Delivery Device for Medical Implant and Medical Procedure

• US 20170216030A1
• Filed: 02/10/2017
• Published: 08/03/2017
• Est. Priority Date: 08/03/2011
• Status: Active Grant

• Current Assignee: Aeeg AB
• Original Assignee: Aeeg AB
• Inventors: Jnsson, Anders
• Granted Patent: US 10,639,153 B2
• Time in Patent Office: 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 catheter (4) based medical system (1), including

a retractable delivery device (2) for delivery of a medical implant, such as an annuloplasty implant (3) for reducing cardiac valve regurgitation, having a distal portion for releasably holding said implant, and for apposition against a target tissue for said implant, such as an annulus (18) of a cardiac valve,

wherein said distal portion comprises a plurality of suction units for providing and/or determining a desired apposition of said distal portion at said target tissue prior to releasing said medical implant to said tissue and retracting said delivery device.

2. The system of claim 1, wherein said suction units are provideable with a negative pressure for suction to said tissue, and wherein said medical implant is not releasable before all suction units are confirmed in apposition with said tissue.

3. The system of claim 1, wherein said plurality of suction units are distributed along a periphery of said distal portion.

4. The system of claims 1-3, wherein a firm seat at said tissue is confirmed by an absence of a reflow of blood from said suction units.

5. The system of claims 1-4, wherein said suction units are arranged to provide for a symmetric delivery of said implant when release to said tissue.

6. The system of claims 1-5, wherein said tissue is a cardiac valve annulus and said implant is an annuloplasty implant, such that said distal portion is arrangeable for a synchronous and simultaneous reshaping procedure of said annulus by said implant.

7. The system of any of the preceding claims 1 to 6, wherein apposition of said suction units is measurable based on a signal for a pressure in said suction unit an energy consumption of a flow generator generating said pressure.

8. The system of any of the preceding claims 1 to 7, wherein said distal portion has arranged thereon a plurality of sensors for indicating contact with said annulus tissue, such as piezo transducers.

9. The system of any of the preceding claims 1 to 8, wherein said cardiac valve is a mitral valve, and wherein said system is adapted for transseptal percutaneous delivery into the left atrium to said atrial side of said mitral valve, and

wherein a delivery portion (202) of said delivery device (2) is distally connected to said distal portion (200) and has a distal curvature to allow access from a septal opening towards said mitral valve.

10. The system of any of the preceding claims 1 to 8, wherein said cardiac valve is a tricuspid valve, and wherein said system is adapted for percutaneous delivery into the right atrium to said atrial side of said tricuspid valve, and

wherein a delivery portion (202) of said delivery device (2) is distally connected to said distal portion (200) and has a distal curvature to allow suitable access towards said tricuspid valve.

11. The system of claims 1-10, wherein said implant is a resilient curvilinear shaped annuloplasty implant (3) that has a tissue engaging conformation based on a desired downsized shape where said regurgitation of said valve is reduced, and said distal portion (200) has a delivery conformation based on a shape of said dilated valve annulus shape, wherein said delivery conformation has a dimension that is larger than said tissue engaging conformation of said annuloplasty implant (3), such that said annuloplasty implant (3) is resiliently kept in said delivery conformation before release from said distal portion.

12. The system of any of the preceding claims 1 to 11, wherein said distal portion (200) has at least one fiducial marker, wherein said fiducial marker is preferably arranged at a periphery of said distal portion (200);

and/or wherein one of said fiducial markers is an annular fiducial marker arranged along said periphery; and

/or having a plurality of fiducial markers distributed along said distal curvilinear shaped portion (200) for identifying said distal curvilinear shaped portion (200) inside a body of a patient having said cardiac valve.

13. The system of claim 12, wherein said fiducial markers include an air inclusion for detection by ultrasound.

24. A method of virtually planning an annuloplasty implantation, such as for a medical procedure of claims 14-23, comprising, in a computer environment, image based, such as ultrasonic based, measuring a geometry of a dilated cardiac valve from patient image data, and determining a reduction of a regurgitation of said valve when downsizing the annulus of said dilated valve;

selecting a patient adapted shape and size of a catheter (4) based medical system, such as of any of claims 1-13, including a resilient annuloplasty implant for a tissue engaging conformation to be arranged at the downsized annulus based on the determined downsized shape and size of the annulus; and

providing production data for said device and/or a delivery system thereof.

25. The method of claim 24, wherein said measuring (80) the geometry of a dilated cardiac valve of a patient including the shape and size of a dilated annulus thereof, and said determining (82) the downsized shape and size of said annulus are made in a computer based, virtual environment.

26. A method of producing a medical device from production data obtained by the virtual planning of claim 24.

27. A computer based system for virtually planning an annuloplasty implantation, such as in a simulated medical procedure of claims 14-23, comprising, in a computer environment, image based, such as ultrasonic based, measuring a geometry of a dilated cardiac valve from patient image data, and computer based determining a reduction of a regurgitation of said valve when downsizing the annulus of said dilated valve is made;

selecting a patient adapted shape and size of a catheter (4) based medical system, such as of any of claims 1-13, including a resilient annuloplasty implant for a tissue engaging conformation to be arranged at the downsized annulus based on the determined downsized shape and size of the annulus; and

providing production data for said device and/or a delivery system thereof.

14. A medical procedure (8) for reducing cardiac valve regurgitation including the steps of:

measuring (80) the geometry of a dilated cardiac valve of a patient including the shape and size of a dilated annulus thereof;

determining (82) the downsized shape and size of said annulus;

selecting (84) a resilient annuloplasty implant having in a tissue engaging conformation a shape and size to be arranged at said downsized annulus based on said determined downsized shape and size of said annulus;

introducing (86) said annuloplasty implant in a delivery device in a compressed state via a catheter to said cardiac valve;

releasing (88) 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 implant assumes an expanded shape;

positioning (90) said aggregate at said annulus;

fixation said distal portion to said annulus, e.g. by activating suction of suction units;

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

releasing (92) and anchoring said annuloplasty implant into said annulus;

reducing (94) the size of said delivery device and/or annuloplasty implant for reshaping said annulus to said downsized shape;

optionally determining (96) a reduction of said cardiac valve regurgitation, and

removing (98) said delivery device and catheter if the reduction is satisfactory, or removing (99) said annuloplasty implant together with said delivery device when said reduction is determined as not being satisfactory.

15. The procedure of claim 14, including ultrasonic measurement for said measuring (80) the geometry of said dilated cardiac valve, and/or said determining (96) a reduction of said cardiac valve regurgitation.

16. The procedure of claim 14, including applying a catheter (4) based medical system (1) for reducing said cardiac valve regurgitation, having said resilient curvilinear shaped annuloplasty implant (3) for reducing the size of a dilated annulus (18) of said valve for reducing said regurgitation, and a delivery device (2) for said annuloplasty implant (3) having a distal portion (200) receiving said annuloplasty implant (3) and has an opening (201) arranged to be in apposition against an annulus (18) of said cardiac valve;

said procedure including

releasably mounting said annuloplasty implant (3) in said hollow with said resilient anchoring elements (300) arranged in a restrained spring loaded delivery conformation in said hollow, for said introducing (86);

positioning (90) said aggregate at said annulus;

fixation said distal portion to said annulus, e.g. by activating suction of suction units;

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

releasing (92) and anchoring said annuloplasty implant into said annulus.

17. The procedure of any of the preceding claims 14 to 16, including restraining said annuloplasty implant (3) in said hollow of said distal portion (200) with a second restraining unit (221), and releasing said annuloplasty implant (3) 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 annulus if the correct positioning of said annuloplasty implant is not confirmed, and avoiding undesired embolization of said annuloplasty implant.

18. The procedure of any of the preceding claims 14 to 17, including making a transseptal puncture in said heart;

wherein said cardiac valve is a mitral valve, and wherein said introducing (86) is a transseptal percutaneous delivery into the left atrium to said atrial side of said mitral valve, and wherein a delivery portion (202) of said delivery device (2) is distally connected to said distal curvilinear shaped portion (200) and has a distal curvature to allow access from a septal opening towards said mitral valve.

19. The procedure of any of preceding claims 14 to 18, including making a transseptal puncture in said heart;

wherein said cardiac valve is tricuspid valve, and wherein said system is adapted for percutaneous delivery into the right atrium to said atrial side of said tricuspid valve, and wherein a delivery portion (202) of said delivery device (2) is distally connected to said distal curvilinear shaped portion (200) and has a distal curvature to allow suitable access towards said tricuspid valve.

20. The procedure of any of the preceding claims 14 to 19, including generating a negative pressure in suction units of said distal portion (200) for suction of said distal portion to said annulus.

21. The procedure of claim 20, including measuring said negative pressure and determining a contact of said suction units(s) with said annulus tissue from said measured pressure or an energy consumption of a flow generator generating said pressure.

22. The procedure of any of the preceding claims 14 to 21, including indicating contact with said annulus tissue with a sensor arranged on said distal portion (200), such as based on sound waves emitted and received from a piezo transducer, such as an ultrasonic transducer.

23. The procedure of any of the preceding claims 14 to 22, including identifying said distal portion (200) inside a body of a patient having said cardiac valve by means of detecting at least one fiducial marker of said delivery device, such as a plurality of fiducial markers distributed along said distal portion (200) for said identifying and/or a fiducial marker that is arranged at a periphery of said distal portion (200), and/or wherein one of said fiducial markers is an annular fiducial marker arranged along said periphery.