# US 11,759,550 B2 · Medical devices for fluid delivery and methods of use and manufacture

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- Number: US 11,759,550 B2
- Document ID: US11759550B2
- Status: Granted
- Kind: B2
- Application number: 17/937,287
- Filed: 2022-09-30
- Published: 2023-07-06
- Granted: 2023-09-19
- Earliest claimed: 2021-04-30
- Assignees: Encompass Vascular, Inc.
- Applicants: Encompass Vascular, Inc.
- Inventors: Jean C. Orth; Zaya Tun; Robert G. Quintos
- Web page: https://patentgrep.com/patent/US11759550B2

## CPC

- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61M 25/0084: {being one or more injection needles}
- A61L 31/022: {Metals or alloys}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 2025/0024: {Expandable catheters or sheaths}
- 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 2025/0093: {wherein at least one needle is a microneedle}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- 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)
- 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)}
- 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

Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The devices may include one or both of one or more spine securing members or one or more needle alignment members.

## Claims

### Claim 1

An intravascular apparatus, comprising:
an inflatable balloon having an inflated cylindrical configuration;
an expandable infusion scaffold comprising at least first and second expandable infusion spines, each of the at least first and second infusion spines defining a lumen therein and each including two or more spaced apart radial openings therethrough,
wherein the expandable infusion scaffold is adapted and positioned about the inflatable balloon such that inflation of the balloon causes the scaffold to radially expand, the at least first and second infusion spines extending about an outer cylindrical surface of the inflatable balloon when the inflatable balloon is in an inflated state; and
a plurality of movable needles assemblies, each one of the plurality of movable assemblies disposed in one of the at least first and second expandable infusion spines and movable within and relative to the infusion spine, each of the plurality of movable assemblies comprising
a rail that includes a rail lumen, a plurality of needles, and one or more fluid delivery lumens within the rail lumen that are in fluid communication with the plurality of needles,
wherein the plurality of needles are coupled to the rail such that movement of the rail within the corresponding infusion spine moves the plurality of the needles as a group relative to the infusion spine between undeployed configurations in which each of the plurality of needles are housed within the infusion spine and deployed configurations in which each of the plurality of needles extends generally radially out of one of the radial openings in the infusion spine for delivery of an agent into a wall of a target vessel,
wherein each rail includes one or more first alignment members that comprises a rail slot, and the corresponding spine in which the rail is disposed includes one or more second alignment members, the one or more first alignment members that comprises a rail slot sized, positioned, and configured to interface with the one or more second alignment members to maintain circumferential alignment of the corresponding plurality of needles and the plurality of radial openings as the rail is axially moved within the spine and thereby facilitates deployment of the plurality of needles out of the plurality of radial openings.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the rail slot includes a flattened rail surface.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the one or more second alignment members comprise a key member extending radially inward toward the rail slot.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the one or more first alignment members comprises a key member extending radially outward toward the spine.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the corresponding spine further includes a needle deployment guide extending into the spine lumen and positioned and configured to guide the needle out of the corresponding radial opening.

### Claim 6 (depends on 3)

The apparatus of claim 3, wherein the one or more second alignment members comprises a plurality of key members extending radially inward toward the rail slot.

### Claim 7 (depends on 3)

The apparatus of claim 3, wherein the key member is a portion of the spine deformed radially inward relative to an outer surface of the spine.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the key member is axially spaced from one or more spine sections that have one or more cuts formed therein.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein the key member comprises a first section that is monolithic with the spine and a second section that is not monolithic with the spine.

### Claim 10 (depends on 5)

The apparatus of claim 5, wherein the needle deployment guide extends radially inward and proximally relative to the spine outer surface.

### Claim 11 (depends on 5)

The apparatus of claim 5, wherein a portion of the needle deployment guide is disposed at a proximal end of the corresponding spine radial opening, and a second portion of the needle deployment guide extends radially inward and distally.

### Claim 12 (depends on 5)

The apparatus of claim 5, wherein the needle deployment guide comprises a first section that is monolithic with a spine outer surface, and a second section that is not monolithic with the spine outer surface.

### Claim 13 (depends on 5)

The apparatus of claim 5, wherein the needle deployment guide extends radially inward at an angle relative to an outermost surface of the spine.

### Claim 14 (depends on 10)

The apparatus of claim 10, wherein a portion of the needle deployment guide is disposed at a distal end of the corresponding spine radial opening, and a second portion of the needle deployment guide extends radially inward and proximally.
