Sheath assembly for insertion of a cord-shaped element, particularly a catheter, into the body of a patient

• US 10,080,871 B2
• Filed: 12/20/2013
• Issued: 09/25/2018
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: ECP Entwicklungsgesellschaft mbH (Johnson & Johnson)
• Original Assignee: ECP Entwicklungsgesellschaft mbH (Johnson & Johnson)
• Inventors: Schumacher, Joerg, Bredenbreuker, Lars, Decke, Robert
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US14/654,078
• Publication Number:
  US 20150343179A1
• Time in Patent Office: 1,740 Days
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2025/0675 Introducing-sheath slitters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: A61M 60/81 : Pump housings
• CPC Class Codes: A61M 60/857 : Implantable blood tubes
• CPC Class Codes: A61M 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

Sheath assembly for the insertion of a cord-shaped element (32, 105), comprising an introducer sheath (101) and an auxiliary sheath (104) for insertion into the introducer sheath (101) together with the cord-shaped element (32, 105), with first fastening means (106) for detachably fastening the auxiliary sheath to the introducer sheath, and with second fastening means (107) for detachably fastening the cord-shaped element to the auxiliary sheath, wherein the introducer sheath (101) has a first sheath housing (13, 114) and a distal tubular section (11, 41a) that terminates in the first sheath housing, and a first flushing device (108), wherein the auxiliary sheath (104) has a second sheath inner chamber (111), a distal, tubular part (112) and a second flushing device (109).

Claims

1. A sheath assembly for insertion of a catheter into the body of patient, said assembly comprising:

an introducer sheath having a proximal end and a distal end, the distal end configured to be inserted into the body of a patient while the proximal end protrudes from the body of the patient;

an auxiliary sheath sized and shaped for insertion into the introducer sheath together with the catheter, the auxiliary sheath having a first fastening means sized and positioned to detachably fasten the auxiliary sheath with respect to the introducer sheath, and second fastening means sized and positioned to detachably fasten the catheter with respect to the auxiliary sheath;

wherein the introducer sheath comprises;

an introducer sheath housing coupled to the proximal end of the introducer sheath;

an introducer sheath inner chamber having a first receiving channel sized for receiving the catheter, the introducer sheath inner chamber extending into the introducer sheath housing,

a proximal tubular section of the introducer sheath that terminates in the introducer sheath housing, the proximal tubular section having a proximal end, and

a first flushing device for flushing the introducer sheath inner chamber;

wherein the auxiliary sheath comprises;

an auxiliary sheath inner chamber having second receiving channel sized for receiving the catheter,

a distal tubular part of the auxiliary sheath, the distal tubular part having distal end, and

a second flushing device for flushing the auxiliary sheath inner chamber; and

wherein when the auxiliary sheath is fastened with respect to the introducer sheath by the first fastening means the introducer sheath housing is configured to position the distal end of the distal tubular part of the auxiliary sheath in the introducer sheath housing proximally in front of the proximal end of the proximal tubular section of the introducer sheath.

2. The sheath assembly according to claim 1, wherein the distal part of the auxiliary sheath is detachably connected to the introducer sheath.

3. The sheath assembly according to claim 1, wherein the auxiliary sheath has an auxiliary sheath housing, and the auxiliary sheath is configured to detachably connect to the introducer sheath housing within the introducer sheath housing.

4. The sheath assembly according to claim 3, wherein the auxiliary sheath is connected to the introducer sheath by any one of the detachable clamp connection with a force-fitting connection or friction connection, a double-cone connection, a screw connection, a bayonet connection, a press fit connection, or a some other detachable mated connection.

5. The sheath assembly according to claim 4, wherein the second flushing device is fluidically connected to the first flushing device.

6. The sheath assembly according to claim 5, wherein the auxiliary sheath inner chamber is connected to the first flushing device by the auxiliary flushing channel.

7. The sheath assembly according to claim 6, wherein the auxiliary flushing channel is configured as a tube attached to an outer periphery of the auxiliary sheath housing.

8. The sheath assembly according to claim 6, wherein the distal tubular part of the auxiliary sheath has at least one outer-surface opening configured to form an auxiliary flushing channel extending from the introducer sheath housing into the interior of the auxiliary sheath inner chamber.

9. The sheath assembly according to claim 6, wherein the auxiliary flushing channel extends through a region of a wall of the auxiliary sheath housing that is located inside the introducer sheath housing.

10. The sheath assembly according to claim 9, wherein the introducer sheath and the auxiliary sheath abut one another in an annular region as connecting partners, and in the annular region, an annular or arcuate circumferential groove extends in the circumferential direction in at least one of the two connecting partners, wherein a channel-like recess is disposed in both the introducer sheath housing and the auxiliary sheath housing, the channel-like recess connecting the inner chamber of the respective sheath to the circumferential groove in the connected state.

11. The sheath assembly according to claim 1, wherein a sterile tube is connected to the introducer sheath in a fluid-tight connection, the sterile tube forming a proximal extension of the introducer sheath and encompassing at least parts of an auxiliary sheath.

12. The sheath assembly according to claim 6, wherein the auxiliary sheath inner chamber is directly connected to the first flushing device by the auxiliary flushing channel.