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WO2025088625A1 - Fil-guide de stimulation - Google Patents

Fil-guide de stimulation Download PDF

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Publication number
WO2025088625A1
WO2025088625A1 PCT/IN2024/052112 IN2024052112W WO2025088625A1 WO 2025088625 A1 WO2025088625 A1 WO 2025088625A1 IN 2024052112 W IN2024052112 W IN 2024052112W WO 2025088625 A1 WO2025088625 A1 WO 2025088625A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
elongate member
section
distal portion
length
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/IN2024/052112
Other languages
English (en)
Inventor
Dr. Pramod Kumar MINOCHA
Deveshkumar Mahendralal KOTHWALA
Amirhamzah Mahmadiqbal SHAIKH
Smit Nitin Patel
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 WO2025088625A1 publication Critical patent/WO2025088625A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09108—Methods for making a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • the present disclosure relates to a guidewire. More specifically, the present disclosure relates to a guidewire having a pacing mechanism.
  • Guidewire is one of the essential components in any percutaneous medical procedure.
  • transcatheter aortic valve implantation/replacement (TAVI/TAVR) procedure is practiced to percutaneously advanced an implant to the site of treatment (usually within the heart) and deploy the implant therein.
  • TAVI/TAVR procedures are practiced by cardiac interventionalists to repair/replace a stenosed native aortic valve.
  • a guidewire is first advanced percutaneously to the treatment site. Only after the guidewire is parked at the treatment site, the delivery system along with the implant is advanced over the guidewire to the treatment site.
  • the guidewire is also used to conduct electrical pulse/signal to the treatment site.
  • the electrical pulse/signal is conducted to control the pacing of the heart during the TAVI/TAVR procedure.
  • the conventional guidewires are provided with two or more coiled conductors of different diameters.
  • the coiled conductors having different diameters imparts uneven physical properties such as, flexibility, deformability, kink resistance, etc. Due to said uneven physical properties, especially at a distal portion of the conventional guidewire, there is an increased risk of ventricular perforation and cardiac effusion.
  • the coiled member is wrapped around at least a portion of the distal portion of the elongate member and intermittently coated with at least one layer of coating.
  • the curved configuration of the distal portion is defined by a length 'L', a height 'H', and a curve ratio between the height 'H' and length 'L' ranging from 1 to 1.2.
  • Fig. 1 depicts a guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • Fig. 2 depicts the guidewire 100 with an uncoated region 'uc' spaced away from the proximal end 110a in accordance with one or more embodiment of the present disclosure.
  • Fig. 3 depicts a curved configuration of the distal portion HObl of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • Fig. 3a depicts another curved configuration of the distal portion HObl of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • Fig. 3b depicts another curved configuration of the distal portion HObl of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • Fig. 3c depicts another curved configuration of the distal portion llObl of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • Fig. 3d depicts another curved configuration of the distal portion llObl of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
  • the present disclosure discloses a guidewire.
  • the guidewire is used in percutaneous medical procedures, for example transcatheter aortic valve implantation/replacement (TAVI/TAVR) procedures, etc. Furthermore, the guidewire is used to control the pacing of the heart (or other organ, as required) during the percutaneous medical procedures.
  • TAVI/TAVR transcatheter aortic valve implantation/replacement
  • the guidewire of the present disclosure is a great tool for interventionalist, as it can be easily maneuvered through the tortuous vasculature and is less likely to become blocked or kinked due to its unique shape. This makes it easier for interventionalist to perform the procedure accurately and efficiently.
  • the guidewire also reduces the need for manual manipulation of the catheter, which can reduce the risk of complications during the interventional procedures.
  • the distal end of the guidewire of the present disclosure is provided with enough flexibility, deformability and softness to minimize the risk of ventricular perforation and cardiac effusion.
  • the guidewire also helps with stability once the guidewire is parked at the treatment site.
  • Fig. la depicts the elongate member 110 of the guidewire 100.
  • the elongate member 110 extends between a proximal end 110a and a distal end 110b of the elongate member 110.
  • the distal end 110b of the elongate member 110 is inserted within the vasculature to advance the guidewire 100 to a treatment site.
  • the elongate member 110 is made of a material selected from stainless steel (S.S.), nitinol, etc.
  • the elongate member 110 is made of stainless steel.
  • the elongate member 110 may include a length ranging from 260 mm to 300 mm.
  • the elongate member 110 may have a pre-defined cross-sectional shape selected from circular, square, rectangular, flat, etc. In an exemplary embodiment, the elongate member 110 has a circular cross-section.
  • the elongate member 110 may include a proximal portion llOal disposed towards the proximal end 110a of the elongate member 110.
  • the proximal portion llOal may have a length ranging from 2420 mm to 2820 mm.
  • the proximal portion llOal may include a uniform diameter ranging from 0.86 mm to 0.90 mm.
  • the length and diameter of the proximal portion llOal of the elongate member 110 is 2580 mm and 0.89 mm respectively.
  • the proximal portion llOal of the elongate member 110 may be coated with one or more layers of coating.
  • the one or more layers of coating may be selected from polytetrafluoroethylene (PTFE), hydrophilic, silicon, etc.
  • PTFE polytetrafluoroethylene
  • the proximal portion llOal is coated with one layer of PTFE. The coating helps to reduce friction and enables ease of insertion.
  • the proximal portion llOal of the elongate member 110 may be provided with one or more uncoated regions 'uc'.
  • the uncoated region 'uc' may be provided as is while manufacturing the guidewire 100.
  • the uncoated region 'uc' may be provided with a "peel-away" coating that is removed by the user if required at the time of performing a percutaneous procedure.
  • the uncoated region 'uc' may have a length ranging from 10 mm to 20 mm. In an exemplary embodiment, the length of the uncoated region 'uc' is 10 mm.
  • the uncoated region 'uc' enables the user to connect the elongate member 110 to at least one terminal of either of a positive terminal or a negative terminal of a direct current (DC) source.
  • DC direct current
  • the uncoated region 'uc' helps the user to transmit electrical pulse/signal through the guidewire 100.
  • the uncoated region 'uc' is electrically connected to the negative terminal of a battery and the positive terminal of the battery is electrically connected to the patient's body. Further, the uncoated region 'uc' helps the user to feel excellent tactile feedback when the guidewire 100 is advanced through the vasculature to the treatment site.
  • the uncoated region 'uc' is disposed at the proximal end 110a of the elongate member 110.
  • the uncoated region 'uc' is spaced away from the proximal end 110a of the elongate member 110.
  • the elongate member 110 may include a distal portion HObl disposed towards the distal end 110b of the elongate member 110.
  • the distal portion HObl may have a length ranging from 140 mm to 180 mm. In an exemplary embodiment, the length of the distal portion llObl is 170 mm.
  • the distal portion llObl may include a plurality of sections 111.
  • the distal portion llObl of the elongate member 110 include a first section Illa, a second section 111b, a third section 111c and a fourth section llld.
  • the sections 111 may have uniform profile/diameter and/or tapered profile/diameter.
  • the first section Illa is disposed adjacent to the proximal portion llOal of the elongate member 110.
  • the first section Illa may have a length ranging from 60 mm to 100 mm. In an exemplary embodiment, the length of the first section Illa is 90 mm. In an exemplary embodiment, the first section Illa tapers towards the distal end 110b.
  • the first section Illa may have a maximum diameter ranging from 0.86 mm to 0.90 mm.
  • the first section Illa may have a minimum diameter ranging from 0.30 mm to 0.35 mm. In an exemplary embodiment, the maximum and minimum diameter of the first section Illa is 0.87 mm and 0.33 mm respectively.
  • the first section Illa helps to provide pushability to the guidewire 100.
  • the second section 111b is disposed adjacent to the first section Illa of the elongate member 110.
  • the second section 111b may have a length ranging from 30 mm to 40mm.
  • the second section 111b includes a uniform diameter.
  • the diameter of the second section 111b ranges from 0.30 mm to 0.35 mm.
  • the length and diameter of the second section 111b is 35 mm and 0.33 mm respectively.
  • the second section 111b provides support to the guidewire 100.
  • the third section 111c is disposed adjacent to the second section 111b of the elongate member 110.
  • the third section 111c may have a length ranging from 20 mm to 30 mm. In an exemplary embodiment, the length of the third section 111c is 25 mm. In an exemplary embodiment, the third section 111c tapers towards the distal end 110b.
  • the third section 111c may have a maximum diameter ranging from 0.30 mm to 0.35 mm.
  • the third section 111c may have a minimum diameter ranging from 0.15 mm to 0.20 mm. In an exemplary embodiment, the maximum and minimum diameter of the third section 111c is 0.33 mm and 0.18 mm respectively.
  • the third section 111c behaves as a transition section and provides flexibility to the guidewire 100.
  • the fourth section llld is disposed at the distal end 110b, adjacent to the third section 111c of the elongate member 110.
  • the fourth section llld may have a length ranging from 15 mm to 25 mm.
  • the fourth section llld includes a uniform diameter.
  • the diameter of the fourth section llld ranges from 0.15 mm to 0.20 mm.
  • the length and diameter of the fourth section llld is 20 mm and 0.18 mm respectively.
  • the fourth section llld helps to behaves as a shaping section and provides flexibility to the guidewire 100.
  • the distal portion llObl may at least partially enclosed/wrapped by the coiled member 130.
  • the second, third and fourth section 111b, 111c, llld are completely enclosed by the coiled member 130 and the first section Illa is partially enclosed by the coiled member 130.
  • the outer diameter of the coiled member 130 ranges from 0.87 mm to 0.92 mm.
  • the coiled member 130 has a uniform outer diameter of 0.89 mm.
  • the coiled member 130 may be relatively more flexible than the elongate member 110 which helps to set flexibility, torqueability and crossability of the guidewire 100. The said difference in flexibility helps to provide more tactile feedback to the operator of the guidewire
  • the coiled member 130 may include at least one cable wrapped around in a predefined pitch.
  • the cable may include a pre-defined cross-sectional shape including but not limited to circular, flat, etc.
  • the cable has a circular cross section.
  • the cable may include a diameter ranging from 0.12 mm to 0.17 mm.
  • the diameter of the cable is 0.15 mm.
  • the pitch of the coiled member 130 is substantially same as the diameter of the cable.
  • the cable may be made of a material including but not limited to stainless steel, nitinol, platinum, titanium, tungsten, etc.
  • the cable of the coiled member 130 is made from stainless steel.
  • the material of the cable may optionally be preshaped.
  • FIG. lb An enlarged view of the coiled member 130 wrapped around the elongate member 110 is depicted in Fig. lb.
  • the coiled member 130 may be intermittently coated with at least one layer of coating selected from PTFE, ethylene tetrafluoroethylene (ETFE) and Hydrophilic, etc.
  • the layer of coating provided on the coiled member 130 is PTFE.
  • the layer of coating disposed over the coiled member 130 provides easy low-friction movement and manipulation of the guidewire 100 through the vasculature and also function as electrical insulation.
  • the coiled member 130 includes four coated regions 'c'. The remaining of the coiled member 130 is left uncoated. The uncoated regions of the coiled member 130 helps to conduct the electrical pulse/signal transmitted from the uncoated region 'uc' of the elongate member 110 (as described above), thus helping in pacing of the treatment (or surrounding) site.
  • the ends of the cable of the coiled member 130 may be coupled to the elongate member 110, via soldering, plasma welding, laser welding, epoxy, etc.
  • the end of the cable (disposed towards the proximal end 110a) is coupled to the first section Illa via a jacket 150.
  • the jacket 150 may be made of a material including but not limited to stainless steel (S.S.), platinum, copper, etc. In an exemplary embodiment, the jacket 150 is made of stainless steel.
  • the jacket 150 may have a pre-defied shaped including but not limited to conical, cylindrical, parabolic, dome, etc. In an exemplary embodiment, the jacket 150 is conical shaped.
  • the jacket 150 helps to clamp the coiled member 130 over the elongate member 110.
  • the end of the cable (disposed towards the distal end 110b) is coupled to the distal end 110b of the elongate member 110 via a dome shaped weld 170.
  • the dome shaped weld 170 disposed at the distal end 110b helps in fracture reduction as well as provides easy cross blockage with less pain.
  • the proximal end 110a of the elongate member 110 is provided with the dome shaped weld 170.
  • the dome shaped weld 170 disposed at the proximal end 110a provides protection from injury during usage of the guidewire 100.
  • the distal portion HObl of the guidewire 100 includes a curved configuration, i.e., the distal portion HObl may form a spiral-like structure.
  • the curved configuration of the distal portion llObl is defined by a length 'L', a height 'H' and a pitch 'P' as shown in Fig. 3.
  • the length 'L' of the curved configuration ranges from 20 mm to 49 mm.
  • the height 'H' of the curved configuration ranges from 23 mm to 50 mm.
  • the pitch 'P' of the curved configuration ranges from 6 mm to 12 mm.
  • the length 'L', height 'H' and pitch 'P' of the curved configuration are partially influenced by a diameter of the distal portion llObl.
  • the height 'H' of the curved configuration may either be same as the length 'L' or more than the length 'L' by 3mm or less. In other words, the height 'H' of the curved configuration is equal to length 'L' + (0mm to 3mm).
  • the said relation between the height 'H' and length "L' of the curved configuration of the distal portion llObl helps to park the guidewire 100 in the left ventricle (LV) and grip the LV wall while it provides central alignment for the transcatheter procedures like transcatheter aortic valve implantation (TAVI) and transcatheter aortic valve repair (TAVR).
  • a curve ratio between the height 'H' and length 'L' of the curved configuration ranges from 1 to 1.2.
  • the said range of curve ration helps to park the guidewire 100 in the left ventricle (LV) and grip the LV wall while it provides central alignment for the transcatheter procedures like transcatheter aortic valve implantation (TAVI) and transcatheter aortic valve repair (TAVR).
  • TAVI transcatheter aortic valve implantation
  • TAVR transcatheter aortic valve repair
  • the length, height and pitch of the curved configuration of the distal portion llObl is 35 mm, 36 mm and 12 mm respectively.
  • the length, height and pitch of the curved configuration of the distal portion llObl is 42 mm, 42 mm and 15 mm respectively.
  • the length, height and pitch of the curved configuration of the distal portion llObl is 49 mm, 50 mm and 18 mm respectively.
  • the above-described embodiments of the guidewire 100 is selected by a medical practitioner based at least on patient's heart size and the dimension of the LV curve wall.
  • Fig. 4 depicts an exemplary method 200 to manufacture the guidewire 100 of the present disclosure.
  • the method commences at step 201 by obtaining a pre-defined length of the elongate member 110.
  • the elongate member 110 is PTFE coated.
  • the distal portion llObl of the elongate member 110 is subjected to a grinding process to obtain the plurality of sections 111.
  • At step 205 at least a part of the distal portion llObl of the elongate member 110 is shaped to the curved configuration using pre-defined molds (not shown).
  • the mold along with the distal portion llObl of the elongate member 110 is kept at a pre-defined temperature of 500 °C to 700 °C for 30 minutes.
  • the elongate member 110 is quenched by rapid cooling the distal portion llObl of the elongate member 110.
  • the distal portion llObl of the elongate member 110 is put in chilled water for rapid cooling.
  • the elongate member 110 is subjected to a cleaning technique.
  • the elongate member 110 is cleaned using an ultrasonic cleaning process.
  • the end of the cable (disposed towards the proximal end 110a) of the coiled member 130 is coupled to the first section Illa of the elongate member 110.
  • the cable is coupled to the elongate member 110 via a laser welding technique.
  • the end of the cable (disposed towards the distal end 110b) of the coiled member 130 is coupled to the distal end 110b of the elongate member 110 via a dome shaped weld 170.
  • the dome shaped weld 170 is formed by plasma welding technique.
  • the jacket 150 is inserted over the elongate member 110 from the proximal end 110a and crimped over the coupling between the end of the cable (disposed towards the proximal end 110a) of the coiled member 130 and the first section Illa of the elongate member 110.
  • the jacket 150 is crimped using a crimping device (not shown).
  • Example 1 (Prior art): Conventional guidewire
  • a ventricular tachycardia procedure was performed using a conventional unipolar guidewire.
  • a femoral puncture was created to advance and position the distal end portion of the unipolar guidewire on a wall of the right ventricle (RV).
  • the proximal end portion of the unipolar guidewire was connected to a first pole of an external pulse generator using an alligator clamp.
  • a second opposite pole of the external pulse generator was electrically connected to a large surface skin electrode placed at a left thigh of the patient.
  • Example 2 Percutaneous procedure with guidewire 100 and observations
  • the guidewire 100 was advanced through a catheter under fluoroscopic guidance.
  • the distal end 110b of the guidewire 100 provided enough flexibility, deformability, and softness to minimize the risk of ventricular perforation and cardiac effusion.
  • the guidewire 100 also helped with stability once the guidewire 100 was parked inside the LV of the heart.
  • the guidewire 100 maintained its position while a balloon catheter was advanced over the guidewire 100.
  • the guidewire 100 was used to control the pacing of the heart during the procedure.
  • the positive terminal of the pulse generator was connected to the patient's body.
  • the negative terminal was connected with the guidewire's 100 uncoated region 'uc' at the proximal portion llOal of the elongate member 110.
  • the pacing was provided via the guidewire 100 after the artery was blocked using the inflated balloon of the balloon catheter.
  • the distal end 110b of the outer curvature of the guidewire 100 made direct contact with the LV wall tissue, which equally distributed the current on the LV wall and maintained the heartbeat at a lower current supply.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un fil-guide comprenant au moins un élément allongé et au moins un élément enroulé. L'élément allongé comprend une partie proximale disposée vers une extrémité proximale associée et une partie distale. La partie proximale est revêtue d'une ou plusieurs couches de revêtement. La partie distale comprend une pluralité de sections présentant un profil uniforme et/ou un profil effilé. Au moins une partie de la partie distale comprend une configuration incurvée. L'élément enroulé est enroulé autour d'au moins une partie de la partie distale de l'élément allongé et revêtu par intermittence d'au moins une couche de revêtement. La configuration incurvée de la partie distale est définie par une longueur 'L', une hauteur 'H', et un rapport de courbe entre la hauteur 'H' et la longueur 'L' allant de 1 à 1,2.
PCT/IN2024/052112 2023-10-23 2024-10-21 Fil-guide de stimulation Pending WO2025088625A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202321072396 2023-10-23
IN202321072396 2023-10-23

Publications (1)

Publication Number Publication Date
WO2025088625A1 true WO2025088625A1 (fr) 2025-05-01

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ID=95515189

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2024/052112 Pending WO2025088625A1 (fr) 2023-10-23 2024-10-21 Fil-guide de stimulation

Country Status (1)

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WO (1) WO2025088625A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8206363B2 (en) * 2004-02-18 2012-06-26 Derby Hospitals Nhs Foundation Trust Medical sleeve
US9233213B2 (en) * 2009-10-16 2016-01-12 Janssen Biotech, Inc. Palm activated drug delivery device
US20180133512A1 (en) * 2008-05-22 2018-05-17 W. Davis Lee Scintillation array apparatus and method of use thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8206363B2 (en) * 2004-02-18 2012-06-26 Derby Hospitals Nhs Foundation Trust Medical sleeve
US20180133512A1 (en) * 2008-05-22 2018-05-17 W. Davis Lee Scintillation array apparatus and method of use thereof
US9233213B2 (en) * 2009-10-16 2016-01-12 Janssen Biotech, Inc. Palm activated drug delivery device

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