CN117729874A - Trocar and pneumoperitoneum type needle with illumination guidance and safety features - Google Patents
Trocar and pneumoperitoneum type needle with illumination guidance and safety features Download PDFInfo
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- CN117729874A CN117729874A CN202280019774.1A CN202280019774A CN117729874A CN 117729874 A CN117729874 A CN 117729874A CN 202280019774 A CN202280019774 A CN 202280019774A CN 117729874 A CN117729874 A CN 117729874A
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Abstract
The present disclosure provides devices and methods for insufflating the abdomen of a subject under direct visualization. In some embodiments, such devices and methods include features for cleaning the device, and certain embodiments of the method allow for surgical procedures that do not require the use of a typical obturator to place the cannula, resulting in safer surgical procedures.
Description
Cross Reference to Related Applications
This patent application claims priority from U.S. patent application Ser. No. 17/501,232, U.S. patent application Ser. No. 17/368,296, U.S. provisional patent application Ser. No. 63/139,298, U.S. patent application Ser. No. 2021, 10/14, and U.S. patent application Ser. No. 17/368,296, 7/2021. This patent application is related to U.S. patent application No. 16/780,938, filed 2/4/2020, which in turn is a continuation of and claims priority to international patent application PCT/US2018/45380, filed 8/6/2018, which in turn is related to and claims priority to U.S. provisional patent application No. 62/541,644, filed 8/4/2017. The entire contents of each of the foregoing patent applications are incorporated herein by reference for any purpose.
Technical Field
The present disclosure relates to instruments and methods of use in the practice of laparoscopic surgery, and more particularly, to devices that can be used to form incisions and insufflate underlying body cavities in a safer manner than prior art devices.
Background
In the practice of minimally invasive laparoscopic surgery, a pneumoperitoneum needle is typically used to make a small incision in the skin and subcutaneous tissue of a patient or subject adjacent to the internal surgical site. These needles include tubular outer sheath catheters having a sharp distal end and inner hollow cylindrical needles, or cannulas terminating in a blunt end. The spring assembly urges the inner cannula forward such that the blunt end of the inner cannula extends beyond the cutting edge of the outer sheath catheter. When the instrument is pressed against the patient's skin, the inner blunt cannula is retracted, allowing the outer sharp cannula to contact the skin and advance into the tissue. Once inside the body cavity, the inner blunt cannula springs forward, thereby avoiding intentional removal of the underlying organ by the sharp outer sheath catheter.
Pneumoperitoneum needles typically include a device for introducing a pressurized gas (typicallyCO 2 ) A tool introduced into the proximal end of the needle allows gas to be delivered through the laparoscopic incision and expands the body cavity to allow easy access to the surgical site. After the first incision is made and the body cavity is insufflated, the pneumoperitoneum needle is typically removed and the trocar is placed through the same incision.
One problem associated with using such a pneumoperitoneum needle assembly is determining when the needle has been advanced through the wall of the body lumen and its distal end has been present within the lumen. Furthermore, during insertion of a standard pneumoperitoneum needle, internal organs such as the intestinal tract and major blood vessels may be unintentionally damaged. This occurs because the initial access is not visible (i.e., the surgeon cannot see the needle's way). The present disclosure provides a solution to these and other problems in the art, as described below.
Disclosure of Invention
The advantages of the present disclosure will be set forth in, and become apparent from, the following description. Additional advantages of the disclosure will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
According to one aspect, the present disclosure is directed to an instrument comprising a handle having a proximal end and a distal end, the handle being connected at the distal end to a hollow distally extending needle having a distal end for penetrating tissue and a proximal end, wherein the handle and the hollow distally extending needle form a conduit for at least one of a fluid or an instrument therethrough. The instrument further includes a visualization stylet having a proximal end and a distal end, the visualization stylet slidably disposed within the catheter, wherein a distal region of the visualization stylet includes an electronic photodetector chip mounted thereon having a distally facing surface configured to detect incident light traveling in a proximal direction. The visualization stylet may also include a light source configured to project light in a distal direction out of the electronic photodetector chip to provide direct illumination, wherein light from the light source is reflected back to the electronic photodetector chip as the instrument travels through tissue. The instrument may further include a spring encased within the handle for biasing the visualization stylet to extend past the sharp distal end of the hollow distally extending needle without resistance of the visualization stylet by tissue.
In further embodiments, the visualization stylet may include a lens element disposed over its distal tip over the electronic photodetector chip. In some embodiments, the lens element may directly contact the electron photodetector chip. In some embodiments, the lens elements may be axially spaced relative to the electron photodetector chip. If desired, the lens elements may be controllably, adjustably axially spaced relative to the electronic photodetector chip to allow a user to focus incident light passing through the lens onto the electronic photodetector chip. For example, the axial spacing of the lens element from the electron photodetector chip along the central longitudinal axis of the instrument may be adjusted by sliding the lens element relative to the electron photodetector chip.
If desired, the axial spacing of the lens element from the electron photodetector chip along the central longitudinal axis of the instrument may be adjusted by rotating the lens element relative to the electron photodetector chip. In some embodiments, the lens element may comprise a convex lens, a plano-convex lens, or other lens. The lens element may be conical, pyramidal, dome-shaped, or the like, for example. In some embodiments, the lens element may include a central lens configured to focus incident light on an electron photodetector chip surrounded by a plurality of auxiliary lenses configured and arranged to disperse light from the light source transmitted distally from the lens element.
In some embodiments, the light source may include a bundle of fiber optic elements coupled to the light source. If desired, the light source may include at least one micro LED element surrounding the electronic photodetector chip. The at least one micro LED element may include an optical component disposed thereon that focuses and directs light from the at least one micro LED element onto at least one of the auxiliary lenses. If desired, the lens element may include a central lens configured to focus incident light on an electron photodetector chip surrounded by an annular region of the lens, wherein the central lens is radially separated from the annular region of the lens by at least one fluid flow channel configured and arranged to direct a jet of cleaning fluid onto at least a portion of the central lens. In some embodiments, the central lens and the annular region of the lens may be integrally molded. The central lens and the annular region of the lens may be formed from at least two discrete components if desired.
In some embodiments, the instrument may further comprise at least one fluid flow channel configured and arranged to direct a jet of cleaning fluid onto at least a portion of the central lens disposed at the distal end of the visualization stylet. The at least one fluid flow channel may be defined by at least one tubular member slidably disposed along the visualization stylet, the tubular member defining a plurality of ejection openings in a sidewall thereof. If desired, the tubular member may be formed of a shape memory material. The tip region of the tubular member may be pushed distally from the visualization stylet and exhibit a heat-set curvature that causes the tubular member to bend toward the lens element.
In some embodiments, the axial spacing of the lens element from the electronic photodetector chip may be adjusted by actuating an actuator near the proximal end of the visualization stylet, if equipped accordingly. If desired, any of the lens elements disclosed herein can include at least one vent therein, e.g., for the passage of insufflation gas, and/or to facilitate focusing of the lens element by allowing axial repositioning of the lens relative to the remainder of the visualization stylet.
In some embodiments, the at least one fluid flow channel may be defined by at least one tubular member attached to an inner wall of the catheter of the hollow needle. The tubular member may define a plurality of spray openings in a sidewall thereof, the spray openings being configured and arranged to clean the lens by directing fluid laterally across the lens. The visualization stylet may also define at least one elongated insufflation catheter therein configured to deliver insufflation gas therethrough to a distal region of the instrument. The insufflation gas may exit through at least one opening defined through a sidewall of the visualization stylet near a distal tip of the visualization stylet. The visualization stylet may be formed at least in part from a light transmissive material. For example, the light source may include at least one LED disposed in the proximal end of the handle.
In some embodiments, the apparatus may further comprise a gas introduction port for receiving insufflation gas from a gas source. The visualization stylet may be configured to be withdrawn proximally to establish a flow path for the insufflation gas through the instrument. The visualization stylet may also include conductors for guiding signals received from the electronic photodetector chip to the processor. The processor may be attached to the visualization stylet. The instrument may also include a display screen for displaying images captured by the electronic photodetector chip, if desired. The instrument may also include a battery for powering the electronic photodetector chip, the processor and the display screen, if desired.
The present disclosure further provides various methods for treating a subject, such as a patient. For example, a first embodiment of a method of using a device such as those described herein is provided. Some methods may include creating a small surface incision in the skin of the abdomen of the subject, pushing the distal end of the hollow distally extending needle including the visualization stylet disposed therein through a continuous layer of the abdominal wall of the subject while the real-time viewing tissue is pushed through by the visualization stylet, the visualization stylet configured to be viewed in a distal direction, and stopping pushing the distal end of the hollow distally extending needle when the visualization stylet is observed to be distally extending relative to the hollow distally extending needle, indicating that the abdomen of the subject has been reached.
In some embodiments, the method may further comprise, after stopping pushing the distal end of the hollow distally extending needle, initiating insufflation through the hollow distally extending needle. Initiating insufflation through the hollow distally extending needle may further comprise removing the visualization stylet through the proximal end of the hollow distally extending needle, and injecting a gas through the hollow distally extending needle. The method may further include directing signals from the electronic photodetector chip to the processor, if desired. The method may further include directing the signal from the processor to a display screen.
In some embodiments of the method, the hollow distally extending needle may act as a sheath at least partially covering the visualization stylet along its length. The handle may include a cannula that is removably attached to the hollow distally extending needle. The method may further include, after insufflation, removing the cannula from the hollow distally extending needle, and proximally withdrawing the cannula over the visualization stylet. Removing the cannula may include disconnecting the threaded connection of the hollow distally extending needle and the cannula. If desired, the method may further include attaching a proximal extension to at least one of the hollow distally extending needle and the visualization stylet to form an assembly, and performing laparoscopic surgery using the assembly as an endoscope. If desired, the method may further include separating the hollow distally extending needle and the handle from the visualization stylet and removing one of the visualization stylet and the hollow distally extending needle and the handle from the subject. Once the visualization stylet is removed, the method may include leaving the hollow distally extending needle in place for use as a cannula for performing further surgical procedures.
In some embodiments, the method may further include removing the lens cap from the visualization stylet, and reintroducing the visualization stylet into the handle and the hollow distally extending needle without the lens cap. For example, the lens cover may be removed by twisting (holding) the distal end of the lens cover away from the visualization stylet on a hinge.
The disclosed methods may further include, for example, while inside the subject, directing a cleaning fluid comprising at least one of a liquid or a gas at least partially in a lateral direction through the distal end of the visualization stylet to enhance visualization. Directing the cleaning fluid may include extending a cleaning wand distally configured and adapted to direct the cleaning fluid toward the distal end of the visualization stylet. Directing the cleaning fluid may include directing the cleaning fluid through the visualization stylet and out through at least one opening at a distal region of the visualization stylet. Directing the cleaning fluid may include directing the cleaning fluid through a lens located at a distal end of the visualization stylet. The cleaning fluid may be directed at least partially along a radially inward path through a central region of the lens. Directing the cleaning fluid may include directing the cleaning fluid through a hollow distally extending needle. If desired, directing the cleaning fluid may include directing the cleaning fluid through at least one tubular passage disposed between the visualization stylet and the inner bore of the hollow distally extending needle, wherein the at least one tubular passage is attached to the inner bore of the hollow distally extending needle.
Further in accordance with the present disclosure, the method may include removing the hollow distally extending needle and handle, leaving the visualization stylet in place. If desired, the method may further include adding a proximal extension to the visualization stylet to form an assembly, and using the assembly as an endoscope. The method may further include placing a cannula having an aperture at least twice the diameter of the visualization stylet over the visualization stylet, resulting in the tissue expanding radially outward. If desired, the visualization stylet may have a diameter of, for example, 1 to 2mm, and the cannula may have a 5mm bore. If desired, the visualization stylet may have a diameter of 1 to 2mm, and the cannula may have a bore of 10 mm.
If desired, the method may further include withdrawing the visualization stylet, leaving the cannula in place. The method may further comprise introducing additional instruments through the cannula. The further instrument may be an endoscope configured to match the size of the cannula bore.
Further in accordance with the present disclosure, embodiments of a surgical instrument are provided. In some embodiments, the surgical instrument includes a distal outer assembly including a distal housing having a fluid input port and a hollow distally extending needle extending distally therefrom. The hollow distally extending needle has a distal end and a proximal end, wherein the distal outer assembly forms a passageway for at least one of a fluid and an instrument to pass therethrough. The surgical instrument further includes a visualization stylet assembly disposed at least partially within the passageway of the distal outer assembly. The visualization stylet assembly is removably coupled to the distal outer assembly. The visualization stylet includes an elongate body having a proximal end and a distal end, an electronic photodetector chip mounted proximate the distal end of the elongate body, the electronic photodetector chip having a distally facing surface to detect incident light traveling in a proximal direction, a light source at least partially integrated into the elongate body to project light out of the electronic photodetector chip in a distal direction to provide direct illumination to guide the passage of the inflation needle assembly, and a sleeve slidably disposed about at least a distal tip region of the removable visualization stylet assembly. The sleeve may include a lens element disposed at a distal end thereof to direct light through the lens element toward the electron photodetector chip. At least a portion of the sleeve may extend proximally through the hollow distally extending needle. The sleeve may terminate in a proximal handle portion of the sleeve to facilitate relative movement of the sleeve with respect to the elongate body. The distal outer assembly and the removable visualization stylet assembly may be removably coupled with the sleeve to allow the outer assembly, the removable visualization stylet, and the sleeve to be pushed through tissue as a single structural unit.
In some embodiments, the visualization stylet assembly may be configured to be removed from the distal outer assembly with the sleeve, and the sleeve may be removed from around the removable visualization stylet assembly to expose the electron photodetector chip and allow the removable visualization stylet assembly to be reintroduced into the catheter of the outer assembly without the sleeve thereon.
In some embodiments, the surgical instrument may be an insufflation needle assembly, or may be a trocar assembly. As an insufflation needle assembly, the removable visualization stylet assembly may include a proximal housing portion defining a bore therein, the proximal housing portion including a compression spring disposed therein. The elongate body of the visualization stylet assembly may be biased in a distal direction relative to the proximal housing portion by a compression spring such that the sleeve and the elongate body extend beyond the distal end of the hollow distally extending needle. In some embodiments, the visualization stylet assembly can further include a connector body concentrically disposed about the proximal region of the elongate body. The connector body may include a distally facing connector to be removably coupled to the handle portion of the sleeve.
The visualization stylet assembly may also include a connector body concentrically disposed about the proximal region of the elongate body, and the connector body may include a distally facing connector to be removably coupled to the handle portion of the sleeve, the connector body being at least partially received within the proximal housing of the surgical instrument. If desired, the handle of the sleeve may include a female locking member that is received by a male locking member of the connector body (or vice versa) to allow the sleeve to be selectively disengaged from the visualization stylet assembly to expose the electronic photodetector chip.
In some embodiments, the proximal housing may define a distally extending boss for sealingly receiving by the distal outer assembly. The distally extending boss may be surrounded by a fluid tight seal to interface with an inwardly facing surface of the distal outer assembly. The distal outer assembly may also include a guide tube, e.g., funnel-shaped, that is placed within the passageway of the distal outer body to guide the visualization stylet assembly into the hollow distally extending needle.
In some embodiments, the visualization stylet assembly may further include a heat sink at least partially disposed within the proximal housing to dissipate heat generated by the surgical instrument. If desired, the proximal housing can define a proximal cavity in which the visualized elongate body terminates at the proximal end of the elongate body. At least one cable may extend from the proximal end of the elongate body through the proximal cavity, through the heat sink, and then to a connector within the proximal cap of the proximal housing. If desired, the heat sink may include a proximal end, a distal end, and an aperture defined at least partially therethrough. The LED chip may be mounted at least partially within the aperture of the heat sink. The LED chip may include a distally facing LED to direct light into the visualization stylet to provide forward illumination.
Further in accordance with the present disclosure, an embodiment of a blow needle assembly is provided that includes a distal assembly including a hollow distally extending needle having a sharpened distal end, a proximal end, and a needle aperture defined therethrough. A hollow distally extending needle may be coupled to the distal housing at a proximal end thereof. The distal housing may define a proximal opening therein that opens into the cavity. The cavity may be in fluid communication with the pinhole. The insufflation needle assembly may further comprise a proximal assembly comprising a proximal housing, a compression spring disposed in a bore of the proximal housing, and a visualization stylet. For example, the visualization stylet may include (i) an elongate body defining a proximal end and a distal end, (ii) an electron photodetector chip mounted proximate the distal end of the elongate body, the electron photodetector chip having a distally facing surface to detect incident light traveling in a proximal direction, (iii) a light source at least partially integrated into the elongate body to project light out of the electron photodetector chip in a distal direction to provide direct illumination to guide the passage of the inflation needle assembly, and (iv) a boss in contact with the distal end of the compression spring to urge the visualization stylet in the distal direction; the proximal assembly may be configured to be received by the distal assembly, and the proximal assembly may be configured to be removably coupled to the distal assembly. The visualization stylet may be biased to extend beyond the distal end of the hollow distally extending needle.
In some embodiments, the proximal housing may form a handle of the device. The handle may be defined by a distal handle segment received by the distal housing. The distal handle segment may include a peripheral seal to interface with an inwardly facing surface of the distal housing. The handle may further comprise a proximal handle segment sealingly received by the distal handle segment, wherein the proximal and distal handle segments cooperate to define a spring bore to receive a compression spring. The boss of the visualization stylet may be placed in the spring bore at a location distal with respect to the compression spring. The compression spring encloses a length of the elongate body of the visualization stylet disposed adjacent to the boss. If desired, the spring may be removed from the handle by separating the proximal handle segment from the distal handle segment and withdrawing the elongate member from the distal handle segment while coupling the elongate body to the proximal handle segment.
In some embodiments, the proximal handle segment may define a proximally facing aperture. The elongate body of the visualization stylet may terminate at its proximal end in a proximally facing bore, and be attached to a cannula sealingly received in the proximally facing bore of the proximal handle segment.
In some embodiments, the proximal handle segment may be coupled to a stress relief assembly at a proximal end thereof. The stress relief assembly may define an area of varying stiffness. The strain relief assembly may terminate proximally in a plurality of connectors. The connector may be coupled to a conductor passing through the elongate body of the visualization stylet. In some embodiments, the conductors may pass distally from the connector, through the stress relief assembly, through the proximal cavity of the proximal handle segment, and then into the elongate body of the visualization stylet. If desired, the stress relief may include a distally extending boss that is received within the proximal end of the proximally facing aperture of the proximal handle segment. In some embodiments, the distal assembly may be coupled to the proximal assembly in at least two discrete axially distinct positions.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the embodiments disclosed. The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to illustrate and provide a further understanding of the disclosed methods and systems. The drawings together with the description serve to explain the principles of the disclosure.
Drawings
Other objects, advantages and applications of the present disclosure will become apparent from the detailed description that follows. The specification makes reference to the accompanying drawings wherein:
fig. 1A-1B present various views according to a first embodiment of the present disclosure.
Fig. 2A-2C present various views according to a second embodiment of the present disclosure.
Fig. 3-10 present various embodiments of a visualization stylet distal tip and lens configuration according to the present disclosure.
Fig. 11A-11B present various views of another embodiment of a visualization stylet distal tip and lens configuration according to the present disclosure.
Fig. 12A-12B present a cross-sectional view and a side view, respectively, of another embodiment of a visualization stylet distal tip and lens configuration according to the present disclosure.
Fig. 13A-13B present cross-sectional and end views, respectively, of another embodiment of a device configured to facilitate cleaning of a distal tip of a visualization stylet in accordance with the present disclosure.
Fig. 14A-14C present views of steps of a method according to the present disclosure.
Fig. 15A-15C present views of steps of yet another method according to the present disclosure.
Fig. 16A-16C present views of steps of yet another method according to the present disclosure.
Fig. 17A is an isometric view of an optical trocar assembly according to the present disclosure.
Fig. 17B is a close-up view of a portion of the device depicted in fig. 17A.
Fig. 17C-17E are views of a removable sheath of the device of fig. 17A.
Fig. 18A is a view of the device of fig. 17A prior to separating the components to remove the sheath from the device.
Fig. 18B is a view of the device of fig. 17A after rotating the handle portion of the device relative to the cannula portion of the device.
Fig. 18C is a view of the device of fig. 17A after withdrawal of the handle portion assembly and the sheath attached thereto from the cannula portion of the device.
Fig. 18D-18G illustrate a series of steps of rotating the sheath relative to the handle portion of the device, and removing the sheath portion from the handle portion (fig. 18G).
Fig. 18H is a view showing the relative placement of the cannula, sheath and handle after the sheath has been removed.
Fig. 18I-19K illustrate reinsertion of the handle with the optical axis into the cannula after the sheath has been removed.
Fig. 18L is an isometric view of a handle of a device having an optical probe, fig. 18M shows a close-up view of the distal end of the optical probe, and fig. 18N shows a close-up view of the distal end portion of the handle.
Figures 19A-19B illustrate full and partial isometric views of a spring-loaded insufflation needle assembly according to the present disclosure.
Fig. 19C and 19D show cross-sectional views of the device of fig. 19A rotated 90 degrees relative to each other along a central axis of the device.
Fig. 19E-19H are views of an optical probe portion of the device of fig. 19A.
Fig. 20A is a view of another embodiment of a blow pin assembly according to the present disclosure.
Fig. 20B-20E illustrate additional aspects of the embodiment of fig. 20A.
FIGS. 20F-20I illustrate further aspects of the embodiment of FIG. 20A.
Fig. 20J-20L depict schematic diagrams of the embodiment of fig. 20A.
Detailed Description
As shown in fig. 1A-1B, the preferred embodiments of the present disclosure act as a pneumoperitoneum needle to form an incision in a body cavity, act as an insufflator to inject gas into the cavity, and act as a visualization tool to monitor the progress of the pneumoperitoneum needle as it is advanced through tissue while advancing toward the abdominal cavity.
480 ten thousand laparoscopic procedures were performed annually in the united states, and access to the abdomen was the most dangerous step in laparoscopic and robotic procedures, resulting in one patient dying and 8 patient being injured each day in the united states. Wherein, the vascular injury risk is 0.2/1000, the intestinal injury risk is 0.4/1000, and the death rate is 13%. There were 2,880 entry-related injuries per year, 374 deaths per year; at least one person dies each day. Each of these injuries will cost hundreds of thousands of dollars, sometimes even millions of dollars to address. The disclosed embodiments substantially eliminate blind laparoscopic access, preventing serious patient injury and death.
For purposes of illustration and not limitation, as embodied herein and as shown in fig. 1, the instrument 100 is provided in the form of a pneumoperitoneum needle. The instrument 100 includes a handle 110 having a proximal end 112, a distal end 114, and a hollow elongate channel 116 therethrough, which in turn is connected to a hollow distally extending needle 120 having a sharp distal end 124 for penetrating tissue and defining a hollow elongate channel 126 therethrough. The passages 116, 126 of the handle 110 and needle 120 cooperate to form a conduit for at least one of a fluid or an instrument therethrough.
The instrument 100 further includes a visualization stylet 140, which in turn includes a proximal end 142 and a blunt distal end 144. Visualization stylet 140 is slidably disposed within the catheters (116, 126) of handle 110 and needle 120. As shown, the distal region of the visualization stylet 140 includes an electron photodetector chip 146 mounted thereon (or therein) having a distally facing surface 146a that includes an array of light sensors configured to detect incident light traveling in a proximal direction (i.e., toward the distal end of the instrument 100). The instrument 100 further includes a light source 150, such as an LED disposed in the handle 110, configured to project light in a distal direction out of the electronic photodetector chip 146 to provide direct illumination of the area traversed by the instrument 100. In operation, light from the light source 150 passes through the body of the visualization stylet (which may be made of light transmissive plastic, for example) and illuminates tissue immediately distal of the visualization stylet 140. The light is reflected back to the electronic photodetector chip 146. According to further embodiments, one or more fiber optic light transmitting fibers may be used to transmit light from a light source internal or external to the handle 110 through the device to the distal end of the device. Light may be transmitted along visualization stylet and/or needle 120 and handle 110 using optical fibers.
The instrument 100 further includes a spring 160 encased within the handle 100 for biasing the visualization stylet 140 (via the boss) 147 to extend past the sharpened distal end 124 of the needle 120 without tissue resistance to the visualization stylet. Thus, in use, as the instrument is pushed against tissue, the visualization stylet is pushed against the tissue with the needle distal end 124. However, once the instrument passes through the abdominal wall and then into the abdominal cavity, visualization stylet 140 is urged forward by spring 160 beyond needle distal end 124, thereby preventing needle 120 from cutting through any additional tissue in the abdominal cavity, including, for example, the intestines, blood vessels, and the like.
If desired, visualization stylet 140 can include a lens element 148 disposed over the electronic photodetector chip 146 on its distal tip. Preferably, the lens element may comprise solid or hollow plastic, glass or other suitable material that may be attached to the electronic photodetector chip. In some embodiments, the electron photodetector chip 146 may be integrally molded into the transparent plastic body of the visualization stylet 140, wherein a lens is molded over the electron photodetector chip, and further wherein the conductor 148 distal from the electron photodetector chip may be directed, for example, along the central axis of the visualization stylet (or the entire device) or embedded in the material of the visualization stylet (by overmolding), or by directing it through a hollow channel (not shown) along the central axis of the visualization stylet 140. If desired, the molding process may result in the transparent plastic material directly contacting the surface of the electron photodetector chip.
Thus, the visualization stylet may be formed of a light transmissive (e.g., transparent or translucent) material such as PET or acrylic, or may be made of other materials, wherein one or more optical fibers pass through the length of the visualization stylet to transmit light from the light source. As shown, an annular outer region 144a of the distal end 144 of the visualization stylet 140 adjacent to the electron photodetector chip 146 may be provided, with the electron photodetector chip being intermediate the distal end 144 to allow light to be conducted along the visualization stylet, through the electron photodetector chip 146, and through the lens 148.
As further shown, the handle 110 may be provided with a gas introduction port 118 for receiving insufflation gas from a gas source 170. Additionally, if desired, an irrigation port 119 may be provided that may direct liquid in the annular space defined between the handle 110/needle 120 and the visualization stylet 140 to clean the distal end of the visualization stylet. Additionally or alternatively, the irrigation ports may be provided in a parallel lumen configuration, indicated by 119 a. In some embodiments, visualization stylet 140 is configured to be withdrawn proximally along channels 126, 116 to establish a flow path for the insufflation gas. For example, the visualization stylet need only be withdrawn near the gas introduction port to provide an unobstructed path for introducing insufflation gas into the abdominal cavity of the subject.
As described above, the conductors 148 may be provided for guiding signals received from the electronic photodetector chip to a second location, such as the processor 180. The processor may thus be coupled to a visualization stylet. The processor may then be in turn connected to a display screen 190 for displaying images captured by the electronic photodetector chip 146. For example, the display device 190 may be a large LCD screen that is part of a separate computer system, or it may be provided as a small local screen attached to the processor and a battery 192 attached in a module at the proximal end 102 of the instrument. If desired, an adapter (not shown) may be provided to connect the instrument 100 to a laparoscopic camera, light source and monitor available in the operating room.
The present disclosure also provides a method of using the apparatus described herein to more safely complete an insufflation procedure in preparation for a laparoscopic surgical procedure in the abdomen. The method includes puncturing a surface of the skin of the subject with a sharp distal end of a hollow needle (e.g., 124) of an instrument (e.g., 100). The method further includes advancing a distal end of a hollow needle (e.g., 124) through successive layers of the subject's abdominal wall while viewing the tissue being pushed through in real-time via a visualization stylet. The procedure may further comprise stopping the advancement when the distal end of the hollow needle reaches the abdominal cavity. When the visualization stylet is ejected distally past the distal end 124 of the needle 120 under the force of the spring 160, the user may notice that the abdominal cavity has been reached. At this point, visualization stylet 140 may be retracted proximally, such as under manual action, and the method may further include initiating insufflation through the hollow needle.
A second embodiment of a visual blowing needle assembly 200 is presented in fig. 2A-2C, further in accordance with the present disclosure. Referring to fig. 2A, the assembly includes an outer sheath 220 having an angled, sharp distal tip for penetrating tissue, including a spring-loaded visualization stylet, similar to the visualization stylet of fig. 1A-1B. The outer sheath may be made of, for example, stainless steel tubing and has a length L1, for example, between about 2 inches and about 6 inches in increments of about one eighth of an inch. The visualization stylet may have a similar length L2. The diameter or width W2 of the visualization stylet may be, for example, between about 0.050 to about 0.1 inches in increments of 0.01 inches. The sheath may have a diameter or width W1 of between about 0.06 to 0.12 inches in increments of 0.01 inches. The distal tube 220 is attached at a proximal end to a cannula body 230 having a removable cannula cover 232. A spring biasing mechanism, functionally similar to the spring biasing mechanism shown in fig. 1A, is contained within cannula body 230, which is operably attached to the visualization stylet to bias it out of the tip of outer tube 220. Cannula 230 may have a length L3 in increments of one-sixteenth of an inch, for example, between about 1.5 and 2.0 inches, and a width or diameter W3 in increments of about 0.05 inches, for example, between about 0.4 and 0.8 inches. The proximal end of the cap 232 is adjacent to a female luer lock connector 234 having a Y connector 242 and a proximal male luer lock connector 240. The connector 240 is received by an electronic connector 250 having a proximal plug 252 that is in turn connected to a light source 266 to direct light to a visualization stylet to provide illumination, and to a camera output connector 264 to direct digital image data to a processor and/or screen. If desired, connector 264 may include dedicated circuitry specifically configured to convert data received from the photodetectors in the visualization stylet into video output signals. A jacket 262 is provided for protecting the video output cable. Body 250 may have any suitable length L, for example, between about 0.75 inches and 2.0 inches in 0.1 inch increments, and a diameter or width W4, between about 0.4 inches and 0.8 inches in about 0.05 inch increments. The length L5 may be any increment between, for example, 8 inches and 24 inches or about a quarter inch therebetween.
Fig. 2B and 2C present end and cross-sectional views of the distal region of the visualization stylet. Fig. 2B shows a view with the distal end of lens 248 removed, thereby showing photodetector array 246 and surrounding structures. The light is transmitted distally by an illumination beam 249 surrounding the photodetector array 246. The illumination beam is in turn surrounded by a polymer illumination sheath 243, which is made of a suitable polymer such as polyimide, for example. A lateral opening 247 is provided to allow insufflation gas to pass down the hollow bore of the visualization stylet to pass through the outer wall of the visualization stylet to insufflate the peritoneum. Conductors (not shown) are connected to the array 246 to conduct data indicative of light received by the array proximally and out of the device 200. The sheath 243 is in turn surrounded by a (preferably metallic) tubular member 245, which is attached at its proximal end to a spring, which is also attached to the cannula body 250.
Visualization of the stylet, and in particular the distal region of the visualization stylet, can be manufactured in a variety of ways and with a variety of features. Fig. 3-11A illustrate cross-sectional views of different embodiments of the portion of the device (e.g., 100, 200), which include like reference numerals for like structures.
Fig. 3 shows such an end region with a distal lens cover 348 that is substantially conical with a curved tip that can be used for blunt dissection. The cover is defined by a solid or hollow end region, which may be, for example, a conical section, that transitions into a recessed portion 345 that slidably receives (and is adhered or otherwise attached to) a body portion of, for example, a visualization stylet, which in turn includes a photodetector array 346 (shown in simplified form). Illumination beams and other structures similar to the embodiments of fig. 2B-2C may also be provided. One or more central channels 347 may also be provided to accommodate channels for data conductors, or for liquid or gaseous flushing fluid to flush the tip of the lens 348, as desired. Fig. 4 illustrates a distal region that optionally includes a sharp conical or pyramidal (e.g., 3, 4, 5, or 6 sided) shaped lens 448.
Fig. 5 is similar to the embodiment of fig. 3 and 4, but includes a dome lens 548 and photodetector 546, etc. Additionally, the embodiment of fig. 5 includes a first embodiment of a lens irrigation mechanism that includes a tubular body 547 that is guided through the body of the visualization stylet, the tubular body including a plurality of irrigation holes. The body 547 may be formed of a hypotube, for example, having a sealed distal tip and one or more laterally formed holes therethrough to direct a jet of fluid through the lens, wherein the fluid may include, for example, a saline solution, another liquid, and/or a gaseous substance, such as carbon dioxide insufflation gas. The tube 547 is preferably slidably movable relative to the visualization stylet and controllably deployable by distally advancing it relative to the visualization stylet distal tip. In one embodiment, the tube 547 is made of a shape memory material (e.g., a Ni Ti alloy) where it is heat set to bend around the tip to direct cleaning liquid and/or gas at the tip in a direction that is partially transverse and partially axially proximal. The tube 547 may still be retracted proximally into the straight guide channel. If desired, more than one such tube 547 (Ni Ti or other material) may be provided at different locations to achieve effective cleaning. In a further embodiment of the apparatus and method (not shown), a mechanical wiper seal or wiper pad is disposed inside the cannula or sheath for wiping the distal tip of the visualization stylet.
Fig. 6 shows an embodiment similar to fig. 5, in which a cavity 652 is provided between the distal tip of the photodetector array and the distal lens 648. If desired, irrigation channels 654 may be provided for directing liquid and/or gas into cavity 652 to enhance optical performance. In this case, a small vent hole may be provided. Further, one or more circumferentially positioned irrigation channels 650 may be provided through the lens 648, if desired. If desired, in some embodiments, such flushing channels may be distributed over the surface of the tip to help keep it clean. Preferably, the index of refraction of the rinsing fluid (e.g., liquid) is matched to the index of refraction of the material of the tip to minimize image distortion. Furthermore, if desired, the tip of the central region of the lens may be positioned nearest the periphery of the lens. As shown, this allows the irrigation channel to direct irrigation fluid (liquid and/or gas) onto the surface of the central portion of the lens 648. Furthermore, it should be appreciated that the flushing channel need not be oriented radially inwardly, or at least need not be oriented significantly, in order to obtain a cleaning benefit. In particular, applicants believe that a proper configuration of the cleaning channel and a proper flow rate of liquid (e.g., saline solution) and/or gas (e.g., carbon dioxide) will result in a cleaning fluid flow against the surface of the lens, even when the lens is bent toward the distal tip. This is known in the fluid mechanics as the "coanda effect". Specifically, the coanda effect is a phenomenon that: the jet will attach itself to the nearby surface and remain attached even when the surface is curved away from the original jet direction. Thus, there may be the advantage of cleaning the channels while minimizing their effect on the field of view reduction of the lens and/or image distortion through the lens. Thus, for example, a liquid stream may be ejected through a cleaning channel, followed by a burst of air. Alternatively, only air flow through the channels may be used.
If desired, the distal tip may be formed by fitting a separate lens 650 into the circumferential region. This may be accomplished, for example, by attaching lens center 650 to the light transmission beam of photodetector 646 or its surroundings, by extending the proximal face of the lens center region so that it abuts the photodetector and/or the surrounding region. In this case, the annular outer portion of the lens may be provided in the form of a separate tubular member that slides over the central region of the lens. If desired, in this case, the lens center 650 and/or the peripheral region may be provided with feet, preferably placed circumferentially (preferably three, but other numbers may be used) to separate and align the inner center portion of the lens with the annular outer portion, and to also define the flow path of the irrigation channel.
Fig. 7 shows another embodiment in which a lens 748 is slidably mounted on the visualization stylet to allow adjustment of the axial distance between the lens and the photodetector 748 to accommodate the focal length of the lens. This may be achieved by an adjustable interference fit or by a push-pull actuation device as discussed below with respect to fig. 12A-12B. Fig. 8 shows an alternative focus adjustment device that utilizes a threaded connection between the lens 848 and the body of the visualization stylet to adjust the axial distance between the lens and the photodetector 846. Fig. 9 shows a ray diagram illustrating a lens 948 in the form of a plano-convex lens configured to focus incident light radially inward on a photodetector 946. Fig. 10 shows a similar arrangement of convex lenses. The curvature (or lack thereof) of the lens may be selected to accommodate narrower or wider fields of view.
Fig. 11A and 11B illustrate a more complex lens arrangement in which light transmitted for illumination purposes passes through one or more lenses separate from the lenses used to collect incident light onto photodetector 1146. In particular, the lens may be a molded lens assembly having, for example, a central portion 1148, which is a convex lens (or other lens) for collecting and focusing light on the photodetector 1146, and one or more (e.g., 2, 3, 4, 5, 6) circumferentially arranged smaller lenses 1149 for distributing light from the light beam outward. Preferably, the optics are arranged to minimize internal reflection in the lens and reduce mixing of the outgoing light and the incoming light. If desired, the light source may include a micro-LED 1143 mounted under suitable optics or lenses 1147 with matching optics to transmit light out of the auxiliary lens 1149. If desired, the electronic photodetector chip and micro-LEDs may be formed on the same chip or circuit board and the optics molded thereon to simplify manufacture.
Fig. 12A-12B illustrate an embodiment of a visualization stylet having a push-pull actuator for adjusting the axial distance between the lens and the photodetector. For example, a first portion of the actuator 1210 is connected to the distal lens and a second portion 1220 is attached to a central portion of the visualization stylet. The axial length may be achieved, for example, by a simple push-pull arrangement. Alternatively, if greater precision is desired, an actuator using threads may be used for finer adjustment. A vent 1202 may be provided to allow liquid or other fluid to flow into or out of the cavity space between the lens and the photodetector. It should be understood that such vents may be provided in any of the embodiments herein.
Fig. 13A-13B illustrate another embodiment of a visualization pneumoperitoneum needle incorporating an irrigation path or catheter into the sheath of the needle surrounding the visualization stylet. As shown, preferably 3, 4 or 6 longitudinal channels 1362 (such as hypotubes) are provided attached to the inner surface of the sheath (e.g., 220). These tubes 1362 serve to uniformly space the visualization stylet from the outer sheath and cooperate with the outer tube and the visualization stylet to define a longitudinal channel 1368 for the passage of insufflation gas or to merely reduce friction. As shown, the distal tip of tube 1362 may be sealed and laser drilling transverse to the visualization stylet may be formed such that cleaning fluid directed through tube 1362 will be directed transversely through the distal tip of the visualization stylet to clean lens 1348. The visualization stylet may be moved proximally and distally relative to the outer sheath when cleaning to facilitate cleaning during the cleaning process.
Fig. 14A-14C illustrate embodiments of a visualization pneumoperitoneum needle that can be disassembled to facilitate different procedures. For example, fig. 14A illustrates a distal portion of a pneumoperitoneum needle, such as the pneumoperitoneum needle illustrated in fig. 2A-2C, having a visualization stylet 1406 connected to an outer sheath 1402, wherein the sheath 1402 is removably connected to a cannula 1404 that provides insufflation gas. After insufflation, portion 1404 may be removed from portion 1402 (e.g., by threaded connection 1409), and a new proximal portion 1408 may be attached to threads 1409 to use the assembly as a laparoscope. If desired, visualization stylet 1406 can be removed from the components of 1402 and 1404 (e.g., by removing the threaded connection). A seal (not shown) may be provided inside the part 1402 or 1404 to prevent loss of insufflation gas.
Fig. 15A-15C illustrate systems and methods for separating a visualization stylet 1506 from an outer catheter 1504, such as by breaking a threaded connection. After the assembly is inserted into the peritoneum under visualization, the visualization stylet can be removed, if desired, leaving the outer sheath in place as a cannula. Alternatively, the outer sheath may be removed, allowing the extension 1508 to attach to the visualization stylet 1506, effectively using the visualization stylet 1506 as a laparoscope. If the visualization stylet is removed, a seal (not shown) may be provided within the body of the cannula 1504 to prevent excessive loss of insufflation gas and maintain pressure in the peritoneum. For example, the visualization stylet may be removed to remove the lens cover (e.g., 148 and below, etc.), allowing the visualization stylet to be reintroduced without the lens cover. In another embodiment of the method, the lens is hinged to the end of the visualization stylet and can be swung open by actuating an actuator.
Fig. 16A-16C illustrate another system and method for separating a visualization stylet from a sheath catheter for insufflating the peritoneum. The outer sleeve catheter includes an insufflation port to receive an insufflation gas input. After insertion of the assembly into the peritoneum under direct visualization in fig. 16A, the peritoneum can be insufflated and then the visualization stylet can be removed as shown in fig. 16B. As discussed elsewhere herein, the inner stylet may include a CMOS chip at its distal end, which may be covered by a removable distal cap or cover. The removable distal cap or cover may have a sharp tip or blunt anatomical tip of any desired shape (e.g., conical, pyramidal, etc.), as well as any additional features desired (e.g., ridges or wings or tabs extending outwardly from the removable tip). The tip can thus be removed and the inner stylet can be replaced into the outer catheter to perform illumination and/or visualization functions. Removal of the tip may be helpful because the tip may become unclear during the initial insertion process. If desired, a different tip may be added to re-cover the CMOS chip, or the CMOS chip may have a lens covered by a removable distal tip. The sheath catheter can continue to introduce carbon dioxide into the peritoneum.
17A-18N illustrate another embodiment of a visualization trocar assembly according to the present disclosure.
Fig. 17A is an isometric view of an optical trocar assembly 1700 according to the present disclosure. Fig. 17B is a close-up view of the distal portion of device 1700. As shown, the device 1700 includes a proximal handle portion 1750 that can be removably coupled to the distal cannula 1710. Distal cannula 1710 includes a proximal handle portion coupled to distal shaft 1712. Shaft 1712 is hollow, has a distal end portion 1714, and is configured to receive an elongate removable sheath 1720 therein. An annular gap may be defined between an inner surface of a lumen defined through shaft 1712 and an outer surface of sheath 1720. An irrigation assembly 1760 is provided that includes an input port, a valve, and an output port that directs a liquid or other beneficial agent to a cavity defined between the cannula 1710 and the handle 1750, resulting in fluid being directed between the shaft 1712 and the sheath 1720, or between the shaft 1712 and the optical probe 1780, when the sheath 1720 is removed, as described below. As shown, sheath 1720 of embodiment 1700 may terminate in an dissection tip 1724, which may include one or more ridges or wings that may help directly dissect the tissue against which it is pressed. If desired, the tip 1724 may be sharpened to the extent necessary to assist in its passage through tissue. As will be appreciated, the shaft 1712 has an outer nominal diameter of about 2mm in the illustrated embodiment, although the shaft may be any desired diameter.
Fig. 17C-17E are views of a removable sheath of the device of fig. 17A. As shown, sheath 1720 includes an elongate tubular member 1725, which is made of, for example, a metallic material, as is shaft 1712. Sheath 1720 includes a female luer lock or other coupling 1722 at its proximal end and includes a distal tip 1724 coupled to its distal end. In fig. 17E, an alternative embodiment of a tip is shown having a pair of opposing wings 1726. The tip is at least partially transparent and, if desired, may include one or more covered portions to make portions of the tip opaque, such as by screen printing, to remove optical artifacts created, for example, by wings 1726 or other geometric features.
Fig. 18A-18K illustrate a process of removing sheath 1720 from device 1700. In use, applicants have increasingly recognized that optical trocars can become easily dirty or shielded during the initial process of guiding the device into the body.
Fig. 18A is a view of device 1700 prior to separating the components to remove sheath 1720 from the device. This may be done after the device 1700 has been inserted into, for example, the peritoneum of a patient. During insertion, the optical tip 1724 may be expected to become unclear. Thus, the proximal portion of the device can be removed, the sheath can be removed from the proximal portion of the device, the optical component or stylet 1780 exposed, and the stylet can then be reinserted into the cannula so that what happens within the patient can be clearly seen.
Fig. 18B is a view of the device 1700 after rotating the handle portion 1750 of the device counter-clockwise relative to the cannula portion of the device to release the "J" connector connecting the two components. When the "J" connector is disengaged, the handle carrying sheath 1720 may be withdrawn in a proximal direction as shown in fig. 18C, and cannula 1710 may be left in place within the patient. As the proximal portion of assembly 1750 is withdrawn, protective sheath 1720 may now be removed from optic/scope/stylet 1780. 18D-18G, a series of steps is illustrated, including rotating sheath proximal connector 1722 relative to the handle portion of device 1750 to disengage the luer lock of the sheath from the connector at the distal end of handle portion 1750. The sheath in this embodiment is comprised of a luer connector at the proximal end and an elongate shaft 1725 terminating in an optically clear distal tip. Once the sheath 1720 is removed, the CMOS sensor at the distal end of the stylet 1780 is exposed, as shown in FIG. 18G. Fig. 18H is a view showing the relative placement of the cannula, sheath and handle after the sheath has been removed.
Fig. 18I-19K illustrate reinsertion of the handle with the optical axis into the cannula after the sheath has been removed. It can be seen that stylet 1780 is reinserted into cannula 1710, and the "J" connector is reconnected. At this point, the entire assembly can be manipulated to view different tissue structures.
Fig. 18L is an isometric view of the handle of the device 1750 with an optical probe or stylet 1780, fig. 18M shows a close-up view of the distal end 1784 of the optical probe, and fig. 18N shows a close-up view of the distal portion of the handle 1750. As shown, stylet 1780 may include a CMOS chip placed in the lumen of a tubular member (e.g., hypotube) made of, for example, stainless steel tubing. The proximal end of the stylet 1780 is coupled to the handle portion 1750 of the device and, correspondingly, to conductors that transmit image signals to a processor (not shown). A close-up view of the distal portion of handle portion 1750 in fig. 18N shows the reduced diameter portion received by the hole in cannula 1710. The reduced diameter portion includes a seal, such as an O-ring 1753, to fluidly seal the cannula 1710 to the handle portion 1750 when the cannula 1710 is connected to the handle portion 1750. Pins 1752 are provided on both sides of the reduced diameter portion to engage the "J" connector. The insert 1751 may be seated in the housing of a handle 1750 that includes, for example, a female luer lock connector.
If the exposed distal end of the stylet 1780 is blocked by tissue debris or the like in use, the stylet can be partially withdrawn into the lumen of the tube 1712 of the cannula 1710, and the irrigation assembly 1760 can be activated to direct pressurized liquid (such as saline) down the bore of the cannula. Withdrawing the stylet into the cannula 1710 forces it to be submerged into the pressurized liquid flow, which has been found to be an effective technique for cleaning CMOS chips at the distal end 1784 of the stylet 1780. Once cleaned, the stylet may be reinserted into the hole to further view the target site.
Figures 19A-19B illustrate full and partial isometric views of a spring-loaded insufflation needle assembly according to the present disclosure. This embodiment is similar to embodiment 1700, but adds the feature of a spring loaded stylet 1980 and a sheath 1920 residing in a sharpened cannula 1910 (fig. 19B), wherein the sharpened tip of the cannula 1910 cuts tissue and after the sharpened distal tip of the cannula 1910 has passed through the tissue and into the peritoneum, the sheath 1920 containing the optical components is pushed back into the handle 1950 against the spring force pushing the sheath and stylet 1980 forward.
Fig. 19C and 19D show cross-sectional views of the device of fig. 19A rotated 90 degrees relative to each other along a central axis of the device. As can be seen, cannula 1910 is connected to the housing by a "J" connector. As will be appreciated by those skilled in the art, the luer connector insert 1951 is slidably received within a bore defined in the distal end of the housing and attached to a stylet 1980. The luer connector allows the stylet 1980 to pass through it and the housing into a proximal cavity defined in the housing, which in turn includes a plug or connector 1956 attached to the stylet 1980. Proximal to the connector 1956 there is a compression spring 1990 that pushes onto the connector 1956, which pushes the stylet 1980, and thus the sheath 1920 and the insert 1951, distally relative to the cannula shaft 1912 and out the distal end of the cannula shaft to protect tissue once the cannula breaks through the abdominal (or other lumen). For example, as is apparent from fig. 19C, stylet 1980 moves back and forth within the housing while being attached to connector 1956 and insert 1951 to limit proximal and distal movement of those components relative to housing 1950. A heat sink 1992 is placed in the proximal cavity of the handle or housing 1950, with the distal end of the heat sink contacting the spring 1990 and the proximal end of the heat sink contacting the washer or spacer 1957. The annular gasket 1957 is delimited at its distal face by a heat sink 1992 and at its proximal face by a cover 1996. The proximal cavity of the handle is similarly sealed by an O-ring placed between the cap 1996 and the housing 1950. A connector 1998 is provided for connection to a power source and computer processor. Wires 1993 extend from the connector to LEDs encased in a heat sink 1992, where the LEDs radiate light along fiber optic wires or other light transmissive material inside the tube of a stylet 1980 that is illuminated distally around the periphery of the CMOS chip. As can be seen, the cannula 1910 includes an inner body 1913 that is located within the bore of the cannula. The inner body acts as a guide tube, which is shown as funnel-shaped and defines a peripheral circumferential flange that abuts a peripheral circumferential shoulder defined in the cavity of the outer body 1917. The inner body 1913 and the outer body 1911 cooperate to define an axial bore therethrough to retain a proximal end or region of the shaft 1912. A shaft may be attached to each of the inner body 1913 and the outer body 1917. The inner body 1913, outer body 1917, and shaft 1912 cooperate to define an annular cavity 1909 to receive irrigation fluid through an irrigation port. Suitably, the proximal end of the shaft 1912 defines at least one fluid conduit 1911 therethrough to allow pressurized liquid from the syringe to be directed, for example, through the valve and flush system, into the chamber 1909, through the opening 1911, and then down an annular lumen defined between the inner surface of the tubular shaft 1912 and the outer surface of the stylet 1980 or the outer surface of the sheath 1920.
Fig. 19E-19H are views of an optical probe portion or stylet 1980 of the device of fig. 19A. It can be seen that the stylet includes an elongate body which terminates distally by a CMOS chip. The electrical conductor passes up through the tubular body of the stylet 1980 to the heat sink 1992, wherein as can be seen in the cross section in fig. 19H, the LED chip 1987 is mounted in a proximal hole of the heat sink 1992, which is coupled to an electrical conductor connected to an external connector 1998, which transfers power to the LED and carries out signals through the data cable. The LED elements are centered about the axis of the device and direct the optical axis distally to the ends of one or more fiber optic elements that pass through the bore of the stylet 1980 and terminate near the CMOS chip to provide direct illumination of the working area.
Fig. 20A is a view of another embodiment of a blow pin assembly 2000 according to the present disclosure. As shown, the assembly includes a removable cannula 2010 including a distally extending tubular shaft 2012 through which a visualization stylet 2080 (fig. 20B) is passed to a distal end 2014 thereof. An irrigation port 2062 coupled to the valve 2064 is provided and may be used to irrigate the distal tips of the device 2000 and stylet 2080, as in the embodiments 1700, 1900. The insufflation gas may be provided through port 2062 or other ports as desired. The proximal handle segment 2050 is removably coupled to the cannula proximal portion and includes a stress relief to provide a gradual change in stiffness to the electrical conductor 2077.
Fig. 20B-20E illustrate additional aspects of the embodiment of fig. 20A, wherein the cannula 2010 is removed from the proximal portion of the device 2000. The cannula can be removed from the proximal portion 2050 in the same manner as the previous embodiments using a "J" type coupling, but it should be appreciated that other types of connections can be used, such as various types of interference fits, keyed connections, and the like. The distal end 2084 of the stylet 2080 includes a rounded end 2085, and a tube attached to the stylet 2080, for example, but bonded at location 2087. The device 2000 may be configured as a small visualization trocar as in embodiment 1700, where the distal end of the cannula 2010 is not sharp and the tip 2085 includes an anatomical tip that may be cleaned after insertion by drawing it proximally back into the cannula and a clean fluid is flushed over it via valve 2064.
20F-20I illustrate further aspects of the embodiment of FIG. 20A. Fig. 20F presents a central cross-section along the central axis of the device 2000, fig. 20G presents an enlarged portion of the cross-section, fig. 20I presents a close-up view of the distal portion of the housing of the device, and fig. 20H presents a rear isometric view of the device 2000 with the cannula 2010 removed. The compression spring 2090 surrounds the stylet 2080 and is encased in a central axial bore defined in the distal handle segment 2053 and the proximal handle segment 2057. A boss 2092, shown in the form of a tube surrounding stylet 2080, is adhered to stylet 2080, and compression spring 2090 urges the boss distally by pushing the boss away from proximal housing section 2057. This results in the stylet and its rounded distal end protruding from the sharp distal end of the cannula 2010. The stylet 2080 is coupled at its proximal end to a cannula 2094, which can include an LED element disposed therein that slides within a corresponding central axial bore defined along a proximal portion of the proximal housing section 2057. A seal, such as an O-ring seal, surrounds the distal housing portion 2053 to form a fluid tight seal with an internal cylindrical bore formed in the proximal portion of the cannula 2010. A conductor passing through the length of stylet 2080 extends through the proximal end of cannula 2094 and proximally through stress relief 2058 for coupling to a processor and/or electrical power source.
FIGS. 20J-20L depict schematic diagrams of aspects of the embodiment of FIG. 20A. Fig. 20J shows a schematic side view of the cannula assembly 2000, and fig. 20K shows a side view of the visualization stylet from its proximal connector to its distal end and the associated cannula attached to the proximal end of the stylet shaft and the distal end of the conductor wire.
Thus, embodiments are disclosed that can be used as a miniature visualization trocar, or as a pneumoperitoneum needle with visualization. Nominally, an optical trocar or needle may have an outer diameter of 2.2mm, for example, a removable outer sheath catheter, and a refastenable connector, such as a "J" connector. The device may include a snap fit or interference fit and a removable visualization stylet to implement the techniques set forth herein. The embodiments 1700, 1900, 2000 may utilize a "J" connector or other connector having two axial positions of the cannula relative to the inner stylet or sheath, as shown, to allow the stylet to be withdrawn slightly to perform flushing and cleaning operations by injecting fluid through the fluid port and along the axis of the cannula and around the distal tip of the visualization stylet or sheath. By making a "click" after the peritoneum has been breached, an audible and/or tactile indication of entry can be provided to the insufflation needle so that the surgeon knows to stop pushing the device.
According to another embodiment, the pneumoperitoneum needle is inserted under direct visualization as described above. The outer sheath catheter is removed by first disconnecting the inner stylet from the electrical connector so that the outer sheath catheter can slide upward thereon. This leaves the inner cannula in place. A second larger cannula (e.g., having a 5mm or 10mm diameter channel, and optionally having an insufflation port) is then slid over the internal visualization stylet to expand the tissue radially outward. The visualization stylet may be left in place or removed so that further instrumentation may be introduced through the newly placed cannula. For example, a larger range with a larger light source and photodetector array may be inserted to provide improved imaging. Advantageously, this allows access to the peritoneum under direct visualization using a small instrument, and allows insertion of a much larger trocar without the need for an obturator. This may be very important because there are many recorded instances in which the surgeon has first tried to insert the obturator with a larger trocar, resulting in damage to internal structures such as the intestinal tract, or in severe cases, the abdominal aorta, resulting in death of the patient. As will be appreciated, the trocar used and sliding over the inner stylet preferably includes external ribs to prevent unwanted axial trocar movement during surgery.
While it is contemplated that the devices disclosed herein are generally configured to access the peritoneum, it should be understood that the disclosed embodiments can be used to access any desired portion of the anatomy, such as the abdominal cavity, bone pelvis, chest cavity, sinus tract, etc., as well as to connect to a robotic arm to allow the disclosed embodiments to be used in robotic surgery. Further in accordance with the present disclosure, PCT/US2019/065723 filed on 12/11 2019, the entire contents of which are incorporated herein by reference, discusses a procedure comprising introducing a needle through the vagina and into the capsular cavity (cul de sac) to define a passageway through which a scope of visualization may pass. This may support diagnostic procedures such as subsequent aspiration of fluid or the taking of tissue samples. A therapeutic procedure may be performed, such as delivering a beneficial agent to tissue in the capsule, or the like. The present disclosure also includes the use of any suitable device as described herein, such as device 1700, to be used in the procedure to access the posterior capsule via the vagina under direct view. The visualization stylet (e.g., 1720, 1780) can then be withdrawn, and the visualization scope of PCT/US2019/065723 can then be inserted into the balloon cavity through cannula 1710, and the bone pelvis examined in this manner. This may be done in conjunction with hysteroscopy, where the uterine cavity is filled with saline solution. In view of hysteroscopic pressure, there will be some fluid flushing through the fallopian tube and into the peritoneal cavity. The fluid may then be aspirated through the viewing device in PCT/US2019/065723, and the aspirated sample may then be sent to a pathology department.
According to further embodiments, the outer sleeve of the insufflation needle disclosed herein may be unsharpened or blunt, and alternatively a relatively sharp tip may be provided on the internal visualization stylet. In this case, a very small spring mechanism may be used, or no spring mechanism may be used, and the tip of the visualization stylet, while sharper, need not be very sharp due to its small diameter. These aspects may be applied to any embodiment of the present disclosure.
It will be appreciated that one or more of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the present disclosure.
Claims (20)
1. A surgical instrument, comprising:
a distal outer assembly comprising a distal housing having a fluid input port and a hollow distally extending needle extending distally therefrom, the hollow distally extending needle having a distal end and a proximal end, wherein the distal outer assembly forms a passageway for at least one of a fluid and an instrument to pass therethrough;
A visualization stylet assembly at least partially disposed within the passageway of the distal outer assembly, the visualization stylet assembly removably coupled to the distal outer assembly, the visualization stylet assembly comprising:
an elongate body having a proximal end and a distal end;
an electron photodetector chip mounted proximate the distal end of the elongated body, the electron photodetector chip having a distally facing surface to detect incident light traveling in a proximal direction;
a light source at least partially integrated into the elongated body to project light in a distal direction out of the electron photodetector chip to provide direct illumination to direct the passage of the blowing needle assembly; and
a sleeve slidably disposed about at least a distal tip region of the removable visualization stylet assembly, the sleeve including a lens element disposed at a distal end thereof to direct light through the lens element toward the electron photodetector chip, wherein at least a portion of the sleeve extends proximally through the hollow distally extending needle and terminates in a proximal handle portion of the sleeve, wherein the handle facilitates relative movement of the sleeve to the elongate body, and further wherein the distal outer assembly and the removable visualization stylet assembly are removably coupleable with the sleeve to allow the outer assembly, removable visualization stylet, and sleeve to be pushed through tissue as a single structural unit.
2. The surgical instrument of claim 1, wherein the visualization stylet assembly is configured to be removed from the distal outer assembly with the sleeve, and further wherein the sleeve is removable from around the removable visualization stylet assembly to expose the electron photodetector chip and to allow the removable visualization stylet assembly to be reintroduced into a catheter of the outer assembly without the sleeve thereon.
3. The surgical instrument of claim 1, wherein the surgical instrument is an insufflation needle, and further wherein the removable visualization stylet assembly comprises a proximal housing portion defining a bore therein, the proximal housing portion comprising a compression spring disposed therein, and further wherein the elongate body of the visualization stylet assembly is biased in a distal direction relative to the proximal housing portion by the compression spring such that the sleeve and elongate body extend beyond the distal side of a hollow distally extending needle.
4. A surgical instrument as recited in claim 1, wherein the visualization stylet assembly further includes a connector body concentrically disposed about a proximal region of the elongate body, the connector body including a distally facing connector to removably couple to the handle portion of the sleeve.
5. A surgical instrument as recited in claim 3, wherein the visualization stylet assembly further includes a connector body concentrically disposed about a proximal region of the elongate body, the connector body including a distally facing connector to be removably coupled to the handle portion of the sleeve, the connector body being at least partially received within a proximal housing of the surgical instrument.
6. A surgical instrument as recited in claim 5, wherein the handle of the sleeve includes a female locking member that is received by a male locking member of the connector body to allow the sleeve to be selectively disengaged from the visualization stylet assembly to expose the electronic photodetector chip.
7. The surgical instrument of claim 6, wherein the proximal housing defines a distally extending boss to be sealingly received by the distal outer assembly, and further wherein the distally extending boss is surrounded by a fluid-tight seal to interface with an inwardly facing surface of the distal outer assembly.
8. The surgical instrument of claim 7, wherein the distal outer assembly further comprises a guide tube disposed within the passageway of the distal outer body to guide the visualization stylet assembly into the hollow distally extending needle.
9. The surgical instrument of claim 8, wherein the visualization stylet assembly further comprises a heat sink at least partially disposed within the proximal housing to dissipate heat generated by the surgical instrument.
10. The surgical instrument of claim 9, wherein the proximal housing defines a proximal cavity in which the visualized elongate body terminates at the proximal end of the elongate body, and further wherein at least one cable extends from the proximal end of the elongate body, through the proximal cavity, through the heat sink, and then to a connector within a proximal cap of the proximal housing.
11. The surgical instrument of claim 9, wherein the heat sink includes a proximal end, a distal end, and an aperture defined at least partially therethrough, and further wherein an LED chip is mounted at least partially within the aperture of the heat sink, the LED chip including a distally facing LED to direct light into a visualization stylet to provide forward illumination.
12. A blowing needle assembly, comprising:
a distal assembly comprising a hollow distally extending needle having a sharpened distal end, a proximal end, and defining a needle aperture therethrough, the hollow distally extending needle coupled at its proximal end to a distal housing defining a proximal opening therein to a cavity in fluid communication with the needle aperture; and
A proximal assembly, comprising:
a proximal housing;
a compression spring disposed in the bore of the proximal housing;
a visualization stylet having (i) an elongate body defining a proximal end and a distal end, (ii) an electron photodetector chip mounted proximate the distal end of the elongate body, the electron photodetector chip having a distally facing surface to detect incident light traveling in a proximal direction, (iii) a light source at least partially integrated into the elongate body to project light out of the electron photodetector chip in a distal direction to provide direct illumination to guide the passage of a blowing needle assembly, and (iv) a boss in contact with a distal end of the compression spring to urge the visualization stylet in a distal direction;
wherein the proximal assembly is configured to be received by the distal assembly and the proximal assembly is configured to be removably coupled to the distal assembly, and the visualization stylet is biased to extend beyond the distal end of the hollow distally extending needle.
13. The inflation needle assembly of claim 12, wherein the proximal housing forms a handle of the device, the handle being defined by a distal handle segment received by the distal housing, the distal handle segment including a peripheral seal to interface with an inwardly facing surface of the distal housing.
14. The inflation needle assembly of claim 13, wherein the handle further comprises a proximal handle segment sealingly received by the distal handle segment, wherein the proximal and distal handle segments cooperate to define a spring aperture to receive the compression spring.
15. The inflation needle assembly of claim 14, wherein the boss of the visualization stylet is disposed in the spring bore at a position relative to the compression spring end, the compression spring surrounding a length of the elongate body of the visualization stylet disposed adjacent to the boss, and further wherein a spring is removable from the handle by separating the proximal handle section from the distal handle section and withdrawing an elongate member from the distal handle section while the elongate body is coupled to the proximal handle section.
16. The blowing needle assembly of claim 15 wherein the proximal handle segment is coupled at a proximal end thereof to a stress relief assembly defining an area of varying stiffness, wherein the stress relief assembly terminates proximally in a plurality of connectors coupled to conductors passing through the elongate body of the visualization stylet.
17. The inflation needle assembly of claim 16, wherein the proximal handle segment defines a proximally facing aperture, and the elongate body of the visualization stylet terminates at a proximal end within the aperture and is attached to a cannula sealingly received within the proximally facing aperture of the proximal handle segment.
18. The inflation needle assembly of claim 17, wherein the conductor passes proximally from the connector, through the stress relief assembly, through a proximal cavity of the proximal handle segment, and then into the elongate body of the visualization stylet.
19. The inflation needle assembly of claim 18, wherein the stress relief comprises a distally extending boss received within a proximal end of the proximally facing aperture of the proximal handle segment.
20. The inflation needle assembly of claim 13, wherein the distal assembly is coupleable to the proximal assembly at least two axially discrete distinct locations.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63/139,298 | 2021-01-19 | ||
| US17/368,296 | 2021-07-06 | ||
| US17/501,232 | 2021-10-14 | ||
| US17/501,232 US11382662B2 (en) | 2017-08-04 | 2021-10-14 | Trocars and veress-type needles with illuminated guidance and safety features |
| PCT/US2022/012652 WO2022159351A1 (en) | 2021-01-19 | 2022-01-17 | Trocars and veress-type needles with illuminated guidance and safety features |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117729874A true CN117729874A (en) | 2024-03-19 |
Family
ID=90207426
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280019774.1A Pending CN117729874A (en) | 2021-01-19 | 2022-01-17 | Trocar and pneumoperitoneum type needle with illumination guidance and safety features |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117729874A (en) |
-
2022
- 2022-01-17 CN CN202280019774.1A patent/CN117729874A/en active Pending
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