Expandable transapical sheath and method of use

• US 8,728,153 B2
• Filed: 11/15/2010
• Issued: 05/20/2014
• Est. Priority Date: 05/14/2008
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Lenker, Jay, Nance, Edward J., Nguyen, Huan T., Jones, Mark T.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/946,799
• Publication Number:
  US 20110144690A1
• Time in Patent Office: 1,282 Days
• Field of Search: 606/108, 623 21- 237
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 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 Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the ventricular myocardium, more specifically at the left ventricular apex, into the aortic root. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. In an exemplary application, the sheath includes a supported proximal end, a supported distal end, and a collapsible center section. Certain configurations of the sheath are capable of being inserted in a first, small cross-sectional configuration, being expanded diametrically to a second, larger cross-sectional configuration, and then being reduced to a diametrically small size for removal.

Claims

1. An introducer sheath adapted for access to a treatment site within the heart or major blood vessels via a transmyocardial access comprising:

an axially elongate sheath tube having a proximal end, a distal end, and a lumen extending therethrough, wherein the sheath tube comprises a collapsible region and further wherein the sheath working length is sufficiently long that the sheath tube can extend from the outside of a myocardium of a patient'"'"'s heart, through the myocardium, and through the cardiac chambers to a point residing within or proximate the heart, further wherein the collapsible region comprises a first, smaller cross-sectional area, and a second, larger cross-sectional area in response to dilation;

a hub affixed to the proximal end of the axially elongate sheath tube, wherein the hub further comprises a hemostasis valve operably connected to the lumen extending through the sheath tube;

a dilator pre-inserted through the lumen in the axially elongate sheath tube, wherein the dilator comprises a length of dilator tubing, a dilator hub comprising a balloon inflation port and a guidewire access port further comprising a hemostasis valve, and a non-compliant balloon, which is deflated and folded about the dilator tubing to form a minimum profile; and

a reverse dilator, removably placeable within the lumen of the axially elongate sheath tube following expansion of the collapsible region by the dilator, wherein the reverse dilator comprises proximal and distal balloons, a reverse dilator tube further comprising inflation lumens for the proximal and distal balloons, a vacuum lumen operably connected to the region between the two balloons by vacuum ports in the reverse dilator tube, and a reverse dilator hub affixed to the proximal end of the reverse dilator further comprising ports for infusion or removal of pressurized fluid into the inflation lumens of the reverse dilator and for generating a vacuum between the proximal and distal balloons;

wherein the dilator is operable to expand the sheath collapsible region from the first, smaller cross-sectional area to the second, larger cross-sectional area; and

wherein the reverse dilator is configured to have its proximal and distal balloons expanded to seal against the lumen of the sheath tube such that the vacuum drawn between the proximal and distal balloons of the reverse dilator causes re-collapse of the collapsible region of the sheath from the second, larger cross-sectional area to a third, smaller cross-sectional area.

2. The introducer sheath of claim 1, wherein the dilator is non-removable and integral to the interior of the axially elongate sheath tube.

3. The introducer sheath of claim 1, wherein the collapsible region comprises malleable reinforcements embedded within a polymeric surround.

4. The introducer sheath of claim 1, wherein the collapsible region extends substantially from the hub affixed to the proximal end of the sheath tube to the distal end of the sheath tube, with the exception of a small region toward the proximal end of the axially elongate sheath tube that is substantially non-collapsible to facilitate affixing the hub to the proximal end of the axially elongate sheath tube.

5. The introducer sheath of claim 1, further comprising a braided resilient reinforcement embedded within the axially elongate sheath tube in a proximal non-collapsible region.

6. The introducer sheath of claim 1, further comprising structures operable to re-collapse the collapsible region of the sheath tube to the third, smaller cross-sectional area, following expansion of the collapsible region to the second, larger cross-sectional area.

7. The introducer sheath of claim 1, wherein the first cross-sectional area of the collapsible region has a collapsed outer diameter of approximately 3 French to 16 French.

8. The introducer sheath of claim 1, wherein the lumen of the expanded, collapsible region can pass objects ranging from about 18 French to 36 French in size.

9. The introducer sheath of claim 1, wherein the proximal and distal balloons of the reverse dilator comprise elastomeric balloons.

10. The introducer sheath of claim 1, wherein the proximal and distal balloons of the reverse dilator comprise substantially inelastic balloons.

11. The introducer sheath of claim 1, wherein the proximal and distal balloons of the reverse dilator are coated with conformable material.

12. The introducer sheath of claim 1, wherein the expanded proximal and distal balloons of the reverse dilator seal against an inside wall of the expanded sheath tube.

13. The introducer sheath of claim 1, wherein the proximal balloon of the reverse dilator resides within a proximal non-expandable region of the sheath tube.

14. The introducer sheath of claim 1, wherein the distal balloon of the reverse dilator resides at the distal end of the sheath tube.

15. The introducer sheath of claim 1, wherein at least the distal balloon of the reverse dilator is configured to be deflated prior to removal from the patient.