# US 2014/0194776 A1 · Precision Directed Medical Instruments

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- Number: US 2014/0194776 A1
- Document ID: US20140194776A1
- Status: Published application
- Kind: A1
- Application number: 13/736,746
- Filed: 2013-01-08
- Published: 2014-07-10
- Earliest claimed: 2013-01-08
- Assignees: Sanovas Intellectual Property, LLC
- Inventors: Erhan H. Gunday; Lawrence J. Gerrans
- Web page: https://patentgrep.com/patent/US20140194776A1

## CPC

- A61B 10/0233: {Pointed or sharp biopsy instruments}
- A61B 1/00098: {Deflecting means for inserted tools}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/0084: {being one or more injection needles}
- A61M 25/065: {Guide needles}
- A61B 2017/22071: {Steering}
- A61B 2017/22082: {after introduction of a substance}
- A61M 25/0155: {with hydraulic or pneumatic means, e.g. balloons or inflatable compartments}
- A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- A61M 2025/0092: {Single injection needle protruding laterally from the distal tip}
- 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 system for delivering a medical instrument into a bodily cavity is provided, including an outer shaft having an aperture in a side wall thereof, wherein the aperture is provided at a distal portion of the outer shaft, an inner shaft positioned inside the outer shaft and having an inflatable balloon disposed at a distal portion thereof, and a needle member movably disposed in the outer shaft, wherein the needle member extends outwardly from the outer shaft through the aperture when the balloon is inflated.

## Claims

### Claim 1

A system for delivering a medical instrument into a bodily cavity, comprising:
an outer shaft having an aperture in a side wall thereof, wherein the aperture is provided at a distal portion of the outer shaft;
an inner shaft positioned inside the outer shaft and having an inflatable balloon disposed at a distal portion thereof; and
a needle member movably disposed in the outer shaft;
wherein the needle member extends outwardly from the outer shaft through said aperture when the balloon is inflated.

### Claim 2 (depends on 1)

The system of claim 1, wherein the needle member extends outwardly from the outer shaft at an angle relative to a longitudinal axis of the outer shaft when in an activated position.

### Claim 3 (depends on 2)

The system of claim 2, wherein the angle at which the needle member extends from the outer shaft is in the range of from about ten degrees to about sixty degrees.

### Claim 4 (depends on 1)

The system of claim 1, wherein a distal end of the needle member extends past the aperture in the distal direction of the outer shaft when in an inactivated position.

### Claim 5 (depends on 1)

The system of claim 1, further comprising a stop member provided on the needle member to prevent advancement of the needle member past the balloon in a proximal direction of the outer shaft.

### Claim 6 (depends on 1)

The system of claim 1, further comprising an actuation member provided at a proximal end of the outer shaft for moving the needle member between an activated position and an inactivated position.

### Claim 7 (depends on 6)

The system of claim 6, wherein the actuation member enables rotational movement of a distal end of the needle member.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a fluid source that supplies fluid to the balloon via a lumen of the inner shaft to inflate the balloon.

### Claim 9 (depends on 8)

The system of claim 8, said fluid source comprises an electro-pneumatic pump.

### Claim 10 (depends on 8)

The system of claim 8, wherein the fluid is a gas.

### Claim 11 (depends on 1)

The system of claim 1, wherein the balloon has a wall with a textured outer surface.

### Claim 12 (depends on 11)

The system of claim 11, wherein the textured surface of the balloon comprises a mesh disposed on the balloon wall.

### Claim 13 (depends on 12)

The system of claim 12, wherein the mesh comprises elastane.

### Claim 14 (depends on 1)

The system of claim 1, further comprising at least one imaging marker positioned at the distal end of the outer shaft adjacent said aperture.

### Claim 15 (depends on 1)

The system of claim 1, wherein the outer shaft comprises an expansion apparatus affixed to the side wall of the outer shaft opposite said aperture.

### Claim 16 (depends on 1)

The system of claim 1, wherein the needle member has at least one lumen fluidly connected to an opening at a distal end of the needle member.

### Claim 17 (depends on 16)

The system of claim 16, wherein the needle member delivers a therapeutic and/or diagnostic agent to tissue via the opening at the distal end.

### Claim 18 (depends on 16)

The system of claim 16, wherein the needle member obtains a tissue sample via the opening at the distal end.

### Claim 19 (depends on 16)

The system of claim 16, wherein the at least one lumen of the needle member accommodates a medical instrument.

### Claim 20 (depends on 16)

The system of claim 16, wherein the needle member has a first lumen fluidly connected to a first opening at the distal end of the needle member and a second lumen fluidly connected to a second opening at the distal end of the needle member.

### Claim 21 (depends on 1)

The system of claim 1, further comprising a second needle member disposed in the outer shaft.

### Claim 22 (depends on 1)

The system of claim 1, wherein the needle member comprises a memory-shape material.

### Claim 23 (depends on 1)

The system of claim 1, further comprising an imaging device disposed in the outer shaft for viewing tissue in the bodily cavity.

### Claim 24 (depends on 23)

The system of claim 23, wherein a distal end of the imaging device extends out through the aperture for viewing surrounding tissue.

### Claim 25 (depends on 23)

The system of claim 23, wherein the imaging device is disposed in the inner shaft and extends out through an opening inside the inflatable balloon, and wherein an outer wall of the balloon is transparent for viewing surrounding tissue via the imaging device.

### Claim 26 (depends on 1)

The system of claim 1, further comprising a second inner shaft positioned inside the outer shaft and having a second inflatable balloon disposed at the distal end thereof.

### Claim 27 (depends on 1)

The system of claim 1, wherein the outer shaft comprises a first lumen for containing the inner shaft and a second lumen for containing the needle member.

### Claim 28

A system for delivering a medical instrument into a bodily cavity, comprising:
an outer shaft having an aperture in a side wall thereof, wherein the aperture is provided at a distal portion of the outer shaft;
an inner shaft positioned inside the outer shaft and having an inflatable balloon disposed at a distal portion thereof; and
a medical instrument movably disposed in the outer shaft;
wherein the medical instrument extends outwardly from the outer shaft through said aperture when the balloon is inflated.

### Claim 29 (depends on 28)

The system of claim 28, wherein the medical instrument is a biopsy instrument.

### Claim 30 (depends on 28)

The system of claim 28, wherein the medical instrument is a drug delivery device.

### Claim 31 (depends on 28)

The system of claim 28, wherein the medical instrument is a diagnostic device.

### Claim 32 (depends on 28)

The system of claim 28, wherein the medical instrument is an energy emitting source.

### Claim 33

A method for delivering a medical instrument into a bodily cavity, comprising the steps of:
inserting an outer shaft into a bodily cavity, said outer shaft having an inner shaft and a needle member disposed therein, and further having an aperture provided in a side wall thereof at a distal portion of the outer shaft; and
inflating a balloon disposed at a distal portion of said inner shaft such that the balloon contacts the needle member and causes it to extend outwardly from the outer shaft through said aperture.

### Claim 34 (depends on 33)

The method of claim 33, further comprising the step of extending the needle member past the aperture in the distal direction of the outer shaft before inserting the outer shaft into the bodily cavity.

### Claim 35 (depends on 33)

The method of claim 33, further comprising the step of retracting the needle member in a proximal direction of the outer shaft after the shaft is inserted until the needle member is positioned adjacent the aperture.

### Claim 36 (depends on 35)

The method of claim 35, wherein a stop member is provided on the needle member to prevent advancement of the needle member past the balloon in the proximal direction of the outer shaft.

### Claim 37 (depends on 33)

The method of claim 33, wherein the needle member extends outwardly from the outer shaft at an angle relative to a longitudinal axis of the outer shaft when the balloon is inflated.

### Claim 38 (depends on 33)

The method of claim 33, further comprising the step of puncturing balloon wall via the needle member.
