Calibrated cavity access port

Abstract

The present disclosure describes a device that provides access to body cavities such as thoracic, abdominal, or pelvic cavities to perform surgeries with a scope. The device includes a diaphragm, a cap, and a plurality of dog ear flaps, and is impregnated with one or more broad spectrum antipathogenic agents. The device is designed to stay in place for at least multiple weeks post-surgery to allow repeat access to the aforementioned cavities for re-inspection, repair, drainage, or bleeding control.

Description

PATENT APPLICATION GK.002PCTCALIBRATED CAVITY ACCESS PORTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 759,785, filed on February 18, 2025, the disclosure of which is hereby incorporated herein in its entirety by reference.BACKGROUND

[0002] Surgical interventions in human body cavities are being performed in less invasive fashion recently due to advancements in thoracoscopy and laparoscopy techniques. Multiple access ports are used for cameras and instruments to perform surgical interventions on visceral organs. These ports are typically removed at the end of the surgery and the skin access is then closed permanently. However, many abdominal surgeries and some thoracic surgeries may require revisiting the cavities for wash out, control of bleeding, drainage of collections, etc. Reopening such cavities increases the morbidity of the procedure.

[0003] Surgical access ports are typically designed to be used only for the duration of surgery, due to concerns regarding leakage, entry of air, infection, and stability.

[0004] Thus there remains a need for a device that allows a surgeon to leave a port in place securely for a defined time period post-surgery without a significant risk of infection or leaks that will allow easy access to surgical sites for additional actions, remedial measures, or observation of progress as warranted by clinical circumstances.SUMMARY

[0005] The present disclosure describes a device that provides access to body cavities such as thoracic, abdominal, or pelvic cavities to perform surgeries with a scope. The device includes a diaphragm, a cap, and a plurality of dog ear flaps, and is impregnated with one or more broad spectrum antipathogenic agents. The device is designed to stay in place for at least multiple weeks post-surgery to allow repeat access to the aforementioned cavities for reinspection, repair, drainage, or bleeding control.- 1 of 9 -PATENT APPLICATION GK.002PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 shows an embodiment of the disclosed device.

[0007] FIG. 2 shows the embodiment of FIG. 1 with calibration markings shown.

[0008] FIG. 3 shows a top view of the embodiment of FIG. 1.

[0009] FIG. 4 shows an embodiment of a trocar used to introduce the device into a cavity.DETAILED DESCRIPTION

[0010] The present disclosure describes a device that provides access to body cavities such as thoracic, abdominal, or pelvic cavities to perform surgeries with a scope. The device is designed to stay in place for at least multiple weeks post-surgery to allow repeat access to the aforementioned cavities for re-inspection, repair, drainage, or bleeding control.

[0011] In some implementations, the disclosed device is a tubular access port with a corrugated surface and is impregnated with one or more broad spectrum antipathogenic agents. The broad spectrum antipathogenic agents may be, for example, silver alginate, copper alginate, or a combination thereof. These compounds are broad spectrum antimicrobial compounds. FIG. 1 shows an embodiment of a calibrated cavity access port that is impregnated with silver alginate and copper alginate.

[0012] In some implementations, the entrance of the port has a diaphragm that does not allow air to pass through when closed but does allow access for a surgical scope, as shown in FIG. 3.

[0013] In some implementations, the top of the port, which is adjacent to the skin, has a screw cap that completely seals the port, as shown in FIG. 1. In some implementations, the screw cap may be tethered to the port. In some implementations, the device may include a visual indicator that the cap is fully seated and properly sealed, such as a twist-lock bayonet with colored dots that are aligned when the cap is fully seated and locked. In some implementations, the device may be configured to allow a surgeon to hold the device with one hand while applying torque to screw on and secure the cap.

[0014] In some implementations, a plurality of dog ear flaps on the side of the thread for the screw cap allow a surgeon to suture the port in place, as shown in FIG. 3. In some implementations, there may be, for example, four (4) dog ear flaps.PATENT APPLICATION GK.002PCT

[0015] In some implementations, the side of the port is calibrated and the port may be cut to a desired length at the end of surgery to minimize protrusion into body cavities but still allow stability and repeat access. In some implementations, the side of the port may be calibrated in millimeters. The length of the port that needs to be trimmed may be determined by retroflexion of the scope. In some implementations, the port may incorporate multiple strain concentrator regions that are frangible for length adjustment and where the resulting end surface breaks away cleanly with no sharp edges.

[0016] In some implementations, the port is placed in the desired body cavity by making a small incision, separating the subcutaneous tissue with a curved hemostat, and introducing the port into the cavity with a trocar, as shown in FIG. 4. The port may be designed in various diameters to accommodate various sizes of scopes. Smaller diameters can be used for reexamination of cavities. In some alternate implementations, an annular lip seal that exhibits minimal leakage under large diametral strain may be provided. This allows accommodation of various sizes of scopes. In some implementations, the range of diameters may be from about 4 to 14 mm.

[0017] The disclosed device effectively addresses issues that prevent reuse of cavity access ports through a combination of features.

[0018] First, impregnation of the device with a combination of broad spectrum antipathogenic agents prevents infection. In some implementations, impregnation with a combination of copper alginate and silver alginate prevents infections from all common pathogens, including both bacterial and fungal pathogens that can infect the thoracic, abdominal, and pelvic cavities of a patient. The use of copper alginate and silver alginate in combination provides synergistic antimicrobial activity that exceeds the independent sum total of the antibacterial and antifungal activities of these compounds used separately.

[0019] Second, the use of a diaphragm prevents the escape and entry of air or fluid from or into the thoracic, abdominal, and pelvic cavities, thereby maintaining the post-surgical integrity of the cavity being accessed during surgery. In addition, the diaphragm allows access into the desired cavity using surgical scopes for inspection or therapeutic intervention such as wash out, ligating, cauterizing a bleeding vessel, repairing an anastomotic leak, etc. without compromising the integrity of the cavity. The diaphragm also allows repeat instillation ofPATENT APPLICATION GK.002PCTchemotherapy or antimicrobial agents to treat malignancies or abscesses in the cavity without additional surgical incisions.

[0020] Third, the use of dog ear flaps and a screw cap further enhances both safety and stability of the device and eliminates the risk of migration into the cavity or inadvertent dislodgement by the patient or providers.

[0021] Fourth, calibration indicators on the device allow a surgeon to customize the length of protrusion into the cavity to avoid pressure on visceral organs due to its prolonged indwelling state.

[0022] FIG. 1 shows an embodiment 100 of the disclosed device having a diaphragm 102, screw cap 104, and dog ear flaps 106 that is impregnated with copper alginate 112 and silver alginate 114.

[0023] FIG. 2 shows another view of the embodiment 100 showing calibration markings 108 in millimeters, with the diaphragm and screw cap not shown.

[0024] FIG. 3 shows a top view of the embodiment 100 showing the diaphragm 102, dog ear flaps 106, and corrugation 110 of the port.

[0025] FIG. 4 shows an embodiment of a trocar 122 used to introduce the device into a cavity.

[0026] The disclosed device allows access to body cavities such as the thoracic cavity, abdominal cavity, and pelvic cavity for surgical maneuvers with a thoracoscope or a laparoscope. In addition, it allows repeat access to body cavities without the need for repeat incisions and may be left in place for multiple weeks. The diaphragm prevents entry of air into the cavities but allows scopes and instruments to be passed therethrough for access. The screw cap provides additional safety and completely seals the port when not in use. Dog ear flaps may be sutured to the skin and dressing applied on top of the sutured dog ear flaps that will prevent inadvertent dislodging of the port. Impregnation of anti-pathogenic agents, such as copper alginate and silver alginate, prevents the port from getting infected and provides broad spectrum antimicrobial protection. Calibrations on the wall of the port allow a surgeon to trim the port to the desired length so as to minimize protrusion in an otherwise closed body cavity.

[0027] The following working examples illustrate clinical use of the device. These examples are merely exemplary and are not intended to limit the scope of the invention disclosed herein.PATENT APPLICATION GK.002PCT

[0028] In the examples below, embodiments of the disclosed calibrated cavity access port are termed C-CAP.

[0029] Example 1. Patient A undergoes a laparoscopic hiatal hernia repair and nissen fundoplication. The surgeon leaves a drain as well as a C-CAP in place. On post operative day 2 the patient suddenly becomes clammy, diaphoretic, and pale. A stat hemoglobin check shows a sudden drop to 6 from a value of 9 the previous day. The surgeon takes the patient back to the operating room and is able to quickly access the peritoneal cavity through the C-CAP after insufflation of CO2through the same device. The surgeon notices an anastomotic leak as well as a bleeding vessel at the site, and is able to repair the leak and ligate the bleeding vessel through the C-CAP without the need to re-open the abdomen.

[0030] Example 2. Patient B is admitted into a hospital with abdominal pain and sepsis. The patient is diagnosed with an ischemic bowel with a perforated viscus. A surgeon takes the patient emergently to the operating room and performs an exploratory laparotomy. A dead loop of bowel is noted with diffuse fecal soiling of the peritoneal cavity. The surgeon removes 2 feet of dead bowel and performs an end-to-end anastomosis of the bowel. The surgeon then irrigates the peritoneal cavity with copious amounts of saline to perform a wash out to remove the soiling. The plan is to take the patient back to the operating room the next day and to perform a wash out on the following day. Presently, the surgeon would leave the abdominal wound open for ease of repeat access. Using the C-CAP, the surgeon can leave a port in place and close the wound, and thereafter perform repeat irrigations of the peritoneal cavity without having to open a new port each time.

[0031] Example 3. Patient C develops pneumonia and the infection spreads to the pleural space and becomes empyema. An interventional pulmonologist performs a thoracoscopy using a C-CAP. The pulmonologist inspects the pleural space and drains the pus, and then administers antibiotics directly into the pleural space and leaves the C-CAP in place. Instead of the current standard of care of treating with IV antibiotics for 6 weeks with an indwelling central line, the pulmonologist accesses the pleural cavity every 3 days through the C-CAP port, drains the fluid, and re-instills antibiotics. This shortens the duration of treatment to 3 weeks instead of 6 weeks. After the first procedure, the C-CAP may be downsized from 10 mm to 4 mm for patient comfort and outpatient management. The pulmonologist is still able to visually inspect the pleural space, drain fluid, and instill antibiotics for multiple weeks.PATENT APPLICATION GK.002PCT

[0032] Conditional language used herein, such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments or implementations include, while other embodiments or implementations do not include, certain features, elements, and / or states. Thus, such conditional language is not generally intended to imply that features, elements, and / or states are in any way required for one or more embodiments or implementations. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied.

[0033] If and as used herein, “substantially” may mean to a considerable degree or extent, or approximately, while still achieving the intended purpose, function, or result. The term may allow for minor deviations that do not materially affect the operation or performance of the invention as described and claimed. For example, the term “substantially the same” may refer to materials, compositions, or compounds that exhibit essentially equivalent chemical identity, structure, and functional performance, notwithstanding minor variations or impurities that do not materially affect the intended properties or performance. For example, “substantially” may mean within 5.0%, 1.0%, 0.5%, 0.1%, or 0.01% of a reference that does not include the term “substantially.”

[0034] Further, any range of numbers recited above describing or claiming various implementations, embodiments, or aspects of the invention, such as ranges that represent a particular set of properties, units of measure, conditions, physical states, or percentages, is intended to literally incorporate any number falling within such range, including any subset of numbers or ranges subsumed within any range so recited. As used herein, the terms “about” and “approximately” when used as modifiers are intended to convey that the numbers and ranges disclosed herein may be flexible as understood by ordinarily skilled artisans and that practice of the disclosed invention by ordinarily skilled artisans using properties that arePATENT APPLICATION GK.002PCToutside of a literal range will achieve the desired result. The use of “about” or “approximately” as modifiers refers to known commercial and / or experimental measurement variations or tolerances for the referenced quantity. In some embodiments or implementations, such known commercial and / or experimental measurement tolerances are ±10% of the measured value, while in other embodiments or implementations such known commercial and / or experimental measurement tolerances are ±5% of the measured value, while in still other embodiments or implementations such known commercial and / or experimental measurement tolerances are ±2.5% of the measured value, and in still other embodiments or implementations, such known commercial and / or experimental measurement tolerances are ±1% of the measured value.

[0035] The previous description of the disclosed embodiments and implementations is provided to enable any person skilled in the art to make or use the invention disclosed herein. Although the various inventive aspects are disclosed in the context of certain illustrated embodiments, implementations, and examples, it should be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments and implementations to other alternative embodiments, implementations, and / or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of various inventive aspects have been shown and described in detail, other modifications that are within their scope will be readily apparent to those skilled in the art based upon reviewing this disclosure. It should be also understood that the scope of this disclosure includes the various combinations or sub-combinations of the specific features and aspects of the embodiments and implementations disclosed herein, such that the various features, modes of implementation, and aspects of the disclosed subject matter may be combined with or substituted for one another. The generic principles defined herein may be applied to other embodiments and implementations without departing from the spirit or scope of the disclosure. Thus, the present disclosure is not intended to be limited to the embodiments and implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0036] Each of the foregoing and various aspects, together with those summarized above or otherwise disclosed herein, including the figures, may be combined without limitation to form claims for a device, apparatus, system, method of manufacture, and / or method of use.

[0037] All references cited herein are hereby expressly incorporated by reference.

Claims

PATENT APPLICATION GK.002PCTCLAIMSWhat is claimed is:

1. A calibrated cavity access port device comprising:a. a diaphragm;b. a cap; andc. a plurality of dog ear flaps;wherein the device is impregnated with one or more broad spectrum antipathogenic agents,wherein the device is configured to allow use in a body cavity of a post-surgical patient for at least multiple weeks post-surgery.

2. The device of Claim 1, wherein the device is configured to be introduced into the body cavity of the post-surgical patient using a trocar.

3. The device of Claim 1 or 2, wherein the device is corrugated.

4. The device of any of Claims 1-3, wherein the device includes calibration markings.

5. The device of any of Claims 1-4, wherein the one or more antipathogenic agents are selected from the group consisting of silver alginate, copper alginate, and a combination thereof6. The device of any of Claims 4, wherein the antipathogenic agents are silver alginate and copper alginate.

7. The device of any of Claims 2-6, wherein the screw cap is tethered to the device.

8. The device of any of Claims 2-7, wherein the device comprises a visual indicator that allows a user to know when the cap is fully seated and properly sealed.

9. The device of any of Claims 2-8, wherein the device is configured to allow a surgeon to hold the device with one hand while applying torque to screw on and secure the cap.

10. The device of any of Claims 2-9, wherein the device further comprises a plurality of strain concentrator regions that are frangible for length adjustment.

11. The device of any of Claims 2-10, wherein the device further comprises an annular lip seal that exhibits minimal leakage under large diametral strain.

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