# US 11,304,803 B2 · Method for replacement of heart valve

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- Number: US 11,304,803 B2
- Document ID: US11304803B2
- Status: Granted
- Kind: B2
- Application number: 17/359,242
- Filed: 2021-06-25
- Published: 2021-10-21
- Granted: 2022-04-19
- Earliest claimed: 2004-10-02
- Assignees: Edwards Lifesciences CardiAQ LLC
- Applicants: Edwards Lifesciences CardiAQ LLC
- Inventors: Christoph Hans Huber
- Web page: https://patentgrep.com/patent/US11304803B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/22004: {using mechanical vibrations, e.g. ultrasonic shock waves (A61B17/225 takes precedence)}
- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 17/3421: {Cannulas}
- A61F 2/012: {Multiple filtering units}
- A61F 2/014: {Retrograde blood flow filters, i.e. device inserted against the blood flow direction}
- A61F 2/07: Stent-grafts
- A61F 2/2403: {with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2433: {using balloon catheter}
- A61F 2/856: Single tubular stent with a side portal passage
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00243: {cardiac}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00278: {Transorgan operations, e.g. transgastric}
- A61B 2017/22024: {with a part reflecting mechanical vibrations, e.g. for focusing}
- A61B 2017/22055: {with three or more balloons}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61B 2017/3441: {with distal sealing means}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/848: having means for fixation to the vessel wall, e.g. barbs
- A61F 2/89: the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
- A61F 2002/018: {made from tubes or sheets of material, e.g. by etching or laser-cutting}
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F 2002/9534: {for repositioning of stents}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0006: circular
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/0069: cylindrical
- A61F 2230/0078: hyperboloidal
- A61F 2230/008: paraboloidal
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0039: differing in diameter
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method for implanting a replacement heart valve within a diseased valve includes accessing a patient's heart by piercing a myocardium, advancing a guidewire into the patient's heart, and installing an access device in a wall of the heart. The access device preferably has at least one valve mechanism. A valve delivery device is advanced over the guidewire and through the access device. The valve delivery device has a replacement heart valve disposed along a distal end portion thereof. The replacement heart valve preferably includes an outer support structure and a leaflet valve disposed within the outer support structure. The replacement heart valve is radially expanded within the diseased valve. During implantation, the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size having a diameter smaller than the diameter of the diseased valve.

## Claims

### Claim 1

A method for implanting a replacement heart valve within an insufficient native valve using a minimally invasive procedure that does not require extracorporeal cardiopulmonary bypass, the method comprising:
advancing a guidewire into a patient's heart;
advancing a valve delivery device over the guidewire into the patient's heart, the valve delivery device having the replacement heart valve disposed along a distal end portion thereof, the replacement heart valve comprising at least three leaflets made from pericardium, a collapsible and expandable stent frame made from a shape memory material, and a fluid-tight membrane formed from a single piece of material, which entirely and continuously encircles an outer perimeter of the leaflets, the fluid-tight membrane positioned between the leaflets and the stent frame, the fluid-tight membrane extending radially outwardly from the leaflets and having an inner circumferential edge that circumscribes the leaflets and an outer circumferential edge spaced radially outwardly from the inner circumferential edge; and
radially expanding the replacement heart valve from a collapsed state to an expanded state in the insufficient native valve;
wherein the stent frame self-expands to a diameter that conforms to an annulus of the insufficient native valve while the leaflets expand to a fixed diameter defined by a central opening in the fluid-tight membrane, wherein the fixed diameter of the leaflets is smaller than the annulus of the insufficient native valve such that an annular space exists between the leaflets and the stent frame and wherein the fluid-tight membrane fills the space; and
wherein the replacement heart valve is implanted within the insufficient native valve without performing a sternotomy and without using extracorporeal cardiopulmonary bypass.

### Claim 2 (depends on 1)

The method of claim 1, wherein the stent frame is made of Nitinol.

### Claim 3 (depends on 1)

The method of claim 1, wherein the insufficient native valve is a native mitral valve.

### Claim 4 (depends on 1)

The method of claim 1, wherein the valve delivery device includes radiopaque markers and the method includes using fluoroscopy equipment for visualizing the markers.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method further comprises:
accessing the patient's heart by piercing a wall of the heart with a cannulated needle having a sharp end, wherein advancing the guidewire into the patient's heart comprises advancing the guidewire through the needle and into the patient's heart; and
installing an access device in the wall of the heart, the access device having at least one valve for preventing blood from escaping the patient's heart, wherein advancing the valve delivery device over the guidewire into the patient's heart comprising advancing the delivery device over the guidewire and through the access device.

### Claim 6 (depends on 5)

The method of claim 5, wherein the patient's heart is accessed via a thoracotomy.

### Claim 7 (depends on 5)

The method of claim 5, wherein the access device comprises multiple valves.

### Claim 8 (depends on 5)

The method of claim 5, wherein purse-string sutures are applied in the wall of the heart for forming a seal around the access device extending through the wall of the heart.

### Claim 9

A method for implanting a replacement heart valve within an insufficient native heart valve using a minimally invasive procedure that does not require extracorporeal cardiopulmonary bypass, the method comprising:
advancing a valve delivery device into a patient's heart, the valve delivery device having the replacement heart valve held in a collapsed state along a distal end portion thereof, the replacement heart valve comprising at least three leaflets made from pericardium, an expandable support structure made from a shape memory material, and a fluid-tight membrane extending between the leaflets and the support structure, wherein the fluid-tight membrane is formed from a single piece of material, which extends entirely and continuously around the leaflets; and
allowing the replacement heart valve to self-expand within the insufficient native valve;
wherein the support structure expands to a diameter that conforms to an annulus of the insufficient native valve and the leaflets expand to a fixed size with a diameter smaller than the annulus of the insufficient native valve and wherein an annular space between the leaflets and the support structure is filled by the fluid-tight membrane; and
wherein the method is performed without performing a sternotomy and without using extracorporeal cardiopulmonary bypass.

### Claim 10 (depends on 9)

The method of claim 9, wherein the insufficient native valve is a native mitral valve.

### Claim 11 (depends on 9)

The method of claim 9, wherein the support structure is made of Nitinol.

### Claim 12 (depends on 9)

The method of claim 9, wherein the fluid-tight membrane extends radially outwardly from the leaflets and has an inner circumferential edge that circumscribes the leaflets and an outer circumferential edge spaced radially outwardly from the inner circumferential edge.

### Claim 13 (depends on 9)

The method of claim 9, wherein after allowing the replacement heart valve to self-expand, the method further comprises compressing the replacement heart valve and then re-positioning the replacement heart valve.

### Claim 14 (depends on 9)

The method of claim 9, wherein the replacement heart valve elutes a drug.

### Claim 15 (depends on 14)

The method of claim 14, wherein the drug prevents formation of calcium on the replacement heart valve.

### Claim 16 (depends on 9)

The method of claim 9, wherein the replacement heart valve is expanded within a previously-implanted heart valve implanted within the native valve such that the replacement heart valve dilates the previously-implanted heart valve.