BR-112022020167-B1 - INTERSPINOUS VERTEBRAL DISTRACTOR

Abstract

INTERSPINOUS VERTEBRAL DISTRACTOR. Designed to be placed between two spinous processes and defining a longitudinal geometric axis (1a), a sagittal plane (1b) and a frontal plane (1c); the distractor (1) comprises a base body (2) designed to be placed between the two spinous processes and defining a first end and a second end; an anchoring unit (3) designed to expand, affixing the distractor (1) between two spinous processes; an actuator (5) designed to control the passage of the unit (3) between an expanded position and a contact position; the base body (2) has a sagittal section with two opposite convexities so as to define a profile with two recesses (2a).

Inventors

• Giovanni GARLATTI
• LORENZO FORTUNA

Assignees

• DIAMETROS MEDICAL S.R.L

Dates

Publication Date

20260310

Application Date

20200408

Claims (5)

1. 1. Interspinous vertebral distractor (1) designed to be placed between two spinous processes and defining a longitudinal geometric axis (1a), a sagittal plane (1b), and a frontal plane (1c); said distractor (1) comprising: - a base body (2) designed to be placed between said two spinous processes and defining, in relation to said longitudinal geometric axis (1a), a first end and a second end; - an anchoring unit (3) firmly affixed to said base body (2) at said first end and designed to expand perpendicularly to said frontal plane (1c); - an actuator (5) designed to control the passage of said unit (3) between an expanded position in which said unit (3) restricts said distractor (1) between said two spinous processes and a contracted position in which said unit (3) ceases to restrict said distractor (1) between said two spinous processes; characterized by the fact that - said base body (2) has a sagittal section with two opposite convexities so as to define a profile with two recesses (2a) placed on the opposite side of said frontal plane (1c), each of which is designed to accommodate one of said two spinous processes; - wherein said base body (2) has a conical frontal section with the minimum section at the first end; - wherein said frontal section of said base body (2) comprises a first sector, a second sector and a central sector; - wherein said first sector is at said first end and has the minimum height, wherein said second sector is at said second end and has the maximum height; wherein said central sector defines two inclinations (2b) joining said first sector and said second sector placed on the opposite side of said sagittal plane (1b).
2. 2. Distractor (1) according to the preceding claim, characterized in that said recesses (2b) are basically formed in at least one inclination (2b).
3. 3. Distractor (1) according to the preceding claim, characterized in that the beginning of said inclination (2b) has a smaller axial distance from said first end than the bottom of said recesses (2a).
4. 4. Distractor (1) according to any one of claims 2 to 3, characterized in that the radial section of said base body (2) made in said bottom of said recesses (2a) has a frontal height and sagittal height basically equal to each other.
5. 5. Distractor (1) according to any of the preceding claims, characterized in that the sagittal height of said base body (2) at the bottom of said recesses (2a) is preferably basically less than 85% of the sagittal height of said base body (2) at the apices of said recesses (2a).

Description

[001] The invention relates to an interspinous vertebral distractor/interspinous vertebral distraction device/interspinous vertebral distraction procedure of the type specified in the preamble of the first claim. [002] In particular, the invention relates to an implant designed to be implanted, preferably percutaneously, in an interspinous space to separate two adjacent vertebrae. [003] As is well known, interspinous distraction can be surgically achieved by introducing an interspinous vertebral distractor between two spinous processes that is controlled by an operator-operated device to insert and control the distractor. [004] Distractors are prostheses designed to be implanted in the space between the spinous processes of two adjacent vertebrae in order to maintain an intervertebral distraction that is adequate to limit the loads transmitted between the vertebrae in cases of degenerative intervertebral disc disease, thereby limiting the associated pain. [005] They basically consist of a base body that can be arranged between the spinous processes and the expanding anchoring means of the distractor. The expansion of the anchoring means is controlled by the control device. [006] The interspinous vertebral distraction procedure consists of positioning a distractor in the space between the spinous processes of two adjacent vertebrae. In detail, with the patient in the prone position, the affected intervertebral space is identified, the spinous processes are approximated by the expansion cannula, the measurement of the distractor to be inserted is determined by means of a probe and, finally, the selected distractor is inserted. [007] A first example of a distraction procedure and device, and in particular of a distractor, is described in WO2006102269. In this case, the distractor has a first ogive end so as to penetrate the intervertebral space, which is formed by a first pair of wings that open; the opposite end is fitted with a second pair of fixed wings enclosing the spine between the two pairs of wings. [008] Another example is described in document US8998955 in which there are two pairs of movable wings. Each wing has one end articulated to the base body and the other end is free. To achieve locking, this patent prescribes rotating the wings at angles greater than 120° so that the free ends face the vertebrae. [009] A further example is described in WO2012069877 where locking and relative ease of insertion and extraction are achieved by means of hook wings. [010] The previously described technique has some significant drawbacks. [011] In particular, despite the solutions outlined here, the interspinous vertebral distraction procedure/device, and in particular the distractor, are relatively complicated and therefore particularly expensive. This is basically attributed to the fact that, during the procedure, the operator encounters particular difficulties in inserting and defining a stable positioning of the interspinous vertebral distractors. [012] Another drawback is the low stability of interspinous vertebral distractors once they have been implanted. [013] An equally important disadvantage is the fact that the control kinematics of movable wings is particularly complex. [014] Another drawback, therefore, is the cost and difficulty in implementing known interspinous vertebral distractors. [015] In this context, the basic technical task of this invention is to design an interspinous vertebral distractor/interspinous vertebral distraction device/interspinous vertebral distraction procedure capable of substantially overcoming at least some of the aforementioned drawbacks. [016] The said technical task comprises the important purpose of the invention of having an interspinous vertebral distractor that, once implanted, is easy to insert and stable. [017] Another objective is to provide an interspinous vertebral distractor that is easy to implement and therefore less expensive. [018] The specified technical task and purposes are achieved by an interspinous vertebral distractor/interspinous vertebral distraction device/interspinous vertebral distraction procedure according to Claim 1. Examples of preferred embodiments are described in the dependent claims. [019] The features and advantages of the invention are elucidated by the following detailed description of preferred embodiments thereof, with reference to the accompanying drawings, in which: - Figure 1 shows, to scale, an interspinous vertebral distractor according to the invention; - Figures 2a-2e illustrate, to scale, the distractor in a sequence during an interspinous vertebral distraction procedure according to the invention; - Figure 3 shows, to scale, a cross-section of the distractor in Figure 1; - Figure 4 shows, to scale, an assembly of an interspinous vertebral distraction device according to the invention; - Figure 5 illustrates, to scale, the assembly in Figure 4; - Figures 6a-6f represent, to scale, a preparation sequence for the interspinous v