DK180060B1

DK180060B1 - Handheld suturing device

Info

Publication number: DK180060B1
Application number: DKPA201800308A
Authority: DK
Inventors: Holbech Esmann Mads; Aarenstrup Daugaard Christine
Original assignee: Esgaard Aps
Priority date: 2018-06-29
Filing date: 2018-06-29
Publication date: 2020-02-27
Also published as: WO2020002389A1; EP3813683A1; DK201800308A1

Abstract

The invention relates to a semi-automatic device for suturing a tissue comprising a curved needle located within an internal circular needle track of the device. The device according to the invention is a small hand-held device for stitching wounds together, that the device is hand-held means that it can be held and operated by one hand; the device ensures efficient and uniform sutures by pushing/pressing or otherwise affecting activation means, i.e. the user of the device need not have the skills of a surgeon. The device comprises a handle, activation means (2), a curved needle (4) and a drive mechanism for the curved needle, the curved needle (4) can move along a circular track (9) and transport a suture (11) in the circular track, the curved needle (4) extends over more than half the length of the circular track (9), the device also comprises a number of locking means (10) comprising at least one through-going opening which locking means (10) can secure one end of a suture relative to another end of the suture; wherein the curved needle (4) is moved repeatedly along the circular track (9) and when moved along the circular track, the curved needle may pass through at least one through-going opening of the locking means (10).

Description

Handheld suturing device

Technical field of invention

The invention relates to a semi-automatic device for suturing a tissue comprising a curved needle located within an internal circular needle track of the device.

The device according to the invention is a small hand-held device for stitching wounds together, that the device is hand-held means that it can be held and operated by one hand; the device ensures efficient and uniform sutures by pushing/pressing or otherwise affecting activation means, i.e. the user of the device need not have the skills of a surgeon.

The needle is positioned inside the device and when the activation means are affected, the needle exits the casing of the device at a first position, penetrates the skin on both sides of a wound and then re-enters into the casing of the device at a second position in a circular movement. During this motion a suture is positioned through the sides of the wound forming a loop. Thereafter, a locking part “ties” or locks the suture ends replacing a traditional “knot” and the ends of the suture are cut if the suture of the device is provided by a continuous thread.

Prior art

Traditional manual suturing methods are slow; each hand-made stitch takes about 30-45 seconds, and often multiple stitches are needed. Moreover, it takes time to prepare for the suturing, particularly because every object used during suturing must be kept sterile or at least very clean. To enhance speed of wound closure, surgeons opt for staplers, which require about 3-5 seconds per staple. Of all competing wound closure products, the most relevant competitor to the traditional needle and suture is the conventional surgical metal skin stapler, since seals, glues, and adhesive bandages are not suitable for open wounds.

Although 6-15 times faster than traditional suturing, metal staples increase risk of infection by a factor of 4, requiring more post-operative visits and increased costs due to wound complications. Skin staples also leave unsightly railroad scarring due to the thickness and rigidity of stainless steel staples. Surgical stapling ultimately presents a 14 times greater risk of wound morbidity at discharge compared to suture closure. The only advantage of stapling is speed of wound closure.

US 2018/000475 disclose a hand-held and hand-operable stitching device capable of securely placing a single interrupted suture through a wound using sterile suturing material with a single squeeze of the device's arms. Using the stitching device provides substantially faster operation than a surgeon, the stitching device has a center assembly capable of closing a wound with traditional suturing material secured by anchors that remain on either side of the wound. The stitching device employs needle-suture units stored in a center assembly and deployed individually when the device is actuated. When actuated, an epicyclic gear train within a center assembly causes a needle-suture unit to move through part of a circular path through the tissue, bringing the edges of separated tissue together. The suture thread is then secured in its position with anchors and the needle is then disjointed from the suture thread with a blade.

EP 2563238 relates to an automatic suturing apparatus to be used with heart valve replacement surgery. Heart valve replacement surgery may take approximately 4 hours or longer. Historically, in a valve replacement operation the patient is placed on cardiopulmonary bypass with the heart arrested and the patient is under anesthesia for a prolonged period. A heart valve replacement surgery normally involves the following steps: 1) expose the valve, 2) resect the valve leaflet tissue, 3) place sutures through the annulus of the native tissue, 4) size the prosthesis, 5) place each individual stitch (10-20 pairs) through the sewing ring of the prosthesis, 6) lower the prosthesis and ring into the patient, 7) tie each pair of sutures, and 8) cut each pair of sutures. The number of sutures may range from 12 to over 25 and each is individually tied. A surgeon must be careful to not apply too much or too little tension on the sutures. EP 2563238 discloses an automatic suturing apparatus wherein triggers activate suturing and securing of the tissue of a patient and wherein triggers activate suturing and securing of a valve to tissue of a patient.

The device according to the present invention provides a series of stitches by use of a curved needle, the device provides a complete suture i.e. no knot needs to be tied when the suture ends are joined. The device ensures safe operation as the needle is covered up between stitches and the device is intuitively operable and may therefore be operated by people with no or little medical education.

Summary of invention

According to a first aspect of the present invention, the invention relates to a device for suturing a tissue comprising a handle, activation means (2), a curved needle (4) and a drive mechanism for the curved needle, the curved needle (4) is adapted to move along a circular track (9) and transport a suture (11) in the circular track. The curved needle (4) extends over more than half the length of the circular track (9). The device also comprises a number of locking means (10) comprising at least one through-going opening, which locking means (10) is adapted to secure one end of a suture relative to the other end of the suture. The curved needle (4) is adapted for moving repeatedly along the circular track (9) and when moved along said circular track, the curved needle is adapted to pass through at least one through-going opening of the locking means (10).

“Relative to the other end of the suture” means that the two ends of a suture are either directly in contact and fixed to each other or the two ends of a suture are both fixed to a single locking means or the two ends of a suture are fixed to each their locking means which two locking means are then fixed to each other.

“The other end of the suture” may be any position of the suture in a distance from the one end, which has passed through the edges of a wound and afterwards is positioned above the skin surface.

“Repeatedly” means that a curved needle moves more than once along the circular track.

A “through-going opening” may be shaped as a pocket or a hollow in the surface of the locking means, i.e. the opening is partly surrounded by material of the locking means, or it may be shaped as a hole through the locking means, i.e. the opening is surrounded with material of the locking means.

In the present context, the term ’’suture” is used to define a thread used for preparing stitches through skin, and the word “suture” is also used to define a complete stitch. Occasionally, the words “thread”, “string” and “stitch” may also be used.

The circular track 9 is not necessarily defined by walls; as the curved needle 4 must exit the outer casing through an opening 3 and re-enter the outer casing through an opening 3, the part of the circular track 9 between the openings 3 are not defined by walls but only by the circular movement of the curved needle 4.

According to some embodiments of the present invention, the device may comprise a thread cutting means configured to cut the suture after a stitch, when the suture is constituted by a continuous thread or suture.

According to some embodiments of the present invention, the device may comprise one or more pre-cut thread(s) or suture(s) where the length of each pre-cut thread or suture is adapted to fit a single stitch. E.g. each pre-cut thread or suture may be configured to be threaded to a curved needle during use or each pre-cut thread or suture may be pre-fixed to each their curved needle before use. E.g. the length of a pre-cut thread or suture may be adapted to a series of stitches e.g. 2, 3, 4, 5, 6, 7, 8, 9, 10 or more stitches.

According to some embodiments of the present invention, the curved needle (4) may move in one direction through the circular track, i.e. the drive mechanism may exclusively drive the curved needle (4) around the circular track in one direction.

According to some embodiments of the present invention, the curved needle (4) is configured to move in two directions through the circular track i.e. both forward and backward, and one or more drive mechanisms drives the curved needle (4) around the circular track between one or more stationary position(s).

According to some embodiments of the present invention, the through-going opening of locking means (10) may be reduced in size or deformed to such an extent that a suture positioned in the through-going opening is fixed or secured within the through-going opening.

E.g. the thread or suture is cut at the same time or by same action as is used when deforming the locking means (10).

According to some embodiments of the present invention, the locking means (10) may be constructed of a plastic material such as a metal or a polymer allowing the material constituting the locking means to be deformed by squeezing and thereby reducing the size of the throughgoing opening. In the context of the present application a “plastic material” is a flexible material which can be deformed and after deformation maintain its new shape, e.g. aluminum is a plastic material. This is contrary to an elastic material as an elastic material after deformation - at least partly - returns to its original shape.

According to some embodiments of the present invention, the locking means (10) may be constructed of a meltable material such as thermo-plastic polymer allowing the material to be deformed by heating and thereby reducing the size of the through-going opening.

According to some embodiments of the present invention, the device may comprise an outer casing (1) defining both an outer barrier holding and protecting the functional parts such as the curved needle (4), the drive mechanism, the thread to be used for suture, locking means (10) etc., and a handle, normally positioned on the side of the outer casing, at one end the outer casing is provided with an opening (3) through which opening a pointy end (5) of the curved needle (4) may exit the outer casing and re-enter into the outer casing, possibly a second opening (3) through which the curved needle (4) may re-enter into the outer casing.

According to some embodiments of the present invention, the outer casing (1) may shield and/or cover more than 50 percent, normally more than 60 percent, of a circle partly constituting the circular path travelled by the curved needle (4).

According to some embodiments of the present invention, the outer casing may be provided with colored markings indicating where the curved needle (4) exits and re-enters the outer casing (1).

According to some embodiments of the present invention, the device may be a single-use or disposable device. I.e. the device is delivered with an outer shield or cover providing a sterile inner environment where at least the curved needle 4, the suture(s) 11 and the locking means 10 are kept sterile and ready for use. The outer shield or cover may be partly constituted of the outer casing 1.

List of figures

Figure 1 shows an outer casing of a device according to the invention.

Figure 2 illustrates the position of the curved needle and circular needle track in a cut-through view of the device when position on a patient's skin.

Figure 3 shows a series of sutures provided by an embodiment of a device according to the invention.

Figure 4 shows an embodiment of a curved needle which may be applied in a device according to the invention.

Detailed description of invention

The invention relates to a hand-held semi-automatic suture device. The device comprises a curved needle 4, a handle which may be constituted of an outer casing 1, and first activation means 2 used to activate a drive mechanism when forcing the curved needle 4 forward. The drive mechanism (not shown in figures) forces the curved needle 4 out of an opening 3 in the outer protective casing 1, through the patient's skin and back into the outer protective casing 1 through an opening 3 at a second position.

The curved needle 4 moves along a circular track 9 having a center 8, and normally the curved needle will be able to complete a full circle inside the circular track 9. A suture 11 is attached to the curved needle 4 and the suture 11 will be moved along the circular track 9 together with the curved needle 4. Normally, the curved needle 4 will extend over more than half the length of the circular track 9, even over more than 60% of the circular track 9, this feature assures that part of the curved needle 4 always is positioned within the housing allowing driving forces to be transferred to the needle and controlling the position of the curved needle.

The device also comprises a number of locking means 10, each locking means 10 comprises at least one through-going opening, and each locking means 10 can secure or lock at least one end of a suture, e.g. both ends of a suture, at a position where edges of a wound are forced together. The dimension of the at least one through-going opening is large enough to allow at least one suture, possibly two sutures, to be placed within the opening, if the curved needle 4 positions the suture within the through-going opening by dragging the suture through the opening, then the dimension of the through-going opening is large enough to allow a curved needle 4 to pass through the through-going opening. Normally, the device comprises or includes one locking means 10 for each stitch the device is designed to provide, i.e. the device may comprise only a single locking means, but normally the device comprises more than one locking means, e.g. more than 5 locking means, and e.g. between 10-20 locking means. In general, the device will comprise enough locking means to be able to provide 5-20 stitches.

The curved needle 4 can be moved repeatedly along the same circular track 9. The curved needle 4 may pass through at least one through-going opening of the locking means 10 when moving along a part of the circular track. If a locking means comprises more than one throughgoing opening the curved needle may pass through one opening in one direction and a second opening - or the same opening - in a second direction.

During use, the curved needle 4 is located within the internal circular track 9 of the device i.e. the curved needle 4 is completely hidden by the outer casing 1 and process providing a stitch starts by activating the first activation means 2 which may comprise pressing a button or similar. Normally, releasing the first activation means 2 will force the complete length of the curved needle 4 out of the outer casing 1 at a first position and the complete length of the curved needle 4 back into the outer casing 1 at a second position.

During a manual stitch, the surgeon/doctor will need to tie a knot securing the two ends of a suture to each other. Instead of a knot, the device of the present invention uses a locking mechanism ensuring a perfectly closed suture. The locking mechanism comprises or is constituted of a unit having at least one through-going opening, e.g. the locking mechanism may be constituted of a small “pearl” of plastic, metal or the like where the through-going opening first forms a closed or semi-closed circle around the suture, and when one or both ends of the suture is/are positioned inside the through-going opening, the walls of the through-going opening may be deformed and closed around the suture thereby fixating the suture to the locking means, e.g. by activating a second activation means which may squeeze or heat the locking means causing the locking means to deform and fix or secure the suture. Normally, the second activation means may comprise a second button extending from the outer casing of the device, and the second activation means may be activated by pressing the button.

The device may comprise an internal cutting mechanism that releases the curved needle 4 from a first suture. The curved needle 4 may then be rethreaded before being ready to perform a new stitch. Alternatively, the suture may be provided in pre-cut lengths which need not be cut after each stitch.

Rethreading of a curved needle may be automatically and take place inside the outer casing before each stitch, or alternatively the device is provided with more than one curved needle 4 where each needle is threaded with a suture e.g. as shown in fig. 4 and placed inside the outer casing before use of the device.

Alternatively, more stitches may be provided with one thread, the device should then be pre-set to a maximum number of stitches for a single operation or use, e.g. if the wound is 3 cm a fivestitch device is chosen, or if the wound is 10 cm a fifteen-stitches device is chosen, etc..

The device may be used with only one hand and can withstand both warm and cold environments.

The device ensures a faster sewing procedure/closing of wounds and allows other healthcare professionals than doctors to take on the job. The device will therefore be very useful in rural environments where medical help is limited, and experienced doctors have more complicated tasks to deal with.

The device will be disposable. I.e. normally the complete device is delivered with the parts which are in connection with a wound in sterile condition, i.e. at least the curved needle 4 and the suture 11 are sterile and the locking means 11 may also be sterile whereas the remaining parts of the device e.g. the outer casing 1 may just be clean when delivered to the user. The complete device may be provided with an outer cover constituting a sterile limit, such cover is then removed before use, exposing the exit and re-enter openings 3 for the curved needle 4 in the outer casing 1. E.g. the outer casing 1 may constitute part of the sterile limit.

Normally, the suture is placed within the outer casing 1, either as a continuous thread which need to be cut between stitches or as pre-cut thread parts which e.g. may be attached to a locking means prior to stitching. The locking means 10 are normally also placed within the outer casing before and during use.

The device will ensure the speed of a stapling machine but the preciseness and effectiveness of suturing as sutures do not need a special device for removing them.

The device can be made of a see-through material making it easier to visualize where the needle will emerge when having passed through the patient's skin. E.g. the outer casing may be provided with colored markings e.g. in red as red indicates risk or danger, indicating where the needle will emerge and exit.

A ruler may be indicated on the side of the machine and help the healthcare professional to asses where the next suture should go.

The device can make single sutures thereby giving the best treatment for emergency patients.

The machine may be suitable for all size hands, and the shaping of the outer casing can be shaped to provide a firm grip providing a more comfortable sewing experience.

The machine can be scaled to carry different needle sizes i.e. both the internal diameter or width of the circular track may be adapted defining a different diameter or thickness of the needle. Also, the diameter of the circular track may be adapted defining different length of a curved needle.

Figure 1 shows an embodiment of an outer casing 1 which may be used in a device according to the invention. The outer casing 1 has a cut ellipsoid shape in one dimension and in a second dimension it has a constant width forming a side-portion. First activation means 2 in form of a button are positioned on the side-portion, so it is possible to grip the device with one hand and push the button with one or more fingers.

Figure 2 shows a cut-through view of an embodiment of a device according to the invention. The embodiment comprises an outer casing 1 of same shape as the device of fig. 1, inside the outer casing 1 is shown the position of a circular track 9 having a center 8 in which circular track 9 a curve needle 4 is positioned. The curved needle 4 has a pointy end 5 - which in fig. 2 points to the left - and a tail end 6.

During operation the curved needle 4 will exit the outer casing 1 with the pointy end 5 forward through a first opening 3, cut-through the patient's skin which is indicated with reference number 7 and re-enter the outer casing 3 through a second opening 3, the first and the second openings 3 may be constituted by a single opening. The dotted lines indicate the curved needle's path when the curved needle travels outside the outer casing 1. According to this embodiment the curved needle 4 extents over approximately 55% of the length of the circular track 9, and a curved needle 4 must always be longer than the length of the track defined by the distance between the exit opening 3 and the re-enter opening 3 for the curved needle 4 in the outer casing. The curved needle 4 may travel either clockwise or counter clockwise through the circular path 9, however, it is advantageous that the curved needle 4 exits the outer casing in proximity of the first activation means 2 (in the embodiment of fig. 2 the curved needle would travel counter clockwise), preferably below the first activation means 2 or at least in the same side or half as the first activation means 2.

Figure 3 shows a series of sutures 11 made by a device according to the present invention. The sutures are unconnected and closed by a locking means 10 in form of a pearl-like structure with one or more through-going openings.

Figure 4 shows a curved needle 4 which may be used in an embodiment of a device according to the invention. In this embodiment a suture string is attached to the tail end 6 of the curved needle 4 and the length of the curved needle 4 is provided with at least two notches 12 comprising a surface which may be used when the drive mechanism forces the needle forward.

The drive mechanism pushes against the surface and at least one notch should always be present inside the outer casing of the device.

Reference no.	Name of reference
1	Outer casing
2	First activation means
3	Opening for curved needle
4	Curved needle
5	Pointy end of curved needle
6	Tail end of curved needle
7	Patients skin
8	Center of circular track
9	Circular track
10	Locking means
11	Sutures
12	Notches

Claims

A device for suturing a tissue, comprising a handle, activating means (2), a curved needle (4), and a drive mechanism for the curved needle, the curved needle (4) being adapted to move along a circular path (9) and for transporting a suture (11) in the circular path; wherein the curved needle (4) extends over more than half the length of the circular path (9), the device further comprising a number of locking means (10), each comprising at least one through-opening, the locking means (10) being adapted to secure one end of a suture relative to the other end of the suture;

characterized in that the curved needle (4) is adapted to move along the circular path (9) repeatedly, and when it is moved along the circular path, the curved needle is adapted to pass through at least one through-opening in the locking means. (10).

The suturing device of claim 1, further comprising thread cutting means configured to cut the suture after a stitch when the suture is a continuous thread or suture.

The suturing device of claim 1, wherein the curved needle (4) is adapted to move solely in one direction through the circular path.

A suturing device according to any one of the preceding claims 1-2, wherein the curved needle (4) is adapted to move both back and forth in the circular path, and wherein one or more drive mechanisms are adapted to guide the curved needle (4) around the circular path between one or more stationary position (s).

A suturing device according to any one of the preceding claims 1-4, wherein the through-opening in the locking means (10) is reduced in size to such an extent that a suture placed in the through-opening is fixed or secured inside the through opening.

A suturing device according to claim 5, wherein the locking means (10) is made of a plastic material, such as a metal or a polymer, which enables the material to be deformed by squeezing and thereby reducing the size of the through-opening.

A suturing device according to any one of the preceding claims 1-6, wherein the locking means (10) are made of a fusible material, such as thermoplastic polymer, which allows the material to be deformed by heating and thereby reduces the size of the through-opening.

A suturing device according to any one of the preceding claims 1-7, wherein

The device further comprises an outer sheath (1) defining both an outer barrier holding and protecting the functional parts and a handle, the outer sheath being provided at one end with an opening (3) through which a the pointed end (5) of the curved needle (4) is adapted to move out of the outer sheath and in again.

A suturing device according to claim 8, wherein the outer sheath (1) protects or covers more than 50% of a ring partially forming the circular path in which the curved needle (4) moves.

A suturing device according to any one of the preceding claims 8-9, wherein the outer

15 cladding (1) is provided with colored markings showing where the curved needle (4) moves out of the outer cladding (1) and in again.