WO2008017834A1 - Aglet for attachment to a graft material - Google Patents
Aglet for attachment to a graft material Download PDFInfo
- Publication number
- WO2008017834A1 WO2008017834A1 PCT/GB2007/003004 GB2007003004W WO2008017834A1 WO 2008017834 A1 WO2008017834 A1 WO 2008017834A1 GB 2007003004 W GB2007003004 W GB 2007003004W WO 2008017834 A1 WO2008017834 A1 WO 2008017834A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- aglet
- surgical
- retaining portion
- tissue
- crimping
- Prior art date
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
- 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
- A61F2002/0864—Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
-
- 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
Definitions
- the invention relates to an aglet for use in surgical procedures, especially procedures in which soft tissues are replaced. It is particularly useful for cruciate ligament surgery.
- the knee is a remarkably complex joint with a large range of stable movement. This is made possible by a complicated array of ligaments that run across the joint from the thigh bone (femur) to the shin bone (tibia). The ligaments work in harmony, throughout the range of movement to control and stabilise the joint.
- the cruciate ligaments are the most important in controlling forward and backward motion.
- the cruciate ligaments cross over in the centre of the knee, one from the front (the anterior cruciate ligament (ACL) and one from the back (the posterior cruciate ligament (PCL).
- ACL anterior cruciate ligament
- PCL posterior cruciate ligament
- ACL deficient ACL deficiency can be diagnosed from patient history, and confirmed by a number of clinical examination techniques, scars shown by magnetic resonance imaging (MRI) and/or keyhole surgery (Arthroscopy).
- MRI magnetic resonance imaging
- Arthroscopy Keyhole surgery
- BTB a 10 mm strip of tendon about 5 cm longs with an attached piece of bone at either end is harvested from the knee cap tendon. This is inserted with the help of a keyhole camera (arthroscopically assisted) and fixed in place with interference screws to form a new strong single strand of ACL.
- hamstring autograft 2 strips of hamstring tendon are harvested from a small incision over the upper inner side of the shin just below the knee.
- the tendons are from the semi- tendinosus gracilis muscle.
- the tendons are longer and thinner than BTB and have no bone attached. They range in diameter from 3 to 5 mm and are about 15 -20 cm long. To make them strong, they are doubled over to make a 4 strand graft. When compressed they form as four strands onto an overall diameter of 8 - 11 mm.
- the double-strand of the hamstring can be fixed in the bone by looping it over a device (suspensory fixation) within the bone tunnel or it can be jammed in the tunnel with a screw running past it (interference fit). It can also be pulled onto the surface and screwed (with a claw) or stapled onto the bone.
- the tendons are all prepared with a whipstitch to enable them to be passed and pulled into position.
- the current practice is to apply a whipstitch to each of the four ends of the hamstring graft. This is done with a suture and needle sewn into a 'saxon stocking' effect into the last two centimetres of ligament. The job can be aided by an assistant and/or a special preparation board. There is significant potential for needle-stick injuries nevertheless. In smaller strands of ligament it can be a little unreliable. Since the whipstitch is done manually, it is time-consuming, potentially dangerous, due to needle-stick injuries, and fiddly. It would be useful to eliminate the need for the whipstitch.
- US5, 108,431 discloses a ligament anchor having two parts, a clamp sleeve that is placed onto the ligament graft and an anchor that is inserted into a bone. When the clamp sleeve is placed into the anchor portion, the clamp sleeve is deformed about the ligament.
- the disadvantage of this device are that two components are required, and the clamp sleeve cannot be fixed on to the ligament until inserted into the anchor. Also, the ligament can only be mounted by drilling into and inserting the anchor sleeve into a bone.
- a surgical aglet for attachment to a graft material comprising a retaining portion for attachment to the material, the retaining portion having a textured inner surface, wherein, in use, the retaining portion is compressed or crimped such that it is attached to the material.
- the retaining portion is preferably permanently deformable, from a position in which the graft material may be inserted, into a gripping position.
- an aglet is a tag or sheath covering the end of a cord. Aglets are typically seen on the ends of shoe laces.
- the term aglet refers to a sheath or cladding for use on material to be used in surgery, especially for use on soft tissue, such as ligaments or tendons.
- the aglet may be used to grip and anchor such tissues.
- the retaining portion of the aglet may be placed on or around the material or soft tissue.
- the retaining portion of the aglet may then be crimped or crushed in order to grip the material.
- the textured surface of the retaining portion aids the gripping of the material.
- the aglet then allows the material to be manoeuvred because the aglet can be held easily.
- the aglet provides significant advantages over the device described in US5, 108,431.
- a second anchor portion is not required.
- the aglet may be crimped into the graft material prior to attachment to bone and can be used to help manoeuvre the graft into position.
- graft material refers to any material for use in surgery to replace or repair damaged tissue. In particular it refers to soft tissue such as a ligament or a tendon. It may also refer to an artificial replacement therefore.
- a number of strands of tissue may be used together to replace, for example, a ligament.
- an aglet may be applied to one or both ends of each strand of tissue, or a number of strands may be put together and one aglet applied to a number of ends.
- the aglet may be applied and fixed in position prior to attachment to the bone, as this is much easier to carry out and ensure all strands are gripped proper.
- the retaining portion of the aglet may be any appropriate shape to receive the material.
- it may be tubular, allowing it to be placed on to the material to be gripped. Alternatively, it may be flat, but, in use, bent or shaped around the tissue.
- the retaining portion is preferably substantially tubular in shape, and is hollow, defining a cavity.
- the retaining portion preferably has two ends, at least one of which is open to allow access of the material to the cavity.
- the other end of the aglet may be open or closed. It is preferably open, to aid entry of the material into the cavity.
- the shape of the retaining portion may be selected to be appropriate for the surgery for which it is to be used.
- the retaining portion may be tapered from one end to the other.
- the retaining portion may be substantially cylindrical or frusto-conical in shape.
- the retaining portion is particularly advantageous for the retaining portion to be tubular, especially cylindrical or frusto-conical in shape, because such shapes allow the retaining portion to be crimped or crushed very easily so that it retains the material.
- the aglet may be used on material that has been harvested from the body. It may be applied to the material during surgery. It is important that any tools used to crimp or crush the aglet are sterilisable. Accordingly, it is helpful if as few tools as possible are required.
- a tubular aglet can be crimped into a retaining position very easily, using one crimping action and one crimping tool that can be sterilised.
- the inner surface of the retaining portion is the surface that contacts the graft material.
- the texture on the inner surface of the body may be made in any manner.
- there may be protrusions such as teeth, or, preferably, one or more ridges on the inner surface.
- Such ridges may run in any direction, but are preferably substantially perpendicular to the axis of insertion of the material into the retaining portion.
- the aglet preferably also comprises a manipulation portion.
- the manipulation portion allows the aglet to be even more easily manoeuvred.
- the manipulation portion may be any appropriate shape, but is preferably an elongate arm extending from one end of the retaining portion.
- the manipulation portion may include or form a tensioning means, such as a hook, loop or aperture, which may be used to aid manipulation of the device, for example by passing an instrument or suture through the hook or hole and pulling the aglet into a particular position using the instrument or suture. Such a means may also be used to tension the material held by the aglet, again by pulling using an instrument or suture.
- the manipulation portion is preferably positioned at the opposite end of the retaining portion to the opening for receiving the material.
- the aglet may comprise a fixing means, to allow the aglet to be fixed to, for example, a bone or other body part.
- the fixing means may be any appropriate means, including, for example, an aperture through which a screw, staple or stitch may be passed.
- the fixing means is preferably found on or in or as part of the manipulation portion.
- the aglet may be used in one of two ways. It may simply be used to position and/or tension material or it may be additionally used to fix the material in place. For example, when replacing a ligament, the aglet is attached to the replacement material and used to hold and position it. The material may then be screwed or stapled to the bone to which it should be attached and the aglet cut away. Alternatively, the aglet may be used to fix the material in place, the aglet being screwed or stapled to the bone, via the fixing means.
- the aglet preferably has a smooth outer surface.
- the outer surface of the retaining portion is preferably smooth.
- the retaining portion preferably does not comprise ridges or shoulders on its outer surface. This is to allow a smooth and easy passage of the aglet through the body, particularly through narrow areas such as bone tunnels.
- the manipulation portion is preferably smaller in diameter than the retaining portion.
- the aglet is preferably suitable for crimping or crushing.
- the aglet may preferably be crimped or crushed substantially in line with the axis of insertion of the material.
- the aglet is preferably crimped or crushed along the axis of elongation of the retaining portion.
- the aglet may be provided with a weakened portion, to encourage crimping or crushing at a particular point or along a particular line.
- the aglet may be made from any material that is suitable for use in surgery and that may be crimped or crushed.
- the material is malleable; it can be crimped or crushed and retains its crimped or crushed shape.
- the aglet may be made from surgical steel, but other materials such as plastics and titanium are also envisaged.
- the aglet may be partially or completely coated with a growth promoting substance. This is to encourage regeneration of the tissues surrounding the site of surgery.
- a pair of crimping bits or jaws preferably comprises a female bit or jaw having at least one recessed portion shaped to receive the aglet, and a male bit or jaw having a protrusion shaped to crimp the aglet when the bits are forced together.
- the female bit or jaw preferably comprises at least one recessed portion shaped to receive a cylindrical aglet, that is, the cross section of the recess portion is substantially semi-circular.
- the female bit or jaw preferably comprises at least one recessed portion shaped to receive a frusto-conical aglet, that is, the cross section of the recess portion is substantially semi-circular and tapers from one end to the other.
- the protrusion on the male jaw or bit is preferably V-shaped, so that the protrusion is wider at the point at which it leaves the surface of the jaw and tapers to a narrow point.
- a crimping tool comprising a pair of jaws or bits according to the invention.
- the crimping jaws and crimping tool are preferably made from sterilisable material.
- tissue graft for surgery comprising inserting the tissue into the body of an aglet according to the invention and crimping the aglet so that it grips the tissue.
- the tissue is preferably isolated from the patient.
- tissue graft comprising an isolated piece of tissue having an aglet according to the invention attached thereto.
- figure 1 shows an aglet according to the invention in uncrimped (A) and crimped (B) forms
- figure 2 shows a second according to the invention in uncrimped (A) and crimped (B) forms
- figure 3 shows views of the aglet from one end (a), and the other end (b) and a cross section of the aglet (c)
- figure 4 shows male and female crimping bits for crimping the aglet
- figure 5 shows the results of a stress test applied to the aglet when attached to a ligament graft.
- the aglet 5 comprises a body or retaining portion 10 and a manipulation portion 12.
- the manipulation portion includes an aperture 14 which can be used to tension the material to be gripped by the aglet.
- the body may be any shape. In the embodiment shown, the body is frusto-conical.
- the body defines a cavity 16, into which material to be gripped by the aglet may be inserted.
- the material is inserted into the cavity via the open first end 18 of the body.
- the second end 20 of the body may also be open to aid insertion of the material.
- the material can be pulled into the body using an instrument or suture inserted through the open second end.
- the inner surface of the body, surrounding the cavity is textured. As shown in the figures, the texture may be made up of one or more ridges 22. The ridges may run in any direction. In the embodiments shown, the ridges run around the circumference of the cavity, rather than from end to end of the body.
- the manipulation portion may include a tensioning means 14. As shown in figure 2, it can also include a fixing means 24 to allow the aglet to be fixed to, for example, a bone.
- the aglet is used for gripping material to be used in surgery, especially soft tissue such as ligaments or tendons.
- the material is inserted into the body via the open first end.
- the aglet is then crimped, preferably along its length, to form an aglet as shown in figures IB or 2B. Crimping the aglet grips the material in the cavity. The material is held in place by the textured inner surface. This is particularly useful when a number of strands of material are being used.
- the aglet is crimped using a crimping tool. Any appropriate tool may be used, but the jaws or bits must be appropriately shaped to receive the aglet and crimp it.
- one jaw 26 is female and has at least one recessed portion 28.
- the other jaw 30 is male and has at least one protrusion 32.
- the aglet can also be used to manoeuvre the material, for example it can be gripped using an instrument, or a suture can be passed through the tensioning means and used to pull the aglet.
- the tensioning means can also be used to place the gripped material under tension.
- the aglet comprises a fixing means it may be used to fix the material in place. For example, a suture, staple or screw may be passed through the fixing means.
- the aglet could also be used for any surgery in which it is necessary to replace strands of soft tissue.
- the size and shape of the aglet may be modified accordingly.
- an aglet was attached to a tendon and the tendon placed under tension, by pulling the aglet. The force at which the aglet came off the tendon was recorded. The aglet was able to withstand a force of up to 160 Newtons before it was separated from the tendon. The results of this test are shown in figure 5. The aglet was able to withstand forces considerably higher than those likely to be placed upon it during normal use.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0903951A GB2454154A (en) | 2006-08-08 | 2009-03-06 | Aglet for attachment to a graft material |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0615750A GB0615750D0 (en) | 2006-08-08 | 2006-08-08 | Aglet |
GB0615750.7 | 2006-08-08 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2008017834A1 true WO2008017834A1 (en) | 2008-02-14 |
Family
ID=37056021
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2007/003004 WO2008017834A1 (en) | 2006-08-08 | 2007-08-07 | Aglet for attachment to a graft material |
Country Status (2)
Country | Link |
---|---|
GB (3) | GB0615750D0 (en) |
WO (1) | WO2008017834A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013033634A1 (en) * | 2011-09-01 | 2013-03-07 | Toby Orthopaedics, Llc | Tendon crimp for passage into a bone tunnel and method for use thereof |
US8506588B2 (en) | 2008-09-16 | 2013-08-13 | Toby Orthopaedics, Inc. | Suture retriever-sheath dilator tool and method for use thereof |
US9060772B2 (en) | 2007-08-14 | 2015-06-23 | Toby Orthopaedics, Inc. | Device for assisting in flexor tendon repair and rehabilitation |
WO2020247373A1 (en) | 2019-06-03 | 2020-12-10 | Khoury David J | Direct soft tissue fixation implantable device and method of use |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB0615750D0 (en) * | 2006-08-08 | 2006-09-20 | Royal Berkshire Nhs Foundation | Aglet |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5151104A (en) * | 1989-10-26 | 1992-09-29 | Pfizer Hospital Products Group, Inc. | Self-locking joint connector |
US5741260A (en) * | 1994-02-24 | 1998-04-21 | Pioneer Laboratories, Inc. | Cable system for bone securance |
WO1999044544A1 (en) * | 1998-03-02 | 1999-09-10 | Bionx Implants Oy | Improved bioabsorbable bone block fixation implant |
US6080192A (en) * | 1994-12-02 | 2000-06-27 | Omeros Medical Systems, Inc. | Tendon and ligament repair system |
WO2000064363A2 (en) * | 1999-04-23 | 2000-11-02 | Sdgi Holdings, Inc. | Adjustable spinal tether |
WO2002032345A2 (en) * | 2000-10-17 | 2002-04-25 | Coapt Systems, Inc. | Intraosseous soft tissue-to-bone anchor |
WO2003007839A2 (en) * | 2001-07-16 | 2003-01-30 | Depuy Products, Inc. | Devices form naturally occurring biologically derived |
WO2005079708A1 (en) * | 2004-02-13 | 2005-09-01 | Frantz Medical Development, Ltd | Soft tissue repair apparatus and method |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB0615750D0 (en) * | 2006-08-08 | 2006-09-20 | Royal Berkshire Nhs Foundation | Aglet |
-
2006
- 2006-08-08 GB GB0615750A patent/GB0615750D0/en not_active Ceased
-
2007
- 2007-08-07 WO PCT/GB2007/003004 patent/WO2008017834A1/en active Application Filing
-
2009
- 2009-03-06 GB GB0903951A patent/GB2454154A/en not_active Withdrawn
-
2011
- 2011-10-07 GB GB201117339A patent/GB2495487A/en not_active Withdrawn
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5151104A (en) * | 1989-10-26 | 1992-09-29 | Pfizer Hospital Products Group, Inc. | Self-locking joint connector |
US5741260A (en) * | 1994-02-24 | 1998-04-21 | Pioneer Laboratories, Inc. | Cable system for bone securance |
US6080192A (en) * | 1994-12-02 | 2000-06-27 | Omeros Medical Systems, Inc. | Tendon and ligament repair system |
WO1999044544A1 (en) * | 1998-03-02 | 1999-09-10 | Bionx Implants Oy | Improved bioabsorbable bone block fixation implant |
WO2000064363A2 (en) * | 1999-04-23 | 2000-11-02 | Sdgi Holdings, Inc. | Adjustable spinal tether |
WO2002032345A2 (en) * | 2000-10-17 | 2002-04-25 | Coapt Systems, Inc. | Intraosseous soft tissue-to-bone anchor |
WO2003007839A2 (en) * | 2001-07-16 | 2003-01-30 | Depuy Products, Inc. | Devices form naturally occurring biologically derived |
WO2005079708A1 (en) * | 2004-02-13 | 2005-09-01 | Frantz Medical Development, Ltd | Soft tissue repair apparatus and method |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9060772B2 (en) | 2007-08-14 | 2015-06-23 | Toby Orthopaedics, Inc. | Device for assisting in flexor tendon repair and rehabilitation |
US8506588B2 (en) | 2008-09-16 | 2013-08-13 | Toby Orthopaedics, Inc. | Suture retriever-sheath dilator tool and method for use thereof |
US8679146B2 (en) | 2008-09-16 | 2014-03-25 | Toby Orthopaedics, Inc. | Method for use of suture retriever-sheath dilator tool |
WO2013033634A1 (en) * | 2011-09-01 | 2013-03-07 | Toby Orthopaedics, Llc | Tendon crimp for passage into a bone tunnel and method for use thereof |
US8900302B2 (en) | 2011-09-01 | 2014-12-02 | Toby Orthopaedics, Inc. | Tendon crimp for passage into a bone tunnel and method for use thereof |
WO2020247373A1 (en) | 2019-06-03 | 2020-12-10 | Khoury David J | Direct soft tissue fixation implantable device and method of use |
Also Published As
Publication number | Publication date |
---|---|
GB201117339D0 (en) | 2011-11-23 |
GB2495487A (en) | 2013-04-17 |
GB0903951D0 (en) | 2009-04-22 |
GB0615750D0 (en) | 2006-09-20 |
GB2454154A (en) | 2009-04-29 |
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