to load the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, the knob 474 is turned, thereby advancing the threaded shaft 472 proximally. The proximal end 478 of the threaded shaft 472 pushes against the distal surface 428 of the sliding plate 420, thereby forcing the sliding plate 420 and the loading plate 430 mounted thereon proximally. As explained above, the transfer sleeve 200 is held between the loading plate 430 and the second shoulder 427 of the sliding plate 420 such that the transfer sleeve 200 moves proximally with the sliding plate 420 and the loading plate 430. With the delivery system 100 held in place by the proximal clamp 460, as the sliding plat 420, loading plate 430, and transfer sleeve 200 are move proximally relative to the delivery system 100, the transfer sleeve 200 is forced over the capsule 114 and the implantable medical device 150 as the capsule 114 and the implantable medical device 150 exit the distal end 439 of the passageway 436 of the loading plate 430. It is noted that in this embodiment, the capsule 114 and the implantable medical device 150 exit the distal end 439 of the passageway 436 via movement of the loading plate 430 proximally relative to a stationary delivery system 100.

[0105] As shown in FIG. 5F, when the sliding plate 420 is moved proximally until a proximal surface of the sliding plate 420 and / or the loading plate 430 abuts a distal surface of the proximal clamp 460, the transfer sleeve 200 will be loaded over the capsule 114 and the implantable medical device 150. The cover loading plate 462B and the proximal cover plate 432B may be removed from the base loading plate 462A and the proximal base plate 432A, respectively, such as by removing screws from the openings 434 and 464, respectively. The delivery system 100 can then be removed from the loading device 400 with the transfer sleeve disposed over the capsule 114 and the implantable medical device 150 for insertion into the patient, as described above with respect to FIGS. 2A-2C.

[0106] FIGS. 6A-6L show a loading device 500 according to embodiments herein. One skilled in the art will realize that FIGS. 6A-6L illustrate one example of a loading device and that existing components illustrated in FIGS. 6A-6L may be removed and / or additional components may be added to the loading device 500. The loading device 500 is configured for loading the transfer sleeve 200 over the capsule 114 and the implantable medical device150, as explained below. The loading device 500 includes a rotatable cup 510, a sleeve holder 520, a receiver 530, a connector 540, a support 550, and a clamp 570.

[0107] The rotatable cup 510 includes an open proximal end 511, a distal end 512, and a cavity 513. An outer wall 514 extends from the proximal end 511 to the distal end 512 and defines the cavity 513. The distal end 512 includes a base 515 extending radially inward from the outer wall 514. The base 515 includes an opening 516 at a central portion thereof. The opening 516 is sized as shaped to receive a portion of the sleeve holder 520 therein. The cup 510 further includes a thread 517 at a proximal end of the outer wall 514. The thread 517 is configured to mate with a corresponding thread on the receiver 530, as described below.

[0108] The sleeve holder 520 is configured to couple the transfer sleeve 200 to the cup 510. The sleeve holder 520 includes a proximal end 521, a distal end 522, and a conduit 523 extending from the proximal end 521 to the distal end 522. The sleeve holder 520 is generally tubular and includes two radial extensions 524 at the proximal end 521. The proximal end 521 further includes two depressions or notches 525 (FIG. 6D) configured to receive the hub 208 of the transfer sleeve 200 and to prevent the transfer sleeve 200 from rotating relative to the sleeve holder 520. The distal end 522 of the sleeve holder 520 includes a shoulder 526 such that the shoulder 526 abuts against the base 515 of the cup 510 and a distal portion of the sleeve holder 520 distal of the shoulder 526 extends within the opening 516 in the base 515 of the cup 510. This rotatably couples the sleeve holder 520 to the cup 510.

[0109] The receiver 530 includes a proximal end 531, a distal end 532, and a conduit 533 extending from the proximal end 531 to the distal end 532. The received is generally tubular and includes an outer wall 534 that defines the conduit 533. The outer wall 534 further includes outer threads 535 extending radially outward along at least a portion of the length of the outer wall. The outer threads 535 are configured to engage the thread 517 of the cup 510, as described below. The proximal end 531 further includes inner threads 536 (FIG. 6B) extending radially inward from the inner surface of the outer wall 534. The inner threads 536 are configured to engage outer threads of the connector 540, described below.

[0110] The connector 540 is configured to couple the catheter 102 to the receiver 530. The connector 540 includes a proximal cylindrical portion 541, a flared portion 542 extending distally from the proximal cylindrical portion 541, and a distal cylindrical portion543. The proximal cylindrical portion 541 and the flared portion 542 include three longitudinal wall sections 544 and three longitudinal gaps 545. The wall sections 544 and gaps 545 enable the connector 540, and in particular the proximal cylindrical portion 541, to crimp onto the catheter 102, as described below. The distal cylindrical portion 543 includes threads 546 on an outer surface thereof configured to engage the inner threads 536 of the receiver. The diameter of the distal cylindrical portion 543 is such that the distal cylindrical portion 543 can be coupled to the receiver via the outer threads 546, inner threads 536. The diameter of the proximal cylindrical portion 541 is such that the proximal cylindrical portion 541 can be clamped onto the catheter 102 via the clamp 560. The flared portion 542 flares from the smaller diameter of the proximal cylindrical portion 541 to the larger diameter of the distal cylindrical portion 543. A conduit 547 extends through the proximal cylindrical portion 541, the flared portion 542, and the distal cylindrical portion 543.

[0111] The support 550 is configured to provide additional support for the catheter 102 to minimize or prevent buckling of the catheter 102 during loading of the transfer sleeve 200 over the capsule 114. The support 550 is generally tubular including a wall 551 defining a conduit 552 sized to fit over a portion of the catheter 102 proximal of the capsule 114, as shown in FIG. 6C. The support 550 further includes fins 553 extending radially outward from the wall 551. In the embodiment shown, there are three fins 553 to match the gaps 545 in the connector 540 as each fin 553 extends radially through a corresponding gap 545. However, this is not meant to be limiting, and there may be more or fewer fins 553 and the quantity of fins 553 may match or not match the quantity of gaps 545.

[0112] The clamp 560 is configured to couple the proximal cylindrical portion 541 of the connector 540 to the catheter 102. The clamp 560 may be any type of clamp that enables a user to crimp the longitudinal wall sections 544 of the proximal cylindrical portion 541 of the connector 540 onto the catheter 102. In the example shown, the clamp 560 is a hose clamp including a loop portion 561, a worm gear 563, and a screw 562 that interacts with the worm gear 563 to tighten or loosen the loop portion 561. However, this is not meant to be limiting, and other types of clamps or crimpers may be used. For example, and not by way of limitation, a loop clamp without a worm gear may be utilized.

[0113] With the parts of the loading device 500 described, a method of loading the transfer sleeve 200 over the capsule 114 (with the implantable medical device 150 loadedin the capsule 114) will now be described. As shown in FIG. 6D, the sleeve holder 520 is coupled to the cup 510. In particular, the portion distal of the shoulder 526 is disposed in the opening 516 in the base 515 of the cup 510 such that the shoulder 526 of the sleeve holder 520 abuts the base 515. As also shown in FIG. 6D, the connector 540 is coupled to the catheter 102 via the clamp 560 and the connector 540 is coupled to the receiver 530 via the corresponding outer threads 546 on the connector 540 and inner threads 536 at the proximal end of the receiver 530. As shown in FIG. 6C, the support 550 is around the catheter 102 within the receiver 530, with the fins 553 thereof extending through the gaps 545 in the flared portion 542 of the connector 540, as shown in FIG. 6D. The capsule 114 is disposed within the conduit 533 of the receiver 530.

[0114] As shown in FIG. 6E the transfer sleeve 200 is inserted into the sleeve holder 520 with the arms of the hub 208 disposed in the notches 525 of the sleeve holder 520. As shown in FIG. 6F, the cup 510 is then aligned with the receiver 530 such that the capsule 114 is aligned with the opening at the proximal end 202 of the transfer sleeve 200, and the cup 510 and the receiver 530 are brought together. As shown in FIG. 6G, the cup 510 is rotated as indicated by the arrow in FIG. 6G such that the cup 510 advances proximally relative to the receiver 530 via the cooperating threads 517 at the proximal end 511 of the cup 510 and the outer threads 535 on the receiver 530. As the cup 510 is advanced proximally, the transfer sleeve 200 is pushed over the capsule 114 by the base 515 of the cup 510 pushing against the sleeve holder 520, which pushes the transfer sleeve 200. The threaded engagement between the cup 510 and the receiver 530 provides a mechanical advantage for pushing the transfer sleeve 200 over the capsule 114.

[0115] As shown in FIG. 6H, the cup 510 is advanced until the distal end of the receiver 530 abuts the base 515 of the cup 510 and / or the threads 517 of the cup 510 reach the proximal limit of the threads 535 of the receiver. As shown by the arrow in FIG. 61, the cup 510 may then be rotated in the opposite direction such that the cup 510 travels distally with respect to the receiver 530. The transfer sleeve 200 will remain disposed over the capsule 114, i.e., the transfer sleeve will not move distally with the cup 510, because the friction force between the capsule 114 and the transfer sleeve 200 is greater than the friction force between the transfer sleeve 200 and the sleeve holder 520. As shown in FIG. 6J, the cup 510 is removed from the receiver 530, leaving the transfer sleeve 200 disposed over the capsule114. The screw 562 of the clamp 560 may then be loosened such that the connector 540 is not coupled to the catheter.

[0116] As shown in FIG. 6K, the connector 540, support 550, and receiver 530 may be removed from the catheter 102, such as by sliding them proximally, leaving the catheter 102 with the transfer sleeve 200 disposed over the capsule 114, as shown in FIG. 6L. The catheter 102 may then be inserted into the introducer 160, as explained above.

[0117] FIGS. 7A-7E show a loading device 600 to embodiments herein. One skilled in the art will realize that FIGS. 7A-7E illustrate one example of a loading device and that existing components illustrated in FIGS. 7A-7E may be removed and / or additional components may be added to the loading device 600. The loading device 600 includes mechanical assistance for loading the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, as explained below. The loading device 600 includes a distal jaw 610 including a holder 620, a movable proximal jaw 630 including a clamp 640, a rail 650, a handle 660, a trigger 670, and a release trigger 680.

[0118] The distal jaw 610 is fixed to the rail 650. In the embodiment shown, the distal jaw 610 is fixed to the distal end of the rail 650. In operation, the distal jaw 610 does not move relative to the rail 650. The distal jaw 610 includes a holder 620 coupled thereto. In the embodiment shown, the holder 620 is a tube sized and shaped to receive the distal end 204 of the transfer sleeve 200, as shown in FIGS. 7A-7B.

[0119] The proximal jaw 630 includes the clamp 640. In particular, the proximal jaw includes an upper or first surface 632. The clamp 640 includes a corresponding lower or second surface 642 that is configured to mate with the first surface 632 of the proximal jaw 632, such as using bolts or screws 636 through corresponding openings 634, 644, or other coupling devices. When coupled together, the proximal jaw 630 and the clamp 640 form a longitudinal passageway 646 for clamping on the catheter 102 such that when the proximal jaw 630 moves the catheter 102 moves with it, as described below.

[0120] The proximal jaw 630 is slidably attached to the rail 650. As in conventional trigger clamps, movement of the movable proximal jaw 630 along the rail 650 is actuated by squeezing the trigger 670 towards the handle 660. Actuation of the trigger 670 pulls the movable proximal jaw 630 along the rail 650 by a predefined amount with each squeeze of the trigger 670, so that multiple squeezes of the trigger 670 are utilized to pull the movable proximal jaw 630 towards the distal jaw 610. It may be appreciated that the movementmechanism of the movable proximal jaw 630 is configured to apply additional force with each squeeze of the trigger 670, so that an increased or desired clamping or spreading force is applied. It may be appreciated that in the trigger 670 and handle 660 may have generally complementary shapes. In some embodiments, a secondary release trigger 680 may be provided to disengage the incremental movement action of the movable proximal jaw 630 relative to the rail 650, so that the movable proximal jaw 630 may freely slide in both directions along the rail 650 (e.g., towards or away from the distal jaw 610). Accordingly, the release trigger 680 may be used to disengage the movable proximal jaw 630 such as after the capsule 114 and implantable medical device 150 are disposed within the transfer sleeve.

[0121] Accordingly, in a method of using the loading device 600 to load the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, transfer sleeve 200 is disposed within the holder 620 of the distal jaw 610. The catheter 102 is held in the passageway 646 defined by the clamp 640 and the proximal jaw 630. The clamp 640 is coupled to the proximal jaw 630 such that the catheter 102 moves with the proximal jaw 630 and does not slide relative to the proximal jaw 630. The catheter 102 is held by the clamp 640 such that the capsule 114 and the implantable medical device 150 are disposed distal of the clamp 640. In particular, in an embodiment, a length of the catheter 102 distal of the clamp 640 is at least equal to an overall length of the transfer sleeve 200 from the proximal end 202 to the distal end 204 of the transfer sleeve 200.

[0122] The trigger 670 may then be squeezed repeatedly to advance the proximal jaw 630, and hence the catheter 102 distally towards the distal jaw 610. The proximal jaw 630 is distally advanced until the implantable medical device 150 is disposed within the transfer sleeve 200, as shown in FIG. 7D. The clamp 640 may then be removed such that the catheter 102 is no longer held between the clamp 640 and the proximal jaw 630. The proximal jaw 630 may then be retracted, such as by activating the release trigger 680 and pulling the proximal jaw 630 proximally.

[0123] The transfer sleeve 200 with the capsule 114 and the implantable medical device 150 may then be removed from the holder 620, as shown in FIG. 7E.

[0124] It should be understood that although the embodiment of FIGS. 7A-7E has been described with the holder 620 for the transfer sleeve 200 coupled to the distal (fixed) jaw 610 and the clamp 640 for the catheter 102 coupled to the proximal (movable) j aw 630, thiscould be reversed. In such an embodiment, the clamp 640 would be coupled to the distal (fixed) jaw 610 with the catheter 102 clamped therein such that the capsule 114 extends towards the proximal (movable) jaw 630. The holder 620 for the transfer sleeve 200 would be coupled to the proximal (movable) jaw 630 with the proximal end 202 of the transfer sleeve 200 facing the distal (fixed) jaw 610. Squeezing the trigger 670 causes the proximal jaw 630 and the transfer sleeve 200 coupled thereto to move towards distal jaw 610, and over the capsule 114 and implantable medical device 150 extending proximally from the clamp 640 coupled to distal jaw 610. The catheter 102 can then be released from the clamp 640 and the catheter 102 with the transfer sleeve 200 loaded over the capsule 114 and the implantable medical device 150 removed from the loading device 600, as described above.

[0125] FIGS 8A-8E show a loading device 700 to embodiments herein. One skilled in the art will realize that FIGS. 8A-8E illustrate one example of a loading device and that existing components illustrated in FIGS. 8A-8E may be removed and / or additional components may be added to the loading device 700. The loading device 700 includes mechanical assistance for loading the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, as explained below. The loading device 700 includes a body 710, a rotatable knob 740 mounted over the body 710, and a holder 770 disposed within the knob 740 and the body 710.

[0126] The body 710 of the loading device 700 includes a proximal end 712, a distal end 714, and a longitudinal passageway or conduit 716 extending from the proximal end 712 to the distal end 714. In the embodiment shown, the body 710 comprises two body halves 710A, 710B split along a longitudinal axis such that the introducer 160, the transfer sleeve 200, and the catheter 102 may be disposed within the conduit 716. In the embodiment shown, the two halves 710A, 710B are coupled together at a proximal clamp 718 and a distal clamp 722. In particular, the proximal clamp 718 includes first and second arms 719A, 719B extending radially from the first body half 710A of the body 710 and first and second arms 720A, 720B extending radially from the second body half 710B of the body 710. The proximal clamp 718 also defines a proximal portion of the conduit 716. Each arm 719A, 719B, 720A, 720B includes a corresponding opening 721A, 721B, 721C, 721D disposed therethrough. Accordingly, the first arm 719A of the first body half 710A is aligned with the first arm 720A of the second body half 710B such that openings 721 A, 72 IB thereof are aligned. Similarly, the second arm 719B of the first body half 710A is aligned with thesecond arm 720B of the second body half 710B such that openings 721C, 721D thereof are aligned. A screw (not shown) or similar coupling device is inserted through the aligned holes to couple the proximal ends 712 of the first and second body halves 710A, 71 OB together. Similarly, the distal clamp 722 includes first and second arms 723A, 723B extending radially from the first body half 710A of the body 710 and first and second arms 724A, 724B extending radially from the second body half 710B of the body 710. The distal clamp 722 also defines a distal portion of the conduit 716. Each arm 723A, 723B, 724A, 724B includes a corresponding opening 725A, 725B, 725C, 725D disposed therethrough. Accordingly, the first arm 723 A of the first body half 710A is aligned with the first arm 724A of the second body half 710B such that openings 725A, 725B thereof are aligned. Similarly, the second arm 723B of the first body half 710A is aligned with the second arm 724B of the second body half 710B such that openings 725C, 725D thereof are aligned. A screw (not shown) or similar coupling device is inserted through the aligned holes to couple the distal ends 714 of the first and second body halves 710A, 710B together.

[0127] The body 710 further includes a threaded shaft 726 extending distally from the proximal clamp 718. The threaded shaft 726 is formed of two halves as the threaded shaft 726 is part of the body 710 formed of the two body halves 710A, 710B. The threaded shaft 726 includes threads 728 disposed on an outer surface thereof, with the threads 728 configured engage with corresponding threads on the rotatable knob 740, as described below. The threaded shaft 726 is hollow such that the threaded shaft 726 defines a portion of the conduit 716. Further, the threaded shaft 726 includes two openings 730 (only one opening 730 is shown in FIG. 8A) defined where the two halves of the threaded shaft 726 meet. Thus, the openings 730 are disposed diametrically opposed from each other and define a channel extending from one of the openings 730, through the conduit 716, and through the other of the openings 730. The openings 730 run longitudinally along at least a portion of the threaded shaft 726. The openings 730 are configured to receive a portion of the holder 770 therethrough, as described below.

[0128] The body 710 further includes a receiving portion 732 extending distally from the threaded shaft 726. The receiving portion 732 extends from the threaded shaft 726 to the distal clamp 722. The receiving portion 732 is defined by two arms 734A, 734B, each arm 734A, 734B extending distally and longitudinally from a corresponding body half 710A, 710B of the threaded shaft 726. The arms 734A, 734B define a cavity 736 configured toreceive the transfer sleeve 200 and the hub 162 of the introducer 160, as described below. Therefore, the arms 734A, 734B are sized and shaped to receive the transfer sleeve 200 and the hub 162 therein.

[0129] The rotatable knob 740 is a generally cylindrical knob that is disposed over the threaded shaft 726 of the body portion 710 of the loading device 700. In the embodiment shown, the rotatable knob 740 is formed of two knob halves 740A, 740B that are joined to form the rotatable knob 740. When joined, the rotatable knob 740 defines a channel 742 configured to receive the holder 770 therein, as described below. Each knob half 740A, 740B includes a semi-circular outer wall 744 with sidewalls 746, 748 extending radially inwardly from proximal and distal ends of the outer wall 744, thereby forming the channel 742. The sidewalls 746, 748 include threads 747, 749, respectively, extending radially inwardly. The threads 747, 749 are configured to interact with the threads 728 of the threaded shaft 726 such that the rotatable knob 740 may be rotated about the threaded shaft 726 and move longitudinally along the threaded shaft 726, as explained below. Each knob half 740A, 740B may further include corresponding openings 750, 751 that are aligned when the knob halves 740A, 740B are mated. A screw 752 or similar connector inserted through the aligned openings 750, 751 couples the knob halves 740A, 740B together.

[0130] The holder 770 of the loading device 700 is disposed within the conduit 716 of the body 710 and is configured to hold the catheter 102. In particular, the holder 770 is configured to translate longitudinally through the conduit 716 while gripping the catheter 102 such that the capsule 114 and the implantable medical device 150 are pushed into the transfer sleeve 200, as described below. The holder 770 includes a holder body 772 defining a catheter conduit 774 extending longitudinally therethrough. The catheter conduit 774 is sized to tightly hold the catheter 102 such that the catheter 102 does not slide relative to the holder 770. The holder body 772 may include a cylindrical portion 776 with an outside diameter approximately equal, but a slightly smaller, than a diameter of the conduit 716 such that the cylindrical portion 776 may slide within the conduit 716. The body 772 further includes tabs 778, 779 extending radially outwardly. The tabs 778, 779 are disposed diametrically opposed from each other and are sized and shaped to extend through the openings 730 in the threaded shaft 726 and are sized and shaped with be reside within the channel 742 ofthe rotatable knob 740. The holder body 772 ofthe holder 770 may be formedin two halves that are coupled together, such as with screws or other connectors extending throughout openings in the body halves 772.

[0131] Accordingly, in a method of using the loading device 700 to load the transfer sleeve 200 over the capsule 114 and the implantable medical device 150, the transfer sleeve 200 is disposed within the cavity 736 defined by the arms 734A, 734B, as shown in FIGS. 8C-8E. In the embodiment shown, the introducer hub 162 is also disposed in the cavity 736, with the transfer sleeve 200 disposed within the introducer hub 162, as shown in FIGS. 8C- 8E. In particular, the shaft 210 of the transfer sleeve 200 is disposed within the introducer hub 162, and the hub 208 of the transfer sleeve 200 abuts the proximal portion 163 of the introducer hub 162 at the entry port 166 thereof, as shown in FIGS. 8C-8E. Further, the introducer sheath 164 extends distally from the introducer hub 162, as shown in FIG. 8E. The catheter 102 is disposed within the catheter conduit 774 of the holder 770. With the holder 770 positioned at the proximal end of the openings 730 such that the rotatable knob 740 is disposed at the proximal end of the threaded shaft 726, the capsule 114 is disposed proximally adjacent the proximal end 202 of the transfer sleeve 200.

[0132] The rotatable knob 740 may then be rotated about the threaded shaft 726. Because the holder 770 cannot rotate (due to the tabs 778, 779 extending through the openings 730), rotation of the knob 740 causes the knob 740 to advance distally along the threads 728 of the threaded shaft 726 thereby translating the holder 770 distally within the conduit 716. Because the catheter 102 is fixedly held by the holder 770, the catheter 102 advances with the holder 770, thereby pushing the capsule 114 and the implantable medical device 150 into the transfer sleeve 200. When the knob 740 reaches the distal end of the threads 728, the capsule and the implantable medical device 150 is at the desired location within the transfer sleeve, and the loading device 700 may be removed from the catheter 102, such as by separating the halves of the parts, leaving the catheter 102 with the capsule 114 and the implantable medical device 150 disposed within the transfer sleeve 200 (and within the introducer hub 162 in the embodiment shown).

[0133] As described previously, it is desirable to protect and maintain implantable medical in a sterile environment after being loaded onto the delivery system and prior to being inserted through an introducer into a patient’s vasculature. As also described above, to achieve such protection and maintain sterility, a transfer sleeve over a distal portion of the delivery system, including at least a proximal portion of a capsule of the delivery systemand the implantable medical device, thereby preventing contamination as the implantable medical device and the distal portion of the delivery system is transferred from a sterile loading bath and introduced into the vasculature of the patient. As shown in FIGS. 1A and IB, in delivery systems with reduced length capsules, a portion of the implantable medical device may not be contained within the capsule. As also described above, in some cases, it may be difficult to push the transfer sleeve over the capsule and the portion of the implantable medical device not contained within the capsule of the delivery system.

[0134] The above embodiments describe devices to provide a mechanical advantage to push a transfer sleeve over the capsule and the implantable medical device. Embodiments shown in FIGS. 9-53 illustrate inflatable transfer sleeves such that the inflatable transfer sleeve may be located over the capsule and implantable medical device in an uninflated configuration, and then inflated to secure the inflatable transfer sleeve to the capsule and the implantable medical device. Embodiments of the inflatable transfer sleeves described herein may be utilized with delivery systems such as, but not limited to, the delivery system 100 described previously.

[0135] FIGS. 9-13 illustrate a transfer sleeve 800 according to embodiments hereof. The transfer sleeve 800 includes a body 802 and an inflation cuff 830. FIGS. 9-11 show a perspective view, a longitudinal cross-section, and a cross-sectional view, respectively, of the transfer sleeve 800 with the inflation cuff 830 in an uninflated configuration. FIGS. 12- 13 show a longitudinal cross-sectional view and a cross-sectional view of the transfer sleeve 800 with the inflation cuff 830 in an inflated configuration.

[0136] In embodiments herein, the transfer sleeve 800 is configured to be positioned or disposed over a distal portion of a delivery system, e.g., the delivery system 100, and an implantable medical device, e.g., the implantable medical device 150 described previously. In greater detail, the transfer sleeve 800 may be disposed over a portion of the capsule 114 of the delivery system 100, the portion 152 of the implantable medical device 150 not received within the capsule 114 of the delivery system 100, and a distal portion of the flexible portion 112 of the delivery system 100, as shown in FIG. IB. When the inflation cuff 830 of the transfer sleeve 800 is in the inflated configuration and engaged with the distal portion of the delivery system 100, the inflation cuff 830 forms a fluid tight cavity 824 around the distal portion of the delivery system 100, thereby providing and maintaining a sterile and air tight environment for the implantable medical device 150 disposed therein,as described below. The sterile and air tight environment prevents contamination of and air ingress into the implantable medical device 150, for example, and not by way of limitation, during transfer of the delivery system 100 from a loading bath to a patient table.

[0137] The body 802 of the transfer sleeve 800 may be a substantially rigid cylindrical tube including a proximal end 804, a distal end 806, and a lumen 808 extending from the proximal end 804 to the distal end 806, as shown in FIGS. 9 and 10. The lumen 808 is sized to receive the distal portion of the delivery system 100 therein. The body 802 further includes an opening 810 extending from an outer surface 812 of the body 802 to an inner surface 814 of the body 802, as shown in FIGS. 10-11. The opening 810 is in fluid communication with an inflation cavity 822 defined between an outer surface 838 of the inflation cuff 830 and the inner surface 814 of the body 802. An inflation port 820 may be coupled to the opening 810 to provide fluid access to the inflation cavity 822. In embodiments herein, the body 802 may be formed of materials such as, but not limited to polymeric materials such as polycarbonate, acrylic, nylon, and polyethylene terephthalate glycol (PETG). In embodiments herein, a longitudinal length of the body 802 may be in a range of 1 inches to 6 inches. In embodiments herein, an outer diameter of the body 802 may be in a range of about 0.400 inch to about 0.700 inch and an inner diameter of the body 802 may be in a range of about 0.300 inch to about 0.600 inch or about 20 French (FR) to about 45 French (FR).

[0138] The inflation cuff 830 may be a flexible tube including a proximal end 832, a distal end 834, and a lumen 836 extending therethrough. The inflation cuff 830 further includes the outer surface 838 and an inner surface 840. In embodiments herein, the inflation cuff 830 is disposed within the lumen 808 of the body 802 of the transfer sleeve 800, as shown in FIGS. 10 and 11. The proximal end 832 of the inflation cuff 830 is sealingly coupled to the inner surface 814 of the body 802 at or near the proximal end 804 of the body 802. The distal end 834 of the inflation cuff 830 is sealing coupled to the inner surface 814 of the body 802 at or near the distal end 806 of the body 802. The inflation cavity 822 is formed between the inner surface 814 of the body 802 and the outer surface 838 of the inflation cuff 830. In embodiments herein, the inflation cuff 830 includes the uninflated configuration, as shown in FIGS. 9-11, and the inflated configuration, as shown in FIGS. 12-13. In embodiments herein, a first inner diameter ID1 of the inflation cuff 830 in the uninflated configuration is larger than a second inner diameter ID2 of the inflation cuff 830in the inflated configuration. Thus, the inner diameter of the lumen 836 of the inflation cuff 830 in the inflated configuration is smaller than the inner diameter of the lumen 836 of the inflation cuff 830 in the uninflated configuration. The inflation cuff 830 may be formed of materials such as, but not limited to, polyethylene terephthalate (PET), polyether block amide (PEBAX), Nylon, high density polyethylene (HDPE), silicone, polyurethane, or other suitable polymeric materials. The inflation cuff 830 may be coupled to the body 802 by methods including, but not limited to adhesives and fusing, non-limiting fusing examples including heat bonding and ultrasonic welding. In embodiments herein, a longitudinal length of the inflation cuff 830 will be smaller than or equal to the length of the body 802. Accordingly, the longitudinal length of the inflation cuff 830 may be in the range of 1 inches to 6 inches. When the inflation cuff 830 is in the uninflated configuration, the inner diameter of the lumen 836 of the inflation cuff 830 may be in a range of about 0.300 inch to about 0.600 inch. When the inflation cuff 830 is in the inflated configuration, the inner diameter of the lumen 836 of the inflation cuff 830 may be in a range of about 0.150 inch to about 0.450 inch.

[0139] FIGS. 22-28 illustrate a transfer sleeve 1000 according to embodiments hereof. In the embodiment of FIGS. 22-28, the transfer sleeve 1000 includes a body 1002, a first inflation cuff 1030, and a second inflation cuff 1050. The first and second inflation cuffs 1030, 1050 each include an uninflated configuration, as shown in FIGS. 22-25, and an inflated configuration, as shown in FIGS. 26-28. Similar to the transfer sleeve 800 described previously, the transfer sleeve 1000 is configured to be disposed over a distal portion of a delivery system. When the first and the second inflation cuffs 1030, 1050 are each in the inflated configuration, the transfer sleeve 1000 forms a fluid tight cavity 1024 around the distal portion of the delivery system, as described below.

[0140] The body 1002 of the transfer sleeve 1000 may be a substantially rigid cylindrical component and includes a proximal end 1004, a distal end 1006, and a lumen 1008 extending from the proximal end 1004 to the distal end 1006, as shown in FIGS. 22 and 23. The lumen 1008 is sized to receive the distal portion of a delivery system therein. The body 1002 further includes an opening 1010 extending from an outer surface 1012 of the body 1002 to an inner surface 1014 of the body 1002, as shown in FIGS. 22-23. The opening 1010 is in fluid communication with an inflation lumen 1070, as described below. An inflation port 1020 may be coupled to the opening 1010 to provide fluid access to theinflation lumen 1070. The body 1002 may be formed of materials similar to the body 802 of FIGS. 9-13, described previously. In embodiments herein, a longitudinal length of the body 1002 may be in a range of about 1 inch to about 6 inches. An outer diameter of the body 1002 may be in a range of about 0.400 inch to about 0.700 inch and an inner diameter of the body 1002 may be in a range of about 0.300 inch to about 0.600 inch.

[0141] The first inflation cuff 1030 may be a flexible, tubular structure having a proximal end 1032, a distal end 1034, and a lumen 1036 extending from the proximal end 1032 to the distal end 1034, as shown in FIG. 23. The first inflation cuff 1030 includes an outer surface 1038 and an inner surface 1040. In embodiments herein, the first inflation cuff 1030 is disposed within a proximal portion of the lumen 1008 of the body 1002 of the transfer sleeve 1000. The proximal end 1032 of the first inflation cuff 1030 is sealingly coupled to the inner surface 1014 at or near the proximal end 1004 of the body 1002. The distal end 1034 of the first inflation cuff 1030 is sealing coupled to the inner surface 1014 of the body 1002 distal of the proximal end 1032. A first inflation cavity 1022 is formed between the inner surface 1014 of the body 1002 and the outer surface 1038 of the first inflation cuff 1030. The first inflation cuff 1030 includes the uninflated configuration and the inflated, as shown in FIGS. 23-24 and FIGS. 26-27, respectively. In embodiments herein, a first inner diameter ID1 of the first inflation cuff 1030 in the uninflated configuration is larger than a second inner diameter ID2 of the first inflation cuff 1030 in the inflated configuration.

[0142] The second inflation cuff 1050 is similar in construction to the first inflation cuff 1030. Accordingly, the second inflation cuff 1050 may be a flexible, tubular structure including a proximal end 1052, a distal end 1054, a lumen 1056, an outer surface 1058, and an inner surface 1060. The second inflation cuff 1050 is disposed within a distal portion of the lumen 1008 of the body 1002 of the transfer sleeve 1000 and is sealingly coupled to the inner surface 1014 of the body 1002 at or near the distal end 1006 of the body 1002. More precisely, the distal end 1054 of the second inflation cuff 1050is sealingly coupled to the inner surface 1014 of the body 1002 at or near the distal end 1004 of the body 1002, and the proximal end 1052 of the second inflation cuff 1050 is sealingly coupled to the inner surface 1014 of the body 1002 proximal of the distal end 1004 of the body 1002 and proximal of the distal end 1054. A second inflation cavity 1026 is formed between the inner surface 1014 of the body 1002 and the outer surface 1058 of the second inflation cuff 1050. Similarto the first inflation cuff 1030, the second inflation cuff 1050 includes the uninflated configuration, as shown in FIG. 23 and FIG. 25, and the inflated configuration, as shown in FIG. 26 and FIG. 28. In embodiments herein, a third inner diameter ID3 of the second inflation cuff 1050 in the uninflated configuration is larger than a fourth inner diameter ID4 of the second inflation cuff 1050 in the inflated configuration.

[0143] In embodiments herein, the first inflation cuff 1030 and the second inflation cuff 1050 each may be formed of materials such as, but not limited to, polyethylene terephthalate (PET), poly ether block amide (PEBAX), Nylon, high density polyethylene (HDPE), silicone, polyurethane, or other suitable polymeric materials. The first inflation cuff 1030 and the second inflation cuff 1050 may be coupled to the body 1002 by methods including, but not limited to, fusing and adhesives. In embodiments herein, a longitudinal length of the first inflation cuff 1030 and the second inflation cuff 1050 may each be in a range of about 0.100 inch to about 1.00 inch. When the first and second inflation cuffs 1030, 1050 are each is in the uninflated configuration, the first and third inner diameters of the lumen 1036, 1056 may be in the range of about 0.300 inch to about 0.600 inch, and when in inflated configuration, the second and fourth inner diameters may the range of about 0. 150 inch to about 0.450 inch.

[0144] As shown in FIG. 23, the transfer sleeve 1000 further includes the inflation lumen 1070. The inflation lumen 1070 extends generally longitudinally within the lumen 1008 of the body 1002, from a first end 1072 to a second end 1074. The first end 1072 is in fluid communication with the first inflation cavity 1022 and the second end 1074 of the inflation lumen 1070 is in fluid communication with the second inflation cavity 1026. Thus, the inflation port 1020 is in fluid communication with the first inflation cavity 1022 and the second inflation cavity 1026. In embodiments herein, the inflation lumen 1070 may be disposed adjacent to the inner surface 1014 of the body 1002. This is not meant to be limiting, and there may be multiple inflation lumens extending from the inflation port 1020 to the inflation cavities 1022, 1026.

[0145] FIG. 14 is a flow chart of a method 900 for using an inflatable transfer sleeve to protect an implantable medical device loaded into a capsule of a delivery system. The method 900 will be described referring to the inflatable transfer sleeves 800 and 1000 described above. FIGS. 15-21 illustrate the method 900 using the transfer sleeve 800 and FIGS. 29-35 illustrate the method 900 using the transfer sleeve 1000.

[0146] In embodiments, in a step 902 of the method 900, the transfer sleeve 800, 1000 in the uninflated configuration is placed within a loading bath filled with a liquid (not shown), such as a chilled saline, such that the transfer sleeve 800, 1000 is filled with liquid, thereby expelling air from the lumen 836 of the inflation cuff 830 or the lumen 1008 of the body 1002 and the lumens 1036, 1056 of the inflation cuffs 1030, 1050.

[0147] In a step 904 of the method 900, the transfer sleeve 800, 1000 with the inflation cuff(s) 830, 1030 / 1050 in the uninflated configuration is located over a distal end of the delivery system 100. In more detail, as shown in FIGS. 15 and 29 the transfer sleeve 800, 1000 may be moved in a proximal direction indicated by an arrow 907, the delivery system 100 may be moved in a distal direction indicated by arrow 909, or both the transfer sleeve 800, 1000 and the delivery system 100 may be moved in the respective directions. Because the transfer sleeve 800, 1000 is in the uninflated configuration, the transfer sleeve 800, 1000 may be located over the capsule 114 and the portion of the implantable medical device 150 proximal of the capsule 114 with relative ease. In other words, due to the larger diameter of the inflation cuff 830 or inflation cuffs 1030, 1050, there is clearance between the outer diameter of the capsule 114 and implantable medical device 150 and the inner diameter of the inflation cuff(s) 830, 1030 / 1050. Such clearance reduces or eliminates difficulty in loading the transfer sleeve over the capsule 114 and the medical implant 114, as described above.

[0148] The transfer sleeve 800, 1000 is loaded over the delivery system 100 such that the implantable medical device 150 is disposed between the proximal end 802, 1002 and the distal end 804, 1004 of the transfer sleeve. Utilizing the transfer sleeve 800, the implantable medical device 150 may be disposed between the proximal end 832 and the distal end 834 of the inflation cuff 830 of the transfer sleeve 800, as shown in FIG. 16. Utilizing the transfer sleeve 1000, the implantable medical device 150 may be disposed between the first inflation cuff 1030 and the second inflation cuff 1050, as shown in FIG. 30. In other words, the implantable medical device 150 may be disposed between the distal end 1034 of the first inflation cuff 1030 and the proximal end 1052 of the second inflation cuff 1050.

[0149] In a step 906 of the method 900, an inflation fluid source is releasably coupled to the transfer sleeve 800, 1000, as shown in FIGS. 17 and 31. In the embodiment shown in FIGS. 17 and 31, a syringe SY filled within an inflation fluid IF is releasably coupled to a stopcock SC, as is known to those skilled in the art, which may be releasably coupled to theinflation port 820, 1020 of the transfer sleeve 800, 1000, as shown in FIGS. 17 and 31. This is not meant to be limiting, and other inflation fluid sources and coupling mechanisms may be used. The inflation fluid IF may be any suitable fluid such as, but not limited to saline or sterile saline. In embodiments, the stopcock SC is transitioned to an open configuration to permit flow of air and / or fluid through the stopcock SC.

[0150] In a step 908 of the method 900, air is removed from the inflation cavity(ies) 822, 1022, 1026 of the inflation cuff(s) 830, 1030, 1050. In the embodiment shown, air may be removed by actuating a plunger PL of the syringe SY in a first direction (retraction), as indicated by the arrow 911 in FIGS. 17 and 31.

[0151] In a step 910 of the method 900, the inflation cuff(s) 830, 1030, 1050 is / are transitioned from the uninflated configuration to the inflated configuration, as shown in FIGS. 18 and 32. In particular, inflation fluid IF from the inflation source is delivered to the inflation cavity(ies) 822, 1022, 1026. In the embodiment shown, the plunger PL of the syringe SY is actuated in a second direction (advanced), as indicated by an arrow 913 in FIGS. 18 and 32, to deliver the inflation fluid IF, under pressure, into the inflation cavity 822, 1022, 1026 of the transfer sleeve 800, 1000. The inflation fluid IF is delivered into the inflation cavity(ies) 822, 1022, 1026 through the inflation port 820, 1020, the opening 810, 1010 and into the inflation cavity(ies) 822, 1022, 1026. The inflation cuff(s) 830, 1030, 1050 radially expand inwardly inward under the pressure of the inflation fluid IF in the inflation cavity(ies) 822, 1022, 1026 such that the inner surface(s) 840, 1040, 1060 of the inflation cuff(s) 830, 1030, 1040 sealingly engage(s) an outer surface of the distal portion of the delivery system 100. Thus, with the step 908 completed, the implantable medical device 150 is disposed within the transfer sleeve 800, 1000 in a fluid tight, air tight, and sterile environment to prevent contamination and air ingress. In an embodiment, once the inflation cuff(s) 830, 1030, 1040 radially expand under pressure of the inflation fluid IF to an inflated state, the stopcock SC may be transitioned to a closed state to prevent fluid flow from the inflation cuff(s) 830, 1030, 1040. The stopcock SC in the closed state maintains pressure in the inflation cuff(s) 830, 1030, 1040, thereby maintaining the inflation cuff(s) 830, 1030, 1040 in the inflated state. If no stopcock is utilized, maintaining the inflation cuff(s) 830, 1030, 1040 in the inflated state may be accomplished with continuous pressure on the plunger PL in the second direction (advanced), as indicated by the arrow 913.

[0152] In a step 912 of the method 900, the delivery system 100 with the transfer sleeve 800, 1000 in the inflated configuration disposed on a distal portion thereof may be is inserted into the introducer sheath 160 such that the transfer sleeve 800 is disposed adjacent to or slightly distal of a proximal end of the introducer sheath 160, as shown in FIGS. 19 and 33. In an example of this step, the delivery system 100 with the transfer sleeve 800, 1000 disposed thereon may be transferred from the loading bath to the patient table, and a distal end of the delivery system 100 may be inserted into the introducer sheath 160 which has been inserted into the patient to gain vascular access, as known to those skilled in the art.

[0153] In a step 914 of the method 900, the delivery system 100 may be distally advanced in a direction indicated by an arrow 921 through the transfer sleeve 800, 1000 and the introducer sheath 160, and into the vasculature of the patient, as shown in FIGS. 20 and 34. If needed, pressure on the inflation cuff(s) 830, 1030, 1050 may be partially released to advance the delivery system 100 more easily through the transfer sleeve 800, 1000.

[0154] In a step 916 of the method 900, when the implantable medical device 150 has been introduced to the vasculature of the patient, the fluid pressure on the inflation cuff(s) 830, 1030, 1050 may be removed to transition the inflation cuff(s) 830, 1030, 1050 from the inflated configuration to the uninflated configuration, as shown in FIGS. 21 and 35. In more detail, the stopcock SC may be actuated to open the flow of inflation fluid and the plunger PL of the syringe SY may be actuated to remove the inflation fluid IF from within the inflation cavity 822 of the transfer sleeve 800. In greater detail, as the plunger PL of the syringe SY is actuated in the first direction indicated by the arrow 911, inflation fluid IF within the inflation cavity 822 of the transfer sleeve 800 flows through the opening 810, and out through the connector 820. Removal of the inflation fluid IF and its associated pressure from within the inflation cavity 822 of the transfer sleeve 800 transitions the inflation cuff 830 from the inflated configuration to the uninflated configuration. When the inflation cuff 830 transitions to the uninflated configuration, the inflation cuff 830 radially contracts such that the inner surface 840 of the inflation cuff 830 disengages the outer surface of the distal portion of the delivery system 100.

[0155] In a step 924, the syringe SY and the stopcock SC may be removed from the connector of the transfer sleeve 800.

[0156] When the inflation cuff 830 is in the uninflated configuration, in a step 926 the transfer sleeve 800 may be proximally retracted in a second direction, indicated by an arrow923 of FIG. 21, over a proximal portion of the delivery system and out of the way of the treating clinician.

[0157] FIGS. 36-43 illustrate a transfer sleeve 1100 according to an embodiment hereof. In embodiments herein, the transfer sleeve 1100 is configured to be positioned over a distal portion of a delivery system, e.g., the distal portion of the delivery system 100 and an implantable medical device, e.g., the implantable medical device 150 mounted thereon. The transfer sleeve is configured to form a fluid tight cavity 1172 around a distal portion of the delivery system 100 and thereby provide a sterile environment for the implantable medical device 150 prior to being inserted through an introducer and into a patient’s vasculature. The transfer sleeve 1100 is configured to longitudinally compress and be translated in a proximal direction towards the handle of the delivery system 100 following insertion of the delivery system 100 into the introducer sheath to thereby providing increased clearance and additional workspace for tending clinicians during the medical procedure, as explained below.

[0158] The transfer sleeve 1100 includes a proximal end 1102, a distal end 1104, and a lumen 1106 extending from the proximal end 1102 to the distal end 1104, as shown in FIGS. 36-37, which are perspective and longitudinal cross-sectional illustrations, respectively, of the transfer sleeve 1100 in a compressed configuration. The transfer sleeve 1100 further includes a proximal portion 1110, a distal portion 1120, and a body portion 1130. The body portion 1130 is coupled between the proximal portion 1110 and the distal portion 1120.

[0159] The proximal portion 1110 of the transfer sleeve 1100 may be a rigid cylindrical tube having a proximal end 1112, a distal end 1114, and a proximal portion 1116 of the lumen 1106 of the transfer sleeve 1100, extending from the proximal end 1112 to the distal end 1114 of the proximal portion 1110, as shown in FIG. 37.

[0160] The distal portion 1120 may be a rigid cylindrical tube having a proximal end 1122, a distal end 1124, and a distal portion 1126 of the lumen 1106 of the transfer sleeve 1100. The distal portion 1126 of the lumen 1106 extends from the proximal end 1122 to the distal end 1124.

[0161] The body portion 1130 includes a proximal end 1132, a distal end 1134, and a central portion 1136 of the lumen 1106 of the transfer sleeve 1100, extending from the proximal end 1132 to the distal end 1134. In embodiments herein, the body portion 1130 includes an outer body 1138 and an inflation cuff 1160, as shown in FIG. 37. The bodyportion 1130 includes a longitudinally unexpanded or compressed state, as shown in FIG. 37, and a longitudinally expanded or extended state, as shown in FIG. 38. In embodiments herein, the longitudinal length of the body portion 1130 in the longitudinally compressed state is less than, or shorter than the longitudinal length of the body portion 1130 in the longitudinally extended state.

[0162] In the embodiment shown, the outer body 1138 includes compressible sections 1140, as best shown in FIG. 38. The compressible sections 1140 are configured to permit the outer body 1138 of the body portion 1130 to longitudinally compress and expand like an accordion. The compressible sections 1140 are disposed along a central longitudinal axis CLA of the transfer sleeve 1100, and are configured to flex, compress, and / or expand as the proximal portion 1110 moves relative to the distal portion 1120. When the body portion 1130 is in the expanded state, the compressible sections 1140 and the inflation section 1148 are configured to form a semi-rigid structure that resists radial deformation, as shown in FIG. 38.

[0163] In the embodiment shown, each of the compressible sections 1140 may include a first rib 1142 and a pair of semi-flexible membranes 1144. Adjacent compressible sections 1140 are coupled at a second rib 1146. In the embodiment shown, the first and second ribs are circular ribs and provide support for the outer body 1138. The semi -flexible membranes 1144 are configured to longitudinally extend and compress against the first and second ribs 1142, 1144. The first and second ribs 1142 may be formed of rigid or semi-rigid materials such as, but not limited to high density polyethylene (HDPE), polyether block amide (PEBAX), Nylon, or other suitable polymeric materials. The semi-flexible membranes 1144 may be formed of materials, non-limiting examples including silicon, rubber, latex, or polymeric materials.

[0164] This inflation cuff 1160 may be a flexible, tubular structure having a proximal end 1162, a distal end 1164, and a lumen extending from the proximal end 1162 to the distal end 1164 to form the central portion 1136 of the lumen 1106 of the transfer sleeve 1100, as best shown in FIG. 38. The inflation cuff 1160 further includes an outer surface 1166 and an inner surface 1168. The inflation cuff 1160 is disposed within the outer body 1138 of the body portion 1130. In an embodiment, the proximal end 1162 of the inflation cuff 1160 is sealingly coupled to the distal end 1114 of the proximal portion 1110 and the distal end 1164 of the inflation cuff 1160 is sealingly coupled to the proximal end 1122 of the distalportion 1120 of the transfer sleeve 1100. However, in other embodiments, the inflation cuff 1160 may be sealingly coupled to proximal and distal ends of the outer body 138 in the body portion 1130. An inflation cavity 1170 is formed between an inner surface of the outer body 1138 and the outer surface 1166 of the inflation cuff 1160. In embodiments herein, the inflation cuff 1160 includes an uninflated configuration, as shown in FIGS. 38-39, and an inflated configuration, as shown in FIGS . 40-41. A first inside diameter ID 1 of the inflation cuff 1160 in the uninflated configuration is larger than a second inside diameter ID2 of the inflation cuff 1160 in the inflated configuration. In embodiments herein, when the transfer sleeve 1100 is disposed over a distal portion of a delivery system, and the inflation cuff 1160 is in the inflated configuration, a fluid tight cavity 1172 is formed around the distal portion of the delivery system disposed within the inflation cuff 1160. The inflation cuff 1160 may be formed of materials, non-limiting examples of which include PET, Pebax, Nylon, HDPE, silicone, polyurethane, or other suitable polymeric materials, he inflation cuff 1160 may be coupled to the proximal portion 1110 and the distal portion 1120, for example, and not by way of limitation, by fusing or adhesives. In embodiments herein, a longitudinal length of the inflation cuff 830 will be smaller than or equal to the length of the body portion 1130 and may be in a range of about 1 inch to about 6 inches. When the inflation cuff 1160 is in the uninflated configuration, the inside diameter of the central portion 1136 of the lumen 1106 may be in a range of about 0.300 inch to about 0.600 inch. When the inflation cuff 1160 is in the inflated configuration, the inside diameter of the central portion 1136 of the lumen 1106 may be in a range of about 0. 150 inch to about 0.450 inch.

[0165] The outer body 1138 includes an opening 1150 disposed therethrough to provide fluid access to the inflation cavity 1170 defined between the outer body 1138 and the inflation cuff 1160. The inflation cavity 1170 extends between the proximal end 1162 to the distal end 1164 of the inflation cuff 1160. An inflation port 1152 may be coupled to outer body 1138 at the opening 1150. The connector 1152 is configured to provide fluid communication to the inflation cavity 1170 by an external device, e.g., a stopcock or a syringe. The inflation section 1148 may be formed of rigid or semi-rigid materials such as, but not limited to silicon, rubber, latex, or polymeric materials.

[0166] In embodiments herein, the transfer sleeve 1100 may include a brace assembly 1180, as shown in FIGS. 42-43. The brace assembly 1180 may be releasably coupled to the transfer sleeve 1100 adj acent to the outer body 1138 of the body portion 1130 of the transfersleeve 1100, and between the proximal portion 1110 and the distal portion 1120 when the transfer sleeve 1100 is in the expanded state. When the brace assembly 1180 is releasably coupled between the proximal portion 1110 and the distal portion 1120 on an outer surface of the body portion 1130 with the transfer sleeve 1100 in the longitudinally extended state, the brace assembly 1180 provides longitudinal rigidity to the body portion 1130 of the transfer sleeve 1100. Stated another way, the brace assembly 1180 prevents the body portion 1130 from longitudinally compressing, thereby preventing the transfer sleeve 1100 from transitioning from the longitudinally extended state to the longitudinally compressed state, as described below. The brace assembly 1180 may be releasably coupled to the transfer sleeve 1100 by press fit or friction fit, for example.

[0167] In the embodiment of FIGS. 42-43, the brace assembly 1180 may be a generally tubular structure including a proximal end 1182, a distal end 1184, and a lumen 1186 extending from the proximal end 1182 to the distal end 1184. The brace assembly 1180 includes an opening 1188 extending from an outer surface to an inner surface of the brace assembly 1180. The opening 1188 is sized, to receive the inflation port 1152 of the outer body 1138 of the transfer sleeve 1100. The brace assembly 1180 may be formed of rigid materials such as, but not limited to, polymeric materials such as polycarbonate, acrylic, polyethylene terephthalate glycol (PETG), Nylon, and (PEEK).

[0168] In an embodiment, the brace assembly 1180 may be formed of a first section 1180A and a second section 1180B, as shown in FIG. 42. The first section 1180A and the second section 1180B may each be one-half of the brace assembly 1180, divided generally longitudinally. The first section 1180A includes the opening 1188. When the transfer sleeve 1100 is in the expanded configuration, the first section 1180A and the second section 1180B of the brace assembly 1180 may be disposed between the proximal portion 1110 and the distal portion 1120, and over the body portion 1130 of the transfer sleeve 1100 to prevent movement of the proximal portion 1110 relative to the distal portion 1120. Thus, the brace assembly 1180 prevents the transfer sleeve 1100 from transitioning from the longitudinally extended state to the longitudinally compressed state.

[0169] Although the brace assembly 1180 is described in embodiments herein as formed of the first section 1180A and the second section 1180B, divided generally longitudinally and in two separate units, in other embodiments, the first and second sections 1180A and 1180B of the brace assembly 1180 may be attached together adjacent a correspondinglongitudinal edge surface by, for example, and not by way of limitation a hinge or similar mechanism to form a clamshell design. The brace assembly 1180 with the clamshell design includes an open configuration wherein the longitudinal edge surfaces of the first and second sections 1180A, 1180B are separated from or do not abut each other, and a closed configuration wherein the longitudinal edge surfaces of the first and second sections 1180A, 1180B abut each other and form the cylindrical brace assembly 1180.

[0170] While the brace assembly 1180 is described in embodiments herein as a generally cylindrical component, this is not meant to be limiting. In another embodiment, the brace assembly may be composed of one or more rods disposed between the proximal portion and the distal portion of the transfer sleeve and may be disposed adjacent to the body portion or spaced radially outward from the body portion. Other embodiments of a brace assembly may also be utilized.

[0171] FIGS. 44-52 illustrate steps in a method of loading the transfer sleeve 1200 over a distal portion of a delivery system, in accordance with an embodiment hereof. The details of each step of the method will not be described in detail where they are the same as or similar to the steps described above with respect to FIGS. 14-35. Thus, the method 900 described above is incorporated into the method described with respect to FIGS. 44-52.

[0172] Thus, in an embodiment, as shown in FIG. 43, the method includes installing the brace assembly 1180 overthe body portion 1130 of the transfer sleeve 1100 to maintain the transfer sleeve 1100 in the longitudinally extended state. The brace assembly 1180 may be installed over the body portion 1130 at any time prior to loading the transfer sleeve 1100 over the delivery system 100, but preferably is installed early in the method.

[0173] Similar to the method described above, the transfer sleeve 1100 in the uninflated configuration may be placed into a loading bath to allow the lumen of the transfer sleeve 1100 to fill with a liquid to expel air therefrom. In another step, the transfer sleeve 1100 in the uninflated configuration and longitudinally extended state with the brace assembly 1180 disposed thereon, is loaded over the distal portion of the delivery system 100, as described above, similar to the method described above, and as shown in FIGS. 44-45.

[0174] In another step of the method, an inflation source, such as the syringe SY described above, is coupled to the inflation port 1152, such as by using a stopcock SC, as described above, and shown in FIG. 46. Further, air may be removed from the inflationcavity 1170 of the transfer sleeve 1100, as described above with respect to FIG. 14, and as indicated by the arrow 911 in FIG. 46.

[0175] In another step of the method, the inflation cuff 1160 is inflated, as shown in FIG. 47 and as described above. The delivery system 100, with the transfer sleeve 100 disposed thereon in the inflation configuration, is then located adjacent to the proximal end of the introducer sheath 160, as shown in FIG. 48 and described in more detail above.

[0176] In another step of the method, with the transfer sleeve 110 disposed over the distal portion of the delivery system 100, the delivery system 100 is advanced distally with respect to the transfer sleeve 1100 and into the introducer sheath 160, as shown in FIG. 49 (indicated by the arrow 921), and as described above. As noted above, if it is difficult to advance the delivery system 100 through the transfer sleeve 1100, the transfer sleeve 100 may be slightly deflated to reduce friction between the inflation cuff 1130 and the delivery system 100. When the capsule 114 and the implantable medical device 150 are within the introducer sheath 160, the transfer sleeve 1100 may be deflated, as described above and shown in FIG. 50.

[0177] Further, utilizing the transfer sleeve 1100, the brace assembly 1180 may be removed from the from the transfer sleeve 1100. FIG. 51 shows the transfer sleeve 1100 with the brace assembly 1180 removed. Removal of the brace assembly 1180 enables transition of the transfer sleeve 1100 from the longitudinally extended state to the longitudinally compressed state, as shown in FIG. 52. In an embodiment, the distal portion 1120 of the transfer sleeve 1100 may be proximally retracted in a second direction, as indicated by an arrow 923. The distal portion 1120 may be moved proximally relative to the proximal portion 1110 of the transfer sleeve 1100. As the distal portion 1120 moves towards the proximal portion 1110, the body portion 1130 collapses or folds like an accordion, to transition the transfer sleeve 1100 to the longitudinally compressed state. In other embodiments, the proximal portion 1110 may be distally advanced, relative to the distal portion 1120 to transition the transfer sleeve 1100 to the longitudinally compressed state, or the proximal portion 1110 may be distally advanced and the distal portion 1120 may be proximally retracted to transition the transfer sleeve 1100 to the longitudinally compressed state.

[0178] The transfer sleeve 1100 may be then proximally retracted in the second direction, indicated by the arrow 923 of FIG. 52, over the delivery system 100 and out of the way of the treating clinician.

[0179] One skilled in the art will realize that FIGS. 9-52 illustrate non-limiting examples of transfer sleeves and that existing components illustrated in FIGS. 9-52 may be removed and / or additional components may be added to the transfer sleeves of FIGS. 9-52. Additional details of example transfer sleeves may be found in U.S. Patent Application No. 17 / 490,177 (U.S. Publication No. 2022 / 0104943), assigned to Medtronic Vascular, Inc., and which is incorporated by reference herein in its entirety.

[0180] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components associated with, for example, a medical device.

[0181] The following examples are illustrative of the techniques described herein.

[0182] Example 1. A system comprising: a delivery catheter, the delivery catheter including a capsule disposed at a distal end of the delivery catheter, the delivery capsule including an open proximal end; an implantable medical device disposed within the capsule, wherein a proximal end of the implantable medical device extends proximally from the open proximal end of the capsule; and a loading device comprising a funnel having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, wherein at the proximal end the central lumen has a first diameter and at the distal end the central lumen has a second diameter, wherein the first diameter is larger than the second diameter; wherein the loading device is configured to be advanced proximally over the capsule such that the proximal end of the funnel passes over the implantable medical device and the distal end of the funnel is disposed over the proximal end of the implantable medicaldevice such that the funnel radially compresses the proximal end of the implantable medical device.

[0183] Example 2. The system of Example 1, further comprising a transfer sleeve, wherein the transfer sleeve is disposed over the capsule such that a proximal end of the transfer sleeve is disposed adjacent a distal end of the funnel.

[0184] Example 3. The system of Example 1, wherein the transfer sleeve is configured to be advanced proximally over the implantable medical device and push the loading device proximally off of the implantable medical device.

[0185] Example 4. The system of any one of Examples 1 to 3, wherein the funnel comprises two halves split longitudinally.

[0186] Example 5. The system of any one of Examples 1 to 4, wherein the loading device further comprises wings extending radially from the funnel.

[0187] Example 6. A loading device comprising: a first holder configured to hold a transfer sleeve; a second holder configured to hold a catheter having a capsule at a distal end thereof; and means for advancing one of the first holder or the second holder toward the second holder or the first holder such that the transfer sleeve is loaded over the capsule with a mechanical advantage.

[0188] Example 7. The loading device of Example 6, wherein the loading device further comprises: distal clamp; a sliding plate; a loading plate coupled to the sliding plate;a rail; and a screw drive; wherein the second holder is a proximal clamp, wherein the first holder is a space between a shoulder of the sliding plate and the loading plate, wherein the distal clamp is fixedly coupled to the rail, the sliding plate is sliding coupled to the rail, and the proximal clamp is fixedly coupled the rail, and wherein the screw drive is configured to push the sliding plate proximally such that the transfer sleeve is pushed over the capsule.

[0189] Example 8. The loading device of Example 7, wherein the loading device is configured to slide from a first position wherein the sliding plate with the loading plate coupled thereto is disposed adjacent the distal clamp and is spaced from the proximal clamp to a second position wherein the sliding plate with the loading plate coupled thereto is disposed closer to the proximal clamp than in the first position.

[0190] Example 9. The loading device of Example 7 or Example 8, wherein the loading plate defines a passageway extending longitudinally therethrough, the passageway configured to receive a portion of the catheter therein.

[0191] Example 10. The loading device of Example 9, wherein the passageway is tapered in the distal direction.

[0192] Example 11. The loading device of Example 6, wherein: the first holder comprises a sleeve holder coupled to a cup; the second holder comprises a connector configured to be coupled to the catheter and a receiver coupled to the connector, the capsule of the catheter configured to be disposed within a conduit of the receiver; and the cup is configured to be rotatably advanced relative to the receiver to translate the sleeve holder relative to the catheter such that the transfer sleeve is loaded over the capsule, wherein rotatably advancing the cup provides the mechanical advantage.

[0193] Example 12. The loading device of Example 11, wherein the cup includes an inner thread and the receiver includes an outer thread, wherein the cup is configured to be rotatably advanced over the receiver via the inner thread and the outer thread.

[0194] Example 13. The loading device of Example 11 or Example 12, wherein the connector comprises a proximal cylindrical portion, a flared portion extending distally from the proximal cylindrical portion, and a distal cylindrical portion, wherein the proximal cylindrical portion and the flared portion include longitudinal wall sections and longitudinal gaps disposed between the longitudinal wall sections such that the proximal cylindrical portion is configured to be crimped onto the catheter.

[0195] Example 14. The loading device of any one of Examples 11 to 13, further comprising a support configured to be disposed over the catheter and within the receiver, the support configured to reduce or prevent bucking of the catheter during loading of the transfer sleeve over the capsule.

[0196] Example 15. The loading device of Example 14, wherein the support comprises fins configured to extend through the longitudinal gaps in the flared portion of the of the connector.

[0197] Example 16. The loading device of Example 6, further comprising: a rail; a first jaw fixedly coupled to the rail; a second jaw slidably coupled to the rail; a handle coupled to the second jaw; and a trigger configured to move the second jaw along the rail, thereby providing the mechanical advantage; wherein the first holder is coupled to the first jaw and the second holder is coupled to the second jaw.

[0198] Example 17. The loading device of Example 6, wherein the loading device comprises a body and a rotatable knob mounted over the body, wherein the first holder is a portion of the body and the second holder is disposed within the knob rotatable knob.

[0199] Example 18. The loading device of Example 17, wherein the body includes a proximal end, a distal end, and a longitudinal conduit extending from the proximal end to the distal end, wherein the first holder and the second holder are disposed within the conduit.

[0200] Example 19. The loading device of Example 18, wherein: a proximal portion of the body includes a threaded shaft and the rotatable knob includes threads configured to engage the threaded shaft such that the rotatable knob translates longitudinally as the know is rotated around the threaded shaft; the second holder is disposed within the rotatable knob and is configured to be translated within the conduit with the rotatable knob, the second holder comprising a catheter conduit configured to fixedly hold the catheter; and a distal portion of the body includes arms forming a cavity as the second holder configured to hold the transfer sleeve therein.

[0201] Example 20. The loading device of Example 19, wherein: the threaded shaft includes at least one longitudinal opening; and the second holder includes at least one tab extending through the at least one longitudinal opening, wherein the at least one tab extending through the at least one opening prevents rotation of the second holder when the rotatable knob is rotated.

[0202] Example 21. The loading device of any one of Examples 18 to 20 wherein the body, the rotatable knob, and the second holder are each longitudinally separable.

[0203] Example 22. A transfer sleeve for use with a delivery system for an implantable medical device, the transfer sleeve comprising: a body, the body including a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; and an inflation cuff coupled to an inner surface of the body, the inflation cuff forming an inflation cavity, the inflation cuff including an uninflated configuration and an inflated configuration; wherein the inflation cuff in the uninflated configuration has a first inner diameter that enables a distal portion of the delivery system to fit within the lumen; and wherein the inflation cuff in the inflated configuration forms a fluid tight cavity engaged with the distal portion of the delivery system.

[0204] Example 23. The transfer sleeve of Example 22, wherein the inflation cuff comprises a first inflation cuff coupled to the inner surface of the body adjacent the proximalend of the body and a second inflation cuff coupled to the body adjacent the distal end of the body, thereby forming two inflation cavities.

[0205] Example 24. The transfer sleeve of Example 22, wherein the inflation cavity is formed between an outer surface of the inflation cuff and the inner surface of the body.

[0206] Example 25. The transfer sleeve of any one of Examples 21 through 24, wherein the body comprises a flexible body portion configured to longitudinally compress and extend, wherein the flexible body portion stiffens in the inflated configuration to prevent longitudinal compression.

[0207] Example 26. The transfer sleeve of any one of Examples 21 through 24, wherein the body comprises a flexible body portion configured to longitudinally compress and extend, further comprising a brace assembly removably coupled to the flexible body portion, wherein the brace assembly is configured to prevent longitudinal compression of the flexible body portion when coupled to the flexible body portion and the flexible body portion is configured to longitudinally compress with the brace assembly removed from the flexible body portion.

[0208] Example 27. A method comprising: loading a transfer sleeve in an uninflated configuration onto a distal portion of a delivery system; inflating the transfer sleeve to form a fluid tight cavity surrounding the distal portion of the delivery system and securing the transfer sleeve to the delivery system; placing a distal end the delivery system into a proximal end of an introducer sheath; advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath; and deflating the transfer sleeve.

[0209] Example 28. The method of Example 27, further comprising: after deflating the transfer sleeve, proximally retracting the transfer sleeve over the delivery system.

[0210] Example 29. The method of Example 27, wherein: the transfer sleeve includes an inflation cuff disposed within and secure to a body; the inflation cuff forms an inflation cavity; and inflating the transfer sleeve comprises delivering an inflation fluid to the inflation cavity.

[0211] Example 30. The method of Example 27, wherein: the transfer sleeve includes a plurality of inflation cuffs disposed within and secure to a body; the inflation cuffs form inflation cavities; and inflating the transfer sleeve comprises delivering an inflation fluid to the inflation cavities.

[0212] Example 31. The method of Example 27, wherein the transfer sleeve includes a flexible body configured to longitudinally compress and extend, wherein the method further comprises: installing a brace assembly onto the flexible body to prevent the transfer sleeve from longitudinally compressing.

[0213] Example 32. The method of Example 31 , further comprising : after advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath, removing the brace assembly; and longitudinally compressing the transfer sleeve.

Claims

WHAT IS CLAIMED IS:

1. A transfer sleeve (800, 1000, 1100) for use with a delivery system for an implantable medical device, the transfer sleeve comprising: a body (802, 1002, 1130), the body including a proximal end (804, 1004, 1132), a distal end (806, 1006, 1134), and a lumen (808, 1008, 1136) extending from the proximal end to the distal end; and an inflation cuff (830, 1030, 1050, 1160) coupled to an inner surface of the body, the inflation cuff forming an inflation cavity (822, 1022, 1026, 1170), the inflation cuff including an uninflated configuration and an inflated configuration; wherein the inflation cuff in the uninflated configuration has a first inner diameter that enables a distal portion of the delivery system to fit within the lumen; and wherein the inflation cuff in the inflated configuration forms a fluid tight cavity engaged with the distal portion of the delivery system.

2. The transfer sleeve of claim 1, wherein the inflation cuff comprises a first inflation cuff (1130) coupled to the inner surface of the body adjacent the proximal end of the body and a second inflation cuff (1150) coupled to the body adjacent the distal end of the body, thereby forming two inflation cavities (1022, 1026).

3. The transfer sleeve of claim 1, wherein the inflation cavity is formed between an outer surface of the inflation cuff and the inner surface of the body.

4. The transfer sleeve of any one of claims 1 through 3, wherein the body comprises a flexible body portion (1140) configured to longitudinally compress and extend, wherein the flexible body portion stiffens in the inflated configuration to prevent longitudinal compression.

5. The transfer sleeve of any one of claims 1 through 3, wherein the body comprises a flexible body portion (1140) configured to longitudinally compress and extend, further comprising a brace assembly (1180) removably coupled to the flexible body portion, wherein the brace assembly is configured to prevent longitudinal compression of the flexiblebody portion when coupled to the flexible body portion and the flexible body portion is configured to longitudinally compress with the brace assembly removed from the flexible body portion.

6. A method comprising: loading a transfer sleeve of any one of claims 1-5 in an uninflated configuration onto a distal portion of a delivery system; inflating the transfer sleeve to form a fluid tight cavity surrounding the distal portion of the delivery system and securing the transfer sleeve to the delivery system; placing a distal end the delivery system into a proximal end of an introducer sheath; advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath; and deflating the transfer sleeve.

7. The method of claim 6, further comprising: after deflating the transfer sleeve, proximally retracting the transfer sleeve over the delivery system.

8. The method of claim 6, wherein inflating the transfer sleeve comprises delivering an inflation fluid to the inflation cavity or to the plurality of inflation cavities.

9. The method of claim 6, wherein the transfer sleeve includes a flexible body configured to longitudinally compress and extend, wherein the method further comprises: installing a brace assembly onto the flexible body to prevent the transfer sleeve from longitudinally compressing.

10. The method of claim 9, further comprising: after advancing the distal portion of the delivery system through the transfer sleeve and into the introducer sheath, removing the brace assembly; and longitudinally compressing the transfer sleeve.

11. A loading device comprising: a first holder (420, 620, 732) configured to hold a transfer sleeve (200); a second holder (460, 630, 640, 740) configured to hold a catheter (102) having a capsule (114) at a distal end thereof; and means for advancing one of the first holder or the second holder toward the second holder or the first holder such that the transfer sleeve is loaded over the capsule with a mechanical advantage.

12. The loading device of claim 11, wherein the loading device further comprises: distal clamp; a sliding plate; a loading plate coupled to the sliding plate; a rail; and a screw drive; wherein the second holder is a proximal clamp, wherein the first holder is a space between a shoulder of the sliding plate and the loading plate, wherein the distal clamp is fixedly coupled to the rail, the sliding plate is sliding coupled to the rail, and the proximal clamp is fixedly coupled the rail, and wherein the screw drive is configured to push the sliding plate proximally such that the transfer sleeve is pushed over the capsule.

13. The loading device of claim 11, wherein: the first holder comprises a sleeve holder coupled to a cup; the second holder comprises a connector configured to be coupled to the catheter and a receiver coupled to the connector, the capsule of the catheter configured to be disposed within a conduit of the receiver; and14. The loading device of claim 11, further comprising: a rail; a first jaw fixedly coupled to the rail; a second jaw slidably coupled to the rail;a handle coupled to the second jaw; and a trigger configured to move the second jaw along the rail, thereby providing the mechanical advantage; wherein the first holder is coupled to the first jaw and the second holder is coupled to the second jaw.

15. The loading device of claim 6, wherein the loading device comprises a body and a rotatable knob mounted over the body, wherein the first holder is a portion of the body and the second holder is disposed within the knob rotatable knob.

Images