Abstract: A body of the device to position a coronary stent or pull a catheter transducer for intravascular ultrasound is composed of a front and a rear portion each of which comprises two similar halves, a ring on the front smooth portion of the body and a brace over the rear portion of the rear portion of the body. The rear portion of the body overlaps the front portion of the body. The front portion of the body is truncated on one side thereof and continuously extends on the opposite side thereof in the form of a smooth cylindrical portion of a smaller diameter and a runner guide. A cylindrical slot with point elements is provided along the circumference of the cylindrical portion of the front portion of the body on the side of the runner guide. A cylindrical brace is mounted on the rear portion of the body.
This invention relates to a body of the device suitable for use in medicine to position a coronary stent in the most accurate, fast and safe manner on a delivery 5 system to carry out endovascular coronary stenting or pull a catheter transducer for intravascular ultrasound (IVUS).
When the device is used to pull the catheter transducer, such catheter transducer is installed in the device instead of the coronary stent delivery system in much the same manner. 10 For intravascular imaging, the guiding catheter is suitably installed within the coronary ostium so that the guiding catheter can be pulled through the target narrowing to distal arteries. The device is placed on the digital IVUS catheter in the same manner as it normally placed on the coronary stent delivery system. A mechanical transducer of the Revolution (Volcano (Philips)) type or other similar 15 devices cannot be currently used due to specific features of their pulling mechanisms. The device is positioned as close as possible to the proximal section of the transmitting catheter, i.e., the section where the transmitting catheter is connected by means of a wire to a station or built-in interface. The transducer is moved through the guide to a distance 30 – 40 mm more distal than the target segment. When in the 20 appropriate zone, the device is fixed on the digital IVUS catheter whereupon the device body is rotated to slowly move the device using the procedure similar to the stent positioning procedure for high-precision estimation of this section. Known on the medical equipment market are devices proposed by the same applicant to position stents in the coronary arteries (RU2598798, RU2652732, 25 RU2650038, RU2661092, RU2710216),with the bodies of such devices differing from the proposed invention the advantages of which are as follows:
- easy and short-time assembly of the device body owing to a brace and a ring and because there is no need for glue to mate the parts;
- higher strength of the product owing to the brace and a large number of tapered 30 projections and their mating tapered holes in the front portion of the device body;
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- greater rigidity of the front portion of the device body when a retainer operates, such rigidity provided by a thicker wall of the front truncated portion of the body in the retainer lug zone, with the maximum possible number of the tapered projections and mating tapered holes made along the edges of the thick wall;
- no need for a tube to position a coronary stent on the delivery system inside the 5 device, such positioning provided by a fillet inside the front truncated portion of the body and chamfers on the rear end portion of the body and a runner in their central hole;
- improved performance of the product during coronary stent positioning owing to greater rigidity of the runner guides provided by an additional wall interconnecting 10 the guides;
- no need for gluing and enhanced mating force of the guides for the runner of the front portion of the body owing to transverse walls provided at the end of the guides, with a tapered projection and mating tapered hole;
- possibility of use of the device body to pull the catheter transducer; 15
- greater rigidity of coupling of the halves of the rear portion of the body owing to additional longitudinal slots and longitudinal projections along the edge of the internal side of the rear portion of the body in the overlap zone;
- maintenance of integrity of the device body in the course of operation owing to the brace securely retained by the projections at the end of the rear portion of the device 20 body;
- when the coronary stent is being positioned or catheter transducer is being pulled, the rear portion of the device body can be readily rotated with the aid of a ring owing to parts engagement;
- when the coronary stent is being positioned, the brace cannot be displaced around 25 the rear portion of the body owing to the longitudinal projections on the external side of the rear portion of the body in the internal thread zone and internal guides on the brace;
- no need for accurate positioning of the brace with respect to the rear portion of the body when the body of the device is being assembled; simple and fast assembly 30
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owing to specially shaped longitudinal projections on the external side of the rear portion of the device body in the internal thread zone;
- reduced load to the operator’s fingers to close the retainer owing to a wall directed at an angle to a point wall projection provided in the opening for the retainer lugs and designed to hold the retainer lugs in the extreme position. 5 The claimed invention is industrially applicable. The subject matter of the present invention is a body of the device to position a coronary stent on a delivery system in coronary arteries or pull a catheter transducer for intravascular ultrasound.
The body is composed of a retainer with a thickening with lugs, a runner with 10 a hole to accommodate a delivery system with projections designed to engage an internal double-start thread of a rear cylindrical portion of the body and with projections used for movement along guides inside the body on one side, and a cap with a hole to accommodate a delivery system with an elastic bushing with a hole to position the delivery system inside with a cone-shaped and end surfaces 15 corresponding to similar surfaces inside the cap and at the end of the runner, installed in the threaded cap to be screwed on the runner on the other side. A mechanism housed in the body is a subject matter of an independent patent (Patent RU 2661092) of the same applicant and cited herein solely for illustration and better understanding of the claimed invention. 20 The device body is composed of two components one of which is essentially a part comprising a front portion truncated on one side thereof and a cylindrical portion on the opposite side thereof, a smooth cylindrical portion of a smaller diameter and guides for a runner, said component forming the front portion of the body, and the other component includes a part arranged over the smooth cylindrical 25 portion of the first component and a rear part with the internal double-start thread and a chamfered end face, said component forming the rear portion of the body. The front portion of the body is truncated on the front side thereof and continuously extends on the opposite side thereof in the form of a cylindrical portion, smooth cylindrical portion of a smaller diameter and runner guides interconnected 30
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by longitudinal walls and provided at the end with transversal walls having tapered holes and mating tapered projections to couple the body halves.
The front truncated portion of the body is adapted to be held by the fingers of the surgeon’s left hand and provided to this end with recesses allowing the surgeon to fix the device in the desired position, with the recesses also serving as a pad to fix 5 a coronary catheter. For more convenient arrangement of the coronary stent delivery system and catheter transducer, the walls in the front truncated portion of the body are made rounded on the internal side opposite to the recesses for the operator’s left hand fingers where said walls contact the mouth of the hole in which the delivery system is installed. 10
Square openings for retainer lugs are provided on both sides of the front cylindrical portion of the body and the walls of the front portion of the body are made thicker within the section between the openings for the retainer lugs. In each square opening two point projections are located on one side at a distance equal to the retainer lug width and designed to hold the retainer lugs in the extreme position and 15 the retainer proper in the closed position, each projection having one flat wall which is directed at an angle to the projection on the side of the retainer open position and along which the retainer lug slides when it changes its position, whereby the force to be applied by the operator’s hand to rotate the retainer lugs to close the mechanism is decreased. 20
The front smooth cylindrical portion of the body has a ring suitably mounted thereon.
The ring has a recess made along the entire internal circumference thereof and designed to receive mating projections located along the circumference of the halves of the rear portion of the body on the side of the retainer so as couple these 25 halves.
On the external circumference of the ring, trapezoidal slots are provided to receive the mating projections of the front end of the rear portion of the body, said projections having a trapezoidal form and designed to fix the rear portion of the body in the ring to prevent its spontaneous rotation while allowing the operator to rotate 30 the rear portion of the body relative to the front portion of the body by the ring.
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A cylindrical slot with point elements is made along the circumference of the end face of the smooth cylindrical portion of the front portion of the body on the side of the runner guide, said cylindrical slot designed for coupling with the mating projection with point elements made along the circumference of the internal smooth cylindrical surface of the rear portion of the body on the side of the surface with the 5 double-start thread. The rear cylindrical portion of the body has longitudinal projections and mating longitudinal slots located on the internal side thereof along the edges of the halves in the zone of the smooth cylindrical surface and used to couple the halves of the rear portion of the body. 10 Point elements arranged on the internal smooth cylindrical surface of the rear portion of the body along the circumference on the retainer side are designed to reduce friction between the rotatable portions of the body. A cylindrical projection with point elements is provided along the circumference between the smooth internal surface and the surface with the internal 15 double-start thread of the rear portion of the body to engage the cylindrical slot of the smooth cylindrical part of the front portion of the body on the runner guide side so that the rear cylindrical portion of the body can be rotated about the axis thereof.
Longitudinal projections are made on the external surface of the rear portion of the body, with the projection ends smoothly curved in the opposite directions in 20 order to center the brace fitted over the rear portion of the body and to prevent spontaneous rotation of the brace. Projections to fix the brace in the holes along the circumference of the brace end face are located on the rear end face of the body.
The brace is fitted over the rear portion of the body in the zone of the internal double-start thread. 25
The brace is essentially a hollow cylinder with internal longitudinal guides along the whole length to ensure snug fit to the external surface of the rear portion of the body on the external side of which mating longitudinal projections are provided having the ends thereof smoothly curved in the opposite directions and used to securely attach the brace. 30
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Holes made along the circumference of the brace end face serve to fix the brace on the surface of the rear portion of the body with the aid of mating projections along the circumference of the end face of the rear portion of the body.
Through holes are made in the front portion of the body, runner, cap, elastic bushing and end face of the rear portion of the body to introduce the coronary stent 5 delivery system or catheter transducer into the device installed in the body.
For easy positioning of the coronary stent on the delivery system or catheter transducer inside the device in the central through hole, chamfers are made on the side of the runner end face and in the rear portion of the body. The body is made of pressure cast plastic and comprises the front and rear 10 portions, each portion composed of two halves. Each half of the front and rear portions of the body is solid cast and the two halves are coupled after assembly of the mechanism with the aid of the tapered projections and mating tapered holes made along the internal edges of the front and rear portions of the body and on the transverse walls at the end of the runner guides. 15 The maximum possible number of the tapered projections and mating tapered holes is made on the tapered protrusion of the front portion of the body and in the zone between the openings for the retainer lugs.
CLAIMS WE CLAIM
1. A body of the device suitable for positioning a coronary stent in coronary arteries or pulling a catheter transducer for intravascular ultrasound, said body comprising a 5 retainer with lugs, a runner with an opening to accommodate a delivery system therein and a chamfered rear portion, said runner provided with projections to engage an internal thread of a rear cylindrical portion of the body and projections for movement along guides inside the body on one side and with a cap with a hole having an elastic bushing with an internal hole with tapered and end surfaces conforming to 10 surfaces inside the cap and the runner, said bushing positioned in the threaded cap to be screwed on the runner on the opposite side, wherein the body is composed of the front and rear portions made of two halves; the front portion of the body is truncated on one side thereof and continuously extends on the opposite side thereof in the form of a cylindrical portion with openings for retainer lugs with point projections in each 15 opening, smooth cylindrical portion of a smaller diameter and runner guides with a cylindrical slot with point elements in front of the guides, whereas the rear portion of the body is made cylindrical and has an internal smooth surface, having point elements along the circumference thereof, and a surface with a double-start thread along the circumference thereof, wherein a cylindrical projection with a point 20 element is provided between the smooth internal surface and the surface with the double-start thread along the circumference thereof, the end face od the rear portion has a chamfer and a through hole is made in the front portion and the end face of the rear portion to introduce the coronary stent delivery system or the catheter transducer for intravascular ultrasound into the device interior, 25
characterized in that said body is composed of:
the front portion of the body comprising:
rounded walls in the truncated front portion of the body on the internal side opposite to recesses for the fingers of the operator’s left hand in a place where said walls adjoin 30
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the mouth of the input hole to accommodate the delivery system or the catheter transducer,
thickened walls in the zone between the opening for the retainer lugs of the front portion of the body,
flat walls located at an angle to the point projections in the openings the for the 5 retainer lugs,
a ring rotatably mounted on the smooth cylindrical surface of the front portion of the body having a recess in which projections of halves of the rear portion of the body are located along the circumference to couple said halves of the rear portion of the body whereas in trapezoidal slots trapezoidal projections of the halves of the rear 10 portion of the body are located to fix said halves of the rear portion of the body,
longitudinal walls connecting the runner guides and transversal walls adjoining at the end of the guides are provided with a tapered projection and a mating tapered hole and the chamfered runner near a central hole,
the rear portion of the body comprising: 15
longitudinal projections and mating slots along the edges of the internal smooth portion of the halves of the body to couple said halves of the body,
longitudinal projections having the ends thereof curved in the opposite directions on the external surface of the body in the zone with the internal double-start thread to engage the longitudinal projections along the circumference of the internal surface 20 of a brace,
the brace having the form of a hollow cylinder and provided with:
longitudinal projections along the circumference of the internal surface to engage the longitudinal projections with having the ends curved in the opposite directions and 25 located on the external surface in the zone of the rear portion of the body with the internal double-start thread,
holes in the end face for attachment to the end face of the rear portion of the body for attachment in the projections along the circumference of the end face of the rear portion of the body to hold the brace. 30
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2. The body of the device as claimed in Claim 1 characterized in that the external surface of the rear portion of said body is smooth and has no longitudinal projections smoothly curved in the opposite directions on the external surface.
3. The body of the device as claimed in Claim 1 characterized in that the end face of 5 the cylindrical brace has no holes along the circumference thereof whereas the end face of the rear portion of the body has no mating projections along the circumference thereof.
| # | Name | Date |
|---|---|---|
| 1 | 202217076858-PRIORITY DOCUMENTS [29-12-2022(online)].pdf | 2022-12-29 |
| 2 | 202217076858-FORM 1 [29-12-2022(online)].pdf | 2022-12-29 |
| 3 | 202217076858-DRAWINGS [29-12-2022(online)].pdf | 2022-12-29 |
| 4 | 202217076858-DECLARATION OF INVENTORSHIP (FORM 5) [29-12-2022(online)].pdf | 2022-12-29 |
| 5 | 202217076858-COMPLETE SPECIFICATION [29-12-2022(online)].pdf | 2022-12-29 |
| 6 | 202217076858.pdf | 2022-12-31 |
| 7 | 202217076858-Verified English translation [24-02-2023(online)].pdf | 2023-02-24 |
| 8 | 202217076858-Proof of Right [24-02-2023(online)].pdf | 2023-02-24 |
| 9 | 202217076858-FORM-26 [24-02-2023(online)].pdf | 2023-02-24 |
| 10 | 202217076858-FORM 3 [29-06-2023(online)].pdf | 2023-06-29 |
| 11 | 202217076858-FORM 18 [27-06-2024(online)].pdf | 2024-06-27 |