The present invention relates to the general field of closure apparatuses and is particularly concerned with an apparatus suitable for binding together two biological tissue portions with a binding component.
There is a need in many medical interventions to bind together two biological tissue portions so that they can be attached to each other temporarily until they bind together through biological healing processes. For example, when performing thoracic surgery, there is a need to re-attach together two sternum halves until the fracture healing process binds them together.
Because of the relatively large forces that must be exerted in many instances onto a binding component that attaches to each other the two biological tissue portions, a specialized apparatus is often used to apply the required force. However, many currently used apparatuses require that the surgeon use both hands to apply the proper force to the binding component. Therefore, the surgeon is unable to use the other hand to guide the apparatus or perform other tasks while the prior art apparatuses are used. In addition, it often happens that the binding component is fixed to the sternum or any other two biological tissue portions using a crimp component that must be crimped to the binding component. In many cases, there is no single apparatus that allows to both apply the proper tension onto the binding component and to crimp the crimped component to the binding component.
Accordingly, against this background, there exists a need for an improved closure apparatus.
In a first broad aspect, the invention provides an apparatus for binding together two biological tissue portions with a binding component. The binding component has a substantially elongated configuration and defines substantially opposed binding component first and second end sections and a binding component middle section extending therebetween. The binding component is securable around the two biological tissue portions with a crimp component. The apparatus is usable by an intended user having first and second hands. The apparatus includes a body defining a body handle for receiving one of the first and second hands; at least one drum rotatably mounted to the body, the at least one drum including a binding component attachment for attaching the binding component first end section thereto; a drum actuating lever mounted to the body, the drum actuating lever being movable between a drum actuating lever first position and a drum actuating lever second position, the drum actuating lever being operatively coupled to the at least one drum for rotating the at least one drum in a predetermined direction when the drum actuating lever is moved from the drum actuating lever first position to the drum actuating lever second position; and a crimping assembly operatively coupled to the body for holding the crimp component and selectively crimping the crimp component to the binding component middle section. The body handle, the drum actuating lever and the crimping assembly are configured, sized and positioned in a manner such that the intended user is able to tighten the binding component around the at least one drum by moving the drum actuating lever between the drum actuating lever first and second positions using the first hand; and the intended user is able to operate the crimping assembly to selectively crimp the crimp component to the binding component middle section using the second hand.
Advantageously, the intended user is able to tighten the binding component around the at least one drum using a single hand, which frees the other hand to perform other tasks and operations. In addition to allowing the intended user to use the second hand to crimp the crimp component to the binding component at a suitable moment during the operation of the proposed apparatus, the intended user may also use the other hand to guide the position of the crimping assembly so as to suitably position the crimp component relatively to the two biological tissue portions and relatively to the binding component to optimize the position of the crimp component. In addition, the second hand may also be used for any other purposes such as, for example, guiding adjacent pieces of biological tissues away from the binding component when tightening the binding component, removing blood from the site at which the crimp component is positioned and any other suitable operation that helps the intended user in performing the binding of the two biological tissue portions to each other rapidly, ergonomically and safely. Therefore, the other hand is usable to enhance the safety of the procedure performed using the proposed apparatus.
In some embodiments of the invention, a clutch is provided for limiting a torque that the drum may exert onto the binding component. In turn, this ensures that excessive pressure is not exerted onto the two biological tissue portions, which facilitates healing. In some embodiments of the invention, the binding component used with the proposed apparatus includes a shape-memory alloy and the clutch is therefore, in these embodiments, advantageous in allowing the intended user to tighten the binding component with a force that remains below a damage threshold at which the force exerted onto the binding component would permanently damage the binding component.
The proposed apparatus is manufacturable using known components and methods at relatively low costs. Furthermore, the proposed apparatus is manufacturable using materials that are relatively easily sterilizable. Yet, furthermore, the proposed apparatus is usable using a relatively small number of quick and ergonomic steps.
An embodiment of the present invention will now be disclosed, by way of example, in reference to the following drawings in which:
Referring to
Returning to
The apparatus 10 also includes a drum actuating lever 34 mounted to the body 26. The drum actuating lever 34 is movable between a drum actuating lever first position, shown in full lines in
The apparatus 10 also includes a crimping assembly 36 operatively coupled to the body 26 for holding the crimp component 24 and selectively crimping the crimp component 24 to the binding component 16 in the binding component middle section 22.
The body handle 28, the drum actuating lever 34 and the crimping assembly 36 are configured, sized and positioned in a manner such that the intended user is able to tighten the binding component 16 around the at least one drum 30 by moving the drum actuating lever 34 between the drum actuating lever first and second positions using a first hand and to operate the crimping assembly 36 to selectively crimp the crimp component 24 to the binding component middle section 22 using the second hand.
In addition to the body handle 28, the body 26 defines a body central section 38 from which the body handle 28 extends and a crimping assembly spacing segment 40 extending from the body central section 38. Typically, the crimping assembly spacing segment 40 is angled relatively to the body handle 28. For example, it has been found that having a crimping assembly spacing segment 40 that extends substantially perpendicularly to the body handle 28 provides good ergonomics to the apparatus 10 as it facilitates positioning of the crimp component 24 relatively to the two biological tissue portions 12 and 14 while facilitating handling of the apparatus 10 and crimping of the crimp component 24 to the binding component 16.
The body handle 28 has a substantially elongated configuration and defines a handle first surface 42 and a substantially opposed handle second surface 44. Handle lateral surfaces 46 and 48 (only one of which is shown in
Typically, the body central section 38 defines a central section cavity 50, shown in
The crimping assembly spacing segment 40 is also substantially elongated and typically defines a pin 52 extending substantially adjacent to the crimping assembly 36. The pin 52 is described in further details hereinbelow.
As shown for example in
The drum actuating lever 34 is pivotally attached to the body 26 substantially adjacent the handle second surface 44. Typically, the drum actuating lever 34 is pivotally attached to the body 26 so as to pivot substantially perpendicularly to the handle second surface 44 when moving between the drum actuating lever first and second positions.
For example, the drum actuating lever 34 defines a drum actuating lever proximal end 54 and a substantially opposed drum actuating lever distal end 56. The drum actuating lever 34 is pivotally attached to the body 26 substantially adjacent the drum actuating lever distal end 56. The drum actuating lever proximal end 54 is typically closer to the handle second surface 44 when the drum actuating lever is in the drum actuating lever second position than when the drum actuating lever 34 is in the drum actuating lever first position. Typically, the drum actuating lever 34 is pivotally attached to the body 26 so as to extend substantially parallel to the body handle 28 when the drum actuating lever is in one of the drum actuating lever first and second positions, and typically in the drum actuating lever second position. This specific configuration enhances the range of motion through which the drum actuating lever 34 may be operated to tighten the binding component 16 using a single hand and facilitates operation and application of a force by the intended user with a single hand so as to optimize force transfer between the hand and the binding component 16.
A drum actuating lever mounting axle 58 extends from the drum actuating lever 34 substantially perpendicularly to a direction leading from the drum actuating lever proximal end 54 and to the drum actuating lever distal end 56 and extends substantially adjacent the drum actuating lever distal end 56. The drum actuating lever 34 pivots between the actuating lever first and second positions by rotating about the drum actuating lever mounting axle 58. As seen in
In some embodiments of the invention, the roller clutch 62 allows the drum actuating lever 34 to move substantially freely from the drum actuating lever second position to the drum actuating lever first position. When the apparatus 10 is used with the handle second surface 44 facing generally downwardly, this movement of the drum actuating lever 34 is performed under the action of gravity, which facilitates the operation of the drum actuating lever 34 with a single hand.
Referring to
More specifically, this is achieved by having a power transmission mechanism 64 that includes a toothed gear 66 engaging the toothed gear 60 that is coupled to the drum actuating lever 34 for transmitting a rotational motion of the toothed gear 60 to the toothed gear 66. In addition, the power transmission mechanism 64 includes a power transmitting axle 68 for transmitting a rotational motion of the toothed gear 66 to the drums 30. The power transmitting axle 68 is rotatably mounted inside the central section cavity 50 and protrudes laterally therefrom. Each of the drums 30 is mechanically coupled to the power transmitting axle 68 for joint rotation therewith.
A torque limiting clutch 70 and another roller clutch 72 are operatively coupled to the toothed gear 66 and to the power transmitting axle 68 for preventing the power transmitting axle 68 from rotating when a maximal torque has been applied thereto and for only allowing movement of the power transmitting axle 68 in a single direction corresponding to the predetermined direction in which the drums 30 are allowed to rotate. The roller clutches 62 and 72 are configured such that the toothed gears 60 and 66 can rotate in opposite directions.
Roller clutches 62 and 72 and the torque limiting clutch 70 are components that are well known in the art and the specific arrangement used in the apparatus 10 is therefore not described in further details. In addition, in alternative embodiments of the invention, any other suitable components performing similar functions are used instead of the roller clutches 62 and 72 and the torque limiting clutch 70.
Referring to
In this specific example, the binding component attachment 32 includes an attachment first member 76 and an attachment second member 78. The attachment first and second members 76 and 78 are operatively coupled to the drum body 74 in a manner such that the binding component attachment 32 is configurable between an attachment opened configuration, shown in
In a specific example of implementation, the attachment first member 76 is substantially annular and substantially eccentrically pivotally attached to the drum body 74 through a first member pivot 80. The attachment first member 76 defines a first member peripheral surface 82 and two substantially opposed first member lateral surfaces 84 and 86, only one of which is shown in
The attachment second member 78 is fixed relatively to the drum body 74. Typically, the attachment second member 78 extends integrally from the drum body 74 and is configured and located so that the first member peripheral surface 82 is partially substantially in register therewith.
A pin 90 extends from the drum body 74 through the first member aperture 88. Typically, the pin 90 is co-axial with the power transmitting axle 68. A biasing element in the form of a coil spring 92 biases the attachment first and second members 76 and 78 towards the attachment closed configuration. The coil spring 92 defines a coil spring first end 94 and a coil spring second end 96. The coil spring first and second ends 94 and 96 are secured to the attachment first member 76 with the coil spring 92 wrapping at least partially around the pin 90. The coil spring first and second ends 94 and 96 are located further away from the attachment second member 78 than the pin 90. In this configuration, the coil spring 92 therefore wraps around the pin 90 in a substantially U-shaped configuration. However, in alternative embodiments of the invention the attachment first and second members 76 and 78 are biased towards the attachment closed configuration in any other suitable manner.
In some embodiments of the invention, the attachment first member 76 defines a first member flange 98 extending substantially radially outwardly therefrom substantially adjacent the first member lateral surface 84. The first member flange 98 guides the binding component 16 as it is rolled around the drum 30. The first member flange 98 extends along an arc segment and is located substantially opposed to the attachment second member 78. Typically, the first member flange 98 is absent from locations adjacent the attachment second member 78 to facilitate insertion of the binding component 16 between the attachment first and second members 76 and 78.
Referring to
Typically, the jaws 100 and 102 include a fixed a jaw, for example the jaw 100, and a mobile jaw, for example the jaw 102. Referring to
The mobile jaw 102 defines a mobile jaw proximal end 112 and a substantially opposed mobile jaw distal end 114. The mobile jaw 102 is pivotally attached to the fixed jaw 100 with the fixed jaw and mobile jaw distal ends 110 and 114 substantially adjacent to each other. For example, this is performed by having a fixed jaw 100 that defines a pin 116 extending generally parallel to the power transmitting axle 68 (not seen in
In some embodiments of the invention, the mobile jaw 102 defines a biasing component attachment aperture 120 at a location intermediate the mobile jaw proximal and distal ends 112 and 114, the biasing component attachment aperture 120 being usable for attaching a biasing component 122 to the mobile jaw 102 as described in further details hereinbelow.
Having a fixed jaw 100 and a mobile jaw 102, as opposed to having two mobile jaws, contributes to the ease of use of the apparatus 10 and facilitates positioning of the crimp component 24 relatively to the two portions of biological tissues 12 and 14 that need to be bound to each other. Also, this configuration facilitates the maintenance of the position of the crimp component 24 when the crimp component 24 is crimped to the binding component 16. However, in alternative embodiments of the invention, both of the jaws 100 and 102 are mobile relatively to the body 26.
A specific configuration of the crimp actuator 106 is described hereinbelow. In this specific configuration, the crimp actuator 106 includes a crimp handle 124 mechanically coupled to the body 26 and a crimp actuating lever 126 located substantially adjacent to the crimp handle 124. The crimp actuating lever 126 is movable between a crimp actuating lever first position and a crimp actuating lever second position. The crimp actuating lever 126 is operatively coupled to the jaws 100 and 102 in a manner such that the jaw 100 and 102 are in the jaw opened configuration when the crimp actuating lever 126 is in the crimp actuating lever first position, shown in
When the crimping assembly 36 is in use, the intended user, (not shown in the drawings), exerts an input force onto the crimping assembly 36 to crimp the crimp component 24 to the binding component 16. In some embodiments of the invention, the manner in which the input force is transmitted to the jaws 100 and 102 is adjustable by having the crimp actuator 106 that is configurable between a crimp actuator low leverage configuration, seen in
The crimp actuator 106 is operatively coupled to the pair of jaws 100 and 102 in a manner such that a larger force is exerted by the crimp actuator onto the jaws 100 and 102 when moving the jaws 100 and 102 from the jaw opened configuration to the jaw closed configuration with the input force when the crimp actuator 106 is in the crimp actuator high leverage configuration than when the crimp actuator 106 is in the crimp actuator low leverage configuration.
The functional characteristics of the crimping assembly 36 described hereinabove are achieved, for example, using the following configuration of the crimping assembly 36. The crimp handle 124 defines a crimp handle proximal end 128 and a crimp handle distal end 130. The crimp handle 124 is attached to the crimping assembly spacing segment 40 substantially adjacent the crimp handle distal end 130 in a substantially space apart relationship relatively to the fixed jaw 100.
For example, the crimp handle extends at an angle of from about 20 to about 40 degrees relatively to the body handle 28. It has been found that this configuration enhances the ergonomics of the apparatus 10 as it facilitates operation of the apparatus 10 by the intended user with one hand remaining on the body handle 28 (not shown in
The crimp handle 124 further defines a handle aperture 136 extending substantially longitudinally between the link receiving recess 132 and the crimp handle proximal end 128. The handle aperture 136 is threaded and receives a bolt 138 that is threadably inserted thereinto for movement between a bolt first position, seen in
The crimp actuating lever 126 defines a crimp actuating lever proximal end 140 and a substantially opposed crimp actuating lever distal end 142. The crimp actuating lever 126 is pivotally attached to the mobile jaw 102 with a crimp actuating lever-to-jaw pivot 144. The crimp actuating lever-to-jaw pivot 144 is located substantially adjacent to the crimp actuating lever distal end 142 and to the mobile jaw proximal end 112.
The crimp actuator link 134 extends between the crimp actuating lever 126 and the crimp handle 124. The crimp actuator link 134 is pivotally mounted to both the crimp handle 124 and the crimp actuating lever 126. The crimp actuator link 134 is pivotally mounted to the crimp actuating lever 126 at a location intermediate the crimp actuating lever distal and proximal ends 142 and 140. The crimp actuator link 134 is received inside the link receiving recess 132 and abuts against and is biased towards the bolt 138. Therefore, the crimp actuator link 134 is mounted to the crimp handle 124 so that an end section thereof is selectively movable substantially longitudinally therealong. This movement allows an achievement of the crimp actuator high and low leverage configurations when the bolt 138 is moved in the handle aperture 136.
Referring to
As seen in
The method schematically illustrated in
Afterwards, the intended user uses a hand to repetitively move the drum actuating lever 34 from the drum actuating lever first position to the drum actuating lever second position and, in between each of these moves, release the drum actuating lever 34 which, under the action of gravity, moves back to the drum actuating lever first position. This has for effect to repetitively move the drums 30 in the predetermined direction until a maximal torque is achieved.
Then, the intended user may use the crimping assembly 36 to crimp the crimp component 24 to the binding component 16 by moving the crimp actuating lever 126 towards the crimp actuating lever second position, thereby exerting a force pushing the mobile jaw 102 towards the fixed jaw 100. If desired, before this operation is performed, the bolt 138 may be moved in and out of the link receiving recess 132 so that a desired leverage effect is achieved from the crimp actuator link 134 to adjust the force with which the crimp component 24 is crimped to the binding component 16. Afterwards, the crimp actuating lever 126 is released, which opens the jaws 100 and 102 and allows removal of the apparatus 10 from the site of operation after the free ends of the binding component 16 have been cut off.
As seen in
Although the present invention has been described hereinabove by way of preferred embodiments thereof, it can be modified without departing from the spirit, scope and nature of the subject invention, as defined in the appended claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/CA2007/002361 | 12/24/2007 | WO | 00 | 6/24/2009 |
Number | Date | Country | |
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60876993 | Dec 2006 | US |