Expandable balloon sheaths

Patent metadata

Field	Value
Publication number	US-12324883-B2
Application number	US-202015930974-A
Country	US
Kind code	B2
Filing date	May 13, 2020
Priority date	Jan 19, 2018
Publication date	Jun 10, 2025
Grant date	Jun 10, 2025

Abstract

A tubular sheath for enclosing an expandable balloon attached to the distal portion of a catheter encloses and protects the expandable balloon. The tubular sheath is configured to be slidable and removable from the catheter. The tubular sheath may include a longitudinal splitting element that is removable as a result of a force applied to the longitudinal splitting element. The longitudinal splitting element is configured to split the wall of the tubular sheath in response to the force. Alternatively, the tubular sheath may include a gripping portion that has relatively poor cohesive strength to adjacent portions of the tubular sheath. The tubular sheath is configured to be removable in response to a force applied to the gripping portion.

First claim

What is claimed is:

1. A medical device comprising:
a catheter configured to be navigated through vasculature of a patient, the catheter comprising a distal portion and a proximal portion;
an expandable balloon that is attached to the distal portion of the catheter;
a tubular sheath comprising a proximal end and a distal end,
wherein the tubular sheath defines a groove extending longitudinally from the proximal end to the distal end, the groove configured to split the tubular sheath from the proximal end to the distal end in response to application of a force above a threshold force,
wherein the tubular sheath defines a radius from a longitudinal axis of the tubular sheath, and
wherein the tubular sheath is configured to separate from the catheter in a radial direction defined by the radius when the groove splits the tubular sheath from the proximal end to the distal end; and
an introducer sheath configured to be inserted into the vasculature,
wherein the introducer sheath is configured to allow the expandable balloon and the catheter to pass through the introducer sheath and stop the tubular sheath from passing through the introducer sheath, and wherein at least one of:
the introducer sheath is configured to threadably engage the tubular sheath,
the introducer sheath defines a proximal internal diameter configured to allow the tubular sheath to insert distal to the proximal internal diameter and defines a distal internal diameter distal to and less than the proximal internal diameter, wherein the distal internal diameter is configured to prevent the tubular sheath from inserting distal to the distal internal diameter, or
the tubular sheath defines a distal inner diameter configured to allow the introducer sheath to insert proximally into an inner lumen defined by the tubular sheath and defines a proximal inner diameter proximal to and less than the distal inner diameter, wherein the proximal inner diameter is configured to prevent the introducer sheath from inserting within the tubular sheath proximal to the proximal inner diameter.

2. The medical device of claim 1 , wherein the tubular sheath defines a hole extending longitudinally through a wall of the tubular sheath, wherein the wall completely surrounds a cross-section defined by the hole.

3. The medical device of claim 2 , wherein the groove is radially in-line with the hole.

4. The medical device of claim 1 , further comprising a gripping portion attached to an outer wall of the tubular sheath, the gripping portion configured to remain attached to the outer wall in response to a force that exceeds the threshold force.

5. The medical device of claim 4 , wherein the gripping portion is a first tab and the medical device further comprising a second tab attached to the outer wall of the tubular sheath, wherein the groove is between the first tab and the second tab.

6. The medical device of claim 1 , wherein the groove is substantially parallel to the longitudinal axis.

7. The medical device of claim 1 , wherein the groove spirals around the longitudinal axis.

8. The medical device of claim 1 , wherein the groove defines a first side of the tubular sheath and a second side of the tubular sheath, and wherein the groove is configured to split the tubular sheath between the first side and the second side.

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

10. The medical device of claim 1 , wherein a length of the tubular sheath along the longitudinal axis is greater than a length of the expandable balloon along a longitudinal axis of the expandable balloon in the deflated state.

11. The medical device of claim 1 , wherein the tubular sheath is configured to remain stationary relative to the introducer sheath while sliding proximally relative to the catheter when the introducer sheath mates with the distal end.

12. A method of inserting expandable balloons, the method comprising:
locating a distal portion of a catheter of a medical device immediately proximal to an introducer sheath inserted in vasculature of a patient, the medical device comprising:
an expandable balloon that is attached to the distal portion of the catheter, and
a tubular sheath comprising a proximal end and a distal end, wherein the tubular sheath is configured to enclose the expandable balloon, and wherein the tubular sheath defines a groove extending longitudinally from the proximal end to the distal end, the groove configured to split the tubular sheath from the proximal end to the distal end in response to application of a force above a threshold force;

distally pushing the catheter toward an introducer sheath and causing the introducer to mate with the tubular sheath to stop the tubular sheath from passing through the introducer sheath into the vasculature when the expandable balloon and the catheter pass through the introducer sheath into the vasculature, wherein causing the introducer sheath to mate with the tubular sheath comprises at least one of:
threadably engaging, by the introducer sheath, the introducer sheath and the tubular sheath,
receiving, by the introducer sheath, the tubular sheath by inserting the tubular sheath distal to a proximal internal diameter defined by the introducer sheath and preventing, using a distal internal diameter of the introducer sheath, the tubular sheath from inserting distal to the distal internal diameter, wherein the distal internal diameter is distal to and less than the proximal internal diameter, or
receiving, by the tubular sheath, the introducer sheath by inserting the introducer sheath proximal to a distal inner diameter defined by the tubular sheath and preventing, using a proximal inner diameter of the tubular sheath, the introducer sheath from inserting within the tubular sheath and proximal to the proximal inner diameter, wherein the proximal inner diameter is proximal to and less than the distal inner diameter; and

splitting the tubular sheath by applying the force above the threshold force to remove the tubular sheath from the catheter when the expandable balloon is fully inserted in the introducer sheath.

13. The method of claim 12 , further comprising distally pushing the catheter into the introducer sheath without substantial contact between the tubular sheath and the expandable balloon.

14. The method of claim 12 , wherein splitting the tubular sheath comprises applying the force above the threshold force to a tab attached to an outer wall of the tubular sheath.

15. A medical device comprising:
a catheter configured to be navigated through vasculature of a patient, the catheter comprising a distal portion and a proximal portion;
an expandable balloon that is attached to the distal portion of the catheter; and
a tubular sheath comprising a proximal end and a distal end,
wherein the tubular sheath defines a structural feature configured to split the tubular sheath from the proximal end to the distal end in response to application of a force above a threshold force; and
an introducer sheath configured to be inserted into the vasculature,
wherein the introducer sheath is configured to allow the expandable balloon and the catheter to pass through the introducer sheath and stop the tubular sheath from passing through the introducer sheath, and wherein at least one of:
the introducer sheath is configured to threadably engage the tubular sheath,
the introducer sheath defines a proximal internal diameter configured to allow the tubular sheath to insert distal to the proximal internal diameter and defines

Assignees

• Medtronic Vascular Inc

Inventors

• Traxler John Wilson
• Baldwin Michael
• Duffy Joseph
• Kantor John
• Le Tony
• Malik Asim
• Peterson Susan
• Schoenhoff Emily
• Hallberg Eric
• Holt Steven
• Svensson Erik
• Cleary Ronan
• Singh Sameer
• Holmgren Steven
• Komatsu Janet
• Colgan Traci
• Hopper Gregory
• Fuhrer Marcel

Classifications

• A61M25/0668 Primary

  splittable, tear apart · CPC title

• A61M25/10

  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

• A61M25/104

  used for angioplasty · CPC title

• A61M2025/1081

  having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths · CPC title

• A61M2025/105

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