Method for vessel access closure

• US 9,445,796 B2
• Filed: 07/21/2010
• Issued: 09/20/2016
• Est. Priority Date: 02/26/2010
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: Ginn, Richard S., Domingo, Nicanor, Valencia, Hans F., DeCou, Robert Elliott, Yerby, Scott
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US12/841,083
• Publication Number:
  US 20110213411A1
• Time in Patent Office: 2,253 Days
• Field of Search: 606/213, 623/1.1, 623 111- 114, 623/1.18, 623/1.2, 623/1.21
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• 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 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

Embodiments are described for closing vascular access ports, such as arteriotomies, which involve placement and deployment of an expandable device configured to prevent blood flow across a subject arteriotomy while also keeping disturbance of intravascular flow to a minimum. Suitable prostheses may comprise one or more frames constructed from lengths of flexible materials, such as shape memory alloys or polymers. Such frames may be coupled to sheetlike or tube-like structures configured to spread loads, minimize thrombosis which may be related to intravascular flow, and maintain hemostasis.

Claims

1. A method for closing a hole in a blood vessel having a lumen therein comprising the steps of:

(a) introducing into the lumen of the blood vessel the distal portion of a delivery sheath and the distal portion of a closure device deployment assembly comprising;

(i) an elongate foot member comprising a relatively short distal region which is bendably coupled to a relatively long proximal region, and

(ii) an expandable closure device removably coupled to said distal region of said foot member,

(b) advancing said distal region of said foot member and said closure device out of the distal end of said closure device deployment assembly into the lumen of said blood vessel with at least some of the proximal portion of said foot member remaining in said delivery sheath and reorienting said closure device by causing said distal region of said foot member to bend with relation to said proximal region of said foot member whereby said closure device is more difficult to withdraw from said blood vessel,

(c) decoupling said closure device from said foot member whereby it expands, and

(d) withdrawing said foot member and said deployment sheath from said blood vessel.

2. The method of claim 1 wherein the bend in said foot member is at a predetermined bending axis.

3. The method of claim 1 wherein said foot member is pre-biased to bend when constraint is removed by advancing the distal region of said foot member out of a constraining structure.

4. The method of claim 3 wherein said constraining structure is said deployment sheath.

5. The method of claim 1 wherein said delivery assembly comprises a deployment tension member and said distal region of said foot member is caused to bend by exerting tension on said deployment tension member.

6. The method of claim 1 wherein said delivery assembly comprises an attachment tension member which is connected to said closure device and an elongate deployment member configured to exert compressive force on said closure device and said distal portion of said foot member is caused to bend by pushing on said elongate deployment device.

7. The method of claim 1 wherein the closure device is coupled to said foot member with a removable tether.

8. The method of claim 7 wherein said removable tether constrains the expandable closure device from expanding prior to removal of the tether.

9. A method for closing a hole in a blood vessel having a lumen comprising the steps of:

(a) introducing into the lumen of the blood vessel the distal portion of a delivery sheath having a distal portion and a proximal portion and the distal portion of a closure device deployment assembly housed in said delivery sheath, said closure device deployment assembly comprising;

(i) an elongate foot member comprising a relatively short distal region and a relatively long proximal region, said distal region being hingedly coupled to said proximal region, and

(ii) an expandable closure device removably coupled to said distal region of said foot member,

(b) advancing said distal region of said foot member out of the distal end of said closure device deployment assembly to move said closure device into the lumen of said blood vessel with at least some of the proximal region of said foot member remaining in said delivery sheath and reorienting said closure device such that it is at an angle with the proximal region of said foot member and more difficult to withdraw from said blood vessel solely by causing said distal region of said foot member to bend at the location where it is hingedly coupled to the proximal region of said foot member,

(c) decoupling said closure device whereby it expands, and s withdrawing said foot member and said delivery sheath from said blood vessel.

10. The method of claim 9 wherein said closure device is coupled to said foot member with a removable tether.

11. The method of claim 10 wherein said removable tether constrains the expandable closure device from expanding prior to removal of the tether.

12. The method of claim 10 wherein the bend in said foot member is at a predetermined bending axis.

13. The method of claim 9 wherein said foot member is pre-biased to bend when constraint is removed by advancing the distal region of said foot member out of a constraining structure.

14. The method of claim 13 wherein said constraining structure is said deployment sheath.

15. The method of claim 9 wherein said delivery assembly comprises a deployment tension member and said distal region of said foot member is caused to bend by exerting tension on said deployment tension member.

16. The method of claim 9 wherein said delivery assembly comprises an attachment tension member which is connected to said closure device and an elongate deployment member configured to exert compressive force on said closure device and said distal portion of said foot member is caused to bend by pushing on said elongate deployment device.

17. A method for closing a hole in a blood vessel having a lumen therein comprising the steps of:

(a) introducing into the lumen of the blood vessel the distal portion of a delivery sheath and the distal portion of a closure device deployment assembly comprising;

i. an elongate foot member comprising a relatively short distal region which is bendably coupled to a relatively long proximal region,

ii. an expandable closure device removably coupled to said distal region of said foot member, and

iii. a deployment tension member comprising a tether which passes through said distal region of said foot member and is releasably coupled to said closure device,

(b) advancing said distal region of said foot member and said closure device out of the distal end of said closure device deployment assembly into the lumen of said blood vessel with at least some of the proximal portion of said foot member remaining in said delivery sheath and causing said distal region of said foot member to bend with relation to said proximal region of said foot member by exerting tension on said deployment tension member whereby said closure device is reoriented and more difficult to withdraw from said blood vessel,

(c) decoupling said closure device from said foot member whereby it expands, and

(d) withdrawing said foot member and said deployment sheath from said blood vessel.

18. A method for closing a hole in a blood vessel having a lumen comprising the steps of:

(a) introducing into the lumen of the blood vessel the distal portion of a delivery sheath having a distal portion and a proximal portion and the distal portion of a closure device deployment assembly housed in said delivery sheath, said closure device deployment assembly comprising;

i. an elongate foot member comprising a relatively short distal region and a relatively long proximal region, said distal region being hingedly coupled to said proximal region,

ii. an expandable closure device removably coupled to said distal region of said foot member, and

iii. a deployment tension member comprising a tether which passes through said distal region of said foot member and is releasably coupled to said closure device,

(b) advancing said distal region of said foot member out of the distal end of said closure device deployment assembly to move said closure device into the lumen of said blood vessel with at least some of the proximal region of said foot member remaining in said delivery sheath and causing said distal region of said foot member to bend at the location where it is hingedly coupled to the proximal region of said foot member by exerting tension on said deployment tension member whereby said closure device is reoriented such that it is at an angle with said proximal region of said foot member and more difficult to withdraw from said blood vessel,

(c) decoupling said closure device whereby it expands, and withdrawing said foot member and said delivery sheath from said blood vessel.