# US 12,544,538 B2 · Infusion device and method for drug delivery

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- Number: US 12,544,538 B2
- Document ID: US12544538B2
- Status: Granted
- Kind: B2
- Application number: 17/615,131
- Filed: 2020-05-29
- Published: 2022-07-21
- Granted: 2026-02-10
- Earliest claimed: 2019-05-31
- Assignees: The Trustees of the University of Pennsylvania; The Children's Hospital of Philadelphia; The United States Government as represented by the Department of Veterans Affairs
- Applicants: The Trustees of the University of Pennsylvania; The Children's Hospital of Philadelphia
- Inventors: Flavia Vitale; Pedro Gonzalez-Alegre; Timothy H. Lucas
- Web page: https://patentgrep.com/patent/US12544538B2

## CPC

- A61M 25/0082: {Catheter tip comprising a tool}
- A61M 25/0084: {being one or more injection needles}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0136: {Handles therefor}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less}
- A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2210/0693: Brain, cerebrum
- 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 medical device (10) and method for infusing a drug or like substance in vivo within tissue of an organ of a patient are provided. The device (10) includes an outer cannula (12) having a distal and proximal ends (14, 16) and a plurality of microcannulas (20, 22, 24) extending within a length of the outer cannula (12). Each of the microcannulas (20, 22, 24) having a distal end (28) and a proximal end (26) and being movable relative to the outer cannula (12) in a lengthwise direction between retracted and extended positions such that, in the retracted position, the distal ends (28) of the microcannulas (20, 22, 24) are located within the outer cannula (12) and, in the extended position, the distal ends (28) of the microcannulas (20, 22, 24) extend beyond the distal end (14) of the outer cannula (12) in a splayed configuration.

## Claims

### Claim 1

A medical device (10) for infusing a drug, cells, nanoparticles or liposomes in vivo to tissue of an organ of a patient, comprising: an outer cannula (12) having a distal end (14) and a proximal end (16); a handle (18) to which the proximal end (16) of the outer cannula (12) is fixed; and a plurality of microcannulas (20, 22, 24) extending within a length of said outer cannula (12), each of said microcannulas (20, 22, 24) having a distal end (28) and a proximal end (26) and defining a lumen extending therethrough; wherein said plurality of microcannulas (20, 22, 24) are movable relative to said outer cannula (12) in a lengthwise direction between retracted and extended positions such that, in said retracted position, said distal ends (28) of said microcannulas (20, 22, 24) are located within said outer cannula (12) and, in said extended position, said distal ends (28) of said microcannulas (20, 22, 24) extend beyond said distal end (14) of said outer cannula (12) in a splayed condition; wherein said handle (18) includes an actuator interconnected to the proximal ends (26) of said plurality of microcannulas (20, 22, 24) and movable relative to said outer cannula (12) for advancing and retracting said plurality of microcannulas (20, 22, 24) lengthwise relative to said outer cannula (12); wherein the actuator comprises a plunger (30) extending from a free end of the handle (18) and being slidable relative to and within said handle (18) and not extending within said outer cannula (12); wherein the handle (18) includes a longitudinally-extending slot (34) and the plunger (30) includes a lateral extension (36) that extends within the slot (34) such that the slot (34) and lateral extension (36) limit the extent of sliding motion of the plunger (30) relative to the handle (18) along a linear path; and wherein the proximal ends (26) of said plurality of microcannulas (20, 22, 24) are interconnected to said lateral extension (36) and extend through said lateral extension (36) such that the proximal ends (26) of said microcannulas (20, 22, 24) and the lumens thereof extend out of and exit said handle (18) through the lateral extension (36) of the plunger (30) and thus through and out of the slot (34) in which the lateral extension (36) extends.

### Claim 2 (depends on 1)

The medical device (10) according to claim 1, wherein the proximal ends (26) of said plurality of microcannulas (20, 22, 24) are connected to a pressure-driven supply of the drug, cells, nanoparticles or liposomes.

### Claim 3 (depends on 1)

The medical device (10) according to claim 1, further comprising a position control mechanism for adjusting the extent of sliding motion of the plunger (30) relative to the handle (18).

### Claim 4 (depends on 1)

The medical device (10) according claim 1, wherein each of the distal ends (28) of said microcannulas (20, 22, 24) includes an array of spaced-apart ports along a length thereof.

### Claim 5 (depends on 1)

The medical device (10) according to claim 1, wherein the distal ends (28) of said microcannulas (20, 22, 24) become splayed in a predetermined pattern when in said extended position.

### Claim 6 (depends on 1)

The medical device (10) according to claim 1, wherein said microcannulas (20, 22, 24) are flexible and said outer cannula (12) is less flexible than said microcannulas (20, 22, 24).

### Claim 7 (depends on 6)

The medical device (10) according to claim 6, wherein said microcannulas (20, 22, 24) are made of an elastomer.

### Claim 8 (depends on 6)

The medical device (10) according to claim 6, wherein said outer cannula (12) is made of a metal or metal alloy.

### Claim 9 (depends on 6)

The medical device (10) according to claim 6, wherein the distal ends (28) of said microcannulas (20, 22, 24) have shape memory such that, in said extended position, the distal ends (28) splay in a predetermined pattern as extended from the distal end (14) of said outer cannula (12).

### Claim 10

A method of infusing a drug, cells, nanoparticles or liposomes in vivo within tissue of an organ of a patient, comprising the steps of: inserting a medical device (10) within the patient adjacent the organ, the medical device (10) including an outer cannula (12) having a distal end (14) and a proximal end (16), a handle (18) to which the proximal end (16) of the outer cannula (12) is fixed, and a plurality of microcannulas (20, 22, 24) each defining a lumen extending within a length of said outer cannula (12), distal ends (28) of said microcannulas (20, 22, 24) being retracted within said outer cannula (12) during said inserting step, the handle (18) including an actuator interconnected to the proximal ends (26) of the plurality of microcannulas (20, 22, 24) and movable relative to the outer cannula (12) for advancing and retracting the plurality of microcannulas (20, 22, 24) lengthwise relative to the outer cannula (12), the actuator comprising a plunger (30) extending from a free end of the handle (18) and being slidable relative to and within said handle (18) and not extending within said outer cannula (12), the handle (18) including a longitudinally-extending slot (34) and the plunger (30) including a lateral extension (36) that extends within the slot (34) such that the slot (34) and lateral extension (36) limit the extent of sliding motion of the plunger (30) relative to the handle (18) along a linear path, and the proximal ends (26) of the plurality of microcannulas (20, 22, 24) are interconnected to the lateral extension (36) and extend through the lateral extension (36) such that the proximal ends (26) of the microcannulas (20, 22, 24) and the lumens thereof extend out of and exit the handle (18) through the lateral extension (36) of the plunger (30) and thus through and out of the slot (34) in which the lateral extension (36) extends; moving said plurality of microcannulas (20, 22, 24) lengthwise relative to said outer cannula (12) to an extended position by sliding the plunger relative to the handle such that the distal ends (28) of the microcannulas (20, 22, 24) extend beyond the distal end (14) of the outer cannula (12), the outer cannula (12) remaining in a fixed location relative to the organ during said moving step and the plurality of microcannulas (20, 22, 24) being flexible and splaying from each other and the distal end (14) of the outer cannula (12) during said moving step; and after said moving step, infusing a pressure-driven drug, cells, nanoparticles or liposomes into the organ simultaneously from the plurality of microcannulas (20, 22, 24).

### Claim 11 (depends on 10)

The method according to claim 10, further comprising the steps of:
retracting the plurality of microcannulas (20, 22, 24) into the outer cannula (12) after said infusing step; and
after said retracting step, withdrawing the outer cannula (12) from the patient.

### Claim 12 (depends on 10)

The method according to claim 10, wherein said inserting step is accomplished with the assistance of magnetic resonance guidance.

### Claim 13 (depends on 10)

The method according to claim 10, wherein the organ is the brain.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the drug, cells, nanoparticles or liposomes is Adeno Associate Virus for therapeutic gene transfer to the putamen of the brain.