Patent ID: 12256924

DETAILED DESCRIPTION OF THE INVENTION

FIG.1shows schematically an embodiment of a surgical apparatus of the invention. The surgical apparatus is generally indicated by reference numeral1.FIG.2shows the distal end of the surgical apparatus in more detail.

The surgical apparatus1comprises a first jaw element2and a second jaw element3. The first jaw element2comprises a first needle holder4configured to hold a needle end of a needle100, and the second jaw element3comprises a second needle holder5configured to hold an opposite needle end of the needle100.

The surgical apparatus1is configured to pass a double-ended surgical needle100forwards and backwards so that the surgical apparatus can be used to apply sutures to human or animal body tissue. The surgical apparatus1may be made of any suitable material such as a (non-toxic and/or biocompatible) plastic or metal, or combinations thereof.

The proximal ends of the first jaw element2and the second jaw element3are connected to each other at a proximal end6of the apparatus1.

The first jaw element2and the second jaw element3are movable with respect to each other between a take-over position, in which the surgical needle100can be taken over between the first needle holder4and the second needle holder5, and an open position, in which the first needle holder4and the second needle holder5are spaced further from each other. InFIG.1, the surgical apparatus1is shown in the open position. In this open position, body tissue can be placed between the needle100and the one of the first jaw element2and the second jaw element3that does not hold the needle100.

Between the first jaw element2and the second jaw element3, a main body7of the surgical apparatus is provided. In this main body7, an operating device8is arranged, which operating device8is configured to operate the first needle holder4and the second needle holder5, to alternately hold the first needle end of the needle100by the first needle holder4and the second needle end by the second needle holder5.

The surgical suture apparatus1may, unless otherwise described an/or shown in this patent application, be constructed as described and shown in WO 2017/155406, the contents of which is herein incorporated by reference, in its entirety.

FIG.1shows the suture apparatus1in the normal, non-actuated state of the apparatus. The first jaw element2and the second jaw element3are arranged in the open position. A first needle end of the needle100is held by the first needle holder4and the second needle holder5is spaced from the opposite second needle end. In this non-actuated position of the apparatus, the needle100can be pierced through body tissue to place a suture using a suture attached to the needle100.

When the needle100is correctly placed through tissue, the first jaw element2and the second jaw element3may be moved from the open position to the take-over position, by exerting a pinching force, for example with a thumb and a finger on a first operating surface29on the first jaw element2and a second operating surface30on the second jaw element3, respectively. In the take-over position, the first needle end is still held by the first needle holder4, and the second needle end is arranged in the second needle holder5.

In the take-over position, it can still be checked whether the needle100is correctly placed in the tissue. When correction of the placement of the needle is desired the pinching force on the first operating surface29and the second operating surface30can be released, and the first jaw element2and the second jaw element3will move back to the open position. When no correction of the placement of the needle100is desired, the operating device8can be activated to release the first needle end in the first needle holder4and simultaneously lock the second needle end in the second needle holder5.

To activate the operating device8, the first jaw element2and the second jaw element3can be moved in an activation movement from the take-over position towards each other. It is remarked that only the middle parts of the first jaw element2and the second jaw element3, i.e. at the location of the first operating surface29and the second operating surface30, will move towards each other during the activation movement, since the proximal ends of the first jaw element2and the second jaw element3are connected to each other, and the needle100prevents further movement of the distal ends of the first jaw element2and the second jaw element3towards each other.

This means that the needle100is used, during the activation movement, as a hinge for rotation of the first jaw element2and the second jaw element3. Furthermore, the activation movement requires bending of the first jaw element2and the second jaw element3in order to move the first operating surface29and the second operating surface30towards each other. To facilitate bending of the first jaw element2and the second jaw element3, the first jaw element2and the second jaw element3may be provided with flexible portions31(seeFIG.1) near the proximal end6of the apparatus1, but the first jaw element2and the second jaw element3are also configured to bend over other parts of their extension to allow the first operating surface29and the second operating surface30to move from the take-over position towards each other.

When the first jaw element2and the second jaw element3are released, the first jaw element2and the second jaw element3will move back to the open position as shown inFIG.1, but the needle is now held by the second needle holder5.

When the first jaw element2and the second jaw element3are now again moved from the open position to the take-over position, and subsequently at least partly further towards each other in the activation movement, the operating device8will again be activated to release the second needle end in the second needle holder5and simultaneously lock the first needle end in the first needle holder4.

It will be clear that by subsequent further actuation of the apparatus1, the needle can be passed forwards and backwards between the first needle holder4and the second needle holder5to apply a suture through the tissue.

FIG.3shows a needle-suture combination101according to the embodiment of the invention that is configured to be used in the embodiment of the surgical apparatus ofFIGS.1and2.

The needle-suture combination101comprises a needle100and a suture150. The suture150comprises a connection loop151, a suture thread152, only partly shown, and a connector153connecting the suture thread152to the connection loop151. The connection loop151is made of a wire or thread having a smaller diameter than the suture thread152.

The needle100comprises a straight needle body102having a first needle end103and a second needle end104. Midway between the first needle end103and the second needle end104, a through-going hole109is provided through which the connection loop151of the suture150is arranged to connect the suture150to the needle100.

Each of the first needle end103and the second needle end104comprises a needle point105, a needle end stop surface106and a circumferential locking groove107.

The needle point105is a pointed end of the needle100that can be used to pierce tissue or other material through which the suture150should be arranged.

The needle end stop surface106is arranged to cooperate with a needle channel stop surface of a needle channel of a needle holder4,5(seeFIGS.5and6). By providing a specific needle end stop surface106on the needle100, separate from the needle point105, to cooperate with the needle channel stop surface of a needle holder, the contact between the needle end stop surface106and the needle channel stop surface can be optimized for rotation of the first jaw element2and the second jaw element3about the respective needle ends103,104. This rotation is required for the activation movement of the operating device8.

Since the needle end stop surface106is arranged to provide a contact between the needle100and the needle channel to facilitate rotation of the first jaw element2and the second jaw element3about the respective needle ends103,104, the needle point105is no longer needed to provide an engagement between the needle100and the associated needle channel. As a result, the needle point105of each of the first needle end103and the second needle end104may be optimized for piercing of tissue.

The circumferential locking groove107is a groove that extends over the whole circumference of the needle body102. This locking groove107is provided to receive a needle locking element of a needle holder to lock the needle100in a needle channel of the needle holder4,5.

The needle body102has a diameter of about 0.4 mm. the needle body may also have any other suitable diameter. The total length of the needle100is for example approximately 10 mm. The length of the needle may be in the range of 7 mm to 12 mm. The needle100may be made of any suitable material, such as stainless steel.

FIG.4shows the first needle end103in more detail. The second needle end104has the same construction and dimensions.

The needle point105comprises a substantially conical needle point surface extending at a first acute angle α with respect to a longitudinal axis110of the needle. The needle end stop surface106is also a substantially conical surface at a second acute angle β with respect to the longitudinal axis110of the needle. The first acute angle α is larger than the second acute angle β. It is advantageous for rotation of the first jaw element4and the second jaw5about the first needle end103and the second needle end104, when the needle end stop surface is more parallel to the longitudinal axis110of the needle than the needle point surface108of the needle point105.

In the embodiment shown inFIGS.3and4, the first acute angle α of the needle point surface is approximately 26 degrees with respect to the longitudinal axis110of the needle100, and the second acute angle β of the conical surface of the needle end stop surface106is approximately 11 degrees with respect to the longitudinal axis110of the needle100.

More generally, the first acute angle α may be in the range of 15 to 40 degrees with respect to the longitudinal axis110of the needle100, for example in the range of 20 to 30 degrees with respect to the longitudinal axis110of the needle100, and the second acute angle β of the needle end stop surface106may be in the range of 5 to 20 degrees with respect to the longitudinal 110 axis of the needle100, for example in the range of 8 to 15 degrees with respect to the longitudinal axis110of the needle100.

The first needle holder4and the second needle holder5of the surgical suture apparatus1ofFIGS.1and2are designed to cooperate with the needle100shown inFIGS.3and4.

FIG.5shows a cross section of the needle holder4. The needle holder4comprises a needle channel10arranged to receive the first needle end103or the second needle end104of the needle100. The needle channel10comprises an inlet11to introduce the first needle end103or the second needle end104into the needle channel10.

At the inlet11of the needle channel10an alignment funnel13is arranged. This alignment funnel13is provided to align the needle100with the needle channel10when the needle100is introduced into the needle channel10. The alignment funnel13comprises a funnel surface14at an acute funnel surface angle γ with respect to a longitudinal axis15of the needle channel10. The acute funnel surface angle γ may be substantially the same as or smaller than the first acute angle α of the needle point surface of the needle point10.

When the needle100is not perfectly aligned with the needle channel10when being introduced into the needle channel10, i.e. when the longitudinal axis110of the needle does not correspond with the longitudinal axis15of the needle channel10, the funnel surface14will guide the first needle end103or the second needle end104being pushed against this funnel surface14towards the needle channel10. This guidance will ensure that the needle100will be properly aligned with the needle channel10to enter the needle channel10. By making the acute funnel surface angle γ approximately the same or smaller than the first acute angle α of the needle, it is prevented that the needle point105of the needle100will pierce into the funnel surface14and prevent further movement of the first jaw element2and the second jaw element3to the take-over position, and/or will damage the funnel surface14.

The wide end of the alignment funnel13for example has a cross section with a diameter of at least two times the needle diameter, for instance at least three times the needle diameter.

It is remarked thatFIG.2shows a perspective view of the inlet11and the alignment funnel13of the second needle holder5.

The needle channel10comprises a needle holding part16having a first diameter and a tissue receipt channel part17between the needle holding part16and the inlet11of the needle channel10.

The tissue receipt channel part17has a second diameter larger than the first diameter of the needle holding part16. In the shown embodiment, the first diameter of the needle holding part16is approximately 0.4 mm, i.e. about the same as the diameter of the needle100, and the second diameter is approximately 0.6 mm. As a result, the second diameter is approximately 1.5 times the first diameter. The length of the tissue receipt channel part17is approximately 1 mm. Thus, the length of the tissue receipt channel part17is approximately 1.7 times the second diameter of the tissue receipt channel part17. Since the second diameter is larger than the diameter of the needle100, a circumferential space (see alsoFIG.6) will be formed around the needle in the tissue receipt channel part17, when the needle100is placed in the needle channel10. This circumferential space can be used to receive tissue that is pulled into the needle channel10together with the needle100. By providing the circumferential space, it is avoided that the needle100and/or the tissue is clamped or jammed in the needle channel. Clamping or jamming of the needle100may result in incorrect take-over of the needle100. Clamping or jamming of tissue may lead to tissue damage when the surgeon pulls away the surgical suture apparatus1while the tissue is still held by the surgical suture apparatus1.

It has been found that the above dimensions of the tissue receipt channel part17are suitable to receive tissue within the tissue receipt channel part17without being clamped or jammed in the needle channel10, but also prevent further entry of tissue into the needle channel10, in particular into the needle holding part16. This ensures proper functioning of the suture apparatus1and avoids damage to tissue by inadvertently pulling tissue that is held by the respective needle holder3,4.

The needle holding part16of the needle channel10is configured to actually hold the needle100. The needle holding part16comprises a needle channel stop surface18configure to cooperate with the needle end stop surface106of the needle100. The needle channel stop surface18is a conical surface arranged at an acute angle θ with respect to the longitudinal axis of the needle channel15that substantially corresponds to the second acute angle β of the needle end stop surface106. Thus, when the needle100is brought into the needle channel10, the needle end stop surface106and the needle channel stop surface18will be placed against each other and cooperate with each other to form a bearing structure that allows some movement of the needle channel stop surface18with respect to the needle end stop surface106to facilitate rotational movement of the first jaw element2and the second jaw element3of the surgical suture apparatus1about the respective needle ends103,104.

The needle channel10further comprises a channel end part19that is arranged at the smaller side of the conical needle channel stop surface18. The channel end part19is arranged to receive the needle point105when a needle100is introduced into the needle channel10such that the needle point will not come into contact with the wall of the needle channel10, once arranged in the needle channel10. This avoids that the shape or surface of the needle point105will get damaged due to pressures exerted by wall of the needle channel10on the needle100. The channel end part19is an open ended channel, such that any tissue or debris that is pushed by the needle100into the channel end part19can be discharged through the open end of the channel end part19.

The needle holder4further comprises a needle locking element20arranged in a needle locking element channel21. The needle locking element20is movable between a non-locking position, as shown inFIG.5, and a locking position, in which the needle locking element20is moved into the needle channel10such that the needle locking element20is placed in the locking groove107of the needle100, when a needle100is arranged in the needle channel10. The movement of the needle locking element20between the locking position and the non-locking position is operated by the operating device8, as known in the art. It is remarked that the needle locking element channel21is also an open ended channel such that tissue and debris present in the needle channel10can also be discharged through the open end of the needle locking element channel21.

FIG.6shows the first jaw element2and the second jaw element3in the take-over position, whereby the needle100is arranged with the first needle end103in the needle channel10of the first needle holder4, and with the second needle end104in the needle channel10of a second needle holder5.

The needle end stop surface106of each respective needle end103,104is arranged against the needle channel stop surface18of each needle channel10. As a result, the first needle holder4cannot be moved further towards the second needle holder5. The needle locking element20of the first needle holder4is in the locking position, in which the needle locking element20extends into the needle locking groove107of the first needle end103. The needle locking element20of the second needle holder5is in the non-locking position, in which the needle locking element20does not extend into the needle locking groove107of the second needle end104.

To pass the needle100from the first needle holder4to the second needle holder5, the operating device8should be activated such that the needle locking element20of the first needle holder4is moved to the non-locking position, while the needle locking element20of the second needle holder5is moved to the locking position.

As explained above, to activate the operating device8, the first operating surface29on the first jaw element3and the second operating surface30on the second jaw element4should be moved towards each other. Since the first needle holder4and the second holder5cannot be moved towards each other due to the presence of the needle100, the movement of the first operating surface29and the second operating surface30towards each other results in rotation R1of the first jaw element2about the first needle end103and rotation R2of the second jaw element3about the second needle end104.

During the rotation R1, the needle end stop surface106of the first needle end103and the needle channel stop surface18of the first needle holder4cooperate with each other to form a bearing structure to facilitate rotational movement of the first jaw element3about the first needle end103. Correspondingly, during the rotation R2, the needle end stop surface106of the second needle end104and the needle channel stop surface18of the second needle holder5cooperate with each other to form a bearing structure to facilitate rotational movement of the second jaw element4about the second needle end104. The needle points105remain unaffected by these rotations R1, R2.

Further, it is remarked that by providing a straight needle100and circumferential locking grooves107, the needle100can properly be arranged in the needle channels10, independent of the rotational position of the needle100about its longitudinal axis110. This is advantageous, as it is no longer required to align the rotational position of the needle100with respect to the needle channel10before loading the needle100into the respective needle holder4,5.

FIGS.7,8and9show a second embodiment of a needle100to be used in a needle-suture combination according to an embodiment of the invention.FIGS.7and8show side views on the needle100, as indicated inFIG.9, in a first viewing direction x perpendicular to a longitudinal axis110of the needle110and a second viewing direction y perpendicular to the longitudinal axis110of the needle110. The second viewing direction y ofFIG.8is rotated 90 degrees with respect to the first viewing direction x ofFIG.7.FIG.9is a side view parallel to the longitudinal axis110of the needle10in the viewing direction z, indicated inFIG.8.

The needle100is configured to be used in an embodiment of the surgical apparatus, as generally depicted inFIGS.1and2. The first needle holder4and the second needle holder5may be adapted to the shape and dimensions of the needle100shown inFIGS.7,8and9.

The needle100comprises a straight needle body102having a first needle end103and a second needle end104. Midway between the first needle end103and the second needle end104, a through-going hole109is provided through which a connection loop of a suture may be arranged to connect a suture to the needle100. The suture may for example be configured as the suture shown inFIG.3, comprising the connection loop, a suture thread and a connector connecting the suture thread to the connection loop.

Corresponding to the embodiment ofFIG.4, each of the first needle end103and the second needle end104comprises a needle point105, a needle end stop surface106and a circumferential locking groove107.

The needle point105is a pointed end of the needle100that can be used to pierce tissue or other material through which the suture should be arranged.

The needle end stop surface106is arranged to cooperate with a needle channel stop surface of a needle channel of a needle holder4,5(seeFIGS.5and6) similar to the embodiment ofFIG.4. The shape and dimensions needle channel stop surface may be adapted to the shape and dimensions of the needle end stop surface106.

Since the needle end stop surface106is arranged to provide a contact between the needle100and the needle channel to facilitate rotation of the first jaw element2and the second jaw element3about the respective needle ends103,104, the needle point105is no longer needed to provide an engagement between the needle100and the associated needle channel. As a result, the needle point105of each of the first needle end103and the second needle end104may be optimized for piercing of tissue.

The circumferential locking groove107is a groove that extends over the whole circumference of the needle body102. This locking groove107is provided to receive a needle locking element of a needle holder to lock the needle100in a needle channel of the needle holder4,5. The locking grooves107of the needle100of the embodiment ofFIGS.7,8and9have a conical base surface. The base surfaces of the locking grooves107taper in the direction of the through-going hole109radially outwards with respect to the longitudinal axis110. The shapes of the needle locking elements20of the first needle holder4and the second needle holder5may be adapted to this shape of the locking grooves107. The angle of the base surface of the locking grooves107may for example be 2 to 15 degrees, for instance 4 to 10 degrees with respect to the longitudinal axis110of the needle100. Such conical base surface of the locking groove may also be applied in any other embodiment of a needle, for example the embodiment shown inFIGS.3and4.

The needle body102has a diameter of about 0.4 mm. The needle body may also have any other suitable diameter. The total length of the needle100is for example approximately 9 mm. The length of the needle is for example in the range of 7 mm to 12 mm. The needle100may be made of any suitable material, such as stainless steel.

FIG.10shows the first needle end103of the needle100ofFIGS.7,8and9in more detail. The second needle end104has the same construction and dimensions.

In the embodiment ofFIGS.7,8and9, the needle points105comprise a three facet needle point surface, formed by three facets111equally distributed over the circumference of the respective needle end103,104. The needle point surface is the surface defining the needle point. The three facets111may for example be machined in a needle having two conical surfaces as the embodiment shown inFIGS.3and4.

The three facets111are each arranged at a facet angle φ with respect to the longitudinal axis110of the needle. The facets111define three needle point edges112arranged at a first acute angle α with respect to the longitudinal axis110of the needle.

The needle end stop surface106is a substantially conical surface at a second acute angle β with respect to the longitudinal axis110of the needle. The first acute angle α and the facet angle φ are each larger than the second acute angle β.

In the embodiment shown inFIGS.7,8and9, the facet angle φ is approximately 17.5 degrees and the first acute angle α is approximately 30 degrees with respect to the longitudinal axis110of the needle100. The second acute angle β of the conical surface of the needle end stop surface106is approximately 9.4 degrees with respect to the longitudinal axis110of the needle100.

More generally, the facet angle φ and the first acute angle α may for example be in the range of 15 to 40 degrees with respect to the longitudinal axis110of the needle100and the second acute angle β of the needle end stop surface106may be in the range of 5 to 20 degrees with respect to the longitudinal 110 axis of the needle100, for example in the range of 8 to 13 degrees with respect to the longitudinal axis110of the needle100.