MEDICAL DEVICE WITH TELESCOPING SEALING ASSEMBLY

• US 20190328564A1
• Filed: 04/26/2019
• Published: 10/31/2019
• Est. Priority Date: 04/26/2018
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Poppe, Kevin Robert, Foster, Daniel J., Scheff, Christopher Jay, Swehla, Bradley S.
• Granted Patent: US 11,266,518 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/007 O-rings

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example system for delivering an implantable medical device includes a handle member including a seal assembly, wherein the seal assembly includes an outer sheath seal assembly coupled to an outer sheath, the outer sheath including a curved portion, the outer sheath seal assembly being translatable relative to the handle. The seal assembly also includes a first fixed seal assembly fixed relative to the handle, the first fixed seal assembly including a first alignment surface and a compression shaft coupled to the first fixed seal assembly. Additionally, first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.

Claims

1. A system for delivering an implantable medical device, comprising:

a handle member including a seal assembly, wherein the seal assembly includes;

an outer sheath seal assembly coupled to an outer sheath, the outer sheath seal assembly being translatable relative to the handle;

a first fixed seal assembly fixed relative to the handle, the first fixed seal assembly including a first alignment surface; and

a compression shaft coupled to the first fixed seal assembly;

wherein the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.

2. The system of claim 1, wherein the first fixed seal assembly is positioned proximal of the outer sheath seal assembly.

3. The system of claim 2, wherein the seal assembly further includes an actuation seal assembly positioned proximal of the first fixed seal assembly, the actuation seal assembly translatable relative to the handle, and wherein actuation of the actuation seal assembly is designed to shift the implantable medical device between a first position and a second expanded position.

4. The system of claim 3, wherein the seal assembly further includes a second fixed seal assembly fixed relative to the handle and positioned proximal of the actuation seal assembly.

5. The system of claim 1, wherein the outer sheath includes a curved portion, and wherein the first alignment surface is designed to align the compression shaft with the curved portion of the outer sheath.

6. The system of claim 5, wherein the outer sheath includes a projection, wherein the projection is aligned with the curved portion of the outer sheath, and wherein the outer sheath seal assembly includes a recess designed to engage with the projection.

7. The system of claim 1, wherein the outer sheath seal assembly includes a first seal, and wherein the first seal is disposed along an outer surface of the outer sheath.

8. The system of claim 7, wherein the compression shaft extends at least partially within a lumen of the outer sheath seal assembly.

9. The system of claim 8, wherein the outer sheath seal assembly includes a second seal, and wherein the second seal is disposed along an outer surface of the compression shaft.

10. The system of claim 9, wherein the system further includes an actuation shaft coupled to the actuation seal assembly, and wherein the actuation shaft extends at least partially within a lumen of the first fixed seal assembly.

11. The system of claim 10, wherein the first fixed seal assembly includes a third seal, and wherein the third seal is disposed along an outer surface of the actuation shaft.

12. The system of claim 11, wherein the system further includes a guidewire shaft coupled to the second fixed seal assembly, and wherein the guidewire shaft extends at least partially within a lumen of the actuation seal assembly.

13. The system of claim 12, wherein the actuation seal assembly includes a fourth seal, and wherein the fourth seal is disposed along an outer surface of the guidewire shaft.

14. A system for delivering an implantable medical device, comprising:

a handle member including a telescoping seal assembly, wherein the telescoping seal assembly includes;

an outer sheath seal assembly coupled to an outer sheath, the outer sheath covering at least a portion of the implantable medical device, the outer sheath seal assembly being translatable relative to the handle;

a first fixed seal assembly including a first alignment surface, the first fixed seal assembly being fixed relative to the handle;

a compression shaft coupled to the first fixed seal assembly;

an actuation seal assembly translatable relative to the handle; and

an actuation shaft coupled to the actuation seal assembly;

wherein the actuation shaft is axially aligned with the compression shaft;

wherein the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.

15. The system of claim 14, wherein the actuation seal assembly is designed to shift the implantable medical device between a first position and a second expanded position.

16. The system of claim 14, wherein the outer sheath includes a curved portion, and wherein the first alignment surface is designed to align the compression shaft with the curved portion of the outer sheath.

17. The system of claim 16, wherein the outer sheath includes a projection, wherein the projection is aligned with the curved portion of the outer sheath, and wherein the outer sheath seal assembly includes a recess designed to engage the projection.

18. The system of claim 14, wherein the first fixed seal assembly is positioned proximal of the outer sheath seal assembly, wherein the actuation seal assembly is positioned proximal of the first fixed seal assembly, and wherein a second fixed seal assembly is positioned proximal of the actuation seal assembly.

19. The system of claim 14, wherein translation of the outer sheath seal assembly is designed to uncover at least a portion of the implantable medical device.

20. A method of manufacturing a medical device, the method comprising:

aligning a first catheter shaft to a handle member, wherein the first catheter shaft includes a curved portion and a projection, wherein the projection is aligned with the curved portion;

positioning the projection within a recess of an outer sheath seal assembly, the outer sheath seal assembly translatable to the handle member;

aligning a second catheter shaft to the handle member, wherein the second catheter shaft is coupled to a first seal body, and wherein the first seal body includes a first alignment surface;

aligning the first alignment surface to a recess in the handle, wherein the recess is designed to mate with the alignment surface; and

wherein aligning the second catheter shaft to the handle member aligns the second catheter shaft with the curved portion of the first catheter shaft.