Medical device delivery system

• US 10,688,282 B2
• Filed: 09/23/2016
• Issued: 06/23/2020
• Est. Priority Date: 09/25/2015
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Sosnowski, Stephen, Matsuura, David, Simpson, Philip, Matsuura, Belinko, Loos, Jeffrey
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US15/274,068
• Publication Number:
  US 20170106168A1
• Time in Patent Office: 1,369 Days
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters

Abstract

A medical device delivery system can be used to advance a medical device to a target area within a patient'"'"'s vasculature. The system can comprise a catheter, a support sheath, and a core member coupled to a medical device. The core member can be used to longitudinally advanced or retracting medical device within a lumen of the support sheath. The support sheath can be advanced within the catheter until a distal end of the support sheath contacts or abuts a reduced diameter section of the catheter lumen. Thereafter, the core member can be advanced into the catheter lumen toward the target area.

Claims

1. A medical device delivery system, comprising:

a support catheter having proximal and distal sections and a lumen having an inner shoulder separating the proximal and distal sections, the catheter lumen having a larger diameter in the proximal section than in the distal section, wherein the distal section of the catheter and at least part of the proximal section of the catheter are each configured to be positioned within the vasculature of a patient;

an introducer sheath having proximal and distal sections and a lumen extending therethrough, the sheath having a larger cross-sectional profile in the proximal section than in the distal section, the sheath being advanceable within the catheter lumen of the catheter proximal section to contact a distal end portion of the sheath against the catheter inner shoulder to stabilize the sheath within the catheter while the distal section of the sheath is wholly disposed within the catheter lumen and the proximal section of the sheath is at least partially disposed within the catheter lumen, the sheath distal section lumen diameter being about equal to the catheter distal section lumen diameter; and

a core member having a proximal section and a distal section configured to carry a medical device thereon, the distal section cross-section profile being less than the sheath distal section lumen inner diameter to allow the core member distal section to be advanced along the sheath distal section, wherein the core member proximal section has a cross-sectional profile that is greater than the catheter distal section lumen diameter and the sheath distal section lumen diameter,

wherein the sheath proximal section has a length of at least 100 cm and the sheath distal section has a length of at least 30 cm.

2. The system of claim 1, wherein the cross-sectional profile of the sheath distal section is greater than the catheter distal section lumen diameter.

3. The system of claim 1, wherein the catheter lumen steps down to a smaller diameter at the inner shoulder between the proximal and distal sections of the catheter.

4. The system of claim 1, wherein the sheath lumen has a larger diameter in the proximal section of the sheath than in the distal section of the sheath.

5. The system of claim 1, further comprising a hub coupled to a proximal end of the catheter, wherein the sheath is advanceable through the hub and into the catheter lumen.

6. The system of claim 1, wherein the catheter lumen tapers at the inner shoulder between the proximal and distal sections of the catheter.

7. The system of claim 6, wherein the catheter lumen tapers conically in a distal direction.

8. The system of claim 6, wherein the sheath distal end portion tapers conically in a distal direction to permit the sheath distal end portion to self-center along a longitudinal axis of the catheter when urged into contact against the catheter inner shoulder.

9. A medical device delivery system, the system comprising:

a catheter having proximal and distal sections, and an inner lumen having a larger inner diameter in the proximal section than in the distal section, wherein the distal section of the catheter and at least part of the proximal section of the catheter are each configured to be positioned within the vasculature of a patient; and

a loading assembly comprising;

a support sheath having proximal and distal sections and a lumen extending therethrough, the support sheath having a larger cross-sectional profile in the proximal section than in the distal section, wherein the support sheath proximal section has a length of at least 100 cm and the support sheath distal section has a length of at least 30 cm; and

a core assembly comprising a core member and a stent engaged by the core member, the core assembly slidably received in the support sheath with the stent positioned in the support sheath lumen in the support sheath distal section such that the stent is movable along the support sheath distal section via the core member,

wherein the loading assembly is removably positioned, or removably positionable, within the catheter proximal section with the support sheath distal section wholly disposed within the catheter lumen and the support sheath proximal section at least partially disposed within the catheter lumen and a distal end of the support sheath distal section adjoining a proximal end of the catheter distal section such that the stent can be advanced distally into the catheter distal section from the support sheath distal section.

10. The system of claim 9, wherein the loading assembly is removably positioned, or removably positionable, within the catheter proximal section with a distal end of the support sheath distal section adjoining a proximal end of the catheter distal section such that the stent can be advanced distally and directly into the catheter distal section from the support sheath distal section.

11. The system of claim 9, wherein a core member distal section has a length greater than the combined length of the support sheath distal section and the catheter distal section.

12. The system of claim 9, wherein the catheter distal section lumen inner diameter is about equal to the support sheath distal section lumen inner diameter.

13. The system of claim 9, wherein the catheter proximal section has an outer diameter that is larger than an outer diameter of the catheter distal section.

14. The system of claim 9, wherein the core member comprises a stent engagement portion for removably securing the stent to the core member.

15. The system of claim 9, wherein when the stent is coupled to the core member via a stent engagement portion of the core member, the core member does not extend distally of the stent.

16. The system of claim 9, further comprising a hub coupled to a proximal end of the catheter, wherein the support sheath is advanceable through the hub and into the catheter lumen.

17. The system of claim 9, wherein, when the loading assembly is positioned in the catheter proximal section, the support sheath distal section and the catheter distal section together form a common lumen having a substantially constant diameter and extending from the support sheath distal section to a distal end opening of the catheter.

18. The system of claim 17, wherein:

the catheter lumen has an inner wall that forms a distally extending inward taper at a junction between the catheter proximal section and the catheter distal section; and

the support sheath forms a distal tip that is received, or receivable, in the distally extending inward taper to form the common lumen when the support sheath is in the catheter proximal section.

19. The system of claim 9, wherein the support sheath lumen has a larger inner diameter in the support sheath proximal section than in the support sheath distal section.

20. The system of claim 19, wherein the support sheath proximal section has an outer diameter that is larger than an outer diameter of the support sheath distal section.

21. The system of claim 20, wherein the support sheath distal section outer diameter is larger than the catheter distal section lumen inner diameter.

22. A medical device delivery system, the system comprising:

a catheter having proximal and distal sections and a lumen having an inner shoulder between the proximal and distal sections, the catheter lumen having a larger diameter in the proximal section than in the distal section, wherein the distal section of the catheter and at least part of the proximal section of the catheter are each configured to be positioned within the vasculature of a patient;

a support sheath having proximal and distal sections and an inner lumen, the support sheath having a greater cross-sectional profile in the proximal section than in the distal section, the support sheath being advanceable within the lumen of the catheter proximal section to contact a distal end portion of the sheath against the catheter inner shoulder to stabilize the sheath within the catheter while the distal section of the sheath is wholly disposed within the catheter lumen and the proximal section of the sheath is at least partially disposed within the catheter lumen, the proximal section of the support sheath having a length of at least 100 cm and the distal section of the sheath having a length of at least 30 cm, wherein the sheath distal section lumen diameter is about equal to the catheter distal section lumen diameter; and

a core member having a proximal section and a distal section, and carrying a medical device via the distal section, the core member distal section cross-sectional profile being less than the sheath distal section lumen inner diameter to allow the medical device and core member distal section to be advanced along the sheath distal section, wherein the core member proximal section has a cross-section profile that is greater than the catheter distal section lumen diameter and the sheath distal section lumen diameter.

23. The system of claim 22, wherein the catheter lumen steps down to a smaller diameter at the inner shoulder between the proximal and distal sections of the catheter.

24. The system of claim 22, wherein the sheath lumen tapers at an inner shoulder of the sheath between the proximal and distal sections of the sheath.

25. The system of claim 22, wherein the core member distal section has a length greater than the combined length of the support sheath distal section and the catheter distal section.

26. The system of claim 22, further comprising a hub coupled to a proximal end of the catheter, wherein the support sheath is advanceable through the hub and into the catheter lumen.

27. The system of claim 22, wherein the catheter lumen tapers at the inner shoulder between the proximal and distal sections of the catheter.

28. The system of claim 27, wherein the catheter lumen tapers conically in a distal direction.

29. The system of claim 27, wherein the sheath distal end portion tapers conically in a distal direction to permit the sheath distal end portion to self-center along a longitudinal axis of the catheter when urged into contact against the catheter inner shoulder.