# US 10,869,655 B2 · Systems and methods for treatment of perforator veins for venous insufficiency

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- Number: US 10,869,655 B2
- Document ID: US10869655B2
- Status: Granted
- Kind: B2
- Application number: 15/884,189
- Filed: 2018-01-30
- Published: 2018-08-16
- Granted: 2020-12-22
- Earliest claimed: 2014-01-09
- Assignees: Covidien LP
- Applicants: Monte Madsen; Bruce Choi; Robert Lichty, II
- Inventors: Monte Madsen; Bruce Choi; Robert Lichty, II
- Web page: https://patentgrep.com/patent/US10869655B2

## CPC

- A61B 17/00491: {Surgical glue applicators}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12186: {liquid materials adapted to be injected}
- A61H 1/008: {Apparatus for applying pressure or blows almost perpendicular to the body or limb axis, e.g. chiropractic devices for repositioning vertebrae, correcting deformation}
- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61B 2017/00495: {for two-component glue}
- A61M 25/0014: {Connecting a tube to a hub}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- 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

Systems and methods for the treatment of perforator veins for venous insufficiency are described. The systems can include a catheter assembly comprising a proximal hub, a spin lock on the proximal hub, a elongate body overmolded to the proximal hub, and a distal end, the catheter, the elongate body configured to be placed within a perforator vein; an extension tubing having a proximal female hub, a distal male hub, and an elongate body therebetween, the distal male hub having a spin lock thereon, the distal male hub configured to be attached to the proximal hub of the catheter assembly; a syringe filled with a volume of media including cyanoacrylate; and an injector configured to automatically dispense a bolus of the media sufficient to coapt the perforator vein from the syringe upon actuation of a control on the injector. Methods are also disclosed.

## Claims

### Claim 1

A method comprising:
advancing an access needle percutaneously into a perforator vein in a patient;
advancing a portion of a catheter assembly through the access needle and into the perforator vein;
injecting a volume of media comprising a vein-occluding substance through the catheter assembly into the perforator vein such that the media substantially does not flow into adjacent superficial or deep veins, the volume of media being sufficient to coapt the perforator vein;
withdrawing the access needle and the catheter assembly from the perforator vein; and
applying external pressure sufficient to coapt the perforator vein.

### Claim 2 (depends on 1)

The method of claim 1, wherein advancing the access needle comprises advancing the access needle percutaneously into the perforator vein in the patient under ultrasound guidance.

### Claim 3 (depends on 1)

The method of claim 1, further comprising confirming coaptation of the perforator vein under ultrasound guidance.

### Claim 4 (depends on 1)

The method of claim 1, wherein injecting the volume of media comprises actuating a control of an injector to automatically dispense a bolus of approximately 0.05 cubic centimeters (cc) of the media from a syringe and out of the catheter assembly.

### Claim 5 (depends on 1)

The method of claim 1, wherein the volume of media is from approximately 0.01 cubic centimeters (cc) to approximately 0.10 cc.

### Claim 6 (depends on 1)

The method of claim 1, wherein the volume of media is approximately 0.05 cubic centimeters (cc).

### Claim 7 (depends on 1)

The method of claim 1, wherein the vein-occluding substance comprises an adhesive.

### Claim 8 (depends on 1)

The method of claim 1, wherein the vein-occluding substance comprises cyanoacrylate.

### Claim 9 (depends on 1)

The method of claim 1, further comprising, prior to injecting the volume of media, applying pressure to a portion of the patient to occlude a portion of the perforator vein.

### Claim 10 (depends on 1)

The method of claim 1, wherein the catheter assembly is operably connected at a proximal end of the catheter assembly to an extension tubing, the method further comprising priming the extension tubing and the catheter assembly with the media prior to injecting the volume of media.

### Claim 11 (depends on 1)

The method of claim 1, wherein:
the catheter assembly comprises:
a proximal hub comprising a first spin lock comprising a threaded sidewall; and
a first elongate body operably connected to the proximal hub, wherein the first elongate body is configured to be placed within the perforator vein; and
the catheter assembly is operably connected to an extension tubing, the extension tubing comprising a proximal female hub, a distal male hub, and a second elongate body therebetween, the distal male hub comprising a second spin lock thereon, the second spin lock comprising a threaded sidewall, and the distal male hub configured to be attached to the proximal hub of the catheter assembly via the second spin lock.

### Claim 12 (depends on 1)

The method of claim 1, wherein the catheter assembly comprises an axial length between approximately 3 inches and approximately 6 inches, and wherein the catheter assembly comprises an elongate body configured to be placed within the perforator vein, the elongate body comprising an outer diameter between approximately 0.02 inches and approximately 0.04 inches.

### Claim 13

A method comprising:
advancing an access needle percutaneously into a perforator vein in a patient under ultrasound guidance;
advancing a portion of a catheter assembly through the access needle and into the perforator vein;
applying pressure to a portion of the patient to occlude a portion of the perforator vein;
subsequent to applying pressure to the portion of the patient, injecting a volume of media comprising an adhesive through the catheter assembly into the perforator vein such that the media substantially does not flow into adjacent superficial or deep veins, the volume of media being sufficient to coapt the perforator vein and from approximately 0.01 cubic centimeters (cc) to approximately 0.10 cc;
withdrawing the access needle and the catheter assembly from the perforator vein;
applying external pressure to the patient sufficient to coapt the perforator vein with the volume of media injected into the perforator vein; and
confirming coaptation of the perforator vein under ultrasound guidance.

### Claim 14 (depends on 13)

The method of claim 13, wherein:
the catheter assembly comprises:
a proximal hub comprising a first spin lock comprising a threaded sidewall; and
a first elongate body operably connected to the proximal hub, wherein the first elongate body is configured to be placed within the perforator vein; and
the catheter assembly is operably connected to an extension tubing, the extension tubing comprising a proximal female hub, a distal male hub, and a second elongate body therebetween, the distal male hub comprising a second spin lock thereon, the second spin lock comprising a threaded sidewall, and the distal male hub configured to be attached to the proximal hub of the catheter assembly via the second spin lock.

### Claim 15 (depends on 14)

The method of claim 14, wherein the catheter assembly comprises an axial length between approximately 3 inches and approximately 6 inches, and wherein the elongate body comprises an outer diameter between approximately 0.02 inches and approximately 0.04 inches.
