WO2006033122A1

WO2006033122A1 - Medical device for precision surgery

Info

Publication number: WO2006033122A1
Application number: PCT/IT2004/000512
Authority: WO
Inventors: Gian Paolo Oddenino
Original assignee: Sapi Med S.P.A.
Priority date: 2004-09-21
Filing date: 2004-09-21
Publication date: 2006-03-30

Abstract

The present invention relates to a medical device for operations on body organs, and particularly it relates to an anoscope. Said surgical instrument advantageously allows to carry out high-precision surgical operations.

Description

DESCRIPTION

"MEDICAL DEVICE FOR PRECISION SURGERY"

[0001] . The present invention relates to a medical device to be used for operations on body organs, and particularly, it relates to an anoscope. Said surgical tool advantageously allows to carry out high-precision operations.

[0002] . In the proctological medical practice, devices known as anoscopes or proctoscopes are known, which are suitable to allow the anus and rectum to be examined and directly operated by a surgeon. These devices generally consist of a first member comprising a first portion provided with a handle to be manipulated, and a second portion to be inserted into the patient's organ, as well as a second member consisting of a cylindrical portion suitable to be inserted in and reversibly locked to said first member. Furthermore, the second member has an inserting end having a rounded tip which allows to facilitate the insertion of the device in the patient's organ.

[0003] . Particularly, the second portion of the first member is provided with an aperture allowing the hemorrhoidal ligature. Through the aperture, with the needle and thread being carried on a needle carrier end, the surgeon can reach the site where the ligature of the venous plexus varixes should be carried out, such as to isolate the hemorrhoid from the blood flow, thereby causing the necrosis thereof.

[0004] . The above operation requires to be carried out with precision, since the surgeon must be sure that only the mucosa where the hemorrhoids or the hemorrhoidal vein are found, or the skin, should the latter be in the cutaneous area of the anus, will be picked by the needle and ligated, but he should not go deeper to avoid that the sphincter muscle of the anus or the rectum muscle may be also ligated.

[0005] . Accordingly, it is evident that this operation is not easy, and mainly in the case where the surgeon is not particularly skilled, very troublesome inconvenience may be caused to the patient.

[0006] . Furthermore, the above medical device can be used only for operations of the above mentioned type. For hemorrhoidal ligature operations, this device is required to be replaced with a device comprising a "recorder mouthpiece" shaped opening.

[0007] . Therefore, the object of the present invention is to provide a medical device allowing to overcome the cited drawbacks. [0008] . This object is achieved by means of a medical device allowing to carry out hemorrhoidal ligatures in a safe and precise manner, and at the same time to allow suture and/or ligature operations by means of a single device, such as set forth in the annexed claims. [0009] . Further characteristics and the advantages of the present invention will be better understood from the following description of some embodiments given by way of non-limiting examples, where:

- Figure IA is an exploded perspective view of the medical device of the invention; - Figure IB is a longitudinal sectional view of an element of the device from figure IA;

- Figure 1C is a cross-sectional view taken along the line A-A of the element from figure IB;

- Figure ID is a perspective view of the medical device from Figure IA, when assembled;

- Figure IE is a partial rear view of the medical device from Figure ID;

- Figure 2A is an exploded perspective view of a first variant embodiment of the invention; - Figure 2B is a perspective view of the medical device from Figure 2A, when partially assembled;

- Figure 3A is an exploded perspective view of a second variant embodiment of the invention;

- Figure 3B is a perspective view of the device from figure 3A in a first assembly step; - Figure 3C is a perspective view of the device from Figure 3A, when assembled;

- Figure 3D is a rear view of the device from figure 3C. [0010] . In Figures IA, IB and 1C a medical device for proctological examinations/operations according to the present invention is generally designated with numeral 1. [0011] . The subject medical device 1 can be generally- employed for examinations/operations on organs and comprises dilating means 2 suitable to be introduced into an organ to hold it wide open, inserting means 3 suitable to facilitate the introduction of said device into said organ and locking means 4 to reversibly lock a probe 8 to said device. [0012] . The dilating means 2 comprise a first substantially cylindrical and hollow portion 5 being connected as one piece to a second portion 6 shaped as a handle, by means of a joining portion 7 such as to form a sort of L. Particularly, the first portion 5 and the second portion 6 define a concave angle comprised between 180° and 90°.

[0013] . The first portion 5 has a first end 51 connected to said joining portion 7 and a second free end 52. Preferably, the second end 52 can be "recorder mouthpiece" shaped. Furthermore, in the vicinity of said second end 52, a window 53 is provided extending along half the circumpherence of the first portion 5. [0014] . On the outer surface of first portion 5 there is formed a seat 54 suitable to house said locking means 4 for a probe. Preferably, the seat 54, such as represented in figures IB and 1C, is formed in the thickness of the first portion 5 wall facing the convex angle being defined by the L-shape of the dilating means 2. Particularly, in the cross-sectional direction, the seat 54 has (figure 1C) two longitudinally extending undercuts 54' being such as to house said locking means 4, as will be described below.

[0015] . In addition, the seat 54 can be communicating with a further seat 55 suitable to house an echo radiography probe 8 such as an echo-Doppler probe. Particularly, the housing 55 is also formed in the thickness of the first portion 5 wall, such as to be open to the outside of said first portion 5. In other words, it is open to the convex angle being defined by the above-mentioned L-shape. Furthermore, the cross section of said seat 55 has two undercuts 55^' such as to house and lock the probe, as will be described below. [0016] . The second portion 6 has a substantially cylindrical shape preferably shaped as an ergonomic handle to facilitate the operator's grip. Preferably, said second portion 6 is hollow and open at both ends. Particularly, the end connected to the joining portion 7 is provided with a hole 61 allowing a luminous beam to pass therethrough, as will be described below.

[0017] . Said second portion 6 is connected to the first portion 5 by means of the substantially ring-shaped joining portion 7. The ring-shaped portion 7 is provided with a flange 71 surrounding the inlet hole 56 for the inserting means 3 in the first portion 5 and is interrupted by a notch 74 at the seat 54 allowing the insertion of the locking means 4 of probe 8. Particularly, the second portion 6 starts from said flange 71. Furthermore, preferably, the flange 71 has a slightly countersunk shape and the inner wall thereof, in the vicinity of the handle 6, is provided with support means 72 which support light-channelling means (not represented) inside the anoscope during an examination or operation, as will be detailed below. Preferably, the support means 72 consist of two flexible wings 73 defining a space for inserting said support means. Preferably, the support means can consist of an optical bar such as described in the Italian Patent No. 1234169 of the same applicant.

[0018] . The locking means 4 preferably comprise a door being suitable to be releasably snap engaged to the device 1. Particularly, the engagement of the door 4 with the device 1 is provided on the outer surface of the first portion 5 of the dilating means 2. Furthermore, the door 4 is provided with two profiles 48 suitable to be engaged with the undercuts 54^' of the seat 54 such that said door can slide like a drawer within its seat. Preferably, the door 4 has a complementary shape to seat 55 and notch 74 such as to restore the outer and flat outer surface of first portion 5 of the dilating means 2. In addition, the door 4 is ^'provided with retaining means 41 to releasably lock the transmission cable 81 of probe 8. Said retaining means 41 are preferably formed on the inner surface 42 of door 4 and comprise at least one elastic fork-shaped member 43. [0019] . The inventive medical device 1 also comprises inserting means 3. The inserting means consist of a core 3, being commonly called the mandrel or introducer, having a substantially the shape of an open L similar to the L shape of the above dilating means 2. Particularly, the mandrel 3 comprises a substantially cylindrical first portion 31, a substantially channel-shaped second portion 32 with a semi-cylindrical section, and a third portion 33.

[0020] . The first 31 and second 32 portions extend along a common longitudinal axis X-X and are such as to be releasably inserted in said dilating means 2. Particularly, the first portion 31 ends on the one side thereof with a free end having a rounded shape in order to facilitate the insertion of said dilating means into an organ, and on the other side thereof with a solid disc 5 34.

[0021] . Advantageously, the disc 34 has guides 35 for the tip of a needle carrier to be used during proctological operations. Particularly, the guides 35 can consist of a couple of diametrally opposed circular

10 grooves being made such as to house the tip of said needle carrier, as will be detailed herein below.

[0022] . From what has been stated above, it is understood that the disc 34 has a half-circle in common with the half-circle of the second portion 32.

15 Preferably, the guides 35 are placed in the disc half- circle portion 34 opposite to the half-circle in common with the second portion 32.

[0023] . The second portion 32 is the prolongation of the first portion 31 and, as stated above, consists of a

20 sort of channel with a bed having a semi-circular section and facing the convex angle of the L shape of the inserting means 3. Preferably, said second portion 32 is

, open, a longitudinal window 36 being provided on the i bottom thereof.

25 [0024] . The third portion 33 is integrally connected to said second portion 32 and advantageously has a concave section facing the concave angle of the L shape thereof. [0025] . The operation and assembly of the medical device 1 of the present invention will be now described particularly with reference to figures ID and IE.

[0026] . The medical device 1 can be easily and safely assembled by introducing the inserting means 3 in the hole 56 of the dilating means 2 on the rounded end side of the first portion 31 thereof, until^' their third portion 33 abuts against the handle 6 of said dilating means. In this position,, the first portion 31 protrudes from the free end 52 of the dilating means 2, whereas the third portion 33, due to the concave section thereof, fits the cylindrical outer surface of said handle 6. Thereby, a proper and safe assembly is provided by the configuration of the parts of device 1.

[0027] . Subsequently, the probe 8 is attached to the door 4 such that the probe will protrude from the door- to-dilating-means assembly side. Particularly, the transmission cable 81 of probe 8 is fixed by a clip to the fork-shaped members 43.

[0028] . Finally, the door 4 carrying the probe 8 is slid on the dilating means 2 until the probe 8 engages with its seat 55 and, at the same time, the door 4 engages to its seat 54. [0029] . This particular arrangement of the door advantageously allows to considerably reduce the probe size, thus allowing to select more compact probes. Furthermore, the transmission cable can be safely housed on the door, thereby it will not interfere with examinations or use of surgical instruments. [0030] . Accordingly, as better shown in figure IE, the hole 56 of the dilating means 2 and the corresponding channel are completely pervious and accessible. The surgeon will thus be able to carry out for example a hemorrhoidal ligature by means of a needle carrier with thread without any hindrance. In this case, after the assembled device has been inserted in the rectum, the surgeon will be able to place the tool such that the window 53 of the dilating means 2 is either upstream or downstream of the hemorrhoidal varix by means of the probe. At this point, the surgeon will be able to insert a needle carrier with thread in the dilating means channel until the tip thereof will engage with one of the two guides 35 being provided in the disc 34. In this position, the needle with thread is free to rotate at the window 53 of the dilating means 2 for the ligature of the hemorrhoids to be carried out.

[0031] . Furthermore, by means of the display (not illustrated) connected to the probe, the surgeon will be able to evaluate the depth of the rectal mucosa or anal skin and the exact position of the hemorrhoid or hemorrhoidal vein in order to carry out a proper ligature without also damaging the underlying muscular layer. [0032] . A further advantage of the present invention is represented by the guides 35 allowing a surgeon to place the tip of the needle carrier in a precise point and turn the needle carrier to carry out the ligature through the window 53, always taking the same amount of tissue. It is understood that both guides 35 and the monitoring by means of the probe 8 allow a more precise control of the operation than the surgical method adopted so far.

[0033] . In addition, the medical device 1 advantageously allows to carry out also a hemorrhoidal ligature by means of a hemorrhoid band ligator without having to change the device. After the device 1 has been introduced in the organ, the inserting means 3 are removed. At this point, due to the "recorder mouthpiece" prearrangement of the dilating means 2, a band ligator can be used, which is introduced in the cavity of said dilating means 2 and, still through the probe 8, a ligature can be carried out in a very precise manner, in accordance with the known techniques. [0034] . Therefore, it is understood that with a single medical device, two operations can be sequentially carried out during a single surgery session: a ligature by suture with needle carrier with thread and a ligature with a band ligation tool.

[0035] . It should also be considered that the provision of such a door as described above enables to recover the probe without being forced to throw away the whole assembly when using disposable devices. On the other hand, when using reusable devices, the cleaning operations, and mainly for the probe, will be much easier and more accurate.

[0036] . In figures 2A and 2B there is represented a variant embodiment of the invention. Particularly, with number 10 there is designated a medical device in which the parts in common with the device 1 described above are indicated with the same numeral.

[0037] . The medical device 10 is characterized by comprising a seat 57 for a probe 82 of a greater size than the above-described probe 8. Accordingly, depending on particular requirements, the probe size may be such as to enable the monitoring of wide rectal or anal areas.

The characteristics of the seat 57 are fully similar to those described above with reference to the seat 55 of probe 8.

[0038] . Furthermore, the door 4 of the previous embodiment may be replaced with a door 44 provided with two elastic wings 45 which can slide within corresponding guides (not shown) being formed on the outer surface of the dilating means 2 in order to lock the probe 82, such as described above. Alternatively, said wings 45 can be snap engaged due to their elastic capacity. These elastic wings also define a seat to house the transmission cable

81 of the probe 82 in a similar manner to what has been described above with reference to the door 4.

[0039] . As represented in figure 2B, the assembly of the medical device 10 first provides for the probe 82 to be inserted into its seat 55 by sliding in the direction of the arrow F and then for the door 44 to be placed in the suitable seat 56 still by sliding in the direction of the arrow F or by a snap engagement through said elastic wings 45. The seat 57 of probe 82 is preferably narrower than the seat 58 of door 44 such that, when inserted, the door will abut against a shoulder 59, thus avoiding the risk that the probe may be hit and damaged. At this point, the probe 82 is prevented from escaping off its seat, both due to the lock provided by the door 44 and the engagement with the undercuts being formed in the seat itself.

[0040] . In the above-described embodiment, the window enabling the use of a needle carrier for hemorrhoid ligature with suture is not represented. A device of this type can be more preferably used for ligatures by a band ligator. Furthermore, the window being not provided, a larger probe can be used.

[0041] . In figures 3A, 3B and 3C there is represented a further variant embodiment of the invention wherein a medical device 100 is substantially similar to the above- described device 10 and equal numerals are used to designate equal members or portions thereof. [0042] . The present device 100 is characterized by a door 46 being provided comprising a first end 46^' being hinged to the outer surface of the dilating means 2 and a second free end 46". Furthermore, the door 46 is provided with a window 47 which, when in the closed position, enables the probe 82 to come in contact with an organ inner cavity. In this case, the assembly of device 100 provides that the door 46 is lifted by pushing its second end 46'' upwards, the probe 82 is placed within its seat 85 being formed on the outer surface of the dilating means 2, the door 46 is lowered on the dilating means 2 such that the probe 82 faces window 47. It should be noted that the shape of the probe is similar to that described with reference to figures 2A and 2B and the window of door 46 is such as to substantially closely house the outer face of the probe 82. Consequently, the door 46, when lowered, holds the probe 82 in position. [0043] . In addition, the door 46 may be snap engaged to with dilating means 2 by means of ribs 49 (figure 3D) being placed on its portion 46" which engage with matching grooves 74 being provided on the flange 71 of the joining portion 7.

[0044] . The advantage provided by the present embodiment is that the medical device consists of a single piece allowing to place the probe in an easy and quick manner, due to the particular configuration of the door.

[0045] . As may be appreciated by what has been stated above, the present application provides a surgical instrument enabling to resolve the drawbacks cited in the introductory section. [0046] . Furthermore, those skilled in the art, will be able to carry out a number of variants to the instrument, all of which fall within the scope of protection of the claims annexed herein. [0047] . Particularly, the medical device in accordance with the invention may be made of commonly employed plastic materials for medical use such as polypropylene, polystyrene, HD (high-density) polyethylene, whether disposable or reusable. Obviously, in the latter case, the materials will have to be sterilizable for example in ethylene oxide or by means of beta radiations or gamma rays and cleanable with suitable detergents. Alternatively, the device may be manufactured with such material as stainless steel or alloys for surgical instruments such as to allow cleaning and sterilization for repeated use.

[0048] . The inserting means can be replaced with a common mandrel without a handle but provided with a retaining flange such as described for example in the European Patent Application No. 04425364.9 in the name of the same Applicant.

[0049] . Furthermore, the inventive device can comprise housing means suitable to receive, and releasably house lighting means for ea"sy inspection of the organ by the operator. Housing and lighting means may be like those described in the Italian Patent No. 1234169 of the same

Applicant, which are incorporated herein by reference.

[0050] . Particularly, the housing means may consist of a seat formed in the thickness of the dilating means handle, and being such as to house a light source such as of the pen type. The pen source can be releasably secured to the handle for example by snap engagement such as described in said patent. The light source will be placed such as to protrude from hole 61. [0051] . Preferably, the handle can be internally provided with light-guiding means such as those described, again, in said patent, which are optionally- made of or coated with a dark material such as not to blind the operator, and at the same time to focus the light along the channel of said dilating means. Said light-guiding means will engage to the wings 73 being provided in the joining portion 7. Furthermore, due to the opening 36 being formed on the inserting means 3, the light supplied from the light source will not be hindered, hereby ensuring a perfect visibility of the dilating means channel interior.

[0052] . Alternatively, as stated above, a conventional mandrel may be used, which can be removed after the medical device has been inserted in the organ to allow operations. Again, a conventional mandrel made of a clear material and provided with an aperture similar to aperture 36 can be arranged. Thereby, said mandrel will have the same function as the inserting means being described above. [0053] . Furthermore, the medical device can comprise a protective sheath to be applied on the outer surface thereof before use, in order to protect the probe from possible damage. Said sheath can be for example a common condom.

Claims

1. A medical device (1;10;100) for examinations/operations in body organs comprising dilating means (2) suitable to be inserted and hold an organ wide open, and means (3) inserting said device in said organ, characterized by further comprising locking means (4;44;46) to releasably lock a probe (8;82) on said device.

2. The medical device according to claim 1, wherein said locking means (4,-44;46) comprise a door suitable to be reversibly snap engaged with said device.

3. The medical device according to claim 2, wherein said door comprises retaining means (41) to support said probe. 4. The medical device according to claim 3, wherein said retaining means comprise at least one elastic fork-shaped member (43) , and define at least one seat suitable to house the transmission cable (81) of said probe.

5. The medical device according to any claim 2 to 4, wherein said door comprises profiles (48) suitable to be slidingly engaged with corresponding undercuts (54') of the dilating means (2) of the device.

6. The medical device according to any claim 2 to 4, wherein said door (44) comprises two elastic wings (45) suitable to be snap engaged with, or slide within corresponding guides on the dilating means outer surface (2) .

7. The medical device (100) according to any claim 2 to 4, wherein said door (46) is hinged on said dilating means (2) of device (100) .

8. The medical device (100) according to claim 7, wherein said door is provided with a window (47) connecting said probe to the outside of said device (100) .

9. The medical device (1;10;100) according to any claim 1 to 8, wherein said locking means are provided on said dilating means.

10. The medical device (l;10;100) according to any claim 1 to 9, comprising a seat (55;57;85) suitable to house a probe (8;82) . 11. The medical device (1;10;100) according to claim 10, wherein said seat for the probe is formed on said dilating means (2) .

12. The medical device (1) according to any claim 10 or

11. comprising an opening (53) formed on said dilating means in the vicinity of said seat for said probe.

13. The medical device (1;10;100) according to any claim 1 to 12, wherein said dilating means (2) comprise a first recorder mouthpiece shaped open end (52) .

14. The medical device (1;10;100) according to any claim 1 to 13, comprising a handle (6) joint to said inserting means (2) by means of a flange (71) .

15. The medical device (1;10;100) according to claim 14, wherein said flange (71) carries support means (72) to support means channelling the light supplied by lighting means.

16. The medical device (l;10;100) according to claim 15, wherein said support means (72) comprise two flexible wings (73) .

17. The medical device (1;10,-100) according to claim 15 or 16, wherein said lighting means are pen-lighting means.

18. The medical device (1;10;100) according to any claim 14 to 17, further comprising light-channelling means.

19. The medical device (1,10;100) according to any claim 1 to 18, wherein said inserting means (3) comprise a disc

(34) provided with guides (35) for the tip of a needle carrier with thread.

20. A method for carrying out ligatures of body organs' tissues comprising the following steps: - providing a medical device (1;10;100) according to any claim 1 to 19; placing said device within an organ to carry out said ligature; inserting a needle carrier with thread in said device until the tip of said needle carrier will engage with one of both guides (35) of the disc

(34) of the inserting means (3) ; turn the needle carrier by pivoting on said guide

(35) such that the needle with thread may prick the tissue facing the window (53), then carrying out the ligature as desired; monitoring the operation through the probe (8;82) being in the vicinity of the point where said operation is being carried out. 21. The method according to claim 20, further comprising a ligature step through a band ligator wherein said ligator is inserted in said device and a band is shot from the recorder mouthpiece aperture of said device.