Device for excision of heart valve

• US 10,292,818 B2
• Filed: 03/14/2013
• Issued: 05/21/2019
• Est. Priority Date: 03/14/2012
• Status: Active Grant

• Current Assignee: Cliniques Universitaires Saint-Luc Asbl (Université catholique de Louvain), Université catholique de Louvain
• Original Assignee: Cliniques Universitaires Saint-Luc Asbl (Université catholique de Louvain), Université catholique de Louvain
• Inventors: Astarci, Parla, Tran Duy, Khanh, Raucent, Benoit, Bollen, Xavier, Herman, Benoit
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US14/385,023
• Publication Number:
  US 20150088246A1
• Time in Patent Office: 2,259 Days
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A device (100) for the excision of a heart valve via a percutaneous route having a proximal (20) and distal (30) end, comprising an expandable cutting instrument, ECI, that forms a receptacle in the open configuration for receiving, compacting and containing the excised heart valve, an expandable cutting block, ECB, and a displacement mechanism (5, 6) for adjusting the distance between the ECI and the ECB (70).

Claims

1. A device (100) for the excision of a heart valve via a percutaneous route having a proximal (20) and distal (30) end, comprising:

a radially expandable cutting instrument, ECI, (50, 50′

) capable of radial expansion from a closed (50′

) to an open (50) configuration,

wherein the open configuration provides a receptacle with a void (64) having an aperture (65) at one end,

the distal edge of the aperture (65) forming a cutting edge (66) for excision of the heart valve,

which receptacle is configured to receive and contain the excised heart valve,

wherein the ECI (50′

) in the closed configuration, is configured for passage through the lumen (42) of a delivery catheter (40), and

wherein the receptacle is configured to compact and store the excised heart valve by contraction of the ECI from the open (50) to the closed configuration (50′

);

an expandable cutting block, ECB, capable of expansion from a closed (70′

) to an open (70) configuration, disposed adjacent to the cutting edge (66),

wherein the ECB in the open configuration (70) provides a support surface (77) to support the heart valve under excision by the ECI (50),

wherein the ECB in the closed configuration (70′

), is configured for the passage through the lumen (42) of the delivery catheter (40);

and

wherein a distance between the cutting edge (66) and the ECB (70) is adjustable,

wherein the ECI (50) comprises a sheet of material rolled to form an expandable cone (500) at least partly conical in the open configuration, which sheet of material in an unrolled flat condition comprises a geometric shape of an annulus segment.

2. A device according to claim 1 further comprising a first elongate member (52) and a second elongate member (72), wherein the ECI (50) is attached to a distal end (30) of the first elongate member (52) and the ECB (70) is attached to a distal end (30) of the second elongate member (72), which first and second members are slidable relative to each other thereby adjusting the distance between the cutting edge (66) and the ECB (70).

3. A device according to claim 2, wherein the first elongate member (52) is provided with a lumen (54) extending between the proximal end (20) and the distal end (30) and is open at both ends, configured for the passage of the second elongate member (72).

4. Device according to claim 2, wherein the second elongate member (72) is provided with a guidewire lumen extending between a proximal end (20) and a distal end (30) and is open at both ends, configured for the passage of a guidewire.

5. Device according to claim 2, wherein the ECB (70) comprises an expandable balloon, and the second elongate member (72) is provided with an inflation lumen in fluidic connection with an inflation lumen of said expandable balloon.

6. Device according to claim 2, wherein the ECB (72) comprises two expandable balloons, an outer expandable balloon (71) and an inner expandable balloon (71′

) provided within a lumen of the outer expandable balloon (71), and the second elongate member (72) is provided with an inner-balloon inflation lumen (74) in fluidic connection with an inflation lumen of said inner-expandable balloon, and with an outer-balloon inflation lumen (73) in fluidic connection with an inflation lumen of said outer-expandable balloon.

7. Device according to claim 2, further comprising an implant deployment unit, (IOU) 90, comprising a replacement heart valve, which IOU (90) is configured to deploy the replacement heart valve upon actuation, wherein the IOU (90) is operatively attached to the second elongate member (72), distal (30) to the ECB (70).

8. Device according to claim 1, further comprising an implant deployment unit, (IOU) 90, comprising a replacement heart valve, which IOU (90) is configured to deploy the replacement heart valve upon actuation.

9. Device according to claim 1, wherein the cutting edge (66) points in a direction towards the distal (30) end and the support surface (77) points in a direction towards the proximal (20) end.

10. Device according to claim 1, wherein the expandable cone is configured to transition from the open to closed configuration by rolling the annulus segment into essentially a cylindrical shape.

11. Device according to claim 10, incorporating the features of claim 2, wherein said rolling actuated by the rotation and proximal displacement of the first elongate member (52) relative to the delivery catheter (40).

12. Device according to claim 1, wherein the ECI (50) and ECB (70) in mutual contact form a closed debris-impermeable receptacle formed by the support surface (77) of the ECB co-operating with the receptacle aperture (66).

13. Device according to claim 8 wherein the IOU (90) comprises an expandable balloon around which the replacement heart valve is disposed, and the replacement heart valve is balloon deployable.

14. Device according to claim 8, wherein the distance between the IDU (90) and the ECB (70) is fixed.