# US 2014/0155861 A1 · Extrusion methods and devices for drug delivery

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- Number: US 2014/0155861 A1
- Document ID: US20140155861A1
- Status: Published application
- Kind: A1
- Application number: 13/962,868
- Filed: 2013-08-08
- Published: 2014-06-05
- Earliest claimed: 2012-08-08
- Assignees: Presage Biosciences, Inc.
- Applicants: Presage Biosciences, Inc.
- Inventors: Edward Gallagher; Alicia Moreno-Gonzelez; Worm Lund, SR.; Worm Lund, JR.; Marc Grenley
- Web page: https://patentgrep.com/patent/US20140155861A1

## CPC

- A61B 17/3403: {Needle locating or guiding means}
- A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves}
- A61M 5/19: having more than one chamber
- A61M 5/3294: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/3298: {Needles arranged in parallel}
- A61M 5/14228: {with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member}
- A61M 5/3291: {Shafts with additional lateral openings}
- A61M 5/427: {Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates}
- A61M 5/46: having means for controlling depth of insertion
- A61M 5/482: {Varying injection pressure, e.g. by varying speed of injection}
- A61M 2005/3114: {Filling or refilling}
- A61M 2202/049: Toxic
- A61M 2209/045: for filling, e.g. for filling reservoirs
- A61M 2209/084: Supporting bases, stands for equipment
- Y10T 428/24322: Composite web or sheet
- 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)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Disclosed herein are devices and methods for delivering agents to a solid tissue.

## Claims

### Claim at position 1

-135. (canceled)

### Claim 136

A device, comprising a top block comprising a first plurality of holes sized to allow a needle to pass through said top block and a bottom block comprising a second plurality of holes sized to allow a needle to pass through said bottom block, wherein said top and bottom blocks are in a substantially parallel arrangement and wherein said first and second plurality of holes are positioned so as to allow one or more needles to pass through a hole in said top block and said bottom block in a path substantially vertical to a plane of both blocks.

### Claim 137

A method of operating a device, comprising:
a. providing a device comprising a top block comprising a first plurality of holes sized to allow a needle to pass through said top block and a bottom block comprising a second plurality of holes sized to allow a needle to pass through said bottom block, wherein said top and bottom blocks are in a substantially parallel arrangement and wherein said first and second plurality of holes are positioned so as to allow one or more needles to pass through a hole in said top block and said bottom block in a path substantially vertical to a plane of both blocks
b. inserting one or more needles through said top block and said bottom block into a solid tissue, wherein at least one needle has a control attachment;
c. simultaneously moving said top block away from said bottom block; and
d. injecting at least one agent into said solid tissue.

### Claim 138 (depends on 137)

The method of claim 137, further comprising, evaluating an effect of said at least one agent on said solid tissue.

### Claim 139

A device for delivering an agent to a solid tissue, comprising:
a. two or more needles, wherein said two or more needles comprises a first end and a second end;
b. a reservoir, wherein said reservoir is in fluid communication with said first end of said two or more needles;
c. a plunger, wherein said plunger is coupled to said reservoir; and
d. a controller, wherein said controller controls a rate of fluid delivery when said two or more needles are withdrawn from said solid tissue.

### Claim 140

A method of delivering an agent to a solid tissue of a subject, comprising:
a. inserting a plurality of needles into said solid tissue; and
b. delivering said agent to said solid tissue, wherein a rate of delivery of said agent is substantially controlled by a rate of needle withdrawal from said solid tissue.

### Claim 141 (depends on 140)

The method of claim 140, wherein said needle is part of a needle array device.

### Claim 142 (depends on 141)

The method of claim 141, wherein said needle array device comprises 5 or more needles.

### Claim 143 (depends on 142)

The method of claim 142, wherein each of said needles comprises a different agent.

### Claim 144 (depends on 142)

The method of claim 142, wherein at least two of said needles comprises a same agent at different concentrations.

### Claim 145 (depends on 140)

The method of claim 140, wherein said agent comprises an anti-cancer agent.

### Claim 146 (depends on 145)

The method of claim 145, wherein said anti-cancer agent comprises a small molecular agent.

### Claim 147 (depends on 140)

The method of claim 140, wherein said agent comprises a position marker.

### Claim 148 (depends on 140)

The method of claim 140, wherein said agent comprises a negative control.

### Claim 149 (depends on 140)

The method of claim 140, wherein said agent comprises a positive control.

### Claim 150 (depends on 140)

The method of claim 140, wherein said agent is present in said solid tissue at a therapeutically effective concentration.

### Claim 151 (depends on 140)

The method of claim 140, wherein said agent is delivered to said solid tissue in an amount that is undetectable outside said solid tissue.

### Claim 152 (depends on 140)

The method of claim 140, wherein said agent is present in said solid tissue at a therapeutically effective concentration, and wherein outside said solid tissue said agent is present at a concentration that is undetectable.

### Claim 153 (depends on 140)

The method of claim 140, wherein said agent is undetectable outside said solid tissue.

### Claim 154 (depends on 140)

The method of claim 140, wherein said solid tissue comprises a tumor.

### Claim 155 (depends on 154)

The method of claim 154, wherein said tumor is selected from the group consisting of: a primary tumor, an invasive tumor and a metastatic tumor.

### Claim 156 (depends on 140)

The method of claim 140, wherein said solid tissue is selected from the group consisting of: brain, liver, lung, kidney, prostate, ovary, spleen, lymph node, thyroid, pancreas, heart, skeletal muscle, intestine, larynx, esophagus, skin, and stomach.

### Claim 157 (depends on 140)

The method of claim 140, further comprising evaluating an effect of said agent on said solid tissue.

### Claim 158 (depends on 157)

The method of claim 157, wherein said evaluating is performed in vitro.

### Claim 159 (depends on 157)

The method of claim 157, wherein said evaluating is performed in vivo.

### Claim 160 (depends on 157)

The method of claim 157, wherein said evaluating comprises histology sectioning.

### Claim 161 (depends on 157)

The method of claim 157, wherein said evaluating comprises imaging said solid tissue.

### Claim 162 (depends on 161)

The method of claim 161, wherein said imaging is selected from the group consisting of: radiographic imaging, magnetic resonance imaging, positron emission tomogoraphy, and biophotonic imaging, or any combination thereof.

### Claim 163 (depends on 161)

The method of claim 161, wherein said imaging occurs at a time point selected from the group consisting of: before introduction of said agents, during introduction of said agents, and after introduction of said agents, or any combination thereof.

### Claim 164 (depends on 157)

The method of claim 157, wherein said evaluating comprises analyzing at least one biomarker for biological activity.

### Claim 165 (depends on 164)

The method of claim 164, wherein said biological activity is selected from the group consisting of: tumor cell death, cell signal changes, proliferation changes, and mitotic changes, or any combination thereof.

### Claim 166 (depends on 157)

The method of claim 157, wherein said evaluating comprises detecting an effect of said one or more agents on a proliferative gradient of said solid tissue.

### Claim 167 (depends on 157)

The method of claim 157, wherein said evaluating comprises detecting an effect of said one or more agents on multiple microenvironments of said solid tissue.