US-20260123957-A1 - INTEGRATED EXPANDABLE ACCESS FOR MEDICAL DEVICE INTRODUCER

Abstract

An integrated sheath assembly for inserting a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.

Inventors

• Glen R. Fantuzzi
• Thorsten Siess

Assignees

• ABIOMED, INC.

Dates

Publication Date

20260507

Application Date

20251112

Claims (19)

1. 1 .- 29 . (canceled)
2. 30 . A method for delivering a medical device through a sheath assembly the method comprising: providing first and second sheaths; wherein the first sheath has a first lumen extending between proximal and distal ends of the first sheath configured to allow for passage of a second portion of the medical device and wherein the proximal end of the first sheath is coupled to a first hub, wherein the second sheath has a second lumen extending between proximal and distal ends of the second sheath, the second lumen being configured to have a first inner diameter at rest, and to be elastically expandable from the first inner diameter to a second inner diameter and wherein the proximal end of the second sheath is coupled to a second hub; inserting a first portion of the medical device through the second lumen of the second sheath, wherein the second lumen expands to the second inner diameter during passage of the first portion of the medical device, and elastically contracts from the second inner diameter after the passage of the first portion of the medical device therethrough; inserting the first sheath over the second portion of the medical device and into the second sheath, wherein the first sheath fills a gap and forms a seal between an inner surface of the second sheath and the second portion of the medical device, wherein the second portion of the medical device has a second width that is smaller than a first width of the first portion of the medical device, wherein, when the second sheath is inserted in a blood vessel and the first sheath is inserted into the second lumen over the second portion of the medical device, blood from the blood vessel is substantially prevented from migrating past the seal; and coupling the first hub of the first sheath to the second hub of the second sheath.
3. 31 . The method of claim 30 , wherein the second hub further comprises a flushing port, the method further comprising flushing a fluid between the inner surface of the second sheath and an outer surface of the first sheath when the second portion of the medical device is contained within the first lumen.
4. 32 . The method of claim 30 , wherein the first hub further comprises a flushing port, the method further comprising flushing a fluid between the inner surface of the first sheath and an outer surface of the second portion of the medical device when the first sheath is inserted into the second lumen.
5. 33 . The method of claim 30 , wherein the first hub further comprises a flushing port, the method further comprising flushing a fluid into the second lumen of the second sheath after the first sheath is inserted into the second lumen.
6. 34 . The method of claim 30 , wherein the first sheath further comprises an auxiliary lumen substantially parallel to the first lumen and extending from the proximal end to the distal end of the first sheath, the method further comprising passing a guidewire through the auxiliary lumen.
7. 35 . The method of claim 30 , wherein an outer surface of the first sheath is tapered from the proximal end to the distal end of the first sheath, an outer diameter of the first sheath at the proximal end of the first sheath being larger than an outer diameter of the first sheath at the distal end of the first sheath.
8. 36 . The method of claim 30 , wherein the first sheath further comprises an expandable balloon, wherein the method further comprises varying a diameter of the second lumen when the first sheath is inserted into the second lumen.
9. 37 . The method of claim 30 , wherein the first hub and the second hub are coupled to each other via at least one of: a threaded connection, a press fit connection, or a cliplock connection.
10. 38 . The method of claim 30 , wherein an outer diameter of the second sheath is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less.
11. 39 . The method of claim 30 , wherein the second sheath comprises either a porous material or a mesh material.
12. 40 . The method of claim 30 , wherein the second sheath comprises a sheet rolled into a tubular configuration; and wherein, when the second lumen is at the first inner diameter, a first end of the sheet overlaps a second end of the sheet.
13. 41 . The method of claim 30 , wherein an outer surface of the first sheath comprises one of: radiopaque markers, visible markers, or markers for determining a depth of insertion.
14. 42 . The method of claim 30 , wherein an outer surface of the first sheath is coated with one of: an antithrombogenic coating, or a coating configured to reduce a likelihood of blood clot formation between the first sheath and the second sheath when inserted into the blood vessel.
15. 43 . The method of claim 30 , wherein an outer surface of the second sheath is coated with one of: a hydrophilic coating, a hydrophobic coating, or a coating to reduce friction.
16. 44 . The method of claim 30 , wherein an outer surface of the second sheath is coated with one of: an antimicrobial coating, or a coating configured to reduce a likelihood of infection occurring in the blood vessel when the second sheath is inserted into the blood vessel.
17. 45 . The method of claim 30 , further comprising inserting the first sheath into the second sheath by moving the first sheath and the second sheath axially relative to one another along a longitudinal axis of the first sheath and the second sheath.
18. 46 . The method of claim 45 , further comprising slidably coupling the first sheath and the second sheath to the second portion of the medical device.
19. 47 . The method of claim 46 , wherein the medical device is a percutaneous heart pump.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 18/368,762, filed on Sep. 15, 2023, now allowed, which application is a continuation of U.S. patent application Ser. No. 17/511,060, filed on Oct. 26, 2021, now U.S. Pat. No. 11,806,046, which is a continuation of U.S. patent application Ser. No. 16/130,475, filed on Sep. 13, 2018, now U.S. Pat. No. 11,197,690, which claims the benefit of the filing date of U.S. Provisional Application No. 62/558,507, filed on Sep. 14, 2017, the entire disclosures of which are hereby incorporated herein by reference. BACKGROUND OF THE INVENTION A medical device, such as an intracardiac heart pump assembly, can be introduced into a patient in various ways. In general, a heart pump can be introduced in the heart to pump blood from the heart into a vessel to support the function of the heart. When deployed in the heart, a heart pump assembly pulls blood from the left ventricle of the heart and expels blood into the aorta, or pulls blood from the inferior vena cava (IVC) bypasses the right atrium and right ventricle and expels blood into the pulmonary artery. Heart pump assemblies are introduced surgically or percutaneously during a cardiac procedure through the vascular system. In one common approach, pump assemblies are inserted by a catheterization procedure through the femoral artery using a sheath, such as a peel-away introducer sheath. The sheath can alternatively be inserted in other locations such as in the femoral vein or any path for delivery of a pump for supporting either the left or right side of the heart. The peel-away introducer sheath can be inserted into the femoral artery through an arteriotomy to create an insertion path for the pump assembly. A portion of the pump assembly is then advanced through an inner lumen of the introducer and into the artery. Once the pump assembly has been inserted, the peel-away introducer sheath is peeled away. A repositioning sheath can then be advanced over the pump assembly and into the arteriotomy. Replacing the introducer sheath with a sheath which does not need to be peeled away can prevent blood clot formation which would otherwise occur in the introducer sheath, and prevent or reduce bleeding at the insertion site in the skin and/or at the insertion site within the vessel because of better fixation of the sheath to the patient when used with a hemostatic valve. Since peel-away introducer sheaths are not radially expandable, the inner diameter of the introducer sheath must always be large enough to accommodate the passage of the largest diameter of the heart pump inserted through the sheath, even if other parts of the pump assembly, such as the catheter, have a smaller diameter. This means that once the pump is inserted, the peel-away introducer creates an opening that has an outer diameter that is wider than necessary to allow passage of the pump catheter into the vessel. Accordingly, the peel-away introducer sheath is peeled away and replaced with a lower-profile repositioning sheath. But peeling away the introducer has several disadvantages. For example, peel-away introducers can peel too easily and risk being torn prematurely, leading to bleeding or vascular complications. On the other hand, peel-away introducers may require excessive force to peel away. If a physician applies too much force, when the introducer finally gives, the physician may inadvertently shift the position of the pump within the heart. Having to peel away the introducer also complicates the design of the hemostatic valve located in the hub of the introducer which also needs to separate. Additionally, the peel away action is an added step that the user must be aware and trained on, and which requires added time to perform. Some medical introducers for applications other than inserting heart pumps have expandable sheath bodies which may expand radially to allow passage of percutaneous devices into the patient's vasculature. These introducers are inserted having inner diameters smaller than the outer diameter of the device being introduced. The introducers expand to allow passage of the device through the sheath and into the vasculature and then shrink again after the device has passed. In the current state, these expandable introducers are for relatively short-term use and are stand-alone components. Since the current expandable sheaths are intended for short term use, they are not configured for preventing thrombosis between the sheath body and an indwelling catheter. Furthermore, the current expandable sheaths do not include means for sealing the arteriotomy for long durations or for preventing migration of the inserted device (in and out of the vessel). SUMMARY OF THE INVENTION Systems, devices and methods for insertion of a medical device (e.g., intravascular medical device) are presented. The devices are delivered through an expandable introducer sheath. Use of an introducer shea