• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:

    公开号:BE1020580A3
    申请号:E201200267
    申请日:2012-04-23
    公开日:2014-01-07
    发明作者:Erik Niville；Lam-Xe Noel；Valery Dalle；Gilles Solecki
    申请人:Biobes Bv Met Beperkte Aansprakelijkheid；Cousin Biotech Soc Par Actions Simplifiee Francaise；
    IPC主号:
    专利说明:

    STIFFENING BODY AND IMPLANT EQUIPPED WITH SUCH A STRAWING BODY
    The present invention is in the technical field of the stiffening members for implants with a feeding chamber, which are for instance provided with a flexible automatic closing membrane accessible for injection means, a tubular access port protruding from the aforementioned chamber. These implants may furthermore contain a flexible feeding catheter in fluid communication according to a first end with the access port and in fluid communication according to a second end with a second implant, such as a gastric ring.
    Such an implant is usually inserted subcutaneously. The system can be used to expand or contract the annular chamber of a gastric ring or to facilitate access to the vascular system for blood collection, transfusions or drug infusion.
    In the case of gastric rings, once implanted, they enclose a part of the stomach and form a throttle limiting the passage of food from the upper part of the stomach to the lower part. If the upper part of the stomach is the adjusted size, the patient will feel saturated because the food is held up in the upper part. Also, a poor ring adjustment or a change in the size of the stomach over time can cause the stomach to have an inadequate ratio which necessitates an adjustment of the ring using the present invention. If the upper part of the stomach is too limited, the patient must vomit and get an unpleasant feeling. On the contrary, if the upper part of the stomach is too large, the stomach ring can no longer fulfill its function of feeling satiety in the patient after eating a certain amount of food. Inflatable stomach rings are provided with an annular chamber that is connected to an implant that allows the fluid to be supplied. The annular chamber is delimited with internal and external walls; the expansion occurs from the internal wall in contact with the stomach to the center of the ring as the injected fluid (e.g., saline) fills the annular chamber through the feeding chamber and through the automatically occluding membrane. The reverse happens when the annular chamber is contracted and the liquid is drained.
    The expansion or contraction of the annular chamber takes place via the feeding chamber in fluid communication with the gastric ring via the tubular access port of this chamber and the feeding catheter. The catheter is usually made of a flexible material. It is fitted tightly around the hard or semi-hard tubular access gate to ensure a tight mechanical connection. Depending on the location of the implant, this mechanical connection is exposed to repeated movements with a large amplitude of the surrounding organs, for example respiratory movements or peristaltic movements of the stomach. It is agreed that the human body performs 10 to 15 breathing cycles per minute at rest, which corresponds on average to 18,000 movements per day and thus 6,570,000 cycles per year that act on the dense mechanical connection and thus on the catheter. In addition, this compound is in a potentially acidic environment that can damage the material or materials that make it up in the long term. It was thus established that this mechanical connection is no longer guaranteed after approximately 3.5 years and that the part of the catheter that is arranged around the access port is partially or completely damaged. A surgical procedure is then inevitable to restore this connection and therefore the feeding catheter.
    Moreover, when inserting the needle, the physician may accidentally puncture the supple automatically closing membrane of the feeding chamber into the joint, and in particular into the catheter, whereby the catheter, sometimes even irreversibly, may be damaged if the latter no longer guarantees a tight mechanical connection to the access gate.
    For example, there are stiffening members with distal and proximal ends and with an internal channel with a longitudinal axis (L) through which the member can be slidably inserted on a catheter and at least partially overlap the tubular access port to reduce the resistance to cutting the catheter. improve. Thanks to these stiffening members, the service life of the dense mechanical connections can be extended, their distal ends being oriented opposite the feeding chamber, while their proximal ends are oriented on the other side of this feeding chamber. However, it is found that, over time, these stiffening members cut off the part of the catheter on which they are mounted, in particular the part of the catheter covered with the proximal ends of the stiffening members, leading to irreversible damage to the catheter, the damaged part or the entire catheter must be replaced. Such a stiffening member is shown in Figure 7.
    It is an object of the present invention to extend the lifespan of the feeding catheter and thus prevent or postpone surgery to replace only the damaged part of the feeding catheter. After all, it is better for the comfort of the patient that the catheter is surgically removed, while also the implant connected to this catheter is removed.
    The present invention relates to a stiffening member developed for an implant with a feeding chamber which is provided with a flexible automatic closing membrane accessible for injection means and a tubular access port protruding on the outside of this chamber with distal and proximal ends and with an internal channel with longitudinal axis (L) through which the member can be slidably inserted on a catheter and at least partially overlap the access port.
    Advantageously, the aforementioned proximal end, which in operation is intended to be opposed to the feeding chamber, has a general open toric shape made such that the distance (I) between the two opposite edges of the proximal end, with the edges on either side of the longitudinal axis (L) is larger than the internal diameter (d) of the internal channel.
    The stiffening member thus hardens the dense mechanical connection between the first end of the catheter mounted on the access port to restrict the movements between the catheter and the access port. Moreover, it offers a protection function against a possible perforation of the catheter when inserting a needle through the automatically closing membrane.
    The proximal end of the stiffening member has an open toric shape to limit or prevent any severing of the catheter through the proximal end when the implant is inserted and exposed to repeated high-amplitude movements of the surrounding organs. This first method ensures that the stiffening member can fulfill its most important task, which is to extend the life of the catheter and, in contrast, not to damage it by cutting.
    After an internally developed test described further (shown in Figs. 8A and 8B), the applicant has surprisingly determined that the fatigue life of the mechanical connection between the proximal end of the stiffening member of this invention and the catheter was improved by at least at least 50% compared to a mechanical connection equipped with a prior art stiffening member (shown in Figure 7) that does not have an open conical shape proximal end according to the present invention.
    It was also surprisingly found that this open conical shape of the proximal end, if it provides a space between the edges of the proximal end and the catheter, allows the development of connective tissue or fibrosis. The fibrosis located in this space between the catheter and the conical proximal end prevents any movement of the stiffening member on the catheter. After all, it would have been logical for the fibrosis to be cut off by the movements of the proximal end of the stiffening member over the part of the catheter that covers it and, therefore, that the fibrosis is destroyed every time it occurs. This fibrosis thus acts as a natural connection that reduces the friction between the edges of the proximal end and the part of the catheter that is covered by this end, thereby improving the resistance to the cutting of the catheter.
    The feeding chamber preferably comprises a flexible, automatically closing membrane that is accessible to injection means.
    In this text, catheter means any narrow and flexible tube that can be implanted in the human body.
    By general conical shape is meant any annular bulge or swelling that is radial to the longitudinal axis (L).
    The access port in the present invention has a tubular shape and is hard or semi-hard. This access port is thus at least partially overlapped by the catheter, which by definition is flexible and capable of taking the form of the access port. The catheter, in turn, is also overlapped by the stiffening member.
    In a variant, the distance (I) separating the two opposite edges from the proximal end of the stiffening member is at least 25% greater than, and preferably at least 50% greater than, the internal diameter (d) of the internal channel .
    This way is preferred to achieve a longer service life of the mechanical connection between the proximal end of the stiffening member and the catheter. This in particular allows the development of fibrosis without the tissue being cut between the edges of this proximal end of the stiffening member and the catheter, and this in a sufficiently large amount to prevent any movement between the stiffening member and the catheter.
    In a variant, a first part of the wall of the stiffening member, positioned approximately from the center of the member and extending to its proximal end, has a decreasing thickness.
    This way provides more flexibility to this first part that ends at the proximal end and thus reduces the force of the frictions between the proximal end of the stiffening member and the catheter, thereby reducing the tendency of the proximal end of the stiffening member to the catheter and also the fibrosis that has formed between this proximal end and the catheter, when the stiffening member is implanted, is limited.
    In a variant, a second part of the wall of the stiffening member, positioned approximately from the center of this member and extending to its distal end, has an increasing thickness.
    This way favors the hardening of this second part of the stiffening member in order to limit the movements of this member relative to the catheter in this second part, and in particular between the part of the access port covered by the catheter and the second part of the stiffening member.
    In addition, during a surgical procedure, the physician causes the stiffening member to slide onto the catheter via the internal channel by pressing the proximal end toward the feeding chamber. The excess in the second part thus favors the placement via overlapping of the distal end of the stiffening member over the partial or full length of the access port.
    In a variant, the stiffening member has a thickening transversal part, so that, viewed from the top, it acquires a generally elongated shape.
    This elongated shape favors the guidance of the stiffening member on the catheter in the direction of the feeding chamber.
    In a variant, the stiffening member is made of a polymer with a Shore A hardness equal to or greater than 40, preferably equal to or greater than 50.
    If the stiffening member has a smaller hardness, it is not sufficiently strong to slide on the catheter and prevent the catheter from moving on the access port.
    If the stiffening device is too hard, it can cause an unpleasant feeling in the patient and cut the catheter more.
    In a variant, the stiffening member has two gripping zones on the outer surface which are attached to both sides of the longitudinal axis (L).
    These gripping zones are preferably more or less flat so that they can act as a support surface for handling the stiffening member.
    The stiffening member is preferably molded. The stiffening member is preferably made from a polymer, either of one type or in combination with one of the following polymers: polydimethylsiloxane, polytetrafluoroethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamide 6-6 or 4-6.
    The stiffening member is preferably made on the basis of a compound with at least one polymer and barium sulfate, this compound preferably consists of at least 5%, and preferably of at least 10% barium sulfate.
    The stiffening member can be made radio-opaque with the barium sulfate.
    According to a second aspect, the object of the present invention is an implant with a feeding chamber which is provided with a flexible, automatically closing membrane that is accessible to injection materials and a tubular access port protruding on the outside of said chamber. This implant also contains a flexible feeding catheter in fluid communication with the access port. The implant advantageously comprises a stiffening member according to one of the embodiment variants described above.
    The present invention will be better understood with reference to a non-limiting example which is illustrated in the figures in the appendix and in which: - figure 1 represents a perspective view of an implant according to the invention with an example of a stiffening member according to the invention; Figure 2 represents a side and perspective view of the implant shown in Figure 1; figure 3 represents a perspective view of the stiffening member in figures 1 and 2; figure 4 represents a top view of the stiffening member shown in figure 3; figure 5 represents a view according to the V-V section in figure 3; figure 6 represents an enlargement according to the V-V section of the proximal end of the stiffening member in figure 3-5; figure 7 represents a stiffening element according to the state of the art in cross-section and schematically; figures 8A and 8B represent the method of a comparative fatigue test between the stiffening member according to the invention shown in particular in figure 3 and the stiffening member according to the prior art shown in figure 7.
    The implant 1 shown in figures 1 and 2 comprises a feeding chamber 2 with a flexible automatic closing membrane 3 that is accessible to injection means and a tubular access port 4 protruding from the outer surface of said chamber 2. This implant 1 furthermore comprises a flexible feeding catheter 5 in fluid communication via the first end 5a with the aforementioned access port 4 and a stiffening member 6. This implant 1 can be connected via the second end of the catheter 5 to a stomach ring (not shown) in the treatment of morbid obesity.
    The stiffening member 6 includes proximal 6a and distal 6b ends and an internal channel 7 with longitudinal axis (L) through which said member 6 can be slidably inserted on the catheter 5 and slide along this axis ILT. The stiffening member 6 is operatively arranged such that it at least partially overlaps the access port 4 along its distal end 6b and thus forms a dense mechanical connection 8. The proximal end 6a of the stiffening member 6 as shown in Figures 5 and 6 is oriented opposite the feeding chamber 2 as shown in Figures 1 and 2, and has a general open toric shape. This open toric shape is designed such that the distance (I) that the two opposite edges 6c and 6d from this proximal end 6a, the edges 6c and 6d on either side of the longitudinal axis (L), is greater than the internal diameter (d) of the internal channel 7.
    Preferably the distance (I) is at least 25% greater than but preferably 50% greater than the internal diameter (d) of the internal channel 7.
    The stiffening member 6 thus hardens the dense mechanical connection 8 and limits the movements of the catheter 5 depending on the part of the access port 4 that it covers. The cutting of the catheter 5 through the access port 4 is thus limited and any breakage of the catheter 5 is postponed.
    In this example, a first portion 9 of the wall of the stiffening member in Figure 5, positioned approximately from the center of the member 6 and extending to its proximal end 6a, exhibits a decreasing thickness e1. The thickness e1 of the first part 9 of the stiffening member 6 is thus smaller than the thickness e0 of the part 10 higher up in relation to the proximal end 6a. Conversely, the stiffening member 6 has a second part 11 with a thickness e2 that is greater than the thickness eO of the part 10. The thickness of the stiffening member 6 thus increases from the central part 10 to the distal part 11 and decreases from the central part 10 to the proximal part 9.
    As can be seen from Figure 4, the stiffening member 6 has a thickening transversal part from the proximal end 6a to the distal end 6b, so that it acquires an elongated shape which facilitates guidance during sliding on the catheter 5.
    Preferably, the stiffening member 6 is made of a polymer with a Shore A hardness equal to or greater than 40, preferably equal to or greater than 50.
    The stiffening member 6 has two gripping zones 12, 13 on the outside which are attached to both sides of the longitudinal axis (L), which improves the grip on member 6, in particular when sliding on catheter 5.
    The stiffening member 6 is made of a polymer either of one kind or in combination with one of the following polymers: polydimethylsiloxane, polytetrafluoroethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamide 6-6 or 4-6 and barium sulfate. This compound preferably contains at least 5%, but preferably at least 10% barium sulfate to make the stiffening member 6 radio-opaque.
    The stiffening member 6 was compared according to the fatigue test described below with a stiffening member 14 as shown in Figure 7 which does not have a proximal end with an open toric shape as described above but has a straight shape.
    In order to simulate the wear of the portion of the catheter that is overlapped by the proximal ends 6a and 14a and of the stiffening members 6 and 14 respectively when implanting the implant 1, a fatigue test was performed in which the catheter was exposed to cyclical movements. The stiffening members 6 and 14 to be latched are mounted on an identical catheter 5 on a hard plate 15 so that their proximal ends 6a and 14a protrude from distance b of 2-3 mm on the outside of plate 15. Plate 15 is then placed between two upper tongs 16 so that the proximal from distance b. The free ends of the catheters 5 are clamped between two lower pincers 17. The upper pincers 16 and lower pincers 17 are connected to traction cells and in turn exert a certain traction in the direction P1 and P2. Once there and back corresponds to one cycle. In practice, only the upper pincers 16 are activated with a reciprocating movement in the direction of P1 and P2, the lower pincers 17 are static. The cyclical displacements cause a load on catheter 5 against the distal ends 6a and 14a, respectively, of the stiffening members 6 and 14 and thus enable a simulation of the friction and wear of catheter 5 / stiffening member 6 and 14. The number of registered cycles comes corresponds to the number of cycles after which catheter 5 is completely broken, that is to say that catheter 5 is no longer connected to the upper pincers 16. The traction exerted by the upper pincers 16 amounts to 30 newtons which corresponds to 3 kg. The results are obtained based on the average for 5 fatigue tests. The rupture of catheter 5 inserted into the stiffening member 6 occurs after an average of 73,064 cycles and the rupture of catheter 5 inserted into the stiffening member 14 occurs after an average of 39 288 cycles. With the reinforcing member 6 according to the invention, the service life of the mechanical connection 8 is thus extended by more than 45%.
    Parallel to the special open conical shape according to the invention, it was furthermore observed that fibrosis develops in the space 18 between the edges 6c and 6d of the proximal end 6a of the stiffening member 6 and the catheter 5 flattened in the internal channel 7.
    This fibrosis favorably prevents the movements of catheter 5 relative to the proximal end 6a, stiffening member 6, and thus extends the life of catheter 5. Moreover, the fibrosis is located between the edges 6c and 6d of the proximal end 6a and has catheter 5 the fibrosis by definition has a smaller abrasive effect than the edges 6c and 6d of the proximal end 6a so that the potential frictions between the proximal end 6a and the catheter 5 are softened and the resistance to cutting the catheter 5 is improved.
    The stiffening member 6 according to the invention allows a certain and longer lifespan of the catheter 5, whereby a surgical intervention to replace the catheter can be postponed. The implants 1 according to the invention can indeed remain in the body for several years.
    权利要求:
    Claims (10)
    [1]
    A stiffening member (6) for an implant (1) with a feeding chamber (2) provided with a flexible automatic closing membrane (3) accessible for injection means and a tubular access port (4) protruding on the outside of said chamber (2) , with distal (6b) and proximal (6a) ends and provided with an internal channel (7) with longitudinal axis (L) through which said member (6) can be slid onto a catheter (5) and said access port (4) at least can partially overlap, characterized in that said proximal end (6a), which is oriented in operation opposite the feeding chamber (2), has a general open toric shape that is designed such that the distance (I) that the two opposite edges (6c) , 6d) separates from this proximal end (6a), said edges (6c, 6d) being on either side of the longitudinal axis (L) being larger than the internal diameter (d) of the internal channel (7).
    [2]
    The stiffening member (6) according to claim 1, characterized in that the distance (I) separating the two opposite edges (6c, 6d) from the proximal end (6a) is greater than at least 25%, preferably 50% of the internal diameter (d) of the internal channel (7).
    [3]
    The stiffening member (6) according to any of claims 1 to 2, characterized in that a first portion (9) of its wall disposed approximately from the center (10) of the member (6) and extending to the proximal end (6a) has a decreasing thickness (el).
    [4]
    The stiffening member (6) according to any of claims 1 to 3, characterized in that a second thickness (11) of its wall, arranged approximately from the center (10) of and reaching to the distal end (6b), has an increasing thickness shows (e2).
    [5]
    The stiffening member (6) according to any of claims 1 to 4, characterized by an increasing transverse portion whereby, viewed from the top, it acquires a generally elongated shape.
    [6]
    The stiffening member (6) according to any of claims 1 to 5, characterized in that it is made from a polymer with a Shore A hardness equal to or greater than 40, preferably equal to or greater than 50.
    [7]
    The stiffening member (6) according to any of claims 1 to 6, characterized in that it has two gripping zones (12, 13) on its outside on either side of the longitudinal axis (L).
    [8]
    The stiffening member (6) according to any of claims 1 to 7, characterized in that a polymer, either one type or in combination with one of the following polymers, is produced: polydimethylsiloxane, polytetrafluoroethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamide 6-6 or 4-6.
    [9]
    The stiffening member (6) according to claim 8, characterized in that it is produced on the basis of a compound with at least one polymer and barium sulfate, said compound preferably containing at least 5% but preferably at least 10% barium sulfate.
    [10]
    An implant (1) with a feeding chamber (2) provided with a flexible, automatically closing diaphragm (3) accessible to injection means and a tubular access port Γ4Τ extending from the outside of said chamber (2). said implant (1) furthermore comprises a flexible feeding catheter (5) in fluid communication with the access port (4), characterized by the presence of a stiffening member (6) according to one of claims 1 to 9.
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    同族专利:
    公开号 | 公开日
    FR2974303A1|2012-10-26|
    FR2974303B1|2013-05-10|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US5637102A|1995-05-24|1997-06-10|C. R. Bard, Inc.|Dual-type catheter connection system|
    US8007474B2|2003-06-16|2011-08-30|Ethicon Endo-Surgery, Inc.|Implantable medical device with reversible attachment mechanism and method|
    US20050148956A1|2004-06-01|2005-07-07|Conlon Sean P.|Surgically implantable injection port having an improved fastener|
    FR2893255B1|2005-11-16|2008-10-17|Cie Euro Etude Rech Paroscopie|ATRAUMATIC IMPLANTABLE MEDICAL SITE OF SIMPLIFIED CONSTRUCTION|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    FR1153530A|FR2974303B1|2011-04-22|2011-04-22|STIFFENING DEVICE AND IMPLANTABLE DEVICE EQUIPPED WITH SUCH A STIFFENING BODY|
    FR1153530|2011-04-22|
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