[go: up one dir, main page]

WO2002034166A1 - Fixation device for use in surgery - Google Patents

Fixation device for use in surgery Download PDF

Info

Publication number
WO2002034166A1
WO2002034166A1 PCT/GB2001/004638 GB0104638W WO0234166A1 WO 2002034166 A1 WO2002034166 A1 WO 2002034166A1 GB 0104638 W GB0104638 W GB 0104638W WO 0234166 A1 WO0234166 A1 WO 0234166A1
Authority
WO
WIPO (PCT)
Prior art keywords
shank
bone
washer
head
fixation device
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.)
Ceased
Application number
PCT/GB2001/004638
Other languages
French (fr)
Inventor
David John Beevers
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.)
Xiros Ltd
Original Assignee
Xiros Ltd
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 Xiros Ltd filed Critical Xiros Ltd
Priority to AU2002210684A priority Critical patent/AU2002210684A1/en
Publication of WO2002034166A1 publication Critical patent/WO2002034166A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0817—Structure of the anchor
    • A61F2002/0823—Modular anchors comprising a plurality of separate parts
    • A61F2002/0829—Modular anchors comprising a plurality of separate parts without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0817—Structure of the anchor
    • A61F2002/0841—Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/087—Anchor integrated into tendons, e.g. bone blocks, integrated rings
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Definitions

  • This invention relates generally to fixation devices for use in surgery, and particular, though not exclusively, for use in implant surgery.
  • fixation device for use in surgery, and which usually comprise devices which can be driven into bone in order to act as an anchorage, either by being hammered into position e.g. a nail or bone staple, or by being screwed into an undersized hole or passage.
  • a fixation device is used to anchor one end of an elongate connecting element, such as a suture, or prosthetic ligament, and there are three important requirements for an acceptable fixation device.
  • the attached device must be capable of forming a reliable anchorage in the bone to which it is fixed, and over an extended period of time while boney or other tissue ingrowth further anchors the attached device (when the latter is a prosthetic ligament).
  • the attached device must remain firmly attached to the fixation device, both during anchoring of the fixation device and also subsequently.
  • the present invention seeks to provide a number of different types of fixation device, having improved solutions to at least one of the three requirements set out above.
  • an implantable fixation device for use in surgery and comprising: a nail device having a shank to which an elongate connecting element is connectable; a point at one end of the shank for insertion into bone during implantation; a head at an opposite end of the shank; and. a threaded portion provided on the shank intermediate the ends thereof and operative to anchor the device to the bone.
  • Figure 1 is a perspective illustration of a first embodiment of the invention, in the form of a nail device
  • Figure la is an illustration of the attachment of an elongate element to the nail device, in a tibial or femoral fixation
  • Figure 2 is a view, similar to Figure 1, of the modification of the first embodiment, and incorporating a washer element slidably engageable with the nail device, and serving for attachment of a looped attachment device thereto;
  • Figure 2a is a detailed view of the washer element shown in Figure 2;
  • Figures 3a, b, c and d are side views of alternative designs for the nail device of Figure 1;
  • Figure 4 is a detailed view of the head end of a nail device according to the invention, and showing means by which driving rotation may be applied to the nail device for insertion into and anchoring in bone;
  • Figure 5 illustrates the manner by which a rotary driving instrument may be used in order to implant the nail device of Figure 4;
  • Figure 6 is a view of an alternative means of driving a nail device into an anchored location in bone, to that as shown in Figure 5;
  • Figure 7 is an exploded view showing a further modified embodiment within the scope of the invention.
  • Figure 8 is a schematic illustration of a further means of anchoring a fixing device according to the invention.
  • Figure 9 shows further means of attachment of different types of elongate element to bone
  • Figure 11 illustrates another embodiment of fixation device according to the invention, which is shorter in length than the other embodiments.
  • the first embodiment of fixation device according to the invention takes the form of a nail device, designated generally by reference 10, and having a shank 11, a point 12 at one end of the shank 1 1, a head 13 at the opposite end of the shank and below which an elongate element (not shown) can be attached to the shank, and a threaded portion 14 provided on the shank 1 1 intermediate to the ends thereof.
  • the head 13 is joined to the shank 11 via a smooth-surfaced cylindrical portion 15, preferably of larger diameter than the remainder of the shank 11, and around which the elongate element e.g. a suture or prosthetic ligament, may be looped.
  • a smooth-surfaced cylindrical portion 15 preferably of larger diameter than the remainder of the shank 11, and around which the elongate element e.g. a suture or prosthetic ligament, may be looped.
  • Figure la is an illustration of use of the nail device 10 which is anchored in bone 20 and which can be used to attach a two, three or four strand semitendinosus 21 (or gracilis graft) for a tibial or femoral fixation, using a looped elongate connector 22.
  • FIG. 2 and 2a An alternative means of attaching an elongate connector element to the shank of a nail device is shown in Figure 2 and 2a.
  • a washer 16 fits loosely around the cylindrical portion 15, and has at least one aperture 17 through which the elongate element 18 can be taken. In the illustrated arrangement, there is a pair of apertures 17, allowing connector loop 18 to be attached thereto.
  • the nail device 10 will be made from any suitable implantable material, and including a polymer, a bioabsorbable or metallic material.
  • the screw thread portion 14 may be of a standard bone screw variety.
  • the head may be as shown in Figures 1 and 2, or may have a low profile design or a large flat appearance, as shown in the variants of Figures 3a to d.
  • FIG 4 this is an enlarged detail of a head design which may be provided for a nail device according to the invention, showing how driving engagement with the head may allow insertion and anchoring in position of the nail device in bone.
  • the head 13 has an axial bore 23 for mating with a cylindrical projection 24 of an insertion instrument 25, as shown in Figure 5.
  • the proximal end of the bore 23 has a hexagonal socket 26 engaged by a hexagonal nose 27 of the instrument 25, whereby torque can be transferred from the instrument 25 to the nail device.
  • the insertion instrument 25 can engage drivingly with the head 13 of the nail device 10, and the cylindrical shaped projection 24 of the instrument 25 may have a ridge that protrudes from the cylindrical nose to enhance contact with the cylindrical bore 23 of the fixation device 10.
  • Adjacent to the nose portion is the preferred hexagonal shaped shank that locates in the hexagonal shaped opening in the fixation device. Adjacent to the hexagonal shaped shank is preferably a shaped surface which contacts with the head of the fixation device to provide transfer of impact load from the instrument 25 to the fixation device 10.
  • Figure 5 also shows attachment of an elongate element 28 via a washer 29 engaging with the conical outer surface of the head 13.
  • Figure 6 shows an alternative means of driving a nail device into an anchored position in bone, and which may be used when the fixation device is manufactured from a softer polymer, or bioabsorbable material.
  • the insertion instrument 25a has an elongated nose portion 24a, which passes through the fixation device thereby to provide the nail portion of the fixation device.
  • the fixation device is designated by reference 30, and is hollow, to allow passage of the nose portion 24a therethrough, and which then forms the nail portion of the composite device. Operation of the instrument 25a drives the nail portion 24a and also the hollow fixation portion 30 into anchored engagement in the bone.
  • the head of the device 30 serves for attachment of an elongate connector element, generally in similar way to that shown in Figure 5.
  • the fixation device may be of various lengths, to enable it to be used with different sizes of bone. When used, a size would be chosen to maintain its distal end inside the bone.
  • Figure 7 shows use of different types of washer. Parts corresponding with those already described are given the same reference numerals, and will not be described in detail again.
  • Figure 7 shows possible use of washer 16, already described with reference to Figure 2. It also shows alternative types of washer which might be used, designated by references 16a, 16b.
  • the washer used may be flat, as shown at 16b, for attachment of sutures, alternatively, as shown at 16a, the washer may be spiked for direct attachment of soft tissue.
  • the washer may incorporate holes for the attachment of sutures, loops of sutures or tapes or continuous loops.
  • Each design of washer may be manufactured from a polymer, a bioabsorbable or a metallic material.
  • this shows another preferred aspect of the invention, and in particular a method of securing a graft, soft tissue, bone fragment, prosthesis or similar object to bone.
  • This includes the steps of placing the fixation device through a washer, as shown.
  • the washer is positioned so that tension is applied to the graft.
  • the fixation device plus washer is then placed in position adjacent to the bone and the fixation device is inserted into the bone using an impact force, until the screw threaded portion of the device engages into the bone.
  • the fixation device then screws itself into the bone.
  • the fixation device is therefore self-tapping into the bone.
  • the fixation device is of limited length, such that placement of the fixation device into the bone results in the distal end of the fixation device being maintained within the bone.
  • the final positioning is by screwing the fixation device so as to be flush with the washer.
  • the fixation device When used for attaching grafts or prostheses for anterior cruciate ligament surgery, the fixation device may be placed inside the bone tunnel mouth in a direction perpendicular to the axis of the bone tunnel. This eliminates any protrusion of the fixation device from the bone surface. If a soft tissue graft, such as a hamstring graft, is to be used for anterior cruciate ligament reconstruction surgery, then the graft may be looped and stitched together such that a continuous loop that is attached to the fixation device may be used, at each end of the loop, to attach the graft to the femur and tibia.
  • a soft tissue graft such as a hamstring graft
  • a loop may be used at one end and a standard method of attachment at the other, for instance an interference screw, as shown in Figure 9.
  • a loop may also be used in a similar method when a bone-patellar tendon-bone graft is used, as shown in Figure 10.
  • Advantages in carrying out the invention include no requirement to carry out pre- drilling of a hole, or pre-tapping of a hole. Also, additional tension may be applied to the elongate connecting element (and also of the device to which it is attached), via increased mandrel diameter, and low profile washer configuration. The use of a continuous loop attached to the washer further reduces the protrusion height of the device, making it even lower profile.
  • the fixation device of Figure 11 is short in length, and incorporate holes or similar method for attaching sutures, and may be used as a method of anchoring sutures to bone.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

There are disclosed embodiments of implantable fixation device for use in implant surgery, and comprising a nail device (10) having a shank (11) to which an elongate connecting element (18) can be connected, a point (12) at one end of the shank (11) for insertion into bone during implantation, a head (13) at an opposite end of the shank and drivingly engaged by an insertion instrument (25), and a threaded portion (14) provided on the shank (11) intermediate the ends thereof and operative to anchor the device to the bone.

Description

FIXATION DEVICE FOR USE IN SURGERY
This invention relates generally to fixation devices for use in surgery, and particular, though not exclusively, for use in implant surgery.
There are many types of fixation device for use in surgery, and which usually comprise devices which can be driven into bone in order to act as an anchorage, either by being hammered into position e.g. a nail or bone staple, or by being screwed into an undersized hole or passage.
A fixation device is used to anchor one end of an elongate connecting element, such as a suture, or prosthetic ligament, and there are three important requirements for an acceptable fixation device.
First of all, it must be capable of forming a reliable anchorage in the bone to which it is fixed, and over an extended period of time while boney or other tissue ingrowth further anchors the attached device (when the latter is a prosthetic ligament). Secondly, the attached device must remain firmly attached to the fixation device, both during anchoring of the fixation device and also subsequently. Thirdly, it is highly desirable that no chafing or other damage is done to the attached device during anchorage, and subsequently.
The present invention seeks to provide a number of different types of fixation device, having improved solutions to at least one of the three requirements set out above.
According to the invention there is provided an implantable fixation device for use in surgery and comprising: a nail device having a shank to which an elongate connecting element is connectable; a point at one end of the shank for insertion into bone during implantation; a head at an opposite end of the shank; and. a threaded portion provided on the shank intermediate the ends thereof and operative to anchor the device to the bone.
Preferred aspects of the invention are set out in dependent claims 2 to 14. Preferred embodiments of implantable fixation device according to the invention will now be described in detail, by way of example only, with reference to the accompanying drawings, in which:
Figure 1 is a perspective illustration of a first embodiment of the invention, in the form of a nail device;
Figure la is an illustration of the attachment of an elongate element to the nail device, in a tibial or femoral fixation;
Figure 2 is a view, similar to Figure 1, of the modification of the first embodiment, and incorporating a washer element slidably engageable with the nail device, and serving for attachment of a looped attachment device thereto;
Figure 2a is a detailed view of the washer element shown in Figure 2;
Figures 3a, b, c and d are side views of alternative designs for the nail device of Figure 1;
Figure 4 is a detailed view of the head end of a nail device according to the invention, and showing means by which driving rotation may be applied to the nail device for insertion into and anchoring in bone;
Figure 5 illustrates the manner by which a rotary driving instrument may be used in order to implant the nail device of Figure 4;
Figure 6 is a view of an alternative means of driving a nail device into an anchored location in bone, to that as shown in Figure 5;
Figure 7 is an exploded view showing a further modified embodiment within the scope of the invention;
Figure 8 is a schematic illustration of a further means of anchoring a fixing device according to the invention;
Figure 9 shows further means of attachment of different types of elongate element to bone;
FigurelO illustrates further modified procedures within the scope of the invention; and
Figure 11 illustrates another embodiment of fixation device according to the invention, which is shorter in length than the other embodiments. Referring now to Figure 1 of the drawings, the first embodiment of fixation device according to the invention takes the form of a nail device, designated generally by reference 10, and having a shank 11, a point 12 at one end of the shank 1 1, a head 13 at the opposite end of the shank and below which an elongate element (not shown) can be attached to the shank, and a threaded portion 14 provided on the shank 1 1 intermediate to the ends thereof.
The head 13 is joined to the shank 11 via a smooth-surfaced cylindrical portion 15, preferably of larger diameter than the remainder of the shank 11, and around which the elongate element e.g. a suture or prosthetic ligament, may be looped.
Figure la is an illustration of use of the nail device 10 which is anchored in bone 20 and which can be used to attach a two, three or four strand semitendinosus 21 (or gracilis graft) for a tibial or femoral fixation, using a looped elongate connector 22.
An alternative means of attaching an elongate connector element to the shank of a nail device is shown in Figure 2 and 2a. A washer 16 fits loosely around the cylindrical portion 15, and has at least one aperture 17 through which the elongate element 18 can be taken. In the illustrated arrangement, there is a pair of apertures 17, allowing connector loop 18 to be attached thereto.
The nail device 10 will be made from any suitable implantable material, and including a polymer, a bioabsorbable or metallic material.
The screw thread portion 14 may be of a standard bone screw variety. The head may be as shown in Figures 1 and 2, or may have a low profile design or a large flat appearance, as shown in the variants of Figures 3a to d.
The parts corresponding to the head 13, smooth attachment portion 15, thread 14 and point 12 of Figures 1 and 2 are designated by the same reference numerals in each of Figures 3a to d but with the addition of the letters a, b, c, d respectively.
Referring now to Figure 4, this is an enlarged detail of a head design which may be provided for a nail device according to the invention, showing how driving engagement with the head may allow insertion and anchoring in position of the nail device in bone. The head 13 has an axial bore 23 for mating with a cylindrical projection 24 of an insertion instrument 25, as shown in Figure 5. The proximal end of the bore 23 has a hexagonal socket 26 engaged by a hexagonal nose 27 of the instrument 25, whereby torque can be transferred from the instrument 25 to the nail device.
Therefore, the insertion instrument 25 can engage drivingly with the head 13 of the nail device 10, and the cylindrical shaped projection 24 of the instrument 25 may have a ridge that protrudes from the cylindrical nose to enhance contact with the cylindrical bore 23 of the fixation device 10. Adjacent to the nose portion is the preferred hexagonal shaped shank that locates in the hexagonal shaped opening in the fixation device. Adjacent to the hexagonal shaped shank is preferably a shaped surface which contacts with the head of the fixation device to provide transfer of impact load from the instrument 25 to the fixation device 10.
Figure 5 also shows attachment of an elongate element 28 via a washer 29 engaging with the conical outer surface of the head 13.
Figure 6 shows an alternative means of driving a nail device into an anchored position in bone, and which may be used when the fixation device is manufactured from a softer polymer, or bioabsorbable material. In this arrangement, the insertion instrument 25a has an elongated nose portion 24a, which passes through the fixation device thereby to provide the nail portion of the fixation device. In Figure 6, the fixation device is designated by reference 30, and is hollow, to allow passage of the nose portion 24a therethrough, and which then forms the nail portion of the composite device. Operation of the instrument 25a drives the nail portion 24a and also the hollow fixation portion 30 into anchored engagement in the bone. The head of the device 30 serves for attachment of an elongate connector element, generally in similar way to that shown in Figure 5.
The arrangement of Figure 6 allows the stronger insertion instrument material to provide the resistance to the impact forces during the insertion procedure.
In different embodiments of the invention, the fixation device may be of various lengths, to enable it to be used with different sizes of bone. When used, a size would be chosen to maintain its distal end inside the bone.
An alternative arrangement is shown in Figure 7, showing use of different types of washer. Parts corresponding with those already described are given the same reference numerals, and will not be described in detail again. In particular Figure 7 shows possible use of washer 16, already described with reference to Figure 2. It also shows alternative types of washer which might be used, designated by references 16a, 16b.
In the arrangement of Figure 7, the washer used may be flat, as shown at 16b, for attachment of sutures, alternatively, as shown at 16a, the washer may be spiked for direct attachment of soft tissue. As shown by reference 16, the washer may incorporate holes for the attachment of sutures, loops of sutures or tapes or continuous loops. Each design of washer may be manufactured from a polymer, a bioabsorbable or a metallic material.
Referring now to Figure 8, this shows another preferred aspect of the invention, and in particular a method of securing a graft, soft tissue, bone fragment, prosthesis or similar object to bone. This includes the steps of placing the fixation device through a washer, as shown. The washer is positioned so that tension is applied to the graft. The fixation device plus washer is then placed in position adjacent to the bone and the fixation device is inserted into the bone using an impact force, until the screw threaded portion of the device engages into the bone. The fixation device then screws itself into the bone. The fixation device is therefore self-tapping into the bone.
The fixation device is of limited length, such that placement of the fixation device into the bone results in the distal end of the fixation device being maintained within the bone. The final positioning is by screwing the fixation device so as to be flush with the washer. A larger diameter mandrel adjacent to the head, at the proximal end of the fixation device, in comparison to the smaller diameter of the nail portion at the distal end of the fixation device, contacts with the washer and causes the washer to move in the direction of the applied tension to the washer, so creating additional tension in the graft.
When used for attaching grafts or prostheses for anterior cruciate ligament surgery, the fixation device may be placed inside the bone tunnel mouth in a direction perpendicular to the axis of the bone tunnel. This eliminates any protrusion of the fixation device from the bone surface. If a soft tissue graft, such as a hamstring graft, is to be used for anterior cruciate ligament reconstruction surgery, then the graft may be looped and stitched together such that a continuous loop that is attached to the fixation device may be used, at each end of the loop, to attach the graft to the femur and tibia. Alternatively, a loop may be used at one end and a standard method of attachment at the other, for instance an interference screw, as shown in Figure 9. A loop may also be used in a similar method when a bone-patellar tendon-bone graft is used, as shown in Figure 10.
Advantages in carrying out the invention include no requirement to carry out pre- drilling of a hole, or pre-tapping of a hole. Also, additional tension may be applied to the elongate connecting element (and also of the device to which it is attached), via increased mandrel diameter, and low profile washer configuration. The use of a continuous loop attached to the washer further reduces the protrusion height of the device, making it even lower profile. The fixation device of Figure 11 is short in length, and incorporate holes or similar method for attaching sutures, and may be used as a method of anchoring sutures to bone.

Claims

1. An implantable fixation device for use in surgery and comprising: a nail device having a shank to which an elongate connecting element is connectable; a point at one end of the shank for insertion into bone during implantation; a head at an opposite end of the shank; and, a threaded portion provided on the shank intermediate the ends thereof and operative to anchor the device to the bone.
2. A device according to claim 1, in which the shank has a smooth-surfaced cylindrical portion around which the elongate element is looped in order to be attached to the device.
3. A device according to claim 2, in which the cylindrical portion is larger in diameter than the remainder of the shank.
4. A device according to claim 1, in which a washer fits loosely on the shank, and to which the elongate element is attached.
5. A device according to claim 4, in which the washer has at least one aperture through which the elongate element is taken.
6. A device according to claim 4, in which the washer is flat for attachment of sutures to the device.
7. A
Figure imgf000009_0001
ice according to claim 4, in which the washer is spiked for direct attachment of soft tissue.
8. A device according to any one of claims 1 to 7, in which the head has an internal socket which is drivingl engageable by an insertion instrument for driving the device into bone.
9. A device according to claim 8, in combination with the insertion instrument.
10. A device according to claim 9, in which the insertion instrument has a short projecting nose receivable by a bore in the head.
1 1. A device according to claim 9, in which the threaded portion is hollow, and the insertion instrument has a long projecting nose receivable by the threaded portion so as to form a nail during driving of the device into bone.
12. A device according to any one of claims 8 to 11, in which the engagement between the insertion instrument and the head is such that the instrument can apply axial and rotary driving of the device into bone.
13. A device according to any one of the preceding claims, and in combination with an elongate connecting element for use in implant surgery.
14. A method of carrying out implant surgery, using a device according to any one of the preceding claims.
PCT/GB2001/004638 2000-10-25 2001-10-17 Fixation device for use in surgery Ceased WO2002034166A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002210684A AU2002210684A1 (en) 2000-10-25 2001-10-17 Fixation device for use in surgery

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0026024.0A GB0026024D0 (en) 2000-10-25 2000-10-25 Fixation device for use in surgery
GB0026024.0 2000-10-25

Publications (1)

Publication Number Publication Date
WO2002034166A1 true WO2002034166A1 (en) 2002-05-02

Family

ID=9901885

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/004638 Ceased WO2002034166A1 (en) 2000-10-25 2001-10-17 Fixation device for use in surgery

Country Status (3)

Country Link
AU (1) AU2002210684A1 (en)
GB (1) GB0026024D0 (en)
WO (1) WO2002034166A1 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102012004070A1 (en) * 2012-03-02 2013-09-05 Marius von Knoch Washer for bone screw for use hospital, has thread eyelets formed to receive threads of long or other fabric seam, where thread eyelet is attached at washer on upper surface, undersurface or other spatial extension of washer
EP1814463A4 (en) * 2004-11-15 2013-10-02 Scandius Biomedical Inc METHOD AND DEVICE FOR REPAIRING A ROTATOR CABLE TAG OR A ROTATOR CUFF TAPE
US9526496B2 (en) 2011-09-26 2016-12-27 Atex Technologies, Inc. Loop
US9974643B2 (en) 2013-03-11 2018-05-22 Medos International Sàrl Implant having adjustable filament coils
US10052094B2 (en) 2013-03-11 2018-08-21 Medos International Sàrl Implant having adjustable filament coils
EP3184078B1 (en) * 2015-12-23 2020-10-07 INOVEDIS GmbH Tendon fixation plate

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2732211A1 (en) * 1995-03-28 1996-10-04 Boyer Thierry Fastening implant for repairing damaged upper arm muscles
EP0908143A1 (en) * 1997-10-06 1999-04-14 Arthrex Inc Suture anchor with associated tissue retaining means
WO2000018309A1 (en) * 1998-09-30 2000-04-06 Bionx Implants Oy Bioabsorbable surgical screw and washer system
EP1018321A2 (en) * 1998-12-25 2000-07-12 Meira Corporation Ligament graft-securing device
WO2000056252A1 (en) * 1999-03-25 2000-09-28 Smith & Nephew, Inc. Graft clamp

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2732211A1 (en) * 1995-03-28 1996-10-04 Boyer Thierry Fastening implant for repairing damaged upper arm muscles
EP0908143A1 (en) * 1997-10-06 1999-04-14 Arthrex Inc Suture anchor with associated tissue retaining means
WO2000018309A1 (en) * 1998-09-30 2000-04-06 Bionx Implants Oy Bioabsorbable surgical screw and washer system
EP1018321A2 (en) * 1998-12-25 2000-07-12 Meira Corporation Ligament graft-securing device
WO2000056252A1 (en) * 1999-03-25 2000-09-28 Smith & Nephew, Inc. Graft clamp

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1814463A4 (en) * 2004-11-15 2013-10-02 Scandius Biomedical Inc METHOD AND DEVICE FOR REPAIRING A ROTATOR CABLE TAG OR A ROTATOR CUFF TAPE
US9526496B2 (en) 2011-09-26 2016-12-27 Atex Technologies, Inc. Loop
US10413398B2 (en) 2011-09-26 2019-09-17 Atex Technologies, Inc. Loop
DE102012004070A1 (en) * 2012-03-02 2013-09-05 Marius von Knoch Washer for bone screw for use hospital, has thread eyelets formed to receive threads of long or other fabric seam, where thread eyelet is attached at washer on upper surface, undersurface or other spatial extension of washer
DE102012004070B4 (en) * 2012-03-02 2015-05-13 Marius von Knoch Surgical attachment device
US9974643B2 (en) 2013-03-11 2018-05-22 Medos International Sàrl Implant having adjustable filament coils
US10052094B2 (en) 2013-03-11 2018-08-21 Medos International Sàrl Implant having adjustable filament coils
US10856967B2 (en) 2013-03-11 2020-12-08 Medos International Sàrl Implant having adjustable filament coils
US10898178B2 (en) 2013-03-11 2021-01-26 Medos International Sàrl Implant having adjustable filament coils
US11896475B2 (en) 2013-03-11 2024-02-13 Medos International Sarl Implant having adjustable filament coils
US12232716B2 (en) 2013-03-11 2025-02-25 Medos International Sàrl Implant having adjustable filament coils
EP3184078B1 (en) * 2015-12-23 2020-10-07 INOVEDIS GmbH Tendon fixation plate

Also Published As

Publication number Publication date
AU2002210684A1 (en) 2002-05-06
GB0026024D0 (en) 2000-12-13

Similar Documents

Publication Publication Date Title
US8100969B2 (en) Methods for anchoring autologous or artificial tendon grafts using first and second bone anchors
US6875214B2 (en) Rotating tendon anchor
US9907646B2 (en) Femoral fixation
EP1006934B1 (en) Apparatus for anchoring autologous or artificial tendon grafts in bone
US6273890B1 (en) Intra-articular tendon sling fixation screw
US7025786B2 (en) Apparatus and method for reconstructing a ligament
US8496705B2 (en) Method of anchoring autologous or artificial tendon grafts in bone
AU2004201994B2 (en) Tissue fixation device
WO2002085256A1 (en) Graft fixation system and method
EP2316378A1 (en) Method and device for the fixation of a tendon graft
WO2002034166A1 (en) Fixation device for use in surgery
AU5070602A (en) Methods for anchoring autologous or artificial tendon grafts in bone

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP