WO2008112865A1

WO2008112865A1 - Device for preventing detachment of the fetal membranes

Info

Publication number: WO2008112865A1
Application number: PCT/US2008/056809
Authority: WO
Inventors: Ruben A. Quintero
Original assignee: University Of South Florida
Priority date: 2007-03-13
Filing date: 2008-03-13
Publication date: 2008-09-18

Abstract

A VSD-fetal membrane attachment device for preventing fetal membrane detachment in patients undergoing endoscopic fetal surgery includes a delivery plunger, a trocar sheath, a delivery sheath, and a VSD device that is deployed from the delivery sheath by retracting the delivery sheath while holding the delivery plunger in place. The VSD has radially contracted discs when housed in the lumen of the delivery sheath that radially expand under their inherent bias when the VSD is deployed from the delivery sheath lumen. A leading disc overlies the amnion and a trailing disc overlies the myometrium.

Description

DEVICE FOR PREVENTING DETACHMENT OF THE

FETAL MEMBRANES

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to currently pending U.S. Provisional Patent Application 60/894,551 , entitled, "Device for Preventing Detachment of the Fetal Membranes", filed March 13, 2007, the contents of which are herein incorporated by reference

BACKGROUND OF THE INVENTION

1. Field of the invention.

This invention relates to surgical tools. More particularly, it relates to a modified Amplatz delivery system having applications in fetal therapy.

2. Description of the prior art

Endoscopic fetal surgery requires that an opening be made in the myometrium, chorion, and amnion with a trocar. Detachment of the fetal membranes from the uterine wall can occur during such surgery. Accordingly, there is a need for a device that prevents fetal membrane detachment in patients undergoing endoscopic fetal surgery.

However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in this art how the identified need could be met.

SUMMARY OF INVENTION

The long-standing but heretofore unfulfilled need for improved tools for preventing fetal membrane detachment in patients undergoing endoscopic fetal surgery is now fulfilled by a new, useful, and nonobvious invention.

The novel VSD-fetal membrane attachment device for preventing fetal membrane detachment in patients undergoing endoscopic fetal surgery includes a delivery plunger, a trocar sheath, a delivery sheath, and a VSD device that is deployed from the delivery sheath by retracting the delivery sheath while maintaining the delivery plunger against movement. More particularly, the novel VSD-fetal membrane attachment device includes a delivery plunger, a trocar sheath having a lumen, a delivery sheath having a lumen and said delivery sheath ensleeved within a lumen of the trocar, and a VSD device ensleeved within the lumen of the delivery sheath

The VSD device has a waist, a leading disc at a first end of the waist and a trailing disc at a second end of the waist. The leading disc and the trailing disc are radially contracted when the VSD device is ensleeved within the lumen of the delivery sheath. The leading disc and the trailing disc are radially expanded under an inherent bias when the VSD device is expelled from the lumen of the delivery sheath.

The leading disc is adapted to overlie an amnion when the leading disc is radially expanded. The trailing disc is adapted to overlie a myometrium when the trailing disc is radially expanded.

The device prevents fetal membrane detachment in patients undergoing endoscopic fetal surgery. Moreover, the device facilitates use of multiple ports, larger ports, or multiple, larger ports thereby allowing performance of more complicated endoscopic fetal procedures.

The VSD device is expelled from the lumen of the delivery sheath when the delivery plunger is held against movement and the delivery sheath is retracted in a proximal-to-distal direction.

The delivery plunger has an externally-threaded leading end. The trailing disc has an internally threaded aperture that is engaged by the delivery plunger leading end. The delivery plunger leading end is disengaged from the trailing disc after the trailing disc is radially expanded.

A valve closes the internally threaded aperture when the delivery plunger leading end is disengaged from the internally threaded aperture.

said delivery sheath ensleeved within said lumen of said trocar.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:

Fig. 1 is a perspective view of a novel VSD-fetal membrane attachment device prior to deployment of the VSD device; Fig. 2 is a perspective view of the apparatus depicted in Fig. 1 when the VSD device is partially deployed; and

Fig. 3 is a perspective view of the apparatus depicted in Fig. 3 when the VSD device is fully deployed;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to Fig. 1 , it will there be seen that a novel VSD-fetal membrane attachment device is denoted as a whole by the reference numeral 10. Device 10 prevents fetal membrane detachment in patients undergoing endoscopic fetal surgery. Use of this device facilitates the use of multiple ports, larger ports, or multiple, larger ports thereby allowing performance of more complicated endoscopic fetal procedures.

Device 10 includes delivery plunger 12, trocar sheath 14, delivery sheath 16, and VSD device 18.

Amnion 20 is a thin membrane forming a closed sac containing amniotic fluid about the fetus. Chorion 22 is an outer embryonic membrane associated with the formation of the placenta. Myometrium 24 is the smooth muscular wall of the uterus.

VSD device 18 is partially deployed in Fig. 2 and fully deployed in Fig. 3. Leading disc 18b and waist 18c are visible in Fig. 2 and trailing disc 18a is visible in Fig. 3. The leading and trailing discs are radially contracted when housed within the lumen of the delivery sheath and said discs are radially expanded when expelled from said lumen.

Delivery plunger 12 performs the function of pushing VSD device 18 from the lumen of delivery sheath 16. More particularly, the delivery sheath is retracted while plunger 12 is held in place. The discs 18a, 18b of VSD device 18 deploy under their inherent bias upon exiting said delivery sheath lumen.

Delivery plunger 12 is retracted after full deployment of the VSD device by a rotational motion 12a as indicated in Fig. 3. More particularly, the leading end of delivery plunger 12 is externally threaded and trailing disc 18a has a central aperture that is internally threaded for screwthreaded engagement with the leading end of the delivery plunger. This screwthreaded engagement ensures that the delivery plunger and VSD device 18 will remain connected to one another until the VSD device is fully deployed. After trailing disc 18a is radially expanded, the physician unscrews the delivery plunger from the internally threaded central aperture. A valve then closes the internally threaded central aperture. It will be seen that the advantages set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween. Now that the invention has been described,

Claims

What is claimed is:

1. A VSD-fetal membrane attachment device, comprising:

a delivery plunger;

a delivery sheath having a lumen;

a VSD device ensleeved within said lumen of said delivery sheath;

said VSD device having a waist, a leading disc at a first end of said waist and a trailing disc at a second end of said waist;

said leading disc and said trailing disc being radially contracted when said VSD device is ensleeved within said lumen of said delivery sheath;

said leading disc and said trailing disc being radially expanded under an inherent bias when said VSD device is expelled from said lumen of said delivery sheath;

said leading disc adapted to overlie an amnion when said leading disc is radially expanded; and

said trailing disc adapted to overlie a myometrium when said trailing disc is radially expanded;

whereby said device prevents fetal membrane detachment in patients undergoing endoscopic fetal surgery;

whereby said device facilitates use of multiple ports, larger ports, or multiple, larger ports thereby allowing performance of more complicated endoscopic fetal procedures.

2. The device of claim 1 , further comprising:

said VSD device being expelled from said lumen of said delivery sheath when said delivery plunger is held against movement and said delivery sheath is retracted in a leading-to-trailing direction.

3. The device of claim 1 , further comprising:

said delivery plunger having an externally-threaded leading end; said trailing disc having an internally threaded aperture that is engaged by said delivery plunger leading end;

said delivery plunger leading end being disengaged from said trailing disc after said trailing disc is radially expanded;

a valve for closing said internally threaded aperture when said delivery plunger leading end is disengaged from said internally threaded aperture.

4. The device of claim 1 , further comprising:

a trocar sheath having a lumen; and

said delivery sheath ensleeved within said lumen of said trocar.