Medical closure device

• US 8,292,917 B2
• Filed: 12/19/2007
• Issued: 10/23/2012
• Est. Priority Date: 08/07/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Chopra, Gopal
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US11/960,641
• Publication Number:
  US 20080097522A1
• Time in Patent Office: 1,770 Days
• Field of Search: 606/213
• US Class Current: 606/213
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

Several alternative designs, structures, assemblies, treatment methods and/or methods of manufacturing medical closure devices adapted and/or configured for closing an opening, for example, an incision or a puncture in the tissue of a patient, for example, the dural membrane of a patient. Some embodiments include a medical closure device including an elongated tubular member extending along a longitudinal axis. The tubular member including a distal section and a proximal section, and the distal section is expandable from a first configuration to a second expanded configuration through the application of a compressive force upon the distal section along the longitudinal axis.

Claims

1. A medical device for closing an opening in a tissue in a body of a patient, the device comprising:

an elongated tubular member extending along a longitudinal axis, the elongated tubular member including a distal section and a proximal section, wherein the distal section is radially expandable from a first configuration to a second expanded configuration through an application of a compressive force upon the distal section along the longitudinal axis;

wherein the proximal section defines an outer surface and includes a widened proximal portion member attached to the outer surface of the proximal section;

a binding material including an adhesive disposed on an interior surface of the elongate tubular member in the distal section, wherein the binding material is configured to maintain the distal section in the second expanded configuration after the distal section is radially expanded from the first configuration to the second expanded configuration;

wherein the elongated tubular member is adapted to permit an insertion device to extend through the elongated tubular member and extend distally therefrom such that withdrawing the insertion device applies the compressive force; and

a first non-return valve disposed within the proximal section.

2. The medical device of claim 1, wherein the distal section includes a plurality of portions, and at least one of the portions has a reduced column strength relative to other portions of the distal section.

3. The medical device of claim 2, wherein the portion of reduced column strength is configured to create an outwardly extending bend or fold in the distal portion relative to the longitudinal axis when the compressive force is applied to the distal section.

4. The medical device of claim 3, wherein the distal section defines an outer surface, and the outwardly extending bend or fold in the distal portion expands the outer perimeter of at least a portion of the outer surface of the distal section.

5. The medical device of claim 1, wherein the distal section defines an outer surface, and when the distal section is in the first configuration, the outer surface of the distal section has a first sized outer perimeter, and when the distal section is in the second configuration, the outer surface of the distal section has a second sized outer perimeter greater than the first sized outer perimeter.

6. The medical device of claim 1, wherein the distal section defines an outer surface, and when the distal section is in the first configuration, the outer surface of the distal section is sized to have an outer perimeter that is adapted for insertion through the opening in the tissue in the body of the patient, and when the distal section is in the second configuration, at least a portion of the outer surface of the distal section is expanded in size to have an outer perimeter that is greater than when in the first configuration.

7. The medical device of claim 6, wherein when the distal section is in the second configuration, at least a portion of the outer surface of the distal section is expanded in size to have an outer perimeter that is greater than an outer perimeter of the opening in the tissue in the body of the patient.

8. The medical device of claim 1, wherein the widened proximal portion member defines an outer surface having an outer perimeter that is greater than an outer perimeter of the opening in the tissue in the body of the patient.

9. The medical device of claim 1, wherein the elongated tubular member further includes an intermediate section connecting the distal section and the proximal section.

10. The medical device of claim 9, wherein the intermediate section is configured to extend within the opening in the body of the patient between the distal section and the proximal section.

11. The medical device of claim 10, wherein the tissue in the body of the patient includes an inner surface and an outer surface, and the device is configured such that when the device is inserted into the opening to close the opening, the proximal section is configured to contact the outer surface of the tissue, and the distal section, when in the second expanded configuration, is configured to contact the inner surface of the tissue.

12. The medical device or claim 1, wherein the opening in the tissue in the body of the patient comprises an opening in the dural membrane of the patient.

13. A medical device for closing an opening in a dural membrane of a patient, the device comprising:

a tubular proximal section defining an outer surface having an outer perimeter;

a tubular intermediate section connected to the proximal section, the intermediate section defining an outer surface having an outer perimeter that is less than the outer perimeter of the proximal section;

a tubular distal section connected to the intermediate section, the distal section being configured to be radially expandable from a first configuration to a second expanded configuration through an application of a compressive force upon the distal section, the distal section being adapted to permit an insertion device to extend therethrough such that withdrawing the insertion device applies the compressive force;

a bonding agent disposed on an interior surface of the tubular distal section, wherein the bonding agent is configured to maintain the tubular distal section in the second expanded configuration after the tubular distal section is radially expanded from the first configuration to the second expanded configuration; and

a non-return valve disposed within the tubular distal section.

14. The medical device of claim 13, wherein the tubular proximal section is configured to contact the outer surface of the dural membrane, the tubular intermediate section is configured to extend within the opening in the dural membrane between the tubular proximal section and the tubular distal section, and the tubular distal section, when in the first configuration, is adapted for insertion through the opening in the dural membrane, and when in the second configuration, is configured to contact the inner surface of the dural membrane.

15. The medical device of claim 13, wherein the outer perimeter of the tubular proximal section is configured to be greater than an outer perimeter of the opening in the dural membrane.

16. The medical device of claim 13, wherein a tubular distal section is configured to be inserted through the opening in the dural membrane when in the first configuration, and is adapted to expand and close the opening when in the second, expanded configuration.

17. The medical device of claim 13, wherein the tubular intermediate section is configured to extend within the opening in the dural membrane.

18. The medical device of claim 13, wherein the tubular distal section includes a plurality of portions, and at least one of the portions has a reduced column strength relative to other portions of the tubular distal section.

19. The medical device of claim 18, wherein the at least one of the portions of reduced column strength is configured to create an outwardly extending bend or fold in the tubular distal portion relative to the longitudinal axis when the compressive force is applied to the tubular distal section.

20. The medical device of claim 19, wherein the tubular distal section defines an outer surface, and the outwardly extending bend or fold in the tubular distal portion expands the outer perimeter of at least a portion of the outer surface of the tubular distal section.