# US 7,540,865 B2 · Medical device

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- Number: US 7,540,865 B2
- Document ID: US7540865B2
- Status: Granted
- Kind: B2
- Application number: 11/180,187
- Filed: 2005-07-13
- Published: 2005-12-01
- Granted: 2009-06-02
- Earliest claimed: 2003-03-27
- Assignees: Boston Scientific Scimed, Inc.
- Inventors: Stephen Griffin; Elaine Lim; Gregory E. Mirigian
- Web page: https://patentgrep.com/patent/US7540865B2

## CPC

- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/001: {Forming the tip of a catheter, e.g. bevelling process, join or taper}
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/0051: {made from fenestrated or weakened tubing layer}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61L 29/02: Inorganic materials
- A61M 2025/0046: {Coatings for improving slidability}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/0227: Materials having sensing or indicating function, e.g. indicating a pressure increase
- A61M 2205/0266: Shape memory materials
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

## Claims

### Claim 1

A medical device comprising:
an elongated inner member having a lumen formed therein, an outer surface, and a distal end; and
an elongated tubular reinforcing member having a distal end, an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;
wherein the distal end of the inner member is disposed distally of the distal end of the reinforcing member;
wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member;
wherein the space is substantially free of any other structures of the device; and
a coil disposed about a distal portion of the inner member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the tubular reinforcing member is coupled to the inner member at a plurality of discrete coupling points.

### Claim 3 (depends on 1)

The medical device of claim 1, wherein the tubular reinforcing member has a proximal end and a length defined between the proximal end and the distal end, wherein the space extends along at least 50% of the length.

### Claim 4 (depends on 3)

The medical device of claim 3, wherein the space extends along at least 75% of the length.

### Claim 5 (depends on 3)

The medical device of claim 3, wherein the space extends along at least 90% of the length.

### Claim 6 (depends on 3)

The medical device of claim 3, wherein the space extends along at least 95% of the length.

### Claim 7 (depends on 1)

The medical device of claim 1, wherein the space is an annular space.

### Claim 8 (depends on 1)

The medical device of claim 1, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.

### Claim 9

A medical device comprising:
an elongated inner member having a lumen formed therein, an outer surface, and a distal end;
an elongated tubular reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;
wherein the reinforcing member has a distal end and wherein the distal end of the inner member is disposed distally of the distal end of the reinforcing member;
wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member;
wherein the space is substantially free of any other structures of the device;
further comprising a coil disposed about a distal portion of the inner member; and
wherein at least a portion of the coil is disposed between the outer surface of the inner member and the inner surface of the tubular reinforcing member.

### Claim 10

A medical device comprising:
an elongated multi-layer inner tubular member having a proximal end, a distal end, and a lumen extending therethrough; and
an elongated tubular reinforcing member disposed about at least a portion of the inner tubular member, the reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;
wherein the reinforcing member has a distal end and wherein the distal end of the multi-layer inner tubular member is disposed distally of the distal end of the reinforcing member;
wherein the tubular reinforcing member is disposed about and spaced away from at least a portion of the inner tubular member such that a space is defined between the outer surface of the inner tubular member and the inner surface of the tubular reinforcing member;
wherein the space is substantially free of any other structures of the device; and
a coil disposed about the inner tubular member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein the multi-layer inner tubular member comprises a first layer and a second layer.

### Claim 12 (depends on 11)

The medical device of claim 11, wherein the multi-layer inner tubular member further comprises a third layer.

### Claim 13 (depends on 10)

The medical device of claim 10, wherein the distal end of the multi-layer inner tubular member includes a tip structure.

### Claim 14 (depends on 10)

The medical device of claim 10, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.

### Claim 15 (depends on 10)

The medical device of claim 10, wherein the tubular reinforcing member is coupled to the multi-layer inner tubular member at a plurality of discrete coupling points.

### Claim 16 (depends on 10)

The medical device of claim 10, wherein the plurality of apertures are unobstructed.

### Claim 17 (depends on 10)

The medical device of claim 10, wherein the plurality of apertures are in fluid communication with the space defined between the outer surface of the multi-layer inner tubular member and the inner surface of the tubular reinforcing member.

### Claim 18 (depends on 10)

The medical device of claim 10, wherein the tubular reinforcing member comprises a metallic material.

### Claim 19 (depends on 10)

The medical device of claim 10, wherein the tubular reinforcing member comprises a polymeric material.

### Claim 20

A method of manufacturing an elongate shaft of a medical device, the method comprising:
providing a first elongated member having a lumen formed therein, a distal end, an outer surface;
providing an elongated tubular reinforcing member having an inner surface, an outer surface and a wall therebetween, the wall defining a plurality of apertures;
disposing the elongated tubular reinforcing member about and spaced away from at least a portion of the first elongated member such that a space is defined between the outer surface of the inner member and the inner surface of the tubular reinforcing member, wherein the space is substantially free of any other structures of the device, wherein the reinforcing member has a distal end and wherein the distal end of the first elongated member is disposed distally of the distal end of the reinforcing member; and
disposing a coil about the first elongated member, wherein the coil is disposed distal of the distal end of the tubular reinforcing member.

### Claim 21 (depends on 20)

The method of claim 20, wherein the first elongated member is a multi-layer tubular member.

### Claim 22 (depends on 20)

The method of claim 20, further comprising coupling the tubular reinforcing member to the first elongated member at a plurality of discrete coupling points.

### Claim 23 (depends on 20)

The method of claim 20, wherein the tubular reinforcing member has a proximal end and a length defined between the proximal end and the distal end, wherein the space extends along at least 50% of the length.

### Claim 24 (depends on 23)

The method of claim 23, wherein the space extends along at least 75% of the length.

### Claim 25 (depends on 23)

The method of claim 23, wherein the space extends along at least 90% of the length.

### Claim 26 (depends on 23)

The method of claim 23, wherein the space extends along at least 95% of the length.

### Claim 27 (depends on 20)

The method of claim 20, wherein the tubular reinforcing member is a monolithic structure comprising a plurality of spines or beams.
