WO2022180476A1 - A minimally invasive system to apply flowable product - Google Patents

A minimally invasive system to apply flowable product Download PDF

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Publication number
WO2022180476A1
WO2022180476A1 PCT/IB2022/051209 IB2022051209W WO2022180476A1 WO 2022180476 A1 WO2022180476 A1 WO 2022180476A1 IB 2022051209 W IB2022051209 W IB 2022051209W WO 2022180476 A1 WO2022180476 A1 WO 2022180476A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
medicant
elongate member
flowable
pump
Prior art date
Application number
PCT/IB2022/051209
Other languages
French (fr)
Inventor
Nir NATIV
Thomas Weindl
Original Assignee
Ethicon, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon, Inc. filed Critical Ethicon, Inc.
Publication of WO2022180476A1 publication Critical patent/WO2022180476A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00522—Sprayers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00544—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated pneumatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075—Valve means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Definitions

  • the present invention relates to a medical device or system for applying flowable medicants to biological tissue for wound treatment, particularly wound sealing, hemostasis and therapeutic treatment.
  • Minimally invasive Surgery is an umbrella term for any surgery less invasive than traditional open surgery.
  • Minimally invasive surgery generally refers to any surgical procedure that is performed through tiny incisions instead of a large opening. Surgeons performing minimally invasive surgery typically make smaller incisions than traditional open surgical procedures.
  • An endoscope or laparoscope i.e. a thin, lighted tube fixed with a camera and other instruments are inserted through the small incisions to perform the surgical procedure. Images from the endoscope are sent to monitors in the operating room so that your surgeon can view clear, magnified pictures of the area needing surgery. The surgeon will then insert surgical instruments through the other incisions, allowing the surgeon to perform the surgery.
  • the surgeon makes smaller incisions, recovery time will likely be quicker and less pain than traditional open surgery but with the same benefits as traditional surgery.
  • the benefits of minimally invasive surgery include smaller incisions; less pain; minimal to no scars; less blood loss; lower rate of complications; and shorter hospital stays.
  • Robotic surgery is a subcategory of minimally invasive surgery.
  • robotic surgery the surgeon places tiny robotic instruments into your body and controls the robot’s movement from a nearby console.
  • the robot is able to access hard-to-reach areas of your body and has greater dexterity than a human.
  • the da Vinci® Surgical Robot is one exemplary embodiment of a surgical robot.
  • MIS minimally invasive surgical procedures
  • various medicants such as flowable hemostatic agents and sealants into the body cavity.
  • a cannula, catheter or other elongate member (hereinafter sometimes generally referred to as an elongate member) is inserted into the body cavity through the endoscope to access the surgical site.
  • the medicant is typically stored in a container or canister (hereinafter sometimes generally referred to as the container) operatively attached to the proximal end of the elongate member.
  • the medicant is expressed at the surgical site by applying force on the container, for example by use of a syringe, plunger, puffer etc.
  • the present invention is directed to systems for delivering a flowable medicant into a surgical site, comprising a container configured to hold the flowable medicant; a tubular elongate member sized and configured to be inserted into a body though a tubular instrument during a minimally invasive surgical procedure, the tubular elongate member being operatively connected to the container, the tubular elongate member having a proximal end and a distal end, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site; and a flow control device operatively connected to the container or the tubular elongate member for metering the flow of medicant from the container, through the tubular elongate member to the exit port.
  • the present invention is further directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurized or pressurizable container configured to hold the flowable medicant; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and a mechanical valve having an operator mechanism located along the elongate member proximal to the exit port, the mechanical valve configured to be operated by a clinician by depressing the operator mechanism with a surgical instrument.
  • the present invention is also directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned remote from the pressurizable container and the elongate tubular member, the electric switch being configured to send a wired or wireless signal to the pump to actuate operation of the pump.
  • the present invention is also directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned along the elongate member proximal to the exit port, the electric switch is configured to be operable by a clinician using a surgical instrument and send a wired or wireless signal to the pump, thus actuating operation of the pump.
  • Figure 1 illustrates an embodiment of the overall system for delivery of flowable medicament.
  • Figure 2 illustrates an aspect of the present invention as a system for delivering a flowable medicant.
  • FIG. 3 illustrates an embodiment of the overall system in schematic form. DETAILED DESCRIPTION OF THE INVENTION
  • system 10 includes a container 12 configured to hold the flowable medicant 100, a tubular elongate member 14 sized and configured to be inserted into a body though a tubular instrument during a surgical procedure.
  • Tubular elongate member 14 will be operatively connected to container 12 at an outlet.
  • Tubular elongate member 14 has a proximal end 16 and a distal end 18, distal end 18 terminating in an exit port 20 configured for discharging the flowable medicant at the surgical site.
  • the system further includes a flow control device 22 that is operatively connected to container 12 or tubular elongate member 14 for metering the flow of medicant from container 12, through tubular elongate member 14 to exit port 20.
  • Flowable medicants are known in the art.
  • the medicants are maintained container 10 in the form of a powder, paste, gel or solution, which can be a suspension or colloid.
  • Flowable medicant or medicinal agent 100 of this nature comprises liquid or semi-liquid formulations of at least one therapeutic agent and optionally containing a diluent.
  • the diluent can be any fluid, such as water, saline, ethanol, polymer and combinations thereof.
  • Flowable medicants can be delivered either in their liquid, gel, aerosol or paste forms as maintained or aerated to various degrees to modify the final consistency as applied, even foam products.
  • additional agents such as buffers, surfactants, thickeners, reactants or catalysts can be introduced into container 10 or co-delivered as an blended formulation or simultaneously but separately or sequentially from a separate container (not shown).
  • therapeutic agent herein is intended to broadly encompass various kinds of agents and medical substances, including but not limited to hemostatic agents, healing agents, adhesives, sealants, anti-bacterial agents, infection-resistant agents, analgesics, conventional pharmaceutical drugs, other chemicals, liquids, powders, etc. It should also be understood that the use of the term “therapeutic agent” herein is not intended to demonstrate that concepts described herein are limited to only agents that are used for therapeutic purposes.
  • therapeutic agent as used herein is intended to encompass various kinds of medical agents/substances, including but not limited to those used for preventative, prophylactic, and/or remedial purposes, and including those used for various purposes that might not be considered “therapeutic” in a traditional sense of the word “therapeutic.”
  • Particularly preferred therapeutic agents are suitable for use as sealants, hemostatic agents, an antihemorrhagic agent and antimicrobial agent.
  • Container 10 is suitable for retaining a medicant in a sealed, preferably sterilized, form prior to delivery.
  • An end cap can be provided over container 10 outlet (not shown) prior to deliver and operatively connecting to tubular elongate member 14.
  • Container 10 can be a single as shown in Figure 1 or a dual barrel syringe that can be pressurized or pressurizable. Single and dual barrel syringes are well-known.
  • Container 10, as shown in Figure 1 exemplifies a single barrel syringe with a displaceable plunger 24 that is subject to a pressure or directional force shown as an arrow. Pressure or directional force can act upon the plunger 24 through the action of air or one or more attachments, such as a plunger rod (not shown).
  • Tubular elongate member 14 can be a cannula, lumen, or catheter.
  • Tubular elongate member can have one or more channels that extend for the entire length of member 14 that provide for fluid communication and transfer from container 10 outlet to exit port 20.
  • Exit port 20 is provided at the distal end of the tubular elongate member 14.
  • Exit port 20 can be provided with a spray nozzle 26.
  • Spray nozzle 26 can be a spray tip having one or more channels in fluid communication with tubular elongate member 14 for transfer of flowable medicant 100.
  • Flowable medicant 100 can be caused to flow through spray nozzle 26 in a linear, circular or non linear path or flow channels depending on desired spray characteristics.
  • One or more flow channels can direct the flowable medicant 100 into a swirl chamber in order to produce an aerosolized spray pattern, directed towards opposing exit streams or directed directly onto an application area.
  • One or more of the flow channels can be fluid communication with a separate air/gas source that facilitates aeration and/or aerosolization of flowable medicant 100.
  • Spray nozzle 26 can be further provided with a flexible diaphragm or end caps that are capable of generating an aerosol spray and adapted to create blended formulations within mixing zones resulting from under fluid pressure.
  • Flow control device 22 is provided on tubular elongate member 14 that is capable of controlling the transfer and fluid communication of flowable medicant 100 through tubular elongate member 14 and through spray nozzle 26 on exit port 20.
  • Flow control device 22 can be a valve in which a barrier or other mechanical means slides or rotates from a first position that allows fluid flow to a second position that prevents fluid flow. Valves of this nature are capable of various intermediate positions from complete fluid flow to a complete stop of all fluid flow.
  • An exemplary valve is a mechanical valve that can located along the proximal end of the tubular elongate member 14.
  • a suitable valve can be a mechanical valve that is located along the distal end of tubular elongate member 14 at or proximal to the exit port 20.
  • flow control device 22 is a suitable valve as described herein that is operable by a clinician using a surgical instrument from a first position to at least a second position, and optionally to one or more intermediate positions.
  • a suitable surgical instrument for operating flow control device 22 is a surgical grasper device or a surgical holder device. Surgical grasper devices and surgical holder devices are known in the art and readily adapted to accessing and operating flow control device 22.
  • Flow control device 22 can be a valve that is a remotely operated.
  • Remotely operated valves are known in the art and transition from a first position to another position in response to a signal to activate and move a mechanically driven barrier.
  • Remote operation and barrier activation can be initiated by receipt by a processor that translates an electrical signal into mechanical activation of a barrier.
  • the mechanical activation can be converted into pneumatic or hydraulic force that acts upon the barrier.
  • the remote operation is initiated by receipt of wireless signal.
  • Figure 2 illustrates an embodiment of the present invention delivering a flowable medicant on a tissue surface. More particularly, a powder form of medicament is delivered from a nozzle having a flow control device that is retained and directed with a surgical grasper known in the art.
  • FIG. 3 illustrates an aspect of the present invention wherein a surgical access device 200 is shown having a hand controller 210 with a shaft 220 and a gripping mechanism 230 having opposable segments. The opposable segments are operationally connected with the hand controller 210 and moveable by activation of a trigger or other means.
  • Hand controller 210 is shown with shaft 220 extending into and through trocar 120b.
  • Gripping mechanism 230 is shown in proximity to flow control device 22, in a ready position to activate the flow control device 22 as needed.
  • Surgical access devices 200 can be used to provide access to a patient's body cavity 310 through a working channel of the access device.
  • Gripping mechanism 230 can be positionable within an opening in a patient's body 300 such that a distal portion of the gripping mechanism 230 extends into a patient's body cavity 310 and a proximal portion configured to couple to the device's housing is positioned adjacent to the patient's skin on an exterior of the patient's body 300.
  • a lumen in trocar 120b can form a pathway through the opening in a patient's body 300 so that surgical instruments can be inserted from outside the body to an interior body cavity 310.
  • More than one trocar can be utilized during a procedure to permit access of multiple devices or permit improved directional access to an area for treatment 305.
  • surgical access device 200 is provided through a first trocar (tubular instrument) 120b, while tubular elongate member 14 and flow control device 22 is provided through a second trocar (tubular instrument) 120a.
  • Flowable medicant 100 is delivered as needed on area 305.
  • flow control device 22 provides fluid communication of flowable medicant 100 by acting as a pump that draws fluid into, through and then out into the device.
  • Suitable pump can be powered electrically and generate fluid flow pneumatically operated or hydraulically.
  • the flow control device as a pump can be activated to cause fluid flow from a switch within the system.
  • a switch can be located on the pump along tubular elongate member 14 and preferably is operable by a clinician using a surgical instrument as described above.
  • the pump can be activated by a switch that is remote to the system, such as in an operators’ console.
  • Pump can be located proximal to container 10 and operably connected to the container.
  • a pump is integrated with container 10 to cause movement of flowable medicant 100.
  • a pump can be located distal to the container and operatively connected to the container.
  • a pump is configured to pressurize the container sufficient to allow medicant to flow from the container through the elongate member to the exit port.
  • a pump is provided that draws flowable medicant 100 from container 10 through the tubular elongate member 14 to the exit port 22.
  • the present invention is a system for delivering a flowable medicant into a surgical site from a pressurized or pressurizable container configured to hold the flowable medicant and a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site.
  • the tubular elongate member is sized and configured to be inserted into a body during a minimally invasive surgical procedure.
  • the system further includes a mechanical valve having an operator mechanism that is located along the elongate member proximal to the exit port, the mechanical valve configured to be operated by a clinician by depressing the operator mechanism with a surgical instrument.
  • the present invention is a system for delivering a flowable medicant into a surgical site from a pressurizable container configured to hold the flowable medicant and an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container.
  • a tubular elongate member is provided having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site.
  • the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure.
  • An electric switch is further provided and positioned remote from the pressurizable container and the elongate tubular member, the electric switch being configured to send a wired or wireless signal to the pump to actuate operation of the pump.
  • the present invention is a system for delivering a flowable medicant into a surgical site from a pressurizable container configured to hold the flowable medicant with an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container.
  • a tubular elongate member is provided having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site.
  • the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure.
  • An electric switch is provided and positioned along the elongate member proximal to the exit port, the electric switch is configured to be operable by a clinician using a surgical instrument and send a wired or wireless signal to the pump, thus actuating operation of the pump.

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  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

The present invention is directed to devices and systems for delivering a flowable medicant (100) into a surgical site from a container (10) configured to hold the flowable medicant. The container having a tubular elongate member (14) sized and configured to be inserted into a body (300) though a tubular instrument (120a), such as a surgical access device. The tubular elongate member is operatively connected to the container and has a proximal end and a distal end. The distal end terminates as an exit port that is configured to discharge the flowable medicant at the surgical site, and a flow control device (22) operatively connected to the container or the tubular elongate member for metering the flow of medicant from the container, through the tubular elongate member to the exit port.

Description

A MINIMALLY INVASIVE SYSTEM TO APPLY FLOW ABLE PRODUCT
FIELD OF THE INVENTION
The present invention relates to a medical device or system for applying flowable medicants to biological tissue for wound treatment, particularly wound sealing, hemostasis and therapeutic treatment.
BACKGROUND OF THE INVENTION
Minimally invasive Surgery or “MIS” is an umbrella term for any surgery less invasive than traditional open surgery. Minimally invasive surgery generally refers to any surgical procedure that is performed through tiny incisions instead of a large opening. Surgeons performing minimally invasive surgery typically make smaller incisions than traditional open surgical procedures. An endoscope or laparoscope, i.e. a thin, lighted tube fixed with a camera and other instruments are inserted through the small incisions to perform the surgical procedure. Images from the endoscope are sent to monitors in the operating room so that your surgeon can view clear, magnified pictures of the area needing surgery. The surgeon will then insert surgical instruments through the other incisions, allowing the surgeon to perform the surgery.
Because the surgeon makes smaller incisions, recovery time will likely be quicker and less pain than traditional open surgery but with the same benefits as traditional surgery. In general, the benefits of minimally invasive surgery include smaller incisions; less pain; minimal to no scars; less blood loss; lower rate of complications; and shorter hospital stays.
Robotic surgery is a subcategory of minimally invasive surgery. In robotic surgery the surgeon places tiny robotic instruments into your body and controls the robot’s movement from a nearby console. The robot is able to access hard-to-reach areas of your body and has greater dexterity than a human. The da Vinci® Surgical Robot is one exemplary embodiment of a surgical robot.
There are however some difficulties associated with MIS. For example, in minimally invasive surgical procedures the surgeon does not have direct control over the application of various medicants, such as flowable hemostatic agents and sealants into the body cavity. Currently, a cannula, catheter or other elongate member (hereinafter sometimes generally referred to as an elongate member) is inserted into the body cavity through the endoscope to access the surgical site. The medicant is typically stored in a container or canister (hereinafter sometimes generally referred to as the container) operatively attached to the proximal end of the elongate member. The medicant is expressed at the surgical site by applying force on the container, for example by use of a syringe, plunger, puffer etc. that is outside of the patient ’s body, which intern allows the medicant to be pushed through the elongate member into the target location. In minimally invasive surgery this action requires the surgeon to free at least one hand to perform this action. Alternatively, the surgeon may ask an assistant to perform this task. In robotic surgery, as the surgeon is away from the patients (at the console) he or she must ask that an assistant perform the task on their behalf via a side port. The current approach of performing the task in minimally invasive surgery reduce the surgeon’s control with regard to when and at what rate these flowable products are being delivered. This may lead to suboptimal hemostasis or sealing and longer surgery time.
SUMMARY OF THE INVENTION
The present invention is directed to systems for delivering a flowable medicant into a surgical site, comprising a container configured to hold the flowable medicant; a tubular elongate member sized and configured to be inserted into a body though a tubular instrument during a minimally invasive surgical procedure, the tubular elongate member being operatively connected to the container, the tubular elongate member having a proximal end and a distal end, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site; and a flow control device operatively connected to the container or the tubular elongate member for metering the flow of medicant from the container, through the tubular elongate member to the exit port.
The present invention is further directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurized or pressurizable container configured to hold the flowable medicant; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and a mechanical valve having an operator mechanism located along the elongate member proximal to the exit port, the mechanical valve configured to be operated by a clinician by depressing the operator mechanism with a surgical instrument.
The present invention is also directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned remote from the pressurizable container and the elongate tubular member, the electric switch being configured to send a wired or wireless signal to the pump to actuate operation of the pump.
The present invention is also directed to systems for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned along the elongate member proximal to the exit port, the electric switch is configured to be operable by a clinician using a surgical instrument and send a wired or wireless signal to the pump, thus actuating operation of the pump.
BRIEF DESCRIPTION OF THE FIGURES
Figure 1 illustrates an embodiment of the overall system for delivery of flowable medicament.
Figure 2 illustrates an aspect of the present invention as a system for delivering a flowable medicant.
Figure 3 illustrates an embodiment of the overall system in schematic form. DETAILED DESCRIPTION OF THE INVENTION
In one embodiment, the systems of the present invention suitable for delivering a flowable medicant into a surgical site, preferably via laparoscopic delivery, minimally invasive procedure, each robotically or directly by a clinician. Referring to Figure 1, system 10 includes a container 12 configured to hold the flowable medicant 100, a tubular elongate member 14 sized and configured to be inserted into a body though a tubular instrument during a surgical procedure. Tubular elongate member 14 will be operatively connected to container 12 at an outlet. Tubular elongate member 14 has a proximal end 16 and a distal end 18, distal end 18 terminating in an exit port 20 configured for discharging the flowable medicant at the surgical site. The system further includes a flow control device 22 that is operatively connected to container 12 or tubular elongate member 14 for metering the flow of medicant from container 12, through tubular elongate member 14 to exit port 20.
The systems described herein are suitable for delivery of flowable medicants or medicaments, terms which are used interchangeably. Flowable medicants are known in the art. The medicants are maintained container 10 in the form of a powder, paste, gel or solution, which can be a suspension or colloid. Flowable medicant or medicinal agent 100 of this nature comprises liquid or semi-liquid formulations of at least one therapeutic agent and optionally containing a diluent. The diluent can be any fluid, such as water, saline, ethanol, polymer and combinations thereof. Flowable medicants can be delivered either in their liquid, gel, aerosol or paste forms as maintained or aerated to various degrees to modify the final consistency as applied, even foam products. Alternatively, additional agents, such as buffers, surfactants, thickeners, reactants or catalysts can be introduced into container 10 or co-delivered as an blended formulation or simultaneously but separately or sequentially from a separate container (not shown).
The term “therapeutic agent” herein is intended to broadly encompass various kinds of agents and medical substances, including but not limited to hemostatic agents, healing agents, adhesives, sealants, anti-bacterial agents, infection-resistant agents, analgesics, conventional pharmaceutical drugs, other chemicals, liquids, powders, etc. It should also be understood that the use of the term “therapeutic agent” herein is not intended to demonstrate that concepts described herein are limited to only agents that are used for therapeutic purposes. The term “therapeutic agent” as used herein is intended to encompass various kinds of medical agents/substances, including but not limited to those used for preventative, prophylactic, and/or remedial purposes, and including those used for various purposes that might not be considered “therapeutic” in a traditional sense of the word “therapeutic.” Various kinds of agents/substances that may be used in accordance with the teachings herein, as well as various purposes for which such agents/substances may be used, will be apparent to those of ordinary skill in the art in view of the teachings herein. All such agents/substances/purposes are intended to be encompassed by the use of the term “therapeutic agent” herein.
Particularly preferred therapeutic agents are suitable for use as sealants, hemostatic agents, an antihemorrhagic agent and antimicrobial agent.
Container 10 is suitable for retaining a medicant in a sealed, preferably sterilized, form prior to delivery. An end cap can be provided over container 10 outlet (not shown) prior to deliver and operatively connecting to tubular elongate member 14. Container 10 can be a single as shown in Figure 1 or a dual barrel syringe that can be pressurized or pressurizable. Single and dual barrel syringes are well-known. Container 10, as shown in Figure 1, exemplifies a single barrel syringe with a displaceable plunger 24 that is subject to a pressure or directional force shown as an arrow. Pressure or directional force can act upon the plunger 24 through the action of air or one or more attachments, such as a plunger rod (not shown). The pressure that acts upon plunger 24 causes the flowable medicant 100 to exit through the container 10 outlet (not shown) into tubular elongate member 14. Tubular elongate member 14 can be a cannula, lumen, or catheter. Tubular elongate member can have one or more channels that extend for the entire length of member 14 that provide for fluid communication and transfer from container 10 outlet to exit port 20.
Exit port 20 is provided at the distal end of the tubular elongate member 14. Exit port 20 can be provided with a spray nozzle 26. Spray nozzle 26 can be a spray tip having one or more channels in fluid communication with tubular elongate member 14 for transfer of flowable medicant 100. Flowable medicant 100 can be caused to flow through spray nozzle 26 in a linear, circular or non linear path or flow channels depending on desired spray characteristics. One or more flow channels can direct the flowable medicant 100 into a swirl chamber in order to produce an aerosolized spray pattern, directed towards opposing exit streams or directed directly onto an application area. One or more of the flow channels can be fluid communication with a separate air/gas source that facilitates aeration and/or aerosolization of flowable medicant 100. Spray nozzle 26 can be further provided with a flexible diaphragm or end caps that are capable of generating an aerosol spray and adapted to create blended formulations within mixing zones resulting from under fluid pressure.
Flow control device 22 is provided on tubular elongate member 14 that is capable of controlling the transfer and fluid communication of flowable medicant 100 through tubular elongate member 14 and through spray nozzle 26 on exit port 20. Flow control device 22 can be a valve in which a barrier or other mechanical means slides or rotates from a first position that allows fluid flow to a second position that prevents fluid flow. Valves of this nature are capable of various intermediate positions from complete fluid flow to a complete stop of all fluid flow. An exemplary valve is a mechanical valve that can located along the proximal end of the tubular elongate member 14. In one embodiment, a suitable valve can be a mechanical valve that is located along the distal end of tubular elongate member 14 at or proximal to the exit port 20. In one embodiment, flow control device 22 is a suitable valve as described herein that is operable by a clinician using a surgical instrument from a first position to at least a second position, and optionally to one or more intermediate positions. In one embodiment, a suitable surgical instrument for operating flow control device 22 is a surgical grasper device or a surgical holder device. Surgical grasper devices and surgical holder devices are known in the art and readily adapted to accessing and operating flow control device 22.
Flow control device 22 can be a valve that is a remotely operated. Remotely operated valves are known in the art and transition from a first position to another position in response to a signal to activate and move a mechanically driven barrier. Remote operation and barrier activation can be initiated by receipt by a processor that translates an electrical signal into mechanical activation of a barrier. The mechanical activation can be converted into pneumatic or hydraulic force that acts upon the barrier. In one embodiment, the remote operation is initiated by receipt of wireless signal.
Figure 2 illustrates an embodiment of the present invention delivering a flowable medicant on a tissue surface. More particularly, a powder form of medicament is delivered from a nozzle having a flow control device that is retained and directed with a surgical grasper known in the art.
Figure 3 illustrates an aspect of the present invention wherein a surgical access device 200 is shown having a hand controller 210 with a shaft 220 and a gripping mechanism 230 having opposable segments. The opposable segments are operationally connected with the hand controller 210 and moveable by activation of a trigger or other means. Hand controller 210 is shown with shaft 220 extending into and through trocar 120b. Gripping mechanism 230 is shown in proximity to flow control device 22, in a ready position to activate the flow control device 22 as needed.
Surgical access devices 200 can be used to provide access to a patient's body cavity 310 through a working channel of the access device. Gripping mechanism 230 can be positionable within an opening in a patient's body 300 such that a distal portion of the gripping mechanism 230 extends into a patient's body cavity 310 and a proximal portion configured to couple to the device's housing is positioned adjacent to the patient's skin on an exterior of the patient's body 300. A lumen in trocar 120b can form a pathway through the opening in a patient's body 300 so that surgical instruments can be inserted from outside the body to an interior body cavity 310. More than one trocar, as shown as 120a and 120b, can be utilized during a procedure to permit access of multiple devices or permit improved directional access to an area for treatment 305. In Figure 3, surgical access device 200 is provided through a first trocar (tubular instrument) 120b, while tubular elongate member 14 and flow control device 22 is provided through a second trocar (tubular instrument) 120a. Flowable medicant 100 is delivered as needed on area 305.
In one embodiment, flow control device 22 provides fluid communication of flowable medicant 100 by acting as a pump that draws fluid into, through and then out into the device. Suitable pump can be powered electrically and generate fluid flow pneumatically operated or hydraulically. The flow control device as a pump can be activated to cause fluid flow from a switch within the system. Such a switch can be located on the pump along tubular elongate member 14 and preferably is operable by a clinician using a surgical instrument as described above. In another embodiment, the pump can be activated by a switch that is remote to the system, such as in an operators’ console.
Pump can be located proximal to container 10 and operably connected to the container. In one embodiment, a pump is integrated with container 10 to cause movement of flowable medicant 100. In another embodiment, a pump can be located distal to the container and operatively connected to the container. In one embodiment, a pump is configured to pressurize the container sufficient to allow medicant to flow from the container through the elongate member to the exit port. Alternatively, a pump is provided that draws flowable medicant 100 from container 10 through the tubular elongate member 14 to the exit port 22. In a preferred embodiment, the present invention is a system for delivering a flowable medicant into a surgical site from a pressurized or pressurizable container configured to hold the flowable medicant and a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site. The tubular elongate member is sized and configured to be inserted into a body during a minimally invasive surgical procedure. The system further includes a mechanical valve having an operator mechanism that is located along the elongate member proximal to the exit port, the mechanical valve configured to be operated by a clinician by depressing the operator mechanism with a surgical instrument.
In an alternative embodiment, the present invention is a system for delivering a flowable medicant into a surgical site from a pressurizable container configured to hold the flowable medicant and an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container. A tubular elongate member is provided having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site. The tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure. An electric switch is further provided and positioned remote from the pressurizable container and the elongate tubular member, the electric switch being configured to send a wired or wireless signal to the pump to actuate operation of the pump.
In another embodiment, the present invention is a system for delivering a flowable medicant into a surgical site from a pressurizable container configured to hold the flowable medicant with an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container. A tubular elongate member is provided having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site. The tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure. An electric switch is provided and positioned along the elongate member proximal to the exit port, the electric switch is configured to be operable by a clinician using a surgical instrument and send a wired or wireless signal to the pump, thus actuating operation of the pump.

Claims

CLAIMS What is claimed is:
1. A system for delivering a flowable medicant into a surgical site, comprising a container configured to hold the flowable medicant; a tubular elongate member sized and configured to be inserted into a body though a tubular instrument during a minimally invasive surgical procedure, the tubular elongate member being operatively connected to the container, the tubular elongate member having a proximal end and a distal end, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site; and a flow control device operatively connected to the container or the tubular elongate member for metering the flow of medicant from the container, through the tubular elongate member to the exit port.
2. A system according to claim 1 wherein the flowable medicant is selected from the group consisting of a sealant, a hemostatic agent, an antimicrobial agent, an antihemorrhagic agent and combinations thereof.
3. A system according to claim 1 wherein the medicant, prior to delivery, is in the form of a foam, paste, gel, powder or liquid.
4. A system according to claim 1 wherein the container is pressurized or pressurizable.
5. A system according to claim 1 wherein the tubular elongate member is a cannula or a catheter.
6. A system according to claim 1 wherein the exit port has a spray nozzle.
7. A system according to claim 1 wherein the exit port is the distal end of the elongate member.
8. A system according to claim 1 wherein the flow control device is a valve.
9. A system according to claim 8 wherein the valve is a mechanical valve located along the proximal end of the elongate member.
10. A system according to claim 8 wherein the valve is a mechanical valve located along the distal end of the elongate member at or proximal to the exit port
11. A system according to claim 8 further comprising a surgical access device and wherein the valve is operable by a clinician using a surgical instrument associated with the surgical access device.
12. A system according to claim 11 wherein the surgical instrument has been provided through a trocar and is a surgical grasper device or surgical holder device.
13. A system according to claim 1 wherein the flow control device is a pump.
14. A system according to claim 13 wherein the pump is electrically operated by battery.
15. A system according to claim 13 wherein the pump is a pneumatic or hydraulic pump.
16. A system according to claim 13 wherein the pump is operated by a switch within the system that is located on the pump or along the elongate member.
17. A system according to claim 13 further comprising a surgical access device and wherein the switch is operable by a clinician using a surgical instrument associated with the surgical access device.
18. A system according to claim 1 further comprising a pressuring pump that is located proximal to the container and operably connected to the container.
19. A system according to claim 18 wherein the pressuring pump is integrated with the container.
20. A system according to claim 18 wherein the pressurizing pump is configured to pressurize the container sufficient to allow medicant to flow from the container through the elongate member to the exit port.
21. A system according to claim 13 wherein the pump is configured to draw the medicant from the container and pump the medicant through the elongate member to the exit port
22. A system for delivering a flowable medicant into a surgical site, comprising a pressurized or pressurizable container configured to hold the flowable medicant; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and a mechanical valve having an operator mechanism located along the elongate member proximal to the exit port, the mechanical valve configured to be operated by a clinician by depressing the operator mechanism with a surgical instrument.
23. A system for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned remote from the pressurizable container and the elongate tubular member, the electric switch being configured to send a wired or wireless signal to the pump to actuate operation of the pump.
24. A system for delivering a flowable medicant into a surgical site, comprising a pressurizable container configured to hold the flowable medicant; an electrically actuated pressurization pump operatively connected to the pressurizable container and configured to pressurize the container; a tubular elongate member having a proximal end and a distal end, the proximal end extending from the container, the distal end terminating in an exit port or spray port configured for discharging the flowable medicant at the surgical site, the tubular elongate member being sized and configured to be inserted into a body during a minimally invasive surgical procedure; and an electric switch positioned along the elongate member proximal to the exit port, the electric switch is configured to be operable by a clinician using a surgical instrument and send a wired or wireless signal to the pump, thus actuating operation of the pump.
PCT/IB2022/051209 2021-02-24 2022-02-10 A minimally invasive system to apply flowable product WO2022180476A1 (en)

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Citations (3)

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WO1998013094A1 (en) * 1996-09-27 1998-04-02 Thermogenesis Corporation A sprayer for fibrin glue
US20060041243A1 (en) * 2001-01-13 2006-02-23 Medtronic, Inc. Devices and methods for interstitial injection of biologic agents into tissue
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Publication number Priority date Publication date Assignee Title
WO1998013094A1 (en) * 1996-09-27 1998-04-02 Thermogenesis Corporation A sprayer for fibrin glue
US20060041243A1 (en) * 2001-01-13 2006-02-23 Medtronic, Inc. Devices and methods for interstitial injection of biologic agents into tissue
WO2018005923A1 (en) * 2016-07-01 2018-01-04 Boston Scientific Scimed, Inc. Delivery devices and methods

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