Methods and devices for controlled delivery

Patent metadata

Field	Value
Publication number	US-11744729-B2
Application number	US-201916402193-A
Country	US
Kind code	B2
Filing date	May 2, 2019
Priority date	May 2, 2018
Publication date	Sep 5, 2023
Grant date	Sep 5, 2023

Abstract

Disclosed herein are exemplary medical devices for controlled delivery of material compositions, particularly occlusive, therapeutic, or diagnostic compositions.

First claim

What is claimed is:

1. A method for occluding at least one fallopian tube in a human or animal body, comprising,
a) providing to the uterus of a human or animal a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing at least one catheter; at least one catheter comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the composition; a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the at least one catheter in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position two; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and a material cartridge containing the composition comprising an occlusive material positioned within the receptacle in the handle;
b) delivering an effective amount of the composition comprising an occlusive material through and out the at least one catheter at or near the uterine cornua such that the occlusive material occludes the lumen of the fallopian comprising the following steps:
i) with the system plunger rigidly coupled with the control rod and the lock in the lock position one, inserting the material cartridge containing the occlusive material within the receptacle in the handle;
ii) moving the slider from a proximal position to a distal position so that the catheter slide moves the at least one catheter so that the at least one catheter delivery end exits the insertion tube and is positioned in the uterine cornua;
iii) distally moving the rigidly coupled system plunger and control rod so that air is moved to fill the end structure of at least one catheter;
iv) moving the lock to the lock position two which uncouples the system plunger from the control rod so that when system plunger moves, the control rod is stationary;
v) moving the system plunger further distally, while the control rod remains stationary, so that the occlusive material is moved from the material cartridge through and out the delivery end of at least one catheter and into at least the uterine cornua;
vi) returning the lock to the lock position one to rigidly reengage the system plunger and the control rod;
vii) moving the rigidly engaged system plunger and control rod in a proximal direction which deflates the end structure of at least one catheter; and
viii) withdrawing the insertion tube from the human or animal body.

2. The method of claim 1 , wherein two fallopian tubes are occluded without removal and re-introduction or substantial repositioning of the controlled delivery device.

3. The method of claim 1 , wherein the composition comprising an occlusive material comprises a biodegradable cyanoacrylate composition.

4. The method of claim 3 , wherein the composition, when cured, swells less than 20%.

5. The method of claim 3 , wherein the composition is about 20% to about 100% substantially resorbed in a range of about 30 to about 365 days.

6. The method of claim 1 , wherein the occlusion is maintained by tissue ingrowth.

7. The method of claim 1 , wherein the composition further comprises tissue scarring agents, fibrosis agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof.

8. The method of claim 1 , wherein the composition further comprises a curable carrier for the occlusive materials, a control release agent, tissue scarring agents, fibrosis agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof.

9. A method for contraception, comprising,
a) providing to the uterus of a human or animal a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing at least one catheter; at least one catheter comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the composition; a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the at least one catheter in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position two; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and a material cartridge containing the composition comprising an occlusive material positioned within the receptacle in the handle;
b) delivering an effective amount of the composition comprising an occlusive material through and out the at least one catheter at or near the uterine cornua such that the occlusive material occludes the lumen of the fallopian comprising the following steps:
i) with the system plunger rigidly coupled with the control rod and the lock in the lock position one, inserting the material cartridge containing the occlusive material within the receptacle in the handle;
ii) moving the slider from a proximal position to a distal position so that the catheter slide moves the at least one catheter so that the at least one catheter delivery end exits the insertion tube and is positioned in the uterine cornua;
iii) distally moving the rigidly coupled system plunger and control rod so that air is moved to fill the end structure of at least one catheter;
iv) moving the lock to the lock position two which uncouples the system plunger from the control rod so that when system plunger moves, the control rod is stationary;
v) moving the system plunger further distally, while the control rod remains stationary, so that the occlusive material is moved from the material cartridge through and out the delivery end of at least one catheter and into at least the uterine cornua;
vi) returning the lock to the lock position one to rigidly reengage the system plunger and the contr

Assignees

• Femasys Inc

Inventors

• Lee-Sepsick Kathy

Classifications

• A61L2400/06

  Flowable or injectable implant compositions · CPC title

• A61F6/20

  Vas deferens occluders; Fallopian occluders · CPC title

• A61L24/0042

  Materials resorbable by the body · CPC title

• A61F6/18

  Inserters or removers · CPC title

• A61B17/1204

  temporary occlusion · CPC title