# US 11,065,138 B2 · Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,065,138 B2 - Document ID: US11065138B2 - Status: Granted - Kind: B2 - Application number: 16/099,793 - Filed: 2017-05-10 - Published: 2019-06-13 - Granted: 2021-07-20 - Earliest claimed: 2016-05-13 - Assignees: JenaValve Technology, Inc. - Applicants: JenaValve Technology, Inc. - Inventors: Stefan Schreck; Hussain Rangwala; Payam Saffari; Makensley Lordeus; Vincent Ming Hai Chow; Kevin Hang Tang Chu - Web page: https://patentgrep.com/patent/US11065138B2 ## CPC - A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod - A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)} - A61F 2/243: {Deployment by mechanical expansion} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument} - A61F 2002/9505: {having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument} - A61F 2002/9665: {with additional retaining means} - A61F 2250/0062: Kits of prosthetic parts to be assembled in various combinations for forming different prostheses - A61F 2250/0064: Sets comprising a plurality of prosthetic parts of different sizes - A61F 2250/0092: Means for cleaning prostheses - 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 The present disclosure relates to a delivery catheter and the stepwise release of a stent from the catheter into the vasculature of a patient, as well as a loading device for a transcatheter heart valve (THV) prosthesis. ## Claims ### Claim 1 A catheter system for deployment of a heart valve prosthesis, the catheter system comprising: a first retaining sleeve configured to house a first portion of the heart valve prosthesis in a first compressed state; a second retaining sleeve disposed distal to the first retaining sleeve and configured to house a second portion of the heart valve prosthesis in a second compressed state; a catheter shaft extending between and coupled to the first retaining sleeve and the second retaining sleeve; and a stent holder configured to be disposed within the first retaining sleeve to releasably engage the heart valve prosthesis in a first position and to move relative to the first retaining sleeve to a second position to deploy the heart valve prosthesis, wherein the second retaining sleeve is axially movable with respect to the catheter shaft, the first retaining sleeve is axially fixated to the catheter shaft, the stent holder is axially movable with respect to the catheter shaft, and the first retaining sleeve and the second retaining sleeve are configured to house the heart valve prosthesis such that an exposed portion of the heart valve prosthesis extends between the first retaining sleeve and the second retaining sleeve. ### Claim 2 (depends on 1) The catheter system of claim 1, wherein the catheter system is configured to deploy the heart valve prosthesis by sequentially releasing the second portion of the heart valve prosthesis from the second retaining sleeve followed by moving the stent holder with respect to the first retaining sleeve resulting in liberation of the first portion of the heart valve prosthesis and deployment of the heart valve prosthesis. ### Claim 3 (depends on 1) The catheter system of claim 1, wherein the first retaining sleeve and the second retaining sleeve are sized and configured such that a first diameter of the first retaining sleeve and a second diameter of the second retaining sleeve is less than an exposed diameter of an exposed portion of the heart valve prosthesis. ### Claim 4 (depends on 1) The catheter system of claim 1, wherein the stent holder is configured to be disposed within the first retaining sleeve. ### Claim 5 (depends on 1) The catheter system of claim 1, wherein the stent holder is configured to releasably engage eyelets of the heart valve prosthesis. ### Claim 6 (depends on 1) The catheter system of claim 1, wherein the heart valve prosthesis comprises a first end and a second end and the second retaining sleeve is configured to deploy the second end and the stent holder is configured to deploy the first end. ### Claim 7 (depends on 6) The catheter system of claim 6, wherein the stent holder is configured to release the first end of the heart valve prosthesis after the second end is released by the second retaining sleeve. ### Claim 8 (depends on 1) The catheter system of claim 1, further comprising a plunger disposed at a proximal end of the catheter system, the plunger configured to move toward a distal end of the catheter system to move the second retaining sleeve. ### Claim 9 (depends on 8) The catheter system of claim 8, wherein the catheter shaft comprises an outer shaft and an internal shaft disposed within the outer shaft, the internal shaft coupled to the second retaining sleeve and in mechanical communication with the plunger. ### Claim 10 (depends on 1) The catheter system of claim 1, further comprising a lock configured to avoid premature deployment of the heart valve prosthesis. ### Claim 11 (depends on 1) The catheter system of claim 1, wherein the exposed portion of the heart valve prosthesis expands radially outward while extended between the first retaining sleeve and the second retaining sleeve. ### Claim 12 (depends on 1) The catheter system of claim 1, wherein the second retaining sleeve is disposed on the catheter shaft distal to the first retaining sleeve. ### Claim 13 A method for deploying a heart valve prosthesis using a catheter system comprising a first retaining sleeve, a second retaining sleeve disposed distal to the first retaining sleeve, a catheter shaft extending between and coupled to the first retaining sleeve and the second retaining sleeve, and a stent holder configured to be disposed within the first retaining sleeve, the method comprising: retaining a heart valve prosthesis in a compressed state such that the first retaining sleeve houses a first portion of the heart valve prosthesis, the second retaining sleeve houses a second portion of the heart valve prosthesis independently deployable from the first portion, and the stent holder releasably engages the heart valve prosthesis; releasing the second portion of the heart valve prosthesis by axially moving with respect to the catheter shaft the second retaining sleeve in a first direction; moving the stent holder axially with respect to the catheter shaft in a second direction that is the same as the first direction; and causing the stent holder to release the heart valve prosthesis to deploy the heart valve prosthesis. ### Claim 14 (depends on 13) The method of claim 13, wherein retaining the heart valve prosthesis comprises housing the heart valve prosthesis within the first retaining sleeve and the second retaining sleeve such that an exposed portion of the heart valve prosthesis extends between the first retaining sleeve and the second retaining sleeve. ### Claim 15 (depends on 14) The method of claim 14, wherein an exposed diameter of the exposed portion of the heart valve prosthesis is larger than a first diameter of the first retaining sleeve and a second diameter of the second retaining sleeve. ### Claim 16 (depends on 13) The method of claim 13, further comprising sterilizing the first retaining sleeve, the second retaining sleeve, and the stent holder together with the heart valve prosthesis. ### Claim 17 (depends on 13) The method of claim 13, wherein the heart valve prosthesis comprises a first end and a second end and moving the second retaining sleeve in a first direction releases the first end of the heart valve prosthesis. ### Claim 18 (depends on 17) The method of claim 17, wherein causing the stent holder to release eyelets of the heart valve prosthesis releases the second end of the heart valve prosthesis. ### Claim 19 (depends on 13) The method of claim 13, wherein maneuvering the second retaining sleeve comprises moving a plunger disposed at a proximal end of the catheter system toward a distal end of the catheter system, the second retaining sleeve disposed at the distal end of the catheter system. ### Claim 20 (depends on 19) The method of claim 19, wherein moving the plunger moves a catheter shaft coupled to the second retaining sleeve and in mechanical communication with the plunger. ### Claim 21 (depends on 13) The method of claim 13, wherein maneuvering the stent holder comprises moving a plunger disposed at a proximal end of the catheter system toward a distal end of the catheter system, the stent holder disposed at the distal end of the catheter system. ### Claim 22 (depends on 13) The method of claim 13, further comprising, disengaging a lock of the catheter system configured to avoid premature deployment of the heart valve prosthesis. ### Claim 23 (depends on 13) The method of claim 13, wherein the stent holder releasably engages eyelets of the heart valve prosthesis and causing the stent holder to release the heart valve prosthesis comprises causing the stent holder to release the eyelets of the heart valve prosthesis to deploy the heart valve prosthesis. ### Claim 24 (depends on 13) The method of claim 13, wherein a portion of the heart valve prosthesis between the first retaining sleeve retaining the first portion of the heart valve prosthesis and the second retaining sleeve retaining the second portion of the heart valve prosthesis expands radially outward. ### Claim 25 (depends on 13) The method of claim 13, wherein the second retaining sleeve is disposed on a catheter shaft distal to the first retaining sleeve.