Protective sheaths for medical devices
First Claim
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1. A method, comprising:
- using a heating space;
using a mandrel having a small diameter section, a large diameter section and a sloped section separating the small and large diameter sections;
using a hollow tube having a bore and solid walls surrounding the bore, wherein the tube is made from a polymer material, the tube has a length and forms a cylindrical portion having a first diameter, and the cylindrical portion extends over at least 25% of the tube length;
holding the tube with a tube holder; and
using the tube holder, pushing the tube over the mandrel to increase the first diameter of the cylindrical portion of the tube to a second diameter;
wherein the large diameter section of the mandrel has the second diameter and a length of the large diameter section is greater than the at least 25% of the tube length; and
wherein the large diameter section of the mandrel is disposed within the heating space and the small diameter section of the mandrel is disposed outside of the heating space when the tube is pushed over the mandrel.
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Abstract
A process for making a sheath used to protect a medical device. The medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath is removed by a health professional either by removing the sheath directly or using a tube containing the catheter.
91 Citations
19 Claims
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1. A method, comprising:
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using a heating space; using a mandrel having a small diameter section, a large diameter section and a sloped section separating the small and large diameter sections; using a hollow tube having a bore and solid walls surrounding the bore, wherein the tube is made from a polymer material, the tube has a length and forms a cylindrical portion having a first diameter, and the cylindrical portion extends over at least 25% of the tube length; holding the tube with a tube holder; and using the tube holder, pushing the tube over the mandrel to increase the first diameter of the cylindrical portion of the tube to a second diameter; wherein the large diameter section of the mandrel has the second diameter and a length of the large diameter section is greater than the at least 25% of the tube length; and wherein the large diameter section of the mandrel is disposed within the heating space and the small diameter section of the mandrel is disposed outside of the heating space when the tube is pushed over the mandrel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method, comprising:
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using a heating nozzle, the nozzle comprising a first housing, a second housing and an opening including a heating space between the housings; using a mandrel having a small diameter section, a large diameter section and a sloped section separating the small and large diameter sections; using a hollow tube having a bore and solid walls surrounding the bore, wherein the tube is made from a polymer material, the tube has a length and forms a cylindrical portion having a first diameter, and the cylindrical portion extends over at least 25% of the tube length; holding the tube with a tube holder; and using the tube holder, pushing the tube over the mandrel to increase the first diameter of the cylindrical portion of the tube to a second diameter; wherein the nozzle opening permits passage of the mandrel into the heating space in a first direction and removal of the mandrel from the heating space in a second direction that is about perpendicular to the first direction. - View Dependent Claims (10, 11, 12, 13)
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14. A method, comprising:
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using a first, hollow tube having a bore and solid walls surrounding the bore, a length and a diameter, wherein the first tube is made from a polymer material; heating a mandrel, the mandrel having first and second diameter portions; while the mandrel is being heated, pushing the first tube onto the mandrel so that the first tube extends over both the first and second diameter portions of the mandrel, whereupon the mandrel increases the first tube diameter over at least 10-20% of the first tube length; and after increasing the first tube diameter, placing a second tube within the first tube. - View Dependent Claims (15, 16, 17, 18)
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19. A method, comprising:
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shaping a hollow tube having a bore and solid walls surrounding the bore, a length and a diameter, wherein the tube is made from a polymer material, the shaping comprising; heating a mandrel, the mandrel having a first diameter portion and a second diameter portion; and pushing the tube onto the mandrel so that the tube extends over both the first and second diameter portions, whereupon the first diameter portion of the mandrel increases the tube diameter over at least 10-20% of the tube length; and after shaping tube, placing the tube over a medical device having a length, wherein the at least 10-20% of the tube length is equal to, or greater than a length of the medical device, and wherein the medical device is a scaffold crimped to a balloon of a balloon catheter.
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Specification