Device for delivering silicone prosthesis into a surgical pocket

Abstract

A device for inserting a pre-filled or silicone prosthesis into a surgical pocket is formed from a sleeve formed of a bottom layer and a top layer attached to the bottom layer along longitudinal edges of the bottom layer and top layer. The top layer has a greater width than the bottom layer so as to form a half-cylinder shape when the sleeve is filled. The sleeve has a constant cross-sectional area along a length of the sleeve. This device reduces the chances for the implant to rotate in an unintended manner due to the non-circular cross-section of the sleeve.

Claims

1. A device for inserting a pre-filled or silicone implant into a surgical pocket, comprising a sleeve formed of a bottom layer having two parallel longitudinal edges, and a top layer having two parallel longitudinal edges, wherein the top layer is attached to the bottom layer by seams along the extent of both parallel longitudinal edges of the bottom layer and top layer with a space between the bottom layer and top layer for receiving the implant, wherein the top layer has a greater width between the seams than the bottom layer so that the device has a half-cylinder shape with the bottom layer being flat and the top layer being curved.

2. The device according to claim 1, wherein the sleeve has a constant cross-sectional area along a length of the sleeve.

3. The device according to claim 1, wherein the bottom layer is formed of a different material than the top layer.

4. The device according to claim 3, wherein the bottom layer is formed of a material having a greater stiffness than the material of the top layer.

5. The device according to claim 1, wherein the top layer is foldable in an unfilled state so as to lie flat with the bottom layer.

6. The device according to claim 1, wherein the device is made of a transparent material.

7. The device according to claim 1, wherein the top layer is made of a stretchable material.

8. The device according to claim 1, wherein an interior surface of the sleeve is coated with a lubricant.

9. A method for inserting a pre-filled or silicone implant into a surgical pocket, comprising: providing a sleeve formed of a bottom layer having two parallel longitudinal edges connected to a top layer having two parallel longitudinal edges, with the top layer being connected to the bottom layer by seams extending along both parallel longitudinal edges of the top layer and bottom layer, the top layer having a greater width between the seams than the bottom layer so that the sleeve has a half-cylinder shape with the bottom layer being flat and the top layer being curved, wherein the sleeve has a constant cross-sectional diameter along a length of the sleeve, placing the implant in the sleeve, and inserting the implant into the surgical pocket by squeezing the sleeve until the implant exits out of a distal end of the sleeve and into the pocket.

10. The method according to claim 9, wherein the implant has a substantially flat bottom and wherein the step of placing comprises placing the implant in the sleeve so that the substantially flat bottom of the prosthesis abuts the bottom layer of the sleeve.

11. The method according to claim 9, further comprising the step of applying a lubricant to an inside surface of the sleeve.

12. The method according to claim 9, further comprising the step of forming the sleeve by attaching the top layer to the bottom layer by heat sealing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Other objects and features of the present invention will become apparent from the following detailed description considered in connection with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention.

(2) In the drawings, wherein similar reference characters denote similar elements throughout the several views:

(3) FIG. 1 shows a perspective view of the device according to the invention;

(4) FIG. 2 shows the device in two separate pieces prior to assembly;

(5) FIG. 3 shows a cross-section of the device along lines 3-3 of FIG. 1, with an implant inserted into the device;

(6) FIG. 4 shows the device in an empty state in a folded position for transport; and

(7) FIG. 5 shows a side view of the device in use for insertion of an implant.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(8) FIG. 1 shows the device 1 according to the invention. Device 1 is in the form of a sleeve having a flat bottom portion 10 and a rounded top portion 20, which is connected to bottom portion 10 via two seams 21, 22. An implant 30 can be placed inside the lumen of the device 1, as shown. As can be seen in FIG. 2, the bottom portion 10 is formed of a flat rectangle having the same length L as the top portion 10, but a smaller width W.sub.1 than the width W.sub.2 of top portion 20.

(9) Device 1 is preferably constructed of a transparent film material that is pliable. Top portion 20 can be made of a different material than bottom portion 10. Top portion 20 is preferably made of a stretchable material. Bottom portion 10 can be made thicker and less pliable for enhanced stability. Top portion 20 is connected to bottom portion 10 via seams 21, 22, which can be formed by heat sealing or any other suitable method.

(10) As shown in FIG. 3, an implant 30 can be placed inside device 1, so that the bottom surface 31 of implant 30 rests against bottom portion 10 of device 1. The top surface 32 then conforms to the shape of top portion 20. When the device is expanded, the cross sectional view is that of a half cylinder. The device when filled takes the shape of a half-cylinder. As a cylinder is a geometric figure with straight or parallel sides and an oval or circular base in cross section, and the base and roof of this device are identical on both sides and the same size and shape which is a half circle, then this device in a 3-dimension figure is a half cylinder.

(11) A lubricant 26 can be disposed on the inside surface 13 and 23 of top and bottom portions 10, 20, to facilitate movement of prosthesis 30 through device 1. Lubricant 26 can be any suitable lubricant, such as K-Y® jelly, which is a water-soluble lubricant containing glycerol and hydroxyethylcellulose. The lubricant can be mixed with a combination of 4% chlorhexidine, a surgical skin preparatory solution used for its ability to reduce or eradicate skin pathogens and BETADINE®, an iodine based solution which is also bactericidal. This combination of substances will coat the prosthesis 30 and allow it to be propelled through the device into the breast pocket as shown in FIG. 5.

(12) When not in use or during transport, device 1 can be folded flat as shown in FIG. 4. Here, the top portion 20 is pleated so as to lie flat against bottom portion 10. This allows many devices 1 to be shipped and stored with a minimum of space.

(13) The device in use is shown in FIG. 5. To insert an implant into a surgical pocket, the implant 30 is placed inside device 1 through end 14 so that bottom surface 31 is adjacent bottom portion 10. The device 1 is then squeezed so that the implant is moved along the sleeve until it exits out end 15 and drops into the surgical pocket (not shown). In use, the surgeon generally uses both hands to squeeze device 1 and propel implant 30 through the interior of device 1 into the pocket. The implant 30 is lodged within the device 1 in its proper orientation and in the manner in which it needs to be deposited without any rotation or turning. As shown in FIG. 5, implant 30 exits the device 1 in its proper orientation with the flat base posteriorly and the concave top superiorly in its proper anatomic orientation.

(14) Accordingly, while only a single embodiment of the device has been shown and described, many modifications may be made thereunto without departing from the spirit and scope of the claimed invention.