WO2021115960A1 - Total hip or shoulder prosthesis and kit of instruments for placement of the same - Google Patents
Total hip or shoulder prosthesis and kit of instruments for placement of the same Download PDFInfo
- Publication number
- WO2021115960A1 WO2021115960A1 PCT/EP2020/084669 EP2020084669W WO2021115960A1 WO 2021115960 A1 WO2021115960 A1 WO 2021115960A1 EP 2020084669 W EP2020084669 W EP 2020084669W WO 2021115960 A1 WO2021115960 A1 WO 2021115960A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis
- acetabular
- glenoid
- femoral
- introducer
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4681—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by applying mechanical shocks, e.g. by hammering
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4687—Mechanical guides for implantation instruments
Definitions
- Total shoulder replacement The joint is completely replaced, i.e. the scapular component (glenoid cavity) and the humeral component (humeral head).
- the implanted device that replaces the scapular component and the humeral component is called a total shoulder prosthesis.
- the instruments needed to place the partial PCT ES2019/070399 prosthesis include a Kirschner wire centring device that enables the placement of a Kirschner wire centred on the femoral or humeral head, a cannulated femoral or humeral head extractor and two inserters for the prosthesis components.
- the most important of these are the inserters for the hemispherical component and the diaphyseal nail. They are shaped like an inverted “U” with a component holder and a handle provided with a groove aligned with the holder.
- the total hip/shoulder prosthesis described in this report consists of the following components:
- the acetabular prosthesis is comprised of an external component designed to be embedded in the hip bone (pelvic acetabulum) — by any method — and an internal component that comes into contact with the femoral prosthesis, specifically with the ball of the metaphyseal component.
- the femoral prosthesis shall preferably be placed using the method set forth in the aforesaid PCT patent, using the same incisions. Other methods may be used although they are non-preferred procedures because they make placement more aggressive.
- the invention also consists of a kit of instruments for the minimally invasive prosthesis placement.
- removal of the femoral head may require an incision in the femoral neck (osteotomy) using a saw blade.
- the saw blade must be guided during performance of this task.
- This guidance may be provided by means of a guide for the osteotomy (cut) of the femoral neck that consists of a generally U-shaped handle (inverted in operating position) and a grip that occupies one vertical leg of the U and all or most of the horizontal section and a centring-nail support.
- the centring nail is designed to be inserted into the femoral diaphyseal canal to immobilise that end of the guide while the grip is held from the outside.
- the acetabulum can be milled by using a bur introducer — also generally U-shaped and inverted while in use — comprised of an introducer handle with a bur-holder attached at one end.
- the free end of the bur-holder is formed by a ring in which the stem of the normally hemispherical bur rotates freely.
- the bur stem is aligned using an aligner formed by a groove or orifice in the handle of the bur introducer that enables a rotary tool to be connected to the bur stem and perfectly aligned with the same.
- the grip of the femoral neck osteotomy (cut) guide, the handle of the bur introducer and the acetabular prosthesis introducer may be equipped with series of marks with an X-ray transparency different from the rest of the instrument and arranged at different angles to help control the anteversion of each one at any given time.
- Figure 3 Perspective view of an example of a femoral neck osteotomy guide.
- Figure 4 Perspective view of the bur introducer.
- Figure 6 Perspective view of the bur introducer prepared for milling.
- Figure 8 Detail view of the alignment marks.
- the acetabular prosthesis (10) of the invention is a body with a generally hemispherical internal opening, as is usual in the present state of the art, for insertion and movement of the spherical ball (19) of the metaphyseal component of the femoral prosthesis.
- This acetabular prosthesis (10) is composed of an external component (11) — the outermost part, — embedded in the acetabulum of the pelvis and an internal component (12) (the "insert” or “liner”) which is the part that comes into contact with the ball of the metaphyseal component of the femoral prosthesis.
- the outer component (11) and the inner component (12) could form a single element if the material possesses the required properties, although this would be a non-preferred embodiment.
- the external component of the acetabular prosthesis (11) may be fixed to the pelvic bone (acetabulum) by threading, impaction, etc. or any other method and is not a relevant aspect of the invention.
- Middle incision below the greater trochanter. It will be approximately aligned with the extension of the equivalent to the femoral neck of the latter. An opening aligned with this middle incision is made in the lateral cortical wall of the femur.
- a Kirschner wire (39) must be inserted through the middle incision towards the centre of the femoral head using the aligner (36) on the grip (31) of the guide for the femoral neck osteotomy (cut) as a guide.
- This aligner (36) is a groove or orifice on the grip (31) of the guide for the femoral neck (3) osteotomy (cut) that marks the direction (37) through which the sheath (57) for insertion of the Kirschner wire (39) must be inserted.
- the femoral head can be removed through the upper incision once the osteotomy (cut) of the femoral neck has been performed. Any method, such as the femoral head extractor described in the aforesaid PCT, may be used for this step.
- This is a cannulated femoral head extractor and is inserted through the middle incision, traversing the femur through the opening in its lateral cortical wall.
- the cannulated extractor is embedded in the cancellous bone inside the femoral head to enable dislocation of the same and removal through the upper incision.
- a bur introducer (5) is used once the femoral head has been removed.
- the introducer may be composed of a generally U-shaped introducer handle (51) and bur support (52) assembly.
- This bur introducer (5) may have parts in common with the femoral neck osteotomy (cut) guide (3).
- the handle of the introducer (51) could be the grip (31), only replacing the support (32) by the bur support (52).
- the bur support (52) is fitted with a bur-holding ring (53) with freedom of rotation for milling
- the bur (54) may consist of central cannula for insertion of a Kirschner wire (39) on the stem of rotation in such a way that the bur (54) is held stable in the acetabulum but is able to rotate enable milling with the rotating tool (59).
- the aligner (55) is first used with a sheath (57) to place the Kirschner wire (39), prior to the insertion of the rotating tool (59).
- the rotating tool (59) also has a central cannula that enables insertion of the same once the Kirschner wire (39) is in place.
- the rotating tool (59) is inserted and the acetabulum is milled. It may be necessary to repeat the operation with burs (54) of different sizes until the acetabulum is milled properly. Marks on the rotating tool (59) enable indicate how much has been milled at any one time by measuring how much said tool (59) has moved with respect to the aligner (55).
- the next step is to place the acetabular prosthesis (10) comprised of the external component (11) and the internal component (12).
- the internal component (12) is already placed inside the external component (11) when insertion takes place.
- Insertion of the external component (11) together with the internal component (12) is performed through the upper incision using an acetabular prosthesis introducer (6), the general shape of which is similar to that of the bur introducer (5), being generally U-shaped and divided into an acetabular prosthesis introducer handle (61) and an acetabular prosthesis holder (62).
- the acetabular prosthesis introducer handle (61) may be the same as the bur introducer handle (51) or as the femoral neck osteotomy guide (3) grip (31).
- the acetabular prosthesis support (62) in contrast, has male fixations (63) on the side facing the femoral head for coupling to female fixations (13) located on the perimeter of the internal component (12) of the acetabular prosthesis (10).
- the fixations (13, 63) can be released from the outside, for example from the acetabular prosthesis introducer (6) by means of a release rod (65).
- acetabular prosthesis fixation device which is inserted through the middle incision, through the opening previously made in the lateral cortex of the femur to act on the acetabular prosthesis (10).
- the acetabular prosthesis fixation device may be an impactor if the fixation is by impaction, any type of screwdriver or any other kind of device to rotate the acetabular prosthesis (10) if fixation is by threading on the acetabulum.
- the external component (11) of the acetabular prosthesis (10) must be provided with external thread that enables it to screw into the bone.
- the acetabular prosthesis fixator is inserted through an acetabular prosthesis aligner (64) on the acetabular prosthesis introducer handle (61) that defines the direction in which the acetabular prosthesis fixator is to be inserted to reach the appropriate point of the acetabular prosthesis (10) with absolute accuracy.
- Placement of the femoral prosthesis (15) starts from the upper and middle incisions already made and the holes previously drilled in the femur for extraction of the femoral head. To do so, the metaphyseal component (16) can be inserted into the middle incision by the acetabular prosthesis aligner (64) to ensure that the ball (19) is inserted into the cavity intended for the purpose in the internal component (12) of the acetabular prosthesis (10).
- the handle of the acetabular prosthesis introducer (61), the introducer handle (51) and the femoral neck osteotomy (cut) guide grip (31) may have a series of marks (35) that enable the surgeon to ascertain the angular orientation (anteversion) of the respective tool.
- These marks consist of objects (holes, inserts%) with an X-ray transparency different from the rest of the instrument. Each one will be set at a different angle (“0°, 8° and 16°”; “0°, 10° and 20°”; “0°, 5°, 10° and 15°”, etc.).
- the mark (35) that is not deformed will indicate the anteversion angle applied with respect to the femur or with respect to the pelvis, as the case may be.
Abstract
Total hip or shoulder prosthesis for minimally invasive replacement of the pelvic acetabulum and the femoral head or the glenoid cavity of the scapula and the humeral head, comprising: - an acetabular/glenoid prosthesis (10) configured to be embedded in the pelvic acetabulum/glenoid cavity. - a femoral prosthesis (15) formed by o a straight metaphyseal component (16) with a ball (19) at one end for placement in the acetabular/glenoid prosthesis (10) and provided with a transverse hole (17) for the passage of o a diaphyseal nail (18) for insertion into the femoral/humeral canal. It also includes a guide (3) for femoral or humeral neck osteotomy to extract the femoral or humeral head and introducers (5, 6) in the shape of an inverted "U" of the different components of the prosthesis using aligners (55, 64) to reach and place said items without needing to see the operating zone.
Description
DESCRIPTION
Total hip or shoulder prosthesis and kit of instruments for placement of the same
TECHNICAL FIELD
This invention is a method for a full hip or shoulder prosthesis and the kit, set, or series of instruments for its placement.
It is applicable to the medical device and instrument manufacturing-industry.
STATE OF THE ART
When a joint is damaged or unhealthy for any reason (fractures, osteoarthritis, neoplasms, etc.) it may be necessary to perform a joint replacement. This consists of removing the damaged parts of the joint and inserting an artificial device in place of the damaged parts to recover the function of the joint. This artificial device is called a joint prosthesis.
The hip and shoulder joints have anatomical similarities since both are enarthrosis or ball- and-socket joints composed of two parts: a hemispherical component (the head of the femur in the case of the hip and the head of the humerus in the shoulder) and a concave component that acts as a receptacle for the aforesaid hemisphere (the pelvic acetabulum or socket of the hip or the glenoid fossa or cavity of the scapula in the case of the shoulder).
Joint replacement may be partial or total in both cases, depending on the parts to be replaced.
The following can be distinguished in the case of the hip:
Partial hip replacement: only the femoral component of the joint is replaced, i.e. the head of the femur. The implanted device that replaces the femoral component is called a partial hip prosthesis.
Total hip replacement: The entire joint is replaced, i.e. the pelvic component (the pelvic acetabulum) and the femoral component (the femoral head). The implanted
device that replaces the pelvic component and the femoral component is called a total hip prosthesis.
In the case of the shoulder we can distinguish:
Partial shoulder replacement: Only the humeral component of the joint (the humeral head) is replaced. The implanted device that replaces the humeral component is called a partial shoulder prosthesis.
Total shoulder replacement: The joint is completely replaced, i.e. the scapular component (glenoid cavity) and the humeral component (humeral head). The implanted device that replaces the scapular component and the humeral component is called a total shoulder prosthesis.
Both the hip and the shoulder prosthesis placement procedures are very aggressive and the associated surgery poses significant risks.
Any approach that aims to mitigate the surgical aggressiveness of the procedure to insert a total hip or shoulder prosthesis must solve several problems:
1. How can the femoral or humeral head in the case of hip or shoulder replacement respectively be extracted in a minimally invasive manner?
2. How can the pelvic acetabulum in the case of the hip or the glenoid cavity in the case of the scapula be milled in a minimally invasive way?
3. What device can we implant — also in a minimally invasive manner — once the first two steps have been performed to completely replace the hip joint (both the pelvic and femoral components) or the shoulder joint (scapular and humeral components)?
In the case of the hip joint, the prostheses of patents US2003060889, US2016256281 and US2002095214 for this third problem are known in the state of the art. They encompass replacement prostheses for the acetabulum or femoral head comprised of smaller components that are joined in situ. A procedure for inserting an acetabulum prosthesis is also known under US5507824.
An instrument and a partial hip or shoulder prosthesis is described in PCT application ES2019/070399 by the undersigned applicant, that provides the starting point for this invention and which solves the problem fora partial hip or shoulder joint replacement. This prosthesis consists of a hemispherical component supported by a straight metaphyseal component with a transverse orifice for insertion of a diaphyseal or shaft nail. This shaft nail is inserted into the femoral or humeral canal. The metaphyseal component is attached to the diaphyseal nail by a longitudinal locking nail that traverses the diaphyseal nail. Since the device is inserted piece-by-piece, the required incision is reduced and is comparable to the incisions for proximal nailing of a standard Gamma-type femur nail (Stryker) or PFNa nail (Synthes), which means that the aggressiveness of the surgery is significantly reduced with respect to placement of standard hip or shoulder prostheses.
The instruments needed to place the partial PCT ES2019/070399 prosthesis include a Kirschner wire centring device that enables the placement of a Kirschner wire centred on the femoral or humeral head, a cannulated femoral or humeral head extractor and two inserters for the prosthesis components. The most important of these are the inserters for the hemispherical component and the diaphyseal nail. They are shaped like an inverted “U” with a component holder and a handle provided with a groove aligned with the holder. Thus, once the hemispherical component of the prosthesis has been inserted through a first or upper incision, another instrument can be inserted, perfectly aligned, through the second or lower incision.
The applicant is not aware of any prostheses or instruments that can be considered similar to this invention to solve the problems outlined in the event of a total hip or shoulder prosthesis.
BRIEF EXPLANATION OF THE INVENTION
The invention consists of a total hip prosthesis (formed by an acetabular prosthesis to replace the pelvic acetabulum and a femoral prosthesis to replace the femoral head) or a shoulder prosthesis (formed by a glenoid prosthesis to replace the glenoid cavity of the scapula and a humeral prosthesis to replace the humeral head) and the kit of instruments for placement of the acetabular prosthesis in the case of the hip or of the glenoid prosthesis in the case of the shoulder, in accordance with the claims.
This prosthesis and the instruments enable minimally invasive placement. The aggressiveness of the operation is considerably reduced with respect to the current techniques for placing total hip or shoulder prostheses and this entails a similar reduction in postoperative complications, pain and the required postoperative recovery.
The adjectives "inverted", “upper" and “lower" as used throughout this report shall not limit the scope of the claim. Their use is illustrative, intended to facilitate understanding of the invention without involving complex explanations. Specifically, “upper" shall be understood to refer to the area of the element in question that, at the specific moment of use, is closest to the patient's head. By contrast, "lower" refers to the part furthest from the patient's head at the time. "Inverted" refers to the position of the object with respect to the patient.
The aim of this prosthesis is to reduce the complications caused by total hip or shoulder prosthetic surgery in cases where the procedure is required.
The design of the prosthesis and its instruments enables placement of the former in a minimally invasive manner: quickly, simply and by a single surgeon, minimising the aggressiveness of the surgery compared to a standard hip or shoulder prosthetic operation.
The total hip/shoulder prosthesis described in this report consists of the following components:
Femoral/humeral prosthesis: for replacement of the femoral/humeral head. These in turn can be divided into: o Metaphyseal component o Diaphyseal nail
Acetabular/glenoid prosthesis: for replacement of the pelvic acetabulum/scapular glenoid cavity. These in turn can be divided into: o External component o Internal component or insert
The following is a brief description of the components of the prosthesis applied to a total hip prosthesis although, as indicated above, it is also applicable to a total shoulder prosthesis. To adapt the text to the shoulder operation, “acetabular” shall be replaced by “glenoid”, “femoral” by “humeral” and other changes consistent with these. The angles and
measurements shall also be adapted to take account of the different shape of the joint to be replaced.
The acetabular prosthesis is comprised of an external component designed to be embedded in the hip bone (pelvic acetabulum) — by any method — and an internal component that comes into contact with the femoral prosthesis, specifically with the ball of the metaphyseal component.
The femoral prosthesis shall preferably be placed using the method set forth in the aforesaid PCT patent, using the same incisions. Other methods may be used although they are non-preferred procedures because they make placement more aggressive.
The femoral prosthesis is comprised of a straight metaphyseal component with a ball at one end designed to fit into the cavity for which it is intended in the internal component of the acetabular prosthesis. The ball of the metaphyseal component replaces the femoral head in the joint since the movement of the hip takes place between the ball of the metaphyseal component and the internal surface of the acetabular prosthesis.
The metaphyseal component has a transverse hole to house the diaphyseal nail to be inserted into the femoral canal. The metaphyseal component and the shaft nail are attached to the metaphyseal component by a longitudinal locking nail.
The invention also consists of a kit of instruments for the minimally invasive prosthesis placement. For example, removal of the femoral head may require an incision in the femoral neck (osteotomy) using a saw blade. The saw blade must be guided during performance of this task. This guidance may be provided by means of a guide for the osteotomy (cut) of the femoral neck that consists of a generally U-shaped handle (inverted in operating position) and a grip that occupies one vertical leg of the U and all or most of the horizontal section and a centring-nail support. The centring nail is designed to be inserted into the femoral diaphyseal canal to immobilise that end of the guide while the grip is held from the outside. In the zone of union between the grip and the support there is a groove that enables the saw blade to extend in one sole direction. In the operating position, this will be the direction in which the femoral neck is to be found. Thus, the cut can be performed unseen, without requiring a large incision or using, at most, the image intensifier commonly found in operating theatres.
The acetabulum can be milled by using a bur introducer — also generally U-shaped and inverted while in use — comprised of an introducer handle with a bur-holder attached at one end. The free end of the bur-holder is formed by a ring in which the stem of the normally hemispherical bur rotates freely. The bur stem is aligned using an aligner formed by a groove or orifice in the handle of the bur introducer that enables a rotary tool to be connected to the bur stem and perfectly aligned with the same.
The acetabular prosthesis can be inserted by means of an acetabular prosthesis introducer, also generally U-shaped, and is comprised of an acetabular prosthesis introducer handle and an acetabular prosthesis holder with male fixation devices designed to engage the female fixation devices on the internal component of the acetabular prosthesis. They can be released by the release rod fitted to the handle of the acetabular prosthesis introducer.
As in the other cases, the U-shape enables definition of an acetabular prosthesis aligner aligned with a central point in the acetabular prosthesis to orient an acetabular prosthesis fixation device (impactor, screwdriver, etc.).
If the acetabular prosthesis is to be fixed to the pelvic bone (acetabulum) by threading, the female fixations of the internal component will be circular grooves into which the male fixations of the acetabular prosthesis support can slide, thus enabling the acetabular prosthesis to rotate.
The grip of the femoral neck osteotomy (cut) guide, the handle of the bur introducer and the acetabular prosthesis introducer may be equipped with series of marks with an X-ray transparency different from the rest of the instrument and arranged at different angles to help control the anteversion of each one at any given time.
All inverted U-shaped devices may have an additional handle opposite the grip or other auxiliary parts provided that they include the parts described for the functions set forth in this report.
Other variants of the prosthesis and of the instruments will be shown later.
DESCRIPTION OF THE DRAWINGS
The following figures are presented by way of example to aid comprehension of the invention and shall not limit the scope of the claim.
Figure 1 : Perspective view of an example of a total hip prosthesis.
Figure 2: Detail of an acetabular prosthesis.
Figure 3: Perspective view of an example of a femoral neck osteotomy guide. Figure 4: Perspective view of the bur introducer.
Figure 5: View of the bur introducer in placement of a Kirschner wire.
Figure 6: Perspective view of the bur introducer prepared for milling.
Figure 7: Perspective view of an acetabular prosthesis introducer.
Figure 8: Detail view of the alignment marks.
Figure 9: View of the osteotomy guide in position of use.
Figure 10: Exploded view of the prosthesis example from figure 1.
Figure 11 : Exploded lateral view of an example of a femoral neck osteotomy guide.
MODES OF EMBODIMENT OF THE INVENTION
The following is a description of an embodiment of the invention presented by way of example and which shall not limit the scope of the claim. It will be described as applied to a total hip prosthesis although, as already noted, it is applicable to a total shoulder prosthesis with the changes set forth above
The acetabular prosthesis (10) of the invention is a body with a generally hemispherical internal opening, as is usual in the present state of the art, for insertion and movement of the spherical ball (19) of the metaphyseal component of the femoral prosthesis. This
acetabular prosthesis (10) is composed of an external component (11) — the outermost part, — embedded in the acetabulum of the pelvis and an internal component (12) (the "insert" or "liner") which is the part that comes into contact with the ball of the metaphyseal component of the femoral prosthesis. The outer component (11) and the inner component (12) could form a single element if the material possesses the required properties, although this would be a non-preferred embodiment.
The external component of the acetabular prosthesis (11) may be fixed to the pelvic bone (acetabulum) by threading, impaction, etc. or any other method and is not a relevant aspect of the invention.
The femoral prosthesis (15) may be consistent with the one described in the aforesaid PCT, with a different model or with the one described below. The preferred femoral prosthesis (15), the one shown in Figures 1 and 10, is comprised of a straight metaphyseal component (16) with a transverse orifice (17) to enable insertion of a diaphyseal nail (18) to be embedded in the femoral canal. The metaphyseal component (16) is attached to the diaphyseal nail (18) by a longitudinal locking nail (4) that traverses both the metaphyseal component (16) and the diaphyseal nail (18). The metaphyseal component (16) ends in a ball (19) which, in use, is placed inside the cavity left by the internal component (12) of the acetabular prosthesis (10) with sufficient tolerance to enable rotation.
Several stages are required for placement of both prostheses (10 and 15). The procedure begins with two incisions. These are:
- An upper incision slightly proximal to the greater trochanter.
Middle incision, below the greater trochanter. It will be approximately aligned with the extension of the equivalent to the femoral neck of the latter. An opening aligned with this middle incision is made in the lateral cortical wall of the femur.
Other incisions may be necessary depending on the femoral prosthesis model (15) but they are no longer inherent to replacement of the acetabulum. The most common optional incision is a lower incision below the middle incision to insert a screw to secure the diaphyseal nail to the femur.
The femoral head must be removed first. An osteotomy (cut) must be performed in the femoral neck to enable removal of the head if the latter is still attached to the femur (i.e. , when there has not been a prior fracture of the femoral neck that separates the head from
the rest of the femur). To do so, a saw (2) — which must be guided — is used to cut the femoral neck. The guide for the femoral neck osteotomy (3) is composed of a handle in the general shape of an inverted “U” similar to the centring nail introducer described in the aforesaid PCT patent. It consists of a grip (31) and a support (32) for a centring nail (33) that is inserted into the femoral diaphysis (shaft). The grip (31) occupies one vertical section of the “U” and all or most of the horizontal section. There is a groove (34) that enables insertion of the saw blade (2) approximately at the junction between the grip (31) and the support (32). The dimensions of the groove (34) and of the saw will only enable the saw cutting blade to be inserted in a single direction and keeps said blade (2) on the plane formed by the femoral neck (3) osteotomy (cut) guide. In use, the mouth of the groove (34) must be positioned close to the upper incision (preferably from the outside) to facilitate insertion of the saw blade (2). As can be seen in the figures, the groove (34) can be made in the funnel-shaped part that helps to position the cutting blade.
To ensure proper positioning of the femoral neck osteotomy (cut) guide (3) oriented towards the femoral neck (3), a Kirschner wire (39) must be inserted through the middle incision towards the centre of the femoral head using the aligner (36) on the grip (31) of the guide for the femoral neck osteotomy (cut) as a guide. This aligner (36) is a groove or orifice on the grip (31) of the guide for the femoral neck (3) osteotomy (cut) that marks the direction (37) through which the sheath (57) for insertion of the Kirschner wire (39) must be inserted. Thus, when the Kirschner wire (39) is centred on the femoral head by intraoperative X-ray control, the femoral neck (3) osteotomy (cut) guide and therefore the saw blade (2) will be properly oriented towards the femoral neck. The shape and dimensions of the aligner will depend on the shape and dimensions of the sheath (54).
The cutting blade of the saw (2) itself may be a known model. The only essential requirement is that the dimension of the groove (34) in the guide for the osteotomy (cut) of the femoral neck (3) is consistent with the size of the saw blade (2) to be inserted into the patient through the upper incision to achieve the desired guidance.
The femoral head can be removed through the upper incision once the osteotomy (cut) of the femoral neck has been performed. Any method, such as the femoral head extractor described in the aforesaid PCT, may be used for this step. This is a cannulated femoral head extractor and is inserted through the middle incision, traversing the femur through the opening in its lateral cortical wall. The cannulated extractor is embedded in the
cancellous bone inside the femoral head to enable dislocation of the same and removal through the upper incision.
A bur introducer (5) is used once the femoral head has been removed. The introducer may be composed of a generally U-shaped introducer handle (51) and bur support (52) assembly. This bur introducer (5) may have parts in common with the femoral neck osteotomy (cut) guide (3). For example, the handle of the introducer (51) could be the grip (31), only replacing the support (32) by the bur support (52). To do this, there is a screw (38) that enables the elements fixed to the grip (31) or handle (51, 61) to be changed.
The bur support (52) is fitted with a bur-holding ring (53) with freedom of rotation for milling
(54), the stem of which (56) is aligned with an aligner (55) on the handle of the introducer (51). This aligner (55) is a groove or hole in the handle of the introducer (51) that marks the direction in which a tool for turning the bur (54) must be inserted “blind” to engage with the latter. The bur (54) is hemispherical in shape with the active part on the outside and an stem (56) that is held in position — with freedom of rotation and locked for translational movement — by the ring (53). When the rotating tool (59) is inserted through the aligner
(55) and the middle incision, the tool couples to the bur (54) and the acetabulum can be milled. The coupling may be of any type, for example, a square or hexagonal blind female part on the stem (56) connected by a male tool of the same shape. The rotating tool (59) will generally be motorised but may be manual.
The bur (54) may consist of central cannula for insertion of a Kirschner wire (39) on the stem of rotation in such a way that the bur (54) is held stable in the acetabulum but is able to rotate enable milling with the rotating tool (59). In this way, the aligner (55) is first used with a sheath (57) to place the Kirschner wire (39), prior to the insertion of the rotating tool (59).
The rotating tool (59) also has a central cannula that enables insertion of the same once the Kirschner wire (39) is in place.
Once the bur (54) has been inserted into the acetabulum using the bur introducer (5) and the position of the bur has been stabilised with a Kirschner wire (39), the rotating tool (59) is inserted and the acetabulum is milled. It may be necessary to repeat the operation with burs (54) of different sizes until the acetabulum is milled properly. Marks on the rotating
tool (59) enable indicate how much has been milled at any one time by measuring how much said tool (59) has moved with respect to the aligner (55).
The next step is to place the acetabular prosthesis (10) comprised of the external component (11) and the internal component (12). Generally, the internal component (12) is already placed inside the external component (11) when insertion takes place.
Insertion of the external component (11) together with the internal component (12) is performed through the upper incision using an acetabular prosthesis introducer (6), the general shape of which is similar to that of the bur introducer (5), being generally U-shaped and divided into an acetabular prosthesis introducer handle (61) and an acetabular prosthesis holder (62). The acetabular prosthesis introducer handle (61) may be the same as the bur introducer handle (51) or as the femoral neck osteotomy guide (3) grip (31). The acetabular prosthesis support (62), in contrast, has male fixations (63) on the side facing the femoral head for coupling to female fixations (13) located on the perimeter of the internal component (12) of the acetabular prosthesis (10). The fixations (13, 63) can be released from the outside, for example from the acetabular prosthesis introducer (6) by means of a release rod (65).
Once the acetabular prosthesis (10) is in position it must be fixed in place by an acetabular prosthesis fixation device which is inserted through the middle incision, through the opening previously made in the lateral cortex of the femur to act on the acetabular prosthesis (10). The acetabular prosthesis fixation device may be an impactor if the fixation is by impaction, any type of screwdriver or any other kind of device to rotate the acetabular prosthesis (10) if fixation is by threading on the acetabulum.
If fixation of the acetabular prosthesis to the pelvic bone (acetabulum) is by threading, the external component (11) of the acetabular prosthesis (10) must be provided with external thread that enables it to screw into the bone.
The acetabular prosthesis fixator is inserted through an acetabular prosthesis aligner (64) on the acetabular prosthesis introducer handle (61) that defines the direction in which the acetabular prosthesis fixator is to be inserted to reach the appropriate point of the acetabular prosthesis (10) with absolute accuracy.
Placement of the femoral prosthesis (15) starts from the upper and middle incisions already made and the holes previously drilled in the femur for extraction of the femoral head. To do so, the metaphyseal component (16) can be inserted into the middle incision by the acetabular prosthesis aligner (64) to ensure that the ball (19) is inserted into the cavity intended for the purpose in the internal component (12) of the acetabular prosthesis (10). This done, the diaphyseal nail (18) is placed by means of a diaphyseal nail inserter which may be a version of one of the inserters (5, 6) with modified supports (52, 62). A locking nail (4) is inserted through a longitudinal orifice in the metaphyseal component (16) using the appropriate aligner (55, 64) to keep the diaphyseal nail (18) in position inside the transverse hole (17) of the metaphyseal component (16).
The diaphyseal nail (18) can be fixed to the diaphysis (shaft) of the femur with a screw (through the middle incision or with a new incision, the lower incision) using cement or any other method.
In the figures it can be seen that the handle of the acetabular prosthesis introducer (61), the introducer handle (51) and the femoral neck osteotomy (cut) guide grip (31) may have a series of marks (35) that enable the surgeon to ascertain the angular orientation (anteversion) of the respective tool. These marks consist of objects (holes, inserts...) with an X-ray transparency different from the rest of the instrument. Each one will be set at a different angle (“0°, 8° and 16°”; “0°, 10° and 20°”; “0°, 5°, 10° and 15°”, etc.). Thus, when the surgeon uses the image intensifier, the mark (35) that is not deformed will indicate the anteversion angle applied with respect to the femur or with respect to the pelvis, as the case may be.
Therefore, the invention comprises, in addition to the two prostheses (10, 15), a whole series of preferred instruments that are designed to assist in placing the prostheses and removing the femoral head.
All materials must be bio-compatible, especially those that will remain inside the patient's body.
Claims
1 - A total hip or shoulder prosthesis characterised in that it is composed of: an acetabular/glenoid prosthesis (10), configured to be embedded in the pelvic acetabulum in the case of the hip or in the glenoid cavity of the scapula in the case of the shoulder, comprised of an external component (11) that comes into contact with the bone and an internal component (12) into which the ball (19) of a femoral/humeral prosthesis (15) is inserted to replace the femoral/humeral head composed of: a straight metaphyseal component (16) with the ball (19) and a transverse hole (17) for the passage of a diaphyseal nail (18) intended to be inserted into the femoral or humeral shaft, fixed to the metaphyseal component (16) by a locking nail (4) longitudinal to the latter.
2 - A total hip or shoulder prosthesis as per claim 1 , characterised in that the mouth of the internal component (12) has the same diameter as the ball (19) with sufficient tolerance to enable one to move against the other.
3- A kit of instruments for placing the total hip or shoulder prosthesis of any of claims 1 or 2.
4 - The kit of claim 3, that comprises a guide for osteotomy of the femoral or humeral neck (3) to guide the cutting blade of the saw (2), composed of a handle in the general shape of an inverted “U” with a grip (31) that occupies a vertical section of the “U” and all or most of the horizontal section and a support (32) for a centring nail (33) configured to be inserted into the diaphysis of the femur or humerus, characterised in that it consists of a groove (34 ) in the joint area between the grip (31) and the support (32) that enables passage of the saw blade (2) in a single direction.
5 - The kit as per claim 4, where the handle (31) has a series of marks (35) arranged at different angles and with different X-ray transparency from the rest of the guide.
6 - The kit of claim 3, that comprises a bur introducer (5) for milling the pelvic acetabulum or the glenoid cavity of the scapula and characterised in that it has a general inverted “U” shape and consists of: an introducer handle (51) a support for the burr (52) attached to the introducer handle (51) at one end and ending in a ring (53) for holding the stem (56) of a bur (54), preferably hemispherical, where the stem (56) is aligned with an aligner (55) formed by a groove or orifice that marks the direction of the stem (56) on the introducer handle (51).
7 - The kit of claim 6, where the burr (54) has a central cannula.
8 - The kit of claim 6, where the introducer handle (51) has a series of marks (35) arranged at different angles and with a different X-ray transparency from the rest of the burr introducer (5).
9 - The kit of claim 3, that comprises an acetabular/glenoid prosthesis introducer (6) for placement of the acetabular/glenoid prosthesis (10), characterised in that it has a general inverted “U” shape and comprises: an acetabular/glenoid introducer handle (61) with an acetabular/glenoid aligner (64) an acetabular/glenoid prosthesis support (62) with male fixation devices (63) configured to engage female fixation devices (13) on the internal component (12) of the acetabular/glenoid prosthesis (10) that can be released from the handle of the acetabular/glenoid prosthesis introducer (61) by means of a release rod (65) where the acetabular/glenoid prosthesis aligner (64) is aligned with a central point inside the acetabular/glenoid prosthesis (10) to orient an acetabular/glenoid prosthesis fixation device.
10 - The kit of claim 9 where the acetabular/glenoid prosthesis introducer handle (61) has a series of marks (35) arranged at different angles with a different X-ray transparency of the rest of the acetabular/glenoid prosthesis introducer (6).
11 - The kit of claim 9 where the fixations (13, 63) enable rotation of the acetabular/glenoid prosthesis to fix it to the bone of the pelvic acetabulum by being screwed into an acetabular/glenoid prosthesis fixation device with thread.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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ESP201931091 | 2019-12-10 | ||
ES201931091A ES2832583B2 (en) | 2019-12-10 | 2019-12-10 | Total hip or shoulder prosthesis and instruments for its placement |
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WO2021115960A1 true WO2021115960A1 (en) | 2021-06-17 |
WO2021115960A4 WO2021115960A4 (en) | 2021-08-19 |
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PCT/EP2020/084669 WO2021115960A1 (en) | 2019-12-10 | 2020-12-04 | Total hip or shoulder prosthesis and kit of instruments for placement of the same |
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WO (1) | WO2021115960A1 (en) |
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EP1344505A2 (en) * | 2002-03-11 | 2003-09-17 | Nicholas G. Sotereanos | A modular hip implant |
US20160256281A1 (en) | 2009-07-10 | 2016-09-08 | Peter Forsell | Hip joint device and method |
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WO2008069800A1 (en) * | 2006-12-07 | 2008-06-12 | Anatol Podolsky | Method and apparatus for total hip replacement |
US8579985B2 (en) * | 2006-12-07 | 2013-11-12 | Ihip Surgical, Llc | Method and apparatus for hip replacement |
US8241286B2 (en) * | 2009-08-26 | 2012-08-14 | Biomet, C.V. | Method for implanting a hip fracture nail system |
US8840675B2 (en) * | 2010-04-22 | 2014-09-23 | Benjamin S. Song | Durable resurfacing hip replacement device |
US20140128986A1 (en) * | 2012-11-06 | 2014-05-08 | Ihip Surgical, Llc | Monoblock head and neck unit for total hip replacement |
ES2735007B2 (en) * | 2018-06-11 | 2020-07-17 | Desarrollos Biomecanicos Innovasan S L | Hip or shoulder prosthesis and placement instruments. |
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2019
- 2019-12-10 ES ES201931091A patent/ES2832583B2/en active Active
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- 2020-12-04 WO PCT/EP2020/084669 patent/WO2021115960A1/en active Application Filing
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US5507824A (en) | 1993-02-23 | 1996-04-16 | Lennox; Dennis W. | Adjustable prosthetic socket component, for articulating anatomical joints |
US6562042B2 (en) * | 2000-02-02 | 2003-05-13 | Owen A. Nelson | Orthopedic implant used to repair intertrochanteric fractures and a method for inserting the same |
US20020095214A1 (en) | 2001-01-16 | 2002-07-18 | Hyde Edward R. | Transosseous core approach and instrumentation for joint replacement and repair |
EP1240879A2 (en) * | 2001-03-13 | 2002-09-18 | Nicholas G. Sotereanos | Hip implant assembly |
DE10120331A1 (en) * | 2001-04-26 | 2002-11-21 | Ulrich Muender | Endoprosthesis of two femur implant elements, with sleeve and medullar rod, hip joint head, conical adapter and ellipsoid metal plate |
US20030060889A1 (en) | 2001-09-24 | 2003-03-27 | Tarabishy Imad Ed. | Joint prosthesis and method for placement |
EP1344505A2 (en) * | 2002-03-11 | 2003-09-17 | Nicholas G. Sotereanos | A modular hip implant |
US20160256281A1 (en) | 2009-07-10 | 2016-09-08 | Peter Forsell | Hip joint device and method |
Also Published As
Publication number | Publication date |
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ES2832583A1 (en) | 2021-06-10 |
WO2021115960A4 (en) | 2021-08-19 |
ES2832583B2 (en) | 2022-05-05 |
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