Tissue grasping devices and related methods

• US 10,667,815 B2
• Filed: 07/21/2015
• Issued: 06/02/2020
• Est. Priority Date: 07/21/2015
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Krone, Ryan T., Greenberg, Jacob L., Basude, Raghuveer
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US14/805,275
• Publication Number:
  US 20170020521A1
• Time in Patent Office: 1,778 Days
• Field of Search: 606139, 606151, 606190, 606205, 606206, 606213, 623 211
• 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 17/08 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition

Abstract

A tissue gripping device is formed from a shape-memory material, and has a base section, a first arm, and a second arm disposed opposite the first arm, each arm having a first end coupled to the base section and a free end extending from the base section. The arms of the tissue gripping device are configured to resiliently flex toward a relaxed configuration in a distal direction as the tissue gripping device is moved from a pre-deployed configuration toward a deployed configuration. The tissue gripping device is usable in a method for gripping tissue. The method includes positioning the tissue gripping device near target tissue and moving the tissue gripping device from a pre-deployed configuration toward a deployed configuration in order to grip the target tissue.

Claims

1. A tissue fixation system configured for intravascular delivery and for use in joining mitral valve tissue during treatment of the mitral valve, comprising:

a body;

a first and second distal elements, each including;

a first end pivotally coupled to the body and extending to a second end; and

a tissue engagement surface between the first and second end, the tissue engagement surface being configured to approximate and engage a portion of leaflets of the mitral valve; and

a tissue gripping device formed of a shape-memory material, including;

a base section; and

a first arm and a second arm, each arm having a distal end coupled to the base section by an arm bend feature, a proximal end extending laterally from the base section, and a furcated section having an opening with a radiused-terminal distal end formed with a first radius in the arm bend feature, a tapered-terminal proximal end formed with a second radius in the first arm, wherein the second radius is smaller than the first radius, and an intermediate portion having a cross-section larger than both the terminal distal end and the tapered-terminal proximal end, the first and second arms being disposed opposite one another and each arm being configured to cooperate with one of the first or second distal elements to form a space for receiving and holding a portion of mitral valve tissue therebetween.

2. The tissue fixation system of claim 1, wherein tissue engagement surfaces of the distal elements are angled apart at about 90 degrees or more when positioned in an open configuration, and wherein the first and second arms of the tissue gripping device are configured to move from a pre-deployed configuration toward a deployed configuration by moving toward the tissue engagement surfaces, the first and second arms being angled apart at about 90 degrees or more when positioned in the deployed configuration.

3. The tissue fixation system of claim 1, wherein tissue engagement surfaces of the distal elements are angled apart at about 120 degrees or more when positioned in a pre-deployed configuration, and wherein the first and second arms of the tissue gripping device are configured to move from a pre-deployed configuration toward a deployed configuration by moving toward the tissue engagement surfaces, the first and second arms being angled apart at about 120 degrees or more when positioned in the deployed configuration.

4. The tissue fixation system of claim 1, wherein the shape-memory material of the tissue gripping device is a nickel titanium alloy.

5. The tissue fixation system of claim 4, wherein the nickel titanium alloy of the tissue gripping device has a transformation temperature of between about −

5 to about 37 degrees C.

6. The tissue fixation system of claim 4, wherein the nickel titanium alloy of the tissue gripping device has a transformation temperature of between about −

5 to about 10 degrees C.

7. The tissue fixation system of claim 1, wherein the tissue gripping device is configured such that upon being positioned in a deployed state against a leaflet of the mitral valve, an arm of the tissue gripping device exerts a force of about 0.06 to about 0.10 pounds against the leaflet.

8. The tissue fixation system of claim 1, wherein the arms of the tissue gripping device, upon moving from a pre-deployed configuration to a deployed configuration, deploy to engage the mitral valve tissue against the tissue engagement surfaces of the distal elements while the distal elements are in an open configuration without any proximal movement of the distal elements.

9. The tissue fixation system of claim 1, wherein a full length of the arms of the tissue gripping device, upon moving from a pre-deployed configuration to a deployed configuration, engage the mitral valve tissue against the tissue engagement surfaces of the distal elements while the distal elements are in an open configuration.