# US 10,478,221 B2 · Introducer for introduction of a prosthesis into a lumen of a patient

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- Number: US 10,478,221 B2
- Document ID: US10478221B2
- Status: Granted
- Kind: B2
- Application number: 15/626,295
- Filed: 2017-06-19
- Published: 2018-12-20
- Granted: 2019-11-19
- Earliest claimed: 2017-06-19
- Assignees: Cook Medical Technologies LLC
- Applicants: Cook Medical Technologies LLC
- Inventors: James Collins
- Web page: https://patentgrep.com/patent/US10478221B2

## CPC

- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0662: {Guide tubes}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/3437: {with means for removing or absorbing fluid, e.g. wicks or absorbent pads}
- A61B 2017/3464: {with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers}
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 2025/0062: {having features to improve the sliding of one part within another by using lubricants or surfaces with low friction}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

An introducer and a delivery assembly for introduction of a prosthesis into a bodily lumen is disclosed. The introducer comprises: a sheath; a housing mounted to a distal end of the sheath, the housing having a passage there-through adapted to receive a delivery assembly; a port for introducing flushing fluid, the port communicating with the passage; and a liquid absorbing seal for sealably receiving the delivery assembly, the liquid absorbing seal disposed within the housing distally of the port. The delivery assembly comprises: a guide wire catheter; a tip mounted to a proximal end of the guide wire catheter; a distal delivery member mounted around the guide wire catheter and located distal of the tip; and a prosthesis receiving portion between the tip and the distal delivery member. The delivery assembly is slidably mounted through the introducer. Absorption of fluid swells the liquid absorbing seal.

## Claims

### Claim 1

An introducer for introduction of a prosthesis into a lumen of a patient, the introducer comprising: a sheath having a proximal end and a distal end; a housing mounted to the distal end of the sheath, the housing having a passage there-through adapted to receive a delivery assembly; a port for introducing flushing fluid, the port communicating with the passage; a liquid absorbing seal for sealably receiving the delivery assembly, a material of the liquid absorbing seal composed of a hydrogel, the liquid absorbing seal disposed within the housing distally of the port; and a compression assembly operable to compress the liquid absorbing seal comprising a rotatable body and a compression segment, wherein the compression segment is disposed between the liquid absorbing seal and the rotatable body and is a separate component to the rotatable body, and wherein the compression segment and the rotatable body are mutually arranged and constructed to allow rotation of the rotatable body relative to the compression segment; whereby introduction of a flushing fluid through the port into the passage results in absorption of a portion of the flushing fluid into the hydrogel.

### Claim 2 (depends on 1)

The introducer of claim 1 wherein the hydrogel comprises a lubricious polymer.

### Claim 3 (depends on 1)

The introducer of claim 1 wherein the hydrogel is a hydrophilic thermoplastic polyurethane elastomer.

### Claim 4 (depends on 1)

The introducer of claim 1 wherein the rotatable body is threadably connected to the housing, wherein the rotation of the rotatable body pushes the compression segment against the liquid absorbing seal thereby compressing the liquid absorbing seal.

### Claim 5 (depends on 1)

The introducer of claim 1, the delivery assembly comprising:
a guide wire catheter;
a tip mounted to a proximal end of the guide wire catheter;
a distal delivery member mounted around the guide wire catheter and located distal of the tip; and
a prosthesis receiving portion between the tip and the distal delivery,
wherein the delivery assembly is slidably mounted through the introducer.

### Claim 6 (depends on 5)

The introducer of claim 5 wherein in a first condition the liquid absorbing seal engages an external surface of the distal delivery member, wherein in a second condition the liquid absorbing seal engages an external surface of a guide wire,
whereby in at least the second condition, absorption of fluid swells the liquid absorbing seal.

### Claim 7 (depends on 5)

The introducer of claim 5 wherein the hydrogel comprises a lubricious polymer.

### Claim 8 (depends on 5)

The introducer of claim 5 wherein the hydrogel is a hydrophilic thermoplastic polyurethane elastomer.

### Claim 9 (depends on 5)

The introducer of claim 5 wherein the rotatable body is threadably connected to the housing, wherein the rotation of the rotatable body pushes the compression segment against the liquid absorbing seal thereby compressing the liquid absorbing seal.

### Claim 10

An introducer and a delivery assembly for introduction of a prosthesis into a lumen of a patient, the introducer comprising: a sheath having a proximal end and a distal end; a housing mounted to the distal end of the sheath, the housing having a passage there-through adapted to receive a delivery assembly; a port for introducing flushing fluid, the port communicating with the passage; a liquid absorbing seal for sealably receiving the delivery assembly, a material of the liquid absorbing seal composed of a hydrophilic thermoplastic polyurethane elastomer hydrogel, the liquid absorbing seal disposed within the housing distally of the port; and a compression assembly operable to compress the liquid absorbing seal comprising a rotatable body and a compression segment, wherein the compression segment is disposed between the liquid absorbing seal and the rotatable body and is a separate component to the rotatable body, and wherein the compression segment and the rotatable body are mutually arranged and constructed to allow rotation of the rotatable body relative to the compression segment, and the delivery assembly comprising: a guide wire catheter; a tip mounted to a proximal end of the guide wire catheter; a distal delivery member mounted around the guide wire catheter and located distal of the tip; and a prosthesis receiving portion between the tip and the distal delivery member wherein the delivery assembly is slidably mounted through the introducer, and wherein in a first condition the liquid absorbing seal engages an external surface of the distal delivery member, and Response to Final Office Action dated Mar. 18, 2019 (BGL No. 12730-1738) wherein in a second condition the liquid absorbing seal engages an external surface of a guide wire, whereby in at least the second condition, absorption of fluid swells the liquid absorbing seal, which is compressed by the compression segment.