# US 2021/0330458 A1 · Auxiliary balloon structure for transcatheter aortic valve replacement (tavr)

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- Number: US 2021/0330458 A1
- Document ID: US20210330458A1
- Status: Published application
- Kind: A1
- Application number: 16/885,285
- Filed: 2020-05-28
- Published: 2021-10-28
- Earliest claimed: 2020-04-27
- Assignees: Fuwai Hospital of Chinese Academy of Medical Sciences
- Applicants: Fuwai Hospital Chinese Academy of Medical Sciences
- Inventors: Yongjian WU; Qingrong LIU
- Web page: https://patentgrep.com/patent/US20210330458A1

## CPC

- A61F 2/2433: {using balloon catheter}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61F 2002/9583: {Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve}
- A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped
- A61F 2230/0067: conical
- A61F 2230/0069: cylindrical
- A61F 2250/0029: differing in bending or flexure capacity
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 25/104: {used for angioplasty}
- A61M 2025/0046: {Coatings for improving slidability}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention discloses an auxiliary balloon structure for transcatheter aortic valve replacement (TAVR), which comprises a balloon head and a balloon body. When unexpanded, the balloon body has two conical ends and a cylindrical middle part. The conical ends are defined as a front and a rear conical part. The cylindrical middle part is provided with a mastoid structure. The front and rear conical parts are made of a semi-compliant material, while the cylindrical middle part is made of a non-compliant material.

## Claims

### Claim 1

An auxiliary balloon structure for transcatheter aortic valve replacement (TAVR), comprising a balloon head and a balloon body, wherein:
when unexpanded, the balloon body has two conical ends and a cylindrical middle part;
the conical ends are defined as a front and a rear conical part;
the cylindrical middle part is provided with a mastoid structure;
the front and rear conical parts are made of a semi-compliant material; and
the cylindrical middle part is made of a non-compliant material.

### Claim 2 (depends on 1)

The balloon structure in claim 1, further comprising a catheter, wherein:
the balloon body is in sealed connection with one end of the catheter by thermal welding or laser welding; and
on the catheter, the balloon head is located on the outer side of the balloon body and sealed with the head of one end of the catheter.

### Claim 3 (depends on 1)

The balloon structure in claim 1, wherein:
the front and rear conical parts are made of a polyamide polymer material; and
the cylindrical middle part is made of an improved polyamide polymer composite material.

### Claim 4 (depends on 1)

The balloon structure in claim 1, wherein the cylindrical middle part has a length of 40 mm.

### Claim 5 (depends on 1)

The balloon structure in claim 1, wherein:
the mastoid structure comprises multiple mastoid rings;
the same one mastoid ring comprises three mastoid groups; and
the three mastoid groups are distributed at 120 degrees relative to each other circumferentially on the section of the cylindrical middle part in the position of a given mastoid ring.

### Claim 6 (depends on 5)

The balloon structure in claim 5, wherein:
each mastoid group includes 6-10 mastoids arranged in a single row;
all the mastoids of each mastoid ring are located on the same section of the cylindrical middle part;
the interval between the adjacent two mastoids of each mastoid group is 2 mm; and
the heights of the mastoids are 1.0 mm and/or 1.5 mm.

### Claim 7 (depends on 5)

The balloon structure in claim 5, wherein:
a mastoid array is arranged in the area between the adjacent two mastoid rings;
the mastoid array comprises multiple array units; and
each array unit comprises at least four mastoids including a central mastoid and at least three surrounding mastoids distributed around the central mastoid.

### Claim 8 (depends on 7)

The balloon structure in claim 7, wherein:
the height of the central mastoid is 1.5 mm: and
the heights of the surrounding mastoids are 1.0 mm.

### Claim 9 (depends on 2)

The balloon structure in claim 2, wherein a hydrophilic coating layer is applied outside the catheter.

### Claim 10 (depends on 2)

The balloon structure in claim 2, wherein:
the other end of the catheter is provided with a first connector and a second connector;
the first connector is used for connecting with a gas phase pressure source or liquid phase pressure source; and
the second connector is used for insertion of a guide wire.

### Claim 11 (depends on 4)

The balloon structure in claim 4, wherein the cylindrical middle part has an external diameter of 16 mm.

### Claim 12 (depends on 4)

The balloon structure in claim 4, wherein the cylindrical middle part has an external diameter of 18 mm.

### Claim 13 (depends on 4)

The balloon structure in claim 4, wherein the cylindrical middle part has an external diameter of 20 mm.

### Claim 14 (depends on 4)

The balloon structure in claim 4, wherein the cylindrical middle part has an external diameter of 24 mm.

### Claim 15 (depends on 4)

The balloon structure in claim 4, wherein the cylindrical middle part has an external diameter of 26 mm.
