Systems and methods for percutaneous access, stabilization and closure of organs

• US 10,028,741 B2
• Filed: 07/24/2015
• Issued: 07/24/2018
• Est. Priority Date: 01/25/2013
• Status: Active Grant

• Current Assignee: Apica Cardiovascular Limited (Thoratec LLC)
• Original Assignee: Apica Cardiovascular Limited (Thoratec LLC)
• Inventors: Jimenez, Jorge Hernan, West, Dustin Seth, Cunniffe, Brendan, Feeney, Thomas, Greene, James L., Stephens, Robin
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US14/808,037
• Publication Number:
  US 20150342602A1
• Time in Patent Office: 1,096 Days
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00305 Constructional details of the flexible means
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00902 transparent or translucent
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0498 : for advancing a suture filament along a helical path through tissue
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3419 : Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3466 : for simultaneous sealing of multiple instruments
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/0801 : Prevention of accidental cutting or pricking
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

Systems and methods for accessing, stabilizing and sealing a device attached to a tissue surface comprising a tissue attaching device having an outer base ring defining an opening therethrough and a distally projecting tissue attachment element. The systems variously utilize annular sealing flanges distally attached to the outer base ring outside or inside the tissue attachment element to create a fluid tight seal. The systems variously utilize coils with regions of differing pitch to create sealing tissue pressure. Methods for installing an apical attaching device with a transapical port into a patient, comprising assessing the patient'"'"'s viability for installation of the apical attaching device by determining an Index of Tissue Elasticity (ITE).

Claims

1. A tissue attaching device comprising:

an outer base ring defining an opening therethrough and a central axis of the tissue attaching device;

a tissue attachment element fixedly attached to the outer base ring and projecting distally therefrom in the direction of the central axis, wherein the tissue attachment element comprises a sharpened distal end configured for piercing a tissue surface of a tissue wall; and

an annular sealing flange attached to the outer base ring outside of the tissue attachment element and projecting distally therefrom in the direction of the central axis, wherein the annular sealing flange comprises a proximal portion projecting away from the central axis at an outward angle to define a first circumference and a distal portion projecting toward the central axis at an inward angle to define a second circumference for interfacing with the tissue surface surrounding the tissue attachment element, and wherein the second circumference is smaller than the first circumference to create a fluid tight seal that is strengthened when fluid pressure is increased inside the annular sealing flange.

2. The tissue attaching device of claim 1, wherein the tissue attachment element is a coil.

3. The tissue attaching device of claim 2, wherein the coil has a radially-expanding helical shape projecting away from the central axis.

7. The tissue attaching device of claim 1, wherein the tissue attachment element is configured for compressing the tissue wall inward toward the central axis.

8. The tissue attaching device of claim 1, wherein the tissue attachment element projects distally beyond the annular sealing flange in the direction of the central axis.

9. The tissue attaching device of claim 1, wherein the annular sealing flange is attached to a distal end of the outer base ring.

10. The tissue attaching device of claim 1, wherein the annular sealing flange has a V-shaped profile defined by the proximal portion and the distal portion.

11. The tissue attaching device of claim 1, wherein the tissue attachment element is configured for inserting into the tissue wall, and wherein the annular sealing flange is configured for pressing against the tissue surface when the tissue attachment element is inserted into the tissue wall.

12. The tissue attaching device of claim 1, wherein the tissue attachment element is configured for inserting into the tissue wall, and wherein the annular sealing flange is configured for compressing against the tissue surface when the tissue attachment element is inserted into the tissue wall.

13. The tissue attaching device of claim 1, wherein the distal portion of the annular sealing flange is configured to be biased away from the central axis when fluid pressure is increased inside the annular sealing flange.

14. The tissue attaching device of claim 1, wherein the annular sealing flange is spaced apart from a proximal end of the outer base ring in the direction of the central axis.

15. The tissue attaching device of claim 1, wherein the outer base ring defines a third circumference that is larger than the second circumference.

16. The tissue attaching device of claim 15, wherein the first circumference is larger than the third circumference.

17. The tissue attaching device of claim 1, wherein the outer base ring has a circular shape, and wherein the opening has a circular shape.

18. The tissue attaching device of claim 1, wherein the outer base ring defines a plurality of apertures therethrough spaced apart from the central axis, and wherein the annular sealing flange covers the apertures.

4. A tissue attaching device comprising:

an outer base ring defining an opening therethrough and a central axis of the tissue attaching device;

a tissue attachment element fixedly attached to the outer base ring and projecting distally therefrom in the direction of the central axis, wherein the tissue attachment element comprises a sharpened distal end configured for piercing a tissue surface of a tissue wall; and

an annular sealing flange attached to the outer base ring inside of the tissue attachment element and projecting distally therefrom in the direction of the central axis.

5. The tissue attaching device of claim 4, wherein the tissue attachment element is a coil.

6. The tissue attaching device of claim 4, wherein the tissue attachment element projects distally beyond the annular sealing flange in the direction of the central axis.