Delivery device for medical implant and medical procedure

• US 10,639,153 B2
• Filed: 02/10/2017
• Issued: 05/05/2020
• Est. Priority Date: 08/03/2011
• Status: Active Grant

• Current Assignee: Aeeg AB
• Original Assignee: Aeeg AB
• Inventors: Jonsson, Anders
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/430,215
• Publication Number:
  US 20170216030A1
• Time in Patent Office: 1,180 Days
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A catheter (4) based medical system (1) and medical procedure for reducing cardiac valve regurgitation are disclosed. The system comprises a resilient curvilinear shaped annuloplasty implant (3) for reducing the size of a dilated annulus (18) of said valve for reducing said regurgitation having resilient anchoring elements (300), and a delivery device (2) for said annuloplasty implant (3) having a distal curvilinear shaped portion (200) that is hollow to mount said annuloplasty implant (3) and has an annular opening (201) arranged to be in apposition against an annulus (18) of said cardiac valve. A plurality of suction units allows for a atrial approach and symmetric implantation of said implant.

Claims

1. A medical procedure for reducing cardiac valve regurgitation including the steps of:

measuring the geometry of a dilated cardiac valve of a patient including the shape and size of a dilated annulus thereof;

determining the downsized shape and size of said dilated annulus;

selecting a resilient annuloplasty implant having in a tissue engaging conformation a shape and size to be arranged at said dilated annulus based on said determined downsized shape and size of said dilated annulus;

introducing said annuloplasty implant in a delivery device in a compressed state via a catheter to said dilated cardiac valve;

releasing an aggregate of a distal portion of said delivery device and said annuloplasty implant in a stretched state in said delivery device from said catheter such that said annuloplasty implant assumes an expanded shape;

positioning said aggregate at said dilated annulus;

affixing said distal portion to said dilated annulus by activating suction of suction units;

providing and/or verifying a desired apposition of said distal portion at said dilated annulus prior to releasing said annuloplasty implant;

releasing and anchoring said annuloplasty implant into said dilated annulus;

reducing the size of said delivery device and/or annuloplasty implant for reshaping said dilated annulus to said downsized shape;

determining a reduction of said dilated cardiac valve regurgitation, and

removing said delivery device and catheter if the reduction is satisfactory, or removing said annuloplasty implant together with said delivery device when said reduction is determined as not being satisfactory; and

including

applying a catheter-based medical system for reducing said cardiac dilated cardiac valve regurgitation, said medical system having said annuloplasty implant for reducing the size of said dilated annulus of said dilated cardiac valve for reducing said regurgitation, and a delivery device for said annuloplasty implant having a distal hollow portion for receiving said annuloplasty implant and having an opening arranged to be in opposition against said dilated annulus of said dilated cardiac valve;

said procedure further including

releasably mounting said annuloplasty implant in said distal hollow portion with said resilient anchoring elements arranged in a restrained spring loaded delivery conformation in said hollow, for said introducing;

positioning said aggregate at said dilated annulus;

providing and/or verifying a desired apposition of said distal portion at said dilated annulus prior to releasing said annuloplasty implant;

releasing and anchoring said annuloplasty implant into said dilated annulus.

2. The procedure of any of claim 1, including restraining said annuloplasty implant in said distal hollow portion with a second restraining unit, and releasing said annuloplasty implant from said hollow upon releasing said second restraining unit, wherein said second restraining unit preferably is only released when a correct position of said annuloplasty implant is confirmed, allowing for removing said annuloplasty implant from said dilated annulus if the correct positioning of said annuloplasty implant is not confirmed, and avoiding undesired embolization of said annuloplasty implant.

3. The procedure of claim 1, including generating a negative pressure in a plurality of suction units of said distal portion for suction of said distal portion to said dilated annulus, and measuring said negative pressure and determining a contact of said suction units with said dilated annulus tissue from said measured pressure or an energy consumption of a flow generator generating said pressure.

4. The procedure of claim 3, including indicating contact with said dilated annulus tissue with a sensor arranged on said distal portion based on sound waves emitted and received from a piezo transducer.

5. The procedure of claim 1, including identifying said distal portion inside a body of a patient having said dilated cardiac valve by means of detecting at least one fiducial marker of said delivery device.

6. The procedure of claim 5, including identifying a plurality of fiducial markers distributed along said distal portion.

7. The method of claim 5, including identifying at least one fiducial marker that is arranged at a periphery of said distal portion, and/or identifying at least one an annular fiducial marker arranged along said periphery.