Medical device shield and methods for delivering a medical device

• US 8,900,286 B2
• Filed: 02/28/2011
• Issued: 12/02/2014
• Est. Priority Date: 03/01/2010
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Oepen, Randolf von, Yribarren, Travis R., Alviar, Alex D., Stamberg, Barbara E.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/037,008
• Publication Number:
  US 20110213451A1
• Time in Patent Office: 1,373 Days
• Field of Search: 623/1.11, 623/1.23, 206/363, 206/349, 600/3
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Device shields for packaging and protecting medical devices during storage and deployment. A device shield includes a housing configured to maintain a medical device and at least a portion of a medical device delivery apparatus within the housing, and a limit element having a first constraining position and a second open position.

Claims

1. A device shield for minimizing contamination of or damage to a medical device having an expandable portion, comprising:

a housing configured to maintain a medical device within the housing such that exposure of the medical device to the environmental particulates and the damage is minimized, the housing having a storage portion formed in the housing at a location disposed between a proximal end and a distal end of the housing; and

a limit element formed with the housing and being pivotally received within the storage portion of the housing, the limit element having a first position and a second position, the limit element being configured in the first position to constrain the expansion of the expandable portion of the medical device relative to the housing and to ensure that the medical device is not exposed to the damage and the environmental particulates, and the limit element configured in the second position to permit movement of the medical device relative to the housing once the risk of exposure to the environmental particulates and the damage is minimized, the limit element including a hinged proximal end, the hinge being transverse to a longitudinal axis of the housing, and a distal end being pivotal towards and away from the longitudinal axis in the direction to constrain and release the medical device a retaining member slidably associated with the housing and configured to extended over the limit element and a portion of the housing constraining the expandable portion of the medical device and maintain the limit element in the first position to ensure that the medical device, with the expandable portion, is not exposed to the damage and the environmental particulates.

2. The device shield of claim 1, wherein the first position is configured to prevent movement of the medical device out of the housing and the second position is configured to permit movement of the medical device out of the housing.

3. The device shield of claim 2, wherein the medical device is a stent and further comprising a medical device delivery apparatus.

4. The device shield of claim 3, wherein the housing is configured to store the medical device and to permit insertion of the medical device into a body without substantial exposure to an air environment surrounding the body and/or without exposure to hand contact.

5. The device shield of claim 4, the housing further comprising an expanded portion configured to direct a guide wire into a guide wire lumen of the medical device delivery apparatus maintained within the housing.

6. The device shield of claim 5, wherein the limit element is configured to preserve at least one specified dimension of the medical device and/or the medical device delivery apparatus while in the first position.

7. The device shield of claim 6, wherein the limit element is molded to conform to a shape of the medical device and at least a portion of the medical device delivery apparatus.

8. The device shield of claim 1, wherein the limit element is coupled to an actuator configured to actuate a movement of the limit element from the first position to the second position.

9. The device shield of claim 1, wherein the retaining member is removably disposed around the housing such that the retaining member can be removed from the housing for transitioning the limit element from the first position to the second position.

10. A device shield for minimizing contamination of a medical device, including an expandable portion, from environmental particulates and damage to the medical device, comprising:

a shaped housing configured to maintain a medical device and at least a portion of a medical device delivery apparatus associated with the medical device within the housing such that exposure of the medical device to the environmental particulates and the damage is minimized, the shaped housing having a storage portion at a location disposed between a proximal end and a distal end of the housing;

a limit element formed with the shaped housing and being pivotally received within the storage portion of the shaped housing, the limit element being configured to constrain the medical device and/or the portion of a medical device delivery apparatus associated with the medical device in at least one dimension, a hinged proximal end of the limit element connected to the shaped housing and extending transversely to a longitudinal axis of the housing and a distal end of the limit element being distal the proximal end of the housing and the hinged proximal end and being pivotal towards and away from the longitudinal axis in the direction to constrain and release the medical device;

a retaining member slidably associated with the housing and configured to extend over the limit element and a portion of the housing constraining the expandable portion of the medical device and maintain the limit element in the first position to ensure that the medical device, with the expandable portion, is not exposed to the damage and the environmental particulates; and

an outlet configured for introducing the medical device into a body of a patient once the risk of exposure to the environmental particulates and the damage is minimized.

11. The device shield of claim 10, wherein the limit element is transitionable from the first constraining position to a second releasing position.

12. The device shield of claim 11, wherein the limit element comprises a first half gate and a second half gate.

13. The device shield of claim 12, wherein the first and second half gates collectively constrain the medical device and/or the portion of a medical device delivery apparatus associated with the medical device in a radial dimension when the first and second half gates are in the first constraining position.

14. The device shield of claim 10, wherein the limit element is configured to preserve at least one specified dimension of the medical device and/or the medical device delivery apparatus.

15. The device shield of claim 14, wherein the limit element is shaped to conform to a shape of the medical device and/or a shape of the portion of a medical device delivery apparatus associated with the medical device.

16. The device shield of claim 10, wherein the limit element further comprises a shaped portion configured to direct a guide wire into a guide wire lumen of the medical device delivery apparatus.

17. The device shield of claim 10, wherein the retaining member is disposed around the housing in a first arrangement configured to maintain the limit element in the first position to ensure that the medical device is not exposed to the damage and the environmental particulates and the retaining member is slidable to a second arrangement configured for transitioning the limit element from the first position to the second position once the risk of exposure to the environmental particulates and the damage is minimized.

18. The device shield of claim 10, wherein the outlet is configured to mate with an introducer sheath and/or a rotating hemostatic valve (RHV) for introducing the medical device into a body of a patient.

19. A kit for minimizing contamination of a medical device, including an expandable portion, from environmental particulates and damage to the medical device, comprising:

a medical device;

a medical device delivery apparatus; and

a device shield, including;

a housing configured to maintain the medical device and at least a portion of the medical device delivery apparatus associated with the medical device within the housing such that exposure of the medical device to the environmental particulates and the damage is minimized, the housing including a proximal end, a distal end, a storage portion spaced apart from the proximal end and the distal end, and a lumen having a longitudinal axis and extending into and from the storage portion, the storage portion being disposed between the proximal end and the distal end of the housing; and

a limit element formed with the housing and being configured to receive and constrain the expansion of the expandable portion of the medical device in the housing in at least one dimension such that exposure of the medical device to the environmental particulates and the damage is minimized, the limit element extending into the storage portion through the housing in a direction transverse to the longitudinal axis and being pivotally coupled to the housing at a hinged proximal end of the limit element, which is transverse to the longitudinal axis, a distal end of the limit element being pivotal towards and away from the longitudinal axis in the direction to constrain and release the medical device a retaining member slidably associated with the housing and configured to extend over the limit element and a portion of the housing constraining the expandable portion of the medical device and maintain the limit element in the first position to ensure that the medical device, with the expandable portion, is not exposed to the damage and the environmental particulates.

20. The kit of claim 19, wherein the medical device is a stent.

21. The kit of claim 20, wherein the stent is supported by a balloon.

22. The kit of claim 19, wherein the medical device delivery apparatus is a catheter.

23. The kit of claim 19, wherein the limit element is shaped to conform to a shape of the medical device and/or a shape of the portion of the medical device delivery apparatus associated with the medical device.