Method and apparatus for a self-venting endoscopic biomaterial applicator

The present invention will provide an endoscopic biomaterial applicator used during laparoscopic surgical procedures that utilizes pressurized gas to facilitate the spray application of a biomaterial while safely and automatically venting the additional volume of gas introduced into the abdominal cavity by endoscopic biomaterial applicator. This is accomplished utilizing a manifold, a plurality of channels, an elongated housing, a spray tip, a cannula gasket, and a gas release valve.

Not Applicable.

FIELD OF THE INVENTION

This invention relates to an endoscopic biomaterial applicator, and more particularly, to an applicator that can self-vent gas introduced by the endoscopic applicator while providing a spray application of a biomaterial.

DISCUSSION OF RELATED ART

Generally, surgical procedures produce a great deal of trauma for the human body, as large incisions are used to permit access to the internal tissue that requires attention. Modern advancements in surgical procedures have given rise to minimally invasive surgeries, where small incisions are used and the stress on the human body is reduced. One popular type of minimally invasive surgery is laparoscopic surgery, where operations on the abdomen are performed through small incisions and surgical devices are inserted into the body, permitting the surgeon to operate using digital images displayed on a monitor.

The advantages of laparoscopic surgery include reduced post-operative pain, bleeding, and reduction in external tissue scarring due to the smaller incisions. Laparoscopic surgery is typically conducted by inserting surgical trocar devices from the outside of the body into the abdominal space. Once these trocar devices are in place, they provide the access from the outside of the body to the intra-abdominal space to introduce cameras and surgical equipment. Furthermore, the trocars also provide a port to connect an insufflator.

During laparoscopic surgeries, biomaterials are commonly used to improve control of surgical bleeding, sealing tissue to prevent gas or liquid leakage, adhering tissue planes together, or alternatively preventing tissue planes from adhering to each other. Biomaterials exist in many different forms, from biologic materials to synthetic components, and the compositions vary from one part systems to multi-part systems. Biomaterial must be introduced into the body using biomaterial applicators, which vary in configuration for each surgery and biomaterial type. Applicators vary from simple drip applicators to gas-assisted spray devices.

With multi-component biomaterials that require thorough mixing at the time of application, gas-assisted propulsion of these biomaterials in a spray deposition has been used with favorable results. With some biomaterials, the faster and more homogenous the components are mixed, the quicker the adherence or polymerization time. Further, the spray application of the biomaterial can cover more tissue area than a conventional drip application of the biomaterial, resulting in more economic and practical utilization of the biomaterial.

An insufflator is a gas ventilator based system used in laparoscopic surgery, where a gas is used to inflate the intra-abdominal cavity with an inert gas, most commonly CO2 gas, in order to distend the abdominal cavity. This provides the surgeon with the necessary space and access to the underlying tissues and organs which need attention. The insufflator connects to one of the available trocars having a gas port, where the insufflator introduces the gas to the abdominal cavity. The insufflator will introduce a flow rate of gas and attempt to maintain this intra-abdominal pressure throughout the procedure.

As gas leaks from the abdominal cavity, the insufflator will increase the flow rate of gas, and as the pressure rises above the selected pressure setpoint, the insufflator will remove gas from the abdominal cavity. The pressure necessary to achieve the appropriate surgical space for the surgeon can vary by procedure, but the common intra-abdominal pressure used for laparoscopic surgery is 15 mm Hg. Any pressures higher than this common pressure level can increase the risk of gas embolization to the patient. This is due to the gas passing through the patient's tissue membranes and into the blood stream as the pressure gradient increases. CO2gas is commonly used for this technique because the human blood stream can absorb this gas type much better than other mediums, such as atmospheric air or nitrogen. However, even CO2gas can be toxic to a human if high levels are absorbed into the blood stream.

Conventional trocar devices only permit one surgical instrument to be introduced through its working channel at one time. However, new trocar device technology with several working channels are emerging where the trocar can accept multiple surgical devices at one time. This permits fewer surgical incisions into the patient's abdomen while still providing the surgeon the appropriate surgical environment to conduct the procedure. This surgical approach is commonly referred to as single incision laparoscopic surgery (SILS).

With gas-assisted spray applicators that also introduce gas into the abdominal cavity in order to provide spray delivery of the biomaterial, this can pose problems for maintaining a safe intra-abdominal pressure. If the flow rate of gas introduced by the biomaterial applicator is greater than the capacity of the insufflator to remove this sudden volume introduction of gas, the intra-abdominal pressure can rise above the desired intra-abdominal pressure setpoint, and subject the patient to potential gas embolism. Therefore, it is ideal for a biomaterial applicator that uses pressurized gas to enable spray delivery of the biomaterial to possess the ability to help remove any excess volume of gas that it introduces.

U.S. Pat. No. 7,682,336 to Hoogenakker et al, hereinafter Hoogenakker, discloses an apparatus for mixing and administering two non-homogenous liquids to tissue in an endoscopic procedure where the apparatus includes a biomaterial spray applicator, a gas regulator system that attaches to the spray applicator with a tubing line, and a tubing vent line that attaches to the gas valve of a surgical trocar and back to the regulator. When the regulator is actuated by a foot pedal to provide a flow of gas from the regulator to the spray applicator, the spray applicator then deposits the biomaterial inside the body cavity in a spray format enhanced by the gas from the regulator. At the same time that the foot pedal is depressed to actuate gas flow rate, the regulator opens up a valve allowing gas to exit the surgical trocar through the tubing vent line.

The first limitation of Hoogenakker is that it requires an independent gas regulator to provide the gas venting function required to reduce the risk of over-pressurization of the abdominal cavity. The gas regulator resides on the non-sterile side the surgical operating room, and as such, the tubing that connects the sterile biomaterial applicator and trocar back to the regulator must be passed to the non-sterile side of the operating room for connection to the regulator. This can pose cumbersome logistical issues in an operating room environment and also requires the coordination between two operating room personnel to make the tubing connections. Furthermore, when objects are passed back and forth between the sterile side and non-sterile side of an operating room, additional risks related to infection can occur.

The second limitation of Hoogenakker is that the venting function of this system requires the available use of a gas vent port on a surgical trocar. In any laparoscopic procedure, one surgical trocar must be dedicated to the connection to the insufflator in order to distend the abdominal cavity. However, if other trocars are used in the procedure, these trocars commonly do not include a gas vent port to reduce the cost of the trocar. Furthermore, for single incision laparoscopic procedures (SILS), only one trocar is used in the procedure and the single available gas port on the trocar must be used by the insufflator, providing no means to connect a biomaterial spray applicator venting feature that requires this trocar gas port to effectively perform its venting function.

U.S. Patent application. No. US20100168779A1 to Redl et al, hereinafter Redl, discloses a laparoscopic tissue sealant spray apparatus and system having a laparoscopic tissue sealant spray assembly combined with a trocar assembly, where the tissue sealant spray assembly has an elongate delivery tube. The trocar assembly includes a vent opening that connects to a venting valve member and provides a vent path which passively opens upon operation of the tissue sealant spray assembly, avoiding excessive pressure build-up within a body cavity. The concept of this patent application is similar in principle to that of Hoogenakker, where excess gas introduced into the abdominal cavity during the spray application of the biomaterial is removed through a passive actuation of a valve associated with the trocar vent valve. However, the same limitation exist for Redl as they do for Hoogenakker, where an available trocar gas valve port may not be available on a trocar if only one trocar with a gas valve port is used and the remaining trocars do not include a gas valve port. Additionally, in a single incision surgery where only one trocar is being used, only one gas valve port is available during the surgery and this gas valve port must be dedicated to the insufflator.

While biomaterial applicators have become increasingly important in minimally invasive surgeries, there is a continued need for an endoscopic biomaterial applicator that can provide a spray delivery of a given biomaterial while also safely minimizing the potential of over-pressurization within a patient's abdominal cavity during the introduction of a gas flow from the biomaterial applicator. Furthermore, there is a continued need for an endoscopic biomaterial applicator that is not dependent on the gas valve port of a surgical trocar to accomplish the management of gas pressure within the abdominal cavity. The present invention satisfies these needs.

SUMMARY OF THE INVENTION

The present invention will provide an endoscopic biomaterial applicator used during laparoscopic surgical procedures that utilizes pressurized gas to facilitate the spray application of a biomaterial while safely venting the additional volume of gas introduced into the abdominal cavity by endoscopic biomaterial applicator. This is accomplished utilizing a manifold, a plurality of channels, an elongated housing, a spray tip, a cannula gasket, and a gas release valve.

The present invention permits surgeons to introduce an endoscopic biomaterial applicator through a surgical trocar, creating an air tight seal, and then dispense one or a plurality of biomaterials into the surgical site. The surgeon will place the device into the trocar, where pressurized gas is channeled through the biomaterial applicator and through the spray tip for dispersing the biomaterial in a spray fashion.

The present invention will also utilize a gas release valve on the biomaterial applicator that is exposed to the internal pressure of the abdominal cavity, wherein the pressure within the abdominal cavity can be automatically released when spray actuation is initiated. Once spray actuation is initiated, the input gas will compress a control piston against a control spring, opening the gas release valve and venting the intra-abdominal pressure to the atmosphere. When spray actuation is terminated, the control spring will return the control piston to a closed position, preventing additional intra-abdominal pressure from venting to the atmosphere.

Alternatively, a check valve may be used to release gas from the body cavity. The various elements of the check valve determine its cracking pressure, such as the spring diameter, length, and material, providing a check valve that will open once the abdominal cavity pressure reaches a desired pressure threshold, typically between 5-20 mmHg. Gas is then released from the abdominal cavity, through the device, and out to the atmospheric outside of the patient. When the abdominal pressure is reduced below the cracking pressure of the check valve, the spring of the gas release valve will return the piston to a closed position, separating the pressure of the abdominal cavity and the atmospheric pressure.

The current invention will separate the gas flow introduced into the biomaterial applicator for dispersing the biomaterial in a spray fashion and the gas release valve such that the gas release valve will only be subjected to the internal pressure of the abdominal cavity and not the gas pressure of the inflow gas passing through the endoscopic applicator.

These and other objectives of the present invention will become obvious to those of ordinary skill in the art after reading the following detailed description of the preferred embodiments. It is to be understood that the foregoing general description and the following detailed description are exemplary, and are intended to provide further explanation of the invention as claimed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention10comprises a manifold21, a vent housing22, an elongated endoscopic housing23having proximal24and distal25ends, a gas release valve26positioned within said vent housing22, one or more biomaterial channels28within said manifold21and elongated endoscopic housing23, a gas channel29enclosed within said manifold21, said vent housing22, and elongated endoscopic housing23, a spray tip30, and a cannula gasket31. These components work in conjunction to deliver biomaterial into a patient's11internal body cavity12during a laparoscopic procedure, where pressurized gas aids in dispersing the biomaterial in a spray fashion. In the preferred embodiment, the present invention10is adapted to simultaneously self-vent the additional volume of gas introduced by the biomaterial applicator10. In an alternative embodiment, gas is self-vented when the intra-abdominal pressure reaches a threshold value, or setpoint cracking pressure, of the gas release valve26. The manifold21and vent housing22can be generally described as a housing.

Biomaterial is delivered through a cannula13adapted for introduction through a surgical trocar14, where the biomaterial channels28will carry the biomaterial component(s) from the manifold21, through the elongated endoscopic housing23, through the cannula gasket31, and to the spray tip30. A pressurized gas source16is connected to the manifold21or vent housing22through a gas attachment33, where the pressurized gas is then delivered into the gas channel29. The pressurized gas is then delivered through the elongated endoscopic housing23and released into the elongated endoscopic housing23at a proximal location24to the spray tip30and a distal location46to the cannula gasket31. The pressurized gas will then exit through the spray tip30, mixing and dispersing the biomaterial component(s) within the body cavity12of the patient11. The cannula gasket31prevents the pressurized gas from flowing proximally24through the elongated endoscopic housing23.

The manifold21comprises a top47and bottom48manifolds, which operate to enclose the biomaterial and gas channels28,29within the manifold21. The manifold21is adapted to receive a plurality of attachments32,33for introducing biomaterial agents and pressurized gas into the biomaterial and gas channels, respectively. Alternatively, the gas channel29can be introduced through the vent housing22. The vent housing22further comprises a vent cavity34adapted to enclose the gas release valve26, an intake port35for introducing the intra-abdominal pressure to the gas release valve26, and an exhaust port36for releasing said intra-abdominal pressure into the atmosphere. While the preferred embodiment utilizes two biomaterial attachments32, one gas release valve26, and one gas attachment33, any number can be used. Once the biomaterial and gas delivery container(s)15,16are attached to the manifold attachments32,33, the biomaterials and gases can be introduced into the manifold21and subsequently through the channels28,29.

The elongated endoscopic housing23is attached to the manifold21and vent housing22at its proximal end24and encloses the biomaterial and gas channels28,29as they travel from the manifold21to the spray tip30. Furthermore, the elongated endoscopic housing23is adapted to be inserted through a surgical trocar14for access to the internal cavity12of a patient11. A plurality of internal abdominal apertures42are positioned on the elongated endoscopic housing23such that, when inserted into the surgical trocar14, the abdominal apertures42are situated within the internal cavity12and not within the trocar delivery sheath14or exterior of the internal cavity12. A single external vent aperture43is positioned at the proximal end24of the elongated endoscopic housing23and is fluidly connected with the intake port35of the vent cavity34. When in use, the abdominal apertures42are exposed to the internal cavity12of the patient, and as such, to the pressure within the internal cavity12. The pressurized gas will travel through the elongated endoscopic housing23, equalizing the pressure within the elongated endoscopic housing23and the internal cavity12of the patient11.

The gas release valve26is positioned on the manifold21or vent housing22and is aligned with the external vent aperture43such that, when in use, the gas release valve26is exposed to the pressure of the internal cavity12. Therefore, the gas release valve26operates as a gateway between the pressure of the internal cavity12and atmospheric pressure. The gas release valve26is adapted to open and release a volume of gas from within the internal cavity12when gas is introduced into the system or when the pressure of the internal cavity12reaches the setpoint of the cracking pressure of the gas release valve26, typically within a range of 5-20 mmHg.

In the preferred embodiment, the gas release valve26comprises a 3-port auto valve (FIG. 7) having a control port37and control piston40with a control piston aperture41. Here, a valve spring38will apply pressure onto the control piston40into the control port37and force the auto valve26into a closed position (FIG. 8). The control port37is fluidly connected to the gas channel29and gas attachment33, whose gas pressure will inherently increase as the pressure from the gas channel29increases. Once this pressure exceeds the valve spring38pressure, or spring force pressure, the control piston40is forced against the valve spring38into an open position (FIG. 9), exposing the control piston aperture41and fluidly connecting the intake and exhaust ports35,36, permitting air flow venting therethrough.

In an alternative embodiment, the gas release valve26comprises a 2-port check valve27(FIG. 10) having an adjustable setpoint cracking pressure, valve spring38, and valve ball39. Here, the valve spring38will apply pressure to the valve ball39, with a pressure adjusting screw adapted to increase or decrease the pressure applied. Once the internal pressure exceeds the pressure of the valve spring38, the check valve27is forced open and the gas is released into the atmosphere.

In yet a further alternative embodiment, the gas release valve26comprises a 2-port fixed pressure check valve27(FIG. 10) with a valve spring38, and valve ball39. Here, the valve spring38will apply pressure to the valve ball39, where the valve spring38has been selected to provide a specific spring force tension that cannot be compressed to open the valve until a specific cracking pressure threshold is achieved. Once the internal pressure exceeds the pressure of the valve spring38, the check valve27is forced open and the gas is released into the atmosphere.

In the check valve and fixed check valve27embodiments, the pressure of the internal cavity12and elongated endoscopic housing23are equivalent, permitting the check valves27to relieve the pressure from the internal cavity12until the pressure becomes equal or lower to the setpoint of the cracking pressure of the check valves27. Once the pressure within the internal cavity12is reduced to equal or lower than the cracking pressure of the check valves27, it will close and no longer allow the flow of gas to leave the internal cavity12, thus sustaining the desired surgical distention.

The cannula gasket31is located inside the elongated endoscopic housing23near its distal end25and provides a gas tight seal between the gas ejected from the gas channel29and the gas release valve26. The cannula gasket31is positioned distally to the abdominal apertures42in the elongated endoscopic housing23and proximally to the distal end49of the gas channel29. This ensures that the gas pressure exiting the gas channel29is delivered to the spray tip30and then to the internal12cavity. The abdominal pressure can then only return through the abdominal apertures42. The gas channel29and the biomaterial channels28travel through the cannula gasket31to the spray tip30.

The spray tip30is mounted at the distal end25of the elongated endoscopic housing23. The spray tip30also incorporates the biomaterial channels28which terminate coincident with the distal face50of the spray tip30through a plurality of spray apertures44. The spray tip's30function is to expel the component(s) of the biomaterial while providing a circular or semi-circular flow of pressurized gas around the biomaterials from the gas channel29through a plurality of gas apertures45. This circular “curtain” of air will then take the biomaterials with the gas flow and disperse the biomaterials in a spray fashion.

In a further alternative embodiment, a plurality of gas release valves26are positioned on the biomaterial applicator10, wherein each gas release valve26will have a different cracking pressure. An adjustable rotating member (not pictured) attached to the proximal side24of the elongated endoscopic housing23will allow selection of a specific gas release valve26mounted in the manifold21or vent housing22in order to provide the surgeon with a selection of different cracking pressures. The adjustable rotating member (not shown) further comprises a plurality of vent apertures43fluidly connecting the gas release valves26with the pressure of the internal cavity12. This rotating member (not shown) could be rotated such that the vent apertures43align with any given gas release valve26in the manifold21or vent housing22.

While the above description contains specific details regarding certain elements, sizes, and other teachings, it is understood that embodiments of the invention or any combination of them may be practiced without these specific details. Specifically, although colors are designated in the above embodiments, any color may be used. These details should not be construed as limitations on the scope of any embodiment, but merely as exemplifications of the presently preferred embodiments. In other instances, well known structures, elements, and techniques have not been shown to clearly explain the details of the invention.