Aorto-mitral heart valve sizer

Abstract

The invention relates to an instrument, also called an aorto-mitral heart valve sizer, for the determination of the size of heart valves that enables during surgical operations with the removal of the aorto-mitral curtain (300) the simultaneous determination of the sizes of the aortic valve and the mitral valve of the human heart, the selection and the subsequent insertion of the aortic valve prosthesis and the mitral valve prosthesis into the human heart. The aorto-mitral heart valve sizer comprises an aortic valve prosthesis template (element 1), a mitral valve prosthesis template (element 2), a first grip member (element 3) that is holding the mitral valve prosthesis template (element 2), and a second grip member (element 4) that is holding the aortic valve prosthesis template (element 1).

Description

[0001] Aorto-Mitral Heart Valve Sizer

[0002] PROBLEM

[0003] To provide a heart valve sizing instrument, also called sizer, that allows simultaneous sizing of the aortic and mitral valve in surgical procedures that include removal of the aorto-mitral curtain.

[0004] TECHNICAL FIELD OF THE INVENTION

[0005] The present invention relates to a sizer that simultaneously sizes two adjacent orifices.

[0006] More precisely, the invention relates to a tool that assists with the selection and simultaneous attachment of both aortic and mitral valve prosthesis in surgical procedures which include replacement of the aorto-mitral curtain.

[0007] BACKGROUND

[0008] The success of the surgical aortic and mitral double-valve replacement in procedures removing the aorto-mitral curtain, known as the “Commando” or “UFO” surgical operations, requires precise valve sizing.

[0009] The difficulty of valve sizing in this situation is caused by the absence of the aorto- mitral continuity and partial or complete absence of the left and right fibrous trigons of the fibrous body of the heart as represented in the drawing Fig. 26.

[0010] After surgical resection of the aortic valve, mitral valve and the part of the central fibrous body that lies between these two valves, the following surgical problems occur:

[0011] 1) By removing the aorto-mitral curtain, the anatomic annular imprints delimiting the non-coronary and left coronary aortic valve annulus and the anterior portion of the mitral valve annulus are not existent.

[0012] 2) Appropriate sizing of the aortic valve and mitral valve is difficult, because these anatomic boundaries are missing. The current valve sizers (example Fig. ..a, ..b) are constructed to size either the aortic or the mitral valve, as typical “orifice sizers” that are optimally proportional to a specific prosthetic device. In the surgical situation consisting of concomitant removal of the aorto-mitral curtain, the two separate aortic and mitral orifices are connected and become one common hole, as it is depicted in Fig. 27.

[0013] 3) False valve sizing may occur easily and simultaneous mismatch of both the aortic and mitral valves prostheses have a significant impact on the postoperative outcome:

[0014] 1. An oversized mitral valve prosthesis increases the tension on the intervalvular pericardial patch and results in bleeding complications. Consequently, the implantation of an oversized mitral valve prosthesis forces the surgeon to implant an undersized aortic valve prosthesis which can result in significant ventriculo-aortic obstruction and patient prosthesis mismatch with all known clinical implications.

[0015] 2. The aorto-mitral angle, named “alpha” in Fig. 3, depends on the anatomical traits of each patient and may differ in the empty arrested heart when compared to the filled beating heart. This makes the use of the presently available aortic and mitral orifice valve sizers inadequate for the use in the “Commando” surgical procedure.

[0016] 3. The removed portion of inter-triangular part of the aorto-mitral curtain differs from patient to patient and the measurement of the length 300 of the removed portion of the aorto-mitral curtain as it is depicted in Figure 26, is important for the shaping and sizing of the pericardial patch used in the operation. This measurement might be a very helpful toll for perfectioning the surgical procedure and improve patient outcome.

[0017] PRIOR ART

[0018] Devices available at present allow separate sizing of the annular orifice of the mitral valve and of the annular orifice of the aortic valve, and thus, they can be used with success in surgical procedures involving with an intact aorto-mitral curtain that separates the two valves.

[0019] Accordingly, a device that would allow simultaneous sizing of the aortic and mitral valves for the replacement with prostheses in the surgical situation where the aorto- mitral curtain has been surgically removed that is not available at present, is now required.

[0020] SUMMARY OF THE INVENTION

[0021] The invention is related to a tool that assists with simultaneous selection and attachment of aortic valve heart and mitral valve heart prostheses.

[0022] The deficiencies of the prior art are overcome with the present invention which includes two orifice sizers - one corresponding to the aortic valve annulus and one corresponding to the mitral valve annulus - which are connected to each other on the midline-axis of the removed aorto-mitral curtain that is defined only by the limits of the resection edges.

[0023] In the first aspect, the invention pertains to a tissue marking device including four parts: two slightly differing cylindrical sections with each having an oppositely attached connector and two slightly differing “L”-shaped handles that can each be specifically attached to only one of the cylindrical sections, and these two “L”-shaped handles can also be connected to each other. One cylindrical section has a diameter approximately equal to the diameter of an aortic heart valve prosthesis, the other cylindrical section has a diameter approximately equal to the diameter of a mitral valve heart prosthesis. The connected portion of the two “L”-shaped handles has a length approximately equal to the longitudinal midline of the missing portion of the aorto-mitral curtain.

[0024] In another aspect, one part of the invention pertains to a tissue marking device including a generally cylindrical section and an “L”-shaped handle attached to the cylindrical section. The generally cylindrical section has a diameter approximately equal to the diameter of an aortic heart valve prosthesis. The cylindrical section is connected to the shorter arm of the “L”- shaped handle, that marks one portion of the longitudinal midline of the removed aorto-mitral curtain. The cylindrical section connected to the shorter arm of the “L”-shaped is positionable to guide the measurement of the aortic valve at any angle existing between the plane of the aortic valve and the horizontal plane of the aorto-mitral curtain and operating field. The other part of the invention pertains to a tissue marking device including a generally cylindrical section and an “L”-shaped handle attached to the cylindrical section. The generally cylindrical section has a diameter approximately equal to the diameter of a mitral heart valve prosthesis. The cylindrical section is connected to the shorter arm of the “L”-shaped handle, that marks the other portion of the longitudinal midline of the removed aorto-mitral curtain. The cylindrical section connected to the shorter arm of the “L”-shaped is positionable to guide the measurement of the mitral valve at any angle existing between the plane of the mitral valve and the horizontal plane of the aorto-mitral curtain and operating field.

[0025] In a further aspect, the invention pertains to a method for guiding the sizing of the pericardial patch that replaces the aorto-mitral curtain. The method includes the simultaneous and opposite movement of the two longer arms of the “L”-shaped handles creating a telescopic movement of the two shorter arms of the “L”-shaped handles that are connected to each other. When the outer endings of the shorter arms of the “L”-shaped handles are abutted against the marking sutures of the removed aorto-mitral tissue, the size of the longitudinal midline of the resected portion of the aorto-mitral curtain is measured.

[0026] In another aspect, the grip members which are equivalent to the two longer arms of the “L”- shaped handles are not occupying the narrow aorta and left atrium as the available valve sizers would do, due to the maneuverability of each connecting part against the other.

[0027] In addition, the invention pertains to a double set of orifice sizers, one aortic and one mitral, each of them including a prosthesis template and one handle extending from the prosthesis template. Each sizer system includes a plurality of sizing cylindrical sections corresponding to prosthesis templates having different diameters.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Fig. 1 is a perspective view of the aorto-mitral heart valve sizer instrument

[0030] Fig. 2 is a top plane view of the instrument template of Fig. 1

[0031] Fig. 3 is a side view of the of the instrument template of Fig. 1 Fig. 4 is a perspective view of element 1 , an aortic valve prosthesis template, of the instrument template of Fig. 2

[0032] Fig. 5 is a top plane view of the element 1 of the instrument template of Fig. 2

[0033] Fig. 6 is a side view of the element 1 of the instrument template of Fig. 2

[0034] Fig. 7 is a cross-section side view of the outer fragment of the connecting part attached to the cylindrical fragment of the element 1 of Fig. 4 and of Fig. 6, in which the surface has been removed to expose internal structure

[0035] Fig. 8 is a side medio-lateral view of the element 1 , when looking frontally into the contact inner surface of the connecting fragment of element 1

[0036] Fig. 9 is a side latero-medial view of the element 1 , when looking frontally to the outer surface of the connecting fragment of element 1

[0037] Fig. 10 is a perspective view of the element 2, a mitral valve prosthesis template, of the instrument template of Fig. 2

[0038] Fig. 11 is a top plane view of the element 2 of the instrument template of Fig. 2

[0039] Fig. 12 is a side view of the element 2 of the instrument template of Fig. 2

[0040] Fig. 13 is a cross-section side view of the outer fragment of the connecting part attached to the cylindrical fragment of the element 1 of Fig. 4 and of Fig. 6, in which the surface has been removed to expose internal structure

[0041] Fig. 14 is a side medio-lateral view of the element 2, when looking frontally into the contact inner surface of the connecting fragment of element 2

[0042] Fig. 15 is a side latero-medial view of the element 2, when looking frontally to the outer surface of the connecting fragment of element 2

[0043] Fig. 16 is a perspective view of the element 3, a first grip member that is holding the mitral valve prosthesis template element 2, of the instrument template of Fig. 2

[0044] Fig. 17 is a front view of the element 3 of the instrument template of Fig. 2 Fig. 18 is a side medio-lateral view of the element 3, when looking frontally into the contact inner surface of the first connecting arm 18 of element 3

[0045] Fig. 19 is a top plane view of the element 3, when looking frontally perpendicular into the cross-section area of the holding arm of element 3

[0046] Fig. 20 is a perspective view of the element 4, a second grip member that is holding the aortic valve prosthesis template element 1 , of the instrument template of Fig. 2

[0047] Fig. 21 is a front view of the element 4 of the instrument template of Fig. 2

[0048] Fig. 22 is a side medio-lateral view of the element 4, when looking frontally into the contact inner surface of the second connecting arm 28 of element 4

[0049] Fig. 23 is a top plane view of the element 4, when looking frontally perpendicular into the cross-section area of the holding arm of element 4

[0050] Fig. 24 is a side view of another alternative view of the instrument template of Fig. 2, in which the outer surface of the connecting areas of element 3 and element 4 can be observed

[0051] Fig. 25 is a longitudinal trans-sectional view of the instrument template of Fig. 2, in which the internal structures of the connecting areas of element 3 and element 4 can be observed

[0052] Fig. 26 is a graphical representation of an anatomical cross-sectional view of the human heart showing the positions of the human valves

[0053] Fig. 27 is graphical representation of a cross-sectional view of the human heart as it looks after the surgical removal of the aortic valve, the mitral valve and the aorto- mitral curtain during the “Commando” operation.

[0054] DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

[0055] An explanation of an embodiment of the present invention will be made below with reference to the drawings.

[0056] Fig. 1 shows the assembled aorto-mitral valve sizer that facilitates simultaneous sizing of the aortic valve, mitral valve and the resected portion of the aorto-mitral curtain during a “Commando” surgical operation performed by a person skilled in the art, as it would be seen in a cranio-caudal view. The instrument is positioned through an incision performed in the ascending aorta and that is prolonged through the aortomitral curtain and into the left atrial dome. The aortic valve is observed and measured through the aortic root, on its aortic surface, with element 1 positioned epianular in the aortic valve annulus and the mitral valve is observed and measured through the left atrium, on its atrial surface, with element 2 positioned epianular in the mitral valve anulus. The assembled aorto-mitral sizer is held by the person skilled in the art with two hands, the left hand holding the long arm 41 of the “L”- shaped element 4 and the right hand holding the long arm 31 of the “L”-shaped element 3.

[0057] As shown in Fig. 2, the instrument consists of 4 elements, where the purpose of element 1 is to size the aortic valve with its cylindrical portion 10, the purpose of element 2 is to size the mitral valve with its cylindrical portion 20, the purpose of element 3 is to support element 2 and the purpose of element 4 is to support element 1 . The connecting part between the element 2 and element 3, as represented by the distance marked by indentation 19 and indentation 29, is equivalent to the midline length of the removed portion of the aorto-mitral curtain during a “Commando” surgical procedure, and it will be described in greater detail later below, as it is depicted by the virtual line 300 in the Fig. 27.

[0058] As shown in Fig. 3, the angle “alpha” between the plane of the aortic valve annulus, in which the cylindrical portion 10 is positioned, and the plane of the mitral valve annulus, in which the cylindrical portion 20 is positioned, may differ according to the anatomical characteristics of each patient.

[0059] As shown in Fig. 4 and in Fig. 5, element 1 consists of three parts: a cylindrical part 10 that is aimed to size the aortic valve anulus, a first connector 17 that enables the attachment of element 1 to the element 4, and an arm 18 which colligates the cylindrical part 10 to the connector 17.

[0060] Fig. 6 depicts the position of the arm 18 in relation to the connector 17 and the cylindrical part 10 of the element 1. This positioning enables free rotation of element 1 connected to element 4 against the element 2 that is connected to element 3, so that the instrument can perform the measurement at any desired “alpha” angle, that has been shown in Fig. 3.

[0061] The cross-section side view of the tubular connector 17, as shown in Fig. 7, is the only part of element 1 that has direct contact to the shorter arm 42 of element 4. The tubular shape of the connector 17 is depicted in Fig. 8 and in Fig. 9 and enables rotation of element 1 against the element 4, as it is individually necessary during the measurement process.

[0062] Of note, the tubular connector 17 has an indentation 19, that is marked in Fig. 1 , Fig. 2, Fig. 5 and Fig. 9. Its function will be described later below.

[0063] As shown in Fig. 10 and in Fig. 11 , element 2 consists of three parts: a cylindrical part 20 that is aimed to size the mitral valve anulus, a second connector 27 that enables the attachment of element 2 to the element 3, and an arm 28 which colligates the cylindrical part 20 to the connector 27.

[0064] Fig. 12 depicts the position of the arm 28 in relation to the connector 27 and the cylindrical part 20 of the element 1 . This positioning enables free rotation of element 2 connected to element 3 against the element 1 that is connected to element 4, so that the instrument can perform the measurement at any desired “alpha” angle, that has been shown in Fig. 3.

[0065] The cross-section side view of the tubular connector 27, as shown in Fig. 13, is the only part of element 2 that has direct contact to the shorter arm 32 of element 3. The tubular shape of the connector 27 is depicted in Fig. 14 and in Fig. 15 and enables rotation of element 2 against the element 3, as it is individually necessary during the measurement process.

[0066] Of note, the tubular connector 27 has an indentation 29, that is situated opposite to indentation 19, and is marked in Fig. 2, Fig. 13 and Fig. 15. Its function will be described later below.

[0067] Fig. 16 and Fig. 17 depict the element 3 of this invention, as it consists of two arms: a first long arm 31 and a first short arm 32 that are positioned perpendicular to each other. The short arm 32 has an extension 33 that is situated beyond the connection point of 31 to 32. The long arm 31 , as depicted in Fig. 16, Fig. 17 and Fig. 18 represents one of the two holder parts of the invention, that is grasped by the person skilled in the art when using the invention to perform sizing and measurement during the cardiac operation. The short arm 32 as depicted in Fig. 16, Fig. 17 and Fig. 19 is a cylinder that enables the connection with the element 4 of the invention, more precisely to the short arm 42 of the element 4 that will be described later below. The extension 33 enables the connection with the element 2 of the invention, more precisely to the connector 27 of element 2, as it is depicted in Fig. 10, Fig. 11 , Fig.12, Fig.13, Fig.14 and Fig.15.

[0068] Fig. 20 and Fig. 21 depict the element 4 of this invention, as it consists of two arms: a second long arm 41 and a second short arm 42 that are positioned perpendicular to each other. The short arm 42 has an extension 43 that is situated beyond the connection point between 41 and 42. Like the long arm 31 that was described before, the long arm 41 , as it is depicted in Fig. 20, Fig. 21 and Fig. 22 represents the other holder parts of the invention, that is grasped by the person skilled in the art when using the invention to perform sizing and measurement during the cardiac operation. The short arm 42 as depicted in Fig. 20, Fig. 21 and Fig. 23 is a bar that is inserted in the cylindrical short arm 32 of the element 3, as it has been described above. In Fig. 20 and in Fig. 25 it is also shown that the short arm 42 has an engraved scale 45 that facilitates the precise measurement of the resected portion of the aorto-mitral curtain 300, as it is depicted as a virtual longitudinal midline in Fig. 27.

[0069] The extension 43 of element 4 enables tie connection with the element 1 of the invention, more precisely to the connector 17 of element 1 , as this is depicted in Fig. 4, Fig. 5, Fig. 6, Fig. 7, Fig. 8 and Fig. 9.

[0070] The telescopic connection of the two short arms 32 and 42 with each other accomplishes the assembling of the entire invention, by connecting all four elements in one aorto-mitral surgical sizing instrument, as depicted in Fig. 1 , Fig. 2, Fig. 3 and Fig. 24.

[0071] Fig 25 shows the longitudinal cross-section of a completely assembled aorto-mitral sizer. The trans-section shows that the telescopic connection between the short arms 32 and 34 enables the use of the scale 45 to determine the exact dimension of the resected portion of the aorto- mitral curtain 300, which needs to be surgically replaced.

[0072] As shown in Fig. 2, the first outer edge 33 of the connecting part 17 of element 1 and the second outer edge 43 of the connecting part 27 of element 2, should be abutted against the resected edges of the trigonal tissues, as marked by the wires 101 and 201 depicted in Fig. 27. The indentation 19 permits perfect apposition of the surgical wire 101 , and indentation 29 permits perfect apposition of the surgical wire 201 . The surgical wires 101 and 201 , as depicted in Fig. 27, are placed by the person skilled in the art to mark the endings of the longitudinal midline of the resected aorto-mitral curtain including parts of the left and right fibrous trigons.

[0073] As shown in Fig. 1 and in Fig. 2, the distance between the indentations 19 and 29 is equal to the length of the longitudinal midline of the resected portion of the aortomitral curtain. The virtual longitudinal midline of the anatomic aortomitral curtain 300 is depicted in Fig. 26 and Fig. 27. The measurement of 300 allows accurate shaping and sizing of the pericardial patch used by the person skilled in the art when performing the “Commando” operation.

[0074] Positioning of the indentations 19 and 29 into the base of the surgical wires 101 and 201 enables the telescopic connection of the two short arms 32 and 42 to separate the aortic annulus from the mitral annulus. The adequate positioning of the instrument by the person skilled in the art, virtually recreates the delimitation between the aortic valve and the mitral valve. Thus, the cylindrical parts 10 and 20 of the elements 1 and 2 will determine the most suitable size of the aortic and mitral valve prostheses, eliminating the risk of mismatch between the aortic valve and mitral valve orifices.

[0075] This kind of appropriate positioning of the indentations 19 and 29 abut the free edges of the resected trigons marked by the wires 101 and 201 makes possible the correct and most adequate sizing of the mitral valve annulus and aortic valve annulus with the elimination of the risk of prostheses oversizing and undersizing.

[0076] Of note, another characteristic of the invention that helps adequate sizing of the aortic valve prosthesis is the possibility of rotating the connector 17 of element 1 against the short arm 42 of the element 4. This rotation allows testing of the aortic template 10 in relation to the size of the left ventricular outflow tract and in relation to the size of the aortic root, as the person skilled in the art knows them. Similarly, the other characteristic of the invention that helps adequate sizing of the mitral valve prosthesis is the possibility of rotating the connector 27 of element 2 against the short arm 32 of the element 3. This rotation allows testing of the mitral template 20 in relation to the size of the left ventricular inflow at the atrio-ventricular junction when this is approached through the left atrial dome, as the person skilled in the art knows it.

[0077] Therefore, the instrument includes a plurality of aortic valve and mitral valve sizer templates. A plurality of elements 1 with differently sized first cylinder 10 can be attached to element 4 and a plurality of elements 2 with differently sized second cylinder 20, can be attached to the element 3.

[0078] This makes it possible to keep a set of differently sized elements 1 and a set of differently sized element 2 available during an operation, allowing the person skilled in the art to test and choose the most appropriate size of the aortic and mitral valve prostheses.

[0079] The set of element 1 contains 6 sizers with an outer diameter of the first cylinder 10 of 19 mm, 21 mm, 2 mm, 25 mm, 27 mm and 29 mm.

[0080] The set of element 2 contains 6 sizers with an outer diameter of the second cylinder 20 of 25 mm, 27 mm, 29 mm, 31 mm. 33 mm and 35 mm.

[0081] Although the invention has been disclosed with reference to certain structural configurations, it will be appreciated that these products are merely representative of many different embodiments of the invention.

[0082] In preferred embodiments, the elements 3 and 4 of the invention with the sizer sets of the multiple elements 1 and of the multiple elements 2 are reusable. Following, use of the sizers, all elements of the invention are sterilized prior to their next use. Appropriate sterilization procedures may depend on the materials used to form the elements. Suitable sterilization procedures include, for example chemical sterilization, radiation sterilization and heat sterilization. INDUSTRIAL APPLICABILITY

[0083] The present invention can be applied suitably to the field of medical instruments.

[0084] DISTRIBUTION AND PACKING

[0085] The invention is distributed as a set comprising: one element 3, one element 4, one sizer set of multiple elements 1 and one sizer set of multiple elements 2. Thus, a sizer will be available to evaluate the size of the aortic valve annulus of a patient in relation to each available aortic valve prosthesis and another sizer set will be available to evaluate the size of the mitral valve annulus of a patient in relation to each available mitral valve prosthesis. The sizing of the aortic valve annulus and of the mitral valve annulus is performed simultaneously.

[0086] For convenience, all elements of the set can be placed within a single container, such as a box, with slots for holding each element. The container can be made to be compatible with radiation or heat sterilization, such that the elements of the sizer set can be sterilized within the container.

[0087] Generally, the sizer sets are distributed to hospitals and any other locations where double valve replacement procedures are performed. Generally, the sizer sets are distributed, such that they are available at the medical facility when needed. The sizer sets can be distributed along with instructions for proper use along with any other desired or required documentation.

[0088] The sizer sets can be sterilized before their storage, so that they are immediately ready to use.

[0089] The embodiments described above are intended to be illustrative and not limiting. Additional embodiments are within the claims below. Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the invention.

Claims

AMENDED CLAIMS received by the International Bureau on 03 June 2025 (03.06.2025) CLAIMS1. An aorto-mitral heart valve sizer device for determining simultaneously the size of the aortic valve and of the mitral valve comprising: a) an aortic valve prosthesis template (element 1 ) with a first cylinder (10) having a diameter approximately equal to an aortic valve prosthesis, with the aortic valve prosthesis template (element 1 ) comprising of three parts: the first cylinder (10), a first connecting arm (18) and a first connector (17); b) a mitral valve prosthesis template (element 2) with a second cylinder (20) having a diameter approximately equal to a mitral valve prosthesis, with the mitral valve prosthesis template (element 2) comprising of three parts: the second cylinder (20), a second connecting arm (28) and a second connector (27); c) a first grip member (element 3) that is holding the mitral valve prosthesis template (element 2); d) a second grip member (element 4) that is holding the aortic valve prosthesis template (element 1 ).

2. The aorto-mitral heart valve sizer according to claim 1 , wherein the first connector (17) of the aortic valve prosthesis template (element 1 ) allows connection of the first cylinder (10) with the second grip member (element 4) that is holding the aortic valve prosthesis template (element 1 ).

3. The aorto-mitral heart valve sizer according to claim 1 , wherein the second connector (27) of the mitral valve prosthesis template (element 2) allows connection of the second cylinder (20) with the first grip member (element 3) that is holding the mitral valve prosthesis template (element 2).

4. The aorto-mitral heart valve sizer according to claim 1 , wherein a first long arm (31 ) of the first grip member (element 3) is the holder and a first short arm (32) with its first outer edge (33) is the first connector (17) connecting with both, the mitral valve prosthesis template (element 2) and the second grip member (element 4) that is holding the aortic valve prosthesis template (element 1 ).

5. The aorto-mitral heart valve sizer according to claim 1 , wherein a second long arm (41 ) of the second grip member (element 4) is the holder and a second short arm (42) with its second outer edge (43) is the second connector (27) connecting with both, the aortic valve prosthesis template (element 1 ) and the first grip member (element 3) that is holding the mitral valve prosthesis template (element 2).Statement under Article 19 (1) of the international Patent Cooperation Treaty (PCT) for the international patent application PCT / EP2024 / 084619May 22, 2025The applicant amends the patent claims of the above captioned patent application, to resolve the objections that were raised in Point VIII of the Written Opinion dated April 07, 2025, of the International Searching Authority. This letter gives a Statement under Article 19 (1 ) PCT, pursuant to Rule 46.4 PCT.1 . Amendments1.

1. Patent claim 2Patent claim 2 is amended by rearranging the features so that patent claim 2 is dependent on patent claim 1. The rearrangement is admissible, because by the rearrangement no further features are added. Furthermore, connection of the first cylinder with the second grip member by the first connector is disclosed in the patent application as filed on page 7, lines 25-28a first connector 17 that enables the attachment of element 1 to the element 4, ..”).1 .

2. Patent claim 3Patent claim 3 is amended by rearranging the features so that patent claim 3 is dependent on patent claim 1. The rearrangement is admissible, because by the rearrangement no further features are added. Furthermore, connection of the second cylinder with the first grip member by the second connector is disclosed in the patent application as filed on page 8, lines 19-23 (“The cross-section side view of the tubular connector 27, as shown in Fig. 13,1 .

3. Patent claim 4Patent claim 4 is amended by rearranging the features so that patent claim 4 is dependent on patent claim 1. The rearrangement is admissible, because by the rearrangement no further features are added. Furthermore, the combination of features of the rearranged patent claim 4 is disclosed in the patent application as filed on page 8, line 29 to page 9, line 5 (“The short arm 32 has an extension 33 that is situated beyond the connection point of 31 to 32. The long arm 31 , as depicted in Fig. 16, Fig. 17 and Fig. 18 represents one of the two holder parts of the invention1 .

4. Patent claim 5Patent claim 5 is amended by rearranging the features so that patent claim 5 is dependent on patent claim 1. The rearrangement is admissible, because by the rearrangement no further features are added. Furthermore, the combination of features of the rearranged patent claim 5 is disclosed in the patent application as filed on page 9, lines 9-16 (“Fig. 20 and Fig. 21 depict the element 4 of this invention, as it consists of two arms: a second long arm 41 and a second short arm 422. ConclusionThe applicant is of the opinion that after the current amendments, the objections in point VIII of the Written Opinion of the International Searching Authority have been resolved.

Images