# US 10,245,388 B2 · Injection device for minimally invasive procedures and uses thereof

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- Number: US 10,245,388 B2
- Document ID: US10245388B2
- Status: Granted
- Kind: B2
- Application number: 14/455,865
- Filed: 2014-08-08
- Published: 2015-02-12
- Granted: 2019-04-02
- Earliest claimed: 2013-08-08
- Assignees: Global Bio Therapeutics, Inc.
- Applicants: Jose Gustavo Cabrera Aquino; Blanca Angelica Segura Pacheco; Steven Gerken; Steven Masterson
- Inventors: Jose Gustavo Cabrera Aquino; Blanca Angelica Segura Pacheco; Steven Gerken; Steven Masterson
- Web page: https://patentgrep.com/patent/US10245388B2

## CPC

- A61M 5/46: having means for controlling depth of insertion
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61D 7/00: Devices or methods for introducing solid, liquid or gaseous remedies or other materials into or onto the bodies of animals (for reproduction or fertilisation A61D19/00)
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 7/06: Antianaemics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 17/14: for baldness or alopecia
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 21/02: Muscle relaxants, e.g. for tetanus or cramps
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/12: Antivirals
- A61P 31/18: for HIV
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2090/08021: {of the patient or his organs}
- A61M 5/31598: {having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed}
- A61M 2202/206: Viruses
- A61M 2210/02: Bones
- A61M 2210/04: Skin
- A61M 2210/0693: Brain, cerebrum
- A61M 2210/1003: Spinal column
- A61M 2210/1039: Lungs
- A61M 2210/1071: Liver; Hepar
- A61M 2210/1089: Urethra
- A61M 2210/125: Heart
- A61M 2210/1433: Uterus
- A61M 2210/166: Prostate
- 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)
- A61D: VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Provided herein is an injection device that can be used in minimally invasive procedures, such as laparoscopic surgeries, for direct administration of a fluid, such as a therapeutic, to a target tissue or organ.

## Claims

### Claim 1

An injection device, comprising:
a) a syringe barrel, wherein the syringe barrel provides a fluid reservoir;
b) a plunger configured to be controlled by the operator of the device and to move within the syringe barrel for loading and releasing fluid from the fluid reservoir in the syringe barrel;
c) an injection needle that is fixed and operably coupled to the syringe barrel providing a fluid pathway for fluid contained in the syringe barrel to be injected into a target tissue when the plunger is depressed, wherein extraction or retraction of the needle is independent of movement of the plunger;
d) an elongate sheath, comprising an internal lumen that contains the injection needle and having a distal tip that contains an opening for the injection needle, wherein:
the sheath is movable around the injection needle; and
control of the sheath is independent from movement of the plunger; and
e) a controller for positioning the sheath, comprising:
a housing, comprising at least a first and second stop to control exposure of the injection needle and that are provided within the housing at a predetermined distance from each other, wherein the stops can be locked;
a central lumen in the housing comprising a connection member, wherein the connection member is configured to be movable in the central lumen in the housing and is coupled to the sheath, wherein the proximal end of the sheath is coupled to the distal end of the connection member so that movement of the connection member controls movement of the sheath; and
a positioner mounted within the housing configured to move forward towards the distal end of the controller and rearward towards the proximal end of the controller, between the stops in the housing, wherein the positioner comprises a lock and release element that is configured in the positioner to engage the positioner with the stops, and is operatively connected to the connection member to guide movement of the connection member in the same direction, whereby movement of the positioner forward towards the distal end engages the first stop and moves the sheath to enclose the injection needle inside the lumen of the sheath, and movement of the positioner rearward towards the proximal end engages the second stop and moves the sheath to expose no more than a predetermined length of the distal tip of the injection needle through the opening for the injection needle for injection into the tissue.

### Claim 2 (depends on 1)

The injection device of claim 1, wherein the elongate sheath is of a sufficient length and width to reach an organ through an endoscopic port.

### Claim 3 (depends on 1)

The injection device of claim 1, wherein the elongate sheath has a length from its proximal to distal end of from about 200 mm to 600 mm and a diameter of from about 2 mm to 15 mm.

### Claim 4 (depends on 1)

The injection device of claim 1, wherein the predetermined length of the distal tip of the injection needle that is exposed is 1 mm to 10 mm.

### Claim 5 (depends on 1)

The injection device of claim 1, comprising at least 3 stops, 4 stops or 5 stops, wherein:
the second stop is the most proximal stop and the first stop is the most distal stop and the other stop or stops are positioned between the first stop and the second stop; and
each stop is positioned at a predetermined distance from the adjacent stop or stops to control exposure of the needle to different predetermined lengths, wherein the second stop controls exposure of the needle to its longest predetermined length, whereby the positioner can move between the adjacent stops to engage with the stop to expose different predetermined lengths of the injection needle.

### Claim 6 (depends on 1)

The injection device of claim 1, wherein the predetermined distance between stops is substantially the same as the predetermined length of the exposed injection needle.

### Claim 7 (depends on 1)

The injection device of claim 1, wherein the lock and release element is a spring that provides an upward force against the positioner and a downward force against the connection member to lock the positioner into the stop, and is capable of being compressed to release the positioner from the stop.

### Claim 8 (depends on 1)

The injection device of claim 1, wherein the injection needle is 5 mm to 40 mm in length.

### Claim 9 (depends on 1)

The injection device of claim 1, wherein the injection needle is 25 gauge to 34 gauge, 25 gauge to 30 gauge or 26 gauge to 28 gauge.

### Claim 10 (depends on 1)

The injection device of claim 1, wherein the syringe barrel is proximal or distal to the controller.

### Claim 11 (depends on 10)

The injection device of claim 10, wherein the syringe barrel is proximal to the controller and is operably coupled to the injection needle by an injection tube, wherein:
the injection tube comprises a proximal and a distal end, the proximal end connected to the syringe barrel and the distal end connected to the injection needle; and
the controller is configured to hold the injection tube and comprises an opening at the proximal end so that the injection tube is operably connected to the syringe barrel.

### Claim 12 (depends on 11)

The injection device of claim 11, wherein the syringe barrel is configured to be connected to the injection tube so that the syringe barrel is detachable from the device.

### Claim 13 (depends on 12)

The injection device of claim 12, wherein the injection tube comprises a hub on its proximal end that is compatible with an adaptor on the distal end of the syringe barrel and the hub of the injection tube connects to the adaptor of the syringe barrel.

### Claim 14 (depends on 11)

The injection device of claim 11, wherein:
the injection tube is fixed in the controller;
the connection member in the controller comprises a recess by which the injection tube is routed to pass from the controller into the sheath at the junction where the connection member is coupled to the sheath; and
the connection member is movable around the injection tube.

### Claim 15 (depends on 11)

The injection device of claim 11, wherein the injection tube is connected directly to the injection needle.

### Claim 16 (depends on 11)

The injection device of claim 11, wherein the injection tube is connected indirectly to the injection needle via a coupler, the coupler having a proximal and distal end, the proximal end connected to the distal end of the injection tube and the distal end connected to the proximal end of the injection needle.

### Claim 17 (depends on 16)

The injection device of claim 16, wherein:
the sheath is opaque;
the coupler is transparent; and
the sheath comprises a window configured in the sheath to view the coupler.

### Claim 18 (depends on 11)

The injection device of claim 11, wherein the injection tube and injection needle are different gauges.

### Claim 19 (depends on 18)

The injection device of claim 18, wherein:
the injection tube has a larger diameter than the injection needle;
the injection needle is 25 gauge to 34 gauge; and
the injection tube is 15 gauge to 25 gauge.

### Claim 20 (depends on 11)

The injection device of claim 11, wherein the injection tube and injection needle are the same gauge.

### Claim 21 (depends on 1)

The injection device of claim 1, wherein:
the injection needle is operably coupled to the syringe barrel by an injection tube, the injection tube comprises a proximal and a distal end, the proximal end connected to the syringe barrel and the distal end directly or indirectly connected to the injection needle;
the injection needle is 25 gauge to 34 gauge and has a length in the range from 5 mm to 40 mm;
the injection tube has a larger diameter than the injection needle, wherein the injection needle has a diameter less than 25 gauge; and
the controller is distal to the syringe barrel and plunger and comprises a cavity for the injection tube and an opening at the proximal end so that the injection tube extends out of the controller to connect to the syringe barrel, wherein the injection tube is fixed in the controller;
the connection member in the central lumen of the housing of the controller comprises a recess by which the injection tube is routed to pass from the controller into the distal lumen of the sheath at the junction where the connection member is coupled to the sheath; and
the connection member is configured to be movable in the central lumen in the housing around the injection tube.

### Claim 22 (depends on 1)

The injection device of claim 1, wherein:
the syringe barrel is positioned distal to the controller and the internal lumen of the sheath comprises the syringe barrel in its distal end; and
the syringe barrel is configured in the lumen so that the sheath is movable around the syringe barrel.

### Claim 23 (depends on 22)

The injection device of claim 22, wherein the sheath comprises an open cavity that comprises the syringe barrel.

### Claim 24 (depends on 23)

The injection device of claim 23, wherein:
the open cavity of the sheath comprises a lining that is configured in the sheath so that the sheath is movable around the lining; and
the syringe barrel is mounted into the lining in the open cavity.

### Claim 25 (depends on 23)

The injection device of claim 23, wherein the plunger is operably connected to the syringe barrel in the distal end of the lumen of the sheath and arranged so that the plunger is movable through the controller and within the lumen of the sheath.

### Claim 26 (depends on 25)

The injection device of claim 25, wherein;
the plunger is operably connected to the syringe barrel by an auxiliary plunger provided in the lumen of the sheath; and
the plunger is adapted to couple with the auxiliary plunger in the lumen of the sheath and arranged so that the plunger is movable through the controller and sheath and the auxiliary plunger is movable through the sheath and configured to move within the syringe barrel, whereby depressing the plunger depresses the auxiliary plunger into the syringe barrel releasing fluid from the fluid reservoir in the syringe barrel and pulling back on the plunger pulls back on the auxiliary plunger to load fluid into the fluid reservoir in the syringe barrel.

### Claim 27 (depends on 26)

The injection device of claim 26, wherein the plunger comprises an adaptor at its distal end to connect to the proximal end of the auxiliary plunger.

### Claim 28 (depends on 26)

The injection device of claim 26, wherein:
the open cavity of the sheath comprises a detachable syringe; and
the detachable syringe comprises the syringe barrel, the auxiliary plunger having a distal end configured to be movable in the syringe barrel and a proximal end coupled to the plunger, and the injection needle that is operably coupled to the syringe.

### Claim 29 (depends on 28)

The injection device of claim 28, wherein the open cavity of the sheath comprises a lining that is configured in the sheath so that the sheath is movable around the lining; and
the detachable syringe is mounted into the lining in the open cavity.

### Claim 30 (depends on 22)

The injection device of claim 22, wherein the plunger is longer than the sheath and has a length that is from or from about 100 mm to 600 mm or 200 mm to 500 mm.

### Claim 31 (depends on 22)

The injection device of claim 22, wherein the controller is configured to hold the plunger so that the plunger is movable within the controller, the controller comprising:
an opening at its proximal end to receive the plunger; and
a recess in the connection member of the controller by which the plunger is routed to pass from the controller into the lumen of the sheath at the junction where the connection member is coupled to the sheath, wherein the plunger and connection member move independently with respect to each other.

### Claim 32 (depends on 22)

The injection device of claim 22, wherein:
the device further comprises an extended plunger configured to be controlled by the operator of the device and coupled to an auxiliary plunger to move within the syringe barrel for loading and releasing fluid from the fluid reservoir in the syringe barrel, whereby depressing the plunger depresses the auxiliary plunger into the syringe barrel releasing fluid from the fluid reservoir in the syringe barrel and pulling back on the plunger pulls back on the auxiliary plunger to load fluid into the fluid reservoir in the syringe barrel;
the injection needle is 25 gauge to 34 gauge and has a length in the range from 5 mm to 40 mm;
the internal lumen of the sheath further contains the plunger and the auxiliary plunger;
the sheath is enclosed at its proximal end and provides a conduit for the plunger, wherein the plunger is movable through the sheath;
the sheath comprises an open cavity at the distal end, the open cavity comprising the auxiliary plunger, syringe barrel and injection needle, wherein:
the open cavity of the sheath comprises a lining that is configured in the sheath so that the sheath is movable around the lining;
the auxiliary plunger, syringe barrel and injection needle are mounted into the lining in the open cavity; and
the auxiliary plunger, syringe barrel and injection needle are detachable as a unit from the open cavity;
the sheath is movable around the plunger, auxiliary plunger, syringe barrel and injection needle;
the controller comprises an opening at its proximal end to receive the plunger and a cavity configured to hold the plunger so that the plunger is movable within the controller; and
the connection member comprises a recess by which the plunger is routed to pass from the controller into the distal lumen of the sheath at the junction where the connection member is coupled to the sheath, wherein the plunger and connection member move independently with respect to each other.

### Claim 33 (depends on 22)

The injection device of claim 22, wherein:
the device further comprises an extended plunger configured to be controlled by the operator of the device to move within the syringe barrel for loading and releasing fluid from the fluid reservoir in the syringe barrel;
the injection needle is 25 gauge to 34 gauge and has a length in the range from 5 mm to 40 mm;
the internal lumen of the sheath further contains the plunger;
the sheath is enclosed to provide a conduit for the plunger, wherein the plunger is movable through the sheath;
the sheath comprises a window to view the syringe barrel;
the sheath is movable around the plunger;
the controller comprises an opening at its proximal end to receive the plunger and a cavity configured to hold the plunger so that the plunger is movable within the controller; and
the connection member comprises a recess by which the plunger is routed to pass from the controller into the distal lumen of the sheath at the junction where the connection member is coupled to the sheath, wherein the plunger and connection member move independently with respect to each other.

### Claim 34 (depends on 22)

The injection device of claim 22, wherein the sheath encloses the syringe barrel.

### Claim 35 (depends on 34)

The injection device of claim 34, wherein the sheath comprises a window to view the syringe barrel.

### Claim 36 (depends on 1)

The injection device of claim 1 for delivering a therapeutic to an organ or tissue.

### Claim 37 (depends on 36)

The injection device of claim 36, wherein the therapeutic is a biologic, chemotherapeutic or gene therapy agent.

### Claim 38 (depends on 36)

The injection device of claim 36, wherein the therapeutic is a small molecule drug, prodrug, protein, peptide, DNA, RNA, virus, antibody, organic molecule, saccharide, polysaccharide, lipid and combinations or conjugates thereof.

### Claim 39 (depends on 1)

A method of directly administering a fluid to a tissue or an organ in a subject during a minimally invasive procedure, comprising:
inserting the injection device of claim 1 into a port or cannula configured to provide access to the tissue or organ during the minimally invasive procedure; and
depressing the plunger to inject the fluid into the tissue.

### Claim 40 (depends on 39)

The method of claim 39, wherein the subject is selected from among a mouse, rat, dog, cow, pig, sheep, goat, horse and human.

### Claim 41 (depends on 39)

The method of claim 39, further comprising removing the device from the port.

### Claim 42 (depends on 41)

The method of claim 41, wherein prior to removing the device from the port, moving the positioner forward towards the distal end to engage with the first stop to move the sheath to enclose the injection needle inside the lumen of the sheath.

### Claim 43 (depends on 39)

The method of claim 39, wherein:
the device is provided for inserting into the port with the positioner moved forward towards the distal end to engage with the first stop to move the sheath to enclose the injection needle inside the lumen of the sheath; and
prior to depressing the plunger, the positioner is moved rearward toward the proximal end to engage the second stop to move the sheath to expose the injection needle.

### Claim 44 (depends on 39)

The method of claim 39, wherein the tissue or organ is selected from among a liver, brain, spinal cord, pancreas, heart, skin, kidney, lung, blood vessel, bone, muscle, uterus, cervix, prostate, urethra, and intestine.

### Claim 45 (depends on 39)

The method of claim 39, wherein the fluid is a composition comprising a therapeutic.

### Claim 46 (depends on 45)

The method of claim 45, wherein the therapeutic is a biologic, chemotherapeutic or gene therapy agent.

### Claim 47 (depends on 45)

The method of claim 45, wherein the composition is a pharmaceutical composition.

### Claim 48 (depends on 45)

The method of claim 45, wherein the therapeutic is a small molecule drug, prodrug, protein, peptide, DNA, RNA, virus, antibody, organic molecule, saccharide, polysaccharide, lipid and combinations or conjugates thereof.

### Claim 49 (depends on 45)

The method of claim 45, wherein the therapeutic is a nucleic acid molecule for gene therapy, and the nucleic acid molecule encodes a polypeptide.

### Claim 50 (depends on 49)

The method of claim 49, wherein the nucleic acid molecule is a therapeutic nucleic acid molecule that encodes a therapeutic product, whereby delivery of the nucleic acid molecule effects treatment of a disease or condition.

### Claim 51 (depends on 49)

The method of claim 49, wherein the nucleic acid molecule is delivered in a vehicle selected from among a lipid vesicle, a virus and a microorganism.

### Claim 52 (depends on 1)

The injection device of claim 1, wherein:
the controller for positioning the sheath comprises at least three stops, wherein:
the second stop is the most proximal stop, and the first stop is the most distal stop and the other stop or stops are positioned between the first stop and the second stop; and
each stop is positioned at a predetermined distance from the adjacent stop or stops to control exposure of the injection needle to different predetermined lengths, wherein the second stop controls exposure of the injection needle at its longest predetermined length, whereby the positioner can move between the adjacent stops to engage with the stop to expose different predetermined lengths of the injection needle; and
the positioner comprises a lock and release element that is a spring that provides an upward force against the positioner and a downward force against the connection member to lock the positioner into the stop, and is capable of being compressed to release the positioner from the stop.