US20060287583A1 - Surgical access instruments for use with delicate tissues - Google Patents

Abstract

One or more surgical instruments provide access to delicate tissue, such as brain tissue or breast tissue, through a transcutaneous incision, for a variety of reasons, such as to access a surgical site for providing a working channel for accessing delicate tissue by surgical instruments, to provide access to insert an inflatable prosthesis, or for providing an external buttress channel for supporting tissue thereon. The surgical instrument assembly includes an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer. The wedge introducer is introduced into an area adjacent to the hollow sleeve. The distal tip of the wedge introducer extends beyond a distal end of the hollow retractor, forward of a distal end of the hollow retractor, so that the wedge introducer traverses delicate tissue ahead of the distal end of the hollow retractor, guiding the hollow retractor into place to the delicate tissue.

Description

FIELD OF INVENTION
• This disclosure relates to surgical access instruments for use with delicate tissues and methods of use.
BACKGROUND
• Traditional surgical brain retractors are thin, firm bands of steel or other metal alloys, with abrupt or well-defined edges and have limited surface areas. The common structural form is a simple strip of sheet metal consisting of a metal strip which can be bent by hand and the surface of which typically is clearly outlined on the brain after a few minutes. Particularly noticeable are the pressure marks of the lateral spatula edges which indicate a high local compression stress. These traditional retractors can be introduced into the tissue of the brain or along brain surfaces, and then pulled with force to either separate or elevate the brain tissue during surgery. This method allows the target area to be illuminated and visualized in order to perform the surgical procedure. However, brain tissue is quite soft and delicate, particularly after trauma, loss of blood supply, or in the presence of brain edema. The brain tissue is a gel-like substance that can be easily damaged, and a complication known as “retraction injury” can occur, sometimes resulting in compromised brain function. The brain tissues can be torn by the relatively sharp edges of these retractors, and/or the retracted brain can loose blood supply when the local pressure beneath the retractor is greater than venous pressure. The result can be ischemic changes in the underlying brain and/or the more serious complication of venous brain infarction.
• The combination factors including the softness of the brain tissue, and the effects of sharp, blunt edges and limited surface area of traditional metal band retractor also results in limited visualization of the surgical target area. The brain tends to extend beyond or “droop” around the edges of the retractor, limiting the area necessary for lighting and reducing overall visibility.
• Furthermore, the amount of local pressure exerted by the retractor on the brain tissue must be limited to avoid injury, which may impede the surgeon's ability to safely gain enough visualization area. Oftentimes, the surgeon will resort to the strategy of exposing far more of the brain tissue than is necessary or desirable to open the area around the brain widely enough so as to limit the amount of local retraction pressure. This method is undesirable, as compared to a less invasive approach, for both the patient and surgeon.
• It would be advantageous to provide a surgical instrument assembly that safely addresses the short comings of the presently-known instruments.
OBJECTS OF THE INVENTION
• The objects and design principles of the surgical access instrument assemblies of this invention are as follows:
• (1) to maximize surface area of the retractor, so as to distribute pressure evenly and minimize effective local retraction pressure;
• (2) to enable integration with stereotactic neuro-navigation computer guidance system;
• (3) to reduce the need to “pull” on a brain retractor, to obviate the possibility of accidental over-retraction and thereby avoid brain damage;
• (4) to allow for binocular vision with the utilization of elliptical architecture;
• (5) to allow for maximal lighting access clearance a target tissue visualization;
• (6) to allow for minimization of brain disruption by limiting the corticotmy via use of a small elliptical window for the transcortical introducer;
• (7) to allow for minimization of brain disruption with the utilization of tapered forward edges;
• (8) to enable stable retraction fixation to avoid accidental retractor displacement;
• (9) to provide retractors which are of lightweight materials to allow for ease of manipulation; and/or,
• (10) to provide transparent retractors to allow for direct visualization of underlying brain tissue.
• Other objects which become apparent from the following description of the present invention.
SUMMARY OF THE INVENTION
• In keeping with these objects and others which may become apparent, the present invention is directed toward an access assembly for surgical instruments. The access assembly for surgical instruments includes two principal components. One component is an internal instrument access assembly and the other is an external instrument access assembly. The internal instrument access assembly is designed to enter the brain to gain access to deeper internal brain structures. The external instrument access assembly is designed to elevate the surfaces of the brain to gain access to external structures along, around or beneath the brain. Both will be produced in varying sizes according to the needs of individual operations. The materials for these retractors will be composed of transparent biocompatible lightweight plastic. Each of the instrument assemblies include two separate parts, a retractor that also functions as a working channel, and a compatible introducer.
• The internal instrument assembly is a wedge retractor introducer, which preferably includes a hollow wedge formed by all or part of a closed curve in cross section, such as an elliptical rounded wedge or an arch shaped wedge. It includes a hollow brain access working channel that can be fixed in space to a standard neurosurgical fixation cable device. First, a protruding introducer element, having a length greater than the length of the hollow working channel, is introduced into the working channel. Its distal smooth and relatively soft tapered end works to spread apart the brain hemispheres or other portions of delicate brain tissue. When the working channel is introduced, the introducer is removed, leaving the hollow working channel for the surgeon to access to the target tissues. Variations will include length (Z axis), and width and height (X and Y axes) of the elliptical working channel and introducer.
• A fixation portion is designed to be attached to a standard neurosurgical armature fixation device.
• The external surgical access instrument assembly is characterized by an arched hemi-elliptical architecture, wider along the base (X axis) than tall (Y axis). It is smooth, tapered at the leading edge, has a handle fixation portion that is o the same design as that of the internal instrument assembly, and is designed to be attached to a standard neurosurgical armature fixation device. Variations will be in length (Z axis) as well in X and Y axes.
• Therefore, the present invention encompasses one or more surgical instrument assemblies to provide access to delicate tissue, such as brain tissue or breast tissue, through a transcutaneous incision, for a variety of reasons, such as to access a surgical site; to provide access to insert an inflatable prosthesis; or to provide access for providing an external buttress channel for supporting tissue thereon. The surgical instrument assembly includes an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer. The wedge introducer is introduced into an area adjacent to the hollow sleeve. The distal tip of the wedge introducer extends beyond a distal end of the hollow retractor, forward of a distal end of said hollow retractor, so that the wedge introducer traverses the delicate tissue ahead of the distal end of the hollow retractor, guiding the hollow retractor into place in the delicate tissue.
• When used in conjunction with working surgical instruments, the distal end of the introducer has a small opening, preferably elliptically oval, to allow for removal of small portions of tissue from a surgical site.
• The hollow retractor may have a diameter which is a closed curve, such as an elliptical oval. In such case, a tapered tipped wedge introducer is inserted into the inside of the closed curved hollow retractor. In an alternate embodiment, the tapered tipped wedge introducer may have a diameter which is an arc, wherein the arc is a portion of a closed curve, and further wherein the tapered tipped wedge is an arch insertable into the closed curved hollow retractor.
• When used as an external working channel, the distal end of the working channel is bell shaped, to allow for increase for increased surface area exposure.
• The hollow retractor may alternatively also be an arc of a portion of a closed curve, also forming an arch shape. In such case, the tapered curved tipped wedge introducer may also be an arc of a portion of a closed curve, also forming an arch shape.
• In the case where the hollow retractor and/or the tapered tipped wedge introducer has a diameter of at least one arc of a curve, they preferably can have a decreasing curved cross sectional diameter.
• Moreover, in such case where the hollow retractor is arch shaped, as opposed to being a closed curved shape, such as being an-elliptical oval in cross section, the wedge introducer is placed adjacent to the concave inner portion of the hollow retractor.
• If the hollow retractor is a closed curve, that is, having an elliptical oval cross section, preferably of decreasing diameter towards it distal, tissue contact edge, then the combination of the hollow retractor and wedge introducer are used to either spread apart adjacent delicate tissues, such as the left and right hemispheres of the brain, or to traverse the delicate tissue, such as brain tissue, to provide internal access to a surgical site within the delicate tissue.
• If the hollow retractor is arch-shaped, that is, having a diameter which is an arc, namely, a portion of a closed curve, then the combination of the hollow retractor and the wedge introducer are used to provide access to a delicate tissue, where the delicate tissue is supported upon the convex outer surface of the hollow retractor, forming a support buttress, after removal of the arch-shaped wedge introducer.
• Additionally, if the hollow retractor is also arch-shaped, that is, having a diameter which is an arc, namely, a portion of a closed curve, then additionally the combination of the hollow retractor and the wedge introducer is used to provide access to a delicate tissue, where an inflatable member, such as a breast prosthesis, is inserted into the delicate breast tissue and inflated, after removal of the arch-shaped wedge introducer from the hollow arched retractor.
• The tipped wedge introducer has an exterior surface corresponding to an interior surface of the hollow sleeve and the closed end tipped wedge introducer may have a diameter with an arc of a decreasing curved cross section approximating the arc of the curved cross section of the open sleeve of the retractor.
• Preferably, the hollow retractor includes a handle attachable to a clamp.
• Optionally, the hollow retractor and the tapered tipped wedge introducer include a lock temporarily locking said tapered tipped wedge introducer adjacent to the hollow retractor.
• When the hollow retractor is elliptically oval in cross section, the closed plane curve is generated by a point moving in such a way that the sums of its distances from two fixed points is a constant, or the closed plane curve is a plane section of a circular cone that is a not perpendicular to an axis of the cone, thereby forming a planar elliptical oval slice through the cone.
• Moreover, the hollow retractor may be flared at a proximal end. Additionally, where a base of a handle is attached, the handle may merge in a cascading shape, interrupting the continuous curve of the proximal end of the hollow retractor. Such a cascading dip in structure allows for easier finger access into the working channel of the hollow retractor.
• Additionally, the hollow retractor may have a changing cross section, where the cross sectional diameter of the elliptical oval is wider or narrower at selected regions of the working channel of the hollow retractor.
DESCRIPTION OF THE DRAWINGS
• The present invention can best be understood in connection with the accompanying drawings. It is noted that the invention is not limited to the precise embodiments shown in drawings, in which:
• FIG. 1 is a view of a patient with a retractor assembly and a buttress channel positioned adjacent to a top of the head and lower skull.
• FIG. 2 is a perspective of retractor assembly ofFIG. 1.
• FIG. 3 shows exploded components ofFIG. 2.
• FIG. 4 is a top plan view of an introducer.
• FIG. 5 is a proximal end view of an introducer.
• FIG. 6 is a side sectional elevational view thereof.
• FIG. 7 is a top plan sectional view thereof.
• FIG. 8 is a sectional detail of a locking tab, taken fromFIG. 7.
• FIG. 9 is a top plan view thereof.
• FIG. 10 is a proximal end view of the retractor.
• FIG. 11 is a side sectional elevation thereof.
• FIG. 12 is a top plan sectional view thereof.
• FIG. 13 is a sectional detail view of the groove, taken fromFIG. 12.
• FIG. 14 is a sectional detail of locking tab and groove, taken at14-14 ofFIG. 2.
• FIG. 15 is a proximal end view of the assembly, taken atarrow15 inFIG. 2.
• FIG. 16 is a view of the instrument assembly being inserted into the top of a skull.
• FIG. 17 is a view of the instrument assembly spreading the brain lobes apart.
• FIG. 18 is a view of the instrument assembly installed, taken at arrows18-18 ofFIG. 17, with an ear of introducer flexed.
• FIG. 19 is a view of the instrument assembly with the introducer removed.
• FIG. 20 is a view of surgical instruments within the retractor channel.
• FIG. 21 is a diagrammatic sectional view of an embodiment which is installed transversely into tissue.
• FIG. 22 is a view of the external instrument assembly system adjacent to the lower skull.
• FIG. 23 is a view of the instrument assembly components ofFIG. 22 exploded.
• FIG. 24 is a perspective view of the instrument assembly system installed in the lower skull.
• FIG. 25 is a diagrammatic side section of installed instrument assembly, with the introducer removed.
• FIG. 26 is a diagrammatic view of the instruments working on an external tumor.
• FIG. 27 is a diagrammatic view of an alternative embodiment, installed through forehead.
• FIG. 28 is a diagrammatic view of the instrument assembly installed into breast tissue.
• FIG. 29 is a perspective exploded view of a surgical kit.
DETAILED DESCRIPTION
• This disclosure relates to a surgical instrument assembly and system for use with delicate tissues and methods of using the instrument assembly. The instruments are designed for use during surgery on delicate tissues, such as brain and breast tissues, although they may be used in any medical context. The instrument assembly includes several portions, such as, an introducer portion, a tissue access channel retractor portion (“channel portion”) having at least one handle portion, and a stylette portion. These instrument portions are formed to maximize the surface area of the retractor, which distributes pressure approximately equally though out the surrounding tissues and minimize effective localized retraction pressure on the tissues in contact or immediately surrounding the Instrument.
• In one embodiment, the surgical instrument assembly can be a retractor in the form of an arch or arc shape, into which an arch or arc shaped wedge introducer may be inserted for surgical access to the external portions or surfaces of the brain.
• In another embodiment, the surgical instrument assembly can be a retractor in the form of a wedge with a tapered elliptical cross sectional shape, into which a tapered elliptical cross sectional introducer may be inserted for surgical access to the external portions or surfaces of the brain.
• Alternatively, the external retractor and wedge introducer may be used to insert medical/cosmetic devices into or under delicate tissues.
• The surgical instrument assembly system may also employ the external retractor as an external brain support buttress channel portion to lift the brain mass upward with respect to the cranium to provide stability and prevent the gelatinous brain materials from shifting during surgery. In the capacity of a brain support buttress channel portion (“buttress portion”) also provides improved visualization and improved access to the surgical area by lifting the brain matter upward in the cranium.
• The formation of the instrument assembly also eliminates the need to “pull” on a retractor portion to clearly visualize the surgical area by initially providing a sufficient work area via the channel retractor. The use of the tissue access channel retractor portion of the instrument assembly eliminates or greatly lowers the possibility of accidental over-retraction. By avoiding excess retraction, damage to the surrounding tissues is also avoided, including possible brain damage.
• While other closed curve configurations may be used, the preferably elliptical or arch shaped architecture formation of the instrument assembly portions is such that medical staff is afforded binocular vision, rather than the monocular vision typically found in similar devices. This elliptical architecture also provides far greater clearance for lighting access to illuminate the target surgical area and allow full visualization of that area. The forward edge of the channel retractor is preferably tapered to gently separate tissue to obtain a surgical area and minimizes disruption of the tissue.
• The surgical instrument assembly system may also be useful as an inserter instrument for breast implants.
• The dimensions of the surgical Instrument assembly may vary and be modified according to an intended use. Generally, the surgical work space formed by theintroducer portion40 can have diameters of in the range of approximately 10 millimeters (“mm”) to approximately 100 mm, and more typically in the range of approximately 25 mm to approximately 75 mm in its closed configuration. The open configuration of theintroducer portion40 may extend the diameter of thedistal end42 of theintroducer portion40 several millimeters, and may generally be determined by amount of extension desired by the surgical team during use as it is introduced into thelumen22 of theretractor20, and may include aflexible band portion14 to enhance its flexibility. The open configuration may also be determined by the overall desired circumference and diameter of the Surgical Instrument assembly for a particular use and may be manufactured in a variety of useful sizes to be available as is practical. The Surgical Instrument assembly may be formed of any biocompatible material which will provide sufficient stability and strength necessary to provide a surgical work area. The biocompatible material may be disposable or sterilize-able for repeated use. In one embodiment, the Surgical Instrument assembly may be formed of a lightweight plastic material for ease of manipulation and/or the material may be transparent to allow direct visualization of underlying brain tissue thorough the Instrument assembly portions.
• The surgical instrument assembly system also enables integration with stereotactic neuro-navigation computer guidance systems to enhance visualization of the surgical area of the brain.
• FIG. 1 illustrates in diagrammatic fashion the surgicalinstrument assembly system10 adjacent a surgical aperture in the cranium of an intubated patient. Anexternal retractor system100 is also spaced from the lower skull, and will be described later in the specification.
• FIG. 2 is an enlarged perspective view of the surgicalinstrument assembly system10 as shown inFIG. 1. Theinstrument assembly system10 is comprised of two components, aretractor20, and anintroducer40.
• FIG. 3 illustrates the relationship ofintroducer40 toretractor20, prior to assembly. It is desirable that the introducer is easily fixed to and removable from the retractor both prior to and during the surgical procedure.
• As also shown inFIG. 3, the surgical instrument assembly system may be formed by any method, including injection molding, as a single piece, or may be formed of two or more pieces which are permanently fixedly attached to each other. Thedistal end42 of theintroducer portion40 is preferably a solid, rounded cone shape which may or may not include anopening52 to the surrounding tissues as opposed to a cannula structure which always provides a distal opening. Thedistal end42 preferably includes a gently increasingcircumference54, which increases and expands towards theproximal end56 of theintroducer portion42. Theintroducer portion40 has amain body50, and may be divided into two approximate handle halves46, having V-shapedcutouts48 between the handle halves. The halves of theproximal end56 are an integral unit, the term “halves” is used as a descriptor only and does not describe separable parts, as opposed to two disassemblable halves. Theproximal end56 may include at least onehandle portion46 which extends outwardly at an angle of approximately 90 degrees. Ahandle portion46 may be useful to allow a medical team member to physically insert, manipulate or hold thehandle portion46, or a conventional surgical fixation cable may be attached to thehandle portion12. At least one of thehandle portions46 include at least one indentation or groove44 to accept or snap into an additional portion of thesurgical instrument assembly10.
• FIGS. 4-8 show a variety of views of theretractor portion20 of this disclosure, includingretractor20 having a hollow workingchannel22 and handle28. Theretractor20 is generally formed to dimensions and shapes to coincide with theintroducer portion40 that may be slidably inserted into the brainaccess work channel22 of theretractor portion20. Theretractor portion20 is generally shorter in length than theintroducer portion40 to allow thedistal end42 of theintroducer portion40 to interact with the surroundinghousing21 tissues. As best seen inFIGS. 6 and 7, theretractor portion20 is formed as a hollow elliptical rounded wedge having a tapered distal leadingedge24. The proximal edge of theretractor20 includes a slightly roundedlip26 and ahandle portion28. At least onetab30 is formed inwedge21, just distal oflip26.Tab30 will positively align withgroove44 ofintroducer40 to prevent or inhibit unnecessary movement or slipping of the instrument assembly components best seen in sectional viewFIG. 15. Thehandle portion28 allows theretractor portion20 to be fixed in space with the use of a standard or conventional neurosurgical fixation cable device.
• FIG. 9 illustrates a side view of aretractor20, having aproximal end26 of the surgical instrument assembly and optionally having ahandle portion28 perpendicular to theproximal end26; and an elliptical length of theretractor21 extends to the roundeddistal end24.FIG. 10 is a frontal view of theretractor20, showing thelumen30 and thehandle portion28.FIG. 11 is a cross-sectional view of theretractor20 of the rounded shape of theretractor20 to avoid damage to delicate tissues.FIG. 12 is a top plan view of theretractor20, emphasizing the groove like cut-out hole30 which can allow theintroducer40 to integrally fit and temporarily lock/snap intohole30, thereby causing both theretractor20 andintroducer50 to function as one, while desired by the medical team.FIG. 13 is an enlarged view of thegrooved hole30.FIG. 14 is a cross-sectional view of thetab44 of theintroducer20 while it is engaged within thegrooved hole30 of theretractor20.
• Shown inFIG. 15 is a proximal end view of assembled instrument where thehandle portions46overlying lip26 ofretractor20, and V-shapedcutouts48 residing inlumen22. Handle28 ofretractor20 is molded integral withlip26, providing both rigidity and strength.FIG. 15 also shows that where a base ofhandle28 is attached toretractor20, handle28 may optionally merge in a cascading shaped dip28a,interrupting the continuous curve of the proximal end ofhollow retractor20. Such a cascading dip28aallows for easier finger access into the working channel ofhollow retractor20.
• FIGS. 16-20 illustrate diagrammatically the method if installingsurgical instrument assembly10 into theaperture12 incranium14. As seen inFIG. 16,instrument assembly10 is inserted intoaperture12.Distal end42 ofintroducer40 is abuttingbrain tissue60. Asinstrument assembly10 is introduced,distal end42 ofintroducer40 begins to spreadlobes62 and64 ofbrain60, as shown inFIG. 17.FIG. 18 is an elevational view of the installedsurgical instrument assembly10, taken along arrows18-18 ofFIG. 17. Upon installation, handles46 ofintroducer40 may be flexed inward, thereby releasing thetab30 ofretractor20 from thegroove44 ofintroducer40.FIG. 19 illustrates introducer40 during removal fromlumen22 ofretractor20.FIG. 20 showssurgical instruments70 withinlumen22 ofretractor20, examiningbrain tissue60.
• FIG. 21 is a diagrammatic perspective view of an embodiment of thesurgical instrument assembly10, adjacent anaperture12 located at the temple region of a patient'scranium14. In this embodiment, the overall length ofsurgical instrument assembly10 is sufficient to transversely penetrate the cranium andbrain tissue60.Surgical instrument assembly10 is shown installed inFIG. 22.
• FIG. 23 is a perspective view of the external retracting buttresschannel100. External buttresschannel instrument assembly100 is comprised of buttresschannel component200, andwedge introducer component400. External buttresschannel component200 has a generally arched, hemi-elliptical architecture, where it is wider along the base than it is tall or high. The buttresschannel component200 includes a smooth, tapered leadingedge202. Ahandle fixation member204 is approximately perpendicular to therounded lip206 of theproximal end208. Thehandle member204 may be employed as an attachment point to a standard neurosurgical armature fixation device. The external buttresschannel component200 may be used to lift, support or manipulate the brain within the skull cavity to provide additional or improved vision of the surgical area, as seen inFIG. 24.
• Also seen inFIG. 23 is the externalwedge introducer portion400 for the external buttresschannel component200. Buttresschannel200 is designed to gain access to external structures along, around or beneath the brain by elevating the surfaces of the brain to allow access to surgical locations on or near the surface of the brain tissues. In operation, prior to insertion,introducer portion400 is attached to buttresschannel200 such that sloping distal end402 protrudes from the distal open end210 of buttresschannel200. This pushes away brain tissue at theouter brain surface66 gently during insertion. After insertion,introducer portion400 is withdrawn to leave a working channel of decreasing hemi-oval cross section fromproximal end208 to distal end210. Radial surface of buttresschannel200 supports theouter surface66 of thebrain tissue60, best seen inFIG. 24. Note that surface ofwedge introducer400 conforms to the inside of buttress channel surface;proximal end208 and handlemember204 conform to proximal end406 and fixation member408 ofintroducer400 respectively.Fixation member204 of buttresschannel200 is designed to be attached to a standard neurosurgical armature fixation device.
• FIGS. 25 and 26 are diagrammatic view of the instruments working on an external tumor, where the furthersurgical instruments70 are inserting in t0 the operating space formed by the instrument assembly system to allow the surgical team to work on the tissues as necessary.
• FIG. 27 is a diagrammatic view of an embodiment, which may be installed through the forehead as necessary for surgical procedures.FIG. 28 is a diagrammatic view of the instrument assembly installed intobreast tissue68, where it may be used for insertion ofimplants72 and the like.
• FIG. 28 shows use of an arched buttresschannel200 andwedge introducer component400 which may be used, for example, for access to brain tissue or for inserting an inflatable prosthesis into breast tissue.
• FIG. 29 is a perspective exploded view of a surgical kit. TheKit600 includes an injection-molded or vacuum-formedhousing602, providingcavities604 to receive components of the surgicalinstrument assembly system10 and the external retracting buttresschannel system100. Astylette80 may also be included. Upon placement of all desired components within thehousing602, the sterile kit will be sealed with aTyvek sheet606. Upon removal ofsheet606 by the surgeon, the sterile components ofkit600 can be utilized and employed as required in a surgical operation.
• In the foregoing description, certain terms and visual depictions are used to illustrate the preferred embodiment. However, no unnecessary limitations are to be construed by the terms used or illustrations depicted, beyond what is shown in the prior art, since the terms and illustrations are exemplary only, and are not meant to limit the scope of the present invention.
• It is further known that other modifications may be made to the present invention, without departing the scope of the invention, as noted in the appended Claims.

Claims (25)

1. An apparatus providing access to delicate tissue through a transcutaneous incision comprising:

an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer;

said wedge introducer being introduced into an area adjacent to said hollow sleeve;

a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue; and,

said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor.

2. The apparatus providing access into delicate tissue as inclaim 1 further comprising:

said hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter;

said tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter;

said tapered tipped wedge introducer retractor having a length exceeding a predetermined length of said hollow retractor, providing an advancing member extending forward of a distal end of said hollow retractor;

said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said tapered tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve;

said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue; and,

said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue.

3. The apparatus as inclaim 1 wherein said hollow retractor provides access for at least one surgical instrument to a surgical site within the delicate tissue.

4. The apparatus for providing access to delicate tissue as inclaim 1 wherein the hollow retractor and the interleaved tapered tipped wedge introducer spread a portion of delicate tissue apart from another portion of delicate tissue toward the surgical site.

5. The apparatus for providing access to delicate tissue as inclaim 1 wherein the hollow retractor and the interleaved tapered tipped wedge introducer intersect transversally into a portion of delicate tissue at the surgical site.

6. The apparatus as inclaim 1 wherein said hollow retractor supports the delicate tissue thereupon.

7. The apparatus as inclaim 1 wherein said apparatus provides access for at least one inflatable prosthetic member into the delicate tissue and inflating the inflatable member.

8. The apparatus as inclaim 1 wherein said hollow retractor includes a handle attachable to a clamp.

9. The apparatus as inclaim 1 wherein said hollow retractor and said tapered tipped wedge introducer include a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor.

10. The apparatus for providing access to delicate tissue as inclaim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is a closed plane curve.

11. The apparatus for providing access to delicate tissue as inclaim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve.

12. The apparatus as inclaim 1 wherein a distal end of said tapered introducer has a small opening at a distal end thereof, allowing for removal of small portions of tissue from a surgical site.

13. The apparatus for providing access to delicate tissue as inclaim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is generated by a point moving in such a way that the sums of its distances from two fixed points is a constant.

14. The apparatus for providing access to delicate tissue as inclaim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is an elliptical oval-shaped plane section of a circular cone that is a not perpendicular to an axis of the cone.

15. The apparatus for providing access to delicate tissue as inclaim 14 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is an elliptical oval.

16. The apparatus for providing access to delicate tissue as inclaim 2 wherein said arc of said hollow retractor is a portion of a continuous arc.

17. The apparatus for providing access to delicate tissue as inclaim 2 wherein said arc of said hollow retractor is a continuous arc.

18. The apparatus for providing access to delicate tissue as inclaim 2 wherein said arc of said tapered tipped wedge introducer is a portion of a continuous arc.

19. The apparatus for providing access to delicate tissue as inclaim 2 wherein said arc of said tapered tipped wedge introducer is a continuous arc.

20. The apparatus for providing access to delicate tissue as inclaim 2 wherein said closed plane curve is flared outward at a proximal end.

21. A method of providing access into delicate tissue for at least one surgical instrument assembly comprising the steps:

making an incision into delicate tissue;

providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter;

providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter;

said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve;

placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue;

advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein;

retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and,

accessing at least one surgical instrument to the surgical site within the delicate tissue.

22. A method of providing access into delicate tissue for at least one surgical instrument comprising the steps:

making an incision into delicate tissue;

providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter;

providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter;

said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve;

placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue;

advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein;

retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and,

supporting the delicate tissue thereupon.

23. A method of providing access into delicate tissue for at least one surgical instrument comprising the steps:

making an incision into delicate tissue;

providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter;

providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter;

said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve;

placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue;

advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein;

retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and,

accessing at least one inflatable prosthetic member into the delicate tissue and inflating the inflatable member.

24. An apparatus providing access to delicate tissue through a transcutaneous incision comprising:

an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer;

said open sleeve hollow retractor being tapered;

said open sleeve hollow retractor having a decreasing elliptical cross section;

said wedge introducer being tapered;

said wedge introducer having a decreasing elliptical cross section;

said wedge introducer being introduced into an area adjacent to said hollow sleeve;

a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue;

said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor;

said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue;

said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue;

said hollow retractor providing access for at least one surgical instrument to a surgical site within the delicate tissue;

said hollow retractor including a handle attachable to a clamp;

said handle having a base where said handle is attached to said hollow retractor, said handle merging with said base in a cascading shape, interrupting the continuous curve of the proximal end of the hollow retractor, said cascading dip providing easier finger access into a working channel of said hollow retractor; and,

said hollow retractor and said tapered tipped wedge introducer including a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor.

25. An apparatus providing access to delicate tissue through a transcutaneous incision comprising:

an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer;

said open sleeve hollow retractor being tapered;

said open sleeve hollow retractor being arch shaped, having a decreasing arched cross section;

said wedge introducer being tapered;

said wedge introducer being arch shaped, having a decreasing arch shaped cross section;

said wedge introducer being introduced into an area adjacent to said hollow sleeve;

a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue;

said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor;

said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve;

said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue;

said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue;

said hollow retractor providing access for at least one surgical instrument to a surgical site within the delicate tissue;

said hollow retractor including a handle attachable to a clamp;

said handle having a base where said handle is attached to said hollow retractor, said handle merging with said base in a cascading shape, interrupting the continuous curve of the proximal end of the hollow retractor, said cascading dip providing easier finger access into a working channel of said hollow retractor; and,

said hollow retractor and said tapered tipped wedge introducer including a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor.

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