Expandable balloon sheath

Patent metadata

Field	Value
Publication number	US-10682492-B2
Application number	US-201815875356-A
Country	US
Kind code	B2
Filing date	Jan 19, 2018
Priority date	Jan 19, 2018
Publication date	Jun 16, 2020
Grant date	Jun 16, 2020

Abstract

A medical device that is configured to house an expandable balloon includes a tubular sheath and a retaining member. The tubular sheath includes a longitudinal slit that extends parallel to a longitudinal axis of the tubular sheath and the retaining member is configured to retain the tubular sheath in a closed configuration. The tubular sheath may house the expandable balloon while the expandable balloon is attached to a catheter that is configured to navigate the expandable balloon into a body of a patient. The tubular sheath may be configured to house the expandable balloon substantially through the process of inserting the expandable balloon into the vasculature of the patient. Once the expandable balloon has been introduced into the introducer sheath and/or inserted into the vasculature of the patient, the retaining member may be disengaged and the tubular sheath removed from the catheter.

First claim

What is claimed is:

1. A medical device comprising:
a tubular sheath having an outer wall and an inner wall that defines an inner lumen configured to house an expandable balloon that is attached to a distal portion of a catheter, wherein the tubular sheath includes a longitudinal slit through the tubular sheath, wherein the longitudinal slit extends substantially parallel to a longitudinal axis of the tubular sheath and defines a first side and a second side of the longitudinal slit, wherein the first side is joined with the second side, wherein the longitudinal slit exposes the inner lumen from a proximal end of the tubular sheath to a distal end of the tubular sheath; and
a retaining member that is configured to engage the tubular sheath on both sides of the longitudinal slit to retain the tubular sheath in a closed configuration around the expandable balloon.

2. The medical device of claim 1 , wherein the retaining member is configured to disengage one or both sides of the longitudinal slit to thereby convert the tubular sheath into an open configuration such that the inner lumen is exposed and the tubular sheath can be removed from around the expandable balloon or the catheter.

3. The medical device of claim 1 , wherein the retaining member comprises a protective sleeve that substantially covers an outer surface of the tubular sheath.

4. The medical device of claim 3 , wherein the protective sleeve comprises a plurality of longitudinal perforations extending through a wall of the protective sleeve in a direction substantially parallel to the longitudinal axis of the tubular sheath.

5. The medical device of claim 3 , wherein the protective sleeve is configured to be peelable along the longitudinal axis of the tubular sheath.

6. The medical device of claim 3 , wherein the protective sleeve comprises a film that has been heat shrunk onto the outer surface of the tubular sheath.

7. The medical device of claim 3 , wherein the protective sleeve includes a tab attached to an end of the protective sleeve, wherein the protective sleeve is configured to be removed from the tubular sheath in a controlled manner in response to a force above a threshold force being exerted upon the tab.

8. The medical device of claim 1 , wherein the retaining member comprises a notched groove that extends longitudinally along the longitudinal axis of the tubular sheath, wherein the notched groove aligns with the longitudinal slit of the tubular sheath.

9. The medical device of claim 1 , wherein the retaining member comprises a strip of adhesive that substantially covers the longitudinal slit to adhere the sides of the tubular sheath on each side of the longitudinal slit to each other, wherein the strip of adhesive is configured to be removeable along the longitudinal axis of the tubular sheath.

10. The medical device of claim 1 , wherein the retaining member comprises a suture that is configured to stitch together the tubular sheath across the longitudinal slit.

11. The medical device of claim 10 , wherein the suture includes a tab attached to an end of the suture, wherein the suture is configured to unravel in a controlled manner in response to a force above a threshold force being exerted upon the tab.

12. The medical device of claim 1 , wherein the retaining member comprises at least one ring that is configured to extend around a circumference of the tubular sheath, wherein the at least one ring is slideable along the longitudinal axis of the tubular sheath to remove the at least one ring from the tubular sheath.

13. The medical device of claim 1 , wherein the retaining member comprises a clasp on the tubular sheath on one side of the longitudinal slit and a mating element on the tubular sheath on the other side of the longitudinal slit, wherein the clasp is configured to engage the mating element to retain the tubular sheath in the closed configuration.

14. The medical device of claim 1 , wherein the tubular sheath is configured to be slideable over the catheter, wherein the tubular sheath is configured to engage and distally displace a storage sheath that is covering the expandable balloon when the expandable balloon is on the distal portion of the catheter without substantial contact to the expandable balloon when the tubular sheath is on the catheter proximal to the protective sleeve.

15. The medical device of claim 1 , wherein a distal portion of the tubular sheath is flared outward from the longitudinal axis of the tubular sheath.

16. The medical device of claim 1 , wherein a proximal portion of the tubular sheath is flared outward from the longitudinal axis of the tubular sheath.

17. The medical device of claim 1 , wherein the inner wall that defines the inner lumen of the tubular sheath is coated with a lubricious material to reduce friction between the tubular sheath and the expendable balloon.

18. The medical device of claim 1 , further comprising a Luer fitting on a distal end of the tubular sheath, wherein the Luer fitting comprises a structural weakness aligned with the longitudinal slit to enable the Luer fitting to be controllably split along the structural weakness.

19. The medical device of claim 1 , wherein the expandable balloon is coated with a drug coating.

20. The medical device of claim 1 , wherein a thickness between the inner and outer walls of the tubular sheath is substantially constant throughout the tubular sheath.

21. The medical device of claim 1 , wherein the tubular sheath comprises at least one of poly(tetrafluoroethylene), high density polyethylene, and low density polyethylene.

22. The medical device of claim 1 , wherein the balloon is in a deflated state on the distal portion of the catheter, and a diameter of the inner lumen is configured to be greater than an outer diameter of the expandable balloon in the deflated state.

23. The medical device of claim 22 , wherein a length of the tubular sheath along the longitudinal axis of the tubular sheath is configured to be greater than a length of the expandable balloon along a longitudinal axis of the expandable balloon in the deflated state.

24. A method of inserting expandable balloons, the method comprising:
positioning a distal portion of a catheter of a medical device immediately proximal to an introducer sheath implanted in a body of a patient, the medical device comprising:
a tubular sheath having an outer wall and an inner wall that defines an inner lumen configured to house an expandable balloon that is attached to the distal portion of the catheter, wherein the tubular sheath includes a longitudinal slit through the tubular sheath, wherein the longitudinal slit extends substantially parallel to a longitudinal axis of the tubular sheath and defines a first side and a second side of the longitudinal slit, wherein the first side is joined with the second side, wherein the longitudinal slit exposes the inner lumen from a proximal end of the tubular sheath to a distal end of the tubular sheath, and
a retaining member that is configured to engage the tubular sheath on both sides of the longitudinal slit to retain the tubular sheath in a closed configuration around the expandable balloon,

disengaging the retaining member from the tubular sheath to thereby convert the tubular sheath into an open configuration after inserting the expandable balloon into the introducer sheath; and
removing the tubular sheath from the catheter in response to converting the tubular sheath into the open conf

Assignees

• Medtronic Vascular Inc

Inventors

• Connors Alan
• Nagasrinivasa Shyam
• Schoenhoff Emily
• Komatsu Janet

Classifications

• A61M25/10 Primary

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61M25/0668

  splittable, tear apart · CPC title

• A61M2025/0046

  Coatings for improving slidability · CPC title

• A61M2025/105

  having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes · CPC title

• A61M25/0074

  Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable · CPC title