# US 10,500,332 B2 · Injection devices and systems and methods for using them

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- Number: US 10,500,332 B2
- Document ID: US10500332B2
- Status: Granted
- Kind: B2
- Application number: 15/284,466
- Filed: 2016-10-03
- Published: 2017-05-04
- Granted: 2019-12-10
- Earliest claimed: 2015-11-03
- Assignees: Clph, LLC
- Applicants: Clph, LLC
- Inventors: Stephen A. Leeflang; Christian S. Eversull
- Web page: https://patentgrep.com/patent/US10500332B2

## CPC

- A61M 5/1407: {Infusion of two or more substances}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61M 5/007: {for contrast media}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- 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 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/0084: {being one or more injection needles}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 2005/2013: {triggering of discharging means by contact of injector with patient body}
- A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- 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)

## Abstract

Systems and methods are provided for injecting one or more agents into tissue within a patient's body. In one embodiment, an injection device includes a substantially axially incompressible elongate member including a lumen extending between proximal and distal ends thereof. A distal stop is provided on the distal end and a needle tip extends distally beyond the distal stop, the needle tip having a cross-section smaller than the distal end. The needle tip includes a passage communicating between the lumen and an outlet in the distal tip that has having a cross-section smaller than the lumen. In an exemplary embodiment, the elongate member includes a coil extending between the proximal and distal ends, and a sleeve disposed within an interior region of the coil extending between the proximal and distal ends. The sleeve defines the lumen and may be free-floating within at least a portion of the coil.

## Claims

### Claim 1

A device for injecting one or more agents into tissue within a patient's body, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a lumen extending between the proximal and distal ends;
a tubular extension extending distally beyond the distal end to terminate at a sharpened distal tip to facilitate penetration into tissue, the tubular extension having a cross-section smaller than the distal end and a passage communicating between the lumen and a tip outlet in the distal tip; and
a manifold coupled to the proximal end comprising a source of injectable material and an actuator for selectively directing the injectable material from the source through the lumen and out the tip outlet;
a bypass member within the lumen of the tubular member having a bypass lumen therein that extends from the proximal end to the distal end and includes a bypass lumen outlet disposed within and communicating with the lumen of the tubular member adjacent the tubular extension, the bypass member sized such that injectable material from the source is deliverable through the lumen of the tubular member around the bypass member and out the tip outlet, and
one or more support elements that axially fix a distal end of the bypass member.

### Claim 2 (depends on 1)

The device of claim 1, further comprising a clog clearing element within the lumen of the tubular member adjacent the tubular extension.

### Claim 3 (depends on 2)

The device of claim 2, wherein the clog clearing element comprises a rotatable auger within the lumen of the tubular member adjacent the tubular extension that includes one or more helical screw elements that extend at least partially into the passage, the auger rotatable in a first direction to cause injectable material within the lumen adjacent the tubular extension to enter the passage.

### Claim 4 (depends on 1)

The device of claim 1, wherein the bypass member is smaller than the passage such that material may be delivered through the passage around the bypass member from the tubular member lumen when the distal end of the bypass member is positioned into the passage.

### Claim 5 (depends on 1)

The device of claim 1, wherein the bypass member is free-floating within the tubular member lumen proximal to the one or more support elements.

### Claim 6 (depends on 1)

The device of claim 1, further comprising a blocker member including a distal end slidably disposed within the lumen of the tubular member, the blocker member sized such that injectable material from the source is deliverable through the lumen of the tubular member around the blocker member, the distal end of the blocker member sized to be inserted into the passage to remove material within the passage.

### Claim 7 (depends on 6)

The device of claim 6, wherein the blocker member comprises a bulbous tip on the distal end, the blocker member movable axially to direct the bulbous tip distally beyond the outlet of the distal extension to provide an atraumatic tip to facilitate advancement of the device through another device or body lumen within a patient's body.

### Claim 8 (depends on 7)

The device of claim 7, wherein the bulbous tip is sized to slidably engage an inner surface of the passage to clear material within the passage.

### Claim 9 (depends on 1)

The device of claim 1, further comprising a port on the manifold communicating with the bypass lumen and a source of fluid coupled to the port to deliver through the bypass lumen, the bypass lumen outlet, the passage, and out the tip outlet.

### Claim 10 (depends on 1)

The device of claim 1, wherein the one or more support members align the bypass lumen outlet with the passage.

### Claim 11 (depends on 1)

The device of claim 1, wherein the one or more support members axially fix the bypass member non-concentrically either against a sidewall of the tubular member or aligned off a central axis of the tubular member.

### Claim 12

A device for injecting one or more agents into tissue within a patient's body, comprising:
a substantially radially fixed tubular member comprising a proximal end and a distal end sized for introduction into a patient's body, at least a distal portion of the tubular member being sufficiently flexible to allow introduction into tortuous anatomy within a patient's body, the tubular member comprising a coil including windings extending between the proximal and distal ends and a tensile element coupled to the proximal and distal ends;
a flexible, fluid-tight member disposed within an interior region of the tubular member and extending between the proximal and distal ends, the fluid-tight member fixed at the distal end of the tubular member and free-floating within the interior region at least partially between the proximal and distal ends of the tubular member, the fluid-tight member defining a lumen extending between the proximal and distal ends of the tubular member, the fluid-tight member being expandable within the interior of the tubular member when exposed to internal fluid pressure with the tubular member limiting expansion of the fluid-tight member; and
a needle tip fixed to and extending from a distal end of the tubular member and having a cross-section smaller than the distal end, the needle tip comprising a passage communicating between the lumen and one or more outlets in the needle tip, the passage having a cross-section smaller than the lumen.

### Claim 13 (depends on 12)

The device of claim 12, further comprising a jacket surrounding the coil.

### Claim 14 (depends on 12)

The device of claim 12, wherein the fluid-tight member comprises a tubular membrane or bladder.

### Claim 15 (depends on 12)

The device of claim 12, wherein the tubular member is substantially axially incompressible.

### Claim 16

A method for delivering one or more agents into tissue, comprising:
providing an injection device comprising:
a substantially radially fixed tubular member including a proximal end, a distal end, a flexible, fluid-tight member disposed within an interior region of the tubular member and extending between the proximal and distal ends, the fluid-tight member defining a primary lumen extending between the proximal and distal ends, and a secondary lumen extending between the proximal and distal ends, the fluid-tight member being expandable within the interior of the tubular member when exposed to internal fluid pressure with the tubular member limiting expansion of the fluid-tight member;
a distal stop; and
a needle tip fixed to and extending from the distal stop including a passage communicating with both the primary lumen and the secondary lumen and an outlet of the needle tip, the needle tip having a cross-section smaller than the distal end and comprising a passage communicating between the primary lumen and one or more outlets in the needle tip, the passage having a cross-section smaller than the lumen, the secondary lumen also communicating with the passage such that fluids may be selectively delivered through the passage from either of the primary lumen and the secondary lumen;
introducing the distal end of the elongate member into a body lumen adjacent a target injection site;
delivering contrast through the secondary lumen and the passage out the outlet into the target injection site;
using external imaging to confirm that the needle tip is positioned at the target injection site;
delivering material through the primary lumen and the passage out the outlet into the target injection site; and
delivering fluid through the secondary lumen to clear residual material from the passage.

### Claim 17 (depends on 16)

The method of claim 16, wherein introducing the distal end of the elongate member into a body lumen adjacent a target injection site comprises directing the needle tip into tissue at the target injection site until the distal stop contacts the tissue.

### Claim 18

A device for injecting one or more agents into tissue within a patient's body, comprising:
a substantially radially fixed tubular member comprising a proximal end and a distal end sized for introduction into a patient's body, at least a distal portion of the tubular member being sufficiently flexible to allow introduction into tortuous anatomy within a patient's body;
a flexible, fluid-tight member disposed within an interior region of the tubular member and extending between the proximal and distal ends, the fluid-tight member defining a lumen extending between the proximal and distal ends, the fluid-tight member being expandable within the interior of the tubular member when exposed to internal fluid pressure with the tubular member limiting expansion of the fluid-tight member; and
a needle tip fixed to and extending from a distal end of the tubular member and having a cross-section smaller than the distal end, the needle tip comprising a passage communicating between the lumen and one or more outlets in the needle tip, the passage having a cross-section smaller than the lumen,
wherein the lumen defined by the fluid-tight member is a primary lumen, the device further comprising a secondary lumen extending between the proximal and distal ends and also communicating with the passage such that fluids may be selectively delivered through the passage from either of the primary lumen and the secondary lumen.

### Claim 19 (depends on 12)

The device of claim 12, further comprising a distal stop on the distal end of the tubular member having an outer dimension larger than an outer dimension of the distal end of the tubular member, the needle tip extending distally from the distal stop.

### Claim 20 (depends on 19)

The device of claim 19, wherein the distal stop comprises a rounded or flat distal surface adjacent the needle tip to limit penetration of the needle tip into tissue.

### Claim 21 (depends on 19)

The device of claim 19, wherein the tensile element comprises a secondary elongate member including a first end attached to the proximal end of the tubular member and a second end attached to one of the distal end of the tubular member and the distal stop, the secondary elongate member including a secondary lumen communicating with the passage in the needle tip.

### Claim 22 (depends on 19)

The device of claim 19, wherein the tensile element comprises a secondary elongate member including a first end attached to the proximal end of the tubular member and a second end attached to one of the distal end of the tubular member and the distal stop, the secondary elongate member including a secondary lumen, and wherein the distal stop includes one or more infusion ports and internal passages that communicate with the secondary lumen to deliver fluid through the secondary elongate member to exit through the one or more infusion ports.