# US 9,872,704 B2 · Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto

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- Number: US 9,872,704 B2
- Document ID: US9872704B2
- Status: Granted
- Kind: B2
- Application number: 14/416,689
- Filed: 2013-07-22
- Published: 2015-06-25
- Granted: 2018-01-23
- Earliest claimed: 2012-07-23
- Assignees: CVDevices, LLC
- Applicants: CVDevices, LLC
- Inventors: Ghassan S. Kassab; Jose A. Navia, Sr.
- Web page: https://patentgrep.com/patent/US9872704B2

## CPC

- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/0662: {Guide tubes}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22055: {with three or more balloons}
- A61B 2017/22069: {Immobilising; Stabilising}
- A61B 2017/306: {holding by means of suction}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2210/125: Heart
- 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

Devices, systems, and methods for delivering a substance within a mammalian luminal organ or area adjacent thereto. In at least one exemplary embodiment of a system of the present disclosure, the system comprises an inner delivery device, comprising an inner portion configured to receive a substance therein, a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ, and an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.

## Claims

### Claim 1

A system, comprising:
an inner delivery device, comprising:
an inner portion configured to receive a substance therein;
a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ; and
an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the inner delivery device further comprises:
a delivery shaft positioned proximal to the embolus, the delivery shaft configured to fit within the inner delivery device and facilitate delivery of the substance by way of distal advancement of the embolus within the inner delivery device.

### Claim 3 (depends on 2)

The system of claim 2, further comprising:
a torque mechanism coupled to the inner delivery device at or near a proximal end of the inner delivery device, the torque mechanism comprising a first rotatable dial configured such that rotation of the first rotatable dial in a first direction advances the delivery shaft distally within the inner delivery device.

### Claim 4 (depends on 3)

The system of claim 3, further comprising:
a first limiter coupled to the inner delivery device, the first limiter configured to limit advancement of the delivery shaft within the inner delivery device.

### Claim 5 (depends on 1)

The system of claim 1, wherein the inner delivery device further comprises:
a needle wire channel defined within the inner delivery device, the needle wire channel configured to receive at least a portion of a needle wire therein.

### Claim 6 (depends on 5)

The system of claim 5, wherein the inner delivery device further comprises:
the needle wire, wherein at least part of the needle wire is configured to fit within the needle wire channel.

### Claim 7 (depends on 1)

The system of claim 1, wherein the inner delivery device is configured to deliver the substance into the mammalian tissue and/or luminal organ or a space adjacent thereto.

### Claim 8 (depends on 1)

The system of claim 1, wherein the pock tip is configured to puncture the mammalian tissue and/or luminal organ.

### Claim 9 (depends on 8)

The system of claim 8, wherein the inner delivery device is configured to deliver the substance into the mammalian tissue and/or luminal organ or a space adjacent thereto after the pock tip has punctured the mammalian tissue and/or luminal organ.

### Claim 10 (depends on 8)

The system of claim 8, wherein the inner delivery device is configured to deliver the substance into the mammalian tissue and/or luminal organ or a space adjacent thereto after the pock tip has punctured the mammalian tissue and/or luminal organ by delivering the substance from the inner portion through the pock tip and into the mammalian tissue and/or luminal organ.

### Claim 11 (depends on 1)

The system of claim 1, further comprising the substance.

### Claim 12 (depends on 11)

The system of claim 11, wherein the substance is selected from the group consisting of a medicament, a polymer, a growth factor, a cell, a myocardial cell, a biological material, and a combination of one or more of the foregoing.

### Claim 13 (depends on 1)

The system of claim 1, wherein the pock tip comprises a material selected from the group consisting of a biologically-compatible metal and a biologically-compatible plastic/polymer.

### Claim 14 (depends on 1)

The system of claim 1, further comprising:
an outer catheter, comprising:
an elongate body;
a guidewire lumen defined within the elongate body and configured to receive at least part of a guidewire therein; and
a central lumen defined within the elongate body, the central lumen configured to receive at least a portion of the inner delivery device.

### Claim 15 (depends on 14)

The system of claim 14, further comprising:
the guidewire, wherein at least part of the guidewire is configured to fit within the guidewire lumen.

### Claim 16 (depends on 14)

The system of claim 14, further comprising:
a first guidewire having a first preformed shape; and
a second guidewire having a second preformed shape;
wherein each of the first guidewire and the second guidewire are configured to separately fit within the guidewire lumen.

### Claim 17 (depends on 14)

The system of claim 14, further comprising:
an inflation tube, the inflation tube defined within the outer catheter and configured to attach to an inflation source.

### Claim 18

A system, comprising:
an inner delivery device, comprising:
an inner portion configured to receive a substance therein;
a pock tip at or near a distal end of the inner delivery device, the pock tip configured to deliver the substance from the inner portion, through a pock tip aperture defined within the pock tip, and into a mammalian tissue and/or luminal organ; and
an embolus positioned within the inner portion, the embolus configured so that the substance remains distal to the embolus when the substance is positioned within the inner portion; and
an outer catheter, comprising:
an elongate body;
a guidewire lumen defined within the elongate body and configured to receive at least part of a guidewire therein; and
a central lumen defined within the elongate body, the central lumen configured to receive at least a portion of the inner delivery device.

### Claim 19

A method to deliver a substance within a mammalian patient, the method comprising the steps of:
introducing at least part of a system into a mammalian patient, the system comprising an inner delivery device and an outer catheter;
advancing the at least part of the system within the mammalian patient to a targeted tissue or luminal organ; and
advancing at least part of the inner delivery device within the outer catheter of to a first location so to deliver a substance from within the inner delivery device, through a pock tip of the inner delivery device, and into the targeted tissue or luminal organ, wherein the pock tip protrudes from a first open channel defined within the outer catheter.

### Claim 20 (depends on 19)

The method of claim 19, wherein the method is performed to treat the mammalian patient by delivering the substance to the mammalian patient.
