CA2531541C - Surgical nail - Google Patents

Surgical nail Download PDF

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Publication number
CA2531541C
CA2531541C CA2531541A CA2531541A CA2531541C CA 2531541 C CA2531541 C CA 2531541C CA 2531541 A CA2531541 A CA 2531541A CA 2531541 A CA2531541 A CA 2531541A CA 2531541 C CA2531541 C CA 2531541C
Authority
CA
Canada
Prior art keywords
insert
transverse bore
nail
transverse
bore
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA2531541A
Other languages
French (fr)
Other versions
CA2531541A1 (en
Inventor
Andre Schlienger
Markus Buettler
Peter Senn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes USA LLC
Original Assignee
Synthes USA LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synthes USA LLC filed Critical Synthes USA LLC
Publication of CA2531541A1 publication Critical patent/CA2531541A1/en
Application granted granted Critical
Publication of CA2531541C publication Critical patent/CA2531541C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7233Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7241Intramedullary pins, nails or other devices with special means of locking the nail to the bone the nail having separate elements through which screws pass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive

Abstract

The invention relates to a surgical nail (1), in the form of an intramedullary nail with a central axis (2), consisting of a material M having a tensile strength F z, compression strength F d, density p2 and modulus of elasticity E. Said nail has a transverse bore (3) extending transversely to the central axis (2) and has a cross-sectional profile F and a transverse axis (4), the transverse cross-sectional profile F having a maximum length a in the direction of the central axis and a maximum width b that runs perpendicular to the length. An insert (10) with a longitudinal axis (13), made from material m and having a modulus of elasticity e that is smaller than the modulus of elasticity E of material M, can be introduced into the transverse bore (3). In addition, the insert (10) has a length L in the direction of the longitudinal axis (13) that satisfies the condition L > 0.2 D.

Description

12.6.2003 CA 02531541 2006-O1-05 English translation of the International Patent Application No. PCT/CH03/00376 "Surgical Nail" in the name of Synthes AG Chur Surgical Nail The invention concerns a surgical nail, in particular an intramedullary nail according to the preamble of patent claim 1.
The locking of intramedullary nails is state-of-the-art. The introduction of locking screws or locking bolts (in the following only the term locking screw will be used that, however, includes also the term locking bolt) into the transverse bores of a intramedullary nail is carried out either with the aid of an imaging process (X-ray control) or a more or less complicated aiming device. A certain aiming accuracy cannot be avoided in either cases, i.e. the tip of the screw cannot be exactly aligned coaxially with the central axis of the transverse bore, rather it deviates from it by a certain amount. So that the locking screw would enter into the transverse bore despite this aiming error and could pass through it, the outside diameter of the screw is so dimensioned, that it will be below that of the diameter of the transverse bore. If the aiming accuracy remains within the limit of this underdimensioning, the locking screw can be guided, despite the aiming error, through the transverse bore without any problem. In any case, as a result of the underdimensioning, the locking screw has a certain clearance relative to the transverse bore..
This clearance defines as to what extent the main bone fragments, fixed by means of locking screws in the corresponding locking hole, can move relative to the nail and thus due to the rigidity of the nail also relative to the other main bone fragments, fastened with the same nail. To guarantee the usefulness of the locking for the surgeons, while this play is essential, in the case of some indications (e.g. in the case of metaphysial fragments) it is clinically undesirable.
Even nails with a solid cross-section, that may have an internal thread in the locking hole, are not without clearance. The internal thread merely prevents the axial displacement of the nail on the locking screw.

'2 From US 6,296,645 Hover et al., a hollow, intramedullary nail from metal is known, that in the diametrally opposed openings on the jacket of the transverse bore, described as windows, has one or two plastic inserts, through which the locking screw can be introduced. A disadvantage of this known intramedullary nail is that the window-like plastic inserts can be easily pushed in, so that its desired function is lost. Even with a careful manipulation the two plastic inserts can be pushed out from their "windows", what also leads to a loss of the function.
This is where the invention wants to provide remedy. The object of the invention is to produce a surgical nail, in particular an intramedullary nail, with which the clearance between it and the locking screw can be eliminated without any risk and an improved holding force as well as an improved guiding can be achieved between the locking screw and the intramedullary nail.
The invention achieves the objective stated with a surgical nail having the features of claim 1.
The following advantages can be achieved with it:
a) the aiming accuracy during the insertion of the locking screw is unimpaired,;
b) the doctor is in the position to decide during the operation whether he uses an angularly stable locking of the locking screw or not, while the term "angularly stable" stands for a certain limitation of the degree of freedom;
c) the feasibility of an angularly stable fixing of the bone fragments in certain directions for a certain amount of the load; and d) the nail and the insert can be packed separately in a sterile manner and the surgeon can choose whether he uses the nail without or with the insert. In the latter case the surgeon himself can insert the insert into the nail and, if necessary, remove it. If the surgeon uses the nail without an insert, it remains in the sterile package for the next occasion.
In the case of a particular embodiment the length L of the insert satisfies the condition L > 0.5 D and preferably L = D.

In the case of a further embodiment the insert is basically congruent with the transverse bore.
In the case of a particular embodiment the insert can have a bore that is coaxial with its longitudinal axis so that to facilitate the introduction of the locking screw.
The material m of the insert has a tensile strength fZ < FZ, a compression strength fd < Fd and modulus of elasticity a < 0.8 E, preferably a < 0.7 E.
In an embodiment the material m of the insert is a biocompatible material, preferably a polyethylene or a high-molecular polyethylene (HMWPE), that has the advantage, that the synthetic material will not disintegrate into unknown decomposing products.
According to a preferred development the insert is made from a material of lesser hardness, a bioabsorbable polymer, preferably a polylactide. The result of this execution is an initial clearance-free transverse locking of the intramedullary nail, that with the increasing absorption of the polymer is successively discontinued, so that the transverse locking screws will become again mobile relative to the intramedullary nail and consequently also the bone fragments involved. Thus following the consolidation of the fracture a dynamisation of the bone fragments takes place. The bioabsorbable material has the advantage that the splinters caused by screwing in the locking screw into the nail can be decomposed by the body. A further advantage is the possibility to realise, as time passes, a different strength of the angularly stable locking of the locking screw, i.e. to achieve a gradual reduction of the holding force.
The transverse bore of the intramedullary nail can be either a circular bore, whereby the cross-section F has the maximum lengths a = b (i.e. a = b is the diameter of the transverse bore), or a slotted hole, whereby the cross-section F
has the maximum lengths a > b.
The material m of the insert has preferably a lower density p, than the material M
with density p2, while preferably p~ < 0.8 p2.

j4 The locking screws or locking bolts, that can be passed through the insert, should preferably have a shaft with a diameter of d (maximum diameter that includes a possible external thread), that satisfies the condition a > d < b. At the same time the diameter d of the external thread should preferably be at feast 5% smaller than the smaller of the two dimensions a, b.
In the case of a special execution the transverse bore expands towards the surface of the nail, preferably in the form of a tapered section. The advantage of this is that an insert having a corresponding tapered section that is inserted into it cannot be axially displaced in the direction of insertion.
The invention and developments of the invention are explained in detail based on the partially schematic illustrations of several embodiments.
They show in:
Fig.1 - a perspective view of a intramedullary nail with a continuous cannula with a transverse bore and an insert fitting it as well as a transverse locking screw, Fig.2 - a longitudinal section through the intramedullary nail according to Fig.1, Fig.3 - a longitudinal section through the intramedulfary nail according to Fig.1, rotated by 90°, Fig.4 - an enlarged schematic view of the section of the transverse bore of the intramedullary nail according to Fig.1, Fig.5 - a single-piece insert with a longitudinal bore for the transverse bore in the intramedullary nail, that after insertion is approximately aligned with the nail's cannula, ' ' " 5 Fig.6 - a partial longitudinal section through a further, modified intramedullary nail with a modified single-piece insert, and Fig.7 - a partial longitudinal section through a further, modified intramedullary nail with a modified single-piece insert.
The surgical nail 1 illustrated in Figs.1-3 is an intramedullary nail for hollow bones with a central axis 2, that is made from a metal or a metal alloy, i.e. a material with relatively high strength (tensile strength FZ, compression strength Fd and modules of elasticity E). The nail 1 has a transverse bore 3, having a transverse axis 4 and extending as a slotted hole with the cross-section F towards the central axis 2. As illustrated in Fig:4, the transverse bore 3 has a cross-section F, that has its maximum length a in the direction of the central axis 2 and right angle to it the maximum width b. The nail can have further, not illustrated, transverse bores (circular or oval).
As illustrated in Fig.1, an insert 10 is provided to be introduced into the transverse bore 3. The dimensions of the insert 10 are congruent with that of the transverse bore 3 or are so chosen that its insertion results in a press fit, thus preventing the falling out of the insert from the transverse bore 3. The insert 10 is made from a material m with lesser strength, in particularly with a lower E modules (when compared with the material M of the intramedullary nail).
As illustrated in Fig.S, the insert 10 can have a longitudinal bore 14 that is coaxial with its longitudinal axis 13 and a transverse bore 24, that after its insertion into the intrameduflary nail at right angle, corresponds with the nail's cannula.
In Fig.6 a version of the single-piece insert 10 is illustrated that comprises a pin 17 with a tapered expanding head 18.
In Fig.7 a further version of a single-piece insert 10 is illustrated, that comprises a pin 19 with a bore centrally passing through it as well as a plurality of tapered expansions 20 provided on the circumference, that in the form of a click lock can ~6 engage corresponding cavities 21 or the longitudinal bore 23 in the region of the transverse bore 3.

Claims (16)

The embodiments of the present invention for which an exclusive property or privilege is claimed are defined as follows:
1. An intramedullary nail comprising:

an elongate body having a longitudinal central axis and formed of a material M

having a tensile strength F z, compressive strength F d, density .rho.2 and modulus of elasticity E;
at least one transverse bore extending transversely to the central axis, the transverse bore having a cross-section F and a transverse axis;

an insert formed of a bioabsorbable material configured and dimensioned for insertion into the transverse bore, the insert having a longitudinal axis and a plurality of projections provided on an outer surface of the insert for engaging the nail body adjacent to the transverse bore and holding the insert in position within the transverse bore, the insert including a central bore coaxial with the transverse axis.
2. The device of claim 1, wherein the insert is formed of a material m having a modulus of elasticity e<E.
3. The device of claim 1, wherein the transverse cross-section F of the transverse bore has a maximum length a in the direction of the central axis and a maximum width b perpendicular to the length a, the intramedullary nail has a diameter D at the transverse bore, and the insert has a length L in the direction of its longitudinal axis that satisfies the condition L>0.2 D.
4. The device of claim 3, wherein the insert has a length L>0.5 D.
5. The device of claim 1, wherein the insert has substantially the same shape as the transverse bore.
6. The device of claim 2, wherein the modulus of elasticity of the insert, e<0.8 E.
7. The device of claim 2, wherein the material m has a tensile strength f z<F
z.
8. The device of claim 2, wherein the material m has a compressive strength f d<F d.
9. The device of claim 1, wherein the bioabsorbable material includes one of a polyethylene, a high-molecular polyethylene (HMWPE), and another biocompatible synthetic material.
10. The device of claim 1, wherein the bioabsorbable material is one of a polymer and a copolymer.
11. The device of claim 3, wherein the transverse bore in the nail has a substantially circular cross-section F, with maximum lengths a=b.
12. The device of claim 3, wherein the transverse bore in the nail has a substantially slotted cross-section F, where the maximum length a>b.
13. The device of claim 2, wherein the density .rho.1 of material m is less than the density .rho.2 of material M.
14. The device of claim 1, further comprising a locking screw adapted for insertion through the insert in the transverse bore, the locking screw having a shaft with an outer diameter d satisfying the conditions a>d<b.
15. The device of claim 1, wherein the nail has an outer surface adjacent the transverse bore, and the transverse bore expands towards the outer surface of the nail to form a depression in the outer surface of the nail.
16. The device of claim 1, wherein the insert is a pin having a tapered expanded head.
CA2531541A 2003-06-12 2003-06-12 Surgical nail Expired - Fee Related CA2531541C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CH2003/000376 WO2004110291A1 (en) 2003-06-12 2003-06-12 Surgical nail

Publications (2)

Publication Number Publication Date
CA2531541A1 CA2531541A1 (en) 2004-12-23
CA2531541C true CA2531541C (en) 2011-05-10

Family

ID=33546137

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2531541A Expired - Fee Related CA2531541C (en) 2003-06-12 2003-06-12 Surgical nail

Country Status (15)

Country Link
US (1) US9737347B2 (en)
EP (1) EP1631206B1 (en)
JP (1) JP4357478B2 (en)
CN (1) CN100457058C (en)
AR (1) AR044330A1 (en)
AT (1) ATE375125T1 (en)
AU (1) AU2003232567B2 (en)
BR (1) BR0318327B1 (en)
CA (1) CA2531541C (en)
CL (1) CL2004000867A1 (en)
DE (1) DE50308380D1 (en)
ES (1) ES2294372T3 (en)
NZ (1) NZ544074A (en)
TW (1) TWI323169B (en)
WO (1) WO2004110291A1 (en)

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AR044330A1 (en) 2005-09-07
ATE375125T1 (en) 2007-10-15
AU2003232567B2 (en) 2007-12-20
TW200505386A (en) 2005-02-16
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JP2006527004A (en) 2006-11-30
EP1631206A1 (en) 2006-03-08
US9737347B2 (en) 2017-08-22
BR0318327A (en) 2006-07-11
CN1787787A (en) 2006-06-14
CA2531541A1 (en) 2004-12-23
AU2003232567A1 (en) 2005-01-04
JP4357478B2 (en) 2009-11-04
CN100457058C (en) 2009-02-04
CL2004000867A1 (en) 2005-01-14
BR0318327B1 (en) 2013-06-18
TWI323169B (en) 2010-04-11
WO2004110291A1 (en) 2004-12-23
DE50308380D1 (en) 2007-11-22
NZ544074A (en) 2007-10-26
ES2294372T3 (en) 2008-04-01
US20060149248A1 (en) 2006-07-06

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