WO2010041101A1

WO2010041101A1 - Haemostatic device for surgical procedures and emergencies

Info

Publication number: WO2010041101A1
Application number: PCT/IB2008/054178
Authority: WO
Inventors: Fabrizio Dal Moro; Walter Artibani
Original assignee: Universita Degli Studi Di Padova
Priority date: 2008-10-10
Filing date: 2008-10-10
Publication date: 2010-04-15

Abstract

The invention is a haemostatic device for use in surgical procedures of various type, characterised in that it comprises at least one strap (F) of the self-locking type with adjustable closing means. Said strap (F) comprises at least one head (T) combined with at least one serrated, flexible band (N) suitable for wrapping around one or more vessels (V1, V2) or structures of the human body and for being inserted in at least one hole (T1) passing through said head (T), wherein there is at least one flexible tooth (T21, T22) on said head (T) designed to engage with teeth (D1, D11, D21) on said band (N), enabling the insertion of said band (N) in one direction and preventing it from sliding in the opposite direction.

Description

TITLE

HAEMOSTATIC DEVICE FOR SURGICAL PROCEDURES AND

EMERGENCIES

DESCRIPTION The present patent relates to haemostatic devices, and particularly concerns a new haemostatic device for use in all types of surgical procedure, and particularly in laparoscopic procedures.

The need to control bleeding represents a crucial issue in any surgical procedure. Haemostasis, or the stoppage of a blood flow, can be done in various ways and using various methods, either intra-operatively or in emergency situations.

There are mechanical haemostatic methods, for instance, which may involve exerting a mechanical pressure, inserting stitches, or using a mechanical stapler or clips. There are also known physical haemostatic methods, such as the methods that involve the use of high temperatures, low temperatures, electricity, ultrasound, laser, radio frequencies, and so on.

There are also known chemical haemostatic methods, such as methods that involve the use of hydrogen peroxide, adrenalin, tranexamic acid or caustic agents, and biological methods that involve the use of thrombin, thromboplastin, adhesives, and the like.

The ideal haemostatic agent should have a powerful, rapid and reliable haemostatic effect; it should also be reabsorbable or, if it is non- reabsorbable, it should be completely inert; it should also be sterile and antibacterial, and practical to use.

The severity of any bleeding and the quality and site of the tissues to treat often determine which of the various methods is chosen. Where medium- to large-calibre vessels are involved, as in the case of the majority of surgical procedures, especially in the abdomen, sutures are the most often used solution for controlling haemostasis. The opportunity to perform some surgical procedures laparoscopically and in robot-assisted laparoscopy has prompted the diffusion of more practical haemostatic methods, given the undeniable difficulty of tying knots after inserting a stitch using laparoscopic instruments. During such laparoscopic procedures, different haemostatic methods are used instead, such as mono- or bi-polar electrocoagulation, mechanical staplers, orthostatic clips, or haemostatic substances. There are situations, however, in which the need to preserve structures adjacent to the vessels being severed makes it advisable to avoid the use of any type of energy: this is the case, for instance, when the neurovascular bundles need to be preserved during radical prostatectomy for prostate cancer in order to retain erectile function after such surgery. In fact, using monopolar electrocoagulation or, to a lesser degree, bipolar electrocoagulation, can directly injure the neural structures that need to be preserved. Using other forms of energy, such as ultrasound or radio frequencies, should cause less damage to these structures, but there is no certain evidence to completely rule out the possibility of their directly or indirectly damaging the nerve fibres.

On the other hand, using only haemostatic substances, such as gels, colloids, adhesives, etc, cannot guarantee a reliable haemostasis in structures such as those mentioned above.

Using metal or plastic clips enables the use of energy to be avoided, but it is not unusual for such clips to prove incapable of assuring a reliable haemostasis, as seen in numerous cases in which clips have been used, and particularly when a kidney is harvested laparoscopically from a living donor. Moreover, the force with which the stems of the clips are closed can cause ischaemic damage due to compression of the nerve structures contained in the neurovascular bundle.

The use of clips, e.g. for renal artery closure, during laparoscopic nephrectomies can often prove scarcely reliable due to the risk of intraoperative or postoperative displacement of the clip.

In addition, where the vessels involved are atherosclerotic, i.e. they have become stiff and calcified, it can be hazardous to use a clip, which exerts a strong compressive force between only two stems, whereas it would be preferable to apply a gradual circumferential compression to bear, as is the case when a stitch is inserted.

For the same reason, using staplers to close large arterial vessels in vascular surgery can prove hazardous due to the risk of traumatic lesions to the calcified vessel wall, so here again it would be preferable to use a circumferentially applied tension. External compression, e.g. around a limb, or internal compression around a vessel may be necessary in emergency situations where a traumatic arterial lesion is involved, such as after road accidents, on battlefields, etc. In such situations, a device that enables a temporary control of bleeding until the patient's arrival in the operating theatre can prevent hazardous haemorrhages.

In the case of radical prostatectomies with the intention to preserve the neurovascular bundles adjacent to the prostate, it is also crucial to be able to adjust the tension around the bundle so as to control bleeding without inducing any ischaemic insult to the nerve structures. The insertion of stitches is still the only known method capable of complying with this requirement, but the previously-mentioned difficulty of inserting stitches during a laparoscopic procedure makes their use troublesome and extends the operating times.

To overcome all the above-mentioned drawbacks, a new type of haemostatic device has been studied and developed for use in various types of surgical procedure, and particularly in laparoscopy.

The main object of the present invention is to enable the tension applied around structures requiring haemostasis to be adjusted, while also assuring the utmost safety in use for the patient, since said device can withstand distinctly stronger forces than those potentially developing in the biological structures for which it is proposed.

Another object of the present invention is to enable a haemostatic control of neurovascular structures without the need to use energy that might damage the neural components that need to be preserved. Another object of the present invention is to enable the rapid and reliable haemostatic control of large vessels, particularly during laparoscopic and robot-assisted laparoscopic procedures, but also in open surgical procedures. Another advantage of the present invention lies in that it has a broad range of uses and can be applied to vessels or structures of various dimensions. A further advantage of the present invention lies in that it is also suitable for use in radical prostatectomy procedures.

Another object of the present invention is to enable haemostatic control either from the outside or directly around a vessel in the event of extreme emergencies.

A further object of the present invention is to enable the temporary closure of large vessels in the event of vascular surgery. Another advantage of the present invention lies in that it is very quick and easy to position, as well as being easy to remove and reposition. The present invention is preferably made of an inert and antibacterial material, such as polyamide 6,6 - nylon. Another characteristic of the present invention, that also represents a novelty in this field, is that the polymer of which the invention is made can be used as a drug-eluting medium, i.e. to release certain substances, such as haemostatic, chemotherapeutic or other kinds of substance, directly in situ. These and other direct and complementary objects are achieved by the new haemostatic device for use in all kinds of surgical procedure, and particularly in laparoscopy, comprising at least one autostatic or self-locking strap, said strap in turn comprising a head combined with a serrated band, suitable for being flexed and inserted through a hole in said head, wherein at least one flexible tooth is contained inside said head, coinciding with said hole, to enable the insertion of said band in one direction and prevent it from accidentally sliding in the opposite direction.

Said strap may be designed to be of the non-reopening type, or of the reopening or removable type, also comprising an external tooth on a level with the heads that, when pressed, enables the band to be released and the strap to be opened. Said device consequently comprises an adjustable closing mechanism, since said strap can easily be inserted during laparoscopic or robot-assisted laparoscopic procedures, and can be tightened around structures needing to be ligated, progressively adjusting the tension thereon, so as to obtain the necessary haemostatic control without causing any damage due to pressure on the structures involved, unlike the situation when clips of the known type are used.

For instance, said device can be used very effectively in applications for controlling haemostasis on a level with the prostatic stumps and the neurovascular bundles during laparoscopic or robot-assisted laparoscopic radical prostatectomy procedures. The new device can also be used in other types of open, non-laparoscopic surgical procedures, however.

Said device can be made entirely or partially of a non-reabsorbable material, preferably poly amide 6,6 - nylon, and/or entirely or partially of various kinds of reabsorbable material. The new device can also include at least one applicator and/or means for positioning and closing the strap. In particular, said band and/or said head on the strap can comprise one or more grooves and/or cavities, and/or teeth for engaging with such means for positioning and closing the strap. For instance, said means can comprise wires or linear probes that, inserted in said grooves, enable the operator to guide the positioning of the strap and to achieve the flexing of the band and the closing of the strap. Said procedure can be completed effectively both during laparoscopic procedures and in open surgery. An advantage of the present invention lies in its considerable safety in use, which is greater than any haemostatic method using forms of energy, without carrying the related risk of damaging the adjacent structures; moreover, it affords a mechanical closure with a shape that makes it distinctly more stable than a closure achieved with any clip of known type. The new invention is quick to position, so it is suitable for use both in open surgery and in laparoscopic procedures. It can also include the possibility to cut off the excess length of band after closing the strap.

Said strap can thus be adjusted, i.e. once in position, the tension can be progressively increased to improve haemostasis in the vessels that need to be closed, reducing the damage due to excessive compression on the nerve structures in the neurovascular bundle where the bleeding has to be controlled, while preserving the vitality of the nerves. The pressure exerted by the strap's band when it is wrapped around the vessel is distributed around the circumference of the vessel in question, instead of pressing the vessel with just two stems, as in the case of using vascular staplers to temporarily close vessels.

The new haemostatic device is versatile and can also serve as a device for use in first aid, for the acute control of bleeding either from the outside or directly on an exposed vessel.

The device can be produced in various sizes and it can be of the non- removable or of the reopenable type; it can be made of a non-reabsorbable and/or a reabsorbable material.

The characteristics of the new haemostatic device are better clarified in the following description with reference to the attached drawings, given here as non-limiting examples. Figures 1-5 show five different embodiments of the new haemostatic device, comprising at least one strap (F) of the self-locking type, with a head (T) attached to a band (N) that is serrated along all or part of at least one side. Figure 6 shows a detail of the head (T") of the strap (F) made according to another possible embodiment.

Figure 7 schematically shows the method for using the new haemostatic device on vessels (Vl, V2).

The haemostatic device comprises at least one strap (F) of the autostatic and self-locking type, said strap (F) in turn comprising a head (T) substantially in the shape of a prism, truncated pyramid or cube, or preferably semi- spherical in shape, combined with a band (N) entirely or partially serrated on at least one side.

Said band (N) is made of a flexible material and can be inserted in a hole (Tl) passing through said head (T).

Inside said head (T), in line with said hole (Tl), there is at least one flexible tooth (T21, T22) that allows for the insertion of said band (N) in one direction, but prevents any accidental reopening of the strap (F).

Said strap (F) is designed to be tied around structures or vessels (Vl, V2) needing to be ligated, progressively adjusting the tension in order to obtain the required haemostatic control without causing any damage due to excessive pressure on said vessels (Vl, V2). According to a possible embodiment, illustrated in Figure 1, said strap (F) comprises a head (T') preferably with a substantially semi-spherical or semi-cylindrical shape, with rounded rather than sharp edges, and with a substantially flat base (T3) suitable for facing towards said vessels (Vl, V2), and a band (N) with locking teeth (Dl) distributed along all or part of the inner side (Nl) of the band (N), i.e. along the side that will face towards the vessels (Vl, V2) and in contact with the walls of the vessels (Vl, V2). Said flexible teeth (T21) on the head (T') are located inside said hole (Tl), in a position corresponding to the position of the locking teeth (Dl) when said band (N) is flexed, inserted and passed through said head (T'). Said hole (Tl) in said head (T') is preferably made in the longitudinal direction, parallel to said band (N) when it is not flexed, i.e. between the wall (T5) of the head (T') to which said band (N) is attached and the opposite wall (T6), and wherein said flexible teeth (T21) are arranged on the underside of said hole (Tl). Thus, when said band (N) is flexed and inserted in said head (T'), said strap (F), positioned so as to throttle one or more vessels (Vl, V2), substantially forms a ring, wherein said locking teeth (Dl) lie facing said flexible teeth (T21), which enable their insertion and passage in a single direction, towards the vessels (Vl, V2). Said locking teeth (Dl) serves the purpose of assuring a greater friction and a better grip of the band (N) on the vessels (Vl, V2) to ensure a more stable positioning of the strap (F).

According to another possible embodiment, shown in Figure 2, said band (N) comprises gripper teeth (DIl) distributed preferably in the stretch closest to said head (T') on the inner side (Nl) of the band (N), serving the purpose of ensuring that the band (N) grips the walls of the vessels (Vl,

V2), and further locking teeth (D21), preferably distributed along the remaining stretch of the outer side (N2) of the band (N), i.e. on the side facing outwards with respect to the vessels being ligated (Vl, V2). Said flexible teeth (T22) in the head (T') are located inside said hole (Tl) in a position corresponding to the position of said locking teeth (D21) when said band (N) is flexed, inserted and passed through said head (T'), i.e. on the upper surface of said hole (Tl).

According to another possible embodiment, illustrated in Figure 3, said strap (F) comprises a head (T") substantially parallelepiped or cubic in shape, with preferably rounded corners and edges. According to another possible embodiment, illustrated in Figure 4, said strap (F) comprises a head (T'") of substantially semi-spherical shape, wherein said hole (Tl) provided in said head (T'") lies in a direction substantially crosswise to the direction of the band (N) when it is not flexed, i.e. said hole (Tl) is made between the bottom wall (T3) of said head (T'") and the opposite wall (T4).

The band (N) can thus be flexed, inserted and passed through said hole (Tl) so as to substantially form a ring of smaller radius.

According to another possible embodiment, shown in Figures 5 and 6, said strap (F) comprises a head (T") with a base (T3) that is not flat and linear but concave, so as to substantially follow the curved trend of the flexed band (N).

Said head (T', T") can also be designed, as shown schematically in Figures 6 and 7, to comprise one or more extensions (A) in the vicinity of the hole (Tl) where the band (N) is inserted, wherein said extensions (A) serve the dual purpose of guiding the proper insertion of the band (N) inside the head

(T', T") and of smoothing the discontinuity or sharp edges that would be formed between the head (T', T") and the band (N) when said band (N) is flexed and said strap is closed around the vessels (Vl, V2). One or more grooves and/or cavities, and/or serrated surfaces can also be provided on said band (N), and preferably on said outer side (N2), i.e. on the side where there are no locking teeth (Dl₅ D2), and/or on said head (T), to engage with means, such as wires or probes, for the positioning and closing of the strap (F).

For instance, there may be one or more linear grooves on said outer side (N2) of said band (N), lying in the direction in which the band (N) extends. Thus, one or more wires or probes, or other means of an applicator device, can be inserted in said groove and manoeuvred by the operator to position said strap, flex the band and close the strap, tightening it as necessary. Thus, with reference to the above description and the attached drawings, the following claims are advanced.

Claims

1. A haemostatic device for surgical procedures of various type, characterised in that it comprises at least one strap (F) of the self-locking type with adjustable closing means.

2. A haemostatic device according to claim 1, characterised in that said strap (F) comprises at least one head (T) combined with at least one serrated, flexible band (N), suitable for wrapping around one or more vessels (Vl, V2) or structures of the human body and for being inserted in at least one hole (Tl) passing through said head (T), and wherein there is at least one flexible tooth (T21, T22) on said head (T) suitable for engaging with teeth (Dl, DI l, D21) on said band (N), to enable the insertion of said band (N) in one direction and prevent it from sliding in the opposite direction.

3. A haemostatic device according to claims 1, 2, characterised in that said band (N) comprises a plurality of locking teeth (Dl), distributed over all or part of the inner side (Nl) of the band (N), i.e. along the side that faces towards said vessels (Vl, V2) or structures, so that said locking teeth (Dl) for engaging in said flexible teeth (T21) located in corresponding positions inside said head (T) are also in contact with said vessels (Vl, V2) or structures.

4, A haemostatic device according to claims 1, 2, characterised in that said band (N) comprises a plurality of locking teeth (D2) distributed over all part of the outer side (N2) of the band (N), i.e. along the side that faces outwards with respect to the vessels (Vl, V2) or structures, said locking teeth (Dl) being designed to engage in said flexible teeth (T22) located in corresponding positions inside said head (T).

5. A haemostatic device according to claims 1, 2, characterised in that said band (N) comprises a plurality of gripper teeth (DIl) distributed along the stretch closest to said head (T') along the inner side (Nl) of the band (N), serving the purpose of ensuring that the band (N) grips the walls of the vessels (Vl, V2), and further locking teeth (D21) distributed over the remainder of the outer side (N2) of the band (N), said locking teeth (D21) being designed to engage with said flexible teeth (T22) located in corresponding positions inside said head (T).

6. A haemostatic device according to claims 1, 2, 3, 4, 5, characterised in that said head (T) has a substantially semi-spherical or semi-cylindrical shape with rounded edges and with a base (T3) that is substantially flat and concave or possibly serrated, suitable for facing towards said vessels (Vl, V2) or structures.

7. A haemostatic device according to claims 1, 2, 3, 4, 5, 6, characterised in that said hole (Tl) in said head (T') lies in a longitudinal direction parallel to said band (N) when it is not flexed, i.e. it is made between the wall (T5) of the head (T') to which said band (N) is attached and the opposite wall (T6), and wherein said flexible teeth (T21) are arranged along the upper surface of said hole (Tl).

8. A haemostatic device according to claims 1, 2, 3, 4, 5, 6, characterised in that said hole (Tl) in said head (T'") is arranged in a direction substantially crosswise to the direction of the band (N) when it is not flexed, i.e. said hole (Tl) is made between the bottom wall (T3) of said head (T'") and the opposite wall (T4).

9. A haemostatic device according to the previous claims, characterised in that said strap (F) is of the type that can be reopened or removed, also comprising an outer tooth on a level with said head (T) that, if pressed, enables said band (N) to be released and the strap (F) to be opened.

10. A haemostatic device according to the previous claims, characterised in that it comprises one or more extensions (A) in the vicinity of the hole (Tl) for inserting the band (N), suitable for facilitating the insertion of the band (N) inside the head (T', T") and for smoothing the discontinuity or sharp edges created between the head (T', T") and the band (N) when said band (N) is flexed and said strap is closed and wrapped around the vessels (Vl , V2) or structures.

11. A haemostatic device according to the previous claims, characterised in that said strap (F) is made entirely or partially of a non- reabsorbable material, preferably polyamide 6,6 - nylon, and/or entirely or partially of a reabsorbable material of various kinds.

12. A haemostatic device according to the previous claims, characterised in that it comprises one or more grooves and/or cavities, and/or serrated surfaces on said band (N), and/or on the head (T), for engaging with means, e.g. wires or probes, for the positioning and closing of said strap (F).

13. A haemostatic device according to claim 12, characterised in that said band (N) comprises one or more of said grooves or cavities along said outer side (N2) of said band (N) and arranged in a longitudinal direction with respect to the direction in which the band (N) extends, and wherein said groove(s) is/are suitable for the insertion of said wire or probe for the positioning of said strap (F), the flexing of the band (N) and the closing of the strap (F).

14. A haemostatic device according to the previous claims, characterised in that it can be used in laparoscopic or robot-assisted laparoscopic surgical procedures.

15. A haemostatic device according to the previous claims, characterised in that it can be used for controlling haemostasis on a level with the prostatic stumps and neurovascular bundles during laparoscopic or robot-assisted laparoscopic radical prostatectomy procedures.