Deep orbital retractor

Abstract

The present disclosure provides a deep orbital access retractor (DOAR) device, which includes an operable body portion, the body portion including a compressible handle having a size and shape that is operated by at least two (2) fingers of a clinician. A flexible head portion has two (2) arms, each arm having a distal end and a proximal end, the distal ends of the arms being spaced apart to form a gap therebetween at a distal tip portion. A flexible flange material wraps around and encapsulates the two arms and the gap and extends around the periphery of the flexible head portion. A flexible diaphragm is attached to and extends between the two arms to provide an overall spoon-shaped flexible head portion. The flexible head portion is connected to the compressible handle portion, and the connection is configured so that upon compression of the handle portion, the arms are looped relative to each other, thereby causing the flexible head portion to narrow to allow insertion into the orbit and positioning between soft tissue and bone, while the flexible diaphragm remains sufficiently stretched so as not to obstruct the operator's observation of the interior of the orbit. When compression is released, the flexible diaphragm is exposed to sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents and allow access to the orbital wall.

Description

Technical Field

[0001] The present disclosure relates to a deep orbital access retractor (DOAR) device designed as a flexible and expandable retractor capable of conforming to the contours of each patient's orbital wall to create a sealed barrier to fat, muscle, and other soft tissue that would otherwise pass through any gaps between the retractor and the bone wall and obstruct visualization and access to the surgical field. Background Art

[0002] Orbital surgery is performed when injury, cancer, or congenital defects change the shape and structure of the eye socket, which consists of four bony walls that meet at one end. Orbital fractures are very common due to trauma. In these cases, the bony walls of the orbit must be rebuilt to ensure full function and appearance of the eye and its surrounding tissues are restored.

[0003] Visualizing these walls to increase surgical precision with better control and instrumentation is a technical challenge experienced by all surgeons performing orbital surgery (plastic surgeons, ophthalmologists, otolaryngologists, etc.) This is because the orbit is a very confined space filled with soft tissues (fat, muscle, globe, etc.) that move fluidly when displaced and must be held under pressure to facilitate visualization of one or more walls.

[0004] Insertion of orbital implants, used to reconstruct orbital walls that have been removed due to cancer or defects due to trauma or birth anomalies, requires full visualization of the surrounding bone (e.g., the edges of a hole in the bone), after which the implant must remain stable and fully restore normal contours. Inadequate visualization of the bone edges and / or incorrect placement of the implant thereon may result in prolonged surgery and numerous complications, including: restricted eye movement, orbital displacement, double vision, etc.

[0005] Current surgical orbital insertion retractable devices and retractors have several disadvantages, including the fact that they are rigid and do not conform to the orbital wall to hold the soft tissue. The inevitable gap between these metal retractors and the bone wall allows soft tissue to "spill over" into the surgical field, thereby hindering visualization and instrument manipulation, which increases surgical time and reduces the precision of surgery and surgical reconstruction. The latter may lead to serious complications such as muscle entrapment (restricted eye movement), orbital displacement due to improper implant placement, or damage to important structures due to poor visualization and poor retraction of those structures. In addition, the rigidity of current retractors leads to significant compression of the orbital contents during retraction, which may cause injury.

[0006] Additionally, prior orbital retractor designs show that the extended head of the retractor is made of a material similar to the frame (i.e., stainless steel and / or titanium) that has significant rigidity in the entire assembly. Furthermore, the head is divided into a series of flat or concave plates that fan outward from a central hinge located at the tip. They are rigidly fixed at this point and can only rotate about this point. The conforming edges of the plates designed to contact the soft tissue and bone are rigid. These edges do not conform to the orbital wall, nor do they seal the orbital contents from the orbital defect.

[0007] It would therefore be advantageous to provide a deep orbital access retractor (DOAR) device that addresses the above-mentioned deficiencies and provides a flexible head portion that allows a greater number of degrees of freedom of movement of the retractor during operation by the operator. Summary of the invention

[0008] The deep orbital access retractor device disclosed herein is designed as a flexible and expandable retractor to be able to conform to the contours of each patient's orbital wall, regardless of anatomical differences, to create a sealed barrier to fat, muscle and other soft tissue that would otherwise pass through any gap between the retractor and the bone wall, obscuring the surgeon's field of view and hindering the use of instruments. The latter is required to replace or repair a broken, missing or defective wall or floor, or to remove bone for tumor ablation, decompression of the orbit, or access to structures adjacent to the orbit. Current retractors are rigid (metal) and suboptimal because they do not conform adequately to the orbital wall to keep soft tissue contents out of view. The gap between the metal retractor and the bone wall allows soft tissue to pass (herniate) into the surgical field, hindering visualization and / or passage of instruments or implants.

[0009] The present disclosure provides a deep orbital approach retractor, comprising:

[0010] a) a compressible handle portion having a size and shape to be manipulated by at least two (2) fingers of a clinician;

[0011] b) a flexible head portion having two (2) arms, each arm having a distal end and a proximal end, said distal ends of said arms being spaced apart to form a gap therebetween at a distal tip portion, a flexible flange material wrapping and encapsulating said two arms and said gap and extending around a periphery of said flexible head portion and including a flexible diaphragm attached to and extending between said arms to provide an overall scoop-shaped flexible head portion; and

[0012] c) the flexible head portion is connected to the compressible handle portion, and the connection between the compressible handle portion and the proximal end of the trailing arm is configured such that upon compression of the handle portion, the arms are looped relative to each other, thereby causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct the operator's observation of the interior of the eye socket, and wherein when the compression is released, the flexible diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's eye socket contents and allow access to the eye socket wall.

[0013] The flange material wrapping and encapsulating the two arms and the gap may have a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement and out-of-plane movement of the distal ends of the arms.

[0014] The deep orbital access retractor may include a deformable material positioned in the gap between the distal ends of the arms and proximate to the distal ends of the arms.

[0015] The present disclosure provides a deep orbital approach retractor, comprising:

[0016] a) a compressible handle portion having a size and shape to be manipulated by at least two (2) fingers of a clinician;

[0017] b) a flexible head portion having two geometrically opposed and arcuate arms, each arm having a proximal end and a distal end, the distal ends of the arcuate arms being separated from each other by a gap at a distal tip portion, each trailing arcuate arm being connected at its proximal end to a compressible handle portion, a flexible flange material being attached to the arcuate arms and extending around a periphery of the flexible head portion and encapsulating the gap at the distal tip portion, a flexible diaphragm being attached to and extending between the arcuate arms, the distal ends of the arcuate arms having a geometry and shape, and the flange material encapsulating the distal tip portion having a material density difference configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement of the distal ends of the arcuate arms and out-of-plane movement; and

[0018] The connection between the compressible handle portion and the proximal ends of the arcuate arms is configured such that upon compression of the handle portion, the arms loop relative to each other, causing the flexible head portion to narrow to allow insertion into the orbit and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct an operator's viewing of the interior of the orbit, and wherein when the compression is released, the diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents while allowing access to the orbital wall.

[0019] The flange material wrapping and encapsulating the two arcuate arms and the gap may have a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement and out-of-plane movement of the distal ends of the arcuate arms.

[0020] The deep orbital access retractor may include a deformable material positioned in the gap between and proximate to the distal ends of the arcuate arms.

[0021] The present disclosure provides a deep orbital approach retractor, comprising:

[0022] a) an operable main body portion comprising a handle and two geometrically opposed handle arms, each having a distal end and a proximal end, the proximal end being hingedly connected to the handle; and

[0023] b) a flexible head portion having two geometrically opposed and arcuate trailing arms, each having a proximal end and a distal end, each trailing arm being hingedly connected at its proximal end to a respective distal end of one of the opposing handle arms, the distal ends of the arcuate trailing arms being separated from one another by a gap at a distal tip portion, each arcuate trailing arm and the gap being encapsulated by a flexible flange material extending around a periphery of the flexible head portion, a flexible diaphragm being connected to the trailing arms to form an overall scoop-shaped flexible head portion, the distal end having a geometric structure and shape, and the flange material encapsulating the distal tip portion having a material density difference configured to produce a hinge-like structure of the distal tip portion that provides asymmetric or overall movement of the distal end of the trailing arm and out-of-plane movement; and

[0024] The opposing handle arms are coupled to a biasing mechanism configured to bias the opposing handle arms away from each other, and when the clinician squeezes the opposing handle arms together, the distal ends of the opposing handle arms and the proximal end of the arcuate trailing arm come together, thereby causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct the operator's observation of the interior of the eye socket, and wherein when the compression is released, the diaphragm exhibits sufficient stretch and rigidity to apply sufficient force to the patient's eye socket contents to allow access to the eye socket wall.

[0025] The biasing mechanism can be a spring mechanism, the opposing arms are coupled to a spring mechanism configured to bias the opposing arms away from each other, and when the clinician squeezes the opposing arms together, the distal ends of the opposing arms and the proximal end of the trailing arm come together, thereby causing the flexible membrane to have sufficient stretch and rigidity to apply sufficient force to the patient's orbital contents to allow access to the orbital wall.

[0026] The device may include a flexible material separating the distal end of the opposing arm and the proximal end of the trailing arm in each hinge connection to provide additional freedom of movement of the opposing arm and the proximal end of the trailing arm.

[0027] The device may include a flexible material separating the proximal ends of the opposing arms in a hinged connection in the handle to provide additional freedom of movement of the opposing arms and the proximal end of the trailing arm.

[0028] The device may include a flexible material located in the gap separating the distal ends of the trailing arms to provide additional freedom of movement of the distal ends of the trailing arms.

[0029] The device may also include a camera mounted on the handle having a field of view including the flexible head portion.

[0030] The deep orbital access retractor device may include at least one light source mounted thereon to illuminate a surgical area of ​​the patient where the device is used.

[0031] The deep orbital access retractor device may include a light source mounted to a geometrically opposed arm at each hinge connection of the trailing arm.

[0032] Each light source may be a light emitting diode.

[0033] The device may include a power source located in the handle that is electrically connected to the camera and the light source.

[0034] The spring mechanism may be secured in geometrically opposed arms.

[0035] The deep orbital access retractor device may also include a finger pad mounted adjacent the proximal ends of the geometrically opposed arms and sized and shaped to accommodate a clinician's finger.

[0036] The flexible diaphragm and the flexible flange may be a single piece made of the same material with the flexible flange being thicker than the flexible diaphragm so as to be more rigid than the flexible diaphragm.

[0037] The flexible diaphragm and the flexible flange may be made of separate materials, the flexible flange portion may be made of a material having a stronger rigidity than the flexible diaphragm, and the flexible diaphragm may be combined with the flexible flange.

[0038] A further understanding of the functionality and advantages of the present disclosure may be realized by referring to the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0040] Figure 1 An orthogonal view of an embodiment of a deep orbital approach retractor (DOAR) showing the major components is shown.

[0041] Figure 2 yes Figure 1 A front view of the device;

[0042] Figure 3 yes Figure 1 A rear view of the device;

[0043] Figure 4 yes Figure 1 A top view of the device;

[0044] Figure 5 yes Figure 1 A bottom view of the device;

[0045] Figure 6 yes Figure 1 A side view of the device;

[0046] Figure 7 is a schematic section of a patient's orbit showing a typical retractor in the initial retracted position, the problem of orbital fat obscuring the defect, and how fat bypasses a typical retractor design that does not compensate for the shape of the orbit;

[0047] Figure 8 is a schematic section of a patient's orbit (viewed from the front) showing the DOAR in an extended position, overcoming the problem;

[0048] Fig. 9 is a schematic portion of a DOAR in an orbit (viewed from above) showing that the device can be looped in multiple alignment directions and that as the retractor head is extended, the flexible flange conforms to the irregular shape of the orbit, wherein the head can be aligned asymmetrically;

[0049] Fig.10 is a schematic section (front view) showing lateral expansion and bending in the retractor head and associated flange deformation as it is aligned with the orbital wall, with different material properties to achieve the desired rigidity or flexibility;

[0050] Fig.11 The retractor is shown with its frame in the closed, flexed (right) position, and the left image is similar;

[0051] Fig.12 The retractor is shown with its frame in a closed, straight position;

[0052] Fig.13 The retractor is shown with its frame in an open, straight position;

[0053] Fig.14 shows a schematic connection section (drag + lever arm), showing possible material arrangements with different densities / flexibilities; and

[0054] Fig.15A schematic partial section is shown through a head assembly, showing possible material arrangements with varying densities / flexibilities.

[0055] Fig.16 An overall view of the self-expanding spoon-like orbital retractor is shown.

[0056] Fig.17 An overall view of the present DOAR device is shown, which comprises a self-expanding "scoop" shaped retractor (or scoop-like) including a flexible head portion and a handle. DETAILED DESCRIPTION

[0057] Various embodiments and aspects of the deep orbital approach retractor device disclosed herein will be described with reference to the details discussed below. The following description and drawings are illustrative of the present disclosure and should not be construed as limiting the present disclosure. The figures are not drawn to scale. Many specific details are described to provide a thorough understanding of the various embodiments of the present disclosure. However, in some cases, well-known or conventional details are not described in order to provide a concise discussion of the embodiments of the present disclosure.

[0058] As used herein, the terms "comprises" and "comprising" should be interpreted as inclusive and open-ended, and not exclusive. Specifically, when used in the specification and claims, the terms "comprises" and "comprising" and variations thereof mean including the specified features, steps, or components. These terms should not be interpreted to exclude the presence of other features, steps, or components.

[0059] As used herein, the term “exemplary” means “serving as an example, instance, or illustration,” and should not be construed as preferred or advantageous over other configurations disclosed herein.

[0060] As used herein, the terms "about" and "approximately" are intended to encompass variations that may exist in the upper and lower limits of a range of values, such as variations in characteristics, parameters, and dimensions. In a non-limiting example, the terms "about" and "approximately" mean plus or minus 10% or less.

[0061] As used herein, the terms "generally" and "substantially" refer to the general overall physical and geometric appearance of a feature, and should not be construed as preferred or advantageous over other configurations disclosed herein.

[0062] Parts List

[0063] 1- Camera / Sensor Assembly

[0064] 2-LED light

[0065] 3-Flexible flange

[0066] 4a-with flexible diaphragm (or flexible sling)

[0067] 4-Proximal edge of flexible diaphragm 4a

[0068] 5-Flexible tip with integrated hinge

[0069] 6-Trailing arm

[0070] 7-Moment arm

[0071] 8-Hinge

[0072] 9- Finger pads

[0073] 10-Handle

[0074] 11-Guide / Base / Barrier

[0075] 12-Integrated spring mechanism

[0076] 13-Hole / Base

[0077] The present deep orbital approach retractor includes a compressible body / handle portion having a size and shape configured to be operated by a clinician, preferably using two (2) fingers. The retractor includes a flexible head portion having an overall spoon-shaped shape. The spoon-shaped shape of the flexible head is achieved by having two geometrically opposed and arcuate trailing arms, each having a proximal end and a distal end, the distal ends being separated from each other by a gap at the distal tip portion, while the proximal end is connected to the compressible handle portion. A flexible flange material wraps around the trailing arms and the gap between the distal ends of the arms and extends around the periphery of the flexible head portion. A flexible diaphragm is attached and extends between the trailing arms, thereby giving the flexible head portion its spoon-shaped shape.

[0078] A compressible handle portion is connected to the flexible head portion, wherein the connection is configured such that when the handle is compressed, the diameter of the flexible head portion decreases and the diaphragm remains stretched and rigid despite the compression, and when the clinician releases the handle so that it is no longer compressed, the stretch increases as the arms move away from each other.

[0079] As a non-limiting embodiment, the handle or body portion can simply be two separate rigid members, one of which is attached to the proximal end of one of the trailing arms, and the other rigid member is attached to the proximal end of the other trailing arm. The shape and size of these rigid members enable the clinician to grasp them with two fingers, and after squeezing or compressing them together, the trailing arms are looped relative to each other (the proximal ends move closer to each other), causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between the soft tissue and bone, while the flexible diaphragm remains stretched enough so as not to obstruct the operator's observation of the interior of the eye socket.

[0080] In the compressed state, the clinician inserts the flexible head portion between the eyeball and the orbit in the patient, and after the clinician releases the compression so that the proximal end of the drag expands to the open position, the head portion expands back to its original diameter, thereby abutting the lateral wall of the orbit and sealing the space, and the diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents and allow access to the orbital wall to perform the repair using a surgical procedure. Once the repair is performed, the insertion route is reversed to remove the retractor.

[0081] A more extensive handle / body portion may be included, for example, instead of the two separate rigid members described above, each of which is attached to an associated trailing arm, in another non-limiting embodiment, the handle may be a continuous compressible ring having two adjacent ends, one end attached to the proximal end of one trailing arm, and the other adjacent end attached to the proximal end of the other trailing arm. In this case, the ring has a sufficient diameter so that when the two spaced sides of the ring are compressed clinically, the proximal ends of the trailing arms come together causing the diameter of the flexible head portion to decrease, as discussed above.

[0082] Will target Figures 1 to 15 Other non-limiting embodiments of the handle / body and flexible head portion are described and illustrated. Figure 1 An orthogonal view of an embodiment of a deep orbital approach retractor (DOAR) is shown, showing the major components, Figure 2 yes Figure 1 A front view of the device, Figure 3 yes Figure 1 Rear view of the device, Figure 4 yes Figure 1 Top view of the device, Figure 5 yes Figure 1 A bottom view of the device, and Figure 6 yes Figure 1 Side view of the device. Figure 7is a schematic portion of a patient's orbit showing a typical retractor in its initial, retracted position, the problem of orbital fat obscuring the defect, and how fat can bypass a typical retractor design that does not compensate for the shape of the orbit, and Figure 8 is a schematic section of a patient's orbit (viewed from the front) showing the DOAR in an extended position, overcoming the problem.

[0083] Fig. 9 is a schematic portion of a DOAR in the orbit (viewed from above) showing that the device can be looped in multiple alignment directions and that as the retractor head is extended, the flexible flange conforms to the irregular shape of the orbit where the head can be aligned asymmetrically, Fig.10 is a schematic section (front view) showing the lateral expansion and bending of the retractor head and the associated flange deformation as it aligns with the orbital wall, with variable material properties to achieve the desired rigidity or flexibility.

[0084] Fig.11 The retractor is shown with the frame in the closed, flexed (right) position, and the left is similar. Fig.12 The retractor is shown with the frame in a closed straight position, and Fig.13 The retractor is shown with the frame in an open, straight position.

[0085] Fig.14 A schematic connection section (drag + lever arm) is shown, showing possible arrangements with different density / flexibility materials, and Fig.15 A schematic partial section is shown through a flexible head assembly, showing possible arrangements with different density / flexibility materials. Fig.16 An overall view of the self-expanding spoon-like orbital retractor is shown.

[0086] refer to Figures 1 to 6 , the deep orbital approach retractor device consists of a main body unit that provides mechanical force and supports the head unit of the retractor, such as Figure 1, wherein the two parts are shown in square brackets marking the main body and head. The main body portion is operated by the surgeon and serves as a fulcrum to adjust the head portion and allow 6DOF operation within the orbit. The main body portion includes two geometrically opposed force arms (7), each having a proximal end and a distal end. The proximal ends are hinged together so that the two opposing force arms (7) can pivot relative to each other. In an embodiment, the hinge connection may include a flexible material located between the proximal ends so that they can bend relative to each other rather than pivoting in one plane, as would occur in the absence of the flexible material. The distal end includes an integrated hinge structure (8). The hinge structure (8) is hinged to the proximal end of the trailing arm (6). The hinge structure (8) may include a flexible material inserted between the respective ends of the arms (7) and (6) to provide planar flexibility that may be required. The arm (7) includes a finger pad (9) to facilitate manual control of the expansion and contraction of the device. The mechanical force is provided by a spring mechanism (12), such as a coil spring fixed in a lever arm (6) of the body, the ring portion being located at the hinge point of the lever arm (6) as shown in the handle (10). The spring mechanism can also be mounted externally using a similar hinge point (12).

[0087] Thus, the present deep orbital device provides a self-expanding spoon-shaped (or spoon-like) retractor that can be compressed to a smaller size under single-handed force applied by the clinician.The head portion consists of a self-expanding rigid frame with a flexible perimeter that can conform to irregular contours.

[0088] More specifically, the DOAR frame as shown has an integrated spring with a central ring as a spring mechanism (12), wherein the arms protrude from the central ring (in an uncompressed state) at preselected angles, wherein the central ring surrounds the central hinge connection between the force arms (6) located in the handle (10), and each arm is embedded in the corresponding force arm (7). The spring mechanism (12) can also be mounted externally, wherein the spring arms rest on the inner surface of the finger pad (9), or can exist as opposed and leaf springs extending from the central hinge point of each force arm (6) in the handle (10) to the distal end.

[0089] The main body may include (but is not required to include) an integrated light emitting diode (LED) light (2) located at each trailing arm (6) hinge, projecting forward into the orbital cavity. The light source for each light is contained in the handle and arm assembly (10). The lights are adjustable. In addition, the main body assembly contains a digital camera or sensor array (1) mounted at the hinge point of the two lever arms (7).

[0090] The electronics of the DOAR device are contained in the handle (10) and / or the lever arm (7) and / or in a separate attachment that is mounted on the handle (10) using guide holes (13) and guide rods (11) as required. The guide rods (11) are mounted on the handle (10) and provide mechanical characteristics that enhance the stability of the mounting. The guide holes (13) and guide rods (11) can also be used as alignment bases for image-guided surgical targets and / or as suture tie points to secure the retractor or to delay the tie of sutures inserted into the field of view. The head assembly includes two geometrically opposed trailing arms (6) having proximal ends connected to the distal ends of the lever arms (7) and forming the main functional components of the retractor. The trailing arms (6) each terminate at a distal end with a small gap therebetween, thereby providing two separate arms (6).

[0091] Located in the gap between the distal ends of the arms (6) is a flexible material (5) whose purpose is to facilitate a small amount of movement of the distal ends of the arms (6) relative to each other so that during surgery, asymmetric alignment of the distal ends of the arms (6) can be achieved to conform to the irregular geometry of the orbital wall. The trailing arms (6) can be made of the same material as the arms (7), or can be made of a material of different density or rigidity.

[0092] The arm (6) is encapsulated with flexible materials of different cross-sections and different densities as required for each area to achieve the required expansion / contraction and flange (3) flexibility. This includes the tip and hinge (5), the flexible diaphragm or sling (4a), the proximal edge (4) and the flange (3). The diaphragm (4a) and the flange (3) can be integrally formed around the trailing arm (6), or they can be two separate structures in which a thin flexible diaphragm (4a) is combined with a harder flange material (3). Alternatively, they can be made of the same material, but the flange portion (3) is thicker to make it more rigid. The diaphragm portion (4a) is selected to have such flexibility that it remains stretched across it regardless of the arm (6) being compressed together so that the arms (7) are close together. Therefore, the flexible diaphragm portion (4a) remains stretched in the device in both the expanded and contracted states.

[0093] like Figure 1 , Figure 4 and Figure 5 As shown in the figure, the distal ends of the arcuate trailing arms (6) are separated from each other by a small gap, and the apex (5) of the head portion near the gap is configured to provide a hinge-like structure to produce asymmetric and / or overall movement and out-of-plane movement of these distal ends relative to each other. Therefore, the hinge-like structure provides movement that is not a rigid pin connection that only allows rotation in one axis.

[0094] The distal ends of the trailing arms (6) and the hinge-like structure are configured in such a way as to reduce the stiffness of the single hinge point at the apex or discontinuity (5) and impart bending motion in more than one plane. In one example, this can be accomplished by creating a flexible gap between the distal ends of the arms (6), which is then laminated into the flange and diaphragm assembly. In another example, the entire hinge point (5) can be a flexible material bonded and / or mechanically connected to the distal end of the arm, such as a ball and socket (6). These are just two possible configurations, and as will be appreciated by those skilled in the art, there are many other ways to accomplish this functionality.

[0095] This hinge-like structure of the apex (5) provides asymmetric and / or global movement and out-of-plane movement in a traditional hinge assembly. It still has sufficient rigidity to provide the mechanical movement required for retractor movement without collapsing or bending too far. This is controlled by the distal geometry, the shape of the end connection, and the material density differences.

[0096] A flexible diaphragm (4a) is connected and enclosed by a flexible flange (3), as described above. The opposing trailing arms (6) are coupled to a spring mechanism configured to bias the opposing arms away from each other. When the clinician squeezes the opposing arms (7) together, the distal ends of the opposing arms (7) and the proximal ends of the trailing arms (6) come together, causing the head portion to narrow while undergoing minimal change in shape, while the diaphragm (4a) remains substantially flat due to the maintained stretch (similar to a stretched ball). The head portion consisting of the arms (6), flange (3), tip (5) and diaphragm (4) is configured to provide sufficient rigidity for the "scoop" and to apply sufficient force to the contents of the orbit, functionally similar to how a solid metal spoon would operate, but with the additional features of being expandable and compressible. The head can be manufactured in a variety of diameters to accommodate orbits of different sizes, for example, in pediatric cases and in adults.

[0097] During surgery, the deep orbital access retractor 10 works as follows. The operator / clinician compresses the lever arm (7), squeezing the finger pads (9) together, thereby reducing the width of the head portion, while tension is maintained throughout the septum (4a) due to its inherent flexibility so that it does not catch and obstruct visualization during retractor insertion. The orbital contents are removed from the surgical site using conventional instruments, exposing the bone of the wall. The retractor is simultaneously inserted and pressed against the wall, while the finger pads (9) remain pressed together by the operator.

[0098] With one side of the DOAR pressed firmly against the wall, all the way to the top of the field of view, the remaining orbital contents are cleared from view as the operator releases the compression on the DOAR finger pad (9), allowing the head portion to expand so that the orbital contents are blocked or sealed behind it.

[0099] The rate at which the operator releases the compression on the spring mechanism can be varied to allow for careful, progressive repositioning of the orbital contents behind the retrieval head, thereby ensuring full retraction. The flexible flange (3) and the operator's fine control of release minimizes the risk of catching orbital contents between the DOAR and the bone wall, and, due to the flexibility of the flange, ensures that there will be no crush injuries if orbital contents are mistakenly caught between the retractor and the bone (as is the case with rigid retractors). Movement of the trailing arm (6) also allows for rapid release of any mistakenly caught tissue without losing the compression barrier in other parts of the field of view.

[0100] The design and configuration of the present deep orbital access retractor provides the operator with very fine continuous control over the expansion of the flexible diaphragm (4a), and it has the ability to expand differentially or asymmetrically, allowing the operator to maintain the barrier on one side while releasing potentially trapped contents on the other side using fine finger compression, clearing them, and then releasing the device to expand to that side.

[0101] The deep orbital approach retractor device disclosed herein is highly advantageous in that the flexible perimeter flange (3) allows the device to conform to the variable anatomy of any bone cavity and thereby facilitates the formation of a sealed barrier between the retracted tissue and the cavity to be accessed and / or visualized. The progressive expansion nature of the retractor allows for progressive sealing (as just shown) from the distal tip (5) of the retractor (deepest point) to the proximal portion (4) of the retractor head, allowing for progressive repositioning of the tissue to be retracted behind the retractor head, making retraction more effective and efficient. The device expands from the tip (5) to the back (4), allowing the surgeon to move tissue behind the retractor head as it expands, making "capture" of tissue between the retractor periphery and the bone less likely.

[0102] The flange (3) rotates upward (e.g. Fig.10 ) allows the soft tissue to be cleared "out" to be retracted behind the retractor head and out of the surgical field, again making "capture" of tissue between the retractor perimeter and the bone less likely.

[0103] Additionally, the diaphragm (4a) allows for consistent pressure to be maintained across the flexible barrier to retrieve the contents, which is less likely to cause damage to vital organs such as the globe.

[0104] Since the retractor head ( Figure 1 )'s entire structure is made of a combination of rigid and flexible materials, including an integrated tip pivot point, so the extension may be asymmetric in response to the bone resistance it encounters during its extension, e.g. Fig. 9 The arm must be rigid enough to create the leverage required for deep retrieval.

[0105] The present deep orbital approach retractor advantageously provides a head assembly configured to allow asymmetric movement by way of a tip (5) design that acts as a flexible hinge with a composite material arrangement that enhances rigidity and flexible behavior in the head portion. This allows the retractor to expand and contract for placement, clearing soft tissue from the viewing field, and accurately conforming to existing bone.

[0106] The present orbital retractor is very advantageous in that it requires only one hand (two fingers) of the clinician to operate the device, while the other hand is free, unlike current expansion devices, which require two hands to operate.

[0107] Fig.17 An overall view of the DOAR device is shown, which includes a self-expanding "scoop" shaped retractor (or scoop-like) that includes a flexible head portion and a handle. The head portion includes a self-expanding rigid frame with a flexible perimeter that is capable of conforming to irregular contours and includes a flexible diaphragm that remains stretched in both the expanded and contracted states of the device. The head frame includes a universal connection that enables out-of-plane movement and asymmetric motion, facilitating the device to conform to asymmetric and irregular anatomical contours. The DOAR device allows dynamic movement, i.e., automatic, synchronized, multi-planar movement, and facilitates soft tissue retraction and conformance of the device seal, and allows automatic folding and reduction of cross-section prior to insertion.

[0108] In summary, a non-limiting embodiment of a deep orbital access retractor includes a compressible handle portion having a size and shape to be manipulated by at least two (2) fingers of a clinician; a flexible head portion having two (2) arms, wherein each arm has a distal end and a proximal end, the distal ends of the arms being spaced apart to form a gap therebetween at a distal tip portion, a flexible flange material wrapping and encapsulating the two arms and the gap and extending around the periphery of the flexible head portion, and including a flexible diaphragm attached to and extending between the arms to provide the flexible head portion with an overall spoon shape. The flexible head portion is connected to the compressible handle portion, wherein the connection between the compressible handle portion and the proximal ends of the trailing arms is configured such that upon compression of the handle portion, the arms are looped relative to each other, thereby causing the flexible head portion to narrow to allow insertion into the orbit and positioning between soft tissue and bone, while the flexible diaphragm remains sufficiently stretched so as not to obstruct the operator's view of the interior of the orbit. When compression is released, the flexible diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents to allow access to the orbital wall.

[0109] In an embodiment, the flexible flange material wrapping and encapsulating the two arms and the gap has a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement and out-of-plane movement of the distal ends of the arms.

[0110] In an embodiment, the deep orbital access retractor includes a deformable material positioned in the gap between the distal ends of the arms and proximate the distal ends of the arms.

[0111] In an embodiment, a deep orbital approach retractor is provided, comprising:

[0112] a) a compressible handle portion having a size and shape to be manipulated by at least two (2) fingers of a clinician;

[0113] b) a flexible head portion having two geometrically opposed and arcuate arms, each arm having a proximal end and a distal end, the distal ends of the arcuate arms being separated from each other by a gap at a distal tip portion, each trailing arcuate arm being connected at its proximal end to a compressible handle portion, a flexible flange material being attached to the arcuate arms and extending around a periphery of the flexible head portion and encapsulating the gap at the distal tip portion, a flexible diaphragm being attached to and extending between the arcuate arms, the distal ends of the arcuate arms having a geometry and shape, and the flange material encapsulating the distal tip portion having a material density difference configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement of the distal ends of the arcuate arms and out-of-plane movement; and

[0114] The connection between the compressible handle portion and the proximal ends of the arcuate arms is configured such that upon compression of the handle portion, the arms loop relative to each other, causing the flexible head portion to narrow to allow insertion into the orbit and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct an operator's viewing of the interior of the orbit, and wherein when the compression is released, the diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents while allowing access to the orbital wall.

[0115] In an embodiment, the flange material wrapping and encapsulating the two arcuate arms and the gap has a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or global movement and out-of-plane movement of the distal ends of the arcuate arms.

[0116] In an embodiment, the deep orbital access retractor includes a deformable material positioned in the gap between the distal ends of the arcuate arms and proximate to the distal ends of the arcuate arms.

[0117] In an embodiment, a deep orbital approach retractor is provided, comprising:

[0118] a) an operable main body portion comprising a handle and two geometrically opposed handle arms, each having a distal end and a proximal end, the proximal end being hingedly connected to the handle; and

[0119] b) a flexible head portion having two geometrically opposed and arcuate trailing arms, each having a proximal end and a distal end, each trailing arm being hingedly linked at its proximal end to a respective distal end of one of the opposing handle arms, the distal ends of the arcuate trailing arms being separated from one another at a distal tip portion by a gap, each arcuate trailing arm and the gap being encapsulated by a flexible flange material extending around a periphery of the flexible head portion, a flexible diaphragm being connected to the trailing arms to form an overall scoop-shaped flexible head portion, the distal end having a geometric structure and shape, and the flange material encapsulating the distal tip portion having a material density difference configured to produce a hinge-like structure of the distal tip portion that provides asymmetric or overall movement of the distal end of the trailing arm and out-of-plane movement; and

[0120] The opposing handle arms are coupled to a biasing mechanism configured to bias the opposing handle arms away from each other, and when the clinician squeezes the opposing handle arms together, the distal ends of the opposing handle arms and the proximal end of the arcuate trailing arm come together, causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct the operator's observation of the interior of the eye socket, and wherein when the compression is released, the diaphragm exhibits sufficient stretch and rigidity to apply sufficient force to the patient's eye socket contents to allow access to the orbital wall.

[0121] In an embodiment, the deep orbital approach retractor device includes a flexible material separating the distal ends of the opposing handle arms from the proximal ends of the arcuate trailing arms in each hinge connection to provide additional freedom of movement of the opposing handle arms and the proximal ends of the arcuate trailing arms.

[0122] In an embodiment, the deep orbital approach retractor device further includes a flexible material separating the proximal ends of the opposing handle arms in a hinged connection in the handle to provide additional freedom of movement of the proximal ends of the opposing handle arms and the arcuate trailing arm.

[0123] In an embodiment, the deep orbital approach retractor device further comprises a flexible material positioned in the gap separating the distal ends of the arcuate trailing arms to provide additional freedom of movement of the distal ends of the arcuate trailing arms.

[0124] In an embodiment, the deep orbital access retractor device further comprises a camera mounted on the handle having a field of view that includes the flexible head portion.

[0125] In an embodiment, the deep orbital access retractor device further comprises at least one light source mounted thereon to illuminate a surgical area of ​​the patient where the device is used.

[0126] In an embodiment, the deep orbital access retractor device further includes a light source mounted to the geometrically opposed handle arms at each hinge connection of the arcuate trailing arm.

[0127] In an embodiment, each light source is a light emitting diode.

[0128] In an embodiment, the deep orbital access retractor further includes a power source located in the handle that is electrically connected to the camera and the light source.

[0129] In an embodiment, the biasing mechanism is a spring mechanism secured in geometrically opposed handle arms configured to bias them apart.

[0130] In an embodiment, the deep orbital access retractor device further includes a finger pad mounted adjacent the proximal ends of the geometrically opposed handle arms and sized and shaped to accommodate a clinician's finger.

[0131] In an embodiment, the flexible diaphragm and the flexible flange are a single piece made of the same material with the flexible flange being thicker than the flexible diaphragm so as to be more rigid than the flexible diaphragm.

[0132] In an embodiment, the flexible diaphragm and the flexible flange are made of different materials, wherein the flexible flange is made of a material having a greater rigidity than the flexible diaphragm, and wherein the flexible diaphragm is bonded to the flexible flange.

[0133] The foregoing description of the preferred embodiments of the invention has been presented to illustrate the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. The scope of the invention is intended to be defined by all embodiments included in the following claims and their equivalents.

Claims

1. Deep orbital approach retractor, including: a) a compressible handle portion having a size and shape to be manipulated by at least two fingers of a clinician; b) a flexible head portion having two geometrically opposed arcuate trailing arms, each of said arcuate trailing arms having a distal end, a proximal end and being arcuate along the entire length of said arcuate trailing arms, said distal ends of said arcuate trailing arms being spaced apart to form a gap therebetween at a distal tip portion, a flexible flange material wrapping and encapsulating said two arcuate trailing arms and said gap and extending around the periphery of said flexible head portion and including a flexible diaphragm attached to and extending between said arcuate trailing arms to provide a retractable generally scoop-shaped flexible head portion; as well as c) the flexible head portion is connected to the compressible handle portion, the connection between the compressible handle portion and the proximal end of the arcuate drag arm is configured so that the longitudinal axis of the flexible head portion is different from the longitudinal axis of the compressible handle portion, and upon compression of the handle portion, the arcuate drag arms are looped relative to each other, thereby causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to hinder the operator's observation of the interior of the eye socket, and wherein when the compression is released, the flexible diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's eye socket contents and allow access to the eye socket wall.

2. The deep orbital approach retractor of claim 1 , wherein the flange material wrapping and encapsulating the two arcuate dragging arms and the gap has a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or omnidirectional movement and out-of-plane movement of the distal ends of the arcuate dragging arms, wherein the asymmetric or omnidirectional movement and out-of-plane movement of the distal ends of the arcuate dragging arms facilitates the flexible head portion to conform to asymmetric and irregular anatomical contours.

3. The deep orbital access retractor of claim 1, comprising a deformable material located in the gap between the distal ends of the arcuate trailing arms and adjacent to the distal ends of the arcuate trailing arms.

4. Deep orbital approach retractor, including: a) a compressible handle portion having a size and shape to be manipulated by at least two fingers of a clinician; b) a flexible head portion having two geometrically opposed arcuate trailing arms, each of the arcuate trailing arms having a proximal end, a distal end and being arcuate along the entire length of the arcuate trailing arms, the distal ends of the arcuate trailing arms being separated from each other by a gap at a distal tip portion, each arcuate trailing arm being connected to the compressible handle portion at its proximal end, a flexible flange material being attached to the arcuate trailing arm and extending around the periphery of the flexible head portion and encapsulating the gap at the distal tip portion, a flexible diaphragm being attached and extending between the arcuate ends and the distal ends of the arcuate trailing arms; a flexible head portion extending between the trailing arms to provide a retractable generally scoop-shaped, distal end of the arcuate trailing arm having a geometric structure and shape, and the flange material encasing the distal tip portion having a material density difference configured to create a hinge-like structure of the distal tip portion providing asymmetric or omnidirectional movement and out-of-plane movement of the distal end of the arcuate trailing arm, the asymmetric or omnidirectional movement and out-of-plane movement of the distal end of the arcuate trailing arm facilitating the flexible head portion to conform to asymmetric and irregular anatomical contours; and The connection between the compressible handle portion and the proximal end of the arcuate drag arm is configured such that the longitudinal axis of the flexible head portion is different from the longitudinal axis of the compressible handle portion, and upon compression of the handle portion, the arcuate drag arms are looped relative to each other, thereby causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct the operator's observation of the interior of the eye socket, and wherein when the compression is released, the flexible diaphragm exhibits sufficient stretch and rigidity to be used to apply sufficient force to retract the patient's orbital contents and allow access to the orbital wall.

5. The deep orbital approach retractor of claim 4, wherein the flange material wrapping and encapsulating the two arcuate trailing arms and the gap has a material density difference near the gap configured to create a hinge-like structure of the distal tip portion that provides asymmetric or omnidirectional movement and out-of-plane movement of the distal ends of the arcuate trailing arms.

6. The deep orbital access retractor of claim 4 including a deformable material located in the gap between the distal ends of the arcuate trailing arms and proximate to the distal ends of the arcuate trailing arms.

7. Deep orbital approach retractor, including: a) an operable main body portion comprising a handle and two geometrically opposed handle arms, each handle arm having a distal end and a proximal end, the proximal end being hinged to the handle; as well as b) a flexible head portion having two geometrically opposed arcuate trailing arms, each arcuate trailing arm having a proximal end, a distal end and being arcuate along the entire length of the arcuate trailing arm, each arcuate trailing arm being connected at its proximal end to a corresponding distal end of one of the opposed handle arms by a hinge, the connection being configured such that a longitudinal axis of the flexible head portion is different from a longitudinal axis of the handle, the distal ends of the arcuate trailing arms being separated from each other at a distal tip portion by a gap, each of the arcuate trailing arms and the gap being formed by a periphery of the flexible head portion an extended flexible flange material encapsulating a flexible diaphragm connected to the arcuate trailing arm to form a retractable generally scoop-shaped flexible head portion, the distal end having a geometry and shape, and the flange material encasing the distal tip portion having a material density difference configured to create a hinge-like structure of the distal tip portion providing asymmetric or omnidirectional movement and out-of-plane movement of the distal end of the arcuate trailing arm, the asymmetric or omnidirectional movement and out-of-plane movement of the distal end of the arcuate trailing arm facilitating the flexible head portion to conform to asymmetric and irregular anatomical contours; and c) the opposing handle arms are coupled to a biasing mechanism configured to bias the opposing handle arms away from each other, and when the clinician squeezes the opposing handle arms together, the distal ends of the opposing handle arms and the proximal ends of the arcuate trailing arms come together, thereby causing the flexible head portion to narrow to allow insertion into the eye socket and positioning between soft tissue and bone, while the flexible diaphragm maintains sufficient stretch so as not to obstruct the operator's observation of the interior of the eye socket, and wherein when the compression is released, the flexible diaphragm exhibits sufficient stretch and rigidity to apply sufficient force to the patient's eye socket contents to allow access to the eye socket wall.

8. The deep orbital approach retractor of claim 7, comprising a first flexible material separating the distal ends of the opposing handle arms and the proximal ends of the arcuate trailing arms in each hinge connection to provide additional freedom of movement of the opposing handle arms and the proximal ends of the arcuate trailing arms.

9. The deep orbital access retractor of claim 8 including a second flexible material separating the proximal ends of the opposing handle arms in the hinge connection in the handle to provide additional freedom of movement of the opposing handle arms and the proximal end of the arcuate trailing arm.

10. The deep orbital access retractor of claim 9, comprising a third flexible material located in the gap separating the distal ends of the arcuate trailing arms to provide additional freedom of movement of the distal ends of the arcuate trailing arms.

11. The deep orbital access retractor of claim 7, further comprising a camera mounted on the handle having a viewing field that includes the flexible head portion.

12. The deep orbital access retractor of claim 7, comprising at least one light source mounted thereon to illuminate a surgical area of ​​a patient where the deep orbital access retractor is used.

13. The deep orbital access retractor of claim 7 including a light source mounted to the geometrically opposed handle arms at each hinge connection of the arcuate trailing arm.

14. The deep orbital access retractor of claim 12, wherein each light source is a light emitting diode.

15. The deep orbital access retractor of claim 11, comprising a power source in the handle electrically connected to the camera and a light source mounted on the deep orbital access retractor having a viewing field that includes the flexible head portion.

16. The deep orbital access retractor of claim 7, wherein the biasing mechanism is a spring mechanism secured in geometrically opposed handle arms configured to bias them apart.

17. The deep orbital access retractor of claim 7, further comprising a finger pad mounted adjacent the proximal ends of the geometrically opposed handle arms and sized and shaped to accommodate a clinician's finger.

18. The deep orbital access retractor of claim 7, wherein the flexible membrane and the flexible flange are a single piece made of the same material as the flexible flange, the flexible flange being thicker than the flexible membrane so as to be more rigid than the flexible membrane.

19. The deep orbital approach retractor of claim 7, wherein the flexible membrane and the flexible flange are made of separate materials, the flexible flange is made of a material having a higher rigidity than the flexible membrane, and wherein the flexible membrane is bonded to the flexible flange.

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