WO2008109822A2

WO2008109822A2 - Device for percutaneously creating a fetal iatrogenic gastroschisis

Info

Publication number: WO2008109822A2
Application number: PCT/US2008/056214
Authority: WO
Inventors: Ruben A. Quintero
Original assignee: University Of South Florida
Priority date: 2007-03-07
Filing date: 2008-03-07
Publication date: 2008-09-12
Also published as: WO2008109822A3

Abstract

An iatrogenic gastroschisis system includes a delivery plunger, a bag, and an ASD-fistula device housed within a delivery sheath. Retracting the delivery sheath while maintaining the delivery plunger against movement deploys the ASD-fistula device to create a relatively large fistulous defect. The bag deploys radially upon being removed from the delivery sheath and deploys longitudinally when disengaged from the delivery plunger.

Description

DEVICE FOR PERCUTANEOUSLY CREATING A

FETAL IATROGENIC GASTROSCHISIS

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to currently pending U.S. Provisional Patent Application 60/893,487, entitled, "Device for Percutaneously Creating a Fetal Iatrogenic Gastroschisis", filed March 07, 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

The septum is a wall that separates the left and right sides of the heart. A septal defect is a hole in the heart. A defect between the atria, the two upper chambers of the heart, is an atrial septal defect (ASD).

When there is a large defect between the atria, a large amount of red, oxygen-rich blood leaks from the heart left side of the heart to the right side. This blood is pumped back to the lungs, even though it has been refreshed with oxygen. The already-oxygenated blood displaces blood that needs oxygen, thereby reducing the efficiency of the heart.

Closing an atrial septal defect in childhood can prevent serious problems later in life.

There are also applications where it may be desired to create a fistula, which is defined by Webster as an abnormal passage that leads from an abscess or hollow organ or part to the body surface or from one hollow organ or part to another and that may be surgically created to permit passage of fluids or secretions.

There remains a need for improved fistula-creating devices in fetal therapy. Specifically, there is a need for a device that creates a fetal iatrogenic gastroschisis percutaneously.

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 needs could be met. SUMMARY OF INVENTION

The long-standing but heretofore unfulfilled need for improved tools for percutaneously creating a fetal iatrogenic gastroschisis is met by a new, useful, and nonobvious invention.

A related patent application filed by the same inventor, entitled: "Vesicoamniotic Shunt," includes an ASD device for creating a fistula. That structure includes no bag.

The novel iatrogenic gastroschisis system is based upon the ASD device in the related application. It includes a delivery plunger, a bag, and an ASD-fistula device housed within a delivery sheath. Advancing the delivery plunger deploys the ASD-fistula device to create a relatively large fistulous defect.

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 the novel iatrogenic gastroschisis system when in its collapsed configuration;

Fig. 2 is a perspective view of the novel system when the ASD-fistula device is deployed; and

Fig. 3 is a perspective view of the novel system when the bag is released.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to Fig. 1 , it will there be seen that the novel iatrogenic gastroschisis system in its collapsed configuration is denoted as a whole by the reference numeral 10. Delivery plunger 12, bag 14, and an ASD-fistula device 16 are housed within delivery sheath 18. Bag 14 and device 16 are deployed from delivery sheath 18 by holding delivery plunger

12 in position and retracting delivery sheath 18 as indicated by directional arrow 13.

Fig. 2 depicts discs 16a and 16b of ASD-fistula device 16 in their deployed configuration. Such deployment is made by retracting delivery sheath 18 in the direction of directional arrow 13 in Fig. 1 while maintaining delivery plunger 12 against movement, as aforesaid, thereby removing ASD-fistula device 16 from the lumen of delivery sheath 18 so that said device 16 deploys under its inherent or self bias. The waist of device 16 is denoted 16c.

In Fig. 2, bag 14 is in a collapsed configuration because it is still engaged to the leading end of delivery plunger 12. Bag 14 is in its expanded and released configuration in Fig. 3. Such expansion is made possible by the retraction of delivery plunger 12 from its Fig. 2 position in the direction indicated by directional arrow 13a. Removal of delivery plunger 12 requires that it be rotated about its axis as indicated by directional arrow 12a. More particularly, external screw threads are formed in the leading end of delivery plunger 12 and said external screw threads engage internal screw threads 14a forme din said bag.

Novel tool 10 is used to create a fetal iatrogenic gastroschisis percutaneously. Bag 14 contains the organs that might extrude through the opening. More particularly, it protects the bowel from coming into contact with amniotic fluid. Some fluid may initially seep into the bag between the fetal skin and the proximal disc, but such leakage is likely to decrease over time.

The outside diameter of ASD-fistula device 16 is up to 3.3 mm when collapsed. The bag length is five centimeters (5 cm) and the bag diameter is substantially the same as the diameter of the ASD disc. The ideal ASD fistula opening is two centimeters (2 cm). The length of ASD waist 16c is five millimeters (5 mm) and said waist diameter is at least two centimeters (2 cm) to accommodate the fistula opening. The disc diameter is four centimeters (4 cm) when deployed.

Tool 10 has the ability to create a relatively large (2 cm) fistulous defect. Bag 14 should be water-tight and therefore preferably includes a double screwing mechanism. A first screwing mechanism is dedicated to keeping the bag attached to the disc and a second screwing mechanism is dedicated to collapsing the device.

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.

Claims

What is claimed is:

1. An iatrogenic gastroschisis device, comprising:

a delivery sheath;

a delivery plunger;

a bag having a stored configuration and a deployed configuration;

said bag being housed within a lumen of said delivery sheath when in said stored configuration and said bag being external to said lumen when in said deployed configuration;

said bag having a radially-contracted diameter substantially equal to a diameter of said delivery sheath and a longitudinally-collapsed configuration when said bag is housed within said lumen of said delivery sheath;

said bag having a radially-expanded diameter greater than a diameter of said delivery sheath when said bag is in its deployed configuration and engaged by said delivery plunger;

said bag having a longitudinally-expanded configuration when deployed external of said delivery sheath and when disengaged from said delivery plunger;

an ASD-fistula device having a stored configuration and a deployed configuration;

said ASD-fistula device being received within a lumen of said delivery sheath when in said stored configuration and said ASD fistula device being external to said lumen when in said deployed configuration;

said ASD-fistula device including a waist, a first disc disposed at a first end of said waist and a second disc disposed at a second end of said waist;

each disc having a radially-contracted diameter substantially equal to a diameter of said waist when said ASD-fistula device is housed within said lumen of said delivery sheath and each disc having a radially-expanded diameter greater than a diameter of said waist when each disc is in its deployed configuration;

whereby said bag and said ASD-fistula device are deployed from said delivery sheath by maintaining said delivery plunger in a fixed position and retracting said delivery sheath so that said delivery sheath at least partially ensleeves said delivery plunger; whereby said discs of said ASD-fistula device are displaced from said radially-contracted housed configuration to said radially-expanded deployed configuration under their inherent bias;

whereby said bag is displaced from said radially-contracted housed configuration to said radially-expanded deployed collapsed configuration under its inherent bias; and

whereby said bag is displaced from said deployed longitudinally-collapsed configuration to said deployed longitudinally expanded configuration under its inherent bias when disengaged from said delivery plunger.

2. The device of claim 1 , further comprising:

said delivery plunger having screw threads formed in a leading end thereof;

said bag having a top wall, a bottom wall, and flexible sidewalls that interconnect said top and bottom walls at the respective peripheries of said top and bottom walls;

said top wall of said bag being apertured and said top wall aperture being internally threaded to screw-threaded Iy engage said delivery plunger screw threads;

said bottom wall of said bag being apertured and said bottom wall aperture being internally threaded to screw-threadedly engage said delivery plunger screw threads;

said bottom wall of said bag being disposed in overlying, engaged relation to said first disc of said ASD-fistula device;

whereby said delivery plunger screw threads engage the screw threads formed in said bag top wall and bottom wall when said bag is longitudinally collapsed; and

whereby said bag longitudinally expands when said delivery plunger screw threaded are disengaged from said top and bottom wall screw threads.