WO1999035984A1 - Soft tissue fixation devices - Google Patents
Soft tissue fixation devices Download PDFInfo
- Publication number
- WO1999035984A1 WO1999035984A1 PCT/US1999/000699 US9900699W WO9935984A1 WO 1999035984 A1 WO1999035984 A1 WO 1999035984A1 US 9900699 W US9900699 W US 9900699W WO 9935984 A1 WO9935984 A1 WO 9935984A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- distal end
- tissue
- main body
- inner sleeve
- body portion
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/148—Probes or electrodes therefor having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00513—Tissue soldering
Definitions
- the present invention relates to surgical instruments and more particularly, surgical instruments for repairing soft tissues wherein the instrument inserts a bioabsorbable member across a lesion to be pepaired and by causing tissue on opposit sides of the lesion to be drawn together.
- Drawbacks to the disclosed methods include the need to physically place the adhesive material on the wound site, the cumbersome and thus inaccurate direction of the energy beam, both disclosures require that the surgeon manipulate several instruments to accomplish the task including physically holding the tissue in place and nekher of patented devices or methods that may be readily used during arthroscopic procedures, such as meniscus repair.
- a device having a body portion with a distal tip, a shaft portion slidingly disposed widiin the body portion and the distal tip, and a mechanism to hold the lesion together after the device is removed from the sutured site.
- FIG. 1 is a partial cross-sectional view of a surgical instrument according to the present invention
- FIG. 2 is a partial cross-sectional view of the surgical instrument shown in FIG.
- FIG. 3 is a partial cross-sectional view of the distal tip according to a first preferred embodiment of the present invention
- FIG. 4 schematically depicts a tubular member formed from woven bioabsorbable fibers according to one embodiment of the present invention
- FIGS. 5A-5C depicts a cross-section of a lesion undergoing repair according to a preferred embodiment of the present invention
- FIGS. 6A-6B schematically depicts an alternative tubular member formed from extruded bioabsorbable fibers according to an alternative preferred embodiment of the present invention
- FIGS. 7A-7B are a partial cross-section and a partial side view, respectively, of the distal tip according to an alternative preferred embodiment of the present invention.
- FIG. 8 is a partial, cross-sectional, exploded view of the preferred embodiment depicted in FIGS 7A and B;
- FIG. 9 is a side view of an anchor according to a further preferred embodiment of the present invention.
- FIGS. 10A and B depict plan and side views, respectively of a sliding member in the embodiment of the present invention depicted in FIG. 9;
- FIG. 11 is a partial cross-sectional, exploded view of the distal tip for the embodiment of the present invention depicted in FIGS. 9-10;
- FIG. 12 is a partial cross-sectional, exploded view of the embodiment depicted in FIGS. 9-11; and FIG. 13A-13H depicts a cross-section of a lesion undergoing repair according to ab alternative embodiment of the present invention utilizing the device depicted in the FIGS. 9- 12.
- surgical instrument 10 includes body portion 12 with distal tip 14, shaft portion 16 slidingly disposed within body portion 12 and distal tip 14, and repair member 18A (shown in Fig. 4) to secure together opposite sides of a soft tissue lesion.
- distal tip 14 comprises outer sleeve 22 with a distal opening, preferably a standard canula or trocar with a needlelike distal end, attached to and in communication with body portion 12.
- Inner sleeve 24 is slidingly disposed within outer sleeve 22 and extends through the distal end of and into body portion 12.
- Shaft portion 16 is slidingly disposed within inner sleeve 24 and is attached to plunger rod 26 at the proximal end of body portion 12 such that axial movement of plunger rod 26 correspondingly slides shaft portion 16 within the inner sleeve.
- inner sleeve 24 may be slid distally to extend out of distal end 30 of outer sleeve 22.
- inner sleeve 24 may be designed to flare outwards when pushed beyond distal opening 30 of outer sleeve 22 (best depicted in FIGS. 5B & 5C) which, as will be discussed shortly, aids in forcing the opposite sides of die lesion together.
- Annular channel 36 is defined between inner sleeve 24 and shaft 16 and provides fluid communication to distal end 30.
- Shaft portion 16 preferably comprises an RF probe, with distal end 17 formed as a mandrel and adapted to deliver radio frequency energy to surrounding tissue when placed therein.
- RF probe with distal end 17 formed as a mandrel and adapted to deliver radio frequency energy to surrounding tissue when placed therein.
- the basic features of such probes for the delivery of RF energy and surgical procedures are known in the art as described, for example, in U.S. Patent No. 5,569,242 and U.S. Patent No. 5,514,130, each of which is incorporated by reference here in its entirety.
- distal mandrel 17 is shaped to carry and deliver repair to number 18.
- Repair member 18A is generally a hollow tubular member, as shown in FIG. 4, manufactured from a biosorbable from material which is relatively inert when exposed to RF energy.
- Member 18A is preferably woven tube made from fibers of bioabsorable material such as various polylactide polymers that are commercially availabel as absorbable suture material.
- Member 18 is disposed over RF probe mandrel 17, which is disposed within inner sleeve 24, which is in turn disposed witiiin trocar 22.
- trocar is inserted through top flap 32 in the tissue to be repaired and into bottom flap 34.
- Trocar 22 is then withdrawn, leaving probe 16 with member 18 on mandrel 17 in place as in FIG. 5A.
- Inner sleeve 24 is then advanced out of trocar 22.
- Inner sleeve 24 is advanced further causing its distal end to abut the surface of tissue flap 32 and force tissue flaps 32 and 34 together (best depicted in FIG. 5B & 5C).
- RF energy is applied to the tissue surrounding repair member 18 via mandrel 17 of probe 16 in a controlled manner to cause the surrounding tissue to shrink and be drawn together around member 18, thus closing the lesion, such tissue shrinkage via controlled application of RF energy is described for example in United States Patent No. 5,458,596, which is encorpated by reference herein.
- Member 18 serves as an integral fastener holding together flaps 32 and 34, while natural healing processes occur.
- the interstices between the briefed fibers enhance this fastening function by receiving tissue therein.
- RF energy also causes tissue proteins to denature and form an adhesive like substance.
- RF probe 16 is removed leaving behind member 18 to which the denatured proteins adhere as they begin to cool down.
- annular channel 36 may be used to deliver a fluid that forms an adhesive after being exposed to RF energy.
- the preferred composition of member 18, absorbable suture materials, such as polyglactin fibers and the like, when subject to RF energy, also forms an adhesive-like substance in addition to the denaturing proteins of the surrounding tissue.
- the materials used in this embodiment are entirely bioabsorbable allowing the body to heal itself and then digest the suture.
- FIGS. 6-8 An alternative preferred embodiment, depicted in FIGS. 6-8, is similar to the first two preferred embodiments except as described below.
- the RF probe 16 comprises shaped wire 48 which can be quickly heated and deliver RF energy.
- Wire/RF- probe 48 is disposed through center lumen 44 of inner sleeve 24. Center lumen 44, .passing through inner sleeve 24 places distal end 30 in fluid communication with proximal end 40 of body portion 12.
- repair member 18B has a tubular shape as before, but is an extruded biocompatible absorbable material, such as polyglactin and the like, rather than braided fibers. Openings 19 are provided for tissue engagement and to permit fluid flow which facillitates the healing process.
- member 18B is disposed witiiin trocar 22 and abuts inner sleeve 24.
- Member 18B and inner sleeve 24 are dimensioned such that the distal end of inner sleeve 24 will abut the proximal end of member 18B. Therefore advancement of inner sleeve 24 will advance member 18B as well.
- inner sleeve 24 only abuts repair member 18B therefore, withdrawal of inner sleeve 24 will not correspondingly withdrawal member 18B.
- repair member 18B is placed across a lesion by inserting trocar 22 through the tissue to position member 18B at the site of repair. Inner sleeve 24 is advanced as trocar 22 is correspondingly withdrawn.
- FIGS. 9-12 illustrate a further preferred embodiment of the present invention.
- the apparatus also includes body portion 12 with distal tip 14.
- Distal tip 14 comprises trocar 22 with a distal opening, attached to and in communication with body portion 12.
- Inner sleeve 24 is slidingly disposed within outer sleeve 22 and extends through the distal end of and into body portion 12 (best depicted in FIGS. 11 & 12).
- Anchor 50 is manufactured by extruding and shaping the end of fibrous absorbable suture material 60 such that anchor 50 formed with distal end 66 and shaft 58, relatively rigid with relatively flexible suture material 60 remaining attached to proximal end 62 of rigid anchor 50.
- Distal end 66 of anchor 50 has at least one resiliently, and preferably a plurality of, deformable barbs 56 such that in the deformed position anchor 50 will fit inside trocar 22 as in FIG. 11.
- Resiliently deformable barb 56 will flare out such that barb 56 will point towards the proximal end of anchor 50.
- Sliding member 52 also has at least one deformable barb 54, and preferably a plurality, such that in the deformed position sliding member 52 will fit inside- trocar 22 as in FIG. 11.
- Sliding member 52 fits over shaft 58.
- Shaft 58 has a locking mechanism 64, preferably a ratchet mechanism such as found on "tie-wraps", that only allows sliding member 52 to move unidirectionally towards distal end 66 of anchor 50. It will be readily recognizable to those skilled in the art that other standard one-way locking mechanisms may be substituted for locking mechanism 64.
- Flexible suture material 60 passes through inner sleeve 24 towards distal end 40 of body portion 12. Flexible suture material is used to set anchor 50 after it has been inserted across lesion 20 as described below.
- Inner sleeve 24 is configured to about proximal end 62 of anchor 50 for the purpose of ejecting anchor 50 trocar outer sleeve 22 and for advancing sliding member 52.
- trocar 22 is inserted across a lesion and inner sleeve 24 advances the distal and 66 of anchor 50 into the tissue. Once distal end 66 is positioned, flexible suture 60 is tugged to set collapsible barbs 56. Inner sleeve 24 is advanced further to advance sliding member 52 towards distal end 66 and force the separate edges of the lesion to come together. Trocar 22 then is withdrawn and flexible suture 60 is trimmed leaving the bioabsorbable anchor in place.
- All of the embodiments of the present invention comprise a single and easily operable device which can be manufactured in small enough sizes to be used in arthroscopic or endoscopic procedures.
- various modifications and adaptations of the structures and examples above described will be readily apparent, in particular, different shapes of sleeves may be used in order to accommodate different sizes or shapes of lesions, without departure from the spirit and scope of the invention, the scope of which is defined in the appended claims.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU22246/99A AU2224699A (en) | 1998-01-14 | 1999-01-13 | Soft tissue fixation devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/007,246 US5976127A (en) | 1998-01-14 | 1998-01-14 | Soft tissue fixation devices |
US09/007,246 | 1998-01-14 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999035984A1 true WO1999035984A1 (en) | 1999-07-22 |
Family
ID=21725065
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/000699 WO1999035984A1 (en) | 1998-01-14 | 1999-01-13 | Soft tissue fixation devices |
Country Status (3)
Country | Link |
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US (1) | US5976127A (en) |
AU (1) | AU2224699A (en) |
WO (1) | WO1999035984A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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EP1404228A2 (en) * | 1999-12-14 | 2004-04-07 | Linvatec Corporation | Fixation system and method |
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EP1404228A4 (en) * | 1999-12-14 | 2006-10-04 | Linvatec Corp | Fixation system and method |
Also Published As
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AU2224699A (en) | 1999-08-02 |
US5976127A (en) | 1999-11-02 |
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