Steerable access sheath and methods of use

• US 8,123,703 B2
• Filed: 02/03/2010
• Issued: 02/28/2012
• Est. Priority Date: 04/09/1999
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Martin, Brian B., Raatikka, Amy R., Thornton, Troy L., Powell, Ferolyn T.
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/699,759
• Publication Number:
  US 20100130924A1
• Time in Patent Office: 755 Days
• Field of Search: 600/585, 604/164.13, 604/165.01, 604/523
• US Class Current: 600/585
• CPC Class Codes: A61B 1/00078 with stiffening means
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 : having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 : by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 : using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

Claims

1. An articulatable access system for accessing a chamber of a heart, said system comprising:

a shaft having a proximal end, a distal end, and a central lumen therethrough, the central lumen having proximal and distal openings, wherein a portion of the shaft comprises a series of articulating members defining a distal region near the distal end, a proximal region proximal to the distal region, and a middle region therebetween, wherein the distal end is passable through to the body cavity and wherein the central lumen and the distal opening are sized for passage of an interventional device to act on a heart valve;

a first set of pullwires operably coupled with the proximal region at a primary attachment location such that applying tension to the first set of pullwires deflects the articulating members to form a primary curve proximal to the primary attachment location, the primary curve having a first radius;

a second set of pullwires operably coupled with the middle region at a secondary attachment location such that applying tension to the second set of pullwires deflects the articulating members to form a secondary curve proximal to the secondary attachment location, the secondary curve distal to the primary curve and having a secondary radius different than the first radius; and

a third set of pullwires operably coupled with the distal region at a distal attachment location such that applying tension to the third set of pullwires moves the distal end of the shaft through an angle theta,

wherein at least some of the pullwires extend through one or more pullwire lumens disposed in one or more of the articulating members, at least some of the pullwire lumens adapted to reduce binding of the pullwire passing therethrough,

wherein the shaft is configured to navigate toward the chamber of the heart to position the interventional device to act on the heart valve.

2. The system of claim 1, further comprising a locking mechanism to hold the articulating members in a fixed articulated position to direct the device to the chamber of the heart.

3. The system of claim 2, wherein the locking mechanism comprises means for holding at least one of the pullwires in a tensioned position so that the articulating members are compressed together.

4. The system of claim 2, wherein the locking mechanism comprises a frictional surface on at least a portion of the articulating members to enhance friction between the articulating members.

5. The system of claim 1, wherein the primary curve has a radius of curvature in the range of approximately 0.125 inches to 1.000 inches.

6. The system of claim 1, wherein the secondary curve has a radius of curvature in the range of approximately 0.050 inches to 0.750 inches.

7. The system of claim 1, wherein the primary curve and secondary curve lie in different planes.

8. The system of claim 7, wherein the primary curve and secondary curve lie in substantially orthogonal planes.

9. The system of claim 1, wherein the distal region terminates in a distal tip and the third set of pullwires is fixedly attached to the distal tip to allow the distal tip to move through the angle theta.

10. The system of claim 9, wherein the secondary curve and the angle theta lie in different planes.

11. The system of claim 10, wherein the secondary curve and the angle theta lie in orthogonal planes.

12. The system of claim 9, wherein the primary curve, secondary curve and the angle theta each lie in different planes.

13. The system of claim 12, wherein the primary curve, secondary curve and the angle theta each lie in orthogonal planes.

14. The system of claim 1, wherein distal end is configured to be passable through a blood vessel.

15. The system of claim 1, wherein at least some of the pullwire lumens have a cross-section that subtends an arc of at least 5°

circumferentially along the articulatable members.

16. The system of claim 1, wherein at least some of the pullwires in either the first set, the second set, or the third set, are coated with a lubricious coating.

17. The system of claim 1, wherein the first set of pullwires comprises a pair of pullwires operably coupled with the articulating members.

18. The system of claim 1, wherein the second set of pullwires comprises a pair of pullwires operably coupled with the articulating members.

19. The system of claim 1, wherein the third set of pullwires comprises a pair of pullwires operably coupled with the articulating members.

20. The system of claim 1, wherein the articulating members comprise interfitting domed rings.

21. The system of claim 20, wherein a first interfitting domed ring comprises a notch, and an adjacent interfitting domed ring comprises an aperture disposed therein, the system further comprising a pin disposed in the notch and in the aperture, thereby limiting movement of the first interfitting domed ring relative to the adjacent interfitting domed ring to rotation about a longitudinal axis of the pin.

22. The system of claim 1, wherein each of the articulating members is independently rotatable against an adjacent articulating members.

23. The system of claim 1, wherein the angle theta is in the range of −

100°

to +100°

degrees.

24. The system as in claim 1, further comprising an obturator removably positioned in the central lumen.

25. The system of claim 24, wherein the obturator is flexible such that the shaft is positionable through the patient'"'"'s vasculature when the obturator is positioned in the central lumen.

26. The system of claim 24, wherein the obturator is configured to position the portion of the shaft into a first shape.

27. The system of claim 24, wherein the obturator further comprises a guidewire lumen configured to slidably receive a guidewire.

28. The system of claim 26, wherein the obturator is generally straight such that the first shape is generally straight.

29. The system of claim 26, wherein the obturator is articulatable such that the first shape has at least one curve.

30. The system of claim 24, further comprising a hemostasis valve in communication with the central lumen, and adapted to inhibit fluid flow therefrom, the hemostasis valve being configured to receive the interventional device and the obturator.