METHOD AND APPARATUS FOR INSERTION OF A FLEXIBLE IMPLANT INTO THE HUMAN BODY

Abstract

An insertion device for inserting an implant into a body through an incision is provided. The device includes a holder for receiving an implant and has an open downstream end that is dimensioned to be inserted into the incision and for passing the implant therethrough. The device also includes a flexible carrier that extends through the downstream end of the implant holder and is positioned along inner and outer wall surfaces of the holder. The carrier is dimensioned to frictionally engage the implant at least at a position on the inner wall surface proximate the downstream end of the holder. The carrier and the holder are configured such that when the carrier is caused to move through the open downstream end, the implant moves with the carrier, through the opening, and into the incision.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Some of the objects of the invention have been set forth above. Other objects and advantages of the invention will appear as the description of the invention proceeds when taken in conjunction with the following drawings, in which:

FIG. 1 is a perspective view of an implant insertion device according to one embodiment of the invention;

FIG. 2 is another perspective view of an implant insertion device according to one embodiment of the invention;

FIG. 3 is a side view of the implant insertion device shown in FIGS. 1 and 2;

FIGS. 4 and 5 are views of the carrier within which the implant is positioned for use with the insertion device; and

FIG. 6 is a partial cross-sectional view of the implant insertion device with an implant positioned in a carrier within the insertion device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE

Referring now specifically to the drawings, an insertion device, without an implant carrier, according to an embodiment of the present invention is shown generally in FIGS. 1, 2, and 3 at reference numeral 10. Insertion device 10 includes a funnel 11 having a relatively small diameter distal end opening 12 that is located downstream of a relatively large diameter proximal end opening 14. The funnel 11 has a wall 13 that has an inner wall surface 13a and an outer wall surface 13b. The funnel 11 is attached by a pair of attachment braces 16, 18 to a propulsion device in the form of a hand crank 20. Hand crank 20 includes a handle 22 that is used to rotate a winding cylinder 24 contained within a cylindrical housing 26. Slots 28, 30 in the housing 26 allow access to the winding cylinder 24, as described in further detail below. The distal and proximal end openings 12, 14 may be circular or non-circular. A small motor or other manually-operated device may be used instead of the hand crank 20.

Referring now to FIGS. 4 and 5, an implant carrier 40 is shown, and comprises a flexible elongated sleeve 42 having a relatively small end opening 44 and a relatively large end opening 46. A pair of loops 48, 50 are formed with or attached to the sleeve 42 at the large end opening 46. The implant carrier 40 is preferably formed of a suitable surgical fabric, such as a synthetic knitted material, or other knitted, woven, non-woven or sheet material that can be sterilized, is flexible and is otherwise suitable for use in a surgical environment.

The carrier 40 is used in conjunction with the insertion device 10 to insert an implant a body through a suitably-sized incision. In one embodiment, the implant is inserted through the incision into a pocket formed in a breast. As is shown in FIG. 6, an implant, such as a breast implant “I” is first positioned in the implant carrier 40, with both ends 44, 46 open. The large end 46 can be closed so long as the carrier 40 is longer than the implant to allow the implant to move backward during insertion. The smaller end 44 can also be closed but must be designed to open upon insertion. The loops 48, 50 should have little or no elasticity.

The carrier 40 is inserted into the funnel 11 of the insertion device 10. The loops 48, 50 are pulled through the distal end of the insertion device 10. The loops 48, 50 are then brought back over the outside of the funnel 11 and attached to the winding cylinder 24 contained within the cylindrical housing 26 through the slots 28, 30. The distal end opening 12 of the funnel 11 is placed against the incision through which the implant “I” will be inserted into the pocket formed in the breast. By turning the hand crank 22, the loops 48, 50 are wound onto the winding cylinder 24, pulling the sleeve 42 out through the distal end opening 12 and doubling the sleeve 42 over itself along the wall surfaces 13a, 13b of the funnel 11. As this occurs, the implant “I” is ejected from the distal end 12 of the funnel and into the pocket through the incision in the breast.

It is believed that the funnel 11 is the most appropriate shape to reduce the cross sectional area of an implant for insertion into a small orifice. The fundamental concept behind the apparatus and method described above is that the implant “I” is being pulled though the opening 12 in the funnel 11 by the carrier 40, rather than pushing as others have attempted. When the implant “I” is pulled, it temporarily distorts to a more elongated shape which is conductive to insertion. When the implant is pushed it becomes flat and thus much more difficult to pass through the funnel.

The silicone shell on the surface of the implant “I” has a very high coefficient of friction on most materials such as stainless steel, which is used in most surgical instruments. There is a slightly lower coefficient of friction with the fabric carrier 40, allowing an implant “I” to distort and move in the sleeve 42 of the carrier 40 as needed during ejection from the insertion device 10 into the breast.

The carrier 40 has a low coefficient of friction with the funnel 11. However, there is enough friction between the implant “I” and carrier 40 to pull the implant “I” through the funnel 11 with minimal slip. In contrast, the traditional hand insertion process produces focused areas of pressure on the implant where the finger pushes the implant into the wound. This pressure is extremely variable. The pressure changes with each pass of the finger, each case, each implant size, each wound size, and each surgeon. The process described above allows the pressure to be reduced and evenly distributed throughout the implant. More importantly, the process is completely reproducible and allows for control of amount of force applied to the implant during insertion, in a reproducible fashion. The carrier 40 also allows the implant “I” to be inserted with no contact to skin, gloves, or instrument. This can dramatically reduce bacterial, material, or chemical contamination, thus decreasing the rate of capsular contracture and infection.

Finally, the process is easier and faster than the traditional hand held technique. It may also reduce liability for the surgeon and implant complaints, while reducing the risk for implant rupture and contamination.

A method and apparatus for inserting a flexible implant into a human or animal body is described above. Various details of the invention may be changed without departing from the scope of the invention. Furthermore, the foregoing description of the preferred embodiment of the invention and best mode for practicing the invention are provided for the purpose of illustration only and not for the purpose of limitation, the invention being defined by the claims.

Claims

1. An insertion device for inserting an implant into a body through an incision, the device comprising: (a) a holder for receiving an implant and having an open downstream end dimensioned to be inserted into the incision and for passing the implant therethrough;(b) a flexible carrier extending through the downstream end of the implant holder and positioned along inner and outer walls of the holder for frictionally-engaging the implant at least at a position on the inner wall surface proximate the downstream end of the holder; and(c) wherein the carrier and the holder are configured such that when the carrier is caused to move through the open downstream end, the implant moves with the carrier, through the opening, and into the incision.

2. An insertion device according to claim 1, and further comprising a propulsion device cooperating with the flexible carrier for propelling the implant from within the implant holder through the downstream end and into the incision by movement of the flexible carrier such that a portion of the flexible carrier moves outside of the holder away from the downstream end and, simultaneously, another portion of the flexible carrier engages the implant and moves inside the holder toward the downstream end, thereby causing the implant to move toward the downstream end.

3. An insertion device according to claim 2, wherein the propulsion device comprises a winding cylinder for pulling the carrier through the opening, the winding cylinder being attached to the holder.

4. An insertion device according to claim 3, wherein the carrier extends through the downstream end of the holder and is attached to the winding cylinder.

5. An insertion device according to claim 4, further comprising a crank attached to the winding cylinder for rotating the winding cylinder, thereby pulling the carrier through the end of the holder.

6. An insertion device according to claim 1, wherein the carrier comprises a flexible sleeve that is dimensioned to receive the implant therein.

7. An insertion device according to claim 1, wherein the holder is funnel shaped and has an open upstream end that is larger than the downstream end.

8. An insertion device for inserting an implant into a body through an incision, comprising: (a) a tubular implant holder for retaining an implant therein, and having a downstream, open end dimensioned to be inserted into the incision and the implant passed in a downstream direction through the open end from a position upstream therefrom;(b) a flexible carrier extending through the open end of the implant holder and positioned along inner and outer wall surfaces of the implant holder for frictionally-engaging the implant at least at a position on the inner wall surface proximate the open end of the implant holder; and(c) a propulsion device cooperating with the flexible carrier adapted for propelling the implant from within the implant holder through the open end and into the incision by upstream movement of the flexible carrier relative to the outer wall surface of the implant holder and simultaneous corresponding downstream implant-engaging movement of the flexible carrier relative to the inner wall surface of the implant holder.

9. An insertion device according to claim 8, wherein the propulsion device comprises a winding cylinder attached to the holder for pulling the carrier through the opening.

10. An insertion device according to claim 9, wherein the carrier extends through the open end of the holder and is attached to the winding cylinder.

11. An insertion device according to claim 10, and further comprising a crank attached to the winding cylinder for rotating the winding cylinder and pulling the carrier through the end of the holder.

12. An insertion device according to claim 8, wherein the carrier comprises a flexible sleeve that is dimensioned to receive the implant therein.

13. An insertion device according to claim 8, wherein the holder is funnel shaped and has an upstream open end that is larger than the downstream open end.

14. A method for inserting an implant into a body through an incision, comprising the steps of: (a) providing a holder for receiving an implant and having an open downstream end dimensioned to be inserted into the incision and for passing the implant therethrough; a flexible carrier extending through the downstream end of the implant holder and positioned along inner and outer wall surfaces of the holder for frictionally-engaging the implant at least at a position on the inner wall surface proximate the downstream end of the holder; and wherein the carrier and the holder are configured such that when the carrier is caused to move through the open downstream end, the implant moves with the carrier, through the opening, and into the incision;(b) placing the implant in the flexible carrier;(c) placing the flexible carrier and the implant into the holder;(d) placing the downstream end of the holder into the incision; and(e) causing the carrier to move through the downstream end such that the implant is propelled from the holder into the incision.

15. A method for inserting an implant into a body through an incision, comprising the steps of: (a) Providing a tubular implant holder for retaining an implant therein, and having a downstream, open end dimensioned to be inserted into the incision and the implant passed in a downstream direction through the open end from a position upstream therefrom; a flexible carrier extending through the open end of the implant holder and positioned along inner and outer wall surfaces of the implant holder for frictionally-engaging the implant at least at a position on the inner wall surface proximate the open end of the implant holder; and a propulsion device cooperating with the flexible carrier adapted for propelling the implant from within the implant holder through the open end and into the incision by upstream movement of the flexible carrier relative to the outer wall surface of the implant holder and simultaneous corresponding downstream implant-engaging movement of the flexible carrier relative to the inner wall surface of the implant holder;(b) placing the implant in the flexible carrier;(c) placing the flexible carrier and the implant into the holder;(d) placing the downstream, open end of the holder into the incision; and(e) operating the propulsion device such that the carrier is pulled out of the downstream end of the holder and the implant is propelled from the holder into the incision.

16. A method for inserting an implant into a body according to claim 15, wherein step (c) of placing the flexible carrier and the implant into the holder includes the step of attaching the flexible carrier to the propulsion device.

17. A method for inserting an implant into a body according to claim 15, wherein the propulsion device comprises a winding cylinder.

18. A method for inserting an implant an open downstream end a body according to claim 15, wherein the step of operating the propulsion device includes the step of doubling the carrier over itself along the walls of the holder.

19. A method for inserting an implant into a body according to claim 15, wherein the step of operating the propulsion device includes the step of inserting the implant into the incision through the holder without the implant contacting skin.