JP2013027708A - Adhesive patch vascular applicator - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an apparatus for applying one or more patches to a tubular structure in a body of a patient.SOLUTION: The apparatus includes an applicator, which is configured to removably hold the one or more patches, and to place the one or more patches at least partially around the tubular structure. The applicator includes one or more patch supports. Each of the patch supports includes a yielding pad, which is removably coupleable to one of the patches; and a stiff back support structure, to which the yielding pad is fixed. Each of the patch supports is shaped so as to define at least one chamber that itself has a volume of at least 0.5 ml when the patch supports are in respective resting states. Other embodiments are also described.

Description

  The present invention relates to an applicator system for applying an adhesive compound or sealant compound to tissues and other structures in vivo.

  Tissue adhesives are becoming more prevalent, improving traditional closure techniques such as suturing and stapling, improving sealing function, preventing unwanted leaks, and allowing rapid hemostasis . When using adhesives for tissue rejoining or repair, it is usually necessary to dry the tissue surface. The method of applying the adhesive material affects the effectiveness of the adhesive.

  Hasidov et al., PCT International Publication No. 10/109471, which is incorporated herein by reference, describes a device that can be used on a tubular structure within a patient's body. The apparatus includes an adhesive that includes a first component and a second component, a container, one or more patches, and an applicator. The container contains the first component of the adhesive and does not contain the second component of the adhesive. The one or more patches include a second component of the adhesive and do not include the first component of the adhesive. The applicator is configured to removably hold the one or more patches and place the one or more patches at least a portion of the circumference of the tubular structure.

  Bianco-Peled et al., PCT International Publication No. 06/092798 and US Patent Application No. 2008/0167400, which are incorporated herein by reference, describe a novel substance composition, a method for producing this substance composition, and various different fields. Describes the application of this material composition as an adhesive, especially in the medical fields of medicine, dentistry and veterinary medicine. These techniques allow medical service providers such as surgeons, dentists, and veterinarians to attach body parts or components, such as tissue of a subject (human or animal), eg, wet surfaces. This technique is used in procedures for rejoining or repairing under wet conditions. The composition comprises at least one fluorinated polymer selected from the group consisting of a water miscible polymer in cross-linked form and a polymer formulated from phloroglucinol, a phloroglucinol derivative, and phloroglucinol or a phloroglucinol derivative. Loglucinol type compound. Exemplary water-miscible polymers include naturally occurring or synthetically formulated salt forms of carbohydrate alginic acid, such as sodium alginate or alginic acid itself.

  Bianco-Peled et al., PCT Publication No. 09/060438, which is incorporated herein by reference, is a water miscible polymer that is used in medicine in particular and can interact with phenolic compound pregels and crosslinkers. Explains adhesive bandages including This mixture comprises a solid support so as to form a bandage. It also describes an in-situ method of applying a bandage.

  Bianco-Peled et al., PCT International Publication No. 09/060439, incorporated herein by reference, is an adhesive comprising a pregel formed by a phenolic compound and a water miscible polymer that interacts with a crosslinker. Explains the material composition to be used. It also describes how to apply this adhesive in place.

PCT International Publication No. 10/109471 PCT International Publication No. 06/092798 US Patent Application No. 2008/0167400 PCT International Publication No. 09/060438 PCT International Publication No. 09/060439 PCT International Application No. 2008/001451 PCT International Application No. 2008/001452 PCT International Application No. 2006/000289 US Patent Application No. 11/885555 US Provisional Patent Application No. 61/202688 US Provisional Patent Application No. 61 / 182,771 US Provisional Patent Application No. 61/186911 PCT International Application No. 2010/000268 PCT International Application No. 2010/000431 PCT International Publication No. 2010/140146 PCT International Application No. 2010/000471 PCT International Publication No. 2010/146582

  Some embodiments of the present invention apply an adhesive patch vascular application that applies a patch to a tissue surface, such as a tubular tissue structure within a patient's body (this term includes not only "applying" but also "applying"). Provide data. The applicator is configured to removably hold each patch and place each patch at least a portion of the circumference of the tubular structure. The applicator comprises one or more (usually just two) patch supports. Each patch support includes a bendable pad and a rigid back support structure to which the bendable pad is fixed. In some applications, each patch support is shaped to form one or more chambers, such as just one chamber. Each chamber can constitute a flexible cushioning member of the cushioning pad, allowing the flexible pad to be adapted to the non-uniform shape of the tubular structure to which the flexible pad is attached. Usually, when the patch support is in its resting state, the volume of at least one chamber itself is 0.5 ml or more.

  For some applications, the applicator comprises forceps. A patch support is typically coupled to each arm of the forceps at each distal end of the arm. The arm and patch support are configured such that the front surfaces of the bendable pads face each other. When holding the arm, the front faces approach each other.

  In some applications, the side of each bendable pad is shaped to form one or more slits configured to removably couple a patch to the bendable pad. This side is shaped to form two or more slits, such as just two slits, which are usually placed on either side of the bendable pad. The bendable pad is shaped so that the slit is opened when the front surface is pressed against an object such as a tubular structure, thereby automatically releasing the patch from the bendable pad. Although it is not necessary to be able to open the slit, the chamber or chambers generally allow the center of the front of the bendable pad to be directed toward the back support structure, thereby providing both sides of the bendable pad. By lifting the front edge of the bendable pad to open the slit, it facilitates the opening as described above.

  In some applications, each bendable pad is shaped such that at least when the bendable pad is in its rest state, the center of the front surface forms a protrusion that projects away from the front surface away from the back support structure. It is. This protrusion can serve to concentrate the pressure applied to the tubular structure by the bendable pad and press the patch against the tubular structure. In applications where the patch includes an adhesive hardener, as described below, pressing the protrusions as described above will supply the hardener to the tubular structure and pre-define the tubular structure as described below. It can help in proper contact with the first component of the adhesive being applied.

  In some applications of the present invention, the methods and applicators described herein are used to apply and affix patches and / or materials as an aid in suturing. In some applications, the first material is applied to one or more tubular structures, such as blood vessels and / or artificial blood vessels. Subsequently, one or more patches are applied to the one or more tubular structures using an applicator. In some applications, each patch includes a first material and a second material that is brought into contact with the one or more tubular structures when it is applied to the one or more tubular structures. The applicator typically also helps spread the first material evenly over the one or more tubular structures.

  In some applications, the first material includes a first component of an adhesive (ie, glue or sealant), such as a viscous pregel. For some applications, the second material may include a gel, liquid, solid, spray, or aerosol that can be applied to and / or absorbed into one or more surfaces of the patch. A second component, usually an adhesive curing agent. When the curing agent contacts the first component of the adhesive, it makes the glue more solid, such as a soft solid gel, and attaches it to the tubular structure. The patch can also mechanically support the tubular structure. The patch is usually left on the tubular structure and eventually biodegrades.

  As noted above, the applicators and techniques described herein typically apply adhesives and patches to a tubular structure, eg, a procedure that is applied and applied to a blood vessel such as an artery, vein, and / or artificial blood vessel. used. In some applications, the patch and / or adhesive components are applied and applied to a junction between two tubular structures, such as two tubular body parts, eg, an anastomosis site between two blood vessels. Attached. This junction may be, for example, an end-to-end junction or an end-side junction. Alternatively, the methods and applicators of the present invention can be applied to anatomical structures such as the gastrointestinal tract (eg, colon), bronchus, or brain (eg, dura mater), or patients such as artificial blood vessels (eg, tubular artificial blood vessels). Used to apply and affix the components of the patch and / or adhesive to other structures such as, but not limited to, synthetic structures in the body. Usually this structure is tubular, but this need not be the case.

  The method and applicator of each embodiment of the present invention allows the patch to be applied quickly and accurately across the tissue surface. Such a quick and accurate application is important because the first component of the adhesive generally cures rapidly upon contact with the curing agent. The techniques described herein can be used to apply an adhesive to a wet tissue surface without first having to dry the tissue surface. Also, the techniques described herein are generally useful for patients who undergo anticoagulation procedures for surgery, as is commonly done with vascular surgery.

Thus, according to an application of the present invention, an apparatus for applying one or more patches to a tubular structure in a patient's body, wherein the one or more patches are removably retained and one or more An applicator configured to place the patch on at least a portion of the circumference of the tubular structure and including one or more patch supports, each patch support comprising:
A bendable pad that can be removably coupled to one patch;
A rigid back support structure with a bendable pad fixed,
An apparatus is provided wherein each patch support is configured to form at least one chamber having a chamber volume of 0.5 ml or more when in its respective rest state.

  In some applications, each patch support is shaped to form its at least one chamber between its bendable pad and its back support structure. Alternatively, in some applications, each patch support is shaped to form its entire at least one chamber within the pliable pad.

  In some applications, the pliable pad of each patch support is shaped to form a front facing away from the back support structure and a side surface between the front and back support structure. The side surfaces are shaped to form one or more slits configured to couple one patch to a removably bendable pad. In some applications, the bendable pad is shaped so that the slit is opened when the front surface is pressed against the tubular structure, thereby releasing one patch from the bendable pad. In some applications, the sides are shaped to form two or more slits, such as just two slits, on either side of the pliable pad. In some applications, at least one slit is arcuate at least when in the closed position. In some applications, the end of the at least one slit is positioned at a position closer to the front surface than the back support structure, at least when the one or more slits are in the closed position.

  In any of the applications described above, the bendable pad of each patch support is shaped to form a front face away from its back support structure, and the center of the front face exerts a force on at least the front face. It may be shaped to form a protrusion that protrudes away from the back support structure from the front surface when not being done. In some applications, the bendable pad is shaped so that the central portion of the front surface forms a protrusion rather than the entire front surface.

  In any of the applications described above, the applicator may include forceps including exactly two arms, and the one or more patch supports are just two patch supports each coupled to the two arms. Each patch support may include exactly two bendable pads, and each arm and each patch support may be configured such that the front surfaces formed by the bendable pads face each other. Each arm has sufficient flexibility to limit the maximum amount of force applied to the tubular structure by the patch support when each patch support is placed on both sides of the tubular structure and the arms are gripped It's okay.

  In any of the applications described above, the pliable pad of each patch support may be shaped to form a front surface facing away from its back support structure, each patch support having a central portion of the front surface and The periphery may be configured to apply a respective different force to the tubular structure when pressed against the tubular structure.

In any of the applications described above, at least one chamber of each patch support may be closed.
In any of the above applications, the contact surface between the pliable pad of each patch support and its back support structure may be generally circular.

In any of the above applications, the pliable pad of each patch support may be shaped to face away from its back support structure and form a front surface having a surface area between 3 cm ² and 18 cm ^2. .

  In any of the above applications, the bendable pad of each patch support may be shaped to form a front surface facing away from its back support structure, and the bendable pad front and back support structure The maximum distance between may be between 4 mm and 20 mm.

In any of the above applications, the volume of at least one chamber of each patch support may be 1 ml or more when the patch support is in its respective rest state.
In any of the applications described above, the applicator may be configured to place one or more patches all around the tubular structure.

  In any of the applications described above, the device may further include one or more patches. In some applications, the one or more patches may include a mesh. In some applications, the one or more patches include an adhesive curing agent. For some applications, the adhesive curing agent is the first component of a two-component adhesive, and the device further includes a container that includes the second component of the adhesive. For some applications, the second component of the adhesive comprises a pregel.

  In any of the applications described above, each patch support further includes a gas filling at least one chamber. Alternatively, in any of the applications described above, each patch support may further include a gel that fills at least one chamber.

  In any of the applications described above, the pliable pad of each patch support may comprise a soft polymer. For example, the soft polymer may include silicone. In some applications, the silicone has a hardness between 5 Shore A and 60 Shore A.

  In any of the applications described above, the at least one patch support may be shaped to form exactly one chamber. Alternatively, in any of the applications described above, the at least one patch support may be shaped to form a plurality of chambers each having a volume of 0.5 ml or more.

In any of the applications described above, the tubular structure may be a tubular body part.
In any of the applications described above, the tubular structure may be one or more structures selected from the group consisting of at least one blood vessel and at least one artificial blood vessel.

In any of the above applications, the applicator may be configured to place one or more patches around at least a portion of the circumference of a tubular structure having a diameter between 2 mm and 30 mm.
In accordance with an application of the present invention, an apparatus for applying one or more patches to a tubular structure within a patient's body, wherein the one or more patches are removably retained and the one or more patches are attached. An applicator configured to be disposed on at least a portion of the circumference of the tubular structure and including one or more patch supports, each patch support comprising:
A rigid back support structure,
The front surface is fixed to the back support structure and faces away from the back support structure.
A bendable pad that forms a side surface between the front and back support structures configured to form one or more slits configured to removably bond a patch to the bendable pad An apparatus is further provided.

  In some applications, the bendable pad is shaped so that the slit is opened when the front surface is pressed against the tubular structure, thereby releasing one patch from the bendable pad.

In some applications, the sides are shaped to form two or more slits, such as just two slits, on either side of the pliable pad.
In some applications, at least one slit is arcuate at least when in the closed position. In some applications, the end of the at least one slit is positioned at a position closer to the front surface than the back support structure, at least when the one or more slits are in the closed position.

  In some applications, the bendable pad of each patch support is shaped to form a front face away from its back support structure, and the center of the front face is at least a force applied to the front face. Shaped to form a protrusion that protrudes away from the back support structure from the front when not. In some applications, the bendable pad is shaped so that the central portion of the front surface forms a protrusion rather than the entire front surface.

In some applications, the applicator includes a forceps that includes exactly two arms.
In any of the applications described above, the device may further include one or more patches. In some applications, the one or more patches include an adhesive curing agent.

According to an application of the present invention, a method of applying one or more patches to a tubular structure in a patient's body, comprising:
Each patch support includes (a) a bendable pad to which one patch is removably coupled, and (b) a rigid back support structure to which the bendable pad is secured, each patch support being a respective one thereof. Providing an applicator comprising one or more patch supports shaped to form at least one chamber wherein the volume of the chamber itself is 0.5 ml or more when in a resting state;
There is further provided a method comprising placing the one or more patches around at least a portion of the tubular structure by pressing the one or more patch supports against the tubular structure using an applicator. .

In some applications,
Providing an applicator ensures that the pliable pad of each patch support binds (a) a front surface facing away from its back support structure, and (b) a single patch to the detachable bendable pad. Providing an applicator shaped to form a side surface between the front and back support structures of the bendable pad, shaped to form one or more slits configured in
Pressing the front face against the tubular structure to open the slits, thereby releasing one patch from the pliable pad.

In any of the applications described above, the method may further include releasing the one or more patches from the patch support after deployment.
In any of the above applications, placing may include placing one or more patches around the entire circumference of the tubular structure.

  In any of the applications described above, the tubular structure may be a tubular body part. In any of the applications described above, the tubular structure may be one or more structures selected from the group consisting of at least one blood vessel and at least one artificial blood vessel.

  In any of the applications described above, the tubular structure may be a blood vessel in which a structure selected from the group selected from an artificial blood vessel and a second blood vessel is anastomosed at the anastomosis site, and placing may be one or Disposing a plurality of patches at least a portion of the tubular structure and around the anastomosis site.

  In any of the applications described above, the tubular structure may be a blood vessel that has undergone end-to-end anastomosis at the anastomosis site, and placing the at least one patch around the tubular structure at the anastomosis site. Disposing to the part.

  In any of the applications described above, the method may further comprise applying a first component of the adhesive to the tubular structure prior to placement, wherein the one or more patches are: Including and placing a second component of the adhesive, placing one or more patches on at least a portion of the circumference of the tubular structure, thereby causing the second component of the adhesive to be in the first portion of the adhesive. Contacting with other ingredients. For some applications, the second component of the adhesive includes a curing agent, and placing the one or more patches includes contacting the curing agent with the first component of the adhesive. For some applications, the first component of the adhesive includes a pregel, and applying the first component includes applying the pregel to the tubular structure.

According to an application of the present invention, a method of applying one or more patches to a tubular structure in a patient's body, comprising:
Each patch support includes one or more patch supports including (a) a rigid back support structure and (b) a bendable pad secured to the back support structure, wherein the bendable pad is (i) A front surface facing away from the back support structure; and (ii) a front surface configured to form one or more slits configured to couple a patch to a releasable and bendable pad; Providing an applicator shaped to form a side surface with the back support structure;
Using an applicator, the one or more patch supports are pressed against the tubular structure to open the slits, thereby releasing the one patch from the pliable pad, thereby removing the one or more patches of the tubular structure. Positioning at least a portion of the periphery is also provided.

In some applications, placing includes placing one or more patches around the perimeter of the tubular structure.
For some applications, the tubular structure is a tubular body part. For some applications, the tubular structure is one or more structures selected from the group consisting of at least one blood vessel and at least one artificial blood vessel.

  In some applications, the tubular structure is a blood vessel in which a structure selected from the group selected from an artificial blood vessel and a second blood vessel is anastomosed at the anastomosis site, and placing the one or more patches At least a portion of the perimeter of the tubular structure and anastomosis site.

  In some applications, the tubular structure is a blood vessel that has undergone an end-to-end anastomosis at the anastomosis site, and placing places one or more patches on at least a portion of the circumference of the tubular structure at the anastomosis site Including doing.

  In some applications, the method further includes applying a first component of the adhesive to the tubular structure prior to placement, wherein the one or more patches are the second of the adhesive. Including and disposing the component, disposing one or more patches on at least a portion of the circumference of the tubular structure, thereby contacting the second component of the adhesive to the first component of the adhesive including.

  The invention will be more fully understood by considering the following detailed description of each embodiment of the invention in conjunction with the drawings.

1 is a schematic view of an adhesive patch vascular applicator according to an application of the present invention. FIG. 2A is a schematic view of one patch support of the applicator of FIG. 1 according to an application of the present invention. 2B is a schematic view of one patch support of the applicator of FIG. 1 according to an application of the present invention. 2 is a schematic cross-sectional view of one patch support of the applicator of FIG. 1 according to an application of the invention. 4A is a schematic cross-sectional view of one patch support and patch of the applicator of FIG. 1 according to an application of the present invention. 4B is a schematic cross-sectional view of one patch support and patch of the applicator of FIG. 1 according to an application of the present invention. 4C is a schematic cross-sectional view of one patch support and patch of the applicator of FIG. 1 according to an application of the present invention. FIG. 2 is a schematic diagram of an example of applying two patches to a tubular structure using the applicator of FIG. 1 according to an application of the present invention. FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 5 according to an application of the present invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. It is the schematic of the end side anastomosis performed by the application example of this invention. FIG. 2 is a schematic diagram of an alternative configuration of the applicator of FIG. 1 according to an application of the present invention. FIG. 9A is a schematic perspective view of a finger applicator according to an application of the present invention. FIG. 9B is a schematic perspective view of a finger applicator according to an application of the present invention. FIG. 9C is a schematic perspective view of a finger applicator according to an application of the present invention.

  FIG. 1 is a schematic diagram of an adhesive patch vascular applicator 10 according to an application of the present invention. Vascular applicator 10 is configured to removably retain one or more patches and place the one or more patches at least partially around the tubular structure within the patient's body. For some applications, the applicator 10 comprises a forceps 20 that comprises just two arms 22, typically connected by a spring to the proximal end 24 as in conventional tweezers. A space is formed between the arms that decreases as the arms approach each other and increases as they move away. Alternatively, in some applications, the arms are joined together by hinges, as described, for example, in the aforementioned Hasidov et al. PCT International Publication No. 10/109471 with reference to FIGS. 1A-1F. , Shaped to form respective handles 10 and 11.

  The applicator 10 further comprises one or more (usually just two) patch supports 30. Each patch support 30 is typically coupled to a respective arm 22 at a respective distal end 32 of the arm. Each patch support 30 includes a respective pliable pad 36 that forms a respective front surface 34. Each arm 22 and each patch support 30 are configured such that the front surfaces 34 face each other. When the arm is gripped, the front surfaces 34 approach each other. The surgeon can use his thumb and index finger to apply pressure near the longitudinal center of each arm.

  For some applications, each arm 22 includes a stainless steel or plastic approved for medical use, such as SS302. The forceps 20 may comprise arms having a plurality of sizes suitable for surgeons having different sized hands. Typically, each arm 22 has a length of 10 cm or more, 25 cm or less, and / or between 10 cm and 25 cm, such as 15 cm, and a thickness of 1 mm or more, 3 mm or less, and / or between 1 mm and 3 mm. Yes, for example 1.2 mm. Optionally, each arm 22 is a bendable portion 35 near the distal end 32 of the arm 22, such as to allow direct access to blood vessels and / or anastomoses, even at a depth of a few centimeters. Have The forceps 20 is typically shaped so that it can be used with both hands. Usually, the forceps 20 does not include a lock mechanism.

  In some applications, applicator 10 does not include forceps 20 but includes a single arm and a single patch support 30 (this configuration is not shown). For example, such a configuration may be useful for treating arterial wounds such as those formed during endarterectomy.

In some applications, applicator 10 is disposable or semi-disposable. Alternatively, the applicator 10 is configured to be reusable.
Continuing to refer to FIG. 1, further refer to FIGS. 2A-2B, which are schematic views of one patch support 30, and FIG. 3, which is a schematic cross-sectional view of one patch support 30, according to an application of the present invention. . Each patch support 30 is secured to one bendable pad 36 and a bendable pad using, for example, a medical silicone adhesive (eg, ELASTOSIL® E41, Wacker Chemie AG, Munich, Germany). A rigid back support structure 38. The back support structure 38 is typically shaped as a flat plate. The back support structure 38 and the arm 22 may be formed as a single member (as shown) or by separate members secured to each other (not shown). In some applications, as shown in the figures, the interface between the bendable pad 36 and the back support structure 38 is generally circular, and the back support structure 38 is generally circular. Alternatively, the contact surface has another shape, such as an oval or a rectangle. In some applications, the front surface 34 of each pliable pad 36 is circular. Alternatively, the anterior surface may have another shape, such as an oval or a rectangle that can be used for certain types of anastomoses, for example.

As described above, each pliable pad 36 is shaped to form a front surface 34. The front surface 34 faces away from the back support structure 38. For example, the front surface 34 may have a surface area of 3 cm ² or more, 18 cm ² or less, and / or between 3 cm ² and 18 cm ² , for example, about 5 cm ² . Also, each pliable pad 36 is typically shaped to form a side surface 40 between its front surface 34 and back support structure 38. (Each bendable pad 36 forms a single side 40 even in an application having a shape including multiple edges, such as a rectangle, in which case the side 40 includes the periphery of this shape. Note that).

  Typically, the pliable pad 36 of each patch support 30 comprises a soft polymer such as soft medical silicone, rubber, medical flexible foam, or a closed pore sponge with a high void volume. For example, the polymer can have a hardness of 5 Shore A or higher, 60 Shore A or lower, and / or between 5 Shore A and 60 Shore A, for example, 5 Shore A. The polymer optionally includes a two component silicone. Typically, the maximum width W (shown in FIG. 3) of the pliable pad 36 measured parallel to the back support structure 38 is 10 mm or more, 50 mm or less, and / or between 10 mm and 50 mm, for example 25 mm. It is. (As mentioned above, the bendable pad 36 may be circular, in which case the width W corresponds to the pad diameter.) Due to these dimensions, generally bendable pads typically have a maximum diameter of 10 mm. Even large blood vessels and artificial blood vessels can be covered. Typically, the maximum height H of the bendable pad 36 (shown in FIG. 3), ie, the maximum distance between the front surface 34 and the back support structure 38 measured perpendicular to the back support structure 38 is 4 mm or more. , 20 mm or less, and / or between 4 mm and 20 mm, for example 9 mm. These dimensions (height and width) allow a pliable pad to be applied to a blood vessel having a wide range of diameters and stiffness.

  Still referring to FIG. In some applications, each patch support 30 is shaped to form one or more chambers 42, such as just one chamber 42. Chamber 42 typically includes (a) a gas such as zero air (usually at or above atmospheric pressure), (b) a silicone gel, a polymer gel, and / or a gel having physical or chemical cross-linking, Alternatively, (c) liquid is filled. The chamber 42 can constitute a flexible cushioning member for the bendable pad 36, thereby adapting the bendable pad to the uneven shape of the one or more tubular structures to which the bendable pad is applied. Enable. In applications where the chamber 42 is filled with gas, the gas is generally compressed somewhat when the patch 42 is applied to one or more tubular structures and the chamber 42 is squeezed.

  When the patch support 30 is in its rest state (ie, no force is applied to the patch support, such as the front surface 34), the volume of at least one chamber 42 itself is typically greater than 0.3 ml, such as greater than 0.5 ml. 10 ml or less, and / or between 0.3 ml or 0.5 ml and 10 ml, for example 1 ml or more or 2 ml or more, 10 m or less (eg 5 ml or less), and / or 1 ml to 5 ml, for example (In other words, if multiple chambers 42 have such a volume, not all such chambers cooperate to have such a volume, each of the multiple chambers separately , Having such a volume). Alternatively or in addition, typically the volume of at least one chamber 42 itself is 20% to 80% of the total volume of the bendable pad 36 including the chamber when the bendable pad is in its rest state, And / or between 20% and 80%, for example between 30% and 50% and / or between 30% and 50%. In configurations where the patch support 30 is configured to form exactly one chamber 42, the single chamber 42 typically has a volume of 0.5 ml or more and 10 ml or less when the bendable pad is in its rest state, and And / or between 0.5 ml and 10 ml, for example 1 ml or more or 2 ml or more, 10 ml or less (eg 5 ml or less), and / or 1 ml to 5 ml, for example about 3 ml. Alternatively or additionally, a single chamber 42 is typically 20% or more, 80% or less, and / or 20% of the total volume of the bendable pad including the chamber when the bendable pad is in its rest state. For example between 30% and 50%, and / or between 30% and 50%.

  In some applications, each chamber 42 is sealed or sealed so that no gas or gel can escape from the chamber. In other applications, the chamber 42 has one or more small openings to the outside of the bendable pad 36, allowing some of the gas or gel to escape when pressure is applied to the bendable pad. Can do.

  For some applications, at least one patch support 30 is shaped to form exactly one chamber 42. In other applications, the at least one patch support 30 is shaped to form a plurality of chambers 42 each having a volume of 0.5 ml or more. Note that each chamber is substantially larger than the void (hole) in the silicone sponge. In experiments conducted by the inventor, a bendable pad with a solid silicone chamber did not adapt to the shape of the tubular structure as well as a bendable pad with a chamber as described herein.

  In some applications, each patch support 30 has its flexible pad 36 and its back support structure 38 as shown in FIG. 3 (and FIGS. 4A-4C, 5 and 6). Are formed to form one or more chambers 42 therebetween. In other applications, each patch support 30 is shaped to form the entire chamber 42 within the flexible pad 36 (this configuration is not shown). In some applications in which the applicator 10 comprises exactly two patch supports 30, one patch support is shaped to form at least one chamber 42 and the other patch support forms which chamber 42. It does not form as well.

Reference is now made to FIGS. 4A-4C, which are schematic cross-sectional views of one patch support 30 and patch 50 according to an application of the present invention. Typically, the pliable pad 36 of the patch support 30 can be removably coupled to the patch 50. Patch 50 typically has an effective area of 1 cm ² or more, 40 cm ² or less, and / or 1 cm ² to 40 cm ² , for example, 3 cm ² or more, 15 cm ² or less, and / or 3 cm ² to 15 cm ^2. . In applications where the patch 50 is generally rectangular, the patch typically has a dimension of 6 cm × 2 cm or more, 7.5 cm × 5 cm or less, and / or between 6 cm × 2 cm and 7.5 cm × 5 cm, for example 5 cm × 2.5 cm. In some applications, the patch 50 is provided by the manufacturer in several sizes, such as small, medium, large, and extra large, optionally pre-attached to the patch support 30. Alternatively, a single size patch is provided by the manufacturer (e.g., 7.5 cm x 7.5 cm) and is cut to a specific patient size on site and attached to the patch support during a medical procedure. In the following, some configurations of the patch 50 will be described in more detail.

  FIG. 4A shows the patch support 30 to which the patch 50 is first removably coupled. The patch 50 covers at least a portion (usually all) of the front surface 34 of the flexible pad 36 and is in contact with the front surface.

  FIG. 4B shows the patch 50 partially separated from the patch support 30. The patch 50 is typically automatically separated when the front surface 34 of the pliable pad 36 is pressed against an object 52 such as a tubular structure.

FIG. 4C shows the patch completely separated from the patch support 30 but still in contact with the front surface 34 of the pad that is pliable.
In some applications, as shown in FIGS. 4A-4C (and FIGS. 1, 2A, 3, 5, 5, 7D-7F, and 8), each bendable pad 36 can be Side 40 is shaped to form one or more slits 60 configured to removably couple patch 50 to a pliable pad. In some applications, the side surface 40 is typically shaped to form two or more slits 60, such as just two slits 60, that are typically placed on either side of the bendable pad. Usually, the pliable pad 36, as shown in FIGS. 4B-4C, opens the slit 60 when the front surface 34 is pressed against an object 52, such as a tubular structure, thereby causing the patch 50 to detach from the pliable pad. Shaped to be automatically released. Although it is not necessary to allow the slit 60 to be opened, the chamber or chambers 42 generally allow the center of the front surface 34 to move toward the back support structure 38, thereby providing a flexible pad. Helping to facilitate such opening by raising the leading edge of the bendable pad on both sides and opening the slit.

  In some applications, the at least one slit 60 is arcuate at least when in the closed position, as can be seen, for example, in FIG. 2A. Typically, the end 62 of the at least one slit 60 is located closer to the front surface 34 than the back support structure 38. This shape can help to allow the patch to be released from the slit. Typically, each slit 60 has a maximum depth of 2 mm or more, 25 mm or less, and / or between 2 mm and 25 mm, such as 3 mm or more, 8 mm or less, and / or between 3 mm and 8 mm, such as about 4. 5 mm. Usually, the depth of each slit is not constant along the slit. The depth is greatest at approximately the center in the longitudinal direction of the slit and reaches zero or almost reaches zero at the longitudinal end of the slit.

In some applications, the bendable pad 36 is at least when the bendable pad is in its rest state, ie when no force is applied to the front face 34 (eg, the front face 34 (and the patch support 30)). Prior to being pressed against the object 52, the central portion of the front surface 34 is shaped to form a protrusion 70 that protrudes away from the front surface 34 away from the back support structure 38. Usually, the bendable pad 36 is shaped such that the central portion of the front surface forms a protrusion rather than the entire front surface. For example, the protrusion 70 may be formed by a region between 0% and 80% of the front surface. The protrusions 70 may have various formations, such as a generally rectangular shape with arbitrarily rounded corners as shown in the figures, or an oval shape (eg, a circle). The dimensions of the protrusions are typically less than 50 × 25 × 15 mm (eg, 12 × 17 × 1.5 mm), and the protrusions have a volume of, for example, 200 mm ³ or more, 2000 mm ³ or less, and / or 200 mm ³ to 2000 mm ³ .

  The protrusions 70 can serve to concentrate the pressure applied to the tubular structure by the bendable pad 36 and press the patch 50 against the tubular structure. In applications where the patch 50 includes an adhesive curing agent, this pressing provides a curing agent around the tubular structure, as described below, to properly contact the first material applied to the tubular structure. Therefore, it can help to cure the adhesive in an optimal state in the field. When the applicator 10 is used for an end-to-side anastomosis, the protrusions 70 can help to press the patch and hardener against both the primary and secondary tubular structures in the vicinity of the junction between these structures. . This pressing is believed to be particularly useful when the diameter of the secondary tubular structure is smaller than the diameter of the primary tubular structure, and in the absence of protrusions, the patch and the hardener are narrower secondary tubular. The structure cannot be properly contacted. In some applications, such as when used for end-to-end anastomosis, the applicator is typically configured to place one or more (eg, two) patches 50 around the entire circumference of the tubular structure.

  In some applications, each patch support 30 is configured such that when pressed against the tubular structure, the central and peripheral portions of the front surface 34 apply different forces to the tubular structure. For example, these different forces can be generated by chambers 42 and / or protrusions 70 that change the effective hardness between the ends of the bendable pad. Usually, the central part of the front surface applies a larger force than the peripheral part. In some applications, the bendable pad 36 comprises two or more layers of materials (eg, silicone) each having a different hardness. For example, the front layer may have a higher hardness than the layer forming the side surface forming the slit.

  Reference is now made to FIGS. 5 and 6, which are schematic illustrations of an example of applying two patches 50 to a tubular structure 80 using the applicator 10 according to an application of the present invention. 6 is a cross-sectional view taken along line VI-VI in FIG. The tubular body structure may be a tubular body part, such as a blood vessel or an artificial blood vessel, and usually includes an anastomosis. Typically, the tubular structure is between 2 mm and 30 mm in diameter. As can be seen in FIGS. 5 and 6, the pliable pad 36 is configured to conform to the shape of the tubular structure so that the patch 50 properly contacts the tubular structure 80.

  In some applications, the applicator 10 is used to perform an end-to-end anastomosis, as shown in FIGS. At the time of such anastomosis, first, the blood vessel ends are stitched together using a conventional technique such as suturing. Optionally, a first component 110 of adhesive (eg, pregel) is applied to the blood vessel at the anastomosis site. The applicator 10 is used to apply one or more patches 50 to at least a portion of the circumference of the blood vessel, for example, the entire circumference of the blood vessel. Usually, in such an end-to-end anastomosis, the patches 50 are joined at the regions 122 along the blood vessels on both sides of the blood vessel by the first component 110. In other applications, the anastomosis is an end-to-side anastomosis as described below with reference to FIGS. 7A-7G.

  In general, the arms 22 of the forceps 20 are configured to apply sufficient pressure to the tubular structure to adequately bring the patch 50 into contact with the tubular structure without applying excessive pressure that may damage the tubular structure; For example, having such pressure and shape. The arm 22 is typically configured to bend when a higher pressure is applied than necessary, thereby preventing the forceps 20 from applying excessive pressure to the tubular structure. In some applications, the arm 22 limits the maximum amount of force applied to the tubular structure by the patch support when the patch support 30 is positioned on both sides of the tubular structure and the arm is gripped. Sufficiently flexible.

  For some applications, as shown in FIGS. 5 and 6, the patch support 30 is positioned such that the tubular structure moves generally along the centers of the patch support 30 and the patch 50. In other applications, the tubular structure is not centered at the anastomosis site, but instead is collected at the anastomosis site. For example, the patch support 30 is such that the tubular structure is about one third of the diameter of the patch support. You may position so that it may be located in. It should be noted that the applicator 10 can be used in various orientations relative to the tubular structure depending on the needs of a particular surgical condition, such as vertical, 45 degrees to the tubular structure, or 135 degrees to the tubular structure. . Various orientations were tested in experiments conducted by the inventors.

  In some applications of the present invention, during the first stage of the application procedure, the first material is manually applied to a structure within the patient's body, such as a tubular structure, such as at least one blood vessel or artificial blood vessel. And / or by using a syringe or the like. During the second phase of the procedure following the first phase, the applicator 10 is used to apply one or more patches 50 to the tubular structure. In some applications, the patch 50 includes a first material and a second material that contacts the tubular structure when the patch is applied to the tubular structure.

  For some applications, the first material includes a first component of an adhesive (ie, glue or sealant). In some applications, the first component includes a viscous pregel, and in other applications, the first component includes a liquid, solid, spray, or aerosol. Alternatively, the first material is free of adhesive and may include a viscous pregel, liquid, solid, spray, or aerosol. The first substance may be provided in the container.

  For some applications, the second material may include a gel, liquid, solid, spray, or aerosol that can be applied to and / or absorbed into one or more surfaces of the patch 50. Contains a second component of the adhesive, usually an adhesive curing agent. When the curing agent contacts the first component of the adhesive, it makes the glue more solid, such as a soft solid gel, and attaches it to the tubular structure. The patch can also mechanically support the tubular structure. The patch is usually left on the tubular structure and eventually biodegrades.

  In some applications, such as those described in PCT International Publication No. 09/060438 described above, the first component of the adhesive includes at least one phenolic compound and at least one water-miscible polymer. Contains pregel. The second component of the adhesive includes, for example, at least one cross-linking agent that may include calcium that can interact with at least one water-miscible polymer. In some applications, each patch 50 includes a biodegradable thin membrane, such as plastic, a woven mesh of fabric made from synthetic or natural polymers, or gauze-prepared oxidized cellulose. In some applications, the pregel may include an insoluble suspended solid that may take the form of particles such as fibers. For some applications, the at least one phenolic compound may take a form selected from monomers, non-crosslinked polymers, or crosslinked polymers.

  Reference is now made to FIGS. 7A-7G, which are schematic illustrations of an end-to-side anastomosis performed according to an application of the present invention. As shown in FIG. 7A, the affected part is incised to expose the primary blood vessel 100. By way of example and not limitation, primary blood vessel 100 is shown as a femoral artery. As shown in FIG. 7B, during anastomosis, using conventional techniques such as suturing, the end of a secondary tubular structure 102, such as a second or artificial blood vessel, becomes the primary blood vessel. Anastomoses. For clarity of illustration, the tubular structure is shown joined at an angle of about 90 degrees. In practice, however, the secondary tubular structure is typically joined to the primary vessel at an angle of about 45 degrees.

  During the first phase of the adhesive application procedure, as shown in FIG. 7C, the primary vessel 100 and the secondary tubular structure are bonded to the first component 110 (eg, pregel) of the adhesive at the site 112 of the anastomosis. Apply to 102. The first component 110 may be applied from a container 114 such as a conventional syringe.

  As shown in FIG. 7D, the applicator 10 includes a patch support 30 that includes a patch 50 near the anastomosis site 112 at the junction between the primary vessel 100 and the secondary tubular structure 102. And located on both sides of the primary blood vessel 100 and on both sides of the secondary tubular structure 102. The arm 22 allows proper access even at an anastomosis site deep in the body. The surgeon can observe and adjust the distance between the arms and between the two patches (to avoid the arms being too far apart from each other, or the arms contacting the tissue around the site, Is too close and the arm contacts the first component 110 of the adhesive too early). The surgeon can also observe the position of the patch and adjust it so that the patch is located directly above the first component 110 of the adhesive, which is its optimal position. It should be noted that the applicator 10 can be used in various orientations relative to the tubular structure as needed for specific surgical conditions.

  The surgeon grasps the arm 22 of the forceps 20 and presses the patch support 30 against the patch 50 to contact both the primary vessel 100 and the secondary tubular structure 102 and to contact the first component 110 of the adhesive. The force applied by the patch support 30 to the primary vessel 100 and the secondary tubular structure 102 opens the slit, thereby releasing the patch 50 from the patch support 30. Normally, the patch support 30 is kept in contact with the primary blood vessel for a short time, such as at most about 1 minute, while moderate pressure is applied using forceps. During this time, the curing agent of the patch 50 cures the first component 110 of the adhesive, thereby attaching the patch 50 to the anastomosis site 112 and, as described below with reference to FIG. The patches 50 adhere to each other at a region surrounding this part. Accordingly, the patch 50 is placed at least partially around the primary vessel 100 at the anastomosis site 112. In contrast, in conventional anastomosis, surgeons typically have to apply pressure to the anastomotic site for several minutes to tens of minutes (possibly up to one hour) after suturing. The reason for applying pressure for such a long time is that a large amount of anticoagulant has been administered to the patient or that the suturing has not been performed properly. In some cases, the anastomosis site is at a significant depth within the body, and the surgeon may need to apply pressure over a long period of time with only one finger or two fingers.

  As shown in FIG. 7F, the applicator 10 is removed from the anastomosis site 112, leaving the patch 50 in place. When moderate pressure is applied by the bendable pad 36 of the patch support 30, the patches 50 are generally pressed against each other at a region 120 surrounding the anastomosis site 112. The curing agent in the patch cures the first component 110 of the adhesive at region 120, and the patches adhere to each other at region 120, thereby forming an airtight adhesive seal around the perimeter of the anastomosis. Is done. Where projections 70 are provided, generally more pressure is applied to the patches at areas 120 to help ensure proper contact between the patches at these critical sealing areas.

As shown in FIG. 7G, the surgeon cuts excess material from the patch.
The procedure described above with reference to FIGS. 7A-7G includes applying two components of a two-component adhesive, but applying this technique mutatis mutandis, a one-component type that does not include the first component. An adhesive procedure can be performed, or a procedure for applying one or more patches 50 without adhesive can be performed.

  In about ten experiments conducted by some inventors on pigs, the performance of a patch applicator similar to the applicator 10 described above with reference to FIGS. 1-7G was evaluated. Using a patch applicator and applying the patch in vivo using the method described above with reference to FIGS. 7A-7G, and between the artificial tubular vessel and the carotid artery and between the artificial tubular vessel and the femoral artery Various end-to-side anastomotic sutures between were sealed. In each anastomosis, a pregel was applied using a syringe and a patch containing a sclerosing agent was applied using an applicator. After pressing the patches against the pregel, the applicator was kept sealed for about 1 minute, and moderate pressure was applied to the pregel treated site. The patch curing agent cured the pregel, thereby attaching the patch to the pregel processing site. When the applicator was removed from the pregel treatment site, the patch remained incorporated into the pregel on the pregel treatment site.

  By visual inspection, it was determined that these procedures were successfully performed. The patch also remained in place after the surgeon lightly touched the patch and after cutting the patch in several procedures, as described above with reference to FIG. 7G. These procedures were evaluated as being functionally successful. When the surgeon removed the surgical clamp from the artery, blood flow resumed (indicated by arterial pulsation) and it was found that hemostasis was complete.

  Reference is now made to FIG. 8, which is a schematic diagram of an alternative configuration of the applicator 10 according to an application of the present invention. This configuration can be used in combination with any of the techniques described above. In this configuration, the applicator 10 is configured to allow the surgeon to adjust the pressure in the one or more chambers 42. The surgeon can adjust the volume of gas in chamber 42 before and / or during patch application to optimally place the patch on the tubular structure.

  Applicator 10 includes one or more conduits 130 that each lumen is in fluid communication with the interior of one or more chambers 42. For example, applicator 10 may include two conduits 130 that are in fluid communication with respective chambers 42 in two patch supports 30. Applicator 10 further includes one or more control mechanisms 132 in fluid communication with at least one conduit 130. For example, each control mechanism 132 may comprise a chamber, such as a balloon, configured to have a variable volume, such as a flexible or elastic chamber. Applying pressure to the control mechanism chamber reduces the size of the control mechanism chamber and allows gas to pass from the control mechanism chamber through one or more conduits 130 to one or more of the one or more patch supports 30. It is pushed into the chamber 42. For example, each control mechanism 132 may include a button 134 that applies pressure to the control mechanism chamber when pressed.

  The applicator 10 can be in fluid communication with a plurality of conduits 130, such as two conduits 130 in fluid communication with each chamber 42 of each patch support 30, as shown in FIG. One control mechanism 132 may be provided. Alternatively, applicator 10 may include two control mechanisms 132 in fluid communication with two conduits 130 in fluid communication with respective chambers 42 of each patch support 30 (this configuration is not shown).

  In some applications, the control mechanism 132 is configured to increase the pressure in the at least one chamber 42. Alternatively or additionally, the control mechanism 132 may be configured to reduce the pressure in the at least one chamber 42, such as by allowing gas to escape through the one or more conduits 130.

  In some applications, the applicator 10 is configured to monitor the time to apply the patch support 30. For example, the patch support 30 or patch 50 may include a material that changes color when interacting with the first component 110.

  All references to blood herein should be construed as an example and not as limitations. The technique for applying patches to blood vessels as described herein can be performed in anatomical structures such as the gastrointestinal tract (eg, colon), bronchus, or brain (such as the dura mater) instead of or in addition to blood vessels. Alternatively, it may be used to apply a patch to another structure, such as but not limited to a synthetic structure within a patient's body, such as an artificial blood vessel (eg, a tubular artificial blood vessel). Usually, this structure is tubular, but this is not always the case. In some applications, one or more patches, and optionally an adhesive component, is a junction between two tubular structures, such as two tubular body parts, such as between two blood vessels. Affixed to the anastomosis site and applied. This joining may be, for example, end-to-end joining or end-side joining. In this application, including the claims, the application and application of an adhesive component and one or more patches to a blood vessel optionally comprises two blood vessels of the adhesive component and one or more patches. It should be understood to include application and application to the anastomosis site between.

  Reference is now made to FIGS. 9A-9B, which are schematic perspective views of a finger applicator 200 according to an application of the present invention. Finger applicator 200 includes a single patch support 30 as described above (eg, with reference to FIGS. 2A-2B and 3) and includes a finger coupling member. For some applications, the finger coupling member comprises a flexible band disposed around the surgeon's finger.

  For some applications, the finger coupling member comprises a finger cap 210 coupled to the patch support 30. The finger cap 210 is shaped to form a cavity into which a surgeon's human finger can be inserted and is usually shaped like a finger remover. For example, the cavity opening may have a diameter greater than or equal to 1 cm, less than 2.5 cm, and / or between 1 cm and 2.5 cm, and the length of the cavity along the central longitudinal axis 222 of the finger cap 210 is It may be 1 cm or more and less than 4 cm and / or between 1 cm and 4 cm. For some applications, the finger cap 210 includes a flexible material such as silicone. Alternatively, finger cap 210 may comprise a rigid material such as plastic or metal.

  In applications where the finger cap 210 includes a rigid material, the finger cap can serve as the rigid back support structure 38 and the patch support 30 does not include the rigid back support structure 38 separately. Usually, the patch support 30 is fixed to the finger cap 210. Alternatively, the patch support is supplied to the surgeon separately, and the surgeon couples the patch support to the finger cap.

  Patch 50 is removably coupled to patch support 30 such that the patch contacts a pliable pad. The bendable pad allows the finger applicator 200 to gently apply the patch to a blood vessel or other tubular structure. In some applications, the side 40 of the pliable pad 36 is shaped to form one or more slits 60 as described above.

  For some applications, the patch support 30 extends laterally from the finger cap 210. For example, the line 220 perpendicular to the surface of the patch support 30 may form an angle between 60 degrees and 120 degrees, such as 90 degrees, with respect to the central longitudinal axis 222 of the finger cap 210.

  Reference is made to FIG. 9C, which is a schematic view of a package of a finger applicator 200 according to an application of the present invention. In this application, finger applicator 200 is packaged by protective cover 230 and patch 50 is removably coupled to patch support 30. In some applications, a kit is provided that includes one or more packaged finger applicators 200 and a container. The container contains the first component of the adhesive and does not contain the second component of the adhesive. For example, the first component may be a highly tacky pregel. The patch 50 includes a second component of the adhesive and does not include the first component of the adhesive.

The scope of the present invention includes the embodiments described in the following applications assigned to the assignee of the present application and incorporated herein by reference. In some applications, the techniques and apparatus described in one or more of the following applications are combined with the techniques and apparatus described herein.
PCT international application PCT / IL / 2008/001451 filed on November 5, 2008 and having the name “Adhering band and methods of applying the same” and published as PCT International Publication No. 09/060438 ,
PCT international application PCT / IL / 2008/001452, filed on November 5, 2008, having the name “Adhesives and methods of applying the same” and published as PCT International Publication No. 09/060439,
PCT International Application PCT / IL / 2006/000289 filed on March 2, 2006 and published as PCT International Publication No. 06/092798, and US Patent Application Publication No. 2008/0167400 in the National Transition Procedure Published US patent application Ser. No. 11/885555,
US Provisional Application No. 61/202688, filed on March 27, 2009,
US Provisional Application No. 61/1822771, filed June 1, 2009,
US Provisional Application No. 61/186911, filed June 15, 2009,
PCT international application PCT / IL / 2010/000268 filed on March 28, 2010 and published as PCT International Publication No. 2010/109471,
PCT international application PCT / IL2010 / 000431 filed June 1, 2010 and published as PCT International Publication No. 2010/140146, and PCT International Publication No. PCT / IL2010 / 000431 filed June 15, 2010 PCT International Application PCT / IL2010 / 000471 published as 2010/146582.

In some applications, the methods and applicators described herein are applied mutatis mutandis to applying materials other than adhesives or hardeners.
Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both the various combinations and subcombinations of the features described above, and the various features described above that do not exist in the prior art and are contemplated by those skilled in the art upon reading the above description. Variations and modifications of features are included.

Claims (15)

An apparatus for applying one or more patches (50) to a tubular structure (80) in a patient's body, comprising an applicator (10), wherein the applicator applies the one or more patches (50). Configured to removably hold and position the one or more patches (50) at least a portion of the circumference of the tubular structure (80), the applicator supporting one or more patch supports Each patch support (30) comprising a body (30)
A pliable pad (36) removably connectable to one said patch (50);
A device comprising a rigid back support structure (38) to which the bendable pad (36) is fixed;
Each patch support (30) is shaped so as to form at least one chamber (42) with a chamber volume of 0.5 ml or more when in its respective rest state.   Each patch support (30) is shaped to form the at least one chamber (42) between the pliable pad (36) and the back support structure (38). Equipment.   The apparatus of claim 1, wherein each patch support (30) is shaped to form the entire at least one chamber (42) within the pliable pad (36). The bendable pads (36) of each patch support (30) are:
A front surface (34) facing away from the back support structure (38);
Shaped to form a side surface (40) between the front surface (34) and the back support structure (38), the side surface (40) being able to remove one of the patches (50) to be bent The apparatus of claim 1, 2 or 3, wherein the apparatus is configured to form one or more slits (60) configured to couple to a facile pad (36).   The bendable pad (36) opens the slit (60) when the front surface (34) is pressed against the tubular structure (80), so that the one patch (50) can be The device of claim 4, wherein the device is shaped to be freed from 36).   The device according to claim 4 or 5, wherein the side surface (40) is shaped to form exactly two slits (60) on either side of the bendable pad (36).   The device according to claim 4, 5 or 6, wherein at least one of said slits (60) is arcuate at least when in the closed position.   The bendable pads (36) of each patch support (30) are shaped to form a front surface (34) facing away from the back support structure (38) and of the front surface (34). The central portion is shaped to form a protrusion (70) that protrudes away from the back support structure (38) from the front surface (34) when no force is applied to the front surface (34). Apparatus according to any one of claims 1 to 7.   The apparatus of claim 8, wherein the bendable pad (36) is shaped such that the central portion of the front surface (34) forms the protrusion (70) rather than the entire front surface (34). The applicator (10) comprises a forceps (20) comprising just two arms (22),
The one or more patch supports (30) comprise exactly two patch supports (30) each coupled to the two arms (22);
Each said patch support (30) comprises exactly two bendable pads (36),
The arm (22) and the patch support (30) are configured such that the front surfaces (34) formed by the flexible pads (36) face each other,
The arm (22) is disposed on both sides of the tubular structure (80) so that the tubular structure (80) is supported by the patch support (30) when the arm (22) is gripped. 10. A device according to any one of claims 1 to 9, which is flexible enough to limit the maximum amount of force applied to it.   The bendable pads (36) of each patch support (30) are shaped to form a front surface (34) facing away from the back support structure (38), and each patch support (30). ) Is configured to apply a respective different force to the tubular structure when the central and peripheral portions of the front surface (34) are pressed against the tubular structure (80). The apparatus as described in any one of.   12. Apparatus according to any one of the preceding claims, wherein the at least one chamber (42) of each patch support (30) is closed.   The volume of the at least one chamber (42) of each patch support (30) is 1 ml or more when the patch support (30) is in its respective resting state. The device according to item.   14. Apparatus according to any one of the preceding claims, wherein at least one said patch support (30) is shaped to form exactly one chamber (42).   The apparatus according to any one of the preceding claims, wherein the at least one patch support (30) is shaped to form a plurality of chambers (42) each having a volume of 0.5 ml or more. .

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