RU2822079C2 - Bariatric forceps having suture sections, magnetic inserts and curvature - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to medical equipment, namely to embodiments of a bariatric clamp. In a first embodiment, the clamp comprises a first elongated portion having a first proximal end and a first distal end opposite the first proximal end, and a first longitudinal axis that is formed between a first distal end and a first proximal end of the first elongated portion. Clamp has a second elongated portion having a second proximal end and a second distal end opposite the second proximal end, and a second longitudinal axis, which is formed between the first distal end and the first proximal end of the first elongated portion. Clamp includes a curved portion forming a flexible hinge connecting the first and second elongated portions at their respective proximal ends. One of the first elongated portion and the second elongated portion is bent to conform to the curvature of the patient's stomach when the bariatric clamp is in the closed position. When the bariatric clamp is in the closed position, the first elongated portion is a curve that is curved from a portion of the second elongated portion, thereby forming a curved separation between the first elongated portion and the second elongated portion. In the second version, the first elongated section comprises the first substrate element and the first moulded polymer section. In the third embodiment, the first suture section has a recess or an opening passing through the corresponding element of the substrate. In a fourth embodiment, a curved portion comprising a third moulded polymer portion forming a flexible hinge, and the first seam section comprises a recess or an opening passing through a corresponding substrate element. In the fifth embodiment, the third substrate element of the bent section is located at an angle in the first direction relative to the first and second elongated sections, and the fourth substrate element of the bent section is located at an angle in the first direction relative to the first and second elongated sections. First elongated section includes the first seam sections provided in the first element.

EFFECT: creation of a bariatric clamp placed on the patient’s stomach.

53 cl, 84 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[01] Pursuant to 35 U.S.C. 119(e), this application has priority under U.S. Provisional Patent Application No. 62/042,117 entitled “Polymer Overmolded Bariatric Clamp with Suture Portions and Installation Tool”, filed August 26, 2014, and U.S. Provisional Patent Application No. 62/118,455 entitled “Polymer Overmolded Bariatric Clamp with Suture Portions, Magnetic Inserts, and Curvature”, filed February 19, 2015, the entire contents of which are incorporated herein by reference.

TECHNICAL FIELD

[02] The present disclosure generally relates to surgical clamps and surgical clamp mounting tools.

BACKGROUND OF THE ART

[03] The provisions set forth in this section provide only general information relevant to this disclosure and may not define prior art.

[04] Recently, there has been increased interest in the use of surgical forceps to separate parts of the stomach. An example of a bariatric surgical clamp can be found in US Patent Application No. 11/984,452, Jacobs et al., U.S. Patent Application No. 11/797,537, Jacobs et al., and U.S. Patent Application No. 13/017,666, Jacobs et al. The above patent applications are incorporated herein by reference in their entirety.

SUMMARY OF THE INVENTION

[05] In one embodiment, a method of installing a bariatric clamp having at least a first elongated portion, a second elongated portion, and a flexible hinge is provided, the method comprising: creating an opening in the abdomen of a patient to gain access to the patient's stomach; removal of tissue associated with the outer surface of the stomach adjacent to the areas where the bariatric clamp should be placed; positioning the bariatric clip in an open position such that the first end of the first elongated section and the first end of the second elongated section are open relative to each other, wherein the second end of the first elongated section and the second end of the second elongated section are connected by one or more elements including a flexible hinge ; inserting a bariatric clamp into the abdominal cavity through the opening when the clamp is positioned in an open position, with the first elongated portion and the second elongated portion of the bariatric clamp separately extending through the opening in the abdominal cavity; positioning the second elongated portion of the bariatric clamp adjacent to a portion of the outer surface of the second side of the stomach; positioning the first elongated portion of the bariatric clamp adjacent to a portion of the outer surface of the first side of the stomach; and closing the bariatric forceps to apply pressure to portions of the outer surface of the stomach to at least partially separate the cavity within the stomach.

[06] In another embodiment, a polymer-molded bariatric clamp comprises: a first elongated portion having a first backing element located at least partially within the first elongated portion, the first elongated portion including a first adjustable portion; a second elongated section having a second substrate element located at least partially within the second elongated section, the second elongated section including a second adjustable section; a curved portion having a first curved substrate element, a second curved substrate element, and a flexible hinge formed from a polymer molding at a proximal end of the bariatric clamp, the curved portion connecting the first and second elongate portions; a fastening portion located near the distal end of the second elongated portion; and an engaging portion located near the distal end of the first elongated portion, wherein the engaging portion is configured to engage the fastening portion to hold the surgical clamp in a closed position.

[07] In another embodiment, a bariatric clamp is provided comprising: a first elongate member having an engagement portion located at a first end of the first elongate member and a first receiving portion located near a second end of the first elongate member; a second elongated member having a fastening portion located at a first end of the second elongated member and a second receiving portion located near the second end of the second elongated member; and also a curved element having a first retaining element configured to connect the curved element to a first receiving portion of the first elongated element, and also having a second retaining element configured to connect the curved element to a second receiving portion of the second elongated element; wherein the first elongated element and the second elongated element comprise a septum-forming section of the bariatric clamp, and the curved element contains a passage-forming section of the bariatric clamp.

[08] In yet another embodiment, the present disclosure provides a bariatric clamp having a polymer overmolding, wherein the bariatric clamp comprises: a first elongated portion having a first adjustable backing element located at least partially within the first elongated portion; a second elongated portion having a second adjustable substrate element located at least partially within the second elongated portion; a curved portion having a flexible hinge formed from a polymer molding at a proximal end of the bariatric clamp, the curved portion connecting the first and second elongate portions; a fastening portion located near the distal end of the second elongated portion; and an engaging portion located near the distal end of the first elongated portion, wherein the engaging portion is configured to engage the fastening portion to hold the surgical clamp in a closed position.

[09] Additional embodiments and devices, including other areas of application, will become apparent from the description provided herein. It should be understood that this description and specific examples are for illustrative purposes only and are not intended to limit the scope of the present disclosure in any way.

BRIEF DESCRIPTION OF THE DRAWINGS

[10] For a more complete understanding of the various embodiments of the present invention and its advantages, reference is made to the following brief description in conjunction with the accompanying drawings and detailed description, wherein like reference numerals represent like parts, wherein:

[11] Figure 1 shows a view of one embodiment of a surgical clamp engaged with a surgical clamp mounting tool of one embodiment having a hinged head;

[12] Figure 2 is a set of views illustrating the engagement of the surgical clamp with the articulating head of the surgical clamp insertion tool in Figures 2(a), 2(b) and 2(c), as well as the engagement of the clamp shown in Figure 2(d). ) to the closed position shown in Figure 2(e), illustrating a view from six sides of the clamp, including the top view in Figure 2(f), the left view in Figure 2(g), the bottom view in Figure 2( h), the right view in Figure 2(i), the distal end view in Figure 2(j), and the proximal end view in Figure 2(k);

[13] Figure 3 shows a set of views illustrating the surgical clamp positioning tool from six sides, with the right side of the handle housing missing, the set of views including the left view in Figure 3(a), the top view in Figure 3(b ), the right view in Figure 3(c), the bottom view in Figure 3(d), the distal end view in Figure 3(e), and the proximal end view in Figure 3(f);

[14] Figure 4(a) is a perspective view illustrating an example of a surgical clamp installation tool where the right side of the handle housing is missing;

[15] Figures 4(b), 4(c), 4(d) and 4(e) show cross-sectional side views of various aspects of one embodiment of a surgical clamp insertion tool;

[16] Figure 5 shows a view of another embodiment of a surgical clamp engaging with a surgical clamp mounting tool of another embodiment having a hinged head;

[17] Figure 6A shows a top view of a rigid member having a male locking end for the clamp shown in Figure 5;

[18] Figure 6B shows a side view of the rigid member shown in Figure 6A having a male locking end for the clamp shown in Figure 5;

[19] Figure 6C is a side view showing the male locking end of Figure 6B in more detail;

[20] Figure 6D is a sectional view showing a cross-section of the rigid member shown in Figure 6A;

[21] Figure 7A shows a top view of a rigid member having a female locking end for the clamp shown in Figure 5;

[22] Figure 7B shows a side view of the rigid member shown in Figure 7A having a female locking end for the clamp shown in Figure 5;

[23] Figure 7C is a side view showing the female locking end of Figure 7B in more detail;

[24] Figure 7D is a sectional view showing a cross-section of the rigid member shown in Figure 7A;

[25] Figure 8A shows a top view of the spring element for the clamp shown in Figure 5;

[26] Figure 8B shows a side view of the spring member for the clamp shown in Figure 5;

[27] Figure 8C is a close-up sectional view showing a cross-section of the spring element of Figure 8B;

[28] Figure 8D shows a view of the proximal end of the spring element of Figure 5;

[29] Figure 9A shows a side view of the clamp shown in Figure 5;

[30] Figure 9B shows a bottom view of the clamp shown in Figure 5;

[31] Figure 9C shows a view of the proximal end of the clamp shown in Figure 5;

[32] Figure 9D shows a perspective view of the clamp shown in Figure 5;

[33] Figure 10 is a view illustrating a surgical clamp mounted in a substantially vertical position on a human stomach;

[34] Figure 11 is a flowchart illustrating one embodiment of a method for clamping an internal organ;

[35] Figure 12 is a flowchart illustrating another embodiment of a method for clamping an internal organ;

[36] Figure 13 shows a view of yet another embodiment of a surgical clamp engaging a surgical clamp mounting tool of yet another embodiment having a hinged head;

[37] Figure 14 shows a perspective view of the surgical clamp shown in Figure 13;

[38] Figure 15(a) shows a top view of the surgical clamp shown in Figure 14;

[39] Figure 15(b) shows a left view of the surgical clamp shown in Figure 14;

[40] Figure 15(c) shows a bottom view of the surgical clamp shown in Figure 14;

[41] Figure 15(d) shows a right view of the surgical clamp shown in Figure 14;

[42] Figure 15(e) shows the proximal end of the spring in the form of a surgical clamp shown in Figure 14;

[43] Figure 15(f) shows the distal closure end of the surgical clamp shown in Figure 14;

[44] Figure 16 shows a detailed view of the breech end of the lower arm of the surgical clamp shown in Figure 14;

[45] Figure 17(a) shows a top view of the surgical clamp installation tool shown in Figure 13;

[46] Figure 17(b) shows a left view of the surgical clamp installation tool shown in Figure 13;

[47] Figure 17(c) shows a bottom view of the surgical clamp installation tool shown in Figure 13;

[48] Figure 17(d) shows a right view of the surgical clamp installation tool shown in Figure 13;

[49] Figure 17(e) shows the proximal end of the handle in a view of the surgical clamp insertion tool shown in Figure 13;

[50] Figure 17(f) shows the distal end of the handle in a view of the surgical clamp insertion tool shown in Figure 13;

[51] Figure 18 shows a detail view of the left end of the handle of the surgical clamp installation tool of Figure 13, where the left side of the handle housing is missing;

[52] Figure 19 is a perspective view of the surgical clamp shown in Figure 14 having a silicone sleeve engaged therewith;

[53] Figure 20 shows a perspective view of the silicone sleeve of Figure 19 in the disengaged state;

[54] Figure 21 shows a bottom view of the silicone sleeve of Figure 20;

[55] Figure 22 shows the proximal end of the silicone sleeve of Figure 20;

[56] Figure 23 shows a top view of the silicone sleeve of Figure 20;

[57] Figure 24 shows a left view of the silicone sleeve of Figure 20;

[58] Figure 25 shows a cross-sectional view of the distal end of the silicone sleeve of Figure 23;

[59] Figure 26 shows a cross-sectional view of the proximal end of the silicone sleeve of Figure 24;

[60] Figure 27 shows a sectional view of the proximal end of Figure 23;

[61] Figure 28 is a flowchart illustrating a method for performing endoscopic surgery using the silicone sleeve, clamp and insertion tool shown in Figures 13-27;

[62] Figure 29 shows a perspective view of one embodiment of a one-piece surgical clamp that includes first and second substrate elements over which a polymeric material is molded;

[63] Figures 30(a) and 30(b) illustrate the respective side view and perspective view of the one-piece surgical clamp shown in Figure 29, with the polymeric material shown as translucent to show the first and second substrate elements;

[64] Figures 31(a) and 31(b) illustrate the respective first and second substrate elements of the one-piece surgical clamp shown in Figure 29;

[65] Figure 32 illustrates another embodiment of a one-piece surgical clamp that includes first and second substrate elements over which a polymeric material is molded;

[66] Figure 33 shows a perspective view of one embodiment of an installation tool used to install a one-piece surgical clamp;

[67] Figures 34(a), 34(b) and 34(c) illustrate various views of yet another embodiment of a one-piece surgical clamp that includes first and second substrate elements over which a polymeric material is molded;

[68] Figure 35 shows a perspective view of another embodiment of a one-piece surgical clamp that includes first and second substrate elements over which a polymeric material is molded;

[69] Figure 36 is a flowchart illustrating an embodiment of a method for clamping an internal organ;

[70] Figure 37 is a flowchart illustrating another embodiment of a method for clamping an internal organ;

[71] Figure 38 shows a perspective view of one embodiment of a two-part surgical forceps that includes first and second support elements, each of which is molded with a polymeric material;

[72] Figures 39(a), 39(b) and 39(c) illustrate various views of the two-piece surgical clamp shown in Figure 38;

[73] Figure 40 is a perspective view of another embodiment of a two-piece surgical forceps comprising first and second backing elements, each of which is molded with a polymeric material;

[74] Figures 41(a)-41(e) illustrate various views of one embodiment of a bariatric clamp;

[75] Figures 42(a) and 42(b) illustrate one embodiment of an adjustable bariatric clamp in a retracted position and an extended position, respectively;

[76] Figures 43(a) and 43(b) illustrate one embodiment of an adjustable bariatric clamp in a retracted position and an extended position, respectively;

[77] Figures 44(a) and 44(b) illustrate one embodiment of an adjustable bariatric clamp having a ratcheting element, with the clamp shown in a retracted position and an extended position, respectively;

[78] Figure 45 is a flowchart illustrating a method for installing a bariatric clamp;

[79] Figure 46 illustrates the bariatric clamp shown in Figures 41(a)-41(e) in a substantially unfolded position;

[80] Figure 47 is a flowchart illustrating a method for inserting a bariatric clamp into the abdomen of a patient;

[81] Figures 48(a) and 48(b) illustrate various views of a patient's stomach;

[82] Figures 49(a) and 49(b) illustrate various views of one example embodiment of the leveling device;

[83] Figures 50(a), 50(b), 50(c) and 50(d) illustrate one embodiment of the described bariatric clamp in various closed and open positions;

[84] Figures 51(a), 51(b) and 51(c) illustrate one embodiment of the described bariatric clamp in various curved positions;

[85] Figure 52(a) illustrates one embodiment of the described clamp in a closed position with the flexible joint in a compressed or unexpanded position;

[86] Figure 52(b) illustrates one embodiment of the described clamp in a closed position with the flexible joint stretched or expanded;

[87] Figures 53(a)-53(e) illustrate various views of the engagement member and fastening portion of one embodiment of the described bariatric clip;

[88] Figure 54(a) illustrates one embodiment in which the described bariatric clamp of one embodiment is mounted on the stomach, wherein the first and second adjustable portions are hinged such that the curved portion is angled in a first direction relative to the first and second extended sections;

[89] Figure 54(b) illustrates another embodiment in which the described bariatric clamp of one embodiment is mounted on the stomach, wherein the first and second adjustable portions are hinged such that the curved portion is angled in a second direction relative to the first and second extended sections;

[90] Figure 55 illustrates one embodiment of the described clamp having ligature needles embedded in a polymer overmolding;

[91] Figures 56(a) and 56(b) illustrate various views of one embodiment of a clip having a single insert along each elongated portion;

[92] Figures 56(c) and 56(d) illustrate various views of one embodiment of a clip having a plurality of inserts along each elongated portion;

[93] Figures 57(a)-57(c) illustrate various embodiments of a clip having inserts located at various locations within the elongated portions of the clip;

[94] Figures 58(a) and 58(b) illustrate various views of one embodiment of a clip having a single insert along each elongated portion and no attachment or engagement portions;

[95] Figures 58(c) and 58(d) illustrate various views of one embodiment of a clip having a plurality of inserts along each elongated portion and no attachment or engagement portions;

[96] Figures 59(a) and 59(b) illustrate various views of one embodiment of a clamp having curved elongated portions;

[97] Figure 60(a) illustrates a perspective view of a patient's stomach;

[98] Figure 60(b) illustrates a cross-sectional view of the stomach shown in Figure 60(a);

[99] Figure 61 illustrates an embodiment of a clamp having curved elongated portions mounted on a patient's stomach;

[100] Figure 62 illustrates one example of a clamp embodiment;

[101] Figures 63(a)-63(n) illustrate cross-sectional views of various embodiments of one elongated clamp portion shown in Figure 62;

[102] Figure 64 illustrates one example embodiment of a polymer overmolded bariatric clamp having suture portions;

[103] Figure 65 illustrates a perspective view of the clamp shown in Figure 64, with the polymeric material shown as translucent to show the first and second substrate elements;

[104] Figures 66(a) and 66(b) illustrate exemplary embodiments of the respective first and second clamp substrate elements shown in Figure 64;

[105] Figures 67(a), 67(b) and 67(c) illustrate various views of one embodiment of the clamp shown in Figure 64, where the overmolding portion has been removed to reveal a portion of the underlying substrate;

[106] Figure 68 illustrates a view of the first elongated portion of the polymer overmolded bariatric clamp shown in Figure 64;

[107] Figure 69 illustrates a view of the second elongated portion of the polymer overmolded bariatric clamp shown in Figure 64, where the polymer overmolded portion has been removed to reveal the underlying substrate element;

[108] Figure 70 illustrates one example embodiment of a polymer overmolded bariatric clamp having an opening in the flexible hinge of the curved portion of the clamp;

[109] Figure 71 illustrates one embodiment of the clamp shown in Figure 70, wherein the flexible joint includes substrate elements;

[110] Figure 72 illustrates one embodiment of the clamp shown in Figure 70, wherein the flexible joint includes substrate elements arranged to overlap each other;

[111] Figure 73 illustrates the flex joint of Figure 72 in an extended position with the substrate elements enclosing the flex joint opening;

[112] Figure 74 illustrates one example embodiment of the clamp shown in Figure 70, wherein the flexible joint includes a wire member;

[113] Figure 75 illustrates one embodiment of a wire member having an annular portion embedded in a flexible joint molding and positioned around the periphery of the opening;

[114] Figure 76 illustrates one embodiment of a wire element having an annular portion located outside the overmolding and within the perimeter of the hole;

[115] Figure 77 illustrates one example embodiment of the clamp shown in Figure 74 in a relaxed position, with the wire member having additional slack incorporated into the flexible joint;

[116] Figure 78 illustrates the clamp shown in Figure 77 in a stretched position, using the slack in the wire element to allow the flexible joint to stretch;

[117] Figure 79 illustrates one example embodiment of the clamp shown in Figure 70, wherein the flexible joint includes a small opening;

[118] Figures 80(a) and 80(b) illustrate one example embodiment of the clamp shown in Figure 70, where there is a plate mounted on top of the curved portion of the clamp;

[119] Figure 81 illustrates one example embodiment of a clamp having a T-shaped fastening device integrated into a flexible joint to secure the clamp to the stomach.

[120] Figure 82 illustrates one example embodiment of a clamp having a loop pre-attached to the suture portion to speed up and facilitate suturing the clamp to the stomach.

[121] Figure 83 illustrates one example embodiment of a clamp having a barbed suture with a hook at its distal end to speed and facilitate suturing the clamp to the stomach.

[122] Figure 84 illustrates one example embodiment of a clamp having a suture with a T-shaped fastening device at its distal end to speed and facilitate suturing the clamp to and securing to the stomach.

[123] In some Figures the dimensions are given in feet. However, it should be understood that the various embodiments are not limited to the dimensions shown. These dimensions are for illustrative purposes only.

[124] In some Figures, dotted lines indicate the ability to change the length of discrete sections.

DETAILED DESCRIPTION OF THE DRAWINGS

[125] The following description is illustrative in nature only and is not intended to limit the present disclosure, application or scope of application. It should be understood at the outset that although an example embodiment of the present invention is illustrated below, the present invention may be implemented using any number of technologies, whether currently known or existing in principle. The present invention is not to be limited in any way by the exemplary embodiments, drawings, and techniques illustrated below, including the exemplary designs and implementations illustrated and described herein. In addition, the drawings contained herein are not necessarily to scale and may contain various sizes, shapes and configurations. Any dimensions given are provided for illustrative purposes only and are not to be construed in any way as limiting the present invention unless such dimensions are expressly given therein, except as to aspects related to the indication of the size or dimensions.

[126] In Figure 1, a surgical clamp 100 of one embodiment (also referred to herein as a bariatric clamp) is engaged with a surgical clamp installation tool 102 of one embodiment. In these embodiments, the clamp 100 and placement tool 102 are designed to perform bariatric surgery via a trocar. The clamp 100 in one preferred embodiment may be approximately fifteen to thirty centimeters in length to allow separation of the human stomach. To satisfy the requirement of insertion through a trocar, the closed clamp 100 should preferably have a diameter or peripheral dimension of less than fifteen millimeters over its entire or most of its length. The non-handle section of the insertion tool 102 for insertion through the trocar has the same diameter or a smaller diameter. It is contemplated that other embodiments of the clamp and installation tool may have different dimensions. It is further contemplated that the clamp may be articulated in at least one plane to provide different angles and lengths with respect to stomach division. It is also contemplated that other embodiments of the clamp and installation tool may be used to clamp other parts of the human body and/or to clamp other types of bodies or structures. Finally, it should be understood that the installation tool 102 may be used to install a surgical clip in embodiments other than those explicitly illustrated in the Figures.

[127] As shown in Figure 2(a), the surgical clamp 100 has two elongate members 104A and 104B. A curved portion 106 connects the two elongate members at the proximal end of the clip 100 and biases the two elongate members into an open position at the distal end of the clip 100. As used herein, the curved portion is a loop, bend, hinge, angle, cavity, fold, or the like. design. In some embodiments, the curved portion has one or more engagement elements, such as a slot opening 108 such as shown in Figure 2(b). It should be understood that, in some embodiments, the engagement element of the curved portion may be referred to as a fastening element. The locking mechanism in one embodiment has a male component 110 located on one of two elongated members at the distal end, as well as a female component 112 located on the second of the two elongated members at the distal end.

[128] Particularly for partial gastric division during bariatric surgery, the gap between the two elongate members 104A and 104B results in the formation of two or more clamp sections, as best illustrated in Figure 2(e). At least one of these sections is a separation-forming section 105A located closer to the distal end of the clamp 100 than the proximal end of the clamp 100. At least the other of these sections is a passage-forming section 105B located closer to the proximal end clamp 100, for example, near the curved portion 106 than toward the distal end of clamp 100.

[129] To reduce trauma to the organ being divided, liner material 116 may be attached to one or more of the two elongate members. For example, liner material 116 may be attached to elongate member 104B at at least a location corresponding to at least a portion of the generatrice. section division. In some embodiments, the liner material may consist primarily of silicone or entirely of silicone or other polymeric material. It is also contemplated that the opposite legs of the clamp may be equipped with magnets to assist in closing.

[130] In some embodiments, the engagement element at the proximal end of the clip 100 may be a slot opening 108, as shown in Figure 2(b), having a width as well as a length greater than the width. The length of the slot opening may be oriented perpendicularly or at an angle relative to the longitudinal axis of the clamp 100. It is contemplated that other types of engagement elements may be used, such as a socket, a loop, a hook, a lock, a thread, a magnet, etc.

[131] In some embodiments, the male lock component 110 at the distal end of the clip may be the end of the elongate member 104A that deviates from the longitudinal axis of the clip when the clip is forced into the closed position. Accordingly, the female component 112 may be a loop attached to the end of the elongate member 104B and configured to engage the male component 110 of the elongate member 104A when the clamp is forced into a closed position. This can be seen more clearly in Figure 2(e). It is contemplated that other types of locking components may be used, such as those found in a hinge, such as a flex hinge, hook and loop, circlip, lobster or pawl clasp, frog clasp, tube, tongue and tongue hole , screw and threaded hole, or any other type of locking structure.

[132] As shown in Figure 1, and as shown generally in both Figure 1 and Figure 2, the clamp 100, when in use, engages the installation tool via a slot opening 108. For example, the installation tool 102 has an elongated member such as a drawbar 138 having a proximal end and a distal end having an engaging member. The distal end of the elongated element of the installation tool 102 engages the proximal end of the clamp 100 through a slot opening 108 of the curved portion 106. In some embodiments, the engagement element takes the form of a T-bar 118. This T-bar 118 is sized and shaped such that to allow it to be inserted through the slot 108 to engage the clip 100. It is contemplated that other engagement elements may be cruciform in shape and may be configured to be inserted through the cruciform slot in the clip. Other forms are also possible.

[133] The installation tool 102 may include a lever radially engaged with a pull rod at its proximal end on the handle 122, which may be configured as a finger control wheel 120 extending from the handle 122 of the installation tool 102 through an opening. When the T-bar 118 is inserted through the slot 108, actuating the finger wheel 120 may cause the T-bar 118 to rotate ninety degrees, as illustrated in one embodiment, from the first position shown in Figure 2(c). , to the second position shown in Figure 2(d).

[134] At this point, the drawbar retraction, which can be achieved by squeezing the drawbar retraction trigger 128, causes the proximal end of the clamp 100 to come close to and then engage between the guide members of the surgical clamp insertion tool 102, such as a pair of wedges 124A. and 124B formed in the hinge head 126 of the installation tool 102 (see Figure 2(b)). The curvature or inclination imparted to the hinge head of the installation tool 102 by the pair of wedges may correspond to the curvature or inclination of the curved portion 106 of the clamp 100 such that fully retracting the drawbar forces the normally open clamp 100 into a closed position, such as shown in Figure 2(e). ).

[135] In Figures 2(f)-2(k), the various elements of the clamp can be easily seen and understood. These elements include curved portion 106, slot opening 108, male component 110, female component 112, and liner material 116. It should be clearly understood that liner material 116 may be formed as a pair of sleeves as shown, but may Other configurations may be used. In addition, non-linear shapes can be used if necessary in a number of applications for clamping various types of organs.

[136] As shown in Figure 3 with reference generally to Figure 1 and Figure 3, retraction of the drawbar of the installation tool 102 is accomplished by actuating or moving another lever or actuator engaged with the proximal end of the drawbar. , for example, by means of axial engagement. This lever may be in the form of a trigger 128 protruding from the handle 122 through an opening or slot. The shape of the handle and the location of the trigger are preferably ergonomically adapted to allow the surgeon to hold the insertion tool parallel to the ground at approximately waist level to grasp the handle 122 and trigger 128 with one hand. The finger control wheel 120 is located within easy reach of the thumb of that hand to assist in holding the clamp 100 by the surgeon in the other hand when the clamp is engaged with the articulation head 126. The finger control wheel 120 can be suitably adjusted to rotate the T- shaped rod 118 into the desired position to secure the T-shaped rod 118 in the clamp 100 on the curved portion 106 through the slot opening 108. In one embodiment, the finger control wheel 120 can rotate the T-shaped rod 118 ninety degrees.

[137] After the surgeon has rotated and pulled back the traction bar using the T-bar 118 and the trigger 128 with one hand, the surgeon's other hand is freed to perform other tasks, such as operating another lever protruding from the handle 122 and formed, for example, in the form of an adjustment disk 130. When the clamp 100 is tightened and locked or partially blocked by a pair of wedges, the head 126 can pivot from side to side due to the rotation of this adjustment disk 130. The movement of the articulated head 126 by rotation of the adjustment disk 130 is illustrated in In one embodiment, a top view of the installation tool 102 in Figure 3(b) shows an arrow 300 indicating the range of motion or articulation in one embodiment.

[138] As shown in Figure 4, in some embodiments, rotation of the adjustment dial 130 may result in rotation of a sleeve 132 or connector located within or adjacent to the handle 122, which is connected to a pair of guides 134A and 134B. These guides 134A and 134B, together with the draw rod 138, may extend through an elongated rigid sleeve, such as a cylindrical tube 136, for connection on either side of the articulation of the articulation head 126. It is contemplated that the guides may be flexible or rigid; the cylindrical tube 136 may be rigid. or semi-rigid, and the drawbar 138 may be rigid or semi-rigid. The term "semi-rigid" implies that the draw rod 138 may be flexible or partially flexible at least in the plane of articulation along at least a portion of its length near the distal end of the installation tool 102, while remaining axially and rotationally rigid or semi-rigid along its length. length. Thus, when the installation tool 102 and clamp 100 are held parallel to the ground, the drawbar 138 can be rotated and retracted by actuating the finger wheel 120 and the trigger 128, and the head 126 can be rotated in a plane orthogonal to the force vector gravity by manipulating the adjustment dial 130. The articulation plane may be adjusted in certain embodiments or may be set in a desired plane that is not orthogonal to the gravity vector.

[139] As shown in Figure 5, other embodiments of the clamp 200 and installation tool 202 may include a multi-part clamp 200, a longer main tube 204, as well as a thumb lever 206 located on the adjustment dial 130, to pivot the tool head 102 attached to the clamp 200. In some embodiments, the clamp 200 may be a three-piece clamp. The installation tool 202 may also be provided with a ratchet release mechanism 208 that, when depressed, allows the draw bar to extend, which in turn causes the clamp 200 to release, allowing it to reopen. In other words, when the surgeon presses the trigger 210, which causes the drawbar to retract and the clamp 200 to close, the ratchet mechanism locks the trigger 210 in the depressed position. Thus, the pull rod will remain retracted without the clamp 200 re-opening even if the surgeon releases pressure on the trigger 210.

[140] As shown in Figure 6 and with reference generally to Figures 6A-6D, one portion of a three-piece clamp may be a rigid member 212 having a male locking end 214. As will be described below with reference to Figure 9, this rigid element 212 serves as one of the elongated elements of the clamp 200 to form a partition separating the stomach. It can be made of plastic, metal or any other hard material. An example of such a material is hardened titanium. Figure 6(c) shows an example contour of the male locking end 214, and Figure 6(d) shows an example contour of the rigid member 212. It should be made clear that the exemplary contour of the rigid member 212 is concave on the inner surface located at towards the outer surface of the organ to be clamped, and convex on the outer surface to engage the spring component. However, other forms may be used if necessary.

[141] As shown in Figure 7 with reference generally to Figures 7A-7D, the other portion of the three-piece clamp may be a rigid member 216 having a female locking end 218 that includes a hinged loop 220 As will be described below with reference to Figure 9, this rigid element 216 serves as one of the elongated clamp elements to form a partition separating the stomach. It can be made of plastic, metal or any other hard material. An example of such a material is hardened titanium. Likewise, loop 220 may be made of various materials, such as titanium wire.

[142] As shown in Figure 8 with reference generally to Figures 8A-8D, the third portion of the three-piece clamp may be a spring member 222 having a slotted curved portion 224. As will be further described below with reference to 9, the spring member engages the rigid members to form a clamp and creates a curved portion allowing a passage to be formed between the two separated regions of the clamped stomach. It can be made of plastic, metal or any other elastic material. An example of such a material is a hardened titanium spring.

[143] As shown in Figure 9 with reference generally to Figures 9A-9D, a three-piece clamp may be assembled by engaging rigid members 212 and 216 with spring member 222. For example, rigid members may be welded or connected to the spring element arms at various points 226. In one embodiment, the rigid elements 212 and 216 may be attached to the internal surfaces of the spring element arms 222, wherein the hinge 220 is pivotable in the direction of the male locking end 214 of the distal end of the rigid element 212 and engaging with it. Thus, the rigid members 212 and 216 are used to form a septum, while the spring member 222 defines a passage between the separated areas of the organ or body, as shown in Figure 10. These rigid members 212 and 216 may have uneven thickness to allow gradual closing the clamp from the proximal end towards the distal end so that organ structures of uneven thickness, such as the stomach wall, can be clamped without causing injury. Alternatively or additionally, the sleeves of cushioning material can slide along the clamp arms, whereby the cushioning material can, if necessary, have an uneven thickness. It is contemplated that the rigid members 212 and 216 and the spacer material may be constructed as desired in variable lengths, variable profiles, and variable thicknesses to suit different patient use requirements.

[144] As shown in Figure 10, some embodiments of a surgical clamp insertion tool may be used to install the clamp 100 into the abdominal cavity for bariatric surgery. Specifically, the clamp may be positioned, closed, and secured to divide the stomach into a small vertical portion or pouch 500 and an excluded section 502. The vertical pouch 500 receives food, as indicated by arrow 504, however, food cannot enter the excluded section 502. Using an insertion tool 102 (or 202) to engage the curved portion 106 of the clamp 100, in one embodiment, the clamp 100 may be mounted in a substantially vertical position on the stomach. In other words, if a person in whom the clamp 100 is installed stood upright, the longitudinal axis of the clamp 100 would be substantially parallel to the vector of gravity. Thus, the passage-forming section formed in the lower part of the stomach by the clamp allows gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical pouch 500.

[145] As shown in Figure 11, a method for clamping an internal organ may include inserting a surgical clamp through an opening into the body of a living organism, block 150. Two elongated surgical clamp members are then positioned on opposite sides of the internal organ of the living organism, block 152. B At block 154, closing and locking the surgical clamp for separating the cavity within the internal organ involves clamping the external portion of the internal organ with two elongated members.

[146] As mentioned above, the internal organ may be a human stomach. In this case, closing and locking the clamp may include positioning the clamp in a substantially vertical or inclined position, with the passage-forming section of the clamp located near the lower portion of the stomach. This arrangement may create a small vertical gastric pouch and thereby limit the flow of food into the excluded section or portion of the stomach while still allowing gastric juices from the excluded portion of the stomach to flow into the vertical gastric pouch. This separation can alter the production of hormones, enzymes, and chemicals that affect metabolism, energy levels, hunger, digestion, and nutrient absorption, which are reduced by eliminating the fundus of the stomach and body of the stomach through separation. Enclosing the elongated clamp elements in a shell of silicone cushioning material along most of their length is aimed at reducing the likelihood of injury and/or necrosis of the stomach or other internal organ, as well as ensuring the possibility of safe reverse surgery. Thus, the method may further include performing a repair operation by removing the clip.

[147] Insertion of a surgical clamp may involve performing natural orifice endoscopic surgery (NOTES). Alternatively or additionally, it may involve performing a NOTES in conjunction with an auxiliary trocar placed in the abdomen. This combination may include two or more of the following surgical technologies: conventional, laparoscopic, NOTES, and single port technology. NOTES technology may involve at least one of the following approaches: transgastric, transvaginal, transrectal, transcolonical, or a combination thereof. The single-port technology is used to insert multiple instruments and contains abdominal (including through the umbilical cord), perineal, retroperitoneal approaches through a single port or a combination of them.

[148] As shown in Figure 12, a method for clamping an internal organ may include engaging a surgical clamp with the head of a surgical clamp setting tool, block 160. At block 162, a surgical clamp setting tool may be used to close the clamp and insert the clamp. through an opening in the body cavity of a living organism. The tool may then be used, block 164, to reopen the clamp and to position the elongated clamp members on opposite sides of the internal organ in the body cavity. Then, at block 166, the tool may be used to close the clamp on the viscera, thereby dividing the cavity within the viscera. The legs, arms or extensions of the clamp are closed so as to result in a gradual reduction in the gap between the two legs as the lumen continues proximally, taking into account the unequal thickness of the stomach. The clamp is closed so as to apply sufficient pressure to hold the opposite walls closed to each other without causing damage/injury/ischemia to the stomach itself or the walls of another organ. Thereafter, block 168, the clamp can be locked to lock it in the position of separating the internal organ and the cavity within the internal organ. In addition, block 170, the clamp may be disengaged from the head of the surgical clamp insertion tool, after which the instrument may be retracted from the body cavity, block 172. It is contemplated that the clamp may be configured to lock automatically when the clamp is fully closed. . Alternatively, the tool may be first disengaged and removed, after which the clamp is locked using an additional tool. In addition, additional steps may be used to secure the clamp in place, such as using suture material.

[149] As described above, a liner material may be applied to the surfaces of the elongate members of the surgical clamp to reduce damage to the internal organ that would prevent reverse surgical procedure. In other embodiments, the thickness or surface contour of the elongated surgical clamp members or arms may be adjusted to match the specific organ or body being clamped to create the desired pressure or force at each point on the organ or body being clamped. In addition, engaging the surgical clamp with the head of the surgical clamp mounting tool may include passing a T-bar adjacent the end of the mounting tool's drawbar through a slot opening formed in the curved portion of the clamp and rotating the T-bar using a lever. or adjustment disc. Additionally, use of the surgical clamp setting tool to close and reopen the clamp may include operating a lever or trigger on the handle of the surgical clamp tool to tighten and release the traction rod. In addition, use of the surgical clamp positioning tool to position the elongate surgical clamp members may include manipulating an adjustment dial on the handle of the surgical clamp to rotate the head from side to side in desired planes.

[150] In Figure 13, another embodiment of the surgical clamp 600 and surgical placement tool 602 is structurally and functionally similar to those embodiments described above. One notable difference from previously described embodiments is that the hinge head 604 of the surgical placement tool 602 is matched with a curvature or radius to securely hold the clamp 600 in place while allowing the clamp 600 to remain in the open position. This configuration allows the surgeon, holding the insertion tool 602 in one hand, to securely hold the clamp 600 in the hinge head 604 of the tool 602 while compressing the distal ends of the clamp 600 together with the other hand for insertion into the trocar. When the distal ends of the clamp 600 are inserted into the trocar, the trocar holds the ends closed, allowing the surgeon to freely use the second hand. Once inserted into the abdomen, the clamp naturally opens via a spring action to engage a body organ such as the stomach, allowing the surgeon to rotate the head from side to side while it is held securely in the head 604 while still remaining in open position. Once placed in the desired position, the surgeon can close the clamp using suture material and/or by applying external or internal pressure using other surgical instruments. Thus, in this particular embodiment, the installation tool 602 may not be used to close the clamp on a patient's internal organ, but may be used to hold, insert, and rotate the clamp to position it in the desired position.

[151] As shown in Figure 14, the clamp 600 may have a three-piece structure similar to that described above. In other words, it may have a spring element 606 consisting primarily of spring steel and engaging with lower and upper rigid members 608 and 610. These rigid members 608 and 610 may be primarily composed of titanium and may be concave, increasing their rigidity. In addition, suture holes 612A-612E may be provided in the upper rigid member 610 as well as in the upper portion of the spring member 606. The surgeon may use these suture holes 612 to secure the clamp 600 in place on the stomach or other body organ. It is contemplated that additional or alternative suture holes 612 may be provided, such as in the lower rigid member 608 and the lower portion of the spring member 606, and the positions of the suture holes 612 may differ from those shown. However, as will be discussed in more detail below with reference to Figures 19-27, the placement of suture holes in the upper rigid element 608 and in the upper portion of the spring element 606 may allow the clip 600 to be sewn in place prior to application of the silicone sleeve (see Figures 19-27 ) which is slidably applied to the clip through the unsewn lower rigid member 608 and the lower portion of the spring member 606. However, once the sleeve is installed, it should be understood that the additional suture holes 612 provided in the lower rigid member 608 and/or on the lower portion of the spring element 606 may be useful when applying additional sutures later.

[152] As shown in and generally with reference to Figures 15(a)-15(f), it will be understood that a dual row of suture holes 612A-612H may be provided in the spring member 606 and on the top rigid member 610, the distal portion of which may be a male locking member 614 configured to engage a female locking member, such as a wire loop 616, of the lower rigid member 608. Suture holes 612D and 612E may be located on the spring member 606 at a location located between the point at which the upper rigid element 610 engages the spring element 606 and the point at which a slot 618 is formed in the curved portion of the spring element 606. In the case where the distal end of the upper rigid element 610 constitutes a male locking element 614, such As the curvature departs from the plane in which the upper rigid member 610 predominantly lies, the complementary female locking member may be represented by the distal end of the lower rigid member 608, such as the aforementioned rectangular wire loop 616 engaging a hinge structure 620 provided at the distal end of the lower rigid member 608. rigid element 608. It should be clearly understood that the same functionality could be provided if the upper rigid element 610 represented the female lock element and the lower rigid element 608 represented the male lock element 614. Thus, in other embodiments, the positions of the lock elements can be swapped.

[153] As shown in Figure 16, another additional element of the clamp 600 may be a latch 622, which is formed in the hinge structure 620 and which engages the wire loop 616 of the female locking element. This latch 622 may be located on the hinge structure 620 at a location distalmost when the latch 600 is held in the closed position, and may be sized and shaped to hold the wire loop 616 in a downward position in which the loop 616 lies in a plane , parallel to the plane in which the lower rigid member 608 primarily rests. A similar or identical retainer (not shown) may be provided on the opposite side of the hinge structure 620, and may likewise be distally positioned to assist in supporting the wire loop 616 in the aforementioned lower position This lower position allows the clamp 600 to be inserted through the trocar and guided to enclose a body organ such as the stomach, where the aforementioned silicone sleeve can be partially applied (see Figures 19-27). Next, before the silicone sleeve is fully engaged with the clamp 600, the wire loop 616 may be forced out of engagement with the latch 622 into a raised position in which it engages the male locking element 614 of the clamp 600.

[154] Before lifting the wire loop 616, it is contemplated that the clamp 600 can be compressed into the closed position by using two or more forceps inserted into the abdominal cavity through additional trocars (ie, multiple port technology). The free end of the thread previously applied to the wire loop 616 can then be used to force the wire loop 616 out of engagement with the latch 622 to a raised position, causing the wire loop 616 to engage the male locking element 614 and retain the clamp 600 in the closed position without the aid of these two or more tongs. Alternatively or additionally, it is contemplated that closure and locking of the clamp 600 can be achieved using any suitable endoscopic surgical instruments and techniques as one skilled in the art will appreciate from the present disclosure.

[155] As shown in and generally with reference to Figures 17(a)-17(f), the endoscopic surgical placement tool for engaging and manipulating the clamp may be similar to those described above. For example, the installation tool may have a handle 650, a trigger 652, a pull rod, a T-bar 654, a cylindrical tube 656, an adjustment dial 658 (e.g., with a thumb lever), a bushing, guides, and a pivot head 604 that are identical or similar to those described above. However, as previously described, the curvature or slope imparted to the head 604 by the head wedges 604 may correspond to a curved portion of the previously described clamp to hold the clamp in a fully open or predominantly open position when the T-bar 654 is fully retracted by actuating the trigger. mechanism 652. Additionally, a bolt release 660 may be provided that may extend on both sides of the handle 650 for ergonomic ambidextrous operation.

[156] As shown in Figure 18, the bolt release 660 may have a hinged plate with a detent spring that exerts an upward force on the bolt release 660 to engage the bolt 662 provided at the proximal end of the draw rod 664. In operation, the surgeon may engage the T-bar with the clamp 600 by rotating the clamp 600 and/or the installation tool on a common longitudinal axis until the T-bar passes through the slot in the curved portion of the clamp 600, and then rotate the clamp 600 and/or the installation tool on in multiples of ninety degrees until the direction of the length of the T-bar is perpendicular to the direction of the length of the slit. Then, engagement of the trigger 652 may cause the drawbar to retract until opposing surfaces of the bolt (e.g., edges, overhangs, faces, flanges, recesses, hooks, ramps, flanges, lips, depressions, overhangs, protrusions, projections, ribs) ridges, skirts, nicks, slots, grooves, teeth, wedges, and combinations thereof) belonging to the bolt 662 and releaser 660 will not be able to engage and hold the drawbar 664 in the fully retracted or predominantly retracted position.

[157] Once the closure 662 is engaged, the clamp 600 is ready to be inserted into the distended abdominal cavity through the trocar as described above, and the seal created between the cylindrical tube 656 and the clamp 668 can prevent gas from escaping from the abdominal cavity through the head 604 and/or cylindrical tube 656. Alternatively, the seal may be created at any location within the cylindrical tube 656. In some embodiments, the seal is achieved by using a circular silicone matrix having a slot and an opening in the middle, with a pull rod 664 threaded through the opening. .

[158] Once the clamp 600 has reached its position in the abdominal cavity to enclose and separate the stomach or other organ, depressing the clamp release 660 may allow the traction rod 664 to be automatically advanced forward under the influence of a torsion spring configured to actuate a screw 666 to forced release of the trigger mechanism 652. The T-shaped rod can then be unhooked from the clamp by rotating the installation tool along its longitudinal axis by a multiple of ninety degrees and removed from the trocar. Thus, it is apparent that in some embodiments, the draw rod may not be rotatable as in the alternative embodiments described above, but only retractable and forward.

[159] As shown in Figure 19, the silicone sleeve 700 may be configured to engage the clamp 600. In some embodiments, the silicone sleeve 700 may be configured to cover primarily the upper console and both ends of the clamp 600. The silicone sleeve 700 may be configured to cover primarily the upper console and both ends of the clamp 600. 700 can be used as a pad to protect surrounding organs from irritation or damage. The thickness of the silicone can vary for different applications such as organ, stomach or vessel separation.

[160] As shown in and generally with reference to Figures 20-27, the silicone sleeve 700 may have a tubular section 702 at its proximal end that is slidable onto the lower arm of the clamp and can be positioned to enclose the previously described curved clamp section. The clamp can then be closed and locked as described above. If the upper arm of the clamp is already sutured to an organ, stomach, or vessel, the distal end of the sleeve 700 may be engaged to enclose the distal end of the clamp. For this purpose, the distal end of the sleeve 700 may be configured as a closure cap 704 that matches the shape of the closure elements in the closed state (see FIG. 25). A spacer strip 706 located between the tubular section 702 and the lock cap 704 may be sized to fit the length of the clamp so as to be pulled taut through the upper arm of the clamp when the sleeve 700 is installed. The slot engagement member 708 formed within the tubular section 702 may be configured to engage the previously described slot in the curved clip portion by being tucked into the slot and thereby holding the tubular section of the sleeve 700 in place in the curved clip portion.

[161] As shown in Figure 28, the method of performing a surgical operation may begin at step 750 by engaging the previously described clamp with the previously described surgical placement tool in one or more previously described ways. The clamp may then be inserted through the trocar at 752 and positioned to enclose an organ (eg, stomach, vessel, etc.) at 754. The upper arm of the clamp may then be sutured to the organ at 756 through suture holes provided clamp as previously described, after which the insertion tool can be released and removed from the trocar at step 758. The previously described silicone sleeve can then slide along the lower arm of the clamp at step 760, as previously described, and then the clamp can be closed and locked at step 762. Finally, at step 764, the silicone sleeve closure cap can be pressed onto the clamp closure and additional sutures applied if necessary. It should be understood that the sequence of the above steps may vary in additional or alternative embodiments, and additional or alternative steps may be used as understood by one skilled in the art.

[162] Figures 29-40 and the accompanying description disclose various embodiments of a surgical clamp with a molded polymeric material. The surgical clamp, in one embodiment, is a laparoscopically implanted device that, when closed and locked or secured, divides the patient's stomach into two sections, such as two vertical sections or other compartments. The clamp may be installed using standard surgical instruments (eg, clamps, scissors, etc.) and/or, in some embodiments, a placement tool, such as one of the placement tools discussed herein. When the clamp is installed, in one installation pattern, the segment of the stomach with less curvature forms the gastric canal, and the segment with greater curvature, including the fundus, generally has no contact with food. In one embodiment, the clamp includes at its proximal end an enlarged radius opening (commonly referred to hereinafter as a "curved section" or "passage section") through which gastric juice generated by the fundus and body of the organ can be discharged into the cavity (atrum). ). By eliminating the fundus, the clamp can alter or reduce the production of hormones such as ghrelin, causing the patient to feel less hungry. In addition, the clamp performs restrictive functions, reducing the size of the gastric canal by creating a small lumen for the vertical passage of nutrients along a trajectory with less curvature.

[163] Figure 29 illustrates one embodiment in which a fully or partially overmolded surgical clamp is a one-piece structure. The one-piece clip 2900 includes first and second substrate elements (shown in Figures 30(a), 30(b), 31(a) and 31(b)) overmolded with a polymeric or elastomeric material to form a first elongated portion 2902, a second elongated portion 2904, curved portion 2906, fastening portion 2908, and engagement portion 2914. As mentioned above, the first and second elongated portions 2902 and 2904 serve as the partition-forming section of the clamp 2900. Briefly referring to both Figures 29 and 10, when The clamp 2900 is installed in the abdominal cavity, the first and second elongated sections 2902 and 2904 are engaged to divide the stomach into a small vertical pouch 500 and an excluded section 502. The curved section 2906 includes a passage-forming section located near the proximal end of the clamp 2900. The passage-forming section allows gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical bag 500.

[164] As used herein, the term “overmolded” means an article in which a support material is substantially completely or partially encased, covered, or coated with one or more layers of one or more materials overlying the support. For example, according to the embodiment illustrated in Figure 29, the first and second backing elements comprise underlying backing materials, wherein the overlying polymeric or elastomeric material comprises a molded material or overmolding. In some embodiments, the overmolding may have uneven thickness or hardness, or be positioned in certain areas to create different portions or features (e.g., fastening portion, flexible joint, etc.) and/or allow the clamp to gradually close from the proximal end toward distal end so that organ structures of uneven thickness, such as the stomach wall, can be properly clamped without causing injury. In some embodiments, the molded polymeric material may contain silicone, such as implantable silicone. In some embodiments, the backing material may comprise the same material as the overmolding. Additionally, in some embodiments, the backing materials and the overmolding materials may have different or variable materials and/or hardness values.

[165] As shown in Figure 29, the first and second elongate portions 2902 and 2904 are connected by a curved portion 2906 at the proximal end of the clamp 2900. The curved portion 2906 includes a flexible hinge 2918, formed in one embodiment from a polymer overmolding, wherein the flexible hinge 2918 allows the curved portion 2906 to expand and move to accommodate any disturbances in the gastric wall or deviations of the passage-forming section when the clamp 2900 is installed. The flexible hinge 2918 also allows the clamp 2900 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 2900, particularly in the septum section. In some embodiments, the flexible hinge 2918 includes one or more fastening elements, such as a slot opening 2920. The fastening element may allow the clamp 2900 to engage an installation tool (for example, the installation tool shown in Figure 33) as discussed above. disclosure. In other embodiments, the flexible hinge 2918 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 2900, such as the first and second elongate portions 2902 and 2904.

[166] When installing the surgical clamp 2900, the clamp 2900 is set in place, as explained in more detail below, with the fastening portion 2908 and the engagement portion 2914 used to hold the clamp 2900 in a substantially closed position. In the embodiment illustrated in Figure 29, the fastening portion 2908 includes a strip made of a molded polymer or other material and located near the distal end of the second elongated portion 2904. The strip may include one or more main openings 2910 for receiving the engaging portion 2914, and also an auxiliary opening 2912 used to adjust or manipulate the fastening portion 2908 and/or the second extension portion 2904. For example, a surgeon may use a tool (not shown) to engage the auxiliary opening 2912 to position the strip such that the engaging portion 2914 engages the one of the main holes 2910. In the embodiment illustrated in Figure 29, the engagement portion 2914 includes a projection, such as a hook or tab, for engaging the holes of the fastening portion 2908.

[167] In some embodiments, the clamp 2900 can be adjusted by disengaging the engaging portion 2914 from one of the main openings 2910 and engaging the engaging portion 2914 with the other main opening 2910 to either increase or decrease the clearance between the first and second elongated portions 2902 and 2904. In some embodiments, the fastening portion 2908 may be sutured to the first elongate portion 2902 using suture through holes 2916, such as those located along the outer surface of the first elongate portion 2902. Additionally, in some embodiments, after positioning on the stomach, through holes 2916 for suture material can be used to sew the 2900 clamp to the stomach wall to avoid displacement. It should be understood that in some embodiments, the suture material may be placed through the overmolding, as will be described in more detail below.

[168] In Figures 30(a) and 30(b), the surgical clip 2900 of Figure 29 is shown from its respective side in perspective views, with the polymeric material rendered translucent to reveal the underlying first substrate member 3001 and second substrate element 3002. As shown in Figures 30(a) and 30(b), the first and second substrate elements 3001 and 3002, in some embodiments, may include respective first and second elongated portions 2902 and 2904, as well as at least a portion of a curved portion 2906. Additionally, in some embodiments, the first substrate element 3001 may also include at least a portion of an engagement element 2914.

[169] Figures 31(a) and 31(b) illustrate the respective first and second substrate elements 3001 and 3002 forming the integral clamp 2900 shown in Figures 29, 30(a) and 30(b). In some embodiments, the first and second substrate elements 3001 and 3002 comprise a 3 mm thick titanium substrate. As shown in Figure 31(a), the first backing element 3001 may include a tab or hook 3102 containing at least a portion of the engagement element 2914, a first section 3104 containing a portion of the first elongated portion 2902, and a second section 3106. comprising a portion of the curved portion 2906. As shown in Figure 31(b), the second substrate element 3002 may include a first section 3108 containing a portion of the second elongated portion 2904 and a second section 3110 containing a portion of the curved portion 2906. It should be understood that the dimensions and materials related to the support elements presented herein are given by way of example only. It is envisaged that the support elements may have different thicknesses and lengths, and may contain various biocompatible materials, such as titanium or biocompatible polymer resins, such as polyetheretherketone (PEKK) or polyetheretherketone (PEEK).

[170] According to the embodiment illustrated in Figures 29, 30(a), 30(b), 31(a) and 31(b), the polymer overmolded portion of the clamp 2900 is a layer of polymer material (e.g., silicone) of thickness 1. 5 mm, encasing the first and second substrate elements 3001 and 3002. The flexible hinge 2918 and attachment portion 2908 are made of a polymeric material and are approximately 6 mm thick to provide a substantially constant thickness along the surgical clamp 2900. However, as previously discussed, in some embodiments, the polymeric material comprising one or more portions of the clamp 2900 or molded onto them may have uneven thickness or overlap. It should be understood that the above dimensions are provided as an example only and are not intended to limit or define any aspect of the clamp or portions thereof.

[171] Figure 32 illustrates another embodiment of a one-piece surgical clamp 3200 comprising first and second substrate elements over which a polymeric material is molded. Clamp 3200 includes a first elongated portion 3202, a second elongated portion 3204, a curved portion 3206 having a flexible hinge 3208 and a fastening member 3210, a fastening portion 3212, and an engagement member 3214. Clamp 3200, illustrated in Figure 32, is similar to clamp 2900. , illustrated in Figure 29, except, for example, that the mounting portion 3212 of the clamp 3200 does not have an auxiliary hole 2912.

[172] Figure 33 illustrates another example of an embodiment of the installation tool 3300. The installation tool 3300 is similar to those described above and can be used in the same manner to engage and install surgical clips of the specific embodiments presented in Figures 29-32. Using the installation tool 3300, the clamp can be engaged (via the curved portion fastener), placed in the abdominal cavity (for example, via a trocar), and positioned such that the first and second elongated portions are on opposite sides of the stomach where the clamp is locked, closed , is secured, fixed or otherwise positioned to at least partially divide the cavity within the stomach, as described above.

[173] Figures 34(a), 34(b), and 34(c) illustrate various views of yet another embodiment of a one-piece surgical clamp 3400 that includes first and second substrate elements 3401 and 3402 with a molded polymeric material 3403. The clamp 3400 includes a first elongated portion 3404, a second elongated portion 3406, a curved portion 3408 having a flexible hinge 3410, a fastening portion 3412, and engagement members 3414 and 3416. The clamp 3400 is illustrated in Figures 34(a), 34(b). and 34(c) is similar to the clamp 3200 illustrated in Figure 32. The fastening portion 3412 of the clamp 3400 includes, for example, rounded main holes 3418, while the curved portion 3412 does not have a fastening element. In addition, the clip 3400 includes first and second engagement elements 3414 and 3416, wherein the first and second engagement elements 3414 and 3416 include a riser element and a retaining loop, respectively, formed from a polymer overmolding 3403. In some embodiments, the riser element may also be formed, at least in part, from the first support element.

[174] According to the embodiment illustrated in Figures 34(a), 34(b) and 34(c), the clamp 3400 can be inserted into the abdominal cavity through a trocar, positioned such that the first and second elongated portions 3404 and 3406 are in opposite directions. sides of the stomach, and also be closed and secured by engaging one of the main openings 3418 with the raised element of the first engagement element 3414 and securing the fastening portion 3412 under the retaining loop of the second engagement element 3416. According to the present embodiment, the steps of insertion, positioning, closure and securing can be performed with using surgical instruments (for example, clamps, forceps, scissors, etc.). However, it should be understood that the curved portion 3408 of the clamp 3400 may be modified to include a fastening element, such as is provided in the clamp 2900 or 3200, to allow engagement and installation of the clamp 3400 using a surgical clamp installation tool, such as that shown in the Figure. 33.

[175] Figure 35 illustrates another embodiment of a one-piece surgical clamp 3500 that includes first and second substrate elements over which a polymeric material is molded. Clamp 3500 includes a first elongated portion 3502, a second elongated portion 3504, a curved portion 3506 having a flexible hinge 3508, a fastening portion 3510, and engagement members 3512, 3514, and 3516. Clamp 3500 is similar to clamp 3400 illustrated in Figures 34( a), 34(b) and 34(c). Clamp 3500 includes an additional engagement element 3516 containing a retaining loop formed from a polymer overmolding to receive a fastening portion 3510. Clamp 3500 is installed in the same manner as clamp 3400 and can be modified to include a fastening element such as is created in the clamp 2900 or 3200 to allow the clamp 3500 to be engaged and installed using a surgical clamp installation tool such as shown in Figure 33. It should be understood that the various embodiments discussed herein may be modified, to include different numbers and different combinations of engagement elements and fastening portion openings without departing from the scope of the present disclosure in accordance with the following aspects.

[176] As shown in Figure 36, a method for clamping an internal organ may include inserting a surgical clamp through an opening (eg, using a trocar) into the body of a living organism, block 3610. The first and second elongated portions of the surgical clamp are then positioned on opposite sides of the internal organ. organ of a living body, block 3620. At block 3630, closing and securing a surgical clamp for separating a cavity within an internal organ includes clamping the external portion of the internal organ using two elongated portions.

[177] As mentioned above, the internal organ may be the human stomach. In this case, closing and securing the clamp may include positioning the clamp in a substantially vertical or inclined position, with the passage-forming section of the clamp located near the lower portion of the stomach. This arrangement may create a small vertical gastric pouch and thereby limit the flow of food into the excluded section or portion of the stomach while still allowing a certain amount of gastric juice from the excluded portion of the stomach to flow into the vertical gastric pouch. This separation can alter the production of hormones, enzymes, and chemicals that affect metabolism, energy levels, hunger, digestion, and nutrient absorption, which are reduced by eliminating the fundus of the stomach and body of the stomach through separation. The polymer molding of the clamp reduces the likelihood of injury and/or necrosis of the stomach or other internal organ, thereby ensuring the possibility of successful reverse surgery. Thus, the above-described method may further include performing a repair operation by removing the clip.

[178] Insertion of a surgical clamp may involve performing natural orifice endoscopic surgery (NOTES). Alternatively or additionally, it may involve performing a NOTES in conjunction with an auxiliary trocar placed in the abdomen. This combination may include two or more of the following surgical technologies: conventional, laparoscopic, NOTES, and single port technology. NOTES technology may involve at least one of the following approaches: transgastric, transvaginal, transrectal, transcolonical, or a combination thereof. The single-port technology is used to insert multiple instruments and contains abdominal (including through the umbilical cord), perineal, retroperitoneal approaches through a single port or a combination of them.

[179] As shown in Figure 37, a method for clamping an internal organ may include engaging a surgical clamp, such as a bariatric clamp, with the head of a surgical clamp mounting tool, block 3710. At block 3720, a surgical clamp mounting tool may be used to close clamping and inserting the clamp through an opening in the body cavity of a living organism. The tool may then be used, block 3730, to reopen the clamp and to position the first and second extended portions of the clamp on opposite sides of the internal organ in the body cavity.

[180] Next, at block 3740, the tool may be used to close the clamp on the viscera, thereby dividing the cavity within the viscera. The legs, arms or extension portions of the clamp are closed so as to result in a gradual reduction in the gap between the two extension portions as the lumen continues proximally, taking into account the varying thickness of the stomach. The clamp is closed so as to apply sufficient pressure to hold the opposing walls against each other without causing any undue damage/trauma/ischemia to the stomach itself or the walls of another organ. Thereafter, block 3750, the clamp may be locked or otherwise secured to secure it in the position of separation of the internal organ and the cavity within the internal organ. In addition, block 3760, the clamp may be disengaged from the head of the surgical clamp insertion tool, after which the instrument may be retracted from the body cavity, block 3770. In some embodiments, the clamp may be locked or secured before or after disengagement and removal. installation tool for surgical clamp. In such embodiments, securing the clamp may be accomplished using surgical instruments alone or in combination with an installation tool. Alternatively, the instrument may be first disengaged and removed, after which the clamp is secured using additional surgical instruments. In addition, additional steps may be used, either before or after fastening, to secure and position the clamp in place, for example using suture material.

[181] As described above, the polymer overmolding of the surgical clamp reduces trauma to the internal organ, which would prevent or significantly reduce the likelihood of a successful reverse surgical procedure. In some embodiments, the thickness or surface contour of the elongated portions of the surgical clamp may be tailored to fit the particular organ or body being clamped to create the desired pressure or force at each point on the organ or body being clamped. In addition, engaging the surgical clamp with the head of the surgical clamp mounting tool may include passing a T-bar adjacent the end of the mounting tool's drawbar through a slot opening formed in the curved portion of the clamp and rotating the T-bar using a lever. or adjustment disc. Additionally, use of the surgical clamp setting tool to close and reopen the clamp may include operating a lever or trigger on the handle of the surgical clamp tool to tighten and release the traction rod. In addition, use of the surgical clamp positioning tool to position the extended portions of the surgical clamp may include manipulating an adjustment dial on the handle of the surgical clamp to rotate the head from side to side in desired planes.

[182] Figures 38, 39(a), 39(b) and 39(c) illustrate one embodiment of the present disclosure, wherein the resin overmolded surgical clip is composed of two parts. Figure 38 illustrates a perspective view of a two-piece clip 3800, with Figures 39(a), 39(b) and 39(c) illustrating various views of the clip 3800, with the polymer overmolding rendered translucent to reveal underlying a first substrate element 3901 and a second substrate element 3902. Figure 39(a) is a profile view of clamp 3800; Figure 39(b) shows a top view of clamp 3800; and Figure 39(c) is a cross-sectional view of clamp 3800 along line A-A in Figure 39(b).

[183] The two-piece clip 3800 includes first and second substrate elements 3901 and 3902 (shown in Figures 39(a), 39(b) and 39(c)) with a molded polymeric material to form the first elongate element 3802 and a separate second elongated member 3804. The first elongated member 3802 includes a first curved portion 3806 located near the proximal end of the clip 3800, and a first elongated section 3808 located near the distal end of the clip 3800. The second elongated member 3804 includes a second curved portion 3810, located near the proximal end of the clamp 3800, and a second elongated portion 3812 located near the distal end of the clamp 3800. When the clamp is installed, the first and second curved portions 3806 and 3810 include a passage-forming section at the proximal end of the clamp 3800, and the first and second extended portions 3808 and 3812 include a septum-forming section at the distal end of the clamp 3800. Briefly referring to both Figures 38 and 10, when the clamp 3800 is installed in the abdominal cavity, the first and second elongated portions 3808 and 3812 are engaged to divide the stomach into a small vertical pouch 500 and excluded section 502, wherein the first and second curved portions 3806 and 3810 are engaged to form a passage allowing gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical bag 500.

[184] As shown in Figures 38, 39(a), 39(b) and 39(c), the first elongate member 3802 includes first and second fastening portions 3814 and 3816 formed at least in part from a polymer overmolding at opposite ends of the first elongate member 3802. The second elongate member 3804 includes first and second receiving portions 3818 and 3820 formed from a polymer molding at opposite ends of the second elongate member 3804, as well as retention members 3822, 3824, 3826, and 3828 formed on the outer surface of the second elongate member 3804. It should be understood that in some embodiments, the first and second receiving portions 3818 and 3820 may be formed from a polymer overmolding or a combination of a second substrate material and a polymer overmolding. Likewise, in some embodiments, the retention elements 3822, 3824, 3826 and 3828 may be formed from a polymer overmolding or a combination of a second support material and a polymer overmolding, as shown in Figure 39(c).

[185] Upon installation of the clamp 3800, the first and second extensions 3802 and 3804 are inserted into the abdominal cavity (eg, using a trocar) and positioned on opposite sides of the stomach. The first and second fastening portions 3814 and 3816 are then fed through the respective first and second receiving portions 3818 and 3820. The gap between the curved portions 3806 and 3810 defines a passage created in the lower portion of the stomach and affects the pressure applied to the internal organ while how the gap between the elongated portions 3808 and 3812 affects the pressure applied to the stomach by the septum-forming clamp section 3800. The gap between the first and second curved portions 3806 and 3810 can be independently controlled primarily by adjusting the length of the first fastening portion 3814 fed through the first receiving portion 3818 Likewise, the clearance between the first and second extension portions 3808 and 3812 can be independently controlled primarily by adjusting the length of the second fastening portion 3816 fed through the second receiving portion 3820. When the desired clearance is achieved, the clamp 3800 is closed, locked, or otherwise secured. by engaging the first and second fastening portions 3814 and 3816 with the outer surface of the second elongate member 3804 using retaining members 3822, 3824, 3826 and 3828. The clip 3800 can be adjusted or removed by performing the steps of the installation procedure in reverse order. Additionally, in some embodiments, installation, removal, and/or adjustment of the clamp 3800 may be accomplished using standard surgical instruments (eg, forceps, clamps, scissors, etc.).

[186] In the embodiment illustrated in Figures 38, 39(a), 39(b) and 39(c), retaining elements 3822 and 3828 include retaining loops, and retaining elements 3824 and 3826 include raised elements. The first fastening portion 3814 is fed through the first receiving portion 3818 and further under the retaining loop 3822. The first fastening portion 3814 includes one or more holes 3830 configured to receive the riser member 3824. After the first fastening portion 3814 is fed through the retaining loop 3822 , it is secured by a friction fit using the raised member 3824 and one of the holes 3830. Likewise, the second fastening portion 3816 is fed through the second receiving portion 3820 and further under the retaining loop 3828. The second fastening portion 3816 includes one or more holes 3832, configured to receive the riser member 3826. Once the second fastening portion 3816 is fed through the retaining loop 3828, it is friction-fitted using the riser member 3826 and one of the openings 3832. In some embodiments, the first and second fastening portions 3814 and 3816 may further secured by sewing fastening portions 3814 and 3816 to the second elongate member 3804 using suture holes (not shown) formed in the second backing member and the resin overmolding.

[187] As briefly discussed above, the clearances in the passage-forming and partition-forming clamp sections can be adjusted independently of each other. Thus, the two-piece surgical clamp 3800 allows for individual installation and adjustment of the surgical clamp 3800, allowing one end of the clamp (ie, the passage-forming section or the septum-forming section) to be adjusted without requiring adjustment of the other end. This allows the surgeon or other medical personnel to control the clamping pressure at each end of the device, regardless of differences in stomach thickness from one end of the 3800 clamp to the other end.

[188] Figure 40 illustrates another example embodiment of a two-piece surgical clip 4000. The two-piece clip 4000 includes first and second substrate elements over which a polymeric material is molded to form a first elongate element 4002 and a separate second elongate element. 4004. The first elongated member 4002 includes a first curved portion 4006 located near the proximal end of the clip 4000 and a first extended section 4008 located near the distal end of the clip 4000. The second elongated member 4004 includes a second curved portion 4010 located near the proximal end clamp 4000, and a second elongated portion 4012 located near the distal end of the clamp 4000. When the clamp is installed, the first and second curved portions 4006 and 4010 contain a passage-forming section at the proximal end of the clamp 4000, and the first and second elongated portions 4008 and 4012 contain a septum-forming section section at the distal end of the clamp 4000. The gap between the curved sections 4006 and 4010 defines a passage created in the lower part of the stomach and affects the pressure applied to the internal organ, while the gap between the elongated sections 4008 and 4012 affects the pressure applied to stomach forming a septum with clamp section 4000.

[189] The first elongate member 4002 includes first and second attachment portions 4014 and 4016 formed from a polymer overmolding at opposite ends of the first elongate member 4002. The second elongate member 4004 includes first and second receiving portions 4018 and 4020 formed from a polymer moldings on opposite ends of the second elongate member 4004. The embodiment illustrated in Figure 40 is similar to that shown in Figures 38, 39(a), 39(b) and 39(c), except that the retaining element in the embodiment, illustrated in Figure 40, is implemented as a ratchet element, wherein the first and second fastening portions 4014 and 4016 include a plurality of “teeth” 4022 configured to engage corresponding receiving portions 4018 and 4020 of the second elongate element 4004.

[190] Upon installation of the clamp 4000, the first and second elongate members 4002 and 4004 are inserted into the abdominal cavity (eg, using a trocar) and positioned on opposite sides of the stomach. The first and second fastening portions 4014 and 4016 are then fed through the respective first and second receiving portions 4018 and 4020. The teeth 4022 on each of the fastening portions 4014 and 4016 are bendable to allow the corresponding fastening portion 4014 or 4016 to be fed through the corresponding receiving portion 4018 or 4020, and engaging a corresponding receiving portion 4018 or 4020 to retain the second elongate member 4004, thereby locking the clamp 4000 in the closed position. In some embodiments, the first and second elongates 4002 and 4004 may be further secured by suturing the first and second elongates 4002 and 4004 to the stomach using suture holes (not shown) formed in the elongates.

[191] The gap between the first and second curved portions 4006 and 4010 can be independently controlled primarily by adjusting the length of the first fastening portion 4014 fed through the first receiving portion 4018. Likewise, the gap between the first and second elongated portions 4008 and 4012 can be independently controlled by the main thus by adjusting the length of the second fastening portion 4016 fed through the second receiving portion 4020. The clamp 4000 can be readjusted or removed by disengaging the teeth 4022 of the fastening portions 4014 and 4016 from the corresponding receiving portions 4018 and 4020 and then adjusting or removing the fastening portions 4014 and 4016 from receiving portions 4018 and 4020. In some embodiments, after the clamp 4000 is installed, excess length of the first and second fastening portions 4014 and 4016 may be removed, for example, by using scissors or other cutting tools. In some embodiments, installation, removal, and/or adjustment of the clamp 4000 may be accomplished using standard surgical instruments (eg, forceps, clamps, scissors, etc.).

[192] Like the clamp 3800 shown in Figure 38, the two-piece clamp 4000 shown in Figure 40 allows for independent adjustment of clearances in the passage-forming and septum-forming sections of the clamp 4000. Thus, the two-piece surgical clamp 4000 provides The ability to individually install and adjust the surgical clamp 4000, allowing one end of the clamp (ie, the passage-forming section or the septum-forming section) to be adjusted without having to adjust the other end. This allows the surgeon or other medical personnel to control the clamping pressure at each end of the device, regardless of differences in stomach thickness from one end of the 4000 clamp to the other end.

[193] Installation of the two-piece polymer overmolded surgical clamp of embodiments can be performed according to the above flowchart shown in Figure 36. In addition, the polymer overmolding of the two-piece surgical clamp reduces or prevents damage caused to the internal organ that would not allow the reverse surgical procedure to be performed or would complicate its implementation. In some embodiments, the thickness or surface contour of the elongated portions of the surgical clamp may be tailored to fit the particular organ or body being clamped to create the desired pressure or force at each point on the organ or body being clamped. It should be understood that in some embodiments, the first and second elongate elements may be made entirely of a polymeric or elastomeric material and may not have an underlying backing element.

[194] It should be understood that one or more different fastening portions and retaining elements of a two-piece overmolded surgical clamp, such as the ratchet element of the clamp 4000, the risers and retaining loops of the clamp 3800, or various combinations thereof, may be included in some embodiments as part of a one-piece overmolded surgical clamp. Additionally, in some embodiments, one or more engagement elements of a one-piece overmolded surgical clamp may be included in a two-piece overmolded surgical clamp. In addition, it should be understood that in some embodiments, the one-piece surgical clamp may be a single integrated unit, or in other embodiments, may be a modular unit formed from a plurality of parts or parts combined to form a one-piece surgical (bariatric) clamp. It should also be understood that in some embodiments, each of the parts forming a two-part surgical clamp may include a single integrated part, or in other embodiments, may be a modular part formed from a plurality of parts combined to form a part consisting of two parts surgical (bariatric) clamp.

[195] Figures 41-81 and the accompanying description disclose various embodiments of a bariatric clamp (or surgical clamp) with molded polymeric material or are otherwise provided in support of such disclosure. A bariatric clamp, in one embodiment, is a laparoscopically implanted device that, when closed and locked or secured, divides the patient's stomach into two sections, such as two vertical sections or other compartments. The clamp can be installed using standard surgical instruments (eg, clamps, scissors, etc.) as further described below. When the clamp is installed, in one installation pattern, the segment of the stomach with less curvature forms the gastric canal, and the segment with greater curvature, including the fundus, generally has no contact with food. In one embodiment, the clamp includes at its proximal end an enlarged radius opening (commonly referred to as a “curved section” or “passage section”) through which gastric juice generated by the fundus and body of the organ can be discharged into the cavity. By eliminating the fundus, the clamp can alter or reduce the production of hormones such as ghrelin, causing the patient to feel less hungry. In addition, the clamp performs restrictive functions, reducing the size of the gastric canal by creating a small lumen for the vertical passage of nutrients along a trajectory with less curvature.

[196] Figures 41(a)-41(e) illustrate various views of one embodiment of an overmolded bariatric clip 4100. The clip 4100 includes first and second substrate elements 4101 and 4103 (shown in dotted line in Figures 41(a) and 41(e) and similar to those shown in Figures 30(a), 30(b), 31(a) and 31(b)) overmolded with a polymeric or elastomeric material to form a first elongated portion 4102, a second elongated portion 4104, curved portion 4106, fastening portion 4108, and engagement portion 4114. As described above, the first and second elongated portions 4102 and 4104 serve as the septum-forming section of the bariatric clamp 4100. Referring briefly to both Figures 41(a) and 10 When the clamp 4100 is installed in the abdominal cavity, the first and second elongated portions 4102 and 4104 are engaged to divide the stomach into a small vertical pouch 500 and an excluded section 502. The curved portion 4106 includes a passage-forming section located near the proximal end of the clamp 4100. the passage section allows gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical bag 500.

[197] As shown in Figures 41(a)-41(e), the first and second extension portions 4102 and 4104 are connected by a curved portion 4106 generally located at the proximal end of the clamp 4100. The curved portion 4106 includes a flexible hinge 4118 , formed in one embodiment from a polymer overmolding. The flexible hinge 4118 allows the clamp 4100 to be positioned in a variety of positions from a substantially closed position illustrated in Figures 41(b) and 41(c) to a substantially unfolded (or fully open) position illustrated in Figure 41(e). It should be understood that the flexible hinge 4118 allows the clamp 4100 to flex, twist, bend, expand, stretch, or deform at essentially any desired angle into virtually any desired position. For example, referring briefly to Figures 50(a)-50(d), in Figure 50(a) the clamp 4100 is shown in a closed position, in Figure 50(b) it is shown open so that the angle α at the curved portion is less than 90° , in Figure 50(c) - open so that the angle α on the curved portion is approximately 180°, and in Figure 50(d) - open so that the angle α on the curved portion exceeds 180°.

[198] Briefly referring to Figures 51(a)-51(c), the clamp 4100 is shown in various curved positions. As shown in Figures 51(a)-51(c), the flexible hinge 4118 allows the clamp 4100 to twist, flex, and deform at substantially any desired angle or in any desired direction such that the first and second elongate portions 4102 and 4104 can move with each other. from each other by an angle (eg, angle α) in an overview view of the clamp 4100, such as that shown in Figure 51(a). In some embodiments, the flexible hinge 4118 is stretchable and twistable to position the first elongate member in a desired position in any of three orthogonal planes relative to the second elongate member. In some embodiments, the flexibility provided by the hinge 4118 may be beneficial in positioning the first and second extension portions on the stomach during installation. For example, in one embodiment, the flexible hinge 4118 allows the clamp 4100 to be installed into a smaller opening, such as a trocar opening, one elongated member at a time, and then the bariatric clamp 4100 to be properly installed and positioned on the stomach in a confined abdominal space.

[199] When the clamp 4100 is installed, the flexible hinge 4118 allows the curved portion 4106 to expand and move to accommodate any irregularities in the gastric wall or deviations of the passage-forming section. For example, Figure 52(a) illustrates the clamp 4100 in a closed position in which the flexible joint 4118 is in a compressed, unexpanded or resting position, and Figure 52(b) illustrates the clamp 4100 in a closed position in which the flexible hinge 4118 is extended. or expanded, being in a tense state. As mentioned previously, such stretching or widening may allow accommodation of disturbances in the gastric wall or deviations of the passage-forming section. Stretching or expanding the flexible joint 4118 also allows the clamp 4100 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 4100, particularly in the septum section. In some embodiments, the flexible joint 4118 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 4100, such as the first and second extension portions 4102 and 4104.

[200] When installing the bariatric clamp 4100, the clamp 4100 is set in place, as explained in more detail below, with the fastening portion 4108 and the engagement portion 4114 used to hold the clamp 4100 in a substantially closed position. Figures 41(b) and 41(c) illustrate the clamp 4100 in a substantially closed position. In the embodiment illustrated in Figures 41(a)-41(e), the fastening portion 4108 includes a strip made of a molded polymer or other material and located near the distal end of the second elongated portion 4104. Since the fastening portion 4108 is made of a molded polymer in some In embodiments, it is stretchable and capable of providing the proper tension to separate the stomach when installed. In addition, as shown in Figures 53(a)-53(e), the fastening portion 4108 is stretchable such that one of the main holes 4110 can receive an engagement portion 4114. The fastening portion 4108 may also include a secondary hole 4112. used to adjust or manipulate the fastening portion 4108, the second extension portion 4104, and/or the clamp 4100. For example, a surgeon may use a tool (not shown) to engage the auxiliary opening 4112 to position the strip such that the engaging portion 4114 engages one of main holes 4110. In the embodiment illustrated in Figures 41(a)-41(e) and 53(a)-53(e), the engagement portion 4114 includes a projection, such as a hook or tab, for engaging the holes of the fastening portion 4108.

[201] In some embodiments, the clamp 4100 may be adjusted by disengaging the engaging portion 4114 from one of the main openings 4110 and engaging the engaging portion 4114 with the other main opening 4110 to either increase or decrease the clearance between the first and second elongated portions 4102 and 4104. In some embodiments, the fastening portion 4108 may be attached to the first elongated portion 4102 by sewing the fastening portion 4108 to the polymer overmolding of the first elongated portion 4102.

[202] Figures 42(a), 42(b), 43(a) and 43(b) illustrate embodiments of an overmolded bariatric clamp similar to that shown in Figures 41(a)-41(e). and described above, except that the embodiments illustrated in Figures 42(a), 42(b), 43(a) and 43(b) have an adjustable length. The adjustable length of the bariatric clamp allows the clamp to be further customized to fit the patient's stomach during installation or even after the clamp is in place. For example, when installing a bariatric clamp, the surgeon can adjust the clamp to the site during installation to fit the patient's stomach. Additionally, if a bariatric clamp having an adjustable length is installed in a patient and the clamp length is subsequently determined to be inadequate, the surgeon can adjust the length of the clamp to better fit the patient's stomach without having to remove the existing clamp or install a new clamp. Therefore, a bariatric clamp having an adjustable length may prevent unnecessary surgery and/or reduce the amount of time required to install or adjust the bariatric clamp.

[203] One embodiment of a bariatric clamp 4200 having an adjustable length is illustrated in Figures 42(a) and 42(b). The clamp 4200 includes first and second adjustable substrate elements 4201 and 4203 (shown in dotted line) overmolded with a polymeric or elastomeric material to form a first elongated portion 4202, a second elongated portion 4204, a curved portion 4206, an attachment portion 4208, and an engagement portion 4214. The first and second extension portions 4202 and 4204 serve as the septum-forming section of the bariatric clamp 4200. Briefly referring to Figures 42(a), 42(b), and 10, when the clamp 4200 is installed in the abdominal cavity, the first and second extension portions 4202 and 4204 are engaged to divide the stomach into a small vertical pouch 500 and an excluded section 502. The curved portion 4206 includes a passage-forming section located near the proximal end of the clamp 4200. The passage-forming section allows gastric juice to flow, as indicated by arrow 506, from the excluded section. 502 per vertical bag 500.

[204] Figure 42(a) illustrates the adjustable bariatric clamp 4200 in a retracted position, with the length of the first extension portion 4202 and the length of the second extension portion 4204 reduced to reduce the overall length of the clamp 4200. Figure 42(b) illustrates the adjustable bariatric clamp 4200 in an extended position, with the first elongated portion 4202 and the second elongated portion 4204 extended to increase the overall length of the clamp 4200. In the embodiment illustrated in Figures 42(a) and 42(b), the adjustable length is provided at least in part, first and second adjustable substrate elements 4201 and 4203, comprising first and second elongated portions 4202 and 4204, respectively, and portions of a curved portion 4206. For purposes of this specification, adjustable substrate elements 4201 and 4203 are referred to as single elements, but it should be understood that they may consist of two or more parts, as shown, for example, in Figures 42(a) and 42(b). It should also be understood that, in the embodiments discussed herein, the molded material is capable of stretching, expanding and/or contracting to accommodate the lengths of the first and second elongate portions 4202 and 4204 in the extended and retracted positions.

[205] In some embodiments, the first adjustable substrate element 4201 may include an outer element 4201A and an internal element 4201B, wherein the first adjustable substrate element 4201 is capable of at least partially positioning or housing the inner element 4201B within the outer element 4201A. For example, the outer member 4201A may be configured to have an opening 4205 or hollow portion configured to receive the inner member 4201B. In this embodiment, the length of the first elongated portion 4202 can be adjusted by extending the inner member 4201B from or retracting the outer member 4201A. Thus, the user may extend the inner member 4201B from the outer member 4201A, as shown in Figure 42(b), to increase the length of the first extended portion 4202. Conversely, the user may retract or insert the inner member 4201B into the outer member 4201A, as shown in 42(a) to reduce the length of the first elongated portion 4202. In some embodiments, the outer member 4201A, the inner member 4201B, or both may include one or more detents (not shown) or other means to maintain a specific length of the first elongated portion. 4202. Additionally (or alternatively), the length of the first elongated portion 4202 may be maintained by suturing the first elongated portion 4202 to the stomach portion or other device or other tissue to prevent inadvertent adjustment of the length of the first elongated portion 4202. In some embodiments, the length of the first elongated portion 4202 portion 4202 may be further enlarged by fully extending or withdrawing the inner member 4201B from the outer member 4201A. In other embodiments, the first adjustable backing element may include one or more telescoping backing elements capable of telescoping or retracting to adjust the length of the first elongated portion 4202 in the same manner as described above.

[206] Similarly, in some embodiments, the second adjustable substrate element 4203 may include an outer element 4203A and an internal element 4203B, wherein the second adjustable substrate element 4203 is capable of at least partially positioning or housing the internal element 4203B within the outer element 4203A. For example, the outer member 4203A may be configured to have an opening 4207 or hollow portion configured to receive the inner member 4203B. In this embodiment, the length of the second elongated portion 4204 can be adjusted by extending the inner member 4203B from or retracting the outer member 4203A. Thus, the user may withdraw the inner member 4203B from the outer member 4203A, as shown in Figure 42(b), to increase the length of the second extended portion 4204. Conversely, the user may retract or insert the inner member 4203B into the outer member 4203A, as shown in 42(a) to reduce the length of the second elongated portion 4204. In some embodiments, the outer member 4203A, the inner member 4203B, or both may include one or more detents (not shown) or other means to maintain a specific length of the second elongated portion. 4204. Additionally (or alternatively), the length of the second elongated portion 4204 may be maintained by suturing the second elongated portion 4204 to the stomach portion or other device or other tissue to prevent inadvertent adjustment of the length of the second elongated portion 4204. In some embodiments, the length of the second elongated portion 4204 portion 4204 may be further enlarged by fully extending or withdrawing the inner member 4203B from the outer member 4203A. In other embodiments, the second adjustable backing element may include one or more telescoping backing elements capable of telescopically extending or retracting to adjust the length of the second elongated portion 4204 in the same manner as described above.

[207] As shown in Figures 42(a) and 42(b), the first and second elongate portions 4202 and 4204 are connected by a curved portion 4206 at the proximal end of the clamp 4200. The curved portion 4206 includes a flexible hinge 4218 formed in one embodiment from polymer molding. The flexible hinge 4218 allows the clamp 4200 to be positioned in a variety of positions from a substantially closed position (similar to that illustrated in Figures 41(b) and 41(c)) to a substantially unfolded (or fully open) position (similar to that illustrated in Figure 41(e)). . When the clamp 4200 is installed, the flexible hinge 4218 allows the curved portion 4206 to expand and move to accommodate any irregularities in the gastric wall or deviations of the passage-forming section. The flexible hinge 4218 also allows the clamp 4200 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 4200, particularly in the septum section. In some embodiments, the flexible joint 4218 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 4200, such as the first and second elongate portions 4202 and 4204.

[208] When installing the bariatric clamp 4200, the clamp 4200 is set in place, as explained in more detail below, with the fastening portion 4208 and the engagement portion 4214 used to hold the clamp 4200 in a substantially closed position. In the embodiment illustrated in Figures 42(a) and 42(b), the fastening portion 4208 includes a strip made of a molded polymer or other material located near the distal end of the second elongated portion 4204. The strip may include one or more main openings. 4210 for receiving an engagement portion 4214, as well as an auxiliary opening 4212 used to adjust or manipulate the fastening portion 4208, a second extension portion 4204, and/or a clamp 4200. For example, a surgeon may use a tool (not shown) to engage the auxiliary opening 4212 to position strip so that the engaging portion 4214 engages one of the main holes 4210. In the embodiment illustrated in Figures 42(a) and 42(b), the engaging portion 4214 includes a protrusion, such as a hook or tab, for engaging with holes of the fastening section 4208.

[209] In some embodiments, the clamp 4200 may be adjusted by disengaging the engaging portion 4214 from one of the main openings 4210 and engaging the engaging portion 4214 with the other main opening 4210 to either increase or decrease the clearance between the first and second elongated portions 4202 and 4204. In some embodiments, this adjustment of the clamp 4200 may also include adjusting the length of the clamp 4200 as described above. In some embodiments, the fastening portion 4208 may be secured to the first elongated portion 4202 by sewing the fastening portion 4208 to the resin molding of the first elongated portion 4202.

[210] Another embodiment of a bariatric clamp 4300 having an adjustable length is illustrated in Figures 43(a) and 43(b). The clip 4300 includes first and second substrate elements 4301 and 4303 (shown in dotted lines), and first and second curved substrate elements 4305 and 4307 (shown in dotted lines) overmolded with a polymeric or elastomeric material to form a first elongated portion 4302, a second elongated portion 4304, curved portion 4306, fastening portion 4308, and engagement portion 4314. First and second elongated portions 4302 and 4304 serve as the septum-forming section of the bariatric clip 4300. Referring briefly to Figures 43(a), 43(b), and 10 When the clamp 4300 is installed in the abdominal cavity, the first and second elongated portions 4302 and 4304 are engaged to divide the stomach into a small vertical pouch 500 and an excluded section 502. The curved portion 4306 includes a passage-forming section located near the proximal end of the clamp 4300. the passage section allows gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical bag 500.

[211] Figure 43(a) illustrates the adjustable bariatric clamp 4300 in a retracted position, with the length of the first extension portion 4302 and the length of the second extension portion 4304 reduced to reduce the overall length of the clamp 4300. Figure 43(b) illustrates the adjustable bariatric clamp 4300 in an extended position, with the first extension portion 4302 and the second extension portion 4304 extended to increase the overall length of the clamp 4300. In the embodiment illustrated in Figures 43(a) and 43(b), the adjustable length is provided at least in part by a first adjustable portion 4302A formed from a polymer overmolding constituting the first elongated portion 4302 and a second adjustable portion 4304A formed from a polymer overmolding constituting the second elongated portion 4304. The first and second adjustable portions 4302A and 4304A are shown in a retracted position in Figure 43 (a) and in the extended position in Figure 43(b). It should be understood that in some embodiments, the first and second adjustable portions 4302A and 4304A may be composed of a material other than a polymer overmolding.

[212] In some embodiments, the first adjustable portion 4302A is capable of extending (e.g., stretching, expanding, etc.) to increase the length of the first elongated portion 4302, as well as retracting (e.g., contracting) to decrease the length of the first elongated portion. 4302. Thus, the user can adjust the length of the first extension portion 4302 by adjusting the position or placement of the first extension portion 4302, while the first adjustable portion 4302A is accordingly extended or retracted in consideration of the corresponding adjustment of the length of the first extension portion 4302. Likewise, in In some embodiments, the second adjustable portion 4304A is capable of extending (e.g., extending, expanding, etc.) to increase the length of the second elongated portion 4304, as well as retracting (e.g., contracting) to decrease the length of the second elongated portion 4304. Thus , the user can adjust the length of the second extended portion 4304 by adjusting the position or placement of the second extended portion 4304 while the second adjustable portion 4304A is accordingly extended or retracted in consideration of the corresponding adjustment of the length of the second extended portion 4304.

[213] As used herein, the first and second adjustable portions 4302A and 4304A are capable of being stretched, expanded, and/or compressed to accommodate the expanded or contracted lengths of the first and second extended portions 4302 and 4304. In some embodiments, the length of the first and/or second extended portions portions 4302 and 4304 may be supported by suturing the first and/or second extension portions 4302 and 4304 to the stomach portion or other device or other tissue to prevent inadvertent adjustment of the length of the first and/or second extension portions 4302 and 4304. Although in Figures 43( a) and 43(b), the first adjustable portion 4302A is located at a location adjacent the first curved substrate element 4305 and the first substrate element 4301, the first adjustable portion 4302A may be located at other locations along the length of the first elongated portion 4302. Likewise, although 43(a) and 43(b), the second adjustable portion 4304A is located at a location adjacent the second curved substrate element 4307 and the second substrate element 4303, the second adjustable portion 4304A may be located at other locations along the length of the second elongated portion 4304.

[214] In some embodiments, the first and second adjustable portions 4302A and 4304A are capable of bending, bending, or articulating such that the curved portion 4306 is capable of being positioned at a desired angle relative to the lengths of the first and second elongated portions 4302 and 4304. For example, in Figure 54 (a) illustrates one embodiment in which the clamp 4300 is mounted on the stomach 5400, with the first and second adjustable portions 4302A and 4304A hinged such that the curved portion 4306 is angled in a first direction relative to the first and second elongated portions 4302 and 4304 In another exemplary embodiment, Figure 54(b) illustrates a clamp 4300 mounted on a stomach 5400 with the first and second adjustable portions 4302A and 4304A pivotally rotated such that the curved portion 4306 is angled in a second direction relative to the first and second extensions. sections 4302 and 4304. In some embodiments, the hinge portion of the clamp 4300 according to the present description may be created by hinges or other elements built into the clamp 4300 at the locations where the first and second elongated portions 4302 and 4304 connect to the curved portion 4306. In some embodiments, the first and the second adjustable portions 4302A and 4304A may maintain the curved portion 4306 at a fixed angle. In some embodiments, the first and second elongated portions define a septum-forming section of the bariatric clamp, and the curved portion may at least partially define a passage-defining section of the bariatric clamp.

Moreover, the bariatric clamp, when in a closed position around the patient's stomach, includes a septum-forming section, which is formed by at least a portion of the first elongated portion and at least a portion of the second elongated portion, and a passage-forming section, which is formed by at least a partially curved portion. In some embodiments, the curved portion is formed from third and fourth substrate elements and a flexible hinge. In some embodiments, the third curved portion substrate element may be angled in a first direction relative to the first and second elongated portions, and the fourth curved portion substrate element may be angled in a first direction relative to the first and second elongated portions. [215] It should be understood that in some embodiments, the clamp may be positioned at various points along the stomach as desired. For example, as shown in Figure 54(a), the upper clamp portion may be located at the apex of the stomach adjacent to the esophagus, and the lower clamp portion may be located at the lower portion of the stomach, horizontally offset from the location of the upper clamp portion. This may be achieved by providing a clamp that is capable of bending, bending, adjusting, pivoting, or contorting to a desired position (as in the case shown in Figure 54(a)), or it may be achieved by positioning the clamp so that it is an angle with a vertical axis extending from the bottom of the stomach to the top of the stomach. In some embodiments, such positioning may be useful to ensure uniform dimensions of the vertical "food pouch" or portion of the stomach under the esophagus from the top of the stomach to the bottom of the stomach.

[216] As shown in Figures 43(a) and 43(b), the first and second elongate portions 4302 and 4304 are connected by a curved portion 4306 at the proximal end of the clip 4300. The curved portion 4306 includes a first curved substrate member 4305, a second curved member 4307 substrate, as well as a flexible hinge 4318 formed in one embodiment from a polymer overmolding. The first and second curved substrate elements 4305 and 4307 are similar (both functionally and compositionally) to the first and second substrate elements 4301 and 4303 (and other substrate elements disclosed herein) and can be made of various biocompatible materials, such as titanium or biocompatible polymer resins such as polyetheretherketone (PEKK) or polyetheretherketone (PEEK). The flexible hinge 4318 allows the clamp 4300 to be positioned in a variety of positions from a substantially closed position (similar to that illustrated in Figures 41(b) and 41(c)) to a substantially unfolded (or fully open) position (similar to that illustrated in Figure 41(e)). . When the clamp 4300 is installed, the first and second curved backing elements 4305 and 4307 provide structural support for the passage-forming section of the clamp 4300. In addition, the flexible hinge 4318 allows the curved section 4306 to expand and move to accommodate any disturbances in the gastric wall or deviations of the generatrix. section passage. The flexible hinge 4318 also allows the clamp 4300 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 4300, particularly in the septum section. In some embodiments, the flexible hinge 4318 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 4300, such as the first and second elongate portions 4302 and 4304.

[217] When installing the surgical clamp 4300, the clamp 4300 is set in place, as explained in more detail below, with the fastening portion 4308 and the engagement portion 4314 used to hold the clamp 4300 in a substantially closed position. In the embodiment illustrated in Figures 43(a) and 43(b), the fastening portion 4308 includes a strip made of a molded polymer or other material located near the distal end of the second elongated portion 4304. The strip may include one or more main openings. 4310 for receiving the engagement portion 4314, as well as an auxiliary opening 4312 used to adjust or manipulate the fastening portion 4308, the second extension portion 4304, and/or the clamp 4300. For example, a surgeon may use a tool (not shown) to engage the auxiliary opening 4312 to position strip so that the engaging portion 4314 engages one of the main holes 4310. In the embodiment illustrated in Figures 43(a) and 43(b), the engaging portion 4314 includes a protrusion, such as a hook or tab, for engaging with holes of the fastening section 4308.

[218] In some embodiments, the clamp 4300 can be adjusted by disengaging the engaging portion 4314 from one of the main openings 4310 and engaging the engaging portion 4314 with the other main opening 4310 to either increase or decrease the clearance between the first and second elongated portions 4302 and 4304. In some embodiments, this adjustment of the clamp 4300 may also include adjusting the length of the clamp 4300 as described above. In some embodiments, the fastening portion 4308 may be secured to the first elongated portion 4302 by sewing the fastening portion 4308 to the resin molding of the first elongated portion 4302.

[219] Figures 44(a) and 44(b) illustrate another embodiment of an adjustable length bariatric clamp 4400. The bariatric clamp 4400 differs from the bariatric clamps discussed above with reference to Figures 41(a)-41(e), 42(a), 42(b), 43(a) and 43(b) in that the bariatric clamp 4400 in Figures 44(a) and 44(b) is composed of multiple elements rather than being a continuous structure. However, it should be understood that the clamp 4400 operates in the same manner as the clamps described above.

[220] The bariatric clamp 4400 includes a first substrate element 4401, a second substrate element 4403, a first curved substrate element 4405, and a second curved substrate element 4407 (each shown in dotted line). The first substrate element 4401 is overmolded with a polymeric material to form a first elongated element 4402 having an engagement portion 4414 at the distal end and a first receiving portion 4416 near the proximal end of the first elongated element 4402. The second substrate element 4403 is overmolded with a polymeric material to form the second elongated element 4404 having an attachment portion 4408 at the distal end and a second receiving portion 4417 at the proximal end of the second elongate member 4404. The first and second curved substrate members 4405 and 4407 are overmolded with a polymeric material to form a curved member 4406 having a flexible hinge 4418, the first retaining member 4420 and a second retaining element 4422. When the clamp 4400 is assembled, the first retaining element 4420 is received by the first receiving portion 4416 to connect the curved element 4406 to the first elongated element 4402, and the second retaining element 4422 receives the second receiving portion 4417 to connect the curved element 4406 to a second elongate member 4404. The curved member 4406 includes a passage-forming section located near the proximal end of the clamp 4400, while the first and second elongated members 4402 and 4404 include a septum-forming section located near the distal end of the clamp 4400.

[221] Briefly referring to Figures 44(a), 44(b) and 10, when the clamp 4400 is installed in the abdominal cavity, the first and second elongated members 4402 and 4404 are engaged to divide the stomach into a small vertical pouch 500 and an excluded section 502. The curved member 4406 includes a passage-forming section located near the proximal end of the clamp 4400 and allows gastric juice to flow, as indicated by arrow 506, from the excluded section 502 into the vertical pouch 500.

[222] In the embodiment illustrated in Figures 44(a) and 44(b), the adjustable length is provided at least in part by the positions of the first and second retention elements 4420 and 4422 relative to the receiving portions 4416 and 4417 of the first and second extension elements, respectively. . For example, Figure 44(a) illustrates an adjustable bariatric clamp 4400 in a retracted position with the first and second retention members 4420 and 4422 positioned such that the overall length of the clamp 4400 is reduced. Figure 44(b) illustrates the adjustable bariatric clamp 4400 in an extended position, with the first and second retaining elements 4420 and 4422 positioned such that the overall length of the clamp 4400 is increased.

[223] In some embodiments, such as those illustrated in Figures 44(a) and 44(b), the first retaining element 4420 and the second retaining element 4422 include a ratchet element having a plurality of teeth 4424 formed from a polymeric molded material, wherein the receiving portions 4416 and 4417 comprise a loop-shaped portion formed from a polymeric molded material. The teeth 4424 are capable of bending to fit into the hinge opening when the retaining member 4420/4422 is inserted into the receiving portion 4416/4417. This allows the retaining element 4420/4422 to slide through the opening of the receiving portion 4416/4417 to connect the curved element 4406 to the corresponding first or second elongate element 4402 or 4404. After the tooth 4424 of the retaining element 4422/4424 has passed through the receiving portion 4416/4417, the tooth 4424 is capable of engaging the receiving portion 4416/4417 to prevent the retaining member 4422/4424 from accidentally disengaging from the receiving portion 4416/4417. However, if the user wishes to remove at least a portion of the retaining member 4420/4422 from the receiving portion 4416/4417 (for example, to extend or disassemble the clamp 4400), the user may bend or stretch the receiving portion 4416/4417, and/or apply pressure to the tooth 4424 to withdraw the holding element 4420/4422 from the corresponding receiving portion 4416/4417.

[224] As mentioned above, the adjustable length of the clamp 4400 is created at least in part by the positions of the first and second retention elements 4420 and 4422 relative to the receiving portions 4416 and 4417 of the first and second extension elements, respectively. To reduce the length of the clamp 4400, the user may insert first and/or second retaining members 4420 and 4422 into respective receiving portions 4416 and 4417, as discussed above. If the user wishes to further reduce the length of the clamp 4400, the user may further insert first and/or second retaining elements 4420 and 4422 into respective receiving portions 4416 and 4417 such that additional teeth 4424 extend through the receiving portions 4416 and 4417. For example, in Figure 44 (a) shows clamp 4400 at its maximum rearward position, i.e. the shortest position. In this embodiment, all of the teeth 4424 of the first and second retaining elements 4420 and 4422 have passed through their respective receiving portions 4416 and 4417. To increase the length of the clamp 4400, the user may remove a portion of the first and/or second retaining elements 4420 and 4422 from their respective receiving portions. 4416 and 4417, as stated above. If the user wishes to further increase the length of the clamp 4400, the user may further extract a portion of the first and/or second retaining elements 4420 and 4422 from the respective receiving portions 4416 and 4417 such that additional teeth 4424 extend through the receiving portions 4416 and 4417. For example, in the Figure. 44(b) illustrates the clamp 4400 at its maximum extension, i.e. longest assembled position. In this embodiment, all of the teeth 4424 extend from the receiving portions 4416 and 4417, except for the last tooth 4424 of each retaining element 4420 and 4422, which supports the connection between the curved element 4406 and the first and second elongate elements 4402 and 4404.

[225] As shown in Figures 44(a) and 44(b), first and second extension members 4402 and 4404 are connected to a curved member 4406 near the proximal end of the clip 4400. As described above, the curved member 4406 includes first and second curved members. substrate elements 4405 and 4407, first and second retention elements 4420 and 4422, and a flexible hinge 4418 formed in one embodiment from a polymer overmolding. The first and second curved substrate elements 4405 and 4407 are similar (both functionally and compositionally) to the first and second substrate elements 4401 and 4403 (and other curved substrate elements disclosed herein) and can be made of various biocompatible materials, such as titanium or biocompatible polymer resins such as polyetheretherketone (PEKK) or polyetheretherketone (PEEK). The flexible hinge 4418 allows the assembled clamp 4400 to be positioned in a variety of positions from a substantially closed position (similar to that illustrated in Figures 41(b) and 41(c)) to a substantially unfolded (or fully open) position (similar to that illustrated in Figure 41(e) ). When the clamp 4400 is installed, the first and second curved backing elements 4405 and 4407 provide structural support for the passage-forming section of the clamp 4400. In addition, the flexible hinge 4418 allows the curved element 4406 to expand and move to accommodate any disturbances in the gastric wall or deviations of the generatrix. section passage. The flexible hinge 4418 also allows the clamp 4400 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 4400, particularly in the septum section. In some embodiments, the flexible hinge 4418 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 4400, such as the first and second elongates 4402 and 4404.

[226] When installing the assembled bariatric clip 4400, the clip 4400 is placed in place, as explained in more detail below, with the fastening portion 4408 and the engagement portion 4414 used to hold the clip 4400 in a substantially closed position. In the embodiment illustrated in Figures 44(a) and 44(b), the fastening portion 4408 includes a strip made of a molded polymer or other material located near the distal end of the second elongate member 4404. The strip may include one or more main holes 4410 for receiving the engagement portion 4414, as well as an auxiliary opening 4412 used to adjust or manipulate the fastening portion 4408, the second extension 4404, and/or the clamp 4400. For example, a surgeon may use a tool (not shown) to engage the auxiliary opening 4412 to position strip so that the engaging portion 4414 engages one of the main holes 4410. In the embodiment illustrated in Figures 44(a) and 44(b), the engaging portion 4414 includes a protrusion, such as a hook or tab, for engaging with holes of the fastening section 4408.

[227] In some embodiments, the assembled clamp 4400 may be adjusted by disengaging an engaging portion 4414 from one of the main openings 4410 and engaging the engaging portion 4414 with the other main opening 4410 to either increase or decrease the clearance between the first and second elongate members 4402 and 4404 In some embodiments, this adjustment of the clamp 4400 may also include adjusting the length of the clamp 4400 as described above. In some embodiments, the fastening portion 4408 may be secured to the first elongate member 4402 by sewing the fastening portion 4408 to the polymer overmolding of the first elongate member 4402.

[228] Figure 45 is a flowchart 4500 illustrating a method for installing a bariatric clip. For clarity, the method illustrated in Figure 45 is generally discussed with reference to the bariatric clamp 4100 illustrated in Figures 41(a)-41(e) and described above, unless otherwise noted. However, it should be understood that the disclosed method of installing a bariatric clamp may be applied to various embodiments of a bariatric clamp, including, but not limited to, any of the embodiments discussed herein, as well as any of the embodiments discussed above with reference to Figures 41 -44. In addition, when considering the method presented in Figure 45 (as well as the method presented in Figure 47), it should be understood that references to the “first elongated portion” and “second elongated portion” are not limited to the specific embodiments of the “first elongated portion” and “second elongated portion” illustrated in any of the Figures described above. For example, in the context of the methods discussed with reference to Figures 45 and 47, the “first elongated portion” of Figure 41 may refer to the first half of the bariatric clamp 4100, which includes a first elongate portion 4102, an engagement portion 4114, and a section of the curved portion 4106. located on the same side of the bariatric clamp 4100. Similarly, a “second elongated portion” may refer to the second half of the bariatric clamp 4100, which includes a second elongated portion 4104, an attachment portion 4108, and a section of the curved portion 4106 located on the same side of the bariatric clamp 4100. clamp 4100. It should also be noted that in some embodiments, the first elongated portion may include a fastening portion while the second elongated portion includes an engaging portion.

[229] The method illustrated in Figure 45 first involves, block 4502, creating an opening in the patient's abdomen to provide access to the patient's stomach. In some embodiments, this may include inserting one or more trocars into the patient's abdomen, wherein the trocars create an opening through which a surgeon can insert various devices and equipment, such as surgical instruments, a camera, and a bariatric forceps 4100. The trocars may comprise various elements known in the art. For example, one or more trocars in some embodiments may include a cutting portion to assist a surgeon (or other personnel) to penetrate the abdomen (or other tissue) of a patient. In some embodiments, other instruments (eg, scissors, needles, dilators, etc.) may be used to create an opening in the abdominal cavity so that the trocar can be inserted into the abdominal cavity. In some embodiments, the abdominal cavity may be inflated by pumping air (eg, CO2) into the abdominal cavity. In such embodiments, a hose or tube may be inserted into or connected to one or more trocars, and the trocars may include a seal to prevent air from escaping from the peritoneal cavity through the trocars. In some embodiments, a camera or endoscope may be placed into the abdominal cavity to allow a surgeon or other personnel to observe the insertion, removal, or adjustment of the bariatric clamp 4100. In such embodiments, the endoscope may be placed into the abdominal cavity through a trocar inserted, for example, through the patient's umbilicus.

[230] At block 4504, the method involves removing tissue associated with the stomach, particularly in areas where the bariatric clamp 4100 would be positioned adjacent to the stomach. Tissue connected or adhered to the outer surface of the stomach is removed to create a tunnel, path or passage on the outer surface of the stomach for the first and second elongated portions 4102 and 4104 of the bariatric clamp 4100 to remain permanently on the stomach, such as in a vertical orientation or a predominantly vertical orientation, on the front and rear sides of the outer surfaces of the stomach to divide the stomach according to the present description, thereby creating a passage-forming section to allow a certain amount of gastric fluids to enter or exchange between the first and second regions. When the bariatric clamp 4100 is in the closed position, it is likely that some gastric acid can be exchanged between the first and second regions, primarily through the passage-forming section of the bariatric clamp 4100.

[231] In some embodiments, tissue removal may be accomplished by excision of tissue using surgical equipment, such as forceps, forceps, vacuum hoses, scalpels, ultrasound probe, or any combination thereof, to create a passage, tunnel, or path for the bariatric clamp 4100 or any other surgical instruments (eg, leveler, guide, etc.) used in the placement process. Additionally, this step may include displacing tissue and/or organs (eg, the liver) located near the top, bottom, front, and/or back of the stomach to expose the stomach for easier access to the stomach. This may also include exposing one or more areas where the bariatric forceps 4100 or other surgical equipment or instruments may be positioned on the stomach with little or no tissue interference.

[232] At a block 4506, the method involves positioning the bariatric clamp 4100 in a substantially extended or open position. Briefly referring to Figures 46 and 50(a)-50(d), the bariatric clamp 4100 shown in Figures 41(a)-41(e) is shown in various open positions (Figure 41(e) also shows the bariatric clamp 4100 in a substantially extended or open position). As shown in Figure 46, the clamp 4100 is positioned in an open position such that the bariatric clamp 4100 is capable of being integrated into the abdominal opening of a patient in the open position, with the first and second extension portions 4102 and 4104 individually extending through the abdominal opening. In some embodiments, this may involve passing the open bariatric clamp 4100 through a trocar (eg, a 12 mm diameter trocar) while the bariatric clamp 4100 is in an open or substantially extended position. It should be understood that the fastening portion 4108 consists of a polymer overmolding and is therefore capable of bending, as shown in Figure 46, to fit into the abdominal opening. Likewise, the flexible joint 4118 is also comprised of a polymer molding and is also capable of flexing to allow the first and second extension portions to flex or adjust when the bariatric clamp 4100 is inserted into the abdominal orifice. In some embodiments, the deployment position of the bariatric clip 4100 may include alignment of the first and second extension portions such that the length l1 of the first extension portion 4102 is substantially collinear with the segment l2 of the second extension portion 4104. In some embodiments, the deployment arrangement of the clamp may include a clamp assembly, for example, if the clamp embodiment 4400 shown in Figures 44(a) and 44(b) is implemented. However, in alternative embodiments, the clip 4400 shown in Figures 44(a) and 44(b) may be assembled after insertion into the abdominal cavity.

[233] At block 4508 shown in Figure 45, the bariatric clamp 4100 is inserted into the abdominal cavity in the substantially extended or open position discussed herein. Figure 47 is a flowchart 4700 illustrating one embodiment of a method for inserting a bariatric clamp 4100 into the abdominal cavity in an open position. The method illustrated in Figure 47 utilizes an alignment device (e.g., Gold finger dissector, clamp, forceps, etc.) to position a guide element (e.g., catgut, cord, thread, twisted thread, wire, etc.) etc.), wherein the guide member is used to guide the bariatric clamp 4100 as it is inserted into the abdominal cavity and/or positioned adjacent the stomach. In describing the method presented in Figure 47, reference is made to Figures 48(a) and 48(b), which illustrate various views of the patient's stomach 4800. Figure 48(a) shows an overview of the first side 4810, the top 4815, and the bottom parts 4817 of the patient's stomach 4800. Figure 48(b) shows a profile view of the stomach 4800 along line A-A indicated in Figure 48(a). A profile view shows a first side 4810, a top 4815 and a bottom 4817 of the stomach 4800, and a second side 4820 of the stomach 4800. In some embodiments, the first side 4810 may be the back side of the stomach and the second side 4820 may be the front side of the stomach however, in other embodiments, the first side 4810 may be the front side of the stomach and the second side 4820 may be the back side of the stomach.

[234] Referring briefly to Figures 49(a) and 49(b), one example embodiment of a leveling device or tool 4900 is shown having an end member 4910 located at the distal end of the tool 4900 and a handle 4920 located at the proximal end. of the tool 4900. An end member 4910 is located at the end of a portion 4915 of the shaft of the tool 4900 and, in some embodiments, includes an opening 4912 for receiving and/or holding a guide element (eg, suture thread). As explained in more detail below, the tool 4900 can be used to assist in positioning the guide element through a tunnel or path created along one side of the stomach and around the apex of the stomach. In some embodiments, the end member 4910 may be articulated in an upward direction relative to the horizontal shaft portion 4915, as shown in Figure 49(a), and may also be articulated to be in line with the shaft portion 4915, as shown in Figure 49 (b). The articulation of the end member 4910 can be controlled by operating the handle 4920, as shown in Figures 49(a) and 49(b).

[235] In the method illustrated in Figure 47, an alignment device is used to position the guide member so that it can be used to guide the bariatric clamp 4100 into the abdominal cavity and then to its intended location, as further described below. At a block 4702, the first end of the guide member is secured to the distal end of the alignment device (or the first end of the guide member is grasped using the distal end of the alignment device), and the alignment device is then inserted into the abdominal cavity (eg, through a trocar). At a block 4704, the leveler is positioned along the first side 4810 of the stomach 4800 by moving the distal end of the leveler along the first side 4810 of the stomach toward the top 4815 of the stomach 4800. Once positioned at the top 4815 of the stomach 4800 (e.g., at 4805), the distal end of the leveler (e.g., the end member 4910 of the instrument 4900) is positioned (e.g., by articulating, advancing, etc.) such that the guide member portion becomes accessible from the second side 4820 of the stomach 4800, while the leveler portion (e.g., the 4915 of the shaft of the instrument 4900) maintains its position along the first side 4810 of the stomach 4800. At a block 4706, the guide element is further positioned on the second side 4820 of the stomach 4800 (for example, using a clamp or forceps), while the first end of the guide element remains attached to the distal end of the leveling device (eg, end member 4910 of tool 4900).

[236] At a block 4708, the alignment device is removed from the first side 4810 of the stomach 4800 (and preferably removed from the abdominal cavity) by traversing the first stomach side 4810 toward the bottom 4817 of the stomach 4800 such that the first guide member portion 4825A is positioned or aligned along the first side 4810 of the stomach 4800, while the second guide member portion 4825B is held (e.g., by a clamp or tongs) on the second side 4820 of the stomach 4800. Figures 48(a) and 48(b) show the first guide member portion 4825A and the second a portion of the guide member 4825B according to the present embodiment. In this embodiment, the first guide member portion is aligned such that the position of the first guide member portion generally corresponds to the location at which the elongated portion 4102/4104 of the clamp 4100 would be positioned adjacent the first side 4810 of the stomach 4800.

[237] At a block 4710, the first end of the guide member is further detached from the alignment device and attached to the first or second elongated portion 4102/4104 of the bariatric clamp 4100. In some embodiments, this may be accomplished by securing the guide member through the accessory hole 4112 and/or around the mounting section 4108 of the second elongated section 4104 of the clamp 4100. In other embodiments, this may be accomplished by attaching the guide member to the engagement portion 4114 of the first elongated section 4102. At a block 4712, when the first end of the guide member is attached to either the first elongated section 4102 or the second elongated section portion 4104 and the clamp 4100 is in a substantially extended position, the second portion of the guide member 4825B is engaged to guide the bariatric clamp 4100 into the abdominal cavity. In some embodiments, this may be accomplished by pulling the second guide portion with surgical instruments (e.g., forceps, clamps, etc.) to remove the first guide portion 4825A from the first side 4810 of the stomach 4800 while feeding the bariatric clamp 4100 into the trocar while the clamp 4100 remains in a substantially extended position.

[238] As again shown in Figure 45, the first or second elongated portion 4102/4104 of the clamp 4100 attached to the guide member in the block 4710 is further positioned adjacent the first side 4810 of the stomach 4800, block 4510, while the clamp 4100 remains in open position. In some embodiments, this may be accomplished by continuing to engage the second portion of the guide member 4825B until the corresponding first or second elongated portion 4102/4104 is positioned adjacent the first stomach side 4810. At this point, the guide member can be detached from the first or second elongated portion 4102/4104 and removed from the abdominal cavity. In addition, other surgical instruments (e.g., clamps, forceps, scissors, etc.) may be used to position the first or second elongated portion 4102/4104 adjacent to the first side 4810 of the stomach 4800.

[239] The remaining elongated portion is further positioned adjacent the second side 4820 of the stomach 4800, block 4512. The clamp 4100 should be positioned such that the curved portion 4106 of the clamp 4100 abuts the lower portion 4817 of the stomach 4800. In some embodiments, surgical instruments may be used to enter the engagement with the remaining elongated portion and properly positioning the elongated portion adjacent the second side 4820 of the stomach 4800. Although the method is described in accordance with the preferred embodiment, it should be understood that in some embodiments, the clamp 4100 may be installed in the sequence in which the operations in the blocks 4510 and 4512 are executed in reverse order.

[240] At a block 4514, the bariatric clamp 4100 is closed to divide the stomach according to the above disclosure regarding various embodiments of bariatric (or surgical) clamps. In some embodiments, this may include stretching the stomach tissue along the length of the clamp 4100 to eliminate wrinkles in the stomach tissue. In some embodiments, closing the clamp 4100 may also include securing the clamp 4100 in a closed position. For example, closing and securing the bariatric clamp 4100 illustrated in Figure 41(a) may involve using a tool to engage the fastening portion 4108 (e.g., on the accessory hole 4112) to position the fastening portion 4108 so that the engaging portion 4114 engages engagement with one of the main holes 4110.

[241] In some embodiments, closure of the bariatric clamp 4100 may also include attaching a first extension portion 4102 to a side of the stomach adjacent to the first extension portion 4102 and/or attaching a second extension portion 4104 to a side of the stomach adjacent to the second extension portion 4104 to prevent unwanted migration or displacement of the clamp portions 4100. In some embodiments, this may be accomplished by suturing the first and second extension portions 4102 and 4104 to the respective sides of the stomach. For example, the first elongated portion 4102 may be sutured to the first side of the stomach (assuming 4100 is positioned such that the first side of the stomach is adjacent to the first elongated portion 4102) by sewing through the molded portion of the first elongated portion 4102. Similarly, the second elongated portion 4104 may sewn to the second side of the stomach (assuming 4100 is positioned such that the second side of the stomach is adjacent to the second elongated portion 4104) by sewing through the molded portion of the second elongated portion 4104.

[242] An example of one such embodiment is illustrated in Figure 55, which shows a clip 5500, similar to the clip 4100 discussed herein, having curved ligature needles 5502 embedded or enclosed in the polymer molding of the bariatric clip 5500 and used to attach the first extension portion. 5508 and/or the second elongated portion 5510 to the stomach when the clamp 5500 is properly installed and in the correct position. In some embodiments, the backing elements (e.g., the first backing element 5504) may be modified to accommodate the ligature needles 5502. For example, as shown in Figure 55, the first backing element 5504 and the second backing element 5512 include different recesses 5506 to accommodate the ligature needles In some embodiments, a clamp modified as shown in Figure 55 may be inserted into the patient's abdomen by having curved ligature needles 5502 embedded or encased in a polymer molding of the bariatric clamp, and having sutures 5514 connected to the curved ligature needles 5502. In one such embodiment, after the first and/or second elongated portions 5508 and/or 5510 are in the proper position, pressure may be applied to the needles 5502 or the elongated clamp portion such that the needles 5502 protrude from the polymer molding into the adjacent stomach wall to sew the corresponding first and/or second elongated sections 5508 and/or 5510 to the stomach. In some embodiments, ligature needles 5502 may be manipulated using suture threads 5514 attached to corresponding needles 5502. In some embodiments, instead of applying pressure to needles 5502 as described above, needles 5502 may be removed from the resin molding by manipulating needles 5502 with attached suture threads. sutures 5514. Referring briefly to Figure 46, the clip, in some embodiments, may include one or more visual indicators 4602 to identify locations at which suture material may be applied to or embedded into the clip.

[243] In some embodiments, the bariatric clamp may be attached to and positioned on the outer surface of the patient's stomach using one or more toggle sutures that are partially or completely placed from the outer stomach to the stomach wall or from the outer stomach wall to the inner stomach. depending on the required “toggle suture” fastening technology. For example, the embodiment of the clamp 5500 illustrated in Figure 55 may be modified such that the curved needles 5502 in Figure 55 are replaced by a toggle suture design or a toggle suture assembly (e.g., a toggle suture assembly known in the art ). In some embodiments, one or more toggle suture assemblies may be temporarily inserted into the clamp 5500 at various points (e.g., at notches 5506) or, in other embodiments, may be molded, machined, or mounted at desired locations on the bariatric clamp to facilitate installing a clamp on the patient's stomach. In some embodiments, toggle suture assemblies may be "retroactively" installed in the prefabricated clamp 5500. In one embodiment, various toggle suture assemblies are installed adjacent to the first and second ends of the bariatric clamp, such as adjacent to a flexible joint and/or the connection point where the bariatric clamp closes, and along the first and second extensions and the curved portion.

[244] It should be understood that the bariatric clamp and/or suture material can be implemented using known or available absorbable materials, such as bioabsorbable materials (eg, catgut suture), providing the desired or suitable mechanical or structural properties, as well as integrity over time. desired or required period of time before resorption or degradation to unacceptable levels. Either natural or synthetic absorbable materials can be used. In some embodiments, for example, a polyglycol may be used.

[245] In some embodiments, the method illustrated in Figure 45 may further include adjusting the length of the bariatric clamp, as discussed above with respect to the clamps illustrated in Figures 42(a), 42(b), 43(a), 43( b), 44(a) and 44(b). Depending on the particular clamp embodiment, the length of the bariatric clamp can be adjusted in a variety of ways. For example, in the embodiments discussed above with reference to Figures 42(a), 42(b), 43(a) and 43(b), the length of the clamp can be adjusted by adjusting the length of the first extension portion and/or the second extension portion. In the embodiments discussed above with reference to Figures 44(a) and 44(b), the length of the clamp can be adjusted by adjusting the positions of the first and second retaining members relative to the receiving portions of the first and second extension members. Regardless of which clamp is used, the length can be adjusted at any time during clamp installation. However, it is preferable to adjust the length of the clamp before attaching the clamp to the patient's stomach. However, the clamp may also be removed by reversing any of the steps discussed above (for example, by removing the suture material attaching any portions of the clamp to the stomach), so that the clamp can be removed or adjusted, which adjustments may include: yourself adjusting the length of the clamp within the scope of this description or adjusting the position of the clamp on the stomach.

[246] In some embodiments, the method of installing the bariatric clamp may further include confirming proper installation of the bariatric clamp 4100. This may include measuring the pressure applied by the clamp 4100 to the stomach. In some embodiments, pressure may be measured by positioning one or more pressure sensors between the clamp 4100 and one side of the stomach. In some embodiments, a pressure in the range of 0-2 or 0-3 mmHg may be required. Art. Additionally, confirming proper placement, in some embodiments, may include introducing a radiopaque fluid, such as a barium suspension, into the stomach and monitoring the fluid, such as by radiography, to confirm that proper flow exists between different regions of the stomach.

[247] Once the clamp placement is complete, the surgical equipment can be removed and the internal organs returned to their natural position. Additional precautions may be taken, including, for example, debridement or cauterization of bleeding tissue to prevent blood clots.

Magnetic inserts

[248] In some embodiments, the clip may include insert portions to assist in holding the clip in a substantially closed position. For example, Figures 56(a) and 56(b) illustrate one embodiment of a clamp 5600 similar to the above-described clamp 4100, wherein the clamp 5600 includes various insert portions 5601 for holding the clamp 5600 in a substantially closed position, as shown in Figure 56(a). The clip 5600 in one embodiment includes first and second backing elements (not shown), as well as inserts 5601 (shown in dotted line) overmolded with a polymeric or elastomeric material to form a first elongated portion 5602, a second elongated portion 5604, and a curved portion 5606 ( including a flexible hinge 5618), a fastening section 5608, and an engagement section 5614.

[249] Inserts 5601 may be used in some embodiments to engage first and second elongated portions 5602 and 5604 to separate the stomach of a patient according to the present disclosure. For example, in some embodiments, the inserts 5601 may include magnets such that the insert 5601 constituting the first elongated portion 5602 (shown in Figure 56(a) at 5601A) is capable of engaging the insert 5601 constituting the second elongated portion 5602 ( shown in Figure 56(a) at reference numeral 5601B), by means of a magnetic force to hold the clamp 5600 in a substantially closed position. In some embodiments, insert 5601A and insert 5601B are magnetic or consist of magnets having opposite polarities such that inserts 5601A are magnetically attracted to inserts 5601B. In other embodiments, one of the inserts 5601A, 5601B is magnetic or consists of magnets, and accordingly the other insert 5601A, 5601B is composed of a metallic material capable of being attracted by a magnetic field to the magnetic insert 5601 constituting the opposing elongated portion. For example, insert 5601A may include a magnet, and insert 5601B may include a metallic material capable of being magnetically attracted to magnetic insert 5601A, and vice versa.

[250] It should be understood that the inserts 5601 constituting one of the elongated portions of the clip 5600 may be a single insert 5601, as shown in Figures 56(a) and 56(b). In other embodiments, the inserts 5601 constituting one of the elongated portions may comprise a plurality of inserts 5601, as shown in Figures 56(c) and 56(d). In yet another embodiment, a single insert 5601 may constitute one of the elongated portions, and multiple inserts 5601 may constitute an opposing elongated portion.

[251] In some embodiments, the inserts 5601 may constitute a portion of a substrate element constituting one of the elongated portions of the clamp 5600. For example, referring briefly to Figure 57(a), the clamp 5600 has a first substrate element 5701 comprising at least a portion a first elongated portion 5602, and a second substrate element 5702 including at least a portion of a second elongated portion 5604. In the embodiment illustrated in Figure 57(a), the first substrate element 5701 includes an insert 5601 located in a recess 5703, formed in the first substrate element 5701. Similarly, the second substrate element 5702 includes an insert 5601 located in a recess 5703 formed in the second substrate element 5702. It should be understood that the embodiment illustrated in Figure 57(a) may be implemented with a single insert 5601 in each of the respective substrate elements 5701 and 5702, as shown, or it may be implemented with a plurality of inserts 5601 in one or both of the respective elements. 5701 and 5702 substrates.

[252] In some embodiments, the inserts 5601 may be located between the surface of the backing element and the outer surface of the polymeric or elastomeric material forming the overmolding. For example, referring briefly to Figure 57(b), the clip 5600 has a first substrate element 5701 including at least a portion of a first elongated portion 5602 and a second substrate element 5702 including at least a portion of a second elongated portion 5604. In the embodiment illustrated in Figure 57(b), the first elongated portion 5602 includes an insert 5601 located between the surface 5704 of the first substrate element 5701 and the overlay 5705. Likewise, the second elongated portion 5604 includes an insert 5601 located between the surface 5706 of the second substrate element 5702 and overmolding 5705. It should be understood that the embodiment illustrated in Figure 57(b) may be implemented with one insert 5601 on each of the respective elongated portions 5602 and 5604 as shown, or it may be implemented with a plurality of inserts 5601 at one or both of the corresponding portions 5602 and 5604.

[253] In yet another embodiment, inserts 5601 may be embedded in the surface of the respective first and second elongated portions 5602 and 5604. For example, referring briefly to Figure 57(c), the clamp 5600 has an insert 5601 embedded in the surface 5708 of the first elongated portion. 5602, as well as an insert 5601 embedded in the surface 5710 of the second elongated portion 5604. It should be understood that the embodiment illustrated in Figure 57(c) may be implemented with one insert 5601 on each of the respective elongated portions 5602 and 5604, as shown. , or it may be implemented with a plurality of inserts 5601 in one or both of the corresponding sections 5602 and 5604.

[254] The first and second elongated portions 5602 and 5604 serve as a septum-forming section located near the distal end of the bariatric clamp 5600. Briefly referring to both Figures 56(a) and 10, when the clamp 5600 is installed in the abdominal cavity, the first and second elongated sections 5602 and 5604 engage by magnetic force to divide the patient's stomach into a small vertical pouch 500 and an excluded section 502. The curved section 5606 includes a passage-forming section located near the proximal end of the clamp 5600. The passage-forming section allows gastric juice to flow as indicated by arrow 506, from the excluded section 502 into the vertical bag 500.

[255] As again shown in Figures 56(a)-56(d) and 57(a)-57(c), the first and second elongated portions 5602 and 5604 are connected by a curved portion 5606 located generally at the proximal end clamp 5600. The curved portion 5606 includes a flexible hinge 5618 formed in one embodiment from a polymer overmolding. Flexible joint 5618 is flexible and stretchable, thereby allowing clamp 5600 to be positioned in a variety of positions from a substantially closed position, as shown in Figure 56(a), to a substantially unfolded (or fully open) position. It should be understood that the flexible hinge 5618 allows the clamp 5600 to flex, twist, bend, expand, stretch, or deform at essentially any desired angle into virtually any desired position.

[256] When the clamp 5600 is installed, the flexible hinge 5618 allows the curved portion 5606 to expand and move to accommodate any irregularities in the gastric wall or deviations of the passage-forming section. Stretching or expanding the flexible joint 5618 also allows the clamp 5600 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 5600, particularly in the septum section. In some embodiments, the flexible joint 5618 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 5600, such as the first and second elongate portions 5602 and 5604.

[257] The clamp 5600 may be installed in a manner consistent with the method discussed above with respect to the clamp 4100, as well as the methods illustrated in Figures 45 and/or 47, except that the arrangement of the first and second elongated portions 5602 and 5604 (as discussed with referring to block 4512 shown in Figure 45) is such that the magnetic attraction between the inserts 5601 engages the respective first and second elongated portions 5602 and 5604 to hold the clamp 5600 in a substantially closed position to apply pressure to the stomach to separate the cavity inside stomach. Likewise, the clip 5600 may be removed by reversing one or more of the steps for installing the clip 5600, including disengaging the first and second elongate portions 5602 and 5604 so that the magnetic force between the inserts 5601 constituting the respective first and second portions is removed. the second extended sections 5602 and 5604.

[258] In some embodiments, the implementation of the inserts, the fastening portion, and the engaging portion may be eliminated. Examples of such embodiments are illustrated in Figures 58(a)-58(d), wherein the clamp 5800 is similar to the clamp 5600 except that the clamp 5800 does not include a fastening portion 5608 or an engagement portion 5614. The clamp 5800, however, includes first and second backing elements (not shown) and inserts 5801 (shown in dotted line) overmolded with a polymeric or elastomeric material to form a first elongated portion 5802, a second elongated portion 5804, and a curved portion 5806 (including a flexible hinge 5818 ).

[259] The clamp 5800 may be installed in a manner consistent with the method discussed above with respect to the clamp 4100, as well as the methods illustrated in Figures 45 and/or 47, except that the arrangement of the first and second elongated portions 5802 and 5804 (as discussed with referring to block 4512 shown in Figure 45) is such that the magnetic attraction between the inserts 5801 engages the respective first and second elongated portions 5802 and 5804 to hold the clamp 5800 in a substantially closed position to apply pressure to the stomach to separate the cavity inside stomach. Likewise, the clip 5800 may be removed by reversing one or more of the steps for installing the clip 5800, including disengaging the first and second elongate portions 5802 and 5804 so that the magnetic force between the inserts 5801 constituting the respective first and second portions is removed. the second extended sections 5802 and 5804.

Curvilinear elongated sections

[260] In some embodiments, the clamp may include curved elongated elements, wherein the curvature of the elongated elements contours the outer walls of the stomach to better conform to the shape of the stomach. For example, Figures 59(a) and 59(b) illustrate one embodiment of a clamp 5900 similar to the above-described clamp 4100, wherein the clamp 5900 includes curved extensions. The clamp 5900 includes first and second substrate elements (shown in dotted line in Figure 59(b)) overmolded with a polymeric or elastomeric material to form a first elongated portion 5902, a second elongated portion 5904, a curved portion 5906 (including a flexible hinge 5918) , an attachment portion 5908, and an engagement portion 5914. In some embodiments, when the bariatric clip is in a closed position, the first elongated portion is a curve that curves away from at least a portion of the second elongate portion, thereby forming a curved separation between the first elongate portion. section and a second extended section. [261] As shown in Figure 59(b), the curvature of the first elongated portion 5902 and the second elongated portion 5904 is created, at least in part, by the curvature of the substrate core elements. Specifically, the first substrate element 5910 defines the curvature of the first elongated portion 5902, and the second substrate element 5912 defines the curvature of the second elongated portion 5904. In some embodiments, the curvature of the first and second elongated portions 5902 and 5904 contours the outer walls of the patient's stomach to better conform to the shape of the stomach. . In some embodiments, at least a portion of the first elongated portion is curved relative to the second elongate portion at an intermediate point between the corresponding proximal end and the corresponding distal end of the first elongated portion. When the bariatric clip is in the closed position, the intermediate point may be closer to the second extension portion than at least one of the first proximal end of the first extension portion and the first distal end of the first extension portion. [262] The first and second elongated portions 5902 and 5904 serve as a septum-forming section located near the distal end of the bariatric clamp 5900. Briefly referring to both Figures 59(a) and 10, when the clamp 5900 is installed in the abdominal cavity, the first and second elongated sections 5902 and 5904 are engaged to divide the patient's stomach into a small vertical pouch 500 and an excluded section 502. The curved section 5906 includes a passage-forming section located near the proximal end of the clamp 5900. The passage-forming section allows gastric juice to flow, as indicated by arrow 506 , from the excluded section 502 into the vertical bag 500.

[263] As again shown in Figures 59(a) and 59(b), the first and second elongated portions 5902 and 5904 are connected by a curved portion 5906 located generally at the proximal end of the clamp 5900. The curved portion 5906 includes a flexible a hinge 5918 formed in one embodiment from a polymer overmolding. Flexible joint 5918 is flexible and stretchable, thereby allowing clamp 5900 to be positioned in a variety of positions from a substantially closed position, as shown in Figure 59(a), to a substantially unfolded (or fully open) position. It should be understood that the flexible hinge 5918 allows the clamp 5900 to flex, twist, bend, expand, stretch or deform at essentially any desired angle, assuming virtually any desired position.

[264] The following briefly refers to Figures 60(a) and 60(b), with Figure 60(a) illustrating an example of a patient's stomach 6000 and Figure 60(b) showing a cross-sectional view of the stomach 6000 along line A-A, indicated in Figure 60(a). Stomach 6000 includes stomach walls 6010 having an outer surface 6012 and a generally curved shape.

[265] When the clamp 5900 is installed, as shown in Figure 61, the curvature of the first and second elongated portions 5902 and 5904 outlines the walls 6010 and the outer surface 6012 of the stomach 6000. The curvature of the first and second elongated portions 5902 and 5904 better conforms to the shape of the stomach 6000, forming wherein the partition 6102 is within the stomach 6000. As described above, the curved section 5906 defines a passage 6104 in the stomach 6000 to allow gastric juice to flow between the excluded section of the stomach 6000 and the vertical pouch of the stomach 6000.

[266] As shown in Figure 61, the flexible joint 5918 allows the curved portion 5906 to expand and move to accommodate any disturbances in the gastric wall 6010 or deviations of the passage 6104. Stretching or expanding the flexible joint 5918 also allows the clamp 5900 to accommodate changes in the thickness of the stomach without disturbing the pressure applied by the clamp 5900, particularly in the partition-forming section. In some embodiments, the flexible joint 5918 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 5900, such as the first and second extension portions 5902 and 5904.

[267] It should be understood that the clip 5900 can be installed and removed in a manner consistent with the method discussed above with respect to the clip 4100, as well as the methods illustrated in Figures 45 and 47. When the first and second elongated portions 5902 and 5904 are positioned, however, the elongated the sections may be positioned such that the curvature of the respective first and second elongated sections 5902 and 5904 is adjusted to match the curvature of the stomach walls 6010.

Sectional views

[268] Reference is now made to Figures 62 and 63(a)-63(n), which are used in combination to show that any clamps of the embodiments disclosed herein can have any cross-sectional shape, including including those shown explicitly in Figures 63(a)-63(n). Figure 62 illustrates an example implementation of a clamp 6200 typical of any of the embodiments discussed herein. The clamp 6200 includes a first elongated portion 6210 and a second elongated portion 6220. Figures 63(a)-63(n) show various examples of typical cross-sectional views of the first elongated portion 6210 of the clamp 6200 along line A-A indicated in Figure 62. It should be understood that the example cross-sectional views illustrated in Figures 63(a)-63(n) may be representative of the cross-sectional shape of the polymer overmolding, the backing element, or both. It should also be understood that the example cross-sectional views illustrated in Figures 63(a)-63(h) may be representative of the cross-sectional shape of any other portion of the clamp 6200, including, for example, the second elongated portion 6220.

[269] Figure 63(a) illustrates an example of a section having a rounded or circular shape 6301. Figure 63(b) illustrates an example of a section having a rectangular shape 6302. Figure 63(c) illustrates an example of a section having a plano-convex shape 6303, wherein the mold has a convex surface 6303(a), a flat surface 6303(b), and side portions 6303(c). Figure 63(d) illustrates an example of a cross-section having a lenticular shape 6304, the shape having a first convex surface 6304(a), a second convex surface 6304(b), and side portions 6304(c). Figure 63(e) illustrates an example of a section having a biconcave shape 6305, the shape having a first concave surface 6305(a), a second concave surface 6305(b), and side portions 6305(c). Figure 63(f) illustrates an example of a section having a plano-concave shape 6306, wherein the shape has a flat surface 6306(a), a concave surface 6306(b), and side portions 6306(c). Figure 63(g) illustrates an example of a section having a positive meniscus shape 6307, the shape having a convex surface 6307(a), a concave surface 6307(b) whose radius of curvature is greater than the radius of curvature of the convex surface 6307(a), and side sections 6307(c). Figure 63(h) illustrates an example of a section having a negative meniscus shape 6308, the shape having a convex surface 6307(a), a concave surface 6308(b) whose radius of curvature is less than the radius of curvature of the convex surface 6308(a), and side sections 6308(c). Figure 63(i) illustrates an example of a section having an elongated rounded or oval shape 6309, the length of which is oriented vertically. Figure 63(j) illustrates an example of a section having an elongated rounded or oval shape 6310, the length of which is oriented horizontally. Figure 63(k) illustrates an example of a section having an octagonal shape 6311. Figure 63(l) illustrates an example of a section having a hexagonal shape 6312. Figure 63(m) illustrates an example of a section having a triangular shape 6313. Figure 63(n) ) illustrates an example of a section having a plano-convex shape 6314, wherein the shape has a flat surface 6314(a), a convex surface 6314(b), and no side portions.

[270] It should be understood that the cross-sectional shapes of the clamp are not limited to those illustrated in Figures 63(a)-63(n) and discussed above. For example, the sectional shape can be any of the shapes and even a combination of shapes, including a combination of those shapes discussed above with reference to Figures 63(a)-63(n). In addition, the sectional shapes discussed above and illustrated in Figures 63(a)-63(n) may have any orientational positions, and are not limited to those shown in Figures 63(a)-63(n).

Suture areas

[271] Figure 64 illustrates one example embodiment of a polymer-molded bariatric clamp 6400 having suture portions 6402 formed therein. Clamp 6400 is similar to the above-discussed clamp 4100 shown in Figure 41, except that clamp 6400 includes seam portions 6401. The clip 6400 includes first and second backing elements (not shown) overmolded with a polymeric or elastomeric material to form a first elongated portion 6402, a second elongated portion 6404, a curved portion 6406 (including a flexible hinge 6418), a fastening region 6408, as well as an engagement region 6414. As shown below, the seam regions 6401 in some embodiments are formed by a polymer overmolding superimposed on recesses formed in the backing elements constituting the first and second elongated regions 6402 and 6404, thereby forming polymer regions, in which the ligature needle can penetrate to attach the 6400 clamp to the stomach. In other embodiments, the polymer may not surround the recesses so that the recesses are left free to create an opening in the underlying backing member to receive suture material for attaching the clip 6400 to the stomach and/or other tissue. In other words, the seam portion 6401 may include a recess or opening extending through both the resin molding and the underlying backing member.

[272] Figure 65 illustrates a clip 6400 with the polymer overmolding rendered translucent to show a first substrate element 6502 comprising at least a portion of a first elongated portion 6402 and a portion of a curved portion 6408, as well as a second substrate element 6504 comprising at least a portion of a second elongated portion 6404 and a portion of a curved portion 6408. In some embodiments, the first suture portions are aligned with the second suture portions when the bariatric clamp is in the closed position. In some embodiments, the first suture portions are not flush with the second suture portions when the bariatric clamp is in the closed position. [273] Figures 66(a) and 66(b) illustrate exemplary embodiments of the respective first substrate element 6502 and second substrate element 6504. Substrate elements 6502 and 6504 are shown in profile view in Figure 66(a) and are also shown in plan view in Figure 66(b). The substrate elements 6502 and 6504 are similar to those discussed above with reference to Figures 31(a) and 31(b), except that the substrate elements 6502 and 6504 are modified to include recesses 6602 formed in the elements 6502 and 6504. 6504 substrates.

[274] Recesses 6602 are openings extending through a corresponding backing member 6502 or 6504 that are capable of receiving a suture, staple, or other device for attaching the clamp 6400 to the stomach and/or other tissue. This may include attaching the clamp 6400 to itself alone or in combination with attaching the clamp 6400 to the stomach and/or other tissue. In some embodiments, the recesses 6602 may also include openings in the overmolding such that the seam portion 6401 is a recess extending simultaneously through the polymer overmolding and the underlying substrate element 6502/6504. The notches 6602 may be formed at various locations of the backing elements 6502/6504, including, for example, along the sides of the elongated portions 6402/6404, along the sides of the curved portion 6408, at the ends of the backing elements 6502/6504 near the proximal end of the clip 6400, as well as on the ends of the backing elements 6502/6504 proximate the distal end of the clip 6400. Figure 66(b) shows notches 6602(a) located at the ends of the backing elements 6502 and 6504 proximal to the proximal end of the clamp 6400, as well as recesses 6602(b) located at the ends substrate elements 6502 and 6504 near the distal end of the clip 6400.

[275] In some embodiments, recesses 6602 are provided in the substrate element 6502 or 6504 such that the perimeter of the recess 6602 is defined by the substrate element 6502 or 6504. For example, Figures 67(a)-67(c) show various views of one embodiment of the clamp 6400, where the overmolding portion is removed to reveal a portion of the underlying substrate 6504. As shown in Figures 67(a)-67(c), the recess 6602 has a perimeter defined, at least in part, by the underlying backing 6504. In addition, the underlying backing member 6504 includes a portion 6504(a) capable of holding a suture in the recess 6602 to prevent the clip 6400 from becoming detached from the fabric. , to which it is sewn. If the retaining portion 6504(a) is missing, the suture may tear through the overmolding, causing the clamp 6400 to become detached.

[276] Figure 68 illustrates an example view of the first elongated portion 6402 and the curved portion 6408 of the clamp 6400 having seam portions 6401.

[277] Figure 69 illustrates an example view of the second elongated portion 6404 and the curved portion 6408 of the clamp 6400 having seam portions 6401, with the overmolding portion partially removed to reveal the underlying substrate element 6504.

[278] As described above, the first and second extension portions 6402 and 6404 serve as the septum-forming section of the bariatric clamp 6400. Briefly referring to both Figures 64 and 10, when the clamp 6400 is installed in the abdominal cavity, the first and second extension portions 6402 and 6404 are engaged to divide the stomach into a small vertical pouch 500 and an exclusion section 502. The curved portion 6406 includes a passage-forming section located near the proximal end of the clamp 6400. The passage-forming section allows gastric juice to flow, as indicated by arrow 506, from the exclusion section 502 in a vertical bag 500.

[279] As shown in Figure 64, the first and second elongate portions 6402 and 6404 are connected by a curved portion 6406 located generally at the proximal end of the clamp 6400. The curved portion 6406 includes a flexible hinge 6418 formed in one embodiment from a polymer overmolding. The flexible hinge 6418 allows the clamp 6400 to be positioned in a variety of positions from a substantially closed position to a substantially unfolded (or fully open) position. It should be understood that the flexible hinge 6418 allows the clamp 6400 to flex, twist, bend, expand, stretch, or deform at essentially any desired angle into virtually any desired position.

[280] When the clamp 6400 is installed, the flexible hinge 6418 allows the curved portion 6406 to expand and move to accommodate any irregularities in the gastric wall or deviations of the passage-forming section. Stretching or expanding the flexible joint 6418 also allows the clamp 6400 to accommodate changes in stomach thickness without disrupting the pressure applied by the clamp 6400, particularly in the septum section. In some embodiments, the flexible joint 6418 may have a desired hardness or resilience that is equal to or different from that of other clamp regions 6400, such as the first and second extension portions 6402 and 6404.

[281] The clip 6400 can be installed in a manner consistent with the method discussed above with respect to the clip 4100, as well as the methods illustrated in Figures 45 and/or 47. Likewise, the clip 6400 can be removed by reversing one or more of the steps designed to for installation of clamp 6400.

Curved section

[282] It should be understood that in some embodiments, the described clamp may have an opening (sometimes referred to herein as a “slot hole”) in the curved portion or flexible joint. For example, Figure 70 illustrates one example embodiment of a clamp 7000 according to any embodiment disclosed herein, wherein the clamp 7000 includes an opening 7002 in the flexible hinge 7004 of the curved portion 7006. Some embodiments may not include such an opening. In some cases, when the clamp 7000 is installed, a suture thread may be placed in the hole 7002 to secure the curved portion 7006 of the clamp 7000 to the stomach. If the stomach or clamp 7000 is moved or adjusted, the suture may tear through the flexible hinge 7004, which typically consists of a molding, thereby causing the clamp 7000 to become partially detached from the patient's stomach or fail to fit.

[283] Embodiments of the described clamp 7000 may include certain elements to prevent a suture thread installed in the hole 7002 from tearing the clamp 7000. For example, in some embodiments, the flexible hinge may include one or more backing elements embedded in molding forming a flexible hinge 7004. Such examples are illustrated in Figures 71-73, which show views of the hole 7002 in the flexible hinge 7004 of the clamp 7000 shown in Figure 70. In some embodiments, one or more backing elements are composed of a material capable of withstanding cutting force suture installed in the hole 7002 or flexible joint 7004. Examples of such material include metal, plastic, rubber, or even a molding portion that is hard enough to withstand the cutting force of the suture.

[284] In Figure 71, the flexible hinge 7004 includes integral backing elements 7101-7104 (shown in dotted line) consisting of a material capable of withstanding the cutting force of a suture thread installed in the hole 7002 or otherwise on the flexible hinge 7004. If the suture suture cuts through or breaks the molding constituting the flexible hinge 7004, one or more embedded backing elements 7101-7104 are capable of holding the suture thread within the area defined by the backing elements 7101-7104, thereby preventing further damage to the clamp 7000 and keeping the clamp 7000 installed on the patient's stomach. Thus, in some embodiments, the hinge is formed by a third substrate portion having an opening formed therein, the third molded polymer portion at least partially surrounding the third substrate portion. In some embodiments, the curved portion includes a third substrate portion having an opening defined therein.

[285] As shown in Figure 71, the substrate elements 7101-7104 are arranged in a rectangular orientation around the opening 7002. Because the flexible joint 7004 is capable of bending, twisting, stretching, and otherwise being distorted, the substrate elements 7101-7104 are not secured to each other to allow flexible hinge 7004 to bend or stretch in various directions without substantially interfering with such movements of the flexible hinge 7004. In some embodiments, the substrate elements 7101-7104 may be combined. In such embodiments, the backing elements 7101-7104 may be comprised of a material capable of stretching or bending and also capable of withstanding the cutting force of a suture thread mounted in an opening 7002 or otherwise on a flexible hinge 7004.

[286] In Figure 72, the flexible joint 7004 includes integral backing elements 7201 and 7202 (shown in dotted line) consisting of a material capable of withstanding the cutting force of a suture installed in the hole 7002 or otherwise on the flexible joint 7004. If the suture suture cuts through or breaks the molding constituting the flexible hinge 7004, one or more embedded backing elements 7201 and 7202 are capable of retaining the suture thread within the area defined by the backing elements 7201 and 7202, thereby preventing further damage to the clamp 7000 and keeping the clamp 7000 installed on the patient's stomach.

[287] As shown in Figure 72, the backing elements 7201 and 7202 have a horseshoe or U-shape configuration arranged to overlap around the opening 7002. Because the flexible hinge 7004 is capable of bending, twisting, stretching, and other distortion, the elements 7201 and The substrates 7202 are not attached to each other to allow the flexible hinge 7004 to flex or stretch in different directions without substantially interfering with such movements of the flexible hinge 7004. In addition, the substrate elements 7201 and 7202 overlap each other so that if the flexible hinge 7004 is stretched as shown in Figure 73, the substrate elements 7201 and 7202 still span the perimeter of the opening 7002. In some embodiments, the substrate elements 7201 and 7202 may be combined. In such embodiments, the backing elements 7201 and 7202 may be composed of a material capable of stretching or bending and also capable of withstanding the cutting force of a suture thread mounted in the hole 7002 or otherwise on the flexible hinge 7004.

[288] Figure 74 illustrates one example embodiment of a clamp 7000, wherein the flexible joint 7004 includes a wire member 7400 at least partially embedded in the overmolding. As shown in Figure 74, clip 7000 includes a first substrate element 7402 and a second substrate element 7404 (both shown in dotted line) according to one example embodiment of the present disclosure. Wire element 7400 is connected at a first end 7401 to a first substrate element 7402 and is also connected at a second end 7403 to a second substrate element 7404. For example, the first substrate element 7402 may have an opening or recess 7406 located near the end of the first substrate element 7402 through which the first end 7401 of the wire element 7400 can be inserted. Likewise, the second substrate element 7404 may have an opening or recess 7408 located near the end of the second substrate element 7404 through which the second end 7403 of the wire element 7400 can be inserted. It should be understood that the wire element can be connected to the first and second substrate elements 7402 and 7404 (or other components) in various other ways than those disclosed herein .

[289] As shown in Figure 74, the wire member 7400 further includes a suture ring 7405 inserted proximate the hole 7002. In some embodiments, the suture ring 7405 is integrated into the molding and located around the periphery of the hole 7002. Figure 75 illustrates one such embodiment, in which the clamp 7000 is shown in an end view, with the suture ring 7405 integrated into the molding forming the flexible hinge 7004 and located around the periphery or perimeter of the opening 7002. In other embodiments, the suture ring 7405 may be located outside the overmolding and within the perimeter of the opening 7002. Figure 76 illustrates one such embodiment in which the clamp 7000 is shown in end view with the suture ring 7405 located outside the overmolding and within the perimeter of the opening 7002 .

[290] The wire element 7400, particularly the suture ring 7405, is composed of a material (e.g., metal wire) capable of withstanding the cutting force of the suture installed in the hole 7002 or flexible joint 7004. If the suture cuts or tears the overmolding that makes up flexible hinge 7004, wire member 7400 is capable of holding the suture thread within the area defined by the suture ring 7405 (or preventing the flexible hinge 7004 from being torn by the suture thread), thereby preventing further damage to the clamp 7000 and keeping the clamp 7000 mounted on the patient's stomach . It should also be understood that the wire member 7400 is capable of increasing the strength and durability of the flexible joint 7004 and the opening 7002 while still maintaining the flexibility of the joint 7004.

[291] In some embodiments, the wire element 7400 may include additional slack in the wire to allow the flexible joint 7004 to stretch. An example of one such embodiment is illustrated in Figures 77 and 78. In Figure 77, the flexible joint 7004 is shown in a relaxed position, with the wire member 7400 includes additional slack 7700 built into the flexible joint 7004. In Figure 78, the flexible joint 7004 is shown in an extended position, with the additional slack 7700 of the wire member 7400 being used to allow the flexible joint 7004 to stretch.

[292] In some embodiments, the hole 7002 of the clamp 7000 may include a small hole located in the region of the hole 7002. An example of one such embodiment is illustrated in Figure 79, wherein the clamp 7000 includes a small hole 7900 located in the region of the hole 7002 in the flexible joint 7004. In some embodiments, the small opening 7900 may include arms 7902 extending into the flexible joint molding 7004 to position the small opening 7900 within the opening 7002 and to secure the small opening 7900 in the flexible joint 7004. In some embodiments, the small opening 7900 may include arms 7902 extending into the flexible joint molding 7004. the opening 7900 may further include projections 7904 connected to the arms 7902 and projecting into the flexible joint 7004 to further secure the small opening 7900 in the flexible joint 7004.

[293] The small hole 7900 includes an opening 7905 for receiving a suture thread, and may be composed of a material capable of withstanding the cutting force of a suture installed in the hole 7905 of the small hole 7900. The small hole 7900 prevents the suture thread from tearing the hole 7002 or the flexible hinge 7004. In addition, the small hole 7900 is located in the area of the hole 7002 and therefore does not prevent the hole 7002 or the flexible joint 7004 from stretching, twisting, bending or otherwise being distorted.

[294] In some embodiments, the clip 7000 may include a separate portion or plate capable of being applied over the curved portion 7006 or flexible joint 7004 of the clip 7000 and then sutured to the clip 7000 and the stomach (or stomach only) to provide reinforcement to the flexible joint. 7004 and/or the curved portion 7006 of the clamp 7000. The individual plate may vary in size depending on the size of the patient's stomach and may be composed of titanium or other material capable of withstanding the cutting force of the suture. Such an example is illustrated in Figures 80(a) and 80(b), wherein in Figure 80(a) the plate 8000 is shown separate from the clamp, and in Figure 80(b) is shown installed over the curved portion 7006 of the clamp 7000. The plate 8000 may include including one or more recesses 8001 for attaching the plate 8000 to the stomach or to the curved portion 7006 of the clamp 7000.

[295] In some embodiments, the curved portion may include a T-shaped fastener (or toggle suture structure) at least partially integrated into the flexible hinge and having an annular portion through which suture can be applied to attach the clamp to the stomach during installation and/or to secure the clamp in place after installation. Figure 81 illustrates one example embodiment of a clamp 8100 having a T-shaped fastener 8102 integrated at least partially into a flexible hinge 8104 of the clamp 8100. Connected to the T-shaped fastener 8102 is an annular portion 8106 through which a suture can pass. thread for attaching the 8100 clamp to the patient's stomach. In one such embodiment, the flexible joint may or may not include an opening. Similarly, Figure 82 illustrates one embodiment of a clamp 8200 having a ring portion 8206 looped through the suture portions of the flexible hinge 8204 of the clamp 8200. To facilitate installation of the clamp 8200, a suture thread may be passed through the ring portion 8206 to secure the clamp 8200 to the stomach of the patient. An example of such stitching technology is discussed in US Patent No. 6,596,014, incorporated herein by reference.

[296] In some embodiments, the suture may be pre-attached to the clamp for use in attaching the clamp to the patient's stomach. Figure 83 illustrates one embodiment of a clamp 8300 having barbed suture threads 8306 attached to the suture portions. The 8306 barbed sutures have hooks at their distal end to facilitate suturing to the patient's stomach. The barbs of the 8306 sutures help prevent the 8306 sutures from coming out, for example, during the process of gastric dilatation caused by the patient consuming a certain amount of food, which causes the stomach to distend. In some embodiments, the suture has a hook at its distal end for guiding the suture through the patient's stomach. In other embodiments, such as shown in Figure 84, the sutures 8406 may not be barbed, but may also have the above-described T-shaped fasteners attached to their distal ends. The T-shaped fastening devices are passed through the patient's stomach while the clamp 8400 is sutured to the patient's stomach and prevent the sutures 8306 from "pulling out".

[297] Many additional and alternative embodiments of surgical clips, placement tools, and placement methods may have features different from those described above. For example, it is contemplated that a surgical clamp not intended for bariatric surgery may not have a passageway section, and such a clamp may be smaller or larger depending on the purpose of the clamp. For example, the clamp may be one-tenth of an inch long to divide a blood vessel, or twenty-two centimeters long to divide a stomach. In addition, the clamp can be configured to separate any internal organ and can vary in length accordingly between these two example length sizes, or can be longer or shorter if desired. In addition, the guide elements may have one or more projections located flush with the engagement element and configured to be inserted into a slot formed in the curved portion of the clamp. In addition, it is contemplated that the insertion tool may be combined with an endoscope and/or a surgical robot, and appropriate robotic elements may be included instead of or in addition to those described above. These and other features may be contained in various combinations without departing from the scope of the invention, as defined by the following claims.

Claims (78)

1. Bariatric clamp containing: a first elongated portion having a first proximal end and a first distal end opposite the first proximal end, and a first longitudinal axis that is formed between the first distal end and the first proximal end of the first elongated portion; a second elongated portion having a second proximal end and a second distal end opposite the second proximal end, and a second longitudinal axis that is formed between the first distal end and the first proximal end of the first elongated portion; And a curved portion defining a flexible hinge connecting the first and second elongate portions at their respective proximal ends; wherein at least one of the first elongated portion and the second elongated portion is curved to conform to the curvature of the patient's stomach when the bariatric clamp is in the closed position, wherein, when the bariatric clip is in the closed position, the first elongated portion is a curve that is curved from at least a portion of the second elongated portion, thereby forming a curved separation between the first elongated portion and the second elongated portion. 2. The clamp according to claim 1, wherein the first elongate portion includes first suture portions configured to be penetrated by a ligature needle to form a suture joint. 3. The clamp of claim 2, wherein the first backing element includes first suture passages formed therein, wherein portions of the first molded polymer portion are located in the first suture passages to form the first suture portions. 4. The clamp according to claim 3, wherein the second elongated portion includes second suture portions configured to be penetrated by a ligature needle to form a suture joint, wherein the second backing element of the second elongated portion includes second passages formed therein for suture, wherein portions of the second molded polymer portion are disposed in second suture passages to form second suture portions. 5. The clamp according to claim 4, wherein the first suture portions are aligned with the second suture portions when the bariatric clamp is in the closed position. 6. The clamp according to claim 4, wherein the first suture portions are not flush with the second suture portions when the bariatric clamp is in the closed position. 7. The clamp of claim 1, wherein the first elongate portion includes first suture portions having a suture ring extending therethrough, wherein the suture ring is configured to allow a suture needle to pass therethrough to form a suture joint. 8. The clamp of claim 1, wherein the first elongate portion includes first suture portions, each of which is connected to a suture thread, and from each of which a suture thread extends to form a suture connection to the patient's stomach. 9. The clamp of claim 8, wherein each suture thread has barbs extending therefrom for attachment to the patient's stomach. 10. The clamp of claim 8, wherein each suture thread has a hook at its distal end for guiding the suture thread through the patient's stomach. 11. The clamp of claim 8, wherein each suture thread has a T-shaped clamp at its distal end for guiding the suture thread through the patient's stomach and attachment to the patient's stomach. 12. The clip according to claim 4, wherein the first overmolded polymer portion and the second overmolded polymer portion comprise a polymer overmolded bariatric clip. 13. The clamp of claim 1, wherein the first elongated portion includes a first insert and the second elongate portion includes a second insert, the first insert being magnetically attracted to the second insert to hold the bariatric clamp in a closed position. 14. The clip according to claim 13, wherein at least one of the first insert and the second insert comprises a magnetic insert. 15. The clip according to claim 14, wherein at least one of the first insert and the second insert comprises a metal insert. 16. The clip of claim 4, wherein the curved portion comprises a third substrate portion having an opening formed therein, the third molded polymer portion at least partially surrounding the third substrate portion. 17. The clamp according to claim 1, in which the flexible joint has a hole formed therein; wherein the curved portion comprises at least one portion of the substrate located around an opening formed in the flexible hinge. 18. The clip according to claim 1, wherein the curved portion includes a wire member coupled to the first and second substrate members. 19. Bariatric clamp containing: a first elongate portion comprising a first substrate element and a first molded polymer portion, the first substrate portion including a recess with at least a first insert portion disposed within the recess of the first substrate element; a second elongated portion comprising a second substrate element and a second molded polymer portion; And a curved portion comprising a flexible hinge connecting the first and second elongate portions at their respective proximal ends; wherein the first insert and the second elongate portion are configured to be forced together by magnetism to hold the bariatric clamp in a closed position, and wherein the first insert is located between the first substrate element and the first molded polymer portion. 20. The clamp according to claim 19, wherein the first insert contains a magnet. 21. The clamp according to claim 19, wherein the first insert comprises a magnet and the second elongated portion comprises a metal mass. 22. The clamp of claim 19, wherein the first elongate portion includes first suture portions configured to be penetrated by a suture needle to form a suture joint. 23. The clip of claim 22, wherein the first backing member includes first suture passages formed therein, wherein portions of the first polymer portion are located in the first suture passages to form the first suture portions. 24. The clamp of claim 22, wherein the first suture portions are aligned with the second suture portions when the bariatric clamp is in the closed position. 25. The clamp of claim 24, wherein the first suture portions are not flush with the second suture portions when the bariatric clamp is in the closed position. 26. The clamp of claim 19, wherein the first elongate portion includes first suture portions having a suture ring extending therethrough, wherein the suture ring is configured to allow a suture needle to pass therethrough to form a suture joint. 27. The clamp of claim 19, wherein the first elongate portion includes first suture portions, each of which is connected to a suture thread, and from each of which a suture thread extends to form a suture connection to the patient's stomach. 28. The clamp of claim 27, wherein each suture thread has barbs extending therefrom for attachment to the patient's stomach. 29. The clamp of claim 27, wherein each suture thread has a hook at its distal end for guiding the suture thread through the patient's stomach. 30. The clamp of claim 27, wherein each suture thread has a T-shaped anchor at its distal end for guiding the suture thread through the patient's stomach and attachment to the patient's stomach. 31. The clip according to claim 19, wherein the curved portion includes a third substrate portion having an opening formed therein. 32. The clamp according to claim 19, wherein the flexible joint has an opening formed therein; wherein the curved portion comprises at least one portion of the substrate located around an opening formed in the flexible joint. 33. The clip as set forth in claim 19, wherein the curved portion includes a wire member coupled to the first and second substrate members. 34. The clamp of claim 19, wherein the first elongate portion and the second elongate portion are curved to conform to the curvature of the patient's stomach when the clamp is in the closed position, the curvature of the first elongate portion and the second elongate portion delineating the outer walls of the stomach. 35. Bariatric clamp containing: a first elongated portion comprising a first substrate element and a first molded polymer portion at least partially surrounding the first substrate element; a second elongate portion comprising a second substrate element, and a second molded polymer portion at least partially surrounding the second substrate element; And a curved portion comprising a third molded polymer portion defining a flexible hinge connecting the first and second elongate portions at their respective proximal ends; wherein the first elongated portion includes first suture portions configured to facilitate the formation of a suture connection with the patient's stomach; wherein the first seam portion comprises a recess or opening extending through a corresponding backing element. 36. The clip of claim 35, wherein the first backing member includes first suture passages formed therein, wherein portions of the first polymer portion are located in the first suture passages to form first suture portions; wherein the second backing element includes second suture passages formed therein, wherein portions of the second polymer portion are located in the second suture passages to form second suture portions. 37. The clamp of claim 36, wherein the first suture portions are aligned with the second suture portions when the bariatric clamp is in the closed position. 38. The clamp of claim 36, wherein the first suture portions are not flush with the second suture portions when the bariatric clamp is in the closed position. 39. The clamp of claim 36, wherein each portion of the first suture sections has a suture ring extending therethrough, wherein the suture ring is configured to allow a ligature needle to pass therethrough to form a suture connection to the patient's stomach. 40. The clamp according to claim 36, wherein a suture thread is connected to each of the sections of the first suture sections and from each of them the suture thread extends to form a suture connection with the patient's stomach. 41. The clamp of claim 40, wherein each suture thread has barbs extending therefrom for attachment to the patient's stomach. 42. The clamp of claim 40, wherein each suture thread has a hook at its distal end for guiding the suture thread through the patient's stomach. 43. The clamp of claim 40, wherein each suture thread has a T-shaped anchor at its distal end for guiding the suture thread through the patient's stomach and attachment to the patient's stomach. 44. The clip according to claim 35, wherein the first overmolded polymer portion, the second overmolded polymer portion, and the third overmolded polymer portion comprise a polymer overmolded bariatric clip. 45. The clamp of claim 35, wherein the first elongated portion includes a first insert and the second elongate portion includes a second insert, the first insert being magnetically attracted to the second insert to hold the bariatric clamp in a closed position. 46. The clip according to claim 45, wherein at least one of the first insert and the second insert comprises a magnetic insert. 47. The clip of claim 35, wherein the curved portion comprises a third substrate portion having an opening formed therein, the third molded polymer portion at least partially surrounding the third substrate portion. 48. The clamp according to claim 35, wherein the flexible joint has an opening formed therein; wherein the curved portion comprises at least one portion of the substrate located around an opening formed in the flexible hinge. 49. The clip of claim 35, wherein the curved portion includes a wire member within a third molded polymer portion, the wire member being coupled to the first and second substrate members. 50. Bariatric clamp containing: a first elongate portion having a first proximal end and a first distal end opposite the first proximal end; a second elongate portion having a second proximal end and a second distal end opposite the second proximal end; And a curved portion forming a flexible hinge connecting the first elongated portion at its first proximal end and connecting the second elongate portion at its second proximal end; wherein at least a portion of the first elongated section is curved relative to the second elongated section at an intermediate point between the corresponding proximal end and the corresponding distal end of the first elongated section, wherein, when the bariatric clamp is in the closed position, the intermediate point is closer to the second elongated portion than at least one of the first proximal end of the first elongated portion and the first distal end of the first elongated portion. 51. Bariatric clamp containing: a first elongated portion comprising a first substrate element and a first molded polymer portion at least partially surrounding the first support element, the first elongated portion having a proximal end and a distal end; a second elongated portion comprising a second support element and a second molded polymer portion at least partially surrounding the second support element, the second elongate portion having a proximal end and a distal end; And a curved portion comprising a third substrate element, a fourth substrate element, and a third molded polymer portion forming a flexible hinge, the curved portion connecting the first and second elongate portions; wherein the third curved portion substrate element is angled in a first direction relative to the first and second elongated portions, and the fourth curved portion substrate element is angled in a first direction relative to the first and second elongated portions; wherein the first elongated portion includes first seam portions provided in the first backing element of the first elongated portion, and wherein the bariatric clamp, when in a closed position around the patient's stomach, includes a septum-forming section that is formed by at least a portion of the first elongated portion and at least a portion of the second elongated portion, and a passage-forming section that is formed by at least a partially curved portion. 52. The bariatric forceps according to claim 51, wherein the passage-forming section is formed by a curved portion. 53. The bariatric clamp according to claim 51, wherein the septum-forming section is formed by a first elongate element and a second elongate element.