WO2025173036A2 - Dispositif de sclérothermique - Google Patents

Dispositif de sclérothermique

Info

Publication number
WO2025173036A2
WO2025173036A2 PCT/IN2025/050215 IN2025050215W WO2025173036A2 WO 2025173036 A2 WO2025173036 A2 WO 2025173036A2 IN 2025050215 W IN2025050215 W IN 2025050215W WO 2025173036 A2 WO2025173036 A2 WO 2025173036A2
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
gearhead
motor
syringe
tooth
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IN2025/050215
Other languages
English (en)
Other versions
WO2025173036A3 (fr
Inventor
Deveshkumar Mahendralal KOTHWALA
Mohamadovesh Mohamadyasin DURANI
Aakash Kanaiyalal Thakor
Vikas Kamlesh Chauhan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Meril Life Sciences Pvt Ltd
Original Assignee
Meril Life Sciences Pvt Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Meril Life Sciences Pvt Ltd filed Critical Meril Life Sciences Pvt Ltd
Publication of WO2025173036A2 publication Critical patent/WO2025173036A2/fr
Publication of WO2025173036A3 publication Critical patent/WO2025173036A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means

Definitions

  • the present disclosure relates to medical device. More particularly, the present disclosure relates to a sclerotherapy device.
  • Varicose veins is a common condition mostly affecting adults. In this condition, the veins become twisted and enlarged, causing pain and discomfort in some patients. They usually appear in legs. Sclerotherapy is one of the most commonly applied method for treating varicose veins.
  • Sclerotherapy is a minimally invasive technique where a chemical solution, for example, an adhesive, is injected directly into the damaged portion of the veins for closure. Delivering a precise quantity of the chemical solution is very crucial.
  • a chemical solution for example, an adhesive
  • Delivering a precise quantity of the chemical solution is very crucial.
  • medical practitioners typically, load a syringe with the chemical solution and push its plunger manually to deliver the chemical solution at a target site.
  • Some devices are currently available that can control the quantity of the chemical solution.
  • a syringe is coupled to the device and the chemical solution is delivered by pushing a piston controlled by a trigger, e.g., a lever in a handle of the device, which is manually operated. Therefore, such devices too are prone to human errors. Further, the medical practitioner needs to continuously press the trigger to push the piston. This makes the devices cumbersome to use.
  • the present disclosure relates to a medical device.
  • the medical device includes a motor, a gearhead and a plunger.
  • the motor has a shaft and rotates at a pre-defined rotational speed.
  • the gearhead is coupled to the shaft and is configured to rotate in response to the rotation of the motor.
  • the gearhead includes at least one tooth provided on a periphery of the gearhead along a partial circumference of the gearhead.
  • the plunger is operatively coupled to the gearhead and a syringe having a liquid.
  • the plunger includes a plurality of teeth with at least one tooth of the plurality of teeth operatively engaging with the at least one tooth of the gearhead.
  • the plunger is configured to move linearly in a distal direction in response to the rotation of the gearhead in a first direction and cause the syringe to the deliver the liquid into a patient's body.
  • Fig. la depicts a right-side perspective view of a device 100 according to an embodiment of the present disclosure.
  • Fig. lb depicts an isometric view of the device 100 according to an embodiment of the present disclosure.
  • Fig. lc depicts a cross-sectional view of the device 100 according to an embodiment of the present disclosure.
  • Fig. Id depicts an exploded view of the device 100 according to an embodiment of the present disclosure.
  • Fig. le depicts a left-side perspective view of the device 100 according to an embodiment of the present disclosure.
  • Fig. 2a depicts a cross-sectional view of a left section 101a of a handle 101 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 2b depicts a cross-sectional view of a right section 101b of the handle 101 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 3a depicts a side view of a plunger 102 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 3b depicts a perspective view of the plunger 102 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 4a depicts a perspective view of a motor 103 along with a shaft 104 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 4b depicts a perspective view of a gearhead 105 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 5a is a perspective view depicting the engagement of the gearhead 105 and the plunger 102 according to an embodiment of the present disclosure.
  • Fig. 5b is a top view depicting the engagement of the gearhead 105 and the plunger 102 according to an embodiment of the present disclosure.
  • Fig. 6 depicts a top perspective view of a clamp 106 in accordance with one or more embodiment of the present disclosure.
  • Fig. 7a depicts a perspective view of a top section 107a of a holder 107 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 7b depicts a perspective view of a bottom section 107b of the holder 107 of the device 100 according to an embodiment of the present disclosure.
  • Fig. 8a depicts a side view of a locking hub 108 according to an embodiment of the present disclosure.
  • Fig. 8b depicts a front view of the locking hub 108 according to an embodiment of the present disclosure.
  • FIG. 9 depicts a syringe 109 according to an embodiment of the present disclosure.
  • Fig. 10 depicts an exemplary flowchart of a method 1000 for operating the device 100 according to an embodiment of the present disclosure.
  • the present disclosure relates to a device capable of delivering a fluid into a patient's body in a controlled manner.
  • the device includes a plunger having a plurality of teeth and a gearhead having at least one tooth engaging the plurality of teeth of the plunger.
  • the gearhead is driven by a motor of the device.
  • the plurality of teeth of the plunger translates the rotational motion of the gearhead into a longitudinal motion and moves the plunger in a forward direction.
  • a syringe loaded with an adhesive is operatively coupled to the plunger.
  • the forward (i.e., the distal) movement of the plunger causes the syringe to deliver the fluid (e.g., the adhesive) at a target location into the patient's body (e.g., into the affected vein).
  • the gearhead includes one tooth.
  • the motor rotates at a constant rotational speed.
  • the rotational speed of the motor, a diameter of the gearhead and a pitch of the plurality of the teeth of the plunger are designed such that the plunger moves by a pre-defined distance for each rotation of the gearhead and the syringe delivers the fluid at a desirable delivery rate.
  • the proposed device is used in a sclerotherapy procedure to deliver an adhesive at a desired delivery rate into an affected vein of the patient to treat varicose vein and/or spider vein.
  • the device delivers precise quantity of the adhesive, thereby improving the accuracy and effectiveness of the sclerotherapy procedure.
  • the device is automatic and hence, reduces manual errors observed with conventional sclerotherapy devices and the associated consequence of delivering incorrect amount of the adhesive.
  • the user can operate the device via a simple press of a control element provided in the device, thereby improving the usability of the device over the conventional sclerotherapy devices requiring continuous manual operation of a trigger by the user.
  • Fig. la illustrates an assembly view of an exemplary embodiment of a sclerotherapy device 100 (hereinafter, device 100).
  • Figs, lb - Id illustrate various views of the device 100, according to an embodiment.
  • the device 100 is used to deliver an adhesive to an affected vein during a sclerotherapy procedure.
  • the adhesive may be Sodium tetradecyl sulfate (STS), Polidocanol (POL), Ethanolamine Oleate (EO), n-butyl-2-cyanoacrylate, etc. or any other suitable adhesive.
  • STS Sodium tetradecyl sulfate
  • POL Polidocanol
  • EO Ethanolamine Oleate
  • n-butyl-2-cyanoacrylate etc. or any other suitable adhesive.
  • the device 100 has a proximal end 100a and a distal end 100b.
  • the device 100 includes a handle 101, a plunger 102, a motor 103, a shaft 104, a gearhead 105, a clamp 106, a holder 107, a locking hub 108, a syringe 109, a control element 110, and a power source 111.
  • the handle 101 has a proximal end 101c and a distal end lOld.
  • the handle 101 has an ergonomic shape, which enables a medical practitioner to comfortably grip and operate the device 100.
  • the handle 101 is shaped in the form of a gun or T- shaped structure having a tubular body lOle and a stem portion lOlf.
  • the tubular body lOle is hollow and has a cylindrical shape.
  • the stem portion lOlf is hollow and has a generally rectangular shape. It should be appreciated that the tubular body lOle and the stem portion lOlf may have any other suitable shape.
  • the handle 101 encloses at least a portion of the plunger 102, the motor 103, the control element 110, the power source 111 as depicted in Fig. lc.
  • the handle 101 can be made of a material such as, without limitation Acrylonitrile Butadiene Styrene (ABS), nylon, High-density Polyethylene (HDPE), Low-density polyethylene (LDPE), Polycarbonate (PC), etc.
  • ABS Acrylonitrile Butadiene Styrene
  • HDPE High-density Polyethylene
  • LDPE Low-density polyethylene
  • PC Polycarbonate
  • the handle 101 is made of ABS.
  • the handle 101 may be suitably dimensioned based upon the requirements.
  • the handle 101 includes a left section 101a and a right section 101b.
  • the right section 101b and the left section 101a are coupled to form the handlelOl.
  • the right section 101b and the left section 101a can be coupled using, for example screws, a snap-fit mechanism, a stud-groove coupling mechanism, etc.
  • the right section 101b and the left section 101a are coupled using the stud-groove mechanism.
  • a plurality of studs 101b3 (shown in Fig. 2b) are provided on edges of the right section 101b and a plurality of grooves 101a3 (shown in Fig. 2a) are provided on edges of the left section 101a.
  • the size and shape of the plurality of studs 101b3 and the grooves 101a3 are complementary to each other to provide a tight fit.
  • the tubular body lOle of the handle 101 includes a channel 112.
  • the channel 112 extends from the proximal end 101c of the handle 101 to the distal end lOld of the handle 101 for at least partial length of the tubular body lOle.
  • the channel 112 is configured to receive at least a portion of the plunger 102 as explained later.
  • the channel 112 can be provided on any one of the left section 101a or the right section 101b of the handle 101. In the depicted embodiment, the left section 101a is provided with the channel 112 (as shown in Fig. le and Fig. 2a).
  • the channel 112 includes a cut-out 112a in a lower arm of the channel 112 for a partial length of the channel 112. The cut-out 112a provides space for the plunger 102 to engage with the gearhead 105 (explained later).
  • the stem portion lOlf of the handle 101 includes holes 101a5 in any one of the left section 101a or the right section 101b for coupling the clamp 106.
  • the clamp 106 is coupled to the holes 101a5 as explained later.
  • the left section 101a includes the holes 101a5 (shown in Fig. 2a).
  • the stem portion lOlf further includes a plurality of protrusions 113 for housing the power source 111.
  • the plurality of protrusions 113 include four protrusions 113 arranged at corners of a rectangular area corresponding to the size of the power source 111 and the power source 111 is pressed between the plurality of protrusions 113 to snugly fit the power source 111 within the rectangular area.
  • the right section 101b includes the plurality of protrusions 113 (shown in Fig. 2b).
  • Figs. 3a and 3b show various views of the plunger 102 according to an embodiment.
  • the plunger 102 is operatively coupled to the gearhead 105 and the syringe 109 having a liquid (e.g., the adhesive).
  • the plunger 102 has a proximal end 102a and a distal end 102b, defining a length therebetween.
  • the plunger 102 includes a head 102c at the distal end 102b and a body 102d extending from the head 102c to the proximal end 102a.
  • the head 102c may have any suitable shape including, without limitation, circular, rectangular, square, etc.
  • the head 102c has a disc shape.
  • the head 102c is operatively coupled to the syringe 109.
  • the body 102d may have any suitable shape.
  • the body 102d has the shape of a rectangular plate with a curved edge at the proximal end 102a.
  • the plunger 102 may optionally include a projection 102e on a top surface of the body 102d extending from the head 102c for at least a partial length of the plunger 102.
  • the plunger 102 includes a plurality of teeth 102f provided on a medial side of the body 102d.
  • the plurality of teeth 102f extends at least for a partial length of the plunger 102. Successive teeth 102f of the plurality of teeth 102f are separated by a pre-defined pitch Pl.
  • the pre-defined pitch Pl is chosen based, at least, upon a desired delivery rate of the adhesive, a rotational speed of the motor 103, dimensions of the gearhead 105, the number of the at least one tooth on the gearhead 105.
  • a set of the plurality of teeth 102f operatively couples with the gearhead 105 and translate a rotational motion of the gearhead 105 into a longitudinal motion of the plunger 102 as explained later.
  • At least a partial length of a lateral side of the body 102d remains in the channel 112 (as depicted in Figs la and lc) during the operation of the device 100. This ensures that the plunger 102 moves longitudinally in a straight path without any deviations.
  • the plunger 102 includes a tab 102g provided towards the proximal end 102a.
  • the tab 102g allows a user to grip the plunger 102 easily and manually move the plunger 102 in the proximal direction as needed.
  • the body 102d partially extends out of the handle 101 at the proximal end 101c. Cut-outs 101a2 and 101b2 are provided in the left section 101a and the right section 101b, respectively, at the proximal end 101c (shown in Figs.
  • the plunger 102 can be made of a suitable material such as, without limitation, ABS, nylon, HDPE, LDPE, PC, etc. In an exemplary implementation, the plunger 102 is made of ABS.
  • the head 102c and the body 102d may be suitably dimensioned.
  • the head 102c may have a diameter ranging between 10.40 mm and 12.40 mm.
  • the length of the head 102c may be between 2.5 mm and 3 mm. In an exemplary implementation, the diameter and the length of the head 102c are 10.40 mm and 2.50 mm, respectively.
  • the length of the body 102d may be between 200 mm and 240 mm.
  • the width of the body 102 may be between 2.5 mm and 2.6 mm.
  • the length and width of the body 102d are 226 mm and 2.6 mm, respectively.
  • the plurality of teeth 102f can be provided for a length between 105 mm and 140 mm. In an exemplary implementation, the plurality of teeth 102f is provided for 139 mm.
  • the longitudinal motion of the plunger 102 is driven by the motor 103.
  • An embodiment of the motor 103 is illustrated in Fig. 4a.
  • the motor 103 can be an AC motor or a DC motor.
  • the motor 103 is a DC motor.
  • the motor 103 is a brushed DC motor.
  • the motor 103 is suitably dimensioned.
  • the motor 103 has a cross-section having a length and a width equal to 12 mm and 10 mm, respectively.
  • the motor 103 may have a power rating ranging from 1 W to 12 W. In an embodiment, the motor 103 has a power rating of 6 W.
  • the motor 103 rotates at a pre-defined rotational speed.
  • the pre-defined rotational speed is designed based upon requirements.
  • a controller e.g., a dimmer (not shown) is provided.
  • the controller is electrically coupled with the motor 103.
  • the controller is configured to control the rotational speed of the motor 103.
  • the user can manipulate the controller to change the rotational speed of the motor 103 and thereby adjust the delivery rate of the fluid (in the depicted embodiment, the adhesive) either before or during the medical procedure as per requirements.
  • the shaft 104 is coupled to the motor 103.
  • the shaft 104 rotates in response to the rotation of the motor 103.
  • the shaft 104 has a first end 104a and a second end 104b.
  • the shaft 104 includes a first portion 104c provided towards the first end 104a and a second portion 104d provided towards the second end 104b.
  • the first portion 104c may have a cross-section of a suitable shape including, without limitation, circular, triangular, hexagonal, square, semi-circular, D shape, etc.
  • the first portion 104c has a D-shaped cross section.
  • the second portion 104d may have a suitable cross-section, such as, circular, semi-circular, D-shape, square, etc.
  • the second portion 104d has a circular cross-section. At least a part of the second portion 104d is disposed within the motor 103.
  • the shaft 104 can be hollow, solid, partially solid, etc. In an embodiment, the shaft 104 is solid. An outer surface of the shaft 104 may be threaded, semi-threaded or smooth. In an embodiment, the shaft 104 has a smooth outer surface.
  • the shaft 104 can be made of a material such as, without limitation, carbon, medium tensile steel, nickel-chromium, chromium-vanadium steel, steel etc. In an embodiment, the shaft 104 is made of steel.
  • the gearhead 105 is coupled to the shaft 104 and is configured to rotate in response to the rotation of the motor 103.
  • the gearhead 105 is coupled to the first portion 104c of the shaft 104 according to an embodiment of the present disclosure.
  • Fig. 4b shows a perspective view of the gearhead 105 according to an embodiment.
  • the gearhead 105 has a first end 105a and a second end 105b.
  • the gearhead 105 may have a cross-section of a suitable shape including, without limitation, circular, triangular, hexagonal, square, semi-circular, D shape, etc. In an embodiment, the gearhead 105 has a circular cross-section.
  • the gearhead 105 includes a hole 105c extending from the second end 105b for at least a partial length of the gearhead 105.
  • the hole 105c has a shape corresponding to the shape of the first portion 104c. In the depicted embodiment, the hole 105c extends for the entire length of the gearhead 105 and is D-shaped.
  • the inner surface of the hole 105c may be threaded, semi-threaded or smooth. In an embodiment, the inner surface of the hole 105c has a smooth inner surface.
  • the first portion 104c of the shaft 104 can be coupled to the hole 105c of the gearhead 105 using, for example, welding, screw mechanism, adhesive, snap-fit mechanism, friction fit mechanism, nut-bolt mechanism, etc.
  • the first portion 104c is coupled to the hole 105c using a friction fit mechanism by inserting the first portion 104c into the hole 105c.
  • the gearhead 105 has at least one tooth 105d provided on a partial circumference of the gearhead 105 towards the first end 105a and having a pitch P2.
  • the at least one tooth 105d is configured to engage with corresponding at least one tooth 102f of the plurality of teeth 102f of the plunger 102.
  • the at least one tooth 105d includes one tooth 105d (as shown in Fig. 4b). The single tooth 105d assures the quantity of the delivered adhesive to be precise due to its timespecific motion and engagement with the plunger 102.
  • the length of the at least one tooth 105d may be between 0.32 mm and 0.60 mm. In an embodiment, the length of the at least one tooth 105d is 0.32 mm.
  • the gearhead 105 can be made of a material such as, without limitation, ABS, nylon, HDPE, LDPE, PC, carbon, medium tensile steel, nickel-chromium, chromium-vanadium steel, steel, etc. In an embodiment, the gearhead 105 is made of ABS.
  • the gearhead 105 has a pre-defined diameter designed based upon the requirements.
  • the coupling of the gearhead 105 and the plunger 102 via the respective teeth forms a rack-and-pinion mechanism and provides a longitudinal motion to the plunger 102 during the operation of the device 100.
  • the rack-and-pinion mechanism and the corresponding longitudinal motion of the plunger 102 is explained herein with reference to the gearhead 105 having one tooth 105d. However, it should not be considered as limiting and its operation for the gearhead 105 having more than one tooth 105d will be apparent to a person skilled in the art, and the same is within the scope of the present disclosure.
  • Figs. 5a and 5b illustrate the coupling of the gearhead 105 and the plunger 102 according to an embodiment.
  • the tooth 105d of the gearhead 105 engages with a corresponding tooth 102f of the plurality of teeth 102f of the plunger 102.
  • the shaft 104 and gearhead 105 rotate in the first direction due to the torque provided by the motor 103. Consequently, the tooth 105d too rotates in the first direction.
  • the tooth 105d exerts force on the corresponding tooth 102f in a distal direction, and as a result, the plunger 102 moves longitudinally in the distal direction by a pre-defined distance, in response to the rotation of the gearhead 105 in the first direction.
  • the tooth 105d engages the next tooth (proximal to the previously engaged tooth) of the plurality of teeth 102f and moves the plunger 102 longitudinally once more in the distal direction by the pre-defined distance.
  • the syringe 109 delivers the adhesive into the patient's vein at a desired delivery rate as explained later.
  • the coupling of the gearhead 105 and the plunger 102 translates the rotational motion of the motor 103 into a longitudinal motion of the plunger 102.
  • the plunger 102 moves longitudinally in a proximal direction.
  • the pre-defined distance that the plunger 102 moves upon completion of one rotation by the gearhead 105 is designed based upon the desired delivery rate of delivery of the adhesive and depends upon one or more parameters including the pitch Pl of the plura lity of teeth 102f, the pitch P2 of the at least one tooth 105d of the gearhead 105, the diameter D of the gearhead 105 and the rotational speed of the motor 103.
  • the values of the one or more parameters may be chosen depending upon the desired delivery rate.
  • the desired delivery rate is between 0.1 cc per second and 0.12 cc per second.
  • the power source 111 is electrically coupled to the motor 103 and provides power to the motor 103.
  • the power source 111 can be an AC power source or a DC power source depending upon the type of the motor 103.
  • the power source 111 is a DC power source and includes at least one battery.
  • the power source 111 includes a 9V battery (depicted in Fig. la).
  • the control element 110 is configured to control the power from the power source 111 to the motor 103.
  • the control element 110 is electrically coupled to the motor 103 and the power source 111.
  • the control element 110 is electrically coupled to the motor 103 and the power source 111 such that the motor 103 can be rotated in both the clockwise and the anticlockwise directions.
  • the control element 110 includes at least one mode of operation.
  • the control element 110 is configurable to be in one of a forward mode, a backward mode and a stop mode.
  • the control element 110 couples the power source 111 to the motor 103 such that it causes the motor 103 to rotate in the first direction (e.g., in the anticlockwise direction) and the plunger 102 moves in the distal (or forward) direction.
  • the control element 110 couples the power source 111 to the motor 103 such that the motor 103 rotates in the second direction (e.g., in the clockwise direction) and the plunger 102 moves in the proximal (or backward) direction.
  • the control element 110 electrically decouples the power source 111 from the motor 103, which causes the motor 103 stops.
  • the control element 110 is a rocker switch (as shown in Figs la - lb).
  • the control element 110 may be placed at a convenient position in the handle 101 for the user to manipulate the control element 110 easily.
  • the control element 110 is provided towards a distal end of the stem portion lOlf (depicted in Fig. lb).
  • the stem portion lOlf includes an opening to receive the control element 110.
  • the opening is formed by cut-outs lOlal and lOlbl (shown in Figs. 2a - 2b) in the left section 101a and the right section 101b, respectively, when the left section 101a and the right section 101b are coupled together.
  • the cut-outs lOlbl and lOlal have a shape and size corresponding to the shape and size of a cross-section of the control element 110.
  • Fig. 6 depict different views of the clamp 106 in accordance with one or more embodiment of the present disclosure.
  • the clamp 106 is used to secure the motor 103 in a place within the handle 101.
  • the clamp 106 includes a frame 106a, and arms 106b.
  • the frame 106a is generally rectangular, though the frame 106a may have any other suitable shape.
  • the frame 106a at least partially surrounds the motor 103.
  • the arms 106b extend away from opposite sides of the frame 106a. Each intersection of the frame 106a and the arms 106b has holes 106c.
  • the clamp 106 may be placed over the motor 103 and coupled to the holes 106c using suitable fasteners, e.g., screws, passing through the respective hole 106c and the respective hole 106c.
  • the clamp 106 can be made of a material such as, without limitation ABS, nylon, HDPE, LDPE, PC, etc. In an embodiment, the clamp 106 is made of ABS.
  • the holder 107 is configured to hold the syringe 109 as explained later.
  • the holder 107 has a proximal end 107c and a distal end 107d (shown in Figs. 5a and 5b).
  • the holder 107 includes a top section 107a and a bottom section 107b coupled together to form the holder 107.
  • Figs. 7a and 7b depict the top section 107a and the bottom section 107b according to one or more embodiments of the present disclosure.
  • the top section 107a and the bottom section 107b are generally semi cylindrical, though they may have any other suitable shape.
  • the top section 107a includes a groove 107al extending from the distal end 107d to the proximal end 107c, a coupling section 107a2 provided at the distal end 107d, an interlocking section 107a3 provided at the proximal end 107c, and a plurality of studs 107a4.
  • the bottom section 107b includes a groove 107bl extending from the distal end 107d to the proximal end 107c, a coupling section 107b2 provided at the distal end 107d, an interlocking section 107b3 provided at the proximal end 107c, and a plurality of grooves 107b4.
  • the grooves 107al and 107bl are semi-circular.
  • the shape and size of the plurality of grooves 107b4 correspond to the shape and size of the plurality of studs 107a4.
  • the top section 107a and bottom section 107b are coupled by mating the plurality of studs 107a4 with the corresponding plurality of grooves 107b4, though any suitable coupling mechanism such as screws, a snap-fit mechanism, etc. can be used.
  • the grooves 107al and 107bl form a channel
  • the coupling sections 107a2 and 107b2 form a coupling portion having semicircular grooves on top and bottom side of the channel
  • the interlocking sections 107a3 and 107b3 form an interlocking portion, which is generally rectangular, distal to the channel.
  • the channel of the holder 107 is configured to receive at least a portion of the syringe 109 and the head 102c of the plunger 102.
  • the cross-sectional diameter of the channel corresponds to the diameter of the head 102c.
  • the holder 107 can be made of a material such as, without limitation ABS, nylon, HDPE, LDPE, PC, etc. In an embodiment, the holder 107 is made of ABS.
  • the proximal end 107c of the holder 107 is coupled to the distal end lOld of the handle 101 as depicted in Figs, la - lb.
  • the holder 107 can be coupled to the handle 101 by any suitable mechanism such as a snap-fit mechanism, a stud-groove coupling mechanism, a roll and twist mechanism, a slide-fit mechanism, push-fit mechanism, etc.
  • the holder 107 is coupled to the handle 101 by a roll and twist mechanism using the locking hub 108.
  • Figs. 8a - 8b depict different views of the locking hub 108 in accordance with one or more embodiment of the present disclosure.
  • the locking hub 108 is configured to lock the handle 101 with the holder 107.
  • the locking hub 108 is circular, though the locking hub 108 may have any other suitable shape.
  • the locking hub 108 includes a rounded projection 108a, C-shaped edges 108b and a flap 108c. the C-shaped edges are provided on a top and a bottom side of the locking hub 108, and extend longitudinally towards a distal end of the locking hub 108.
  • the C-shaped edges 108b are hollow.
  • Each C-shaped edge 108b has a curved ledge open on one side and closed on the other side such that the open ends of the curved ledges are on opposite sides of the C-shaped edges 108b as depicted in Fig. 8a.
  • Each open end of the curved ledges of C- shaped edges 108b is configured to receive a respective coupling section (one of the coupling sections 107a2 and 107b2 of the holder 107), thereby coupling the locking hub 108 to the holder 107.
  • the rounded projection 108a is provided centrally and extends towards the distal end of the locking hub 108.
  • the locking hub 108 includes a hole 108d extending for the length of the locking hub 108 and having a cross-section corresponding to the cross-sectional shape of the body 102d of the plunger 102 to facilitate free movement of the plunger 102.
  • the flap 108c is provided toward the proximal end of the locking hub 108.
  • the flap 108c fits within notches 101a4 and 101b4 (shown in Figs. 2a - 2b) provided on the left section 101a and the right section 101b, respectively, thereby coupling the locking hub 108 to the handle 101 as depicted in Fig. la.
  • the locking hub 108 can be made of a material such as, without limitation ABS nylon, HDPE, LDPE, PC, etc. In an embodiment, the locking hub 108 is made of ABS.
  • Fig. 9 shows a side view of the syringe 109.
  • the syringe 109 includes a piston 109a, barrel 109b and flanges 109c.
  • the piston 109a includes a head 109al provided at a distal end of the syringe 109 and a plurality of arms 109a2 extending away from the head 109al in a proximal direction, and a tail 109a3 at a proximal end of the syringe 109.
  • the head 109al is generally cylindrical with a taper towards its proximal end.
  • the plurality of arms 109a2 may have a uniform or a non-uniform width.
  • the plurality of arms 109a2 have a non- uniform width.
  • the tail 109a3 is shaped as a disc with a circular cross-section.
  • the barrel 109b is tubular with a circular cross-section.
  • the diameter of the barrel 109b corresponds to the diameter of the head 109al.
  • the barrel 109b may include a plurality of markings (not shown) indicating volumes of the adhesive when loaded into the barrel 109b.
  • the barrel 109b defines a volume indicating the capacity of the syringe 109.
  • the barrel 109b includes an elongated nozzle 109bl at the distal end of the syringe 109.
  • the nozzle 109bl has a smaller diameter compared to the diameter of the barrel 109b.
  • a luer lock 109b2 is provided to lock the nozzle 109bl with, for example, a catheter hub (not shown).
  • Fig. 10 illustrates a flowchart of a method 1000 of operating the device 100 according to an embodiment.
  • the device 100 is used during a medical procedure, for example, in the sclerotherapy procedure.
  • the syringe 109 is loaded with a suitable adhesive.
  • the syringe 109 with a desired capacity is chosen.
  • the syringe 109 has the capacity of 3 cc.
  • the piston 109a is stretched away from the barrel 109b to load the syringe 109.
  • the syringe 109 is coupled with the holder 107.
  • the loaded syringe 109 is placed into the holder 107.
  • the flanges 109c are placed within the corresponding interlocking sections 107a3 and 107b3.
  • the piston 109a is placed within the groove 107bl such that a proximal face of the tail 109a3 contacts a distal face of the head 102c of the plunger 102 as depicted in Fig. lb.
  • the top sectionl07a of the holder 107 is coupled to the bottom portion 107b of the holder 107.
  • the motor 103 is switched ON.
  • the user operates the control element 110 to be in the forward mode.
  • the user presses a button of the rocker switch towards 'I' indicator (as depicted in Fig. lb) to configure the control element 110 in the forward mode.
  • the control element 110 electrically couples the power source 111 with the motor 103 such that the motor 103 rotates in the anticlockwise direction. Consequently, the shaft 104 and the gearhead 105 rotate in the anticlockwise direction.
  • the engagement between the plurality of teeth 102f of the plunger 102 and the tooth 105d of the gearhead 105 as described earlier converts the rotational motion into the linear motion and results in the forward motion of the plunger 102 in the distal direction.
  • the head 102c of the plunger 102 pushes the piston 109a in the distal (or forward direction) inside the barrel 109b of the syringe 109. Consequently, the adhesive is delivered inside the affected vein of the patient.
  • the motor 103 is switched OFF once the desired amount of the adhesive is delivered into the patient's vein.
  • the user operates the control element 110 to be in the stop mode.
  • the user presses the button of the rocker switch to align with 'O' indicator (depicted in Fig. lb) to configure the control element 110 in the stop mode.
  • the power source 111 is electrically decoupled from the motor 103, thereby stopping the motor 103.
  • the syringe 109 can then be unloaded from the holder 107.
  • the user may want to move the plunger 102 in the proximal (or backward) direction (for example, when the head 102c moves beyond a pre-defined distance within the channel of the holder 107).
  • the user may manipulate the control element 110 to be in the backward mode (e.g., by pressing the rocker switch towards the 'II' indicator (shown in Fig. lb). Consequently, the motor 103 moves in the second direction (e.g., the clockwise direction) and the user pinches the tab 102g and manually pulls the plunger 102 in the backward direction.
  • the device 100 can be used for multiple applications.
  • the device 100 can be used for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation.
  • the device 100 can also be employed to treat adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
  • DUS duplex ultrasound
  • the proposed device presents several advantages over conventional devices. Due to the automatic operation and delivery of precise amount of the adhesive at the desired delivery rate, the device overcomes manual errors associated with conventional sclerotherapy devices and the consequence of delivering incorrect amount of the adhesive. Therefore, the proposed device improves the effectiveness of the sclerotherapy procedure and the patient outcome. Further, the proposed device is very easy to operate (for example, via a simple press of the control element provided in the device) unlike conventional device which require continuous manual operation of a trigger by the user.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente divulgation concerne un dispositif comprenant un moteur, une tête motrice et un piston. La tête motrice est couplée à l'arbre et est conçue pour tourner en réponse à la rotation du moteur. La tête motrice comprend au moins une dent disposée sur une périphérie de la tête motrice. Le piston est couplé de manière fonctionnelle à la tête motrice et à une seringue. Le piston comporte également une pluralité de dents, au moins une dent de la pluralité de dents venant en prise fonctionnelle avec ladite au moins une dent de la tête motrice. Le piston est en outre conçu pour se déplacer de façon linéaire dans une direction distale en réponse à la rotation de la tête motrice dans une première direction et pour amener la seringue à administrer le liquide dans le corps d'un patient.
PCT/IN2025/050215 2024-02-16 2025-02-14 Dispositif de sclérothermique Pending WO2025173036A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202421011075 2024-02-16
IN202421011075 2024-02-16

Publications (2)

Publication Number Publication Date
WO2025173036A2 true WO2025173036A2 (fr) 2025-08-21
WO2025173036A3 WO2025173036A3 (fr) 2025-09-18

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Application Number Title Priority Date Filing Date
PCT/IN2025/050215 Pending WO2025173036A2 (fr) 2024-02-16 2025-02-14 Dispositif de sclérothermique

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WO (1) WO2025173036A2 (fr)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7077836B2 (en) * 2000-07-21 2006-07-18 Vein Rx, Inc. Methods and apparatus for sclerosing the wall of a varicose vein
JP5307891B2 (ja) * 2009-06-26 2013-10-02 昭和薬品化工株式会社 線形歯科用電動注射器

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