Preservation device for transplantation
The organ support system addresses the challenges of bulkiness and cooling inefficiencies in current devices by providing a customizable, low-profile, and robotically manipulable structure for effective organ cooling and positioning, reducing warm ischemia time and graft loss.
Patent Information
- Application Number
- PCT/US2025/031073
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-27
- Filing Date
- 2025-05-27
- Publication Date
- 2025-12-04
AI Technical Summary
Current devices for organ transplantation face challenges such as a bulky spatial footprint, unsuitable for varying organ sizes and shapes, incompatibility with robotic surgery, and inadequate cooling during the surgical procedure, leading to issues like delayed graft function and increased morbidity.
An organ support system with an oblong housing assembly and adjustable outer wall structures, including endcap wall members and a tether structure, designed for low-profile integration and robotic manipulation, providing customizable fit and effective cooling, and enabling easy release of the organ during transplantation.
The system ensures efficient cooling and stable positioning of organs during transplantation, reducing warm ischemia time and minimizing graft loss, thereby improving surgical workflow and patient outcomes.
Smart Images

Figure US2025031073_04122025_PF_FP_ABST
Abstract
Description
PRESERVATION DEVICE FOR TRANSPLANTATIONRELATED APPLICATIONS
[0001] This application claims the benefit of pending U.S. Provisional Patent Application No. 63 / 652,162 filed on 27 May 2024, the contents of which are incorporated herein by reference in their entirety.FIELD
[0002] The described examples relate generally to apparatuses, methods, and systems that include a preservation device for medical transplantation (e.g., organ transplantation).BACKGROUND
[0003] Kidney transplantation is the best current treatment for kidney failure. However, 20%- 30% of kidney transplant patients experience delayed graft function (DGF), which is defined as a transplant recipient requiring dialysis within seven days of transplantation surgery. Patients that develop delayed graft function have shorter graft survival by an estimated 3-year to 5-year halflife. Early graft loss in these patients often means a return to long-term dialysis and increased morbidity from continued immunosuppression therapy or transplantectomy without the benefits of transplantation. Kidney allograft warming above the threshold of necrosis can begin as early as 10 minutes into the surgical anastomosis. This period, called the “warm ischemia time” or “anastomosis time,” can be a key contributor to DGF and is often dependent on surgeon skills, allograft anatomy, and patient anatomy.
[0004] Certain devices for improving transplantation have been introduced in recent years. Unfortunately, adoption rates across the medical industry have been low because such devices suffer from various drawbacks. One drawback is a bulky spatial footprint that limits the already highly constrained surgical workspace during sew-in (e.g., about 1.5 inches of workspace). Other drawbacks can additionally or alternatively include, for instance, undesired coolant tubing, surgical workflow inhibitive, slow and / or difficult application / release of the organ, unsuitability for organ size / shape variation, incompatibility with robotic surgery, failure to maintain a threshold organ temperature, and / or incapable of cooling the organ throughout sew-in. Therefore, there is an ongoing need for improving transplantation.
[0005] The subject matter claimed herein is not limited to examples that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some examples described herein may be practiced.SUMMARY
[0006] An aspect of the present disclosure relates an organ support system. The organ support system can include an oblong housing assembly that includes: a plurality of outer wall structures defining an inner cavity and a proximal opening; a longitudinal axis extending lengthwise through the oblong housing assembly; a first transverse axis orthogonal to the longitudinal axis, and comprising a distal direction and a proximal direction, the first transverse axis intersecting the proximal opening; and a second transverse axis orthogonal to the longitudinal axis and the first transverse axis. The plurality of outer wall structures can include: first and second oblong wall members, each oblong wall member including an outer convex surface, an inner concave surface defining a portion of the inner cavity, and first and second ends located at opposite sides of the longitudinal axis of the oblong housing assembly; and first and second endcap wall members, wherein each endcap wall member includes an outer surface and an inner concave surface defining an endcap cavity, wherein the endcap cavity of the first endcap wall member is configured to receive the first end of the first oblong wall member and the second end of the second oblong wall member, and the endcap cavity of the second endcap wall member is configured to receive the second end of the first oblong wall member and the first end of the second oblong wall member. The oblong housing assembly can additionally include a tether structure that interconnects: the first oblong wall member to the second oblong wall member; the first oblong wall member to the first endcap wall member; and the second oblong wall member to the second endcap wall member. In another embodiment the organ support system further comprises a tray with first recess configured to receive the first endcap wall member and the first oblong wall member, and a second recess configured to receive the second endcap wall member and the second oblong wall member.
[0007] In some examples, the inner cavity is configured to receive a kidney, and wherein the proximal opening is configured for passthrough of kidney hilar portions. In certain examples, the tether structure comprises a first arm attached to the first oblong wall member and a second arm attached to the second oblong wall member. In at least one example, the first arm is further attached to the first endcap wall member and the second arm is further attached to the second endcap wall member. In particular examples, the first arm is fixedly attached to the first oblong wall member and movably attached to the first endcap wall member.
[0008] In one or more examples, the first endcap wall member comprises an arm opening through which the first arm slidably passes through. In some examples, the first arm is attached to the first oblong wall member at a first attachment site spaced away from the first end of the first oblong wall member. In certain examples, the first attachment site is located at the inner concave surface of the first oblong wall member. In at least one example, the tether structure further comprises a hub, and wherein the first and second arms of the tether structures extend from the hub. In specific implementations, the tether structure further comprises a suspension arm extendingfrom the hub, wherein when the suspension arm is raised, the organ support system is suspended in air. In some examples, the tether structure comprises a ribbon structure.
[0009] In some examples, the first and second endcap wall members comprises front and back edges that are non-parallel and non-orthogonal to at least one of the first transverse axis or the longitudinal axis. In certain examples, proximal regions of the front edges of the first and second endcap wall members are spaced farther apart from the first transverse axis than distal regions of the front edges of the first and second endcap wall members. In particular examples, the oblong housing assembly is size adjustable along multiple axes.
[0010] In one or more examples, the first and second oblong wall members each comprise a cooling structure comprising an outer convex surface complementary to the inner concave surface of the corresponding oblong wall member, and an inner concave surface. In some examples, the first and second oblong wall members each further comprise an inner contact structure, the inner contact structure comprising an outer convex surface complementary to the inner concave surface of the corresponding cooling structure, and a concave surface configured to contact an organ located in the inner cavity. In certain examples, the cooling structure includes a phase-change material. In particular examples, the first and second oblong wall members and the first and second endcap wall members each comprise a closed cell foam.
[0011] In some examples, the oblong housing assembly further includes a handle extending out from opposing end portions of the plurality of outer wall structures. In certain examples, the oblong housing assembly further includes an attachable strap member removably attachable to at least one of the first or second oblong wall members. In one example, in a secured configuration, the attachable strap members each comprise an orientation that is non-orthogonal to the longitudinal axis and the first transverse axis. In specific implementations, upon releasing the attachable strap members from a secured configuration, the first and second endcap members are configured to radially rotate toward the distal direction and expand the proximal opening. In at least one example, in the secured configuration, the attachable strap members are configured to partially cover the proximal opening.
[0012] Other aspects of the disclosure relate to systems, methods, and additional apparatuses. For example, other aspects of the present disclosure relate to a method of cooling an organ using an organ support system.
[0013] In another embodiment, a method of opening an organ support device, comprising separating complementary shell portions apart from one other at least as a result of application of gravitational force at the shell portions thereby causing a greater portion of the organ to be revealed from the housing for reperfusion. The complementary shell portions may be radially separated apart from one another at least as a result of the application of the gravitational force at the shellportions. The complementary shell portions may be radially separated apart from one another at least as a result of the application of the gravitational force at the shell portions and without exerting axial compression on the anastomosed vessels via the complementary shell portions.
[0014] In another embodiment, a method of robotically exposing a transplant organ contained in an organ-preservation housing, the housing including (i) a suspension lanyard affixed to opposed shell portions and (ii) at least one releasable closure strap secured to an outer wall, the method comprising (a) introducing the housing into a recipient’s abdominal cavity and positioning the housing adjacent iliac vessels, (b) gripping the suspension lanyard with a first robotic arm and maintaining that grip, (c) with a second robotic arm, engaging a manipulation feature of the housing, (d) with the same second robotic arm and without transferring the housing to any other instrument, applying a peeling or separation force that detaches the closure strap from the outer wall, (e) completing detachment of the closure strap using the same second robotic arm while the first robotic arm continues to stabilize the housing via the lanyard, and (f) permitting the shell portions to separate radially under gravitational force, thereby revealing the organ for reperfusion without exerting axial compression on the anastomosed vessels. The second robotic arm may peel a first end of the strap with a first jaw orientation and, without releasing the strap, rotates its wrist joint to peel a remaining portion of the strap with a second jaw orientation. The manipulation feature may be a closed shape having an average internal diameter of 6-12 mm. The method may further comprise extracting the empty housing through a single access port with the first robotic arm still gripping the lanyard. The closure strap may include a radiopaque indicator that remains visible on post-procedure fluoroscopy to confirm complete removal.
[0015] In still another embodiment, an ornamental design for a kidney support device as shown and described is provided. In some embodiments, the ornamental design is as shown in described in FIGS. 12-35, 12-19, 20-27 or 18-35. Other technical features may be apparent to one skilled in the art, having the benefit of this disclosure, in connection with the following figures, descriptions, and claims. Further, the subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this summary section is only provided to illustrate certain feature and embodiments.BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The disclosure will be readily understood by the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements, and in which:
[0017] FIG. 1A illustrates a front plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0018] FIG. IB illustrates a front plan view of an organ support system in a closed, unsecured configuration in accordance with one or more examples of the present disclosure;
[0019] FIG. 1C illustrates a front plan view of an organ support system in released configuration in accordance with one or more examples of the present disclosure;
[0020] FIG. 2A illustrates a front plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0021] FIG. 2B illustrates a rear plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0022] FIG. 2C illustrates a side plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0023] FIG. 2D illustrates another side plan view (opposite the side plan view of FIG. 2C) of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0024] FIG. 2E illustrates a top (distal) plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0025] FIG. 2F illustrates a bottom (proximal) plan view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0026] FIG. 2G illustrates a perspective view of an organ support system in a closed, secured configuration in accordance with one or more examples of the present disclosure;
[0027] FIG. 2H illustrates an exploded view of an organ support system in accordance with one or more examples of the present disclosure;
[0028] FIG. 3 A illustrates a front plan view of an organ support system in an open configuration in accordance with one or more examples of the present disclosure;
[0029] FIG. 3B illustrates a rear plan view of an organ support system in an open configuration in accordance with one or more examples of the present disclosure;
[0030] FIG. 3C illustrates a side plan view of an organ support system in an open configuration in accordance with one or more examples of the present disclosure;
[0031] FIG. 3D illustrates a bottom (proximal) plan view of a constituent portion of an organ support system in accordance with one or more examples of the present disclosure;
[0032] FIG. 3E illustrates a top (distal) plan view of a constituent portion of an organ support system in accordance with one or more examples of the present disclosure;
[0033] FIG. 3F illustrates a perspective view of an organ support system in an open configuration in accordance with one or more examples of the present disclosure;
[0034] FIG. 3G illustrates a cross-sectional view along a longitudinal axis of a constituent portion of an organ support system in accordance with one or more examples of the present disclosure;
[0035] FIG. 3H illustrates a cross-sectional view along a first transverse axis of a constituent portion of an organ support system in accordance with one or more examples of the present disclosure;
[0036] FIG. 4A illustrates a front perspective view of an inner contact structure in accordance with one or more examples of the present disclosure;
[0037] FIG. 4B illustrates a rear perspective view of an inner contact structure in accordance with one or more examples of the present disclosure;
[0038] FIG. 4C illustrates a top (distal) plan view of an inner contact structure in accordance with one or more examples of the present disclosure;
[0039] FIG. 5A illustrates a front perspective view of an oblong wall member in accordance with one or more examples of the present disclosure;
[0040] FIG. 5B illustrates a rear perspective view of an oblong wall member in accordance with one or more examples of the present disclosure;
[0041] FIG. 5C illustrates a distal perspective view of an oblong wall member with an endcap wall member in accordance with one or more examples of the present disclosure;
[0042] FIG. 6A illustrates a perspective view of an endcap wall member in accordance with one or more examples of the present disclosure;
[0043] FIG. 6B illustrates another perspective view of an endcap wall member in accordance with one or more examples of the present disclosure;
[0044] FIG. 7A illustrates a perspective view of a cooling structure in accordance with one or more examples of the present disclosure;
[0045] FIG. 7B illustrates a top (distal) plan view of a cooling structure in accordance with one or more examples of the present disclosure;
[0046] FIG. 7C illustrates a cross-sectional view along a longitudinal axis of a cooling structure in accordance with one or more examples of the present disclosure;
[0047] FIG. 7D illustrates a cross-sectional view along a first transverse axis of a cooling structure in accordance with one or more examples of the present disclosure;
[0048] FIGS. 8A-8D illustrate an example method flow of retaining an organ to cool within another example implementation of an organ support system, in accordance with one or more examples of the present disclosure;
[0049] FIG. 8E illustrates a top (distal) plan view of the organ support system of FIGS. 8A-8F, in accordance with one or more examples of the present disclosure;
[0050] FIG. 8F illustrates a close-up view of an endcap wall member portion of the organ support system of FIGS. 8A-8F, in accordance with one or more examples of the present disclosure;
[0051] FIGS. 9A-9F illustrate an example method flow of retaining an organ to cool within an organ support system, in accordance with one or more examples of the present disclosure;
[0052] FIG. 10 illustrates an example method flow of utilizing an organ support system in accordance with one or more examples of the present disclosure; and
[0053] FIG. 11 illustrates — in relation to the current standard of care and certain conventional devices — experimental data of utilizing an organ support system in accordance with one or more examples of the present disclosure.
[0054] FIG. 12 is a top perspective view of an organ support device;
[0055] FIG. 13 is a bottom perspective view of the organ support device;
[0056] FIG. 14 is a front view of the organ support device;
[0057] FIG. 15 is a back view of the organ support device;
[0058] FIG. 16 is a left side view of the organ support device;
[0059] FIG. 17 is a right side view of the organ support device;
[0060] FIG. 18 is a top plan view of the organ support device; and
[0061] FIG. 19 is a bottom plan view of the organ support device.
[0062] FIG. 20 is a top perspective view of an organ support device;
[0063] FIG. 21 is a bottom perspective view of the organ support device;
[0064] FIG. 22 is a front view of the organ support device;
[0065] FIG. 23 is a back view of the organ support device;
[0066] FIG. 24 is a left side view of the organ support device;
[0067] FIG. 25 is a right side view of the organ support device;
[0068] FIG. 26 is a top plan view of the organ support device; and
[0069] FIG. 27 is a bottom plan view of the organ support device.
[0070] FIG. 28 is a top perspective view of an organ support device;
[0071] FIG. 29 is a bottom perspective view of the organ support device;
[0072] FIG. 30 is a front view of the organ support device;
[0073] FIG. 31 is a back view of the organ support device;
[0074] FIG. 32 is a left side view of the organ support device;
[0075] FIG. 33 is a right side view of the organ support device;
[0076] FIG. 34 is a top plan view of the organ support device; and
[0077] FIG. 35 is a bottom plan view of the organ support device.
[0078] The broken lines are for illustrative purposes only and form no part of the claimed designDETAILED DESCRIPTION
[0079] Reference will now be made in detail to representative examples illustrated in the accompanying drawings. It should be understood that the following descriptions are not intended to limit the examples to one preferred example. To the contrary, it is intended to cover alternatives, modifications, and equivalents as can be included within the spirit and scope of the described examples as defined by the appended claims.
[0080] The following disclosure relates to an organ cooling device (also referred to herein as an organ support system) designed to maintain the organ at a cooled temperature during transplantation. The organ cooling device can include insulative components and cooling structures for thermal regulation. The organ cooling device is low profile and conforms well to a variety of different organ shapes and sizes for increased surface contact with the organ (and minimal air gaps). The organ cooling device can be robotically and / or manually manipulated via handles, tether structures, etc.
[0081] These and other examples are discussed below with reference to FIGS. 1A-11. However, a person of ordinary skill in the art — having the benefit of this disclosure — will readily appreciate that the detailed description given herein with respect to these figures is for explanatory purposes only and should not be construed as limiting. Furthermore, as used herein, a system, a method, an article, a component, a feature, or a sub-feature including at least one of a first option, a second option, or a third option should be understood as referring to a system, a method, an article, a component, a feature, or a sub-feature that can include one of each listed option (e.g., only one of the first option, only one of the second option, or only one of the third option), multiple of a single listed option (e.g., two or more of the first option), two options simultaneously (e.g., one of the first option and one of the second option), or combination thereof (e.g., two of the first option and one of the second option).
[0082] FIGS. 1A-1C illustrate an organ support system 100 in accordance with one or more examples of the present disclosure. As discussed herein, the organ support system 100 can help facilitate organ transplantation. The structures of the disclosed organ support system 100 can be low-profile, easily integrated into a surgical workflow, and manipulated by robotic operation and / or surgeon technicians. In addition, the various disclosed structures of the organ support system 100 can provide a desired cooling of the organ throughout sew-in, as well as readily position, stabilize, and release the organ in a transplant procedure.
[0083] As shown, the organ support system 100 includes an oblong housing assembly 102. The oblong housing assembly 102 can include a plurality of outer wall structures defining an inner cavity sized and shaped to receive an organ. In addition, the plurality of outer wall structures can define a proximal opening 112. The plurality of outer wall structures are discussed in greater detailbelow. The organ support system 100 can include a longitudinal axis 114 extending lengthwise through the organ support system 100, a first transverse axis 116 extending height-wise through the organ support system 100, and a second transverse axis 118 extending width-wise (in and out of the page in FIG. 1A) through the organ support system 100. The first transverse axis 116 is orthogonal to the longitudinal axis 114 and defines a distal direction and a proximal direction. The second transverse axis 118 is orthogonal to the longitudinal axis 114 and the first transverse axis 116. These axes will be used to reference positional relationships of the various components of the organ support system 100.
[0084] The plurality of outer wall structures can include a first oblong wall member 104, a second oblong wall member 106 (not shown in FIGS. 1A-1B), a first endcap wall member 108, and a second endcap wall member 110. In the depicted example, the plurality of outer wall structures can include separate and discrete portions. For instance, the first oblong wall member 104 and the first endcap wall member 108 can be discrete components. In other examples, however, such members or components can be integrally formed together as a single piece unit (e.g., as shown in FIGS. 8A-8F).
[0085] In particular examples, the plurality of outer wall structures work together or are otherwise complementary to each other to retain an organ. In some examples the plurality of outer wall structures are slid together, intermeshed with one another, folded or tucked into one another e.g., origami-style), interlocked together, and / or are inserted into each other. In specific implementations, the plurality of outer wall structures are configured as shell halves that are entirely (or substantially) detachable from one another. In some further variations, the interrelationships between the outer wall structures may be variable, e.g., different degrees or amount of overlap, to accommodate organs of different sizes and shapes, while still maintaining sufficient or adequate surface contact with the organ to provide cooling. The variations may be along the longitudinal length, height, width and / or circumference of the outer wall structures.
[0086] As used herein, “overlap distance 5” refers to the linear amount by which one shell portion margin overlies, underlies, or intermeshes with the opposing shell portion margin in the closed configuration. The device is engineered to provide an adjustable overlap window. Accordingly, in an adult setting the overlap distance 5_L may range from approximately 8 mm to 45 mm, 5_H from 3 mm to 18 mm, and 5_W from 1 mm to 12 mm, corresponding to about 8-45 %, 5-35 %, and 3-25 % of the respective shell dimensions; pediatric or xenograft applications may employ proportionally smaller values while still falling within these percentage ranges.
[0087] In these or other examples, the plurality of outer wall structures can include a variety of shapes and sizes. In certain examples, the plurality of outer wall structures are sized and shaped to accommodate a particular type of organ (e.g., a kidney). In at least one example, the plurality ofouter wall structures when assembled can include an oblong shape, an egg shape, melon shape, etc. In at least some examples, the plurality of outer wall structures are size and / or shape adjustable. For instance, the plurality of outer wall structures can be adjusted (e.g., lengthened or shortened) along the longitudinal axis 114 to accommodate different length dimensions of a retained organ. Similarly, in some examples, the plurality of outer wall structures can be adjusted in height along the first transverse axis 116 to accommodate different height dimensions of a retained organ. By manipulating the overlap distances 5L, 5H, and 5W within the foregoing quantitative ranges, the shell halves may be made to overlap or retract from one another to provide a custom fit for a given organ and / or reduce air gaps between the kidney 126 and the organ-support system 100. Likewise, in some examples, the plurality of outer wall structures can be adjusted in width along the second transverse axis 118 to accommodate different width dimensions of a retained organ. In such examples, the plurality of outer wall structures can be manipulated to overlap one another and / or retract from one another along the various axes to provide a custom fit for a given organ and / or reduce air gaps between the kidney 126 and the organ support system 100. Additionally or alternatively, the plurality of outer wall structures may be reconfigurable (e.g., pliant, bendable, reshapable, moldable, malleable, etc.). In one example, the plurality of outer wall structures can include shape memory.
[0088] The plurality of outer wall structures can include a variety of one or more different materials. In some examples plurality of outer wall structures can include a nonabsorbent, biocompatible material. For instance, the plurality of outer wall structures can include a foam material (e.g., a closed cell foam, open cell foam, aerogel or other porous material), metal, silicone, or combinations thereof. In one implementation, the first and second oblong wall members 104, 106 and the first and second endcap wall members 108, 110 each comprise a closed cell foam. In particular examples, the plurality of outer wall structures can include an insulative material to help limit heat transfer from one or more cooling structures inside the organ support system 100 into the ambient environment. For instance, the plurality of outer wall structures can include a closed-cell polyurethane foam with thermal conductivity not greater than 0.05 W nr' K-1. In at least one example, the plurality of outer wall structures can include nylon or polyethylene. In specific implementations, the plurality of outer wall structures can include an attachment material (e.g., at least one of a hook and loop material). In one example, the plurality of outer wall structures can include a shape memory material (e.g., Nitinol).
[0089] In addition to various materials, the plurality of outer wall structures can include one or more indicators. The indicators can include position indicators, orientation indicators, temperature indicators, time-lapse indicators, etc. Orientation indicators, for example, can be color-coded or depicted via symbols and / or alphanumeric characters (e.g., such that the organ is properly orientedwithin the organ support system 100 and / or to ensure proper placement of the organ support system 100 relative to the patient). In one example, an orientation indicator indicates which pole-end is the ureter pole 130 so that a ureter is properly oriented toward a patient’s bladder. Temperature indicators can also be color-coded (e.g., to visually ensure thermal readiness of the organ support system 100).
[0090] The attachable strap members 122, 124 can maintain the organ support system 100 in a secured configuration. The attachable strap members 122, 124 can include straps, bands, tighteners, cinches, belts, etc. In some examples, the attachable strap members 122, 124 can include a hook and loop material securable to the plurality of outer wall structures. Additionally or alternatively, the attachable strap members 122, 124 can include fasteners (e.g., clasps, clips, buttons, ties, etc.). In some examples, the attachable strap members 122, 124 can be attached (e.g., removably or permanently) to at least one the plurality of outer wall structures, such as one of the first or second oblong wall members 104, 106. In at least one example, the attachable strap members 122, 124 include a fixed end permanently attached to one of the plurality of outer wall structures.
[0091] In these or other examples, the attachable strap members 122, 124 can secure an organ within the organ support system 100. Specifically, the attachable strap members 122, 124 can maintain the positional relationship of the plurality of outer wall structures relative to each other, thereby maintaining a desired fit or compression of the organ support system 100 about the retained organ. The attachable strap members 122, 124 can also at least partially cover or define the proximal opening 112 (e.g., for adjusting a size and / or shape of the proximal opening 112, for adjusting visualization of the hilar portions 128, etc.). In specific implementations, the attachable strap members 122, 124 can adjustably overlap each other or cross (e.g., in an X-configuration). In the depicted example of FIG. 1A showing a secured configuration of the organ support system 100, the attachable strap members 122, 124 can each include an orientation that is non-orthogonal to the longitudinal axis 114 and the first transverse axis 116.
[0092] Further shown in the secured configuration depicted in FIG. 1 A when the organ (e.g., kidney 126) is retained within the organ support system 100, a proximal opening 112 can allow certain portions of the organ (e.g., hilar portions 128) to be accessed. For example, the proximal opening 112 can specifically enable anastomosis to be performed where the hilar portions 128 (renal vein and renal artery) extending through the proximal opening 112 are joined with the iliac vein and iliac artery — all while the kidney 126 is secured (and cooled) within the organ support system 100.
[0093] The proximal opening 112 can include a variety of shapes and sizes. In specific examples, the proximal opening 112 is sized and shaped for passage of the hilar portions 128therethrough. In one or more embodiments, a ureter can optionally pass through the proximal opening 112 (or else reside within the inner cavity with the kidney). Additionally or alternatively the proximal opening 112 can be sized and shaped for optimal minimization of heat transfer from the ambient environment to the kidney 126.
[0094] The proximal opening 112 can be positioned in various places. In some examples, the proximal opening 112 is positioned in a proximal region of the organ support system 100 opposite a tether structure 120. In certain examples, the proximal opening 112 is positioned between a ureter pole 130 and an upper pole 132 opposite the ureter pole 130 (the ureter pole 130 being a lower pole). In specific examples, the proximal opening 112 is positioned between the ureter pole 130 and the upper pole 132 such that the first transverse axis 116 can intersect the proximal opening 112.
[0095] In some examples, the oblong housing assembly 102 can additionally include a tether structure 120. The tether structure 120 can include one or more stay elements, hoist elements, suspension elements, positioning elements, connectors, etc. For example, the tether structure 120 can include a ribbon structure, such as a lanyard, rope, strap, band, belt, wire, etc.
[0096] In these or other examples, a tether structure 120 can couple certain portions of the oblong housing assembly 102 together. For example, the tether structure 120 can couple the first oblong wall member 104 to the second oblong wall member 106. The tether structure 120 can additionally or alternatively couple the first oblong wall member 1042 the first endcap wall member 108. The tether structure 120 can additionally or alternatively couple the second oblong wall member 106 to the second endcap wall member 110.
[0097] In some examples, the tether structure 120 can also be used to position, manipulate, orient, suspend, and / or move the organ support system 100. In one or more examples, the tether structure 120 can be handled via robotic operation and / or human technician, as will be discussed in more detail below.
[0098] FIG. IB shows an example of an unsecured configuration, in which the attachable straps 122, 124 are at least partially removed from the organ support system 100. For example, the attachable straps 122, 124 are at least partially unwrapped from covering the proximal opening 112. Accordingly, the proximal opening 112 can be increased or enlarged to expose more of a proximal portion of the kidney 126.
[0099] In FIG. 1C, the kidney 126 is released from the organ support system 100. Release of the kidney 126 (or other organ) can be achieved in various ways. In one example, handles 134 (e.g., loops, rings, notches, grips, eyelets, knobs, shafts, depressions, protrusions, etc.) can be utilized. Handles 134, for instance, can extend out from opposing end portions of the plurality of wall structures and can be pulled apart in opposite directions (indicated by longitudinal arrows138) along the longitudinal axis. Alternatively, only a single handle 134 can be pulled for single- handed actuation or release. Pulling one or both of the handles 134 in such a longitudinal fashion can increasingly enlarge the proximal opening 112 until the kidney 126 can fall through the proximal opening 112. In these or other examples, handles 134 can be pulled via robotic arms and / or human technicians. In specific examples, however, handles 134 can be particularly sized and shaped to receive robotic grippers or robotic hooks (e.g., first and second robotic arms). An additional robotic arm (e.g., tertiary robot arm can hold, hoist, and / or lower the organ support system 100 into a desired position e.g., via the suspension arm discussed further below). Handles 134 can include various materials (e.g., webbing, rubber, metal, etc.) and can be rigid or non-rigid. In at least one example, the handles 134 can be adapted to receive a threshold pulling force designed to separate the organ support system 100.
[0100] In another example, the kidney 126 can be released from the organ support system 100 with or without pulling the handles 134. Specifically, the kidney 126 can exit the proximal opening 112 due to the weight of the kidney 126 acting on the organ support system 100 when in the unsecured configuration. To illustrate, the weight of the kidney 126 can naturally impart a downward force upon one or more of the plurality of wall structures of the organ support system 100. In response to the weight of the kidney 126, various structures of the organ support system 100 can be gently displaced.
[0101] For instance, the various structures of the organ support system 100 can radially rotate toward the distal direction — specifically in the direction of radial arrows 136. By radially rotating in the direction of radial arrows 136, the proximal opening 112 can increasingly enlarge the proximal opening 112 until the kidney 126 can fall through the proximal opening 112. In specific implementations, upon releasing the attachable strap members 122, 124 from the secured configuration (shown in FIG. 1 A), the first and second endcap members are configured to radially rotate toward the distal direction and expand the proximal opening 112 (e.g., in a controlled manner). In at least one example, releasing the attachable strap members 122, 124 from the secured configuration (shown in FIG. 1A) can allow the joined halves or constituent portions of the organ support system 102 to entirely separate — at which point the separated halves or portions may only be loosely coupled via the tether structure 120. Like cracking an egg, distal portions of the organ support system 100 can pivot (or swing) closer to each other while proximal portions of the organ support system 100 can pivot (or swing) away from each other to allow the kidney 126 to drop out. Generally, though, the overlapping of constituent portions of the organ support system 100 decreases during radial rotation for release of the kidney.
[0102] In yet another example, the foregoing gravity release of the kidney 126 can be aided by pulling the tether structure 120 in the distal direction indicated by distal arrow 140. To illustrate,the organ support system 100 can undergo a greater normal force in response to the combination of an upward force (or acceleration) in the direction of the distal arrow 140 and the downward force from the weight of the kidney 126. When in the unsecured configuration, the organ support system 100 does not provide this resultant normal force and thus is forcefully rotated in the radial fashion along radial arrows 136, as discussed above.
[0103] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 1 A-1C can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS, can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 1 A-1C.
[0104] FIGS. 2A-2G illustrate additional views of the organ support system 100 in a closed or secured configuration, in accordance with one or more examples of the present disclosure. FIG. 2H illustrates an exploded view of the organ support system 100 including constituent portions 200, 202 comprising the organ support system 100 in accordance with one or more examples of the present disclosure. The components illustrated in these figures is discussed in detail below in relation to subsequent figures.
[0105] FIGS. 3A-3I illustrate various views of the organ support system 100 in an open configuration, in accordance with one or more examples of the present disclosure. As discussed above, the organ support system 100 can be separated into constituent portions 200, 202. Constituent portions 200, 202 can include a variety of mating geometry, complementary features, surfaced contours, etc. designed to receive corresponding elements of the other constituent portion. FIGS. 3A-3C and FIG. 3F depict the constituent portions 200, 202 side-by-side in an open configuration (e.g., ready to receive an organ). Conversely, and for purposes of illustration, FIGS. 3D-3E and 3G-3H depict a single constituent portion of the organ support system 100.
[0106] As shown, the organ support system 100 can include endcap cavities 300, 302. The endcap cavities 300, 302 at least partially define the inner cavity of the organ support system 100 for receiving an organ. In particular examples, the endcap cavities 300, 302 allow for sizing / shape adjustment such that the organ tissue retained within the organ support system 100 maintains as much surface contact as possible with the oblong wall members 104, 106 for continued heat dissipation from the organ. Indeed, as will be discussed below, the margin or amount of overlap between the endcap wall members 108, 110 and the oblong wall members 104, 106 can vary depending on organ size and shape.
[0107] The endcap cavity 300 is defined at least in part by the first endcap wall member 108 and the first oblong wall member 104. In these or other examples, the endcap cavity 300 of the first endcap wall member 108 can receive a first end 308 of the first oblong wall member 104 and a second end 306 of the second oblong wall member 106. The first and second ends 308, 304 are located at opposite sides of the longitudinal axis 114 of the oblong housing assembly 102.
[0108] Similarly, the endcap cavity 302 is defined at least in part by the second endcap wall member 110 and the second oblong wall member 106. In one or more examples, the endcap cavity 302 of the second endcap wall member 110 can receive a first end 310 of the second oblong wall member 106 and a second end 304 of the first oblong wall member 104. The first and second ends 306, 310 are located at opposite sides of the longitudinal axis 114 of the oblong housing assembly 102.
[0109] In these or other examples, a front edge 328 of the first and second endcap wall members 108, 110 can at least partially define the metes and bounds of the endcap cavities 300, 302. In particular examples, the front edge 328 can guide the second end of the opposing constituent portion into the endcap cavity. The front edge 328 (and the endcap cavity as a whole) can also support and help retain the received second end in position.
[0110] Additionally or alternatively, the front edge 328 can be asymmetrically shaped or angled non-orthogonally and non-parallel relative to at least one of the longitudinal axis 114 or the first transverse axis 116. In some examples, the front edge 328 is shaped in this way to help define the proximal opening 112 when the constituent portions 200, 202 are joined together. Additionally or alternatively, the angle of the front edge 328 can help facilitate one or more methods of releasing the kidney from the organ support system 100. For example, a distal portion of the front edge 328 can be closer to the first transverse axis 116 than a proximal portion of the front edge 328. Thus, when the constituent portions 200, 202 radially rotate toward the distal direction, the distance of radial translation (or rotation) needed to exit the kidney from the organ support system 100 can be reduced. In particular embodiments, the front edge 328 is angled about 10° to about 60° relative to the first transverse axis 116, about 15° to about 45° relative to the first transverse axis 116, or about 20° to about 30° relative to the first transverse axis 116. In these or other examples, larger angles of the front edge 328 relative to the first transverse axis 116 can provide a larger proximal opening 112.
[0111] In these or other examples, a back edge 330 (shown in FIG. 3B) of the first and second endcap wall members 108, 110 can at least partially define the metes and bounds of the endcap cavities 300, 302. Additionally or alternatively, the back edge 330 can be asymmetrically shaped or angled non-orthogonally and non-parallel relative to at least one of the longitudinal axis 114 or the first transverse axis 116. In some examples, the back edge 330 cups (e.g., in a C-Shape fashion)around the outer convex surface of the oblong wall members, particularly the first ends 308, 310 of the respective first oblong wall member 104 and the second oblong wall member 106. In so doing, the back edge 330 can help the first and second endcap wall members 108, 110 serve as a partial moving joint (like a ball-and-socket). In some examples, the back edge 330 can have an adjustable amount of overlap to the oblong wall members to allow adjustment in various dimensions, particularly along the second transverse axis 118 to accommodate greater widths of kidneys.
[0112] FIGS. 3 A-3G show additional detail of the tether structure 120. As discussed above, the tether structure 120 can couple together various components of the organ support system 100. To do so, the tether structure 120 can include certain arms (e.g., members, supports, tether portions, etc.). For example, tether structure 120 can include a first arm 312, a second arm 314, and a suspension arm 316. The arms can include a variety of connectors (e.g., straps, bands, cinches, belts, cords, harnesses, yokes, etc.). The tether may comprise a solid sheet material or a woven material, and may comprise a ribbon shape, as depicted in FIGS. 3A to 3G, though in other variations, the tether may comprise one or more cords or cable-like shape, and may comprise a polymer such as nylon or EVA plastic. The attachment straps may comprise .
[0113] The first arm 312 can connect to at least one of the first endcap wall member 108 or the first oblong wall member 104. The second arm can connect to at least one of the second endcap wall member 110 or the second oblong wall member 106. In one example, the first arm 312 is attached to the first oblong wall member 104, and the second arm 314 is attached to the second oblong wall member 106. In another example, the first arm 312 is additionally attached to the first endcap wall member 108, and the second arm 314 is additionally attached to the second endcap wall member 110. In a certain example, the first arm 312 is fixedly attached to the first oblong wall member 104 and movably attached to the first endcap wall member 108. Similarly, the second arm 314 can be fixedly attached to the second oblong wall member 106 and movably attached to the second endcap wall member 110. By allowing respective movement of the endcap wall members 108, 110 relative to the first arm 312 and the second arm 314, the endcap wall members 108, 110 can take up slack in (e.g., slide along) the first and second arms 312, 314 to allow the endcap wall members to radially rotate during kidney removable from the organ support system 100. Additionally or alternatively, the endcap wall members 108, 110 can take up slack in (e.g., slide along) the first and second arms 312, 314 to flexibly allow adjustment of the endcap cavities 300, 302 to accommodate different kidney sizes and shapes. In other variations, the endcap wall members may be fixedly attached to the tether arms, with a fixed length of tether between the endcap wall members and its corresponding oblong wall member. Length of the connection between the shell and buckle is 55mm. Length of lanyard extending from buckle to end is 10-30cm. The lanyard length is user-adjustable or selectable between about 100 mm and about 300 mm, with a preferred operating band of 150-220 mm. The lanyard length is long enough for gravity-assisted radial opening (AO ~ 30 - 50°) yet short enough to avoid externalizing the lanyard through the access port during insertion.
[0114] In these or other examples, the first and second arms 312, 314 can be attached to the plurality of outer wall structures in various ways. In some examples, the attachment of the arms can include fasteners, bonding, adhesives, welding, stitching, etc. Attachment sites for the first and second arms 312, 314 can be positioned in various locations. In some examples, the attachment sites for the first and second arms 312, 314 are located on a distal portion of the organ support system 100. The attachment site can be an external and viewable from external view. Conversely, the attachment site can be internal and at least partially obscured from external view. In at least one example, arm openings 320 are defined by one or more of the plurality of outer wall structures, wherein the arm openings 320 are sized and shaped to receive the first and second arms 312, 314. The first and second arms 312, 314 can slidably pass through the arm openings 320. In this particular exemplary embodiment, the arm openings 320 comprises a slot shape corresponding to the ribbon shape of the arms 312, 314, but in other variations, the openings may be circular, ovular or polygonal. Internal to the arm openings 320, end portions of the first and second arms 312, 314 can be secured in place (e.g., against one or more surfaces of the endcap wall members or the oblong wall members). As shown in FIG. 3B, the arm openings 320 are defined by at least the first and second endcap wall members 108, 110. In some further variations, the configuration of the arm opening may vary depending on the desired sliding resistance between the arms 312, 314 and the openings 320. In some other variations, the arms 312, 314 may be fixedly attached via adhesive or suture to the endcap wall members at a location along its length so as to limit the amount or range of displacement of the endcap wall member from the oblong wall member or hub. In FIGS. 5C, 6A, 6B, for example, a U-shape suture has been used to attach the arm to the endcap wall member, to limit separation of the endcap wall member from the oblong wall member.
[0115] As mentioned, the tether structure 120 can include suspension arm 316. The suspension arm 316 can be sized and shaped for suspending the organ support system 100 in the air (e.g., above a surgical site for organ transplantation). The suspension arm 316 can thus include a durable material (e.g., rated to hold a certain weight or execute a certain number of suspension cycles). In these or other examples, the suspension arm 316 can be raised or held in place via robotic operation (e.g., robotic grippers or hooks) and / or human technician. Although depicted as a strap, the suspension arm 316 can include a rigid member (e.g., metal beam with an eyelet configured for a robotic gripper). A rigid member can, in some examples, be advantageous to prevent undesiredsway or movement of the organ support system 100, particularly during anastomosis or other procedure portion.
[0116] Further shown in the figures, the tether structure 120 can include a hub 318. The first and second arms 312, 314 and the suspension arm 316 can each connect to or extend from the hub 318. The hub 318 can include a connection feature, such as a slider, buckle, clip, ratchet, cam, and the like. In one or more examples, the hub 318 can facilitate adjustment of the first and second arms 312, 314 and the suspension arm 316. In at least one example, the hub 318 can facilitate complete detachment of the first and second arms 312, 314 and the suspension arm 316.
[0117] Additionally shown, the organ support system 100 can include an inner contact structure 322. The inner contact structure 322 is configured to make direct, intimate contact with an organ (e.g., the kidney 126). In some examples, the inner contact structure 322 can be an insulative layer, a freeze protection layer, a spacer layer, a temperature control layer, etc. In particular examples, the inner contact structure 322 can be positioned between an oblong wall member and a cooling structure (e.g., a cooling structure 324 discussed below). In particular examples, the inner contact structure 322 is sized and shaped to substantially or entirely overlap a cooling structure. In these or other examples, the inner contact structure 322 can help prevent freezing of organ cells that could otherwise occur if a cooling structure had direct contact with the organ. In some examples, the inner contact structure 322 include a thin, waterproof, biocompatible material (e.g., closed cell foam, silicone, etc.).
[0118] In one or more examples, the inner contact structure 322 can fit complementary to various elements. As used herein, the terms “complementary” or “complementary surfaces” should refer to surfaces that fit together, match, continuously (or substantially continuously) abut, follow surface geometry, and / or mimic surface contours. Thus, as shown in FIGS. 3G-3H, the first oblong wall member 104 (and the second oblong wall member 106) can include an inner contact structure 322. The inner contact structure 322 can include an outer convex surface complementary to the inner concave surface of the cooling structure 324. The concave surface of the inner contact structure 322, as just mentioned, is configured to directly contact an organ located in the inner cavity of the organ support system 100.
[0119] As mentioned above, the organ support system 100 can include a cooling structure 324. In one or more examples, the first and second oblong wall members 104, 106 can each comprise a cooling structure 324. Cooling structure 324 can include one or more elements that can absorb or dissipate heat from the retained organ within the organ support system 100. One example of the cooling structure 324 can include a layer that includes a phase-change material (e.g., that can change from solid to liquid form throughout the transplantation procedure). The phase-change material can include saline, water, gel (e.g., biocompatible phase-change gels, such as 1 -Decanol(Decyl alcohol), n-tetradecane (n-TD), and the like), eutectic mixture (e.g., a water-tetradecane blend), etc. In some examples, the phase-change material can be designed to maintain a kidney temperature of about 1 degree Celsius to about 7 degrees Celsius for a predetermined duration (e.g., about 30 minutes to about 90 minutes, about 45 minutes to about 70 minutes, or about 60 minutes). In particular examples, the cooling structure 324 is expressly devoid of coolant tubes or external cooling feeds into the organ support system 100.
[0120] Like other elements of the organ support system 100, the cooling structure 324 can fit complementary to other surfaces. For example, an outer convex surface of the cooling structure 324 can fit complementary to the inner concave surface of the corresponding oblong wall member. In addition, an inner concave surface of the cooling structure 324 can fit complementary to the outer convex surface of the inner contact structure 322.
[0121] One or more elements of the organ support system 100 can include a variable thickness along one or more axes. In specific implementations, the cooling structure 324 can include a thickness 326. As shown in the longitudinal cross-section of FIG. 3G and the first transverse axis cross-section of FIG. 3H, the thickness 326 of the cooling structure 324 can vary across the organ support system 100. In particular examples, the thickness 326 of the cooling structure 324 is greatest at a central region of the organ support system 100. In such examples, the thickness 326 of the cooling structure 324 can gradually decrease or taper toward one or more perimeter edges. By thinning the thickness 326 toward the perimeter edges, particularly the proximal edges, the organ support system 100 can advantageously maintain a smaller footprint immediately adjacent to the surgical workspace around the proximal opening 112 (e.g., between the proximal opening 112 and the patient). Additionally, by maintaining greater thickness in the center and / or distal regions, the cooling structure 324 can help maintain a desired temperature of the organ tissue. In specific implementations, the thickness 326 can vary in a range of about 20 percent to about 35 percent across the longitudinal and / or first transverse axes. In at least one embodiment, the thickness 326 measures about 0.5 mm to about 5 mm, about 1 mm to about 3mm, or about 2 mm toward the proximal edge of the cooling structure 324 (adjacent to the proximal opening 112). In comparison, the thickness 326 can measure about 3 mm to about 12 mm, about 4 mm to about 8 mm, or about 6 mm in the central and / or more distal regions of the cooling structure 324.
[0122] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 3A-3I can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS.can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 3A-3I.
[0123] FIGS. 4A-4C illustrate the inner contact structure 322 in accordance with one or more examples of the present disclosure. As shown, FIG. 4A depicts a perspective view of the inner contact structure 322 as including a concave surface 400 configured to contact an organ. FIG. 4A additionally depicts an indicator 402 (e.g., a temperature indicator, orientation indicator, etc.).
[0124] FIG. 4B illustrates a perspective view of the inner contact structure 322 including a convex surface 404. The convex surface 404 can be positionable against a concave surface of the cooling structure 324. In some examples, the convex surface 404 can define a temperature window 406 (e.g. , a through hole or thermally conductive passageway) sized and shaped to receive to allow the indicator 402 to detect or gauge the temperature of the cooling structure 324 (e.g. , for indicating thermal readiness of the cooling structure 324). Additionally or alternatively, the temperature window 406 can be sized and shaped to receive a temperature sensor communicatively coupled to the indicator 402.
[0125] FIG. 4C illustrates a top (distal) plan view of the inner contact structure 322 in accordance with one or more examples of the present disclosure.
[0126] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 4A-4C can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS, can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 4A-4C.
[0127] FIGS. 5A-5C illustrate one of the oblong wall members 104, 106 in accordance with one or more examples of the present disclosure. As shown, FIG. 5A illustrates the oblong wall member 104 / 106 including a concave surface 500 at least partially defining the inner cavity sized and shaped to receive the cooling structure 324, the inner contact structure 322, and at least part of an organ. The concave surface 500 defines an arm opening 502 and a handle opening 504. The arm opening 502 and the handle opening 504 extend through to a convex surface 506 (shown in FIG. 5B). In one or more examples, the arm opening 502 is sized and positioned correspond to the arm opening 320 in the endcap wall member 108 / 110. Thus, in some embodiments, the first and second arms 312, 314 can pass through the endcap wall members 108, 110 and the oblong wall members 104, 106. In these or other examples, an end portion of the first and second arms 312, 314 (discussed and shown in relation to FIG. 3 A for example) can be retained at an attachment site 508 against the concave surface 500. In one or more examples, the attachment site 508 is spacedaway from one or both pole ends of the longitudinal axis 114 of the oblong wall member. In certain examples, this positioning of the attachment site 508 can serve as a pivot point (e.g., at a distal oblong wall portion) for the corresponding arm of the tether structure 120 to induce a radial rotation when the organ support system 100 is moved / adjusted to the released configuration.
[0128] In other examples, the handle opening 504 is sized and shaped to receive the handle 134 discussed above. In some examples, the handle 134 can be anchored or otherwise coupled to the concave surface 500.
[0129] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 5A-5C can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS, can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 5A-5C.
[0130] FIGS. 6A-6B illustrate perspective views of one of the endcap wall members 108, 110 in accordance with one or more examples of the present disclosure. These views depict one of the endcap cavities 300, 302 (e.g., as defined by the front edge 328 and the back edge 330 discussed above). The endcap cavities 300, 302 are defined at least in part by an inner concave surface 600 opposite an outer convex surface 602.
[0131] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 6A-6B can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS, can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 6A-6B.
[0132] FIGS. 7A-7D illustrate the cooling structure 324 in accordance with one or more examples of the present disclosure. FIGS. 7A-7B illustrate perspective views of the cooling structure 324 including a concave surface 700 sized and shaped to complement the convex surface 404 of the inner contact structure 322, and a convex surface 702 sized and shaped to complement the concave surface 500 of the oblong wall member. In the longitudinal cross-section of FIG. 7C and the first transverse axis cross-section of FIG. 7D, the thickness 326 of the cooling structure 324 can vary in certain dimensions. In particular examples, the thickness 326 can decrease in the proximal direction, as discussed above.
[0133] Any of the features, components, and / or parts, including the arrangements and configurations thereof shown in FIGS. 7A-7D can be included, either alone or in any combination, in any of the other examples of devices, features, components, and parts shown in the other figures described herein. Likewise, any of the features, components, and / or parts, including the arrangements and configurations thereof shown and described with reference to the other FIGS, can be included, either alone or in any combination, in the example of the devices, features, components, and parts shown in FIGS. 7A-7D.
[0134] FIGS. 8A-8D illustrate an example method flow of a series of acts (or steps) of retaining an organ to cool within another example implementation of an organ support system, in accordance with one or more examples of the present disclosure. While FIGS. 8A-8D illustrate acts (or steps) according to one embodiment, alternative embodiments may omit, add to, reorder, and / or modify any of the acts shown in FIGS. 8A-8D. The acts of FIGS. 8A-8D can be performed as part of a method. Alternatively, a non-transitory computer-readable medium can comprise instructions that, when executed by one or more processors, cause a computing device (or a computer component, such as a processor, implemented on or in communication with a robotic apparatus) to perform the acts of FIGS. 8A-8D. In some embodiments, a system can perform the acts of FIGS. 8A-8D.
[0135] As shown in FIG. 8A, a step 800a can include providing an organ support system 802 with constituent portions 804, 806. The organ support system 802 can be the same as or similar to the organ support system 100 discussed above. In particular examples, however, the constituent portions 804, 806 of the organ support system 802 each comprise a single piece unit including a combined oblong wall member portion and an endcap wall member portion integrally formed together.
[0136] In FIG. 8B, a step 800b can include inserting the kidney 126 into the constituent portion 806. Kidney 126 can be oriented with hilar portions extending in a proximal direction and a ureter extending toward a ureter pole of the organ support system 802.
[0137] In FIG. 8C, a step 800c can include bringing the constituent portions 804, 806 together, thus covering the kidney 126 and closing the organ support system 802. In addition, the step 800c can include cinching or tightening a tether structure 808 (e.g., to remove slack in the tether structure 808 and help maintain the constituent portions 804, 806 together).
[0138] In FIG. 8D, a step 800d can include securing attachable strap members 810 provide a closed, secured configuration of the organ support system 802. FIG. 8E illustrates a top (distal) plan view of the organ support system 802 in the closed, secured configuration. FIG. 8F illustrates a close-up view of an endcap wall member portion of the organ support system 802 in the closed, secured configuration. Specifically, FIG. 8F shows an endcap wall member portion of the organ support system 802 including a slot 812. In one or more examples, the slot 812 can allow the organsupport system 802 to expand or contract for suitably fitting periods shapes and sizes of organs. In some examples, the attachable strap members 810 can maintain a spacing of the slot 812, and thus maintaining a fit of the organ support system 802 about the kidney 126.
[0139] FIGS. 9A-9F illustrate another example method flow of retaining an organ to cool within an organ support system, in accordance with one or more examples of the present disclosure. While FIGS. 9A-9F illustrate acts (or steps) according to one embodiment, alternative embodiments may omit, add to, reorder, and / or modify any of the acts shown in FIGS. 9A-9F. The acts of FIGS. 9A- 9F can be performed as part of a method. Alternatively, a non-transitory computer-readable medium can comprise instructions that, when executed by one or more processors, cause a computing device (or a computer component, such as a processor, implemented on or in communication with a robotic apparatus) to perform the acts of FIGS. 9A-9F. In some embodiments, a system can perform the acts of FIGS. 9A-9F.
[0140] As shown in FIG. 9A, a step 900a can include providing a package including an organ support system of the present disclosure. In one or more examples, the package is frozen (e.g., until retrieved at step 900a).
[0141] In FIG. 9B, a step 900b can include removing the organ support system from the package.
[0142] In FIG. 9C, a step 900c can include providing an organ (e.g., in a cooled condition, transport condition, etc.) ready for transplantation into a patient. The organ can be positioned in proximity to the organ support system of the present disclosure in preparation for step 900d. Step 900c can additionally include positioning the organ support system in an open configuration ready to receive the organ.
[0143] In FIG. 9D, a step 900d can include inserting the organ (e.g., kidney) into a constituent portion of the organ support system.
[0144] In FIG. 9E, a step 900e can include closing the organ support system (e.g., inserting oblong wall members into endcap wall members) to substantially enclose the organ. Step 900e can include ensuring contact of the oblong wall members with the organ.
[0145] In FIG. 9F, a step 900f can include securing attachable strap members in place to provide a secured configuration of the organ support system. Upon completion of the step 900f, the organ support system is ready for subsequent procedures steps (e.g., anastomosis) discussed briefly below in relation to FIG. 10.
[0146] FIG. 10 illustrates an example method flow of utilizing an organ support system in accordance with one or more examples of the present disclosure. While FIG. 10 illustrate processes, acts (or steps) according to one embodiment, alternative embodiments may omit, add to, reorder, and / or modify any of the acts shown in FIG. 10. The processes of the workflow in FIG.10 can be performed as part of a method. Alternatively, a non-transitory computer-readable medium can comprise instructions that, when executed by one or more processors, cause a computing device (or a computer component, such as a processor, implemented on or in communication with a robotic apparatus) to perform the acts of FIG. 10. In some embodiments, a system can perform the acts of FIG. 10.
[0147] As shown, FIG. 10 includes a transplantation workflow 1004, comprising branched processes 1006, 1008, 1010, 1012 that can be performed by a robot 1000 and / or a surgeon 1002. The workflow 1004 an initial workflow 1014 that includes preparing the patient for the procedure 1016, which may positioning of the patient, sterilizing and draping of the operative site, and achieving anesthesia. Once prepped, the operative procedure may begin, with the initial incision 1018, and isolation of vasculature in preparation for anastomosis of the donor kidney 1020. In parallel or conjunction, the workflow 1004 can include a workflow 1006 (discussed above in relation to FIGS. 9A-9F) for positioning a donor kidney within an organ support system of the present disclosure. The donor kidney can thus be maintained at a cooled temperature during the subsequent acts. Although not expressly shown, the set of acts 1006 can include suspending the organ support system (with the donor kidney) above the patient or immediately proximate to the iliac vein and iliac artery. The workflow 1006 includes removal of the kidney support device from the freezer 1024, opening and placing the sterile contents of the device packaging onto the sterile field 1026, and placing the donor kidney into the kidney support device 1028, before the prepped kidney is brought into the surgical field 1022.
[0148] Following initial patient preparation 1014 and donor kidney preparation 1006, the venous anastomosis workflow 1008 can be performed. In this workflow 1008, the iliac vein is initially clamped 1030, and an opening cut is made on the iliac vein 1032. Corner suture stitches are placed on the cut 1033. The combined kidney and kidney support device is then brought close to the anastomosis site 1034, and the renal vein is attached to the iliac vein with comer stitches placed on the cut 1035 to complete the venous anastomosis 1036. Next, the arterial anastomosis workflow 1012 is started, with the clamping of the iliac artery 1040, followed by an incision into the iliac artery 1042. The renal artery is then sutured to the to the iliac artery to complete the arterial anastomosis 1044. At that point the kidney support device can be separated from the kidney, and the kidney support device may then be removed from the surgical field 1046 and disposed 1048. Next, the ureteral anastomosis workflow 1012 is started, with removal of the clamps of the iliac vein and artery 1050. The bladder is filled with saline 1052, and the ureter of the donor kidney is sized and trimmed 1054 to an appropriate length. The bladder is opened 1056 and the ureter is then sutured to the bladder 1058. Once the ureteral anastomosis is completed, closure of the surgical site is performed 1060 to complete the procedure 1062.
[0149] Upon completion of the set of acts 1006, the donor kidney can be dropped or otherwise placed into the patient by performing acts 1010 discussed above in relation to FIGS. 1 A-1C (e.g., removing the attachment strap members from their secured configuration and allowing the constituent portions to radially rotate away from the proximal opening). Additionally or alternatively, the acts 1010 can include pulling the organ support system apart via application of separating forces at handles attached to the organ support system (e.g., handles 134). Postanastomosis steps 1012 can then be performed for completion of the series of transplantation acts 1004.
[0150] For a robotic iliac-fossa transplantation the charged kidney support assembly is opened on the back table while pneumoperitoneum is being established and the recipient’s iliac vessels — or other planned anastomotic site — are exposed in the usual manner. When the team is ready to proceed, and with the device still resting in its sterile tray, the surgeon (or scrub nurse under direct vision) withdraws the frozen color temperature insert or component, verifies that the indicator liquid is uniformly blue, and immediately lowers the ice-slush-cooled kidney graft into the inferior green shell. The ureter is aligned with the yellow orientation arrow at the lower pole; the superior white shell is folded over and nested into the inferior shell, and the two hook-and-loop straps are crossed in an X-pattern tight enough to close the overlap margins without parenchymal compression. Total bench exposure is typically less than ninety seconds, after which the loaded kidney support assembly — now weighing approximately 250 g including graft and residual PCM — is brought to the operative field.
[0151] The assembly is delivered into the abdomen through the wound retractor or gel port exactly as a conventional graft would be introduced. A laparoscopic grasper may first engage the lanyard to guide the organ into the pelvis; once inside the insufflated cavity robotic arm A advances a 10 mm (or comparable) grasper to seize the suspension lanyard situated opposite the hilar window, thereby orienting that window laterally with the renal vein directed toward the iliac vessels. Either the lanyard or the closed lateral loops may be grasped — the continuous-ring geometry prevents accidental disengagement and facilitates tool purchase. Single- or dual-arm control stabilizes the housing and positions the hilum precisely without the need for an assistant.
[0152] Venous and arterial anastomoses are performed while the latent heat of fusion stored in the shell-embedded phase-change material maintains cortical temperature between about 1 °C and 7 °C for at least sixty minutes under 12-14 mm Hg insufflation and 22-25 °C ambient conditions. To mitigate cortical bleeding on reperfusion, hemostatic adjuncts such as oxidised regenerated cellulose may be packed around the graft before it is enclosed in the kidney support assembly; the compliant foam shells conform without occluding the hilar window. When vascular suturing is complete, the straps are peeled away with robotic forceps; alternatively they may be transectedwith robotic scissors, the severed ends remaining conspicuous because each strap tip contains a radiopaque filament. Detaching both straps leaves the shell halves connected only by the lanyard; lifting the lanyard in the +Z direction allows gravity and the intrinsic mass of each half to swing them radially apart, unveiling the kidney while avoiding vertical compression or traction on the freshly sewn vessels. The graft may then be rotated laterally into its definitive retroperitoneal position before ureteroneocystostomy is commenced.
[0153] The now-empty kidney support assembly is grasped by its lanyard and withdrawn through the same gel port, completing device removal in less than thirty seconds. Ureteral anastomosis and fascial closure then follow standard robotic protocols. All disposable components — including shells, straps, lanyard, and spent temperature color insert — are discarded as regulated medical waste. Extended cold-chain hand-off, alternative eutectic PCM chemistries melting between about -2 °C and +5 °C, and substitute loop geometries (e.g., stainless-steel eyelets or reinforced polymer rings) are expressly contemplated, provided they satisfy latent-heat, biocompatibility, and dimensional constraints (no more than 5 mm added wall thickness for integrated sensors, LEDs, or BLE telemetry modules).
[0154] Although described principally in the context of kidney transplantation, the devices and methods disclosed herein may be applied to other solid organs — including heart, lung, liver and pancreas — to vascular grafts, extremities, heart valves and other tissues, and to xenotransplants such as porcine grafts. The devices may likewise be employed during partial nephrectomy, for cooling preservation solutions during procurement, or for protecting temperature-sensitive fluids, blood products, plasma or medications at any stage from donor surgery through recipient implantation.
[0155] A sterile kidney support assembly is supplied within a Tyvek® pouch over-packed in an insulated sleeve that contains two frozen phase-change bricks; the assembly comprises a two- shell housing pre-loaded with a frozen Cool-Bean™ insert, two pre-attached hook-and-loop straps, two spare straps and a data-collection sheet. Upon receipt the transplant coordinator inspects sterile indicators, verifies package integrity and stores the sleeve flat at -20 °C for no less than twenty- four hours. While charging, the Cool-Bean insert solidifies; a food-grade dye dispersed within the insert turns intense blue at or below 0 °C, providing an unequivocal visual indication that both insert and housing are fully charged.
[0156] Immediately before vascular anastomosis the circulating nurse retrieves the insulated sleeve from the freezer, peels the Tyvek® lid and deposits the inner tray directly onto the sterile field, maintaining the tray horizontal so intimate thermal contact between insert and housing remains undisturbed. The scrub nurse removes the transparent tray cover by pulling four tabs, then optionally flexes each foam shell once along its mould parting line, an elastic manoeuvre thatenhances conformability around unusually bulbous grafts without compromising structural integrity. With the Cool-Bean insert still inside the cavity the operator confirms that the indicator liquid is wholly blue and that no pink or colourless zone is present. At the surgeon’s command the insert is withdrawn by its colour-coded tab and discarded into a sterile basin; removal marks time zero of a validated sixty -minute thermal budget.
[0157] The kidney, freshly removed from slush after back-table preparation, is immediately lowered into the green inferior shell. The ureter is aligned with a yellow arrow and ureter label at the lower pole. The white superior shell is folded over and nested into the inferior shell. Two hook- and-loop straps are crossed in an X-pattern tight enough to close overlapping margins yet loose enough to avoid parenchymal compression; the fixed hilar window remains unobstructed. If desired the artery may be tucked temporarily inside the kidney support assembly while the vein is sewn first, or vice versa. Initial sutures may be placed while the kidney and kidney support assembly remain in the tray, stabilizing the graft before it is lifted into the operative field.
[0158] During open surgery the suspension lanyard affixed to the superior shell margins is clamped to a table-mounted arm, suspending the kidney support assembly so gravity keeps the hilum dependent and freeing the assistant’s hands. Fine adjustment of lanyard tension modulates graft height relative to the iliac vessels; in certain embodiments the lanyard may be shortened or removed at the surgeon’s discretion. Throughout venous and arterial anastomosis the latent heat of fusion stored within the shell-embedded PCM maintains cortical temperature between approximately 1 °C and 7 °C under 22-25 °C ambient conditions. Optional radiopaque markers in the lanyard buckle, straps and shell rims permit fluoroscopic confirmation that no device component remains in the field. Upon reperfusion the straps are peeled free; without the straps the paired shells are connected only by the lanyard, and gravity causes them to swing radially apart, unveiling the kidney while avoiding vertical compression or traction on the vascular sutures. The lanyard is then lifted clear and the empty shells are withdrawn en bloc and discarded as regulated medical waste. Ureteral implantation and fascial closure proceed per standard practice; all disposable components — including shells, straps, insert, inner tray and spent PCM bricks — are disposed of according to institutional biohazard protocols, whereas the insulated sleeve may be recycled if clean.
[0159] Extended cold-chain hand-off is accommodated because the insulated sleeve maintains the charged assembly below 4 °C for at least two hours, enabling transport from an off-site freezer to the operating theatre without supplemental ice. Equivalent performance is achieved with any eutectic PCM melting between about -2 °C and +5 °C and possessing latent heat of fusion not less than 200 kJ kg '. Closed EVA-plastic rings are preferred as graspable loops, yet stainless-steel eyelets, reinforced polymer loops and analogous geometries are fully contemplated. Temperaturesensors, LEDs, timers and Bluetooth-Low-Energy telemetry modules may be encapsulated within either shell or the handle plate, provided they add no more than five millimeters of wall thickness and meet biocompatibility requirements.
[0160] In describing representative examples, the specification may have presented the method or process as a particular sequence of steps. To the extent that practice of the method does not rely upon that specific order, the claimed method should not be limited by the sequence recited. One of ordinary skill in the art will recognize that equivalent or additional steps may be employed, that certain steps may be omitted, or that the order may be rearranged without departing from the invention. Accordingly, the particular order in which steps are described should not be construed as a limitation on the claims.
[0161] FIG. 11 illustrates — in relation to the current standard of care and certain conventional devices — experimental data 1100 of utilizing an organ support system in accordance with one or more examples of the present disclosure. As shown, the experimental data 1100 illustrates a chart with a temperature axis (Y-axis) in degrees Celsius and a time axis (X-axis) in minutes. There are three sets of lines that depict organ (Kidney) temperature as a function of time. Each set of lines is also shown relative to a threshold temperature 1108 of 7 degrees Celsius.
[0162] The first set of lines 1102 corresponds to the current standard of care using ice and gauze wraps around the kidney. The experimental data 1100 indicates that kidney temperature under the current standard of care rapidly (e.g., in under 10 minutes) surpasses the threshold temperature 1108.
[0163] The second set of lines 1104 corresponds to certain other experimental devices used to cool a donor kidney. These experimental devices can provide a temperature improvement to the donor kidney relative to the current standard of care. However, the kidney temperature surpasses the threshold temperature 1108 within approximately 15 minutes.
[0164] The third line 1106 corresponds to the kidney temperature of a donor kidney continuously cooled using the organ support system of the present disclosure. The kidney temperature indicated in the third line 1106 is maintained below the temperature threshold for an entire duration of the transplant procedure.
[0165] In some examples, the organ support system of the present disclosure can thus significantly reduce warm ischemia time. Studies have shown that limiting warm ischemia time to less than 30 minutes can reduce the risk of DGF by 3.5-fold. Furthermore, elimination of warm ischemia by graft cooling during implantation to a temperature of 4°C results in a reduction ofmetabolism to 5-8% in the majority of cells, diminished enzyme activity, and mitigate ischemic injury. The organ support system of the present disclosure can thus reduce the rate of DGF and improve allograft function.
[0166] Be it known that we, Keith S. Hansen, Darja Wendel, Eiger Oberweilz, Jorg Student and Kyle Hartelt, have invented a new, original and ornamental design for a kidney support device, embodiments of which are shown in the accompanying drawings. These include but are not limited to the exemplary embodiments in FIGS. 12-19, 20-27, and 28-35, respectively.
[0167] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the described examples. However, it will be apparent to one skilled in the art — having the benefit of this disclosure — that the specific details are not required in order to practice the described examples. Thus, the foregoing descriptions of the specific examples described herein are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the examples to the precise forms disclosed.
[0168] It will be apparent to one of ordinary skill in the art, having the benefit of this disclosure, that many modifications and variations are possible in view of the above teachings. Indeed, various inventions have been described herein with reference to certain specific aspects and examples. However, many variations are possible without departing from the scope and spirit of the inventions disclosed herein. Specifically, those inventions set forth in the claims below are intended to cover all variations and modifications of the inventions disclosed without departing from the spirit of the inventions. The terms “including” or “includes” as used in the specification shall have the same meaning as the term “comprising.” Additionally, the terms “about,” “approximately,” and “substantially” should be interpreted as + / - 10 percent of a stated value.
Claims
CLAIMSWhat is claimed is:
1. An organ support system, comprising: an oblong housing assembly comprising: a plurality of outer wall structures defining an inner cavity and a proximal opening; a longitudinal axis extending lengthwise through the oblong housing assembly; a first transverse axis orthogonal to the longitudinal axis, and comprising a distal direction and a proximal direction, the first transverse axis intersecting the proximal opening; and a second transverse axis orthogonal to the longitudinal axis and the first transverse axis, wherein the plurality of outer wall structures comprises: first and second oblong wall members, each oblong wall member comprising an outer convex surface, an inner concave surface defining a portion of the inner cavity, and first and second ends located at opposite sides of the longitudinal axis of the oblong housing assembly; and first and second endcap wall members, wherein each endcap wall member comprises an outer surface and an inner concave surface defining an endcap cavity, wherein the endcap cavity of the first endcap wall member is configured to receive the first end of the first oblong wall member and the second end of the second oblong wall member, and the endcap cavity of the second endcap wall member is configured to receive the second end of the first oblong wall member and the first end of the second oblong wall member; and a tether structure interconnecting: the first oblong wall member to the second oblong wall member; the first oblong wall member to the first endcap wall member; and the second oblong wall member to the second endcap wall member.
2. The organ support system of claim 1, wherein the inner cavity is configured to receive a kidney, and wherein the proximal opening is configured for passthrough of kidney hilar portions.
3. The organ support system of claim 1, wherein the tether structure comprises a first arm attached to the first oblong wall member and a second arm attached to the second oblong wall member.
4. The organ support system of claim 3, wherein the first arm is further attached to the first endcap wall member and the second arm is further attached to the second endcap wall member.
5. The organ support system of claim 4, wherein the first arm is fixedly attached to the first oblong wall member and movably attached to the first endcap wall member.
6. The organ support system of claim 5, wherein the first endcap wall member comprises an arm opening through which the first arm slidably passes through.
7. The organ support system of claim 3, wherein the first arm is attached to the first oblong wall member at a first attachment site spaced away from the first end of the first oblong wall member.
8. The organ support system of claim 7, wherein the first attachment site is located at the inner concave surface of the first oblong wall member.
9. The organ support system of claim 3, wherein the tether structure further comprises a hub, and wherein the first and second arms of the tether structures extend from the hub.
10. The organ support system of claim 9, wherein the tether structure further comprises a suspension arm extending from the hub, wherein when the suspension arm is raised, the organ support system is suspended in air.
11. The organ support system of claim 3, wherein the tether structure comprises a ribbon structure.
12. The organ support system of claim 1, wherein the first and second endcap wall members comprises front and back edges that are non-parallel and non-orthogonal to at least one of the first transverse axis or the longitudinal axis.
13. The organ support system of claim 12, wherein proximal regions of the front edges of the first and second endcap wall members are spaced farther apart from the first transverse axis than distal regions of the front edges of the first and second endcap wall members.
14. The organ support system of claim 1, wherein the oblong housing assembly is size adjustable along multiple axes.
15. The organ support system of claim 1, wherein the first and second oblong wall members each comprise a cooling structure comprising an outer convex surface complementaryto the inner concave surface of the corresponding oblong wall member, and an inner concave surface.
16. The organ support system of claim 15, wherein the first and second oblong wall members each further comprise an inner contact structure, the inner contact structure comprising an outer convex surface complementary to the inner concave surface of the corresponding cooling structure, and a concave surface configured to contact an organ located in the inner cavity.
17. The organ support system of claim 15, wherein the cooling structure comprises a phase-change material.
18. The organ support system of claim 16, wherein the first and second oblong wall members and the first and second endcap wall members each comprise a closed cell foam.
19. The organ support system of claim 1, further comprising a handle extending out from opposing end portions of the plurality of outer wall structures.
20. The organ support system of claim 1, further comprising an attachable strap member removably attachable to at least one of the first or second oblong wall members.
21. The organ support system of claim 20, wherein, in a secured configuration, the attachable strap members each comprise an orientation that is non-orthogonal to the longitudinal axis and the first transverse axis.
22. The organ support system of claim 20, wherein upon releasing the attachable strap members from a secured configuration, the first and second endcap members are configured to radially rotate toward the distal direction and expand the proximal opening.
23. The organ support system of claim 20, wherein, in the secured configuration, the attachable strap members are configured to partially cover the proximal opening.
24. The organ support system of claim 1, further comprising a tray with first recess configured to receive the first endcap wall member and the first oblong wall member, and a second recess configured to receive the second endcap wall member and the second oblong wall member.
25. A method of opening an organ support device, comprising separating complementary shell portions apart from one other at least as a result of application of gravitational force at the shell portions thereby causing a greater portion of the organ to be revealed from the housing for reperfusion.
26. The method of claim 25, wherein the complementary shell portions are radially separated apart from one another at least as a result of the application of the gravitational force at the shell portions.
27. The method of claim 25, wherein the complementary shell portions are radially separated apart from one another at least as a result of the application of the gravitational force at the shell portions and without exerting axial compression on the anastomosed vessels via the complementary shell portions.
28. A method of robotically exposing a transplant organ contained in an organpreservation housing, the housing including (i) a suspension lanyard affixed to opposed shell portions and (ii) at least one releasable closure strap secured to an outer wall, the method comprising:(a) introducing the housing into a recipient’s abdominal cavity and positioning the housing adjacent iliac vessels;(b) gripping the suspension lanyard with a first robotic arm and maintaining that grip;(c) with a second robotic arm, engaging a manipulation feature of the housing;(d) with the same second robotic arm and without transferring the housing to any other instrument, applying a peeling or separation force that detaches the closure strap from the outer wall;(e) completing detachment of the closure strap using the same second robotic arm while the first robotic arm continues to stabilize the housing via the lanyard; and(f) permitting the shell portions to separate radially under gravitational force, thereby revealing the organ for reperfusion without exerting axial compression on the anastomosed vessels.The method of claim 1, wherein the second robotic arm peels a first end of the strap with a first jaw orientation and, without releasing the strap, rotates its wrist joint to peel a remaining portion of the strap with a second jaw orientation.
29. The method of claim 28, wherein the manipulation feature is a closed shape having an average internal diameter of 6-12 mm.
30. The method of claim 28, further comprising, after step (f), extracting the empty housing through a single access port with the first robotic arm still gripping the lanyard.
31. The method of claim 28, wherein the closure strap includes a radiopaque indicator that remains visible on post-procedure fluoroscopy to confirm complete removal.
32. The ornamental design for a kidney support device as shown and described.
33. The ornamental design of claim 32, as shown and described in FIGS. 12-35.
34. The ornamental design of claim 32, as shown and described in FIGS. 12-19.
35. The ornamental design of claim 32, as shown and described in FIGS. 20-27.
36. The ornamental design of claim 32, as shown and described in FIGS. 18-35.
Citation Information
Patent Citations
Film-shaped tissue storage transport container and storage transport method
US20140302602A1
Suspendable organ transplant system and method of use
US20150289940A1
Actively cooled organ transplant system
US20220369625A1
Devices and methods for regulating temperature of organs during or before surgical procedures
US20240000067A1
Apparatus and methods for controlling organ temperature prior to and / or during transplantation procedures
US20240023541A1