Portal Saver Assembly

Abstract

To provide a flexible portal saver device that allows easy insertion and removal of instruments from a surgical site.SOLUTION: A portal saver device includes an obturator (12), the obtulator has an obturator body (24) having a cannulated outer obturator tube (44) extending therethrough. The outer obturator tube (44) has a distal tip (50) with a movable dilating assembly (52). A shaft expander has a movable cannulated inner obturator tube (48). In a first position, the inner obturator tube (48) is retracted from the distal tip (50) of the outer obturator tube (44), and the dilating assembly is in a first configuration. In a second position, the inner obturator tube (48) is advanced within the distal tip (50) of the outer obturator tube (44), and the dilating assembly (52) is in a second configuration.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 598,094, filed December 13, 2017, entitled "Baggula Hip Access Portal Saver," U.S. Provisional Application No. 62 / 673,365, filed May 18, 2018, entitled "Expanding Mechanism for Cannula Dermal Fixation," U.S. Provisional Application No. 62 / 673,451, filed May 18, 2018, entitled "Adhesive Disc for Cannula Dermal Fixation," U.S. Provisional Application No. 62 / 673,541, filed May 18, 2018, entitled "Adhesive Disc for Cannula Dermal Fixation," and U.S. Provisional Application No. 62 / 673,520, filed May 18, 2018, entitled "Suction Cup for Cannula Dermal Fixation."

[0002] FIELD OF THE INVENTION This application relates generally to portal saver devices, and more particularly to obturators with expansion assemblies for accommodating instruments of various sizes and geometries. [Background technology]

[0003] 2. Description of Related Art To maintain arthroscopic intra-articular hip joint access, traditionally, a series of access tools (e.g., switch sticks, slotted cannulas, disposable cannulas, etc.) are frequently used to insert and remove instruments from the patient. The time the surgeon spends using the access tools accounts for a significant portion of the procedure time; during this time, the surgeon is not performing any actual work related to the patient's pathology.

[0004] A common access tool in the arthroscopic surgical field is the "cannula." A cannula is used to maintain an open portal from outside the patient's body to the inside of the body, where the arthroscopic procedure will be performed. It is important that this cannula remain inside the body, maintain this pathway, and not become dislodged, dislodge laterally, or dislodge further inward. This is accomplished in many ways today, most often by placing aggressive threads on the exterior of the cannula to perforate (or drill) the dermis layer and underlying tissue. This requires a large incision to accommodate these threads, resulting in a correspondingly large scar.

[0005] Current cannulas 1, as shown in Figures 1A-1C, mostly use mechanical threads 2 on the exterior 3 of the cannula's tube-like body 4. Figure 1A shows a standard cannula 1 with a rigid tube-like body 4. The cannula 1 of Figure 1B is less rigid than the cannula shown in Figure 1A, but the tube-like body 4 does not move substantially radially. Figure 1C shows a more flexible cannula 1 than the cannula shown in Figure 1B. However, although semi-flexible, the cannula 1 of Figure 1C cannot accommodate a wide range of instruments. Conventional cannulas 1 have a fluid seal 5 at the proximal end to prevent fluid leakage from the surgical site. Some cannulas have indicators 6 along the tube-like body 4 to customize the size of the tube-like body 4, as also shown in Figure 1C. These cannulas are often threaded using an obturator.

[0006] Current surgical procedures require instruments to be inserted and removed from the patient multiple times (through multiple portals). For example, in lumbar surgery, surgeons must insert instruments into the patient's anus through two or three portals. To access these portals, surgeons must work through the portals, and lumbar portals are typically 4 to 6 inches long. Because of these lumbar portals, surgeons cannot simply remove their instruments / scope and move to another portal. Two to three different instruments (and approximately nine steps or actions) are required to transfer the primary instrument / scope between portals, which is performed multiple times throughout the entire surgical procedure. Current commercially available cannulas, such as those shown in Figures 1A-1C, are too rigid, resulting in limited mobility and preventing surgeons from using them throughout the procedure. Cannulas are typically only used at the end of the procedure to place anchors and thread sutures.

[0007] Therefore, there is a need for a flexible portal saver device that allows for easy insertion and removal of instruments from a surgical site.

[0008] Alternatively, or in addition, some cannulas have barbs, allowing for straight insertion into the surgical site while benefiting from a slight oscillatory rotation during advancement into the body. Furthermore, cannulas use a folded, accordion-like member that can be stretched to reduce its diameter and compressed to increase its diameter. However, none of these conventional cannulas allow for insertion through a small incision and subsequent removal because their rigid bodies cannot move significantly under the skin. Furthermore, none of these conventional cannulas allow for small incisions or minimal trauma in the area surrounding the incision site. Furthermore, none of the conventional cannulas allow for a wide range of movement or freedom.

[0009] Related Art Section Disclaimer Explanation: To the extent that specific patents / publications / products are discussed in this Related Art Section description or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for purposes of patent law. For example, some or all of the patents / publications / products discussed may not be sufficiently early in time, may not reflect subject matter that developed early enough in time, and / or may not be sufficiently valid to be prior art for purposes of patent law. To the extent that a specific patent / publication is discussed above in this Related Art Section description and / or throughout the application, the description / disclosure is incorporated herein by reference in its entirety. Summary of the Invention

[0010] Embodiments of the present invention recognize that conventional cannulas and access tools have potential problems and / or drawbacks. For example, the aggressive external threads of conventional cannulas (as described above) can cause additional trauma to the incision site. Therefore, there is a need for a portal saver device that allows removal through a small incision and minimizes trauma at the incision site. Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and / or drawbacks described herein.

[0011] The present disclosure relates to the inventive composition, structure, and resulting function of a portal saver assembly and a method for attaching a flexible cannula tube to a surgical site. According to one aspect, the portal saver assembly includes an obturator. The obturator has an obturator body with a cannulated outer obturator tube extending therethrough. The outer obturator tube may have a distal tip with an expander assembly movable between a collapsed first configuration and an expanded second configuration. The shaft expander may have a cannulated inner obturator tube movable between a first position and a second position within the outer obturator tube. In the first position, the inner obturator tube is retracted from the distal tip of the outer obturator tube and the expander assembly is in the first configuration. In the second position, the inner obturator tube is advanced within the distal tip of the outer obturator tube and the expander assembly is in the second configuration.

[0012] According to an embodiment, the expansion assembly is a duckbill portion at the distal tip of the outer obturator tube, the duckbill portion having at least two arms that are made up of the outer obturator tube.

[0013] According to one embodiment, the obturator also includes an actuator, such as a post on the inner obturator tube, that forces the at least two arms radially outward from a collapsed first configuration to an expanded second configuration.

[0014] According to an embodiment, the outer obturator tube extends beyond the distal end of the obturator body.

[0015] According to an embodiment, the obturator includes a cannula tube distal to the obturator body and extending around the outer obturator tube.

[0016] According to an embodiment, the obturator includes a pair of stirrups extending proximally from the cannula tube.

[0017] According to an embodiment, the pair of stirrups are removably attached to the obturator body via one or more connectors.

[0018] According to an embodiment, the obturator includes a stirrup release actuator on the obturator body configured to release the pair of stirrups from the one or more connectors.

[0019] According to an embodiment, the cannula tube is made from a flat sheet of material with a pair of seams extending along the length of the cannula tube.

[0020] According to an embodiment, the cannula tube has a flat section between two rounded sections.

[0021] According to an embodiment, the obturator includes a rigid body connected about the cannula tube that is movable along the length of the cannula tube.

[0022] According to an embodiment, the rigid body includes a proximal telescoping assembly and a distal external barb.

[0023] According to embodiments, the proximal telescoping assembly comprises one or more braids.

[0024] According to another aspect, a method of attaching a cannula tube includes, but is not limited to, (i) providing an obturator comprising an obturator body having a cannulated outer obturator tube extending through and passing through a distal end of the obturator body, a shaft dilator comprising a cannulated inner obturator tube movable within the outer obturator tube, a cannula tube around the outer obturator tube distal to the obturator body, and a rigid body; (ii) advancing the cannula tube into the surgical incision; (iii) sliding the rigid body along the cannula tube; (iv) securing the rigid body below the dermis layer; (v) adjusting the length of the cannula tube; and (vi) removing the obturator from the cannula tube.

[0025] According to embodiments, the rigid body includes a proximal telescoping assembly having a braid and a distal external barb, the external barb configured to grasp the dermis layer.

[0026] According to an embodiment, adjusting the length of the cannula tube includes moving a telescoping assembly along the cannula tube and cutting the cannula tube with a blade.

[0027] According to an embodiment, a pair of stirrups extend proximally from the cannula tube.

[0028] According to an embodiment, the method includes removably attaching a pair of stirrups to an obturator body via one or more connectors.

[0029] According to an embodiment, the obturator includes a stirrup release actuator on the obturator body.

[0030] According to an embodiment, removing the obturator from the cannula tube includes actuating a stirrup release actuator on the obturator body.

[0031] According to one aspect, a portal saver assembly includes a portal saver device including a tubular flexible body extending distally from a dermal-threaded body, the tubular flexible body being radially movable relative to the dermal-threaded body, and a first seal and a second seal connected to the dermal-threaded body.

[0032] According to an embodiment, the tubular flexible body is made of thermoplastic urethane (TPU).

[0033] According to embodiments, the portal saver device includes external threads on a dermal-threaded body.

[0034] According to an embodiment, the first seal includes a circular opening.

[0035] According to an embodiment, the second seal includes an opening formed from three slits that converge at a central location.

[0036] According to an embodiment, the tubular flexible body includes a seal along its length.

[0037] According to an embodiment, the tubular flexible body is a single continuous piece of material. [Brief explanation of the drawings]

[0038] The present invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the accompanying drawings, which illustrate only typical embodiments of the disclosed subject matter and, therefore, should not be considered as limiting the scope thereof, since the disclosed subject matter may admit of other equally effective embodiments.

[0039] Reference will now be made briefly to the accompanying drawings, in which:

[0040] [Figure 1A] FIG. 1A is a schematic perspective view of a prior art cannula. [Figure 1B] FIG. 1B is a schematic perspective view of another cannula of the prior art. [Figure 1C] FIG. 1C is a schematic perspective view of yet another cannula of the prior art. [Figure 2A] FIG. 2A is a schematic perspective view of a portal saver device, according to one embodiment. [Figure 2B] FIG. 2B is another schematic perspective view of a portal saver device, according to one embodiment. [Figure 2C] FIG. 2C is a schematic perspective view of the portal saver device of FIG. 2B with the flexible body in a knot configuration. [Figure 2D] FIG. 2D is a schematic perspective view of the portal saver device of FIG. 2B with the flexible body in a twisted configuration. [Figure 2E]FIG. 2E is a schematic side view of a dermal threaded body and seal, according to an embodiment. [Figure 2F] FIG. 2F is a schematic top view of a dermal threaded body and seal, according to an embodiment. [Figure 2G] FIG. 2G is a schematic front view of a seal, according to an embodiment. [Figure 2H] FIG. 2H is a schematic front view of a double seal, according to an embodiment. [Figure 2I] FIG. 2I is a schematic front view of a double seal, according to an embodiment. [Figure 2J] FIG. 2J is a schematic perspective view of a double seal, according to an embodiment. [Figure 3A] FIG. 3A is a schematic perspective view of a portal saver assembly, according to one embodiment. [Figure 3B] FIG. 3B is a schematic perspective view of a portal saver assembly according to another embodiment. [Figure 4] FIG. 4 is a schematic perspective view of a portal saver device according to an alternative embodiment. [Figure 5] FIG. 5 is a schematic perspective cross-sectional view of a portal saver assembly, according to an embodiment. [Figure 6] FIG. 6 is a schematic side cross-sectional view of a distal tip of a portal saver assembly in a first configuration, according to an embodiment. [Figure 7] FIG. 7 is a schematic perspective side cross-sectional view of a portal saver assembly in a first configuration, according to an embodiment. [Figure 8] FIG. 8 is a schematic side view of a portal saver assembly in a first configuration, according to an embodiment. [Figure 9] FIG. 9 is a schematic cross-sectional side view of a portal saver assembly in a first configuration, according to an embodiment. [Figure 10] FIG. 10 is a schematic perspective view of a portal saver assembly in a second configuration, according to an embodiment. [Figure 11] FIG. 11 is a schematic side view of a portal saver assembly in a second configuration, according to an embodiment. [Figure 12] FIG. 12 is a schematic exploded perspective view of a portal saver assembly according to an alternative embodiment. [Figure 13] FIG. 13 is a schematic perspective view of a distal body according to an alternative embodiment. [Figure 14] FIG. 14 is a schematic side cross-sectional view of a distal body in a first configuration, according to an alternative embodiment. [Figure 15] FIG. 15 is a schematic side cross-sectional view of a distal body in a second configuration according to an alternative embodiment. [Figure 16] FIG. 16 is a perspective view of a dermal fixation device, according to an embodiment. [Figure 17] FIG. 17 is a perspective view of a dermal fixation device according to an alternative embodiment. [Figure 18] FIG. 18 is a schematic side perspective view of a portal saver assembly according to an alternative embodiment. [Figure 19] 19 is a schematic side perspective view of an obturator of the portal saver assembly of FIG. 18. FIG. [Figure 20] 20 is a detailed schematic side cross-sectional view of the seal assembly of the obturator of FIG. 19. [Figure 21] FIG. 21 is a schematic top perspective view of the obturator of FIG. 19 in a first configuration. [Figure 22] FIG. 22 is a schematic top perspective view of the obturator of FIG. 19 in a second configuration. DETAILED DESCRIPTION OF THE INVENTION

[0041] Aspects of the present invention and specific features, advantages, and details thereof will be more fully described with reference to non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention. It should be understood, however, that the detailed description and specific non-limiting examples, while illustrating aspects of the present invention, are given by way of illustration only and not limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the central concept of the present invention will be apparent to those skilled in the art from this disclosure.

[0042] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, FIGS. 2A-2J are schematic illustrations of various views of a portal saver device 16, according to one embodiment. The portal saver device 14 of FIGS. 2A and 2B includes a tube-like (or cannula-like) flexible body 11 extending distally from a dermal-threaded body 13 (with a fluid seal 17). In the embodiment shown in FIG. 2A, the portal saver device 14 includes indicators 15 along the flexible body 11 to allow for customization of the size of the flexible body 11. The portal saver device 14 maintains a path from the outside of the body (e.g., the skin) to the surgical site (e.g., a joint), allowing the surgeon to move instruments from one portal to another in two steps or actions (versus nine steps or actions in conventional devices). In the embodiment shown in FIG. 2B, the flexible body 11 is formed by extrusion. However, in alternative embodiments, there may be one or more seals along the length of the flexible body 11. The seals may be angled relative to one another along the longitudinal axis of the flexible body 11 or may be perpendicular (ie, generally parallel to the length of the flexible body 11).

[0043] The flexible body 11 in Figures 2A and 2B may be composed of thermoplastic urethane (hereinafter "TPU"). TPU is a thermoplastic elastomer including a block copolymer. Specifically, TPU comprises linear alternating hard and soft segments, as understood by those skilled in the art. The hard segments are composed of diisocyanates with short-chain diols (i.e., "chain extenders"), making them short, highly polar segments. The soft segments are composed of diisocyanates with long-chain diols, making them long, less polar segments. The stiffness of TPU can be fine-tuned by increasing or decreasing the ratio of hard segments to soft segments. TPU has high mechanical properties, high heat resistance, high mineral oil resistance, high hydrolysis resistance, temperature flexibility, high resistance to microbial degradation, and high elasticity throughout the hardness range. TPU has a hardness of 30 Shore A to 60 Shore D under standard atmospheric conditions, as should be understood by those skilled in the art in conjunction with a review of this disclosure. One example of a TPU is Elastomaran®. Another example of a TPU is Isotan grade 5090A manufactured by Greco.

[0044] TPU offers many advantages for use as the composition for the flexible body 11. In Figures 2C and 2D, the flexible body 11 is an extruded TPU composition that can retain its shape after being manipulated. It is more flexible and thinner than conventional cannulas. Figure 2C shows the flexible body 11 in a knotted configuration, and Figure 2D shows the flexible body 11 in a twisted configuration. Both the knotted and twisted configurations demonstrate the flexibility of the flexible body 11, which is constructed from TPU. The flexibility and resilience of the flexible body 11 allows the surgeon to operate more percutaneously, providing a greater range of motion. The flexible body 11 is free to move anywhere, limited only by the proximal dermal threaded body 13, which is anchored to the dermis. TPU is also resistant to cuts and other damage from sharp instruments, such as shaver blades and burrs. Additionally, the heat-resistant, high-quality TPU briefly described above allows for the passage of cutting instruments without deformation or other damage to the flexible body 11.

[0045] Referring now to Figures 2E-2G, various schematic views of the dermal-threaded body 13 and seal 17 are shown, according to embodiments. In the illustrated embodiment, the dermal-threaded body 13 includes external threads 19, as shown in Figures 2E and 2F. Figure 2G shows the seal 17 at the proximal end of the dermal-threaded body 13. The seal 17 includes an opening 21 that is as small as possible but sized to fit all surgical equipment (e.g., lumbar surgical equipment) for the surgical field or procedure. The seal 17 prevents fluid leakage from the surgical site, but also prevents air bubbles from migrating to the surgical site and obscuring the view of the videoscope. An exemplary embodiment of the seal 17 is shown in Figures 2H-2J. In the illustrated embodiment, the seal 17 is a double seal. The double seal 17 includes a first seal 23A with a circular opening 21A and a second seal 23B with a "Mercedes" opening 21B (i.e., openings formed from three slits that meet in a central position), as shown in Figures 2I and 2J.

[0046] 3A and 3B, schematic perspective views of a portal saver assembly 10 are shown, according to an embodiment. The portal saver assembly 10 includes an obturator 12 removably connected to an alternative embodiment of a portal saver device 14. The portal saver device 14 includes a rigid, flexible body 16 extending into a pair of stirrups 18A, 18B, as shown in FIG. 4. In the embodiment shown in FIG. 4, the flexible body 16 is made of a flat sheet of material that is welded to create two seams 20A, 20B that extend along the length of the flexible body 16. By its nature, the flat sheet of material that makes up the flexible body 16 has a tendency to fold back to a flat shape, which is beneficial for sealing and fluid management. In an alternative embodiment, the flat sheet of material that makes up the flexible body 16 is imperfectly welded to allow the seal to peel away from the flexible body 16. In yet another embodiment, the flexible body 16 is extruded from the same flexible material (e.g., thermoplastic urethane (“TPU”)) without welded seams so that the flexible body 16 remains in a relaxed state (as shown in FIGS. 2A-2D).

[0047] As also shown in FIG. 4 , the stirrups 18A, 18B of the portal saver device 14 extend closely from the flexible body 16 such that the stirrups 18A, 18B are spaced apart and generally parallel. In the illustrated embodiment, the stirrups 18A, 18B each have an opening 22A, 22B extending therethrough, and the openings 22A, 22B are aligned. In an alternative embodiment, the portal saver device 14 does not have stirrups, i.e., the flexible body 16 is directly connected to the obturator 12. In yet another embodiment, the flexible body 16 does not extend to the stirrups 18A, 18B, but instead has an externally threaded portion adjacent a tubular end cap.

[0048] 3A and 3B, as briefly described above, the portal saver device 14 is connected to the obturator 12. Specifically, in the illustrated embodiment, the obturator 12 includes an obturator body 24 with stirrups 18A, 18B extending into or over the obturator body 24, while the flexible body 16 extends from a distal end 26 of the obturator body 24. The obturator body 24 of FIGS. 3A and 3B is ergonomically shaped with spaced ridges 28 to aid in a secure grip for the surgeon (or any other user). Near or at the distal end 26 of the obturator body 24, a retaining pin 30 (or any other conventional connector) extends through the obturator body 24 and through an opening 20A in the stirrup 18A within the obturator body 24. The second retaining pin 30 may also extend through the obturator body 24 and through the other opening 20B on the other stirrup 18B within the obturator body 24. The retaining pin 30 secures the stirrups 18A, 18B in place within the obturator body 24. The portal saver assembly 10 further includes a stirrup release actuator 38. In the illustrated embodiment, the stirrup release actuator 38 is a push button. Depressing or otherwise activating the stirrup release actuator 38 releases the portal saver device 14 from the obturator body 24. The actuator body 24 is released.

[0049] 3A-3B, the portal saver assembly 10 includes a distal rigid body 33. As shown, the rigid body 33 is secured about the portal saver device 14. In the illustrated embodiment, the rigid body 33 is connected to the proximal end 36 of the flexible body 16. The rigid body 33 includes a telescoping assembly 32, which is movable along the flexible body 16. The telescoping assembly 32 includes one or more braids 34 (FIG. 8) that shorten the effective length of the portal saver assembly 10 by axially slitting the flexible body 16. As also shown in FIGS. 3A-3B, the rigid body 33 also includes an external barb 40 for anchoring to the patient. In the illustrated embodiment, the barb 40 is adjacent to and distal to the telescoping assembly 32.

[0050] The portal saver assembly 10 of Figures 3A-3B also includes an obturator shaft dilator 42 that is movable within the obturator 12 and flexible body 16. Referring now to Figure 5, a schematic perspective cross-sectional view of the portal saver assembly 10 is shown, according to one embodiment. In the illustrated embodiment, the shaft dilator 42 is movable within a cannulated outer obturator tube 44 within the obturator body 24. As shown in Figure 5, the outer obturator tube 44 extends through the obturator body 24, creating a channel within the obturator body 24 that receives the shaft dilator 42.

[0051] The shaft dilator 42 includes a proximal handpiece 46 connected to a cannulated inner obturator tube 48. The inner obturator tube 48 is sized and configured to slide within the channel of the cannulated outer obturator tube 44. Furthermore, the inner obturator tube 48 extends through the handpiece 46 such that instruments can be inserted through the handpiece 46 and inner obturator tube 48 and exit the outer obturator tube 44 (FIG. 7). As shown in FIG. 5, when the portal saver device 14 is connected to the obturator 12, the inner obturator tube 48 can extend through the outer obturator tube 44 and the flexible body 16 of the portal saver device 14.

[0052] Referring now to FIG. 6 , a schematic, enlarged perspective view of the distal tip 50 of the portal saver assembly 10 is shown, according to one embodiment. As shown in the illustrated embodiment, the distal tip 50 comprises a duckbill portion 52 of the outer obturator tube 44. The duckbill portion 52 includes a pair of arms or prongs 56 (which may include additional arms or prong portions, or in some embodiments, may include a single arm) formed by a recess (e.g., triangular or prismatic) in the outer obturator tube 44 that narrows toward the distal tip 50 of the outer obturator tube 44 (or portal saver assembly 10). When an actuator (e.g., a small post) 54 of the inner obturator tube 48 is advanced toward the distal tip 50 of the outer obturator tube 44, the duckbill portion 52 opens. When the small post 54 is not advanced toward the distal tip 50 in FIG. 6 , the arms 56 of the duckbill portion 52 are collapsed (i.e., in a first configuration).

[0053] 7-9, there are shown schematic perspective and side cross-sectional views of the portal saver assembly 10 in a first configuration, according to one embodiment. Referring now to FIG. 7, there is shown a schematic side cross-sectional view of the portal saver assembly 10 in a first configuration, according to one embodiment. Specifically, FIG. 7 shows the obturator 12 with the portal saver device 14 removed (or unattached). In the illustrated embodiment, the shaft dilator 42 is in a first position relative to the obturator body 12. With the shaft dilator 42 in the first position, the inner obturator tube 48 is at least partially retracted proximally within the outer obturator tube 44. As a result, the duckbill portion 52 is at least partially retracted proximally within the outer obturator tube 44, as shown in FIG. 7. It collapses into one configuration.

[0054] 8 and 9 show schematic side and cross-sectional side views, respectively, of the portal saver assembly 10 in a first configuration, according to an embodiment. In both FIGS. 8 and 9, the portal saver device 14 is connected to the obturator 12. As shown, when the shaft dilator 42 is retracted to the first position, the duckbill portion 52 is collapsed in the first configuration. While the outer obturator tube 44 is collapsed, the flexible body 16 of the portal saver device 14 is not collapsed, as shown in FIG. 8.

[0055] 10 and 11 , schematic perspective and side cross-sectional views, respectively, are shown of the portal saver assembly 10 in a second configuration, according to an embodiment. FIG. 10 illustrates the obturator 12 with the portal saver device 14 removed (or unattached). As the shaft dilator 42 is advanced and moved distally, or completely toward the obturator body 24, to a second position, the inner obturator tube 48 extends distally into the duckbill portion 52 of the outer obturator tube 44. Specifically, a small post 54 on the inner obturator tube 48 advances toward the distal tip 50 of the outer obturator tube 44, forcing the arms 56 of the duckbill portion 52 to open into the expanded, second configuration, as shown in FIGS. 10 and 11 . Thus, the small post 54 functions to increase the inner diameter of the outer obturator tube 44.

[0056] 11 shows the duckbill portion 52 in the expanded second configuration when the portal saver device 14 is attached to the obturator 12. When the duckbill portion 52 is opened to the second configuration, a frictional force is applied to the flexible body 16 near the distal tip 50. The friction of the duckbill portion 52 overcomes the friction of the patient's tissue as the flexible body 16 is inserted into the joint (i.e., the surgical site), further preventing the flexible body 16 from slipping or rotating. The expanded or increased inner diameter of the outer obturator tube 44 in the second configuration also allows for flexibility in instruments passing through the portal saver assembly 10. Thus, instruments with larger diameters or bends can pass through the portal saver assembly 10.

[0057] Although a duckbill portion 52 is shown, any other expansion assembly that applies a radially outward force to the outer obturator tube 44 can be used. In an alternative embodiment, the expansion assembly is a bead rather than a small post 54. The inner obturator tube 48 extends through the beaded duckbill portion 52 and forcibly expands the outer obturator tube 44 (via arms 56). Other actuators or expansion assemblies are contemplated for alternative embodiments. For example, a small pocket on the outside of the distal tip 50 of the outer obturator tube 44 may be used. In another example, a solid rod can be used to displace the distal tip 50 of the outer obturator tube 44.

[0058] To use the portal saver assembly 10, the surgeon (or other user) may slide the portal saver assembly 10 in the first configuration into the hip joint. The portal saver assembly 10 is advanced into the patient until the distal tip 50 accesses the intraocular junction. The rigid body 33 is then advanced distally down the flexible body 16 until it fully engages the patient's dermis. (The portal saver assembly 10 can be configured for dermal openings used in most procedures, including dermal opening diameters of 16 mm.) At this point, the proximal telescoping assembly 32 simultaneously cuts (with blade 34) the flexible body 16 while locking its position until the distal barb 40 is approximately flush with the patient's dermis. The flexible body 16 is now cut flush with the blade 34 of the proximal telescoping assembly 32.

[0059] In an alternative embodiment, the length of the flexible body 16 can be adjusted by cutting it to the desired length. In such an embodiment, the flexible body 16 may have measurements or indicators (e.g., via printing or etching) along the length of the flexible body 16. In yet another embodiment, the flexible body 16 may have perforations or other similar grooves along its length for cutting to a desired length.

[0060] With the flexible body 16 cut to the desired length and the rigid body 33 secured within the patient by the barbs 40, the stirrup release actuator 38 of the obturator 12 is actuated, actuating the rigid body 33 and the ejection actuator 38 to disengage the rigid body 33 from the severed flexible body 16. The obturator 12 is then removed. The obturator 12 may be reloaded with an additional rigid body 33 and cannula tube 16 to place additional intra-articular access portals in the patient. Now, with the rigid body 33 and flexible body 16 in place, all surgical instruments can gain intra-articular access through the flexible body 16 instead of dedicated access instruments. The rigid body 33 and flexible body 16 may be removed at the end of the procedure.

[0061] 12, a schematic exploded perspective view of a portal saver assembly 100 is shown, according to an alternative embodiment. In the illustrated embodiment, the portal saver assembly 100 includes a proximal obturator 102 having an outer obturator tube 104 extending therefrom. In one embodiment, the outer obturator tube 104 is constructed from a flat sheet of material that is welded to create two seams (not shown) that extend along the length of the outer obturator tube 104. By its nature, the flat sheet of material that makes up the outer obturator tube 104 easily folds back into a flat shape, which is beneficial for sealing and fluid management.

[0062] As shown in FIG. 12 , the outer obturator tube 104 terminates at a distal tip 106. The obturator 102 and the outer obturator tube 104 are cannulated so as to be configured to receive an instrument therethrough. The outer obturator tube 104 further includes a sheath 108 connected to an exterior 110 of the outer obturator tube 104. As shown in FIG. 12 , the sheath 108 is rectangular (or square) with a central opening 112 sized and configured to centrally fit and connect (or secure) to the outer obturator tube 104. In the illustrated embodiment, the outer obturator tube 104 and the sheath 108 are formed by molding so that they are made from the same piece of material.

[0063] 12 , the portal saver assembly 100 also includes an adjustable seal 114 and a dermal-threaded body 116 for securing the portal saver assembly 100 to the patient. The adjustable seal 114 is flexible and includes a rectangular (or square) distal end 118 and an inner obturator tube 120 extending proximally therefrom. The inner obturator tube 120 is flexible such that the inner obturator tube 120 can expand to accommodate the outer obturator tube 104 and the instruments therein. The rectangular distal end 118 includes an opening 122 for receiving the distal tip 106 of the outer obturator tube 104. The dermal-threaded body 116 includes a rectangular (or square) distal end 124 and a cannula tube 126 extending proximally therefrom. The cannula tube 126 has a plurality of threads 128 on its outer surface 130 that lock the dermal-threaded body 116 (and portal saver assembly 100) within the patient.

[0064] In use, the distal end 124 of the dermal-threaded body 116 is configured to lock (by a snap connection or other similar connection) within the distal end 118 of the adjustable seal 114 and the sheath 108 around the outer obturator tube 104, securing the adjustable seal 114 between the dermal-threaded body 116 and the sheath 108. The portal saver assembly 100 Once advanced into the incision site, the dermal-threaded body 116 rotates into the dermal layer. (The portal saver assembly 100 can be configured for dermal openings used in most procedures, including a 15 mm dermal opening diameter.) The threads 128 on the outer surface 130 of the dermal-threaded body 116 create a retention force in the dermal layer. The connection (e.g., snap connection) between the distal end 124 of the dermal-threaded body 116 and the covering 108 around the outer obturator tube 104 can be broken (e.g., unsnapped) to remove the obturator 102 from the excision site. The retention force created by the threads 128 of the dermal-threaded body 116 prevents cannulas, instruments, and other tools from backing out of the portal. Once the surgical procedure is complete, the adjustable seal 114 can be disconnected (e.g., unsnapped), the dermal threaded body 116 loosened or removed, and then threaded back through the original incision for easy removal without further trauma or scarring to the patient's skin or dermis.

[0065] 13-15, various schematic views of a distal (unthreaded) body 116 are shown, according to one embodiment. FIG. 13 shows a schematic perspective view of the distal body 116. The distal body 116 includes a cup-like upper portion 131. In the illustrated embodiment, the upper portion 131 has a rectangular (or square) cross-section. The upper portion 131 includes a threaded inner bore 134 at a first end 136 and at least two petals 138 extending from a second end 140 of the upper portion 131. The petals 138 are arms or prongs that are movable relative to one another from a first configuration to a second configuration. While two petals 138 are shown in FIG. 13, additional petals 138 may be utilized.

[0066] FIG. 14 shows the petals 138 in a first configuration. In the first configuration, the petals 138 are generally parallel to one another so that they extend in the same direction. As shown, each petal 138 has a raised portion 142 (e.g., a ridge or other protrusion) on an inner surface 144 of the petal 138. When a force is applied to the raised portion 140 in a distal direction, the petal 138 moves from the first configuration to the second configuration. In one embodiment, the raised portion 140 is pressed downward (distally) by a disk 146 having external threads 148 configured to mate with internal threads 150 of the inner bore 134 of the top portion 131. As the disk 146 advances downward (distally) through the inner bore 134, it presses or applies pressure to the raised portion 142, causing the petal 138 to expand (or pivot about a pivot point) into the second configuration shown in FIG. 15. That is, the discs 146 push the petals 138 from a relatively parallel position, which is a first configuration, to an angled position, which is a second configuration.

[0067] In use, the distal body 116 is in a first configuration in which the petals 138 are generally parallel, reducing the size of the distal body 116. The small size allows the distal body 116 to be inserted through a smaller incision compared to other cannulas with rougher, more aggressive external threads. The distal body 116 is inserted deep into the incision where the upper portion 131 contacts the patient's skin. The disk 146 is then threaded or advanced into the inner bore 134 of the upper portion 131. As a result, the disk 146 pushes the petals 138 radially outward to the expanded second configuration. The expansion of the petals 138 beneath the patient's dermis layer creates a retaining force within the dermis layer. The retaining force prevents the cannula from dislodging from the portal. Once the surgical procedure is complete, the disk 146 can be loosened or removed, allowing the petals 138 to retract and move toward each other to the first configuration. The distal body 116 can then be loosened or retracted through the original incision to allow for easy removal of the cannula without further trauma or scarring to the patient's skin or dermis.

[0068] In an alternative embodiment, rather than a mechanical pivot point (as shown in Figures 13-15), each petal 138 has a "living hinge" as a means of connecting the petal 138 to the upper portion 131. Furthermore, although Figures 13-15 show the petals 138 as being semi-cylindrical in cross section, it is understood that the petals 138 may be semi-cylindrical in cross section. Any available shape, length, and cross-section may be used. In the illustrated embodiment, the petals 138 each have small barbs 152 on their outer surface 154. However, in other embodiments, any number of barbs 152 or other features may be used to increase the force holding the petals 138 to the tissue.

[0069] Referring now to FIGS. 16 and 17, a dermal fixation device 60 is shown according to an alternative embodiment. The dermal fixation device 60 of FIGS. 16 and 17 may be used as an alternative to the external machine threads of the dermal-threaded body 116 (FIG. 12) or other machine threads described herein for securing an access tool to a patient's skin or within the dermis. FIGS. 16 and 17 provide a dermal fixation device 60 that does not require such external machine threads. The dermal fixation device 60 of FIG. 16 is an adhesive disk. The disk 60 includes a central opening 62, as shown in FIG. 16, for a cannula 64 to be placed therethrough. In one embodiment, the disk 60 is flexible to conform to the shape of the patient's skin. In other embodiments, the disk 60 is semi-rigid or rigid. While the disk 60 in the illustrated embodiment is circular, the disk 60 need not be circular. Additionally, multiple disks 60 or a network of disks 60 may be utilized with multiple instruments and cannulas 64 to form a surgical system.

[0070] As shown in FIG. 16 , the disc 60 includes a plurality of weep hole holes 66 (i.e., openings) adjacent to a central opening 62. In the illustrated embodiment, the plurality of weep holes 66 surround the central opening 62. Ideally, the plurality of weep holes 66 are positioned above the surgical incision to allow fluids leaking from the incision to escape from beneath the disc 60 in a controlled manner without disrupting the adhesive / skin interface. That is, the weep holes 66 allow fluids that might otherwise lift the adhesive disc 60 away from the skin to escape. Although the weep holes 66 are shown in FIG. 16 , the disc 60 may be utilized without the weep holes 66.

[0071] In one embodiment, the cannula 64 can be attached to the disc 60 prior to using the disc 60 in the surgical incision. In one example, the disc 60 may include a layer of hook-and-loop fastener (or any similar fastener) configured to attach to a complementary hook-and-loop fastener on the cannula 64. The hook-and-loop fastener can be used to temporarily (i.e., removably) attach the cannula 64 to the disc 60. Any other surgical resource may also include a complementary hook-and-loop fastener for this purpose. With the cannula 64 attached to the disc 60, the disc 60 is more likely to remain in place for the entire duration of the surgical procedure. Furthermore, the user can optionally and selectively attach or detach the cannula 64 (or other surgical resource) during the surgical procedure without disturbing the adhesive / skin interface.

[0072] In another embodiment, the adhesive of disk 60 is covered with a protective covering (e.g., a peel-off liner) that protects the adhesive film until needed. Additionally, once cannula 64 is inserted into the surgical incision, the area around the patient's incision can be cleaned before removing the protective covering to improve adhesion of disk 60 to the patient's skin.

[0073] In one embodiment, as shown in FIG. 16, a funnel-shaped lead-in 68 can be used on the distal end 70 of the cannula 64 for easy insertion of surgical instruments. The flexibility of the disc 60 allows for great flexibility and freedom of movement for surgical instruments. Because the disc 60 shown in FIG. 16 does not have threads or barbs, the diameter of the disc 60 is small enough to easily pass through small incisions, minimizing scarring and trauma to the area around the incision. To remove the disc 60, pull the disc 60 out of the incision, starting from the outer edge of the disc 60 and slowly lifting it up to peel it away. Once the disc 60 is separated from the incision site, remove the cannula. The tube 64 (which is preferably free of barbs or threads) can be easily and smoothly removed with minimal trauma.

[0074] 17, the dermal fixation device 60 is a suction cup. In the illustrated embodiment, the suction cup 60 is ring-shaped with a central opening 62 that receives and attaches to a cannula 64. The cannula 64 is connected to the suction cup 60 so that the cannula 64 can articulate and pivot relative to the suction cup 60 (via an articulation adjustment mount 67). In the illustrated embodiment, the suction cup 60 is flexible to conform to the contours of the patient's skin to provide a tight seal. In other embodiments, the suction cup 60 is semi-rigid or rigid. While the suction cup 60 in the illustrated embodiment is ring-shaped, the suction cup 60 need not be circular or ring-shaped. Additionally, multiple suction cups 60 or a network of suction cups 60 may be utilized with multiple instruments and cannulas 64 forming a surgical system.

[0075] The suction cup 60 may also include a plurality of weep holes 66 (i.e., openings) adjacent to or surrounding the central opening 62. The weep holes 66 are positioned above the surgical incision to prevent fluid from interfering with the cup / skin interface and allow fluid leaking from the incision to escape from underneath the suction cup 60. Although the weep holes 66 are shown in FIG. 17, the suction cup 60 may be utilized without the weep holes 66.

[0076] In one embodiment, a cannula 64 can be attached to the suction cup 60 prior to using the suction cup 60 at the surgical incision. In one example, the suction cup 60 may include a layer of hook-and-loop fastener (or any similar fastener) configured to attach to a complementary hook-and-loop fastener on the cannula 64. The hook-and-loop fastener can be used to temporarily (i.e., removably) attach the cannula 64 to the suction cup 60. Any other surgical resource may also include a complementary hook-and-loop fastener for this purpose. With the cannula 64 attached to the suction cup 60, the suction cup 60 is more likely to remain in place for the entire duration of the surgical procedure. Furthermore, a user can optionally and selectively attach or detach the cannula 64 (or other surgical resource) during the surgical procedure without disturbing the suction cup / skin interface.

[0077] In use, the cannula 64 is inserted into the patient to cleanse the area surrounding the incision to improve the suction cup / skin interface. The suction cup 60 is then brought into contact with the patient's skin at the incision site. A vacuum 72 from a regulated vacuum source is applied to the annular suction cup 60 through a portal 74 in the suction cup 60. In the illustrated embodiment, the portal 74 is located on the proximal side 76 of the suction cup 60, but the portal 74 may be located at any accessible location on the suction cup 60. The suction of the vacuum 72 causes the suction cup 60 to adhere to the skin, securing the cannula 64 to the patient's skin.

[0078] Similar to the dermal fixation device 60 described above and shown in FIG. 16, a funnel-shaped lead-in 68 can be used on the distal end 70 of the cannula 64 to facilitate easy insertion of surgical instruments. The flexibility of the articulating attachment points allows for great flexibility and freedom of movement for surgical instruments. Because the suction cup 60 shown in FIG. 17 lacks threads or barbs, the diameter of the suction cup 60 is small enough to easily pass through small incisions, minimizing scarring and trauma to the area around the incision. To remove the suction cup 60, the vacuum source is turned off and the suction cup 60 is lifted away from the incision site. Once the suction cup 60 is separated from the incision site, the cannula 64 (preferably lacking barbs or threads) can be easily and smoothly removed with minimal trauma.

[0079] 18-22, a portal saver assembly is shown in accordance with another alternative embodiment. Various views of the assembly 200 are shown. As shown in FIG. 18, the portal saver assembly 200 includes a proximal handpiece 202 configured to removably attach to a distal obturator 204. The obturator 204 can be removably connected to a distal tube-like (cannulated) flexible body 206 extending from a proximal seal assembly 208. The flexible body 206 can be constructed from TPU and has the same characteristics and can be used in the same configuration as the flexible body 11 described above with reference to FIGS. 2A-2D. The flexible body 206 has a flat (or narrow) section 210 that acts as a seal and is constructed through a thermoforming process. The flat section 210 is heat sealed to flatten the obturator tube. As shown in FIG. 19, the flexible body 206 has two rounded sections 211 with the flat section 210 between them. The flat section 210 can be used as an alternative to a welded flat sheet material with a seam (as described above for the portal saver assembly 10 of FIGS. 1-11). In some situations, a welded seam is preferred for the flat section 210 of the flexible body 206 because the compressive forces on the flexible body 206 with a welded seam create high friction and tend to trap instruments within the flexible body 206. This can lead to accidental withdrawal of the instrument from the portal and can add a distinctive feature (i.e., sound) to the surgeon's sensory experience. The flat section 210 forms a seal between itself and the instrument, extending through the flexible body 206. Thus, the flexible body 206 wraps around the instrument. After the instrument is removed, the flat section 210 (i.e., the heat-pressed or sealed portion) returns to its flat shape. The flat section 210 also prevents fluids from the incision site from leaking out of the flexible body 206.

[0080] 20 , a schematic detailed cross-sectional view of a seal assembly 208 is shown, according to one embodiment. The seal assembly 208 comprises a body 212 (e.g., a rectangular body) having a central opening 214 extending through a rotating portion 216 and a non-rotating portion 218. The rotating portion 216 and the non-rotating portion 218 are configured to interlock to fine-tune the attachment of the obturator 204 to a tubular body 220 extending through the handpiece 202. The rotating portion 216 is a movable female connector, such as a threaded channel 222 extending from the central opening 214, as shown. The non-rotating portion 218 is an unthreaded (or relatively smooth) channel 224 connected within the threaded channel 222. The unthreaded channel 222 is also connected to the flexible body 206 near the flat section 210, as shown in FIG. 18 . When seal assembly 208 is attached to handpiece 202, rotating portion 216 and non-rotating portion 218 receive tubular body 220 extending through handpiece 202 ( FIG. 18 ), and rotating portion 216 rotates such that threaded channel 222 tightens around tubular body 220. In use, an instrument can be inserted into proximal end 226 of tubular body 220 and passed through flexible body 206 of seal assembly 208.

[0081] As shown in FIGS. 21 and 22 , one or more petals 228 extend distally from within the body 212 of the seal assembly 208. The petals 228 are movable from a first configuration to a second configuration using an actuator 230 on the body 212. Referring briefly to FIG. 21 , the petals 228 are in the first configuration and closed relative to the flexible body 206. In the illustrated embodiment, the petals 228 extend in a direction parallel to the length of the flexible body 206 in the first configuration. When the petals 228 are in the first configuration, as shown, the actuator 230 is in a first position. In one embodiment, the first position is an unlocked position, in which the petals 228 are substantially flush with the flexible body 206 for insertion into a patient.

[0082] 22, the petal 228 is in the second configuration. To move the petal 228 to the second configuration, the actuator 230 is activated. In the illustrated embodiment, the actuator 230 is rotated or otherwise moved to the second position. (The first and second positions of the actuator 230 may be indicated by an indicator 232 of 212, as shown.) When the petal 228 is in the second configuration, as shown, Thus, they are expanded and extend obliquely relative to flexible body 206. In the second configuration, petals 228 function to retain portal saver assembly 200 within the patient.

[0083] In use, the obturator 204 is attached to the proximal handpiece 202 using the rotating and non-rotating portions 216 and 218, as described above. The length of the body 206 may be cut (e.g., within 11 mm) before insertion into the incision site. Because of its small diameter, the portal saver assembly 200 can be partially advanced into the incision site without posing a risk to surrounding structures (e.g., the femoral head). (The portal saver assembly 200 can be configured for dermal openings used in most procedures, including dermal opening diameters of 12 mm, smaller than those used with most cannulas.) The portal saver assembly 200 (flexible body 206) is further advanced until the petals 228 reach the dermal layer. The actuator 230 further moves from a first position to a second position, deploys the petals 228, and moves them from the first configuration to the second configuration. The length of the flexible body 206 can be cut at any time to fine-tune the length. The proximal handpiece 202 can be detached from the obturator by loosening the rotating portion 216. Once the surgical procedure is complete, the petals 228 can return to the first configuration (via the actuator 230), and the obturator 202 and flexible body 206 can be easily removed through the original incision without causing further trauma or scarring to the patient's skin or dermis.

[0084] Definitions and all definitions used herein should be understood to control for dictionary definitions, documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0085] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision numerous other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications for which the teachings are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Accordingly, the foregoing embodiments are presented merely as illustrative, and it will be understood that, within the scope of the appended claims and their equivalents, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0086] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The terms "comprise" (and any form of comprise, such as "comprises" or "comprising"), "have" (and any form of have, such as "has" or "having"), "include" (and any form of include, such as "includes" or "including"), and "contain" (and "contains" or "including") It will be further understood that "contain" (any form of "contain," such as "containing") is an open-ended linking verb. Consequently, a method or apparatus that "comprises," "has," "includes," or "contains" one or more steps or elements. Similarly, a method step or apparatus element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to possessing only those one or more features. Furthermore, an apparatus or structure that is configured in a particular way is configured in at least that way, but may also be configured in ways not listed.

[0087] Corresponding structure, materials, acts, and equivalents of all means or step-plus-function elements in the following claims are intended to include the structure, materials, or acts for performing the function, if any, in combination with the elements of other claims that are specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described to best explain the principles and practical application of one or more aspects of the invention and to enable others skilled in the art to appreciate one or more aspects of the invention in various embodiments with various modifications suitable for the particular use contemplated.

Claims

1. A portal saver assembly comprising an obturator, a seal, and a dermal fixation device for fixing the portal saver assembly to the dermis, wherein the seal is fixed between the obturator and the dermal fixation device so that the obturator can be attached and detached, The dermis fixing device is an upper proximal end with an internal bore; a lower distal end including a first prong and a second prong extending distally from the upper proximal end; Equipped with the first prong and the second prong are movable relative to each other from a first configuration in which they extend parallel to each other to a second configuration in which they extend at a predetermined angle to each other; a disk disposed in the inner bore of the upper proximal end, the disk being moved distally to spread the prongs from the first configuration to the second configuration; the upper proximal end having a rectangular or square cross section; The portal saver assembly, wherein the disk is configured to allow a surgical instrument to pass therethrough.

2. The portal saver assembly of claim 1 , wherein the upper proximal end includes a threaded inner bore.

3. 2. The portal saver assembly of claim 1, wherein in the first configuration, the first prong extends in a first plane, the second prong extends in a second plane, and the first plane is generally parallel to the second plane.

4. 4. The portal saver assembly of claim 3, wherein in the second configuration, the first prong extends in a third plane, the second prong extends in a fourth plane, and the third plane extends at an angle relative to the fourth plane.

5. The portal saver assembly of claim 4 , wherein each of the first prong and the second prong includes an inner surface including at least one raised portion extending therefrom.

6. 6. The portal saver assembly of claim 5, wherein the disk is configured and structured to move distally within the inner bore to apply pressure to each of at least one raised portion to move the prongs from the first configuration to the second configuration.

7. The portal saver assembly of claim 6 , wherein the disk is threaded, the disk being configured to mate with threads located within the inner bore.

8. 2. The portal saver assembly of claim 1, wherein each of the first prong and the second prong is movable relative to one another from the first configuration to the second configuration via a living hinge.

9. 2. The portal saver assembly of claim 1, wherein each of the first prong and the second prong is movable relative to one another from the first configuration to the second configuration via a mechanical pivot point.

10. The portal saver assembly of claim 1 , wherein at least one of the first prong and the second prong includes a barb on an outer surface thereof.

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