WO2024242877A1 - Trocars having an optics channel and separation mechanism, kits including the same, and methods of use thereof - Google Patents
Trocars having an optics channel and separation mechanism, kits including the same, and methods of use thereof Download PDFInfo
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- WO2024242877A1 WO2024242877A1 PCT/US2024/028293 US2024028293W WO2024242877A1 WO 2024242877 A1 WO2024242877 A1 WO 2024242877A1 US 2024028293 W US2024028293 W US 2024028293W WO 2024242877 A1 WO2024242877 A1 WO 2024242877A1
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- WIPO (PCT)
- Prior art keywords
- trocar
- cannula
- elongate structure
- light source
- surgical procedure
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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
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00131—Accessories for endoscopes
- A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/3445—Cannulas used as instrument channel for multiple instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/3445—Cannulas used as instrument channel for multiple instruments
- A61B2017/3447—Linked multiple cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
Definitions
- Trocars are devices that are used in many such minimally invasive surgical procedures, and are commonly employed to maintain substantially small incisions within a patient while providing for the facilitated passage of surgical instruments therethrough. Trocars are often positioned throughout a patient to view an operating region from different angles using fiber optic cameras and the like. In use, a removable or retractable piercing end is included and used to enable the trocar to puncture the abdominal or the chest wall of the patient, thereby essentially creating a port into the patient.
- an instrument, a camera, a light, and various other items are inserted into the patient for the performance of the necessary procedure.
- these procedures also involve active insufflation or passive introduction of air into the cavity through a trocar, thereby providing spacing between the external cavity wall and the internal organs of the patient, and providing an adequate working environment.
- Endoscopic surgery generally involves the placement of multiple openings or ports in the patient, the insertion of trocars into each hole, and the introduction of different instruments through the different trocars (e.g., endoscopes, gas injectors, powder insufflators, electric cauterizers, forceps and cutters, etc.).
- instruments e.g., endoscopes, gas injectors, powder insufflators, electric cauterizers, forceps and cutters, etc.
- surgeons often require the simultaneous use of multiple instruments to carry out a procedure.
- an endoscope to be inserted along with other instruments so the surgeon is able to visualize the procedure being carried out with said instruments.
- These holes are generated by a blunt dissection technique, i.e., the separation of tissues along tissue planes.
- Some thoracic surgeries involve the placement of indwelling devices into a patient.
- One common indwelling device is a chest tube, i.e., a flexible tube that is placed into a patient'
- the present inventor has realized that conventional trocars and the methods with which they are placed generate undesirable complications in endoscopic surgery.
- the invasiveness associated with techniques such as blunt dissection limits the use of some thoracoscopic surgeries to specific providers and patients who can tolerate this procedure.
- procedures necessitating the placement of multiple trocars require multiple dissections, further increasing risk to the patient.
- conventional trocars are generally not optimized for the placement of indwelling devices such as chest tubes. Particularly, after the indwelling device has been introduced via the trocar, the trocar must be removed while the indwelling device remains. As such, solutions for extricating the trocar while leaving the device in place are desired.
- the present inventor has also discovered that, prior to the development of the present invention, attempts to develop a surgical solution allowing for each of i) a reduction in the size and number of incisions, ii) ease of visualization via optical components and iii) a means to place indwelling instruments (e.g., chest tubes) had not been successful.
- indwelling instruments e.g., chest tubes
- use of a disposable flexible bronchoscope with a tunneled pleural catheter peel-away sheath was described in Hamilton and Gesthalter. Journal of Bronchology & Interventional Pulmonology, 29(1 ), e2-e4.
- visualization within the pleural cavity was suboptimal.
- only one instrument could be inserted at a time, thereby restricting the procedure.
- flexibility of the components made certain manipulations more challenging in the pleural cavity. Accordingly, improved trocars and methods of use thereof capable of solving the above technical problems are desired.
- the trocars, kits, and methods disclosed herein satisfy these and other
- Trocars of interest include an elongate structure including a cannula configured to receive an instrument running therethrough from a proximal end to a distal end, and an optics channel configured to receive an optical component running therethrough from the proximal end to the distal end.
- Trocars of the invention also include a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
- the separation mechanism is a peelable mechanism.
- the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
- the trocar may, in certain embodiments, include a plurality of peelable mechanisms (e.g., 2 peelable mechanisms).
- the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure.
- the trocar also includes the optical component, such as where the optical component is integrated with the elongate structure in the optics channel.
- the optical component may, in certain cases, be an optical fiber.
- the optics channel is tapered at the distal end of the elongate structure.
- the trocar includes a light source channel for housing a light source. In some such cases, the trocar further comprises the light source. The light source may, in some versions, be integrated with the trocar in the light source channel.
- the length of the elongate structure may vary, and can range in some embodiments from 5 cm to 15 cm.
- the radius of the elongate structure may also vary, and can range in some embodiments from 2 mm to 10 mm.
- the cross-sectional shape of the subject trocars may also vary. In some cases, the cannula has a crescent- shaped cross-section. In other cases, the cannula has a circular cross section or an oval-shaped cross section.
- the trocar may be composed of any suitable material, such as a 3D printed polymer or an injection-moldable polymer.
- kits of interest include the trocar of the invention (e.g., described above).
- Embodiments of the subject kits may additionally include an obturator.
- the obturator has a diameter ranging from 15 mm to 25 mm.
- the obturator comprises an inner hole.
- the inner hole comprises a radius ranging from 2 mm to 10 mm.
- the obturator comprises a length ranging from 100 mm to 150 mm.
- kits also include one or more dilators.
- each dilator in the plurality of dilators has a different diameter.
- kits also include a hollow needle and/or a guidewire.
- Methods of interest include inserting a trocar of the invention (e.g., described above) into a subject to perform a surgical procedure.
- methods also include inserting the instrument into a cavity of the subject via the cannula, separating the cannula using the separation mechanism, and removing the trocar from the subject.
- the method includes inserting the trocar into the subject via a Seidinger technique.
- methods can include puncturing the subject using a needle to create an entry port, threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators.
- the instrument is a chest tube and the surgical procedure involves chest tube placement.
- methods include separating the cannula using the separation mechanism such that the trocar may be removed from the patient but the chest tube remains in place.
- the surgical procedure may, in some cases, involve endoscopy (e.g., pleuroscopy) or pleurodesis.
- the surgical procedure is selected from an orthopedic procedure, a urologic procedure, a laparoscopic procedure, a colorectal procedure, or a gynecological procedure.
- FIG. 1A-1 E depict a trocar according to certain embodiments of the invention.
- FIG. 2A-2B depict a trocar having a peelable separation mechanism according to certain embodiments.
- FIG. 3A-3B depict a trocar having a slidable separation mechanism according to certain embodiments.
- FIG. 4A-4D depict an obturator according to certain embodiments.
- FIG. 5A-5C depict a dilator according to certain embodiments.
- the subject trocars include an elongate structure having a cannula configured to receive an instrument running therethrough from a proximal end to a distal end, and an optics channel configured to receive an optical component running therethrough from the proximal end to the distal end.
- Trocars of interest also include a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end. Kits including the disclosed trocars, and methods of use thereof are also provided.
- trocars of the invention are configured to reduce the number, size and/or severity of the incisions required for the introduction of instruments to a cavity of a subject.
- the subject trocars are configured to reduce the number of different incisions required to perform a surgical procedure by 30% or more, such as 40%, such as 50% or more, and including 60% or more.
- the subject trocars are configured to reduce the size of the incisions that are made by 5% or more, such as 10% or more, such as 20% or more, such as 30% or more, such as 40%, such as 50% or more, such as 60% or more, and including 70% or more.
- trocars may be configured to reduce instances of tissue damage that may be required to insert traditional trocars (e.g., via a blunt dissection technique).
- trocars of the invention may reduce tissue damage by 5% or more, such as 10% or more, such as 20% or more , such as 40% or more, and including 50% or more.
- Embodiments of the subject trocars are also configured to reduce pain according to a suitable metric (e.g., self-report), e.g., by 5% or more, such as 10% or more, such as 20% or more, such as 40% or more, and including 50% or more.
- a suitable metric e.g., self-report
- Trocars of the invention are comprised of an elongate structure.
- elongate structure it is meant that the trocar possesses a greater length than width.
- the trocar possesses a distinct proximal and distal end.
- the proximal end is the end that, when the trocar is placed in a subject, remains outside of the subject and is configured to receive one or more surgical instruments.
- the distal end is the end that, when the trocar is placed in the subject, is located in the cavity of the subject. Surgical instruments passed through the trocar exit the trocar at the distal end for the purpose of carrying out the surgical procedure.
- the elongate structure when considered in its entirety, may have any suitable cross-sectional shape, where cross-sectional shapes of interest include, but are not limited to rectilinear cross-sectional shapes, e.g., squares, rectangles, trapezoids, triangles, hexagons, etc., curvilinear cross- sectional shapes, e.g., circles, ovals, as well as irregular shapes, e.g., a parabolic bottom portion coupled to a planar top portion.
- the elongate structure possesses a substantially circular cross-sectional shape at locations along the length.
- substantially circular cross-section it is meant that, in embodiments, the trocar may have a cross-section that slightly deviates from a circular cross-section.
- the elongate structure is not a perfect cylinder and instead possesses some regions having a circular cross-sectional shape with a diameter that is larger than those of other regions.
- the dimensions of the elongate structure may vary.
- the elongate structure has a length ranging from 3 cm to 20 cm, such as 4 cm to 17 cm, such as 5 cm to 15 cm, such as 7 cm to 14 cm, such as 9 cm to 13 cm, such as 10 cm to 12 cm, and including 11 to 12 cm.
- the elongate structure has a radius ranging from 1 mm to 15 mm, such as 2 mm to 10 mm, such as 3 mm to 7 mm, and including 4 mm to 5 mm.
- a radius may be measured in several different ways. In some cases, the radius of the elongate structure is measured as shown in FIG. 1 E.
- the subject trocars additionally include a cannula.
- Cannulas are referred to herein in their conventional sense to describe a tubular structure through which instruments may be delivered to a cavity of a subject and/or samples may be removed therefrom, etc.
- the cannulas of the invention run through the elongate structure from the proximal end to the distal end.
- the cross-sectional shape of the cannula may vary. In certain cases, the cross-sectional shape of the cannula is selected from a crescent-shaped cross-section, a circular cross section or an oval-shaped cross-section. In certain cases, the cannula has a crescent-shaped cross-section. In other cases, the cannula has a circular cross section.
- the cannula has an oval cross section.
- the cross section of the cannula may have any suitable radius.
- the cannula has a cross-sectional radius ranging from 1 mm to 15 mm, such as 2 mm to 10 mm, such as 3 mm to 7 mm, such as 4 mm to 5 mm.
- the elongate structure additionally comprises an optics channel.
- the optics channel of the invention is configured to house one or more optical components, e.g., for imaging the structures in the cavity of the subject.
- the optics channel may run through the elongate structure from the proximal end to the distal end.
- the optics channel may have any suitable cross section, such as circular cross sections, oval-shaped cross sections and crescent-shaped cross sections. In select cases, the optics channel has a circular cross section.
- the radius of the optics channel may range in select embodiments from 1 mm to 5 mm, including 2 mm to 4 mm.
- the optics channel may be adjacent to, but separate from the cannula, such that the optics channel and cannula together comprise the elongate structure.
- the optics channel may be adjacent to the concave portion of the crescent such that the overall profile of the elongate structure remains substantially circular (see, e.g., FIG. 1 E).
- the optics channel may or may not span the entire length of the elongate structure. In some cases, the optics channel is tapered at a distal end of the elongate structure.
- the taper may begin along the length of the elongate structure at a distance from the distal end that ranges, e.g., from 0.25 cm to 5 cm, such as 0.5 cm to 4 cm, such as 1 cm to 3 cm, and including 1 .5 cm to 2 cm.
- the trocars of the invention may or may not include the one or more optical components within the optics channel.
- the optical components are not located within the optics channel.
- the optics channel is configured to receive the optical components at a point of use, e.g., during or before surgery.
- the optics channel is configured to restrict the movement of the optical component(s) when inserted therein. For example, where a surgical procedure is being performed at a given location within the cavity of the subject, it may be desirable for an optical component such as an optical fiber to be fixed in a particular location relative to the trocar, e.g., such that movement of the trocar results in the movement of the optical fiber so that the surgeon is able to visualize the relevant location.
- the optics channel may be configured for the controlled movement of an optical component relative to the trocar.
- an optical component such as an optical fiber may be advanced through the optics channel and into the cavity. The fiber may then be manipulated by the surgeon such that the fiber can visualize different locations within the cavity independently of the trocar.
- trocars of the invention include one or more optical components integrated with the elongate structure in the optics channel.
- integrated is meant that the one or more optical components are integral to the optics channel such that the optical components and optics channel form a cohesive whole.
- the optical components cannot be removed from the optics channel without destroying the trocar. Integration of optical components with the trocar may result a reduction of the number, size, and severity of incisions required for arthroscopic surgery because such may reduce the need for additional incisions to facilitate the visualization of the surgical procedure. Integration of optical components with the optics channel may be achieved in any suitable manner. In some cases, the one or more optical components are integrated using an optical adhesive.
- Optical adhesives may include, for example, epoxies, light curable acrylics, elastomers (e.g., silicone, silicone-free silane), cyanoacrylates, structural adhesives (e.g., those having a resin and activator), as well as combinations thereof.
- the adhesive is curable by exposure to light (e.g., UV light).
- the optical adhesive is clear.
- integration occurs via press fit.
- Trocars of the invention may be configured for visualization during multiple points in a surgical procedure.
- the trocars may provide for visualization while being used in conjunction with devices including, but not limited to, obturators, dilators and/or guidewires.
- an obturator such as those described below may be used to facilitate insertion of the trocar.
- the provision of the optics channel allows the insertion process to be visualized using the optical component(s) because the optics channel is separate from the cannula, and the use of the obturator consequently does not displace the optical component(s). Accordingly, embodiments of the invention permit constant visualization, e.g., throughout the entirety of the surgical procedure including trocar insertion and separation.
- Optical components that may be housed in the optics channel may include, but are not limited to, light sources, lenses, mirrors, filters, fiber optics and combinations thereof.
- trocars include an optical fiber.
- Optical fibers of interest are configured to collect and transmit light so that it can be imaged.
- the optical fiber is also configured to emit illuminating light.
- one portion of the optical fiber is configured to emit the illuminating light, while another portion of the optical fiber is configured to collect light reflected from a surface, e.g., within the cavity.
- optical components for use in the subject invention include one or more fiber bundles.
- Optical components that may be adapted for use in the subject trocars are described in, e.g., U.S. Patent Nos. 6,997,868; 7,018,330; 7,160,248; 7,496,259; 7,715,673; 7,942,814; 8,419,622; 8,480,566; 8,602,971 ; 8,676,013; 9,033,870; 9.459,415; 9,848,761 ; 10,506,142; 10,687,696; 11 ,061 ,185; and 1 1 ,256,080.
- trocars include a light source channel.
- the elongate structure includes a channel configured to house a light source that is distinct from the optics channel and the cannula.
- Any convenient light source may be included.
- the light source is a light emitting diode (LED).
- the light source is comprised of a laser, such as a continuous wave laser.
- the laser may be a diode laser.
- the light source may or may not be integrated with the light source channel.
- the light source is integrated with the light source channel.
- the light source is not integrated with the light source channel, and the light source may be introduced into the trocar at a time of use, e.g., before or during a surgical procedure.
- FIG. 1 A-1 E present different views of trocar 100 according to certain embodiments of the invention.
- trocar 100 includes elongate structure 101 having a proximal end (bottom) and distal end (top). Cannula 102 can be viewed at the distal end of elongate structure 101.
- optics channel 103 is shown running along the length of elongate structure 101 , and tapers towards the distal end of elongate structure 101 .
- FIG. 1 B-1C present an alternative view of trocar 100 in which the proximal end of elongate structure 101 is at the top and the distal end of elongate structure is at the bottom.
- optical component 104 positioned in optics channel 103.
- FIG. 1 D presents a profile view of trocar 100 having the same components.
- FIG. 1 E presents a view of trocar 100 looking down the length of elongate structure 101 .
- cannula 102 has a crescent-shaped cross section, while optics channel 103 has a circular cross section.
- FIG. 1 E also demonstrates an exemplary way to measure the radius of the elongate structure, as shown by radius r.
- separation mechanism it is meant a means by which a separation may be generated along a length of the cannula from the proximal end to the distal end. When the separation is generated, a portion of the cannula wall becomes non- continuous. In other words, the cannula as such no longer exists. In this manner, it is possible to position an instrument (e.g., chest tube) within a cavity of a subject via the trocar while maintaining continuous visualization and then maintain that instrument in place while the trocar is removed. Any suitable separation mechanism may be employed. In some embodiments, the separation mechanism is a peelable separation mechanism.
- peelable separation mechanism it is meant that a peeling action is used to generate the separation in the cannula.
- the peelable separation mechanism includes a pull tab operably attached to the proximal end of the elongate structure.
- a portion of the elongate structure i.e., the cannula wall
- the “separation path” is the segment of the cannula wall along which the separation is generated by the peelable separation mechanism.
- the separation path comprises a perforation. The number of peelable separation mechanisms may vary.
- trocars include a single peelable separation mechanism. In other embodiments, trocars include a plurality of peelable separation mechanisms, such as 2 separation mechanisms, or 3 separation mechanisms. In some such embodiments, trocars include a plurality of pull tabs, i.e., one for each separation mechanism.
- FIG. 2A-2B depict a trocar 200 having a peelable separation mechanism.
- FIG. 2A depicts trocar 200 prior to separation, while FIG. 2B depicts trocar 200 with a separation in progress.
- trocar 200 includes elongate structure 201 , cannula 202, and optics channel 203.
- Trocar 200 also includes a pull tab 205 that may be grasped by a user to generate a separation in the wall of cannula 202. The separation, once initiated, will be generated along separation path 206, which may or may not include a perforation. As shown in FIG.
- pull tab 205 has been used to create a separation 207 in cannula 202 that forms along the length of elongate structure 201 according to separation path 206. Pull tab 205 is torn in the direction of the arrow to generate separation 207. Once complete, separation 207 will span the entire length of elongate structure 201 , and cannula 202 will no longer have walls that form a continuous, enclosed, tubular structure. In other words, cannula 202 ceases to exist, as such.
- trocars of the invention include a slidable separation mechanism.
- slidable separation mechanism it is meant a means by which a separation may be generated in the cannula involving a segment of the cannula wall that has a slidable relationship with respect to other portions of the cannula wall. By sliding the slidable segment of the cannula wall, it can be removed from the elongate structure, thereby generating the separation.
- the slidable segment may have edges that interlock with edges of the rest of the cannula, such that the slidable portion remains in place prior to the point at which separation is desired.
- the slidable portion of the cannula wall may be grasped, and an upward force may be exerted. Said slidable portion will slidably move relative to the remainder of the cannula wall until the slidable portion has been completely extricated from the elongate structure.
- FIG. 3A-3B depict a trocar 300 having a slidable separation mechanism.
- FIG. 3A depicts trocar 300 prior to separation, while FIG. 3B depicts trocar 300 with a separation in progress.
- trocar 300 includes elongate structure 301 , cannula 302, and optics channel 303.
- slidable segment 306. Prior to separation at a desired time, slidable segment remains in place and constitutes part of the wall forming cannula 302.
- slidable portion 306 is being moved in the direction denoted by the arrow. This results in the gradual formation of separation 307.
- separation 307 will span the entire length of elongate structure 301 , and cannula 302 will no longer have walls that form a continuous, enclosed, tubular structure. In other words, cannula 302 ceases to exist, as such.
- trocars may be comprised of any convenient material.
- trocars include one or more metal components including, for example, aluminum, titanium, brass, iron, lead, nickel, steel (e.g., stainless steel), copper, tin as well as combinations and alloys thereof.
- trocars include one or more rigid plastic materials such as, for example, polycarbonates, polyvinyl chloride (PVC), polyurethanes, polyethers, polyamides, polyimides, among other polymeric plastic materials.
- the clamp includes a 3D printed polymer.
- Any convenient 3D printed polymer may be employed, such as, for example, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), acrylic styrene acrylonitrile (ASA), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), polyaryletherketones (PAEK), polyetherimides (PEI), polypolycarbonate (PC), polypropylene, (PP), nylon as well as composites and hybrids thereof.
- ABS acrylonitrile butadiene styrene
- PLA polylactic acid
- ASA acrylic styrene acrylonitrile
- PET polyethylene terephthalate
- PET glycol-modified polyethylene terephthalate
- PAEK polyaryletherketones
- PEI polyetherimides
- PC polypolycarbonate
- PP polypropylene, nylon as well as composites and hybrids thereof.
- the trocars include an injection-moldable polymer. Any convenient injection-moldable polymer may be employed. Injection- moldable polymers may include, but are not limited to: acrylonitrile butadiene styrene (ABS), polycarbonate (PC), aliphatic polyamides (PPA), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polypropylene (PP), polybutylene terephthalate (PBT), polyphenylsulfone (PPSU), polyether ether ketone (PEEK) and polyetherimide (PEI).
- ABS acrylonitrile butadiene styrene
- PC polycarbonate
- PPA polyoxymethylene
- PMMA polymethyl methacrylate
- PMMA polypropylene
- PBT polybutylene terephthalate
- PPSU polyphenylsulfone
- PEEK polyether ether ketone
- PEI polyetherimide
- the trocars include a glass-filled polymer (i.e. having glass fibers in a matrix of polymeric material).
- any suitable polymer e.g., such as those described above
- glass filled polymers of interest may include glass-filled nylon or glass-filled polyetherimide.
- Trocars of the invention may be configured for single use or multiple uses.
- the trocars are disposable. Such may, in some cases, reduce the burden of having to sterilize the trocars between uses. KITS
- kits of interest include a trocar of the invention (such as those described above).
- the number of trocars in the subject kits may vary.
- kits described herein include a single trocar.
- kits include a plurality of trocars.
- the number of trocars in the subject kits ranges from 2 to 20, including 3 to 10.
- kits include 2 or more trocars, such as 3 or more trocars, such as 4 or more trocars, such as 5 or more trocars, such as 6 or more trocars, such as 7 or more trocars, such as 8 or more trocars, such as 9 or more trocars and including 10 or more trocars.
- Kits of the invention may also include one or more components configured to be employed along with the subject trocar(s) in methods of the invention (e.g., described below).
- kits include one or more obturators.
- the subject obturators are configured to facilitate insertion of the trocar into the subject.
- Obturators of interest include an elongate structure having a proximal and distal end.
- the elongate structure comprises a shape that is complementary to the cannula of the trocar, such that the obturator can be inserted therein.
- embodiments of the elongate structure of the obturator are also crescent shaped such that the obturator can be received in the cannula.
- the distal end of the obturator is pointed, e.g., to facilitate piercing of the skin during insertion of the trocar.
- obturators of the invention also include an inner hole running through the elongate structure from the proximal to distal end.
- the guidewire can be inserted into the patient and then threaded through the obturator so that the obturator can enlarge the incision prior to the placement of the trocar.
- the inner hole may have any suitable radius. In some cases, inner hole radii range from 1 mm to 10 mm, such as 2 mm to 6 mm, and including 3 mm to 5 mm.
- obturators comprise a head at the proximal end, such as a rounded head. In some such embodiments, the head has a diameter ranging from 10 mm to 30 mm, such as 15 mm to 25 mm, and including 18 mm to 20 mm.
- kits described herein include a single obturator. In other cases, kits include a plurality of obturators. For example, in some instances, the number of obturators in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more obturators, such as 3 or more obturators, such as 4 or more obturators, such as 5 or more obturators, such as 6 or more obturators, such as 7 or more obturators, such as 8 or more obturators, such as 9 or more obturators and including 10 or more obturators.
- obturators may be comprised of any convenient material.
- obturators include one or more metal components including, for example, aluminum, titanium, brass, iron, lead, nickel, steel (e.g., stainless steel), copper, tin as well as combinations and alloys thereof.
- obturators include one or more rigid plastic materials such as, for example, polycarbonates, polyvinyl chloride (PVC), polyurethanes, polyethers, polyamides, polyimides, among other polymeric plastic materials.
- the clamp includes a 3D printed polymer.
- Any convenient 3D printed polymer may be employed, such as, for example, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), acrylic styrene acrylonitrile (ASA), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), polyaryletherketones (PAEK), polyetherimides (PEI), polypolycarbonate (PC), polypropylene, (PP), nylon as well as composites and hybrids thereof.
- ABS acrylonitrile butadiene styrene
- PLA polylactic acid
- ASA acrylic styrene acrylonitrile
- PET polyethylene terephthalate
- PET glycol-modified polyethylene terephthalate
- PAEK polyaryletherketones
- PEI polyetherimides
- PC polypolycarbonate
- PP polypropylene, nylon as well as composites and hybrids thereof.
- the obturators include an injection-moldable polymer. Any convenient injection-moldable polymer may be employed. Injection- moldable polymers may include, but are not limited to: acrylonitrile butadiene styrene (ABS), polycarbonate (PC), aliphatic polyamides (PPA), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polypropylene (PP), polybutylene terephthalate (PBT), polyphenylsulfone (PPSU), polyether ether ketone (PEEK) and polyetherimide (PEI).
- FIG. 4A-4D present different views of obturator 400 according to certain embodiments of the invention. As shown in FIG.
- obturator 400 includes elongate structure 401 having a proximal end (bottom) and distal end (top). The distal end is pointed to facilitate insertion into the cavity of the subject, and the proximal end includes a rounded head.
- FIG. 4B depicts an flipped view of obturator 400 where the proximal end of elongate structure 401 is at the top and the distal end is at the bottom. In FIG. 4B, inner hole 402 is visible.
- Obturator 400 may be passed over a guidewire via inner hole 402.
- FIG. 4C depicts the proximal end of obturator 400, while FIG. 4D presents a profile view of obturator 400.
- Kits of the invention may further include dilators.
- Dilators may be employed to dilate the incision to the extent necessary to place the trocar.
- Dilators of interest may have an elongate structure with a tapered distal end.
- dilators have a passage running therethrough so that they may be used in conjunction with a guidewire, e.g., in a Seldinger-based process.
- kits include a plurality of dilators. For example, in some instances, the number of dilators in the subject kits ranges from 2 to 20, including 3 to 10.
- kits include 2 or more dilators, such as 3 or more dilators, such as 4 or more dilators, such as 5 or more dilators, such as 6 or more dilators, such as 7 or more dilators, such as 8 or more dilators, such as 9 or more dilators and including 10 or more dilators.
- kits of the invention include multiple dilators, kits include dilators having differing diameters. Such dilators may be employed, e.g., for a serial dilation.
- FIG. 5A-5C present different views of dilator 500 according to certain embodiments of the invention.
- dilator 500 includes elongate structure 501 and passage 502 running therethrough.
- FIG. 5B presents a profile view of dilator 500.
- FIG. 5C presents a view looking down the length of dilator 500 from the proximal end.
- kits of the invention also include a needle, e.g., a hollow needle.
- the needle is a Seidinger needle, i.e., a needle that is suitable for use with a Seidinger technique (e.g., described below).
- Needles of interest may include a hub at a proximal end, e.g., where a guidewire may be inserted through the needle into the subject. Needles that may be adapted for use in the subject kits are described in, e.g., U.S. Patent No. 10,065,020.
- kits include a plurality of needles. For example, in some instances, the number of needles in the subject kits ranges from 2 to 20, including 3 to 10.
- kits include 2 or more needles, such as 3 or more needles, such as 4 or more needles, such as 5 or more needles, such as 6 or more needles, such as 7 or more needles, such as 8 or more needles, such as 9 or more needles and including 10 or more needles.
- kits of the invention also include a guidewire.
- the tip of the guide wire can have any desired design, e.g., it can be a Seidinger guidewire having a straight tip, a J-tip or a slightly bent tip.
- Guidewires that may be adapted for use in the subject kits are described in, e.g., U.S. Patent No. 11 ,141 ,571 .
- kits include a plurality of guidewires. For example, in some instances, the number of guidewires in the subject kits ranges from 2 to 20, including 3 to 10.
- kits include 2 or more guidewires, such as 3 or more guidewires, such as 4 or more guidewires, such as 5 or more guidewires, such as 6 or more guidewires, such as 7 or more guidewires, such as 8 or more guidewires, such as 9 or more guidewires and including 10 or more guidewires.
- components of the subject kits are provided in sealed packaging.
- the sealed packaging is sufficient to maintain sterility of the kit’s components prior to their use in the surgical procedure.
- each trocar of the invention is individually packaged in sealed packaging.
- aspects of the invention also include methods. Methods of interest involve inserting a trocar of the invention (such as those described above) into a subject to perform a surgical procedure.
- the trocar may be inserted into the subject in any suitable manner.
- the trocar is inserted into the subject via a Seidinger technique.
- the “Seidinger” technique is referred to herein in its conventional sense to describe a method for gaining access to body cavities via a puncture with a needle and the threading of a guidewire.
- the Seidinger technique is described in, e.g., Acta Radiologies. 39 (5): 368-7.
- the method comprises puncturing the subject using a needle to create an entry port, threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators.
- the trocar may subsequently be located within the cavity of the subject via the entry port.
- methods include using an obturator to assist the insertion of the trocar into the cavity of the subject through the entry port.
- Obturators and dilators that may be employed along with the subject trocars are described above with respect to the kits of the invention. While methods of the invention are described primarily with respect to Seldinger-based techniques, the methods are not limited to such.
- trocars of the invention are employed with a blunt dissection.
- the surgical procedure is an ultrasound-guided procedure.
- methods include providing constant visualization of the subject, e.g., throughout the entirety of the surgical procedure including the insertion of the trocar and the separation of the trocar.
- visualization using optical components within the optics channel may occur simultaneously with use of devices configured for trocar insertion including but not limited to obturators, guidewires and dilators because of the physical separation of the cannula and the optics channel.
- the subject trocars may be employed to gain access to any suitable body cavity.
- the cavity is selected from a thoracic cavity, an abdominal cavity, a dorsal body cavity, a joint cavity, or a pelvic cavity.
- the cavity is a thoracic cavity.
- the cavity is an abdominal cavity.
- the cavity is a dorsal body cavity.
- the cavity is a pelvic cavity.
- the cavity is a joint cavity.
- Surgical procedures performed via the subject methods may vary.
- the surgical procedure comprises endoscopy.
- the endoscopy comprises pleuroscopy, i.e., passage of an endoscope through the chest wall for visualization of the pleura.
- the surgical procedure can include, but is not limited to, diagnosis of pleural conditions, biopsy, fluid drainage, chest tube placement, indwelling tunneled pleural catheter placement, pleurodesis, and adhesiolysis.
- methods may include placing the instrument via the trocar, creating a separation in the cannula of the trocar via the separation mechanism, and removing the trocar from the subject while maintaining the instrument in place.
- methods of the invention include one or more of: pleural biopsy, lysis of adhesions or thoracic washouts.
- the endoscopy comprises laparoscopy.
- the trocar of the invention may be inserted into the abdomen and/or pelvis, e.g., at a location at or adjacent to the umbilicus.
- methods include removing and/or taking biopsies of one or more structures (e.g., lymph nodes) within in the pelvis or abdomen.
- the surgical procedure is a gynecological procedure.
- methods of the invention include taking biopsies of or treating certain gynecologic cancers including, but not limited to, cervical cancer, ovarian cancer, and endometrial cancer.
- gynecologic procedures include, but are not limited to, hysterectomy (e.g., total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic assisted vaginal hysterectomy), fibroid removal (e.g., laparoscopic myomectomy), and ovarian cyst removal.
- the procedure is a urologic procedure.
- the urologic procedure comprises laparoscopic nephrectomy, percutaneous nephrolithotomy (PCNL), prostatectomy, cystectomy, adrenalectomy, and the like.
- the procedure is a colorectal procedure.
- procedures may include but are not limited to laparoscopic rectal prolapse repair, laparoscopic colectomy, laparoscopic cholecystectomy, laparoscopic segmental resections, laparoscopic small intestinal resection, and laparoscopic splenectomy.
- the procedure is an orthopedic procedure.
- the trocar of the invention is used to access a joint cavity.
- Orthopedic procedures that may be performed include, but are not limited to knee arthroscopy, ankle arthroscopy, elbow arthroscopy, hip arthroscopy, shoulder arthroscopy, wrist arthroscopy, and the like. Methods may additionally include tendon repair or reconstruction, joint replacement or repair, ligament repair or reconstruction, etc.
- the instrument(s) inserted into the subject via the subject trocars may vary according to the type of procedure performed. Instruments of interest include, but are not limited to, chest tubes, indwelling tunneled pleural catheters, biopsy forceps, unipolar coagulation forceps, and the like.
- the subject is a “mammal” or “mammalian”, where these terms are used broadly to describe organisms which are within the class Mammalia, including the orders carnivore (e.g., dogs and cats), Rodentia (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). In some instances, the subjects are humans.
- the methods may be applied to human subjects of both genders and at any stage of development (i.e., neonates, infant, juvenile, adolescent, adult), where in certain embodiments the human subject is a juvenile, adolescent or adult.
- non-human subjects such as, but not limited to, birds, mice, rats, dogs, cats, livestock and horses.
- the trocars, kits and methods of the invention find multiple uses.
- the present invention may be employed where it desired to simplify endoscopic surgery.
- the invention allows for a simple method for thoracic trocar placement using a Seldinger-based approach.
- the invention facilitates pleural procedures such as biopsies, chest tube placement, thoracic washouts and pleurodesis.
- the Seidinger fashion is a widely used method by physicians, and does not require blunt surgical dissection. This results in less patient discomfort, making the procedure easier to tolerate.
- This also makes thoracic procedures easier to do and expands the reach of these procedures to physicians who cannot perform surgical blunt dissection but have patients who require thoracic interventions.
- the hospitals stand to gain from lower costs given the device being a disposable item that does not require sterilization.
- the Seldinger-based methods of the invention result in a more comfortable procedure.
- the integration of an optical fiber would allow the replacement of commercially available tools that are expensive to maintain.
- the peelable mechanism would also help with chest tube placement and increase the scope of procedures feasibly done in this approach.
- the trocars, kits and methods of the invention may additionally be used to replace other devices that require expensive maintenance.
- a trocar comprising: an elongate structure comprising: a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
- the separation mechanism is a peelable mechanism.
- the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
- the trocar according to any one of the preceding clauses further comprising a light source channel for housing a light source.
- trocar according to any one of the preceding clauses, wherein the trocar is comprised of a 3D printed polymer.
- trocar according to any one of the preceding clauses, wherein the trocar is comprised of an injection-moldable polymer.
- a kit comprising the trocar according to any one of clauses 1 to 20.
- kit according to Clause 21 further comprising an obturator.
- a method comprising: inserting a trocar into a subject to perform a surgical procedure, the trocar comprising: an elongate structure comprising: a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
- the optics channel is tapered at the distal end of the elongate structure.
- the trocar further comprises a light source channel for housing a light source.
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Abstract
Trocars are provided. The subject trocars include an elongate structure having a cannula configured to receive an instrument running therethrough from a proximal end to a distal end, and an optics channel configured to receive an optical component running therethrough from the proximal end to the distal end. Trocars of interest also include a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end. Kits including the disclosed trocars, and methods of use thereof are also provided.
Description
TROCARS HAVING AN OPTICS CHANNEL AND SEPARATION MECHANISM, KITS INCLUDING THE SAME, AND METHODS OF USE THEREOF
CROSS-REFERENCE TO RELATED APPLICATION
Pursuant to 35 U.S.C. § 1 19 (e), this application claims priority to the filing date of United States Provisional Patent Application Serial No. 63,468,866 filed May 25, 2023, the disclosure of which is herein incorporated by reference in its entirety.
INTRODUCTION
In the medical field, endoscopic surgeries such as laparoscopy and thoracoscopy are minimally invasive surgeries that are commonly preferred due to their ability to achieve the same beneficial results as a fully invasive procedure, but through small openings or ports formed in the patient. Trocars are devices that are used in many such minimally invasive surgical procedures, and are commonly employed to maintain substantially small incisions within a patient while providing for the facilitated passage of surgical instruments therethrough. Trocars are often positioned throughout a patient to view an operating region from different angles using fiber optic cameras and the like. In use, a removable or retractable piercing end is included and used to enable the trocar to puncture the abdominal or the chest wall of the patient, thereby essentially creating a port into the patient. Through that port an instrument, a camera, a light, and various other items are inserted into the patient for the performance of the necessary procedure. Typically, these procedures also involve active insufflation or passive introduction of air into the cavity through a trocar, thereby providing spacing between the external cavity wall and the internal organs of the patient, and providing an adequate working environment.
Endoscopic surgery generally involves the placement of multiple openings or ports in the patient, the insertion of trocars into each hole, and the introduction of different instruments through the different trocars (e.g., endoscopes, gas
injectors, powder insufflators, electric cauterizers, forceps and cutters, etc.). This is because surgeons often require the simultaneous use of multiple instruments to carry out a procedure. For example, it is generally necessary for an endoscope to be inserted along with other instruments so the surgeon is able to visualize the procedure being carried out with said instruments. These holes are generated by a blunt dissection technique, i.e., the separation of tissues along tissue planes. Some thoracic surgeries involve the placement of indwelling devices into a patient. One common indwelling device is a chest tube, i.e., a flexible tube that is placed into a patient's chest cavity to allow for drainage of fluids following trauma or surgery.
SUMMARY
The present inventor has realized that conventional trocars and the methods with which they are placed generate undesirable complications in endoscopic surgery. In particular, the invasiveness associated with techniques such as blunt dissection limits the use of some thoracoscopic surgeries to specific providers and patients who can tolerate this procedure. In addition, procedures necessitating the placement of multiple trocars require multiple dissections, further increasing risk to the patient. The inventor has also found that conventional trocars are generally not optimized for the placement of indwelling devices such as chest tubes. Particularly, after the indwelling device has been introduced via the trocar, the trocar must be removed while the indwelling device remains. As such, solutions for extricating the trocar while leaving the device in place are desired.
The present inventor has also discovered that, prior to the development of the present invention, attempts to develop a surgical solution allowing for each of i) a reduction in the size and number of incisions, ii) ease of visualization via optical components and iii) a means to place indwelling instruments (e.g., chest tubes) had not been successful. For example, use of a disposable flexible bronchoscope with a tunneled pleural catheter peel-away sheath was described in Hamilton and Gesthalter. Journal of Bronchology & Interventional
Pulmonology, 29(1 ), e2-e4. However, it was found that visualization within the pleural cavity was suboptimal. In addition, only one instrument could be inserted at a time, thereby restricting the procedure. In addition, flexibility of the components made certain manipulations more challenging in the pleural cavity. Accordingly, improved trocars and methods of use thereof capable of solving the above technical problems are desired. The trocars, kits, and methods disclosed herein satisfy these and other desires.
Aspects of the invention include trocars. Trocars of interest include an elongate structure including a cannula configured to receive an instrument running therethrough from a proximal end to a distal end, and an optics channel configured to receive an optical component running therethrough from the proximal end to the distal end. Trocars of the invention also include a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end. In some instances, the separation mechanism is a peelable mechanism. In some such instances, the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula. The trocar may, in certain embodiments, include a plurality of peelable mechanisms (e.g., 2 peelable mechanisms). In other embodiments, the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure. In select versions, the trocar also includes the optical component, such as where the optical component is integrated with the elongate structure in the optics channel. The optical component may, in certain cases, be an optical fiber. In some embodiments, the optics channel is tapered at the distal end of the elongate structure. In certain versions, the trocar includes a light source channel for housing a light source. In some such cases, the trocar further comprises the light source. The light source may, in some versions, be integrated with the trocar in the light source channel. The length of the elongate structure may vary, and can range in some embodiments from 5 cm to 15 cm. The radius of the elongate structure may also vary, and can range in some embodiments from 2 mm to 10 mm. The cross-sectional shape of the subject trocars may also vary. In some cases, the cannula has a crescent-
shaped cross-section. In other cases, the cannula has a circular cross section or an oval-shaped cross section. The trocar may be composed of any suitable material, such as a 3D printed polymer or an injection-moldable polymer.
Aspects of the invention also include kits. Kits of interest include the trocar of the invention (e.g., described above). Embodiments of the subject kits may additionally include an obturator. In select cases, the obturator has a diameter ranging from 15 mm to 25 mm. In some instances, the obturator comprises an inner hole. In some such instances, the inner hole comprises a radius ranging from 2 mm to 10 mm. In certain cases, the obturator comprises a length ranging from 100 mm to 150 mm. In some embodiments, kits also include one or more dilators. In some versions where kits include a plurality of dilators, each dilator in the plurality of dilators has a different diameter. In some instances, kits also include a hollow needle and/or a guidewire.
Aspects of the invention also include methods. Methods of interest include inserting a trocar of the invention (e.g., described above) into a subject to perform a surgical procedure. In embodiments, methods also include inserting the instrument into a cavity of the subject via the cannula, separating the cannula using the separation mechanism, and removing the trocar from the subject. In some embodiments, the method includes inserting the trocar into the subject via a Seidinger technique. For example, methods can include puncturing the subject using a needle to create an entry port, threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators. In select cases, the instrument is a chest tube and the surgical procedure involves chest tube placement. In some such cases, methods include separating the cannula using the separation mechanism such that the trocar may be removed from the patient but the chest tube remains in place. The surgical procedure may, in some cases, involve endoscopy (e.g., pleuroscopy) or pleurodesis. In select embodiments, the surgical procedure is selected from an orthopedic procedure, a urologic procedure, a laparoscopic procedure, a colorectal procedure, or a gynecological procedure.
BRIEF DESCRIPTION OF THE FIGURES.
The invention may be best understood from the following detailed description when read in conjunction with the accompanying drawings. Included in the drawings are the following figures:
FIG. 1A-1 E depict a trocar according to certain embodiments of the invention.
FIG. 2A-2B depict a trocar having a peelable separation mechanism according to certain embodiments.
FIG. 3A-3B depict a trocar having a slidable separation mechanism according to certain embodiments.
FIG. 4A-4D depict an obturator according to certain embodiments.
FIG. 5A-5C depict a dilator according to certain embodiments.
DETAILED DESCRIPTION
Trocars are provided. The subject trocars include an elongate structure having a cannula configured to receive an instrument running therethrough from a proximal end to a distal end, and an optics channel configured to receive an optical component running therethrough from the proximal end to the distal end. Trocars of interest also include a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end. Kits including the disclosed trocars, and methods of use thereof are also provided.
Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates
otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Certain ranges are presented herein with numerical values being preceded by the term "about." The term "about" is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.
All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.
As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.
While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 U.S.C. §1 12, are not to be construed as necessarily limited in any way by the construction of "means" or "steps" limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 U.S.C. §1 12 are to be accorded full statutory equivalents under 35 U.S.C. §112.
T ROCARS
As discussed above, aspects of the invention include trocars. In some cases, trocars of the invention are configured to reduce the number, size and/or severity of the incisions required for the introduction of instruments to a cavity of a subject. For example, in some cases, the subject trocars are configured to reduce the number of different incisions required to perform a surgical procedure by 30% or more, such as 40%, such as 50% or more, and including 60% or more. Furthermore, in certain embodiments, the subject trocars are configured to reduce the size of the incisions that are made by 5% or more, such as 10% or more, such as 20% or more, such as 30% or more, such as 40%, such as 50%
or more, such as 60% or more, and including 70% or more. In addition, trocars may be configured to reduce instances of tissue damage that may be required to insert traditional trocars (e.g., via a blunt dissection technique). For example, trocars of the invention may reduce tissue damage by 5% or more, such as 10% or more, such as 20% or more , such as 40% or more, and including 50% or more. Embodiments of the subject trocars are also configured to reduce pain according to a suitable metric (e.g., self-report), e.g., by 5% or more, such as 10% or more, such as 20% or more, such as 40% or more, and including 50% or more.
Trocars of the invention are comprised of an elongate structure. By “elongate structure” it is meant that the trocar possesses a greater length than width. In other words, the trocar possesses a distinct proximal and distal end. The proximal end is the end that, when the trocar is placed in a subject, remains outside of the subject and is configured to receive one or more surgical instruments. The distal end is the end that, when the trocar is placed in the subject, is located in the cavity of the subject. Surgical instruments passed through the trocar exit the trocar at the distal end for the purpose of carrying out the surgical procedure. The elongate structure, when considered in its entirety, may have any suitable cross-sectional shape, where cross-sectional shapes of interest include, but are not limited to rectilinear cross-sectional shapes, e.g., squares, rectangles, trapezoids, triangles, hexagons, etc., curvilinear cross- sectional shapes, e.g., circles, ovals, as well as irregular shapes, e.g., a parabolic bottom portion coupled to a planar top portion. In embodiments, the elongate structure possesses a substantially circular cross-sectional shape at locations along the length. By “substantially” circular cross-section, it is meant that, in embodiments, the trocar may have a cross-section that slightly deviates from a circular cross-section. In certain embodiments, the elongate structure is not a perfect cylinder and instead possesses some regions having a circular cross-sectional shape with a diameter that is larger than those of other regions.
The dimensions of the elongate structure may vary. In some cases, the elongate structure has a length ranging from 3 cm to 20 cm, such as 4 cm to 17
cm, such as 5 cm to 15 cm, such as 7 cm to 14 cm, such as 9 cm to 13 cm, such as 10 cm to 12 cm, and including 11 to 12 cm. In additional cases, the elongate structure has a radius ranging from 1 mm to 15 mm, such as 2 mm to 10 mm, such as 3 mm to 7 mm, and including 4 mm to 5 mm. In some cases where the cross section of the elongate structure is not strictly circular, a radius may be measured in several different ways. In some cases, the radius of the elongate structure is measured as shown in FIG. 1 E.
The subject trocars additionally include a cannula. Cannulas are referred to herein in their conventional sense to describe a tubular structure through which instruments may be delivered to a cavity of a subject and/or samples may be removed therefrom, etc. The cannulas of the invention run through the elongate structure from the proximal end to the distal end. The cross-sectional shape of the cannula may vary. In certain cases, the cross-sectional shape of the cannula is selected from a crescent-shaped cross-section, a circular cross section or an oval-shaped cross-section. In certain cases, the cannula has a crescent-shaped cross-section. In other cases, the cannula has a circular cross section. In still other cases, the cannula has an oval cross section. The cross section of the cannula may have any suitable radius. In some cases, the cannula has a cross-sectional radius ranging from 1 mm to 15 mm, such as 2 mm to 10 mm, such as 3 mm to 7 mm, such as 4 mm to 5 mm.
The elongate structure additionally comprises an optics channel. The optics channel of the invention is configured to house one or more optical components, e.g., for imaging the structures in the cavity of the subject. Like the cannula, the optics channel may run through the elongate structure from the proximal end to the distal end. The optics channel may have any suitable cross section, such as circular cross sections, oval-shaped cross sections and crescent-shaped cross sections. In select cases, the optics channel has a circular cross section. The radius of the optics channel may range in select embodiments from 1 mm to 5 mm, including 2 mm to 4 mm. The optics channel may be adjacent to, but separate from the cannula, such that the optics channel and cannula together comprise the elongate structure. For example, in some
cases where the cannula has a crescent-shaped cross section, the optics channel may be adjacent to the concave portion of the crescent such that the overall profile of the elongate structure remains substantially circular (see, e.g., FIG. 1 E). The optics channel may or may not span the entire length of the elongate structure. In some cases, the optics channel is tapered at a distal end of the elongate structure. In some such cases, the taper may begin along the length of the elongate structure at a distance from the distal end that ranges, e.g., from 0.25 cm to 5 cm, such as 0.5 cm to 4 cm, such as 1 cm to 3 cm, and including 1 .5 cm to 2 cm.
The trocars of the invention may or may not include the one or more optical components within the optics channel. In some embodiments, the optical components are not located within the optics channel. In such embodiments, the optics channel is configured to receive the optical components at a point of use, e.g., during or before surgery. In some instances, the optics channel is configured to restrict the movement of the optical component(s) when inserted therein. For example, where a surgical procedure is being performed at a given location within the cavity of the subject, it may be desirable for an optical component such as an optical fiber to be fixed in a particular location relative to the trocar, e.g., such that movement of the trocar results in the movement of the optical fiber so that the surgeon is able to visualize the relevant location. In additional cases, the optics channel may be configured for the controlled movement of an optical component relative to the trocar. In such embodiments, an optical component such as an optical fiber may be advanced through the optics channel and into the cavity. The fiber may then be manipulated by the surgeon such that the fiber can visualize different locations within the cavity independently of the trocar.
In other embodiments, trocars of the invention include one or more optical components integrated with the elongate structure in the optics channel. By “integrated” is meant that the one or more optical components are integral to the optics channel such that the optical components and optics channel form a cohesive whole. In some embodiments in which the optical components are
integrated with the optics channel, the optical components cannot be removed from the optics channel without destroying the trocar. Integration of optical components with the trocar may result a reduction of the number, size, and severity of incisions required for arthroscopic surgery because such may reduce the need for additional incisions to facilitate the visualization of the surgical procedure. Integration of optical components with the optics channel may be achieved in any suitable manner. In some cases, the one or more optical components are integrated using an optical adhesive. Optical adhesives may include, for example, epoxies, light curable acrylics, elastomers (e.g., silicone, silicone-free silane), cyanoacrylates, structural adhesives (e.g., those having a resin and activator), as well as combinations thereof. In some embodiments, the adhesive is curable by exposure to light (e.g., UV light). In certain embodiments, the optical adhesive is clear. In other embodiments, integration occurs via press fit.
Trocars of the invention may be configured for visualization during multiple points in a surgical procedure. In some embodiments, the trocars may provide for visualization while being used in conjunction with devices including, but not limited to, obturators, dilators and/or guidewires. For example, an obturator such as those described below may be used to facilitate insertion of the trocar. The provision of the optics channel allows the insertion process to be visualized using the optical component(s) because the optics channel is separate from the cannula, and the use of the obturator consequently does not displace the optical component(s). Accordingly, embodiments of the invention permit constant visualization, e.g., throughout the entirety of the surgical procedure including trocar insertion and separation.
Optical components that may be housed in the optics channel may include, but are not limited to, light sources, lenses, mirrors, filters, fiber optics and combinations thereof. In some cases, trocars include an optical fiber. Optical fibers of interest are configured to collect and transmit light so that it can be imaged. In select cases, the optical fiber is also configured to emit illuminating light. In such cases, one portion of the optical fiber is configured to emit the
illuminating light, while another portion of the optical fiber is configured to collect light reflected from a surface, e.g., within the cavity. In some cases, optical components for use in the subject invention include one or more fiber bundles. Optical components that may be adapted for use in the subject trocars are described in, e.g., U.S. Patent Nos. 6,997,868; 7,018,330; 7,160,248; 7,496,259; 7,715,673; 7,942,814; 8,419,622; 8,480,566; 8,602,971 ; 8,676,013; 9,033,870; 9.459,415; 9,848,761 ; 10,506,142; 10,687,696; 11 ,061 ,185; and 1 1 ,256,080.
In some cases, trocars include a light source channel. In such cases, the elongate structure includes a channel configured to house a light source that is distinct from the optics channel and the cannula. Any convenient light source may be included. For example, in some versions, the light source is a light emitting diode (LED). In other embodiments, the light source is comprised of a laser, such as a continuous wave laser. For example, in some embodiments, the laser may be a diode laser. Where a light source channel is included, the light source may or may not be integrated with the light source channel. In some cases, the light source is integrated with the light source channel. In other cases, the light source is not integrated with the light source channel, and the light source may be introduced into the trocar at a time of use, e.g., before or during a surgical procedure.
FIG. 1 A-1 E present different views of trocar 100 according to certain embodiments of the invention. As shown in FIG. 1A, trocar 100 includes elongate structure 101 having a proximal end (bottom) and distal end (top). Cannula 102 can be viewed at the distal end of elongate structure 101. In addition, optics channel 103 is shown running along the length of elongate structure 101 , and tapers towards the distal end of elongate structure 101 . FIG. 1 B-1C present an alternative view of trocar 100 in which the proximal end of elongate structure 101 is at the top and the distal end of elongate structure is at the bottom. Also shown in FIG. 1 B is optical component 104 positioned in optics channel 103. FIG. 1 D presents a profile view of trocar 100 having the same components. FIG. 1 E presents a view of trocar 100 looking down the length of elongate structure 101 . As shown in FIG. 1 E, cannula 102 has a crescent-shaped cross section, while
optics channel 103 has a circular cross section. FIG. 1 E also demonstrates an exemplary way to measure the radius of the elongate structure, as shown by radius r.
Another aspect of the subject trocars is a separation mechanism. By “separation mechanism”, it is meant a means by which a separation may be generated along a length of the cannula from the proximal end to the distal end. When the separation is generated, a portion of the cannula wall becomes non- continuous. In other words, the cannula as such no longer exists. In this manner, it is possible to position an instrument (e.g., chest tube) within a cavity of a subject via the trocar while maintaining continuous visualization and then maintain that instrument in place while the trocar is removed. Any suitable separation mechanism may be employed. In some embodiments, the separation mechanism is a peelable separation mechanism. By “peelable” separation mechanism, it is meant that a peeling action is used to generate the separation in the cannula. In some cases, the peelable separation mechanism includes a pull tab operably attached to the proximal end of the elongate structure. When the pull tab is grasped by a user and pulled along the length of the elongate structure, a portion of the elongate structure (i.e., the cannula wall) is removed along a separation path, thereby generating a separation in the cannula. The “separation path” is the segment of the cannula wall along which the separation is generated by the peelable separation mechanism. In some embodiments, the separation path comprises a perforation. The number of peelable separation mechanisms may vary. In some embodiments, trocars include a single peelable separation mechanism. In other embodiments, trocars include a plurality of peelable separation mechanisms, such as 2 separation mechanisms, or 3 separation mechanisms. In some such embodiments, trocars include a plurality of pull tabs, i.e., one for each separation mechanism.
FIG. 2A-2B depict a trocar 200 having a peelable separation mechanism. FIG. 2A depicts trocar 200 prior to separation, while FIG. 2B depicts trocar 200 with a separation in progress. As shown in FIG. 2A, trocar 200 includes elongate structure 201 , cannula 202, and optics channel 203. Trocar 200 also includes a
pull tab 205 that may be grasped by a user to generate a separation in the wall of cannula 202. The separation, once initiated, will be generated along separation path 206, which may or may not include a perforation. As shown in FIG. 2B, pull tab 205 has been used to create a separation 207 in cannula 202 that forms along the length of elongate structure 201 according to separation path 206. Pull tab 205 is torn in the direction of the arrow to generate separation 207. Once complete, separation 207 will span the entire length of elongate structure 201 , and cannula 202 will no longer have walls that form a continuous, enclosed, tubular structure. In other words, cannula 202 ceases to exist, as such.
In other cases, trocars of the invention include a slidable separation mechanism. By “slidable” separation mechanism, it is meant a means by which a separation may be generated in the cannula involving a segment of the cannula wall that has a slidable relationship with respect to other portions of the cannula wall. By sliding the slidable segment of the cannula wall, it can be removed from the elongate structure, thereby generating the separation. The slidable segment may have edges that interlock with edges of the rest of the cannula, such that the slidable portion remains in place prior to the point at which separation is desired. At the time of separation, the slidable portion of the cannula wall may be grasped, and an upward force may be exerted. Said slidable portion will slidably move relative to the remainder of the cannula wall until the slidable portion has been completely extricated from the elongate structure.
FIG. 3A-3B depict a trocar 300 having a slidable separation mechanism. FIG. 3A depicts trocar 300 prior to separation, while FIG. 3B depicts trocar 300 with a separation in progress. As shown in FIG. 3A, trocar 300 includes elongate structure 301 , cannula 302, and optics channel 303. Also shown is slidable segment 306. Prior to separation at a desired time, slidable segment remains in place and constitutes part of the wall forming cannula 302. As shown in FIG. 3B slidable portion 306 is being moved in the direction denoted by the arrow. This results in the gradual formation of separation 307. Once complete, separation 307 will span the entire length of elongate structure 301 , and cannula 302 will no
longer have walls that form a continuous, enclosed, tubular structure. In other words, cannula 302 ceases to exist, as such.
The subject trocars may be comprised of any convenient material. In certain instances, trocars include one or more metal components including, for example, aluminum, titanium, brass, iron, lead, nickel, steel (e.g., stainless steel), copper, tin as well as combinations and alloys thereof. In additional embodiments, trocars include one or more rigid plastic materials such as, for example, polycarbonates, polyvinyl chloride (PVC), polyurethanes, polyethers, polyamides, polyimides, among other polymeric plastic materials. In certain cases, the clamp includes a 3D printed polymer. Any convenient 3D printed polymer may be employed, such as, for example, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), acrylic styrene acrylonitrile (ASA), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), polyaryletherketones (PAEK), polyetherimides (PEI), polypolycarbonate (PC), polypropylene, (PP), nylon as well as composites and hybrids thereof.
In additional embodiments, the trocars include an injection-moldable polymer. Any convenient injection-moldable polymer may be employed. Injection- moldable polymers may include, but are not limited to: acrylonitrile butadiene styrene (ABS), polycarbonate (PC), aliphatic polyamides (PPA), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polypropylene (PP), polybutylene terephthalate (PBT), polyphenylsulfone (PPSU), polyether ether ketone (PEEK) and polyetherimide (PEI).
In some embodiments, the trocars include a glass-filled polymer (i.e. having glass fibers in a matrix of polymeric material). In such embodiments, any suitable polymer (e.g., such as those described above) may be combined with glass fibers to generate a glass filled polymer. For example, glass filled polymers of interest may include glass-filled nylon or glass-filled polyetherimide.
Trocars of the invention may be configured for single use or multiple uses. In some cases, the trocars are disposable. Such may, in some cases, reduce the burden of having to sterilize the trocars between uses.
KITS
As discussed above, aspects of the invention also include kits. Kits of interest include a trocar of the invention (such as those described above). The number of trocars in the subject kits may vary. In some cases, kits described herein include a single trocar. In other cases, kits include a plurality of trocars. For example, in some instances, the number of trocars in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more trocars, such as 3 or more trocars, such as 4 or more trocars, such as 5 or more trocars, such as 6 or more trocars, such as 7 or more trocars, such as 8 or more trocars, such as 9 or more trocars and including 10 or more trocars.
Kits of the invention may also include one or more components configured to be employed along with the subject trocar(s) in methods of the invention (e.g., described below). In some embodiments, kits include one or more obturators. The subject obturators are configured to facilitate insertion of the trocar into the subject. Obturators of interest include an elongate structure having a proximal and distal end. In some cases, the elongate structure comprises a shape that is complementary to the cannula of the trocar, such that the obturator can be inserted therein. For example, where the cannula is crescent-shaped, embodiments of the elongate structure of the obturator are also crescent shaped such that the obturator can be received in the cannula. In certain cases, the distal end of the obturator is pointed, e.g., to facilitate piercing of the skin during insertion of the trocar. In select cases, obturators of the invention also include an inner hole running through the elongate structure from the proximal to distal end. In some cases where trocar insertion is aided by a guidewire, the guidewire can be inserted into the patient and then threaded through the obturator so that the obturator can enlarge the incision prior to the placement of the trocar. The inner hole may have any suitable radius. In some cases, inner hole radii range from 1 mm to 10 mm, such as 2 mm to 6 mm, and including 3 mm to 5 mm. In some embodiments, obturators comprise a head at the proximal end, such as a rounded head. In some such embodiments, the head has a diameter ranging
from 10 mm to 30 mm, such as 15 mm to 25 mm, and including 18 mm to 20 mm.
The number of obturators in the subject kits may vary. In some cases, kits described herein include a single obturator. In other cases, kits include a plurality of obturators. For example, in some instances, the number of obturators in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more obturators, such as 3 or more obturators, such as 4 or more obturators, such as 5 or more obturators, such as 6 or more obturators, such as 7 or more obturators, such as 8 or more obturators, such as 9 or more obturators and including 10 or more obturators.
The subject obturators may be comprised of any convenient material. In certain instances, obturators include one or more metal components including, for example, aluminum, titanium, brass, iron, lead, nickel, steel (e.g., stainless steel), copper, tin as well as combinations and alloys thereof. In additional embodiments, obturators include one or more rigid plastic materials such as, for example, polycarbonates, polyvinyl chloride (PVC), polyurethanes, polyethers, polyamides, polyimides, among other polymeric plastic materials. In certain cases, the clamp includes a 3D printed polymer. Any convenient 3D printed polymer may be employed, such as, for example, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), acrylic styrene acrylonitrile (ASA), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), polyaryletherketones (PAEK), polyetherimides (PEI), polypolycarbonate (PC), polypropylene, (PP), nylon as well as composites and hybrids thereof.
In additional embodiments, the obturators include an injection-moldable polymer. Any convenient injection-moldable polymer may be employed. Injection- moldable polymers may include, but are not limited to: acrylonitrile butadiene styrene (ABS), polycarbonate (PC), aliphatic polyamides (PPA), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polypropylene (PP), polybutylene terephthalate (PBT), polyphenylsulfone (PPSU), polyether ether ketone (PEEK) and polyetherimide (PEI).
FIG. 4A-4D present different views of obturator 400 according to certain embodiments of the invention. As shown in FIG. 4A, obturator 400 includes elongate structure 401 having a proximal end (bottom) and distal end (top). The distal end is pointed to facilitate insertion into the cavity of the subject, and the proximal end includes a rounded head. FIG. 4B depicts an flipped view of obturator 400 where the proximal end of elongate structure 401 is at the top and the distal end is at the bottom. In FIG. 4B, inner hole 402 is visible. Obturator 400 may be passed over a guidewire via inner hole 402. FIG. 4C depicts the proximal end of obturator 400, while FIG. 4D presents a profile view of obturator 400.
Kits of the invention may further include dilators. Dilators may be employed to dilate the incision to the extent necessary to place the trocar. Dilators of interest may have an elongate structure with a tapered distal end. In some cases, dilators have a passage running therethrough so that they may be used in conjunction with a guidewire, e.g., in a Seldinger-based process. In some cases, kits include a plurality of dilators. For example, in some instances, the number of dilators in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more dilators, such as 3 or more dilators, such as 4 or more dilators, such as 5 or more dilators, such as 6 or more dilators, such as 7 or more dilators, such as 8 or more dilators, such as 9 or more dilators and including 10 or more dilators. In some cases where kits of the invention include multiple dilators, kits include dilators having differing diameters. Such dilators may be employed, e.g., for a serial dilation.
FIG. 5A-5C present different views of dilator 500 according to certain embodiments of the invention. As shown in FIG. 5A, dilator 500 includes elongate structure 501 and passage 502 running therethrough. FIG. 5B presents a profile view of dilator 500. FIG. 5C presents a view looking down the length of dilator 500 from the proximal end.
In some cases, kits of the invention also include a needle, e.g., a hollow needle. In some cases, the needle is a Seidinger needle, i.e., a needle that is suitable for use with a Seidinger technique (e.g., described below). Needles of interest may include a hub at a proximal end, e.g., where a guidewire may be
inserted through the needle into the subject. Needles that may be adapted for use in the subject kits are described in, e.g., U.S. Patent No. 10,065,020. In some cases, kits include a plurality of needles. For example, in some instances, the number of needles in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more needles, such as 3 or more needles, such as 4 or more needles, such as 5 or more needles, such as 6 or more needles, such as 7 or more needles, such as 8 or more needles, such as 9 or more needles and including 10 or more needles.
In embodiments, kits of the invention also include a guidewire. The tip of the guide wire can have any desired design, e.g., it can be a Seidinger guidewire having a straight tip, a J-tip or a slightly bent tip. Guidewires that may be adapted for use in the subject kits are described in, e.g., U.S. Patent No. 11 ,141 ,571 . In some cases, kits include a plurality of guidewires. For example, in some instances, the number of guidewires in the subject kits ranges from 2 to 20, including 3 to 10. In some cases, kits include 2 or more guidewires, such as 3 or more guidewires, such as 4 or more guidewires, such as 5 or more guidewires, such as 6 or more guidewires, such as 7 or more guidewires, such as 8 or more guidewires, such as 9 or more guidewires and including 10 or more guidewires.
In some cases, components of the subject kits are provided in sealed packaging. In certain cases, the sealed packaging is sufficient to maintain sterility of the kit’s components prior to their use in the surgical procedure. In certain instances, each trocar of the invention is individually packaged in sealed packaging.
METHODS
As discussed above, aspects of the invention also include methods. Methods of interest involve inserting a trocar of the invention (such as those described above) into a subject to perform a surgical procedure. The trocar may be inserted into the subject in any suitable manner. In some cases, the trocar is inserted into the subject via a Seidinger technique. The “Seidinger” technique is referred to herein in its conventional sense to describe a method for gaining
access to body cavities via a puncture with a needle and the threading of a guidewire. The Seidinger technique is described in, e.g., Acta Radiologies. 39 (5): 368-7. In embodiments where a Seidinger technique is employed, the method comprises puncturing the subject using a needle to create an entry port, threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators. The trocar may subsequently be located within the cavity of the subject via the entry port. In some cases, methods include using an obturator to assist the insertion of the trocar into the cavity of the subject through the entry port. Obturators and dilators that may be employed along with the subject trocars are described above with respect to the kits of the invention. While methods of the invention are described primarily with respect to Seldinger-based techniques, the methods are not limited to such. For example, in some cases, trocars of the invention are employed with a blunt dissection. In some embodiments, the surgical procedure is an ultrasound-guided procedure.
In some embodiments, methods include providing constant visualization of the subject, e.g., throughout the entirety of the surgical procedure including the insertion of the trocar and the separation of the trocar. As discussed above, visualization using optical components within the optics channel may occur simultaneously with use of devices configured for trocar insertion including but not limited to obturators, guidewires and dilators because of the physical separation of the cannula and the optics channel.
The subject trocars may be employed to gain access to any suitable body cavity. In some cases, the cavity is selected from a thoracic cavity, an abdominal cavity, a dorsal body cavity, a joint cavity, or a pelvic cavity. In select versions, the cavity is a thoracic cavity. In further embodiments, the cavity is an abdominal cavity. In still further embodiments, the cavity is a dorsal body cavity. In yet further embodiments, the cavity is a pelvic cavity. In some instances, the cavity is a joint cavity.
Surgical procedures performed via the subject methods may vary. In some cases, the surgical procedure comprises endoscopy. In some cases, the
endoscopy comprises pleuroscopy, i.e., passage of an endoscope through the chest wall for visualization of the pleura. In such cases, the surgical procedure can include, but is not limited to, diagnosis of pleural conditions, biopsy, fluid drainage, chest tube placement, indwelling tunneled pleural catheter placement, pleurodesis, and adhesiolysis. In some embodiments where methods include chest tube placement or indwelling tunneled pleural catheter placement, methods may include placing the instrument via the trocar, creating a separation in the cannula of the trocar via the separation mechanism, and removing the trocar from the subject while maintaining the instrument in place. In select cases, methods of the invention include one or more of: pleural biopsy, lysis of adhesions or thoracic washouts.
In some cases, the endoscopy comprises laparoscopy. In some such cases, the trocar of the invention may be inserted into the abdomen and/or pelvis, e.g., at a location at or adjacent to the umbilicus. In some embodiments, methods include removing and/or taking biopsies of one or more structures (e.g., lymph nodes) within in the pelvis or abdomen. In some cases, the surgical procedure is a gynecological procedure. For example, in certain instances, methods of the invention include taking biopsies of or treating certain gynecologic cancers including, but not limited to, cervical cancer, ovarian cancer, and endometrial cancer. Other gynecologic procedures include, but are not limited to, hysterectomy (e.g., total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic assisted vaginal hysterectomy), fibroid removal (e.g., laparoscopic myomectomy), and ovarian cyst removal. In other cases, the procedure is a urologic procedure. In some such cases, the urologic procedure comprises laparoscopic nephrectomy, percutaneous nephrolithotomy (PCNL), prostatectomy, cystectomy, adrenalectomy, and the like. In select versions, the procedure is a colorectal procedure. In some such versions, procedures may include but are not limited to laparoscopic rectal prolapse repair, laparoscopic colectomy, laparoscopic cholecystectomy, laparoscopic segmental resections, laparoscopic small intestinal resection, and laparoscopic splenectomy.
In some cases, the procedure is an orthopedic procedure. For example, in some cases, the trocar of the invention is used to access a joint cavity. Orthopedic procedures that may be performed include, but are not limited to knee arthroscopy, ankle arthroscopy, elbow arthroscopy, hip arthroscopy, shoulder arthroscopy, wrist arthroscopy, and the like. Methods may additionally include tendon repair or reconstruction, joint replacement or repair, ligament repair or reconstruction, etc.
The instrument(s) inserted into the subject via the subject trocars may vary according to the type of procedure performed. Instruments of interest include, but are not limited to, chest tubes, indwelling tunneled pleural catheters, biopsy forceps, unipolar coagulation forceps, and the like.
The methods described herein may be performed on any suitable subject In certain embodiments the subject is a “mammal” or “mammalian”, where these terms are used broadly to describe organisms which are within the class Mammalia, including the orders carnivore (e.g., dogs and cats), Rodentia (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). In some instances, the subjects are humans. The methods may be applied to human subjects of both genders and at any stage of development (i.e., neonates, infant, juvenile, adolescent, adult), where in certain embodiments the human subject is a juvenile, adolescent or adult. While the present invention may be applied to human subject, it is to be understood that the methods may also be carried-out on samples from other animal subjects (that is, in “non-human subjects”) such as, but not limited to, birds, mice, rats, dogs, cats, livestock and horses.
UTILITY
The trocars, kits and methods of the invention find multiple uses. For example, the present invention may be employed where it desired to simplify endoscopic surgery. Particularly, the invention allows for a simple method for thoracic trocar placement using a Seldinger-based approach. Additionally, the invention facilitates pleural procedures such as biopsies, chest tube placement,
thoracic washouts and pleurodesis. The Seidinger fashion is a widely used method by physicians, and does not require blunt surgical dissection. This results in less patient discomfort, making the procedure easier to tolerate. This also makes thoracic procedures easier to do and expands the reach of these procedures to physicians who cannot perform surgical blunt dissection but have patients who require thoracic interventions. This is especially relevant for an aging population with increasing co-morbidities that would benefit from the less invasive way of performing thoracic procedures. The hospitals stand to gain from lower costs given the device being a disposable item that does not require sterilization. For the patient, the Seldinger-based methods of the invention result in a more comfortable procedure. The integration of an optical fiber would allow the replacement of commercially available tools that are expensive to maintain. The peelable mechanism would also help with chest tube placement and increase the scope of procedures feasibly done in this approach. The trocars, kits and methods of the invention may additionally be used to replace other devices that require expensive maintenance.
Notwithstanding the appended claims, the present invention may be described by the following clauses:
1. A trocar comprising: an elongate structure comprising: a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
2. The trocar according to Clause 1 , wherein the separation mechanism is a peelable mechanism.
3. The trocar according to Clause 2, wherein the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
4. The trocar according to Clause 2 or 3, wherein the trocar comprises a plurality of peelable mechanisms.
5. The trocar according to Clause 4, wherein the trocar comprises 2 peelable mechanisms.
6. The trocar according to Clause 1 , wherein the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure.
7. The trocar according to any one of the preceding clauses, further comprising the optical component.
8. The trocar according to Clause 7, wherein the optical component is integrated with the elongate structure in the optics channel.
9. The trocar according to Clause 7 or 8, wherein the optical component is an optical fiber.
10. The trocar according to any one of the preceding clauses, wherein the optics channel is tapered at the distal end of the elongate structure.
1 1 . The trocar according to any one of the preceding clauses, further comprising a light source channel for housing a light source.
12. The trocar according to Clause 1 1 , further comprising the light source.
13. The trocar according to Clause 12, wherein the light source is integrated with the elongate structure in the light source channel.
14. The trocar according to Clause 12 or 13, wherein the light source is a light emitting diode (LED).
15. The trocar according to any one of the preceding clauses, wherein the elongate structure has a length ranging from 5 cm to 15 cm.
16. The trocar according to any one of the preceding clauses, wherein the elongate structure has a radius ranging from 2 mm to 10 mm.
17. The trocar according to any one of the preceding clauses, wherein the cannula has a crescent-shaped cross-section.
18. The trocar according to any one of Clauses 1 to 16, wherein the cannula has a circular cross section or an oval-shaped cross section.
19. The trocar according to any one of the preceding clauses, wherein the trocar is comprised of a 3D printed polymer.
20. The trocar according to any one of the preceding clauses, wherein the trocar is comprised of an injection-moldable polymer.
21 . A kit comprising the trocar according to any one of clauses 1 to 20.
22. The kit according to Clause 21 , further comprising an obturator.
23. The kit according to Clause 22, wherein the obturator has a diameter ranging from 15 mm to 25 mm.
24. The kit according to Clause 22, wherein the obturator comprises an inner hole.
25. The kit according to Clause 24, wherein the inner hole comprises a radius ranging from 2 mm to 10 mm.
26. The kit according to any one of Clauses 22 to 25, wherein the obturator comprises a length ranging from 100 mm to 150 mm.
27. The kit according to any one of Clauses 21 to 26, further comprising a dilator.
28. The kit according to Clause 27, wherein the kit comprises a plurality of dilators.
29. The kit according to Clause 28, wherein each dilator in the plurality of dilators has a different diameter.
30. The kit according to any one of Clauses 21 to 29, further comprising a hollow needle.
31 . The kit according to any one of Clauses 21 to 30, further comprising a guidewire.
32. A method comprising: inserting a trocar into a subject to perform a surgical procedure, the trocar comprising: an elongate structure comprising:
a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
33. The method according to Clause 32, further comprising inserting the instrument into a cavity of the subject via the cannula, separating the cannula using the separation mechanism, and removing the trocar from the subject.
34. The method according to Clause 32 or 33, wherein the method comprises inserting the trocar into the subject via a Seidinger technique.
35. The method according to any one of Clauses 32 to 34, wherein the method comprises puncturing the subject using a needle to create an entry port, threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators.
36. The method according to any one of Clauses 32 to 35, wherein the instrument is a chest tube.
37. The method according to any one of Clauses 32 to 35, wherein the instrument is an indwelling pleural catheter.
38. The method according to any of Clauses 32 to 37, wherein the surgical procedure comprises endoscopy.
39. The method according to Clause 38, wherein the surgical procedure comprises pleuroscopy.
40. The method according to Clause 39, wherein the surgical procedure comprises pleurodesis.
41 . The method according to Clause 39, wherein the surgical procedure comprises pleural biopsy.
42. The method according to Clause 39, wherein the surgical procedure comprises lysis of adhesions.
43. The method according to Clause 39, wherein the surgical procedure comprises a thoracic washout.
44. The method according to any one of Clauses 32 to 35, wherein the surgical procedure is an orthopedic procedure.
45. The method according to any one of Clauses 32 to 35, wherein the surgical procedure is a urologic procedure.
46. The method according to any one of Clauses 32 to 35, wherein the surgical procedure is a laparoscopic procedure.
47. The method according to any one of Clauses 32 to 35, wherein the surgical procedure is a colorectal procedure.
48. The method according to any one of Clauses 32 to 35, wherein the surgical procedure is a gynecological procedure.
49. The method according to any one of Clauses 32 to 48, wherein the separation mechanism is a peelable mechanism.
50. The method according to Clause 49, wherein the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
51 . The method according to Clause 49 or 50, wherein the trocar comprises a plurality of peelable mechanisms.
52. The method according to Clause 51 , wherein the trocar comprises 2 peelable mechanisms.
53. The method according to Clause any one of Clauses 32 to 48, wherein the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure.
54. The method according to any one of Clauses 32 to 53, wherein the trocar further comprises the optical component.
55. The method according to Clause 54, wherein the optical component is integrated with the elongate structure in the optics channel.
56. The method according to Clause 54 or 55, wherein the optical component is an optical fiber.
57. The method according to any one of Clauses 32 to 56, wherein the optics channel is tapered at the distal end of the elongate structure.
58. The method according to any one of Clauses 32 to 57, wherein the trocar further comprises a light source channel for housing a light source.
59. The method according to Clause 58, wherein the trocar further comprises the light source.
60. The method according to Clause 59, wherein the light source is integrated with the elongate structure in the optics channel.
61 . The method according to Clause 59 or 60, wherein the light source is a light emitting diode (LED).
62. The method according to any one of Clauses 32 to 61 , wherein the elongate structure has a length ranging from 5 cm to 15 cm.
63. The method according to any one of Clause 32 to 62, wherein the elongate structure has a radius ranging from 2 mm to 10 mm.
64. The method according to any one of Clauses 32 to 63, wherein the cannula has a crescent-shaped cross-section.
Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.
Accordingly, the preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof.
Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.
The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims. In the claims, 35 U.S.C. §1 12(f) or 35 U.S.C. §112(6) is expressly defined as being invoked for a limitation in the claim only when the exact phrase "means for" or the exact phrase "step for" is recited at the beginning of such limitation in the claim; if such exact phrase is not used in a limitation in the claim, then 35 U.S.C. § 1 12 (f) or 35 U.S.C. §1 12(6) is not invoked.
Claims
1 . A trocar comprising: an elongate structure comprising: a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
2. The trocar according to Claim 1 , wherein the separation mechanism is a peelable mechanism.
3. The trocar according to Claim 2, wherein the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
4. The trocar according to Claim 2 or 3, wherein the trocar comprises a plurality of peelable mechanisms.
5. The trocar according to Claim 4, wherein the trocar comprises 2 peelable mechanisms.
6. The trocar according to Claim 1 , wherein the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure.
7. The trocar according to any one of the preceding claims, further comprising the optical component.
8. The trocar according to Claim 7, wherein the optical component is integrated with the elongate structure in the optics channel.
9. The trocar according to Claim 7 or 8, wherein the optical component is an optical fiber.
10. The trocar according to any one of the preceding claims, wherein the optics channel is tapered at the distal end of the elongate structure.
1 1 . The trocar according to any one of the preceding claims, further comprising a light source channel for housing a light source.
12. The trocar according to Claim 11 , further comprising the light source.
13. The trocar according to Claim 12, wherein the light source is integrated with the elongate structure in the light source channel.
14. The trocar according to Claim 12 or 13, wherein the light source is a light emitting diode (LED).
15. The trocar according to any one of the preceding claims, wherein the elongate structure has a length ranging from 5 cm to 15 cm.
16. The trocar according to any one of the preceding claims, wherein the elongate structure has a radius ranging from 2 mm to 10 mm.
17. The trocar according to any one of the preceding claims, wherein the cannula has a crescent-shaped cross-section.
18. The trocar according to any one of Claims 1 to 16, wherein the cannula has a circular cross section or an oval-shaped cross section.
19. The trocar according to any one of the preceding claims, wherein the trocar is comprised of a 3D printed polymer.
20. The trocar according to any one of the preceding claims, wherein the trocar is comprised of an injection-moldable polymer.
21 . A kit comprising the trocar according to any one of claims 1 to 20.
22. The kit according to Claim 21 , further comprising an obturator.
23. The kit according to Claim 22, wherein the obturator has a diameter ranging from 15 mm to 25 mm.
24. The kit according to Claim 22, wherein the obturator comprises an inner hole.
25. The kit according to Claim 24, wherein the inner hole comprises a radius ranging from 2 mm to 10 mm.
26. The kit according to any one of Claims 22 to 25, wherein the obturator comprises a length ranging from 100 mm to 150 mm.
27. The kit according to any one of Claims 21 to 26, further comprising a dilator.
28. The kit according to Claim 27, wherein the kit comprises a plurality of dilators.
29. The kit according to Claim 28, wherein each dilator in the plurality of dilators has a different diameter.
30. The kit according to any one of Claims 21 to 29, further comprising a hollow needle.
31 . The kit according to any one of Claims 21 to 30, further comprising a guidewire.
32. A method comprising: inserting a trocar into a subject to perform a surgical procedure, the trocar comprising: an elongate structure comprising: a cannula running therethrough from a proximal end to a distal end, wherein the cannula is configured to receive an instrument; and an optics channel running therethrough from the proximal end to the distal end, wherein the optics channel is configured to receive an optical component; and a separation mechanism configured to generate a separation along a length of the cannula from the proximal end to the distal end.
33. The method according to Claim 32, further comprising inserting the instrument into a cavity of the subject via the cannula, separating the cannula using the separation mechanism, and removing the trocar from the subject.
34. The method according to Claim 32 or 33, wherein the method comprises inserting the trocar into the subject via a Seidinger technique.
35. The method according to any one of Claims 32 to 34, wherein the method comprises puncturing the subject using a needle to create an entry port,
threading a guidewire through the needle into the cavity of the subject, and dilating the entry port using one or more dilators.
36. The method according to any one of Claims 32 to 35, wherein the instrument is a chest tube.
37. The method according to any one of Claims 32 to 35, wherein the instrument is an indwelling pleural catheter.
38. The method according to any of Claims 32 to 37, wherein the surgical procedure comprises endoscopy.
39. The method according to Claim 38, wherein the surgical procedure comprises pleuroscopy.
40. The method according to Claim 39, wherein the surgical procedure comprises pleurodesis.
41 . The method according to Claim 39, wherein the surgical procedure comprises pleural biopsy.
42. The method according to Claim 39, wherein the surgical procedure comprises lysis of adhesions.
43. The method according to Claim 39, wherein the surgical procedure comprises a thoracic washout.
44. The method according to any one of Claims 32 to 35, wherein the surgical procedure is an orthopedic procedure.
45. The method according to any one of Claims 32 to 35, wherein the surgical procedure is a urologic procedure.
46. The method according to any one of Claims 32 to 35, wherein the surgical procedure is a laparoscopic procedure.
47. The method according to any one of Claims 32 to 35, wherein the surgical procedure is a colorectal procedure.
48. The method according to any one of Claims 32 to 35, wherein the surgical procedure is a gynecological procedure.
49. The method according to any one of Claims 32 to 48, wherein the separation mechanism is a peelable mechanism.
50. The method according to Claim 49, wherein the peelable mechanism comprises a pull tab configured to actuate the separation of the cannula.
51 . The method according to Claim 49 or 50, wherein the trocar comprises a plurality of peelable mechanisms.
52. The method according to Claim 51 , wherein the trocar comprises 2 peelable mechanisms.
53. The method according to Claim any one of Claims 32 to 48, wherein the separation mechanism comprises a wall segment configured to be slidably removed from the elongate structure.
54. The method according to any one of Claims 32 to 53, wherein the trocar further comprises the optical component.
55. The method according to Claim 54, wherein the optical component is integrated with the elongate structure in the optics channel.
56. The method according to Claim 54 or 55, wherein the optical component is an optical fiber.
57. The method according to any one of Claims 32 to 56, wherein the optics channel is tapered at the distal end of the elongate structure.
58. The method according to any one of Claims 32 to 57, wherein the trocar further comprises a light source channel for housing a light source.
59. The method according to Claim 58, wherein the trocar further comprises the light source.
60. The method according to Claim 59, wherein the light source is integrated with the elongate structure in the optics channel.
61 . The method according to Claim 59 or 60, wherein the light source is a light emitting diode (LED).
62. The method according to any one of Claims 32 to 61 , wherein the elongate structure has a length ranging from 5 cm to 15 cm.
63. The method according to any one of Claim 32 to 62, wherein the elongate structure has a radius ranging from 2 mm to 10 mm.
64. The method according to any one of Claims 32 to 63, wherein the cannula has a crescent-shaped cross-section.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363468866P | 2023-05-25 | 2023-05-25 | |
| US63/468,866 | 2023-05-25 |
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| Publication Number | Publication Date |
|---|---|
| WO2024242877A1 true WO2024242877A1 (en) | 2024-11-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2024/028293 Pending WO2024242877A1 (en) | 2023-05-25 | 2024-05-08 | Trocars having an optics channel and separation mechanism, kits including the same, and methods of use thereof |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2024242877A1 (en) |
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| US20040193113A1 (en) * | 2003-01-29 | 2004-09-30 | Durect Corporation | Expandable bore injection needle |
| US6994667B2 (en) * | 2000-01-10 | 2006-02-07 | Singh Errol O | Method and apparatus for facilitating urological procedures |
| GB2425483A (en) * | 2005-04-29 | 2006-11-01 | Hans-Ulrich Laasch | A single step trocar based insertion device |
| USRE47491E1 (en) * | 2006-05-03 | 2019-07-09 | Light Sciences Oncology, Inc. | Light transmission system for photoreactive therapy |
| US10716585B2 (en) * | 2016-03-17 | 2020-07-21 | Trice Medical, Inc. | Clot evacuation and visualization devices and methods of use |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6994667B2 (en) * | 2000-01-10 | 2006-02-07 | Singh Errol O | Method and apparatus for facilitating urological procedures |
| US20040193113A1 (en) * | 2003-01-29 | 2004-09-30 | Durect Corporation | Expandable bore injection needle |
| GB2425483A (en) * | 2005-04-29 | 2006-11-01 | Hans-Ulrich Laasch | A single step trocar based insertion device |
| USRE47491E1 (en) * | 2006-05-03 | 2019-07-09 | Light Sciences Oncology, Inc. | Light transmission system for photoreactive therapy |
| US10716585B2 (en) * | 2016-03-17 | 2020-07-21 | Trice Medical, Inc. | Clot evacuation and visualization devices and methods of use |
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