WO2011047857A1

WO2011047857A1 - Circular hemostatic apparatus and method of use thereof

Info

Publication number: WO2011047857A1
Application number: PCT/EP2010/006431
Authority: WO
Inventors: Alain Sezeur
Original assignee: Le Groupe Hospitalier Des Diaconesses Croix Saint-Simon; L'université Pierre Et Marie Curie
Priority date: 2009-10-23
Filing date: 2010-10-21
Publication date: 2011-04-28
Also published as: EP2490600A1

Abstract

The device is a circular hemostatic apparatus for use in treating hemorrhoids. The device includes a clamp comprising a hollow cylindrical portion and a tapered head portion. Prolapsed hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane is drawn into the hollow cylindrical portion by way of a vacuum, and the tapered head portion is drawn toward the hollow cylindrical portion to capture the hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane. Ultrasonic or electrical energy is then applied to the clamp thereby forming a circular fused area of tissue and severing the tissue which extends beyond the circular fused area, hi other words, the two edges of the severed inner wall are placed side by side and then anastomosed. A circular blade may be included to sever the tissue.

Description

CIRCULAR HEMOSTATIC APPARATUS AND METHOD OF USE THEREOF

BACKGROUND OF THE INVENTION

Field of the Invention

[0001] The present invention relates generally to a circular hemostatic apparatus and the method of use thereof. In particular, the present invention allows for the treatment of internal or external hemorrhoids by the use of a circular hemostatic apparatus which performs circular fusing and cutting of the mucous membrane and the sub-mucous membrane of the lower rectum without the need for suturing or stapling, thereby reducing or alleviating the hemorrhoids which are fed by the veins of mucous membrane and sub-mucous membrane.

Description of the Prior Art

[0002] It is well-known that hemorrhoids are evidenced by the swelling and inflammation of veins in the rectum or anus. Hemorrhoids affect a large percentage of the population and can be very painful. There are many procedures available for the reduction and alleviation of the symptoms associated with hemorrhoids.

[0003] There are many surgical and non-surgical methods for treating hemorrhoids.

One disadvantage of many of the surgical methods is that the surgery is frequently performed below the dentate line inside of the anal canal, so that many nerve endings are affected and the patient is likely to feel significant pain from the surgery.

[0004] The LONGO method for surgically treating hemorrhoids is well known in the prior art and typically involves surgery above the dentate line thereby reducing the pain felt by the patient. The apparatus involved for this method typically includes a circular anal dilator, an anal endoscopic suturer, a circular anal-rectum stapler and a thread eyelet. This procedure

CONFIRMATION COPY involves the forming of a pocket followed by suturing or stapling, thereby repositioning the anal canal tissue and reducing blood blow to the internal hemorrhoids. This procedure is advantageous in that it is performed above the dentate line inside the anal canal so that the user is less likely to feel significant pain. However, the suturing or stapling, with the foreign bodies left in place within the user's body, is disadvantageous.

SUMMARY AND OBJECTS OF THE INVENTION

[0005] It is therefore an object of the present invention to provide a surgical apparatus and method for the treatment of hemorrhoids wherein the surgery is performed above the dentate line.

[0006] It is therefore a further object of the present invention to provide a surgical apparatus and method for the treatment of hemorrhoids wherein the quantity of foreign materials, such as sutures or staples, left in the patient's body after the surgery is eliminated or reduced.

[0007] These and other objects are attained by providing a surgical hemostatic apparatus and method wherein the hollow center of a clamp is depressurized thereby drawing the prolapsed hemorrhoidal tissue, or other mucous membrane and the sub-mucous membrane, into the hollow center of a clamp. The clamp is closed and ultrasonic energy or electrical energy with a modulated impedance is applied, thereby fusing the tissue captured within the clamp. The prolapsed tissues are therefore severed within the fused portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Further objects and advantages of the invention will become apparent from the following description and from the accompanying drawings, wherein:

[0009] Figure 1 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention inserted into a patient whereby the cylindrical dilator raises the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue.

[00010] Figure 2 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the cylindrical portion of the clamp has been inserted to the cylindrical dilator and the tapered head portion of the clamp has been raised to an open position above the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue.

[00011] Figure 3 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue, has prolapsed into the central channel of the cylindrical portion of the clamp in response to a vacuum or depressurization within the clamp.

[00012] Figure 4 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the tapered head portion of the clamp has closed against the cylindrical portion of the clamp thereby capturing the mucous membrane and submucous membrane, including the hemorrhoidal tissue. The mucous membrane and the submucous membrane include the blood vessels which supply blood to the hemorrhoidal tissue. Ultrasonic or electrical energy is thereafter applied to the circular cutting surface thereby severing the prolapsed mucous membrane and sub-mucous membrane and fusing the edges of the severed inner wall. Additionally, as shown in Figure 5, a circular blade may be provided from the interior wall of the cylindrical portion to sever the prolapsed tissue.

[00013] Figure 5 is a cross-sectional view of an alternative embodiment to that shown in Figure 2, showing a circular blade extending from the interior wall of the cylindrical portion of the clamp.

[00014] Figure 6 is a cross-sectional view of an alternative embodiment to that shown in Figure 2, including lateral apertures for the depressurization of the hollow center of the clamp.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[00015] Referring now to the drawings in detail wherein like numerals indicate like elements throughout the several views, one sees from the various figures that hemostatic apparatus 10 includes an anal dilator 12, a cylindrical portion 14 of the hemostatic clamp and a tapered head portion 16 of the hemostatic clamp.

[00016] Anal dilator 12 includes a hollow cylindrical segment 20 for insertion into the anus of the patient, as well as a cylindrically flared lower portion 22 for limiting the insertion of anal dilator 12. Furthermore, as shown in Figure 1, the anal dilator 12 is used to lift the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue, to an elevated position.

[00017] Cylindrical portion 14 of the hemostatic clamp is cylindrically shaped and hollow, with a central channel 26 formed therein. Circular cutting surface 28 is formed on the top edge of cylindrical portion 14. Retractable stops 29 are used to initially position the hemostatic clamp with respect to the anal dilator 12 (see Figure 1) and are then placed into a retracted position to allow the cylindrical portion 14 to be inserted into the anal dilator 12 (see Figures 2-4). Likewise, circular rubber seal 30 is positioned on the outer surface of the lower edge of cylindrical portion 14. As shown in Figure 2, the movement of cylindrical portion 14 into hollow cylindrical segment 20 of anal dilator 14 urges circular rubber seal 30 urged downwardly to push against the interior of hollow cylindrical segment 20 of anal dilator 14 thereby forming a leak-proof or leak-resistant seal with respect thereto. Cylindrical portion 14 of the hemostatic clamp further includes a lower cylindrical segment 31 of reduced diameter, which includes apertures 32 which communicate with vacuum device 33 for depressurizing central channel 26 so as to draw the hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, into the interior of the cylindrical portion 14 of the hemostatic clamp. These apertures 32 may be positioned on cylindrical portion 14 of the hemostatic clamp 10. Figure 6 shows an alternative embodiment wherein the apertures 32 for depressurizing central channel 26 can be formed laterally on the cylindrical portion 14. Additionally, a source of ultrasonic or electrical energy 34 to provide energy for the cutting process. The electrical energy may be applied with a modulated impedance.

[00018] Tapered head portion 16 of the hemostatic clamp includes a rounded, hemispheric or partially ovoid head 35 with a bottom surface 36 and an outwardly flared seal 38 extending around the periphery of bottom surface 36 to form a leak-proof or leak-resistant seal with respect to the hollow cylindrical segment 20 of the inner wall anal dilator 12 as shown in Figure 1. Tapered head portion 16 is attached to rod 40 which extends through central channel 26 of cylindrical portion 14. Rod 40 allows the tapered head portion 16 to move between a position wherein the hemostatic clamp is open as shown in Figure 2 and a position wherein the hemostatic clamp is closed as shown in Figure 4. The tapered head portion 16 is sized so as to engage against circular cutting surface 28 of cylindrical portion 14 as shown in Figure 4. Rod 40 is used to apply a force to tapered head portion 16 against circular cutting surface 28 and likewise to apply electrical or ultrasonic energy to effect the fusing and cutting of the prolapsed tissue engaged between tapered head portion 16 and circular cutting surface of cylindrical portion 14.

[00019] In order to use hemostatic apparatus 10, the physician or other medical staff first inserts anal dilator 12 into the anus of the patient thereby raising the hemorrhoids as high as possible as shown in Figure 1. The physician or other medical staff can look through the anal dilator 12 to assure themselves that the hemorrhoids are sufficiently elevated. The retractable stops 29 are in place so that the tapered head portion 16 of the hemostatic clamp is inserted to the extent of the upper edge of the anal dilator 12 (outwardly flared seal 38 forming a leak-proof or leak-resistant configuration with respect to anal dilator 14) while cylindrical portion 14 is initially inserted into anal dilator 12 as likewise shown in Figure 1. The stops 29 are then retracted, and cylindrical portion 14 and the tapered head portion 16 are then pushed so that the circular cutting surface 28 of the cylindrical portion 14 reaches the upper end of the hollow cylindrical segment 20 of anal dilator 12 and tapered head portion 16 extends above the prolapsed hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, as shown in Figure 2. As likewise shown in Figure 2, circular rubber seal 30 comes into contact with the inner wall of hollow cylindrical segment 20 thereby forming a leak-proof or leak-resistant seal. It may be the preference of some physicians or other medical providers to delay the movement of tapered head portion 16 away from the leak- proof or leak-resistant configuration of outwardly flared seal 38 as shown Figure 1 until the leak-proof or leak-resistant configuration of circular rubber seal 30 is formed as shown in Figure 2. Additionally, the physician or medical provider may momentarily remove cylindrical portion 14 thereby permitting a better visibility of the level of the rectal mucous membrane which will be resected by operation of the hemostatic clamp 10.

[00020] A sufficiently strong vacuum or depressurization is created in the central channel 26 of cylindrical portion 14 by vacuum device 33 thereby drawing the prolapsed hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, into central channel 26 as shown in Figure 3.

[00021] The tapered head portion 16 is then drawn downwardly so to be urged against the circular cutting surface 28 of cylindrical portion 14. Ultrasonic energy or electrical energy with a modulated impedance is then applied by source 34 to the tapered head portion 16 and/or the circular cutting surface 28 thereby fusing the tissues immediately between the tapered head portion 16 and the circular cutting surface 28 and severing the tissues extending beyond the fused portion. In other words, the two edges of the severed inner wall are placed side by side and then anastomosed. Further, hemostatis is assured by the circular cutting surface 28 thereby forming a circular fused area around the inner periphery of the anal canal. As shown in Figure 5, circular blade 42 extending upwardly from the inner wall of cylindrical portion 14 may be provided in order to sever the tissues extending beyond the fused portion.

[00022] Thus the several aforementioned objects and advantages are most effectively attained. Although preferred embodiments of the invention have been disclosed and described in detail herein, it should be understood that this invention is in no sense limited thereby and its scope is to be determined by that of the appended claims.

Claims

CLAIMS What is Claimed is:

1. A hemostatic apparatus for use in treating the anal-rectum area, comprising: a first clamp portion including a passageway therethrough, one end of said first clamp portion forming a cutting surface; a second clamp portion which can vary in distance with respect to said first clamp portion, wherein the second clamp portion includes a surface for engaging toward said cutting surface, thereby be capable of gripping tissue therebetween; and

a source of energy applied to at least one of said first clamp portion and said second clamp portion to a fused together area in the tissue gripped between the first clamp portion and the second clamp portion.

2. The hemostatic apparatus of Claim 1 wherein the source of energy further severs tissue extending beyond the fused area.

3. The hemostatic apparatus of Claim 2 wherein the source of energy is chosen from the group consisting of ultrasonic energy and electrical energy.

4. The hemostatic apparatus of Claim 3 further including a vacuum source for drawing tissue into said passageway of the first clamp portion and positioning a portion of tissue onto said cutting surface.

5. The hemostatic apparatus of Claim 4 wherein the first clamp portion is cylindrical and wherein said passageway within the first clamp portion is cylindrical thereby causing said first clamp portion to be hollow.

6. The hemostatic apparatus of Claim 1 further including a circular blade extending from the interior wall of the passageway of the first clamp portion.

7. The hemostatic apparatus of Claim 1 further including an anal dilator through which said first clamp portion passes.

8. A method of using a hemostatic apparatus for use in treating the anal-rectum area, comprising the steps of: providing a hemostatic apparatus of the type including a first clamp portion including a passageway therethrough, one end of said first clamp portion forming a cutting surface; a second clamp portion which can vary in distance with respect to said first clamp portion, wherein the second clamp portion includes a surface for engaging toward said cutting surface, thereby be capable of gripping tissue therebetween; and a source of energy applied to at least one of said first clamp portion and said second clamp portion to a fused area in the tissue gripped between the first clamp portion and the second clamp portion; and inserting an anal dilator portion of the hemostatic apparatus into the anus of a patient for raising the hemorrhoids.

9. The method of Claim 8 further including the step of applying a vacuum within the hemostatic apparatus for drawing prolapsed hemorrhoidal tissue into the hemostatic apparatus.

10. The method of Claim 1 further including the step of applying ultrasonic energy or electrical energy to the hemostatic apparatus for forming a circular fused area around the inner periphery of the anal canal.

11. A hemostatic apparatus for use in treating the anal-rectum area, comprising: an anal dilator; a cylindrical portion having a circular cutting surface; and a clamp having a tapered head portion.

12. The hemostatic apparatus of Claim 11, wherein the anal dilator defines

a hollow cylindrical segment for insertion into the anus of the patient.

13. The hemostatic apparatus of Claim 12, further including a cylindrically flared lower portion for limiting the insertion of said anal dilator.

14. The hemostatic apparatus of Claim 1 1, wherein the cylindrical portion is hollow, having a central channel formed therein.

15. The hemostatic apparatus of claim 14, wherein said circular cutting surface is formed on a top edge of said cylindrical portion.

16. The hemostatic apparatus of Claim 11 , further including at least one retractable stop to position the hemostatic clamp with respect to said anal dilator.

17. The hemostatic apparatus of Claim 11, wherein said cylindrical portion further includes a circular sealing flange positioned on an outer surface of said cylindrical portion.

18. The hemostatic apparatus of Claim 11, wherein said cylindrical portion further includes a lower cylindrical segment having an aperture therethrough, said aperture in fluid communication with a vacuum device for depressurizing a central channel of said cylindrical portion as to draw hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, therein.

19. The hemostatic apparatus of claim 11, further including an energy source for applying energy to said tapered head portion thereby fusing tissues between said tapered head portion and said circular cutting surface.

20. The hemostatic apparatus of claim 11, further including an energy source for applying energy to said circular cutting surface thereby fusing tissues between said circular cutting surface and said tapered head portion.