WO2006129171A2 - Procede et trousse medicale pour la reparation de tendons par la chirurgie - Google Patents

Procede et trousse medicale pour la reparation de tendons par la chirurgie Download PDF

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Publication number
WO2006129171A2
WO2006129171A2 PCT/IB2006/001424 IB2006001424W WO2006129171A2 WO 2006129171 A2 WO2006129171 A2 WO 2006129171A2 IB 2006001424 W IB2006001424 W IB 2006001424W WO 2006129171 A2 WO2006129171 A2 WO 2006129171A2
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WO
WIPO (PCT)
Prior art keywords
muscle
neurotoxin
tendon
surgery
paralysis
Prior art date
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Ceased
Application number
PCT/IB2006/001424
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English (en)
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WO2006129171A3 (fr
Inventor
Polydoor Emile Huijsmans
Johann Frederick De Beer
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Individual
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Individual
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Publication of WO2006129171A2 publication Critical patent/WO2006129171A2/fr
Publication of WO2006129171A3 publication Critical patent/WO2006129171A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines

Definitions

  • This invention relates to a method and medical package for repairing tendons by surgery and, more particularly, a method that covers the extended procedure including preoperative preparation and postoperative rehabilitation.
  • the surgical repair of tendons is typically accompanied by significant immobilisation following on the surgery and pending healing of the repaired tendon, typically for a period of the order of six weeks.
  • Different forms of immobilisation are generally employed such as a sling in the case of a rotator cuff tendon repair and a plaster cast in the case of an Achilles tendon repair.
  • rehabilitation is often accompanied by significant pain.
  • the infliction of pain results in involuntary muscular movements that are deleterious to, and consequently prolong, the healing process. Indeed, active motion or too much tension on the repaired tendon increases the risk of failure of the surgery.
  • neurotoxins the most well-known of which is botulinum toxin.
  • This neurotoxin has been known for many decades and its medical uses, as far as applicant is aware, are restricted to the treatment of cervical dystonia; blepharospasm; strabismus; axilliary hyperhydrosis: spasticity in cerebral palsy; myofacial pain syndromes; and headaches.
  • the dosages used in such applications are typically 5-10 units. It has also been used extensively in the field of cosmetics, particularly facial cosmetics, where the substance is injected into the facial muscles to lessen the degree of wrinkling caused by the "muscles of expression" in the face - the dosages used are typically 2-5 units.
  • a method of repairing tendons by surgery comprising the steps of i identifying a tendon to be repaired; ii identifying a muscle associated with that tendon and treating that muscle with a predetermined dose of a neurotoxin sufficient to effectively cause temporary paralysis of the muscle; iii allowing a sufficient period of time to elapse to enable said temporary paralysis of the muscle to set in; iv performing repair surgery on the relevant tendon; and, v optionally, if necessary, treating said muscle with one or more additional doses of neurotoxin to maintain temporary paralysis for at least an initial period of rehabilitation.
  • a method of preparing a human body for the surgical repair of a tendon comprising the steps of i identifying a tendon to be repaired; ii identifying a muscle associated with that tendon and treating that muscle with a predetermined dose of a neurotoxin sufficient to effectively cause temporary paralysis of the muscle; and iii allowing a sufficient period of time to elapse to enable said temporary paralysis of the muscle to set in prior to conducting surgery in order to repair said tendon.
  • the neurotoxin to be a slow acting neurotoxin, in particular, botulinum toxin, in which case the said sufficient period of time indicated in step iii is preferably of the order of 7 to 21 days and usually about 7-14 days and, in such an instance, for no additional doses of neurotoxin to be administered as envisaged in step v indicated above in the instance of the surgical method; for the degree of paralysis of the muscle to be tested immediately prior to performing the repair surgery, typically using a nerve stimulator; and for the results of the test for the degree of paralysis to be used as the basis for a decision on whether or not a particular patient will require any immobilisation post operatively.
  • the said sufficient period of time indicated in step iii is preferably of the order of 7 to 21 days and usually about 7-14 days and, in such an instance, for no additional doses of neurotoxin to be administered as envisaged in step v indicated above in the instance of the surgical method; for the degree of paralysis of the muscle to be tested immediately prior to performing the repair
  • One particularly important application of the present invention is to the repair of rotator cuff tendons in which case a tear to be repaired is generally of the tendon or tendons associated with the supraspinatus or infraspinatus muscles, or both, and in any event both of these muscles are preferably subjected to temporary paralysis preparatory to conducting the surgery irrespective of the fact that only the tendon associated with one of them is to be repaired.
  • the reason for this is that even if only one of them is repaired, the other one could still contract and exert tension on the repair site as they are very close to each other and movement of one also generally causes motion of the tendon of the other.
  • a medical package comprising at least one dose of a neurotoxin in association with information indicating or describing its use in a method as defined above.
  • the invention is thus also directed at a neurotoxin for use in a method as defined above.
  • the overall effect of the invention is thus to temporarily paralyse the muscle of a repaired tendon thereby preventing its contraction with consequent pain to the patient; possible further muscular contractions following on the experiencing of pain; and the possibility of the repair being disturbed and possibly deleteriously affected.
  • Figure 1 illustrates, schematically, the anatomy of a shoulder generally from the front thereof;
  • Figure 2 illustrates, schematically, a shoulder generally from the front thereof and wherein a tear of the supraspinatus tendon is to be repaired and indicates one injection being instilled into one site in the supraspinatus muscle;
  • Figure 3 illustrates the shoulder from the rear thereof and illustrates tears of both the supraspinatus and infraspinatus tendons of the affected shoulder and indicates one injection being instilled into one site in each of the supraspinatus and infraspinatus muscles;
  • Figure 4 is similar to Figure 1 but illustrates a repair having been performed on the supraspinatus tendon;
  • Figure 5 illustrates, schematically, a shoulder generally from the front thereof and shows a preferred technique of injecting the supraspinatus muscle in multiple sites to ensure adequate paralysis; and,
  • Figure 6 illustrates, schematically, a shoulder generally from the rear thereof and shows the preferred technique of injecting both the supraspinatus muscle and the infraspinatus muscle in multiple sites.
  • a patient having a tear (1) in the tendon (2) attaching the supraspinatus muscle (3) to the greater tuberosity (4) of the shoulder (5) is treated according to the invention.
  • a patient has a tear (6) in the tendon (7) attaching the infraspinatus muscle (8) to the greater tuberosity of the shoulder as well, or in the alternative.
  • Such a tear is illustrated in Figure 3.
  • both of the supraspinatus and infraspinatus muscles (3) and (7) of the affected shoulder (5) are treated with neurotoxin, in this case botulinum toxin type A that is sold under the trade name BOTOXTM by the American company Allergan Sales lnc of California.
  • This treatment is scheduled suitably in advance of the planned surgery and typically between 7 and 21 days in advance, and most typically from 10 to 14 days in advance of the surgery.
  • Two vials of Botulinum toxin type A of 100 units each are used.
  • One vial is used to treat the supraspinatus muscle and one vial to treat the infraspinatus muscle.
  • Each vial is diluted to a total volume of 3.5 ml (about 0.21 cubic inches) with 0,9 % saline solution.
  • These doses are required to ensure a complete paralysis of the muscles. This is considered to be safe as there are no other vital muscles in the immediate vicinity that may be endangered by the injections.
  • the positioning of the injections is selected with the aim of optimising the effect of the neurotoxin to effectively paralyse the muscle without affecting any other muscles.
  • the dose indicated above applies to an average adult having an average size of supraspinatus and infraspinatus muscles and could be varied according to muscle size in instances in which a significant deviation exists.
  • the injection technique is preferably as follows and is indicated by numeral (11) in Figures 2 and 3 as a single injection site in respect of each muscle, simply to indicate the application of the invention.
  • the diffusion of the neurotoxin into the muscle would generally be expected to be too slow to be effective from a single injection site.
  • Multiple injection sites (12) as described hereinafter and illustrated in Figures 5 and 6 would thus undoubtedly be used in the absence of any special technique of enhancing diffusion into the entire muscle from a single injection site.
  • Trials conducted to date indicate that typically four injection sites would be appropriate to each of the muscles although more or less may be employed according to advancing experience as time goes by.
  • the injection procedure can be done with the patient either in a sitting or lateral lying position on the unaffected side.
  • the supraspinatus and infraspinatus muscles are injected with the botulinum toxin with a needle (10) having a minimum length of 35 mm and a thickness typically between 26 and 30 Gauge. These muscles are easily palpated above and below the spine of the scapula (the bony prominence on the back of the scapula). Cognisance must be taken of the fact that other muscles are more superficial than the supraspinatus and infraspinatus muscles.
  • the trapezius muscle is superficial to the supraspinatus muscle and the deltoid muscle is superficial to the infraspinatus muscle.
  • the first method may generally be considered to be suitable if there is no availability of special equipment such as EMG (electromyography) or ultrasound to localize the target muscle.
  • EMG electromyography
  • ultrasound to localize the target muscle.
  • a 26 Gauge or thinner needle with a minimum length of 35 mm (about 1 3 / 8 inches) is used.
  • the spine of the scapula is palpated and approximately halfway down the spine a line is drawn perpendicular to the spine in the anterior direction. Measuring 2 cm (about 3 / 4 inch) from the spine, a point on the skin is marked. This is then used as the entry point.
  • the needle is penetrated through the skin, perpendicular to the skin surface, until the bone that forms the bottom of the supraspinatus fossa is reached. This step is necessary to make sure that the needle is not too superficial, and therefore avoids accidental injection of the more superficial Trapezius muscle.
  • the needle is then retracted for approximately 1 cm and the first deposit of neurotoxin is administered (+/- 0.2 ml or 0.0012 cubic inches). From this point the technique described above is repeated with administering deposits in a fanwise manner, to ensure that the complete supraspinatus muscle belly has been injected with a total of 3,5 ml (about 0.21 cubic inches) neurotoxin solution.
  • a similar technique may be used to inject the infraspinatus muscle.
  • the entry point for the needle is approximately halfway down the spine of the scapula and 3 cm (about 1 V 4 inches down).
  • the needle is inserted perpendicular to the skin and pushed down to the bone.
  • the needle is retracted 1 cm and the first deposit of neurotoxin solution is injected (+/- 0.2 ml or 0.0012 cubic inches).
  • the complete infraspinatus muscle belly is injected using a total of 3,5 ml (about 0.21 cubic inches) neurotoxin solution (100 units of neurotoxin).
  • the target muscles may be identified with a 3.5 Mhz angular transducer.
  • the muscle is then injected using the technique described above.
  • the injection of the neurotoxin solution can be observed on the ultrasound monitor.
  • EMG electromyography
  • the clinical effect of the botulinum toxin is generally noticeable after 48 hours, and has its maximum effect between 1 and 4 weeks after the injection.
  • the surgery is typically scheduled for approximately 1-2 weeks after the injection treatment. In this application the surgery is carried out by way of arthroscopy or open surgery.
  • the surgical procedure is usually done under general anaesthesia and involves the following.
  • a conduction needle is placed in the muscle belly of the supraspinatus and infraspinatus and stimulated to record muscle contraction.
  • nerve stimulators are standard equipment in operating theatres as they are routinely used by anaesthetists.
  • the needle is then directed to the suprascapular notch, where the suprascapular nerve is located, and the nerve is stimulated while the muscles are directly viewed with the artroscope. The presence and degree of contraction is recorded.
  • the patient will generally not have to wear an immobilisation sling and is allowed to move the shoulder freely.
  • the patient will then be examined postoperatively according to a standard follow-up schedule that typically includes a 3 week and 6 week postoperative check.
  • the benefits to patients suffering muscle and tendon ruptures requiring surgical repair by employing the invention are as follows: 1. During the pre-operative period there is excellent pain relief due to the relaxation/paralysis of the injured muscle/tendon.
  • the patient is not immobilised as he or she cannot inadvertently contract the repaired muscle/tendon
  • the most important benefit is that the repaired structure is substantially immobilised by temporary selective paralysis, therefore preventing inadvertent contraction and disrupting the repair; a not infrequent occurrence.

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Prostheses (AREA)

Abstract

La présente invention a trait à un procédé de réparation de tendons (2, 7) par la chirurgie, et à un procédé pour la préparation d'un patient pour une telle chirurgie, dans lequel le muscle (3, 8) associé au tendon à réparer est traité avec une dose prédéterminée de neurotoxine, typiquement de toxine botulinique, suffisante pour entraîner une paralysie temporaire du muscle. Tout autre muscle lié inextricablement à ce tendon peut également être soumis à une paralysie temporaire. On accorde une période de temps suffisante pour permettre à ladite paralysie temporaire du muscle ou des muscles de s'établir préalablement à la réalisation de la chirurgie de réparation requise sur le tendon concerné de manière sensiblement classique. La paralysie temporaire du ou des muscles concernés élimine la nécessité d'immobilisation postopératoire, typiquement par une attelle ou un plâtre, et assure l'incapacité du patient à contracter les muscles concernés lors de la rééducation entraînant un effet nuisible à la réparation. L'invention a également trait à une trousse médicale et de neurotoxine destinée à être utilisée dans un tel procédé.
PCT/IB2006/001424 2005-05-31 2006-05-31 Procede et trousse medicale pour la reparation de tendons par la chirurgie Ceased WO2006129171A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA2005/04424 2005-05-31
ZA200504424 2005-05-31

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Publication Number Publication Date
WO2006129171A2 true WO2006129171A2 (fr) 2006-12-07
WO2006129171A3 WO2006129171A3 (fr) 2007-03-29

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Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5366465A (en) * 1992-12-07 1994-11-22 M. Ather Mirza Endoscopic surgical procedure and instrument for implementation thereof
US20030004495A1 (en) * 1996-07-11 2003-01-02 Eunoe, Inc. Apparatus and methods for volumetric CSF removal
US6423319B1 (en) * 2000-10-04 2002-07-23 Allergan Sales, Inc. Methods for treating muscle injuries

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Publication number Publication date
WO2006129171A3 (fr) 2007-03-29

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