# US 8,540,694 B2 · Systems and methods for delivering drugs to selected locations within the body

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- Number: US 8,540,694 B2
- Document ID: US8540694B2
- Status: Granted
- Kind: B2
- Application number: 13/338,106
- Filed: 2011-12-27
- Published: 2012-07-05
- Granted: 2013-09-24
- Earliest claimed: 1998-03-25
- Assignees: Medtronic Vascular, Inc.
- Applicants: J. Christopher Flaherty; Joshua Makower; Philip C. Evard; Patrick E. Macaulay; Jason B. Whitt; Robert C. Colloton; K. Angela Macfarlane
- Inventors: J. Christopher Flaherty; Joshua Makower; Philip C. Evard; Patrick E. Macaulay; Jason B. Whitt; Robert C. Colloton; K. Angela Macfarlane
- Web page: https://patentgrep.com/patent/US8540694B2

## CPC

- A61M 25/0084: {being one or more injection needles}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/12022: {Occluding by internal devices, e.g. balloons or releasable wires (plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20)}
- A61B 17/12045: {double occlusion, e.g. during anastomosis}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/3417: {Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00)}
- A61M 5/007: {for contrast media}
- A61M 5/46: having means for controlling depth of insertion
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 17/00491: {Surgical glue applicators}
- A61B 17/0643: {with separate closing member, e.g. for interlocking with staple}
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00)
- A61B 18/1477: {Needle-like probes}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
- A61B 2017/00243: {cardiac}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel}
- A61B 2017/00504: {Tissue welding}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/12127: {Double occlusion, e.g. for creating blood-free anastomosis site}
- A61B 2017/22077: {with a part piercing the tissue (A61B2017/22044 takes precedence)}
- A61B 2017/306: {holding by means of suction}
- A61B 2017/347: {Locking means, e.g. for locking instrument in cannula}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61B 2018/1425: {Needle}
- A61F 2/2493: {Transmyocardial revascularisation [TMR] devices}
- A61F 2002/30079: {magnetic}
- A61F 2210/009: magnetic
- A61M 25/0069: {Tip not integral with tube}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 39/04: having pierceable self-sealing members
- A61M 2025/0037: {characterized by lumina being arranged side-by-side}
- A61M 2025/0076: {Unidirectional valves}
- A61M 2025/0086: {the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter}
- A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip}
- A61M 2025/009: {the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter}
- A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

Systems and methods for delivering drugs or other substances to target locations outside of blood vessel lumens or other body lumens. In some embodiments, a catheter having a penetrator is advanced into the body lumen and the penetrator is then advanced from the catheter toward a target location outside of that body lumen. The substance is then delivered through a the penetrator itself or through a delivery catheter that has been advanced through the penetrator to the target location. In other embodiments, the blood vessel or other body lumen is blocked at spaced-apart first and second locations and a quantity of the substance is introduced into the closed-off body lumen between the blocked first and second locations. The substance then diffuses into or through the wall of the vessel or body conduit to reach the target location.

## Claims

### Claim 1

A method for delivering a therapeutic substance to a target region within a patient's body, said method comprising the steps of:
A) blocking, at spaced-apart first and second locations, a body conduit having a lumen and a wall, said body conduit being located at or near the target region; and
B) causing a quantity of the substance to be contained between the blocked first and second locations, such that the substance will diffuse into or through the wall of the body conduit to reach the target region;
wherein the body conduit is blocked by implanting a first blocker device and a second blocker device at the spaced-apart first and second locations within the body conduit lumen to thereby create a substance reservoir zone within the body conduit lumen between the first and second blocker devices and the substance is then deposited between the first and second blocker devices;
wherein at least one of the blocker devices comprises a recrossable region and wherein the substance is deposited by i) advancing an injector through a recrossable region of a blocker device, ii) using the injector to deposit the substance between the first and second blocker devices and iii) retracting the injector through the recrossable region and removing the injector.

### Claim 2 (depends on 1)

A method according to claim 1 wherein each blocker device comprises an expandable frame and a flexible lumen-blocking membrane attached to the frame.

### Claim 3 (depends on 1)

A method according to claim 1 wherein one of the blocker devices is implanted, the substance is the deposited within the body conduit lumen and then the other blocker device is implanted, thereby capturing the substance between the blocker devices.

### Claim 4 (depends on 1)

A method according to claim 1 wherein the body conduit is a vein.

### Claim 5 (depends on 1)

A method according to claim 1 wherein the target region comprises all or part of the wall of the body conduit.

### Claim 6 (depends on 1)

A method according to claim 1 wherein the target region is located beyond the wall of the body conduit.

### Claim 7 (depends on 6)

A method according to claim 6 wherein the target region is within another body conduit located adjacent to the body conduit in which the substance is deposited.

### Claim 8 (depends on 2)

A method according to claim 2 wherein the expandable frame is formed of material selected from the group consisting of: shape memory alloy, Nitinol, stainless steel, platinum, polymers and plastics.

### Claim 9 (depends on 2)

A method according to claim 2 wherein the expandable frame has a structure selected from the group consisting of: woven wire mesh, criss-cross structures, sinusoidal structures, expandable rings.

### Claim 10 (depends on 1)

A method according to claim 1 wherein the first and second blocker devices are part of a unitary implantable apparatus.

### Claim 11 (depends on 10)

A method according to claim 10 wherein the implantable apparatus comprises a frame and a membrane, said membrane having end panels which extend transversely across the body conduit lumen when the apparatus is implanted to thereby block the body conduit lumen at said first and second spaced apart locations and a permeable peripheral regions through which the substance diffuses into or through the body conduit wall.

### Claim 12 (depends on 1)

A method according to claim 1 wherein the recrossable region comprises a recorssable end panel.

### Claim 13 (depends on 1)

A method according to claim 1 wherein the recrossable region is penetrable by the injector but automatically reseals upon removal of the injector therefrom.