# US 8,784,714 B2 · Steroid eluting collar undermold

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- Number: US 8,784,714 B2
- Document ID: US8784714B2
- Status: Granted
- Kind: B2
- Application number: 13/760,326
- Filed: 2013-02-06
- Published: 2013-10-03
- Granted: 2014-07-22
- Earliest claimed: 2012-03-30
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Benn Horrisberger; Joel T. Eggert; Kimberly A. Morris
- Web page: https://patentgrep.com/patent/US8784714B2

## CPC

- B29C 45/14549: {Coating rod-like, wire-like or belt-like articles (B29C45/14426 takes precedence)}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0568: {with drug delivery}
- B29C 69/02: of moulding techniques only
- B29C 65/02: by heating, with or without pressure
- B29C 66/1222: {comprising at least a lapped joint-segment}
- B29C 66/1224: {comprising at least a butt joint-segment}
- B29C 66/53241: {said articles being tubular and said substantially annular single elements being of finite length relative to the infinite length of said tubular articles (making T-shaped pieces by joining tubular articles B29C66/52241)}
- B29C 66/71: {characterised by the composition of the plastics material of the parts to be joined (welding bar compositions B29C65/125)}
- B29C 66/91411: {of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account}
- B29C 66/91421: {of the joining tools}
- B29C 66/91431: {the temperature being kept constant over time}
- B29C 66/919: {characterised by specific temperature, heat or thermal flux values or ranges (specific electrical resistance values B29C66/81262)}
- B29C 66/91935: {lower than said fusion temperature}
- B29C 66/91945: {lower than said glass transition temperature}
- B29C 2045/1477: {Removable inserts, e.g. the insert being peeled off after moulding}
- B29K 2071/00: Use of polyethers {, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof}, as moulding material
- B29K 2083/00: Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
- B29L 2023/007: {Medical tubes other than catheters (catheters B29L2031/7542)}
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

Methods of manufacturing implantable medical devices with one or more undermolded features are disclosed. An example method includes injection molding an annular-shaped member onto an inner surface of a sacrificial mold insert, and then undermolding an elongate medical device body directly to the member. The member is directly coupled to the device body without the use of adhesives or bonding agents, thus eliminating the presence of gaps or surface irregularities that can affect device performance.

## Claims

### Claim 1

A method of manufacturing an implantable medical device, comprising:
inserting a mold insert into a molding tool and molding a member onto an interior surface within an interior cavity of the mold insert, the mold insert comprising a disk having a first side, a second side opposite the first side, and a peripheral edge, the molding tool comprising plates that engage the first and second sides of the disk to secure the mold insert during the molding;
inserting an elongate medical device body into an interior lumen of the member while the member remains molded onto the interior surface of the mold insert;
undermolding the elongate medical device body directly to the member to cause material defining the interior lumen of the member to thermally bond to material of the elongate medical device body while the member remains within the interior cavity the mold insert; and
removing the mold insert from the member after the undermolding step.

### Claim 2 (depends on 1)

The method of claim 1, wherein molding a member onto an interior surface of the mold insert comprises:
inserting an elongate rod into the interior cavity of the mold insert; and
injection molding an annular-shaped ring onto the interior surface of the mold insert.

### Claim 3 (depends on 1)

The method of claim 1, wherein the disk comprises a sacrificial disk.

### Claim 4 (depends on 1)

The method of claim 1, wherein the at least one plate comprises a pair of plates that respectively engage the first side and the second side of the disk to secure the mold insert during the molding.

### Claim 5 (depends on 1)

The method of claim 1, wherein undermolding the elongate medical device body directly to the member comprises molding the body onto an interior surface of the member.

### Claim 6 (depends on 1)

The method of claim 1, wherein the disk comprises at least one notch projecting inwardly from the peripheral edge, the at least one notch aligning the mold insert within the molding tool.

### Claim 7 (depends on 1)

The method of claim 1, wherein removing the mold insert from the member comprises cutting the mold insert away from the member.

### Claim 8 (depends on 1)

The method of claim 1, wherein the medical device is an implantable medical electrical lead, and wherein the elongate medical device body is a lead body.

### Claim 9 (depends on 1)

The method of claim 1, wherein the member comprises a drug-eluting collar.

### Claim 10

A method of manufacturing an implantable medical electrical lead, comprising:
inserting a mold insert into a molding tool and molding a collar onto an interior surface within an interior cavity of the mold insert, wherein the mold insert comprises a disk and the molding tool engages opposite sides of the disk to secure the disk within the molding tool during the molding;
inserting an elongate lead body into an interior lumen of the collar while the collar remains molded onto the interior surface of the mold insert;
undermolding the lead body directly to the collar to cause material defining the interior lumen of the collar to thermally bond to material defining an exterior of the lead body while the collar remains within the interior cavity the mold insert; and
removing the mold insert from the collar after the undermolding step.

### Claim 11 (depends on 10)

The method of claim 10, wherein molding a collar onto an interior surface of the mold insert comprises:
inserting an elongate rod into the interior cavity of the mold insert; and
injection molding an annular-shaped collar onto the interior surface of the mold insert.

### Claim 12 (depends on 10)

The method of claim 10, wherein the mold insert comprises a sacrificial disk.

### Claim 13 (depends on 12)

The method of claim 12, wherein the molding tool comprises a pair of plates that respectively engage opposite sides of the disk to secure the mold insert during the molding.

### Claim 14 (depends on 10)

The method of claim 10, wherein undermolding the lead body directly to the collar comprises injection molding the lead body onto an interior diameter surface of the collar.

### Claim 15 (depends on 10)

The method of claim 10, wherein undermolding the lead body directly to the collar comprises molding the lead body onto an interior surface of the collar.

### Claim 16 (depends on 10)

The method of claim 10, wherein removing the mold insert from the collar comprises cutting the mold insert away from the collar.

### Claim 17

A method of manufacturing an implantable medical electrical lead, comprising:
inserting a mold insert into a molding tool, the molding tool comprising a pair of plates;
bringing the pair of plates together to clamp the mold insert in the molding tool;
inserting an elongate rod into an interior cavity of the mold insert;
injection molding a polymeric collar, the collar molded such that an exterior surface of the elongate rod forms an interior lumen of the collar and an interior surface of the interior cavity of the mold insert forms an exterior surface of the collar;
removing the elongate rod while the collar remains within the interior cavity of the mold insert;
inserting an elongate polymeric lead body into the interior lumen of the collar while the collar remains within the interior cavity of the mold insert;
undermolding the lead body directly to the collar to cause polymeric material defining the interior lumen of the collar to thermally bond to polymeric material of the lead body while the collar remains within the interior cavity the mold insert; and
removing the collar from within the interior cavity of the mold insert after the undermolding step.

### Claim 18 (depends on 17)

The method of claim 17, wherein the mold insert is metallic.

### Claim 19 (depends on 17)

The method of claim 17, wherein the mold insert is formed from a polymeric material having a higher melting temperature than the polymeric material that defines the collar.

### Claim 20 (depends on 17)

The method of claim 17, wherein the mold insert is a disk.
