# US 2014/0189994 A1 · Post-Crimping Inspection of Scaffolds Mounted on Scaffold Delivery Systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0189994 A1 - Document ID: US20140189994A1 - Status: Published application - Kind: A1 - Application number: 13/735,871 - Filed: 2013-01-07 - Published: 2014-07-10 - Earliest claimed: 2013-01-07 - Assignees: Abbott Cardiovascular Systems Inc. - Applicants: Abbott Cardiovascular Systems Inc. - Inventors: Jason Van Sciver - Web page: https://patentgrep.com/patent/US20140189994A1 ## CPC - B23P 11/005: {by expanding or crimping} - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument} - A61F 2002/9583: {Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve} - Y10T 29/49769: Using optical instrument [excludes mere human eyeballing] - Y10T 29/53022: with means to test work or product - B23P: METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS (arrangements for copying or controlling B23Q) - 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) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A system for mounting a scaffold on a balloon catheter includes two positioning and alignment stations, which are used to prepare a scaffold and catheter for crimping using the same crimping head. The system is configured for automated assembly of the scaffold and catheter prior to crimping and performing post-crimping inspection for the crimped scaffold and prior to placing a restraining sheath over the crimped scaffold. ## Claims ### Claim 1 A method for crimping a scaffold to a balloon catheter, comprising: connecting the scaffold and balloon catheter to a member including an actuator capable of inserting a distal end of the catheter into and removing the distal end from a crimper head, the crimper head configured for crimping the scaffold to the balloon; inserting the balloon and scaffold into the crimper head using the actuator; crimping the scaffold to the balloon to produce a crimped scaffold; removing the crimped scaffold from the crimper head using the actuator; collecting images of the crimped scaffold and balloon using the actuator; and after collecting images, placing a restraining sheath over the crimped scaffold. ### Claim 2 (depends on 1) The method of claim 1, wherein the crimping step includes reducing the diameter of the scaffold down to about an inflated diameter of the balloon. ### Claim 3 (depends on 1) The method of claim 1, wherein a pre-crimp scaffold diameter is at least 2, 2.5, 3 and 3.5 times a final crimp diameter for the scaffold. ### Claim 4 (depends on 1) The method of claim 1, wherein the scaffold is made from a polymer comprising PLLA. ### Claim 5 A method of crimping a scaffold to a balloon of a balloon catheter, comprising placing the scaffold in a receptacle, engaging the catheter by an actuator; inserting the balloon at least partially within the scaffold using the actuator; positioning the scaffold on the balloon by either of pulling a distal end of the balloon towards a distal end of the scaffold, or pushing the distal end of the scaffold towards the distal end of the balloon using the actuator; and crimping the scaffold to the balloon. ### Claim 6 An apparatus for mounting a scaffold to a balloon catheter, comprising: a crimper head having jaws and configured to crimp the scaffold to a balloon of the balloon catheter; an actuator including a motor capable of rotating a distal end of the balloon catheter about a longitudinal axis and inserting the distal end into and removing the distal end from the crimper head; an imaging device; a processor; and machine executable code, executable by the processor, for performing a mounting process, the machine executable code including a first code for causing the actuator to translate and/or rotate about the longitudinal axis; a second code for crimping the scaffold to the balloon using the crimper head; and a third code for collecting images of the crimped scaffold. ### Claim 7 (depends on 6) The apparatus of claim 6, wherein the processor is further configured to cause the actuator to automatically advance the scaffold and balloon into the crimper head when the processor receives a signal indicating that the scaffold is aligned on the balloon. ### Claim 8 (depends on 7) The apparatus of claim 7, wherein the positioning portion further includes an arm connected to an electric motor for supporting and displacing the catheter or scaffold relative to the other; and an actuator for displacing the carriage towards the crimper head, thereby advancing the scaffold and catheter into the crimper head, upon receiving a command signal from the processor. ### Claim 9 (depends on 6) The apparatus of claim 6, the third code further configured to compute an outer diameter of the scaffold and compare the outer diameter to an average or target diameter, and generate a signal if the measured diameter is outside of a tolerance. ### Claim 10 (depends on 6) The apparatus of claim 6, the third code further configured to cause the actuator to place the crimped scaffold in an imaging area, illuminate the scaffold with a plurality of lights and collect images of the scaffold and/or balloon in their crimped position and prior to placing a sheath over the scaffold. ### Claim 11 (depends on 6) The apparatus of claim 6, wherein the processor includes a personal computer or workstation, wherein the personal computer or workstation includes a network connection, a storage medium, a display, an input/output device and software-based device drivers for operating the actuator and imaging device. ### Claim 12 (depends on 6) The apparatus of claim 6, wherein the processor is configured for automatically accessing crimping parameters that define the crimping sequence, and scaffold and catheter attributes from a storage area upon receiving an identification code for the first scaffold and the second scaffold. ### Claim 13 (depends on 6) The apparatus of claim 6, further including a database connected to the apparatus and containing scaffold and balloon data including, diameter, length, number of crowns, number of rings, crown angles when crimped, and one or both of the first code and third code includes code capable of analyzing an image of the scaffold and determining, and based on a comparison between the balloon and scaffold data sending a signal indicating that the crimped scaffold is accepted, rejected or requires manual inspection. ### Claim 14 A method for evaluating a crimping process, comprising: providing a crimping apparatus including a crimper head and an automated control actuator capable of placing a scaffold and a balloon of a balloon catheter into and removing the scaffold and the balloon from a crimper head; crimping a first plurality of scaffolds to balloons using a first crimping process parameter including generating images of each of the first crimped scaffolds; crimping a second plurality of scaffolds to balloons using a second process parameter including generating images of each of the second crimped scaffolds; comparing images of the first and second plurality of crimped scaffolds including generating a number indicating whether a difference between the first or second process parameter and a difference between the first and second plurality of crimped scaffolds is statistically significant. ### Claim 15 (depends on 14) The method of claim 14, wherein the first and second crimping process parameter is one or more of a crimping temperature, balloon pressure, crimp time, crimp speed, and target diameter. ### Claim 15 (depends on 14) The method of claim 14, wherein the scaffold is the type requiring a sheath placed over the scaffold to avoid recoil in the scaffold and the images are generated prior to placing a sheath over the scaffold. ### Claim 16 (depends on 15) The method of claim 15, further including the step of placing a sheath over the scaffold within two minutes of removing the scaffold from the crimper head. ### Claim 17 (depends on 14) The method of claim 14, further including the step of measuring the outer diameter of the scaffold before placing a restraining sheath over the scaffold. ### Claim 18 (depends on 14) The method of claim 14, wherein the generating the images step includes generating a first and second image over the crimped scaffold using a respective first and second light type. ### Claim 19 (depends on 18) The method of claim 18, wherein the first light type illuminates scaffold edges and the second light type illuminates balloon markers. ### Claim 20 (depends on 14) The method of claim 14, further including the step of leaking testing each of the first and second plurality of scaffolds prior to placing sheaths over the first and second plurality of scaffolds. ### Claim 21 (depends on 1) The method of claim 1, wherein after collecting images performing a pass/fail check including checking the crimped diameter, alignment between balloon markers and/or checking for any visual damage to the scaffold. ### Claim 21 (depends on 1) The method of claim 1, wherein after collecting images performing a pass/fail check including checking the crimped diameter, alignment between balloon markers and/or checking for any visual damage to the scaffold. ### Claim 22 (depends on 6) The apparatus of claim 6, wherein the third code is configured for performing a pass/fail check including checking the crimped diameter, alignment between balloon markers and/or checking for any visual damage to the scaffold.