A polyurethane-based recoverable hematoma device for minimally invasive spine

Abstract

The application relates to the technical field of medical devices and medical polymer materials, in particular to a polyurethane-based recoverable blood absorption device for spine minimally invasive surgery, which comprises a microporous anti-adhesion outer membrane, and a blood absorption inner core is filled in the microporous anti-adhesion outer membrane; an X-ray developing line is arranged in the microporous anti-adhesion outer membrane; a through type traction tail line is arranged in the microporous anti-adhesion outer membrane and is arranged along the central longitudinal axis of the blood absorption inner core. Through the semi-permeable membrane structure, the wound tissue is still isolated outside the outer membrane after being left for 48 hours; the lubricating effect of the HA coating is matched, smooth pulling-out is realized, and secondary tearing and bleeding are reduced; when a doctor pulls out, the pulling force is directly applied to the bottom through type anchoring point at the end of the consumable, the whole is pushed out like a net, and the sponge is prevented from being broken due to the pulling of the middle section.

Description

Technical Field

[0001] This invention relates to the field of medical devices and medical polymer materials technology, specifically to a polyurethane-based recyclable absorbent device for absorbing blood accumulation in the surgical area, suitable for minimally invasive spinal surgery. Background Technology

[0002] In minimally invasive spinal endoscopic surgery, after nerve root decompression, bleeding and aseptic inflammatory exudation of the epidural venous plexus and surrounding soft tissues are unavoidable. If the exudate is not drained properly, an epidural hematoma can easily form in the narrow spinal canal and intervertebral foramen area, directly compressing or chemically irritating the fragile nerve root, causing patients to experience transient or persistent severe lower limb / back pain (i.e., postoperative rebound pain, which is common in clinical practice) after surgery.

[0003] Traditional absorbable hemostatic materials (such as gelatin sponges, oxidized regenerated cellulose, etc.): These materials gelatinize and degrade within hours of contact with blood, completely losing their mechanical strength. If left in place for 24-48 hours, they cannot be removed under force, and the debris remaining in the narrow spinal canal can easily cause severe foreign body rejection and aseptic granulomas, which can worsen nerve adhesion and compression. If traditional sponges absorb water and expand rapidly and disorderly, they can cause dangerous physical compression damage to the dural sac and nerve roots in the narrow space next to the spinal canal.

[0004] Therefore, a polyurethane-based recyclable and absorbable surgical site blood device suitable for minimally invasive spinal surgery is proposed to solve the problems mentioned above. Summary of the Invention

[0005] To achieve the above objectives, the present invention provides the following technical solution: a microporous anti-adhesion outer membrane, the microporous anti-adhesion outer membrane being filled with a blood-absorbing inner core; an X-ray imaging line being provided within the microporous anti-adhesion outer membrane; a through-type traction tail line being provided within the microporous anti-adhesion outer membrane, the through-type traction tail line being arranged along the central longitudinal axis of the blood-absorbing inner core, forming a bottom through-anchor point at the very bottom of the blood-absorbing inner core to prevent slippage towards the proximal end; and a wrapping pouch being connected to the other end of the through-type traction tail line away from the bottom through-anchor point.

[0006] Preferably, the blood-absorbing inner core material is a highly cross-linked acetalized polyvinyl alcohol expanded sponge or a hydrophilic medical polyurethane sponge.

[0007] Preferably, the microporous anti-adhesion outer membrane is a medical-grade perforated silicone film or expanded polytetrafluoroethylene film, with a micropore diameter of 5μm to 50μm.

[0008] Preferably, the outer surface of the microporous anti-adhesion outer membrane is coated with a hydrophilic lubricating active coating; The coating comprises cross-linked hyaluronic acid and positively charged medical chitosan.

[0009] Preferably, the end of the through-type traction tail line is provided with a wrapping pouch, which is fixedly connected to the connection point. The connection point is connected to the center of the wrapping film, and multiple sets of adhesive layers are connected to the edge of the wrapping film.

[0010] Preferably, the through-type traction tail line has a channel, and a connecting strip is slidably connected in the channel. One end of the connecting strip near the wrapping bladder is connected to a connecting component, and the other end of the connecting strip is connected to the expanding bladder. The expanding bladder is connected to the inner wall of the microporous anti-adhesion outer membrane.

[0011] Preferably, the connecting strip consists of an outer membrane and an inner membrane.

[0012] Preferably, the connecting component includes a first connecting layer, and a delivery channel is formed between the outer membrane and the inner membrane, the delivery channel communicating with the expansion bladder.

[0013] Preferably, a first check valve and a second check valve are connected to the outer membrane; The first check valve and the second check valve are connected to the conveying channel; The ends of the outer membrane and the inner membrane are connected to the first connecting layer.

[0014] Preferably, the ends of the outer membrane and the inner membrane are connected to a second connecting layer.

[0015] Compared with the prior art, the present invention provides a polyurethane-based retrievable and absorbable surgical site hemostasis device suitable for minimally invasive spinal surgery, which has the following beneficial effects: 1. This invention utilizes a semi-permeable membrane structure, ensuring that wound tissue remains isolated outside the outer membrane even after 48 hours of placement. Combined with the lubricating effect of the HA coating, it achieves smooth removal, reducing secondary tearing and bleeding. When the doctor removes the consumable, the pulling force is directly applied to the bottom anchor point at the very end, similar to a net, pushing the entire consumable out and preventing the sponge from breaking due to pulling in the middle, ensuring safe removal. A special compression process provides uniform and gentle physical pressure for hemostasis, ensuring nerve root safety. The highly cross-linked PVA / PU substrate fundamentally eliminates the risk of aseptic inflammation caused by shedding of ordinary cotton pads.

[0016] 2. The wrapping film in this invention can be unfolded outwards, and the adhesive layer on the wrapping film can be brought into contact with the skin to cover the outer area of ​​the wound. After use, the wrapping film is pulled upwards to completely enclose the microporous anti-adhesion outer membrane. Then, the ends of the wrapping film are connected to each other through the adhesive layer, so that the wrapping film can enclose the microporous anti-adhesion outer membrane and prevent the blood absorbed inside the microporous anti-adhesion outer membrane from coming into contact with the external area.

[0017] 3. The present invention replenishes gas or extracts air in the delivery channel through the first one-way valve and the second one-way valve, so that the gas is delivered to the expansion bladder to expand or contract the expansion bladder. The degree of contact between the microporous anti-adhesion outer membrane and the wound is adjusted by the expansion or contraction of the expansion bladder. Attached Figure Description

[0018] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a schematic diagram of the structure of the present invention; Figure 2 This is a schematic diagram of the structure in use of the present invention; Figure 3 This is a schematic diagram of the through-type traction tail wire structure of the present invention; Figure 4 This is a schematic diagram of the encapsulation film structure of the present invention; Figure 5 This is a schematic diagram of the connecting strip structure of the present invention; Figure 6 This is a schematic diagram of the connection component structure of the present invention. Figure 1 ; Figure 7 This is a schematic diagram of the connection component structure of the present invention. Figure 2 .

[0019] In the diagram: 1. Microporous anti-adhesion outer membrane; 2. Blood-absorbing inner core; 3. X-ray imaging line; 4. Through-type traction tail wire; 5. Bottom through-anchor point; 6. Encapsulation bag; 41. Channel; 42. Connecting strip; 43. Connecting component; 44. Spreading bladder; 431. Outer membrane; 432. Inner membrane; 433. Conveying channel; 434. First connecting layer; 435. First check valve; 436. Second check valve; 437. Second connecting layer; 61. Connection point; 62. Wrapping film; 63. Adhesive layer. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] Example 1: Please see Figures 1-2In this embodiment, a polyurethane-based recyclable and absorbent surgical site blood accumulation device suitable for minimally invasive spinal surgery includes a microporous anti-adhesion outer membrane 1, and a blood-absorbing inner core 2 filled inside the microporous anti-adhesion outer membrane 1. Specifically, the blood-absorbing inner core 2 is made of non-degradable medical polymer porous sponge material, in the shape of a cylinder or a long strip, used to quickly absorb more than ten times its own weight of blood and exudate, and maintain extremely high tear resistance in a wet state. Specifically, the microporous anti-adhesion outer membrane 1 tightly covers or is composited with the outer surface of the four sides of the blood-absorbing inner core 2; the surface of the outer membrane is uniformly distributed with semi-permeable micropores, and the pore size is configured to allow only blood and exudate molecules to permeate and be absorbed by the inner core, but to physically absolutely block the growth of blood cell clots, fibroblasts and granulation tissue into the inner core; the microporous anti-adhesion outer membrane 1 is a medical-grade perforated silicone film or expanded polytetrafluoroethylene film, and its micropore size is 5μm to 50μm; Specifically, the microporous anti-adhesion outer membrane 1 is provided with an X-ray imaging line 3, which can be a high-resistivity X-ray filament. Specifically, the blood-absorbing inner core 2 has a through-type traction tail line 4 inside the microporous anti-adhesion outer membrane 1. The through-type traction tail line 4 is set along the central longitudinal axis of the blood-absorbing inner core 2. A bottom through-type anchor point 5 is formed at the bottom of the blood-absorbing inner core 2 to prevent slippage to the proximal end. The bottom through-type anchor point 5 is either tied in a knot or connected to a micro anti-slip pad. Specifically, the other end of the blood-absorbing inner core 2 and the through-type traction tail line 4, away from the bottom through-anchor point 5, is connected to a wrapping bag 6. Specifically, the blood-absorbing inner core 2 is made of highly cross-linked acetalized polyvinyl alcohol expanded sponge or hydrophilic medical polyurethane sponge. Specifically, the blood-absorbing inner core 2 is radially oriented compression and shaping during preparation. Before drying and insertion, its outer diameter is 4-5 mm. After full liquid absorption and expansion, the maximum outer diameter is physically limited to 8-10 mm to prevent excessive expansion and nerve compression. Specifically, the outer surface of the microporous anti-adhesion outer membrane 1 is coated with a hydrophilic lubricating active coating; Specifically, the coating comprises cross-linked hyaluronic acid and positively charged medical chitosan; Specifically, the through-type traction tail wire 4 is made of ultra-high molecular weight polyethylene multi-strand braided thread; Specifically, during use, the endoscopic intervertebral disc is inserted into the lumbar incision space through the working channel of the percutaneous endoscopic disc, adjacent to the dural sac and nerve roots, but without direct compression; the through-type traction tail wire 4 extends to the body surface through the skin incision; The microporous anti-adhesion outer membrane 1 is placed into the treatment area where hemostasis is to be achieved. The blood-absorbing inner core 2 absorbs the blood inside. After absorbing the blood, the blood-absorbing inner core 2 expands, and hemostasis is completed. In the subsequent process, the entire blood accumulation device is pulled outward by pulling the through-type traction tail wire 4.

[0022] Example 2: Please see Figures 3-4 In this embodiment, a polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery is provided at the end of the through-type traction tail wire 4, and a wrapping bag 6 is provided at the end of the wrapping bag 6. The wrapping bag 6 is fixedly connected to the connection point 61. The connection point 61 is connected to the center of the wrapping film 62. Multiple sets of adhesive layers 63 are connected to the edge of the wrapping film 62. A release film is provided on the adhesive layer 63. The release film can be torn open to allow the adhesive layer 63 to come into contact with the outside world. When the hemostatic device is used in the hemostatic area, the wrapping bag 6 can be squeezed open, and then the wrapping film 62 can be unfolded outward. The adhesive layer 63 on the wrapping film 62 is brought into contact with the skin, and the wrapping film 62 can be used to cover the outer area of ​​the wound. After use, the wrapping film 62 is pulled upward to completely wrap the microporous anti-adhesion outer membrane 1. Then, the ends of the wrapping film 62 are connected to each other through the adhesive layer 63, so that the wrapping film 62 can wrap the microporous anti-adhesion outer membrane 1 and prevent the blood absorbed inside the microporous anti-adhesion outer membrane 1 from coming into contact with the external area.

[0023] Example 3: Please see Figures 5-7 In this embodiment, a polyurethane-based recyclable and absorbable surgical site hemostasis device suitable for minimally invasive spinal surgery is provided. The through-type traction tail wire 4 is provided with a channel 41. A connecting strip 42 is slidably connected in the channel 41. A connecting component 43 is connected to one end of the connecting strip 42 near the wrapping bag 6. The other end of the connecting strip 42 is connected to the expansion bag 44. The expansion bag 44 is connected to the inner wall of the microporous anti-adhesion outer membrane 1. More specifically, the connecting strip 42 is composed of an outer membrane 431 and an inner membrane 432; More specifically, the connecting component 43 includes a first connecting layer 434, a conveying channel 433 is formed between the outer membrane 431 and the inner membrane 432, and the conveying channel 433 communicates with the expanding bladder 44; More specifically, a first check valve 435 and a second check valve 436 are connected to the outer diaphragm 431; More specifically, the first check valve 435 and the second check valve 436 are connected to the delivery channel 433; More specifically, the ends of the outer membrane 431 and the inner membrane 432 are connected to the first connecting layer 434, which has the same structure as the adhesive layer 63. More specifically, the ends of the outer membrane 431 and the inner membrane 432 are connected to a second connecting layer 437; More specifically, the connecting strip 42, the connecting component 43, and the expanding bladder 44 form an adjustment component. The adjustment component is provided in multiple sets, and the expanding bladders 44 on the multiple sets of adjustment components are respectively located at multiple points on the inner wall of the microporous anti-adhesion outer membrane 1. More specifically, the second connecting layer 437 can be a suction cup, which allows the device to be attached and suspended in other areas of the outside world. More specifically, when the blood-absorbing inner core 2 absorbs blood, the microporous anti-adhesion outer membrane 1 expands as a whole. The microporous anti-adhesion outer membrane 1 pulls and moves the expanding sac 44. The expanding sac 44 pulls and moves the outer membrane 431 and the inner membrane 432. The outer membrane 431 and the inner membrane 432 pull and move the connecting component 43. By observing the position of the connecting component 43, the degree of expansion of different areas of the microporous anti-adhesion outer membrane 1 can be determined. In use, gas can be added to or air can be extracted from the delivery channel 433 through the first one-way valve 435 and the second one-way valve 436, so that the gas is delivered to the expansion bladder 44 to expand or contract. The degree of contact between the microporous anti-adhesion outer membrane 1 and the wound can be adjusted by expanding or contracting the expansion bladder 44. At the same time, the release paper on the first connecting layer 434 can be peeled off, and the first connecting layer 434 is connected and fixed to the human body.

[0024] The installation method, connection method, or setting method disclosed in this embodiment are all common mechanical connections. Any connection method that can achieve its beneficial effect can be implemented, so the specific structural composition and working principle will not be described in detail in this embodiment.

[0025] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the statement "comprising a..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0026] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A polyurethane-based recyclable absorbent device for minimally invasive spinal surgery, characterized in that: It includes a microporous anti-adhesion outer membrane (1), and the microporous anti-adhesion outer membrane (1) is filled with a blood-absorbing inner core (2); The microporous anti-adhesion outer membrane (1) is equipped with an X-ray imaging line (3); The microporous anti-adhesion outer membrane (1) is provided with a through-type traction tail wire (4). The through-type traction tail wire (4) is set along the central longitudinal axis of the blood-absorbing inner core (2), and a bottom through-type anchor point (5) is formed at the bottom of the blood-absorbing inner core (2) to prevent slippage to the proximal end. The end of the through-type traction tail line (4) away from the bottom through anchor point (5) is connected to a wrapping bag (6).

2. The polyurethane-based recyclable and absorbable surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 1, characterized in that: The blood-absorbing inner core (2) is made of highly cross-linked acetalized polyvinyl alcohol expanded sponge or hydrophilic medical polyurethane sponge.

3. The polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 1, characterized in that: The microporous anti-adhesion outer membrane (1) is a medical-grade perforated silicone film or expanded polytetrafluoroethylene film with a micropore diameter of 5μm to 50μm.

4. The polyurethane-based recyclable and absorbable surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 1, characterized in that: The microporous anti-adhesion outer membrane (1) has a hydrophilic lubricating active coating on its outer surface; The coating comprises cross-linked hyaluronic acid and positively charged medical chitosan.

5. The polyurethane-based recyclable and absorbable surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 1, characterized in that: The end of the through-type traction tail line (4) is provided with a wrapping bag (6), which is fixedly connected to the connection point (61). The connection point (61) is connected to the center of the wrapping film (62), and multiple sets of adhesive layers (63) are connected to the edge of the wrapping film (62).

6. The polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 1, characterized in that: The through-type traction tail wire (4) has a channel (41) inside, and a connecting strip (42) is slidably connected inside the channel (41). The end of the connecting strip (42) near the wrapping bag (6) is connected to a connecting component (43), and the other end of the connecting strip (42) is connected to the expansion bag (44). The expansion bag (44) is connected to the inner wall of the microporous anti-adhesion outer membrane (1).

7. A polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 6, characterized in that: The connecting strip (42) consists of an outer membrane (431) and an inner membrane (432).

8. A polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 6, characterized in that: The connecting component (43) includes a first connecting layer (434), a delivery channel (433) is formed between the outer membrane (431) and the inner membrane (432), and the delivery channel (433) communicates with the expansion bladder (44); The expansion or contraction of the sac (44) adjusts the degree of contact between the microporous anti-adhesion outer membrane (1) and the wound.

9. A polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 7, characterized in that: The outer membrane (431) is connected to a first check valve (435) and a second check valve (436). The first check valve (435) and the second check valve (436) are connected to the conveying channel (433); The ends of the outer membrane (431) and the inner membrane (432) are connected to the first connecting layer (434).

10. A polyurethane-based recyclable absorbent surgical site hemostasis device suitable for minimally invasive spinal surgery according to claim 7, characterized in that: The outer membrane (431) and the inner membrane (432) are connected at their ends by a second connecting layer (437).

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