RU2829413C1 - Device for introduction of drugs, implant, graft into bone - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to traumatology and orthopedics, can be used for the introduction of drugs, and/or grafts, and/or implants for the purpose of surgical treatment of diseases of bones and joints, including aseptic necrosis of the femoral head, Legg–Calve–Perthes disease and others. Device for administering drugs, implants and transplants consists of an injector, a guide and a pusher axis, which are placed one into the other and assembled to make a single rod. Injector is a sleeve with an outer diameter equal to the inner diameter of the guide sleeve. On the working end of the injector there is a rounding with a radius equal to the radius of rounding on the end of the guide. Pusher represents an axis the diameter of which is equal to the inner diameter of the injector sleeve. On the working end of the pusher there is a rounding, the radius of which is equal to roundings on the guide and the injector. Roundings of guide, injector and pusher assembly form rounding on end of formed rod, which has semi-ball shape and radius equal to outer radius of guide sleeve. Injector comprises a syringe connector.

EFFECT: proposed device makes it possible to perform introduction of drug, and/or graft, and/or implant into bone, while having high strength characteristics, and is atraumatic due to design features.

2 cl, 4 dwg

Description

The invention relates to medicine, namely to traumatology and orthopedics, and can be used for the administration of drugs and/or transplants and/or implants for the purpose of surgical treatment of bone and joint diseases, including aseptic necrosis of the femoral head, Legg-Calve-Perthes disease and others.

State of the art:

There is a device for restoring the head of the femur [1] comprising a nipple with a hand rest, in which the inner end is narrowed and has 4 holes, and the outer part of the nipple cavity is expanded and made with an internal thread.

The disadvantage of this device is that the design does not provide for the placement of a bone graft close to the diameter of the canal in the bone canal while the device is in the canal, while placing a bone graft in the canal after removal of the device is associated with technical difficulties. In addition, the hollow nature of the design can lead to deformation and fracture of the device when inserted into the bone.

There is an intraosseous needle with an external thread [2]. The device is an intraosseous needle with an external thread and a removable mandrel. The thread allows the needle to be installed for a long time, which ensures a long-term outflow of fluid from the bone, as well as the possibility of multiple administration.

The disadvantage of this device is that the design does not provide for the placement of a bone graft close to the diameter of the canal into the bone canal while the device is in the bone canal, while placing a bone graft into the canal after removal of the device is associated with technical difficulties.

There are intraosseous needles for the introduction of drugs into the bone. The closest to the proposed device is the Jamshidi intraosseous needle [3]. The instrument includes an outer cannula, an inner cannula and a stylet.

The disadvantage of this needle is that it does not allow the introduction of a non-liquid transplant or implant into the bone. In addition, such a needle is quite thin and during manipulations the needle may break.

The objective of the invention is to provide atraumatic administration of drugs and/or an implant and/or a transplant into the bone while maintaining the high strength characteristics of the device.

The set task is achieved by the fact that the assembled device is a single rod, in which the outer diameter of the inner component corresponds to the inner diameter of the adjacent outer one, which ensures the strength of the device when inserted into the bone canal; the rounding at the end of all three elements ensures the advancement of the device along the canal and atraumatic use - during insertion, the rounded end of the device moves apart the soft tissues; the injector has a specialized connector for attaching a syringe for administering drugs, and the ability to remove the injector and pusher (detachable nature of the connection) ensures the ability to introduce grafts and/or implants into the guide canal with their subsequent advancement into the bone connected by the injector and pusher.

Device design: The device is disassemblable and consists of 3 parts: a guide, an injector and a pusher. The guide is a sleeve with a rounding of a certain radius at its working end. At the end opposite the working end there is a transverse handle with a cutout to form a detachable connection with the injector. The injector is a sleeve with an external diameter equal to the internal diameter of the guide sleeve, which ensures tight contact of the surfaces when the injector is inserted into the guide. Just like the guide, the injector has a transverse handle with a cutout that ensures a detachable connection between the injector and the guide. At the working end of the injector there is a rounding with a radius equal to the radius of the rounding at the end of the guide. At the opposite end of the injector sleeve, the channel of the sleeve expands, turning into a connector for attaching the syringe nozzle or attaching the pusher. The pusher is an axis with a diameter equal to the inner diameter of the injector sleeve, which ensures tight contact of the surfaces when the pusher is inserted into the injector. The working end of the pusher has a rounding with a radius equal to the roundings on the guide and injector. There is a handle for holding at the opposite end of the pusher. When assembled, the parts of the device form a single rod with a rounding at the end. The radius of the rounding is generally equal to the outer radius of the guide sleeve and is equal to the outer radius of the annular drill used to obtain the bone column. Thus, when using standard-size annular drills with a diameter of 6-12 mm, the radius of the guide and rounding can be from 3 to 6 mm. If it is necessary to form a channel of a non-standard size, it is possible to manufacture a device with other radii of rounding and a rod.

The general design of the proposed device is shown in Fig. 1, where

1 - a guide in the form of a sleeve with a transverse handle;

2 - injector in the form of a sleeve with a side handle;

3 - pusher;

4 - rounding formed by parts.

The design of the “guide” part is shown in Fig. 2, where

5 - guide bushing;

6 - guide handle;

7 - rounding of the guide.

The design of the “injector” part is shown in Fig. 3, where

8 - injector bushing;

9 - injector handle;

10 - rounding of the injector;

11 - connector for syringe nozzle.

The design of the “pusher” part is shown in Fig. 4, where

12 - pusher axis;

13 - pusher handle;

14 - rounding of the pusher.

It is assumed that the device will be made of steel, however, it can be made of other materials that are equally strong.

Implementation of the invention:

The device is used to administer a drug and an autograft in case of aseptic necrosis of the femoral head as follows. The location and volume of the pathological process, the size of the aseptic necrosis zone are determined using computed tomography (CT) and magnetic resonance imaging (MRI). During preoperative planning, taking into account the MRI results, the zone of surgical intervention is determined. Surgical anesthesia is administered and the surgical field is treated. Under the control of an electron-optical converter, a Kirschner wire is passed from the trochanteric region through the femoral neck into the necrosis focus. The wire is inserted into the center of the focus without damaging the subchondral plate. A channel is drilled into the bone along the wire with a crown drill to the lesion, the resulting bone column is preserved. The device is assembled: an injector is placed on the pusher, and a guide is placed on the injector. In the version of the device used, the rounding radii of the pusher, injector and guide are equal to the outer radius of the injector sleeve. The device is inserted into a previously prepared channel. Due to the hemispherical shape of the rounding, the device moves apart the soft tissues when passing to the bone and moves strictly along the bone channel. The pusher is removed, thus freeing the connector for connecting the syringe. The syringe is attached to the injector and aspiration of the liquid contents of the lesion is performed until blood appears. Next, a syringe is attached to the injector and previously prepared autoplasma or a drug is injected through the injector with a syringe. The injector together with the syringe is removed, only the guide is left in the bone channel. An autograft in the form of a previously preserved column of bone tissue is inserted through the channel of the guide. The syringe is removed from the injector connector and the pusher is inserted. The formed structure is advanced along the channel of the guide until it stops. Then, by pulling on the handle of the guide, the guide is gradually removed until all three parts are connected. The device is removed. The wound is sutured.

Clinical example: patient M.M., 37 years old, consulted an orthopedic traumatologist complaining of pain in the left hip joint, which intensified under load, as well as limited motion. CT and MRI were performed, and the diagnosis was: "Aseptic necrosis of the left femoral head, grade 2B according to ARCO". After standard preoperative preparation, surgery was performed, namely: tunneling (decompression) of the affected femoral head with the introduction of plasma enriched with growth factors (Plasma Reach with Growth Factors, PRGF) using the proposed device. Under the control of an electron-optical converter, a Kirschner wire was passed from the trochanteric region through the femoral neck into the center of the lesion without damaging the subchondral plate. A canal was drilled into the bone along the wire with a 7 mm crown drill to the lesion, the bone column was preserved. The device was assembled by putting the injector on the pusher and the pusher on the injector. In the used version of the device, the rounding radii of the pusher, injector and guide were equal to the outer radius of the injector sleeve and were 7 mm. The device was inserted. The pusher was removed, a syringe was attached to the injector and the liquid contents of the lesion were aspirated until blood appeared. The syringe with blood was removed and a syringe with previously prepared autoplasma (PRGF) was attached. The injector was removed together with the syringe. An autograft in the form of a previously preserved bone tissue column was inserted through the guide channel. The syringe was removed from the injector connector and the pusher was inserted. The resulting structure was used to advance the bone column along the guide channel until it stopped. The guide was pulled out by the handle until all three parts were connected. The device was removed. Drug therapy was prescribed. During follow-up examinations, a decrease in pain syndrome was noted compared to the period before the operation (before the operation - up to 6 points on the VAS, after the operation - no more than 2 points on the VAS in the 1st month after the operation, then - no complaints). According to instrumental control using MRI 3 months after the operation: there are no signs of progression of the femoral head lesion.

The proposed device allows for the introduction of a medicinal product and/or a transplant and/or an implant into the bone, while having high strength characteristics and being atraumatic due to the design features.

Sources:

1. Patent RU 88939 U1 (Kazakh State Medical University named after Prof. V.F. Voino-Yasenetsky, Ministry of Health of the Russian Federation) 11/27/2009.

2. Patent RU 2212903 C2 (Zoykin V.P.) 09.27.2003.

3. Patent WO 2014/022567 (SAFE WIRE HOLDINGS, LLC) 06.02.2014.

Claims (2)

1. A device for administering medicinal preparations, implants and transplants, consisting of an injector, a guide and a pusher axis, which are placed one inside the other and when assembled form a single rod, characterized in that the injector is a sleeve with an outer diameter equal to the inner diameter of the guide sleeve, while at the working end of the injector there is a rounding with a radius equal to the radius of the rounding at the end of the guide, while the pusher is an axis, the diameter of which is equal to the inner diameter of the injector sleeve, and at the working end of the pusher there is a rounding, the radius of which is equal to the roundings on the guide and the injector, while the roundings of the guide, injector and pusher in the assembly form a rounding at the end of the resulting rod, which has a hemispherical shape and a radius equal to the outer radius of the guide sleeve, while the injector contains a connector for connecting a syringe. 2. The device according to claim 1, wherein the guide, injector and pusher have handles for holding and removing.