# US 10,765,544 B2 · Push and pull medical device delivery system

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- Number: US 10,765,544 B2
- Document ID: US10765544B2
- Status: Granted
- Kind: B2
- Application number: 14/701,508
- Filed: 2015-04-30
- Published: 2015-11-05
- Granted: 2020-09-08
- Earliest claimed: 2014-05-02
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Edward H. Cully; Ryan D. Kariniemi; David M. Williams
- Web page: https://patentgrep.com/patent/US10765544B2

## CPC

- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/92: Stents in the form of a rolled-up sheet expanding after insertion into the vessel {, e.g. with a spiral shape in cross-section}
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2/97: the outer sleeve being splittable
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61F 2/07: Stent-grafts
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2002/823: {Stents, different from stent-grafts, adapted to cover an aneurysm}
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0019: differing in hardness, e.g. Vickers, Shore, Brinell
- A61F 2250/0029: differing in bending or flexure capacity
- 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 system for delivery of a medical device includes a delivery member and a medical device, which is mounted to the delivery member and releasably retained in a delivery configuration for endoluminal delivery of the medical device toward a treatment site in a human vessel. The delivery member includes an elongated first portion configured to extend outside of the body from a first percutaneous access site and an elongated second portion configured to extend outside the body from a second percutaneous access site to allow positioning of the medical device at the treatment site by manipulation of the first portion and second portion from outside of the body.

## Claims

### Claim 1

A system for delivery of a medical device, said system comprising:
a first member including an elongated first portion and a guidewire lumen, wherein the first member is configured to extend outside of a body from a first percutaneous access site;
a second member separate from the first member and configured to be inserted into a body of a patient separately from the first member, the second member including an elongated second portion, wherein the second member is configured to extend outside the body from a second percutaneous access site, the second portion defining a a bore and the second percutaneous access site being different from the first percutaneous access site;
a constraining member; and
a medical device disposed about an exterior of the first portion of the first member and releasably retained in a delivery configuration about the first portion by the constraining member for endoluminal delivery of the medical device toward a treatment site in a human vessel,
wherein the first and second members allow for positioning of the medical device at the treatment site by manipulation of the first portion and the second portion from outside of the body, and wherein the second portion is configured to receive the medical device and the constraining member within the bore of the second portion while the medical device is disposed about the first portion of the first member in the delivery configuration such that the second portion is releasably coupleable to the medical device, wherein an end of one of the first and second portions is configured to be received within an end of the other first and second end portions.

### Claim 2 (depends on 1)

The system as set forth in claim 1, wherein the first portion of the first member and the second portion of the second member are separable so as to be axially displaceable relative to each other.

### Claim 3 (depends on 2)

The system as set forth in claim 2, wherein the bore is defined in the second portion of the second member, wherein the second portion of the second member includes a generally annular inner wall defining the bore for receiving at least a first section of the medical device therein.

### Claim 4 (depends on 3)

The system as set forth in claim 3, wherein the inner wall engages and maintains at least the first section of the medical device in the delivery configuration.

### Claim 5 (depends on 4)

The system as set forth in claim 4, wherein at least the first section of the medical device can be deployed by axial displacement of the second portion of the second member relative to the medical device.

### Claim 6 (depends on 5)

The system as set forth in claim 5, wherein the medical device is an expandable stent graft.

### Claim 7 (depends on 6)

The system as set forth in claim 6, wherein the medical device is self-expanding.

### Claim 8 (depends on 7)

The system as set forth in claim 7, wherein a second section of the medical device is releasably retained in the delivery configuration by the constraining member, wherein the constraining member is a flexible constraining sleeve.

### Claim 9 (depends on 8)

The system as set forth in claim 8, wherein the second section of the medical device is mounted to the first portion of the first member.

### Claim 10 (depends on 3)

The system as set forth in claim 3, wherein the first portion of the first member and the second portion of the second member are releasably coupled to each other.

### Claim 11 (depends on 10)

The system as set forth in claim 10, wherein an engagement between the medical device and the inner wall of the second portion of the second member defines the releasable coupling between the first portion of the first member and the second portion of the second member.

### Claim 12 (depends on 1)

The system as set forth in claim 1, wherein the constraining member is a flexible constraining sleeve.

### Claim 13 (depends on 12)

The system as set forth in claim 12, wherein the first member includes a mounting portion between the first and second portions, the medical device being mounted to the mounting portion.

### Claim 14 (depends on 1)

The system as set forth in claim 1, wherein at least one of the first portion of the first member and the second portion of the second member have substantially no column strength.

### Claim 15 (depends on 14)

The delivery system as set forth in claim 14, wherein a compressive force to a tensile force ratio of the first portion is less than 1/8.

### Claim 16 (depends on 14)

The delivery system as set forth in claim 14, wherein a compressive force ratio of the first portion to the second portion is less than 8/10.

### Claim 17

A delivery system for an implantable prosthesis, said delivery system comprising:
a first elongated delivery member including a first guidewire limen;
a constraining member;
a second elongated delivery member separate from the first elongated delivery member, and configured to be inserted into a body of a patient separately from the first elongated delivery member; and
an expandable device coupled to the first and second elongated delivery members and constrained by the constraining member, wherein a partial deployment of a portion of the expandable device within a bore of the second delivery member and toward engagement with the second delivery member while the expandable device is disposed about an exterior of the first delivery member defines a releasable coupling between the expandable device and the second delivery member, wherein the partial deployment includes releasing the constraining member from the portion of the expandable device, wherein an end of one of the first and second elongated delivery members is configured to be received within an end of the other first and second elongated delivery members.

### Claim 18 (depends on 17)

The delivery system as set forth in claim 17, wherein the second delivery member includes an annular surface defining the bore.

### Claim 19 (depends on 18)

The delivery system of claim 18, wherein the expandable device is partially deployed and engaged with the annular surface thereby defining the releasable coupling.

### Claim 20 (depends on 17)

The system of claim 17, wherein each of the elongated first portion and the elongated second portion is at least 3× the length of the expandable device.

### Claim 21

A system for delivery of a medical device, said system comprising:
a catheter having a mounting portion; and
a medical device disposed about an exterior of the mounting portion and constrained by a constraining member,
wherein the catheter further includes an elongated first portion having a first guidewire lumen and configured to exit a body through a first insertion site and an elongated second portion configured to exit the body through a second insertion site that is different from the first insertion site while the medical device is positioned at the treatment site, the second portion being configured to receive the medical device and the constraining member within a bore of the second portion while the medical device is disposed about the mounting portion, and
wherein at least one of the first and second portions has substantially no column strength, wherein an end of one of the first and second portions is configured to be received within an end of the other first and second end portions.

### Claim 22

A system for delivery of a medical device, said system comprising:
a first elongated delivery member having a first guidewire lumen and configured to exit a body through a first insertion site;
a second elongated delivery member configured to exit the body through a second insertion site that is different from the first insertion site, the second elongated delivery member being separate from the first elongated delivery member and configured to be inserted into a body of a patient separately from the first elongated delivery member; and
a medical device mounted between the first elongated delivery member and the second elongated delivery member such that the medical device is disposed about an exterior of the first elongated delivery member and constrained by a constraining member such that the medical device, the first elongated delivery member, and the constraining member are disposed within a bore of the second elongated delivery member,
wherein the first and second elongated delivery members extending outside the body through the respective first and second insertion sites are configured to be manipulated to position the medical device, and
wherein at least one of the first elongated delivery member and the second elongated delivery member is sufficiently flexible in that it is not capable of being advanced through the body by pushing, wherein an end of one of the first and second elongated delivery members is configured to be received within an end of the other first and second elongated delivery members.

### Claim 23 (depends on 22)

The system as set forth in claim 22, wherein both the first elongated delivery member and the second elongated delivery member are sufficiently flexible in that they are not capable of being advanced through the body by pushing.

### Claim 24 (depends on 22)

The system of claim 22, wherein each of the first elongated delivery member and the second elongated delivery member is at least 3× the length of the medical device; and
wherein at least one of the first elongated delivery member and the second elongated delivery member is sufficiently flexible in that it is not capable of being advanced through the body by pushing.

### Claim 25 (depends on 24)

The system as set forth in claim 24, wherein both the first elongated delivery member and the second elongated delivery member are sufficiently flexible that they are not capable of being advanced through the body by pushing.

### Claim 26

A delivery system for an implantable prosthesis, said delivery system comprising:
an expandable implantable prosthesis;
a first catheter having a first guidewire lumen, a first catheter outer wall, and a first catheter inner wall, the first catheter being configured to extend outside of a body from a first percutaneous access site; and
a second catheter having a second catheter outer wall and a second catheter inner wall, the second catheter being configured to extend outside of the body from a second percutaneous access site that is different from the first percutaneous access site, the second catheter being separate from the first catheter and configured to be inserted into a body of a patient separately from the first catheter,
wherein the first catheter inner wall extends along the second catheter outer wall such that the first and second catheters partially overlap, and
wherein the expandable implantable prosthesis is constrained at least partially by the first catheter inner wall and constrained at least partially along the second catheter outer wall by a releasable constraining member, wherein an end of one of the first and second catheters is configured to be received within an end of the other first and second catheters.

### Claim 27 (depends on 26)

The delivery system as set forth in claim 26, wherein the constraining member releasably constraining the implantable prosthesis along the second catheter outer wall is a sheath.

### Claim 28 (depends on 27)

The delivery system as set forth in claim 27, wherein the second catheter outer wall and the second catheter inner wall are substantially parallel.

### Claim 29 (depends on 28)

The delivery system as set forth in claim 28, wherein the first catheter inner wall is textured.

### Claim 30 (depends on 29)

The delivery system as set forth in claim 29, wherein the constraining member is an ePTFE tubular structure.

### Claim 31

A system for delivery of a medical device, said system comprising:
a delivery member including an elongated first portion having a first guidewire lumen and configured to extend outside of a body from a first percutaneous access site, and an elongated second portion configured to extend outside the body from a second percutaneous access site that is different from the first percutaneous access site, the elongated second portion being separate from the elongated first portion and configured to be inserted into a body of a patient separately from the elongated first portion; and
a medical device releasably coupled to the delivery member and releasably retained in a delivery configuration by a constraining member for endoluminal delivery of the medical device toward a treatment site in a human vessel,
wherein the delivery member allows for positioning of the medical device at the treatment site by manipulation of the first portion and the second portion from outside of the body, and wherein the second portion is releasably coupleable with the first portion such that the first and second portions are coaxially aligned with the medical device, the constraining member, wherein an end of one of the first and second portions is configured to be received within an end of the other first and second end portions.
