GB2452987A - Implant delivery unit - Google Patents

Implant delivery unit Download PDF

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Publication number
GB2452987A
GB2452987A GB0718563A GB0718563A GB2452987A GB 2452987 A GB2452987 A GB 2452987A GB 0718563 A GB0718563 A GB 0718563A GB 0718563 A GB0718563 A GB 0718563A GB 2452987 A GB2452987 A GB 2452987A
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GB
United Kingdom
Prior art keywords
implant delivery
delivery unit
implant
defect
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.)
Withdrawn
Application number
GB0718563A
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GB0718563D0 (en
Inventor
Neil Rushton
Enda Kenny
Tim Mead
Andrew Lynn
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.)
ORTHOMIMETICS Ltd
Original Assignee
ORTHOMIMETICS 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 ORTHOMIMETICS Ltd filed Critical ORTHOMIMETICS Ltd
Priority to GB0718563A priority Critical patent/GB2452987A/en
Publication of GB0718563D0 publication Critical patent/GB0718563D0/en
Publication of GB2452987A publication Critical patent/GB2452987A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/92Identification means for patients or instruments, e.g. tags coded with colour
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613Component parts
    • A61B17/1615Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1635Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for grafts, harvesting or transplants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1735Guides or aligning means for drills, mills, pins or wires for rasps or chisels
    • 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897Guide wires or guide pins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00469Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033Abutting means, stops, e.g. abutting on tissue or skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4618Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of cartilage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30224Three-dimensional shapes cylindrical
    • A61F2002/30235Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30601Special structural features of bone or joint prostheses not otherwise provided for telescopic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4635Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4677Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4687Mechanical guides for implantation instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical

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

Abstract

The unit comprises a body 10 defining a proximal and distal end with a bore disposed therein and an attachment 100 for securing the distal end to a tissue defect or an area containing the defect. Also disclosed is an instrument kit comprising the unit, drill bits 250, plunger rods 300, obturators 190, guide wires and implants 170. The attachment may comprise at least one projection 100 extending from the unit which comprises a blade 130. The attachment may also comprise a suction device, at least one magnet, an adhesive or cement, or a guide wire.

Description

* 2452987 ImpLant delivery device This invention relates to a surgical instrument and a kit comprising same for the implantation of a medical material into a patient. More particularly the invention relates to an implant delivery device and a kit which can be used to deliver an implant into e.g. bone or cartilage for the repair of a defect or stimulation of bone/cartilage growth, or delivery of a therapeutic substance locally.
Surgical treatment of bone or cartilage defects is frequently and optimally, in most cases, carried out under direct vision using an arthroscope and a minimally invasive procedure. Alternatively, an open procedure can be performed resulting in a larger incision. It is preferable to make a smaller incision in the skin and soft tissues for the patient, resulting in less trauma, reduced potential for infection and post operative complications. However, placing an implant into bone or cartilage defects is more difficult and technically demanding by arthroscopic techniques relative to an open procedure. First, the site must be prepared, usually by drilling and then an implant must be manipulated into place using instrumentation through a relatively small : incision with reduced physical access to the defect site. Second, when the site is drilled to prepare a proper implant bed, the field of view is frequently obscured by blood. This makes the site of implantation more difficult to locate on introduction of the implant through the skin incision. Placement may be difficult and require additional time to complete. Also, with absorbent implants the physical properties *:* may change on contact with the aqueous field in the surgical site making them soft, pliable and more difficult to place in the implant bed.
WO 2007/065150 discloses a bone or cartilage implant delivery device suitable for arthroscopic use, the device comprising a tubular outer shaft and a plunger rod which can slide within the outer shaft, and which is used to advance an implant through the barrel into a defect. The outer shaft can be straight or bent, for example forming an angle of up to 90 degrees with the rest of the outer shaft. The proximal end of the plunger rod can be used as a probe to determine the depth of a defect and at the same time determine the depth of the implant required to fit that defect. One of the problems associated with the device is that it cannot be positioned and maintained accurately in position over the site of a defect, and any resulting undesirable movement away from the optimal position for accurate and quick implant delivery can complicate and lengthen the surgical procedure.
There is therefore a need for an implant delivery device that can be positioned and maintained accurately in position over the site of a defect and which increases the prospects for successful implant placement and reduces operative time.
According to a first aspect of the present invention, there is provided an implant delivery unit for delivering an implant to a defect in a target tissue, the unit comprising a body defining a proximal and distal end; a bore disposed in the body and extending longitudinally from the proximal end to the distal end; and an attachment for securing the distal end to the defect or an area containing the defect.
The body may comprise a tube or sleeve. Preferably the body is tubular. The cross-sectional area of the bore may be a regular or irregular shape, and may for example be circular, oval, elliptical, hexagonal, or octagonal. The cross-sectional area of the bore may be shaped to match the cross-sectional area of a defect, thereby allowing precise alignment of the bore with the defect and delivery of correctly shaped implant into the defect. The cross-sectional area of the bore may match or be substantially the same as the cross-sectional area of one or more drill tips which may be used to prepare the defect site. In a preferred embodiment, the cross-sectional area of the bore is circular, and the implant delivery unit is used to deliver implants having a circular cross-sectional area. p *
S
Preferably, the cross-sectional area of the bore is large enough to allow an implant to be advanced through the bore and into a defect, but not so large that the implant has room to change its orientation within the bore. This can be important when delivering implants comprising two or more layers (multi-phased implants), or gradient implants.
In essence, the implant delivery unit forms a stable conduit connecting e.g. bone at the distal end to the external environment at the proximal end and crosses the skin and soft tissues of a patient.
The body may comprise a stop defined at or toward its proximal end, the stop being configured to provide an abutment for limiting the length of travel for other surgical instruments adapted to fit within the bore of the implant delivery unit. In one embodiment the stop is a step formed by an increase in the diameter of the bore at or toward the proximal end of the body. The stop may engage with a corresponding stop on the shaft of other surgical instruments, thereby limiting their travel within the bore of the implant delivery unit. The stop can therefore be useful in e.g. preventing a surgical drill unit from drilling too far into the tissue of a patient.
The body may comprise a threaded outer surface to facilitate insertion of the implant delivery unit into an incision. In this way, a user of the implant delivery unit may facilitate insertion of the unit into an incision by rotating the unit one way and rotating the unit in the opposite direction to facilitate its removal from the incision.
The attachment may extend from the distal end of the implant delivery unit. The attachment may comprise one or more projections extending from the distal end of the body, each projection defining a proximal and distal end and being adapted to penetrate the tissue of a patient and thereby facilitate anchoring of the implant S. delivery unit in position at a defect site. I...
Each projection may comprise a prong, tooth, extension, spike, or spur. Each *.S. . . . . . . projection may be adapted to attach the implant delivery unit in position over the defect, preferably so that the bore is aligned as accurately as possible with the defect.
Each projection may comprise a blade at its distal end. One or more of the projections may be configured to incise about an area containing the defect. The blade is preferably adapted to be inserted into a defect or around the site of a defect. The blades may be adapted so that a rotation of the implant delivery unit about its longitudinal axis promotes insertion of the blade into a tissue of the patient.
One or more projections may be graduated to facilitate assessment of depth penetration in the target tissue and facilitate correct orientation of the implant delivery unit, which is optimally 90 degrees relative to the e.g. bone surface. The one or more projections may be coloured, or shaped in such a way as to allow a user to gauge the depth of insertion/penetration. In a preferred embodiment a series of indentations are marked on the projection, preferably comprising a deeper, longer or otherwise larger indentation to mark every other millimetre, or every 5mm, or other desired depth increment.
The projections may extend 1-20mm beyond the distal end of the body, and more preferably 2-10mm beyond the distal end of the body. The projections may each extend the same distance from the distal end of the implant delivery unit, or they may extend different distances. The distance of extension of each projection from the body
may be adjustable.
The implant delivery unit may comprise three projections, for example in a trident configuration. Each projection may be spaced equally or regularly around the circumference of the body. An equal or regular spacing may provide more stability when the implant delivery unit is positioned over a defect.
The implant delivery unit and/or the attachment may comprise a suction device, which may be adapted to attach to the defect, or the tissue surrounding the defect. The body * .1 may comprise a seal or sealing means at its proximal and/or distal end. The body and/or attachment may be adapted to create a seal around the defect, and the device may comprise pressure reducing means to allow the pressure in the bore to be reduced, thereby creating a negative pressure with respect to the atmosphere outside the bore, and thereby facilitating the pressure-mediated attachment of the implant delivery unit to the defect. The pressure within the bore may be reduced using a pump, or by cooling the air within the bore, or heating the air outside of the bore. The distal end of the implant delivery unit may be shaped to promote such pressure-mediated attachment. The distal end may comprise smooth and/or rounded edges which may promote the creation of a pressure seal around the defect. The implant delivery unit preferably comprises means to equalise the pressure in the bore with the pressure outside the bore, thereby enabling a user to detach the implant delivery unit from the patient without causing any damage to the tissue, or the freshly-repaired defect.
The distal end andior the attachment may comprise one or more magnets adapted to magnetically attach to one or more magnets positioned in or around the defect.
Alternatively, electrostatic forces may be used to attach the implant delivery unit in position.
The attachment may comprise an adhesive or cement adapted to bond to the target tissue andlor the defect, or a tissue located near the defect, or a structure positioned in or about the defect. Any suitable surgical adhesive or cement is envisaged and these are well known to a person skilled in the art.
The attachment may comprise a dilation device, the dilation device being adapted to fit within the defect and circumferentially expand within the defect to attach the implant delivery unit to the defect. The dilation device may comprise an expandable ring adapted to fit within the defect and yet still allow an implant to be delivered through the bore and into the defect. The implant delivery unit preferably comprises means to expand and shrink the dilation device. The dilation device may for example be expanded using gas or liquid. The implant delivery device may comprise a pump, which is preferably adapted to safely inflate the dilation device in a controlled manner. In an alternative embodiment, a separate pump may be used to inflate/expand the dilation device.
I S * S.
I... . . . * The attachment may compnse at least one guide wire, the each guide wire defining a distal and a proximal end and being suitable for insertion into a defect or about a defect. The guide wire may be attached to the implant delivery unit or it may be attachable to the implant delivery unit, or it may be separate from it. The guide wire may be threaded at its distal end to facilitate insertion into and removal from the defect by a user. The guide wire may be threaded at its proximal end for attachment to a rotation device andlor a handle. The rotation device may be a manually operated or power operated drill. The guide wire is preferably rigid and resistant to bending, and more preferably comprises metal, for example steel. The guide wire may be between 0.5-5mm in diameter, and more preferably 1-2 mm in diameter. In one embodiment, the implant delivery unit comprises a guide wire which can be positioned within the bore and which is adapted to be inserted into or around the centre of the defect. An implant, itself comprising a longitudinally extending bore can be threaded onto and advanced along the guide wire, and thereby delivered and accurately positioned within the defect. The guide wire may be a Kirschner-wire (K-wire).
In an alternative embodiment, the attachment may comprise one or more guide wires, which may be attachable to the defect, or the site surrounding the defect. Each guide wire may be attachable to the defect or the site surrounding the defect for example by using surgical suturing.
The attachment may be removable from the body or may be integral with it. The attachment may be disposable or re-useable.
The implant delivery unit may further comprise a handle, the handle partially covering the body of the unit and leaving at least the distal end of the body exposed. The handle may be between 70-95 mm in length. The handle may be adapted or shaped such that when the handle is gripped by a user, the implant delivery unit is held in one particular orientation.
The implant delivery unit may comprise at least one opening, window, or slot within the distal end of the body for visualising an implant positioned within the bore. The each opening, window or slot may extend partially or fully along the length of the *. body, and may extend from one or more points about the circumference of the body, either in a regular or irregular spacing, thereby allowing a user to easily visualise an implant positioned within the bore without having to rotate the implant delivery unit within the surgical incision. The each opening, window, or slot may be positioned in correlation with the shape or positiomng of the handle, such that when a user gnps the handle of the implant delivery unit and holds the unit in the prescribed orientation, the opening, window, or slot is positioned to allow visualisation of an implant within the bore, without the need to rotate the unit within the surgical incision.
The body of the implant delivery unit may be straight, curved, or bent or may comprise one or more regions each of which may be straight, curved, or bent. The body may be curved or bent at or near its distal end. The body may contain one or more curves or bends of up to 180 degrees, more preferably 5-90 degrees, and more preferably still 10-80 degrees. The bend or curve may be abrupt or smooth.
The body may comprise a flexible section at or near the distal end of the body, with the flexible section allowing the distal end of the body to be bent or shaped into different angles and positions. The body may comprise at least one hinge at or near the distal end of the body.
A curved or bent body, or a body comprising one or more flexible sections or hinges may facilitate access to a defect and improve positioning of the implant delivery unit at a defect site.
The flexible section is preferably flexible enough so that the angle and orientation of the distal end can be adjusted by hand, but is able to retain it shape while the implant delivery unit is being positioned over a defect.
The body may comprise a rigid material andior a flexible material. The body may be deformable to allow a user to adapt the shape to match the cross-sectional area of the defect. The rigid material may comprise stainless steel which is preferably surgical grade stainless steel. The handle andlor the body may comprise a material selected from the group consisting of: nylon, polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), polycarbonate, polymethylmethacrylate, glass, carbon fibre, and latex. The handle and/or body preferably comprises a surgically compatible plastics material, or any other plastics material that is non-toxic, autoclavable, gamma resistant and/or ethanol compatible. The flexible material may comprise a rubber ** material and/or a plastics material, or any surgically compatible material which provides the required flexibility, but which is able to maintain its shape throughout the surgical procedure.
The body may be coated or plated with one or more surgically compatible materials which may include one or more of heparin, antibiotics, or a lubricant.
Preferably the implant delivery unit is sized for use in arthroscopic surgical procedures. The implant delivery unit may be between 120-155mm in length.
The body of the implant delivery unit may comprise means to provide friction-retarded movement of other surgical instruments adapted to fit within the bore of the delivery unit. In one embodiment the body comprises serrated teeth within the bore, the teeth being adapted to frictionally engage with teeth positioned on other surgical instruments, and thereby limit any unwanted movement. In an alternative embodiment the body comprises a series of ridges or beads adapted to frictionally engage with beads or ridges positioned on other surgical instruments. Other means of frictionally limiting movement between objects in a sliding relationship are envisaged and will be known to a person skilled in the art.
At least a portion of the body of the implant delivery unit may be transparent or translucent, which may allow a user to visualise an implant positioned within it.
The implant delivery unit may comprise one or more longitudinal slits cut through the distal end of the body, creating leaves, which preferably taper inwardly (i.e. toward the centre of the bore), and which may create compression on an implant positioned within the distal end of the unit. Alternatively, the distal end of the device may itself be tapered inwardly. The resulting compression on the implant provides a greater degree of precision and control on delivery to the defect, and ensures that the implant can fit into the defect. S.
The implant delivery unit may be fulLy or partially disposable. The body andlor handle may be re-useable. The materials of the implant delivery unit may be autoclavable and resistant to detergents and ethanol.
The implant delivery unit may further comprise an implant positioned within the bore.
The implant may comprise a longitudinally extending bore adapted to fit a guide wire in a sliding relationship. The guide wire may be attachable to a defect.
The invention therefore allows for the delivery of implants with a range of diameters for example between 2 and 20mm. For optimal arthroscopic use, the diameter of implants may be 15mm or less. The implants may be single or multi-layered, for example as disclosed in WO 2005/051447, WO 2006/034365, and WO 2006/095154, the disclosure of each of which is incorporated herein by reference in its entirety. The implant may be solid, a liquid or a gel, and may be contained in a cartridge.
The implant delivery unit may comprise a cartridge assembly adapted to partially or fully fit within the bore of the implant delivery unit and contain an implant, the cartridge assembly comprising an assembly body having a proximal end and a distal end, a bore extending longitudinally from the distal end to the proximal end, the bore having substantially the same diameter as the bore of the implant delivery unit to allow advancement of an implant disposed within the assembly through the bore of the implant delivery unit and into a target tissue. An implant may be located within the cartridge assembly. The implant, which may be absorbable, is protected from e.g. blood, saline solution, or other fluids encountered or used during the procedure, thereby ensuring that the implant is delivered into the defect in the best condition possible.
The cartridge assembly may be attachable to the proximal end of the implant delivery unit. The proximal end of the implant delivery unit and/or the cartridge assembly may comprise means to facilitate attachment of the cartridge assembly to the implant delivery unit. In one embodiment, the proximal end of the implant delivery unit may comprise a groove, and the cartridge assembly may comprise a ridge, rim, or one or more beads which are adapted to snap-fit into the groove. Other means of attachment are envisaged and will be well known to a person skilled in the art. The cartridge assembly may contact the stop of the implant delivery unit, thereby limiting its movement within the bore.
S..... * 25
* :* According to another aspect of the present invention, there is provided an implant * : * delivery kit for delivery of an implant to a target tissue in a patient, the kit comprising the implant delivery unit of the first aspect of the present invention. The kit may comprise two or more implant delivery units, which may each differ in one or more dimensions, thereby allowing a user to select the implant delivery unit which is most optimally shaped for the size of defect and the procedure at hand. The kit preferably comprises instructions for a user.
The kit may further comprise at least one implant. Preferably, the kit comprises a plurality of implants, which may each differ in one or more dimensions. The implant may comprise a longitudinally extending bore adapted to fit a guide wire in a sliding relationship. In an alternative embodiment the implant may be shaped in an e.g. block, and may have to be cut or trimmed to the size of the defect by a person performing the procedure.
The kit may further comprise a cartridge assembly adapted to partially or fully fit within the bore of the implant delivery unit and contain an implant, the cartilage assembly comprising an assembly body having a proximal end and a distal end, a bore extending longitudinally from the distal end to the proximal end, the bore having substantially the same diameter as the bore of the implant delivery unit to allow advancement of an implant disposed within the assembly through the bore of the implant delivery unit and into a target tissue.
The cartridge assembly may be adapted to fit the proximal end of the implant delivery unit. An implant may be located within the cartridge assembly.
The implant delivery kit may further comprise an obturator, the obturator comprising a shaft having proximal and distal ends, the shaft being adapted to fit within the bore * : :* of the implant delivery unit in a sliding relationship. The distal end of the shaft may *.*. comprise a rounded or bullet-nosed tip. The obturator is insertable into the bore of the * implant delivery unit. When positioned within the bore of the implant delivery unit, the distal end of the shaft andlor the tip is adapted to protrude from the distal end of **.*.e * 25 the implant delivery unit, and the rounded or bullet-nosed tip is adapted to facilitate * the advancement of the implant delivery unit through the incision toward the site of a *: * defect. The rounded or bullet-nosed tip is adapted to minimise any damage to the tissue within an incision. In one embodiment, the obturator and/or the rounded or bullet-nosed tip is coated with one or more of heparin, an antibiotic, or a lubricant.
The proximal end of the obturator may comprise means to contact the stop or abutment of the implant delivery device.
The kit may further comprise a plunger rod, the plunger rod comprising a shaft having a proximal end and a distal end, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship. The plunger rod may further comprise a bore extending longitudinally from its distal end to its proximal end, the bore being adapted to fit a guide wire in a sliding relationship. The plunger rod is insertable into the proximal end of the implant delivery unit, and may be used to advance an implant located within the bore, or an implant located within a cartridge assembly, along the bore and into a defect.
The kit may further comprise a surgical drill unit for preparing an area containing a defect within a target tissue, the surgical drill unit comprising a drill shaft having proximal and distal ends and a drill tip, the drill shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship, and to be rotatable about its longitudinal axis. The rotation of the drill tip may be performed manually or may be power assisted. The drill tip may have a cross-sectional area which is similar to that of the implant, so that when the defect site is prepared (i.e. drilled out), the resulting defect is essentially the same shape and size as the drill tip. The shaft and/or the drill tip may be graduated or otherwise marked to show the depth of insertion of the drill tip/shaft. The surgical drill unit may further comprise an attachment tip on the proximal end of the drill shaft, the attachment tip being configured to be received in a rotation device. The surgical drill unit may further comprise a bore extending longitudinally from the distal end to the proximal end, the bore being adapted to fit a guide wire in a sliding relationship. * . * S..
. : The obturator, plunger rod and surgical drill unit may be resilient or flexible, and may * be shaped to slide within straight, hinged, andlor curved sections of the bore of the *S..*.
* 25 implant delivery unit. The obturator, plunger rod and surgical drill unit may comprise * the same material as the implant delivery unit. The obturator, plunger rod, andlor surgical drill unit may each comprise a handle at their proximal end. The handle may comprise a plastics material, or may comprise the same material as the implant delivery unit.
The kit may comprise a plurality of implant delivery units, the units having various dimensions; and/or a plurality of surgical drill bits having various drill dimensions; and/or a plurality of obturators having various obturator dimensions; and/or a plurality of plunger rods having various plunger dimensions; and/or a plurality of guide wires having various guide wire dimensions; and/or a plurality of implants having various implant dimensions.
There is provided an implant delivery kit compnsing: o at least one implant delivery unit according to the present invention; o at least one surgical drill unit for preparing an area containing a defect within a target tissue, the surgical drill unit comprising a drill shaft having proximal and distal ends and a drill tip, the drill shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship and to be rotatable about its longitudinal axis; o at least one obturator, the obturator comprising a shaft having proximal and distal ends, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship o at least one plunger rod, the plunger rod comprising a shaft having a proximal end and a distal end, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship; and o at least one implant.
The various tools of the kit may be fully or partially disposable. In one embodiment, it is envisaged that the kit is entirely disposable, and is used for delivering one or more implants into one or more defects within the same patient. Alternatively, one or more * of the tools, or indeed parts of the tools within the kit may be re-useable, for example the surgical drill unit, the drill tip, and/or the attachment.. The materials of the various tools of the kit and the tools themselves may therefore be autoclavable and resistant to * 25 detergents, gamma radiation, ethanol, and indeed any other chemicals and processes required to clean and sterilise the tools in preparation for another surgical procedure. ** * I * *
* The kit may comprise an implant delivery unit and one or more implants, and may further comprise one or more: obturators, surgical drill units, plunger rods, guide wires, and cartridge assemblies.
According to a third aspect of the present invention, there is provided a method of delivering an implant to a defect in a target tissue, the method comprising: * providing access to the defect through a surgical incision in the body of a patient; * delivering an implant into the defect using the kit of the second aspect of the present invention.
There is provided a method of delivering an implant to a defect in a target tissue, the method comprising: * providing access to the defect through a surgical incision in the body of a patient; * inserting an implant delivery unit according to a first aspect of the present invention into the surgical incision; * attaching the implant delivery unit to the target tissue or the defect; * delivering an implant through the bore of the implant delivery unit into the defect.
The me thod may further comprise (i) inserting an obturator into the bore of the implant delivery unit prior to inserting the implant delivery unit into the surgical incision, and (ii) removing the obturator from the bore of the implant delivery unit prior to attachment of the implant delivery unit to the target tissue or the defect. * S.
* The method may further comprise preparing an area containing the defect with a
SS
surgical drill unit prior to delivery of the implant into the defect. Preparing the area * :* : may involve drilling the edges of the defect to modify its shape, improve its structural * : integrity, and create a better fit between implant and defect.
* The step of attaching the implant delivery unit to the target tissue or the defect may * : *. comprise attaching a guide wire to the defect and threading the guide wire through the bore of the implant delivery unit. The other instruments used in the procedure and the implant can be threaded onto the guide wire for accurate positioning and delivery.
Further provided is a method of delivering an implant to a defect in a target tissue, the method comprising: * providing access to the defect through a surgical incision in the body of a patient; * attaching a guide wire to the defect; the guide wire having a proximal end and a distal end, * taking an implant having a longitudinal bore adapted to fit the guide wire in a sliding relationship and threading the implant onto the proximal end of the guide wire; and * advancing the implant along the guide wire toward the defect to deliver the implant into the defect.
The implant may be advanced along the guide wire toward the defect using a plunger rod, the plunger rod having a proximal end and a distal end and comprising a longitudinal bore extending between the proximal and distal ends and being adapted to fit the guide wire in a sliding relationship.
The method may further comprise preparing an area containing the defect with a surgical drill unit prior to delivery of the implant into the defect.
The implant may be contained within a cartridge assembly.
The target tissue may be selected from the group consisting of: cartilage, bone, S...
*... ligament, tendon, meniscus, periodontal tissue, dentine, enamel, intervertebral discs, *:*. annulus fibrosus, and nucleus pulposus.
S. *Se* * 25 The patient may be selected from the group consisting of: human, dog, camel, and horse. * . * SS S.
In summary, this invention provides a means whereby the implant site remains connected to the external environment throughout the procedure by a device which traverses the skin and soft tissues. In a preferred embodiment the distal end of the device penetrates the target tissue arid allows it to be held in place at the defect site.
The proximal end of the device is used to attach and guide instrumentation for the preparation of the site and also guide placement of the implant itself. Thus the device provides a conduit for instrumentation and implant products to be accurately placed in the correct position without the need for direct vision once the device has been placed.
The invention will now be described with reference to the following drawings, in which: Figure 1 is a side view of an implant delivery unit according to a first aspect of the present invention; Figure 2 shows a kit of instruments according to a second aspect of the present invention; Figures 3a-3j depict the instruments in the kit according to a second aspect of the present invention; Figures 4a-4c depict the first stage in the process for delivering an implant to defect site; Figures 5a-5c depict the second stage in the process for delivering an implant to defect site; Figures 6a-6c depict the third stage in the process for delivering an implant to defect site; Figures 7a-7c depict the fourth stage in the process for delivering an implant to defect site; Figures 8a-8c depict the first stage in a second process for delivering an implant to *:*::* defect site; * Figures 9a-9d depict the second stage in a second process for delivering an implant to defect site and * . Figures 1 Oa-I Oc depict the third stage in a second process for delivering an implant to S.....
* 25 defect site; *5 S. * . . * S Referring initially to Figures 1, 2, 3a and 3b of the drawings, an implant delivery unit (10) comprises a tubular body (20) defining a proximal end (30), distal end (40) and a bore (50) (Figure 3c) disposed in the body (20) and extending longitudinally from the proximal end (30) to the distal end (40). The bore (50) is the conduit through which an implant travels prior to insertion into a defect. The body (20) further defines an attachment (60) for securing the distal end (40) of the unit (10) to a defect or an area containing a defect. The bore (50) defines a cross-sectional area (70) (Figure 3b). The implant delivery unit (10) is between 120-155mm in length and is sized for use in arthroscopic surgical procedures.
The body (20) is shown straight, however, in alternative embodiments (not shown) the body can comprise one or more curves or bends, flexible sections or hinges. The body (20) comprises surgical grade stainless steel, which can be coated with one or more surgically compatible materials such as heparin, antibiotics, or lubricants.
The body (20) comprises a stop (80) defined toward its proximal end (30), the stop (80) being configured to provide an abutment (90) for limiting the length of travel for other surgical instruments adapted to fit within the bore (50) of the implant delivery unit (10).
The attachment (60) extends from the distal end (40) of the implant delivery unit (10) and comprises three projections (100) each extending from the distal end (40) of the body (20), each projection (100) defining a proximal end (110) and a distal end (120) and being adapted to penetrate the tissue of a patient. Each projection (100) comprises a blade (130) at its distal end (120), the blades (130) being configured to incise about an area containing the defect. The blades (130) are adapted so that a rotation of the implant delivery unit (10) about its longitudinal axis promotes insertion of the blades (130) into a tissue of the patient. * * S...
. : In alternative embodiments (not shown), the implant delivery unit (10) comprises * different numbers of projections, for example five or seven, or any number suitable **....
* 25 for providing maximum stability of the implant delivery unit (10). In alternative *:* embodiments, the attachment is removable from the body, and can be re-used in * * subsequent surgical procedures.
In one embodiment (also not shown) the projections (100) are graduated to facilitate assessment of depth penetration in the target tissue.
The projections (100) extend 2-10mm beyond the distal end (40) of the body (20).
The projections (100) are regularly spaced around the circumference of the body (20) (Figure 2), with each projection (100) extending the same distance from the distal end (40) of the implant delivery unit (10).
The implant delivery unit further comprises a handle (135), the handle (135) partially covering the body (20) and leaving the distal end (40) of the body (20) exposed. The handle (135) is between 70-95 mm in length.
In one embodiment (not shown) the attachment (60) comprises a guide wire (140), having a distal and a proximal end, the guide wire (140) being suitable for insertion into a defect or about a defect. The guide wire (140) is rigid, is made of surgical steel, and is 1-2 mm in diameter. The guide wire (140) remains unattached to the implant delivery unit (10), and is preferably threaded at its distal end to facilitate insertion into (by screwing) and removal from the defect by a user. The guide wire (140) is also threaded at its proximal end for attachment to a rotation device and/or a handle (not shown). The guide wire (140) can be inserted into or around the centre of the defect and threaded into the bore (50) of the implant delivery unit (10). An implant (not shown), itself comprising a longitudinally extending bore can be threaded onto and advanced along the guide wire (140), and thereby delivered and accurately positioned within the defect.
In another embodiment (not shown) the attachment (60) of the implant delivery unit * :* (10) comprises guide wires (140) which are attached to the implant delivery unit (10) * : and which can be attached to an area about the defect, either by screwing or suturing.
S.....
* 25 The implant delivery unit (10) comprises slots (150) within the distal end (40) of the body (20) (Figure 3d), which allows a user to visualise an implant positioned within * : the bore (50). In alternative embodiments, the slots (150) extend further along the length of the body (20), toward the proximal end (30).
The body (20) of the implant delivery unit (10) comprises means to provide friction-retarded movement (not shown) of other surgical instruments adapted to fit within the bore (50) of the implant delivery unit (10). In one embodiment the body comprises serrated teeth within the bore (50), the teeth being adapted to frictionally engage with teeth positioned on other surgical instruments, and thereby limit any unwanted movement. In an alternative embodiment the body comprises a series of ridges or beads adapted to frictionally engage with beads or ridges positioned on other surgical instruments.
In one embodiment a portion of the body (20) is transparent, thereby allowing a user to visualise an implant positioned within it.
Referring now to Figures 2, and 3e-3g, the kit according to the present invention comprises a cartridge assembly (160) (Figures 3e, 3f, 3g) which contains an implant (170), the cartridge assembly (160) defining an assembly bore (180) (Figure 3f and 3g) with substantially the same diameter as bore (50). The cartridge assembly (160) is adapted to fit to the proximal end (30) of the implant delivery unit (10) so that the bore (50) and assembly bore (180) are in alignment, thereby allowing an implant (170), positioned within the cartridge assembly (160) to be pushed into the bore (50) of the implant delivery unit (10). The cartridge assembly (160) comprises stop (165) which contacts abutment (90) when the cartridge assembly (160) is attached to the proximal end (30) and/or inserted into the bore (50) of the implant delivery unit (10) Referring now to Figures 2 and 3h, the kit of instruments further comprises an obturator (190). The obturator (190) comprises a shaft (200) having proximal (210) * *. and distal (220) ends, the shaft (200) being adapted to slide within the bore (50) of the implant delivery unit (10). The distal end (220) of the shaft (200) comprises a rounded tip (230). When positioned within the bore (50) of the implant delivery unit (10), the distal end (220) of the shaft (200) is adapted to protrude beyond the distal end of the S.....
* 25 projections (100), with the rounded tip being adapted to facilitate the advancement of :* the implant delivery unit (10) through the incision toward the site of a defect, and * : * prevent any damage being caused to the tissue by projections (100) as the implant delivery unit (10) is placed in position over a defect. In one embodiment, the obturator is coated with one or more of heparin, an antibiotic, or a lubricant. The proximal end (210) of the obturator comprises a step (230) to contact the abutment (90) of the implant delivery unit (10). The obturator further comprises a handle (240) at its proximal end. The handle (240) preferably comprises the same material as the handle of the implant delivery unit.
Referring now to Figures 2 and 31, the kit of instruments further comprises a surgical drill unit (250) which is used to prepare the area containing a defect, prior to insertion of the implant. The surgical drill unit (250) comprises a drill shaft (260) having proximal (270) and distal ends (280) and a drill tip (290) located at the distal end (280). The drill shaft (260) is adapted to slide within the bore (50) of the implant delivery unit (10) and can be rotated about its longitudinal axis to provide drilling torque, either by hand or using a power attachment. The surgical drill unit (250) comprises stop (295) at the proximal end (270) of the drill shaft (260) which engages with abutment (90) when the surgical drill unit (250) is inserted into the bore of the implant delivery unit (10), thereby limiting the travel of the surgical drill unit (250) within the bore (50). The drill tip and the implant preferably have the same cross-sectional area, to allow a good fit between the defect and the implant, and thereby improving the chances of success. In one embodiment, the surgical drill unit comprises an attachment tip (not shown) on the proximal end (270) of the drill shaft (260), the attachment tip being configured to be received in a rotation device.
Preferably, the surgical drill unit further comprises a bore (not shown), the bore extending longitudinally from the distal end to the proximal end, and through which a guide wire can be threaded to guide the surgical drill unit to the defect and enable the user to drill the defect accurately. The surgical drill unit (250) further comprises a handle (297) at its proximal end. The handle (240) preferably comprises the same material as the handle of the implant delivery unit. * ** * S S.C.
: Referring now to Figures 2 and 3j, the kit of instruments further comprises a plunger * rod (300), the plunger rod (300) comprising a shaft (310) having a proximal end (320) *.S.�*I * 25 and a distal end (330), the shaft (310) being adapted to slide within the bore of the :* implant delivery unit (10). In a preferred embodiment (not shown), the plunger rod *.: (300) comprises a bore extending longitudinally from its distal end to its proximal end, and through which a guide wire (140) can be threaded. The plunger rod (300) further comprises a handle (335) at its proximal end. The handle (335) preferably comprises the same material as the handle of the implant delivery unit (10). The plunger rod is insertable into the proximal end (30) of the implant delivery unit (10), and is used to advance either an implant or an implant located within a cartridge assembly (160) along the bore (50) and into the defect. Where a guide wire (140) is being used (attached to the defect), the plunger rod (300) slides along the guide wire through the bore (50), pushing the implant (also threaded on the guide wire) through the bore.
The method of the invention will now be described by reference to the following examples which describe the delivery and insertion of an implant into bone andlor cartilage.
Example 1
The instruments are as shown in Figures 1, 2 and 3. The kit consists of an implant (170) held within cartridge assembly (160). The instruments required to deliver the implant (170) comprise: an implant delivery unit (10) fabricated from metal and plastic (Figure 4a), a bullet-nosed obturator (190), a plunger rod (300), and a surgical drill unit (250) which can be operated manually or optionally may be power operated using standard equipment known in art.
Referring to Figures 4-7, the procedure is as follows: 1. M incision is made in the skin over the position of the bone/cartilage defect using standard surgical techniques. The obturator (190) is placed within the implant delivery unit (10) (Figure 4b) and extends beyond the projections (100) at its distal end (40). This acts to prevent the sharp edges and points of projections (100) damaging the soft or hard tissue during the insertion procedure.
2. The obturator/delivery unit combination is pressed through the skin and placed at the bony/cartilage surface under direct vision from an arthroscope (Figure 4c)).
3. The obturator (190) is withdrawn, exposing the projections (100) on the distal S.....
* ° end (20) of the implant delivery unit (10).
* 4. The projections (100) are pressed into the bone by manual force alone or with assistance from an impact device (Figure 5a).
5. The implant delivery unit (10) is now anchored in the bone and the drill shaft (260) of a surgical drill unit (250) is fed into the proximal end (30) of the implant delivery unit (10) (Figure 5b). When fully inserted, drill tip (290) contacts the bone at the distal end (20) of the implant delivery unit (10) and the drill shaft (260) is then rotated to remove the implant bed area by a drilling action (Figure 5c). The depth of drilling can be fixed or variable. Optimally, the diameter of the drill tip is equivalent to the diameter of the implant to be placed, thereby ensuring a good fit between the implant and the defect.
6. The cartridge assembly (160) is attached to the proximal end (30) of the implant delivery unit (10) (Figures 6b and 6c).
7. The plunger rod (300) is then placed into the assembly bore (180) of the cartridge assembly (160) (Figure 7a) and pushed through the assembly bore (180) and then the bore (50) of the implant delivery unit (10) (Figure 7b), forcing the implant (170) from the cartridge assembly (160), down the bore (50) of the implant delivery unit (10) and into the prepared defect site.
8. The implant delivery unit (10) is then removed from the bone, leaving the implant in place (not shown).
Example 2
The implant delivery kit consists of a guidewire (320) having a proximal end (322), a distal end (324) and optionally a handle (326), a hollow drill (330) which can be passed over the guidewire (320), a plunger rod (340), and an implant (70) in a delivery cartridge (350) which can also be passed over the guidewire (320). The hollow section of both the implant and the drill bit are the same diameter as that of the guidewire.
The guidewire (320) is rigid and resistant to bending by accidental or inadvertent *:*::* manual force. The stiffness of the guidewire (320) is controlled by its diameter and material properties. Optimally, the guidewire (320) is made from metal and has a diameter of 1-2mm. Optionally, the distal end of the guidewire may be threaded to facilitate insertion into and removal from the bony site by rotation using manual or * power force. ** .. * * . * S
*:*. Referring to Figures 8-10, the procedure is as follows: 1. An incision is made in the skin over the position of the implant using standard surgical techniques.
2. The rigid guidewire (320) is passed through the skin and the distal end (324) is placed at or near the centre of the defect site (Figure 8b). Using power or manual force, the guidewire (320) is inserted into the bone to a depth of 5-25 mm and optimally 15mm (Figure 8c).
3. The handle (326) is removed (Figure 9a) and hollow drill (330) is then passed over the guidewire (320) (Figure 9b) from the proximal end (322), pushed through the skin incision and placed in contact with the bony surface (Figure 9c).
4. The bone is then drilled to a variable or fixed depth depending on the size of the defect to be repaired. The force applied can be either manual or power driven. The guidewire prevents the drill from moving during the drilling process and damaging the surrounding soft or hard tissue.
5. The drill (330) is removed (Figure 9d).
6. The implant (70) within its delivery cartridge (350) is then placed over the guidewire (320). The implant (70) contains a small hole at its centre which is approximately the same size as the diameter of the guidewire.
7. The delivery cartridge (350) is then pushed to the skin incision (Figure IOa) and then the plunger rod (340) is placed over the guidewire at its proximal end (322). This is then pushed down to contact the proximal end of the delivery cartridge (350) and implant (70) (Figure lOb) and then used to push the delivery cartridge (350) and implant (70) through the incision, to the bone surface and then finally expel the implant (70) from the delivery cartridge (350) and into the prepared bony site (Figure 1 Oc).
8. Finally, the guidewire is removed by a reverse drilling action either with manual or power force (Figure 1 Oc). * S. * . . * .. * . S... ** 25
S..... * . *. .. * . . * . S. * S *

Claims (74)

  1. Claims 1. An implant delivery unit for delivering an implant to a defect in a target tissue, the unit comprising a body defining a proximal and distal end; a bore disposed in the body and extending longitudinally from the proximal end to the distal end; and an attachment for securing the distal end to the defect or an area containing the defect.
  2. 2. The implant delivery unit of claim I, wherein the body is a tube or sleeve.
  3. 3. The implant delivery unit of claim I or claim 2, wherein the body comprises a stop defined at or toward the proximal end of the body, the stop being configured to provide an abutment for limiting the length of travel for other surgical instruments adapted to fit within the bore of the delivery unit.
  4. 4. The implant delivery unit of any one of claims 1-3 wherein the attachment comprises at least one projection extending from the distal end of the body, the projection defining a proximal and distal end and being adapted to penetrate the target tissue.
  5. 5. The implant delivery unit of claim 4, wherein the at least one projection is selected from the group consisting of: prong, tooth, extension, spike, and spur. * S. * S * * S. *55S
  6. 6. The implant delivery unit of claim 4 or claim 5, wherein the at least one * projection comprises a blade at its distal end. 25
    * S's..
    *
  7. 7. The implant delivery unit of claim 6 wherein the at least one projection is configured to incise about an area containing the defect. 5* 5 5* 55
  8. 8. The implant delivery unit of any one of claims 4-7, wherein the at least one projection is graduated to facilitate assessment of depth penetration in the target tissue.
  9. 9. The implant delivery unit of any one of claims 4-8, wherein the at least one projection extends 2-10mm beyond the distal end of the body.
  10. 10. The implant delivery unit of any one of claims 4-9, wherein the implant delivery unit comprises three projections.
  11. 11. The implant delivery unit of claim 10, wherein each projection is spaced equally around the circumference of the body.
  12. 12. The implant delivery unit of claim 11, wherein each projection comprises a cutting blade at its distal end.
  13. 13. The implant delivery unit of any one of claims 1-3 wherein the attachment comprises a suction device.
  14. 14. The implant delivery unit of any one of claims 1-3 wherein the attachment comprises at least one magnet adapted to magnetically attach to one or more magnets positioned in or around the defect.
  15. 15. The implant delivery unit of any one of claims 1-3 wherein the attachment comprises an adhesive or cement adapted to bond to the target tissue andlor the defect or a tissue located near the defect.
  16. 16. The implant delivery unit of any one of claims 1-3 wherein the attachment * *** comprises a dilation device, the dilation device being adapted to fit within the defect *: and circumferentially expand within the defect to attach the implant delivery unit to the defect.
    **S..I * *
  17. 17. The implant delivery unit of any one of claims 1-3 wherein the attachment *:*. comprises at least one guide wire, the guide wire defining a distal and a proximal end and being suitable for insertion into a defect.
  18. 18. The implant delivery unit as claimed in claim 17 wherein the at least one guide wire is threaded at its distal end to facilitate insertion into and removal from the defect.
  19. 19. The implant delivery unit as claimed in claim 17 or claim 18 wherein the at least one guide wire is threaded at its proximal end for attachment to a rotation device and/or a handle.
  20. 20. The implant delivery unit of any one of claims 17-19 wherein the at least one guide wire is rigid and resistant to bending
  21. 21. The implant delivery unit of any one of claims 17-20 wherein the at least one guide wire comprises metal.
  22. 22. The implant delivery unit of any one of claims 17-21 wherein the at least one guide wire is between 1-2 mm in diameter.
  23. 23. The implant delivery unit of any one of claims 1-22 further comprising at least one opening or slot within the distal end of the body for visualising an implant positioned within the body.
  24. 24. The implant delivery unit of any one of claims 1-23 wherein the body is straight, curved, or bent.
  25. 25. The implant delivery unit of claim 24 wherein the body is curved or bent at or * ** near the distal end of the body. *.*. * S *.**
  26. 26. The implant delivery unit of any one of claims 1-25 wherein the body comprises a rigid material and/or a flexible material.
    S.....
    S
  27. 27. The implant delivery unit of any one of claims 1-26 wherein the body * * comprises a flexible section at or near the distal end of the body, wherein the flexible section allows the distal end of the body to be bent or shaped into different angles and positions.
  28. 28. The implant delivery unit of any one of claims 1-27 wherein the body comprises at least one hinge at or near the distal end of the body.
  29. 29. The implant delivery unit of claim 26, wherein the rigid material comprises stainless steel.
  30. 30. The implant delivery unit of claim 26, wherein the flexible material is a rubber material andlor a plastics material.
  31. 31. The implant delivery unit of any one of claims 1-30 wherein the body is coated or plated with a surgically compatible material.
  32. 32. The implant delivery unit of any one of claims 1-31 wherein the implant delivery unit is sized for use in arthroscopic surgical procedures.
  33. 33. The implant delivery unit of any one of claims 1-32, wherein the implant delivery unit is between 120-155mm in length
  34. 34. The implant delivery unit of any one of claims 1-33, further comprising a handle, the handle partially covering the body leaving at least the distal end of the body exposed.
  35. 35. The implant delivery unit of claim 34 wherein the handle is between 70-95 mm in length. * S. * * . * ** ****
  36. 36. The implant delivery unit of claim 34 or claim 35, wherein the handle comprises a surgically compatible material selected from the group consisting of: 25 nylon, polytetrafluoroethylene (PTFE), acrylonitrile butadiene styrene (ABS), 5.S..
    * polycarbonate, polymethylmethacrylate, glass, carbon fibre, and latex. *5 S. * . S * S
    **
  37. 37. The implant delivery unit of any one of claims 1-36, wherein the body comprises means to provide friction-retarded movement of other surgical instruments adapted to fit within the bore of the delivery unit.
  38. 38. The implant delivery unit of any one of claims 1-37, wherein at least a portion of the body is transparent or translucent.
  39. 39. The implant delivery unit of any one of claims 1-38 further comprising an implant positioned within the bore.
  40. 40. The implant delivery unit of claim 39, wherein the implant comprises a longitudinally extending bore adapted to fit a guide wire attached to a defect in a sliding relationship.
  41. 41. The implant delivery unit of claim 39 or claim 40, further comprising a cartridge assembly adapted to fit within the bore of the implant delivery unit and contain an implant, the cartilage assembly comprising an assembly body having a proximal end and a distal end, a bore extending longitudinally from the distal end to the proximal end, the bore having substantially the same diameter as the bore of the implant delivery unit to allow advancement of an implant disposed within the assembly through the bore of the implant delivery unit and into a target tissue.
  42. 42. The implant delivery unit of claim 41, wherein the cartridge assembly is attachable to the proximal end of the implant delivery unit.
  43. 43. The implant delivery unit of claim 41 or claim 42, wherein the implant is located within the cartridge assembly.
    **,.*
  44. 44. The implant delivery unit of any one of claims 41-43, wherein the cartridge *.S.
    assembly is moveable through the bore of the implant delivery unit. * * *
    * 25
  45. 45. An implant delivery kit for delivery of an implant to a target tissue in a patient, S...
    * the kit comprising an implant delivery unit as claimed in any one of claims 1-38. S. es * S * * .
    **
  46. 46. An implant delivery kit as claimed in claim 45, further comprising at least one implant.
  47. 47. An implant delivery kit as claimed in claim 46, wherein the implant comprises a longitudinally extending bore adapted to fit a guide wire attached to a defect in a sliding relationship.
  48. 48. An implant delivery kit as claimed in claim 45 or claim 46. further comprising a cartridge assembly adapted to fit within the bore of the implant delivery unit and contain an implant, the cartilage assembly comprising an assembly body having a proximal end and a distal end, a bore extending longitudinally from the distal end to the proximal end, the bore having substantially the same diameter as the bore of the implant delivery unit to allow advancement of an implant disposed within the assembly through the bore of the implant delivery unit and into a target tissue.
  49. 49. An implant delivery kit as claimed in claim 48, wherein the implant is located within the cartridge assembly.
  50. 50. An implant delivery kit as claimed in any one of claims 45-49, the kit further comprising an obturator, the obturator comprising a shaft having proximal and distal ends, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship.
  51. 51. An implant delivery kit as claimed in claim 50, wherein the distal end of the shaft comprises a rounded or bullet-nosed tip.
  52. 52. An implant delivery kit as claimed in claim 50 or claim 51, wherein the * proximal end of the obturator comprises means to contact the abutment of the implant delivery device. * S *.**
    *:*.
  53. 53. An implant delivery kit as claimed in any one of claims 50-52, wherein the obturator further comprises a handle at its proximal end.
    * S.S** * * *.
  54. 54. An implant delivery kit as claimed in claim 53, wherein the handle comprises ** a plastics material.
  55. 55. An implant delivery kit as claimed in any one of claims 45-54, the kit further comprising a plunger rod, the plunger rod comprising a shaft having a proximal end and a distal end, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship.
  56. 56. An implant delivery kit as claimed in claim 55, wherein the plunger rod further comprises a bore extending longitudinally from the distal end to the proximal end, the bore being adapted to fit a guide wire attached to a defect in a sliding relationship.
  57. 57. An implant delivery kit as claimed in any one of claims 45-56, the kit further comprising a surgical drill unit for preparing an area containing a defect within a target tissue, the surgical drill unit comprising a drill shaft having proximal and distal ends and a drill tip, the drill shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship and to be rotatable about its longitudinal axis.
  58. 58. An implant delivery kit as claimed in claim 57, wherein the rotation of the drill tip is performed manually or is power assisted.
  59. 59. An implant delivery kit as claimed in claim 57 or claim 58, wherein the surgical drill unit further comprises an attachment tip on the proximal end of the drill shaft, the attachment tip being configured to be received in a rotation device.
  60. 60. An implant delivery kit as claimed in claim 57, wherein the surgical drill unit further comprises a bore extending longitudinally from the distal end to the proximal end, the bore being adapted to fit a guide wire attached to a defect in a sliding * :* ::* relationship. **** * * *.*.
    *:*.
  61. 61. An implant delivery kit as claimed in any one of claims 45-60, wherein the kit comprises at least one selected from the group consisting of: ****** * a a plurality of implant delivery units, the units having various S. ** : * * dimensions; * : * o a plurality of surgical drill bits having various drill dimensions; o a plurality of obturators having various obturator dimensions; o a plurality of plunger rods having various plunger dimensions; o a plurality of guide wires having various guide wire dimensions; and o a plurality of implants having various implant dimensions.
  62. 62. An implant delivery kit comprising: o at least one implant delivery unit as claimed in any one of claims 1-44; o at least one surgical drill unit for preparing an area containing a defect within a target tissue, the surgical drill unit comprising a drill shaft having proximal and distal ends and a drill tip, the drill shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship and to be rotatable about its longitudinal axis; o at least one obturator, the obturator comprising a shaft having proximal and distal ends, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship a at least one plunger rod, the plunger rod comprising a shaft having a proximal end and a distal end, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship; and o at least one implant.
  63. 63. A method of delivering an implant to a defect in a target tissue, the method comprising: * providing access to the defect through a surgical incision in the body of a patient; * attaching an implant delivery unit as claimed in any one of claims 1-38 to the target tissue or the defect; * * delivering an implant through the bore of the implant delivery unit into the defect. * . *.* S
  64. 64. The method as claimed in claim 63, further comprising (i) inserting an obturator into the bore of the implant delivery unit prior to attaching the implant delivery unit to the target tissue or the defect, and (ii) removing the obturator ** ** * * following attachment of the implant delivery unit to the target tissue or the defect, * * wherein the obturator comprises a shaft having proximal and distal ends, the shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship.
  65. 65. The method as claimed in claim 63 or claim 64 further comprising preparing an area containing the defect with a surgical drill prior to delivery of the implant into the defect, wherein the surgical drill unit comprises a drill shaft having proximal and distal ends and a drill tip, the drill shaft being adapted to fit within the bore of the implant delivery unit in a sliding relationship and to be rotatable about its longitudinal axis.
  66. 66. The method as claimed in any one of claims 63-65, wherein the implant is contained within a cartridge assembly adapted to fit with the proximal end of the implant delivery unit, the cartilage assembly comprising an assembly body having a proximal end and a distal end and a bore extending longitudinally from the distal end to the proximal end, the bore having substantially the same diameter as the bore of the implant delivery unit to allow advancement of an implant disposed within the assembly through the bore of the implant delivery unit and into a target tissue.
  67. 67. The method as claimed in claim 63, wherein the step of attaching the implant delivery unit comprises attaching a guide wire to the defect and threading the guide wire through the bore of the implant delivery unit, wherein the implant comprises a longitudinal bore adapted to fit the guide wire in a sliding relationship.
  68. 68. The method as claimed in claim 67, further comprising preparing an area containing the defect with a surgical drill unit prior to delivery of the implant into the defect, wherein the surgical drill unit comprises a drill shaft and a drill tip, the drill unit having proximal and distal ends and being adapted to fit within the bore of the implant delivery unit in a sliding relationship and to be rotatable about its longitudinal *:*. axis, and comprising a longitudinal bore extending between the distal and proximal * .25 ends, the guide wire being adapted to fit within the bore of the drill unit in a sliding relationship. ** *. * * * * S
  69. 69. A method of delivering an implant to a defect in a target tissue, the method comprising: * providing access to the defect through a surgical incision in the body of a patient; * attaching a guide wire to the defect; the guide wire having a proximal end and a distal end, * threading an implant having a longitudinal bore adapted to fit the guide wire in a sliding relationship onto the proximal end of the guide wire; and * advancing the implant along the guide wire toward the defect to deliver the implant into the defect.
  70. 70. The method as claimed in claim 69, wherein the implant is advanced along the guide wire toward the defect using a plunger rod, the plunger rod having a proximal end and a distal end and comprising a longitudinal bore extending between the proximal and distal ends and being adapted to fit the guide wire in a sliding relationship.
  71. 71. The method as claimed in claim 69 or claim 70, further comprising preparing an area containing the defect with a surgical drill unit prior to delivery of the implant into the defect, wherein the surgical drill unit comprises a drill shaft and a drill tip, the drill unit having proximal and distal ends and comprising a longitudinal bore extending between the distal and proximal ends, the bore of the drill unit being adapted to fit the guide wire in a sliding relationship.
  72. 72. The method as claimed in claim 70 or claim 71, wherein the implant is contained within a cartridge assembly, the cartridge assembly being adapted to fit * over the guide wire, the method comprising advancing the cartridge assembly toward * the defect and using the plunger rod to expel the implant from the cartridge assembly *.. * *
    into the defect. ** I * II
    .,: 25
  73. 73. The implant delivery unit of any one of claims 1-44 or the kit of any one of claims 45-62 or the method or any one of claims 63-72 wherein the target tissue is ** I. : selected from the group consisting of: cartilage, bone, ligament, tendon, meniscus, * * periodontal tissue, dentine, enamel, intervertebral discs, annulus fibrosus, and nucleus pulposus.
  74. 74. The implant delivery unit of any one of claims 1-44 or the kit of any one of claims 45-62 or the method of claims 63-73 wherein the patient is selected from the group consisting of: human, dog, camel, and horse.
GB0718563A 2007-09-24 2007-09-24 Implant delivery unit Withdrawn GB2452987A (en)

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EP2233114A3 (en) * 2009-03-27 2011-01-19 DePuy Mitek, Inc. Methods and devices for delivering and affixing tissue scaffolds
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US11554028B2 (en) 2009-03-27 2023-01-17 DePuy Synthes Products, Inc. Methods and devices for delivering and affixing tissue scaffolds
CN111658119B (en) * 2020-06-30 2021-07-06 重庆西山科技股份有限公司 Bone meal propeller
CN111658119A (en) * 2020-06-30 2020-09-15 重庆西山科技股份有限公司 Bone meal propeller

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