# US 6,689,103 B1 · Injection array apparatus and method

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- Number: US 6,689,103 B1
- Document ID: US6689103B1
- Status: Granted
- Kind: B1
- Application number: 09/457,453
- Filed: 1999-12-08
- Granted: 2004-02-10
- Earliest claimed: 1999-05-07
- Assignees: SciMed Life System, Inc.
- Inventors: Maria Palasis
- Web page: https://patentgrep.com/patent/US6689103B1

## CPC

- A61B 17/3207: Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)}
- A61M 25/0084: {being one or more injection needles}
- A61B 18/1477: {Needle-like probes}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/22077: {with a part piercing the tissue (A61B2017/22044 takes precedence)}
- A61B 2017/22082: {after introduction of a substance}
- A61B 2018/00291: {using suction}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61B 2018/1425: {Needle}
- A61B 2218/002: Irrigation
- A61M 37/0015: {by using microneedles}
- A61M 2025/0085: {Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- A61M 2025/0093: {wherein at least one needle is a microneedle}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

A fluid delivery system for delivering and injecting fluid into heart tissue, or other organ tissues. The fluid delivery system includes an injection catheter disposed in an elongate sheath. A nozzle, including an injection array, is disposed adjacent the distal end of the injection catheter. In a first (microneedle) embodiment, the injection array comprises a plurality of microneedles each defining an injection lumen in fluid communication with the lumen of the catheter. In a second (needle-less) embodiment, the injection array comprises a plurality of injection lumens in fluid communication with the lumen of the catheter. Fluid is transferred to the injection lumen array from a fluid source through the lumen in the catheter. The injection lumen array distributes the fluid at the injection site over a greater area than would otherwise be achieved with a single needle injection. Thus, the injection lumen array improves fluid retention in the tissue at the injection site.

## Claims

### Claim 1

A catheter for delivering a therapeutic to target tissue within the body of a patient, comprising:
a flexible elongate tubular member having a proximal end, a distal end, and a lumen extending therethrough; and
a nozzle member disposed proximate the distal end of the tubular member, the nozzle member including an injection array at a distal end of the nozzle member,
the injection array comprising a plurality of injection orifices, each injection orifice fluidly coupled to the lumen of the elongate tubular member,
the orientation of the injection orifices being fixed relative to each other.

### Claim 2 (depends on 1)

The catheter of claim 1, further comprising:
an outer sheath having a proximal end, a distal end, and a lumen extending therethrough
wherein the tubular member is slidingly disposed in the lumen of the sheath.

### Claim 3 (depends on 2)

The catheter of claim 2, further comprising:
an anchor disposed at an end of the sheath.

### Claim 4 (depends on 3)

The catheter of claim 3, wherein the anchor comprises a vacuum orifice.

### Claim 5 (depends on 4)

The catheter of claim 4, wherein the vacuum orifice is in fluid communication with a vacuum source via the lumen of the elongate tubular member.

### Claim 6 (depends on 2)

The catheter of claim 2, wherein the sheath further comprises:
a hood disposed at the distal end of the sheath.

### Claim 7 (depends on 6)

The catheter of claim 6, wherein the distal end of the elongate tubular member may be retracted within the hood.

### Claim 8 (depends on 2)

The catheter of claim 2, further comprising:
a fluid source in fluid communication with the lumen of the sheath.

### Claim 9 (depends on 2)

The catheter of claim 2, wherein the sheath further comprises:
a support member disposed around the elongate tubular member.

### Claim 10 (depends on 2)

The catheter of claim 2, wherein the sheath is made of polyether block amide.

### Claim 11 (depends on 1)

The catheter of claim 1, wherein each injection orifice is positioned at an end of a micro-needle, the micro-needle coupled to the lumen.

### Claim 12 (depends on 11)

The catheter of claim 11, wherein the micro-needle is slidably placed in the nozzle member.

### Claim 13 (depends on 11)

The catheter of claim 11, wherein the micro-needle has a penetrating length of approximately 0.5 to 5 mm.

### Claim 14 (depends on 1)

The catheter of claim 1, wherein the orifices are an open end of a plurality of injection lumens defined by the nozzle member.

### Claim 15 (depends on 14)

The catheter of claim 14, wherein the orifices have a diameter of approximately 0.00005 to 0.005 inches.

### Claim 16 (depends on 1)

The catheter of claim 1, wherein the target tissue is the heart.

### Claim 17 (depends on 1)

The catheter of claim 1, wherein the elongate tubular member is made of polytetrafluoroethylene.

### Claim 18 (depends on 1)

The catheter of claim 1, wherein the elongate tubular member is made of material having a low-friction surface.

### Claim 19 (depends on 1)

The catheter of claim 1, further comprising an anchor disposed proximate the distal end of the tubular member.
