WO1997040749A1

WO1997040749A1 - Breast implant introducer

Info

Publication number: WO1997040749A1
Application number: PCT/US1996/006020
Authority: WO
Inventors: Walter J. Ledergerber
Original assignee: Ledergerber Walter J
Priority date: 1994-07-08
Filing date: 1996-04-30
Publication date: 1997-11-06
Also published as: US5571178A

Abstract

This invention is a tool and method for introducing an implant (10) through an incision in a body utilizing a tube (16) having a hole (20) through which the implant is pressed. In the preferred embodiment, a two-part tube has one open end (20) and one closed end (19). The tube contains an expanding structure (5), for applying pressure on the implant, optionally a pressure-transmitting structure (9), and an implant (10). The expanding structure is expanded optionally by gas or fluid (18) filling the structure. Optionally, a collar (12) is disposed around the tube near the opening, selectively covering and uncovering a cut-out in the tube (15) which permits manipulation of the implant prior to insertion.

Description

DESCRIPTION

BREAST IMPLANT INTRODUCER

BACKGROUND OF THE INVENTION Reconstruction of the human breast involves intro¬ ducing a fixed or changeable-volume sac-like silicone rubber structure into a body cavity surgically created to receive such an implant. The implants and coverings therefor are described, by way of illustration and not by limitation, in: Braumann U.S. Patent 4,648,880; Hamas U.S. Patent 4,531,244; and Ledergerber U.S. Patent 4,955,907. The usual skin incision is on the order of 3-8 centimeters in length and is stretched open with retrac¬ tors to facilitate the introduction of the implant. By virtue of the displacement of fluid contained in the sac¬ like implant from outside of the body into the portion of the sac which has been introduced into the implant cavity, it is possible to gradually advance the membrane of the sac in pursuit of its fluid contents.

A number of sheet-like structures have been utilized to facilitate the introduction of implants into the body by enveloping the implant, with the primary object being to shape the fluid-filled sac for presentation to the retracted wound margins. The use of these sheet-like devices has not been of benefit in the hands of many practitioners of the art.

With advancing technology in breast implant design have come new designs exhibiting textured as opposed to smooth surfaces which are brought into intimate contact with the patient's tissues in the implanted state. A variety of textured surfaces for implants are disclosed in my issued U.S. Patent No. 4,955,907, incorporated herein by reference. Since breast implants are usually placed into the body through incisions considerably smaller than the implant, it has always been a challenge to introduce them. With greatly increased friction at the interface between the surface of newer texturized implants and the wound margins (body tissue) , it has become correspondingly more difficult to introduce these implants. Increased manipulation of both implants and patient tissue often results in trauma to both implants and patient tissue, thereby increasing the risk associated with the procedure both in terms of immediate consequences as well as delayed structural failure and the implications deriving therefrom. It has become a matter of some urgency to be able to introduce breast implants atraumatically.

SUMMARY OF THE INVENTION A new breast implant introducer has as its object the alleviation of the difficulty of introducing breast implants and thus limiting greatly both damage to implants and trauma to patient tissues. In one of the preferred embodiments, a two-part rigid or flexible tube has one open end and one closed end. The two parts of the tube are held in apposition by closure means in order to create a single large cavity: the large cavity contains three soft structures (in the present preferred embodiment) including the breast implant which is extruded out of the open end of the tube upon increasing the pressure inside the topmost soft structure . The topmost soft structure is expanded by introducing fluid or a gas by actuating the pump which may be con¬ nected to a fluid reservoir if fluid is utilized, or may simply be combined with a valve for gas intake and/or ex¬ haust. The expanding medium in the topmost soft structure applies pressure to the middle soft structure which in turn applies pressure to the lowest structure, the im¬ plant . The implant is extruded via the open end of the flexible or rigid structure. A soft or rigid collar assists in containing the implant within the neck of the tube during extrusion.

In another embodiment, a flexible tube has two open ends, one large enough to receive the implant, and the other small enough to insert the implant into the wound. In this embodiment, the tube is flexible, and permits direct user application of force through the flexible tube onto the implant, optionally, a relatively rigid ring or partial annulus is affixed to the smaller opening. The ring or partial annulus may be placed partially inside the wound to stabilize the implant introducer tube.

A generally circular retractor adapted for use with the implant introducer is sized to be placed inside the wound when unexpanded, and to expand out, thereby facilitating implant introduction.

Accordingly, it is a principal object of this invention to provide a useful structure and method for introducing an implant through an incision in the human body.

It is a further object of the invention to provide for atraumatic introduction of an implant.

BRIEF DESCRIPTION OF THE DRAWINGS The above objects and advantages of this invention will be more easily understood with reference to the following drawings and detailed descriptions.

Fig. 1 is a cross-section of a breast implant intro¬ ducer. Fig. 2 is a sectional view of Fig. 1 at "X-X" .

Fig. 3 shows a retractor for use with the introducer, in plan view and side view.

Fig. 4 shows an introducer in combination with the retractor.

DETAILED DESCRIPTION OF THE PREFERRED

EMBODIMENTS AND THEIR OPERATION IN USE

Referring to Fig. 1, a rigid tube 16 and a rigid cup

19 in which these structures may be hinged to each other to permit closure and thereby create a single joined structure, may have as its inner wall 22 a highly polished or otherwise treated surface with a very low coefficient of friction. A pump 2 with valves 3, 21 and possibly a fluid reservoir, are provided.

Two or three soft structures 5, 8, and 10 are enclosed within the combined tube and cup structure, one of which is an expansible structure 5 and another of which is the breast implant 10. A third structure 8 may be optionally interposed between the expansible structure 5 and the implant 10 for the purpose of limiting trauma to the implant 10 and also to provide for uniform transmission of pressure from the expansible structure to the implant.

Referring to Fig. 2, the collar 12 is positioned relative to the rigid or flexible tube 16 in such a way that a relief gap/void or cut-out in each superimposes on the other in such a way that the implant can be grasped or otherwise manipulated by the surgeon's fingers during the early "loading phase" during operation of the device. During active extrusion of the implant the collar 12 is rotated 180 degrees from its loading position in order to present a barrier to the transversely expanding portion of the implant.

Optionally, a relatively rigid ring or partial annulus 29 may be disposed at the end of the implant introducer which is used adjacent the body. The ring may be disposed inside the wound, and serve to stabilize the introducer during insertion of the implant.

In operation, with the rigid cup/tube combined structure open, the implant is introduced in the tube 16 portion and pushed toward the smaller open end 20 of the tube 16. The surgeon grasps the leading edge 24 of the implant through the relief gap/void/cut-out 13 while advancing the leading edge 24 of the implant through the neck 23 and part way through the open end 20 of the tube 16. A second soft structure 8 is placed on top of the implant 10 and thus positioned between the implant 10 and the expansible soft structure 5 in the rigid cup 19 portion of the combined cup/tube structure. The combined cup/tube structure is then closed and sealed by utilizing optional closure/locking means 6. Pump 2 is actuated to expand the expansible soft structure 5 sufficient to exert pressure through the middle soft structure 8 onto the implant 10. The collar 12 is turned 180 degrees in such a way that the body of the collar 25 presents a barrier to transverse expansion of that portion of the implant 10 positioned in the neck 23 of the tube 16. Further expansion of the expansible structure 5 by filling with fluid or gas 18 forces the implant to be extruded via the opening 20 in the tube 16. The leading lobe 14 of the implant is positioned directly over the incision through which it is to be introduced into the implant cavity of the patient. Additional actuation of the pump 2 completes extrusion of the implant 10. During final extrusion the surgeon's hands stabilize the neck 23 and collar 12 as well as the cup 19 or pump 2 portions of the invented device.

Another embodiment of the device is that where the cup 19 and tube 16 are rigid and the expansible structure 5 is a rigid sliding piston-like element and where the middle structure 8 may be either a sac-like structure or a sliding piston-like structure.

Another embodiment of the device is that where the cup 19 and tube 16 are flexible and sheet-like and either joined as are the cup 19 and tube 16 above or joined by virtue of being made of the same piece of flexible . material. In this embodiment the implant 10 is loaded into the device through the large opening at the end opposite the open extrusion end 20 exactly as described above. Extrusion of the implant 10 results upon closing the end through which the implant was loaded by twisting, folding, rolling, constricting, or otherwise closing and by applying and maintaining hand and digital pressure external to the flexible cup/tube combined structure while stabilizing the neck 23 as well as the closed end of the device with the surgeon's hands. The ring may be positioned inside the body cavity created to receive the implant. A preferred material of the ring - is a semi- dense biocompatible rubber compound. Preferred sheetlike materials for this embodiment include Gore-Tex (PTFEe, expanded polytetrafluoroethylene) as well as other materials exhibiting low coefficients of friction.

Preferred materials for the rigid embodiments of cup 19 and tube 16 as described above include teflon, nylon, polyethylene and other plastic polymers as well as metals including stainless steel, annealed glass, and others. The preferred fluid 18 for filling of the expansible chamber 5 is normal saline solution. Other fluids may also be suitable.

One of the preferred gases 18 for filling the expansible chamber 5 is room air. The preferred embodiment of the pump 2 described above may be a hand actuated pump. The position of the pump 2 with respect to the rigid or flexible structures 19 and 16 described above is variable and dependent only upon an efficient design of the entire invented device. An expansible chamber 5 in another embodiment may be comprised of a rigid cup 19 and an expansible membrane 26 positioned and fixed to a cross-sectional perimeter of the rigid cup as, for example, along the seam plane 17.

Another preferred embodiment is that in which pressure is applied to implant 10 and structure 8 by a rigid or flexible metal or plastic piston which is advanced mechanically through the cup/tube combination along the long axis of the tube 19.

In connection with any embodiment of this invention, it may be desirable to include the implant within a sheet of slippery material, such as Gore-Tex, for easing insertion of the implant, once the implant and sheet are introduced into the body, the sheet may be removed.

Fig. 3 shows a self-retaining ring retractor for use in connection with the implant introducer of this invention. The retractor 30 is sized to be inserted into the wound when partially collapsed or folded, and then expanded to effect wound retraction for insertion of the implant. The retractor may be made of any suitable material, such as spring metal, or plastic or a dense rubber. It may be of one piece or may be segmented. Hinges 32 provide flexibility. A ratchet expansion device may be used to hold the retractor in an expanded state. As shown in Fig. 4, optionally, the implant inserter may be attachable to the ring retractor 30. In one embodiment, the implant introducer has a blade at the end for introduction of the implant, where the blade is retained by the ring retractor 30.

Claims

1. A surgical implant inserter comprising a first enclosure adapted to receive an implant, said first enclosure having a first end with a first opening and a second end with a second opening, a second enclosure having a first end with a first opening through which a gas or fluid may pass and a second end with a second opening connected to said second end of said first enclosure, an expansible structure adapted to receive gas or fluid to force an implant received in said first enclosure through said first opening of said first enclosure, said expansible structure being enclosed by said first and second enclosures while said first and second enclosures are in adjacent relationship, a slit in said first end of said first enclosure adjacent said first opening of said first enclosure, and a collar disposed around said first end of said first enclosure, adjacent to said first opening of said first enclosure, said collar being movable relative to said first end of said first enclosure to reveal and obscure said slit .

2. A surgical implant inserter comprising a first enclosure adapted to receive an implant, said first enclosure having a first end with a first opening and a second end with a second opening, a second enclosure having a first end with a first opening through which a gas or fluid may pass and a second end with a second opening connected to said second end of said first enclosure, and an expansible structure enclosed by said first and second enclosures while said first and second enclosures are in adjacent relationship, said expansible structure being adapted to receive gas or fluid to force an implant received in said first enclosure through said first opening of said first enclosure.

3. The surgical implant inserter of claim 2, further comprising a pressure transmitting member enclosed by said first and second enclosures and interposed between said expansible structure and said first opening of said first enclosure .

4. The surgical implant inserter of claim 2, further comprising a source of gas or fluid.

5. The surgical implant inserter of claim 4, wherein the source of gas or fluid is a pump.

6. The surgical implant inserter of claim 4, wherein the source of gas or fluid is a reservoir.

7. The surgical implant inserter of claim 2, further comprising a cut-out in said first end of said first enclosure adjacent said first opening of said first enclosure.

8. The surgical implant inserter of claim 2, further comprising a collar disposed around said first end of said first enclosure, adjacent to said first opening of said first enclosure.

9. The surgical implant inserter of claim 8, further comprising a slit in said first end of said first enclosure adjacent said first opening of said first enclosure, and wherein said collar is movable relative to said first end of said first enclosure to reveal and obscure said relief cut .

10. The surgical implant inserter of claim 2, further comprising a retractor connected to said first end of said first enclosure to retract an incision in a body.

11. A surgical implant introducer comprising a first enclosure adapted to receive an implant, said first enclosure having a first end with a first opening and a second end with a second opening, a second enclosure having a first end with a first opening through which a gas or fluid may pass and a second end with a second opening connected to said second end of said first enclosure, an expansible structure adapted to receive gas or fluid to force an implant through said first opening of said first enclosure, said expansible structure being enclosed by said first and second enclosures while said first and second enclosures are in adjacent re1ationship, and a pressure transmitting member interposed between said expansible structure and said first opening of said first enclosure.

12. The surgical implant introducer of claim 11, further comprising a source of gas or fluid.

13. The surgical implant introducer of claim 12, wherein the source of gas or fluid is a pump.

14. The surgical implant introducer of claim 12, wherein the source of gas or fluid is a reservoir.

15. The surgical implant introducer of claim 11, further comprising a slit in said first end of said first enclosure adjacent said first opening of said first enclosure.

16. The surgical implant introducer of claim 11, further comprising a collar disposed around said first end of said first enclosure, adjacent to said first opening of said first enclosure.

17. The surgical implant introducer of claim 16, further comprising a cut-out in said first end of said first enclosure adjacent said first opening of said first enclosure, and wherein said collar is movable relative to said first end of said first enclosure to reveal and obscure said cut-out.

18. The surgical implant introducer of claim 11, further comprising a retractor connected to said first end of said first enclosure to retract an incision in a body.

19. A breast implant introducer comprising a flexible tube having a first end and a second end, said first end having an opening sized to mate with an incision in a body, said second end having an opening sized to receive an implant, said tube being closable at said second end, and a ring affixed to the opening of said first end of said tube to stabilize said first end of said tube during insertion of the implant into the body. 20. The breast implant introducer of claim 20, further comprising a retractor connected to said first end of said tube to retract the incision. 21. A method for introducing an implant into a body comprising: making an incision in the body, disposing the implant within a tube, the tube having an opening and a circumscribing ring for retaining the tube and circumscribing ring within the incision at its end, placing the opening of the tube with attached ring at the incision in the body such that the circumscribing ring is disposed inside the incision, pressing the implant through the opening at the end of the tube, thereby causing insertion of the implant into the body cavity.

22. A wound retractor for use in connection with a tool for inserting an implant through a wound, comprising: one or more segments sized to form a substantially circular shape when expanded, said retractor being sized to fit within the wound, means for permitting expansion of the retractor, and docking means to stabilize the tool for inserting the implant. AMENDED CLAIMS

[received by the International Bureau on 10 September 1996 (10.09.96); original claim 21 cancelled; original claim 22 amended and renumbered as claim 21; remaining claims unchanged (1 page)] with an incision in a body, said second end having an opening sized to receive an implant, said tube being closable at said second end, and a ring affixed to the opening of said first end of said tube to stabilize said first end of said tube during insertion of the implant into the body.

20. The breast implant introducer of claim 20, further comprising a retractor connected to said first end of said tube to retract the incision.

21. A wound retractor for use in connection with a tool for inserting an implant through a wound, comprising: one or more interconnected segments sized to form a substantially circular shape when expanded, said retractor being sized to fit within the wound, means for permitting expansion of the retractor, and docking means to stabilize the tool for inserting the implant .

STATEMENT UNDER ARTICLE 19

In the International Search Report dated 18 July 1996, cited documents Kirkman USA 5,509,900 and Cresswall USA 4,035,850 were denoted as category "X" documents, i.e., "document of particular relevance; the claimed invention cannot be considered novel or cannot be considered to involve an inventive step when the document is taken alone. " Kirkman was cited as relevant to claim 22 and Cresswall was cited as relevant to claims 2-6, 10 and 19-22.

In regard to Kirkman, Figs. 2A, 2B, 3 and 5-9 and accompanying text do not show nor disclose a retractor having one or more interconnected segments sized to form a substantially circular shape when expanded or a means for docking the retractor in an incision in the body. Rather, Kirkman shows and discloses a device having a plurality of individual, unconnected extendable positioning wires that retain a catheter tip in a fixed position with a blood flow and prevent it from contacting the vessel wall.

In regard to Cresswall, the document does not teach or disclose the claimed invention as presented in claims 2-6, 10 and 19-22. For instance, Cresswall does not disclose an expansible structure enclosed in a first and second enclosure and adapted to receive fluid as claimed in claim 2. More particularly, Cresswall does not disclose a first enclosure. According to Cresswall, item 24 is an upper member of a sealing ring assembly 14 shown in Fig. 1 (Column 2, lines 18-20) and, thus, can hardly be an enclosure. Further, Cresswall does not disclose an expansible member that receives fluid. According to Cresswall, item 10 is "a first open mouthed bag . . . adapted to contain a prefilled mammary prosthesis. " Item 10 is simply a bag that is open to the exterior of Cresswall' s apparatus and in which a mammary prosthesis is inserted (Column 1, lines 60-64). Furthermore, Cresswall does not disclose "a pressure transmitting member enclosed by [the] first and second enclosures and interposed between [the] expansible structure and [the] first opening of [the] first enclosure" as claimed in claim 3. Moreover, if, for purposes of this statement only, item 10 were considered an expansible member and item 28 were considered a pressure element in Cresswall, the mammary prosthesis (or implant) would be adjacent this expansible member 10 such that the so-called pressure element 28 could not be interposed between the implant and pressure element, let alone act as a pressure transmitting member (Fig. 1).

In regard to claims 4-6, Cresswall does not disclose a source of fluid or gas wherein the source of fluid or gas is a reservoir or a pump.

Cresswall also does not disclose "a flexible tube" having first and second ends, respectively, which have openings sized to mate with an incision in a body and receive an implant as claimed in claim 19.

Further, Cresswall does not disclose a retractor connected to the first end of the enclosure to retract an incision in a body as claimed in claims 10 and 20, or a retractor having one or more interconnected segments sized to form a substantially circular shape when expanded as claimed in claim 22.

Claim 21 has been cancelled. Claim 22 has been amended and renumbered claim 21. Claims 1-21 are now pending.

In view of the foregoing, Cresswall and Kirkman neither teach nor disclose the subject matter of claims 1-20 and 21 (amended claim 22) of the subject application. Thus, the claimed invention of claims 1-21, in view of the cited documents, is novel and involves inventive step.