JP5496677B2 - Surgical access device for sensitive tissue - Google Patents

Description

  The present disclosure relates to surgical access instruments and methods of use for sensitive tissue.

  Conventional surgical brain retractors are thin, rigid bands of steel alloy or other metal alloy with sharp or well-defined edges and limited surface area. A common structural form is a simple piece of sheet metal that includes a metal piece that can be folded by hand and a surface that is typically fringed to the brain after a few minutes. Of particular prominence is the pressure mark on the outer edge of the spatula, which indicates a high local compressive stress. These conventional retractors can be introduced into or along the brain tissue and then during surgery, the brain tissue can be pulled strongly, separated or lifted. With this method, it is possible to illuminate and visualize the target area for performing a surgical operation. However, brain tissue is very flexible and delicate, especially after trauma, after a lack of blood supply, or when brain edema is present. Brain tissue is a gel-like substance that is susceptible to damage and can cause complications known as “exclusion injury,” which can lead to brain dysfunction. Brain tissue can be torn by the relatively sharp edges of these retractors, or the displaced brain loses blood supply when local pressure under the retractors exceeds venous pressure There are possibilities, or both. At least one of ischemic changes in the underlying brain and more severe complications of cerebral venous infarction may occur.

  The combination of factors, including the flexibility of brain tissue and the effects of the sharp and dull edges and limited surface area of conventional metal band retractors, results in limiting the visualization of the surgical target area. The brain tends to extend beyond the edge of the retractor or “droop” around it, limiting the area required for illumination and reducing overall visibility.

  Furthermore, the amount of local pressure applied to the brain by the retractor must be limited to avoid injury, which can hinder the surgeon's ability to safely obtain sufficient visualization area. In many cases, surgeons will rely on strategies that expose brain tissue much more than necessary or desirable to open the area around the brain sufficiently wide to limit the amount of retraction pressure. . This method is undesirable for both patients and surgeons when compared to a minimally invasive approach. It would be advantageous to provide a surgical instrument assembly that safely addresses the shortcomings of currently known instruments.

(Object of invention)
The objectives and design principles of the surgical access instrument of the present invention include at least one of the following.
(1) Maximize the surface area of the retractor so that the pressure is evenly distributed and the effective local relieving pressure is minimized.
(2) Enables integration with stereotactic nerve navigation computer guidance systems.
(3) Reduce the need to “pull” the brain retractor and prevent the possibility of inadvertent excessive retraction, thereby avoiding brain damage.
(4) Binocular vision is possible using an elliptical structure.
(5) Enables visualization of target tissue with maximum irradiation access interval.
(6) The use of a small oval window for the supercortical introducer makes it possible to limit corticotomy and minimize brain destruction.
(7) Use a tapered leading edge to minimize brain destruction.
(8) Enables a stable retraction fixation so as to avoid accidental displacement of the retractor.
(9) Provide a retractor of lightweight material and enable easy operation.
(10) Provide a transparent retractor, allowing direct visualization of the underlying brain tissue.
Other objects will become apparent from the following description of the invention.

  In light of these and other objectives that may become apparent, the present invention is directed to a surgical instrument access assembly. The surgical instrument access assembly includes two main components. One component is an internal instrument access assembly and the other element is an external instrument access assembly. The internal instrument access assembly is designed to enter the brain and access deep internal brain structures. The external instrument access assembly is designed to raise the surface of the brain and access external structures along, below or below the brain. Both access assemblies are manufactured in different sizes depending on the needs of individual operations. These retractor materials are made of transparent biocompatible lightweight plastic. Each of the instrument assemblies includes two separate parts: a retractor that also functions as a working channel, and a compatible introducer.

  The internal instrument assembly is preferably a wedge-shaped retractor introducer that includes a hollow wedge formed by, or part of, a closed cross-section such as an elliptical wedge or an arched wedge. . The internal instrument assembly includes a hollow brain access working channel that can be secured in the space of a standard neurosurgical fixation cable device. First, a projecting introducer element having a length that exceeds the length of the hollow working channel is introduced into the working channel. The smooth and relatively flexible tapered end serves to spread the hemisphere of the brain or other parts of delicate brain tissue. Once the working channel is introduced, the introducer is removed, leaving the hollow working channel in place so that the surgeon can access the target tissue. The elliptical working channel, introducer length (Z-axis), width and height (X-axis and Y-axis), etc. can be varied.

  The fixation portion is designed to attach to a standard neurosurgical armature fixation cable device.

  The external surgical access instrument assembly features an arcuate semi-elliptical structure that is wider along the base (X axis) than at height (Y axis). It is designed to attach to a standard neurosurgical armature fixation cable device with a smooth and tapered leading edge, a handle fixation portion of the same design as the handle fixation portion of the internal instrument assembly. The length (Z axis) and the X and Y axes can be varied.

  Thus, the present invention provides access to access a surgical site, insert an inflatable prosthesis, or provide an external buttress channel to support tissue thereon, etc. For one of various reasons, it includes one or more surgical instrument assemblies for providing access to sensitive tissue such as brain tissue or breast tissue through a percutaneous incision. The surgical instrument assembly includes an interleaved combination of hollow retractors with open sleeves and tapered tip wedge introducers. A wedge-shaped introducer is introduced in the region adjacent to the hollow sleeve. The distal end of the wedge-shaped introducer is a hollow retractor such that the wedge-shaped introducer traverses the delicate tissue in front of the distal end of the hollow retractor and guides the hollow retractor into place in the delicate tissue. Extends beyond the distal end of the hollow retractor forward of the distal end of the tube.

  When used in conjunction with a working surgical instrument, the distal end of the introducer preferably has a small oval opening to allow very little tissue removal from the surgical site.

  The hollow retractor may have a diameter that is a closed curve such as an ellipse. In such cases, a tapered tip wedge introducer is inserted into a closed curve hollow retractor. In an alternative embodiment, the tapered tip wedge introducer has a diameter that is an arc, the arc is part of a closed curve, and the tapered tip wedge is an arc that can be inserted into a closed curved hollow retractor. It is.

  When used as an external working channel, the distal end of the working channel is bell-shaped, allowing for increased surface area exposure.

  Alternatively, the hollow retractor can be an arc that is part of a closed curve or can form an arcuate shape. In such cases, the wedge-shaped introducer at the tapered tip of the curve can be an arc that is part of a closed curve or can also form an arcuate shape.

  In the case where at least one of the hollow retractor and the wedge-shaped introducer with a tapered tip has a diameter of at least one arc of the curve, preferably they have a decreasing diameter of the curved cross section.

  Also, when the hollow retractor is arcuate, such as an oval cross section, as opposed to a closed curve type, the wedge-shaped introducer is placed adjacent to the concave surface of the hollow retractor.

  If the hollow retractor is a closed curve, i.e. has an elliptical cross-section, preferably a closed curve with a diameter decreasing towards the edge that contacts its distal tissue, the hollow retractor and wedge-shaped introducer Using interleaved combinations, spread adjacent to delicate tissues such as the left and right hemispheres of the brain, or across delicate tissues such as brain tissue to the surgical site within the delicate tissues Provide internal access.

  If the hollow retractor is arcuate, i.e. arcuate, i.e. has a diameter that is part of a closed curve, then a combination of hollow retractor and wedge-shaped introducer is used and the delicate tissue is the convex surface of the hollow retractor Providing access to the delicate tissue supported by the outer surface of the tube and forming a support buttress after removal of the arcuate wedge introducer.

  Furthermore, if the hollow retractor is also arched, i.e. having an arc, i.e. a diameter that is part of a closed curve, additionally, a combination of hollow retractor and wedge-shaped introducer can be used to achieve delicate tissue. After removing the arched wedge introducer from the hollow arched retractor, an expandable member such as a breast prosthesis is inserted into the delicate breast tissue and inflated.

  The wedge-shaped introducer with the tip has an outer surface corresponding to the inner surface of the hollow sleeve, and the wedge-shaped introducer with the closed tip is a declining curved section arch that approximates the curved section arch of the opening sleeve of the retractor. Can have a diameter of

  Preferably, the hollow retractor includes a handle attachable to the clamp.

  Optionally, the hollow retractor and the tapered tip wedge introducer include a lock that temporarily locks the tapered tip wedge introducer adjacent to the hollow retractor.

  If the hollow retractor has an elliptical cross section, the plane closed curve is caused by a point that moves so that the sum of its distances from the two fixed points is constant, or the plane closed curve is on the axis of the cone. An oval planar cross section of a non-conical cone, thereby forming a plane elliptical piece through the cone.

  The hollow retractor can also extend at the proximal end. In addition, where the base of the handle is attached, the handle can be coupled in a cascade fashion to block the continuous curve at the proximal end of the hollow retractor. Such a cascade-type indentation structure allows easier finger access to the working channel of the hollow retractor.

  Further, the hollow retractor can have an elliptical cross-sectional diameter that has a wider varying cross-section or a narrower varying cross-section in selected regions of the hollow retractor working channel. .

  The invention can best be understood in conjunction with the accompanying drawings. It should be noted that the present invention is not limited to the specific embodiments shown in the drawings.

FIG. 6 is a view of a patient with a retractor assembly and support channel disposed adjacent to the upper and lower skull. FIG. 2 is a perspective view of the retractor assembly of FIG. 1. FIG. 3 is an exploded view of the part of FIG. 2. It is a top view of an introducer. FIG. 6 is a proximal end view of an introducer. It is an elevational view of a side section of the introducer. It is upper surface sectional drawing of an introducer. FIG. 8 is a rectangular view of the locking tab taken from FIG. 7. It is a top view of a locking tab. FIG. 3 is a proximal end view of a retractor. FIG. 4 is an elevational view of a side cross section of a retractor. It is a top sectional view of a retractor. FIG. 13 is a rectangular view of the groove taken from FIG. 12. FIG. 14 is a rectangular view of the locking tab and groove as seen from 14-14 in FIG. 2; FIG. 3 is a proximal end view of the assembly as viewed from arrow 15 of FIG. FIG. 6 is an illustration of an instrument assembly inserted into the upper skull. FIG. 6 is an illustration of an instrument assembly for spreading the cerebral lobe. FIG. 18 is a view of the installed instrument assembly with the introducer ear bent as seen from arrows 18-18 of FIG. FIG. 6 is a view of the instrument assembly with the introducer removed. FIG. 6 is a view of a surgical instrument in a retractor channel. 1 is a schematic cross-sectional view of an embodiment installed laterally within a tissue. FIG. FIG. 6 is an external instrument assembly system adjacent to the lower skull. FIG. 23 is an exploded view of the assembly part of FIG. 22. FIG. 3 is a perspective view of an instrument assembly system installed in the lower skull. FIG. 4 is a diagrammatic side view of an installed instrument assembly with the introducer removed. FIG. 3 is a diagram of an instrument for tackling an external tumor. FIG. 6 is a diagram of an alternative embodiment installed from the front. FIG. 4 is a diagrammatic view of an instrument assembly installed in breast tissue. It is an exploded perspective view of a surgical kit.

  The present disclosure relates to surgical instrument assemblies and systems for use with delicate tissue and methods of using the instrument assemblies. The instrument can be used in any medical situation, but is designed to be used on delicate tissues such as brain tissue and breast tissue during surgery. The instrument assembly includes various portions such as an introducer portion, a tissue access channel retractor portion having at least one handle portion ("channel portion"), and a stylet portion. These instrument parts maximize the surface area of the retractor that distributes pressure almost uniformly across the surrounding tissue, minimizing the local effective relieving pressure to the tissue that contacts or immediately surrounds the instrument. To be formed.

  In one embodiment, the surgical instrument assembly is an arched or arcuate retractor into which an arched or arcuate wedge introducer can be inserted for surgical access to the exterior or surface of the brain. There should be.

  In another embodiment, the surgical instrument assembly comprises a tapered elliptical cross-section wedge retractor into which a tapered elliptical cross-section introducer can be inserted for surgical access to the exterior or surface of the brain. It is good to be.

  Alternatively, an external retractor and wedge introducer can be used to insert a medical / beauty device into or under sensitive tissue.

  The surgical instrument assembly system also uses an external retractor as an external brain support buttress channel portion that lifts the brain tumor upward relative to the skull, provides stability during surgery, and prevents migration of gelatinous brain material Can do. The ability of the brain support buttress channel portion ("buttress portion") also provides improved visualization and improved access to the surgical site by lifting the cranial brain material upward.

  The construction of the instrument assembly initially provides sufficient working area through the channel retractor, eliminating the need to “pull” the retractor portion to clearly visualize the surgical area. The use of the tissue access channel retractor portion of the instrument assembly eliminates or significantly reduces the possibility of inadvertent excessive retraction. By avoiding excessive exclusion, damage to surrounding tissues, including possible brain damage, is also avoided.

  The structure of the instrument assembly is preferably oval or arched so that when other closed curve structures are used, the binocular vision can be provided to the medical staff, rather than the monocular vision typically found in similar devices. It is a shape structure. This elliptical structure also provides a better spatial distance for illumination access that illuminates the target surgical area and makes it fully visible. The leading edge of the channel retractor is preferably tapered in order to lightly separate the tissue to obtain a surgical area and minimize tissue collapse.

  The surgical instrument assembly system is also useful as an insertion instrument for breast implants.

  The dimensions of the surgical instrument assembly can vary and can vary depending on the intended use. Generally, the surgical working space formed by introducer portion 40 ranges from about 10 millimeters ("mm") to about 100 mm, more typically from about 25 mm to about 75 mm, in its closed configuration. Have a range of diameters. The open configuration of the introducer portion 40 extends the diameter of the distal end 42 of the introducer portion 40 by a few millimeters and is typically surgical teams as it is introduced into the lumen 22 of the retractor 20 during use. Can be determined by the amount of extension desired, which results in a roller including a flexible band portion 14 for increased flexibility. The open structure can also be determined by the overall circumference and diameter desired for the particular use of the surgical instrument assembly and is manufactured in various practical sizes so that it can be used as a practical one. be able to. The surgical instrument assembly can be formed of any biocompatible material that provides sufficient stability and strength necessary to provide a surgical work area. The biocompatible material can be disposable or sterilized for repeated use. In one embodiment, the surgical instrument assembly can be formed of a lightweight plastic material for easy manipulation, or the material provides direct visualization of the underlying brain tissue through the instrument assembly portion. It can be transparent to allow, or both.

  The surgical instrument assembly system also allows for integration with a stereotactic nerve navigation computer guidance system to enhance visualization of the surgical area of the brain.

  FIG. 1 shows, in diagram form, a surgical instrument assembly system 10 adjacent to a surgical opening in the intubated patient's skull. The external retractor system 100 is also spaced from the lower skull and will be described later herein.

  FIG. 2 is an enlarged perspective view of the surgical instrument assembly system 10 shown in FIG. The instrument assembly system 10 includes two components, a retractor 20 and an introducer 40.

  FIG. 3 shows the relationship between the introducer 40 and the retractor 20 before assembly. It is desirable that the introducer be easily secured to and removable from the retractor both before and during surgery.

  As also shown in FIG. 3, the surgical instrument assembly system can be formed in any manner, including injection molding, as a single piece or from two or more pieces that are permanently fixed and bonded together. be able to. The distal end 42 of the introducer portion 40 is preferably a hard, round cone that may or may not include an opening 52 in the surrounding tissue, as opposed to a cannula structure that always provides a distal opening. It is a shape. The distal end 42 preferably includes a gently increasing circumference that increases and expands toward the proximal end 56 of the introducer portion 42. Introducer portion 40 has a body 50 and is divided into two approximate handle halves 46 and may have a V-shaped cutout 48 between the handle halves. The half end of the proximal end 56 is an integrated unit, and the term “half end” is used only to describe the shape and is not two separable half ends and does not represent a separable part. The proximal end 56 can include at least one handle portion 46 that extends outward at an angle of about 90 degrees. The handle portion 46 is useful to allow medical team members to physically insert, manipulate, or grasp the handle portion 46, or attach a conventional surgical fixation cable to the handle portion 12. be able to. The at least one handle portion 46 includes at least one indentation or groove 44 to incorporate or fit into an additional portion of the surgical instrument assembly 10.

  FIGS. 4-8 show various views of the retractor portion 20 of the present disclosure, including the retractor 20 with a hollow working channel 22 and a handle 28. The retractor 20 can generally be slidably inserted into the brain access working channel 22 of the retractor portion 20 and is sized and shaped to match the introducer portion 40. The retractor portion 20 is generally shorter than the introducer portion 40 so that the distal end 42 of the introducer portion 40 can interact with the surrounding housing 21 tissue. As best seen in FIGS. 6 and 7, the retractor portion 20 is formed as a hollow oval and round wedge with a tapered distal leading edge 24. The proximal edge of the retractor 20 includes a slightly circular lip 26 and a handle portion 28. At least one tab 30 is formed in the wedge 21, just distal to the lip 26. The tab 30 is reliably aligned with the groove 44 of the introducer 40 so as to prevent or inhibit unnecessary movement or slipping of the instrument assembly parts, most commonly seen in the cross-sectional view of FIG. The handle portion 28 allows the retractor portion 20 to be secured in space using standard or conventional neurosurgical fixation cable devices.

  FIG. 9 shows a side view of the retractor 20 having a proximal end 26 of the surgical instrument assembly, and optionally having a handle portion 28 perpendicular to the proximal end 26, wherein the length of the oval of the retractor 21 is Extends to the circular distal end 24. FIG. 10 is a front view of retractor 20 showing lumen 30 and handle portion 28. FIG. 11 is a side view of the retractor 20 of the circular shape retractor 20 avoiding damage to delicate tissue. FIG. 12 shows that both the retractor 20 and the introducer 50 allow the introducer 40 to be fully secured in the hole 30 and temporarily locked and fitted, thereby being desirable for the medical team. FIG. 6 is a plan view of the retractor 20 with the groove-like cutout hole 30 acting as one highlighted. FIG. 13 is an enlarged view of the groove-shaped hole 30. FIG. 14 is a side view of the tab 44 of the introducer 20 when engaged within the slotted hole 30 of the retractor 20.

  FIG. 15 shows a proximal end view of the assembled instrument with the handle portion 46 covering the lip 26 of the retractor 20 and a V-shaped cutout 48 within the lumen 22. The handle 28 of the retractor 20 is molded integrally with the lip 26 and provides both rigidity and strength. FIG. 15 is the portion where the base of the handle 28 is attached to the retractor 20, the handle 28 being optionally coupled to a cascaded recess 28 a to block the continuous curve at the proximal end of the hollow retractor 20. Also shown. Such a cascaded recess 28a allows for easier finger access into the working channel of the hollow retractor 20.

  FIGS. 16-20 schematically illustrate a method for implanting the surgical instrument assembly 10 into the opening 12 of the skull 14. As seen in FIG. 16, the instrument assembly 10 is inserted into the opening 12. The distal end 42 of the introducer 40 is adjacent to the brain tissue 60. As shown in FIG. 17, when the instrument assembly 10 is introduced, the distal end 42 of the introducer 40 begins to expand the leaves 62 and 64 of the brain 60. 18 is an elevational view of the installed surgical instrument assembly 10 taken along arrows 18-18 of FIG. When installed, the handle 46 of the introducer 40 can be bent inward, thereby releasing the tab 30 of the retractor 20 from the groove 44 of the introducer 40. FIG. 19 shows the introducer 40 being removed from the lumen 22 of the retractor 20. FIG. 20 shows the surgical instrument 70 within the lumen 22 of the retractor 20 examining the brain tissue 60.

  FIG. 21 is a schematic perspective view of an embodiment of the surgical instrument assembly 10 adjacent to the opening 12 located in the temporal region of the patient's skull 14. In this embodiment, the overall length of the surgical instrument assembly 10 is sufficient to penetrate the skull and brain tissue 60 laterally. FIG. 22 shows the surgical instrument assembly 10 installed.

  FIG. 23 is a perspective view of the external contraction buttress channel 100. The outer buttress channel instrument assembly 100 includes a buttress channel component 200 and a wedge introducer component 400. The outer buttress channel component 200 generally has an arcuate semi-elliptical structure that is wider along its base than its height. Buttress channel component 200 includes a smooth, tapered leading edge 202. The handle securing member 204 is generally perpendicular to the circular lip 206 at the proximal end 208. The handle member 204 can be used as a connection point to a standard neurosurgical fixation device. As seen in FIG. 24, the external buttress channel component 200 is used to lift, support, or support the brain within the cranial cavity to provide further or improved visibility of the surgical area, or It is possible to manipulate its brain.

  FIG. 23 also shows the outer wedge-shaped introducer portion 400 of the outer buttress channel component 200. Buttress channel 200 raises the surface of the brain to allow access to surgical locations on or near the surface of the brain tissue, and external structures along, around or below the brain. Designed to be accessible to. During operation, the introducer portion 400 is attached to the buttress channel 200 such that the angled distal end 402 protrudes from the open end 210 of the buttress channel 200 prior to insertion. This causes the brain tissue to be gently pushed onto the outer surface 66 of the brain during insertion. After insertion, the introducer portion 400 is withdrawn and a decreasing semi-elliptical section working channel is placed from the proximal end 208 to the distal end 210. As best seen in FIG. 24, the radial surface of the buttress channel 200 supports the outer surface 66 of the brain tissue 60. Note that the surface of wedge-shaped introducer 400 conforms to the inside of the buttress channel surface, and proximal end 208 and handle member 204 conform to proximal end 406 and securing member 408 of introducer 400, respectively. The fixation member 204 of the buttress channel 200 is designed to be attached to a standard neurosurgical armature fixation device.

  FIGS. 25 and 26 are diagrammatic views of an instrument that operates on an external tumor, where the operations formed by the instrument assembly system so that the surgical team can perform operations on the tissue as needed. A further surgical instrument 70 is inserted into the space.

  FIG. 27 is a diagram of an embodiment that may be placed from the frontal as needed for surgery. FIG. 28 is a diagram of an instrument assembly installed in breast tissue 68 that can be used to insert implant 72 and the like.

  FIG. 28 illustrates the use of arcuate buttress channel 200 and wedge-shaped introducer portion 400 that can be used, for example, to access brain tissue or to insert an inflatable prosthesis into breast tissue.

  FIG. 29 is an exploded perspective view of the surgical kit. The kit 600 includes an injection molded or vacuum formed housing 602 that provides a cavity 604 for receiving components of the surgical instrument assembly system 10 and the external shrinkable buttress channel system 100. A stylet 80 may also be included. Once all desired parts are installed in the housing 602, the sterile kit is sealed with a Tyvek sheet 606. When the surgeon removes the seat 606, the sterile parts of the kit 600 can be used as needed for the surgical procedure.

  In the foregoing description, certain terms and visual depictions are used to indicate preferred embodiments. However, the terms and illustrations are for illustrative purposes only and are not intended to limit the scope of the present invention, and are not to be construed as unnecessary limitations due to the terms used or the illustrations shown.

  It is further well known that other modifications can be made to the invention without departing from the scope of the invention as set forth in the appended claims.

Claims (21)

A device that provides access to delicate tissue by percutaneous incision,
Comprising interleaved combinations of hollow retractors with open sleeves and tapered tip wedge introducers;
The wedge-shaped introducer is introduced into a region of the hollow retractor adjacent to the opening sleeve;
The distal tip of the wedge-shaped introducer causes the wedge-shaped introducer to traverse the delicate tissue in front of the distal end of the hollow retractor and guide the hollow retractor to a predetermined location of the delicate tissue. A rounded wedge extending beyond the distal end of the hollow retractor in a position region forward of the distal end of the hollow retractor;
The tapered wedge-shaped introducer is removable from the open sleeve of the hollow retractor adjacent to the delicate tissue, leaving the delicate tissue exposed to the open sleeve of the hollow retractor;
The hollow retractor has an open sleeve having a diameter of at least one arc of curve having a diameter of a decreasing curved cross section;
The tapered tip wedge introducer has a diameter of at least one arc of a curve having a decreasing cross-sectional diameter;
The tapered tip wedge introducer has an outer surface corresponding to the inner surface of the open sleeve of the hollow retractor ;
The tapered tip wedge introducer has a diameter with a decreasing curved cross-section arc that approximates the curved cross-section arc of the opening sleeve;
The device wherein the distal end of the tapered tip introducer has a small opening at its distal end to allow removal of a small portion of tissue from the surgical site. An apparatus for providing access to delicate tissue according to claim 1,
The tapered tip wedge introducer has a length that exceeds a predetermined length of the hollow retractor and provides an advancement member that extends forward of the distal end of the hollow retractor;
The hollow retractor and the tapered tip wedge introducer can be inserted adjacent to the delicate tissue;
The device wherein the hollow retractor and the tapered tip wedge introducer are advanced together into the delicate tissue.   The apparatus of claim 1, wherein the hollow retractor provides at least one surgical instrument with access to a surgical site in the delicate tissue.   2. The device for providing access to delicate tissue according to claim 1, wherein the hollow retractor and the interleaved tapered tip wedge-shaped introducer are configured so that a portion of the delicate tissue is another part of the delicate tissue. A device characterized in that it is spread out in the direction of the surgical site.   2. The apparatus for providing access to delicate tissue according to claim 1, wherein the hollow retractors and the interleaved tapered tip wedge-shaped introducers laterally into a portion of the delicate tissue at the surgical site. A device characterized by intersecting.   The device of claim 1, wherein the hollow retractor supports the delicate tissue thereon.   The device of claim 1, wherein the device provides at least one inflatable prosthetic member with access to the delicate tissue and inflates the inflatable member.   The device of claim 1, wherein the hollow retractor includes a handle attachable to a clamp.   The hollow retractor and the tapered tip wedge introducer include a lock that temporarily locks the tapered tip wedge introducer adjacent to the hollow retractor. The device described in 1.   The apparatus for providing access to delicate tissue according to claim 2, wherein the at least one arc of the curve of the diameter of the hollow retractor is a planar closed curve.   3. The apparatus for providing access to delicate tissue according to claim 2, wherein at least one arc of the curve of the diameter of the hollow retractor is a partial arc of a planar closed curve. apparatus.   The apparatus for providing access to delicate tissue according to claim 2, wherein the at least one arc of the curve of the diameter of the hollow retractor is an arc of a portion of a plane closed curve, and the plane closed curve. Is caused by a point moving so that the sum of its distances from two fixed points is a constant value.   The apparatus for providing access to delicate tissue according to claim 2, wherein the at least one arc of the curve of the diameter of the hollow retractor is an arc of a portion of a plane closed curve, the plane closed curve being A device characterized in that it is an elliptical cross section of a cone that is not perpendicular to the axis of the cone.   14. The apparatus for providing access to delicate tissue according to claim 13, wherein at least one arc of the curve of the diameter of the hollow retractor is a partial arc of a plane closed curve, the plane closed curve being an ellipse. A device characterized by being.   The apparatus for providing access to delicate tissue according to claim 2, wherein the arc of the hollow retractor is part of a continuous arc.   The apparatus for providing access to delicate tissue according to claim 2, wherein the arc of the hollow retractor is a continuous arc.   The apparatus of claim 2, wherein the apparatus provides access to delicate tissue, wherein the arc of the tapered tip wedge introducer is part of a continuous arc.   3. The device of claim 2, wherein the device provides access to delicate tissue, wherein the arc of the tapered tip wedge introducer is a continuous arc.   The device of claim 2, wherein the device provides access to delicate tissue, wherein the planar closed curve extends outward at the proximal end. A device that provides access to delicate tissue by percutaneous incision,
Comprising an interleaved combination of hollow retractors with open sleeves and tapered tip wedge-shaped introducers;
The hollow retractor comprising the opening sleeve is tapered,
The hollow retractor provided with the said opening sleeve has a decreasing elliptical cross section,
The wedge-shaped introducer is tapered;
The wedge-shaped introducer has a decreasing elliptical cross section;
The wedge-shaped introducer is introduced into a region of the hollow retractor adjacent to the opening sleeve;
The distal tip of the wedge-shaped introducer causes the wedge-shaped introducer to traverse the delicate tissue in front of the distal end of the hollow retractor and guide the hollow retractor to a predetermined location of the delicate tissue. A rounded wedge extending beyond the distal end of the hollow retractor in a position region forward of the distal end of the hollow retractor;
The wedge-shaped introducer at the tapered tip is removable from the opening sleeve of the hollow retractor adjacent to the delicate tissue while exposing the delicate tissue to the opening sleeve of the hollow retractor.
The tapered tip wedge introducer has an outer surface corresponding to the inner surface of the open sleeve of the hollow retractor ;
The hollow retractor and the tapered tip wedge introducer can be inserted adjacent to the delicate tissue;
The hollow retractor and the tapered tip wedge introducer advance together into the delicate tissue;
The hollow retractor provides at least one surgical instrument with access to a surgical site in the delicate tissue;
The hollow retractor includes a handle attachable to a clamp;
The handle has a base to which the handle is attached to the hollow retractor, the handle being coupled to the base in a cascade fashion, blocking a continuous curve at the proximal end of the hollow retractor, and The mold cavity provides easier finger access to the working channel of the hollow retractor;
The hollow retractor and the tapered tip wedge introducer include a lock that temporarily locks the tapered tip wedge introducer adjacent to the hollow retractor;
The hollow retractor has an open sleeve having a diameter of at least one arc of curve having a diameter of a decreasing curved cross section;
The tapered tip wedge introducer has a diameter of at least one arc of a curve having a decreasing cross-sectional diameter;
The tapered tip wedge introducer has a diameter with a decreasing curved cross-section arc that approximates the curved cross-section arc of the opening sleeve;
The device wherein the distal end of the tapered tip introducer has a small opening at its distal end to allow removal of a small portion of tissue from the surgical site. A device that provides access to delicate tissue by percutaneous incision,
Comprising an interleaved combination of hollow retractors with open sleeves and tapered tip wedge-shaped introducers;
The hollow retractor with the open sleeve is tapered,
The hollow retractor with the opening sleeve is arched, having a reduced arched cross-section,
The wedge-shaped introducer is tapered;
The wedge-shaped introducer is arcuate, having a reduced arcuate cross-section;
The wedge-shaped introducer is introduced into a region of the hollow retractor adjacent to the opening sleeve;
The distal tip of the wedge-shaped introducer causes the wedge-shaped introducer to traverse the delicate tissue in front of the distal end of the hollow retractor and guide the hollow retractor to a predetermined location of the delicate tissue. A rounded wedge extending beyond the distal end of the hollow retractor in a position region forward of the distal end of the hollow retractor;
The wedge-shaped introducer at the tapered tip is removable from the opening sleeve of the hollow retractor adjacent to the delicate tissue while exposing the delicate tissue to the opening sleeve of the hollow retractor.
The tapered tip wedge introducer has an outer surface corresponding to the inner surface of the open sleeve of the hollow retractor ;
The hollow retractor and the tapered tip wedge introducer can be inserted adjacent to the delicate tissue;
The hollow retractor and the tapered tip wedge introducer advance together into the delicate tissue;
The hollow retractor provides at least one surgical instrument with access to a surgical site in the delicate tissue;
The hollow retractor includes a handle attachable to a clamp;
The handle has a base to which the handle is attached to the hollow retractor, and the handle is coupled to the base in a cascaded manner, interrupting a continuous curve at the proximal end of the hollow retractor, and the cascaded Indentation provides easier finger access to the working channel of the hollow retractor;
The hollow retractor and the tapered tip wedge introducer include a lock that temporarily locks the tapered tip wedge introducer adjacent to the hollow retractor;
The hollow retractor has an open sleeve having a diameter of at least one arc of curve having a diameter of a decreasing curved cross section;
The tapered tip wedge introducer has a diameter of at least one arc of a curve having a decreasing cross-sectional diameter;
The tapered tip wedge introducer has a diameter with a decreasing curved cross-section arc that approximates the curved cross-section arc of the opening sleeve;
The device wherein the distal end of the tapered tip introducer has a small opening at its distal end to allow removal of a small portion of tissue from the surgical site.

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