US20220008052A1 - Catheter system for introducing expandable medical device and methods of using same - Google Patents
Catheter system for introducing expandable medical device and methods of using same Download PDFInfo
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- US20220008052A1 US20220008052A1 US17/175,210 US202117175210A US2022008052A1 US 20220008052 A1 US20220008052 A1 US 20220008052A1 US 202117175210 A US202117175210 A US 202117175210A US 2022008052 A1 US2022008052 A1 US 2022008052A1
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Images
Classifications
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- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
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- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
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Definitions
- the present disclosure relates generally to medical devices that are used in the human body.
- the present disclosure relates to a catheter system for introducing expandable medical devices into a mammalian body and methods of using the same.
- Heart disease is a major health problem that claims many lives per year. After a heart attack or other major cardiac event, a small number of patients can be treated with medicines or other non-invasive treatment. A significant number of other patients can recover from a heart attack or other cardiac event if provided with mechanical circulatory support in a timely manner.
- a blood pump is inserted into a heart chamber, such as into the left ventricle of the heart and the aortic arch, to assist the pumping function of the heart.
- Other known conventional applications involve providing for pumping venous blood from the right ventricle to the pulmonary artery for support of the right side of the heart.
- the object of the pump is to reduce the load on the heart muscle for a period of time allowing the affected heart muscle to recover and heal.
- Blood pumps may also be used in some cases for percutaneous coronary intervention. In some cases, surgical insertion may potentially cause additional stresses in heart failure patients.
- an introducer typically formed of a thin walled polymeric tube, is placed through the site of the incision directly into the blood vessel.
- the catheter is then inserted (i.e., introduced) through the introducer into the blood vessel.
- the introducer may remain in place until the catheter is removed. In some instances, this can be several hours or even several days.
- the introducer may be removed from the catheter (e.g., by peeling away) and the patient's body after the catheter is advanced to the target location to reduce the cross-sectional area of the catheter system in the patient's vasculature. Other portions of the catheter system, however, remain in the patient's vasculature until the catheter is removed.
- the present disclosure is directed to a catheter system that includes a catheter, a recovery sheath, and an outer sheath assembly.
- the catheter includes an elongate body that has an expandable medical device coupled with a distal end thereof.
- the recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein in a stored configuration.
- the recovery sheath is axially movable relative to the catheter body.
- the outer sheath assembly includes an outer sheath disposed over the catheter body.
- the outer sheath includes an elongate body that extends from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath.
- the outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration.
- the outer sheath is removable from the catheter body.
- the present disclosure is further directed to a method that includes inserting an introducer sheath into a vasculature of a patient through an incision site, and introducing a catheter system into a proximal end of the introducer sheath and into the vasculature through the introducer sheath.
- the catheter system includes a catheter that includes an elongate body having an expandable medical device coupled with a distal end thereof.
- the catheter system also includes a recovery sheath disposed around a proximal section of the catheter body, and an outer sheath disposed around the catheter body and positioned distally from the recovery sheath.
- the method further includes removing the introducer sheath from the catheter system and the vasculature of the patient, and removing the outer sheath from the catheter body and the vasculature of the patient while the catheter body remains in the vasculature.
- the present disclosure is further directed to a catheter system for a catheter pump.
- the system includes a catheter, a recovery sheath, and an outer sheath assembly.
- the catheter includes an elongate body having a distal portion including an expandable medical device including an expandable cannula and an impeller disposed within the expandable cannula and operable to draw fluid into the expandable cannula when rotated in the fluid.
- the catheter also includes a drive cable coupled to the impeller and disposed within a lumen defined by the catheter body.
- the recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein in a stored configuration.
- the recovery sheath is axially movable relative to the catheter body.
- the outer sheath assembly includes an outer sheath disposed over the catheter body.
- the outer sheath includes an elongate body extending from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath.
- the outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration.
- the outer sheath is removable from the catheter body.
- FIG. 1 is a plan view of a catheter system.
- FIG. 2 is an enlarged sectional view of an expandable medical device of the catheter system shown in FIG. 1 .
- FIG. 3 illustrates one exemplary use of the catheter system shown in FIG. 1 within the chamber of a patient's heart.
- FIG. 4 is a plan view of the catheter system of FIG. 1 including a removable outer sheath assembly and a recovery sheath assembly.
- FIG. 5 is a sectional view of the catheter system of FIG. 4 , taken along line “ 5 - 5 ” in FIG. 4 .
- FIG. 6 is a side view of a portion of the catheter system of FIG. 4 , illustrating the outer sheath assembly being removed from the catheter system.
- FIG. 7 is a perspective view of a cutting tool used to separate the outer sheath assembly along a separation zone.
- FIG. 8 is another perspective view of the cutting tool of FIG. 7 illustrating the outer sheath assembly being pulled proximally relative to the cutting tool to separate the outer sheath assembly along the separation zone.
- FIG. 9 is a perspective view of the recovery sheath assembly shown in FIG. 4 .
- FIG. 10 is a sectional view of the recovery sheath assembly shown in FIG. 4 .
- FIGS. 11-16 are simplified diagrams of a patient's vasculature illustrating various techniques for introducing and removing the catheter system of FIG. 4 .
- the present disclosure is directed to catheter systems for introducing expandable medical devices into a mammalian body that facilitate reducing obstructions or occlusions to blood flow while the catheter is positioned within the body.
- the catheter systems of the present disclosure enable one or more portions of the catheter system to be removed from the catheter body while the catheter is positioned within a patient to reduce the cross-sectional area of the catheter system within the patient's vasculature and thereby reduce obstructions to blood flow.
- the catheter systems described herein include a removable outer sheath assembly that can be used to deliver an expandable medical device to a target site in a stored or collapsed configuration, and subsequently removed from the catheter system (e.g., by peeling away) and the patient's vasculature to reduce the cross-sectional area of the catheter system remaining the patient's vasculature.
- catheter systems of the present disclosure may include a recovery sheath assembly to facilitate sealing openings or gaps around the catheter body at the incision site following removal of the outer sheath assembly, and to facilitate re-sheathing and/or removing the expandable medical device when the catheter system is removed.
- the recovery sheath assembly can include a removable plug configured to seal an opening at the incision site following removal of the outer sheath assembly. Consequently, catheter systems of the present disclosure may have a reduced-diameter proximal section, and thereby reduce obstructions to blood flow.
- the recovery sheath assembly can include a relatively-large diameter recovery sheath that is held outside of a patient's body until the expandable medical device is ready to be removed from the patient's body.
- the recovery sheath can then be advanced into a patient's vasculature to facilitate collapsing and/or re-sheathing the expandable medical device within a lumen defined by the recovery sheath, and can be withdrawn from the patient's vasculature along with the collapsed medical device.
- FIGS. 1-3 illustrate one non-limiting example of a catheter system 100 in which embodiments of the present disclosure may be used.
- the catheter system 100 is a percutaneous heart pump catheter suitable for providing high performance flow rates of blood within the left ventricle of a patient. While embodiments of the present disclosure are described with reference to a catheter pump, it should be understood that the disclosed embodiments are not limited to use with a catheter pump and may be used in combination with other catheters and catheter systems. Moreover, it should be understood that the disclosed embodiments are not limited to use with catheters, and may be used in combination with other surgical or medical devices, for example, to facilitate insertion, placement, and/or removal of such surgical and medical devices within a patient's body.
- FIG. 1 is a plan view of the catheter system 100 .
- the catheter system 100 generally includes a catheter 102 and an expandable medical device 104 .
- the catheter 102 has an elongate body 106 extending from a proximal end 108 to a distal end 110 , and includes a retainer or outer sheath 112 disposed over the elongate body 106 .
- proximal refers to a direction away from the body of a patient and toward an operator of the catheter system 100 .
- distal refers to a direction toward the body of a patient and away from the operator.
- the expandable medical device 104 is coupled at the distal end 110 of the catheter body 106 .
- the term “expandable medical device” refers to a catheter medical device, typically coupled to the distal end of the catheter, that is radially expandable from a stored or delivery profile to a deployed or operational profile that is larger than the delivery profile.
- the expandable medical device 104 is shown as a radially-expandable heart pump that includes a collapsible and expandable cannula 114 and a collapsible and expandable impeller 116 (shown in FIG. 2 ).
- the embodiments of the present disclosure are not limited to use with radially-expandable pumps, and are suitable for use with other types of expandable medical devices.
- the distal end of the catheter system 100 can be advanced to the heart, for example, through an artery.
- the medical device 104 In the expanded state (shown in FIGS. 1-3 ), the medical device 104 is operational and is capable of performing one more functions for which it is designed. In the illustrated embodiment, the expandable medical device 104 is able to pump or output blood at high flow rates in the expanded state.
- the catheter system 100 is coupled with a motor 118 for driving the impeller 116 .
- the catheter system 100 includes a coupling 120 that can be engaged with the motor 118 in certain embodiments.
- the impeller 116 is rotated by the motor 118 via a drive cable or shaft 122 ( FIG. 2 ) of the catheter 102 when the pump is operating.
- the motor 118 can be disposed outside the patient.
- the motor 118 is coupled to a controller 124 that directs operation of the motor and other components of the catheter system 100 (e.g., an infusion system).
- the motor 118 is separate from the controller 124 , e.g., to be placed closer to the patient.
- the motor 118 is part of the controller 124 .
- the motor is miniaturized to be insertable into the patient.
- the catheter system 100 may not include a motor 118 .
- the outer sheath 112 is disposed over the catheter body 106 , and includes an elongate body 126 that extends from a proximal end 128 to a distal end 130 .
- the elongate body 126 has at least one lumen defined therein that houses the elongate body 106 of the catheter 102 .
- the catheter body 106 can be disposed in the lumen of the outer sheath body 126 such that the elongate bodies 106 , 126 can move (e.g., axially) relative to one another.
- the outer sheath elongate body 126 is sized and shaped to receive the catheter body 106 therein to allow the catheter body 106 to be advanced through the at least one lumen defined by the outer sheath 112 .
- the outer sheath 112 is removable from the catheter body 106 , for example, along one or more separation zones.
- the outer sheath 112 is configured to maintain the expandable medical device 104 in the collapsed state to facilitate advancing the catheter 102 through a patient's vasculature. More specifically, the outer sheath 112 includes a retention section 132 located at the distal end 130 of the outer sheath elongate body 126 that is disposed over the expandable medical device 104 when in the collapsed state. The retention section 132 thereby enables the expandable medical device 104 to be maintained in the collapsed state until the catheter body distal end 110 is advanced to a desired position, for example, within a patient's heart.
- the expandable medical device 104 is configured to self-deploy or self-expand into a deployed or expanded configuration when the expandable medical device 104 is advanced distally out of the outer sheath 112 .
- the expandable medical device 104 can be collapsed into the collapsed state by advancing the outer sheath distal end 130 distally over the expandable medical device 104 to cause the expandable medical device 104 to collapse.
- the catheter 102 includes a reduced-diameter proximal portion or section 134 that has a smaller diameter than a distal end of the catheter 102 .
- the retention section 132 of the outer sheath 112 has a suitable diameter for receiving and retaining the expandable medical device 104 therein.
- the expandable medical device 104 even in the collapsed state, may have a diameter larger than the remainder of the catheter body 106 . That is, the catheter body distal end 110 and the expandable medical device 104 , in the collapsed state, may have a larger diameter than a proximal section of the catheter 102 that extends from the catheter body proximal end 108 .
- a proximal section 134 of the catheter 102 located at the proximal end 108 may have a reduced diameter relative to the distal end of the catheter 102 .
- each of the catheter body 106 and the outer sheath 112 has a reduced diameter along the catheter proximal section 134 relative to the distal ends of the catheter body 106 and the outer sheath 112 .
- only the catheter body 106 may have a reduced diameter along the catheter proximal section 134 .
- the reduced-diameter proximal section 134 can have a diameter that is less than 95% of the diameter at the distal end of the catheter 102 (e.g., the diameter of the catheter body distal end 110 and/or the expandable medical device 104 , in the collapsed state), less than 90% of the diameter at the distal end of the catheter 102 , less than 85% of the diameter at the distal end of the catheter 102 , less than 80% of the diameter at the distal end of the catheter 102 , less than 75% of the diameter at the distal end of the catheter 102 , less than 70% of the diameter at the distal end of the catheter 102 , less than 60% of the diameter at the distal end of the catheter 102 , and even less than 50% of the diameter at the distal end of the catheter 102 .
- the distal end of the catheter 102 i.e., the catheter body distal end 110 and/or the expandable medical device 104 , in the collapsed state
- the reduced-diameter proximal section 134 e.g., the catheter body 106
- the catheter body 106 has an outer diameter of 9 Fr along the reduced-diameter proximal section 134 .
- Reducing the diameter of the catheter proximal section 134 facilitates lowering the profile of the portion of the catheter 102 in the body, and opens up space in the vasculature for blood flow around the remainder of the catheter system 100 that remains in the vasculature after the larger-diameter catheter distal end 110 and expandable medical device 104 are advanced therethrough.
- a luer 136 or other suitable connector is connected in fluid communication with the catheter 102 and/or the outer sheath 112 at a corresponding proximal end thereof.
- the luer 136 is connected by a hemostatic valve 138 configured to control fluid flow therethrough.
- the luer 136 can be configured to deliver fluids to the catheter 102 , such as priming fluid, infusant, or any other suitable fluid.
- the expandable medical device 104 of the illustrated embodiment is a pump that includes a cannula 114 and an impeller 116 .
- the cannula 114 has a stored, or collapsed configuration, and a deployed or expanded configuration.
- the cannula 114 can be formed of a superelastic material, and in some embodiments, may have various shape memory material properties.
- the impeller 116 is positioned within the cannula 114 , and includes one or more blades 140 that extend from an impeller hub 142 .
- the blades 140 of the impeller 116 are self-expandable such that when the impeller 116 is positioned at a desired location, e.g., a chamber of a subject's heart, the blades 140 can be expanded into a deployed or expanded configuration, in which the blades 140 extend radially from the hub 142 .
- the cannula 114 and the impeller 116 may deploy from the stored configurations from within the outer sheath 112 into the expanded configuration.
- the outer sheath 112 can keep the blades 140 and the cannula 114 compressed until the blades 140 and cannula 114 are urged from within a lumen of the outer sheath 112 .
- the blades 140 can self-expand to a deployed configuration using strain energy stored in the blades 140 due to deformation of the blades 140 within the outer sheath 112 .
- the expandable cannula 114 may also self-deploy using stored strain energy after being urged from the outer sheath 112 .
- the combined energy stored in the expandable cannula 114 and blades 140 generates a force that preferably is opposed by the retention section 132 of the outer sheath 112 .
- the retention section 132 should be of robust design to avoid premature deployment of the cannula 114 and blades 140 , e.g., prior to positioning in the heart or other source of blood.
- the expandable medical device 104 has a diameter that is preferably small enough to be inserted percutaneously into a patient's vascular system.
- it can be advantageous to fold the expandable medical device 104 into a small enough stored configuration such that the expandable medical device 104 can fit within the patient's veins or arteries, particularly small veins or arteries that are peripheral and superficial, e.g., femoral veins or arteries, jugular and subclavian veins, radial and subclavian arteries.
- the expandable medical device 104 can have a diameter in the stored configuration corresponding to a catheter size between 8 Fr and 21 Fr.
- the expandable medical device 104 When the expandable medical device 104 is positioned within a chamber of the heart, it can be advantageous to expand the expandable medical device 104 to have a diameter as large as possible in the expanded or deployed configuration.
- an increased diameter of the impeller 116 advantageously increases flow rate through the pump at a given rotational speed.
- a larger diameter impeller can also lead to an improved ratio of flow rate to hemolysis rate.
- the expandable medical device 104 can have a diameter corresponding to a catheter size greater than 12 Fr in the deployed configuration. In other embodiments, the expandable medical device 104 can have a diameter corresponding to a catheter size greater than 21 Fr in the deployed or expanded configuration.
- FIG. 3 illustrates one exemplary use of the catheter system 100 .
- a distal portion of the catheter system 100 which includes the expandable medical device 104 , is placed in the left ventricle (LV) of the heart to pump blood from the LV into the aorta.
- the catheter system 100 can be used in this way to treat patients with a wide range of conditions, including cardiogenic shock, myocardial infarction, and other cardiac conditions, and also to support a patient during a procedure such as percutaneous coronary intervention.
- One convenient manner of placement of the distal portion of the catheter system 100 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the catheter system 100 to be used in emergency medicine, a catheter lab and in other non-surgical settings.
- FIG. 4 is another plan view of the catheter system 100 of FIG. 1 including a removable outer sheath assembly 200 and a recovery sheath assembly 300 .
- the outer sheath assembly 200 and recovery sheath assembly 300 facilitate reducing the cross-sectional area or profile of the catheter system 100 that remains in a patient's body during operation.
- the outer sheath assembly 200 is removable from the catheter body 106 to reduce the cross-sectional area or profile of the catheter system 100 within the patient's body, and the recovery sheath assembly 300 facilitates sealing or occluding openings or gaps formed between the catheter 102 and the incision site as a result of the reduced profile and further removing the expandable medical device 104 from the patient's body when the catheter system 100 is removed.
- the outer sheath assembly 200 includes the outer sheath 112 , which, in this embodiment, is removable from the patient's body and, in some embodiments, entirely from the catheter body 106 to lower the profile of the portion of the catheter system 100 that remains in the body. More specifically, at least a portion of the sheath assembly 200 is configured to separate from the catheter body 106 in a controlled manner at a selected time. In the illustrated embodiment, for example, a separation zone 202 is provided along the outer sheath body 126 to enable the outer sheath body 126 to be opened such that the catheter body 106 can pass through the separation zone 202 . In some embodiments, the separation zone 202 enables the outer sheath body 126 to be separated into a plurality of pieces or segments.
- the separation zone 202 may extend any suitable length along the outer sheath body 126 that enables the outer sheath assembly 200 to function as described herein. In the illustrated embodiment, the separation zone 202 extends the entire length of the outer sheath body 126 , i.e., from the proximal end 128 of the outer sheath body 126 to the distal end 130 of the outer sheath body 126 . In other embodiments, the separation zone 202 may extend less than the full length of the outer sheath body 126 .
- the separation zone 202 extends distally from the proximal end 128 of the outer sheath body 126 towards the distal end 130 of the outer sheath body 126 and terminates proximally from the distal end 130 of the outer sheath body 126 . In yet other embodiments, the separation zone 202 extends proximally from the distal end 130 of the outer sheath body 126 towards the proximal end 128 of the outer sheath body 126 and terminates distally from the proximal end 128 of the outer sheath body 126 .
- a portion of the outer sheath 112 may remain on the catheter body 106 after another portion of the outer sheath 112 is removed via the separation zone 202 .
- the portion of the outer sheath 112 that remains on the catheter body 106 may be removed from the patient's body through a lumen defined in the recovery sheath assembly 300 , described in more detail below.
- the separation zone or zones 202 can have any suitable configuration that facilities separating the outer sheath body 126 into a plurality of pieces or that facilitates changing the configuration of the outer sheath body 126 from a tubular body to one or more sheet-like bodies.
- the separation zone 202 comprises a linear seam disposed along the outer sheath body 126 .
- the separation zone 202 comprises two seams in one embodiment, one of the seams disposed along a first lateral side of the outer sheath body 126 and another of the seams disposed along a second later side of the outer sheath body 126 . Two of a plurality of seams can be disposed at 180 degrees apart from each other on the outer sheath body 126 .
- the linear seam or seams may include one or more lines of weakness, including, for example and without limitation, perforated lines, score lines, and combinations thereof.
- the linear seam or seams are formed by laser cutting.
- the linear seam or seams comprise a composite seam.
- the composite seam can include a first portion adjacent the proximal end of the seam that has a resistance to separation (i.e., higher or lower) than a second portion of the composite seam adjacent the distal end of the seam.
- the separation zone or zones 202 may be formed in only a portion of the outer sheath body 126 .
- the outer sheath body 126 may comprise a reinforced structure including an inner tube and an outer jacket enclosing or covering the inner tube.
- the separation zone or zones 202 may be formed in only a portion of the reinforced outer sheath body 126 , such as along the inner tube.
- the outer sheath body 126 comprises an inner tube and an outer polymeric jacket, wherein at least one separation zone 202 is formed along the inner tube, for example, by laser cutting (e.g., a laser cut perforation line).
- the outer polymeric jacket may be free of separation zones.
- the outer sheath assembly 200 of the illustrated embodiment includes a first lateral separation zone 202 a disposed on a first lateral side of the outer sheath body 126 , and a second lateral separation zone 202 b disposed on a second lateral side of the outer sheath body 126 .
- the first and second lateral sides can oppose each other, e.g., by being about 180 degrees apart.
- the first and second lateral separation zones 202 a, 202 b are positioned diametrically opposite one another.
- the outer sheath assembly 200 may also include a hub to facilitate manipulating the outer sheath assembly 200 and/or removing the outer sheath assembly 200 from the catheter body 106 .
- the outer sheath assembly 200 includes a hub 204 disposed at the proximal end 128 of the outer sheath body 126 .
- the hub 204 includes first and second lateral handles 206 , 208 that can be grasped by a clinician to provide relative movement between outer sheath body 126 and catheter body 106 .
- the first and second handles 206 , 208 can also be used to cause the hub 204 to separate into two pieces, and propagate separation of the outer sheath body 126 along the separation zone 202 , for example, by applying laterally opposing forces (indicated by arrows 210 ) to the first and second handles 206 , 208 .
- the catheter system 100 may further include a cutting tool 220 , shown in FIGS. 7 and 8 , to facilitate removing the outer sheath 112 from the catheter body 106 .
- the cutting tool 220 may include, for example, a handle 222 and a blade 224 protruding from the handle 222 to facilitate cutting the outer sheath body 126 along one or more separation zones.
- the separation zones may be pre-formed on the outer sheath body 126 , or the cutting tool 220 may be used to form one or more separation zones along which the outer sheath body 126 is separated. In the embodiment illustrated in FIGS.
- the cutting tool 220 is used to initiate a separation zone at the proximal end 128 of the outer sheath body 126 .
- the outer sheath body 126 is pulled proximally relative to the cutting tool 220 while the blade 224 is engaged with the outer sheath body 126 to separate the outer sheath body 126 along the separation zone.
- the outer sheath assembly 200 can be used to deliver the expandable medical device 104 to a target site within a patient's body while the outer sheath assembly 200 is in a first, intact configuration (shown in FIGS. 4 and 5 ).
- the outer sheath assembly 200 can subsequently be removed from the catheter body 106 and the patient's body by separating the outer sheath assembly 200 (e.g., along the separation zone 202 , as illustrated in FIG. 6 ).
- the outer sheath body 126 is separated into at least two portions or segments 126 a, 126 b, although in other embodiments the outer sheath body 126 may not be separated into multiple segments.
- the recovery sheath assembly 300 is adapted to seal or occlude openings or gaps at the incision site following removal of the outer sheath assembly 200 from the catheter, and is further configured to facilitate removal of the expandable medical device 104 from the patient's body when the catheter system 100 is removed.
- the recovery sheath assembly 300 may have any suitable configuration that enables the catheter system 100 to function as described herein.
- the recovery sheath assembly 300 has the same or similar configuration as the introducer sheath assembly described in U.S. patent application Ser. No. 16/864,545, filed May 1, 2020, the entire contents of which are incorporated herein by reference for all purposes.
- the recovery sheath assembly 300 of the illustrated embodiment includes a valve 302 , a recovery sheath 304 connected to and protruding from the valve 302 , and a tubular plug 306 that is releasably fixed relative to the recovery sheath 304 such that the plug can be removed or withdrawn from the recovery sheath 304 , as described in greater detail herein.
- the recovery sheath 304 and the tubular plug 306 are coupled to the valve 302 such that the recovery sheath assembly 300 is movable as a unit along the catheter body 106 .
- the recovery sheath assembly 300 is disposed on the catheter 102 , specifically, around the catheter body 106 .
- the recovery sheath assembly 300 is disposed on a proximal end of the catheter 102 , specifically, along the reduced-diameter proximal section 134 (shown in FIG. 1 ) of the catheter 102 .
- the recovery sheath assembly 300 is disposed on the catheter 102 distally from the fluid valve 138 (shown in FIG. 1 ).
- the fluid valve 138 may be incorporated with the recovery sheath assembly 300 , for example, as the valve 302 .
- the valve 302 is configured to control fluid flow through one or more lumens defined by the recovery sheath assembly 300 and/or the catheter 102 , for example, to inhibit blood flow out of a patient.
- the valve 302 includes a valve body 308 , an actuator 310 , and a valve member 312 .
- the valve 302 has a proximal end 314 and a distal end 316 , and has an elongate passage 318 defined therein.
- the elongate passage 318 is defined by and extends through each of the valve body 308 , the actuator 310 , and the valve member 312 .
- the valve body 308 has a proximal end 320 and a distal end 322 , which in this embodiment, defines the distal end 316 of the valve 302 .
- the actuator 310 is coupled to the valve body proximal end 320 , and the valve member 312 is positioned between the valve body 308 and the actuator 310 .
- the valve 302 is a rotatable hemostatic valve that includes a rotatable actuator 310 and a compressible valve member 312 .
- the actuator 310 is configured to compress the valve member 312 between an engagement portion 324 of the actuator 310 and the valve body 308 , and thereby cause the valve member 312 to deflect radially inward and apply a radial compressive force on the plug 306 .
- the valve member 312 thereby seals one or more lumens defined between the plug 306 and the catheter 102 and/or defined within the catheter 102 .
- the actuator 310 is threadably coupled to the valve body 308 in this embodiment such that rotation of the actuator 310 in a first direction (e.g., clockwise) displaces the actuator 310 towards the valve member 312 , and compresses the valve member 312 between the actuator 310 and the valve body 308 . Rotation of the actuator 310 in a second, opposite direction (e.g., counterclockwise) displaces the actuator 310 away from the valve member 312 , releasing compression on the valve member 312 .
- the recovery sheath assembly 300 may include any suitable valve that enables the recovery sheath assembly 300 to function as described herein, and is not limited to rotatable hemostatic valves.
- the valve 302 also includes a retainer 330 for releasably fixing the plug 306 relative to the recovery sheath 304 .
- the retainer 330 includes an O-ring that is positioned within an annular recess 332 defined by the actuator 310 . The O-ring engages a portion of the plug 306 , and maintains an axial position of the plug 306 relative to the recovery sheath 304 via a friction fit.
- the valve 302 may include a retainer other than an O-ring for releasably fixing the plug 306 relative to the recovery sheath 304 .
- one or both of the plug 306 and the recovery sheath 304 may include a retainer for maintaining a fixed relative position of the two components.
- the recovery sheath 304 includes an elongate body 334 extending from a proximal end 336 to a distal end 338 , and defines a lumen 340 therein that extends from the recovery sheath proximal end 336 to the recovery sheath distal end 338 .
- the recovery sheath body 334 has an outer diameter 342 that is sized and shaped to seal an incision formed, for example, in a patient's vasculature.
- the recovery sheath body 334 may have any suitable outer diameter 342 that enables the recovery sheath assembly 300 to function as described herein.
- the outer diameter 342 of the recovery sheath 304 is the same as the introducer sheath used to introduce the catheter 102 into a patient's vasculature.
- Suitable outer diameters 342 of the recovery sheath body 334 include, for example and without limitation, between 8 Fr and 21 Fr, between 8 Fr and 19 Fr, between 10 Fr and 21 Fr, between 8 Fr and 17 Fr, between 10 Fr and 19 Fr, between 12 Fr and 21 Fr, between 8 Fr and 15 Fr, between 10 Fr and 17 Fr, between 12 Fr and 19 Fr, between 14 Fr and 21 Fr, between 10 Fr and 15 Fr, between 12 Fr and 17 Fr, between 14 Fr and 19 Fr, and between 13 Fr and 16 Fr.
- the outer diameter 342 of the recovery sheath body 334 is less than 8 Fr. In yet other embodiments, the outer diameter 342 of the recovery sheath 304 is greater than 21 Fr. In one embodiment, the outer diameter 342 of the recovery sheath body 334 is 14 Fr.
- the recovery sheath lumen 340 is configured to be slidably disposed over the catheter 102 (e.g., over the catheter body 106 ) such that the catheter 102 can be advanced distally and proximally relative to the recovery sheath 304 .
- the recovery sheath lumen 340 is sized to permit the expandable medical device 104 and, in some embodiments, the outer sheath retention section 132 to fit therethrough.
- the recovery sheath 304 has an inner diameter 344 sized larger than an outer diameter of the expandable medical device 104 in the collapsed state such that the recovery sheath 304 can be used to re-sheath or collapse the expandable medical device 104 when removing the catheter 102 from a patient.
- the recovery sheath inner diameter 344 is sized to permit an object having an outer diameter of up to 13 Fr, up to 14 Fr, up to 15 Fr, and even up to 16 Fr to pass through the recovery sheath lumen 340 .
- the recovery sheath 304 is coupled to the valve body 308 at the valve body distal end 322 .
- the recovery sheath 304 may be coupled to the valve body 308 using any suitable fastening means including, for example and without limitation, a frictional fit, adhesives, and tacking.
- the recovery sheath 304 extends from the valve body distal end 322 a length 346 ( FIG. 9 ).
- the recovery sheath 304 may extend from the valve body 308 by any suitable length 346 that enables the recovery sheath assembly 300 to function as described herein including, for example and without limitation, between 10 centimeters (cm) and 40 cm, between 10 cm and 35 cm, between 20 cm and 45 cm, between 10 cm and 30 cm, between 20 cm and 40 cm, between 25 cm and 40 cm, between 10 cm and 25 cm, between 25 cm and 35 cm, between 20 cm and 30 cm, between 30 cm and 40 cm, and between 10 cm and 20 cm.
- centimeters (cm) and 40 cm between 10 cm and 35 cm, between 20 cm and 45 cm, between 10 cm and 30 cm, between 20 cm and 40 cm, between 25 cm and 40 cm, between 10 cm and 25 cm, between 25 cm and 35 cm, between 20 cm and 30 cm, between 30 cm and 40 cm, and between 10 cm and 20 cm.
- the length 346 the recovery sheath 304 extends from the valve body 308 is sufficient to allow the distal end 338 of the recovery sheath 304 to be inserted into a patient's vasculature to allow the expandable medical device 104 to be re-sheathed with the recovery sheath 304 while still in the patient's vasculature.
- the recovery sheath 304 may be constructed of any suitable materials using any suitable techniques that enable the recovery sheath 304 to function as described herein.
- the recovery sheath 304 has a suitably rigid construction to enable to the recovery sheath 304 to re-sheath or collapse the expandable medical device 104 when the catheter 102 is removed from a patient.
- Suitable constructions for the recovery sheath 304 include, for example and without limitation, a braided reinforced sheath (e.g., braided nitinol) with a lubricious liner, and a thicker-wall single material component.
- the plug 306 is disposed along the catheter 102 , between the recovery sheath 304 and the catheter 102 .
- the plug includes an elongate tubular body 348 extending from a proximal end 350 ( FIG. 10 ) to a distal end 352 of the plug 306 , and defines a lumen 354 extending therethrough.
- the elongate body 348 extends through each of the elongate passage 318 and the recovery sheath lumen 340 .
- the recovery sheath assembly 300 is disposed over the reduced-diameter proximal section 134 of the catheter 102 such that a gap 356 is defined between the recovery sheath 304 and the catheter 102 (e.g., the catheter body 106 ).
- the plug 306 is disposed over the catheter 102 (specifically, over the catheter body 106 ), and between the catheter 102 and the recovery sheath 304 to occlude the gap 356 defined therebetween.
- the plug 306 has a suitable thickness to substantially fill or occlude the gap 356 and inhibit outward fluid flow (i.e., towards a proximal end of the recovery sheath assembly 300 ) therethrough. That is, in some embodiments, the plug body 348 has a suitable inner diameter 358 and outer diameter 360 to substantially fill the gap 356 between the recovery sheath 304 and the catheter 102 . In some embodiments, for example, the plug body 348 has an outer diameter 360 of between 85% and 100% of the recovery sheath inner diameter 344 , between 85% and 95% of the recovery sheath inner diameter 344 , or between 90% and 100% of the recovery sheath inner diameter 344 .
- the plug body 348 has an inner diameter 358 of between 1.0 and 1.25 times an outer diameter of the catheter 102 (e.g., the reduced-diameter proximal section of the catheter 102 ), between 1.0 and 1.2 times an outer diameter of the catheter 102 , or between 1.0 and 1.15 times an outer diameter of the catheter 102 .
- the plug body 348 has an outer diameter 360 of 13 Fr, and an inner diameter 358 sized to permit an object having a diameter up to 10 Fr to pass therethrough.
- the plug 306 is releasably fixed relative to the recovery sheath 304 such that the plug 306 can be removed from the recovery sheath lumen 340 , for example, to allow a relatively-large diameter distal end of the catheter 102 (e.g., the expandable medical device 104 ) to pass therethrough.
- the plug 306 is releasably coupled to the valve 302 , specifically, to the valve actuator 310 by an O-ring.
- the plug 306 is removed from the recovery sheath lumen 340 by pulling the plug 306 proximally relative to the recovery sheath 304 , thereby decoupling the plug 306 from the valve 302 , prior to the catheter 102 being removed from a patient's vasculature.
- the plug 306 includes a handle 362 coupled with the plug proximal end 350 to facilitate positioning and/or moving the plug 306 relative to the recovery sheath 304 and/or the valve 302 .
- the handle 362 has a diameter larger than the plug body outer diameter 360 to facilitate grasping the handle 362 .
- the handle 362 includes an annular concave groove 364 to facilitate grasping the handle 362 .
- the handle 362 may include other gripping features in addition to or as an alternative to the concave groove, including, for example and without limitations, ribs, grooves, and textured surface(s).
- the handle 362 extends proximally from the valve proximal end 314 , and is accessible from an exterior of the valve 302 .
- the plug handle 362 may be formed integrally with the plug body 348 (i.e., as a unitary member), or may be formed separately from the plug body 348 and coupled thereto.
- the plug 306 is fixed relative to the recovery sheath 304 by the plug handle 362 being secured to the O-ring via a frictional fit.
- the plug distal end 352 protrudes from the distal end 338 of the recovery sheath 304 by a distance 366 .
- the plug distal end 352 may protrude from the recovery sheath distal end 338 by any suitable distance 366 that enables the recovery sheath assembly 300 to function as described herein.
- the plug distal end 352 protrudes from the recovery sheath distal end 338 by a distance 366 of up to 1 cm, up to 2 cm, up to 3 cm, 4 cm, up to 5 cm, up to 6 cm, up to 7 cm, up to 8 cm, and even up to 10 cm.
- the plug distal end 352 tapers radially inward towards a distal tip 368 of the plug 306 to facilitate insertion of the plug distal end 352 into an incision site.
- the plug body 348 includes multiple hardness or durometer zones. That is, the plug body 348 may be constructed to have zones of differing hardness or stiffness.
- the plug distal end 352 has a relatively stiff or hard construction relative to the remainder of the plug body 348 , for example, to facilitate insertion of the plug distal end 352 into an incision site.
- a proximal portion of the plug body 348 such as the portion of the plug body 348 that engages the valve member 312 , has a relatively soft, flexible, or elastic construction relative to the remainder of the plug body 348 , for example, to facilitate compression by the valve member 312 and sealing of one or more lumens defined by the plug body 348 and/or the catheter 102 . That is, the proximal portion of the plug body 348 may be radially compliant to facilitate sealing the lumens defined by or within the plug 306 .
- the plug 306 may be constructed of any suitable materials using any suitable techniques that enable the plug 306 to function as described herein.
- the plug 306 is formed by an extrusion process, and multiple hardness zones are formed along the plug body 348 using known reflow techniques.
- Suitable materials from which the plug 306 may be constructed include, for example and without limitation, polyethylene.
- the valve body 308 defines a fluid port 370 that is in fluid communication with the valve body elongate passage 318 .
- the fluid port 370 is configured for connection to a fluid source (e.g., heparinized saline) via a fluid line 372 , and allows one or more fluids F to be delivered or supplied to one or more lumens defined by the recovery sheath 304 and/or the plug 306 .
- fluid is supplied to one or more lumens defined by the recovery sheath 304 and/or the plug 306 to flush the lumens and inhibit blood products from accumulating and forming clots within the recovery sheath assembly 300 .
- the fluid port 370 is located between the valve member 312 and the distal end 322 of the valve body 308 , and extends radially inward from a radial outer surface of the valve body 308 to the elongate passage 318 .
- the recovery sheath proximal end 336 is positioned distally from the valve body fluid port 370 such that the recovery sheath lumen 340 is in fluid communication with the fluid port 370 .
- the plug 306 defines one or more fluid ports 374 that extend through the plug body 348 .
- the plug fluid ports 374 are coupled in fluid communication with the valve body fluid port 370 such that fluid may be supplied to the plug lumen 354 via the valve body fluid port 370 .
- the plug fluid ports 374 enable fluid to be supplied to the plug lumen 354 using the same fluid port 370 used to supply fluid to the recovery sheath lumen 340 .
- the plug fluid ports 374 are located distally from the elastic proximal portion of the plug body 348 that engages the valve member 312 to inhibit fluid supplied through the fluid port 370 from leaking out of the proximal end of the recovery sheath assembly 300 .
- FIG. 11 is a simplified diagram of a patient's vasculature illustrating one technique for introducing the catheter system 100 of FIG. 4 into the patient's vasculature.
- the catheter system 100 is shown in FIG. 11 in one operational configuration, following insertion of the catheter 102 into the patient's vasculature through an incision site 402 using an introducer sheath 404 .
- FIG. 11 shows the outer sheath 112 in a proximal position, with the expandable medical device 104 advanced distally out of the outer sheath 112 and in the expanded state.
- the expandable medical device 104 is delivered to a target site by advancing the expandable medical device 104 through the patient's vasculature while the expandable medical device 104 is maintained in a collapsed state within the outer sheath 112 , specifically, within the retention section 132 .
- the expandable medical device 104 can subsequently be deployed within the patient, such that the expandable medical device 104 radially expands from the collapsed state to an expanded state, by advancing the expandable medical device 104 distally out of the outer sheath 112 , as illustrated in FIG. 11 .
- the catheter system 100 is illustrated with the introducer sheath 404 positioned within the patient's vasculature.
- the recovery sheath assemblies of the present disclosure enable the introducer sheath 404 to be removed from the patient's vasculature, and thereby facilitate reducing obstructions to blood flow within the patient's vasculature.
- the recovery sheath assembly 300 is disposed on a proximal section of the catheter 102 , as shown in FIG. 11 .
- the introducer sheath 404 is removed from the patient's vasculature, and removed from the catheter 102 , for example, by separating the introducer sheath 404 along a separation zone (e.g., by peeling), as illustrated in FIG. 12 .
- FIG. 13 illustrates the catheter system 100 of FIG. 4 in the patient's vasculature after removal of the introducer sheath 404 .
- removal of the introducer sheath 404 reduces the profile or cross-sectional area of the portion of the catheter system 100 that remains in the body, and opens up space in the vasculature for blood flow around the remainder of the catheter system 100 .
- the profile or cross-sectional area of the catheter system 100 can be further reduced by removing the outer sheath assembly 200 from the catheter system 100 . As illustrated in FIG.
- the outer sheath assembly 200 can be removed from the catheter body 106 , for example, by separating the outer sheath body 126 along one or more separation zones (e.g., separation zone 202 , shown in FIG. 4 ) such that the catheter body 106 can pass through the separation zone 202 .
- the outer sheath body 126 is separated into two segments along 126 a, 126 b along first and second lateral separation zones 202 a, 202 b (shown in FIGS. 5 and 6 ) by applying laterally opposing forces at the proximal end 128 of the outer sheath body 126 .
- the outer sheath assembly 200 is pulled proximally along the catheter body 106 and out of the patient's vasculature until the outer sheath body 126 is completely removed from the patient's vasculature.
- removal of the outer sheath assembly 200 further reduces the profile or cross-sectional area of the portion of the catheter system 100 that remains in the body, and opens up additional space in the vasculature for blood flow around the remainder of the catheter system 100 .
- the reduced-diameter proximal section 134 of the catheter body 106 (shown in FIG. 1 ), and components enclosed therein, remains in the femoral artery.
- the reduced-diameter proximal section 134 of the catheter body 106 has a diameter less than the outer diameter of the outer sheath assembly 200 , and can be in the range of, for example, 7-11 Fr.
- the recovery sheath assembly 300 can be advanced distally along the catheter body 106 , subsequent to the outer sheath assembly 200 being removed from the catheter body 106 , to seal the incision site 402 and/or to facilitate removal of the expandable medical device 104 . More specifically, in illustrated embodiment, the recovery sheath 304 and the removable plug 306 are advanced distally along the catheter body 106 , subsequent to the outer sheath assembly 200 being removed from the catheter body 106 , so that the distal end 352 of the removable plug 306 (shown in FIG. 9 ) is positioned within the incision site 402 of the patient's vasculature.
- the distal end 352 of the removable plug 306 is tapered, and can be inserted through the incision site 402 as far as needed to seal or occlude the incision site 402 .
- the recovery sheath assembly 300 is advanced distally until the recovery sheath 304 is positioned within the incision site 402 to seal the incision site 402 .
- the removable plug 306 occludes the gap formed between the relatively-large diameter recovery sheath 304 and the relatively-small diameter catheter body 106 .
- the incision site 402 may be sealed by means other than the removable plug 306 .
- the incision site 402 may be sealed by suturing around the catheter body 106 and/or by using a suture-mediated closure system, such as Perclose ProGlideTM, commercially available from Abbott Laboratories.
- the recovery sheath 304 may remain outside the patient's vasculature until just prior to removal of the catheter 102 from the patient's vasculature.
- FIG. 16 illustrates one technique for removing the catheter system 100 from the patient's vasculature.
- the catheter 102 is removed from the vasculature of the patient by pulling the catheter 102 proximally out of patient's vasculature through the recovery sheath lumen 340 (shown in FIG. 10 ). More specifically, the removable plug 306 is removed from the recovery sheath 304 (e.g., by sliding the removable plug 306 proximally along the catheter 102 relative to the recovery sheath 304 ) such that the large diameter distal end of the catheter 102 can pass through the recovery sheath lumen 340 . As the catheter 102 is pulled proximally out of the patient's vasculature, as illustrated in FIG.
- the expandable medical device 104 engages the distal end 338 of the recovery sheath 304 (shown in FIG. 9 ), causing the expandable medical device 104 to collapse into the collapsed configuration.
- the expandable medical device 104 can then be pulled proximally through the recovery sheath lumen 340 , and the catheter 102 can be removed from the patient's vasculature.
- valve 302 may be actuated to close valve member 312 (e.g., by rotating the actuator 310 and causing the valve member 312 to compress the recovery sheath 304 ) to inhibit blood flow out of the recovery sheath 304 .
- the recovery sheath 304 may be left in place, for example, to allow access for other catheters to be introduced by an operator.
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Abstract
Description
- This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/705,662, filed Jul. 9, 2020, entitled CATHETER SYSTEM FOR INTRODUCING EXPANDABLE MEDICAL DEVICE AND METHODS OF USING SAME, which is incorporated by reference herein in its entirety.
- The present disclosure relates generally to medical devices that are used in the human body. In particular, the present disclosure relates to a catheter system for introducing expandable medical devices into a mammalian body and methods of using the same.
- Heart disease is a major health problem that claims many lives per year. After a heart attack or other major cardiac event, a small number of patients can be treated with medicines or other non-invasive treatment. A significant number of other patients can recover from a heart attack or other cardiac event if provided with mechanical circulatory support in a timely manner.
- In one conventional approach for treating patients, a blood pump is inserted into a heart chamber, such as into the left ventricle of the heart and the aortic arch, to assist the pumping function of the heart. Other known conventional applications involve providing for pumping venous blood from the right ventricle to the pulmonary artery for support of the right side of the heart. The object of the pump is to reduce the load on the heart muscle for a period of time allowing the affected heart muscle to recover and heal. Blood pumps may also be used in some cases for percutaneous coronary intervention. In some cases, surgical insertion may potentially cause additional stresses in heart failure patients.
- When a catheter is inserted into the body of a patient, an introducer, typically formed of a thin walled polymeric tube, is placed through the site of the incision directly into the blood vessel. The catheter is then inserted (i.e., introduced) through the introducer into the blood vessel. After the catheter has been extended to its target location, the introducer may remain in place until the catheter is removed. In some instances, this can be several hours or even several days. In some catheter systems, the introducer may be removed from the catheter (e.g., by peeling away) and the patient's body after the catheter is advanced to the target location to reduce the cross-sectional area of the catheter system in the patient's vasculature. Other portions of the catheter system, however, remain in the patient's vasculature until the catheter is removed.
- The present disclosure is directed to a catheter system that includes a catheter, a recovery sheath, and an outer sheath assembly. The catheter includes an elongate body that has an expandable medical device coupled with a distal end thereof. The recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein in a stored configuration. The recovery sheath is axially movable relative to the catheter body. The outer sheath assembly includes an outer sheath disposed over the catheter body. The outer sheath includes an elongate body that extends from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath. The outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration. The outer sheath is removable from the catheter body.
- The present disclosure is further directed to a method that includes inserting an introducer sheath into a vasculature of a patient through an incision site, and introducing a catheter system into a proximal end of the introducer sheath and into the vasculature through the introducer sheath. The catheter system includes a catheter that includes an elongate body having an expandable medical device coupled with a distal end thereof. The catheter system also includes a recovery sheath disposed around a proximal section of the catheter body, and an outer sheath disposed around the catheter body and positioned distally from the recovery sheath. The method further includes removing the introducer sheath from the catheter system and the vasculature of the patient, and removing the outer sheath from the catheter body and the vasculature of the patient while the catheter body remains in the vasculature.
- The present disclosure is further directed to a catheter system for a catheter pump. The system includes a catheter, a recovery sheath, and an outer sheath assembly. The catheter includes an elongate body having a distal portion including an expandable medical device including an expandable cannula and an impeller disposed within the expandable cannula and operable to draw fluid into the expandable cannula when rotated in the fluid. The catheter also includes a drive cable coupled to the impeller and disposed within a lumen defined by the catheter body. The recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein in a stored configuration. The recovery sheath is axially movable relative to the catheter body. The outer sheath assembly includes an outer sheath disposed over the catheter body. The outer sheath includes an elongate body extending from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath. The outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration. The outer sheath is removable from the catheter body.
-
FIG. 1 is a plan view of a catheter system. -
FIG. 2 is an enlarged sectional view of an expandable medical device of the catheter system shown inFIG. 1 . -
FIG. 3 illustrates one exemplary use of the catheter system shown inFIG. 1 within the chamber of a patient's heart. -
FIG. 4 is a plan view of the catheter system ofFIG. 1 including a removable outer sheath assembly and a recovery sheath assembly. -
FIG. 5 is a sectional view of the catheter system ofFIG. 4 , taken along line “5-5” inFIG. 4 . -
FIG. 6 is a side view of a portion of the catheter system ofFIG. 4 , illustrating the outer sheath assembly being removed from the catheter system. -
FIG. 7 is a perspective view of a cutting tool used to separate the outer sheath assembly along a separation zone. -
FIG. 8 is another perspective view of the cutting tool ofFIG. 7 illustrating the outer sheath assembly being pulled proximally relative to the cutting tool to separate the outer sheath assembly along the separation zone. -
FIG. 9 is a perspective view of the recovery sheath assembly shown inFIG. 4 . -
FIG. 10 is a sectional view of the recovery sheath assembly shown inFIG. 4 . -
FIGS. 11-16 are simplified diagrams of a patient's vasculature illustrating various techniques for introducing and removing the catheter system ofFIG. 4 . - The present disclosure is directed to catheter systems for introducing expandable medical devices into a mammalian body that facilitate reducing obstructions or occlusions to blood flow while the catheter is positioned within the body. In particular, the catheter systems of the present disclosure enable one or more portions of the catheter system to be removed from the catheter body while the catheter is positioned within a patient to reduce the cross-sectional area of the catheter system within the patient's vasculature and thereby reduce obstructions to blood flow. For example, the catheter systems described herein include a removable outer sheath assembly that can be used to deliver an expandable medical device to a target site in a stored or collapsed configuration, and subsequently removed from the catheter system (e.g., by peeling away) and the patient's vasculature to reduce the cross-sectional area of the catheter system remaining the patient's vasculature.
- Additionally, catheter systems of the present disclosure may include a recovery sheath assembly to facilitate sealing openings or gaps around the catheter body at the incision site following removal of the outer sheath assembly, and to facilitate re-sheathing and/or removing the expandable medical device when the catheter system is removed. For example, the recovery sheath assembly can include a removable plug configured to seal an opening at the incision site following removal of the outer sheath assembly. Consequently, catheter systems of the present disclosure may have a reduced-diameter proximal section, and thereby reduce obstructions to blood flow. Moreover, the recovery sheath assembly can include a relatively-large diameter recovery sheath that is held outside of a patient's body until the expandable medical device is ready to be removed from the patient's body. The recovery sheath can then be advanced into a patient's vasculature to facilitate collapsing and/or re-sheathing the expandable medical device within a lumen defined by the recovery sheath, and can be withdrawn from the patient's vasculature along with the collapsed medical device.
- Embodiments of the present disclosure are suitable for use in combination with numerous different catheters and catheter systems.
FIGS. 1-3 illustrate one non-limiting example of acatheter system 100 in which embodiments of the present disclosure may be used. In this embodiment, thecatheter system 100 is a percutaneous heart pump catheter suitable for providing high performance flow rates of blood within the left ventricle of a patient. While embodiments of the present disclosure are described with reference to a catheter pump, it should be understood that the disclosed embodiments are not limited to use with a catheter pump and may be used in combination with other catheters and catheter systems. Moreover, it should be understood that the disclosed embodiments are not limited to use with catheters, and may be used in combination with other surgical or medical devices, for example, to facilitate insertion, placement, and/or removal of such surgical and medical devices within a patient's body. -
FIG. 1 is a plan view of thecatheter system 100. As shown inFIG. 1 , thecatheter system 100 generally includes acatheter 102 and an expandablemedical device 104. Thecatheter 102 has anelongate body 106 extending from aproximal end 108 to adistal end 110, and includes a retainer orouter sheath 112 disposed over theelongate body 106. As used herein, “proximal” refers to a direction away from the body of a patient and toward an operator of thecatheter system 100. In contrast, “distal” as used herein refers to a direction toward the body of a patient and away from the operator. The expandablemedical device 104 is coupled at thedistal end 110 of thecatheter body 106. As used herein, the term “expandable medical device” refers to a catheter medical device, typically coupled to the distal end of the catheter, that is radially expandable from a stored or delivery profile to a deployed or operational profile that is larger than the delivery profile. In this embodiment, the expandablemedical device 104 is shown as a radially-expandable heart pump that includes a collapsible andexpandable cannula 114 and a collapsible and expandable impeller 116 (shown inFIG. 2 ). It should be understood that the embodiments of the present disclosure are not limited to use with radially-expandable pumps, and are suitable for use with other types of expandable medical devices. In the collapsed state, the distal end of thecatheter system 100 can be advanced to the heart, for example, through an artery. In the expanded state (shown inFIGS. 1-3 ), themedical device 104 is operational and is capable of performing one more functions for which it is designed. In the illustrated embodiment, the expandablemedical device 104 is able to pump or output blood at high flow rates in the expanded state. - In the illustrated embodiment, the
catheter system 100 is coupled with amotor 118 for driving theimpeller 116. Thecatheter system 100 includes acoupling 120 that can be engaged with themotor 118 in certain embodiments. In various embodiments, theimpeller 116 is rotated by themotor 118 via a drive cable or shaft 122 (FIG. 2 ) of thecatheter 102 when the pump is operating. For example, themotor 118 can be disposed outside the patient. In some embodiments, themotor 118 is coupled to acontroller 124 that directs operation of the motor and other components of the catheter system 100 (e.g., an infusion system). In some embodiments, themotor 118 is separate from thecontroller 124, e.g., to be placed closer to the patient. In other embodiments, themotor 118 is part of thecontroller 124. In still other embodiments, the motor is miniaturized to be insertable into the patient. In still other embodiments, thecatheter system 100 may not include amotor 118. - The
outer sheath 112 is disposed over thecatheter body 106, and includes anelongate body 126 that extends from aproximal end 128 to adistal end 130. Theelongate body 126 has at least one lumen defined therein that houses theelongate body 106 of thecatheter 102. Thecatheter body 106 can be disposed in the lumen of theouter sheath body 126 such that theelongate bodies elongate body 126 is sized and shaped to receive thecatheter body 106 therein to allow thecatheter body 106 to be advanced through the at least one lumen defined by theouter sheath 112. In some embodiments, described further below, theouter sheath 112 is removable from thecatheter body 106, for example, along one or more separation zones. - The
outer sheath 112 is configured to maintain the expandablemedical device 104 in the collapsed state to facilitate advancing thecatheter 102 through a patient's vasculature. More specifically, theouter sheath 112 includes aretention section 132 located at thedistal end 130 of the outer sheathelongate body 126 that is disposed over the expandablemedical device 104 when in the collapsed state. Theretention section 132 thereby enables the expandablemedical device 104 to be maintained in the collapsed state until the catheter bodydistal end 110 is advanced to a desired position, for example, within a patient's heart. In some embodiments, the expandablemedical device 104 is configured to self-deploy or self-expand into a deployed or expanded configuration when the expandablemedical device 104 is advanced distally out of theouter sheath 112. The expandablemedical device 104 can be collapsed into the collapsed state by advancing the outer sheathdistal end 130 distally over the expandablemedical device 104 to cause the expandablemedical device 104 to collapse. - In some embodiments, the
catheter 102 includes a reduced-diameter proximal portion orsection 134 that has a smaller diameter than a distal end of thecatheter 102. In the illustrated embodiment, for example, theretention section 132 of theouter sheath 112 has a suitable diameter for receiving and retaining the expandablemedical device 104 therein. The expandablemedical device 104, even in the collapsed state, may have a diameter larger than the remainder of thecatheter body 106. That is, the catheter bodydistal end 110 and the expandablemedical device 104, in the collapsed state, may have a larger diameter than a proximal section of thecatheter 102 that extends from the catheter bodyproximal end 108. Accordingly, in some embodiments, such as the embodiment shown inFIG. 1 , aproximal section 134 of thecatheter 102 located at theproximal end 108 may have a reduced diameter relative to the distal end of thecatheter 102. In some embodiments, for example, each of thecatheter body 106 and theouter sheath 112 has a reduced diameter along the catheterproximal section 134 relative to the distal ends of thecatheter body 106 and theouter sheath 112. In other embodiments, such as embodiments that do not have anouter sheath 112 or that include a removable outer sheath 112 (described in more detail below), only thecatheter body 106 may have a reduced diameter along the catheterproximal section 134. The reduced-diameterproximal section 134 can have a diameter that is less than 95% of the diameter at the distal end of the catheter 102 (e.g., the diameter of the catheter bodydistal end 110 and/or the expandablemedical device 104, in the collapsed state), less than 90% of the diameter at the distal end of thecatheter 102, less than 85% of the diameter at the distal end of thecatheter 102, less than 80% of the diameter at the distal end of thecatheter 102, less than 75% of the diameter at the distal end of thecatheter 102, less than 70% of the diameter at the distal end of thecatheter 102, less than 60% of the diameter at the distal end of thecatheter 102, and even less than 50% of the diameter at the distal end of thecatheter 102. In some embodiments, for example, the distal end of the catheter 102 (i.e., the catheter bodydistal end 110 and/or the expandablemedical device 104, in the collapsed state) has a diameter of between 13-16 French (Fr), and the reduced-diameter proximal section 134 (e.g., the catheter body 106) has a diameter of between 7-11 Fr. In one particular embodiment, thecatheter body 106 has an outer diameter of 9 Fr along the reduced-diameterproximal section 134. Reducing the diameter of the catheterproximal section 134 facilitates lowering the profile of the portion of thecatheter 102 in the body, and opens up space in the vasculature for blood flow around the remainder of thecatheter system 100 that remains in the vasculature after the larger-diameter catheterdistal end 110 and expandablemedical device 104 are advanced therethrough. - In some embodiments, such as the embodiment illustrated in
FIG. 1 , aluer 136 or other suitable connector is connected in fluid communication with thecatheter 102 and/or theouter sheath 112 at a corresponding proximal end thereof. In the illustrated embodiment, theluer 136 is connected by ahemostatic valve 138 configured to control fluid flow therethrough. Theluer 136 can be configured to deliver fluids to thecatheter 102, such as priming fluid, infusant, or any other suitable fluid. - With additional reference to
FIG. 2 , the expandablemedical device 104 of the illustrated embodiment is a pump that includes acannula 114 and animpeller 116. Thecannula 114 has a stored, or collapsed configuration, and a deployed or expanded configuration. Thecannula 114 can be formed of a superelastic material, and in some embodiments, may have various shape memory material properties. Theimpeller 116 is positioned within thecannula 114, and includes one ormore blades 140 that extend from animpeller hub 142. In some embodiments, theblades 140 of theimpeller 116 are self-expandable such that when theimpeller 116 is positioned at a desired location, e.g., a chamber of a subject's heart, theblades 140 can be expanded into a deployed or expanded configuration, in which theblades 140 extend radially from thehub 142. - The
cannula 114 and theimpeller 116 may deploy from the stored configurations from within theouter sheath 112 into the expanded configuration. In such implementations, theouter sheath 112 can keep theblades 140 and thecannula 114 compressed until theblades 140 andcannula 114 are urged from within a lumen of theouter sheath 112. Once theblades 140 are released from the sheath assembly, theblades 140 can self-expand to a deployed configuration using strain energy stored in theblades 140 due to deformation of theblades 140 within theouter sheath 112. Theexpandable cannula 114 may also self-deploy using stored strain energy after being urged from theouter sheath 112. The combined energy stored in theexpandable cannula 114 andblades 140 generates a force that preferably is opposed by theretention section 132 of theouter sheath 112. Thus, theretention section 132 should be of robust design to avoid premature deployment of thecannula 114 andblades 140, e.g., prior to positioning in the heart or other source of blood. - In the stored configuration, the expandable
medical device 104 has a diameter that is preferably small enough to be inserted percutaneously into a patient's vascular system. Thus, it can be advantageous to fold the expandablemedical device 104 into a small enough stored configuration such that the expandablemedical device 104 can fit within the patient's veins or arteries, particularly small veins or arteries that are peripheral and superficial, e.g., femoral veins or arteries, jugular and subclavian veins, radial and subclavian arteries. In some embodiments, therefore, the expandablemedical device 104 can have a diameter in the stored configuration corresponding to a catheter size between 8 Fr and 21 Fr. - When the expandable
medical device 104 is positioned within a chamber of the heart, it can be advantageous to expand the expandablemedical device 104 to have a diameter as large as possible in the expanded or deployed configuration. For example, in the illustrated embodiment, an increased diameter of theimpeller 116 advantageously increases flow rate through the pump at a given rotational speed. A larger diameter impeller can also lead to an improved ratio of flow rate to hemolysis rate. In some implementations, the expandablemedical device 104 can have a diameter corresponding to a catheter size greater than 12 Fr in the deployed configuration. In other embodiments, the expandablemedical device 104 can have a diameter corresponding to a catheter size greater than 21 Fr in the deployed or expanded configuration. -
FIG. 3 illustrates one exemplary use of thecatheter system 100. In the illustrated embodiment, a distal portion of thecatheter system 100, which includes the expandablemedical device 104, is placed in the left ventricle (LV) of the heart to pump blood from the LV into the aorta. Thecatheter system 100 can be used in this way to treat patients with a wide range of conditions, including cardiogenic shock, myocardial infarction, and other cardiac conditions, and also to support a patient during a procedure such as percutaneous coronary intervention. One convenient manner of placement of the distal portion of thecatheter system 100 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable thecatheter system 100 to be used in emergency medicine, a catheter lab and in other non-surgical settings. - Various additional aspects of the catheter system and associated components may be similar to those disclosed in U.S. Pat. Nos. 7,022,100; 7,393,181; 7,841,976; 7,998,054; 8,376,707; 8,485,961; 8,535,211; 8,591,393; 8,597,170; 8,721,517; 9,138,518; 9,358,329; 9,421,311; 9,446,179; 9,872,947; and 10,105,475, the entire contents of which are incorporated herein for all purposes by reference.
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FIG. 4 is another plan view of thecatheter system 100 ofFIG. 1 including a removableouter sheath assembly 200 and arecovery sheath assembly 300. Theouter sheath assembly 200 andrecovery sheath assembly 300 facilitate reducing the cross-sectional area or profile of thecatheter system 100 that remains in a patient's body during operation. As described further herein, for example, at least a portion of theouter sheath assembly 200 is removable from thecatheter body 106 to reduce the cross-sectional area or profile of thecatheter system 100 within the patient's body, and therecovery sheath assembly 300 facilitates sealing or occluding openings or gaps formed between thecatheter 102 and the incision site as a result of the reduced profile and further removing the expandablemedical device 104 from the patient's body when thecatheter system 100 is removed. - The
outer sheath assembly 200 includes theouter sheath 112, which, in this embodiment, is removable from the patient's body and, in some embodiments, entirely from thecatheter body 106 to lower the profile of the portion of thecatheter system 100 that remains in the body. More specifically, at least a portion of thesheath assembly 200 is configured to separate from thecatheter body 106 in a controlled manner at a selected time. In the illustrated embodiment, for example, aseparation zone 202 is provided along theouter sheath body 126 to enable theouter sheath body 126 to be opened such that thecatheter body 106 can pass through theseparation zone 202. In some embodiments, theseparation zone 202 enables theouter sheath body 126 to be separated into a plurality of pieces or segments. - The
separation zone 202 may extend any suitable length along theouter sheath body 126 that enables theouter sheath assembly 200 to function as described herein. In the illustrated embodiment, theseparation zone 202 extends the entire length of theouter sheath body 126, i.e., from theproximal end 128 of theouter sheath body 126 to thedistal end 130 of theouter sheath body 126. In other embodiments, theseparation zone 202 may extend less than the full length of theouter sheath body 126. In some embodiments, for example, theseparation zone 202 extends distally from theproximal end 128 of theouter sheath body 126 towards thedistal end 130 of theouter sheath body 126 and terminates proximally from thedistal end 130 of theouter sheath body 126. In yet other embodiments, theseparation zone 202 extends proximally from thedistal end 130 of theouter sheath body 126 towards theproximal end 128 of theouter sheath body 126 and terminates distally from theproximal end 128 of theouter sheath body 126. In embodiments where theseparation zone 202 extends less than the full length of theouter sheath body 126, a portion of theouter sheath 112 may remain on thecatheter body 106 after another portion of theouter sheath 112 is removed via theseparation zone 202. The portion of theouter sheath 112 that remains on thecatheter body 106 may be removed from the patient's body through a lumen defined in therecovery sheath assembly 300, described in more detail below. - The separation zone or
zones 202 can have any suitable configuration that facilities separating theouter sheath body 126 into a plurality of pieces or that facilitates changing the configuration of theouter sheath body 126 from a tubular body to one or more sheet-like bodies. In some embodiments, theseparation zone 202 comprises a linear seam disposed along theouter sheath body 126. Theseparation zone 202 comprises two seams in one embodiment, one of the seams disposed along a first lateral side of theouter sheath body 126 and another of the seams disposed along a second later side of theouter sheath body 126. Two of a plurality of seams can be disposed at 180 degrees apart from each other on theouter sheath body 126. The linear seam or seams may include one or more lines of weakness, including, for example and without limitation, perforated lines, score lines, and combinations thereof. In one particular embodiment, the linear seam or seams are formed by laser cutting. In some embodiments, the linear seam or seams comprise a composite seam. For example, the composite seam can include a first portion adjacent the proximal end of the seam that has a resistance to separation (i.e., higher or lower) than a second portion of the composite seam adjacent the distal end of the seam. - In some embodiments, the separation zone or
zones 202 may be formed in only a portion of theouter sheath body 126. For example, theouter sheath body 126 may comprise a reinforced structure including an inner tube and an outer jacket enclosing or covering the inner tube. In such embodiments, the separation zone orzones 202 may be formed in only a portion of the reinforcedouter sheath body 126, such as along the inner tube. In one particular embodiment, theouter sheath body 126 comprises an inner tube and an outer polymeric jacket, wherein at least oneseparation zone 202 is formed along the inner tube, for example, by laser cutting (e.g., a laser cut perforation line). In such embodiments, the outer polymeric jacket may be free of separation zones. - With additional reference to
FIGS. 5 and 6 , theouter sheath assembly 200 of the illustrated embodiment includes a firstlateral separation zone 202 a disposed on a first lateral side of theouter sheath body 126, and a secondlateral separation zone 202 b disposed on a second lateral side of theouter sheath body 126. The first and second lateral sides can oppose each other, e.g., by being about 180 degrees apart. In the illustrated embodiment, the first and secondlateral separation zones - In some embodiments, the
outer sheath assembly 200 may also include a hub to facilitate manipulating theouter sheath assembly 200 and/or removing theouter sheath assembly 200 from thecatheter body 106. In the illustrated embodiment, for example, theouter sheath assembly 200 includes ahub 204 disposed at theproximal end 128 of theouter sheath body 126. As shown inFIGS. 5 and 6 , thehub 204 includes first and second lateral handles 206, 208 that can be grasped by a clinician to provide relative movement betweenouter sheath body 126 andcatheter body 106. The first andsecond handles hub 204 to separate into two pieces, and propagate separation of theouter sheath body 126 along theseparation zone 202, for example, by applying laterally opposing forces (indicated by arrows 210) to the first andsecond handles - In some embodiments, the
catheter system 100 may further include acutting tool 220, shown inFIGS. 7 and 8 , to facilitate removing theouter sheath 112 from thecatheter body 106. Thecutting tool 220 may include, for example, ahandle 222 and ablade 224 protruding from thehandle 222 to facilitate cutting theouter sheath body 126 along one or more separation zones. In this embodiment, the separation zones may be pre-formed on theouter sheath body 126, or thecutting tool 220 may be used to form one or more separation zones along which theouter sheath body 126 is separated. In the embodiment illustrated inFIGS. 7 and 8 , thecutting tool 220 is used to initiate a separation zone at theproximal end 128 of theouter sheath body 126. Theouter sheath body 126 is pulled proximally relative to thecutting tool 220 while theblade 224 is engaged with theouter sheath body 126 to separate theouter sheath body 126 along the separation zone. - As described further herein, the
outer sheath assembly 200 can be used to deliver the expandablemedical device 104 to a target site within a patient's body while theouter sheath assembly 200 is in a first, intact configuration (shown inFIGS. 4 and 5 ). Theouter sheath assembly 200 can subsequently be removed from thecatheter body 106 and the patient's body by separating the outer sheath assembly 200 (e.g., along theseparation zone 202, as illustrated inFIG. 6 ). In the illustrated embodiment, theouter sheath body 126 is separated into at least two portions orsegments outer sheath body 126 may not be separated into multiple segments. - The
recovery sheath assembly 300 is adapted to seal or occlude openings or gaps at the incision site following removal of theouter sheath assembly 200 from the catheter, and is further configured to facilitate removal of the expandablemedical device 104 from the patient's body when thecatheter system 100 is removed. Therecovery sheath assembly 300 may have any suitable configuration that enables thecatheter system 100 to function as described herein. In some embodiments, therecovery sheath assembly 300 has the same or similar configuration as the introducer sheath assembly described in U.S. patent application Ser. No. 16/864,545, filed May 1, 2020, the entire contents of which are incorporated herein by reference for all purposes. - With additional reference to
FIG. 9 , therecovery sheath assembly 300 of the illustrated embodiment includes avalve 302, arecovery sheath 304 connected to and protruding from thevalve 302, and atubular plug 306 that is releasably fixed relative to therecovery sheath 304 such that the plug can be removed or withdrawn from therecovery sheath 304, as described in greater detail herein. In this embodiment, therecovery sheath 304 and thetubular plug 306 are coupled to thevalve 302 such that therecovery sheath assembly 300 is movable as a unit along thecatheter body 106. - With additional reference to
FIG. 10 , therecovery sheath assembly 300 is disposed on thecatheter 102, specifically, around thecatheter body 106. In the illustrated embodiment, therecovery sheath assembly 300 is disposed on a proximal end of thecatheter 102, specifically, along the reduced-diameter proximal section 134 (shown inFIG. 1 ) of thecatheter 102. In some embodiments, therecovery sheath assembly 300 is disposed on thecatheter 102 distally from the fluid valve 138 (shown inFIG. 1 ). In other embodiments, thefluid valve 138 may be incorporated with therecovery sheath assembly 300, for example, as thevalve 302. - The
valve 302 is configured to control fluid flow through one or more lumens defined by therecovery sheath assembly 300 and/or thecatheter 102, for example, to inhibit blood flow out of a patient. Thevalve 302 includes avalve body 308, anactuator 310, and avalve member 312. Thevalve 302 has aproximal end 314 and a distal end 316, and has anelongate passage 318 defined therein. In this embodiment, theelongate passage 318 is defined by and extends through each of thevalve body 308, theactuator 310, and thevalve member 312. Thevalve body 308 has aproximal end 320 and a distal end 322, which in this embodiment, defines the distal end 316 of thevalve 302. Theactuator 310 is coupled to the valve bodyproximal end 320, and thevalve member 312 is positioned between thevalve body 308 and theactuator 310. - In this embodiment, the
valve 302 is a rotatable hemostatic valve that includes arotatable actuator 310 and acompressible valve member 312. More specifically, theactuator 310 is configured to compress thevalve member 312 between anengagement portion 324 of theactuator 310 and thevalve body 308, and thereby cause thevalve member 312 to deflect radially inward and apply a radial compressive force on theplug 306. Thevalve member 312 thereby seals one or more lumens defined between theplug 306 and thecatheter 102 and/or defined within thecatheter 102. Theactuator 310 is threadably coupled to thevalve body 308 in this embodiment such that rotation of theactuator 310 in a first direction (e.g., clockwise) displaces theactuator 310 towards thevalve member 312, and compresses thevalve member 312 between the actuator 310 and thevalve body 308. Rotation of theactuator 310 in a second, opposite direction (e.g., counterclockwise) displaces theactuator 310 away from thevalve member 312, releasing compression on thevalve member 312. It should be understood that therecovery sheath assembly 300 may include any suitable valve that enables therecovery sheath assembly 300 to function as described herein, and is not limited to rotatable hemostatic valves. - The
valve 302 also includes aretainer 330 for releasably fixing theplug 306 relative to therecovery sheath 304. In this embodiment, theretainer 330 includes an O-ring that is positioned within anannular recess 332 defined by theactuator 310. The O-ring engages a portion of theplug 306, and maintains an axial position of theplug 306 relative to therecovery sheath 304 via a friction fit. In other embodiments, thevalve 302 may include a retainer other than an O-ring for releasably fixing theplug 306 relative to therecovery sheath 304. In yet other embodiments, one or both of theplug 306 and therecovery sheath 304 may include a retainer for maintaining a fixed relative position of the two components. - The
recovery sheath 304 includes anelongate body 334 extending from aproximal end 336 to adistal end 338, and defines alumen 340 therein that extends from the recovery sheathproximal end 336 to the recovery sheathdistal end 338. Therecovery sheath body 334 has anouter diameter 342 that is sized and shaped to seal an incision formed, for example, in a patient's vasculature. Therecovery sheath body 334 may have any suitableouter diameter 342 that enables therecovery sheath assembly 300 to function as described herein. In some embodiments, theouter diameter 342 of therecovery sheath 304 is the same as the introducer sheath used to introduce thecatheter 102 into a patient's vasculature. Suitableouter diameters 342 of therecovery sheath body 334 include, for example and without limitation, between 8 Fr and 21 Fr, between 8 Fr and 19 Fr, between 10 Fr and 21 Fr, between 8 Fr and 17 Fr, between 10 Fr and 19 Fr, between 12 Fr and 21 Fr, between 8 Fr and 15 Fr, between 10 Fr and 17 Fr, between 12 Fr and 19 Fr, between 14 Fr and 21 Fr, between 10 Fr and 15 Fr, between 12 Fr and 17 Fr, between 14 Fr and 19 Fr, and between 13 Fr and 16 Fr. In some embodiments, theouter diameter 342 of therecovery sheath body 334 is less than 8 Fr. In yet other embodiments, theouter diameter 342 of therecovery sheath 304 is greater than 21 Fr. In one embodiment, theouter diameter 342 of therecovery sheath body 334 is 14 Fr. - The
recovery sheath lumen 340 is configured to be slidably disposed over the catheter 102 (e.g., over the catheter body 106) such that thecatheter 102 can be advanced distally and proximally relative to therecovery sheath 304. Therecovery sheath lumen 340 is sized to permit the expandablemedical device 104 and, in some embodiments, the outersheath retention section 132 to fit therethrough. For example, therecovery sheath 304 has an inner diameter 344 sized larger than an outer diameter of the expandablemedical device 104 in the collapsed state such that therecovery sheath 304 can be used to re-sheath or collapse the expandablemedical device 104 when removing thecatheter 102 from a patient. In some embodiments, the recovery sheath inner diameter 344 is sized to permit an object having an outer diameter of up to 13 Fr, up to 14 Fr, up to 15 Fr, and even up to 16 Fr to pass through therecovery sheath lumen 340. - In this embodiment, the
recovery sheath 304 is coupled to thevalve body 308 at the valve body distal end 322. Therecovery sheath 304 may be coupled to thevalve body 308 using any suitable fastening means including, for example and without limitation, a frictional fit, adhesives, and tacking. Therecovery sheath 304 extends from the valve body distal end 322 a length 346 (FIG. 9 ). Therecovery sheath 304 may extend from thevalve body 308 by anysuitable length 346 that enables therecovery sheath assembly 300 to function as described herein including, for example and without limitation, between 10 centimeters (cm) and 40 cm, between 10 cm and 35 cm, between 20 cm and 45 cm, between 10 cm and 30 cm, between 20 cm and 40 cm, between 25 cm and 40 cm, between 10 cm and 25 cm, between 25 cm and 35 cm, between 20 cm and 30 cm, between 30 cm and 40 cm, and between 10 cm and 20 cm. Thelength 346 therecovery sheath 304 extends from thevalve body 308 is sufficient to allow thedistal end 338 of therecovery sheath 304 to be inserted into a patient's vasculature to allow the expandablemedical device 104 to be re-sheathed with therecovery sheath 304 while still in the patient's vasculature. - The
recovery sheath 304 may be constructed of any suitable materials using any suitable techniques that enable therecovery sheath 304 to function as described herein. In some embodiments, therecovery sheath 304 has a suitably rigid construction to enable to therecovery sheath 304 to re-sheath or collapse the expandablemedical device 104 when thecatheter 102 is removed from a patient. Suitable constructions for therecovery sheath 304 include, for example and without limitation, a braided reinforced sheath (e.g., braided nitinol) with a lubricious liner, and a thicker-wall single material component. - The
plug 306 is disposed along thecatheter 102, between therecovery sheath 304 and thecatheter 102. The plug includes an elongatetubular body 348 extending from a proximal end 350 (FIG. 10 ) to adistal end 352 of theplug 306, and defines alumen 354 extending therethrough. Theelongate body 348 extends through each of theelongate passage 318 and therecovery sheath lumen 340. - In some embodiments, such as the embodiment illustrated in
FIGS. 4-8 , therecovery sheath assembly 300 is disposed over the reduced-diameterproximal section 134 of thecatheter 102 such that agap 356 is defined between therecovery sheath 304 and the catheter 102 (e.g., the catheter body 106). As shown inFIG. 10 , theplug 306 is disposed over the catheter 102 (specifically, over the catheter body 106), and between thecatheter 102 and therecovery sheath 304 to occlude thegap 356 defined therebetween. Theplug 306 has a suitable thickness to substantially fill or occlude thegap 356 and inhibit outward fluid flow (i.e., towards a proximal end of the recovery sheath assembly 300) therethrough. That is, in some embodiments, theplug body 348 has a suitableinner diameter 358 and outer diameter 360 to substantially fill thegap 356 between therecovery sheath 304 and thecatheter 102. In some embodiments, for example, theplug body 348 has an outer diameter 360 of between 85% and 100% of the recovery sheath inner diameter 344, between 85% and 95% of the recovery sheath inner diameter 344, or between 90% and 100% of the recovery sheath inner diameter 344. Further, in some embodiments, theplug body 348 has aninner diameter 358 of between 1.0 and 1.25 times an outer diameter of the catheter 102 (e.g., the reduced-diameter proximal section of the catheter 102), between 1.0 and 1.2 times an outer diameter of thecatheter 102, or between 1.0 and 1.15 times an outer diameter of thecatheter 102. In one particular embodiment, theplug body 348 has an outer diameter 360 of 13 Fr, and aninner diameter 358 sized to permit an object having a diameter up to 10 Fr to pass therethrough. - As noted above, the
plug 306 is releasably fixed relative to therecovery sheath 304 such that theplug 306 can be removed from therecovery sheath lumen 340, for example, to allow a relatively-large diameter distal end of the catheter 102 (e.g., the expandable medical device 104) to pass therethrough. In the illustrated embodiment, theplug 306 is releasably coupled to thevalve 302, specifically, to thevalve actuator 310 by an O-ring. In one method of using therecovery sheath assembly 300, theplug 306 is removed from therecovery sheath lumen 340 by pulling theplug 306 proximally relative to therecovery sheath 304, thereby decoupling theplug 306 from thevalve 302, prior to thecatheter 102 being removed from a patient's vasculature. - In the illustrated embodiment, the
plug 306 includes ahandle 362 coupled with the plugproximal end 350 to facilitate positioning and/or moving theplug 306 relative to therecovery sheath 304 and/or thevalve 302. Thehandle 362 has a diameter larger than the plug body outer diameter 360 to facilitate grasping thehandle 362. Further, in this embodiment, thehandle 362 includes an annularconcave groove 364 to facilitate grasping thehandle 362. Thehandle 362 may include other gripping features in addition to or as an alternative to the concave groove, including, for example and without limitations, ribs, grooves, and textured surface(s). Thehandle 362 extends proximally from the valveproximal end 314, and is accessible from an exterior of thevalve 302. The plug handle 362 may be formed integrally with the plug body 348 (i.e., as a unitary member), or may be formed separately from theplug body 348 and coupled thereto. In the illustrated embodiment, theplug 306 is fixed relative to therecovery sheath 304 by the plug handle 362 being secured to the O-ring via a frictional fit. - Referring again to
FIG. 9 , the plugdistal end 352 protrudes from thedistal end 338 of therecovery sheath 304 by adistance 366. The plugdistal end 352 may protrude from the recovery sheathdistal end 338 by anysuitable distance 366 that enables therecovery sheath assembly 300 to function as described herein. In some embodiments, for example, the plugdistal end 352 protrudes from the recovery sheathdistal end 338 by adistance 366 of up to 1 cm, up to 2 cm, up to 3 cm, 4 cm, up to 5 cm, up to 6 cm, up to 7 cm, up to 8 cm, and even up to 10 cm. - In some embodiments, the plug
distal end 352 tapers radially inward towards adistal tip 368 of theplug 306 to facilitate insertion of the plugdistal end 352 into an incision site. Moreover, in some embodiments, theplug body 348 includes multiple hardness or durometer zones. That is, theplug body 348 may be constructed to have zones of differing hardness or stiffness. In some embodiments, for example, the plugdistal end 352 has a relatively stiff or hard construction relative to the remainder of theplug body 348, for example, to facilitate insertion of the plugdistal end 352 into an incision site. Additionally or alternatively, in some embodiments, a proximal portion of theplug body 348, such as the portion of theplug body 348 that engages thevalve member 312, has a relatively soft, flexible, or elastic construction relative to the remainder of theplug body 348, for example, to facilitate compression by thevalve member 312 and sealing of one or more lumens defined by theplug body 348 and/or thecatheter 102. That is, the proximal portion of theplug body 348 may be radially compliant to facilitate sealing the lumens defined by or within theplug 306. - The
plug 306 may be constructed of any suitable materials using any suitable techniques that enable theplug 306 to function as described herein. In one embodiment, theplug 306 is formed by an extrusion process, and multiple hardness zones are formed along theplug body 348 using known reflow techniques. Suitable materials from which theplug 306 may be constructed include, for example and without limitation, polyethylene. - Referring to
FIG. 10 , thevalve body 308 defines afluid port 370 that is in fluid communication with the valve bodyelongate passage 318. Thefluid port 370 is configured for connection to a fluid source (e.g., heparinized saline) via afluid line 372, and allows one or more fluids F to be delivered or supplied to one or more lumens defined by therecovery sheath 304 and/or theplug 306. In some embodiments, fluid is supplied to one or more lumens defined by therecovery sheath 304 and/or theplug 306 to flush the lumens and inhibit blood products from accumulating and forming clots within therecovery sheath assembly 300. In this embodiment, thefluid port 370 is located between thevalve member 312 and the distal end 322 of thevalve body 308, and extends radially inward from a radial outer surface of thevalve body 308 to theelongate passage 318. - The recovery sheath
proximal end 336 is positioned distally from the valvebody fluid port 370 such that therecovery sheath lumen 340 is in fluid communication with thefluid port 370. Additionally, in this embodiment, theplug 306 defines one or morefluid ports 374 that extend through theplug body 348. When theplug 306 is connected to thevalve 302, as shown inFIGS. 7 and 8 , theplug fluid ports 374 are coupled in fluid communication with the valvebody fluid port 370 such that fluid may be supplied to theplug lumen 354 via the valvebody fluid port 370. In other words, theplug fluid ports 374 enable fluid to be supplied to theplug lumen 354 using thesame fluid port 370 used to supply fluid to therecovery sheath lumen 340. In this embodiment, theplug fluid ports 374 are located distally from the elastic proximal portion of theplug body 348 that engages thevalve member 312 to inhibit fluid supplied through thefluid port 370 from leaking out of the proximal end of therecovery sheath assembly 300. -
FIG. 11 is a simplified diagram of a patient's vasculature illustrating one technique for introducing thecatheter system 100 ofFIG. 4 into the patient's vasculature. Thecatheter system 100 is shown inFIG. 11 in one operational configuration, following insertion of thecatheter 102 into the patient's vasculature through anincision site 402 using anintroducer sheath 404. - More specifically,
FIG. 11 shows theouter sheath 112 in a proximal position, with the expandablemedical device 104 advanced distally out of theouter sheath 112 and in the expanded state. In some embodiments, the expandablemedical device 104 is delivered to a target site by advancing the expandablemedical device 104 through the patient's vasculature while the expandablemedical device 104 is maintained in a collapsed state within theouter sheath 112, specifically, within theretention section 132. The expandablemedical device 104 can subsequently be deployed within the patient, such that the expandablemedical device 104 radially expands from the collapsed state to an expanded state, by advancing the expandablemedical device 104 distally out of theouter sheath 112, as illustrated inFIG. 11 . - In
FIG. 11 , thecatheter system 100 is illustrated with theintroducer sheath 404 positioned within the patient's vasculature. As described herein, the recovery sheath assemblies of the present disclosure enable theintroducer sheath 404 to be removed from the patient's vasculature, and thereby facilitate reducing obstructions to blood flow within the patient's vasculature. In some embodiments, for example, therecovery sheath assembly 300 is disposed on a proximal section of thecatheter 102, as shown inFIG. 11 . Once the distal end of thecatheter 102 is advanced to a desired location within the patient, theintroducer sheath 404 is removed from the patient's vasculature, and removed from thecatheter 102, for example, by separating theintroducer sheath 404 along a separation zone (e.g., by peeling), as illustrated inFIG. 12 . -
FIG. 13 illustrates thecatheter system 100 ofFIG. 4 in the patient's vasculature after removal of theintroducer sheath 404. As shown inFIG. 13 , removal of theintroducer sheath 404 reduces the profile or cross-sectional area of the portion of thecatheter system 100 that remains in the body, and opens up space in the vasculature for blood flow around the remainder of thecatheter system 100. In accordance with the present disclosure, the profile or cross-sectional area of thecatheter system 100 can be further reduced by removing theouter sheath assembly 200 from thecatheter system 100. As illustrated inFIG. 14 , for example, theouter sheath assembly 200 can be removed from thecatheter body 106, for example, by separating theouter sheath body 126 along one or more separation zones (e.g.,separation zone 202, shown inFIG. 4 ) such that thecatheter body 106 can pass through theseparation zone 202. In the illustrated embodiment, theouter sheath body 126 is separated into two segments along 126a, 126b along first and secondlateral separation zones FIGS. 5 and 6 ) by applying laterally opposing forces at theproximal end 128 of theouter sheath body 126. As the separation zones advance distally along the length of theouter sheath body 126, theouter sheath assembly 200 is pulled proximally along thecatheter body 106 and out of the patient's vasculature until theouter sheath body 126 is completely removed from the patient's vasculature. - As shown in
FIG. 15 , removal of theouter sheath assembly 200 further reduces the profile or cross-sectional area of the portion of thecatheter system 100 that remains in the body, and opens up additional space in the vasculature for blood flow around the remainder of thecatheter system 100. In particular, after removal of theouter sheath assembly 200, only the reduced-diameterproximal section 134 of the catheter body 106 (shown inFIG. 1 ), and components enclosed therein, remains in the femoral artery. As noted above, the reduced-diameterproximal section 134 of thecatheter body 106 has a diameter less than the outer diameter of theouter sheath assembly 200, and can be in the range of, for example, 7-11 Fr. - As further illustrated in
FIG. 15 , therecovery sheath assembly 300, including therecovery sheath 304 and theremovable plug 306, can be advanced distally along thecatheter body 106, subsequent to theouter sheath assembly 200 being removed from thecatheter body 106, to seal theincision site 402 and/or to facilitate removal of the expandablemedical device 104. More specifically, in illustrated embodiment, therecovery sheath 304 and theremovable plug 306 are advanced distally along thecatheter body 106, subsequent to theouter sheath assembly 200 being removed from thecatheter body 106, so that thedistal end 352 of the removable plug 306 (shown inFIG. 9 ) is positioned within theincision site 402 of the patient's vasculature. As noted above, thedistal end 352 of theremovable plug 306 is tapered, and can be inserted through theincision site 402 as far as needed to seal or occlude theincision site 402. Although not illustrated inFIG. 15 , in some embodiments, therecovery sheath assembly 300 is advanced distally until therecovery sheath 304 is positioned within theincision site 402 to seal theincision site 402. Theremovable plug 306 occludes the gap formed between the relatively-largediameter recovery sheath 304 and the relatively-smalldiameter catheter body 106. - In other embodiments, the
incision site 402 may be sealed by means other than theremovable plug 306. In some embodiments, for example, theincision site 402 may be sealed by suturing around thecatheter body 106 and/or by using a suture-mediated closure system, such as Perclose ProGlide™, commercially available from Abbott Laboratories. In such embodiments, therecovery sheath 304 may remain outside the patient's vasculature until just prior to removal of thecatheter 102 from the patient's vasculature. -
FIG. 16 illustrates one technique for removing thecatheter system 100 from the patient's vasculature. In this embodiment, thecatheter 102 is removed from the vasculature of the patient by pulling thecatheter 102 proximally out of patient's vasculature through the recovery sheath lumen 340 (shown inFIG. 10 ). More specifically, theremovable plug 306 is removed from the recovery sheath 304 (e.g., by sliding theremovable plug 306 proximally along thecatheter 102 relative to the recovery sheath 304) such that the large diameter distal end of thecatheter 102 can pass through therecovery sheath lumen 340. As thecatheter 102 is pulled proximally out of the patient's vasculature, as illustrated inFIG. 16 , the expandablemedical device 104 engages thedistal end 338 of the recovery sheath 304 (shown inFIG. 9 ), causing the expandablemedical device 104 to collapse into the collapsed configuration. The expandablemedical device 104 can then be pulled proximally through therecovery sheath lumen 340, and thecatheter 102 can be removed from the patient's vasculature. - Once the
catheter 102 is removed from therecovery sheath 304, the valve 302 (shown inFIG. 9 ) may be actuated to close valve member 312 (e.g., by rotating theactuator 310 and causing thevalve member 312 to compress the recovery sheath 304) to inhibit blood flow out of therecovery sheath 304. Additionally, in some embodiments, therecovery sheath 304 may be left in place, for example, to allow access for other catheters to be introduced by an operator. - Although the embodiments and examples disclosed herein have been described with reference to particular embodiments, it is to be understood that these embodiments and examples are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and examples and that other arrangements can be devised without departing from the spirit and scope of the present disclosure as defined by the claims. Thus, it is intended that the present application cover the modifications and variations of these embodiments and their equivalents.
- This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
Claims (20)
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US17/175,210 US20220008052A1 (en) | 2020-07-09 | 2021-02-12 | Catheter system for introducing expandable medical device and methods of using same |
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US17/175,210 Pending US20220008052A1 (en) | 2020-07-09 | 2021-02-12 | Catheter system for introducing expandable medical device and methods of using same |
US18/154,459 Pending US20230190250A1 (en) | 2020-07-09 | 2023-01-13 | Catheter system for introducing expandable medical device and methods of using same |
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CN116251289A (en) * | 2022-10-25 | 2023-06-13 | 苏州心擎医疗技术有限公司 | Catheter pump and method for folding pump head of catheter pump |
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EP4178663A1 (en) | 2023-05-17 |
US20230190250A1 (en) | 2023-06-22 |
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US11963671B2 (en) | 2024-04-23 |
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