RU151477U1 - DEVICE FOR PROLONGED TRANSPEDICULAR LOCOREGIONAL CHEMOTHERAPY OF TUMORS OF VERTEBRALS - Google Patents

Abstract

1. A device for prolonged transpedicular local chemotherapy of vertebral tumors, consisting of a catheter with an inflated cuff, and a port, while the catheter with an inflated cuff is made with the possibility of its connection with the port, which is made with the possibility of fixation of the catheter. 2. The device according to claim 1, characterized in that the catheter has an oval 3.8 × 1.8 mm cross section, length 40 cm, the diameter of the main working lumen of the catheter is 1.2 mm, the lumen for inflating the cuff is 0.5 mm. 3. The device according to claim 1, characterized in that a flexible spring nitinol conductor is inserted into the lumen of the working channel of the catheter. The device according to claim 1, characterized in that the cuff width is 4 mm, the cuff length is 4 mm. The device according to claim 1, characterized in that an oval cross-sectional trocar needle with an internal lumen of 3.8 × 1.8 mm, corresponding to the cross section of the catheter, and an oval stylet are used transpedicularly for catheter placement. The device according to claim 1, characterized in that the rigid metal conductor for subcutaneous catheter passage to the port has an oval section equal to the oval section of the catheter, and the fitting for introducing it into the catheter lumen and subcutaneous catheter is displaced from the center to the corner of the oval conductor.

Description

The utility model relates to the field of medical technology. In particular, to special reusable surgical instruments. The device can be used in oncology for the treatment of spinal tumors.

Given the increasing number of tumor lesions of the spine, the ongoing development of methods for their chemotherapy and ways to deliver chemotherapy to the tumor, the issue of prolonged multi-course local-area chemotherapy remains relevant. To date, devices are known: a Fogarty catheter having an inflated cuff at the end; trocar for percutaneous puncture vertebroplasty and arterial thromboresistant implantable port system Selsayt.

Fogarty's catheter (Fig. 1) is a specialized tool designed to remove blood clots and emboli from limb arteries. Like most vascular devices made of polyvinyl chloride. At the end of the tube there is a latex inflated balloon. Similar to the Fogarty catheter balloon, the catheter we developed has a balloon cuff. However, in the Fogarty catheter, the balloon is designed to remove emboli and blood clots from the arteries of the limbs, and not to fix the catheter in the vertebral body.

A needle with trocar sharpening (Fig. 2) for percutaneous vertebroplasty or bone biopsy Osteo-SiteDBBN-13-15.0-M2 or DBBN-13-15.0-M1M, or as in the Synicem VPT kit. However, the trocar cross section for puncture vertebroplasty is round and its purpose is the introduction of bone cement with monomer into the vertebral body to eliminate, for example, hemangiomas. But this device cannot be used for multi-course transpedicular locoregional chemotherapy.

Celsite® ports of the ST305C, ST305P, CR305-A6 type (Fig. 3) are fully implantable systems providing simple and reliable drug administration. They can be used both for bolus injections and for long-term infusions, the chamber is made of titanium / polysulfone. However, this device has a round-shaped catheter that does not allow it to be fixed in the vertebral body, since there is no balloon balloon in its distal tip.

Thus, the claimed model has no analogues.

The technical result of our device is the ability to conduct multiple transpedicular locoregional chemotherapy of vertebral tumors due to reliable fixation of the catheter by means of an inflated cuff in the vertebral body.

The technical result is achieved by the fact that “A device for prolonged transpedicular locoregional chemotherapy of vertebral tumors” consisting of a catheter with an inflated cuff, and a port, while the catheter with an inflated cuff is made with the possibility of its connection to the port, which is configured to fix the catheter. The catheter has an oval 3.8 × 1.8 mm cross section, length 40 cm. The diameter of the main working lumen of the catheter is 1.2 mm, the lumen for balloon inflating is 0.5 mm. The proximal end of the catheter has both a nipple for inflating the cuff that holds it in the vertebral body and seals around the circumference of the inlet to the vertebral body, and the inlet of the working channel into which the port fitting is inserted. For its introduction, an oval cross section is proposed for a trocar needle, with an internal lumen of 3.8 × 1.8 mm, corresponding to the cross section of the catheter, and an oval stylet. Cuff width 4 mm, cuff length 4 mm. Considering that the port is implanted in areas typical for this, it is necessary to conduct a catheter of the port subcutaneously with a rigid metal conductor (similar to how the Selsite port system catheter is inserted).

The rigid metal conductor also has an oval cross-section equal to the oval cross-section of the catheter, and the fitting for introducing it into the working lumen of the catheter and subcutaneous catheter is shifted from the center to the corner of the oval conductor. A flexible spring nitinol conductor was introduced into the lumen of the working channel of the catheter.

The objective of the utility model "Device for the treatment of spinal tumors" is to expand the range of medical products for high-tech types of treatment by expanding the functionality of the model.

The constructive ability of the utility model we developed allows us to carry out multi-course transpedicular locoregional chemotherapy of vertebral tumors.

The essence of the proposed utility model is illustrated by drawings, which depict:

In FIG. 1 shows a diagram of a Fogarty catheter.

In FIG. 2. shows a trocar needle for percutaneous vertebroplasty or bone biopsy Osteo-SiteDBBN-13-15.0-M2 or DBBN-13-15.0-M1M.

In FIG. 3.Celsite® port type ST305C, ST305P, CR305-A6 is shown.

In FIG. 4 shows a catheter with an inflated cuff, a channel for an inflated cuff, a valve, an internal channel.

In FIG. 5 shows the port.

In FIG. 6 shows a nitinol conductor

In FIG. 7 shows a trocar needle.

In FIG. 8 depicts a hard metal conductor.

The device operates as follows.

In the X-ray room, after marking under the electron-optical transducer (EOP), the trocar needle (Fig. 7) is transpedicular to its largest diameter in the vertical plane (for entering the vertebral arch in accordance with its shape), a vertebra affected by the tumor or adjacent to it is punctured.

Venospondylography is performed by introducing a radiopaque substance into the trocar needle and the time it takes for the radiopaque substance to fill the adjacent vertebra is determined. The stylet of the trocar needle is removed, then a catheter is inserted into its lumen (Fig. 4).

Under the control of the tube, the trocar needle is pulled out of the vertebral body, remaining only in its arch, with the help of a spring nitinol guide (Fig. 6), the catheter moves forward into the vertebral body, and the trocar is pulled back 1 cm.

After this manipulation, the catheter cuff is extended into the vertebral body and it must be inflated by introducing into the nipple of sterile saline with an insulin syringe in a volume of up to 0.5 cm ³ , which fixes the catheter in the vertebral body. A skin incision is performed 1 cm up and down from the puncture point with a trocar.

After the catheter is fixed in the vertebral body with a swollen cuff, the trocar needle is removed. A second skin incision is performed at a distance of 20 cm from the skin incision at the puncture point to conduct a catheter subcutaneously between them using a rigid metal conductor (Fig. 8), and the third skin incision is above the port implantation (Fig. 5) at the standard port implantation point .

The port is filled with heparin solution, connected to the catheter by introducing the port fitting into the lumen of the working channel of the catheter, the catheter itself is also washed with the heparin solution, after which the port is inserted subcutaneously.

Suturing of skin incisions is performed.

To conduct prolonged transpedicular locoregional chemotherapy of vertebral tumors with a Huber needle, the port membrane is punctured percutaneously and chemotherapeutic drugs are injected at a rate of 2-2.5 ml per minute (average value calculated from the average contrast time of the adjacent vertebra). Thus, it is possible to conduct multiple transpedicular locoregional chemotherapy of vertebral tumors due to reliable fixation of the catheter by means of an inflated cuff in the vertebral body.

The testing of this device was carried out in 5 patients undergoing treatment at the RNII for metastatic spinal lesions in lung and breast cancer.

The main advantage of the claimed useful “Device for carrying out prolonged transpedicular locoregional chemotherapy of vertebral tumors” is the possibility of prolonged multi-course transpedicular locoregional chemotherapy.

The proposed "Device for prolonged transpedicular locoregional chemotherapy of vertebral tumors" can be manufactured industrially using modern materials and technologies, highly efficient, technologically advanced, convenient and reliable.

Claims (6)

1. A device for prolonged transpedicular locoregional chemotherapy of vertebral tumors, consisting of a catheter with an inflated cuff, and a port, while the catheter with an inflated cuff is made with the possibility of its connection with the port, which is configured to fix the catheter. 2. The device according to claim 1, characterized in that the catheter has an oval 3.8 × 1.8 mm cross section, length 40 cm, the diameter of the main working lumen of the catheter is 1.2 mm, the lumen for inflating the cuff is 0.5 mm. 3. The device according to claim 1, characterized in that a flexible spring nitinol conductor is inserted into the lumen of the working channel of the catheter. 4. The device according to claim 1, characterized in that the cuff width is 4 mm, the cuff length is 4 mm. 5. The device according to claim 1, characterized in that an oval cross-sectional trocar needle with an internal lumen of 3.8 × 1.8 mm corresponding to the cross section of the catheter and an oval stylet are used transpedicularly for catheter placement. 6. The device according to p. 1, characterized in that the rigid metal conductor for subcutaneous catheter passage to the port has an oval section equal to the oval section of the catheter, and the nozzle for introducing it into the catheter’s lumen and subcutaneous catheter is displaced from the center to the corner of the oval conductor .

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