# US 8,147,452 B2 · Method of joining a hub to an introducer sheath tube

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- Number: US 8,147,452 B2
- Document ID: US8147452B2
- Status: Granted
- Kind: B2
- Application number: 12/360,614
- Filed: 2009-01-27
- Published: 2009-07-30
- Granted: 2012-04-03
- Earliest claimed: 2008-01-29
- Assignees: Medical Components, Inc.
- Inventors: Mahase Nardeo; Trevor Spence
- Web page: https://patentgrep.com/patent/US8147452B2

## CPC

- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0014: {Connecting a tube to a hub}
- A61M 25/0668: {splittable, tear apart}
- B29C 66/712: {the composition of one of the parts to be joined being different from the composition of the other part}
- A61M 2039/1061: {Break-apart tubing connectors or couplings}
- B29C 65/02: by heating, with or without pressure
- B29C 65/56: using mechanical means {or mechanical connections, e.g. form-fits}
- B29C 65/76: Making non-permanent or releasable joints
- B29C 66/5344: {said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends (B29C66/5346 takes precedence)}
- B29C 66/71: {characterised by the composition of the plastics material of the parts to be joined (welding bar compositions B29C65/125)}
- B29C 2793/0036: Slitting
- B29K 2023/06: {PE, i.e. polyethylene}
- B29K 2027/18: PTFE, i.e. polytetrafluoroethylene {, e.g. ePTFE, i.e. expanded polytetrafluoroethylene}
- B29L 2023/007: {Medical tubes other than catheters (catheters B29L2031/7542)}
- Y10T 29/49826: Assembling or joining
- 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)}
- 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)
- 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
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A tearaway introducer sheath assembly (10) for use in implantation of a catheter into a patient, having an elongated polytetrafluoroethylene sheath tube (12) and a proximal polyethylene hub component (16). The hub comprises two halves (22) insert molded about the sheath tube proximal end and joined to each other by frangible webs (28) enabling manual splitting. At least one pair of opposed holes (42) is formed through the tube proximal end portion 44, and a polyethylene liner (46) is inserted into the tube's proximal end portion. The polyethylene flows into the at least one pair of holes (42) to fuse with the liner, establishing a pair of physical joints (50′) integrally joining the liner (46) to a respective hub half (22). Upon manual splitting of the hub halves, the sheath tube easily splits along its length as a result of a property of the polytetrafluoroethylene material.

## Claims

### Claim 1

A method of forming an introducer sheath assembly, comprising the steps of: providing an elongated sheath tube having a proximal end and having at least one pair of opposed apertures therethrough adjacent the proximal end; and affixing a hub of hub material to the sheath tube proximal end by using the hub material to integrally join the hub to an interior lining portion within the sheath tube proximal end through the at least one pair of opposed apertures by use of an insert molding process, wherein at least the hub is formed to have an opposed pair of frangible webs enabling manual splitting thereof into respective halves to remove the introducer sheath assembly from around a catheter inserted therethrough during catheter implantation into a patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sheath tube is formed of a first material, and the hub is formed of a second, dissimilar material.

### Claim 3 (depends on 2)

The method of claim 2, wherein the interior lining portion is a liner preformed of a material different from the first material but at least compatible with the second material.

### Claim 4 (depends on 2)

The method of claim 2, wherein the sheath tube is formed of polytetrafluoroethylene.

### Claim 5 (depends on 2)

The method of claim 2, wherein the interior lining portion is formed of the second material.

### Claim 6 (depends on 5)

The method of claim 5, wherein the interior lining portion is formed simultaneously with the hub.

### Claim 7 (depends on 6)

The method of claim 6, wherein the interior lining portion extends circumferentially around the interior surface of the sheath tube proximal end.

### Claim 8 (depends on 2)

The method of claim 2, wherein the interior lining portion is a liner preformed of the second material.

### Claim 9 (depends on 2)

The method of claim 2, wherein the first material is polytetrafluoroethylene and the second material is polyethylene.

### Claim 10 (depends on 1)

The method of claim 1, wherein the interior lining portion is a liner pre-formed and includes longitudinal score lines along opposed sides thereof, or notches into the proximal end thereof, or both, for alignment with the frangible webs of the hub, to facilitate manual splitting thereof during splitting of the assembly.

### Claim 11 (depends on 1)

The method of claim 1, wherein the sheath tube includes defined thereinto a pair of notches into the proximal end thereof, or slits extending distally partially therealong from the proximal end, or both, to initiate splitting for eventual sheath removal.

### Claim 12 (depends on 1)

The method of claim 1, wherein the sheath tube is formed of polytetrafluoroethylene.

### Claim 13 (depends on 1)

The method of claim 1, wherein the method includes, prior to the insert molding step, the step of enlarging the sheath tube proximal end radially outwardly.

### Claim 14 (depends on 13)

The method of claim 13, wherein, after the enlarging step, the method includes the step of inserting a preformed interior lining portion at least partially into the sheath tube proximal end prior to the insert molding step.

### Claim 15 (depends on 13)

The method of claim 13, wherein the insert molding step includes insert molding the interior lining portion simultaneously with the hub.

### Claim 16 (depends on 15)

The method of claim 15, wherein the interior lining portion extends circumferentially around the interior surface of the sheath tube proximal end.

### Claim 17

A method of forming an introducer sheath assembly, comprising the steps of providing an elongated sheath tube having a proximal end; and affixing a hub of hub material to the sheath tube proximal end by using the hub material to integrally join the hub, by use of an insert molding process, to an interior lining portion that is within and extends at least just proximally of the sheath tube proximal end further providing the step of forming apertures on opposed sides of the proximal sheath tube end through which joints form between the hub and the interior lining portion further integrally joining the hub to the interior lining portion, and wherein the method includes, prior to the insert molding step, the step of enlarging the sheath tube proximal end radially outwardly.

### Claim 18 (depends on 17)

The method of claim 17, wherein the interior lining portion is preformed.

### Claim 19 (depends on 17)

The method of claim 17, wherein, after the enlarging step, the method includes the step of inserting a preformed interior lining portion at least partially into the sheath tube proximal end prior to the insert molding step.

### Claim 20 (depends on 17)

The method of claim 17, wherein the insert molding step includes insert molding the interior lining portion simultaneously with the hub.