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Title:
TISSUE DISSECTION DEVICE AND METHOD
Document Type and Number:
WIPO Patent Application WO/2009/147638
Kind Code:
A3
Abstract:
A tissue dissection device comprises an insufflator configured to provide pressurized gas, and having gas pressure and flow rate adjusting means, said insufflator being connectable to a pneumatic manipulator.

Inventors:
BARDINI ROMEO (IT)
Application Number:
PCT/IB2009/052374
Publication Date:
February 25, 2010
Filing Date:
June 04, 2009
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BARDINI ROMEO (IT)
International Classes:
A61B17/32; A61M13/00; A61B17/00
Domestic Patent References:
WO2005035035A12005-04-21
WO1999002089A11999-01-21
Foreign References:
US5152745A1992-10-06
US4207887A1980-06-17
US20050159764A12005-07-21
US20080119759A12008-05-22
Attorney, Agent or Firm:
LEIHKAUF, Steffen, Falk et al. (Via Senato 8, Milano, IT)
Download PDF:
Claims:

Claims

1. A tissue dissection device, comprising an insufflator configured to provide pressurized gas, and having gas pressure and flow rate adjusting means, said insufflator being connectable to a pneumatic manipulator.

2. The tissue dissection device according to claim 1, wherein the insufflator comprises:

- a cab suitable to receive a gas cylinder containing CO 2 gas, preferably at a pressure of about 40-50 bar.

- a connection system between the gas cylinder and a first pressure reduction assembly, preferably in stainless steel, in which such connection system comprises a double supply circuit, as well as manually controlled filters and stop valves ;

- the first pressure reduction assembly (first drop) having a tubing system preferably in stainless steel, as well as manually controlled valves and reducing and stabilizing filters configured to reduce the gas pressure from 40-50 bar to about 3-4 bar;

- a second pressure reduction assembly connected to the first reduction assembly downstream the latter with reference to the gas flow direction and configured to reduce the gas pressure from 3-4 bar to about 0.02 - 0.03 bar;

- a graduated knob, preferably with micrometric graduation, connected to the insufflator, preferably with the second

pressure reduction assembly, so as to allow a very fine adjustment of the gas pressure. connecting means for the connection of a pneumatic manipulator device.

3. The tissue dissection device according to claim 1 or 2, wherein the insufflator is configured to allow a CO 2 gas maximum flow rate of about 2 litres per minute.

4. The tissue dissection device according to any one of the preceding claims, wherein the tissue dissection insufflator comprises at least two pressure reduction assemblies arranged in series, and preferably at least two parallel pneumatic circuits in each reduction assembly.

5. The tissue dissection device according to any one of the preceding claims, wherein the insufflator comprises pressure fine adjusting means configured to allow setting different pressure gradients for the dissection of different anatomical districts.

6. The tissue dissection device according to any one of the preceding claims, further comprising a pneumatic manipulator configured to be connected to said dissection insufflator so as to insufflate CO 2 at a constant, yet adjustable pressure into the tissues during surgery interventions.

7. The tissue dissection device according to claim 6, wherein said pneumatic manipulator comprises a cannula in plastic material and of a substantially conical, elongate

shape.

8. The tissue dissection device according to claim 7, wherein the cannula length is of about 33 cm.

9. The tissue dissection device according to claim 7, wherein the cannula has a proximal diameter of 0.5 cm, and a distal diameter of 0.3 cm, and a wall thickness of about 0.1 cm at the proximal end, which decreases to a wall thickness of about 0.05 cm at the cannula distal end.

10. The tissue dissection device according to one of the claims 7 to 9, wherein a connecting portion is formed at the cannula proximal end, for the connection of the cannula to a gas hose.

11. The tissue dissection device according to one of the claims 7 to 10, wherein a cock is provided in the proximity of the cannula distal end, for the opening and closure of the gas passage.

12. The tissue dissection device according to one of the claims 7 to 11, further comprising a metal mandrel with a length which is higher than the cannula length, and a diameter below the diameter of the cannula, so as to be insertable from the proximal side in the distal direction in the cannula, said metal mandrel comprising:

- a manual grip portion formed at the mandrel proximal end;

- a distal end length configured to exit the cannula distal opening and having a tapered, preferably conical shape, to

make the penetration of the mandrel in the tissue to be dissected easier.

13. α tissue dissection method comprising the step of insufflating pressurized gas in a dissection zone of the tissue to be dissected

14. The method according to claim 13, comprising the steps of:

- arranging a pressure of gas, preferably of CO2, through a gas insufflator configured to reduce the gas pressure from a value of about 40-50 bar (gas cylinder pressure) to a value of 0.02 - 0.03 bar, in which the gas insufflator implements two reduction drops of the CO 2 gas pressure;

- supplying the pressurized gas in a continuous and adjustable manner (through a manual adjustment member) , with a maximum flow rate of 2 litres per minute to a pneumatic manipulator configured to eject a pressurized gas flow; moving the pneumatic manipulator, preferably laparoscopically, along a dissection plane.

15. The method according to claim 13 or 14, comprising the steps of:

- using an insufflation cannula as a pneumatic manipulator, and laparoscopically introducing the cannula via a trocar in the patient's abdominal cavity;

- positioning a mandrel within the cannula by inserting the mandrel through the cannula proximal opening in the distal

direction;

- pushing the mandrel, under visual control, beyond the cannula distal end, within the peritoneal surface;

- pushing the cannula distal end, guided by the mandrel, into the tissue to be dissected, and then removing the mandrel, withdrawing it in the proximal direction from the cannula.

16. The method according to claim 15, comprising the steps of:

- after withdrawing the mandrel from the cannula, connecting the cannula to a duct, in turn connected to the dissection insufflator;

- actuating the dissection insufflator to inject a gas flow through the cannula distal opening into the tissues, in order to dissect them.

Description:

"Tissue dissection device and method" DESCRIPTION

[0001] The present invention relates to a tissue dissection device and method.

[0002] To date, tissue dissection can be achieved only by means of mechanical or thermo-mechanical dissection, through a mechanical handling of the tissue layers, also known as

"mobilization" .

[0003] According to the invention, tissue dissection comprises the steps of:

[0004] - arranging a pressure of gas, preferably of CO2, through a gas insufflator, preferably of CO 2 , configured to reduce the gas pressure from a value of about 40-50 bar (gas cylinder pressure) to a value of 0.02 - 0.03 bar, in which the gas insufflator implements two reduction drops of the CO 2 gas pressure;

[0005] - supplying the gas (preferably CO 2 ) which is pressurized at a constant and adjustable pressure (through a manual adjustment member) , and preferably continuously, and preferably with a maximum flow rate of 2 litres per minute, to a pneumatic manipulator;

[0006] - moving the pneumatic manipulator configured to eject a pressurized gas flow, preferably laparoscopically, along a dissection line or plane, preferably along the so-called cleavage planes.

[0007] Therefore, object of the invention is a system to insufflate CO 2 into the different types of anatomical tissues in order to obtain a dissection thereof which is easier, bloodless, and rapid.

[0008] In order to better understand the invention and appreciate the advantages thereof, some exemplary, non- limiting embodiments will be described herein below, with reference also to the annexed Figures, in which: [0009] - Fig. 1 illustrates a pneumatic scheme of an insufflator configured to reduce the CO 2 gas pressure through two reduction stages (drops) in accordance with an embodiment of the invention;

[0010]- Figs. 2, 3, and 4 represent a plastic cannula (A) and a metal mandrel (B) according to embodiments of the invention.

[0011] The insufflator can comprise:

[0012] - a cab suitable to receive a gas cylinder containing CO2 gas, preferably at a pressure of about 40-50 bar. [0013] - a connection system between the gas cylinder and a first pressure reduction assembly, preferably in stainless steel, in which such connection system comprises a double supply circuit, as well as manually controlled filters and stop valves,

[0014] - the first pressure reduction assembly (first drop) having a tubing system preferably in stainless steel, as

well as manually controlled valves and reducing and stabilizing filters configured to reduce the gas pressure from 40-50 bar to about 3-4 bar;

[0015] - a second pressure reduction assembly connected to the first reduction assembly downstream the latter with reference to the gas flow direction and configured to reduce the gas pressure from 3-4 bar to about 0.02 - 0.03 bar;

[0016] - a graduated knob, preferably with micrometric graduation, connected to the insufflator, preferably with the second pressure reduction assembly so as to allow a very fine adjustment of the gas (CO 2 ) pressure as a function of the resistance which is given by the different anatomical tissues which are intended to be dissected.

[0017] The above-mentioned pneumatic manipulator can be connected to the insufflator by means of one or more hoses.

[0018] In accordance with an embodiment, the insufflator or the connection system between the insufflator and the pneumatic manipulator are configured to allow a CO 2 gas maximum flow rate of about 2 litres per minute.

[0019] As already pointed out before, the tissue dissection insufflator comprises at least two pressure reduction assemblies arranged in series, and preferably at least two parallel circuits in each reduction assembly.

[0020] Advantageously, insufflation occurs at a constant pressure and with a substantially continuous flow, and with

a maximum flow rate, which is preferably limited to 2 litres per minute, in order to conciliate the need to dissect mutually connected tissues, while avoiding side effects, for example, damages to the tissues.

[0021] The pressure fine adjusting means allow setting different pressure gradients for the dissection of different anatomical districts.

[0022] The pneumatic manipulator preferably comprises a cannula for insufflation into the tissues during laparoscopic surgery.

[0023] The cannula can be in plastic material and of a substantially conical, extended shape (preferably with a proximal (outer) diameter of about 0.5 cm and a distal diameter of about 3 mm) and assembled to a metal mandrel. The length of the cannula can be of about 33 cm, and that of the mandrel of 36 cm. The cannula is configured to be connected to the above-mentioned dissection insufflator so as to insufflate CO 2 at a constant, yet adjustable pressure into the tissues during laparoscopic surgery interventions. [0024] The plastic cannula can have a length of about 33 cm and a substantially conical shape with proximal diameter of 0.5 cm and distal diameter of 0.3 cm. The wall thickness of the cannula is of about 0.1 cm at the proximal end, and it decreases, preferably gradually, to a wall thickness of about 0.05cm at the cannula distal end. The cannula inner

diameter at the proximal end is of about 0.3 cm, and such inner diameter is of about 0.2 cm at the distal end.

[0025] A connecting portion (for example, of the female luer lock type) is formed at the cannula proximal end, for the connection of the cannula to a plastic hose.

[0026] In the proximity of the distal end (surgeon side), preferably at about 2 cm from such end, a cock is provided for the opening and closure of the CO 2 gas passage.

[0027] The metal mandrel has a length which is higher than the length of the cannula, e.g., about 36 cm, and a diameter below the diameter of the cannula, for example, about 0.15 cm, in order to be insertable from the proximal side

(surgeon side) in the distal direction into the cannula.

[0028] A manual grip portion is formed at the mandrel proximal end, for example, an ovoid metal plate which can have a length of about 2.5 cm and a width of about 2 cm, as well as a thickness of about 0.15 cm, in order to allow handling the mandrel.

[0029] The mandrel distal end, for example, an end length of about 2 cm, has a tapered, preferably conical shape, to make the penetration of the mandrel into the tissue to be dissected easier.

[0030] The cannula - mandrel kit is preferably used in laparoscopic surgery, for example, by using a method which provides the steps of:

[0031] - laparoscopically introducing the cannula via a trocar into a patient's abdominal cavity;

[0032] - positioning the mandrel within the cannula by inserting the mandrel through the cannula proximal opening in the distal direction;

[0033] pushing the mandrel, under visual control, beyond the cannula distal end (so that the mandrel tip or distal end exits the cannula distal opening) within the peritoneal surface;

[0034] - pushing the cannula distal end, guided by the mandrel, into the tissue to be dissected and then removing the mandrel, withdrawing it in the proximal direction from the cannula;

[0035] - connecting the cannula proximal end (connecting portion) to a plastic duct, in turn connected to the CO 2 insufflator.

[0036] - actuating the CO 2 gas insufflator to inject

(insufflate) the CO 2 flow through the cannula distal opening into the tissues in order to dissect them.

[0037] Through the devices and method which have been described and illustrated, the dissection in a completely bloodless manner is obtained of vascular structures contained in the mesentery or mesocolon, making the surgical intervention extremely easier.

[0038] It shall be noted that the conical shape of the cannula

allows an easy penetration into the tissue, and a good maintenance of the insufflation pressure.

[0039] It shall be apparent that to the device and the method according to the present invention, those of ordinary skill in the art, in order to meet specific, contingent needs, will be able to make further modifications and variations, all of which in any case falling within the protection scope of the invention, as defined by the following claims.




 
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