CN112472955A - Multi-segment hardness interventional catheter and weaving method thereof - Google Patents

Multi-segment hardness interventional catheter and weaving method thereof Download PDF

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Publication number
CN112472955A
CN112472955A CN202011481001.4A CN202011481001A CN112472955A CN 112472955 A CN112472955 A CN 112472955A CN 202011481001 A CN202011481001 A CN 202011481001A CN 112472955 A CN112472955 A CN 112472955A
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China
Prior art keywords
hardness
metal
segment
section
layer
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Pending
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CN202011481001.4A
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Chinese (zh)
Inventor
李世文
韩建超
胡文忠
丁双喜
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Shanghai Rongmai Medical Technology Co ltd
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Shanghai Rongmai Medical Technology Co ltd
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Priority to CN202011481001.4A priority Critical patent/CN112472955A/en
Publication of CN112472955A publication Critical patent/CN112472955A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0012Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0054Catheters; Hollow probes characterised by structural features with regions for increasing flexibility

Abstract

The invention discloses a multi-segment hardness interventional catheter and a weaving method thereof, and belongs to the technical field of interventional medical treatment. The composite material comprises an inner PTFE lubricating layer, a middle metal reinforcing layer and an outer high polymer material base layer, wherein the metal reinforcing layer comprises a first hardness section at the near end and a second hardness section at the far end; the first hardness section of the metal reinforcing layer is of a tubular metal braided net structure; the second hardness section of the metal reinforcing layer is a tubular metal spring ring structure or a tubular metal woven net structure with lower weaving density than the first hardness section. The metal woven mesh structure is adopted at the near end, the metal spring ring or the metal woven mesh structure with low weaving density is adopted at the far end, the near end weaving density is high, the hardness is high, the propelling performance is good, the far end weaving density is low, the hardness is reduced, the flexibility is good, and the cooperation of the near end weaving density and the far end weaving density can be better suitable for the tortuous vascular access characteristic in the interventional operation.

Description

Multi-segment hardness interventional catheter and weaving method thereof
Technical Field
The invention relates to a multi-segment hardness interventional catheter and a weaving method thereof, belonging to the technical field of interventional medical treatment.
Background
The minimally invasive interventional intravascular technology is to deliver interventional medical instruments to important organs and parts of a human body under the guidance of medical imaging equipment, such as: the novel technology and the method for diagnosing and treating the heart, the liver, the brain, the kidney, the digestive system and the reproductive system have the advantages of small wound, remarkably shortened treatment process and hospitalization time and relatively low medical cost, the diagnosis and treatment operation by utilizing the minimally invasive technology to replace the traditional medical method becomes the most popular medical means for treating various diseases threatening the health of human beings in western countries at present, and the proportion of minimally invasive interventional therapy in all operations is over 85 percent. The minimally invasive intravascular interventional medicine has been developed into one of three diagnostic and therapeutic technologies which are parallel to internal medicine and surgery in modern medicine in recent years, is a clinical subject which develops the fastest in recent years, and is a hot point for development in the medical field.
During interventional therapy, some lesions are far away from the puncture site, blood vessels near the puncture site are straight, thrombus near the lesion site is tortuous, and a long sheath is usually needed to assist in guiding therapeutic instruments. For example, pulmonary embolism treatment requires puncture from the femoral vein, through the heart to the pulmonary aorta and its branches. Therefore, the catheter sheath firstly passes through the inferior vena cava close to a straight line and then passes through the S-shaped bend of the heart, and reaches the left and right pulmonary arteries only by turning at an angle close to 90 degrees after reaching the pulmonary aorta. The sheath tube is easier to pass through a straight blood vessel, and better pushing property is needed; traversing tortuous vessels is relatively difficult and requires a sheath with good flexibility.
At present, catheters on the market are generally composed of three layers, wherein the inner layer is made of PTFE material, the middle layer is made of metal woven mesh, and the outer layer is made of high polymer material. The single metal woven mesh has better bending resistance, thereby providing excellent pushing performance and stability, but cannot perfectly adapt to the characteristic that the blood vessel has straight bending.
Therefore, a multi-hardness interventional catheter is proposed, which adopts a metal mesh grid structure at the proximal end (the end close to the operating doctor) and a metal spring ring or a metal mesh grid structure with low weaving density at the distal end, wherein the proximal first hardness section provides good pushing performance and stability, and the distal second hardness section provides good flexibility so as to adapt to the characteristics of straight before curved after curved of the interventional operation vascular access.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the utility model provides a multi-segment hardness interventional catheter and a weaving method thereof, which solves the technical problem that the pushing performance and the flexibility of the existing sheath in the market cannot be considered at the same time.
The technical problem to be solved by the invention is realized by adopting the following technical scheme:
a multi-segment hardness interventional catheter is composed of an inner PTFE lubricating layer, a middle metal reinforcing layer and an outer high polymer material base layer, wherein the metal reinforcing layer comprises a first hardness segment at the near end and a second hardness segment at the far end;
the first hardness section of the metal reinforcing layer is of a tubular metal braided net structure;
the second hardness section of the metal reinforcing layer is a tubular metal spring ring structure or a tubular metal woven net structure with lower weaving density than the first hardness section.
As a preferred example, the second hardness section is formed by continuously weaving part of the metal wires in the first hardness section.
As a preferable example, a transition section is arranged between the first hardness section and the second hardness section of the metal reinforcing layer, and the transition section is formed by continuously weaving part of metal wires in the first hardness section.
A method for weaving a multi-segment rigid interventional catheter, comprising the following steps:
a. sleeving the prepared tubular PTFE lubricating layer into the metal core rod;
b. the metal enhancement layer is woven in the outside coiling of PTFE lubricating layer, and the metal enhancement layer includes the first hardness section of near-end and the second hardness section of distal end:
selecting 2N metal wires (N is a positive integer), selecting N positive rotations and N reverse rotations, and carrying out tubular alternate spiral weaving from the near end of the PTFE lubricating layer according to the thread pitch of 2-15mm to form a first hardness section; removing part of the metal wires at the end of the first hardness section, reserving at least 1 metal wire, and continuously performing tubular knitting on the remaining metal wires in a certain pitch and direction to obtain a second hardness section with reduced knitting density;
c. coating a polymer material base layer and a heat shrinkable tube on the metal reinforcing layer for rheologic reaction;
d. and peeling the heat shrinkable tube to obtain the interventional catheter product.
As a preferred example, the metal reinforcing layer in step b is composed of a proximal first hardness segment, a middle connecting transition segment and a distal second hardness segment:
selecting 2N metal wires (N is more than 1, N is a positive integer), selecting N positive rotations and N reverse rotations, and carrying out tubular alternate spiral weaving from the near end of the PTFE lubricating layer according to the thread pitch of 2-15mm to form a first hardness section; removing M positive-rotation metal wires and M reverse-rotation metal wires (0< M < N, M is a positive integer) at the end of the first hardness section, continuously carrying out tubular weaving on the rest metal wires in a certain pitch and direction to obtain a transition section with reduced weaving density, removing part of the metal wires again at the end of the transition section, reserving at least 1 metal wire, and continuously carrying out tubular weaving on the rest metal wires in a certain pitch and direction to obtain a second hardness section with further reduced weaving density.
The invention has the beneficial effects that:
(1) the near end adopts a metal woven mesh structure, the far end adopts a metal spring ring or a metal woven mesh structure with low weaving density, the near end has high weaving density and high hardness, and has better pushing performance, the far end has low weaving density, the hardness is reduced, and better flexibility is realized;
(2) the hardness change is realized by reducing the number of metal wires, the knitting process is continuously formed, the integrity is good, the hardness is excessive and natural, the product quality is reliable, the production process is simple, and the production cost can be reduced.
Drawings
FIG. 1 is a schematic cross-sectional view along an axis of the present invention;
FIG. 2 is a schematic structural view of a second hardness section of the present invention using a tubular metal mesh;
FIG. 3 is a schematic view of the construction of the second hardness section of the present invention using a tubular metal coil spring;
fig. 4 is a schematic view of a winding structure of embodiment 1 of the present invention;
fig. 5 is a schematic view of a winding structure in embodiment 2 of the present invention;
fig. 6 is a schematic view of a winding structure in embodiment 3 of the present invention;
fig. 7 is a schematic view of a winding structure in embodiment 4 of the present invention.
In the figure: the composite material comprises a PTFE lubricating layer 1, a metal reinforcing layer 2, a first hardness section 201, a second hardness section 202, a transition section 203 and a high polymer material base layer 3.
Detailed Description
In order to make the technical means, the original characteristics, the achieved purpose and the efficacy of the invention easy to understand, the invention is further described with reference to the specific drawings.
As shown in fig. 1-3, a multi-segment hardness interventional catheter is composed of an inner PTFE lubricating layer 1, a middle metal reinforcing layer 2 and an outer polymer material base layer 3, wherein the metal reinforcing layer 2 comprises a proximal first hardness segment 201 and a distal second hardness segment 202; the first hardness section 201 of the metal reinforcing layer 2 is a tubular metal braided net structure; the second hardness section 202 of the metal reinforcing layer 2 is a tubular metal coil structure or a tubular metal woven mesh structure having a lower weaving density than the first hardness section 201.
A method for weaving a multi-segment rigid interventional catheter, comprising the following steps:
a. sleeving the prepared tubular PTFE lubricating layer 1 into the metal core rod;
b. a metal reinforcing layer 2 is wound and woven outside the PTFE lubricating layer 1;
c. sleeving the high molecular material base layer 3 and the heat shrinkable tube outside the metal reinforced layer 2 for rheologic again;
d. and peeling the heat shrinkable tube to obtain the interventional catheter product.
Example 1
As shown in fig. 4, the interventional catheter embodiment 1 manufactured according to the above weaving method, wherein the specific implementation steps of winding the metal reinforcing layer 2 outside the PTFE lubricating layer 1 in step b are as follows: taking 16 wires (8 plus and 8 minus) to weave according to the pitch of 8mm as an example, when the weaving reaches the length of the first hardness section 201, 4 wires which are reversely rotated and 4 wires which are positively rotated are removed, 8 wires (4 plus and 4 minus) are remained to continue to weave according to the pitch of 8mm, and a woven mesh structure with the weaving density reduced to 1/4 can be obtained as the transition section 203. When the length of the transition section 203 is reached by knitting, removing 4 counter-rotating wires and 2 forward-rotating wires, and remaining 2 forward-rotating wires to continue knitting according to the thread pitch of 8mm, so that a double-spiral spring ring structure with the overall thread pitch of 4mm can be obtained as a second hardness section 202 (tubular metal spring ring structure); and cutting off the metal wires to finish weaving when the weaving reaches the length of the second hardness section 202.
Example 2
As shown in fig. 5, the interventional catheter of example 2 manufactured according to the above weaving method, wherein the step b of winding the metal reinforcing layer 2 around the PTFE lubricating layer 1 is implemented as follows: taking 16 wires (8 positive and 8 negative) to weave according to the thread pitch of 8mm as an example, when the weaving reaches the length of the first hardness section 201, 8 wires in the reverse rotation and 7 wires in the positive rotation are removed, 1 wire in the positive rotation is kept to continue to weave according to the thread pitch of 8mm, and a single helical spring ring structure with the thread pitch of 8mm can be obtained to serve as the second hardness section 202 (tubular metal spring ring structure); and cutting off the metal wires to finish weaving when the weaving reaches the length of the second hardness section 202.
Example 3
As shown in fig. 6, the interventional catheter of embodiment 3 manufactured according to the above weaving method, wherein the step b of winding the metal reinforcing layer 2 around the PTFE lubricating layer 1 is implemented as follows: taking 16 wires (8 plus and 8 minus) to weave according to the thread pitch of 8mm as an example, when the weaving reaches the length of the first hardness section 201, 6 counter-rotating wires and 6 positive-rotating wires are removed, 4 (2 plus and 2 minus) symmetrical wires are remained to continue to weave according to the thread pitch of 8mm, and a woven mesh structure with the weaving density reduced to 1/16 can be obtained as a second hardness section 202 (a tubular metal woven mesh structure with low weaving density); and cutting off the metal wires to finish weaving when the weaving reaches the length of the second hardness section 202.
Example 4
As shown in fig. 7, the interventional catheter embodiment 4 manufactured according to the above weaving method, wherein the specific implementation steps of winding the metal reinforcing layer 2 outside the PTFE lubricating layer 1 in the step b are as follows: taking 16 wires (8 positive and 8 negative) to weave according to the thread pitch of 8mm as an example, when the weaving reaches the length of the first hardness section 201, 8 metal wires which are reversely rotated and 6 metal wires which are positively rotated are removed, 2 metal wires which are positively rotated are reserved to continue weaving according to the thread pitch of 4mm, and a double-spiral spring ring structure with the overall thread pitch of 2mm can be obtained to serve as the second hardness section 202 (tubular metal spring ring structure); and cutting off the metal wires to finish weaving when the weaving reaches the length of the second hardness section 202.
The foregoing illustrates and describes the principles, general features, and advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims (5)

1. A multi-segment hardness interventional catheter is composed of an inner PTFE lubricating layer (1), a middle metal reinforcing layer (2) and an outer high polymer material base layer (3), and is characterized in that the metal reinforcing layer (2) comprises a first hardness segment (201) at the near end and a second hardness segment (202) at the far end;
the first hardness section (201) of the metal reinforcing layer (2) is of a tubular metal braided net structure;
the second hardness section (202) of the metal reinforcing layer (2) is a tubular metal spring ring structure or a tubular metal woven net structure with lower weaving density than the first hardness section (201).
2. A multi-segment stiffness interventional catheter as set forth in claim 1, wherein the second stiffness segment (202) is continuously braided from a portion of the wire in the first stiffness segment (201).
3. A multi-segment hardness interventional catheter according to claim 1, characterized in that a transition segment (203) is arranged between the first hardness segment (201) and the second hardness segment (202) of the metal reinforcing layer (2), and the transition segment (203) is formed by continuously weaving part of the metal wires in the first hardness segment (201).
4. A method for weaving a multi-segment rigid interventional catheter, characterized in that it comprises the following steps:
a. sleeving the prepared tubular PTFE lubricating layer (1) into the metal core rod;
b. a braided metal reinforcement layer (2) is wound outside the PTFE lubricating layer (1), the metal reinforcement layer (2) comprises a first hardness section (201) at the proximal end and a second hardness section (202) at the distal end:
selecting 2N metal wires (N is a positive integer), selecting N positive rotations and N reverse rotations, and carrying out tubular alternate spiral weaving from the proximal end of the PTFE lubricating layer (1) according to the thread pitch of 2-15mm to form a first hardness section (201); at the end of the first hardness section (201), removing part of the metal wires, retaining at least 1 metal wire, and continuing to perform tubular knitting on the remaining metal wires at a certain pitch and direction to obtain a second hardness section (202) with reduced knitting density;
c. sleeving the metal reinforcing layer (2) with the polymer material base layer (3) and the heat-shrinkable tube for rheologic again;
d. and peeling the heat shrinkable tube to obtain the interventional catheter product.
5. The method for braiding a multi-segment stiffness interventional catheter according to claim 4, wherein the metal reinforcement layer (2) in step b is composed of a proximal first stiffness segment (201), a mid-connecting transition segment (203) and a distal second stiffness segment (202):
selecting 2N metal wires (N is more than 1, N is a positive integer), selecting N positive rotations and N reverse rotations, and carrying out tubular alternate spiral weaving from the proximal end of the PTFE lubricating layer (1) according to the thread pitch of 2-15mm to form a first hardness section (201); at the end of the first hardness section (201), removing M positive rotation metal wires and M negative rotation metal wires (0< M < N, M is a positive integer), carrying out tubular knitting on the rest metal wires in a certain pitch and direction to obtain a transition section (203) with reduced knitting density, removing part of the metal wires again at the end of the transition section (203), reserving at least 1 metal wire, carrying out tubular knitting on the rest metal wires in a certain pitch and direction to obtain a second hardness section (202) with further reduced knitting density.
CN202011481001.4A 2020-12-15 2020-12-15 Multi-segment hardness interventional catheter and weaving method thereof Pending CN112472955A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114098904A (en) * 2021-11-10 2022-03-01 北京泰杰伟业科技有限公司 Thrombus collection device
CN114191685A (en) * 2021-10-19 2022-03-18 深圳北芯医疗科技有限公司 Catheter sheath
CN115644990A (en) * 2022-12-09 2023-01-31 上海珩畅医疗科技有限公司 Aspiration catheter for interventional procedures
CN115845220A (en) * 2022-11-28 2023-03-28 株洲茂物医疗科技有限公司 A catheter

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US20020156460A1 (en) * 2001-04-20 2002-10-24 Scimed Life Systems, Inc Microcatheter with improved distal tip and transitions
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US20100049168A1 (en) * 2008-08-20 2010-02-25 Cook Incorporated Introducer sheath having dual reinforcing elements
US20150100043A1 (en) * 2013-10-09 2015-04-09 Biosense Webster (Israel) Ltd. Catheter with cross-braided proximal section and helical-coiled distal end
CN108514677A (en) * 2018-04-28 2018-09-11 业聚医疗器械(深圳)有限公司 A kind of microtubular
CN109498957A (en) * 2018-12-19 2019-03-22 深圳市业聚实业有限公司 A kind of novel microtubular
CN214679633U (en) * 2020-12-15 2021-11-12 上海融脉医疗科技有限公司 Multi-section hardness interventional catheter

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891114A (en) * 1997-09-30 1999-04-06 Target Therapeutics, Inc. Soft-tip high performance braided catheter
US20020156460A1 (en) * 2001-04-20 2002-10-24 Scimed Life Systems, Inc Microcatheter with improved distal tip and transitions
US20080262472A1 (en) * 2007-04-17 2008-10-23 Medtronic Vascular, Inc. Catheter With Reinforcing Layer Having Variable Strand Construction
US20080262471A1 (en) * 2007-04-17 2008-10-23 Medtronic Vascular, Inc. Catheter with braided and coiled reinforcing layer
US20100049168A1 (en) * 2008-08-20 2010-02-25 Cook Incorporated Introducer sheath having dual reinforcing elements
US20150100043A1 (en) * 2013-10-09 2015-04-09 Biosense Webster (Israel) Ltd. Catheter with cross-braided proximal section and helical-coiled distal end
CN108514677A (en) * 2018-04-28 2018-09-11 业聚医疗器械(深圳)有限公司 A kind of microtubular
CN109498957A (en) * 2018-12-19 2019-03-22 深圳市业聚实业有限公司 A kind of novel microtubular
CN214679633U (en) * 2020-12-15 2021-11-12 上海融脉医疗科技有限公司 Multi-section hardness interventional catheter

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114191685A (en) * 2021-10-19 2022-03-18 深圳北芯医疗科技有限公司 Catheter sheath
CN114098904A (en) * 2021-11-10 2022-03-01 北京泰杰伟业科技有限公司 Thrombus collection device
CN115845220A (en) * 2022-11-28 2023-03-28 株洲茂物医疗科技有限公司 A catheter
CN115644990A (en) * 2022-12-09 2023-01-31 上海珩畅医疗科技有限公司 Aspiration catheter for interventional procedures
CN115644990B (en) * 2022-12-09 2024-04-23 上海珩畅医疗科技有限公司 Aspiration catheter for interventional procedures

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