Port for minimally invasive surgery

Abstract

A surgical port system for use in minimally invasive procedures. The port includes a port shaft configured to receive 3 mm instruments, and a low-profile head assembly designed to minimize external bulk over the skin surface. The port further includes a novel retention assembly comprising an internal retention member and an external retention member. The internal retention member is positioned near the distal end of the port shaft and transitions from a low-profile insertion configuration to an expanded deployed configuration to resist withdrawal. The expansion is achieved via an actuator-operated reservoir secured to the port shaft and configured to transfer fluid through one or more channels to the internal retention member. The retention assembly is specifically configured to minimize the lateral expanse of both internal and external components, making the port system ideal for pediatric surgical applications.

Description

[0001] PORT FOR MINIMALLY INVASIVE SURGERY

[0002] PRIORITY INFORMATION

[0003] This nonprovisional application claims priority to provisional application No. 63634162, entitled “3 mm Mini Laparoscopic Port,” filed April 15, 2024, by the same inventors.

[0004] FIELD OF THE INVENTION

[0005] This invention relates, generally, to medical devices and methods of use.

[0006] BACKGROUND

[0007] Minimally invasive surgical techniques such as laparoscopy and thoracoscopy have become increasingly prevalent in pediatric surgery due to their well-established benefits, including reduced postoperative pain, quicker recovery times, and smaller incisions. Due to their smaller anatomical size, pediatric patients (e.g., patients five years old and younger) are especially well-suited for instrumentation scaled appropriately for their physiology, including the use of laparoscopic and thoracoscopic ports and instruments that are roughly 3 millimeters (mm) in diameter.

[0008] Current options for 3 mm access ports are limited, and many existing designs are not optimized for use in very young children. Issues such as bulkiness, dislodgement during surgery, high cost, or limited reusability present barriers to widespread and effective use. More specifically, existing designs often fail to secure the port within the cavity adequately, leading to interruptions in the procedure and potential risks to the patient. Another significant issue is the overcrowding of the surgical field caused by the size of laparoscopic port heads. The current dimensions occupy considerable space over the patient's skin, increasing the risk of collisions with other port heads and hindering the surgeon's ability to maneuver instruments effectively.

[0009] Furthermore, maintaining insufflation and creating a sealed environment within the surgical cavity is essential for visibility and optimal surgical conditions. However, achieving effective sealing while accommodating smaller instruments can be challenging. Ports must be designed with sealing mechanisms that can accommodate 3 mm instruments without compromising the integrity of the seal. If an inside diameter of 3 mm is not maintained, current surgical instruments may not fit within the port.

[0010] Accordingly, there is a need for a low-profile, disposable, affordable, and secure port that is specifically designed for use in small pediatric patients. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.

[0011] All referenced publications are incorporated herein by reference in their entirety. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein, is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0012] While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.

[0013] The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.

[0014] In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.

[0015] BRIEF SUMMARY OF THE INVENTION

[0016] The long-standing but heretofore unfulfilled need for a low-profile, pediatric-specific port system that minimizes the lateral expanse both internally and externally is now met by a new, useful, and nonobvious invention.

[0017] The novel structure includes a port system configured for use with 3 mm laparoscopic instruments, an ultra-compact head assembly that minimizes the surface area above the skin, and a deployable internal retention mechanism that transitions from a low-profile insertion configuration to a secure anchoring configuration without significantly increasing the internal footprint or requiring a typical fluid port and / or valve. These features make the system particularly suitable for pediatric use, including neonates and patients five years of age or younger.

[0018] More specifically, the novel structure includes a port system for use in minimally invasive pediatric procedures. The system includes a port shaft with an internal lumen configured to receive surgical instruments sized for 3 mm ports. Positioned near the distal end of the port shaft is an internal retention member that is capable of transitioning between a low-profile insertion configuration and an expanded deployed configuration to secure the port within a patient's tissue. Fluid is delivered to the internal retention member via one or more fluidic channels, which are in communication with a fluid reservoir mounted to the port shaft. An actuator is operably coupled to the reservoir and configured to compress the reservoir, thereby forcing fluid into the internal retention member and effecting its deployment. Once the actuator is released, the reservoir is configured to return to its decompressed state, allowing fluid to be withdrawn and the internal retention member to revert to its insertion configuration.

[0019] In some embodiments, the fluid reservoir is mounted externally to the port shaft and is selectively collapsible by the actuator. The actuator can include a slidable collar movable along the shaft to compress the reservoir, with some designs incorporating a surface that nests into a reservoir support structure for optimized fluid displacement. The actuator may include a locking mechanism to maintain its position once the reservoir has been compressed, and the reservoir may be made of resilient material that permits re-expansion to withdraw fluid from the internal retention member.

[0020] The internal retention member may include an inflatable structure that radially expands from the shaft, and may be positioned within 8 to 10 mm of the shaft's distal end. Some embodiments include an external retention member that is slidably positionable along the shaft and configured to clamp the patient’s tissue between the external and internal retention members.

[0021] In some cases, the system is configured such that the external diameter of the distal end is less than or equal to approximately 4.75 mm, enabling use in very small patients, including children five years old or younger. Some implementations also include a trocar removably received within the internal lumen of the port shaft, with a shaft and head section configured to minimize the lateral expanse of the assembled system. A port cap may also be included to interface with both the trocar and port shaft to prevent relative motion. In certain embodiments, one or more leaflets are included to establish a seal within the port shaft, and the reservoir may either be pre-filled and closed to ambient fluid or initially open and configured to seal upon actuation.

[0022] The present invention also includes a method of use of a port system for use in minimally invasive pediatric procedures, including steps of inserting the port into the patient while the internal retention member is in a collapsed state, deploying the internal retention member via the actuator and fluid reservoir, and securing the port by positioning an external retention member against the patient's outer tissue surface. The method further includes reversing these steps to deflate the internal retention member and then withdraw the port upon completion of the surgical procedure.

[0023] In some embodiments, the method includes sliding the actuator into contact with the fluid reservoir to compress the fluid reservoir and thereby force the contained fluid into fluidic channels and ultimately, into the internal retention member. Similarly, upon completion of a medical procedure, the actuator is slid away from the fluid reservoir thereby allowing the fluid reservoir to return to its expanded configuration and in turn pull the fluid from the internal retention member back into the fluid reservoir.

[0024] These and other important objects, advantages, and features of the invention will become clear as this disclosure proceeds. The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the disclosure set forth hereinafter and the scope of the invention will be indicated in the claims.

[0025] BRIEF DESCRIPTION OF THE DRAWINGS

[0026] For a fuller understanding of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:

[0027] Fig. 1 is a perspective view of an embodiment of the present invention with the retention assembly in an insertion configuration.

[0028] Fig. 2 is a perspective view of an embodiment of the present invention with the retention assembly in an anchoring configuration.

[0029] Fig. 3 is a side view of an embodiment of the present invention with the retention assembly in an anchoring configuration.

[0030] Fig. 4 is a cross-sectional view of an embodiment of the present invention with the retention assembly in an insertion configuration.

[0031] Fig. 5 is a cross-sectional view of an embodiment of the present invention with the retention assembly in an anchoring configuration.

[0032] Fig. 6 is an exploded view of an embodiment of the present invention.

[0033] Fig. 7A is a side view of a trocar in accordance with an embodiment of the present invention.

[0034] Fig. 7B is a cross-sectional view of a trocar in accordance with an embodiment of the present invention.

[0035] Fig. 7C is a distal end view of a trocar in accordance with an embodiment of the present invention.

[0036] Fig. 8A is a side view of a port shaft in accordance with an embodiment of the present invention.

[0037] Fig. 8B is a cross-sectional view of a port shaft in accordance with an embodiment of the present invention.

[0038] Fig. 9A is a top view of a port cap in accordance with an embodiment of the present invention.

[0039] Fig. 9B is a side elevation view of a port cap in accordance with an embodiment of the present invention.

[0040] Fig. 9C is a bottom end view of a port cap in accordance with an embodiment of the present invention.

[0041] Fig. 10A is a side elevation view of an open leaflet in accordance with an embodiment of the present invention.

[0042] Fig. 10B is a side cross-sectional view of an open leaflet in accordance with an embodiment of the present invention. Fig. 11 A is a top view of a closed leaflet in accordance with an embodiment of the present invention.

[0043] Fig. 11 B is a side cross-sectional view of a closed leaflet in accordance with an embodiment of the present invention.

[0044] Fig. 12A is a top view of an internal retention mechanism in accordance with an embodiment of the present invention.

[0045] Fig. 12B is a side elevation view of an internal retention mechanism in accordance with an embodiment of the present invention.

[0046] Fig. 12C is a side cross-sectional view of an internal retention mechanism in accordance with an embodiment of the present invention.

[0047] Fig. 13A is aside elevation view of an intermediate structure in accordance with an embodiment of the present invention.

[0048] Fig. 13B is a top view of an intermediate structure in accordance with an embodiment of the present invention.

[0049] Fig. 14A is aside elevation view of a reservoir in accordance with an embodiment of the present invention.

[0050] Fig. 14B is a side cross-sectional view of a reservoir in accordance with an embodiment of the present invention.

[0051] Fig. 14C is a bottom view of a reservoir in accordance with an embodiment of the present invention.

[0052] Fig. 15A is a side elevation view of an actuator and a reservoir in an expanded configuration in accordance with an embodiment of the present invention.

[0053] Fig. 15B is a side elevation view of an actuator and a reservoir in a compressed configuration in accordance with an embodiment of the present invention.

[0054] Fig. 16A is a side cross-sectional view of an actuator and a reservoir in an expanded configuration in accordance with an embodiment of the present invention.

[0055] Fig. 16B is a side cross-sectional view of an actuator and a reservoir in a compressed configuration in accordance with an embodiment of the present invention.

[0056] Fig. 16C is a bottom view of a reservoir support structure in accordance with an embodiment of the present invention.

[0057] Fig. 17A is a side elevation view of an actuator in accordance with an embodiment of the present invention.

[0058] Fig. 17B is a top elevation view of an actuator in accordance with an embodiment of the present invention. Fig. 17C is a transparent side elevation view of an actuator in an unlocked position in accordance with an embodiment of the present invention.

[0059] Fig. 17D is a transparent side elevation view of an actuator in a locked position in accordance with an embodiment of the present invention.

[0060] Fig. 18A is a side elevation view of an actuator and a reservoir in an expanded configuration in accordance with an embodiment of the present invention.

[0061] Fig. 18B is a side elevation view of an actuator and a reservoir in a compressed configuration in accordance with an embodiment of the present invention.

[0062] Fig. 19A is a perspective view of an external retention member in accordance with an embodiment of the present invention.

[0063] Fig. 19B is a top view of an external retention member in accordance with an embodiment of the present invention.

[0064] Fig. 19C is a side cross-sectional view of an external retention member in accordance with an embodiment of the present invention.

[0065] Fig. 20A is a flowchart of a method of inserting the port in accordance with an embodiment of the present invention.

[0066] Fig. 20B is a flowchart of a method of retracting the port in accordance with an embodiment of the present invention.

[0067] DETAILED DESCRIPTION OF THE INVENTION

[0068] In the following detailed description of the present invention, reference is made to the accompanying drawings, which form a part thereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. Numerous specific details are set forth to provide a thorough description of the embodiments of the present invention. It will be apparent to one of ordinary skill in the art that some embodiments may be practiced without some of these specific details. It is to be understood that other embodiments may be utilized, and structural changes may be made without departing from the scope of the invention.

[0069] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the context clearly dictates otherwise.

[0070] All numerical designations, such as measurements, efficacies, physical characteristics, forces, and other designations, including ranges, are approximations which are varied up or down by increments of 1.0 or 0.1 , as appropriate. It is to be understood, even if it is not always explicitly stated that all numerical designations are preceded by the term “approximately.” As used herein, “approximately” refers to being within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined. When an acceptable range is not dictated by the one of ordinary skill in the art, “approximately” refers to ±15% of the numerical when used in connection with particular values; it should be understood that a numerical including an associated range with a lower boundary of greater than zero must be a non-zero numerical, and the term “approximately” should be understood to include only non-zero values in such scenarios.

[0071] As used herein, the term “subject” refers to a human or non-human animal, optionally a mammal including a human, non-primate such as cows, pigs, horses, goats, sheep, cats, dogs, avian species and rodents; and a non-human primate such as monkeys, chimpanzees, and apes; and a human, also denoted specifically as a “human subject.”

[0072] The phrases “in some embodiments,” “according to some embodiments,” “in the embodiments shown,” “in other embodiments,” and the like generally mean the particular feature, structure, or characteristic following the phrase is included in at least one implementation. In addition, such phrases do not necessarily refer to the same embodiments or different embodiments.

[0073] Referring in general to the following description and accompanying drawings, various embodiments of the present disclosure are illustrated to show its structure and method of operation. Common elements of the illustrated embodiments may be designated with similar reference numerals.

[0074] Accordingly, the relevant descriptions of such features apply equally to the features and related components among all the drawings. For example, any suitable combination of the features, and variations of the same, described with components illustrated in Fig. 1 , can be employed with the components of Fig. 2, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereinafter. It should be understood that the figures presented are not meant to be illustrative of actual views of any particular portion of the actual structure or method but are merely idealized representations employed to more clearly and fully depict the present invention defined by the claims below.

[0075] As noted in the background section, the surgical setup for neonatal laparoscopy can be challenging due to limited space and very small abdominal cavities. In addition, thin abdominal walls can lead to frequent port dislodgment and loss of insufflation. The present invention addresses these challenges through a port system specifically dimensioned for pediatric patients, including neonates, infants, and small children. The system is centered around a port shaft to accommodate standard 3 mm laparoscopic instruments, and each component — from the trocar and head section to the retention assembly — is engineered to minimize lateral expanse. The head assembly is streamlined to avoid external crowding near the incision site, while the distal retention components are collapsible or inflatable to allow for secure fixation with minimal internal bulk. In addition, the retention components, including the fluid delivery components, have a lateral expanse that is less than (or at most equal to) the lateral expanse of head section to avoid external crowding near the incision site. Referring now to Figs. 1 -6, embodiments of the present invention include a minimally invasive port 100. As will be explained, port 100 includes a novel retention assembly comprising an internal retention member and an external retention member in some embodiments. The internal retention member is positioned near the distal end of the port shaft and transitions from a low-profile insertion configuration to an expanded, deployed configuration (also referred to as an anchoring configuration) to resist withdrawal. In some embodiments, the expansion is achieved via an actuator-operated reservoir secured to the port shaft and configured to transfer fluid through one or more channels to the internal retention member. The retention assembly is specifically configured to minimize the lateral expanse of both internal and external components, making the port system ideal for pediatric surgical applications.

[0076] Port 100 includes, among other things, trocar 102 configured to temporarily reside within the internal lumen 117 of port shaft 104. As best depicted in Figs. 7, trocar 102 includes head section 106 connected to shaft 108.

[0077] Head section 106 has a generally hemispherical shape established by a generally rounded outer surface 107 and a distal facing generally flat surface 109. The overall size and shape are configured to minimize the area occupied by head section 106. In addition, the outer lateral expanse proximate to flat surface 109 is configured to engage port shaft 104. However, alternative shapes and designs are considered to further aid in minimizing the size of head section 106.

[0078] Head section 106 may also include one or more ergonomic grip features 112 to assist the user in securely grasping and / or removing trocar 102 from port shaft 104. The exemplary figures depict one such ergonomic grip feature 112 in the form of a peripheral groove extending about outer surface 107 of head section 106. It should be understood that alternative ergonomic grip features 112 may be used, including but not limited to textured surfaces, knurled patterns, raised ridges, finger contours, indentations, overmolded rubberized materials, or flared edges — all configured to enhance tactile feedback and improve manual engagement during placement and removal.

[0079] In some embodiments, head section 106 is configured to temporarily engage proximal end 110 of port shaft 104 thereby establishing the outer housing of head assembly 105 of port 100. The engagement may occur through the interaction of one or more intermediate components (such as the port cap) or through direct engagement with port shaft 104. Direct engagement may include outwardly extending projections configured to engage corresponding slots or apertures in proximal end 110 of port shaft 104. However, alternative engagement mechanisms may be used to temporarily secure head section 106 to proximal end 110 of port shaft 104 including but not limited to bayonet fittings, quarter-turn locking mechanisms, threaded interfaces, magnetic couplings, snap-fit features with complementary detents, or interference-fit geometries designed to provide tactile resistance and positional stability during use. As previously noted, trocar 102 includes shaft 108. Shaft 108 has main body 114 extending between proximal end 116 and distal end 1 18. Proximal end 116 is connected to head section 106 and distal end 118 is a free end. In some embodiments, distal end 118 terminates at a sharp point that allows for the dissection of layers of the abdominal wall as the port is being inserted.

[0080] Main body 114 is a rigid, elongated member that fits concentrically within port shaft 104. As a result, the diameter or lateral expanse of main body 114 is approximately 3 mm in some embodiments to fit within internal lumen 117 of port shaft 104. Main body 114 is depicted as having a circular cross-sectional shape, however, alternative shapes may be employed so long as main body 114 retains the ability to fit within port shaft 104.

[0081] Referring now to Figs. 8 port shaft 104 includes shaft body 1 11 extending between proximal end 113 and distal end 115. Shaft body 111 includes internal lumen 117 extending from proximal end 113 to distal end 115. Both proximal end 113 and distal end 115 include openings to internal lumen 117. As previously noted, internal lumen 117 is configured to receive shaft 108 of trocar 102 and thus has a cross-sectional size and shape sufficient to accommodate shaft 108.

[0082] In some embodiments, proximal end 113 includes a tapered section with an internal volume sufficient to receive various components of the head assembly 105. Proximal end 113 may also include engagement features 132 configured to allow trocar 102 and / or other components of head assembly 105 to temporarily engage port shaft 104. In some embodiments, distal end 115 is tapered to a point.

[0083] Port shaft 104 includes a distal section that is configured for insertion into a patient. Generally, this section is distal from external retention device 160 and includes internal retention device 142. This insertable section of port shaft 104 is minimized to better work with smaller patients. In some embodiments, the outer diameter of the insertable section is less than the outer diameter of typical 5 mm ports, which tend to be approximately 6.5 mm. In some embodiments, the outer diameter of the insertable section is less than or equal to approximately 4.75 mm, which is closer to the typical outer diameter of 3 mm ports, which is approximately 3.6 mm.

[0084] As best depicted in Figs. 4-6, in some embodiments, shaft 108 of trocar 102 also passes through a series of components prior to entering internal lumen 117 of port shaft 104. These components are considered part of head assembly 105 and may include port cap 120, open leaflet 134, and / or closed leaflet 136.

[0085] Port cap 120 is configured to create a generally enclosed space within head assembly 105 to accommodate one or more leaflets while also allowing for passage of trocar 102 and various instruments during use. As such, port cap 120 includes aperture 128 to allow for passage of shaft 108 and other medical instruments. Aperture 128 is generally located at a center point of port cap 120 and has a size and shape sufficient to accommodate shaft 108. To establish the enclosed space in head assembly 105, in some embodiments, at least a portion of port cap 120 has a lateral expanse sufficient to overlay the opening in proximal end 113 of port shaft 104. For example, as best depicted in Figs. 4-5, a middle portion of port cap 120 has a lateral expanse that is generally equal to the outer portion of proximal end 1 13 of port shaft 104 and distal end of head section 106 of trocar 102.

[0086] In some embodiments, port cap 120 is also configured to interface with trocar 102 and port shaft 104 to aid in alignment and prevent rotation of trocar 102 relative to the rest of port 100 as port 100 is being inserted into a patient. As such, some embodiments of port cap 120 (see Figs. 9) include top surface 122 with interface ridges 124 to accomplish this functionality. More specifically, interface ridges 122 have a size and shape that correspond to interface features 126 on head section 106 of trocar 102. As previously noted, head section 106 includes distal facing surface 109. Surface 109 may include interface features 126 in the form of recesses in surface 109 to receive interface ridges 124 of port cap 120. As provided in Figs. 4-5, interface features 126 and interface ridges 124 have specific shapes and / or orientations to prevent motion of trocar 102 relative to port cap 120, which also prevents motion relative to the rest of port 100 as it is being inserted into a patient. It should be understood that the interface components may be inverted such that the ridges reside on surface 109 of trocar 102 and the corresponding recesses resides on port cap 120. In addition, alternative features may be employed to prevent motion of trocar 102 relative to the rest of port 100.

[0087] It should be noted that some embodiments, such as those depicted in the exemplary figures and described above do not include a locking feature between trocar 102 and port cap 120 or port shaft 104. As such, trocar 102 can be easily removed from port shaft 104 without requiring an unlocking step, which allows an individual to more easily use port 100.

[0088] Port cap 120 may also be configured to engage port shaft 104 to prevent movement of port cap 120 relative to port shaft 104. As provided in the depicted embodiments, port cap 120 may accomplish this functionality through a series of radially extending ribs 130 located on a recessed cylindrical section 132. Cylindrical section 132 is sized to reside at least partially within the opening in proximal end 113 of port shaft 104 and ribs 130 have a size and shape sufficient to pass through a series of passages 132 in proximal end 1 13 of port shaft 104. Both the series of ribs 130 and passages 132 may be arranged in radial alignment about the circumference of their respective parts. It should also be noted that the ribs may be on the port shaft and the passages may be on the port cap. In addition, alternative methods and features may be used to temporarily engage these components, such as the non-limiting examples described herein in relation to other components.

[0089] Referring now to Figs. 4-6 and 10-11 , some embodiment of port 100 include one or more leaflets. The depicted embodiment includes open leaflet 134 in overlying relation to closed leaflet 136. However, an oppositely arranged configuration is considered. Moreover, open leaflet 134 and closed leaflet 136 are within the enclosed area as established by port cap 120 and the tapered section of port shaft 104. As shown in Figs. 10, open leaflet 134 has a generally frustoconical shape that tapers inwardly in a distal direction. The taper leads to aperture 138. Aperture 138 has a size and shape sufficient to allow for passage of trocar 102. In addition, aperture 138 is concentrically aligned with internal lumen 117 of port shaft 104.

[0090] As shown in Figs. 11 , closed leaflet 136 has a generally conical shape that also tapers inwardly in a distal direction. The taper leads to internal lumen 117 of port shaft 104. Closed leaflet 136 is configured to permit passage of trocar 102 and also configured to self-seal or seal around an inserted object to prevent unwanted insufflation during procedures, specifically after trocar removal and instrument insertion / removal. To do so, some embodiments employ a plurality of flexible flaps 140 arranged in a radial or segmented pattern to form a self-closing valve structure. Flaps 140 are configured to remain normally closed in the absence of an inserted instrument, thereby preventing the unintentional escape of insufflation gas or loss of cavity pressure. Upon insertion of a surgical instrument, flaps 140 flex and separate, allowing tool passage. Once the instrument is withdrawn, flaps 140 automatically return to their closed configuration, driven by the inherent elasticity of the material.

[0091] Continuing in a distal direction, port 100 further includes retention assembly 101 configured to maintain port 100 in a fixed position relative to the patient’s body wall during a minimally invasive surgical procedure. Retention assembly 101 is particularly useful in pediatric applications where thin abdominal walls and limited insertion depth can result in dislodgment of conventional ports. In addition, retention assembly 101 (the assembly configured to transition port 100 between an insertion configuration and an anchoring configuration) and its components have a lateral expanse that is less than (or at most equal to) the lateral expanse of head section 105. In the depicted embodiment, the retention assembly includes, among other things, internal retention mechanism 142 which is positioned at a point along port shaft 104 to expand within the body cavity and thereby resist outward migration of port 100 once inserted.

[0092] Internal retention mechanism 142 may have aperture 141 for receiving port shaft 104. Moreover, internal retention mechanism 142 may be integrated with or fixedly secured to port shaft 104 to ensure that internal retention mechanism 142 does not move axially relative to port shaft 104.

[0093] Referring back to Figs. 1-5 in conjunction with Figs. 12, internal retention mechanism 142 is located near distal end 115 of port shaft 104 to ensure that internal retention mechanism 142 is positioned within the body cavity when inserted into a patient. The specific distance from distal end 115 may vary based on the anatomical target area, but internal retention mechanism 142 is generally positioned within approximately 3 to 7 mm of distal end 115 of port shaft 104. In some embodiments, internal retention mechanism 142 is located within approximately 6 mm from distal end 115 of port shaft 104.

[0094] Internal retention mechanism 142 is capable of transitioning between an insertion orientation, which is depicted in Figs. 1 and 4 and an anchoring orientation, which is depicted in Figs. 2-3 and 5. The insertion orientation is characterized by a low-profile or collapsed state, allowing easy passage through the body wall. Once positioned within the body, internal retention mechanism 142 may expand laterally into the anchoring orientation. In some embodiments, the shape of internal retention mechanism 142 in the expanded state may resemble a torus, disc, flange, or balloon, depending on the retention strategy employed. However, alternative shapes are also considered.

[0095] The lateral expanse of internal retention mechanism 142 from shaft port 104 may vary depending on size of the insertion and the intended surgical procedure. For pediatric patients, the lateral expanse of internal retention mechanism 142 is generally within approximately 5 to 7 mm. In some embodiments, the lateral expanse of internal retention mechanism 142 is greater than or equal to approximately 6 mm.

[0096] In some embodiments, internal retention mechanism 142 may be inflatable. When deflated, internal retention mechanism 142 resides against or within recesses in the lateral wall of port shaft 104, presenting a minimal profile for insertion. Upon inflation, internal retention mechanism 142 expands outwardly from port shaft 104, forming a radial structure that resists withdrawal forces. Inflatable internal retention mechanism 142 offer the advantage of adjustable anchoring force and improved patient comfort due to the soft, compliant nature of the materials used.

[0097] As provided in Figs. 12, some embodiments of internal retention mechanism 142 include cylindrical support structure 141 with aperture 143 configured to receive port shaft 104. Cylindrical support structure 141 may be secured to port shaft 104 through an interference friction fit or through other known methods and devices for securing an object about a shaft, including the non-limiting approaches disclosed herein in connection with other components of port 100.

[0098] In some embodiments, cylindrical support structure 141 is also configured to provide the structure for fluidic channels 144 or include portions thereof that function as fluidic channels for delivering fluid into the inflatable portion of internal retention mechanism 142.

[0099] To enable inflation, port 100 may include one or more fluidic channels 144 extending between internal retention mechanism 142 and fluid reservoir 146. In some embodiments, fluidic channel(s) 144 is located within the wall of port shaft 104 (internal), while in others, it may be disposed along the outer surface of port shaft 104 (external). Each configuration provides unique advantages in terms of manufacturability, fluid control, and ease of integration with external components.

[0100] As best depicted in Figs. 3-5 and 13, some embodiments of port 100 include intermediate structure 148 that partially ensleeves port shaft 104 while providing space for fluid to flow around port shaft 104 in fluidic channels 144c. As such, intermediate structure 148 includes aperture 149 configured to receive port shaft 104. Cylindrical support structure 141 may be secured to port shaft 104 through an interference friction fit or through other known methods and devices for securing an object about a shaft, including the non-limiting approaches disclosed herein in connection with other components of port 100. Alternatively, intermediate structure 148 and channels 144c may be integrated into port shaft 104. In addition, while two channels are depicted, some embodiments include one channel and some include more than two channels.

[0101] In some embodiments, fluidic channels 144 are established in part by channels 144a in reservoir 146, channels 144b in internal retention mechanism 142, and channels 144c in intermediate structure 148. As a result, each of reservoir 146, internal retention mechanism 142, and intermediate structure 148 include axially aligned and nestable channel structures.

[0102] Referring now to Figs. 1 -5 and 14, reservoir 146 provides a fluid chamber that can be manipulated to deliver fluid through fluid channels 144 and into internal retention mechanism 142. Reservoir 146 may contain a gas (e.g., ambient air or oxygen) and / or a liquid (e.g., sterile saline) that can be transferred through fluidic channels 144. The choice of fluid medium may depend on factors such as desired expansion rate, sealing characteristics, and compatibility with surrounding tissues. Gas-filled systems may allow quicker inflation, whereas liquid-filled systems may offer better conformability and pressure control.

[0103] In some embodiments, reservoir 146 may be a closed chamber with a pre-set maximum volume of fluid enclosed in reservoir 146. This closed configuration prevents overinflation of internal retention mechanism 142, ensuring that expansion does not exceed safe limits and protecting surrounding tissues. The volume of fluid contained within reservoir 146 may vary depending on the size and shape of internal retention mechanism 142, but exemplary volumes may range from 0.1 mL to 4.0 mL.

[0104] In some embodiments, reservoir 146 may be open to ambient air and not pre-filled with fluid. Reservoir 146 or another operable component may be employed to close reservoir 146 prior to manipulation to ensure that a predetermined volume of fluid can be transferred to internal retention mechanism 142. This design simplifies storage and may improve shelf life by eliminating concerns related to fluid degradation or leakage. In such configurations, filling reservoir 146 is achieved by drawing in ambient air. In some embodiments, ambient air is drawn in using a fluid delivery mechanism, including but not limited to a pump mechanism or syringe. In other embodiments, ambient air is drawn into reservoir 146 due to reservoir 146 having a position of repose in which reservoir 146 is expanded as depicted in Figs. 1 and 4.

[0105] Regardless of whether reservoir 146 is closed and prefilled or initially open, reservoir 146 is configured to transition between an expanded configuration (filled with fluid or air) as shown in Figs. 1 and 4 and a collapsed configuration (after fluid transfer) as shown in Figs. 2-3. This functionality allows reservoir 146 to re-expand after compression, returning to its original shape without permanent deformation. When re-expanded, reservoir 136 withdraws the fluid from internal retention mechanism 142, thereby minimizing the cross-section of internal retention mechanism 142. In some embodiments, reservoir 146 is constructed from a flexible and resilient material that permits it to transition between an expanded configuration and a collapsed configuration. This resiliency allows reservoir 146 to re-expand after compression. Suitable materials may include but are not limited to elastomeric polymers or multi-layered films with shape memory characteristics.

[0106] Some embodiments of reservoir 146 may incorporate a semi-rigid structure or frame to transition between an expanded configuration and a collapsed configuration and achieve a predetermined expansion volume upon deployment. For example, as depicted in Figs. 15, reservoir 146 may include accordion-like folds 150 that allow reservoir 146 to collapse under force and re-expand when the force is removed. Non-limiting alternative structures may be used to achieve the same functionality including internal baffles, embedded ribs, living hinges, and internal springs that allow expansion up to a fixed geometric profile. This design ensures consistent inflation volumes, even when the system is actuated manually.

[0107] As depicted, reservoir 146 may be secured to the outer surface of port shaft 104 at a location sufficiently distanced from distal end 115 such that reservoir 146 remains outside of the patient. In addition, reservoir 146 may be secured at its proximal and / or distal end or it may simply ensleeve port shaft 104 so long as reservoir 146 can be compressed or collapsed to force fluid into fluidic channels 144. Non-limiting examples of the interface between port shaft 104 and reservoir 146 include adhesive, over-moldings, mechanical clips, and slidable rings.

[0108] In some embodiments, port 100 includes reservoir support structure 152 to provide a structural backstop for reservoir 146 and actuator 154. As provided in Figs. 16, support structure 152 is depicted in distal relation to reservoir 146 to prevent distal movement of at least the distal portion of reservoir 146 relative to port shaft 104. However, support structure 152 may be located in proximal relation to reservoir 146 to prevent proximal movement of at least the proximal portion of reservoir 146 relative to port shaft 104.

[0109] Support structure 152 may take the form of a ring, flange, bracket, or any other form to provide a physical stop during compression of reservoir 146. In addition, support structure may have aperture 153 for receiving port shaft 104 and fluidic channels 144. Moreover, support structure 152 may be integrated with or fixedly secured to port shaft 104 to ensure that support structure does not move axially relative to port shaft 104. However, some embodiments may include a support structure that is configured to translate to aid in the compression of reservoir 146.

[0110] The retention assembly of port 100 also includes actuator 154 for deploying internal retention mechanism 142. In this manner, actuator 154 has a first position in which the internal retention mechanism 142 is in the insertion configuration and a second position in which internal retention mechanism 142 has transitioned to the deployed configuration. In some embodiments, actuator 154 is configured to transmit force to reservoir 146 when moving from the first position to the second position to displace the contained fluid and drive it into internal retention mechanism 142. In some embodiments, actuator 154 includes a slidable structure that surrounds port shaft 104 and is movable in an axial direction as shown in comparing Fig. 1 to Fig. 2. When advanced into contact with reservoir 146, actuator 154 compresses reservoir 146 and forces fluid through fluidic channels 144.

[0111] As best depicted in Figs. 17, some embodiments of actuator 154 include a smooth and optionally curved reservoir-contacting surface 156 to minimize the risk of puncturing reservoir 146. Surface 156 may also have a size and shape sufficient to correspond to a surface of support structure 152 to ensure maximum displacement of fluid in reservoir 146. In some embodiments, actuator 154 includes a distal surface 156 having a shape and contour that nests into reservoir 146 support structure 152. This configuration ensures that actuator 154 can fully compress reservoir 146 during deployment, maximizing fluid transfer and ensuring complete expansion of internal retention mechanism 142.

[0112] Actuator 154 may also include a size and shape sufficient to allow a user to easily grasp actuator 154. Some embodiments of actuator 154 includes an annular constriction 157 to enhance grippability. It should be understood that alternative ergonomic grip features may be used, including but not limited to texturing, knurling, elevated ridges, contoured finger grips, recessed areas, rubberized overlays, or outwardly flared regions.

[0113] In some embodiments, actuator 154 includes aperture 158 that is larger than the outer diameter of port shaft 104, allowing it to slide concentrically along port shaft 104. This configuration enables actuation without interfering with instrument passage through internal lumen 117. Additionally, sliding actuator 154 may include alignment features or detents that engage with mating surfaces on port shaft 104 to provide tactile feedback and prevent unintentional movement.

[0114] In some embodiments, port 100 includes one or more locking feature 145 that temporarily secures actuator 154 at a location in which reservoir 146 is compressed. Locking feature(s)

[0115] 145 prevents actuator 154 from unintentionally returning to its initial location in which reservoir

[0116] 146 is in the expanded configuration and in turn preventing internal retention member from unintentionally returning to its insertion orientation. As depicted in Figs. 17C-17D, locking feature 145 may be in the form of a resilient locking tab with an internally extending projection

[0117] 147 that is configured to engage a similar projection 149 extending from a section of port shaft 104.

[0118] In various embodiments, the locking feature may include one or more of the following: a ratcheting mechanism configured to permit distal advancement of actuator 154 while preventing proximal movement unless a release tab is engaged; a twist-lock interface in which actuator 154 is rotated into a detent or notch after full depression; a snap-fit engagement that provides tactile and audible feedback upon full engagement; a friction-based interference fit that resists proximal displacement until an applied threshold force is exceeded; or a spring-loaded latch that automatically engages when actuator 154 reaches the fully translated position. It should be understood that alternative locking mechanisms may be employed to achieve the desired functionality, including other mechanical, magnetic, or material-based configurations that resist unintentional movement and maintain actuator 154 in a fixed position until deliberately released.

[0119] As exemplified in Figs. 18, actuator 154 may be in the form of a lever configured to compress reservoirs 146. The lever-style actuator 154 provides a similar functionality in that it can apply a force to reservoir 146 and remove said force or apply a decompressing force to reservoir 146 to move reservoir 146 into an expanded configuration. In some embodiments, the lever actuator may include locking tab 145 for attaching to a portion of port shaft 104.

[0120] In some embodiments, a lever actuator 154 may operate in conjunction with a one-way valve to draw ambient air into fluid reservoir 146, fluidic channels 144, and / or internal retention mechanism 142. In such embodiments, the lever functions as a manual pump, where user actuation cycles the lever through a defined arc to create a negative pressure condition within fluid reservoir 146, fluidic channels 144, and / or internal retention mechanism 142. Upon upward or return motion, ambient air is drawn through a one-way intake valve. Subsequent downward motion causes the air to be forced out through an outflow valve and into fluid reservoir 146, fluidic channels 144, and / or internal retention mechanism 142. The lever may be mounted directly to port shaft 104 or another component of the retention assembly. The design allows for controlled, incremental inflation of internal retention mechanism 142 without requiring direct compression of reservoir 146 or without requiring a reservoir. It should be understood that alternative mechanisms may be employed to achieve the same functionality, including sliding plungers, rotary pumps, or collapsible bellows, each adapted to deliver fluid or air to internal retention mechanism 142.

[0121] Referring now to Figs. 1 -5 and 19, the retention assembly may also include external retention member 160. External retention member 160 is provided and configured to be positioned along port shaft 104 into an adjacent relation to the patient’s body. As such, external retention member 160 operates in cooperation with internal retention mechanism 142 to securely sandwich or clamp the patient's tissue between the two retention members. This arrangement helps to maintain the position of port 100 within the surgical or anatomical opening and minimize movement or accidental dislodgement. External retention member 160 may include features such as a low-profile outer surface, gripping structures for enhanced friction against tissue, or a locking mechanism that allows it to be temporarily or permanently secured at a desired position along port shaft 104. In addition, external retention member 160 may include aperture 162 to slidably receive port shaft 104 and fluidic channels 144.

[0122] Referring now to Figs. 20, a method of use 200 of the port 100 includes, at step 202, inserting the port 100 through an incision in the patient's tissue while internal retention mechanism 142 is in an insertion configuration. In this insertion configuration, internal retention mechanism 142 may be collapsed, deflated, or otherwise configured to allow passage through the tissue opening with minimal resistance. At step 204, the port 100 is advanced until internal retention mechanism 142 passes through the interior surface of the tissue, such as the peritoneum or fascia, and the external portion of port 100 remains accessible from outside the body. At step 206, actuator 154, such as a plunger or sliding collar, is manually or mechanically translated along port shaft 104 to compress fluid reservoir 146. As actuator 154 advances, it applies a force that collapses reservoir 146, thereby forcing fluid — such as saline, air, or another biocompatible medium — through one or more fluidic channels 144. Fluidic channels 144 are in fluid communication with internal retention mechanism 142, and the flow of fluid into internal retention mechanism 142 causes it to transition from the insertion configuration to an expanded or deployed configuration. In the deployed configuration, internal retention mechanism 142 assumes a shape, such as a balloon, flange, umbrella, or petal array, that resists withdrawal of port 100 through the tissue. At step 208, an external retention member is advanced along port shaft 104 until it contacts the patient's external tissue surface. At step 210, external retention member 160 is secured in place on the shaft to apply a compressive force, thereby sandwiching the patient's tissue between the internal and external retention members and retaining port 100 in a desired position. At step 212, with the port 100 secured in position, the trocar 102 is removed from port 100 and the port may be used to perform a desired medical or surgical procedure, such as providing access to an internal body cavity, facilitating passage of instruments, enabling insufflation, or permitting fluid flow or drainage.

[0123] At step 214, once the desired medical or surgical procedure is complete, external retention member 160 is disengaged or released from its secured position along port shaft 104. This may involve actuating a release mechanism, such as pressing a latch, rotating a locking collar, or disengaging a ratchet, to allow external retention member 160 to slide freely along the shaft. At step 216, external retention member 160 is translated away from the patient's body, thereby relieving the compressive force applied to the tissue. At step 218, actuator 154 is retracted or manipulated in a reverse direction to decompress reservoir 146, or an evacuation valve is opened to allow fluid to be withdrawn from internal retention mechanism 142. As the fluid exits through fluidic channels 144, internal retention mechanism 142 deflates or collapses, returning to its insertion configuration. At step 220, with both the internal and external retention members in their insertion or non-retaining configurations, the port 100 is withdrawn from the tissue and removed from the patient's body.

[0124] The advantages set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

[0125] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.

Claims

What is claimed is:

1. A surgical port system for use in minimally invasive pediatric procedures, the system comprising: a port shaft having a proximal end, a distal end, and an internal lumen extending therebetween, the internal lumen configured to receive a surgical instrument configured for 3 mm ports; an internal retention member coupled to the port shaft proximate the distal end, the internal retention member being movable between a low-profile insertion configuration and an expanded deployed configuration; a fluid reservoir secured to the port shaft and in fluid communication with the internal retention member via one or more fluidic channels, the fluid reservoir configured to house a fluid for delivery to the internal retention member; an actuator operably coupled to the fluid reservoir, the actuator configured to compress the fluid reservoir and thereby force the fluid through the one or more fluidic channels to inflate the internal retention member into the deployed configuration; wherein the fluid reservoir is configured to return to a decompressed state when the actuator is no longer compressing the fluid reservoir.

2. The port system of claim 1 , wherein the fluid reservoir is mounted on an exterior surface of the port shaft and is selectively collapsible by the actuator.

3. The port system of claim 1 , wherein the internal retention member comprises an inflatable structure that expands radially outward from the port shaft in the deployed configuration.

4. The port system of claim 3, wherein the internal retention member is positioned within approximately 5 mm to 8 mm of the distal end of the port shaft.

5. The port system of claim 1 , wherein the actuator comprises a slidable collar disposed about the port shaft and configured to move axially along the port shaft to compress the fluid reservoir.

6. The port system of claim 5, wherein the actuator includes a distal surface configured to nest into a complementary reservoir support structure.

7. The port system of claim 1 , further comprising an external retention member slidably positionable along the port shaft, the external retention member configured to clamp tissue between the external retention member and the deployed internal retention member.

8. The port system of claim 1 , wherein the actuator comprises a locking mechanism configured to temporarily retain the actuator in a position in which the fluid reservoir is compressed.

9. The port system of claim 1 , wherein the fluid reservoir comprises a resilient material configured to re-expand after compression to draw fluid back from the internal retention member.

10. The port system of claim 9, wherein the internal retention member is deflatable via re-expansion of the fluid reservoir, thereby returning the internal retention member to the insertion configuration.11 . The port system of claim 1 , wherein the external diameter of the distal end of the port is equal to or less than approximately 4.75 mm thereby permitting use in pediatric patients five years old or younger.

12. The port system of claim 1 , further comprising a trocar configured to be removably received within the internal lumen of the port shaft, the trocar comprising a shaft and a head section, the head section configured to interface with a proximal portion of the port shaft to minimize a lateral expanse of the system when assembled.

13. The port system of claim 1 , further including a port cap configured to interface with the trocar and the port shaft to prevent unwanted relative movement between the trocar and the port shaft.

14. The port system of claim 1 , further including one or more leaflets configured to create a seal in the port shaft.

15. The port system of claim 1 , wherein the fluid reservoir is closed to ambient fluid and pre-filled with a predetermined volume of fluid.

16. The port system of claim 1 , wherein the fluid reservoir is open to ambient fluid when in the expanded state and is configured to close upon actuation of the actuator.

17. A surgical port system for use in minimally invasive pediatric procedures, the system comprising: a port shaft having a proximal end, a distal end, and an internal lumen extending therebetween; an internal retention member coupled to the port shaft proximate the distal end, the internal retention member being movable between a low-profile insertion configuration and an expanded deployed configuration; a fluid reservoir secured to the port shaft and in fluid communication with the internal retention member via one or more fluidic channels, wherein the fluid reservoir is closed to ambient fluid and pre-filled with a predetermined volume of fluid for delivery to the internal retention member; an actuator operably coupled to the fluid reservoir, the actuator configured to compress the fluid reservoir and thereby force the fluid through the one or more fluidic channels to inflate the internal retention member into the deployed configuration;wherein the fluid reservoir is configured to return to a decompressed state when the actuator is no longer compressing the fluid reservoir.

18. The port system of claim 17, wherein the fluid reservoir is mounted on an exterior surface of the port shaft and is selectively collapsible by the actuator.

19. The port system of claim 17, wherein the internal retention member comprises an inflatable structure that expands radially outward from the port shaft in the deployed configuration.

20. The port system of claim 19, wherein the internal retention member is positioned within approximately 5 mm to 8 mm of the distal end of the port shaft.21 . The port system of claim 17, wherein the actuator comprises a slidable collar disposed about the port shaft and configured to move axially along the port shaft to compress the fluid reservoir.

22. The port system of claim 21 , wherein the actuator includes a distal surface configured to nest into a complementary reservoir support structure.

23. The port system of claim 17, further comprising an external retention member slidably positionable along the port shaft, the external retention member configured to clamp tissue between the external retention member and the deployed internal retention member.

24. The port system of claim 17, wherein the actuator comprises a locking mechanism configured to temporarily retain the actuator in a position in which the fluid reservoir is compressed.

25. The port system of claim 17, wherein the fluid reservoir comprises a resilient material configured to re-expand after compression to draw fluid back from the internal retention member.

26. The port system of claim 25, wherein the internal retention member is deflatable via re-expansion of the fluid reservoir, thereby returning the internal retention member to the insertion configuration.

27. The port system of claim 17, wherein the external diameter of the distal end of the port is equal to or less than approximately 4.75 mm thereby permitting use in pediatric patients five years old or younger.

28. The port system of claim 17, further comprising a trocar configured to be removably received within the internal lumen of the port shaft, the trocar comprising a shaft and a head section, the head section configured to interface with a proximal portion of the port shaft to minimize a lateral expanse of the system when assembled.

29. The port system of claim 17, further including a port cap configured to interface with the trocar and the port shaft to prevent unwanted relative movement between the trocar and the port shaft.

30. The port system of claim 17, further including one or more leaflets configured to create a seal in the port shaft.31 . A method of securing a surgical port in tissue of a patient, the method comprising: inserting a port having a port shaft and an internal retention member through tissue while the internal retention member is in an insertion configuration; positioning the port such that the internal retention member is disposed inside the tissue; actuating a fluid reservoir by translating an actuator to compress the fluid reservoir and deliver fluid through one or more fluidic channels to inflate the internal retention member into a deployed configuration; and positioning an external retention member along the port shaft into contact with an outer surface of the tissue to secure the tissue between the external retention member and the deployed internal retention member.

32. The method of claim 31 , further comprising securing the external retention member in position on the port shaft to maintain the port in place.

33. The method of claim 31 , further comprising decompressing the fluid reservoir to withdraw fluid from the internal retention member, thereby deflating the internal retention member into the insertion configuration.

34. The method of claim 34, further comprising removing the port from the tissue after the internal retention member is deflated.

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