ES2681573B2 - OSEO INTRODUCTORY DEVICE DEVICE - Google Patents

Description

DESCRIPTION

BONE GRAFT INTRODUCTIVE DEVICE

OBJECT OF THE INVENTION

The purpose of the present invention is to register a bone graft introducer device, which incorporates notable innovations and advantages over the techniques used so far.

More specifically, the invention proposes the development of a bone graft introducer device, which by its particular arrangement, facilitates the introduction of bone graft in areas of complicated and difficult access, in a safe way.

BACKGROUND OF THE INVENTION

Bone grafting is known in the current state of the art, which is a surgical procedure that replaces the missing bone in order to repair those bone fractures that are extremely complex, or that represent a significant risk to the patient's health, or that They don't heal well.

In the known state of the art, bone grafts are used in virtually all aspects of reconstructive orthopedic surgery and range from fracture treatment to complex limb salvage techniques in tumor surgery. Therefore, the introduction of bone graft is necessary in cases where it is required:

• Merge joints to prevent movement

• Repair broken bones (fractures) that have bone loss

• Repair injured bone that has not healed.

In the resulting concrete problem when an intersomatic fusion is performed, surgical fusion of the lumbar spine is a widely used method for the treatment of painful lumbar segmental instability associated or not with root compression; Its objective is to eliminate this instability and thus stabilize and strengthen the spine to relieve low back pain.

Intersomatic fusions are those that eliminate the intervertebral disc and replace it with bone graft.

Thus, vertebral fusion is the union or fusion of two or more vertebrae. To facilitate this fusion, the use of bone grafting is necessary. Small amounts of bone are taken from the patient's pelvis (autologous graft) or from a donor (allograft), and packed between the vertebrae, in order to "fuse" them. Implants are often used (such as grilles, bars, hooks and screws), designed to ensure proper intervertebral alignment and increase the chances of successful fusion. In addition, as the consolidation process progresses, these implants provide greater strength and stability to the spine.

Within the intersomatic fusions there are different techniques, depending on the access route. The most frequent ones, also followed by their acronyms in English, are the so-called Posterior Intersomatic Lumbar Arthrodesis (PLIF), Anterior Intersomatic Lumbar Arthrodesis (ALIF), Transforaminal Intersomatic Lumbar Arthrodesis (TLIF) and Extralateral Lumbar Intersomatic Arthrodesis (XLIF).

Although devices for introducing bone grafting have already been proposed, in practice it is common to use generic instruments to introduce it, with the drawbacks that this entails:

- The introduction of bone graft with the current devices (that is, general instruments not specifically intended for this use, such as tweezers) becomes quite uncomfortable and tedious, which implies that the procedure is very slow.

- The introduction of graft is insecure, since neither the instruments nor the graft itself is guided towards the desired area.

- It is the main surgeon who has to perform all the actions for the introduction.

In relation to all of the above, documents US2017340455A1 or US2016228261A1 can be considered as representative of the prior art.

Document US2017340455A1 refers to a discharge device (1) comprising a housing (200), a graft (300) rotatably disposed therein and a piston (400). A lateral cut (205) is formed in a wall (204) of the housing, and a lateral opening (303) of the graft contacts a wall (304) of the graft. To prevent the Compound is compressed as it is discharged, the lateral opening (303) of the graft continuously extends to the distal end (302) of the graft. To facilitate the placement of the compound, the thickness of the wall of the housing wall continuously decreases towards the lateral cut (205). To avoid clogging of the piston (400), the cross section of the graft (300) is continuously widened in the distal direction.

Document US2016228261A1 refers to a device and method of injection of graft material. The injector device includes an elongated injector tube and a side loading opening to receive graft material. Optionally, a graft material loader and a cover for the side loading opening can be included.

However, these documents do not adequately guarantee a tightness in the case of bone introduction, especially in the case of bone powder, in the sense of preventing spillage.

In addition and above all, these documents cited in themselves do not prevent any type of damage to the nerve roots and / or medullary sac near and / or surrounding the area where the bone graft is performed, with the obvious danger and risk that This implies for the patient, with such prevention falling exclusively on the skill and skill of the user surgeon.

The present invention contributes to solve and solve the present problem, since it facilitates the introduction of bone graft in difficult and difficult access areas and also preventing the difficulties explained above.

DESCRIPTION OF THE INVENTION

The present invention has been developed in order to provide a bone graft introducer device, comprising a main introducer, a wrap jacket and a pusher plunger; the main introducer presenting a geometry as a hollow elongated rod, with a hollow space inside which communicates with the lateral exterior of said main introducer through a window or opening, and also provided with a proximal part arranged at one end, of an annular stop disposed next to the proximal part towards the inside of the main introducer itself and of an end-of-stroke element arranged in turn towards the inside of the main introducer and following the stop cancel; the envelope jacket having an elongated and hollow cylinder geometry inside, which is essentially characterized by the fact that said envelope jacket has a stop and close element at one end and a stroke stop at the other end; the pusher piston presenting a geometry as an elongated rod and with a stop at one of its ends; the main introducer and the wrap jacket having adequate proportions for the mobile housing of the main introducer inside the wrap sleeve with the same axial axis and from the end of the wrap sleeve where the stop element is; the stop element of the wrap jacket and the end element of the main introducer having a geometry suitable for complementary coupling in the introduction of the main introducer through the inside of the wrap sleeve; the pusher piston and the main introducer having suitable proportions for the mobile introduction of the main pusher piston through the interior of the hollow space of the main introducer housed in turn in the jacket.

Preferably, in the bone graft introducer device, the proximal part of the main introducer has a blunt geometry termination.

Additionally, in the bone graft introducer device, the running stop of the wrap jacket has a circular geometry accompanied by a cut.

Additionally, in the bone graft introducer device, the thrust plunger stop has a circular geometry accompanied by a cut.

Thanks to the present invention, it is possible to facilitate the introduction of bone graft in areas of complicated and difficult access.

Other features and advantages of the bone graft introducer device will be apparent from the description of a preferred but not exclusive embodiment, which is illustrated by way of non-limiting example in the accompanying drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1, 2 and 3.- They are schematic and perspective views of the different constituent elements and separately from a preferred embodiment of the bone graft introducer device of the present invention.

Figures 4, 5, 6 and 7.- They are schematic and perspective views indicating the use of a preferred embodiment of the bone graft introducer device of the present invention.

DESCRIPTION OF A PREFERRED EMBODIMENT

The bone graft introducer device of the present invention comprises a main introducer 1, a wrap sleeve 2 and a pusher plunger 3, as shown schematically and respectively separately in Figures 1, 2 and 3.

As can be seen in Figure 1, the main introducer 1 has a hollow elongated rod-like geometry, with a hollow and longitudinal space 11 inside which communicates with the lateral exterior of said main introducer 1 through a window 12 or also longitudinal opening.

The main introducer 1 has a proximal part 13 disposed at one end and with a blunt geometry termination, an annular stop 14 arranged next to the proximal part 13 and into the main introducer 1 itself.

The same main introducer 1 also has an end-of-stroke element 15 also arranged inwardly of the main introducer 1 and then the annular stop 14.

As shown in Figure 2, the jacket 2 has a geometry in the form of an elongated and hollow cylinder in its interior, with a stop element 21 and closure at one end and a stroke stop 22 at the other end.

As shown schematically in Figure 3, the pusher piston 3 has an elongated rod-like geometry and with a stop 31 at one of its ends.

As shown schematically in Figure 4, the main introducer 1 and the wrap jacket 2 have mutual proportions suitable for the mobile housing of the main introducer 1 inside the wrap sleeve 2, by the end of the wrap jacket 2 where there is the stop member 21, and as indicated by the arrow in Figure 4, resulting in an arrangement with the same axial axis 4. For this, the jacket envelope 2 fits perfectly to the outer contour of the main introducer 1, thus ensuring the effective closure of the window 12 of the main introducer 1.

After the introduction and accommodation of the main introducer 1 inside the jacket 2, the stop element 21 of the jacket 2 and the end element 15 of the main introducer 1 are coupled as shown schematically in the Figure 5, and for which they present a suitable geometry for this purpose.

Similarly, the pusher piston 3 and the main introducer 1 have suitable mutual proportions for the mobile introduction of the main pusher piston 3 inside the main introducer 1 in turn housed inside the jacket 2, as It is indicated by the arrow in Figure 6.

The bone graft introducer device is designed to be used to facilitate the introduction of bone graft in difficult and difficult areas.

In the use of the bone graft introducer device, the bone graft is introduced into the hollow space 11 of the main introducer 1 through the window 12 enabled for this purpose.

The main introducer 1 is arranged in the area in which it is desired to insert the bone graft through the proximal part 13, and it is for this reason that said proximal part 13 has a blunt termination in order to avoid possible injuries to nerve structures. In addition, the annular stop 14 of the main introducer 1 prevents its inadequate or excessive introduction and damage of sensitive structures.

The wrapping jacket 2 then closes the window 12 of the main introducer 1 by perfectly adjusting to the outer section of the main introducer 1, as shown in Figure 4, in order to avoid the loss of bone graft during transport, as well as the introduction and graft compaction.

The coupling of the abutment element 21 of the jacket 2 and of the end-of-stroke element 15 of the main introducer 1 means that the jacket 2 and the main introducer 1 become a single element and thus facilitate its handling, as It can be seen schematically in Figure 5.

This supposes an extraordinary advantage in relation to the state of the art known and represented for example in documents US2017340455A1 or US2016228261A1, since during the adjustment of the jacket 2 in the main introducer 1 represented in figures 4 and 5, the coupling of the element of stop 21 of the wrap jacket 2 and of the end-of-travel element 15 of the main introducer 1 assumes that the wrap sleeve 2 cannot advance and invade the section of the main introducer 1 between its stop 14 and its same end element 15 of career.

Thanks to this, the necessary preservation of the nerve roots and / or medullary sac next to and / or surrounding the area where the bone graft is performed is assured, for example and especially in the intervertebral spaces, and that are present around the referred section of the main introducer 1, and therefore not preserving said preservation exclusively on the skill and skill of the user surgeon.

Then, as can be seen in Figures 6 and 7, the pusher pin 3 is introduced through the inner hollow space 11 of the main introducer 1, and compacts and displaces the graft previously introduced in said hollow space 11 of the main introducer 1 to place it in the desired area. The stop 31 at one of the ends of the pusher pin 3 facilitates its manual thrust or allows it to be impacted, as well as the introduction and compaction. In addition, said stop 31 and the stroke stop 22 of the jacket 2 also determine the end of the stroke of the pusher 3 to prevent it from protruding from the other end of the main introducer 1 and causing possible damage.

The race stop 22 also acts as a safety stop for the user in case of being hit, that is, so that the pusher pin 3 does not protrude from the bone graft introducer device of the invention and, in addition, protects the hand of the user surgeon in case it is necessary to hit to introduce it.

In addition, the race stop 22 of the jacket 2 is circular in geometry and accompanied by a cut 23 that eliminates a circular segment in order to avoid rolling.

Also, the stop 31 of the pusher plunger 3 has a circular geometry accompanied by a cut 32 that eliminates a circular segment in order to avoid rolling.

The bone graft introducer device of the proposed invention provides many advantages over the prior art.

It facilitates the introduction of bone tissue, making the procedure effective and comfortable.

It makes the introduction of bone graft safe, avoiding damaging risk elements and placing the graft in the desired area.

Shorten the times of the surgical procedure, since the procedure is simpler.

Take advantage of the amount of bone graft, since it is not wasted in areas where it is not necessary.

The bone graft introducer device of the invention helps the bone graft compaction, with the advantages that it provides to the main objective of the surgical procedure, which is bone regeneration.

It improves the total time of surgery, since the introduction of the graft can be done in two phases:

- Loading of the device, which can be carried out by personnel attached to the main surgeon, such as the nurse. Meanwhile, said surgeon uses that time for other phases required in the surgical intervention.

- Introduction of the graft, which is always performed by the surgeon, but since everything is prepared beforehand, the execution time is very short (approx. 1 minute).

In surgical procedures of intersomatic fusion, the problem of tissue introduction is clearly presented since the area is difficult to access and risky. The disc space to be filled with graft is about 10 cm away and also in the vicinity of vertebral body structures such as the aorta and cava. All this implies a difficulty and risk, solved by the bone graft introducer device of the invention.

In the result obtained with the bone graft introducer device of the present invention, the duration of the bone graft introduction phase is reduced by 90%, which means a very important reduction in the total time of fusion intersomatic This reduction in time is due to the fact that the introduction is done in a safe, comfortable and effective way, and that the load has been carried out by a person attached to the surgeon as is the nursing staff.

The details, shapes, dimensions and other accessory elements, as well as the materials used in the manufacture of the bone graft introducer device of the invention, may be conveniently replaced by others that are technically equivalent and do not depart from the essentiality of the invention or the scope defined by the claims included below.

Claims (4)

1. Bone graft introducer device, comprising a main introducer (1), a wrap jacket (2) and a pusher plunger (3); the main introducer (1) presenting a hollow elongated rod-like geometry, with a hollow space (11) inside which communicates with the lateral exterior of said main introducer (1) through a window (12) or opening, and also provided with a proximal part (13) disposed at one end, an annular stop (14) then disposed of the proximal part (13) into the main introducer itself (1) and an element (15) of limit switch arranged in turn towards the inside of the main introducer (1) and then the annular stop (14); the envelope jacket (2) presenting an elongated and hollow cylinder geometry in its interior, characterized in that said envelope jacket (2) has a stop element (21) and closure at one end and a career stop (22) at the other end; the pusher piston (3) presenting a geometry as an elongated rod and with a stop (31) at one of its ends; the main introducer (1) and the wrap jacket (2) having suitable proportions for the mobile housing of the main introducer (1) inside the wrap sleeve (2) with the same axial axis (4) and from the end of the wrapping jacket (2) where the stopper element (21) is; the stop element (21) of the jacket (2) and the end element (15) of the main introducer (1) presenting a geometry suitable for complementary coupling in the introduction of the main introducer (1) inside of the enveloping shirt (2); the pusher piston (3) and the main introducer (1) having suitable proportions for the mobile introduction of the main pusher piston (3) inside the hollow space (11) of the main introducer (1) in turn housed in the sleeve envelope (2). 2. Bone graft introducer device according to claim 1, characterized in that the proximal part (13) of the main introducer (1) has a blunt geometry termination. 3. Bone graft introducer device according to claim 1, characterized in that the stroke stop (22) of the wrap jacket (2) has a circular geometry accompanied by a cut (23) that eliminates a circular segment. 4. Bone graft introducer device according to claim 1, characterized in that the stop (31) of the pusher plunger (3) has a circular geometry accompanied by a cut (32) that eliminates a circular segment.